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.
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.
To further clarify various aspects of implementations of the present disclosure, a more particular description of certain examples and implementations will be made by reference to various aspects of the appended drawings. These drawings depict only example implementations of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures can be drawn to scale for some examples, the figures are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
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.
The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, seen in
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Various disease processes can impair proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's Disease, fibroelastic deficiency, etc.), inflammatory processes (e.g., Rheumatic Heart Disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or the right ventricle RV from prior heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) may distort a native valve's geometry, which may cause the native valve to dysfunction. However, the majority of patients undergoing valve surgery, such as surgery to the mitral valve MV, suffer from a degenerative disease that causes a malfunction in a leaflet (e.g., leaflets 20, 22) of a native valve (e.g., the mitral valve MV), which results in prolapse and regurgitation.
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.
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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 leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent or inhibit regurgitation of blood through the mitral valve MV. As can be seen in
In some implementations, a coaptation element (e.g., spacer, coaption element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) of the device 10 has a generally tapered or triangular shape that naturally adapts to the native valve geometry and to its expanding leaflet nature (toward the annulus). In this application, the terms spacer, 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 in
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 leaflets 20, 22 of the mitral valve MV to prevent or inhibit regurgitation of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (
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 leaflets 20, 22 or tricuspid valve leaflets 30, 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.
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The device or implant 100 is deployed from a delivery system 102. The delivery system 102 can comprise one or more of a catheter, a sheath, a guide catheter/sheath, a delivery catheter/sheath, a steerable catheter, a device/implant catheter, a tube, a channel, a pathway, combinations of these, etc. The device or implant 100 includes a coaptation portion/coaptation region 104 and an anchor portion/anchor region 106.
In some implementations, the coaptation portion 104 of the device or implant 100 includes a coaptation element 110 (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 element 112 (e.g., actuation wire, shaft, tube, hypotube, line, suture, braid, etc.). The anchor portion 106 includes one or more anchors 108 that are actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element 112 opens and closes the anchor portion 106 of the device 100 to grasp the native valve leaflets during implantation. The actuation element 112 (as well as other means for actuating and actuation elements disclosed herein) can take a wide variety of different forms (e.g., as a wire, rod, shaft, tube, screw, suture, line, strip, combination of these, etc.), be made of a variety of different materials, and have a variety of configurations. As one example, the actuation element can be threaded such that rotation of the actuation element moves the anchor portion 106 relative to the coaptation portion 104. Or, the actuation element can be unthreaded, such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the coaptation portion 104.
The anchor portion 106 and/or anchors of the device 100 include outer paddles 120 and inner paddles 122 that are, in some implementations, connected between a cap 114 and the coaptation element 110 by portions 124, 126, 128. The portions 124, 126, 128 can be jointed and/or flexible to move between all of the positions described below. The interconnection of the outer paddles 120, the inner paddles 122, the coaptation element 110, and the cap 114 by the portions 124, 126, and 128 can constrain the device to the positions and movements illustrated herein.
In some implementations, the delivery system 102 includes a steerable catheter, device/implant catheter, and actuation element 112 (e.g., actuation wire, actuation shaft, etc.). These can be configured to extend through a guide catheter/sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuation element 112 extends through a delivery catheter and the coaptation element 110 to the distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuation element 112 increases and decreases the spacing between the coaptation element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively. In some implementations, a collar or other attachment element (e.g., clamp, clip, lock, sutures, friction fit, buckle, snap fit, lasso, etc.) removably attaches the coaptation element 110 to the delivery system 102, either directly or indirectly, so that the actuation element 112 slides through the collar or other attachment element and, in some implementations, through a coaptation element 110 during actuation to open and close the paddles 120, 122 of the anchor portion 106 and/or anchors 108.
In some implementations, the anchor portion 106 and/or anchors 108 can include attachment portions or gripping members (e.g., gripping arms, clasp arms, etc.). The illustrated gripping members can comprise clasps 130 that include a base or fixed arm 132, a movable arm 134, optional friction-enhancing elements, or other securing structures 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and a joint portion 138. The fixed arms 132 are attached to the inner paddles 122. In some implementations, the fixed arms 132 are attached to the inner paddles 122 with the joint portion 138 disposed proximate a coaptation element 110. The joint portion 138 provides a spring force between the fixed and movable arms 132, 134 of the clasp 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint portion 138 is a flexible piece of material integrally formed with the fixed and movable arms 132, 134. The fixed arms 132 are attached to the inner paddles 122 and remain stationary or substantially stationary relative to the inner paddles 122 when the movable arms 134 are opened to open the clasps 130 and expose the optional barbs, friction-enhancing elements, or securing structures 136.
In some implementations, the clasps 130 are opened by applying tension to actuation lines 116 attached to the movable arms 134, thereby causing the movable arms 134 to articulate, flex, or pivot on the joint portions 138. The actuation lines 116 extend through the delivery system 102 (e.g., through a steerable catheter and/or a device/implant catheter). Other actuation mechanisms are also possible.
The actuation line 116 can take a wide variety of forms, such as, for example, a line, a suture, a wire, a rod, a catheter, or the like. The clasps 130 can be spring loaded so that in the closed position the clasps 130 continue to provide a pinching force on the grasped native leaflet. Optional barbs, friction-enhancing elements, or securing structures 136 of the clasps 130 can grab, pinch, and/or pierce the native leaflets to further secure the native leaflets.
During implantation, the paddles 120, 122 can be opened and closed, for example, to grasp the native leaflets (e.g., native mitral valve leaflets, etc.) between the paddles 120, 122 and/or between the paddles 120, 122 and a coaptation element 110 (e.g., a spacer, plug, membrane, gap filler, etc.). The clasps 130 can be used to grasp and/or further secure the native leaflets by engaging the leaflets with optional barbs, friction-enhancing elements, or securing structures 136 and pinching the leaflets between the movable and fixed arms 134, 132. The optional barbs, friction-enhancing elements, or other securing structures 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.) of the clasps 130 increase friction with the leaflets or can partially or completely puncture the leaflets. The actuation lines 116 can be actuated separately so that each clasp 130 can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a clasp 130 on a leaflet that was insufficiently grasped, without altering a successful grasp on the other leaflet. The clasps 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing leaflets to be grasped in a variety of positions as the particular situation requires.
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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).
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In some implementations, the device or implant 200 includes a coaptation portion 204, a proximal or attachment portion 209, an anchor portion 206, and a distal portion 207. In some implementations, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., a spacer, coaption element, plug, membrane, sheet, etc.) for implantation between leaflets of a native valve. In some implementations, the anchor portion 206 includes a plurality of anchors 208. The anchors can be configured in a variety of ways. In some implementations, each anchor 208 includes outer paddles 220, inner paddles 222, paddle extension members or paddle frames 224, and clasps 230. In some implementations, the attachment portion 209 includes a first or proximal collar 211 (or other attachment element) for engaging with a capture mechanism 213 (see e.g.,
In some implementations, the coaptation element 210 and paddles 220, 222 are formed from a flexible material that can be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The material can be cloth, shape-memory alloy wire—such as Nitinol—to provide shape-setting capability, or any other flexible material suitable for implantation in the human body.
An actuation element 212 (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from the delivery system 202 to engage and enable actuation of the device or implant 200. In some implementations, the actuation element 212 extends through the capture mechanism 213, proximal collar 211, and coaptation element 210 to engage a cap 214 of the distal portion 207. The actuation element 212 can be configured to removably engage the cap 214 with a threaded connection, or the like, so that the actuation element 212 can be disengaged and removed from the device 200 after implantation.
The coaptation element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddles 222. In some implementations, the coaptation element 210 has a generally elongated and round shape, though other shapes and configurations are possible. In some implementations, the coaptation element 210 has an elliptical shape or cross-section when viewed from above (e.g.,
The size and/or shape of the coaptation element 210 can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In some implementations, the anterior-posterior distance at the top of the coaptation element is about 5 mm, and the medial-lateral distance of the coaptation element at its widest is about 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategy described above. It should be readily apparent that the use of other anterior-posterior distance anterior-posterior distance and medial-lateral distance as starting points for the device will result in a device having different dimensions. Further, using other dimensions and the shape strategy described above will also result in a device having different dimensions.
In some implementations, the outer paddles 220 are jointably attached to the cap 214 of the distal portion 207 by connection portions 221 and to the inner paddles 222 by connection portions 223. The inner paddles 222 are jointably attached to the coaptation element by connection portions 225. In this manner, the anchors 208 are configured similar to legs in that the inner paddles 222 are like upper portions of the legs, the outer paddles 220 are like lower portions of the legs, and the connection portions 223 are like knee portions of the legs.
In some implementations, the inner paddles 222 are stiff, relatively stiff, rigid, have rigid portions and/or are stiffened by a stiffening member or a fixed portion 232 of the clasps 230. The stiffening of the inner paddle allows the device to move to the various different positions shown and described herein. The inner paddle 222, the outer paddle 220, the coaptation can all be interconnected as described herein, such that the device 200 is constrained to the movements and positions shown and described herein.
In some implementations, the paddle frames 224 are attached to the cap 214 at the distal portion 207 and extend to the connection portions 223 between the inner and outer paddles 222, 220. In some implementations, the paddle frames 224 are formed of a material that is more rigid and stiff than the material forming the paddles 222, 220 so that the paddle frames 224 provide support for the paddles 222, 220.
The paddle frames 224 provide additional pinching force between the inner paddles 222 and the coaptation element 210 and assist in wrapping the leaflets around the sides of the coaptation element 210 for a better seal between the coaptation element 210 and the leaflets, as can be seen in
Configuring the paddle frames 224 in this manner provides increased surface area compared to the outer paddles 220 alone. 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 paddles 220 and paddle frames 224 against the native leaflets over a relatively larger surface of the native leaflets in order to further protect the native leaflet tissue. Referring again to
In some implementations the clasps comprise a movable arm coupled to the anchors. In some implementations, the clasps 230 include a base or fixed arm 232, a movable arm 234, with optional barbs, friction-enhancing elements, or securing structures 236, and a joint portion 238. The fixed arms 232 are attached to the inner paddles 222, with the joint portion 238 disposed proximate the coaptation element 210. The joint portion 238 is spring-loaded so that the fixed and movable arms 232, 234 are biased toward each other when the clasp 230 is in a closed condition. In some implementations, the clasps 230 include friction-enhancing elements or securing structures, such as barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.
In some implementations, the fixed arms 232 are attached to the inner paddles 222 through holes or slots 231 with sutures (not shown). The fixed arms 232 can be attached to the inner paddles 222 with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, clamps, latches, or the like. The fixed arms 232 remain substantially stationary relative to the inner paddles 222 when the movable arms 234 are opened to open the clasps 230 and expose the optional barbs, friction-enhancing elements, or securing structures 236. The clasps 230 are opened by applying tension to actuation lines 216 (e.g., as shown in
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During implantation, the paddles 220, 222 of the anchors 208 are opened and closed to grasp the native valve leaflets 20, 22 between the paddles 220, 222 and the coaptation element 210. The anchors 208 are moved between a closed position (
As the device 200 is opened and closed, the pair of inner and outer paddles 222, 220 are moved in unison, rather than independently, by a single actuation element 212. Also, the positions of the clasps 230 are dependent on the positions of the paddles 222, 220. For example, the clasps 230 are arranged such that closure of the anchors 208 simultaneously closes the clasps 230. In some implementations, the device 200 can be made to have the paddles 220, 222 be independently controllable in the same manner (e.g., the device 101 illustrated in
In some implementations, the clasps 230 further secure the native leaflets 20, 22 by engaging the leaflets 20, 22 with optional barbs, friction-enhancing elements, or securing structures 236 and/or pinching the leaflets 20, 22 between the movable and fixed arms 234, 232. In some implementations, the clasps 230 are barbed clasps that include barbs that increase friction with and/or can partially or completely puncture the leaflets 20, 22. The actuation lines 216 (
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Configuring the device or implant 200 such that the anchors 208 can extend to a straight or approximately straight configuration (e.g., approximately 120-180 degrees relative to the coaptation element 210) can provide several advantages. For example, this configuration can reduce the radial crimp profile of the device or implant 200. It can also make it easier to grasp the native leaflets 20, 22 by providing a larger opening between the coaptation element 210 and the inner paddles 222 in which to grasp the native leaflets 20, 22. Additionally, the relatively narrow, straight configuration can prevent or reduce the likelihood that the device or implant 200 will become entangled in native anatomy (e.g., chordae tendineae CT shown in
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To adequately fill the gap 26 between the leaflets 20, 22, the device 200 and the components thereof can have a wide variety of different shapes and sizes. For example, the outer paddles 220 and paddle frames 224 can be configured to conform to the shape or geometry of the coaptation element 210 as is shown in
This coaptation of the leaflets 20, 22 against the lateral and medial aspects 201, 203 of the coaptation element 210 (shown from the atrial side in
Referring to
Additional features of the device 200, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2018/028189 (International Publication No. WO 2018/195215). 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 to
The device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device/implant 300 includes a coaptation portion/region 304, and the coaptation portion/region 304 can optionally include a coaptation element 310 (e.g., spacer, plug, membrane, sheet, gap filler, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles, e.g., outer paddles 320, inner paddles 322, paddle extension members or paddle frames 324. The anchors can also include and/or be coupled to clasps 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging with a capture mechanism (e.g., a capture mechanism such as the capture mechanism 213 shown in
The anchors 308 can be attached to the other portions of the device and/or to each other in a variety of different ways (e.g., directly, indirectly, welding, sutures, adhesive, links, latches, integrally formed, a combination of some or all of these, etc.). In some implementations, the anchors 308 are attached to a coaptation element 310 by connection portions 325 and to a cap 314 by connection portions 321.
The anchors 308 can comprise first portions or outer paddles 320 and second portions or inner paddles 322 separated by connection portions 323. The connection portions 323 can be attached to paddle frames 324 that are hingeably attached to a cap 314 or other attachment portion. In this manner, the anchors 308 are configured similar to legs in that the inner paddles 322 are like upper portions of the legs, the outer paddles 320 are like lower portions of the legs, and the connection portions 323 are like knee portions of the legs.
In implementations with a coaptation member or coaptation element 310, the coaptation member or coaptation element 310 and the anchors 308 can be coupled together in various ways. For example, as shown in the illustrated example, the coaptation element 310 and the anchors 308 can be coupled together by integrally forming the coaptation element 310 and the anchors 308 as a single, unitary component. This can be accomplished, for example, by forming the coaptation element 310 and the anchors 308 from a continuous strip 301 of a braided or woven material, such as braided or woven nitinol wire. In the illustrated example, the coaptation element 310, the outer paddle portions 320, the inner paddle portions 322, and the connection portions 321, 323, 325 are formed from a continuous strip of fabric 301.
Like the anchors 208 of the device or implant 200 described above, the anchors 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.). This movement can be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device. For example, the anchors 308 can be positioned in a fully extended or straight configuration (e.g., similar to the configuration of device 200 shown in
In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some implementations, the connection portions 323 of the anchors 308 are adjacent the longitudinal axis of the coaptation element 310 (e.g., similar to the configuration of device 200 shown in
In some implementations, the clasps comprise a movable arm coupled to an anchor. In some implementations, the clasps 330 (as shown in detail in
The fixed arms 332 are attached to the inner paddles 322 through holes or slots 331 with sutures (not shown). The fixed arms 332 can be attached to the inner paddles 322 with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, or the like. The fixed arms 332 remain substantially stationary relative to the inner paddles 322 when the movable arms 334 are opened to open the clasps 330 and expose the optional barbs, friction-enhancing elements, or securing structures 336. The clasps 330 are opened by applying tension to actuation lines (e.g., the actuation lines 216 shown in
In short, the device or implant 300 is similar in configuration and operation to the device or implant 200 described above, except that the coaptation element 310, outer paddles 320, inner paddles 322, and connection portions 321, 323, 325 are formed from the single strip of material 301. In some implementations, the strip of material 301 is attached to the proximal collar 311, cap 314, and paddle frames 324 by being woven or inserted through openings in the proximal collar 311, cap 314, and paddle frames 324 that are configured to receive the continuous strip of material 301. The continuous strip 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of the strip of material 301 and other portions are formed from multiple overlapping or overlying layers of the strip of material 301.
For example,
As with the device or implant 200 described above, the size of the coaptation element 310 can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In particular, forming many components of the device 300 from the strip of material 301 allows the device 300 to be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance of the device 300 (i.e., the width of the paddle frames 324 which can be wider than the coaptation element 310) at its widest is about 5 mm.
Additional features of the device 300, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/055320 (International Publication No. WO 2020/076898). 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.
In some implementations, the valve repair device or treatment device 402 includes a base assembly 404, a pair of paddles 406, and a pair of gripping members 408 (e.g., clasps, clasp arms, grippers, gripping arms, latches, etc.). In some implementations, the paddles 406 can be integrally formed with the base assembly. For example, the paddles 406 can be formed as extensions of links of the base assembly. In the illustrated example, the base assembly 404 of the valve repair device 402 has a shaft 403, a coupler 405 configured to move along the shaft, and a lock 407 configured to lock the coupler in a stationary position on the shaft. The coupler 405 is mechanically connected to the paddles 406, such that movement of the coupler 405 along the shaft 403 causes the paddles to move between an open position and a closed position. In this way, the coupler 405 serves as a means for mechanically coupling the paddles 406 to the shaft 403 and, when moving along the shaft 403, for causing the paddles 406 to move between their open and closed positions.
In some implementations, the gripping members 408 are pivotally connected to the base assembly 404 (e.g., the gripping members 408 can be pivotally connected to the shaft 403, or any other suitable member of the base assembly), such that the gripping members can be moved to adjust the width of the opening 414 between the paddles 406 and the gripping members 408. The gripping member 408 can include a gripping portion 409 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.) for attaching the gripping members to valve tissue when the valve repair device 402 is attached to the valve tissue. The gripping member 408 forms a means for gripping the valve tissue (in particular tissue of the valve leaflets) with a sticking means or portion such as the gripping portion 409. When the paddles 406 are in the closed position, the paddles engage the gripping members 408, such that, when valve tissue is attached to the gripping portion 409 of 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 device 402 to the valve tissue. In some implementations, the gripping members 408 are configured to engage the paddles 406 such that the gripping portion 409 engages the valve tissue member and the paddles 406 to secure the valve repair device 402 to the valve tissue member. For example, in certain situations, it can be advantageous to have the paddles 406 maintain an open position and have the gripping members 408 move outward toward the paddles 406 to engage valve tissue and the paddles 406.
While the implementations shown in
In some implementations, the valve repair system 400 includes a placement shaft 413 that is removably attached to the shaft 403 of the base assembly 404 of the valve repair device 402. After the valve repair device 402 is secured to valve tissue, the placement shaft 413 is removed from the shaft 403 to remove the valve repair device 402 from the remainder of the valve repair system 400, such that the valve repair device 402 can remain attached to the valve tissue, and the delivery device 401 can be removed from a patient's body.
The valve repair system 400 can also include a paddle control mechanism 410, a gripper control mechanism 411, and a lock control mechanism 412. The paddle control mechanism 410 is mechanically attached to the coupler 405 to move the coupler along the shaft, which causes the paddles 406 to move between the open and closed positions. The paddle control mechanism 410 can 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 shaft 413 and the shaft 403 and is connected to the coupler 405.
The gripper control mechanism 411 is configured to move the gripping members 408 such that the width of the opening 414 between the gripping members and the paddles 406 can be altered. The gripper control mechanism 411 can 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 mechanism 412 is configured to lock and unlock the lock. The lock 407 serves as a locking means for locking the coupler 405 in a stationary position with respect to the shaft 403 and can take a wide variety of different forms and the type of lock control mechanism 412 can be dictated by the type of lock used. In some implementations the lock 407 includes a pivotable plate having a hole, in which the shaft 403 of the valve repair device 402 is 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 shaft 403 to maintain a position on the shaft 403, but, when the pivotable plate is in a substantially non-tilted position, the pivotable plate can be moved along the shaft (which allows the coupler 405 to move along the shaft 403). In other words, the coupler 405 is prevented or inhibited from moving in the direction Y (as shown in
In order to move the valve repair device from the open position (as shown in
Referring to
Referring to
Referring to
In order to move the valve repair device 402 from the open position to the closed position, the lock 407 is moved to an unlocked condition (as shown in
Referring to
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 in
The valve repair device or treatment device 402 can include any other features described with respect to other devices discussed in the present application, and the device 402 can 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 device 402, 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.
As shown in
The delivery catheter assembly 606 and the steerable catheter assembly 608 can 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 assembly 610 at the implantation location. Accordingly, in various implementations, the delivery catheter assembly 606 and the steerable catheter assembly 608 are 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 assemblies 606, 608, 610. U.S. Pat. Nos. 10,653,862 and 10,646,342 are hereby incorporated by reference in their entireties.
In some implementations, the outer shaft 611 of the device/implant catheter assembly 610 can be configured to be steerable. For example, although not shown, the device/implant catheter assembly 610 can 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 in
In the example of
As shown in
In some implementations, the catheter assembly is used to deliver and/or operate a device, such as the device 8200 illustrated in
In the example illustrated in
In some implementations, a connector 8266 (e.g., shaped metal component, shaped plastic component, tether, wire, strut, line, cord, suture, etc.) attaches to the outer frame portions 8256 at outer ends of the connector 8266 and to a coupler 8972 at an inner end 8968 of the connector 8266 (see
The inner frame members 8260 extend from the proximal portion 8205 toward the distal portion 8207. The inner frame members 8260 then extend inward to form retaining portions 8272 that are attached to the actuation cap 8214. The retaining portions 8272 and the actuation cap 8214 can be configured to attach in any suitable manner.
In some implementations, the inner frame members 8260 are rigid frame portions, while the outer frame members 8256 are flexible frame portions. The proximal end portion of the outer frame members 8256 connects to the proximal end portion of the inner frame members 8260, as illustrated in
The width adjustment element 8211 (e.g., width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment screw or bolt etc.) is configured to move the outer frame members 8256 from the expanded position to the narrowed position by pulling the inner end 8968 (
As shown in
The width adjustment element 8211 allows a user to expand or contract the outer frame members 8256 of the device 8200. In the example illustrated in
In some implementations, the receiver 8912 can be integrally formed with or fixedly connected to a distal cap 8214. Moving the cap 8214 relative to a body of the attachment portion 8205 opens and closes the paddles. In the illustrated example, the receiver 8912 slides inside the body of the attachment portion 8205. When the coupler 8972 is detached from the width adjustment element 8211, the width of the outer frame members 8256 is fixed while the actuation element 8102 moves the receiver 8912 and cap 8214 relative to a body of the attachment portion 8205. Movement of the cap can open and close the device in the same manner as the other implementations disclosed above.
In the illustrated example, a driver head 8916 is disposed at a proximal end of the actuation element 8102. The driver head 8916 releasably couples the opening/closing control actuation element 8102 to the receiver 8912. In the illustrated example, the width adjustment element 8211 extends through the actuation element 8102. The actuation tube is axially advanced in the direction opposite to direction Y to move the distal cap 8214. Movement of the distal cap 8214 relative to the attachment portion 8205 is effective to open and close the paddles, as indicated by the arrows in
Also illustrated in
The movement of the outer frame members 8256 to the narrowed position can allow the device or implant 8200 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart—e.g., chordae—and the device 8200. The movement of the outer frame members 8256 to the expanded position provides the anchor portion of the device or implant 8200 with a larger surface area to engage and capture leaflet(s) of a native heart valve.
Referring to
The width adjustment element 8211 can extend distally from the paddle width control 1628, through the paddle actuation control 1626 and through the actuation element 8102 (and, consequently, through the handle 1616, the outer shaft 1611, and through the device 8200), where it couples with the movable coupler 8972. The width adjustment element 8211 can be axially movable relative to the actuation element 8102, the outer shaft 1611, and the handle 1616. The clasp actuation lines 624 can extend through and be axially movable relative to the handle 1616 and the outer shaft 1611. The clasp actuation lines 624 can also be axially movable relative to the actuation element 8102.
Referring to
In the examples of
In various implementations, the handle 1616 including 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 handle 1616 can be incorporated into the control system 1000 shown in FIG. 72. Features of the control system illustrated in
It should be appreciated that handle 7300 can be an implementation of the handle 1616 in
The paddle actuation knob 7302 is rotatable about axis A-A extending longitudinally along the handle 7300. The actuation element 8102 extends through the paddle actuation knob 7302 and is fixed to a ferrule 7312. The ferrule 7312 is affixed to a frame 7310 that includes external threads for engaging with internal threads of the paddle width control knob 7304, as will be described in greater detail below. The distal end of the paddle actuation knob 7302 includes external threads 7314, which are configured to engage internal threads in a housing of the handle 7300. The paddle actuation knob 7302 is rotatable relative to both the housing of the handle 7300 and relative to the frame 7310 and attached ferrule 7312. Accordingly, as the paddle actuation knob 7302 is rotated about the axis A-A with respect to the handle 7300, the paddle actuation knob 7302 axially drives the frame 7310 and attached ferrule 7312 (and, therefore, the actuation element 8102) with respect to the handle 7300, which is effective to axially drive the actuation element 8102 with respect to the device 8200.
The paddle width control knob 7304 is also rotatable about axis A-A extending longitudinally along the handle 7300. The width adjustment element 8211 extends through the actuation element 8102, the paddle actuation knob 7302, the ferrule 7312, and the paddle width control knob 7304. The width adjustment element 8211 is fixedly attached to a ferrule 7316 that is connected inside the control element connection knob 7308. The ferrule 7316 fixes the width adjustment element 8211 rotationally and axial with respect to the control element connection knob 7308. The paddle width control knob 7304 is rotatably coupled to the control element connection knob 7308 and relative to the width adjustment element 8211.
In some implementations, the paddle width control knob 7304 is threadably connected to a threaded component that is fixed or part of the paddle actuation assembly. When the paddle width control knob 7304 is rotated, the threaded connection drives or forces the paddle width control knob 7304 and coupled with control element 7316, such as the illustrated ferrule, away from the paddle actuation knob 7302 and coupled actuation element 7312 or ferrule. For example, as shown in the
The control element connection knob 7308 is coupled to a proximal end of the paddle width control knob 7304 and includes the ferrule 7316 to which the width adjustment element 8211 is affixed. In implementations, the control element connection knob 7308 does not rotate with respect to the axis A-A during implantation of the device 8200. The paddle release clip 7306 locks the control element connection knob 7308 and the paddle width control knob 7304 axially together, while allowing rotation there between. Accordingly, to disengage the width adjustment element 8211 from the device 8200, the paddle release clip 7306 is removed and the control element connection knob 7308 is rotated with respect to the paddle width control knob 7304. This rotates the width adjustment element 8211 with respect to the device 8200, which is effective to uncouple the width adjustment element 8211 from the device 8200. The control element connection knob 7308 and the width adjustment element 8211 can then be pulled axially to remove the width adjustment element from the device 8200.
In some implementations, the device 8200 is released from the device/implant catheter 1622 by the following sequence of actions by the handle. The paddle release clip 7306 is removed and the control element connection knob 7308 is rotated to uncouple the width adjustment element 8211 from the device 8200. The control element connection knob 7308 and the width adjustment element 8211 can then be pulled proximally past a distal end of the actuation element 8102 to decouple the actuation element 8102 driver head 8916 and connected receiver, such as the illustrated tube. For example, in one implementation fingers at the distal end flex inward when the width adjustment element 8211 is pulled proximally past the distal end of the actuation element 8102 to decouple the actuation element 8102 from the driver head 8916. The paddle width control knob 7304 and the actuation element 8102 can then be pulled proximally past a distal end or coupler of the catheter 1622 to decouple the distal end or coupler of the catheter 1622 from the device 8200. For example, in one implementation fingers at the distal end or coupler flex outward when the actuation element 8102 is pulled proximally past the distal end or coupler of the catheter 1622 to decouple the catheter 1622 from the device 8200.
Turning now to
The handle 616 further comprises a flush port 638, as shown in
As shown in
Also included on the handle 616 is a slide lock 642 that is configured to slide between a first position, in which the slide lock 642 is coupled to one of the clasp control members 628, to a second position, in which the slide lock 642 is coupled to both clasp control members 628. For example, each of the clasp control members 628 can include a flange 643 to which the slide lock 642 is slidably coupled. Accordingly, the slide lock 642 can be moved to the first position (as indicated by the arrow shown in
In implementations, each of the clasp control members 628 can 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 member 628 can have a different color and/or texture (e.g., ribbed, smooth) than the other clasp control member 628. As shown in the figures, in implementations, each of the clasp control members 628 is wrapped approximately 180 degrees around the circumference of the housing 632 such that together the clasp control members 628 surround and encircle the housing 632. Such an arrangement can, for example, enable the clasp control members 628 to be accessible to the user from any angle with a single hand. Moreover, in the implementation depicted in
Each clasp control member 628 can 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 housing 632. As best shown in
Referring to
In the example illustrated by
In some implementations, each clasp control tube 648 can comprise one or more optional keying features 671 at various positions or all along the axial length of the clasp control tube 648. In some implementations, no keying features are included. When included, the optional keying features 671 are complementary to corresponding keying features 675 formed in one or more components of the handle 616, such as in the housing 632 of the handle. These keying features 671, 675 can prevent or inhibit rotation of the clasp control tube 648 in the housing and thereby limit movement of the clasp control tube to linear movement along the length of the housing 632. For example, the optional keying feature 671 of the clasp control tube 648 can comprise a wire welded to the external surface of the clasp control tube 648 (see
The suture lock can take a wide variety of different forms. In the example illustrated by
The suture lock body receptacle 662 includes a central bore that extends from a first end to a second end of the suture lock body receptacle 662. The central bore of the suture lock body receptacle 662 is sized to receive the suture lock body 660 at threaded end of the suture lock body receptacle 662 and is sized to receive and be attached to the clasp control tube 648 at the second end of the suture lock body receptacle 662. An optional O-ring 664 is positioned around the suture lock body 660 to form a fluid-tight seal between the suture lock body 660 and the suture lock body receptacle 662.
The clasp actuation line 624 is fixed at one end of the clasp actuation line 624 to the post 658, which is inserted into the suture lock body 660, thereby coupling the clasp actuation line 624 to the suture lock body 660. In implementations, the clasp actuation line 624 can be welded, adhered, or otherwise fixedly coupled to the post 658.
The clasp actuation line 624 is threaded through the central bore in the suture lock body 660, through the central bore in the suture lock body receptacle 662, and through the clasp control tube 648. The clasp control tube 648 guides and protects the clasp actuation line 624 through the interior of the handle 616. The clasp actuation line 624 exits the clasp control tube 648 near the distal end of the handle 616 and extends through the outer shaft 611 of the device/implant catheter assembly 610. As described herein, the clasp actuation line 624 exits the outer shaft 611 at the distal end of the outer shaft, and is coupled to the device, such as by passing through one or more holes 235 in the clasp 130 (see, e.g.,
To release the clasp from the clasp actuation line, the suture lock body 660 is removed (e.g., by unscrewing) from the suture lock body receptacle 662, freeing the end of the clasp actuation line 624 pinched between the suture lock body 660 and the suture lock body receptacle 662. Once the clasp actuation line 624 is released, the clasp actuation line can be pulled through the clasp control tube 648, the outer shaft 611, the hole 235 of the clasp and back through the outer shaft 611 and clasp control tube 648. As such, the clasp actuation line 624 is no longer connected to the clasp and is removed from the patient.
Returning to
As previously mentioned, the handle 616 further comprises a knob 626 (or other control, e.g., button, switch, gears, etc.) that is configured to control the position of the actuation element 112 relative to the handle 616 and outer shaft 611. In some implementations, the knob 626 is configured to rotate about an axis of the handle 616. As can be seen in
In some implementations, when the knob 626 is rotated about the axis of the handle 616, the internally threaded tube 652 rotates with respect to the housing 632. An externally threaded nut or retractor 654 is positioned within and engaged with the internally threaded tube 652. The externally threaded nut or retractor 654 and is rotationally fixed with respect to the housing 632. The externally threaded nut or retractor 654 can be rotationally fixed in a wide variety of different ways. In the example illustrated by
The externally threaded retractor 654 is connected to the actuation element 112 such that linear movement of the externally threaded retractor 654 causes linear movement of the actuation element 112, 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 knob 626 into linear motion of the actuation element 112 can result in improved control and precision, thereby leading to improved precision during the opening and closing of the device.
The internally threaded tube 652 includes and unthreaded portion 657. A clutch spring 656 is positioned around an unthreaded proximal portion 659 of the retractor 654. The clutch spring presses against a proximal end surface 655 of the threaded portion of the retractor 654. Proximal movement of the actuation element 112 after closure of the device 604 can result in overclosure or compression of the valve repair device or treatment device. The position of the unthreaded portion 657 is selected to prevent or inhibit over-retraction of the actuation element 112 and thereby prevent or inhibit over-closing of the valve repair device. That is, the externally threaded retractor 654 is no longer driven proximally when the externally threaded nut or retractor 654 reaches the unthreaded portion 657. The clutch spring is configured to bias the externally threaded retractor 654 distally (e.g., toward the threads of the internally threaded tube 652) when the externally threaded retractor 654 has reached the end of the threads of the internally threaded tube 652. Continued rotation of the knob 626 following disengagement of the external threads of the externally threaded retractor 654 and the internal threads of the internally threaded tube 652 results in an audible indication that the device is in a closed position. The biasing of the externally threaded retractor 654 can also reduce slop in the threaded connection, thereby improving stability of the paddle angle. The biasing of the externally threaded retractor 654 towards the internal threads of the internally threaded tube 652 ensures that the externally threaded retractor 654 will be re-engaged by the internally threaded tube 652 when the knob 626 is rotated in an opposite direction that corresponds to advancement of the actuation element 112.
As shown in
In some implementations, in use, the knob 626 is rotated, which rotates the internally threaded tube 652 to rotate with respect to the housing 632, thereby driving the externally threaded retractor 654 axially. The axial movement of the externally threaded retractor 654 causes axial movement of the actuation element 112, which moves the device between a fully elongated configuration, an open configuration, and a closed configuration. Axial movement of the externally threaded retractor 654 also causes axial movement of the release knob 630 between a proximal, or extended, position (shown in
When the device 604 is in a closed configuration (e.g., shown in
As shown in
Each of the pawls 678 is in contact with the outer surface of the elongated shaft 673. Accordingly, as the release knob 630 is rotated in the unscrewing or loosening direction, each pawl 678 slides up and over the edge of the tooth 674 with 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 tooth 674 with the steeper slope catches the pawl 678 prevents or inhibits the release knob 630 from being rotated in the opposite, tightening direction. Enabling a single direction of rotation of the release knob 630 prevents or inhibits torsion that can build up as a result of the torquing of the actuation element 112 during release of the device 604 from turning the release knob 630 back in the tightening direction.
Once the actuation element 112 is decoupled from the device 604, the actuation element 112 can be withdrawn into the device/implant catheter assembly 610, and the device/implant catheter assembly 610 can be withdrawn through the steerable catheter assembly 608 and the delivery catheter assembly 606.
In implementations, a cap 634 (shown in
In implementations, the handle 616 shown and described in
In implementations, such as the implementation depicted in
The ring gear 892 is housed within a barrel 898 that is fixed to the width control or knob 890 such that rotation of the width control or knob 890 turns the barrel 898 and the ring gear 892 fixed within the barrel 898. In the illustrated example, the axle of each planet gear 894 is fixed. Teeth of the ring gear 892 engage with teeth of the pair of planet gears 894 such that rotation of the ring gear 892 causes rotation of the planet gears 894 on their fixed axles. The teeth of the pair of planet gears 894 also engage with teeth of the elongated central gear 896 such that rotation of the pair of planet gears 894 causes rotation of the elongated central gear 896.
In the implementation shown in
The elongated central gear 896 is positioned within the handle 616 proximate the externally threaded retractor 654 and receives a shaft 904 extending from one end of the externally threaded retractor 654. The shaft 904 is rotatably coupled to the elongated central gear 896 adjacent the follower 902. The width adjustment element 8211 extends through a central passage of the shaft 904 and the externally threaded retractor 654. A clip 906 axially fixes the shaft 904 with respect to the elongated central gear 896. As described above, the externally threaded retractor 654 is rotationally fixed relative to the housing of the handle 616 and is configured to open and close the device coupled to the handle 616 as it is driven axially. The elongated configuration allows the elongated central gear 896 to maintain meshing contact with the planet gears 894 as the elongated central gear moves axially with the externally threaded retractor 654. Rotation of the elongated central gear 896 is effective to drive the follower 902 axially with respect to the externally threaded retractor 654. The movement of the follower 902 relative to the externally threaded retractor 654 is effective to move the width adjustment element 8211 with respect to the actuation portion of the device, thereby adjusting the width of the paddles.
In
As shown in
The housing 3632 can 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 in
The handle 3616 can further comprise a flush port 3638 similar to the flush port 638 of the handle 616 of
In some implementations, the paddle actuation control 3626 is configured to control the position of the actuation element 8102 relative to the handle 3616 and the catheters of delivery assembly. The paddle actuation control 3626 can be configured in a variety of ways, such as, for example, a knob, a button, a switch, one or more gears, etc. In some implementations, the paddle actuation control 3626 can be a lead screw mechanism that converts rotational motion to linear motion. For example, in some implementations, the paddle actuation control 3626 is configured to rotate about a longitudinal axis B of the handle 3616 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 handle 3616 to control the position of the actuation element 8102. In some implementations, the paddle actuation control 3626 can 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 handle 3616. 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 element 8102.
In the illustrated example of
In some implementations, the externally threaded retractor 3654 is connected to a proximal end of the actuation element 8102 such that linear movement of the externally threaded retractor 3654 causes linear movement of the actuation element 8102, thereby moving the device 8200 between an open configuration and a closed configuration, as described herein. The proximal end of the actuation element 8102 can connect to the externally threaded retractor 3654 in any suitable manner. In the illustrated example, the proximal end of the actuation element 8102 is fixed to the externally threaded retractor 3654. The proximal end of the actuation element 8102 can be fixed to the externally threaded retractor 3654 in any suitable manner, such as by a ferrule 3612, or other crimped connection, positioned within a distal portion of a central longitudinal passage 3683 extending through the externally threaded retractor 3654. The translation of the rotational movement of the paddle actuation control 3626 into linear motion of the actuation element 8102 can result in improved control and precision, thereby leading to improved precision during the opening and closing of the device 8200.
The first internally threaded tube 3652 includes a proximal unthreaded portion 3657. Proximal movement of the actuation element 8102 after closure of the device 8200 can result in overclosure or compression of the device. The position of the unthreaded portion 3657 is selected to prevent or inhibit over-retraction of the actuation element 8102 and thereby prevent or inhibit over-closing of the device 8200. That is, the externally threaded retractor 3654 is no longer driven proximally when the externally threaded nut or retractor 3654 reaches the unthreaded portion 3657.
In some implementations, one or more optional springs 3656 or other suitable biasing elements, can be positioned to press against one or more proximally facing surfaces 3655 of the externally threaded retractor 3654. As shown in
As shown in
In some implementations, the handle 3616 includes an extension or link 3688 configured to transfer proximal motion of the externally threaded retractor 3654 to the width control portion 3627. The link 3688 can be configured in a variety of ways. In the illustrated example of
The width control 3629 is configured to control the width of a portion of the anchors of the device, e.g., to control the width of the outer paddles 8120 of the device 8200. The width control 3629 can 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 control 3629 can be a lead screw mechanism that converts rotational motion to linear motion. For example, in some implementations, the width control 3629 is configured as a knob that rotates about the longitudinal axis B of the handle 3616 to control movement of a mechanism (e.g., line, shaft, screw, internally threaded component, externally threaded component, lever, pulley, or any combination thereof) within the handle 3616 to control the position of the width control element 8211. In some implementations, the width control 3629 can 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 handle 3616. 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 element 8211.
As can be seen in the example in
The connection between the barrel 3700 and the second internally threaded tube 3708 can be any suitable connection that provides for rotational movement of the second internally threaded tube 3708 in response to rotation of the barrel 3700 while also allowing for axial movement of the second internally threaded tube 3708. In the illustrated example, the barrel 3700 connects to the second internally threaded tube 3708 via a splined connection.
The second internally threaded tube 3708 includes a central longitudinal passage 3712. Positioned within the central longitudinal passage 3712 is an externally threaded drive member 3714 and a cap 3715. The externally threaded drive member 3714 is configured to engage the internal threads of the second internally threaded tube 3708. The cap is positioned at a distal end of the externally threaded drive member 3714.
In some implementations, the externally threaded drive member 3714 is rotationally fixed with respect to the housing 3632. The externally threaded drive member 3714 can be rotationally fixed in a wide variety of different ways. In the example illustrated by
In the illustrated example, the externally threaded drive member 3714 is configured as a tube having a central longitudinal passage 3718 extending through the externally threaded drive member 3714. The central longitudinal passage 3718 includes a threaded nut 3720 adjacent a proximal end of the externally threaded drive member 3714. In some implementations, instead of a threaded nut, internal threads can be formed integrally within the passage 3718 of the externally threaded drive member 3714. A biasing member, such as a coil spring 3722 can be positioned within the central longitudinal passage 3718 between the threaded nut 3720 and the cap 3715 to bias the threaded nut 3720 toward the proximal end of the central longitudinal passage 3718.
The release control 3630 is configured to release the device 8200 from the device/implant catheter assembly 3610. The release control 3630 can be configured in a variety of ways, such as, for example, a knob, a button, a switch, one or more gears, etc. In some implementations, the release control 3630 can be a lead screw mechanism that converts rotational motion to linear motion. In some implementations, the release control 3630 can be a release button configured to release the device upon depression of the button. In some implementations, the release control 3630 can 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 handle 3616. 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 control 3630 is configured as a knob that rotates about the longitudinal axis B of the handle 3616. As can be seen in
In some implementations, the width adjustment element 8211 extends through the length of the handle 3616 from the distal end 3617 to the release control 3630 where it is fixed such that movement of the release control 3630 results in corresponding movement of the width adjustment element 8211. In some implementations, at least a portion of the width adjustment element 8211 is received within a support tube 8212 (e.g., a hypotube) within the handle 3616. The support tube 8212 can be fixed at the release control 3630 along with the width adjustment element 8211. The support tube 8212 is configured to add strength to the portion of the width adjustment element 8211 within the handle 3616. The handle 3616 can also include a cover or cap 3728 over the release control 3630 to prevent or inhibit unintended release of the device 8200.
The clasp control members 3628 can be configured in a variety of ways, including similar to any clasp control member disclosed herein. In the implementation depicted in
In some implementations, the handle 3616 can include a fluid body housing 3734 positioned within the housing 3632 of the handle 3616. The fluid body housing includes a distal stem 3736 defining a passage 3738, a main body portion 3740 defining an interior space 3742, and a proximal cap 3744. The proximal cap 3744 includes a plurality of orifices 3746 configured to allow the actuation element 8102 and the width adjustment element 8211 to extend through proximal cap 3744. In addition, each of the pair of line-engaging members 3730 extends distally from the clasp control members 3628 through a corresponding orifice 3746 in the proximal cap 3744 and into the interior space 3742. The main body portion 3740 further includes a line anchor 3748 to which the proximal ends of the clasp actuation lines 3624 attach. The line anchor 3748 can be configured in a variety of ways, including location, orientation, and anchoring means. In the illustrated example, the line anchor 3748 includes a passage 3750 from the interior space 3742 to the exterior of the main body portion 3740 and a boss 3752 surround the passage 3750 to which the clasp actuation lines 3624 attach.
As shown in
To move the device 200 through the partially closed condition (
To retract the actuation element 8102, the paddle actuation control 3626 is rotated, which rotates the first internally threaded tube 3652 to rotate with respect to the housing 3632, thereby driving the externally threaded retractor 3654 axially in the proximal direction, as shown in
Axial movement of the externally threaded retractor 3654 also causes axial movement of the second internally threaded tube 3708 via the link 3688. Axial movement of the second internally threaded tube 3708 causes axial movement of the release control 3630 between a position within the cavity 3706 of the barrel 3700 (shown in
As shown in
To move the outer paddles 8120 from the expanded position (
To retract the width adjustment element 8211, the width control 3629 is rotated, which rotates the barrel 3700 and the second internally threaded tube 3708 relative to the housing 3632, thereby driving the externally threaded drive member 3714 axially in the proximal direction, as shown in
Once the release screw 3726 and width adjustment element 8211 are unscrewed from the threaded nut 3720 and the coupler 8972, respectively, the release control 3630 can be pulled axially away from the barrel 3700, as shown by arrow B in
In the example illustrated in
In some implementations, after the release screw 3726 and width adjustment element 8211 are unscrewed from the threaded nut 3720 and the coupler 8972, respectively, as the release control 3630 is pulled axially in the proximal direction, the width adjustment element 8211 is withdrawn relative to the actuation element 8102. Once the width adjustment element 8211 is withdrawn past the coupler 8213, the two longitudinally extending legs 8215 move inward to decouple the actuation element 8102 from the coupler 8213.
As shown in the example of
In some implementations, the proximal end of each clasp actuation line 3624 is attached to the line anchor 3748. Each clasp actuation line 3624 extends from the line anchor 3748, passes through the passage 3732 at the distal end of each line-engaging member 3730, and extends distally through the device/implant catheter assembly 3610 (e.g., into a catheter/sheath) to the device 8200. At the device, each clasp actuation line 3624 extends through an opening 8235 in a corresponding one of the clasps 8134 of the device 8200 and the closed loop 3758 attaches to the capture mechanism 3760. The capture mechanism 3760 is configured to releasably attach the device 8200 to the device/implant catheter assembly 3610. The closed loops 3758 can attach to any suitable portion of the capture mechanism 3760 that allows the clasp actuation lines 3624 to be released when the capture mechanism 3760 releases the device 8200.
The capture mechanism 3760 can be configured in a variety of ways. In the example illustrated in
The proximal collar 8251 of the device 8200 can include a central opening 8252 configured to slidably receive the actuation element 8102. The proximal collar 8251 can also include a plurality of bosses or projections 8254 and a plurality of guide openings 8255. The projections 8254 can extend radially outwardly and can be circumferentially offset (e.g., by about 90 degrees) relative to the guide openings 8255. The guide openings 8255 can be disposed radially outwardly from the central opening 8252. The projections 8254 and the guide openings 8255 of the proximal collar 8251 can be configured to releasably engage the capture mechanism 3760, as shown in
Referring to
In some implementations, the clasp actuation line 3624 has a tensile strength in the range of 20-100 N, or 30-70 N, or 30-50 N. In some implementations, the clasp actuation line 3624 is made from an ultra-high-molecular-weight polyethylene material, such as for example, Dyneema® fibers. In some implementations, the closed loop 3758 of the clasp actuation line 3624 has a nominal loop diameter in the range of 0.0275 inches to 0.0425 inches, or 0.03 inches to 0.04 inches, or 0.0325 inches to 0.0375 inches and a circumference in the range of 0.07 inches to 0.15 inches, or 0.09 inches to 0.13 inches. In some implementations, the clasp actuation line 3624 has a diameter in the range of 0.003 inches to 0.008 inches, or 0.004 inches to 0.006 inches. In some implementations, the clasp actuation line 3624 has a permanent deformation of less than 0.5% under a cyclic load of 0 to 10 N, or less than 0.3% under a cyclic load of 0 to 10 N.
Referring to
To form the clasp actuation line 3624 from a single continuous braided line 3766. A section of the single continuous braided line 3766 having the desired length and one bifurcated section 3762 is cut from the continuous braided line 3766 with the bifurcated section 3762 near an end (e.g., near where the continuous braided line 3766 is cut). The end near the bifurcated section 3762 forms the distal end 3756 of the clasp actuation line 3624. The distal end 3756 can be heat sealed or treated, or sealed or treated in another manner, to prevent or inhibit separation of the yarns at the distal end 3756.
Referring to
Referring to
Referring to
In particular, the distal terminal end portion 3768 can be attached to a piercing device 3769, such as a splicing needle. As shown in
Referring to
As shown in
In the example of
As shown in
In the illustrated example of
In the illustrated example of
The clasp control member 628a, 628b can be biased to the second position with sufficient force to rapidly move the clasp control member 628a, 628b from the first position to the second position to rapidly close the clasps. In some implementations, the clasp control member 628a, 628b moves 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 to
In some implementations, the coaptation portion 9104 of the device or implant 9100 includes a coaptation element 9110 (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 element 9112 (e.g., actuation wire, actuation shaft, actuation tube, etc.).
The anchor portion 9106 includes one or more anchors 9108 that are actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element 9112 opens and closes the anchor portion 9106 of the device 9100. The actuation element 9112 (as well as other means for actuating and actuation elements disclosed herein) can take a wide variety of different forms (e.g., as a wire, rod, shaft, tube, screw, suture, line, strip, combination of these, etc.), be made of a variety of different materials, and have a variety of configurations. As one example, the actuation element can be threaded such that rotation of the actuation element moves the anchor portion 9106 relative to the coaptation portion 9104. Or, the actuation element can be unthreaded, such that pushing or pulling the actuation element 9112 moves the anchor portion 9106 relative to the coaptation portion 9104.
The anchor portion 9106 and/or anchors of the device can take a variety of different forms. For example, the anchor portion 9106 can have any of the features of any of the anchor portions disclosed herein. In the illustrated example, the anchor portion 9106 and/or anchors of the device 9100 include outer paddles 9120 and inner paddles 9122 that are, in some implementations, connected between a cap 9114 and coaptation element 9110 by portions 9124, 9126, 9128. The portions 9124, 9126, 9128 can be jointed and/or flexible to move between all of the positions described below. The interconnection of the outer paddles 9120, the inner paddles 9122, the coaptation element 9110, and the cap 9114 by the portions 9124, 9126, and 9128 can constrain the device to the positions and movements illustrated herein.
In some implementations, the delivery system 9102 includes a steerable catheter, device/implant catheter, and the actuation element 9112 (e.g., actuation wire, actuation shaft, etc.). These can be configured to extend through a guide catheter/sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuation element 9112 extends through a delivery catheter and to or through the coaptation element 9110. Extending and retracting the actuation element 9112 increases and decreases the spacing between the coaptation element 9110 and the distal end of the device (e.g., the cap 9114 or other attachment portion), respectively. In some implementations, a collar or other attachment element removably attaches the coaptation element 9110 to the delivery system 9102, either directly or indirectly, so that the actuation element 9112 slides through the collar or other attachment element and, in some implementations, through a coaptation element 9110 during actuation to open and close the paddles 9120, 9122 of the anchor portion 9106 and/or anchors 9108.
In some implementations, the anchor portion 9106 and/or anchors 9108 can 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 clasps 9130 that include a base or fixed arm 9132, a moveable arm 9134, optional friction-enhancing elements or other securing structures 9136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and a joint portion 9138. The fixed arms 9132 are attached to the inner paddles 9122. In some implementations, the fixed arms 9132 are attached to the inner paddles 9122 with the joint portion 9138 disposed proximate the coaptation element 9110. The joint portion 9138 provides a spring force between the fixed and moveable arms 9132, 9134 of the clasp 9130. The joint portion 9138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint portion 9138 is a flexible piece of material integrally formed with the fixed and moveable arms 9132, 9134. The fixed arms 9132 are attached to the inner paddles 9122 and remain stationary or substantially stationary relative to the inner paddles 9122 when the moveable arms 9134 are opened to open the clasps 9130 and expose the optional barbs, friction-enhancing elements, or securing structures 9136.
In some implementations, the clasps 9130 are opened by applying tension to actuation lines 9116 attached to the moveable arms 9134, thereby causing the moveable arms 9134 to articulate, flex, or pivot on the joint portions 9138. The actuation lines 9116 extend through the delivery system 9102 (e.g., through a steerable catheter and/or a device/implant catheter). Other actuation mechanisms are also possible.
The actuation lines 9116 can take a wide variety of forms, such as, for example, a line, a suture, a wire, a rod, a catheter, or the like. The clasps 9130 can be spring loaded so that in the closed position the clasps 9130 continue to provide a pinching force on the grasped native leaflet. Optional barbs, friction-enhancing elements, or securing structures 9136 of the clasps 9130 can grab, pinch, and/or pierce the native leaflets to further secure the native leaflets.
During implantation, the paddles 9120, 9122 can be opened and closed, for example, to press the native leaflets (e.g., native mitral valve leaflets, etc.) between the paddles 9120, 9122 and/or between the paddles 9120, 9122 and the coaptation element 9110 (e.g., a spacer, plug, membrane, gap filler, etc.). The clasps 9130 can be used to grasp and/or further secure the native leaflets by engaging the leaflets with optional barbs, friction-enhancing elements, or securing structures 9136 and pinching the leaflets between the fixed and moveable arms 9132, 9134. The optional barbs or other friction-enhancing elements 9136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.) of the clasps 9130 increase friction with the leaflets or can partially or completely puncture the leaflets. The actuation lines 9116 can be actuated separately so that each clasp 9130 can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a clasp 9130 on a leaflet that was insufficiently grasped, without altering a successful grasp on the other leaflet. The clasps 9130 can be opened and closed relative to the position of the inner paddle 9122 (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.
In
Referring to
In the example illustrated by
As shown in
In the example of
As shown in
In the illustrated example of
In the illustrated example of
In some implementations, the one or more biasing elements 9632 are configured to remove slack from the clasp actuation elements 9624 (e.g., when the clasp actuation elements 9624 are configured as suture lines). The one or more biasing elements 9632 can be configured to apply the force during movement of the clasp control members 9628a, 9628b from the second position to the first position and after the clasp control members 9628a, 9628b are in the fully proximal first position. Thus, even when the clasp control members 9628a, 9628b have reached the fully proximal first position (e.g., the clasp control members cannot further pull on the clasp actuation elements 9624 to move the clasps 9630), the one or more biasing elements 9632 continue to apply a force to pull the first clasp toward the open position. For example, the one or more biasing elements 9632 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, the one or more biasing elements 9632 can be configured to take-up 0.1 mm to 10 mm of droop, such as 0.2-5 mm of droop, such as 0.3-2 mm of droop, or any subrange of these ranges.
The one or more biasing elements 9632 can be configured in a variety of ways. In some examples, the one or more biasing elements 9632 can be springs, elastic elements capable of applying a suitable force to the clasp actuation elements 9624 and/or clasp control member 9628a, 9628b, elastic portion(s) of the clasp actuation elements 9624, clasp actuation elements 9624 made entirely of an elastic material, a clasp control member 9628a and/or 9628b having a spring or elastic element, etc. In some examples, the droop compensation mechanism 9630 can correct droop in one clasp 9130a independent of the other clasp 9130b (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).
In some examples, each clasp actuation element 9624 can be made to be elastic, along the entire clasp actuation element 9624 or along one or more sections of the clasp actuation element 9624. 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 element 9624, or portions thereof, can function as the one or more biasing elements 9632. For example, in the example illustrated by
The clasp actuation element 9624, 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 elements 9632 can be separate elements from the clasp actuation element 9624 but attached inline. For example, the biasing elements 9632 can be springs or other suitable elastic elements that are separate from, but attached in-line with, the clasp actuation element 9624. The biasing elements 9632 can attach in-line with the clasp actuation element 9624 in 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 element 9624.
An example method of utilizing the elastic clasp actuation elements 9624 in the device/implant catheter assembly 9710 can include setting or selecting a length of the elastic clasp actuation elements 9624 when the device 9604 is in the fully elongated position, as shown in
The clasp actuation portion 9831 can include first and second clasp control members 9828a, 9828b which are configured to move the clasps (e.g., clasps 9130 of device 9100) of the device via clasp actuation elements 9824. The clasps can be configured in the same manner as any of the clasps described herein. The clasp actuation portion 9831 can be configured in a variety of ways. In some implementations, the device/implant catheter assembly 9810 includes two clasp actuation elements 9824 each coupled to a corresponding clasp control member 9828a, 9828b at the proximal end of the clasp actuation elements 9824. For ease of illustration, only one clasp actuation element 9824 is shown in
Each clasp control member 9828a, 9828b can be, for example, an axially-moving control or slider coupled to a corresponding clasp actuation element 9824 to axially move the clasp actuation element 9824 relative to the actuation element 8102. Each of the clasp control members 9828a, 9828b can be operated independently of the other clasp control member such that each clasp actuation element 9824 is moved relative to the actuation element 8102 and the other clasp actuation element 9824. The clasp control members 9828a, 9828b can also be fixed with respect to one another (e.g., locked) such that the clasp actuation elements 9824 are axially moved together relative to the actuation element 8102.
The clasp control members 9828a, 9828b can be configured in a variety of ways, including similar to any clasp control member disclosed herein. In the implementation depicted in
The handle 9816 includes a housing 9834 having a distal stem 9836 defining a passage 9838, a main body portion 9840 defining an interior space 9842, and a proximal cap 9844 through which the actuation element 8102 extends. In addition, each of the line-engaging members 9833a, 9833b extend distally from the respective clasp control members 9828a, 9828b through the proximal cap 9844 and into the interior space 9842. The main body portion 9840 further includes a line anchor (illustrated by an x in
In the example illustrated by
In the illustrated example of
In the example illustrated by
The second biasing element 9832b can be identical to the first biasing element 9832a and arranged in mirror image to the first biasing element 9832a about a central longitudinal axis Z. Thus, the description of the first biasing element 9832a applies equally to the second biasing element 9832b. The biasing elements 9832a, 9832b are configured to be biased outward away from each other to a wide first position, as shown in
Each clasp control member 9828a, 9828b is moveable between a first position (e.g., fully proximal), as shown in
As shown in
As shown in
Depending on the amount of slack in the clasp actuation elements 9824, the first and second biasing elements 9832a, 9832b can expand to a position less than the wide first position (e.g., once all slack has been removed, the clasp actuation elements 9824 can prevent or inhibit the first and second biasing elements 9832a, 9832b from fully expanding). The first clasp control member 9828a and associated first biasing element 9832a can work independent of the second clasp control member 9828b and associated second biasing element 9832b. 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 element 9832a, 9832b is 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.
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 claims 4-7, 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.
This patent application is a continuation of Patent Cooperation Treat Application No. PCT/US2023/011452, filed on Jan. 24, 2023, which claims priority to U.S. Provisional Application No. 63/267,184, filed on Jan. 26, 2022, U.S. Provisional Application No. 63/352,635, filed Jun. 15, 2022, and U.S. Provisional Application No. 63/399,041, filed Aug. 18, 2022, which are incorporated herein by reference.
Number | Date | Country | |
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63399041 | Aug 2022 | US | |
63352635 | Jun 2022 | US | |
63267184 | Jan 2022 | US |
Number | Date | Country | |
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Parent | PCT/US2023/011452 | Jan 2023 | WO |
Child | 18784810 | US |