DELIVERY DEVICES AND METHODS FOR HEART VALVE REPAIR AND REPLACEMENT DEVICES

Delivery systems and methods of delivering devices or implants are disclosed. The devices or implants can be configured as valve repair devices or treatment devices have gripping members that are openable and closable to attach the device to leaflets of a native heart valve. The delivery systems are configured to position the device or implant and open and close the gripping members of the device or implant.

BACKGROUND

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

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

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

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

SUMMARY

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

The present disclosure discloses components for a delivery system for a valve repair or replacement device. While not required, these components can make the delivery system easier to use, more ergonomic, more intuitive, and/more accurate than previous delivery systems. One or more of these components can be used with existing delivery systems. Any combination or subcombination of the disclosed components can be used together, but there is no requirement that any of the components disclosed by the present application be used with any other component disclosed by the present application.

In some implementations, devices, such as valve repair devices, have anchors that are openable and closable to attach the device to leaflets of a native heart valve. The anchors have an adjustable width. The delivery systems are configured to position the device, open and close the anchors of the device, and adjust the width of the anchors of the device.

In some implementations, a handle assembly for controlling a transvascular device (e.g., an implantable device, a treatment device, a repair device, etc.) includes a handle housing, a sheath, an actuation element, a paddle actuation knob (or the like, e.g., button, switch, etc.), a paddle width adjustment element, and a paddle width control knob (or the like, e.g., button, 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 (e.g., rotation, pressing, sliding, etc.) of the paddle actuation knob causes movement (e.g., one or more of axial movement, rotational movement, translational movement, etc.) of the actuation element with respect to the handle housing and the sheath. In some implementations, the movement of the actuation element causes the device to move between open and closed positions.

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 a pair of paddles of the device. The paddle width control knob is coupled to the paddle width adjustment element and is rotatable relative to the handle housing. In some implementations, actuation (e.g., rotation, pressing, sliding, etc.) of the paddle width control knob causes movement (e.g., one or more of axial movement, rotational movement, translational movement, etc.) of the paddle width adjustment element with respect to the handle housing and the sheath. In some implementations, the movement of the paddle width adjustment element causes a width of the at least one of the pair of paddles of the device to be moved from a first width to a second width.

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

In some implementations, a distal end of the paddle actuation knob comprises external threads configured to engage with internal threads of the handle housing.

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.

In some implementations, rotation of the paddle width control knob axially drives the paddle width control knob and the paddle width adjustment element with respect to the paddle actuation knob and the actuation element.

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

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

In some implementations, each suture lock is angled with respect to a central axis extending through the handle assembly.

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

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

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 axial movement of the rotationally fixed follower, which in turn causes axial movement of the paddle width adjustment element with respect to the housing.

In some implementations, external teeth of the elongated central gear engage with teeth of the pair of planet gears.

In some implementations, a 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 extendable coaxially 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., button, switch, etc.), a paddle width adjustment element, and a paddle width control knob (or the like, e.g., button, 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.).

In some implementations, the paddle actuation knob (or the like, e.g., button, switch, etc.) is coupled to (e.g., operatively coupled to) the actuation element. In some implementations, the paddle actuation knob is rotatable relative to the handle housing. Actuation (e.g., rotation, pressing, sliding, etc.) of the paddle actuation knob causes movement (e.g., one or more of axial movement, rotational movement, translational movement, etc.) of the actuation element with respect to the handle housing and the sheath. The movement of the actuation element causes the device to move between open and closed positions. The 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.

In some implementations, the paddle width control knob (or the like, e.g., button, switch, etc.) is coupled to (e.g., operatively coupled to) the paddle width adjustment element. In some implementations, the paddle width control knob is rotatable relative to the handle housing. Actuation (e.g., rotation, pressing, sliding, etc.) of the paddle width control knob causes movement (e.g., one or more of axial movement, rotational movement, translational movement, etc.) of the paddle width adjustment element with respect to the handle housing and the sheath. The movement of the paddle width adjustment element causes a width of the at least one of the pair of paddles of the device to be moved from a first width to a second width.

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

In some implementations, a distal end of the paddle actuation knob comprises external threads configured to engage with internal threads of the handle housing.

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.

In some implementations, rotation of the paddle width control knob axially drives the paddle width control knob and the paddle width adjustment element with respect to the paddle actuation knob and the actuation element.

In some implementations, a pair of clasp actuation lines extend through the sheath and are connected to a pair of clasp control members. Each clasp control member 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.

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

In some implementations, each suture lock is angled with respect to a central axis extending through the handle assembly.

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

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

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 axial movement of the rotationally fixed follower, which in turn causes axial movement of the paddle width adjustment element with respect to the housing.

In some implementations, external teeth of the elongated central gear engage with teeth of the pair of planet gears.

In some implementations, a method includes delivering a device (e.g., a treatment 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., button, switch, etc.) is actuated (e.g., rotated, pressed, slid, etc.) to cause movement (e.g., one or more of axial movement, rotational movement, translational movement, etc.) of the actuation element 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., button, switch, etc.) is actuated (e.g., rotated, pressed, slid etc.) to cause movement (e.g., one or more of axial movement, rotational movement, translational movement, etc.) of the paddle width adjustment element to adjust the width of a paddle of the device.

In some implementations, the paddle actuation knob is rotated to cause axial movement of the actuation element to move the device from the open configuration to a closed configuration.

As part of the method, the device can be decoupled from the actuation element, the paddle width adjustment element, and the sheath.

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

In some implementations, the paddle width adjustment element is coupled to the at least one of the pair of paddles through an inner end. Axial movement of the paddle width adjustment element causes axial movement of the inner end with respect to an actuation portion of the device. Axial movement of the inner end causes the at least one of the pair of paddles to move relative to the actuation portion of the device effective to move the width of at least one of the pair of paddles from the first width to the second width.

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

In some implementations, rotating the paddle width control knob causes axial movement of the paddle width control knob and the paddle width adjustment element relative to a frame coupled to the paddle actuation knob.

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.

In some implementations, the device is decoupled by pulling the adjustment through the actuation element and pulling the actuation element through the sheath.

Any of the above method(s) can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, anthropomorphic ghost, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can comprise, for example, computerized and/or physical representations.

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, a paddle actuation control operatively coupled to the actuation element. In some implementations, the handle assembly also comprises 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. In some implementations, the handle assembly also includes a release control operatively coupled to the paddle width adjustment element.

In some implementations, the handle assembly is configured such that actuation of the paddle actuation control causes axial movement of the actuation element with respect to the handle housing and the sheath. Axial movement of the actuation element causes the device to move between open and closed positions.

In some implementations, the handle assembly is configured such that actuation of the paddle width control causes axial movement of the paddle width adjustment element with respect to the handle housing and the sheath. Axial movement of the paddle width adjustment element causes a width of the at least one of the pair of paddles of the device to be moved from a first width to a second width.

In some implementations, the handle assembly is configured such that actuation of the release control caused axial movement of the paddle width adjustment element and the actuation element to decouple the device from the sheath. Actuation of the paddle actuation control causes axial movement of the release control.

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 treatment device, etc.) includes a steerable catheter assembly having a handle and a sheath extending from the handle in an axial direction 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 extendable coaxially 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 treatment device, a repair device, an implant, an implantable device, a valve repair device, etc.), and a paddle actuation control operatively 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 operatively coupled to the paddle width adjustment element. In some implementations, the delivery system also includes a release control operatively coupled to the paddle width adjustment element.

In some implementations, the delivery system is configured such that actuation of the paddle actuation control causes movement (e.g., one or more of axial movement, rotational movement, translational movement, etc.) of the actuation element with respect to the handle housing and the sheath. The movement of the actuation element causes the device to move between open and closed positions.

In some implementations, the delivery system is configured such that actuation of the paddle width control causes movement of the paddle width adjustment element with respect to the handle housing and the sheath. The movement of the paddle width adjustment element causes a width of the at least one of the pair of paddles of the device to be moved from a first width to a second width.

In some implementations, the delivery system is configured such that actuation of the release control can cause movement of the paddle width adjustment element and the actuation element to decouple the device from the sheath.

In some implementations, the delivery system is configured such that actuation of the paddle actuation control causes axial movement of the release control.

In some implementations, a method of delivering and/or using a device (e.g., a treatment 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 the paddle actuation control on the handle, thereby causing movement of the actuation element to move the device from the open configuration to a closed configuration, actuating a paddle width control on the handle, thereby causing movement of 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 causing movement of the paddle width adjustment element and the actuation element to decouple the device from the sheath. In some implementations, actuating of the paddle actuation control causes axial movement of the release control and the paddle width adjustment element.

Any of the above method(s) can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, anthropomorphic ghost, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can comprise, for example, computerized and/or physical representations.

In some implementations, a delivery system for a device (e.g., for an implantable device, for a repair device, for a treatment device, etc.) has a plurality of clasps for securing native leaflets of a heart valve includes 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 handle and a sheath extending from the handle in an axial direction and having a distal end portion comprising a capture mechanism for attaching the sheath to a device (e.g., a treatment device, a repair device, an implant, an implantable device, a valve repair device, etc.). 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 aperture 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.

In some implementations, a method of using a device, e.g., valve repair device etc., on a heart valve of patient includes closing the first clasp of the device to grasp a first leaflet of the heart valve by releasing tension in the first clasp actuation line, closing the second clasp of the device to grasp a second leaflet of the heart valve by releasing tension in the 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 and the capture mechanism and releases the second clasp actuation line from both the second clasp and the capture mechanism.

Any of the above method(s) can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, anthropomorphic ghost, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can comprise, for example, computerized and/or physical representations.

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, the first clasp actuation line operatively coupled to a first clasp of the plurality of clasps on the device, and a first clasp control member operatively connected to the first clasp actuation line, the first clasp control member movable relative to the housing between a first position associated with the first clasp being in an open position and a second position associated with the clasp being in a closed position. The first clasp control member is biased to the second position.

In some implementations, a method of using a device or implant, such as a valve repair device, having a plurality of clasps for securing 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 the first clasp of the device to grasp a first leaflet of the heart valve by releasing tension in the first clasp actuation line, and closing the second clasp of the device to grasp a second leaflet of the heart valve by releasing tension in the second clasp actuation line. Releasing tension in the first clasp actuation line comprising biasing a first clasp control member from a first position to a second position releasing tension in the second clasp actuation line comprising biasing a second clasp control member from a third position to a fourth position.

Any of the above method(s) can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, anthropomorphic ghost, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can comprise, for example, computerized and/or physical representations.

In some implementations, a clasp actuation line for actuating a clasp of 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 in 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 terminal end of the braided body extends axially through a portion of the braided body at a location proximal the closed loop to form a tucked-in portion. In some implementations, a distal terminal end portion of the braided body extends laterally through a portion of the braided body at a location proximal the closed loop to form a threaded portion. In some implementations, a distal terminal end portion of the braided body extends axially through a portion of the braided body at a location proximal the closed loop to form a tucked-in portion proximal a threaded portion.

In some implementations, a method of forming a clasp actuation line for actuating a clasp of a device includes braiding an elongated body and forming a closed loop at a distal end of the elongated body. In some implementations, braiding the elongated body includes braiding a bifurcated portion to form the closed loop. In some implementations, braiding the elongated body further comprising braiding a plurality of a bifurcated portions separated by unitary portions and cutting the elongated body into sections that have a single bifurcated portion adjacent a distal end of the section. In some implementations, forming the closed loop comprises extending a distal terminal end of the braided body axially through a portion of the braided body to form a tucked-in portion proximal the closed loop. In some implementations, forming the closed loop comprises extending a distal terminal end portion of the braided body laterally through a portion of the braided body to form a threaded portion at a location proximal the closed loop.

Any of the above method(s) can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, anthropomorphic ghost, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can comprise, for example, computerized and/or physical representations.

In some implementations, there is a provided a handle assembly (which can be the same as or similar to other handle assemblies described herein) for controlling a device (which can be the same as or similar to other devices described herein), the handle assembly comprising a handle housing, a sheath extending distally from the handle housing, and an actuation element (which can be the same as or similar to other actuation elements described herein) extending through at least a portion of the sheath, the actuation element configured to be coupled to the device. In some implementations, the handle assembly also includes a width adjustment element (which can 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 configured to be coupled to at least one of a pair of anchors (which can 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 can be the same as or similar to other actuation controls described herein) coupled to the actuation element, wherein actuation of the actuation control causes movement of the actuation element with respect to the handle housing and/or the sheath, wherein the movement of the actuation element can move the device between an open configuration and a closed configuration.

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

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

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

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

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 in 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 terminal end of the braided body extends axially through a portion of the braided body at a location proximal the closed loop to form a tucked-in portion. In some implementations, a distal terminal end portion of the braided body extends laterally through a portion of the braided body at a location proximal the closed loop to form a threaded portion. In some implementations, a distal terminal end portion of the braided body extends axially through a portion of the braided body at a location proximal the closed loop to form a tucked-in portion proximal a threaded portion.

In some implementations, each suture lock is angled with respect to a central axis extending through the handle assembly.

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 planet 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 axial movement of the rotationally fixed follower, which in turn causes axial movement of the width adjustment element with respect to the housing. In some implementations, external teeth of the elongated central gear engage with teeth of the pair of planet gears.

In some implementations, a handle assembly (which can 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 operatively coupled to a first clasp of a plurality of clasps on the device.

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

In some implementations, the first biasing element is configured to apply a force to pull the first clasp toward the open position.

The handle assembly can 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 can include a sheath extending from the handle assembly in an axial direction. The sheath can include a distal end portion comprising a capture mechanism for releasably attaching the sheath to the device.

In some implementations, the first biasing element can apply the force onto the first clasp actuation element. The first biasing element can directly contact the first clasp actuation element when applying the force. The force can be directed radially outward from a centerline of the handle housing.

In some implementations, the force is not applied to pull the first clasp toward the open position when the first clasp control member is in the second position.

In some implementations, the first biasing element can have an elongated body having a proximal end fixed relative to the handle housing and a free distal end. The elongated body can have a semi-elliptical shape. The elongated body can have an opening extending laterally through the elongated 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.

In some implementations, the first clasp actuation element is a suture line.

In some implementations, the first biasing element has a wide position in which the force is applied to pull the first clasp toward the open position and a narrow position in which the force is not 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.

In some implementations, the first biasing element is positioned in-line with the first clasp actuation element.

In some implementations, the first biasing element comprises an elastic portion of the first clasp actuation element. The elastic portion can extend along an entire length of the first clasp actuation element or can extend along a partial length of the first clasp actuation element. The elastic portion of the first clasp actuation element can be positioned inside the handle housing.

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

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

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 be operatively coupled to a second clasp of the plurality of clasps on the device.

In some implementations, the second clasp control member can be operatively connected to the second clasp actuation element and be movable relative to the housing between a third position associated with the second clasp being in an open position and a fourth position associated with the second clasp being in a closed position.

The second biasing element can be configured to apply a second force to pull the second clasp toward the open position.

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

In some implementations, a method of using a device, e.g., a valve repair device etc., having one or more clasps for securing 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.

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

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

In some implementations, applying the force to the first clasp actuation element includes applying a force onto the first clasp actuation element. The force can be a radially outward force. In some implementations, the first clasp actuation element is a suture line.

In some implementations, applying the force to the first clasp actuation element after the first clasp control member is in the first position includes moving a 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.

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 with the first clasp control member.

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

In some implementations, applying force to the first clasp actuation element includes stretching an elastic portion of the first clasp actuation element.

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.

In some implementations, a second clasp control member is moved to a third position to hold the second clasp of the device in the open position and is moved to a fourth position to close the first clasp. Holding the second clasp of the device in the 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.

In some implementations, the first force is applied independent of the second force.

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

In some implementations, the first portion of the braided body has a first number of picks per inch and the second portion of the braided body has a second number of picks per inch that is greater than the first number of picks per inch. Both of the first portion and the second portion can be formed from an ultra-high-molecular-weight polyethylene material.

In some implementations, the second portion can extend the majority of an entire length of the clasp actuation line. In some implementations, the second portion is adjacent the first end and extends less than half a total length of the clasp actuation line.

Any of the above method(s) can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, anthropomorphic ghost, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can comprise, for example, computerized and/or physical representations.

Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the above methods can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

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

DETAILED DESCRIPTION

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

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

As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection can be direct as between the components or can be indirect such as through the use of one or more intermediary components. Also as described herein, reference to a “member,” “component,” or “portion” shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements. Also as described herein, the terms “substantially” and “about” are defined as at least close to (and includes) a given value or state (preferably within 10% of, more preferably within 1% of, and most preferably within 0.1% of). The terms “clasp” and “clasp arm” are often used herein with respect to specific examples, but the terms “gripping member” and/or “gripper arm” can be used in place of and function in the same or similar ways, even if not configured in the same way as a typical clasp.

FIGS.1and2are cutaway views of the human heart H in diastolic and systolic phases, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV; i.e., the atrioventricular valves. Additionally, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets20,22shown inFIGS.3-6and leaflets30,32,34shown inFIG.7) extending inward across the respective orifices that come together or “coapt” in the flow stream to form the one-way, fluid-occluding surfaces. The native valve repair systems of the present application are frequently described and/or illustrated with respect to the mitral valve MV. Therefore, anatomical structures of the left atrium LA and left ventricle LV will be explained in greater detail. However, the devices described herein can also be used in repairing other native valves, e.g., the devices can be used in repairing the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

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

Referring now toFIGS.1-7, the mitral valve MV includes two leaflets, the anterior leaflet20and the posterior leaflet22. The mitral valve MV also includes an annulus24(seeFIG.5), which is a variably dense fibrous ring of tissues that encircles the leaflets20,22. Referring toFIGS.3and4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., the muscles located at the base of the chordae tendineae CT and within the walls of the left ventricle LV) to the leaflets20,22of the mitral valve MV. The papillary muscles PM serve to limit the movements of leaflets20,22of the mitral valve MV and prevent the mitral valve MV from being reverted. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, the papillary muscles PM support or brace the leaflets20,22against the high pressure needed to circulate blood throughout the body. Together the papillary muscles PM and the chordae tendineae CT are known as the subvalvular apparatus, which functions to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As seen from a Left Ventricular Outflow Tract (LVOT) view shown inFIG.3, the anatomy of the leaflets20,22is such that the inner sides of the leaflets coapt at the free end portions and the leaflets20,22start receding or spreading apart from each other. The leaflets20,22spread apart in the atrial direction, until each leaflet meets with the mitral annulus.

Various disease processes can impair proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's Disease, fibroelastic deficiency, etc.), inflammatory processes (e.g., Rheumatic Heart Disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or the right ventricle RV from prior heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) may distort a native valve's geometry, which may cause the native valve to dysfunction. However, the majority of patients undergoing valve surgery, such as surgery to the mitral valve MV, suffer from a degenerative disease that causes a malfunction in a leaflet (e.g., leaflets20,22) of a native valve (e.g., the mitral valve MV), which results in prolapse and regurgitation.

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

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

Referring toFIG.5, when a healthy mitral valve MV is in a closed position, the anterior leaflet20and the posterior leaflet22coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Referring toFIGS.3and6, mitral regurgitation MR occurs when the anterior leaflet20and/or the posterior leaflet22of the mitral valve MV is displaced into the left atrium LA during systole so that the edges of the leaflets20,22are not in contact with each other. This failure to coapt causes a gap26between the anterior leaflet20and the posterior leaflet22, which allows blood to flow back into the left atrium LA from the left ventricle LV during systole, as illustrated by the mitral regurgitation MR flow path shown inFIG.3. Referring toFIG.6, the gap26can have a width W between about 2.5 mm and about 17.5 mm, between about 5 mm and about 15 mm, between about 7.5 mm and about 12.5 mm, or about 10 mm. In some situations, the gap26can have a width W greater than 15 mm or even 17.5 mm. As set forth above, there are several different ways that a leaflet (e.g., leaflets20,22of mitral valve MV) may malfunction which can thereby lead to valvular regurgitation.

In any of the above-mentioned situations, a device (e.g., an implant, a non-implantable device, a treatment device, a repair device, a valve repair device, etc.) is desired that is capable of engaging the anterior leaflet20and the posterior leaflet22to close the gap26and prevent or inhibit regurgitation of blood through the mitral valve MV. As can be seen inFIG.4, an abstract representation of a valve repair device, repair device, implantable device, or implant10is shown implanted between the leaflets20,22such that regurgitation does not occur during systole (compareFIG.3withFIG.4).

In some implementations, a coaptation element (e.g., spacer, coaption element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) of the device10has a generally tapered or triangular shape that naturally adapts to the native valve geometry and to its expanding leaflet nature (toward the annulus). In this application, the terms spacer, coaption element, coaptation element, and gap filler are used interchangeably and refer to an element that fills a portion of the space between native valve leaflets and/or that is configured such that the native valve leaflets engage or “coapt” against (e.g., such that the native leaflets coapt against the coaptation element, e.g., spacer, coaption element, gap filler, etc. instead of only against one another).

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

Malfunctioning native heart valves can either be repaired or replaced. Repair typically involves the preservation and correction of the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Because stenotic damage sustained by the leaflets is irreversible, treatments for a stenotic aortic valve or stenotic pulmonary valve can be removal and replacement of the valve with a surgically implanted heart valve, or displacement of the valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more prone to deformation of leaflets and/or surrounding tissue, which, as described above, may prevent the mitral valve MV or tricuspid valve TV from closing properly and allows for regurgitation or back flow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for regurgitation or back flow from the left ventricle LV to the left atrium LA as shown inFIG.3). The regurgitation or back flow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or the tricuspid valve TV are often repairable. In addition, regurgitation may occur due to the chordae tendineae CT becoming dysfunctional (e.g., the chordae tendineae CT may stretch or rupture), which allows the anterior leaflet20and the posterior leaflet22to be reverted such that blood is regurgitated into the left atrium LA. The problems occurring due to dysfunctional chordae tendineae CT can be repaired by repairing the chordae tendineae CT or the structure of the mitral valve MV (e.g., by securing the leaflets20,22at the affected portion of the mitral valve).

The devices and procedures disclosed herein often make reference to repairing the structure of a mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve, as well as any component of a native valve. Such devices can be used between the leaflets20,22of the mitral valve MV to prevent or inhibit regurgitation of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG.7), any of the devices and concepts herein can be used between any two of the anterior leaflet30, the septal leaflet32, and the posterior leaflet34to prevent or inhibit regurgitation of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used on all three of the leaflets30,32,34together to prevent or inhibit regurgitation of blood from the right ventricle to the right atrium. That is, the valve repair devices, treatment devices, or other devices and implants provided herein can be centrally located between the three leaflets30,32,34.

An example device or implant can optionally have a coaptation element (e.g., spacer, coaption element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, a device or implant can have any combination or sub-combination of the features disclosed herein without a coaptation element.

When included, the coaptation element (e.g., coaption element, spacer, etc.) can 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 regurgitation described above. The coaptation element can have a structure that is impervious to blood (or that resists blood flow therethrough) and that allows the native leaflets to close around the coaptation element during ventricular systole to block blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The device or implant can be configured to seal against two or three native valve leaflets; that is, the device can be used in the native mitral (bicuspid) and tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element can fill a space between improperly functioning native leaflets (e.g., mitral valve leaflets20,22or tricuspid valve leaflets30,32,34) that do not close completely.

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

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

The device or implant can be configured to be implanted via a delivery system or other means for delivery. The delivery system can comprise one or more of a guide/delivery sheath, a delivery catheter, a steerable catheter, a device/implant catheter, tube, combinations of these, etc. The coaptation element and the anchor can be compressible to a radially compressed state and can be self-expandable to a radially expanded state when compressive pressure is released. The device can be configured for the anchor to be expanded radially away from the still compressed coaptation element initially in order to create a gap between the coaptation element and the anchor. A native leaflet can then be positioned in the gap. The coaptation element can be expanded radially, closing the gap between the coaptation element and the anchor and capturing the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to self-expand. The implantation methods for various implementations can be different and are more fully discussed below with respect to each implementation. Additional information regarding these and other delivery methods can be found in U.S. Pat. No. 8,449,599 and U.S. Patent Application Publication Nos. 2014/0222136, 2014/0067052, 2016/0331523, and PCT patent application publication Nos. WO2020/076898, each of which is incorporated herein by reference in its entirety for all purposes. These method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc. mutatis mutandis.

The disclosed devices or implants can be configured such that the anchor is connected to a leaflet, taking advantage of the tension from native chordae tendineae to resist high systolic pressure urging the device toward the left atrium. During diastole, the devices can rely on the compressive and retention forces exerted on the leaflet that is grasped by the anchor.

Referring now toFIGS.8-15, a schematically illustrated device or implant100(e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, a treatment device, an implantable device, a repair device, etc.) is shown in various stages of deployment. The device or implant100and other similar devices/implants are described in more detail in PCT patent application publication Nos. WO2018/195215, WO2020/076898, and WO 2019/139904, which are incorporated herein by reference in their entirety. The device100can include any other features for another device or implant discussed in the present application or the applications cited above, and the device100can be positioned to engage valve tissue (e.g., leaflets20,22,30,32,34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application, or the applications cited above).

The device or implant100is deployed from a delivery system102. The delivery system102can comprise 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 of these, etc. The device or implant100includes a coaptation portion/coaptation region104and an anchor portion/anchor region106.

In some implementations, the coaptation portion104of the device or implant100includes a coaptation element110(e.g., spacer, plug, filler, foam, sheet, membrane, coaption element, etc.) that is adapted to be implanted between leaflets of a native valve (e.g., a native mitral valve, native tricuspid valve, etc.) and is slidably attached to an actuation element112(e.g., actuation wire, shaft, tube, hypotube, line, suture, braid, etc.). The anchor portion106includes one or more anchors108that are actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element112opens and closes the anchor portion106of the device100to grasp the native valve leaflets during implantation. The actuation element112(as well as other means for actuating and actuation elements disclosed herein) can take a wide variety of different forms (e.g., as a wire, rod, shaft, tube, screw, suture, line, strip, combination of these, etc.), be made of a variety of different materials, and have a variety of configurations. As one example, the actuation element can be threaded such that rotation of the actuation element moves the anchor portion106relative to the coaptation portion104. Or, the actuation element can be unthreaded, such that pushing or pulling the actuation element112moves the anchor portion106relative to the coaptation portion104.

The anchor portion106and/or anchors of the device100include outer paddles120and inner paddles122that are, in some implementations, connected between a cap114and the coaptation element110by portions124,126,128. The portions124,126,128can be jointed and/or flexible to move between all of the positions described below. The interconnection of the outer paddles120, the inner paddles122, the coaptation element110, and the cap114by the portions124,126, and128can constrain the device to the positions and movements illustrated herein.

In some implementations, the delivery system102includes a steerable catheter, device/implant catheter, and actuation element112(e.g., actuation wire, actuation shaft, etc.). These can be configured to extend through a guide catheter/sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuation element112extends through a delivery catheter and the coaptation element110to the distal end (e.g., a cap114or other attachment portion at the distal connection of the anchor portion106). Extending and retracting the actuation element112increases and decreases the spacing between the coaptation element110and the distal end of the device (e.g., the cap114or other attachment portion), respectively. In some implementations, a collar or other attachment element (e.g., clamp, clip, lock, sutures, friction fit, buckle, snap fit, lasso, etc.) removably attaches the coaptation element110to the delivery system102, either directly or indirectly, so that the actuation element112slides through the collar or other attachment element and, in some implementations, through a coaptation element110during actuation to open and close the paddles120,122of the anchor portion106and/or anchors108.

In some implementations, the anchor portion106and/or anchors108can include attachment portions or gripping members (e.g., gripping arms, clasp arms, etc.). The illustrated gripping members can comprise clasps130that include a base or fixed arm132, a movable arm134, optional friction-enhancing elements, or other securing structures136(e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and a joint portion138. The fixed arms132are attached to the inner paddles122. In some implementations, the fixed arms132are attached to the inner paddles122with the joint portion138disposed proximate a coaptation element110. The joint portion138provides a spring force between the fixed and movable arms132,134of the clasp130. The joint portion138can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint portion138is a flexible piece of material integrally formed with the fixed and movable arms132,134. The fixed arms132are attached to the inner paddles122and remain stationary or substantially stationary relative to the inner paddles122when the movable arms134are opened to open the clasps130and expose the optional barbs, friction-enhancing elements, or securing structures136.

In some implementations, the clasps130are opened by applying tension to actuation lines116attached to the movable arms134, thereby causing the movable arms134to articulate, flex, or pivot on the joint portions138. The actuation lines116extend through the delivery system102(e.g., through a steerable catheter and/or a device/implant catheter). Other actuation mechanisms are also possible.

The actuation line116can take a wide variety of forms, such as, for example, a line, a suture, a wire, a rod, a catheter, or the like. The clasps130can be spring loaded so that in the closed position the clasps130continue to provide a pinching force on the grasped native leaflet. Optional barbs, friction-enhancing elements, or securing structures136of the clasps130can grab, pinch, and/or pierce the native leaflets to further secure the native leaflets.

During implantation, the paddles120,122can be opened and closed, for example, to grasp the native leaflets (e.g., native mitral valve leaflets, etc.) between the paddles120,122and/or between the paddles120,122and a coaptation element110(e.g., a spacer, plug, membrane, gap filler, etc.). The clasps130can be used to grasp and/or further secure the native leaflets by engaging the leaflets with optional barbs, friction-enhancing elements, or securing structures136and pinching the leaflets between the movable and fixed arms134,132. The optional barbs, friction-enhancing elements, or other securing structures136(e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.) of the clasps130increase friction with the leaflets or can partially or completely puncture the leaflets. The actuation lines116can be actuated separately so that each clasp130can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a clasp130on a leaflet that was insufficiently grasped, without altering a successful grasp on the other leaflet. The clasps130can be opened and closed relative to the position of the inner paddle122(as long as the inner paddle is in an open or at least partially open position), thereby allowing leaflets to be grasped in a variety of positions as the particular situation requires.

Referring now toFIG.8, the device100is shown in an elongated or fully open condition for deployment from an implant delivery catheter of the delivery system102. The device100is disposed at the end of the catheter of the delivery system102in the fully open position. In the elongated condition the cap114is spaced apart from the coaptation element110such that the paddles120,122are fully extended. In some implementations, an angle formed between the interior of the outer and inner paddles120,122is approximately 180 degrees. The clasps130can be kept in a closed condition during deployment through the delivery system102, so that the optional barbs, friction-enhancing elements, or other securing structures136(FIG.9) do not catch or damage the delivery system102. The actuation lines116can extend and attach to the movable arms134.

Referring now toFIG.9, the device100is shown in an elongated condition, similar toFIG.8, but with the clasps130in a fully open position, ranging from about 140 degrees to about 200 degrees, from about 170 degrees to about 190 degrees, or about 180 degrees between fixed and movable portions132,134of the clasps130. Fully opening the paddles120,122and the clasps130has been found to improve ease of detanglement or detachment from anatomy of the patient, such as the chordae tendineae CT, during implantation of the device100.

Referring now toFIG.10, the device100is shown in a shortened or fully closed condition. To move the device100from the elongated condition to the shortened condition, the actuation element112is retracted to pull the cap114towards the coaptation element110(e.g., towards a spacer). The connection portion(s)126(e.g., joint(s), flexible connection(s), etc.) between the outer paddle120and inner paddle122are constrained in movement such that compression forces acting on the outer paddle120from the cap114being retracted towards the coaptation element110cause the paddles or gripping elements to move radially outward. During movement from the open position to the closed position, the outer paddles120maintain an acute angle with the actuation element112. The outer paddles120can optionally be biased toward a closed position. The inner paddles122during the same motion move through a considerably larger angle as they are oriented away from the coaptation element110in the open condition and collapse along the sides of the coaptation element110in the closed condition.

Referring now toFIGS.11-13, the device100is shown in a partially open, grasp-ready condition. To transition from the fully closed to the partially open condition, the actuation element (e.g., actuation wire, actuation shaft, etc.) is extended to push the cap114away from the coaptation element110, thereby pulling on the outer paddles120, which in turn pull on the inner paddles122, causing the anchors or anchor portion106to partially unfold. The actuation lines116are also retracted to open the clasps130so that the leaflets can be grasped. In some implementations, the pair of inner and outer paddles122,120are moved in unison, rather than independently, by a single actuation element112. Also, the positions of the clasps130are dependent on the positions of the paddles122,120. For example, referring toFIG.10closing the paddles122,120also closes the clasps. In some implementations, the paddles120,122can be independently controllable. In the example illustrated byFIG.15, the device100can have two actuation elements111,113and two independent caps115,117(or other attachment portions), such that one independent actuation element (e.g., wire, shaft, etc.) and cap (or other attachment portion) are used to control one paddle, and the other independent actuation element and cap (or other attachment portion) are used to control the other paddle.

Referring now toFIG.12, one of the actuation lines116is extended to allow one of the clasps130to close. Referring now toFIG.13, the other actuation line116is extended to allow the other clasp130to close. Either or both of the actuation lines116can be repeatedly actuated to repeatedly open and close the clasps130.

Referring now toFIG.14, the device100is shown in a fully closed and deployed condition. The delivery system102and actuation element112are retracted and the paddles120,122and clasps130remain in a fully closed position. Once deployed, the device100can be maintained in the fully closed position with a mechanical latch or can be biased to remain closed through the use of spring materials, such as steel, other metals, plastics, composites, etc. or shape-memory alloys such as Nitinol. For example, the connection portions124,126,128, the joint portions138, and/or the inner and outer paddles122, and/or an additional biasing component (not shown) can be formed of metals such as steel or shape-memory alloy, such as Nitinol—produced in a wire, sheet, tubing, or laser sintered powder—and are biased to hold the outer paddles120closed around the coaptation element110and the clasps130pinched around native leaflets. Similarly, the fixed and movable arms132,134of the clasps130are biased to pinch the leaflets. In some implementations, the attachment or connection portions124,126,128, joint portions138, and/or the inner and outer paddles122, and/or an additional biasing component (not shown) can be formed of any other suitably elastic material, such as a metal or polymer material, to maintain the device100in the closed condition after implantation.

FIG.15illustrates an example where the paddles120,122are independently controllable. The device101illustrated byFIG.15is similar to the device100illustrated byFIG.11, except the device101ofFIG.15includes an actuation element that is configured as two independent actuation elements (e.g., actuation shafts, actuation rods, actuation tubes, actuation wires, etc.)111,113that are coupled to two independent caps115,117. To transition a first inner paddle122and a first outer paddle120from the fully closed to the partially open condition, the actuation element111is extended to push the cap115away from the coaptation element110, thereby pulling on the outer paddle120, which in turn pulls on the inner paddle122, causing the first anchor108to partially unfold. To transition a second inner paddle122and a second outer paddle120from the fully closed to the partially open condition, the actuation element113is extended to push the cap115away from the coaptation element110, thereby pulling on the outer paddle120, which in turn pulls on the inner paddle122, causing the second anchor108to partially unfold. The independent paddle control illustrated byFIG.15can be implemented on any of the devices disclosed by the present application. For comparison, in the example illustrated byFIG.11, the pair of inner and outer paddles122,120are moved in unison, rather than independently, by a single actuation element112.

Referring now toFIGS.16-21, the device100ofFIGS.8-14is shown being delivered and deployed within the native mitral valve MV of the heart H. Referring toFIG.16, a delivery sheath/catheter is inserted into the left atrium LA through the septum and the implant/device100is deployed from the delivery catheter/sheath in the fully open condition as illustrated inFIG.16. The actuation element112is then retracted to move the implant/device into the fully closed condition shown inFIG.17.

As can be seen inFIG.18, the implant/device is moved into position within the mitral valve MV into the ventricle LV and partially opened so that the leaflets20,22can be grasped. For example, a steerable catheter can be advanced and steered or flexed to position the steerable catheter as illustrated byFIG.18. The implant/device catheter connected to the implant/device can be advanced from inside the steerable catheter to position the implant as illustrated byFIG.18.

Referring now toFIG.19, the implant/device catheter can be retracted into the steerable catheter to position the mitral valve leaflets20,22in the clasps130. An actuation line116is extended to close one of the clasps130, capturing a leaflet20.FIG.20shows the other actuation line116being then extended to close the other clasp130, capturing the remaining leaflet22. Lastly, as can be seen inFIG.21, the delivery system102(e.g., steerable catheter, implant/device catheter, etc.), actuation element112and actuation lines116are then retracted and the device or implant100is fully closed and deployed in the native mitral valve MV.

Any of the features disclosed by the present application can be used in a wide variety of different devices or valve repair devices (which can be implantable or non-implantable).FIGS.22-27,55,57-63, and67-71illustrate examples of devices or valve repair devices that can be modified to include any of the features disclosed by the present application. Any combination or sub-combination of the features disclosed by the present application can be combined with, substituted for, and/or added to any combination or sub-combination of the features of the devices illustrated byFIGS.22-27,55,57-63, and67-71.

Referring now toFIGS.22-27, an example of a device or implant200is shown. The device200is one of the many different configurations that the device100that is schematically illustrated inFIGS.8-14can take. The device200can include any other features for a device or implant discussed in the present application, and the device200can be positioned to engage valve tissue20,22as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). The device/implant200can be a treatment device, a prosthetic spacer device, valve repair device, or another type of device or implant that attaches to leaflets of a native valve.

In some implementations, the device or implant200includes a coaptation portion204, a proximal or attachment portion209, an anchor portion206, and a distal portion207. In some implementations, the coaptation portion204of the device optionally includes a coaptation element210(e.g., a spacer, coaption element, plug, membrane, sheet, etc.) for implantation between leaflets of a native valve. In some implementations, the anchor portion206includes a plurality of anchors208. The anchors can be configured in a variety of ways. In some implementations, each anchor208includes outer paddles220, inner paddles222, paddle extension members or paddle frames224, and clasps230. In some implementations, the attachment portion209includes a first or proximal collar211(or other attachment element) for engaging with a capture mechanism213(see e.g.,FIGS.43-49) of a delivery system202(see e.g.,FIGS.38-42and49). Delivery system202can be the same as or similar to delivery system102described elsewhere and can comprise 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 of these, etc. The capture mechanism can be configured in a variety of ways and, in some implementations, can comprise one or more of a clamp, clip, pin, suture, line, lasso, noose, snare, buckle, lock, latch, etc.

In some implementations, the coaptation element210and paddles220,222are formed from a flexible material that can be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The material can be cloth, shape-memory alloy wire—such as Nitinol—to provide shape-setting capability, or any other flexible material suitable for implantation in the human body.

An actuation element212(e.g., actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from the delivery system202to engage and enable actuation of the device or implant200. In some implementations, the actuation element212extends through the capture mechanism213, proximal collar211, and coaptation element210to engage a cap214of the distal portion207. The actuation element212can be configured to removably engage the cap214with a threaded connection, or the like, so that the actuation element212can be disengaged and removed from the device200after implantation.

The coaptation element210extends from the proximal collar211(or other attachment element) to the inner paddles222. In some implementations, the coaptation element210has a generally elongated and round shape, though other shapes and configurations are possible. In some implementations, the coaptation element210has an elliptical shape or cross-section when viewed from above (e.g.,FIG.51) and has a tapered shape or cross-section when seen from a front view (e.g.,FIG.23) and a round shape or cross-section when seen from a side view (e.g.,FIG.24). A blend of these three geometries can result in the three-dimensional shape of the illustrated coaptation element210that achieves the benefits described herein. The round shape of the coaptation element210can also be seen, when viewed from above, to substantially follow or be close to the shape of the paddle frames224.

The size and/or shape of the coaptation element210can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In some implementations, the anterior-posterior distance at the top of the coaptation element is about 5 mm, and the medial-lateral distance of the coaptation element at its widest is about 10 mm. In some implementations, the overall geometry of the device200can be based on these two dimensions and the overall shape strategy described above. It should be readily apparent that the use of other anterior-posterior distance anterior-posterior distance and medial-lateral distance as starting points for the device will result in a device having different dimensions. Further, using other dimensions and the shape strategy described above will also result in a device having different dimensions.

In some implementations, the outer paddles220are jointably attached to the cap214of the distal portion207by connection portions221and to the inner paddles222by connection portions223. The inner paddles222are jointably attached to the coaptation element by connection portions225. In this manner, the anchors208are configured similar to legs in that the inner paddles222are like upper portions of the legs, the outer paddles220are like lower portions of the legs, and the connection portions223are like knee portions of the legs.

In some implementations, the inner paddles222are stiff, relatively stiff, rigid, have rigid portions and/or are stiffened by a stiffening member or a fixed portion232of the clasps230. The stiffening of the inner paddle allows the device to move to the various different positions shown and described herein. The inner paddle222, the outer paddle220, the coaptation can all be interconnected as described herein, such that the device200is constrained to the movements and positions shown and described herein.

In some implementations, the paddle frames224are attached to the cap214at the distal portion207and extend to the connection portions223between the inner and outer paddles222,220. In some implementations, the paddle frames224are formed of a material that is more rigid and stiff than the material forming the paddles222,220so that the paddle frames224provide support for the paddles222,220.

The paddle frames224provide additional pinching force between the inner paddles222and the coaptation element210and assist in wrapping the leaflets around the sides of the coaptation element210for a better seal between the coaptation element210and the leaflets, as can be seen inFIG.51. That is, the paddle frames224can be configured with a round three-dimensional shape extending from the cap214to the connection portions223of the anchors208. The connections between the paddle frames224, the outer and inner paddles220,222, the cap214, and the coaptation element210can constrain each of these parts to the movements and positions described herein. In particular the connection portion223is constrained by its connection between the outer and inner paddles220,222and by its connection to the paddle frame224. Similarly, the paddle frame224is constrained by its attachment to the connection portion223(and thus the inner and outer paddles222,220) and to the cap214.

Configuring the paddle frames224in this manner provides increased surface area compared to the outer paddles220alone. This can, for example, make it easier to grasp and secure the native leaflets. The increased surface area can also distribute the clamping force of the paddles220and paddle frames224against the native leaflets over a relatively larger surface of the native leaflets in order to further protect the native leaflet tissue. Referring again toFIG.51, the increased surface area of the paddle frames224can also allow the native leaflets to be clamped to the device or implant200, such that the native leaflets coapt entirely around the coaptation member or coaptation element210. This can, for example, improve sealing of the native leaflets20,22and thus prevent, inhibit, or further reduce valve regurgitation.

In some implementations the clasps comprise a movable arm coupled to the anchors. In some implementations, the clasps230include a base or fixed arm232, a movable arm234, with optional barbs, friction-enhancing elements, or securing structures236, and a joint portion238. The fixed arms232are attached to the inner paddles222, with the joint portion238disposed proximate the coaptation element210. The joint portion238is spring-loaded so that the fixed and movable arms232,234are biased toward each other when the clasp230is in a closed condition. In some implementations, the clasps230include friction-enhancing elements or securing structures, such as barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.

In some implementations, the fixed arms232are attached to the inner paddles222through holes or slots231with sutures (not shown). The fixed arms232can be attached to the inner paddles222with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, clamps, latches, or the like. The fixed arms232remain substantially stationary relative to the inner paddles222when the movable arms234are opened to open the clasps230and expose the optional barbs, friction-enhancing elements, or securing structures236. The clasps230are opened by applying tension to actuation lines216(e.g., as shown inFIGS.43-48) attached to holes235in the movable arms234, thereby causing the movable arms234to articulate, pivot, and/or flex on the joint portions238.

Referring now toFIG.29, a close-up view of one of the leaflets20,22grasped by a clasp such as clasp230is shown. The leaflet20,22is grasped between the movable and fixed arms232,234of the clasp230. The tissue of the leaflet20,22is not pierced by the optional barbs, friction-enhancing elements, or securing structures236, though in some implementations the optional barbs236can partially or fully pierce through the leaflet20,22. The angle and height of the optional barbs, friction-enhancing elements or securing structures236relative to the movable arm234helps to secure the leaflet20,22within the clasp230. In particular, a force pulling the implant off of the native leaflet20,22will encourage the optional barbs, friction-enhancing elements, or securing structures236to further engage the tissue, thereby ensuring better retention. Retention of the leaflet20,22in the clasp230is further improved by the position of fixed arm232near the optional barbs, friction-enhancing elements, or securing structures236when the clasp230is closed. In this arrangement, the tissue is formed by the fixed arms232and the movable arms234and the optional barbs, friction-enhancing elements, or securing structures236into an S-shaped torturous path. Thus, forces pulling the leaflet20,22away from the clasp230will encourage the tissue to further engage the optional barbs, friction-enhancing elements, or securing structures236before the leaflets20,22can escape. For example, leaflet tension during diastole can encourage the optional barbs, friction-enhancing elements, or securing structures236to pull toward the end portion of the leaflet20,22. Thus, the S-shaped path can utilize the leaflet tension during diastole to engage the leaflets20,22more tightly with the optional barbs, friction-enhancing elements or securing structures236.

Referring toFIG.25, the device or implant200can also include a cover240. In some implementations, the cover240can be disposed on the coaptation element210, the outer and inner paddles220,222, and/or the paddle frames224. The cover240can be configured to prevent, inhibit, or reduce blood-flow through the device or implant200and/or to promote native tissue ingrowth. In some implementations, the cover240can be a cloth or fabric such as PET, velour, or other suitable fabric. In some implementations, in lieu of or in addition to a fabric, the cover240can include a coating (e.g., polymeric) that is applied to the device or implant200.

During implantation, the paddles220,222of the anchors208are opened and closed to grasp the native valve leaflets20,22between the paddles220,222and the coaptation element210. The anchors208are moved between a closed position (FIGS.22-25) to various open positions (FIGS.26-37) by extending and retracting the actuation element212. Extending and retracting the actuation element212increases and decreases the spacing between the coaptation element210and the cap214, respectively. The proximal collar211(or other attachment element) and the coaptation element210slide along the actuation element212during actuation so that changing of the spacing between the coaptation element210and the cap214causes the paddles220,220to move between different positions to grasp the valve leaflets20,22during implantation.

As the device200is opened and closed, the pair of inner and outer paddles222,220are moved in unison, rather than independently, by a single actuation element212. Also, the positions of the clasps230are dependent on the positions of the paddles222,220. For example, the clasps230are arranged such that closure of the anchors208simultaneously closes the clasps230. In some implementations, the device200can be made to have the paddles220,222be independently controllable in the same manner (e.g., the device101illustrated inFIG.15).

In some implementations, the clasps230further secure the native leaflets20,22by engaging the leaflets20,22with optional barbs, friction-enhancing elements, or securing structures236and/or pinching the leaflets20,22between the movable and fixed arms234,232. In some implementations, the clasps230are barbed clasps that include barbs that increase friction with and/or can partially or completely puncture the leaflets20,22. The actuation lines216(FIGS.43-48) can be actuated separately so that each clasp230can be opened and closed separately. Separate operation allows one leaflet20,22to be grasped at a time, or for the repositioning of a clasp230on a leaflet20,22that was insufficiently grasped, without altering a successful grasp on the other leaflet20,22. The clasps230can be fully opened and closed when the inner paddle222is not closed, thereby allowing leaflets20,22to be grasped in a variety of positions as the particular situation requires.

Referring now toFIGS.22-25, the device200is shown in a closed position. When closed, the inner paddles222are disposed between the outer paddles220and the coaptation element210. The clasps230are disposed between the inner paddles222and the coaptation element210. Upon successful capture of native leaflets20,22the device200is moved to and retained in the closed position so that the leaflets20,22are secured within the device200by the clasps230and are pressed against the coaptation element210by the paddles220,222. The outer paddles220can have a wide curved shape that fits around the curved shape of the coaptation element210to grip the leaflets20,22more securely when the device200is closed (e.g., as can be seen inFIG.51). The curved shape and rounded edges of the outer paddle220also prohibits or inhibits tearing of the leaflet tissue.

Referring now toFIGS.30-37, the device or implant200described above is shown in various positions and configurations ranging from partially open to fully open. The paddles220,222of the device200transition between each of the positions shown inFIGS.30-37from the closed position shown inFIGS.22-25up extension of the actuation element212from a fully retracted to fully extended position.

Referring now toFIGS.30-31, the device200is shown in a partially open position. The device200is moved into the partially open position by extending the actuation element212. Extending the actuation element212pulls down on the bottom portions of the outer paddles220and paddle frames224. The outer paddles220and paddle frames224pull down on the inner paddles222, where the inner paddles222are connected to the outer paddles220and the paddle frames224. Because the proximal collar211(or other attachment element) and coaptation element210are held in place by the capture mechanism213, the inner paddles222are caused to articulate, pivot, and/or flex in an opening direction. The inner paddles222, the outer paddles220, and the paddle frames all flex to the position shown inFIGS.30-31. Opening the paddles222,220and frames224forms a gap between the coaptation element210and the inner paddle222that can receive and grasp the native leaflets20,22. This movement also exposes the clasps230that can be moved between closed (FIG.30) and open (FIG.31) positions to form a second gap for grasping the native leaflets20,22. The extent of the gap between the fixed and movable arms232,234of the clasp230is limited to the extent that the inner paddle222has spread away from the coaptation element210.

Referring now toFIGS.32-33, the device200is shown in a laterally extended or open position. The device200is moved into the laterally extended or open position by continuing to extend the actuation element212described above, thereby increasing the distance between the coaptation element210and the cap214of the distal portion207. Continuing to extend the actuation element212pulls down on the outer paddles220and paddle frames224, thereby causing the inner paddles222to spread apart further from the coaptation element210. In the laterally extended or open position, the inner paddles222extend horizontally more than in other positions of the device200and form an approximately 90-degree angle with the coaptation element210. Similarly, the paddle frames224are at their maximum spread position when the device200is in the laterally extended or open position. The increased gap between the coaptation element210and inner paddle222formed in the laterally extended or open position allows clasps230to open further (FIG.33) before engaging the coaptation element210, thereby increasing the size of the gap between the fixed and movable arms232,234.

Referring now toFIGS.34-35, the example device200is shown in a three-quarters extended position. The device200is moved into the three-quarters extended position by continuing to extend the actuation element212described above, thereby increasing the distance between the coaptation element210and the cap214of the distal portion207. Continuing to extend the actuation element212pulls down on the outer paddles220and paddle frames224, thereby causing the inner paddles222to spread apart further from the coaptation element210. In the three-quarters extended position, the inner paddles222are open beyond 90 degrees to an approximately 135-degree angle with the coaptation element210. The paddle frames224are less spread than in the laterally extended or open position and begin to move inward toward the actuation element212as the actuation element212extends further. The outer paddles220also flex back toward the actuation element212. As with the laterally extended or open position, the increased gap between the coaptation element210and inner paddle222formed in the laterally extended or open position allows clasps230to open even further (FIG.35), thereby increasing the size of the gap between the fixed and movable arms232,234.

Referring now toFIGS.36-37, the example device200is shown in a fully extended position. The device200is moved into the fully extended position by continuing to extend the actuation element212described above, thereby increasing the distance between the coaptation element210and the cap214of the distal portion207to a maximum distance allowable by the device200. Continuing to extend the actuation element212pulls down on the outer paddles220and paddle frames224, thereby causing the inner paddles222to spread apart further from the coaptation element210. The outer paddles220and paddle frames224move to a position where they are close to the actuation element. In the fully extended position, the inner paddles222are open to an approximately 180-degree angle with the coaptation element210. The inner and outer paddles222,220are stretched straight in the fully extended position to form an approximately 180-degree angle between the paddles222,220. The fully extended position of the device200provides the maximum size of the gap between the coaptation element210and inner paddle222, and, in some implementations, allows clasps230to also open fully to approximately 180 degrees (FIG.37) between the fixed and movable arms232,234of the clasp230. The position of the device200is the longest and the narrowest configuration. Thus, the fully extended position of the device200can be a desirable position for bailout of the device200from an attempted implantation or can be a desired position for placement of the device in a delivery catheter, or the like.

Configuring the device or implant200such that the anchors208can extend to a straight or approximately straight configuration (e.g., approximately 120-180 degrees relative to the coaptation element210) can provide several advantages. For example, this configuration can reduce the radial crimp profile of the device or implant200. It can also make it easier to grasp the native leaflets20,22by providing a larger opening between the coaptation element210and the inner paddles222in which to grasp the native leaflets20,22. Additionally, the relatively narrow, straight configuration can prevent or reduce the likelihood that the device or implant200will become entangled in native anatomy (e.g., chordae tendineae CT shown inFIGS.3and4) when positioning and/or retrieving the device or implant200into the delivery system202.

Referring now toFIGS.38-49, an example device200is shown being delivered and deployed within the native mitral valve MV of the heart H. As described above, the device200shown inFIGS.38-49includes the optional covering240(e.g.,FIG.25) over the coaptation element210, clasps230, inner paddles222and/or the outer paddles220. The device200is deployed from a delivery system202(e.g., which can comprise a device/implant catheter that is extendable from a steerable catheter and/or a guide sheath) and is retained by a capture mechanism213(see e.g.,FIGS.43and48) and is actuated by extending or retracting the actuation element212. Fingers of the capture mechanism213removably attach the collar211to the delivery system202. In some implementations, the capture mechanism213is held closed around the collar211by the actuation element212, such that removal of the actuation element212allows the fingers of the capture mechanism213to open and release the collar211to decouple the capture mechanism213from the device200after the device200has been successfully implanted.

Referring now toFIG.38, the delivery system202(e.g., a delivery catheter/sheath thereof) is inserted into the left atrium LA through the septum and the device/implant200is deployed from the delivery system202(e.g., a device/implant catheter retaining the device/implant can be extended to deploy the device/implant out from a steerable catheter) in the fully open condition for the reasons discussed above with respect to the device100. The actuation element212is then retracted to move the device200through the partially closed condition (FIG.39) and to the fully closed condition shown inFIGS.40-41. Then the delivery system or catheter maneuvers the device/implant200towards the mitral valve MV as shown inFIG.41. Referring now toFIG.42, when the device200is aligned with the mitral valve MV, the actuation element212is extended to open the paddles220,222into the partially opened position and the actuation lines216(FIGS.43-48) are retracted to open the clasps230to prepare for leaflet grasp. Next, as shown inFIGS.43-44, the partially open device200is inserted through the native valve (e.g., by advancing a device/implant catheter from a steerable catheter) until leaflets20,22are properly positioned in between the inner paddles222and the coaptation element210and inside the open clasps230.

FIG.45shows the device200with both clasps230closed, though the optional barbs, friction-enhancing elements, or securing structures236of one clasp230missed one leaflet22. As can be seen inFIGS.45-47, the out of position clasp230is opened and closed again to properly grasp the missed leaflet22. When both leaflets20,22are grasped properly, the actuation element212is retracted to move the device200into the fully closed position shown inFIG.48. With the device200fully closed and implanted in the native valve, the actuation element212is disengaged from the cap214and is withdrawn to release the capture mechanism213from the proximal collar211(or other attachment element) so that the capture mechanism213can be withdrawn into the delivery system202(e.g., into a catheter/sheath), as shown inFIG.49. Once deployed, the device200can be maintained in the fully closed position with a mechanical means such as a latch or can be biased to remain closed through the use of spring material, such as steel, and/or shape-memory alloys such as Nitinol. For example, the paddles220,222can be formed of steel or Nitinol shape-memory alloy—produced in a wire, sheet, tubing, or laser sintered powder—and are biased to hold the outer paddles220closed around the inner paddles222, coaptation element210, and/or the clasps230pinched around native leaflets20,22.

Referring toFIGS.50-54, once the device200is implanted in a native valve, the coaptation element210functions as a gap filler in the valve regurgitant orifice, such as the gap26in the mitral valve MV illustrated byFIG.6or a gap in another native valve. In some implementations, when the device200has been deployed between the two opposing valve leaflets20,22, the leaflets20,22no longer coapt against each other in the area of the coaptation element210, but instead coapt against the coaptation element210. This reduces the distance the leaflets20,22need to be approximated to close the native valve during systole, thereby facilitating repair of functional valve disease that may be causing valvular regurgitation. A reduction in leaflet approximation distance can result in several other advantages as well. For example, the reduced approximation distance required of the leaflets20,22reduces or minimizes the stress experienced by the native valve. Shorter approximation distance of the valve leaflets20,22can also require less approximation forces which can result in less tension experienced by the leaflets20,22and less diameter reduction of the valve annulus. The smaller reduction of the valve annulus—or none at all—can result in less reduction in valve orifice area as compared to a device without a coaptation element or spacer. In this way, the coaptation element210can reduce the transvalvular gradients.

To adequately fill the gap26between the leaflets20,22, the device200and the components thereof can have a wide variety of different shapes and sizes. For example, the outer paddles220and paddle frames224can be configured to conform to the shape or geometry of the coaptation element210as is shown inFIGS.50-54. As a result, the outer paddles220and paddle frames224can mate with both the coaptation element210and the native valve leaflets20,22. In some implementations, when the leaflets20,22are coapted against the coaptation element210, the leaflets20,22fully surround or “hug” the coaptation element210in its entirety, thus small leaks at lateral and medial aspects201,203of the coaptation element210can be prevented or inhibited. The interaction of the leaflets20,22and the device200is made clear inFIG.51, which shows a schematic atrial or surgeon's view that shows the paddle frame224(which would not actually be visible from a true atrial view, e.g.,FIG.52), conforming to the coaptation element210geometry. The opposing leaflets20,22(the ends of which would also not be visible in the true atrial view, e.g.,FIG.52) being approximated by the paddle frames224, to fully surround or “hug” the coaptation element210.

This coaptation of the leaflets20,22against the lateral and medial aspects201,203of the coaptation element210(shown from the atrial side inFIG.52, and the ventricular side inFIG.53) would seem to contradict the statement above that the presence of a coaptation element210minimizes the distance the leaflets need to be approximated. However, the distance the leaflets20,22need to be approximated is still minimized if the coaptation element210is placed precisely at a regurgitant gap26and the regurgitant gap26is less than the width (medial-lateral) of the coaptation element210.

FIG.50illustrates the geometry of the coaptation element210and the paddle frame224from an LVOT perspective. As can be seen in this view, the coaptation element210has a tapered shape being smaller in dimension in the area closer to where the inside surfaces of the leaflets20,22are required to coapt and increase in dimension as the coaptation element210extends toward the atrium. Thus, the depicted native valve geometry is accommodated by a tapered coaptation element geometry. Still referring toFIG.50, the tapered coaptation element geometry, in conjunction with the illustrated expanding paddle frame224shape (toward the valve annulus) can help to achieve coaptation on the lower end of the leaflets, reduce stress, and minimize transvalvular gradients.

Referring toFIG.54, the shape of the coaptation element210and the paddle frames224can be defined based on an Intra-Commissural view of the native valve and the device200. Two factors of these shapes are leaflet coaptation against the coaptation element210and reduction of stress on the leaflets due to the coaptation. Referring toFIGS.54and24, to both coapt the valve leaflets20,22against the coaptation element210and reduce the stress applied to the valve leaflets20,22by the coaptation element210and/or the paddle frames224, the coaptation element210can have a round or rounded shape and the paddle frames224can have a full radius that spans nearly the entirety of the paddle frame224. The round shape of the coaptation element210and/or the illustrated fully rounded shape of the paddle frames224distributes the stresses on the leaflets20,22across a large, curved engagement area205. For example, inFIG.54, the force on the leaflets20,22by the paddle frames is spread along the entire rounded length of the paddle frame224, as the leaflets20try to open during the diastole cycle.

Additional features of the device200, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2018/028189 (International Publication No. WO 2018/195215). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2018/028189 (International Publication No. WO 2018/195215). Patent Cooperation Treaty International Application No. PCT/US2018/028189 (International Publication No. WO 2018/195215) is incorporated herein by reference in their entirety for all purposes.

Referring now toFIG.55, an example of a device or implant300(e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, a repair device, a treatment device, etc.) is shown. The device300is one of the many different configurations that the device100that is schematically illustrated inFIGS.8-14can take. The device300can include any other features for a device or implant discussed in the present application, and the device300can be positioned to engage valve tissue20,22as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).

The device or implant300includes a proximal or attachment portion305, an anchor portion306, and a distal portion307. In some implementations, the device/implant300includes a coaptation portion/region304, and the coaptation portion/region304can optionally include a coaptation element310(e.g., spacer, plug, membrane, sheet, gap filler, etc.) for implantation between the leaflets20,22of the native valve. In some implementations, the anchor portion306includes a plurality of anchors308. In some implementations, each anchor308can include one or more paddles, e.g., outer paddles320, inner paddles322, paddle extension members or paddle frames324. The anchors can also include and/or be coupled to clasps330. In some implementations, the attachment portion305includes a first or proximal collar311(or other attachment element) for engaging with a capture mechanism (e.g., a capture mechanism such as the capture mechanism213shown inFIGS.43-49, or another capture mechanism described herein or otherwise known) of a delivery system (e.g., a delivery system such as the system shown inFIGS.38-42and49).

The anchors308can be attached to the other portions of the device and/or to each other in a variety of different ways (e.g., directly, indirectly, welding, sutures, adhesive, links, latches, integrally formed, a combination of some or all of these, etc.). In some implementations, the anchors308are attached to a coaptation element310by connection portions325and to a cap314by connection portions321.

The anchors308can comprise first portions or outer paddles320and second portions or inner paddles322separated by connection portions323. The connection portions323can be attached to paddle frames324that are hingeably attached to a cap314or other attachment portion. In this manner, the anchors308are configured similar to legs in that the inner paddles322are like upper portions of the legs, the outer paddles320are like lower portions of the legs, and the connection portions323are like knee portions of the legs.

In implementations with a coaptation member or coaptation element310, the coaptation member or coaptation element310and the anchors308can be coupled together in various ways. For example, as shown in the illustrated example, the coaptation element310and the anchors308can be coupled together by integrally forming the coaptation element310and the anchors308as a single, unitary component. This can be accomplished, for example, by forming the coaptation element310and the anchors308from a continuous strip301of a braided or woven material, such as braided or woven nitinol wire. In the illustrated example, the coaptation element310, the outer paddle portions320, the inner paddle portions322, and the connection portions321,323,325are formed from a continuous strip of fabric301.

Like the anchors208of the device or implant200described above, the anchors308can be configured to move between various configurations by axially moving the distal end of the device (e.g., cap314, etc.) relative to the proximal end of the device (e.g., proximal collar311or other attachment element, etc.). This movement can be along a longitudinal axis extending between the distal end (e.g., cap314, etc.) and the proximal end (e.g., collar311or other attachment element, etc.) of the device. For example, the anchors308can be positioned in a fully extended or straight configuration (e.g., similar to the configuration of device200shown inFIG.36) by moving the distal end (e.g., cap314, etc.) away from the proximal end of the device.

In some implementations, in the straight configuration, the paddle portions320,322are aligned or straight in the direction of the longitudinal axis of the device. In some implementations, the connection portions323of the anchors308are adjacent the longitudinal axis of the coaptation element310(e.g., similar to the configuration of device200shown inFIG.36). From the straight configuration, the anchors308can be moved to a fully folded configuration (e.g.,FIG.55), e.g., by moving the proximal end and distal end toward each other and/or toward a midpoint or center of the device. Initially, as the distal end (e.g., cap314, etc.) moves toward the proximal end and/or midpoint or center of the device, the anchors308bend at connection portions321,323,325, and the connection portions323move radially outwardly relative to the longitudinal axis of the device300and axially toward the midpoint and/or toward the proximal end of the device (e.g., similar to the configuration of device200shown inFIG.34). As the cap314continues to move toward the midpoint and/or toward the proximal end of the device, the connection portions323move radially inwardly relative to the longitudinal axis of the device300and axially toward the proximal end of the device (e.g., similar to the configuration of device200shown inFIG.30).

In some implementations, the clasps comprise a movable arm coupled to an anchor. In some implementations, the clasps330(as shown in detail inFIG.56) include a base or fixed arm332, a movable arm334with optional barbs, friction enhancing elements, or securing structures336, and a joint portion338. The fixed arms332are attached to the inner paddles322, with the joint portion338disposed proximate the coaptation element310. The joint portion338is spring-loaded so that the fixed and movable arms332,334are biased toward each other when the clasp330is in a closed condition.

The fixed arms332are attached to the inner paddles322through holes or slots331with sutures (not shown). The fixed arms332can be attached to the inner paddles322with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, or the like. The fixed arms332remain substantially stationary relative to the inner paddles322when the movable arms334are opened to open the clasps330and expose the optional barbs, friction-enhancing elements, or securing structures336. The clasps330are opened by applying tension to actuation lines (e.g., the actuation lines216shown inFIGS.43-48) attached to holes335in the movable arms334, thereby causing the movable arms334to articulate, pivot, and/or flex on the joint portions338.

In short, the device or implant300is similar in configuration and operation to the device or implant200described above, except that the coaptation element310, outer paddles320, inner paddles322, and connection portions321,323,325are formed from the single strip of material301. In some implementations, the strip of material301is attached to the proximal collar311, cap314, and paddle frames324by being woven or inserted through openings in the proximal collar311, cap314, and paddle frames324that are configured to receive the continuous strip of material301. The continuous strip301can be a single layer of material or can include two or more layers. In some implementations, portions of the device300have a single layer of the strip of material301and other portions are formed from multiple overlapping or overlying layers of the strip of material301.

For example,FIG.55shows a coaptation element310and inner paddles322formed from multiple overlapping layers of the strip of material301. The single continuous strip of material301can start and end in various locations of the device300. The ends of the strip of material301can be in the same location or different locations of the device300. For example, in the illustrated example ofFIG.55, the strip of material301begins and ends in the location of the inner paddles322.

As with the device or implant200described above, the size of the coaptation element310can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In particular, forming many components of the device300from the strip of material301allows the device300to be made smaller than the device200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element310is less than 2 mm, and the medial-lateral distance of the device300(i.e., the width of the paddle frames324which can be wider than the coaptation element310) at its widest is about 5 mm.

Additional features of the device300, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/055320 (International Publication No. WO 2020/076898). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/055320 (International Publication No. WO 2020/076898). Patent Cooperation Treaty International Application No. PCT/US2019/055320 (International Publication No. WO 2020/076898) is incorporated herein by reference in its entirety for all purposes.

The concepts disclosed by the present application can be used with a wide variety of different devices or valve repair devices, including implantable and non-implantable ones.FIGS.57-63illustrate another example of one of the many valve repair systems400for repairing a native valve of a patient that the concepts of the present application can be applied to. The valve repair system400includes a delivery device401and a device402(illustrated here, for example, as a valve repair device or valve treatment device).

In some implementations, the valve repair device or treatment device402includes a base assembly404, a pair of paddles406, and a pair of gripping members408(e.g., clasps, clasp arms, grippers, gripping arms, latches, etc.). In some implementations, the paddles406can be integrally formed with the base assembly. For example, the paddles406can be formed as extensions of links of the base assembly. In the illustrated example, the base assembly404of the valve repair device402has a shaft403, a coupler405configured to move along the shaft, and a lock407configured to lock the coupler in a stationary position on the shaft. The coupler405is mechanically connected to the paddles406, such that movement of the coupler405along the shaft403causes the paddles to move between an open position and a closed position. In this way, the coupler405serves as a means for mechanically coupling the paddles406to the shaft403and, when moving along the shaft403, for causing the paddles406to move between their open and closed positions.

In some implementations, the gripping members408are pivotally connected to the base assembly404(e.g., the gripping members408can be pivotally connected to the shaft403, or any other suitable member of the base assembly), such that the gripping members can be moved to adjust the width of the opening414between the paddles406and the gripping members408. The gripping member408can include a gripping portion409(e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.) for attaching the gripping members to valve tissue when the valve repair device402is attached to the valve tissue. The gripping member408forms a means for gripping the valve tissue (in particular tissue of the valve leaflets) with a sticking means or portion such as the gripping portion409. When the paddles406are in the closed position, the paddles engage the gripping members408, such that, when valve tissue is attached to the gripping portion409of the gripping members, the paddles act as holding or securing means to hold the valve tissue at the gripping members and to secure the valve repair device402to the valve tissue. In some implementations, the gripping members408are configured to engage the paddles406such that the gripping portion409engages the valve tissue member and the paddles406to secure the valve repair device402to the valve tissue member. For example, in certain situations, it can be advantageous to have the paddles406maintain an open position and have the gripping members408move outward toward the paddles406to engage valve tissue and the paddles406.

While the implementations shown inFIGS.57-63illustrate a pair of paddles406and a pair of gripping members408, it should be understood that the valve repair device402can include any suitable number of paddles and gripping members.

In some implementations, the valve repair system400includes a placement shaft413that is removably attached to the shaft403of the base assembly404of the valve repair device402. After the valve repair device402is secured to valve tissue, the placement shaft413is removed from the shaft403to remove the valve repair device402from the remainder of the valve repair system400, such that the valve repair device402can remain attached to the valve tissue, and the delivery device401can be removed from a patient's body.

The valve repair system400can also include a paddle control mechanism410, a gripper control mechanism411, and a lock control mechanism412. The paddle control mechanism410is mechanically attached to the coupler405to move the coupler along the shaft, which causes the paddles406to move between the open and closed positions. The paddle control mechanism410can take any suitable form, and can comprise, for example, a shaft, wire, tube, hypotube, rod, suture, line, etc. For example, the paddle control mechanism can comprise a hollow shaft, a catheter tube or a sleeve that fits over the placement shaft413and the shaft403and is connected to the coupler405.

The gripper control mechanism411is configured to move the gripping members408such that the width of the opening414between the gripping members and the paddles406can be altered. The gripper control mechanism411can take any suitable form, such as, for example, a line, a suture, a wire, a rod, a catheter, a tube, a hypotube, etc.

The lock control mechanism412is configured to lock and unlock the lock. The lock407serves as a locking means for locking the coupler405in a stationary position with respect to the shaft403and can take a wide variety of different forms and the type of lock control mechanism412can be dictated by the type of lock used. In some implementations the lock407includes a pivotable plate having a hole, in which the shaft403of the valve repair device402is disposed within the hole of the pivotable plate. In this implementation, when the pivotable plate is in the tilted position, the pivotable plate engages the shaft403to maintain a position on the shaft403, but, when the pivotable plate is in a substantially non-tilted position, the pivotable plate can be moved along the shaft (which allows the coupler405to move along the shaft403). In other words, the coupler405is prevented or inhibited from moving in the direction Y (as shown inFIG.61A) along the shaft403when the pivotable plate of the lock407is in a tilted (or locked) position, and the coupler is allowed to move in the direction Y along the shaft403when the pivotable plate is in a substantially non-tilted (or unlocked) position. In implementations in which the lock407includes a pivotable plate, the lock control mechanism412is configured to engage the pivotable plate to move the plate between the tilted and substantially non-tilted positions. The lock control mechanism412can be, for example, a rod, a suture, a wire, or any other member that is capable of moving a pivotable plate of the lock407between a tilted and substantially non-tilted position. In some implementations, the pivotable plate of the lock407is biased in the tilted (or locked) position, and the lock control mechanism412is used to move the plate from the tilted position to the substantially non-tilted (or unlocked) position. In some implementations, the pivotable plate of the lock407is biased in the substantially non-tilted (or unlocked) position, and the lock control mechanism412is used to move the plate from the substantially non-tilted position to the tilted (or locked) position.

FIGS.61A-61Billustrate the valve repair device or treatment device402moving from an open position (as shown inFIG.61A) to a closed position (as shown inFIG.61B). The base assembly404includes a first link1021extending from point A to point B, a second link1022extending from point A to point C, a third link1023extending from point B to point D, a fourth link1024extending from point C to point E, and a fifth link1025extending from point D to point E. The coupler405is movably attached to the shaft403, and the shaft403is fixed to the fifth link1025. The first link1021and the second link1022are pivotally attached to the coupler405at point A, such that movement of the coupler405along the shaft403moves the location of point A and, consequently, moves the first link1021and the second link1022. The first link1021and the third link1023are pivotally attached to each other at point B, and the second link1022and the fourth link1024are pivotally attached to each other at point C. One paddle406ais attached to first link1021such that movement of first link1021causes the paddle406ato move, and the other paddle406bis attached to the second link1022such that movement of the second link1022causes the paddle406bto move. In some implementations, the paddles406a,406bcan be connected to links1023,1024or be extensions of links1023,1024.

In order to move the valve repair device from the open position (as shown inFIG.61A) to the closed position (as shown inFIG.61B), the coupler405is moved along the shaft403in the direction Y, which moves the pivot point A for the first link1021and the second link1022to a new position. Movement of the coupler405(and pivot point A) in the direction Y causes a portion of the first link1021near point A to move in the direction H, and the portion of the first link1021near point B to move in the direction J. The paddle406ais attached to the first link1021such that movement of the coupler405in the direction Y causes the paddle406ato move in the direction Z. In addition, the third link1023is pivotally attached to the first link1021at point B such that movement of the coupler405in the direction Y causes the third link1023to move in the direction K. Similarly, movement of the coupler405(and pivot point A) in the direction Y causes a portion of the second link1022near point A to move in the direction L, and the portion of the second link1022near point C to move in the direction M. The paddle406bis attached to the second link1022such that movement of the coupler405in the direction Y causes the paddle406bto move in the direction V. In addition, the fourth link1024is pivotally attached to the second link1022at point C such that movement of the coupler405in the direction Y causes the fourth link1024to move in the direction N.FIG.61Billustrates the final position of the valve repair device402after the coupler405is moved as shown inFIG.61A.

Referring toFIG.58, the valve repair device402is shown in the open position (similar to the position shown inFIG.61A), and the gripper control mechanism411is shown moving the gripping members408to provide a wider gap at the opening414between the gripping members and the paddles406. In the illustrated example, the gripper control mechanism411includes a line, such as a suture, a wire, etc. that is threaded through an opening in an end of the gripping members408. Both ends of the line extend through the delivery opening516of the delivery device401. When the line is pulled through the delivery opening516in the direction Y, the gripping members408move inward in the direction X, which causes the opening414between the gripping members and the paddles406to become wider.

Referring toFIG.59, the valve repair device402is shown such that valve tissue20,22is disposed in the opening414between the gripping members408and the paddles406. Referring toFIG.60, after the valve tissue20,22is disposed between the gripping members408and the paddles406, the gripper control mechanism411is used to lessen the width of the opening414between the gripping members and the paddles. That is, in the illustrated example, the line of the gripper control mechanism411is released from or pushed out of the opening516of the delivery member in the direction H, which allows the gripping members408to move in the direction D to lessen the width of the opening414. While the gripper control mechanism411is shown moving the gripping members408to increase the width of the opening414between the gripping members and the paddles406(FIG.59), it should be understood that the gripping members may not need to be moved in order to position valve tissue in the opening414. In certain circumstances, however, the opening414between the paddles406and the gripping members408can be wider in order to receive the valve tissue.

Referring toFIG.62, the valve repair device402is in the closed position and secured to valve tissue20,22. The valve repair device402is secured to the valve tissue20by the paddles406a,406band the gripping members408a,408b. In particular, the valve tissue20,22is attached to the valve repair device402by the gripping portion409of the gripping members408a,408b, and the paddles406a,406bengage the gripping members408to secure the valve repair device402to the valve tissue20,22.

In order to move the valve repair device402from the open position to the closed position, the lock407is moved to an unlocked condition (as shown inFIG.62) by the lock control mechanism412. Once the lock407is in the unlocked condition, the coupler405can be moved along the shaft403by the paddle control mechanism410. In the illustrated example, the paddle control mechanism410moves the coupler405in a direction Y along the shaft, which causes one paddle406ato move in a direction X and the other paddle406bto move in a direction Z. The movement of the paddles406a,406bin the direction X and the direction Z, causes the paddles to engage the gripping members408a,408band secure the valve repair device402to the valve tissue20,22.

Referring toFIG.63, after the paddles406are moved to the closed position to secure the valve repair device402to the valve tissue20,22(as shown inFIG.62), the lock407is moved to the locked condition by the lock control mechanism412(FIG.62) to maintain the valve repair device402in the closed position. After the valve repair device402is maintained in the locked condition by the lock407, the valve repair device402is removed from the delivery device401by disconnecting the shaft403from the placement shaft413(FIG.62). In addition, the valve repair device402is disengaged from the paddle control mechanism410(FIG.62), the gripper control mechanism411(FIG.62), and the lock control mechanism412. Removal of the valve repair device402from the delivery device401allows the valve repair device to remain secured to valve tissue20,22while the delivery device401is removed from a patient.

During delivery and/or implantation of a device or implant in the native heart valve, movement of the device to the implanted position may be impeded or obstructed by the native heart structures. For example, articulable portions of a device or implant (such as paddle portions of anchors used to secure the device to the native heart valve tissue) may rub against, become temporarily caught, or be temporarily blocked by the chordae tendineae CT (shown inFIGS.3and4) that extend to the valve leaflets. An example device or implant can be configured to reduce the likelihood of the device or implant getting temporarily caught or blocked by the CT. For example, the device or implant can take a wide variety of different configurations that are configured to be actively or passively narrowed to reduce the width of a paddle frame of an anchor portion of the device and, consequently, reduce the surface area of the device, which will make it easier to move the device/implant past and/or through the CT.

The valve repair device or treatment device402can include any other features described with respect to other devices discussed in the present application, and the device402can be positioned to engage valve tissue as part of any suitable valve repair system or treatment system (e.g., any valve repair or treatment system disclosed in the present application). Additional features of the device402, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904).

In various implementations, a delivery apparatus is configured to make it easier to move the device or implant between its various configurations and/or to implant (and/or deliver) the device or implant in the native heart valve. For example, controls on a handle used in a delivery assembly can be configured to enable improved control of the device or implant, as will be described.

FIGS.64-65show an example of a delivery assembly600and its components. Referring toFIG.64, the delivery assembly600can comprise the delivery apparatus602and a device604(e.g., a treatment device, a repair device, an implant, an implantable device, a valve repair device, etc.). The delivery apparatus602can comprise a plurality of catheter assemblies and optional catheter stabilizers (not shown inFIGS.64and65). For example, in the illustrated example, the delivery apparatus602includes a delivery catheter assembly606, a steerable catheter assembly608, and a device/implant catheter assembly610(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 assembly608extends coaxially through the delivery catheter assembly606, and the device/implant catheter assembly610extends coaxially through the steerable catheter assembly608and the delivery catheter assembly606. The device604can be releasably coupled to a distal portion of the device/implant catheter assembly610, as further described below. It should be appreciated that the device604can be any device described herein.

As shown inFIG.65, each of the delivery catheter assembly606, the steerable catheter assembly608, and the device/implant catheter assembly610includes a sheath or shaft607,609,611extending from a handle612,614,616, respectively. The handles612,614,616are located at a proximal end of each of the corresponding sheaths or shafts, and include one or more control members to enable 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).

The delivery catheter assembly606and the steerable catheter assembly608can be used, for example, to access an implantation location (e.g., a native mitral valve region of a heart) and/or to position the device/implant catheter assembly610at the implantation location. Accordingly, in various implementations, the delivery catheter assembly606and the steerable catheter assembly608are configured to be steerable. Features of catheter assemblies disclosed by U.S. Pat. Nos. 10,653,862 and 10,646,342 can be used in the catheter assemblies606,608,610. U.S. Pat. Nos. 10,653,862 and 10,646,342 are hereby incorporated by reference in their entireties.

FIG.66illustrates an example of a device/implant catheter assembly610.FIG.66illustrates a generalized device/implant catheter assembly610. In the example illustrated byFIG.66, the device/implant catheter assembly610can comprise the inner or actuation element112, a coupler620, an outer shaft611, a handle616(shown schematically), and clasp actuation lines624. A proximal end portion622aof the outer shaft611can be coupled to extend distally from the handle616, and a distal end portion622bof the outer shaft611can be coupled to the coupler620. The actuation element112can extend distally from the actuation control or knob626(shown schematically inFIG.66), through the handle616, through the outer shaft611, and through the coupler620. The actuation element112can be movable (e.g., axially and/or rotationally) relative to the outer shaft611and the handle616. The clasp actuation lines624can extend through and be axially movable relative to the handle616and the outer shaft611. The clasp actuation lines624can also be axially movable relative to the actuation element112.

In some implementations, the outer shaft611of the device/implant catheter assembly610can be configured to be steerable. For example, although not shown, the device/implant catheter assembly610can comprise a pull element, such as a wire, and a flexible sleeve, such as a flexible axially non-compressible pull wire sleeve (e.g., a helical coil).

As shown inFIG.66, the actuation element112(e.g., actuation rod, actuation tube, actuation shaft, actuation wire, etc.) of the device/implant catheter assembly610can be releasably coupled to the cap114of the device604. The actuation element extends from a proximal end portion112ato a distal end portion112b. In some implementations, the distal end portion112bof the actuation element112can comprise external threads configured to releasably engage interior threads of the cap114of the device604. As such, rotating the actuation element112in a first direction (e.g., clockwise) relative to the cap114of the device604releasably secures the actuation element112to the cap114, while rotating the actuation element112in a second direction (e.g., counterclockwise) relative to the cap114of the device604releases the actuation element112from the cap114.

In the example ofFIG.66, the outer shaft611of the device/implant catheter assembly610is an elongate shaft extending axially between the proximal end portion622a, which is coupled to the handle616, and the distal end portion622b, which is coupled to the coupler620. The outer shaft611can also include an intermediate portion622cdisposed between the proximal and distal end portions622a,622b. The outer shaft611can be formed from various materials, including metals and polymers. For example, in one particular implementation, the proximal end portion622acan comprise stainless steel and the distal and intermediate portions622b,622ccan comprise polyether block amide (PEBA). The outer shaft611can also comprise an outer covering or coating, such as a polymer that is reflowed over the portions622a,622b, and622c.

As shown inFIG.66, the clasp actuation lines624are coupled to the clasps130through holes235in the clasps130and extend axially through the outer shaft611between the clasps130and the handle616. In some implementations, the clasp actuation lines624are each coupled to a clasp control member628at the proximal end of the clasp actuation lines624. Each clasp control member628can be, for example, an axially-moving control or slider coupled to a corresponding clasp actuation line624to axially move the clasp actuation line624relative to the outer shaft611and the actuation element112. Each of the clasp control members628can be operated independently of the other clasp control member such that each clasp actuation line624is moved relative to the outer shaft611, the actuation element112, and the other clasp actuation line624, or the clasp control members628can be fixed with respect to one another (e.g., locked) such that the clasp actuation lines624are axially moved together relative to the outer shaft611and the actuation element112. Additional information on example clasp control members628and device/implant catheter assemblies including the same can be found, for example, in US Provisional Application Ser. No. 63/181,120, filed on Apr. 28, 2021, which is incorporated herein by reference in its entirety.

In some implementations, the catheter assembly is used to deliver and/or operate a device, such as the device8200illustrated inFIG.67or other treatment device or repair devices herein.FIGS.67-71illustrate one of the many valve repair systems or treatment systems for repairing or treating a native valve of a patient that the concepts of the present application can be applied to. Referring toFIGS.70and71, the valve repair system or treatment system includes a delivery device1611and a device8200, e.g., a treatment device, a repair device, a valve repair device, an implantable valve repair device, an implant, etc. Referring toFIGS.67-69, the device8200includes a proximal or attachment portion8205, paddle frames8224, outer paddle portions8120, inner paddle portions8122, and a distal portion8207. The proximal portion8205, the distal portion8207, and the paddle frames8224can be configured in a variety of ways. The outer paddle portions8120, inner paddle portions8122, and paddle frames8224can open and close in the same or similar manner as the outer paddle portions220, inner paddle portions222, and paddle frames224described above.

In the example illustrated inFIG.67, the paddle frames8224can be symmetric along longitudinal axis YY. However, in some implementations, the paddle frames8224are not symmetric about the axis YY. Moreover, referring toFIG.67, the paddle frames8224include outer frame members8256and inner frame members8260.

In some implementations, a connector8266(e.g., shaped metal component, shaped plastic component, tether, wire, strut, line, cord, suture, etc.) attaches to the outer frame portions8256at outer ends of the connector8266and to a coupler8972at an inner end8968of the connector8266(seeFIG.69). Between the connector8266and the proximal portion8205, the outer frame portions8256form a curved shape. For example, in the illustrated example, the shape of the outer frame portions8256resembles an apple shape in which the outer frame portions8256are wider toward the proximal portion8205and narrower toward the distal portion8207. In some implementations, however, the outer frame portions8256can be otherwise shaped.

The inner frame members8260extend from the proximal portion8205toward the distal portion8207. The inner frame members8260then extend inward to form retaining portions8272that are attached to the actuation cap8214. The retaining portions8272and the actuation cap8214can be configured to attach in any suitable manner.

In some implementations, the inner frame members8260are rigid frame portions, while the outer frame members8256are flexible frame portions. The proximal end portion of the outer frame members8256connects to the proximal end portion of the inner frame members8260, as illustrated inFIG.67.

The width adjustment element8211(e.g., width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment screw or bolt etc.) is configured to move the outer frame members8256from the expanded position to the narrowed position by pulling the inner end8968(FIG.69) and portions of the connector8266into the actuation cap8214. The actuation element8102(e.g., as a wire, rod, shaft, tube, screw, suture, line, strip, combination of these, etc.) is configured to move the inner paddle frame portions8260to open and close the paddles in accordance with some implementations disclosed herein.

As shown inFIGS.68and69, the paddle frames8224have an inner end8968that engages with the width adjustment element8211such that a user can move the inner end8968relatively inside the receiver8912(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, tracks, a cylinder. etc.) to move the outer frame members8256between a narrowed position and an expanded position. In the illustrated example, the inner end8968includes a post8970that attaches to the outer frame members8256and a coupler8972that extends from the post8970. The coupler8972is configured to attach and detach from both the width adjustment element8211and the receiver8912. When the coupler8972is attached to the width adjustment element8211, the coupler is released from the receiver8912. When the coupler8972is detached from the width adjustment element8211, the coupler is secured to the tube. The inner end8968can, however, be configured in a variety of ways. Any configuration that can suitably attach the outer frame members8256to the coupler to allow the width adjustment element8211to move the outer frame members8256between the narrowed position and the expanded position can be used.

The width adjustment element8211allows a user to expand or contract the outer frame members8256of the device8200. In the example illustrated inFIGS.68and69, the width adjustment element8211includes an externally threaded end that is threaded into the coupler8972. The width adjustment element8211moves the coupler in the receiver8912to adjust the width of the outer frame members8256. When width adjustment element8211is unscrewed from the coupler8972, the coupler engages the inner surface of the receiver8912to set the width of the outer frame members8256.

In some implementations, the receiver8912can be integrally formed with or fixedly connected to a distal cap8214. Moving the cap8214relative to a body of the attachment portion8205opens and closes the paddles. In the illustrated example, the receiver8912slides inside the body of the attachment portion8205. When the coupler8972is detached from the width adjustment element8211, the width of the outer frame members8256is fixed while the actuation element8102moves the receiver8912and cap8214relative to a body of the attachment portion8205. Movement of the cap can open and close the device in the same manner as the other implementations disclosed above.

In the illustrated example, a driver head8916is disposed at a proximal end of the actuation element8102. The driver head8916releasably couples the opening/closing control actuation element8102to the receiver8912. In the illustrated example, the width adjustment element8211extends through the actuation element8102. The actuation tube is axially advanced in the direction opposite to direction Y to move the distal cap8214. Movement of the distal cap8214relative to the attachment portion8205is effective to open and close the paddles, as indicated by the arrows inFIG.68. That is movement of the distal cap8214in the direction Y closes the device and movement of the distal cap in the direction opposite to direction Y opens the device.

Also illustrated inFIGS.68and69, the width adjustment element8211extends through the actuation element8102, the driver head8916, and the receiver8912to engage the coupler8972attached to the inner end8968.

The movement of the outer frame members8256to the narrowed position can allow the device or implant8200to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart—e.g., chordae—and the device8200. The movement of the outer frame members8256to the expanded position provides the anchor portion of the device or implant8200with a larger surface area to engage and capture leaflet(s) of a native heart valve.

Referring toFIGS.70and71, an implementation of a device/implant catheter assembly1611(e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.) in which clasp actuation lines624extend through a handle1616, the actuation element8102is coupled to an actuation control1626(which may be referred to herein as an anchor actuation control or paddle actuation control, etc.), and the width adjustment element8211is coupled to a width control1628(which may be referred to herein as an anchor width control, paddle width control, etc.). A proximal end portion1622aof the shaft or catheter of the device/implant catheter assembly1611can be coupled to the handle1616, and a distal end portion1622bof the shaft or catheter can be coupled to the device8200. The actuation element8102can extend distally from the paddle actuation control1626, through the handle1616, through the shaft or catheter of the delivery device1611, and through the proximal end of the device8200, where it couples with the driver head8916. The actuation element8102can be axially movable relative to the shaft of the device/implant catheter assembly1611and the handle1616to open and close the device.

The width adjustment element8211can extend distally from the paddle width control1628, through the paddle actuation control1626and through the actuation element8102(and, consequently, through the handle1616, the outer shaft1611, and through the device8200), where it couples with the movable coupler8972. The width adjustment element8211can be axially movable relative to the actuation element8102, the outer shaft1611, and the handle1616. The clasp actuation lines624can extend through and be axially movable relative to the handle1616and the outer shaft1611. The clasp actuation lines624can also be axially movable relative to the actuation element8102.

Referring toFIGS.70and71, the width adjustment element8211can be releasably coupled to the coupler8972of the device8200. Advancing and retracting the width adjustment element8211with the control1628widens and narrows the paddles. Advancing and retracting the actuation element8102with the control1626opens and closes the paddles of the device.

In the examples ofFIGS.70and71, the catheter or shaft of the device/implant catheter assembly1611is an elongate shaft extending axially between the proximal end portion1622a, which is coupled to the handle1616, and the distal end portion1622b, which is coupled to the device8200. The outer shaft1611can also include an intermediate portion1622cdisposed between the proximal and distal end portions1622a,1622b.

In various implementations, the handle1616including the controls for adjusting the width of the paddle frames can be incorporated into a control system having a variety of forms. For example, the handle1616can be incorporated into the control system1000shown in FIG.72. Features of the control system illustrated inFIG.72can be found in U.S. Pat. No. 10,820,998, filed Apr. 8, 2020, and entitled “Valve Repair Device,” the entire contents of which is incorporated by reference herein.

FIGS.73-75depict an example implementation of a handle7300incorporating paddle width adjustment controls. The handle7300can be used to position the device/implant catheter1622to position the device, advance and retract the actuation element8102to open and close the device, and advance and retract the width adjustment element8211to widen and narrow the paddle frames (seeFIG.75). As shown inFIG.73, the handle7300generally includes a paddle actuation control7302, a paddle width control7304, a paddle release clip7306, and a width control element connection control7308.FIG.74shows the paddle actuation control7302, paddle width control7304, paddle release clip7306, and the control element connection control7308in greater detail.FIG.75shows a cross-section of the paddle actuation control7302, paddle width control7304, paddle release clip7306, and the control element connection control7308.

It should be appreciated that handle7300can be an implementation of the handle1616inFIGS.70and71. For example, the paddle actuation control or knob7302is an example of the paddle actuation control1626inFIGS.70and71, and the paddle width control or knob7304is an example of the paddle width control1628inFIGS.70and71. Different types of controls/controllers can be used for any of the controls or knobs described herein, e.g., knobs as depicted in many of the figures or other controls such as buttons, switches, gears, etc. can be used. Below the term “knob” can be used to match the variation depicted in the figures, but it should be understood that this is an example and other types of controls or controllers could be used instead of knobs.

The paddle actuation knob7302is rotatable about axis A-A extending longitudinally along the handle7300. The actuation element8102extends through the paddle actuation knob7302and is fixed to a ferrule7312. The ferrule7312is affixed to a frame7310that includes external threads for engaging with internal threads of the paddle width control knob7304, as will be described in greater detail below. The distal end of the paddle actuation knob7302includes external threads7314, which are configured to engage internal threads in a housing of the handle7300. The paddle actuation knob7302is rotatable relative to both the housing of the handle7300and relative to the frame7310and attached ferrule7312. Accordingly, as the paddle actuation knob7302is rotated about the axis A-A with respect to the handle7300, the paddle actuation knob7302axially drives the frame7310and attached ferrule7312(and, therefore, the actuation element8102) with respect to the handle7300, which is effective to axially drive the actuation element8102with respect to the device8200.

The paddle width control knob7304is also rotatable about axis A-A extending longitudinally along the handle7300. The width adjustment element8211extends through the actuation element8102, the paddle actuation knob7302, the ferrule7312, and the paddle width control knob7304. The width adjustment element8211is fixedly attached to a ferrule7316that is connected inside the control element connection knob7308. The ferrule7316fixes the width adjustment element8211rotationally and axial with respect to the control element connection knob7308. The paddle width control knob7304is rotatably coupled to the control element connection knob7308and relative to the width adjustment element8211.

In some implementations, the paddle width control knob7304is threadably connected to a threaded component that is fixed or part of the paddle actuation assembly. When the paddle width control knob7304is rotated, the threaded connection drives or forces the paddle width control knob7304and coupled with control element7316, such as the illustrated ferrule, away from the paddle actuation knob7302and coupled actuation element7312or ferrule. For example, as shown in theFIG.75implementation, the width control knob7304(e.g., paddle width control knob, etc.) includes internal threads7311that engage with the external threads7313of the frame7310. Accordingly, rotation of the paddle width control knob7304is effective to axially move the paddle width control knob7304. Since the paddle width control knob7304is rotatably coupled to the control element connection knob7308, the rotation of the paddle width control knob7304axially, but not rotatably, moves the width adjustment element8211with respect to the paddle actuation knob7302. This is effective to axially drive the width adjustment element8211with respect to the attachment portion8205of the device8200. Movement of the width adjustment element8211with respect to the attachment portion8205is effective to adjust the width of the paddles, as described hereinabove.

The control element connection knob7308is coupled to a proximal end of the paddle width control knob7304and includes the ferrule7316to which the width adjustment element8211is affixed. In implementations, the control element connection knob7308does not rotate with respect to the axis A-A during implantation of the device8200. The paddle release clip7306locks the control element connection knob7308and the paddle width control knob7304axially together, while allowing rotation there between. Accordingly, to disengage the width adjustment element8211from the device8200, the paddle release clip7306is removed and the control element connection knob7308is rotated with respect to the paddle width control knob7304. This rotates the width adjustment element8211with respect to the device8200, which is effective to uncouple the width adjustment element8211from the device8200. The control element connection knob7308and the width adjustment element8211can then be pulled axially to remove the width adjustment element from the device8200.

In some implementations, the device8200is released from the device/implant catheter1622by the following sequence of actions by the handle. The paddle release clip7306is removed and the control element connection knob7308is rotated to uncouple the width adjustment element8211from the device8200. The control element connection knob7308and the width adjustment element8211can then be pulled proximally past a distal end of the actuation element8102to decouple the actuation element8102driver head8916and connected receiver, such as the illustrated tube. For example, in one implementation fingers at the distal end flex inward when the width adjustment element8211is pulled proximally past the distal end of the actuation element8102to decouple the actuation element8102from the driver head8916. The paddle width control knob7304and the actuation element8102can then be pulled proximally past a distal end or coupler of the catheter1622to decouple the distal end or coupler of the catheter1622from the device8200. For example, in one implementation fingers at the distal end or coupler flex outward when the actuation element8102is pulled proximally past the distal end or coupler of the catheter1622to decouple the catheter1622from the device8200.

Turning now toFIG.77, an implementation of a handle616of a device/implant catheter assembly610(e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.) is shown. InFIG.77, the handle616includes a housing632to which the various controls are coupled. The housing632can be formed from various materials, including polymers such as polycarbonate, and can be formed as a unitary body (e.g., through injection molding) or fastened together in any one of a variety of manners, including fasteners, pins, adhesives, or the like. As shown inFIGS.78-81, the housing632comprises a plurality of lumens, through which the clasp actuation lines624and the actuation element (e.g., actuation rod, actuation tube, actuation wire, actuation shaft, etc.)112extend.

The handle616further comprises a flush port638, as shown inFIGS.77-79. The flush port638is configured for flushing (e.g., with a saline solution) the outer shaft611prior to inserting the outer shaft611into a patient's vasculature. Additionally, the flush port638enables air present in the outer shaft611to be removed as fluid is drawn into the proximal end of the outer shaft611. Additional information regarding a flush port that can be used in the handle616can be found in, for example, International Publication No. WO 2020/112622, the entire contents of which is incorporated by reference herein.

As shown inFIGS.77-79, the housing632comprises an aperture for receiving a marking pin640. The marking pin640can be removably coupled with the aperture of the housing632for storage of the marking pin640. During use, the marking pin640can be removed from the aperture of the housing and inserted into an aperture641(shown inFIG.77) on one of the clasp control members628. For example, the marking pin640can be inserted into an aperture641on the clasp control member628that controls the clasp to be coupled to a posterior leaflet of the mitral valve. Accordingly, in the event that the handle616is rotated during use, the user can readily identify the clasp control member628for control of the clasp to be coupled to the posterior leaflet (e.g., the marked clasp control member628) and the clasp control member628for control of the clasp to be coupled to the anterior leaflet (e.g., the unmarked clasp control member628). Although the marking pin640is described as being coupled to the clasp control member628that controls the clasp to be coupled to the posterior leaflet, it is contemplated that the marking pin640can be coupled to either of the clasp control members628to indicate any particular orientation of the device/implant catheter assembly.

Also included on the handle616is a slide lock642that is configured to slide between a first position, in which the slide lock642is coupled to one of the clasp control members628, to a second position, in which the slide lock642is coupled to both clasp control members628. For example, each of the clasp control members628can include a flange643to which the slide lock642is slidably coupled. Accordingly, the slide lock642can be moved to the first position (as indicated by the arrow shown inFIG.77) in which the slide lock is engaged with the flange643of one of the clasp control members628(e.g., to enable independent movement of each clasp actuation line relative to the other) and the second position (shown in theFIG.77) in which the slide lock642is engaged with the flange643of both of the clasp control members628(e.g., to enable simultaneous movement of the clasp actuation lines) in order to selectively control relative movement between the clasp control members628. When the slide lock is in the first position, each of the clasp control members is axially movable independently of the other clasp control member, and when the slide lock is in the second position, the clasp control members are axially movable together. Although not shown in the figures, in implementations, each flange643can include a stop to limit the position of the slide lock642along the flange643.

In implementations, each of the clasp control members628can include one or more tactile or visual indicators to enable the user to differentiate one clasp control member from the other with improved accuracy. For example, one clasp control member628can have a different color and/or texture (e.g., ribbed, smooth) than the other clasp control member628. As shown in the figures, in implementations, each of the clasp control members628is wrapped approximately 180 degrees around the circumference of the housing632such that together the clasp control members628surround and encircle the housing632. Such an arrangement can, for example, enable the clasp control members628to be accessible to the user from any angle with a single hand. Moreover, in the implementation depicted inFIG.68, the clasp control members628include a depressed region644that is generally shaped to receive and cradle the thumb of the user. Although the inclusion of such a depressed region is optional in some implementations, it can provide comfort for the user and improve the ease of use of the clasp control members628when it is included.

Each clasp control member628can further comprise one or more keyed projections or tongues that are configured to be received by and slide along a corresponding groove or slot in the housing632. As best shown inFIG.82, in implementations, the housing632further includes a pair of detents645. A first detent645is located at a first axial position along a path of one of the clasp control members628, and a second detent645is located at a second axial position along the path of the clasp control member628. For example, inFIG.82, one of the detents645projects from the housing632at a location that places the clasp control member628in a fully proximal position (e.g., a fully open position), thereby maintaining the clasp control member628in the fully proximal position (e.g., a fully open position) and preventing or inhibiting the clasp control member628from moving distally without intention of the user. A second one of the detents645projects from the housing632at a location that places the clasp control member628in a fully distal position (e.g., a fully closed position), thereby maintaining the clasp control member628in the fully distal position (e.g., a fully closed position) and preventing or inhibiting the clasp control member628from moving proximally without intention of the user. To release the clasp control member628for operation of the clasps, the user simply presses the clasp control member628with enough force to depresses the detent645and slide over the detent645. When the clasp control member628moved to either the proximal position (open) or distal position (closed), the corresponding detent645provides tactile and audible feedback to the user indicative that the clasp control member628is in the open or closed position.

Referring toFIG.82, the clasp control member628can comprise a coupler646configured to attach the clasp control member628to a clasp control tube648. As described in more detail below, the clasp control tube648is releasably coupled to the clasp control lines624. Sliding movement of the clasp control member628along the housing moves the clasp control tube648relative to the housing632to open and close the clasps.

In the example illustrated byFIGS.77and78, the coupler646includes at least one aperture647, in which the clasp control tube648is connected. The clasp control member628is slidably coupled to the housing632, such as by the mating channels629of the housing632and the projections631of the clasp control member628(seeFIG.77) and/or by the clasp control tube648extending through a guide passage649formed in the housing (seeFIG.81). The clasp control member, the coupler646, and the clasp control tube648can slide together axially (i.e., distally and proximally) with respect to the housing632to open and close the clasp. Only a single coupler646and clasp control tube648can be seen inFIGS.77and78.FIG.81shows that each clasp control member628is fixedly coupled and slides in conjunction with a corresponding clasp control tube648in the same manner. The clasp control tube648can be fixed at a proximal end to a suture lock650that is used to secure the clasp control line624to the to the clasp control tube648.

In some implementations, each clasp control tube648can comprise one or more optional keying features671at various positions or all along the axial length of the clasp control tube648. In some implementations, no keying features are included. When included, the optional keying features671are complementary to corresponding keying features675formed in one or more components of the handle616, such as in the housing632of the handle. These keying features671,675can prevent or inhibit rotation of the clasp control tube648in the housing and thereby limit movement of the clasp control tube to linear movement along the length of the housing632. For example, the optional keying feature671of the clasp control tube648can comprise a wire welded to the external surface of the clasp control tube648(seeFIG.78). In such implementations, one or more portions of the axial path defined by the handle for the clasp control tube648, can include a corresponding groove configured to receive the wire and provide a path along which the wire can slide. The optional keying features671,675can enhance stabilization of the clasp control member628by preventing or inhibiting rotation or torquing of the clasp control tube648within the handle616. For example, the optional features671,675can prevent or inhibit rotation or torquing of the clasp control tube648within the handle616when the control lines are pulled by the clasp control tube648to open the clasps and/or the control lines are pulled through the clasp control tube648to release the clasps.

The suture lock can take a wide variety of different forms. In the example illustrated byFIG.88, the suture lock650comprises a post658, a suture lock body660, and a suture lock body receptacle662. In the illustrated example, the suture lock body660has external threads665that mate with internal threads667of the suture lock body receptacle662to connect the suture lock body and the suture lock body receptacle together. The suture lock body660includes a central bore that extends from a first end to a second end of the suture lock body660. In implementations, the central bore of the suture lock body660has a diameter that varies from the first end to the second end of the suture lock body660. At least a portion of the central bore is sized to receive the post658. Accordingly, the diameter of the central bore of the suture lock body660can vary to form a flange to limit the position of the post658within the bore of the suture lock body660while enabling the post658to be inserted into a first end of the suture lock body660.

The suture lock body receptacle662includes a central bore that extends from a first end to a second end of the suture lock body receptacle662. The central bore of the suture lock body receptacle662is sized to receive the suture lock body660at threaded end of the suture lock body receptacle662and is sized to receive and be attached to the clasp control tube648at the second end of the suture lock body receptacle662. An optional O-ring664is positioned around the suture lock body660to form a fluid-tight seal between the suture lock body660and the suture lock body receptacle662.

The clasp actuation line624is fixed at one end of the clasp actuation line624to the post658, which is inserted into the suture lock body660, thereby coupling the clasp actuation line624to the suture lock body660. In implementations, the clasp actuation line624can be welded, adhered, or otherwise fixedly coupled to the post658.

The clasp actuation line624is threaded through the central bore in the suture lock body660, through the central bore in the suture lock body receptacle662, and through the clasp control tube648. The clasp control tube648guides and protects the clasp actuation line624through the interior of the handle616. The clasp actuation line624exits the clasp control tube648near the distal end of the handle616and extends through the outer shaft611of the device/implant catheter assembly610. As described herein, the clasp actuation line624exits the outer shaft611at the distal end of the outer shaft, and is coupled to the device, such as by passing through one or more holes235in the clasp130(see, e.g.,FIGS.66and76). The clasp actuation line624is then threaded back through the outer shaft611from the distal end to the proximal end and through the clasp control tube648to form a loop in the clasp actuation line624that extends from the distal end of the outer shaft611. The clasp actuation line624then exits the clasp control tube648and passes between the suture lock body660and the suture lock body receptacle662to exit the central bore of the suture lock body receptacle662. The threaded connection665,667between the suture lock body660and the suture lock body receptacle662can be tightened to pinch the clasp actuation line624in position between a tapered nose679of the suture lock body660and a reduced diameter passage681of the suture lock body receptacle662. Tightening the threaded connection665,667also compresses the seal, such as an O-ring, between the suture lock body660and the suture lock body receptacle662to form a fluid-tight seal between the suture lock body660and the suture lock body receptacle662.

To release the clasp from the clasp actuation line, the suture lock body660is removed (e.g., by unscrewing) from the suture lock body receptacle662, freeing the end of the clasp actuation line624pinched between the suture lock body660and the suture lock body receptacle662. Once the clasp actuation line624is released, the clasp actuation line can be pulled through the clasp control tube648, the outer shaft611, the hole235of the clasp and back through the outer shaft611and clasp control tube648. As such, the clasp actuation line624is no longer connected to the clasp and is removed from the patient.

Returning toFIG.78, as the clasp control member628is moved in a proximal direction, the clasp control tube648also moves in the proximal direction, pushing the suture lock650in the proximal direction with respect to the handle616. As the suture lock650moves in the proximal direction, the loop of the clasp actuation line624extending from the distal end of the outer shaft611moves proximally, pulling the clasp130. To release the clasp130, such as to grasp the leaflet, the clasp control member628is moved in a distal direction, which in turn moves the clasp control tube648and suture lock650in the distal direction, thereby moving the loop of the clasp actuation line624in the distal direction, enabling the clasp130to move toward the inner paddles122, grasping the leaflet between the clasp130and the inner paddle122.

As previously mentioned, the handle616further comprises a knob626(or other control, e.g., button, switch, gears, etc.) that is configured to control the position of the actuation element112relative to the handle616and outer shaft611. In some implementations, the knob626is configured to rotate about an axis of the handle616. As can be seen inFIGS.78-81, the knob626can be fixedly coupled to an internally threaded tube652positioned within the housing632of the handle616.

In some implementations, when the knob626is rotated about the axis of the handle616, the internally threaded tube652rotates with respect to the housing632. An externally threaded nut or retractor654is positioned within and engaged with the internally threaded tube652. The externally threaded nut or retractor654and is rotationally fixed with respect to the housing632. The externally threaded nut or retractor654can be rotationally fixed in a wide variety of different ways. In the example illustrated byFIG.79, a pair of guide rods661extend axially within the handle616, and each of the pair of guide rods661is fixed to the housing632at both ends of the guide rod661. A mounting bracket663couples the pair of guide rods661to the housing632at the distal end of each of the pair of guide rods661. Accordingly, as the internally threaded tube652is rotated, the externally threaded retractor654is advanced linearly in an axial direction (i.e., distally and proximally) along the pair of guide rods661.

The externally threaded retractor654is connected to the actuation element112such that linear movement of the externally threaded retractor654causes linear movement of the actuation element112, thereby moving the device between a fully elongated configuration, an open configuration, and a closed configuration, as described herein. The translation of the rotational movement of the knob626into linear motion of the actuation element112can result in improved control and precision, thereby leading to improved precision during the opening and closing of the device.

The internally threaded tube652includes and unthreaded portion657. A clutch spring656is positioned around an unthreaded proximal portion659of the retractor654. The clutch spring presses against a proximal end surface655of the threaded portion of the retractor654. Proximal movement of the actuation element112after closure of the device604can result in overclosure or compression of the valve repair device or treatment device. The position of the unthreaded portion657is selected to prevent or inhibit over-retraction of the actuation element112and thereby prevent or inhibit over-closing of the valve repair device. That is, the externally threaded retractor654is no longer driven proximally when the externally threaded nut or retractor654reaches the unthreaded portion657. The clutch spring is configured to bias the externally threaded retractor654distally (e.g., toward the threads of the internally threaded tube652) when the externally threaded retractor654has reached the end of the threads of the internally threaded tube652. Continued rotation of the knob626following disengagement of the external threads of the externally threaded retractor654and the internal threads of the internally threaded tube652results in an audible indication that the device is in a closed position. The biasing of the externally threaded retractor654can also reduce slop in the threaded connection, thereby improving stability of the paddle angle. The biasing of the externally threaded retractor654towards the internal threads of the internally threaded tube652ensures that the externally threaded retractor654will be re-engaged by the internally threaded tube652when the knob626is rotated in an opposite direction that corresponds to advancement of the actuation element112.

As shown inFIGS.79,80, and81, the externally threaded retractor654includes a central passage683. A crimp assembly668is coupled in the passage683. The crimp assembly attaches the actuation element112(e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.) that is in an actuation tube669to the paddle release knob630. The crimp assembly668can take a variety of different forms. In the illustrated example, the crimp assembly668comprises a collet687and a nut670. The collet687includes external threads and the nut includes internal threads. The collet and nut each have a central bore that is sized to receive the actuation tube669which surrounds the actuation element112. The actuation element112can be fixed to the actuation tube669near the proximal end of the actuation tube669. The actuation tube669is fixed to the crimp assembly668, which is fixed to the externally threaded retractor654. The external threads on the outer surface of the collet687engage with the internal threads of the nut670. When tightened, the collet687and nut670fix the crimp assembly to both the actuation tube669and a shoulder689at the proximal end of the retractor654. The nut is positioned within the central bore683of the externally threaded retractor654. A spring672is also positioned within the central bore683of the externally threaded retractor654such that the nut670is biased against the shoulder689. The positioning of the nut670against the shoulder689allows the collet687to be easily attached to the nut670.

In some implementations, in use, the knob626is rotated, which rotates the internally threaded tube652to rotate with respect to the housing632, thereby driving the externally threaded retractor654axially. The axial movement of the externally threaded retractor654causes axial movement of the actuation element112, which moves the device between a fully elongated configuration, an open configuration, and a closed configuration. Axial movement of the externally threaded retractor654also causes axial movement of the release knob630between a proximal, or extended, position (shown inFIG.84) and a distal, or retracted, position (shown inFIG.83). Accordingly, in implementations, the axial position of the release knob630with respect to the housing632is a visual indicator of the configuration of the device604.

When the device604is in a closed configuration (e.g., shown inFIG.21), the release knob630is in a proximal position, extending from the housing632, as shown inFIG.84. To release the device from the device/implant catheter assembly610, the release knob630is rotated in an unscrewing or loosening direction, which rotates the crimp assembly668, the actuation tube669, and the actuation element112. Rotation of the actuation element112extends down the length of the actuation element to the distal end portion112bof the actuation element, thereby unscrewing the actuation element112from the cap114of the device604.

As shown inFIGS.85-87, in implementations, the release knob630comprises an elongated shaft673and a plurality of teeth674extending from the outer surface of the elongated shaft673. Each of the plurality of teeth674are uniform, but asymmetrical in shape, with each of the plurality of teeth674having a moderate slope on one edge and a much steeper slope on the other edge. A ratchet insert676is positioned within the housing632of the handle616, between the elongated shaft673and the housing632. The ratchet insert676includes one or more pawls678flexibly mounted to a ratchet frame680. In implementations, the pawls678and the ratchet frame680are made from a unitary piece from a material that enables the pawls678to flex with respect to the ratchet frame680.

Each of the pawls678is in contact with the outer surface of the elongated shaft673. Accordingly, as the release knob630is rotated in the unscrewing or loosening direction, each pawl678slides up and over the edge of the tooth674with a moderate slope, and springs back into the area between the tooth and an adjacent tooth. In implementations, the springing back of the pawl into the area between teeth generates an audible indication that a tooth has been cleared. The edge of the tooth674with the steeper slope catches the pawl678prevents or inhibits the release knob630from being rotated in the opposite, tightening direction. Enabling a single direction of rotation of the release knob630prevents or inhibits torsion that can build up as a result of the torquing of the actuation element112during release of the device604from turning the release knob630back in the tightening direction.

Once the actuation element112is decoupled from the device604, the actuation element112can be withdrawn into the device/implant catheter assembly610, and the device/implant catheter assembly610can be withdrawn through the steerable catheter assembly608and the delivery catheter assembly606.

In implementations, a cap634(shown inFIG.89) is removably couplable to the proximal end of the handle to cover the release knob630and the suture locks650. Accordingly, the cap634can be positioned over the release knob630and suture locks650to prevent or inhibit the release knob630and suture locks650from being accidentally contacted or caught on something during manipulation of the device and removed to access the release knob630and suture locks650.

In implementations, the handle616shown and described inFIGS.77-88can be modified to include the width control elements described hereinabove (e.g., paddle width control1628inFIGS.70and71). As described above, the width control element or paddle width control element can take any one of a variety of forms and, in the implementation depicted inFIGS.89-99, the paddle width control element is in the form of a paddle width control knob890. In the implementation depicted inFIGS.89-99, the paddle width control knob890is configured as a rotatable knob that rotates about a central axis extending through the handle616without interfering with the clasp control tubes and/or clasp control lines624(shown inFIGS.77and78) that extend to the suture locks650positioned at the end of the handle616.

In implementations, such as the implementation depicted inFIG.90, the suture locks650are angled relative to the central axis to accommodate the components associated with the paddle width controls, while in some implementations, such as the implementation depicted inFIG.99, the suture locks650are parallel to the central axis. Accordingly, it should be appreciated that various modifications can be made to the handle616to incorporate the paddle width controls.

FIG.90illustrates various components of example anchor width controls or paddle width controls incorporated into the handle616. As shown inFIG.90, the width control or knob890is coupled to a planetary gearbox that includes a ring gear892, a pair of planet gears894(one shown inFIG.90), and an elongated central gear896. Accordingly, rotation of the width control knob890with respect to the handle616is effective to cause rotation of the elongated central gear896, which in turn is effective to move the width adjustment element (not shown inFIG.90) in an axial direction, thereby adjusting the width of the anchors or paddles, as described hereinabove.

The ring gear892is housed within a barrel898that is fixed to the width control or knob890such that rotation of the width control or knob890turns the barrel898and the ring gear892fixed within the barrel898. In the illustrated example, the axle of each planet gear894is fixed. Teeth of the ring gear892engage with teeth of the pair of planet gears894such that rotation of the ring gear892causes rotation of the planet gears894on their fixed axles. The teeth of the pair of planet gears894also engage with teeth of the elongated central gear896such that rotation of the pair of planet gears894causes rotation of the elongated central gear896.

In the implementation shown inFIG.90, the paddle release knob630extends from the end of the elongated central gear896. In implementations in which the handle616includes the paddle width control knob890, the paddle release knob630can function as the control element connection knob7308(shown and described inFIGS.73-75) to enable the device to be disengaged from the implant delivery system that includes the handle616.

FIG.91shows the planet gears894and the elongated central gear896in greater detail. As shown inFIG.91, the paddle release knob630is disposed at one end of a shaft900. A second end of the shaft900is coupled to a follower902. The follower902includes external threading that is configured to engage with internal threads of the elongated central gear896. However, the follower902is rotationally fixed such that as the elongated central gear896is rotated, the follower902is axially driven with respect to the elongated central gear896. The follower902is further fixedly coupled to the width adjustment element8211. Accordingly, axial movement of the follower902results in axial movement of the width adjustment element8211, which is effective to adjust the width of the paddles, as described above.

The elongated central gear896is positioned within the handle616proximate the externally threaded retractor654and receives a shaft904extending from one end of the externally threaded retractor654. The shaft904is rotatably coupled to the elongated central gear896adjacent the follower902. The width adjustment element8211extends through a central passage of the shaft904and the externally threaded retractor654. A clip906axially fixes the shaft904with respect to the elongated central gear896. As described above, the externally threaded retractor654is rotationally fixed relative to the housing of the handle616and is configured to open and close the device coupled to the handle616as it is driven axially. The elongated configuration allows the elongated central gear896to maintain meshing contact with the planet gears894as the elongated central gear moves axially with the externally threaded retractor654. Rotation of the elongated central gear896is effective to drive the follower902axially with respect to the externally threaded retractor654. The movement of the follower902relative to the externally threaded retractor654is effective to move the width adjustment element8211with respect to the actuation portion of the device, thereby adjusting the width of the paddles.

FIG.93shows the barrel898extending from the handle616and surrounding various other components housed within the handle616. Extending from the end of the barrel898, the follower902can be seen in position without being obstructed by the elongated central gear896. As shown inFIG.94, a guide908extends around the follower902and is configured to prevent or inhibit the follower902from rotating. The guide908is rotationally fixed with respect to the handle616.

InFIG.95, the elongated central gear896is shown extending from one end of the barrel898. The guide908and the follower902extend through a central passage of the elongated central gear896. As described above, rotation of the elongated central gear896is effective to drive the follower902axially, since rotation of the follower902is prevented or inhibited by the guide908. The external teeth of the elongated central gear896engage with the teeth of the pair of planet gears894, one of which is shown inFIG.96.

FIG.96also shows a carrier910, which is part of the planetary gearbox. The carrier910is fixedly coupled to a portion of the handle616, such as the housing632, and provides support for the axels and gears (e.g., the pair of planet gears894). To facilitate coupling to the handle616, the carrier910is attached to a coupler912. In the implementation shown in the Figures, the coupler912is configured to receive a screw (e.g., screw914inFIG.99). However, in some implementations, the coupler912can take other forms or can be omitted, provided that the carrier910is otherwise coupled to the handle616.

FIG.97shows the carrier and pair of planet gears in position within the barrel898. The ring gear892is positioned within the barrel898to engage with the pair of planet gears894. The elongated central gear896extends between and engages with the pair of planet gears894.

FIG.98is an end view of the handle616showing the planetary gear box. More particularly,FIG.98shows the control or knob626, clasp control member628, and the paddle width control890, in addition to the ring gear892, the pair of planet gears894and the elongated central gear896. As shown by the arrows, counter-clockwise rotation of the paddle width control890causes counter-clockwise rotation of the ring gear892, which turns the pair of planet gears894counter-clockwise. The counterclockwise rotation of the pair of planet gears894rotates the elongated central gear896clockwise. As described above, the rotation of the elongated central gear896is effective to drive the width adjustment element8211axially, thereby adjusting the width of the paddles of the device.

FIG.99depicts the housing632positioned about the barrel898. As described above, a screw914extends through the housing632and is received by the coupler912to fix the carrier910with respect to the handle616. In implementations, the housing632includes features that enable the cap634(FIG.89) to be coupled to the housing632.

FIG.100illustrates an implementation of a handle3616of a device/implant catheter assembly3610(e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.) and/or delivery system used to deliver a device or implant, such as the device8200(FIG.67). While described regarding delivery of the device8200, the handle3616can be used to deliver any suitable device or implant, such as any of the devices described herein. In the example ofFIG.100, the handle3616has a distal end3617and a proximal end3619opposite the distal end3617. The handle3616can include some or all of a housing3632, a paddle actuation portion3625having a paddle actuation control3626, a clasp actuation portion3631having one or more clasp control members3628, a paddle width control portion3627having a paddle width control3629, and a release control3630(FIG.101).

As shown inFIGS.100-102and discussed below, in some implementations of the handle3616, the clasp actuation portion3631, the paddle actuation portion3625, the paddle width control portion3627, and the release control3630are arranged is series in the handle3616. For example, in some implementations, the clasp actuation portion3631is positioned distally from the paddle actuation portion3625which is positioned distally from the paddle width control portion3627which is positioned distally from the release control3630in series in the handle3616.

The housing3632can be formed from various materials, including polymers such as polycarbonate, and can be formed as a unitary body (e.g., through injection molding) or fastened together in any one of a variety of manners, including fasteners, pins, adhesives, or the like. As shown inFIGS.101-102, the housing3632comprises a plurality of lumens, through which the clasp actuation lines3624, the actuation element (e.g., actuation rod, actuation tube, actuation wire, actuation shaft, etc.)8102, and the width control element8211extend.

The handle3616can further comprise a flush port3638similar to the flush port638of the handle616ofFIG.77. Additional information regarding a flush port that can be used in the handle3616can be found in, for example, International Publication No. WO 2020/112622, the entire contents of which is incorporated by reference herein. The housing3632can additionally comprise an aperture for receiving a marking pin3640that can be removably coupled with the aperture of the housing3632for storage of the marking pin3640. The aperture for the marking pin3640can be similar to the aperture for the marking pin640of the handle616ofFIG.77.

In some implementations, the paddle actuation control3626is configured to control the position of the actuation element8102relative to the handle3616and the catheters of delivery assembly. The paddle actuation control3626can 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 control3626can be a lead screw mechanism that converts rotational motion to linear motion. For example, in some implementations, the paddle actuation control3626is configured to rotate about a longitudinal axis B of the handle3616to control movement of a mechanism (e.g., line, shaft, screw, internally threaded component, externally threaded component, lever, pulley, or any combination thereof) within the handle3616to control the position of the actuation element8102. In some implementations, the paddle actuation control3626can include one or more linear actuators (e.g., electric actuator, manual actuator, pneumatic actuator, and/or hydraulic actuator) to control movement of a mechanism (e.g., line, shaft, screw, internally threaded component, externally threaded component, lever, pulley, or any combination thereof) within the handle3616. A user interface, such as one or more actuation buttons, a touch screen, voice command interface or other suitable interface, can be provided (e.g., mounted on the handle housing and/or in the handle housing) and operatively connected to the linear actuators to allow a user to control the position of the actuation element8102.

In the illustrated example ofFIGS.101-102, the paddle actuation control3626can be fixedly coupled to a first internally threaded tube3652positioned within the housing3632of the handle3616. In some implementations, when the paddle actuation control3626is rotated about the longitudinal axis B of the handle3616, the first internally threaded tube3652rotates with respect to the housing3632. In some implementations, an externally threaded nut or retractor3654is positioned within, and engaged with, the first internally threaded tube3652. The externally threaded nut or retractor3654can be rotationally fixed with respect to the housing3632. The externally threaded nut or retractor3654can be rotationally fixed in a wide variety of different ways. In the example illustrated byFIG.101, a pair of guide rods3661extend axially within the handle3616, and each of the pair of guide rods3661is fixed to the housing3632at both ends of each of the guide rod3661. In some implementations, a mounting bracket3663can optionally be included to couple the pair of guide rods3661to the housing3632at the distal end of each of the pair of guide rods3661and a collar3666couples the pair of guide rods3661to the housing3632at the proximal end of each of the pair of guide rods3661. In some implementations, the system is configured such that as the first internally threaded tube3652is rotated, the externally threaded retractor3654is advanced linearly in an axial direction (i.e., distally and proximally) along the pair of guide rods3661.

In some implementations, the externally threaded retractor3654is connected to a proximal end of the actuation element8102such that linear movement of the externally threaded retractor3654causes linear movement of the actuation element8102, thereby moving the device8200between an open configuration and a closed configuration, as described herein. The proximal end of the actuation element8102can connect to the externally threaded retractor3654in any suitable manner. In the illustrated example, the proximal end of the actuation element8102is fixed to the externally threaded retractor3654. The proximal end of the actuation element8102can be fixed to the externally threaded retractor3654in any suitable manner, such as by a ferrule3612, or other crimped connection, positioned within a distal portion of a central longitudinal passage3683extending through the externally threaded retractor3654. The translation of the rotational movement of the paddle actuation control3626into linear motion of the actuation element8102can result in improved control and precision, thereby leading to improved precision during the opening and closing of the device8200.

The first internally threaded tube3652includes a proximal unthreaded portion3657. Proximal movement of the actuation element8102after closure of the device8200can result in overclosure or compression of the device. The position of the unthreaded portion3657is selected to prevent or inhibit over-retraction of the actuation element8102and thereby prevent or inhibit over-closing of the device8200. That is, the externally threaded retractor3654is no longer driven proximally when the externally threaded nut or retractor3654reaches the unthreaded portion3657.

In some implementations, one or more optional springs3656or other suitable biasing elements, can be positioned to press against one or more proximally facing surfaces3655of the externally threaded retractor3654. As shown inFIG.101, the illustrated example includes a pair of springs3656, with each spring3656received around a corresponding one of the pair of guide rods3661. The springs3656are configured to bias the externally threaded retractor3654distally (e.g., toward the threads of the first internally threaded tube3652) when the externally threaded retractor654has reached the end of the threads of the first internally threaded tube3652. In some implementations, the system and handle are configured such that continued rotation of the paddle actuation control or knob3626following disengagement of the external threads of the externally threaded retractor3654and the internal threads of the first internally threaded tube3652results in an audible indication that the device is in a closed position. The biasing of the externally threaded retractor3654can also reduce slop in the threaded connection, thereby improving stability of the paddle angle. The biasing of the externally threaded retractor3654towards the internal threads of the first internally threaded tube3652ensures that the externally threaded retractor3654will be re-engaged by the first internally threaded tube3652when the paddle actuation knob3626is rotated in an opposite direction that corresponds to advancement of the actuation element8102.

As shown inFIGS.101-102, in some implementations, the externally threaded retractor3654includes a proximally extending stem3682having a radial shoulder3684in the central longitudinal passage3683that acts as a stop. In some implementations, the width adjustment element8211extends through the interior of the actuation element8102, through the central longitudinal passage3683, and out of a proximal end of the stem3682. In some implementations, an annular stop3686is attached to the exterior of the width adjustment element8211within the central passage3683, such as to the optional illustrated reinforcement tube8212that is fixed to the proximal portion of the width adjustment element. The annular stop3686is movable within the central longitudinal passage3683and configured to engage the radial shoulder3684to prevent or inhibit further proximal movement of the width adjustment element8211relative to the actuation element8102. As such, when the annular stop3686reaches the radial shoulder3684, the width adjustment element8211, the externally threaded retractor3654, and the actuation element8102all move together when the width adjustment element is moved further proximately.

In some implementations, the handle3616includes an extension or link3688configured to transfer proximal motion of the externally threaded retractor3654to the width control portion3627. The link3688can be configured in a variety of ways. In the illustrated example ofFIGS.101-102, the link3688is formed as an elongated tube having a distal end3690, a proximal end3692opposite the distal end3690, and a central longitudinal passage3694extending through the link3688. The width adjustment element8211extends through the central longitudinal passage3694. The central longitudinal passage3694includes a counterbore3696at the distal end3690and a radial flange3698at the proximal end3692. The counterbore3696is configured to receive the proximal end of the stem3682within the central longitudinal passage3694. The radial flange3698defines a proximally facing engagement surface3699.

The width control3629is configured to control the width of a portion of the anchors of the device, e.g., to control the width of the outer paddles8120of the device8200. The width control3629can 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 width control3629can be a lead screw mechanism that converts rotational motion to linear motion. For example, in some implementations, the width control3629is configured as a knob that rotates about the longitudinal axis B of the handle3616to control movement of a mechanism (e.g., line, shaft, screw, internally threaded component, externally threaded component, lever, pulley, or any combination thereof) within the handle3616to control the position of the width control element8211. In some implementations, the width control3629can include one or more linear actuators (e.g., electric actuator, manual actuator, pneumatic actuator, and/or hydraulic actuator) to control movement of a mechanism (e.g., line, shaft, screw, internally threaded component, externally threaded component, lever, pulley, or any combination thereof) within the handle3616. A user interface, such as one or more width control inputs, such as one or more actuation buttons, a touch screen, voice command interface or other suitable interface, can be provided (e.g., mounted on the handle housing and/or in the handle housing) and operatively connected to the linear actuators to allow a user to control the position of the width control element8211.

As can be seen in the example inFIGS.101-102, in some implementations, the width control3629is fixed to a rotatable barrel3700such that rotation of the width control3629rotates the barrel3700about the longitudinal axis B of the handle3616. The barrel3700has a distal end3702rotatably coupled to the housing3632and a proximal end3704defining a cavity3706within which the release control3630is received. In some implementations, the barrel3700is operatively coupled to a second internally threaded tube3708positioned within the housing3632of the handle3616such that rotation of the barrel3700about the longitudinal axis B, via the width control3629, rotates the second internally threaded tube3708relative to the housing3632. In the illustrated example, the second internally threaded tube3708can also move axially relative to the housing3632. The distal end of the second internally threaded tube3708abuts the proximally facing engagement surface3699of the radial flange3698of the link3688such that axial movement of the link3688moves the second internally threaded tube3708proximally. The proximal end of the second internally threaded tube3708abuts an end cap3710.

The connection between the barrel3700and the second internally threaded tube3708can be any suitable connection that provides for rotational movement of the second internally threaded tube3708in response to rotation of the barrel3700while also allowing for axial movement of the second internally threaded tube3708. In the illustrated example, the barrel3700connects to the second internally threaded tube3708via a splined connection.

The second internally threaded tube3708includes a central longitudinal passage3712. Positioned within the central longitudinal passage3712is an externally threaded drive member3714and a cap3715. The externally threaded drive member3714is configured to engage the internal threads of the second internally threaded tube3708. The cap is positioned at a distal end of the externally threaded drive member3714.

In some implementations, the externally threaded drive member3714is rotationally fixed with respect to the housing3632. The externally threaded drive member3714can be rotationally fixed in a wide variety of different ways. In the example illustrated byFIGS.101-102, a pair of guide rods3716extend axially through the central longitudinal passage3712of the second internally threaded tube3708. Each of the pair of guide rods3716is fixed relative to the housing3632at both ends of the guide rod3716. The pair of guide rods3716mount to the housing3632at the distal end of each of the pair of guide rods3716and the proximal end of each of the guide rods3716are fixed to the end cap3710. Accordingly, as the barrel3700is rotated, the externally threaded drive member3714is advanced linearly in an axial direction (i.e., distally and proximally) along the pair of guide rods3716. In some implementations, the externally threaded drive member3714can include longitudinal grooves (not shown) that receive the pair of guide rods3716.

In the illustrated example, the externally threaded drive member3714is configured as a tube having a central longitudinal passage3718extending through the externally threaded drive member3714. The central longitudinal passage3718includes a threaded nut3720adjacent a proximal end of the externally threaded drive member3714. In some implementations, instead of a threaded nut, internal threads can be formed integrally within the passage3718of the externally threaded drive member3714. A biasing member, such as a coil spring3722can be positioned within the central longitudinal passage3718between the threaded nut3720and the cap3715to bias the threaded nut3720toward the proximal end of the central longitudinal passage3718.

The release control3630is configured to release the device8200from the device/implant catheter assembly3610. The release control3630can 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 control3630can be a lead screw mechanism that converts rotational motion to linear motion. In some implementations, the release control3630can be a release button configured to release the device upon depression of the button. In some implementations, the release control3630can include one or more linear actuators (e.g., electric actuator, manual actuator, pneumatic actuator, and/or hydraulic actuator) to control movement of a mechanism (e.g., line, shaft, screw, internally threaded component, externally threaded component, lever, pulley, or any combination thereof within the handle3616. A user interface, such as one or more buttons, a touch screen, voice command interface or other suitable interface, can be provided (e.g., mounted on the handle housing and/or in the handle housing) and operatively connected to the linear actuators to allow a user to release the device.

In the illustrated example, the release control3630is configured as a knob that rotates about the longitudinal axis B of the handle3616. As can be seen inFIGS.101-102, the release control3630is positioned at the proximal end3619of the handle3616and is received within the cavity3706of the barrel3700. In some implementations, the handle3616includes a stem3724attached proximally to the release control3630and extending distally toward the externally threaded drive member3714. A release screw3726is threadably received in the threaded nut3720in the externally threaded drive member3714. The distal end of the stem3724is configured to engage a head of the release screw3726such that the release screw3726can be screwed into, or unscrewed from, the threaded nut3720by rotational movement of the release control3630.

In some implementations, the width adjustment element8211extends through the length of the handle3616from the distal end3617to the release control3630where it is fixed such that movement of the release control3630results in corresponding movement of the width adjustment element8211. In some implementations, at least a portion of the width adjustment element8211is received within a support tube8212(e.g., a hypotube) within the handle3616. The support tube8212can be fixed at the release control3630along with the width adjustment element8211. The support tube8212is configured to add strength to the portion of the width adjustment element8211within the handle3616. The handle3616can also include a cover or cap3728over the release control3630to prevent or inhibit unintended release of the device8200.

FIGS.103-105illustrate an example clasp actuation portion3631of the handle3616. The illustrated clasp actuation portion3631includes the clasp control members3628which are configured to move the clasps of the device via clasp actuation lines (e.g., clasps8134of device8200via actuation lines8102as shown inFIGS.122-124). The clasps8134can be configured in the same manner as any of the clasps described herein. The clasp actuation portion3631can be configured in a variety of ways. In some implementations, the device/implant catheter assembly3610includes two clasp actuation lines3624(FIGS.120-121), each coupled to a corresponding clasp control member3628at the proximal end of the clasp actuation lines3624. Each clasp control member3628can be, for example, an axially movable control or slider coupled to a corresponding clasp actuation line3624to axially move the clasp actuation line3624relative to the actuation element8102. Each of the clasp control members3628can be operated independently of the other clasp control member such that each clasp actuation line3624is moved relative to the actuation element8102and the other clasp actuation line3624. The clasp control members3628can also be fixed with respect to one another (e.g., locked) such that the clasp actuation lines3624are axially moved together relative to the actuation element8102.

The clasp control members3628can be configured in a variety of ways, including similar to any clasp control member disclosed herein. In the implementation depicted inFIG.103, the clasp control members3628are similar to the clasp control members628ofFIG.77, and thus the previous description of the clasp control members3628applies equally to the clasp control members3628shown inFIG.103. The handle3616includes a pair of line-engaging members3730configured to engage the clasp actuation lines3624to move the lines in response to movement of the clasp control members3628. The line-engaging members3730can be configured in a variety of ways. In the illustrated example, each line-engaging member3730is configured as an elongated rod having a proximal end fixed to a corresponding clasp control member3628and a distal end configured to engage a corresponding clasp actuation line3624. In the illustrated example, the distal end of each line-engaging member3730includes a laterally extending passage3732through which a clasp actuation line3624can extend.

In some implementations, the handle3616can include a fluid body housing3734positioned within the housing3632of the handle3616. The fluid body housing includes a distal stem3736defining a passage3738, a main body portion3740defining an interior space3742, and a proximal cap3744. The proximal cap3744includes a plurality of orifices3746configured to allow the actuation element8102and the width adjustment element8211to extend through proximal cap3744. In addition, each of the pair of line-engaging members3730extends distally from the clasp control members3628through a corresponding orifice3746in the proximal cap3744and into the interior space3742. The main body portion3740further includes a line anchor3748to which the proximal ends of the clasp actuation lines3624attach. The line anchor3748can be configured in a variety of ways, including location, orientation, and anchoring means. In the illustrated example, the line anchor3748includes a passage3750from the interior space3742to the exterior of the main body portion3740and a boss3752surround the passage3750to which the clasp actuation lines3624attach.

FIGS.106-114illustrate various stages of an example deployment of an example device8200by the handle3616. The handle3616can be used to deploy any of the devices disclosed herein, such as the repair device or treatment device8200,100,200,300,402,9100, etc. As shown inFIG.107, the device8200is in a fully elongated position where the outer paddles8120and the inner paddles8122are fully extended and clasps8134are in a fully open position. In addition, the outer paddles8120are in the expanded position.

As shown inFIG.106, when the device200is in the fully open position, the externally threaded retractor3654is in a distal most position within the first internally threaded tube3652, the radial flange3698is positioned near or adjacent the collar3666, and the release control3630is positioned within the cavity3706of the barrel3700.

To move the device200through the partially closed condition (FIG.109) and to the fully closed condition (FIG.110), the actuation element8102is retracted causing the paddles to move radially outward, as shown inFIG.109and, in the fully closed position, be positioned alongside the clasps8134.

To retract the actuation element8102, the paddle actuation control3626is rotated, which rotates the first internally threaded tube3652to rotate with respect to the housing3632, thereby driving the externally threaded retractor3654axially in the proximal direction, as shown inFIG.108. The axial movement of the externally threaded retractor3654causes axial movement of the actuation element8102, which moves the device8200between the fully extended configuration (FIG.107) and the closed configuration (FIG.110).

Axial movement of the externally threaded retractor3654also causes axial movement of the second internally threaded tube3708via the link3688. Axial movement of the second internally threaded tube3708causes axial movement of the release control3630between a position within the cavity3706of the barrel3700(shown inFIG.106) to an extended position where the release control3630extends proximately from the cavity3706of the barrel3700(shown inFIG.108). Accordingly, in implementations, the axial position of the release control3630with respect to the housing3632is a visual indicator of the configuration of the device8200.

As shown inFIG.112, the device8200is in the fully closed position and the outer paddles8120are in the expanded or widened position. In this position, as shown inFIG.111, the link3688, the release control3630, the second internally threaded tube3708, and the components within the second internally threaded tube3708(e.g., the externally threaded drive member3714) have moved axially such that the radial flange3698of the link3688is position within the distal end3702of the barrel3700.

To move the outer paddles8120from the expanded position (FIG.112) to the narrowed position (as shown by arrows N inFIG.114), the width adjustment element8211is retracted. WhileFIGS.111and113illustrate the device8200in the fully closed position when the outer paddles8120are moved from the expanded position to the narrowed position, the outer paddles8120can also be moved between the expanded and narrowed positions while the device8200is in the fully extended position, the open position or any partially closed position. Retracting the width adjustment element8211causes the inner end8968of the paddle frames8224(FIG.69) and portions of the connector8266to be pulled into the actuation cap8214(as shown by arrow C inFIG.114).

To retract the width adjustment element8211, the width control3629is rotated, which rotates the barrel3700and the second internally threaded tube3708relative to the housing3632, thereby driving the externally threaded drive member3714axially in the proximal direction, as shown inFIG.113. The axial movement of the externally threaded drive member3714causes axial movement of the release control3630via the stem3724. Since the width adjustment element8211is attached to the release control3630, the axial movement of the release control3630causes axial movement of the width adjustment element8211to move the outer paddles8120of the device8200to the narrowed position. With the axial movement of the width adjustment element8211, the annular stop3686moves axially within the central longitudinal passage3683of the externally threaded retractor3654(e.g., axial movement relative to the externally threaded retractor3654).

FIGS.115-117illustrate the handle3616at various stages of release of the device8200. InFIG.115, with the cover3728over the release control3630, the handle3616is shown in the same position as inFIG.113(e.g., the device8200is in the fully closed position and the outer paddles8120are in the narrowed position). To release the device8200, the width adjustment element8211is decoupled from the coupler8972of the device8200(FIG.68-69). To decouple the width adjustment element8211from the coupler8972, the cover3728is removed from over the release control3630and the release control3630is rotated, as shown by arrow R inFIG.116. Rotating the release control3630rotates the release screw3726to unscrew the release screw3726from the threaded nut3720within the handle3616while also rotating the width adjustment element8211to unscrew the width adjustment element8211from the coupler8972within the device8200. Unscrewing the release screw3726from the threaded nut3720also decouples the width adjustment element8211from the width control3629.

Once the release screw3726and width adjustment element8211are unscrewed from the threaded nut3720and the coupler8972, respectively, the release control3630can be pulled axially away from the barrel3700, as shown by arrow B inFIG.117. As the release control3630is pulled axially away, the width adjustment element8211is pulled with the release control3630resulting in the annular stop3686moving axially within the central longitudinal passage3683.

In the example illustrated inFIG.118, the device8200is coupled to the device/implant catheter assembly by a capture mechanism3760. The actuation element8102extends through the device/implant catheter assembly, through the capture mechanism3760, and is attached to the device8200by a coupler8213. InFIG.118, the device8200is illustrated in the open condition to provide an unobstructed view of the coupler8213. During release of the device8200, however, the device8200will be in the fully closed position. In the illustrated example ofFIG.118, the distal end of the actuation element8102is received within the coupler8213and include two longitudinally extending legs8215separated by a slot8216. The longitudinally extending legs8215can be configured (e.g., shape-set) to be biased inward toward each other. The width adjustment element8211(not shown inFIG.118) extends coaxially within the actuation element8102and presses the longitudinally extending legs8215outward away from each other, which couples the actuation element8102to the coupler8213. Various different capture mechanisms are possible that function in similar or different ways, e.g., threaded portions, snap-fit connections, locks, clasps, suture, loops, etc.

In some implementations, after the release screw3726and width adjustment element8211are unscrewed from the threaded nut3720and the coupler8972, respectively, as the release control3630is pulled axially in the proximal direction, the width adjustment element8211is withdrawn relative to the actuation element8102. Once the width adjustment element8211is withdrawn past the coupler8213, the two longitudinally extending legs8215move inward to decouple the actuation element8102from the coupler8213.

As shown in the example ofFIG.117, sufficient axial movement of the annular stop3686within the central longitudinal passage3683can result in the annular stop3686engaging the radial shoulder3684at the proximal end of the central longitudinal passage3683. As a result, since the externally threaded retractor3654is in the proximal unthreaded portion3657of the first internally threaded tube3652(e.g., not engaged with the internal threads of the first internally threaded tube3652), the externally threaded retractor3654is pulled with the release control3630and the width adjustment element8211with further axially movement of the release control3630. Since the actuation element8102is attached to the externally threaded retractor3654and detached from the coupler8213, the actuation element8102is pulled axially relative to the housing3632as well. The actuation element8102can be pulled until a proximal end of the actuation element clears the coupler3760to release the coupler from the device.

FIG.119illustrates an example clasp actuation line3624. The clasp actuation line3624can be configured in a variety of ways, including, but not limited to, the materials used, the construction (e.g., braiding), the length, and the diameter. In the illustrated example ofFIG.119, the clasp actuation line3624includes a proximal or terminal end3754, a distal end3756opposite the proximal terminal end3754, and a closed opening3758, such as a loop or eyelet, formed at the distal end3756. The distance between the proximal terminal end3754and the distal end3756define a length L of the clasp actuation line3624. In some implementations, the length Lis less than 100 inches or is less than 80 inches. In some implementations, the length is in the range of 65 inches to 75 inches, or 68 inches to 72 inches.

FIGS.120-124illustrate a simplified or schematic view (FIGS.120-121) and a more detailed view (FIGS.122-124) of the example device/implant catheter assembly3610coupled to the device8200, in which each of the clasp actuation lines3624is coupled to a corresponding clasp control member3628positioned on the handle3616. The device8200is coupled to the device/implant catheter assembly3610by the capture mechanism3760through which the actuation element8102(e.g.,FIG.120) extends.

In some implementations, the proximal end of each clasp actuation line3624is attached to the line anchor3748. Each clasp actuation line3624extends from the line anchor3748, passes through the passage3732at the distal end of each line-engaging member3730, and extends distally through the device/implant catheter assembly3610(e.g., into a catheter/sheath) to the device8200. At the device, each clasp actuation line3624extends through an opening8235in a corresponding one of the clasps8134of the device8200and the closed loop3758attaches to the capture mechanism3760. The capture mechanism3760is configured to releasably attach the device8200to the device/implant catheter assembly3610. The closed loops3758can attach to any suitable portion of the capture mechanism3760that allows the clasp actuation lines3624to be released when the capture mechanism3760releases the device8200.

The capture mechanism3760can be configured in a variety of ways. In the example illustrated inFIGS.120-124, the capture mechanism3760includes a plurality of flexible arms8228that are configured to pivot between a first or release configuration (FIGS.121,123-124) and a second or coupled configuration (FIGS.120and122). The flexible arms8228are held in the coupled configuration by the actuation element8102. When the actuation element8102is retracted from the capture mechanism3760, the flexible arms8228pivot open to release the device8200from the device/implant catheter assembly3610(FIGS.121and123-124). When the flexible arms3672pivot open, the closed loops3758at the distal ends3756of the clasp actuation lines3624are released from the capture mechanism3760allowing the clasp actuation lines3624to be withdrawn through the openings8235in the clasps8134and removed with the device/implant catheter assembly3610.

FIGS.125-127illustrate the example capture mechanism3760through various stages of releasing the device8200. The capture mechanism3760can be releasably coupled to a proximal collar8251of the device8200. The capture mechanism3760includes the plurality of flexible arms8228and a plurality of stabilizer members8230. The flexible arms8228and the stabilizer members8230can be configured in a variety of ways. In the illustrated example, the stabilizer members8230are formed as longitudinally projecting fingers or prongs having a distal terminal end. The flexible arms8228can comprise apertures8232and eyelets8234. The flexible arms8228can be configured to pivot between a first or release configuration (FIGS.126-127) and a second or coupled configuration (FIG.125). In the first configuration, the flexible arms8228extend radially outwardly relative to the stabilizer members8230. In the second configuration, the flexible arms8228extend axially parallel to the stabilizer members8230and the eyelets8234radially overlap. The flexible arms8228can be configured (e.g., shape-set) to be biased to the first configuration.

The proximal collar8251of the device8200can include a central opening8252configured to slidably receive the actuation element8102. The proximal collar8251can also include a plurality of bosses or projections8254and a plurality of guide openings8255. The projections8254can extend radially outwardly and can be circumferentially offset (e.g., by about 90 degrees) relative to the guide openings8255. The guide openings8255can be disposed radially outwardly from the central opening8252. The projections8254and the guide openings8255of the proximal collar8251can be configured to releasably engage the capture mechanism3760, as shown inFIG.125, to attach the device8200to the device/implant catheter assembly. In particular, as shown inFIG.125, when the capture mechanism3760is in the coupled configuration, the plurality of bosses or projections8254are received in the apertures8232of the flexible arms8228, the plurality of stabilizer extensions or stabilizer members8230are received in the guide openings8255, and the actuation element8102is received through the radially overlapping eyelets8234. In addition, the clasp actuation lines3624are attached to the capture mechanism3760by receiving each of the stabilizer extensions/members8230through the closed loop3758of a corresponding clasp actuation line3624before the stabilizer extension/member8230is received in the guide openings8255. Thus, the closed loop3758is captured between the proximal collar8251of the device8200and the capture mechanism3760.

Referring toFIGS.126-127, in some implementations, the device8200can be released from the device/implant catheter assembly by retracting the actuation shaft8102proximally relative to the capture mechanism3760such that the distal end portion of the actuation shaft8102withdraws from the eyelets8234of the capture mechanism3760. This allows the flexible arms8228of the capture mechanism3760to move radially outwardly away from the projections8254of the proximal collar8251. The stabilizer extensions or stabilizer members8230of the capture mechanism3760can then be withdrawn from the guide openings8255of the proximal collar8251by pulling the capture mechanism3760proximally, as shown by arrow Y inFIG.126. With the stabilizer members8230withdrawn from the guide openings8255, the closed loops3758are no longer trapped on the stabilizer extensions/members8230by the proximal collar8251. As a result of pulling the capture mechanism3760proximally, the stabilizer members8230withdraw from the closed loops3758freeing the clasp actuation lines3624. The clasp actuation lines3624can then be retracted through the opening8235in the clasps8134thereby releasing the device8200from the device/implant catheter assembly. as shown inFIG.127.

FIGS.128-137illustrate various implementations of the clasp actuation line3624ofFIG.119, including various configurations of the distal end3756of the clasp actuation line3624. The clasp actuation line3624can be configured in a variety of ways, including, but not limited to, the materials used, the construction (e.g., braiding), the line length, the line diameter, shape, and the diameter of the closed loop3758. In some implementations, the clasp actuation line3624is braided. The braided clasp actuation line3624can comprise any suitable number and size of yarns. For example, the clasp actuation line3624can be a braid having 4 to 100 ends using 10 to 400 dtex yarn. In some implementations, the clasp actuation line3624is a 16-end braid of 25 dtex yarn, is a 32-end braid of 10 dtex yarn, is an 8-end braid of 55 dtex yarn or is a 4-end braid of 110 dtex yarn.

In some implementations, the clasp actuation line3624has a tensile strength in the range of 20-100 N, or 30-70 N, or 30-50 N. In some implementations, the clasp actuation line3624is made from an ultra-high-molecular-weight polyethylene material, such as for example, Dyneema® fibers. In some implementations, the closed loop3758of the clasp actuation line3624has 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 line3624has 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 line3624has a permanent deformation of less than 0.5% under a cyclic load of 0 to 10 N, or less than 0.3% under a cyclic load of 0 to 10 N.

Referring toFIGS.128-129, the illustrated example of the clasp actuation line3624has an elongated braided body3767having a bifurcated section3762that forms the closed loop3758and a unitary section3764that forms the remainder of the clasp actuation line3624. The bifurcated section3762can be formed as part of a braiding process, as opposed to forming a loop in a unitary section of a braided line after that line has been braided. In some implementations, the clasp actuation line3624can be made in a continuous process where multiple clasp actuation lines are formed in a single continuous braided line3766with alternating bifurcated and unitary sections and then cut into multiple clasp actuation lines. In some implementations, however, only a single clasp actuation line3624can be formed.

To form the clasp actuation line3624from a single continuous braided line3766. A section of the single continuous braided line3766having the desired length and one bifurcated section3762is cut from the continuous braided line3766with the bifurcated section3762near an end (e.g., near where the continuous braided line3766is cut). The end near the bifurcated section3762forms the distal end3756of the clasp actuation line3624. The distal end3756can be heat sealed or treated, or sealed or treated in another manner, to prevent or inhibit separation of the yarns at the distal end3756.

Referring toFIGS.130-131, the illustrated example of the clasp actuation line3624has an elongated braided body3767having a distal terminal end portion3768of the braided body3767tucked back into a more proximal portion of the braided body3767to form the closed loop3758and a tucked-in portion3771. The terminal end portion3768can be tucked-in the braided body3767in a number of ways. In the illustrated example, a pull line or needle3770is tied to or connected to the terminal end portion3768, as shown inFIG.131. The pull line3770is inserted axially through a portion of the braided body3767proximal of the terminal end portion3768. For example, a needle or other piercing device (not shown) can be attached to the pull line3770and used to thread the pull line3770axially along a portion of the braided body3767to form the closed loop3758. In some implementations, the terminal end portion3768can attach directly to the needle or other piercing device. The tucked-in portion3771has a tucked-in length TL (FIG.131) that can vary in different implementations. In some implementations, the tucked-in length TL is 0.25 inches or greater, is 0.5 inches or greater, is 1.0 inches or greater, or is 1.5 inches or greater. In some implementations, the tucked-in length is in the range of 0.25 inches to 1.5 inches.

Referring toFIGS.132-133, the illustrated example of the clasp actuation line3624has a braided body3767that uses a Brummel lock-splice, or other method of threading a distal terminal end portion3768of the braided body3767through a more proximal portion of the braided body3767, to form a closed loop3758at a distal end3756. The distal terminal end portion3768can be attached to a piercing device3769, such as a splicing needle. As shown inFIG.132, the piercing device3769, with the distal terminal end portion3768attached, can be inserted laterally through a more proximal portion of the braided body3767to form a threaded portion3773proximal the closed loop3758, as shown inFIG.133. The distal terminal end portion3768can be threaded back and forth through the braided body3767at locations adjacent each other along the braided body3767any suitable number of times to lock the closed loop3758in place and secure the distal terminal end portion3768. The exposed distal terminal end portion3768after being woven back and forth through the braided body3767can be cut-off, secured against the braided body3767in any suitable manner, or tucked-in a portion of the braided body3767.

Referring toFIGS.134-135, the illustrated example of the clasp actuation line3624has an elongated braided body3767and forms a closed loop3758at a distal end3756via a combination of weaving a distal terminal end portion3768of the braided body3767through a more proximal portion of the braided body3767to form a threaded portion3773and tucking the distal terminal end portion3768axially into the braided body3767to form a tucked-in portion3771(e.g., a combination of the methods described for the clasp actuation lines3624ofFIGS.130-133). In the illustrated example, the tucked-in portion3771is proximal the threaded portion3773.

In particular, the distal terminal end portion3768can be attached to a piercing device3769, such as a splicing needle. As shown inFIG.134, the piercing device3769, with the distal terminal end portion3768attached, can be inserted laterally through a more proximal portion of the braided body3767to form the closed loop3758, as shown inFIG.133. The distal terminal end portion3768can be threaded back and forth through the braided body3767at locations adjacent each other along the braided body3767any suitable number of times to lock the closed loop3758in place and secure the distal terminal end portion3768. After weaving laterally through the braided body3767one or more times, the piercing device3769can be inserted axially through a portion of the braided body3767and pulled through to pull the distal terminal end portion3768into the braided body3767axially along a portion of the braided body3767to lock the closed loop3758in place and secure the distal terminal end portion3768. The tucked-in portion3771has a tucked-in length TL that can vary in different implementations. In some implementations, the tucked-in length TL is 0.25 inches or greater, is 0.5 inches or greater, is 1.0 inches or greater, or is 1.5 inches or greater. In some implementations, the tucked-in length is in the range of 0.25 inches to 1.5 inches.

Referring toFIGS.136-137, the illustrated example of the clasp actuation line3624has a braided body3767having a closed loop3758formed at a distal end portion3768. In the illustrated example, the closed loop3758is formed by piercing a distal end portion3768laterally with any suitable piercing device3769, such as a needle or pin, to create a lateral hole3772in the distal end portion3768. Thus, the braided body3767is split by the piercing device3769to create the hole3772and form the closed loop3758. The distal terminal end3768of the braided body can be heat sealed, or sealed in another manner, to prevent or inhibit separation of the yarns at the distal terminal end3768.

FIG.138illustrates an implementation of a device/implant catheter assembly610(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 byFIG.138, the device/implant catheter assembly610can comprise an inner or actuation element112, a coupler or capture mechanism620, an outer shaft611, a handle616(shown schematically), and clasp actuation lines624. A proximal end portion622aof the outer shaft611can be coupled to extend distally from the handle616, and a distal end portion622bof the outer shaft611can be coupled to the coupler or capture mechanism620. The actuation element112can extend distally from the actuation control626(shown schematically inFIG.138), through the handle616, through the outer shaft611, and through the coupler or capture mechanism620. The actuation element112can be movable (e.g., axially and/or rotationally) relative to the outer shaft611and the handle616. The clasp actuation lines624can extend through and be axially movable relative to the handle616and the outer shaft611. The clasp actuation lines624can also be axially movable relative to the actuation element112.

As shown inFIG.138, the actuation element112(e.g., actuation rod, actuation tube, actuation shaft, actuation wire, etc.) of the device/implant catheter assembly610can be releasably coupled to the cap114of the device604. The actuation element112extends from a proximal end portion112ato a distal end portion112b. In some implementations, the distal end portion112bof the actuation element112can comprise external threads configured to releasably engage interior threads of the cap114of the device604. As such, rotating the actuation element112in a first direction (e.g., clockwise) relative to the cap114of the device604releasably secures the actuation element112to the cap114, while rotating the actuation element112in a second direction (e.g., counterclockwise) relative to the cap114of the device604releases the actuation element112from the cap114.

In the example ofFIG.138, the outer shaft611of the device/implant catheter assembly610is an elongate shaft extending axially between the proximal end portion622a, which is coupled to the handle616, and the distal end portion622b, which is coupled to the coupler620. The outer shaft611can also include an intermediate portion622cdisposed between the proximal and distal end portions622a,622b. The outer shaft611can be formed from various materials, including metals and polymers. For example, in one particular implementation, the outer shaft can comprise stainless steel, polyether block amide (PEBA) and/or an outer covering or coating, such as a polymer that is reflowed over outer portions.

As shown inFIG.138, the clasp actuation lines624are coupled to the clasps130a,130bon the device604through holes235in the clasps130a,130band extend axially through the outer shaft611between the clasps130a,130band the handle616. In some implementations, the clasp actuation lines624are each coupled to a clasp control member628a,628bat the proximal end of the clasp actuation lines624. Each clasp control member628a,628bcan be, for example, an axially moving control or slider coupled to a corresponding clasp actuation line624to axially move the clasp actuation line624relative to the outer shaft611and the actuation element112. Each of the clasp control members628a,628bcan be operated independently of the other clasp control member such that each clasp actuation line624is moved relative to the outer shaft611, the actuation element112, and the other clasp actuation line624, or the clasp control members628a,628bcan be fixed with respect to one another (e.g., locked) such that the clasp actuation lines624are axially moved together relative to the outer shaft611and the actuation element112.

In the illustrated example ofFIG.138, each clasp control member628a,628bis movable between a first position, as shown by clasp control member628binFIG.138, and a second position, as shown by clasp control member628ainFIG.138. The first position of each clasp control member628a,628bis associated with an open position of the corresponding clasp130and the second position is associate with a closed position of the corresponding clasp130. For example, in the illustrated example, moving one of the clasp control members628a,628bto the first position pulls the corresponding clasp130to the open position and moving one of the clasp control members628a,628bto the second position releases the corresponding clasp130to allow the clasp to move to a closed position.

In the illustrated example ofFIG.138, each clasp control member628a,628bis biased to the second position. Each clasp control member628a,628bcan be biased to the second position in a variety of ways, such as springs, magnets, and elastic materials. In the illustrated example ofFIG.138, each clasp control member628a,628bis spring-loaded. In particular, the handle616includes a pair of springs627. Each spring627is coupled to a corresponding one of the clasp control member628a,628bin such a way to bias the clasp control members628a,628bto the second position. Each of the clasp control members628a,628bcan further have a releasable retaining device633, such as for example, a locking mechanism, associated with each clasp control members628a,628b. The releasable retaining devices633can be configured in any suitable manner capable of holding the corresponding clasp control member628a,628bin the first position against the bias of the spring627until being released. Each of the retaining device633can include a manual interface for a user to actuate in order to release the clasp control member628a,628band allow the spring627to move the clasp control member628a,628bto the second position.

The clasp control member628a,628bcan be biased to the second position with sufficient force to rapidly move the clasp control member628a,628bfrom the first position to the second position to rapidly close the clasps. In some implementations, the clasp control member628a,628bmoves 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.

Referring now toFIG.139, a schematically illustrated device or implant9100(e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, a treatment device, etc.) is shown in a partially open, grasp-ready condition. The device or implant9100corresponds to the previously described device100ofFIGS.8-14and the description of the device100applies equally to the device9100. However, the device9100can be any of the valve repair devices or treatment devices disclosed herein. The device or implant9100is deployed from a delivery system9102. The delivery system9102can comprise 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 of these, etc. The device or implant9100includes an optional coaptation portion/coaptation region9104and an anchor portion/anchor region9106.

In some implementations, the coaptation portion9104of the device or implant9100includes a coaptation element9110(e.g., a spacer, coaption element, plug, membrane, sheet, etc.) that is adapted to be implanted between leaflets of a native valve (e.g., a native mitral valve, native tricuspid valve, etc.) and is slidable relative to an actuation element9112(e.g., actuation wire, actuation shaft, actuation tube, etc.).

The anchor portion9106includes one or more anchors9108that are actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element9112opens and closes the anchor portion9106of the device9100. The actuation element9112(as well as other means for actuating and actuation elements disclosed herein) can take a wide variety of different forms (e.g., as a wire, rod, shaft, tube, screw, suture, line, strip, combination of these, etc.), be made of a variety of different materials, and have a variety of configurations. As one example, the actuation element can be threaded such that rotation of the actuation element moves the anchor portion9106relative to the coaptation portion9104. Or, the actuation element can be unthreaded, such that pushing or pulling the actuation element9112moves the anchor portion9106relative to the coaptation portion9104.

The anchor portion9106and/or anchors of the device can take a variety of different forms. For example, the anchor portion9106can have any of the features of any of the anchor portions disclosed herein. In the illustrated example, the anchor portion9106and/or anchors of the device9100include outer paddles9120and inner paddles9122that are, in some implementations, connected between a cap9114and coaptation element9110by portions9124,9126,9128. The portions9124,9126,9128can be jointed and/or flexible to move between all of the positions described below. The interconnection of the outer paddles9120, the inner paddles9122, the coaptation element9110, and the cap9114by the portions9124,9126, and9128can constrain the device to the positions and movements illustrated herein.

In some implementations, the delivery system9102includes a steerable catheter, device/implant catheter, and the actuation element9112(e.g., actuation wire, actuation shaft, etc.). These can be configured to extend through a guide catheter/sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuation element9112extends through a delivery catheter and to or through the coaptation element9110. Extending and retracting the actuation element9112increases and decreases the spacing between the coaptation element9110and the distal end of the device (e.g., the cap9114or other attachment portion), respectively. In some implementations, a collar or other attachment element removably attaches the coaptation element9110to the delivery system9102, either directly or indirectly, so that the actuation element9112slides through the collar or other attachment element and, in some implementations, through a coaptation element9110during actuation to open and close the paddles9120,9122of the anchor portion9106and/or anchors9108.

In some implementations, the anchor portion9106and/or anchors9108can include attachment portions or gripping members. The gripping members can take a variety of different forms. For example, the gripping members can have any of the features of any of the gripping members disclosed herein. The illustrated gripping members can comprise clasps9130that include a base or fixed arm9132, a moveable arm9134, optional friction-enhancing elements or other securing structures9136(e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and a joint portion9138. The fixed arms9132are attached to the inner paddles9122. In some implementations, the fixed arms9132are attached to the inner paddles9122with the joint portion9138disposed proximate the coaptation element9110. The joint portion9138provides a spring force between the fixed and moveable arms9132,9134of the clasp9130. The joint portion9138can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint portion9138is a flexible piece of material integrally formed with the fixed and moveable arms9132,9134. The fixed arms9132are attached to the inner paddles9122and remain stationary or substantially stationary relative to the inner paddles9122when the moveable arms9134are opened to open the clasps9130and expose the optional barbs, friction-enhancing elements, or securing structures9136.

In some implementations, the clasps9130are opened by applying tension to actuation lines9116attached to the moveable arms9134, thereby causing the moveable arms9134to articulate, flex, or pivot on the joint portions9138. The actuation lines9116extend through the delivery system9102(e.g., through a steerable catheter and/or a device/implant catheter). Other actuation mechanisms are also possible.

The actuation lines9116can take a wide variety of forms, such as, for example, a line, a suture, a wire, a rod, a catheter, or the like. The clasps9130can be spring loaded so that in the closed position the clasps9130continue to provide a pinching force on the grasped native leaflet. Optional barbs, friction-enhancing elements, or securing structures9136of the clasps9130can grab, pinch, and/or pierce the native leaflets to further secure the native leaflets.

During implantation, the paddles9120,9122can be opened and closed, for example, to press the native leaflets (e.g., native mitral valve leaflets, etc.) between the paddles9120,9122and/or between the paddles9120,9122and the coaptation element9110(e.g., a spacer, plug, membrane, gap filler, etc.). The clasps9130can be used to grasp and/or further secure the native leaflets by engaging the leaflets with optional barbs, friction-enhancing elements, or securing structures9136and pinching the leaflets between the fixed and moveable arms9132,9134. The optional barbs or other friction-enhancing elements9136(e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.) of the clasps9130increase friction with the leaflets or can partially or completely puncture the leaflets. The actuation lines9116can be actuated separately so that each clasp9130can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a clasp9130on a leaflet that was insufficiently grasped, without altering a successful grasp on the other leaflet. The clasps9130can be opened and closed relative to the position of the inner paddle9122(if the inner paddle is in an open or at least partially open position), thereby allowing leaflets to be grasped in a variety of positions as the particular situation requires.

InFIG.139, the device9100is shown in a partially open, grasp-ready condition with the clasps9130in a fully open position such that the moveable arms9134of the clasps9130are in contact with an outer surface9135of the coaptation element9110. Referring toFIG.140, the device9100is shown in the partially open, grasp-ready condition but the clasps9130are in a drooped position. The drooped position is an undesired clasp position that can occur in some devices. In the drooped position, the clasps9130are actuated to be in the fully open position shown inFIG.139, but instead of being in, or remaining in, the fully open position, the moveable arms9134are positioned, or prematurely move, away from the outer surface of the coaptation element9110(e.g., the angle between the fixed arm9132and the movable arm9134is less in the drooped position than in the fully open position). In the drooped position, there can be slack in the actuation lines9116such that the actuation lines9116do not hold the clasps9130in the fully open position. The clasps9130can be positioned at, or prematurely lower to, the drooped position if, for example, the actuation element9112stretches during implant elongation, the implant elongation length setting procedure is incorrect, or the length of the actuation lines9116is incorrect.

Referring toFIG.141, the device9100is shown in an elongated condition with the clasps9130in a fully open position (e.g., approximately 180 degrees between fixed and moveable arms9132,9134of the clasps9130).FIG.142illustrates that the clasps9130can be in a drooped position when the device9100is also in the elongated condition. As shown inFIG.142, instead of being in the fully open position, the moveable arms9134are positioned or move away from the coaptation element9110(e.g., the angle between the fixed arm9132and the movable arm9134is less in the drooped position than in the fully open position).

FIG.143is a schematic illustration of an example device/implant catheter assembly9610(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 droop. 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 example, the device/implant catheter assembly9610corresponds to the previously disclosed device/implant catheter assembly610and the description of the device/implant catheter assembly9610applies equally to the device/implant catheter assembly9610. The device/implant catheter assembly9610can include any feature for a device/implant catheter assembly9610discussed in the present application or the applications cited above.

In the example illustrated byFIG.142, the device/implant catheter assembly9610can comprise an inner or actuation element9112, a coupler or capture mechanism9620, an outer shaft9611, a handle9616(shown schematically), and clasp actuation elements9624(e.g., clasp actuation line, clasp actuation wire, clasp actuation shaft, clasp actuation rod, clasp actuation tube, etc.). A proximal end portion9622aof the outer shaft9611can be coupled to extend distally from the handle9616, and a distal end portion9622bof the outer shaft9611can be coupled to the coupler or capture mechanism9620. The actuation element9112can extend distally from an actuation control9626(shown schematically inFIG.143), through the handle9616, through the outer shaft9611, and through the coupler or capture mechanism9620. The actuation element9112can be movable (e.g., axially and/or rotationally) relative to the outer shaft9611and the handle9616. The clasp actuation elements9624can extend through and be axially movable relative to the handle9616and the outer shaft9611. The clasp actuation elements9624can also be axially movable relative to the actuation element9112.

As shown inFIG.143, the actuation element9112(e.g., actuation rod, actuation tube, actuation shaft, actuation wire, etc.) of the device/implant catheter assembly9610can be releasably coupled to the cap9114of the device9604, either directly or through one or more intermediate components. The actuation element9112extends from a proximal end portion9112ato a distal end portion9112b. In some implementations, the distal end portion9112bof the actuation element9112can comprise external threads configured to releasably engage interior threads of the cap9114or an intermediate component of the device9604. As such, rotating the actuation element9112in a first direction (e.g., clockwise) relative to the cap9114of the device9604releasably secures the actuation element9112to the cap9114or intermediate component, while rotating the actuation element9112in a second direction (e.g., counterclockwise) relative to the cap9114of the device9604releases the actuation element9112from the cap9114or intermediate component. However, the actuation element9112can be coupled to the cap or intermediate component in a wide variety of different ways. For example, the actuation element can be coupled to the cap or intermediate component in any manner that any of the actuation elements disclosed in this application are coupled (see, for example,FIGS.67-71).

In the example ofFIG.143, the outer shaft9611of the device/implant catheter assembly9610is an elongate shaft extending axially between the proximal end portion9622a, which is coupled to the handle9616, and the distal end portion9622b, which is coupled to the coupler9620. The outer shaft9611can also include an intermediate portion9622cdisposed between the proximal and distal end portions9622a,9622b. The outer shaft9611can be formed from various materials, including metals and polymers. For example, in one implementation, the outer shaft can comprise stainless steel, polyether block amide (PEBA) and/or an outer covering or coating, such as a polymer that is reflowed over outer portions.

As shown inFIG.143, the clasp actuation elements9624are coupled to the clasps9130a,9130bon the device9604through holes9235in the clasps9130a,9130band extend axially through the outer shaft9611between the clasps9130a,9130band the handle9616. In some implementations, the clasp actuation elements9624are each coupled to a clasp control member9628a,9628bat the proximal end of the clasp actuation elements9624. Each clasp control member9628a,9628bcan be, for example, an axially moving control or slider coupled to a corresponding clasp actuation element9624to axially move the clasp actuation element9624relative to the outer shaft9611and the actuation element9112. Each of the clasp control members9628a,9628bcan be operated independently of the other clasp control member such that each clasp actuation element9624is moved relative to the outer shaft9611, the actuation element9112, and the other clasp actuation element9624, or the clasp control members9628a,9628bcan be fixed with respect to one another (e.g., locked) such that the clasp actuation elements9624are axially moved together relative to the outer shaft9611and the actuation element9112.

In the illustrated example ofFIG.143, each clasp control member9628a,9628bis moveable proximally to a first position to pull the corresponding clasp9130a,9130bto the open position and distally to a second position to release the corresponding clasp9130a,9130bto allow the clasp to move to a closed position. In the illustrated example ofFIG.143, the handle9616includes a droop compensation mechanism9630configured to prevent or reduce drooping of the clasps9130a,9130b. The droop compensation mechanism9630can prevent or reduce clasp droop in a variety of ways.

In the illustrated example ofFIG.143, the droop compensation mechanism9630includes one or more biasing elements9632configured to apply a force to each of the clasp actuation elements9624, to each of the clasp control members9628a,9628b, or to both, such that the clasp actuation elements9624move the clasps9130a,9130bto the fully open position. For example, in some implementations, the one or more biasing elements9632can engage each of the clasp actuation elements9624and/or clasp control member9628a,9628bto cause each of the clasp actuation elements9624to pull the clasps9130a,9130bfrom the drooped position to the fully open position.

In some implementations, the one or more biasing elements9632are configured to remove slack from the clasp actuation elements9624(e.g., when the clasp actuation elements9624are configured as suture lines). The one or more biasing elements9632can be configured to apply the force during movement of the clasp control members9628a,9628bfrom the second position to the first position and after the clasp control members9628a,9628bare in the fully proximal first position. Thus, even when the clasp control members9628a,9628bhave reached the fully proximal first position (e.g., the clasp control members cannot further pull on the clasp actuation elements9624to move the clasps9630), the one or more biasing elements9632continue to apply a force to pull the first clasp toward the open position. For example, the one or more biasing elements9632can be configured to take-up (e.g., elastically stretch and return to its original length) a distance that is greater than or equal to an anticipated maximum clasp droop. For example, the one or more biasing elements9632can be configured to take-up 0.1 mm to 10 mm of droop, such as 0.2-5 mm of droop, such as 0.3-2 mm of droop, or any subrange of these ranges.

The one or more biasing elements9632can be configured in a variety of ways. In some examples, the one or more biasing elements9632can be springs, elastic elements capable of applying a suitable force to the clasp actuation elements9624and/or clasp control member9628a,9628b, elastic portion(s) of the clasp actuation elements9624, clasp actuation elements9624made entirely of an elastic material, a clasp control member9628aand/or9628bhaving a spring or elastic element, etc. In some examples, the droop compensation mechanism9630can correct droop in one clasp9130aindependent of the other clasp9130b(e.g., can move the clasp actuation element and/or clasp control member associated with one clasp independently from the clasp actuation control and/or clasp actuation element associated with the other clasp).

FIG.144is a schematic illustration of an example device/implant catheter assembly9710(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 droop. The device/implant catheter assembly9710corresponds to the previously disclosed device/implant catheter assembly9610and the description of the device/implant catheter assembly9610applies equally to the device/implant catheter assembly9710with reference numbers of like elements kept the same. The device/implant catheter assembly9710can include any feature of any device/implant catheter assembly discussed in the present application or the applications cited above. In the example illustrated byFIG.144, the droop compensation mechanism9630incorporates the one or more biasing elements9632as part of each of the clasp actuation elements9624.

In some examples, each clasp actuation element9624can be made to be elastic, along the entire clasp actuation element9624or along one or more sections of the clasp actuation element9624. For example, an entire elastic clasp actuation line or an elastic portion of a clasp actuation line can be configured to take-up (e.g., elastically stretch and return to its original length) a distance that is greater than or equal to an anticipated maximum clasp droop. For example, an entire elastic clasp actuation line or an elastic portion of a clasp actuation line can be configured to take-up 0.1 mm to 10 mm of droop, such as 0.2-5 mm of droop, such as 0.3 mm-2 mm of droop, or any subrange of these ranges. The elastic clasp actuation element9624, or portions thereof, can function as the one or more biasing elements9632. For example, in the example illustrated byFIG.144, each clasp actuation element9624can include a portion near or adjacent each corresponding clasp control member9628a,9628bwithin the handle9616that functions as a biasing element9632. The elastic portion or portions of the clasp actuation element9624can, however, be located along the clasp actuation element9624at any suitable location.

The clasp actuation element9624, when configured as a suture line in some examples, can be made as a braided suture line. To increase the elasticity of the braided suture line or a portion of the suture line, the suture line or elastic portion of the suture line can be made with higher picks per inch of current suture material or from elastic materials. In some examples, one or more biasing elements9632can be separate elements from the clasp actuation element9624but attached inline. For example, the biasing elements9632can be springs or other suitable elastic elements that are separate from, but attached in-line with, the clasp actuation element9624. The biasing elements9632can attach in-line with the clasp actuation element9624in any suitable manner. For example, a spring or elastic element can have suture lines attached to either end of the spring or elastic element with the combined spring/elastic element and suture lines functioning as the clasp actuation element9624.

An example method of utilizing the elastic clasp actuation elements9624in the device/implant catheter assembly9710can include setting or selecting a length of the elastic clasp actuation elements9624when the device9604is in the fully elongated position, as shown inFIG.141and the clasp control members9628a,9628bare in a fully forward position, as shown inFIG.145(e.g., the clasps are in the first closed or fully forward position). This provides the minimum length of the clasp actuation element9624required to allow the clasps to move to the fully forward position at the fully elongated configuration. Thus, the biasing elements9632are in a non-stretched or natural condition so that little or no tension is applied to the clasps so that the clasps can move to the closed position without interference. When the clasp control members9628a,9628bare retracted to move the clasps up against the coaptation element9110, the travel of the clasp control members can be configured to be greater than the travel when not using the biasing elements9632. In this way, the biasing elements9632are stretched, which provides a pulling force on the clasps. As a result, if conditions that can result in clasp droop are present, the pulling force of the stretched biasing elements9632pulls the clasps to the fully open position.

FIGS.145-146illustrate an example clasp actuation portion9831of a handle9816of a device/implant catheter assembly9810(e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.). The clasp actuation portion9831corresponds to the previously disclosed clasp actuation portion3631of the handle3616and the description of the clasp actuation portion3631applies equally to the clasp actuation portion9831. The clasp actuation portion9831can include any feature of any clasp actuation portion of any handle discussed in the present application or the applications cited above.

The clasp actuation portion9831can include first and second clasp control members9828a,9828bwhich are configured to move the clasps (e.g., clasps9130of device9100) of the device via clasp actuation elements9824. The clasps can be configured in the same manner as any of the clasps described herein. The clasp actuation portion9831can be configured in a variety of ways. In some implementations, the device/implant catheter assembly9810includes two clasp actuation elements9824each coupled to a corresponding clasp control member9828a,9828bat the proximal end of the clasp actuation elements9824. For ease of illustration, only one clasp actuation element9824is shown inFIG.145. In the illustrated example, the clasp actuation element9824is configured as a clasp actuation line. In some implementations, the clasp actuation element9824can be configured as a clasp actuation wire, a clasp actuation shaft, a clasp actuation rod, a clasp actuation tube, etc.

Each clasp control member9828a,9828bcan be, for example, an axially-moving control or slider coupled to a corresponding clasp actuation element9824to axially move the clasp actuation element9824relative to the actuation element8102. Each of the clasp control members9828a,9828bcan be operated independently of the other clasp control member such that each clasp actuation element9824is moved relative to the actuation element8102and the other clasp actuation element9824. The clasp control members9828a,9828bcan also be fixed with respect to one another (e.g., locked) such that the clasp actuation elements9824are axially moved together relative to the actuation element8102.

The clasp control members9828a,9828bcan be configured in a variety of ways, including similar to any clasp control member disclosed herein. In the implementation depicted inFIGS.145-146, the clasp control members9828a,9828bare similar to the clasp control members3628ofFIGS.104-105, and thus the previous description of the clasp control members628applies equally to the clasp control members9828a,9828bshown inFIGS.145-146. The handle9816includes a first and second line-engaging member9833a,9833bconfigured to engage the clasp actuation elements9824to move the elements in response to movement of the clasp control members9828a,9828b. The line-engaging members9833a,9833bcan be configured in a variety of ways. In the illustrated example, each line-engaging member9833a,9833bis configured as an elongated projection having a proximal end fixed to a corresponding clasp control member9828a,9828band a distal end configured to engage a corresponding clasp actuation element9824. In the illustrated example, the distal end of each line-engaging member9833a,9833bincludes a passage9837through which a clasp actuation element9824can extend.

The handle9816includes a housing9834having a distal stem9836defining a passage9838, a main body portion9840defining an interior space9842, and a proximal cap9844through which the actuation element8102extends. In addition, each of the line-engaging members9833a,9833bextend distally from the respective clasp control members9828a,9828bthrough the proximal cap9844and into the interior space9842. The main body portion9840further includes a line anchor (illustrated by an x inFIG.145), similar to line anchor3748ofFIGS.104-105, to which the proximal ends of the clasp actuation elements3624attach.

In the example illustrated byFIG.145-146, the clasp actuation portion9831includes a droop compensation mechanism9830configured to prevent or reduce drooping of the clasps of a device or implant. The droop compensation mechanism9830has features of the previously disclosed droop compensation mechanism3630ofFIG.144and the description of the compensation mechanism3630applies to the droop compensation mechanism9830. The droop compensation mechanism9830can include any feature of any droop compensation mechanism discussed in the present application.

In the illustrated example ofFIGS.145-146, the droop compensation mechanism9830includes a first biasing element9832aand a second biasing element9832bconfigured to apply a force to a corresponding clasp actuation element9824such that the clasp actuation elements9624move the clasps to the fully open position if conditions that can result in clasp droop are present. The biasing elements9832a,9832bcan be configured in a variety of ways. In the illustrated example, the first biasing element9832ais associated with the first clasp control member9828aand the second biasing element9832bis associated with the second clasp control member9828b.

In the example illustrated byFIGS.145and146, the first biasing element9832ahas an elongated body9850having a proximal end9852and a free distal end9854. The proximal end9852is fixed relative to the housing9834. For example, the proximal end9852can be fixedly attached to the proximal cap9844or another suitable portion of the handle9816. The elongated body9850has an outward bowed or semi-elliptical shape resembling a band or leaf (e.g., a thin body with generally parallel inner and outer faces). A slot or opening9856can extend along a portion of the elongated body9850through which the corresponding clasp actuation element9824extends. In some examples, the slot or opening9856is positioned in a distal portion, such as a distal half, of the elongated body9850. In some examples, the slot or opening9856extends along a majority of the distal half of the elongated body9850.

The second biasing element9832bcan be identical to the first biasing element9832aand arranged in mirror image to the first biasing element9832aabout a central longitudinal axis Z. Thus, the description of the first biasing element9832aapplies equally to the second biasing element9832b. The biasing elements9832a,9832bare configured to be biased outward away from each other to a wide first position, as shown inFIG.146.

Each clasp control member9828a,9828bis moveable between a first position (e.g., fully proximal), as shown inFIG.146, and a second position (e.g., fully distal), as shown inFIG.145. The first position of each clasp control member9828a,9828bis associated with an open position of the corresponding clasp (e.g., the clasp position shown inFIGS.139and141) and the second position is associated with a closed position of the corresponding clasp (e.g., the clasp position shown inFIG.8). For example, in the illustrated example, moving one of the clasp control members9828a,9828bto the first position pulls the corresponding clasp to the open position and moving one of the clasp control members9828a,9828bto the second position releases the corresponding clasp to allow the clasp to move to a closed position.

As shown inFIG.145, when the clasp control members9828a,9828bare in the second position, each of the first and second line-engaging members9833a,9833bextends outward of and along a length of the respective first and second biasing elements9832a,9832bto engage and move the distal ends9854of the first and second biasing elements9832a,9832btoward each other such that the first and second biasing elements9832a,9832bare in the narrow second position, as shown inFIG.145. In the narrow second position, the clasp actuation elements9824extend through the openings9856without the first and second biasing elements9832a,9832bapplying any force onto the clasp actuation elements9824. Thus, the clasps can close without disruption from any force from the first and second biasing elements9832a,9832bbeing applied to the clasp actuation elements9824.

As shown inFIG.146, when the clasp control members9828a,9828bare in the first position, the first and second line-engaging members9833a,9833bare retracted and do not engage the first and second biasing elements9832a,9832b. In addition, a portion of the clasp actuation elements9824are pulled by the first and second line-engaging members9833a,9833bto be along and outward of the first and second biasing elements9832a,9832b. With the clasp control members9828a,9828bretracted, the first and second biasing elements9832a,9832bare free to expand outward to the wide first position. When expanding outward toward the wide position, the first and second biasing elements9832a,9832bengage (e.g., an outer face of each biasing members can contact a corresponding clasp actuation elements) and apply a force to the clasp actuation elements9824. The outward force applied to the clasp actuation elements9824by the first and second biasing elements9832a,9832bcan take up any slack in the clasp actuation elements9824and cause the clasp actuation elements9824to pull the clasps to the fully open position, thus eliminating or reducing any droop in the clasp.

Depending on the amount of slack in the clasp actuation elements9824, the first and second biasing elements9832a,9832bcan expand to a position less than the wide first position (e.g., once all slack has been removed, the clasp actuation elements9824can prevent or inhibit the first and second biasing elements9832a,9832bfrom fully expanding). The first clasp control member9828aand associated first biasing element9832acan work independent of the second clasp control member9828band associated second biasing element9832b. Thus, droop in one clasp can be addressed independent of droop in the other clasp. Further, if clasp droop is asymmetric (e.g., one clasp droops more than the other clasp), since each biasing element9832a,9832bis independent of the other, each biasing member can correct and compensate for the amount of droop present in the clasp associated with the biasing member.

Examples

Example 1. A handle assembly for controlling a transvascular device, the handle assembly comprising: (i) a handle housing; (ii) a sheath extending distally from the handle housing; (iii) an actuation element extending through the sheath, the actuation element configured to be coupled to the device; and (iv) a paddle actuation control operatively coupled to the actuation element, wherein actuation of the paddle actuation control causes movement of the actuation element with respect to the handle housing and the sheath, wherein the movement of the actuation element causes the device to move between open and closed positions.

Example 2. The handle assembly according to example 1, further comprising a paddle width adjustment element extending through the actuation element, the paddle width adjustment element configured to be coupled to at least one of a pair of paddles of the device.

Example 3. The handle assembly according to example 2, further comprising a paddle width control operatively coupled to the paddle width adjustment element, wherein actuation of the paddle width control causes movement of the paddle width adjustment element with respect to the handle housing and the sheath, wherein the movement of the paddle width adjustment element causes a width of the at least one of the pair of paddles of the device to be moved from a first width to a second width.

Example 4. The handle assembly according to example 3, wherein the paddle actuation control is operatively coupled to a retractor to cause the movement of the actuation element and the paddle width control is operatively coupled to a drive member to cause the movement of the paddle width adjustment element, wherein actuation of the paddle actuation control causes movement of both the retractor and the drive member.

Example 5. The handle assembly according to example 4, further comprising a release control operatively coupled to the paddle width adjustment element, wherein actuation of the release control causes movement of the paddle width adjustment element and actuation element to decouple the device from the sheath.

Example 6. The handle assembly according to any one of examples 4-5, wherein the paddle actuation control is configured as a paddle actuation control knob, and wherein rotation of the paddle actuation control knob axially drives the retractor, and/or the paddle width control is configured as a paddle width control knob, and wherein rotation of the paddle width control knob axially drives the drive member.

Example 7. The handle assembly according to any one of examples 4-6, wherein the retractor is positioned within the handle distally from the drive member.

Example 8. The handle assembly according to any of claims4-7, wherein the paddle actuation control is operatively coupled to a first internally threaded tube and actuation of the paddle actuation control rotates the first internally threaded tube to cause the movement of the retractor.

Example 9. The handle assembly according to any of examples 4-8, wherein the paddle width control is operatively coupled to a second internally threaded tube and actuation of the paddle width control rotates the second internally threaded tube to cause the movement of the drive member.

Example 10. The handle assembly according to example 9, wherein the handle assembly is configured such that movement of the retractor causes axial movement of the second internally threaded tube.

Example 11. The handle assembly according to any of examples 3-10, further comprising a release control operatively coupled to the paddle width adjustment element, wherein the release control is configured as a release control knob, and wherein rotation of the release control knob decouples the paddle width adjustment element from the paddle width control.

Example 12. The handle assembly according to example 11, further comprising a release nut that is operatively coupled with the paddle width control such that actuation of the paddle width control moves the release nut axially, and wherein rotation of the release control unscrews a release screw from the release nut to decouple the paddle width adjustment element from the paddle width control.

Example 13. The handle assembly according to example 11 or 12, wherein after the release control decouples the paddle width adjustment element from the paddle width control, the movement of the release control causes the movement of both the paddle actuation element and the paddle width adjustment element.

Example 14. A delivery system, comprising: (i) a steerable catheter assembly having a handle and a sheath extending from the handle in an axial direction, the sheath of the steerable catheter assembly having a distal end portion comprising a steerable section; (ii) a device/implant catheter assembly having a handle with a handle housing and a sheath that extends distally from the handle housing, wherein the sheath of the device/implant catheter assembly is extendable coaxially through the sheath of the steerable catheter assembly, wherein the handle of the device/implant catheter assembly comprises: (a) an actuation element extending through the sheath, the actuation element configured to be coupled to the device; and (b) a paddle actuation control operatively coupled to the actuation element, wherein actuation of the paddle actuation control causes movement of the actuation element with respect to the handle housing and the sheath, wherein the movement of the actuation element causes the device to move between open and closed positions.

Example 15. The delivery system according to example 14 further comprising a paddle width adjustment element extending through the actuation element, the paddle width adjustment element configured to be coupled to at least one of a pair of paddles of the device; and/or a paddle width control operatively coupled to the paddle width adjustment element, wherein actuation of the paddle width control causes movement of the paddle width adjustment element with respect to the handle housing and the sheath, wherein the movement of the paddle width adjustment element causes a width of the at least one of the pair of paddles of the device to be moved from a first width to a second width.

Example 16. The delivery system according to any one of examples 14-15 wherein the device/implant catheter assembly further comprises a release control operatively coupled to the paddle width adjustment element, wherein actuation of the release control causes movement of the paddle width adjustment element and actuation element to decouple the device from the sheath.

Example 17. The delivery system according to any one of examples 15-16 wherein the device/implant catheter assembly is configured such that actuation of the paddle width control and/or actuation of the paddle actuation control can cause axial and/or rotational movement of the release control.

Example 18. The delivery system according to any of examples 15-17, wherein the paddle actuation control is operatively coupled to a retractor to cause the movement of the actuation element and the paddle width control is operatively coupled to a drive member to cause the movement of the paddle width adjustment element, wherein actuation of the paddle actuation control can cause the movement of both the retractor and the drive member.

Example 19. The delivery system according to example 18, wherein the paddle actuation control is configured as a paddle actuation control knob, and wherein rotation of the paddle actuation control knob axially drives the retractor, and/or wherein the paddle width control is configured as a paddle width control knob, and wherein rotation of the paddle width control knob axially drives the drive member.

Example 20. The delivery system according to any of examples 18-19, wherein the retractor is positioned within the handle distally from the drive member.

Example 21. The delivery system according to any of examples 18-20, wherein the paddle actuation control is operatively coupled to a first internally threaded tube and actuation of the paddle actuation control rotates the first internally threaded tube to cause the axial and/or rotational movement of the retractor.

Example 22. The delivery system according to any of examples 18-21, wherein the paddle width control is operatively coupled to a second internally threaded tube and actuation of the paddle width control rotates the second internally threaded tube to cause the movement of the drive member.

Example 23. The delivery system according to example 22, wherein the device/implant catheter assembly is configured such that movement of the retractor causes axial movement of the second internally threaded tube.

Example 24. The delivery system according to any of examples 14-23, wherein the device/implant catheter assembly further comprises a release control operatively coupled to the paddle width adjustment element, wherein the release control is configured as a release control knob, and wherein rotation of the release control knob decouples the paddle width adjustment element from the paddle width control.

Example 25. The delivery system according to example 24, further comprising a release nut that is operatively coupled with the paddle width control such that actuation of the paddle width control moves the release nut axially, and wherein rotation of the release control unscrews a release screw from the release nut to decouple the paddle width adjustment element from the paddle width control.

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

Example 27. A method of delivering a device comprising: (i) obtaining the 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, wherein the sheath is coupled at a proximal end of the sheath to a handle of the device/implant catheter assembly; (ii) advancing the sheath of the device/implant catheter assembly to position the device at a delivery site in an open configuration; (iii) actuating the paddle actuation control on the handle, thereby causing movement of the actuation element to move the device from the open configuration to a closed configuration; and (iv) actuating a paddle width control on the handle, thereby causing movement of 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.

Example 28. The method according to example 27, further comprising actuating a release control on the handle, thereby causing movement of the paddle width adjustment element and the actuation element to decouple the device from the sheath.

Example 29. The method according to example 28, wherein actuating of the paddle actuation control can cause axial movement of the release control and the paddle width adjustment element.

Example 30. The method according to any one of examples 27-29, wherein the paddle actuation control is a paddle actuation knob, and wherein actuating the paddle actuation control comprises rotating the paddle actuation knob such that one or more of the actuation element, the paddle width adjustment element, and the release control move axially relative to the housing of the handle.

Example 31. The method according to example 30, wherein the paddle width adjustment element is rotationally fixed during rotation of the paddle width control knob, and wherein the actuation element is rotationally fixed during rotation of the paddle actuation knob.

Example 32. The method according to any one of examples 28-30, wherein the release control is a release control knob, and wherein actuating the release control on the handle to decouple the device from the sheath further comprises rotating the release control knob to decouple the paddle width adjustment element from the paddle width control and then axially moving the release knob to axially move the actuation element and the paddle width adjustment element and the actuation element.

Example 33. A delivery system for a device having a plurality of clasps for securing native leaflets of a heart valve, the delivery system comprising: (i) a device/implant catheter assembly having a handle and a sheath extending from the handle in an axial direction, the sheath having a distal end portion comprising 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 release position in which the capture mechanism is decoupled from the device; and (ii) 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 aperture in the first clasp; and wherein 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.

Example 34. The delivery system according to example 33, wherein the first distal end of the first clasp actuation line is captured between the capture mechanism and the device when the capture mechanism is in the coupled position.

Example 35. The delivery system according to example 33 or 34, wherein the capture mechanism includes a first longitudinally projecting finger and wherein the first distal end of the first clasp actuation line is attached to the first longitudinally projecting finger.

Example 36. The delivery system according to example 35, wherein the first distal end of the first clasp actuation line is formed as a first closed loop and the first longitudinally projecting finger extends through the first closed loop.

Example 37. The delivery system according to any of examples 33-36 wherein movement of the capture mechanism from the closed position to the open position and axial movement of the capture mechanism away from the device releases the first distal end of the first clasp actuation line from the capture mechanism.

Example 38. The delivery system according to any of examples 33-37, wherein the handle includes a first clasp control member that engages the first clasp actuation line and is movable relative to the housing.

Example 39. The delivery system according to example 37, wherein the first clasp control member includes a first passage through which the first clasp actuation line extends, wherein the first clasp actuation line slides through the first passage when the first clasp control member moves relative to the housing.

Example 40. The delivery system according to example 39, wherein the first clasp actuation line includes a first proximal end fixed relative to the to the handle.

Example 41. The delivery system according to any of examples 33-40, further comprising a second clasp actuation line configured to move a second clasp of the plurality of clasps between a closed position and an open position, the second clasp actuation line extending from the handle, through the sheath, and through a second aperture in the second clasp; and wherein a second distal end of the second clasp actuation line is attached to the capture mechanism when the capture mechanism is in the coupled position.

Example 42. The delivery system according to example 41, wherein the second distal end of the second clasp actuation line is captured between the capture mechanism and the device when the capture mechanism is in the coupled position.

Example 43. The delivery system according to example 41 or 42, wherein the capture mechanism includes a second longitudinally projecting finger and wherein the second distal end of the second clasp actuation line is attached to the second longitudinally projecting finger.

Example 44. The delivery system according to example 43, wherein the second distal end of the second clasp actuation line is formed as a second closed loop and the second longitudinally projecting finger extends through the second closed loop.

Example 45. The delivery system according to any of examples 41-44 wherein movement of the capture mechanism from the closed position to the open position and axial movement of the capture mechanism away from the device releases the second distal end of the second clasp actuation line from the capture mechanism.

Example 46. The delivery system according to any of examples 41-45, wherein the handle includes a second clasp control member that engages the second clasp actuation line and is movable relative to the housing.

Example 47. The delivery system according to example 46, wherein the second clasp control member slides axially relative to the handle.

Example 48. The delivery system according to example 46 or 47, wherein the second clasp control member includes a second passage through which the second clasp actuation line extends, wherein the second clasp actuation line slides through the second passage when the second clasp control member moves relative to the housing.

Example 49. The delivery system according to example 48, wherein the second clasp actuation line includes a second proximal end fixed relative to the to the handle.

Example 50. The delivery system according to any of examples 41-49, wherein the second clasp control member and the first clasp control member are movable independently of each other.

Example 51. A method of treating a heart valve with a treatment device or valve repair device, comprising: (i) closing a first clasp of the treatment device or valve repair device to grasp a first leaflet of the heart valve by releasing tension in a first clasp actuation line coupled to the first clasp; (ii) closing a second clasp of the valve repair device to grasp a second leaflet of the heart valve by releasing tension in a second clasp actuation line coupled to the second clasp; and (iii) releasing the treatment device or valve repair device from a capture mechanism and withdrawing the capture mechanism from the treatment device or valve repair device, wherein releasing the treatment device or valve repair device from the capture mechanism and withdrawing the capture mechanism from the valve repair device comprises uncoupling the first clasp actuation line from the first clasp and uncoupling the second clasp actuation line from both the second clasp.

Example 52. The method according to example 51, wherein the first clasp and the second clasp are simultaneously closed.

Example 53. The method according to example 51, wherein the first clasp and the second clasp are sequentially closed.

Example 54. The method according to any of examples 51-53, wherein connecting the first clasp actuation line to the capture mechanism comprises capturing a first distal end of the first clasp actuation line between the capture mechanism and the treatment device or valve repair device.

Example 55. The method according to example 54, wherein the first distal end includes a first closed loop and connecting the first clasp actuation line to the capture mechanism further comprises receiving a first portion of the capture mechanism through the first closed loop.

Example 56. The method according to example 55, wherein releasing the first clasp actuation line from the capture mechanism further comprises withdrawing the first portion from the first closed loop.

Example 57. The method according to example 55 or 56, wherein releasing the first clasp actuation line from the first clasp further comprises pulling the first closed loop through a first aperture in the first clasp.

Example 58. The method according to any of examples 51-57, wherein connecting the second clasp actuation line to the capture mechanism includes capturing a second distal end of the second clasp actuation line between the capture mechanism and the treatment device or valve repair device.

Example 59. The method according to example 58, wherein the second distal end includes a second closed loop and connecting the second clasp actuation line to the capture mechanism further comprises receiving a second portion of the capture mechanism through the second closed loop.

Example 60. The method according to example 59, wherein releasing the second clasp actuation line from the capture mechanism further comprises withdrawing the second portion from the second closed loop.

Example 61. The method according to example 59 or 60, wherein releasing the second clasp actuation line from the second clasp further comprises pulling the second closed loop through a second aperture in the second clasp.

Example 62. A handle assembly for controlling a transvascular device having one or more clasps for securing one or more portions of tissue, the handle assembly comprising: (i) a handle housing; (ii) a sheath extending distally from the handle housing; (iii) a first clasp actuation line extending through the sheath, the first clasp actuation line operatively coupled to a first clasp of the plurality of clasps on the device; and (iv) a first clasp control member operatively connected to the first clasp actuation line, the first clasp control member movable relative to the housing between a first position associated with the first clasp being in an open position and a second position associated with the clasp being in a closed position, and wherein the first clasp control member is biased to the second position.

Example 63. The handle assembly according to example 62, further comprising a first spring arranged to bias the first clasp control member to the second position.

Example 64. The handle assembly according to example 62 or 63, further comprising a first releasable retaining device configured to hold the first clasp control member in the first position.

Example 65. The handle assembly according to any of examples 62-64, wherein the first clasp control member is movable axially relative to the housing between the first position and the second position.

Example 66. The handle assembly according to any of example 63-65, wherein first clasp control member is biased to move from the first position to the second position in less than 500 milliseconds.

Example 67. The handle assembly according to any of example 63-65, wherein first clasp control member is biased to move from the first position to the second position in less than 75 milliseconds.

Example 68. The handle assembly according to any of examples 63-67, further comprising: (i) a second clasp actuation line extending through the sheath, the second clasp actuation line operatively coupled to a second clasp of the plurality of clasps on the device; and (ii) a second clasp control member operatively connected to the second clasp actuation line, the second clasp control member is movable relative to the housing between a third position associated with the second clasp being in an open position and a fourth position associated with the second clasp being in a closed position, and wherein the second clasp control member is biased to the fourth position.

Example 69. The handle assembly according to example 68, further comprising a second spring arranged to bias the second clasp control member to the fourth position.

Example 70. The handle assembly according to example 68 or 69, further comprising a second releasable retaining device configured to hold the second clasp control member in the third position.

Example 71. The handle assembly according to any of examples 68-70, wherein the second clasp control member is movable axially relative to the housing between the third position and the fourth position.

Example 72. The handle assembly according to any of examples 68-71, wherein second clasp control member is biased to move from the third position to the fourth position in less than 500 milliseconds.

Example 73. The handle assembly according to any of examples 68-71, wherein second clasp control member is biased to move from the third position to the fourth position in less than 75 milliseconds.

Example 74. The handle assembly according to any of examples 68-73, wherein the first clasp control member is movable from the first position to the second position independent of movement of the second clasp control member.

Example 75. A method of using a treatment device or valve repair device having a plurality of clasps for securing native leaflets of a heart valve, the method comprising: (i) delivering the treatment device or valve repair device to the heart valve via a device/implant catheter assembly having a first clasp actuation line that holds a first clasp of the treatment device or valve repair device in an open position and a second clasp actuation line that holds a second clasp of the treatment device or valve repair device in an open position; (ii) closing the first clasp of the treatment device or valve repair device to grasp a first leaflet of the heart valve by releasing tension in the first clasp actuation line; (iii) closing the second clasp of the treatment device or valve repair device to grasp a second leaflet of the heart valve by releasing tension in the second clasp actuation line; wherein releasing tension in the first clasp actuation line comprising biasing a first clasp control member from a first position to a second position; and wherein releasing tension in the second clasp actuation line comprising biasing a second clasp control member from a third position to a fourth position.

Example 76. The method according to example 75, wherein the first clasp control member is mounted on a handle of the device/implant catheter assembly and the first clasp control member moves axially relative to the handle when biased from the first position to a second position.

Example 77. The method according to example 75 or 76, wherein the first clasp control member is biased from the first position to the second position by a first spring.

Example 78. The method according to example 76 or 77, wherein the second clasp control member is mounted on the handle of the device/implant catheter assembly and the second clasp control member moves axially relative to the handle when biased from the third position to a fourth position.

Example 79. The method according to any of examples 75-78, wherein the second clasp control member is biased from the third position to the fourth position by a second spring.

Example 80. The method according to any of example 75-79, wherein the first clasp and the second clasp are simultaneously closed.

Example 81. The method according to any of examples 75-79, wherein the first clasp and the second clasp are sequentially closed.

Example 82. The method according to any of examples 75-81, wherein first clasp control member is biased to move from the first position to the second position in less than 500 milliseconds.

Example 83. The method according to any of examples 75-81, wherein first clasp control member is biased to move from the first position to the second position in less than 75 milliseconds.

Example 84. The method according to any of examples 75-83, wherein second clasp control member is biased to move from the third position to the fourth position in less than 500 milliseconds.

Example 85. The method according to any of examples 75-83, wherein second clasp control member is biased to move from the third position to the fourth position in less than 75 milliseconds.

Example 86. A clasp actuation line for actuating a clasp of a treatment device or repair device, comprising: a braided body having a proximal end, a distal end opposite the proximal end, and a closed loop formed at the distal end.

Example 87. The clasp actuation line according to example 86, wherein the braided body is formed from ultra-high-molecular-weight polyethylene material.

Example 88. The clasp actuation line according to example 86 or 87, wherein the braided body has 4 to 100 ends using 10 to 400 dtex yarn.

Example 89. The clasp actuation line according to any of examples 86-88, wherein the clasp actuation line has a tensile strength in the range of 20-100 N and a diameter in the range of 0.003 inches to 0.008 inches.

Example 90. The clasp actuation line according to any of examples 86-89, wherein the closed loop has a nominal loop diameter in the range or 0.0275 inches to 0.0425 inches and a circumference in the range of 0.07 inches to 0.15 inches.

Example 91. The clasp actuation line according to any of examples 86-90, wherein the closed loop is formed by a bifurcated braided portion of the braided body.

Example 92. The clasp actuation line according to any of example 86-91, wherein a distal terminal end of the braided body extends axially through a portion of the braided body at a location proximal the closed loop to form a tucked-in portion.

Example 93. The clasp actuation line according to example 92, wherein the tucked-in portion has a length of 0.25 inches or greater.

Example 94. The clasp actuation line according to example 92, wherein the tucked-in portion has a length of 1 inch or greater.

Example 95. The clasp actuation line according to any of example 86-91, wherein a distal terminal end portion of the braided body extends laterally through a portion of the braided body at a location proximal the closed loop to form a threaded portion.

Example 96. The clasp actuation line according to any of example 86-91, wherein a distal terminal end portion of the braided body threads laterally back and forth, at least twice, through a portion of the braided body at a location proximal the closed loop to form a threaded portion.

Example 97. The clasp actuation line according to example 95 or 96, wherein the distal terminal end portion of the braided body extends axially through a portion of the braided body at a location proximal the closed loop to form a tucked-in portion proximal the threaded portion.

Example 98. The clasp actuation line according to example 97, wherein the tucked-in portion has a length of 0.25 inches or greater.

Example 99. The clasp actuation line according to example 97, wherein the tucked-in portion has a length of 1 inch or greater.

Example 100. A method of forming a clasp actuation line for actuating a clasp of a treatment device or valve repair device, the method comprising: (i) braiding an elongated body; and (ii) forming a closed loop at a distal end of the elongated body.

Example 101. The method according to example 100, wherein braiding the elongated body includes braiding a bifurcated portion to form the closed loop.

Example 102. The method according to example 101, further comprising heat sealing a distal terminal end of the braided body.

Example 103. The method according to example 100, wherein braiding an elongated body further comprising braiding a plurality of a bifurcated portions separated by unitary portion, and wherein the method further comprises cutting the elongated body into sections comprising a single bifurcated portion adjacent a distal end of the section.

Example 104. The method according to example 100, wherein forming the closed loop comprises extending a distal terminal end of the braided body axially through a portion of the braided body to form a tucked-in portion proximal the closed loop.

Example 105. The method according to example 100, wherein forming the closed loop comprises extending a distal terminal end portion of the braided body laterally through a portion of the braided body to form a threaded portion at a location proximal the closed loop.

Example 106. The method according to example 105 further comprising extending the distal terminal end portion of the braided body clasp actuation line laterally through the portion of the braided body at least twice.

Example 107. The method according to example 105 or 106, further comprising extending a distal terminal end of the braided body axially through a portion of the braided body to form a tucked-in portion proximal the threaded portion.

Example 108. The method according to example 100, wherein forming the closed loop comprises extending a piercing device laterally through a portion adjacent a distal end of the braided body to form a lateral passage through the braided body.

Example 109. A handle assembly for controlling a transvascular device, the handle assembly comprising: (i) a handle housing; (ii) a sheath extending distally from the handle housing; (iii) an actuation element extending through the sheath, the actuation element configured to be coupled to the device; and (iv) a paddle actuation control operatively coupled to the actuation element, wherein actuation of the paddle actuation control causes movement of the actuation element with respect to the handle housing and the sheath, wherein movement of the actuation element causes the device to move between open and closed positions.

Example 110. The handle assembly according to example 109, further comprising a paddle width adjustment element extending through the actuation element, the paddle width adjustment element 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 movement of the paddle width adjustment element with respect to the handle housing and the sheath, wherein movement of the paddle width adjustment element causes a width of the at least one of the pair of paddles of the device to be moved from a first width to a second width.

Example 111. The handle assembly according to example 109 or example 110, wherein a distal end of the paddle actuation control comprises external threads configured to engage with internal threads of the handle housing.

Example 112. The handle assembly according to any one of examples 110-111, wherein the paddle width control is configured as a paddle width control knob, and wherein rotation of the paddle width control knob axially drives a frame that is attached to the actuation element.

Example 113. The handle assembly according to example 112, wherein the paddle width control knob is rotatable relative to the frame.

Example 114. The handle assembly according to example 112 or example 113, wherein the paddle actuation control is configured as a paddle actuation knob that is rotatable relative to the frame.

Example 115. The handle assembly according to any one of examples 112-114, wherein rotation of the paddle width control knob axially drives the paddle width control knob and the paddle width adjustment element with respect to the paddle actuation knob and the actuation element.

Example 116. A delivery system comprising: (i) a steerable catheter assembly having a handle and a sheath extending from the handle in an axial direction, the sheath of the steerable catheter assembly having a distal end portion comprising a steerable section; (ii) a device/implant catheter assembly having a handle and a sheath extendable coaxially through the sheath of the steerable catheter assembly, wherein the handle of the device/implant catheter assembly comprises: (a) a handle housing, wherein the sheath of the device/implant catheter assembly extends distally from the handle housing; (b) an actuation element extending through the sheath, the actuation element configured to be coupled to the device; and (c) a paddle actuation control operatively coupled to the actuation element, wherein actuation of the paddle actuation control causes movement of the actuation element with respect to the handle housing and the sheath, wherein the movement of the actuation element causes the device to be moved between an open configuration and a closed configuration.

Example 117. The device delivery system according to example 116, further comprising a paddle width adjustment element extending through the actuation element, the paddle width adjustment element configured to be coupled to at least one of a pair of paddles of the device; and a paddle width control coupled to the paddle width adjustment element, wherein actuation of the paddle width control causes movement of the paddle width adjustment element with respect to the handle housing and the sheath, wherein the movement of the paddle width adjustment element causes a width of the at least one of the pair of paddles of the device to be moved from a first width to a second width.

Example 118. The device delivery system according to example 116 or example 117, wherein a distal end of the paddle actuation control comprises external threads configured to engage with internal threads of the handle housing.

Example 119. The device delivery system according to any one of examples 117-118, wherein the paddle width control is configured as a paddle width control knob, and wherein rotation of the paddle width control knob axially drives a frame that is attached to the actuation element.

Example 120. The device delivery system according to example 119, wherein the paddle width control knob is rotatable relative to the frame.

Example 121. The handle assembly according to example 119 or example 120, wherein rotation of the paddle width control knob in a first direction axially drives the paddle width control knob and the paddle width adjustment element in a direction away from the paddle actuation control and the actuation element.

Example 122. A method of delivering a device comprising: (i) obtaining the 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, wherein the sheath is coupled at a proximal end of the sheath to a handle of the device/implant catheter assembly; (ii) advancing the sheath of the device/implant catheter assembly to position the device at a delivery site; (iii) actuating a paddle actuation control on the handle, thereby causing movement of the actuation element to move the device from a closed configuration to an open configuration; (iv) actuating a paddle width control on the handle, thereby causing movement of 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; (v) actuating the paddle actuation control on the handle, thereby causing movement of the actuation element to move the device from the open configuration to a closed configuration; and (vi) decoupling the device from the actuation element and the paddle width adjustment element.

Example 123. The method according to example 122, wherein moving the paddle actuation control in a single direction can move the device from a fully elongated configuration to the open configuration and move the device from the open configuration to the closed configuration.

Example 124. The method according to example 122 or example 123, wherein the paddle width adjustment element is coupled to the at least one of the pair of paddles through an inner end, wherein axial movement of the paddle width adjustment element causes axial movement of the inner end with respect to an actuation portion of the device, and wherein axial movement of the inner end causes the at least one of the pair of paddles to move relative to the actuation portion of the device effective to move the width of at least one of the pair of paddles from the first width to the second width.

Example 125. The method according to any one of examples 122-124, wherein the paddle actuation control is a paddle actuation knob, and wherein actuating the paddle actuation control comprises rotating the paddle actuation knob such that the paddle actuation knob and the paddle width control move axially relative to the housing of the handle.

Example 126. The method according to any one of examples 122-125, wherein the paddle width control is a paddle width control knob, and wherein actuating the paddle width control comprises rotating the paddle width control knob such that the paddle width control knob and the paddle width adjustment element move axially relative to a frame coupled to the paddle actuation knob.

Example 127. The method according to example 126, wherein the paddle width adjustment element is rotationally fixed during rotation of the paddle width control knob, and wherein the actuation element is rotationally fixed during rotation of the paddle actuation knob.

Example 128. The method according to any one of examples 122-127, wherein decoupling the device comprises: (i) releasing a first end of the paddle width adjustment element and pulling a second end of the paddle width adjustment element to cause the first end of the paddle width adjustment element to be pulled through the sheath of the device/implant catheter assembly and the actuation element; and (ii) releasing a first end of the actuation element and pulling a second end of the actuation element to cause the first end of the actuation element to be pulled through the sheath of the device/implant catheter assembly.

Example 129. A handle assembly for controlling a transvascular device, the handle assembly comprising: (i) a handle housing; (ii) a sheath extending distally from the handle housing; (iii) an actuation element extending through the sheath, the actuation element configured to be coupled to the device; (iv) a paddle width adjustment element extending through the actuation element, the paddle width adjustment element configured to be coupled to at least one of a pair of paddles of the device; and (v) a paddle actuation control coupled to the actuation element, wherein actuation of the paddle actuation control causes movement of the actuation element with respect to the handle housing and the sheath, wherein the movement of the actuation element causes the device to be moved between an open configuration and a closed configuration.

Example 130. The handle assembly according to example 129, further comprising a paddle width control coupled to the paddle width adjustment element, wherein actuation of the paddle width control causes movement of the paddle width adjustment element with respect to the handle housing and the sheath, wherein the movement of the paddle width adjustment element causes a width of the at least one of the pair of paddles of the device to be moved from a first width to a second width.

Example 131. The handle assembly according to any one of examples 129-130, 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; and a pair of clasp control members, wherein each clasp control member of the pair of clasp control members is movable relative to the handle housing, wherein the movement of each clasp control member causes a clasp of the device to be moved between an open configuration and a closed configuration.

Example 132. The handle assembly according to example 131, wherein 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.

Example 133. The handle assembly according to any one of examples 129-131, wherein the paddle width control is coupled to a planetary gearbox and actuation of the paddle width control is effective to cause rotation of the planetary gearbox.

Example 134. The handle assembly according to example 133, wherein the planetary gearbox comprises an elongated central gear, wherein 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 movement of the rotationally fixed follower, which in turn causes movement of the paddle width adjustment element with respect to the housing.

Example 135. The handle assembly according to example 134, wherein external teeth of the elongated central gear engage with teeth of the pair of planet gears.

Example 136. A delivery system comprising: (i) a steerable catheter assembly having a handle and a sheath extending from the handle in an axial direction, the sheath of the steerable catheter assembly having a distal end portion comprising a steerable section; (ii) a device/implant catheter assembly having a handle and a sheath extendable coaxially through the sheath of the steerable catheter assembly, wherein the device/implant catheter assembly comprises: (a) a handle housing, wherein the sheath of the device/implant catheter assembly extends distally from the handle housing; (b) an actuation element extending through the sheath, the actuation element configured to be coupled to the device; (c) a paddle width adjustment element extending through the actuation element, the paddle width adjustment element configured to be coupled to at least one of a pair of paddles of the device; (d) a paddle actuation control coupled to the actuation element, wherein actuation of the paddle actuation control causes movement of the actuation element with respect to the handle housing and the sheath, wherein the movement of the actuation element causes the device to be moved between an open configuration and a closed configuration; and (e) a paddle width control coupled to the paddle width adjustment element, wherein actuation of the paddle width control causes movement of the paddle width adjustment element with respect to the handle housing and the sheath, wherein the movement of the paddle width adjustment element causes a width of the at least one of the pair of paddles of the device to be moved from a first width to a second width.

Example 137. The device delivery system according to example 136, wherein the device/implant catheter assembly further comprises (i) 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; and (ii) a pair of clasp control members, wherein each clasp control member of the pair of clasp control members is movable relative to the handle housing, wherein the movement of each clasp control member causes a respective clasp of the device to be moved between an open configuration and a closed configuration; and wherein 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.

Example 138. The device delivery system according to any one of examples 136-137, wherein each suture lock is angled with respect to a central axis extending through the handle of the device/implant catheter assembly.

Example 139. The device delivery system according to any one of examples 136-138, wherein the paddle width control is configured as a paddle width control knob that is coupled to a planetary gearbox and rotation of the paddle width control knob is effective to cause rotation of the planetary gearbox.

Example 140. The device/implant catheter assembly according to example 139, wherein the planetary gearbox comprises an elongated central gear, wherein 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 axial movement of the rotationally fixed follower, which in turn causes axial movement of the paddle width adjustment element with respect to the housing.

Example 141. The device/implant catheter assembly according to example 140 or example 140, wherein external teeth of the elongated central gear engage with teeth of the pair of planet gears.

Example 142. A handle assembly for controlling a device, the handle assembly comprising: (i) a handle housing; (ii) a sheath extending distally from the handle housing; (iii) an actuation element extending through at least a portion of the sheath, the actuation element configured to be coupled to the device; (iv) a width adjustment element extending through at least a portion of the sheath, the width adjustment element configured to be coupled to at least one of a pair of anchors of the device; (v) an actuation control coupled to the actuation element, wherein actuation of the actuation control causes movement of the actuation element with respect to the handle housing and/or the sheath, wherein the movement of the actuation element can move the device between an open configuration and a closed configuration; and (vi) a width control coupled to the width adjustment element, wherein actuation of the width control causes movement of the width adjustment element relative to the handle housing and/or the sheath, wherein the movement of the width adjustment element can transition at least one of the pair of anchors of the device between a first width and a second width.

Example 143. The handle assembly according to example 142, further comprising one or more clasp actuation lines extending through the sheath, the one or more clasp actuation lines configured to be coupled to the device.

Example 144. The handle assembly according to example 143, wherein 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 in the distal end.

Example 145. The handle assembly according to any one of examples 142-144, further comprising one or more clasp control members, wherein the one or more clasp control members are movable relative to the handle housing, wherein movement of the one or more clasp control members causes one or more clasps of the device to be moved between an open configuration and a closed configuration.

Example 146. The handle assembly according to any one of examples 143-145, wherein the one or more clasp actuation lines are coupled to a suture lock extending from a proximal end of the handle housing.

Example 147. The handle assembly according to example 146, wherein each suture lock is angled with respect to a central axis extending through the handle assembly.

Example 148. The handle assembly according to any one of examples 142-147, wherein the width control is coupled to a planetary gearbox and actuation of the width control is effective to cause rotation of the planetary gearbox.

Example 149. The handle assembly according to example 148, wherein the planetary gearbox comprises at least a ring gear, a pair of planet gears, and an elongated central gear.

Example 150. The handle assembly according to example 149, wherein 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 axial movement of the rotationally fixed follower, which in turn causes axial movement of the width adjustment element with respect to the housing.

Example 151. The handle assembly according to example 149 or example 150, wherein external teeth of the elongated central gear engage with teeth of the pair of planet gears.

Example 152. A handle assembly for controlling a transvascular device having a plurality of clasps for securing native leaflets of a heart valve, the handle assembly comprising: (i) a handle housing; (ii) a sheath extending distally from the handle housing; (iii) a first clasp actuation element extending through the sheath, the first clasp actuation element operatively coupled to a first clasp of the plurality of clasps on the device; (iv) a first clasp control member operatively connected to the first clasp actuation element, the first clasp control member movable relative to the housing between a first position associated with the first clasp being in an open position and a second position associated with the first clasp being in a closed position; and (v) a first biasing element configured to apply a first force to pull the first clasp toward the open position.

Example 153. The handle assembly according to example 152, wherein the first biasing element applies the first force onto the first clasp actuation element.

Example 154. The handle assembly according to example 153, wherein the first biasing element directly contacts the first clasp actuation element when applying the first force.

Example 155. The handle assembly according to any of examples 153-154, wherein the first force is directed radially outward from a centerline of the handle housing.

Example 156. The handle assembly according to any of examples 153-155, wherein the first force is not applied to pull the first clasp toward the open position when the first clasp control member is in the second position.

Example 157. The handle assembly according to any of examples 152-156, wherein the first biasing element has an elongated body having a proximal end fixed relative to the handle housing and a free distal end.

Example 158. The handle assembly according to example 157, wherein the elongated body has a semi-elliptical shape.

Example 159. The handle assembly according to example 157 or example 158, wherein the first biasing element has an opening extending laterally through the elongated body and the first clasp actuation element extends through the opening.

Example 160. The handle assembly according to example 159, wherein the opening is positioned closer to the distal end than the proximal end.

Example 161. The handle assembly according to any of examples 152-160, wherein the first clasp actuation element is a suture line.

Example 162. The handle assembly according to any of examples 152-161, wherein the first biasing element has a wide position in which the force is applied to pull the first clasp toward the open position and a narrow position in which the force is not applied to pull the first clasp toward the open position.

Example 163. The handle assembly according to example 162, wherein the first biasing element is biased to the wide position.

Example 164. The handle assembly according to example 163, wherein 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.

Example 165. The handle assembly according to example 163 or 164, wherein 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.

Example 166. The handle assembly according to example 152, wherein the first biasing element is positioned in-line with the first clasp actuation element.

Example 167. The handle assembly according to example 166, wherein the first biasing element comprises an elastic portion of the first clasp actuation element.

Example 168. The handle assembly according to example 167, wherein the elastic portion extends along an entire length of the first clasp actuation element.

Example 169. The handle assembly according to example 167, wherein the elastic portion extends along a partial length of the first clasp actuation element.

Example 170. The handle assembly according to example 169, wherein the elastic portion of the first clasp actuation element is positioned inside the handle housing.

Example 171. The handle assembly according to any of examples 166-170, wherein the first biasing element does not apply the first force to pull the first clasp toward the open position when the first clasp control member is in the second position.

Example 172. The handle assembly according to any of examples 152-171, wherein the first clasp control member is movable axially relative to the housing between the first position and the second position.

Example 173. The handle assembly according to any of example 152-172, further comprising: (i) a second clasp actuation element extending through the sheath, the second clasp actuation element operatively coupled to a second clasp of the plurality of clasps on the device; (ii) a second clasp control member operatively connected to the second clasp actuation element, the second clasp control member movable relative to the housing between a third position associated with the second clasp being in an open position and a fourth position associated with the second clasp being in a closed position; and (iii) a second biasing element configured to apply a second force to pull the second clasp toward the open position.

Example 174. The handle assembly according to example 173, wherein the second biasing element is configured to apply the second force independent of the first biasing element.

Example 175. A method of using a treatment device or valve repair device having one or more clasps for securing one or more native leaflets of a heart valve, the method comprising: (i) delivering the treatment device or valve repair device to the heart valve via a device/implant catheter assembly; (ii) moving a first clasp control member to a first position to hold a first clasp of the treatment device or valve repair device in an open position with a first clasp actuation element; (iii) moving the first clasp control member to a second position to close the first clasp of the treatment device or valve repair device to grasp a first leaflet of the heart valve; and wherein holding the first clasp of the treatment device or 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.

Example 176. The method according to example 175, wherein applying the first force to the first clasp actuation element further comprises applying a force onto the first clasp actuation element.

Example 177. The method according to example 175 or example 176, wherein the first force is a radially outward force.

Example 178. The method according to any of examples 175-177, wherein the first clasp actuation element is a suture line.

Example 179. The method according to any of example 175-177, wherein applying the first force to the first clasp actuation element after the first clasp control member is in the first position further comprises moving a biasing element to a wide position.

Example 180. The method according to any of example 179, wherein moving the biasing element to the wide position further comprises moving the first clasp control member to the first position.

Example 181. The method according to example 177 or example 180, wherein moving the first clasp control member to a second position further comprises moving the biasing element to a narrow position.

Example 182. The method according to example 181, wherein moving the biasing element to the narrow position further comprises engaging the biasing element with the first clasp control member.

Example 183. The method according to example 182, further comprising holding the biasing element in the narrow position with the first clasp control member.

Example 184. The method according to any one of examples 175-183, wherein moving the first clasp control member to the second position further comprises moving the first clasp control member axially.

Example 185. The method according to example 175, wherein applying force to the first clasp actuation element further comprises stretching an elastic portion of the first clasp actuation element.

Example 186. The method according to any of examples 175-185, further comprising: (i) moving a second clasp control member to a third position to hold a second clasp of the treatment device or valve repair device in an open position with a second clasp actuation element; (ii) moving the second clasp control member to a fourth position to close the second clasp of the treatment device or valve repair device to grasp a second leaflet of the heart valve; and wherein holding the second clasp of the treatment device or valve repair device in an open position further comprises applying a second force to the second clasp actuation element after the second clasp control member is in the third position.

Example 187. The method according to example 186, wherein the first force is applied independent of the second force.

Example 188. A delivery system for a device having one or more clasps for securing native leaflets of a heart valve, the delivery system comprising a device/implant catheter assembly having a handle assembly for controlling the device and a sheath extending from the handle assembly in an axial direction; wherein the sheath has distal end portion comprising a capture mechanism for releasably attaching the sheath to the device; and wherein the device/implant catheter assembly, comprises: (i) a handle housing, the sheath extending distally from the handle housing; (ii) a first clasp actuation element extending through the sheath, the first clasp actuation element operatively coupled to a first clasp of one or more clasps on the device; (iii) a first clasp control member operatively connected to the first clasp actuation element, the first clasp control member movable relative to the housing between a first position associated with the first clasp being in an open position and a second position associated with the first clasp being in a closed position; and (iv) a first biasing element configured to apply a force to pull the first clasp toward the open position.

Example 189. The delivery system according to example 188, wherein the first biasing element applies the force onto the first clasp actuation element.

Example 190. The delivery system according to example 189, wherein the first biasing element directly contacts the first clasp actuation element when applying the force.

Example 191. The delivery system according to any of examples 188-190, wherein the force is directed radially outward from a centerline of the handle housing.

Example 192. The delivery system according to any of examples 188-191, wherein the force is not applied to pull the first clasp toward the open position when the first clasp control member is in the second position.

Example 193. The delivery system according to any of examples 188-191, wherein the first biasing element has an elongated body having a proximal end fixed relative to the handle housing and a free distal end.

Example 194. The delivery system according to example 193, wherein the elongated body has a semi-elliptical shape.

Example 195. The delivery system according to example 193 or example 194, wherein the first biasing element has an opening extending laterally through the elongated body and the first clasp actuation element extends through the opening.

Example 196. The delivery system according to example 195, wherein the opening is positioned closer to the distal end than the proximal end.

Example 197. The delivery system according to any of examples 188-196, wherein the first clasp actuation element is a suture line.

Example 198. The delivery system according to any of examples 188-197, wherein the first biasing element has a wide position in which the force is applied to pull the first clasp toward the open position and a narrow position in which the force is not applied to pull the first clasp toward the open position.

Example 199. The delivery system according to example 198, wherein the first biasing element is biased to the wide position.

Example 200. The delivery system according to example 199, wherein 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.

Example 201. The delivery system according to example 199 or example 200, wherein 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.

Example 202. The delivery system according to example 188, wherein the first biasing element is positioned in-line with the first clasp actuation element.

Example 203. The delivery system according to example 202, wherein the first biasing element comprises an elastic portion of the first clasp actuation element.

Example 204. The delivery system according to example 203, wherein the elastic portion extends along an entire length of the first clasp actuation element.

Example 205. The delivery system according to example 203, wherein the elastic portion extends along a partial length of the first clasp actuation element.

Example 206. The delivery system according to example 205, wherein the elastic portion of the first clasp actuation element is positioned inside the handle housing.

Example 207. The delivery system according to any of examples 202-206, wherein the first biasing element does not apply the force to pull the first clasp toward the open position when the first clasp control member is in the second position.

Example 208. The delivery system according to any of examples 188-207, wherein the first clasp control member is movable axially relative to the housing between the first position and the second position.

Example 209. The delivery system according to any of examples 188-208, further comprising: (i) a second clasp actuation element extending through the sheath, the second clasp actuation element operatively coupled to a second clasp of the one or more clasps on the device; (ii) a second clasp control member operatively connected to the second clasp actuation element, the second clasp control member movable relative to the housing between a third position associated with the second clasp being in an open position and a fourth position associated with the second clasp being in a closed position; and (iii) a second biasing element configured to apply a second force to pull the second clasp toward the open position.

Example 210. The delivery system according to example 209, wherein the second biasing element is configured to apply the second force independent of the first biasing element.

Example 211. A clasp actuation line for actuating a clasp of a treatment device or valve repair device via a clasp control member, the clasp actuation line comprising: (i) a braided body having a first end configured to operatively couple to the clasp control member and a second end opposite the first end; and (ii) wherein the braided body has a first portion having a first elasticity and a second portion having a second elasticity greater than the first elasticity.

Example 212. The clasp actuation line according to example 211, wherein the first portion of the braided body has a first number of picks per inch and the second portion of the braided body has a second number of picks per inch that is greater than the first number of picks per inch.

Example 213. The clasp actuation line according to example 211, wherein both the first portion and the second portion are formed from an ultra-high-molecular-weight polyethylene material.

Example 214. The clasp actuation line according to example 211, wherein the second portion extends the majority of an entire length of the clasp actuation line.

Example 215. The clasp actuation line according to example 211, wherein the second portion is adjacent the first end and extends less than half a total length of the clasp actuation line.

Example 216. The clasp actuation line according to any one of examples 211-215 used as the clasp actuation line of any of the foregoing systems and/or assemblies of any of the foregoing examples.

Any of the various systems, assemblies, devices, apparatuses, elements, etc. in this disclosure, including the enumerated examples above, can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the above methods can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

While various inventive aspects, concepts and features of the disclosures can be described and illustrated herein as embodied in combination in the example implementations, these various aspects, concepts, and features can be used in many alternative implementations, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the present application. Still further, while various alternative implementations as to the various aspects, concepts, and features of the disclosures-such as alternative materials, structures, configurations, methods, devices, and components, alternatives as to form, fit, and function, and so on—may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative implementations, whether presently known or later developed. Those skilled in the art may readily adopt one or more of the inventive aspects, concepts, or features into additional implementations and uses within the scope of the present application even if such implementations are not expressly disclosed herein.

Additionally, even though some features, concepts, or aspects of the disclosures can be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, example or representative values and ranges can be included to assist in understanding the present application, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated.

Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of a disclosure, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a specific disclosure, the disclosures instead being set forth in the appended claims. Descriptions of example methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated. Further, the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a living subject (e.g., human, other animal, etc.) or on a non-living subject (e.g., a simulation, such as a cadaver, cadaver heart, simulator, anthropomorphic phantom, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can comprise computerized and/or physical representations of the body parts, tissue, etc. The words used in the claims have their full ordinary meanings and are not limited in any way by the description of the implementations in the specification.