DELIVERY DEVICE FOR CARDIAC VALVE TREATMENT DEVICES - Patent application

Abstract

Components for a valve treatment system are disclosed. The valve treatment system can include a delivery system for an implantable device. The delivery system can include one or more of a clasp control component slidably disposed on a catheter handle, a control member for opening and closing the implantable device, a catheter assembly having features for reducing friction against another catheter assembly, a grip for attaching the catheter assembly to a clamp, a catheter assembly having features for stiffening or providing variable stiffness, and a catheter assembly having one or more steering control lumens incorporated within a reinforcing layer.

Description

[Background technology]

[0001] Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 181,120, filed April 28, 2021, entitled "Delivery Devices for Heart Valve Treatment Devices," and U.S. Provisional Patent Application No. 63 / 268,845, filed March 3, 2022, entitled "Delivery Devices for Heart Valve Treatment Devices," which are incorporated by reference in their entireties for all purposes.

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform important functions in ensuring forward flow for adequate blood supply through the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc., and thus can become less effective. Such damage to the valves can result in serious cardiovascular problems or even death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and can result in complications. Using transvascular techniques, devices can be introduced and implanted in a much less invasive manner than open-heart surgery. As an example, a transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, advancing the catheter 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 inside the tricuspid valve, beginning similarly to the transseptal technique, but rather than puncturing the septum, a delivery catheter is instead guided within the right atrium towards the tricuspid valve.

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

[0004] When operating properly, the anterior and posterior leaflets function together as a one-way valve that allows blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygen-rich blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle relaxes (also called "ventricular diastole" or "diastole"), oxygen-rich blood that has collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricle muscle contracts (also called "ventricular systole" or "systole"), the rising blood pressure in the left ventricle forces the two leaflets side-to-side together, thereby closing off the one-way mitral valve and preventing blood from flowing back into the left atrium, but instead expelling blood from the left ventricle through the aortic valve. To prevent the leaflets from prolapsing under pressure and from folding back through the mitral annulus into the left atrium, fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle. Summary of the Invention [Problem to be solved by the invention]

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

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

[0007] The present disclosure discloses components for a treatment system (e.g., a valve treatment system). For example, the treatment system herein can include a delivery system and an implantable device or implant (e.g., a valve repair or replacement device). Although not required, these components can make the delivery system easier to use, more ergonomic, more intuitive, and more accurate than traditional delivery systems. One or more of these components can be used with existing delivery systems. Although any combination or subcombination of the disclosed components may be used together, it is not required that any component disclosed in this application be used with any other component disclosed in this application.

[0008] In some implementations, a catheter assembly for controlling a transvascular implantable device includes a handle (which may include a handle housing) and a sheath or shaft (e.g., a catheter shaft, a tube with a lumen, etc.) extending distally from the handle housing. The catheter assembly may also include a drive member (e.g., a drive wire, a drive shaft, a drive rod, a drive tube, etc.) and a control member (e.g., a control knob, a button, a switch, a slider, a motor, combinations thereof, etc.) for controlling, driving, and / or moving the drive member. The control member may be directly or indirectly coupled to the drive member (drive wire, drive shaft, etc.). The drive member may extend through a sheath and be configured to be coupled to the implantable device.

[0009] In some implementations, the control member is a control knob rotatable relative to the handle housing such that rotational actuation of the control knob causes axial movement of the drive member relative to the handle housing and relative to the sheath.

[0010] In some implementations, the catheter assembly includes one or more clasp control lines and one or more clasp control members (e.g., a pair of clasp control lines and a pair of clasp control members, etc.).

[0011] In some implementations, one or more drive lines (e.g., a pair of clasp drive lines) extend through the sheath. Each clasp drive line is configured to be coupled to an implantable device. Each clasp control member can be axially and / or slidably movable along the handle housing. Movement (e.g., axial movement) of each clasp control member drives a clasp of the implantable device between an open configuration and a closed configuration.

[0012] In some implementations, a delivery system, such as a delivery system for delivering an implantable device, includes a first catheter assembly (e.g., a steerable catheter assembly, etc.) and a second catheter assembly (e.g., an implant catheter assembly, etc.). The first catheter assembly includes a handle and a sheath or shaft. The sheath or shaft extends axially from the handle. In some implementations, the sheath or shaft of the first catheter assembly has a steerable distal end portion.

[0013] In some implementations, the second catheter assembly includes a handle or handle housing and a sheath or shaft (e.g., a catheter shaft, a tube with a lumen, etc.) extending distally from the handle or handle housing. The second catheter assembly can further include a drive member (e.g., a drive wire, a drive shaft, a drive rod, a drive tube, etc.) and a control member (e.g., a control knob, a button, a switch, a slider, a motor, combinations thereof, etc.). The control member can be directly or indirectly coupled to the drive member. The drive member can extend through the sheath and be configured to be coupled to the implantable device.

[0014] In some implementations, the control member is a control knob rotatable relative to the handle housing such that rotational actuation of the control knob causes axial movement of the drive member relative to the handle housing and relative to the sheath.

[0015] In some implementations, the second catheter assembly includes one or more clasp control lines (e.g., a pair of clasp control lines, etc.) and one or more clasp control members (e.g., a pair of clasp control members).

[0016] In some implementations, one or more clasp drive lines (e.g., a pair of clasp drive lines) extend through the sheath or shaft. Each clasp drive line is configured to be coupled to an implantable device. In some implementations, each clasp control member is configured to be axially and / or slidably movable along the handle housing. Movement (e.g., axial movement) of each clasp control member drives a clasp of the implantable device between an open configuration and a closed configuration. A sheath of a second catheter assembly (e.g., an implant catheter assembly, etc.) can extend through the first catheter assembly (e.g., a steerable catheter assembly). In some implementations, the clasp control member is configured to extend over more than half, more than 90%, all, or substantially all of the circumference of the handle housing to allow an end user to easily actuate the clasp control member in any rotational orientation of the handle housing.

[0017] In some implementations, the implantable device is coupled to a drive member and to a pair of clasp drive lines. The drive member and pair of clasp drive lines extend from a distal end of a sheath or shaft of a first catheter assembly (e.g., an implant catheter assembly, etc.). The sheath or shaft is coupled at a proximal end to a handle of the first catheter assembly. In some methods, the implantable device is positioned at a delivery site by advancing the sheath or shaft of the first catheter assembly through a second catheter assembly (e.g., a steerable catheter assembly, etc.).

[0018] The method can further include actuating a control member (e.g., a knob, button, switch, slider, motor, combinations thereof, etc.) on the handle to cause axial movement of the drive member to transition the implantable device from a fully extended configuration to an open configuration (e.g., a partially open configuration as shown in FIGS. 30-31 ) or to a capture-ready configuration. The method can further include actuating a control member on the handle to cause axial movement of the drive member to transition the implantable device from the open or capture-ready configuration to a closed configuration.

[0019] In some implementations, the control member is a knob and actuating the control member includes rotating the knob relative to a housing of a handle of the implant catheter assembly. Rotation of the knob causes axial movement of the drive member, thereby transitioning the implantable device from the fully extended configuration to an open or capture-ready configuration. The method can further include rotationally driving a knob on the handle relative to the housing of the handle, thereby causing axial movement of the drive member, thereby transitioning the implantable device from the open or capture-ready configuration to an occluded configuration.

[0020] In some implementations, each of transitioning the implantable device from a fully extended configuration to an open configuration by rotationally driving the knob and transitioning the implantable device from the open configuration to a closed configuration by rotationally driving the knob includes rotationally driving the knob in a clockwise direction.

[0021] In some implementations, transitioning the implantable device from the open configuration to the occluded configuration by rotationally driving the knob includes rotationally driving the knob until the catheter assembly provides an audible indication.

[0022] In some implementations, actuation of the control member causes a release knob to move axially from a retracted position to an extended position relative to the handle housing, the release knob being coupled to the drive member.

[0023] In some implementations, decoupling the implantable device involves rotating a release knob, which is effective to rotate the drive member relative to the implantable device, thereby decoupling the implantable device from the drive member.

[0024] In some implementations, the method further includes sliding one or more clasp control members on the handle proximally to cause axial movement of one or more clasp drive lines to open one or more clasps (e.g., a pair of clasps) on the implantable device.

[0025] In some implementations, the method further includes sliding one or more clasp control members on the handle distally to cause axial movement of a pair of clasp drive lines to close a pair of clasps on the implantable device.

[0026] In some implementations, sliding the pair of clasp control members on the handle includes sliding each clasp control member in the pair of clasp control members independently of the other clasp control member in the pair.

[0027] The method may further include decoupling the implantable device from the drive member and from the pair of clasp drive lines.

[0028] In some implementations, decoupling the implantable device includes releasing a first end of each clasp control line in the pair of clasp drive lines and pulling a second end of each clasp control line in the pair of clasp drive lines, thereby pulling the first end of each clasp control line in the pair of clasp drive lines through a sheath of the catheter assembly, thereby decoupling the implantable device from the pair of clasp drive lines.

[0029] The above methods can be performed on a live animal or can be performed on a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0030] In some implementations, a delivery system, such as a delivery system for delivering an implantable device, includes one or more catheter assemblies. In some implementations, the delivery system includes a first catheter assembly (e.g., an implant catheter assembly, etc.) and a second catheter assembly (e.g., a steerable catheter assembly). The first catheter assembly includes a handle, a nose grip, and a sheath. The handle of the first catheter assembly has a number of control members positioned on an upper surface thereof.

[0031] In some implementations, a first nosegrip having a distal flange is positioned at a distal end of the handle of the first catheter assembly and has a passageway. The distal flange can be configured to have an outer diameter greater than an outer diameter of a central portion of the first nosegrip. A sheath of the first catheter assembly extends distally from the handle and through the passageway of the first nosegrip.

[0032] In some implementations, the second catheter assembly includes a handle, a second nosegrip, and a sheath. The second nosegrip can be configured to have a distal flange at a distal end of the second nosegrip. A proximal end of the second nosegrip is connected to a distal end of the handle of the second catheter assembly. The second nosegrip includes a passageway or lumen. The distal flange of the second nosegrip has an outer diameter greater than an outer diameter of a central portion of the second nosegrip. The sheath of the second catheter assembly can extend distally from the handle and through the passageway or lumen of the second nosegrip. The sheath of the second catheter assembly has a distal end portion including a steerable section.

[0033] In some implementations, the implantable device is coupled to the adapter at a distal end of a sheath of a first catheter assembly (e.g., an implant catheter assembly, etc.). The sheath is coupled to a handle of the first catheter assembly at a proximal end. The sheath extends through a passageway or lumen of a first nosegrip. The first nosegrip extends between a distal flange at the distal end and a proximal end connected to the distal end of the handle. In some methods, the first nosegrip is coupled to a first clamp slidably coupled to a base plate by positioning the first nosegrip within an opening in the first clamp. A second nosegrip of a second catheter assembly (e.g., a steerable catheter assembly, etc.) is coupled to a second clamp slidably coupled to a base plate by positioning the second nosegrip within an opening in the second clamp.

[0034] The method can also include advancing a sheath of the first catheter assembly through the second catheter assembly to position the implantable device at the delivery site, hi some implementations, one or more of the first catheter assembly and the second catheter assembly are rotationally driven relative to the base plate to position the implantable device at the delivery site.

[0035] In some implementations, the shaft of the first catheter assembly frictionally engages within at least one of the handle of the second catheter assembly and the shaft of the second catheter assembly.

[0036] In some implementations, the method includes (i) positioning a first locking knob in an unlocked position in which the first clamp is slidable relative to the base plate; (ii) positioning a second locking knob in an unlocked position in which the second clamp is slidable relative to the base plate; and (iii) axially moving a handle of the first catheter assembly effective to slide the first clamp and the second clamp relative to the base plate.

[0037] In some implementations, the method includes positioning a second locking knob in a locked position in which the second clamp is prevented from sliding relative to the base plate, and axially moving a handle of the first catheter assembly effective to slide the first clamp relative to the base plate and effective to axially move a shaft of the first catheter assembly relative to the shaft of the second catheter assembly.

[0038] In some implementations, the method includes positioning the first locking knob in a locked position in which the first clamp is prevented from sliding relative to the base plate.

[0039] In some implementations, the first nose grip has a first outer diameter and the second nose grip has a second outer diameter, and the first clamp opening and the second clamp opening are the same size, hi some implementations, the first outer diameter is different from the second outer diameter.

[0040] In some implementations, the second outer diameter is larger than the first outer diameter such that rotationally driving the first catheter assembly relative to the base plate has a different tactile feel as compared to rotationally driving the second catheter assembly relative to the base plate.

[0041] In some implementations, the first nose grip is rotatable relative to the first catheter assembly and the second nose grip is rotatable relative to the second catheter assembly, and positioning the implantable device at the delivery site by rotationally driving at least one of the first catheter assembly and the second catheter assembly relative to the base plate includes rotating at least one of the first catheter assembly and the second catheter assembly relative to the base plate while leaving the first nose grip and the second nose grip unrotated relative to the base plate.

[0042] In some implementations, the first catheter assembly is an implant catheter assembly and the second catheter assembly is a steerable catheter assembly.

[0043] The above methods can be performed on a live animal or can be performed on a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0044] In some implementations, a catheter assembly for a transvascular delivery system includes a handle housing and a sheath extending longitudinally from the handle, the proximal portion of the sheath being stiffer than the distal portion of the sheath.

[0045] In some implementations, a delivery system, such as a delivery system for delivering an implantable device, includes a first catheter assembly (e.g., a steerable catheter assembly, etc.) and a second catheter assembly (e.g., an implant catheter assembly). The first catheter assembly has a handle and a sheath extending axially from the handle. The sheath includes a proximal portion and a distal portion including a steerable section. The second catheter assembly has a handle and a sheath including a proximal portion and a distal portion. The sheath is extendable through or configured to extend coaxially through the sheath of the first catheter assembly. At least one of the proximal portion of the sheath of the first catheter assembly and the proximal portion of the sheath of the second catheter assembly is stiffer than the distal portion of the sheath of the first catheter assembly or the distal portion of the sheath of the second catheter assembly, respectively.

[0046] In some implementations, a catheter assembly for a transvascular delivery system includes a handle housing and a sheath extending distally from the handle housing between a proximal end and a distal end, the sheath having a first outer diameter along a first length of the sheath and a second outer diameter along a second length of the sheath.

[0047] In some implementations, a catheter assembly for a transvascular delivery system includes a handle housing and a sheath (e.g., catheter, tube, etc.) extending longitudinally from the handle. The sheath has a proximal portion and a distal portion. The proximal portion of the sheath is configured to have a different stiffness as compared to the distal portion of the sheath.

[0048] In some implementations, the proximal portion of the sheath comprises a material having a greater durometer than the material comprising the distal portion of the sheath.

[0049] In some implementations, only a proximal portion of the sheath includes a braid, mesh, or woven material. In some implementations, only a distal portion of the sheath includes a braid, mesh, or woven material. In some implementations, both the proximal and distal portions of the sheath include a braid, mesh, or woven material.

[0050] In some implementations, only the proximal portion of the sheath includes at least one laser cut hypotube, in some implementations, only the distal portion of the sheath includes at least one laser cut hypotube, in some implementations, both the proximal and distal portions of the sheath include at least one laser cut hypotube.

[0051] In some implementations, at least one laser cut hypotube extends through the outer jacket of the sheath.

[0052] In some implementations, the sheath is a multi-layer sheath and at least one laser cut hypotube comprises a layer of the multi-layer sheath.

[0053] In some implementations, the at least one laser cut hypotube has a stiffness that varies along a length of the at least one laser cut hypotube.

[0054] In some implementations, the sheath includes a steerable portion. In some implementations, the steerable portion of the sheath is located at a distal portion of the sheath. In some implementations, the steerable portion of the sheath includes one or more of a pull wire, a pull ring, a pull wire lumen, etc. In some implementations, the pull wire, the pull ring, the pull wire lumen, etc. are located radially inward of at least one of the braid (or other mesh or woven material) and the at least one laser cut hypotube. In some implementations, the pull wire, the pull ring, the pull wire lumen, etc. are located radially outward of at least one of the braid (or other mesh or woven material) and the at least one laser cut hypotube.

[0055] In some implementations, the sheath is a multi-layer sheath, and a proximal portion of the sheath includes a first layer including at least one laser cut hypotube and a second layer including a braid (or other mesh or woven material). In some implementations, the sheath is a multi-layer sheath, and a distal portion of the sheath includes a first layer including at least one laser cut hypotube and a second layer including a braid (or other mesh or woven material).

[0056] In some implementations, a braided, mesh, or woven material is positioned between a lumen extending through the sheath and at least one laser cut hypotube.

[0057] In some implementations, the proximal portion of the sheath includes a first laser cut hypotube along a first length of the sheath and a second laser cut hypotube along a second length of the sheath, the first laser cut hypotube and the second laser cut hypotube having different stiffnesses.

[0058] In some implementations, the sheath defines a lumen extending longitudinally therethrough, the lumen having a cross-section that transitions from having a circular shape to having a non-circular shape.

[0059] The various sheaths described in any implementation herein can include any of the features related to the sheaths described herein.

[0060] In some implementations, a delivery system for an implantable device includes a first catheter assembly (e.g., an implant catheter assembly, etc.) and a second catheter assembly (e.g., a steerable catheter assembly, etc.). The second catheter assembly has a handle and a sheath extending axially from the handle. The sheath has a steerable section. The first catheter assembly has a handle and a sheath. The sheath of the first catheter assembly extends coaxially through the sheath of the second catheter assembly. The sheath of the first catheter assembly has a first outer diameter along a first length and a second outer diameter along a second length.

[0061] In some implementations, the implantable device is coupled to a drive member extending from a distal end of a sheath of a first catheter assembly (e.g., an implant catheter assembly, etc.). The sheath is coupled at a proximal end to a handle of the first catheter assembly. The sheath has a first outer diameter along a first length of the sheath and a second outer diameter along a second length of the sheath. In some methods, the implantable device is positioned at a delivery site by advancing the sheath of the first catheter assembly through a second catheter assembly (e.g., a steerable catheter assembly, etc.).

[0062] In some implementations, the position of the implantable device relative to the delivery site is adjusted by extending a distal end of a sheath of a first catheter assembly relative to a distal end of a sheath of a second catheter assembly such that a second length of the sheath is coaxially positioned within the steerable section of the sheath of the second catheter assembly.

[0063] The above methods can be performed on a live animal or can be performed on a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0064] In some implementations, a method for delivering an implantable device includes providing a first catheter assembly coupled to the implantable device and positioning the implantable device at a delivery site by advancing a sheath (e.g., catheter, tube, lumen, etc.) of the first catheter assembly through a second catheter assembly. In some implementations, the first catheter assembly includes a drive member extendable from a distal end of the sheath, the drive member coupled to the implantable device.

[0065] In some implementations, the sheath is coupled at a proximal end to a handle of the first catheter assembly.

[0066] In some implementations, the sheath has a first outer diameter along a first length of the sheath and a second outer diameter along a second length of the sheath, hi some implementations, the first length is located between the second length of the sheath and a proximal end of the sheath of the first catheter assembly.

[0067] In some implementations, the sheath of the second catheter assembly includes a steerable section.

[0068] In some implementations, the method includes adjusting a position of the implantable device relative to the delivery site by extending a distal end of a sheath of a first catheter assembly relative to a distal end of a sheath of a second catheter assembly, hi some implementations, during adjustment, a second length of sheath is coaxially positioned within a steerable section of the sheath of the second catheter assembly.

[0069] In some implementations, the method includes decoupling the implantable device from the drive member.

[0070] In some implementations, the second outer diameter is smaller than the first outer diameter. In some implementations, the difference between the first outer diameter and the second outer diameter is between about 0.25 mm and about 0.76 mm. In some implementations, the transition from the first outer diameter to the second outer diameter forms a smooth taper over a distance between about 25 mm and about 50 mm.

[0071] In some implementations, the sheath includes a lubricious coating on an exterior surface of the sheath along the second length of the sheath, hi some implementations, the lubricious coating includes a hydrophilic coating.

[0072] In some implementations, the first catheter assembly is an implant catheter assembly and the second catheter assembly is a steerable catheter assembly.

[0073] The above methods can be performed on a live animal or can be performed on a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0074] In some implementations, a catheter assembly for controlling an implantable device includes a handle housing, a sheath (e.g., catheter, tube, etc.) extending distally from the handle housing, and a drive member extending through the sheath, the drive member configured to be coupled to the implantable device. In some implementations, the catheter assembly further includes a control member coupled to the drive member, where actuation of the control member causes axial movement of the drive member relative to the handle housing and relative to the sheath.

[0075] In some implementations, the catheter assembly further includes a pair of clasp drive lines (e.g., a first clasp drive line and a second clasp drive line) extending through the sheath, and each clasp drive line in the pair of clasp drive lines (e.g., the first clasp drive line and / or the second clasp drive line) is configured to be coupled to the implantable device.

[0076] In some implementations, the catheter assembly further includes a first clasp control member, actuation of which drives the first clasp of the implantable device between an open configuration and a closed configuration. In some implementations, the first clasp control member is physically or operatively coupled to the first clasp via one of a pair of clasp drive lines (e.g., a first clasp drive line), and actuation of the first clasp control member can cause axial movement of the clasp drive line to drive the first clasp between the open configuration and the closed configuration. The first clasp control member can be configured in various manners, for example, as a knob, a slider, a latch, a switch, a button, a gear, etc. In some implementations, the first clasp control member is configured to extend across 45%-90% of the circumference of the handle housing, across 60%-90% of the circumference of the handle housing, across 75%-90% of the circumference of the handle housing, across 85%-90% of the circumference of the handle housing, or across 90% (or substantially 90%) of the circumference of the handle housing, or across substantially 90% of the circumference of the handle housing.

[0077] In some implementations, the first clasp control member is axially movable relative to the handle housing and relative to the sheath, and axial movement of the first clasp control member drives a first clasp of the implantable device between an open configuration and a closed configuration. In some implementations, the first clasp control member is axially movable relative to the handle housing and relative to the sheath, and axial movement of the first clasp control member causes axial movement of one clasp drive line (e.g., the first clasp drive line) of the pair of clasp drive lines, thereby driving a first clasp of the implantable device between an open configuration and a closed configuration.

[0078] In some implementations, the catheter assembly further includes a second clasp control member, and actuation of the second clasp control member drives the second clasp of the implantable device between an open configuration and a closed configuration. In some implementations, the second clasp control member is physically or operatively coupled to the second clasp via one clasp drive line (e.g., the second clasp drive line) of a pair of clasp drive lines, and actuation of the second clasp control member can cause axial movement of the clasp drive line, thereby driving the second clasp between the open configuration and the closed configuration. The second clasp control member can be configured in various manners, for example, as a knob, a slider, a latch, a switch, a button, a gear, etc. In some implementations, the second clasp control member is configured to extend across 45%-90% of the circumference of the handle housing, across 60%-90% of the circumference of the handle housing, across 75%-90% of the circumference of the handle housing, across 85%-90% of the circumference of the handle housing, or across 90% (or substantially 90%) of the circumference of the handle housing.

[0079] In some implementations, both the first and second clasp control members are configured to extend around 60%-90% of the circumference of the handle housing, around 75%-90% of the circumference of the handle housing, around 85%-90% of the circumference of the handle housing, or around 90% (or substantially 90%) of the circumference of the handle housing such that the clasp control members may be easily actuated by an end user in any rotational orientation of the handle housing. In some implementations, both the first and second clasp control members are configured to extend around 90% (or substantially 90%) of the circumference of the handle housing such that together they encircle the handle housing such that the clasp control members may be easily actuated by an end user in any rotational orientation of the handle housing.

[0080] In some implementations, the second clasp control member is axially movable relative to the handle housing and relative to the sheath, and axial movement of the second clasp control member drives the second clasp of the implantable device between an open configuration and a closed configuration. In some implementations, the second clasp control member is axially movable relative to the handle housing and relative to the sheath, and axial movement of the second clasp control member causes axial movement of one clasp drive line (e.g., the second clasp drive line) of the pair of clasp drive lines, thereby driving the second clasp of the implantable device between an open configuration and a closed configuration.

[0081] In some implementations, the catheter assembly includes a slide lock configured to slide between (i) a first position in which the slide lock is not coupled to at least one of the first and second clasp control members, and (ii) a second position in which the slide lock is coupled to both the first and second clasp control members. In some implementations, when the slide lock is in the first position, the first clasp control member is actuable independently of the second clasp control member, and when the slide lock is in the second position, the first and second clasp control members are coupled such that actuation of the first clasp member also actuates the second clasp member.

[0082] In some implementations, the first clasp control member and the second clasp control member are actuable by their axial movement, and when the slide lock is in the first position, the first clasp control member is axially movable independently of the second clasp control member, and when the slide lock is in the second position, the first clasp control member and the second clasp control member are coupled such that when actuated, the first clasp member and the second clasp control member are configured to move axially together.

[0083] In some implementations, the handle housing includes a first detent at a first axial position along the path of the one clasp control member of the pair of clasp control members to maintain the one clasp control member of the pair of clasp control members in a proximal position, and a second detent at a second axial position along the path of the one clasp control member of the pair of clasp control members to maintain the one clasp control member of the pair of clasp control members in a distal position.

[0084] In some implementations, the catheter assembly further includes an externally threaded retractor coupled to the control member and to the drive member, the externally threaded retractor being rotatably fixed to the handle housing, and actuation of the control member advances the externally threaded retractor axially, thereby causing linear movement of the drive member.

[0085] In some implementations, the catheter assembly further includes a clutch spring positioned around the externally threaded retractor, the clutch spring configured to bias the externally threaded retractor distally toward the threads of the internally threaded tube inside the handle housing.

[0086] In some implementations, the control member is a control knob, and rotation of the control knob causes rotation of the internally threaded tube relative to the handle housing, thereby driving the externally threaded retractor to a proximal position where the external threads of the externally threaded retractor and the internal threads of the internally threaded tube disengage, and continued rotation of the control knob provides an audible indication.

[0087] In some implementations, the catheter assembly includes a handle housing and a sheath. The sheath extends longitudinally from the handle. The sheath includes a woven layer. A lumen is woven within the woven layer. A bend control member extends through the lumen.

[0088] In some implementations, the bend control member can include a wire. The lumen can include a metal tube. The lumen can extend the length of the sheath and / or have a helical configuration.

[0089] Other features, members and components from any of the various implementations and any of the various examples herein may also be included in the catheter assembly, mutatis mutandis.

[0090] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like elements bear like reference characters and in which:

[0091] In order to further clarify various aspects of the implementation of the present disclosure, a more detailed description of some examples and some implementations will be given by referring to various aspects of the accompanying drawings. It will be understood that these drawings illustrate only exemplary implementations of the present disclosure and therefore should not be considered as limiting the scope of the present disclosure. Moreover, although the drawings may be drawn to scale for some examples, the drawings 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. [Brief description of the drawings]

[0092] [Figure 1] FIG. 1 illustrates a cross-sectional view of a human heart in diastole. [Diagram 2] FIG. 2 illustrates a cross-sectional view of a human heart during systole. [Diagram 3] FIG. 3 illustrates a cross-section of a human heart during systole, showing mitral valve regurgitation. [Figure 4] FIG. 4 is a cross-sectional view of FIG. 3, annotated to illustrate the natural shape of the mitral valve leaflets during systole. [Diagram 5] FIG. 5 illustrates a healthy mitral valve with the leaflets in occlusion when viewed from the atrial side of the mitral valve. [Figure 6] FIG. 6 illustrates a dysfunctional mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 7] FIG. 7 illustrates the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 8]FIG. 8 shows an example of an implantable device or implant at various stages of deployment. [Figure 9] FIG. 9 shows an example of an implantable device or implant at various stages of deployment. [Figure 10] FIG. 10 shows an example of an implantable device or implant at various stages of deployment. [Figure 11] FIG. 11 shows an example of an implantable device or implant at various stages of deployment. [Figure 12] FIG. 12 shows an example of an implantable device or implant at various stages of deployment. [Figure 13] FIG. 13 shows an example of an implantable device or implant at various stages of deployment. [Figure 14] FIG. 14 shows an example of an implantable device or implant at various stages of deployment. [Figure 15] FIG. 15 shows an example of an implantable device or implant similar to the devices shown in FIGS. 8-14, but with independently controllable paddles. [Figure 16] FIG. 16 illustrates the implantable device or implant of FIGS. 8-14 as delivered and implanted within a native valve. [Figure 17] FIG. 17 illustrates the implantable device or implant of FIGS. 8-14 as delivered and implanted within a native valve. [Figure 18] FIG. 18 illustrates the implantable device or implant of FIGS. 8-14 as delivered and implanted within a native valve. [Figure 19] FIG. 19 illustrates the implantable device or implant of FIGS. 8-14 as delivered and implanted within a native valve. [Figure 20]FIG. 20 illustrates the implantable device or implant of FIGS. 8-14 as delivered and implanted within a native valve. [Figure 21] FIG. 21 illustrates the implantable device or implant of FIGS. 8-14 as delivered and implanted within a native valve. [Figure 22] FIG. 22 shows a perspective view of an exemplary implantable device or implant in an occluded position. [Diagram 23] FIG. 23 shows a front view of the implantable device or implant of FIG. [Figure 24] FIG. 24 shows a side view of the implantable device or implant of FIG. [Diagram 25] FIG. 25 shows a front view of the implantable device or implant of FIG. 22 with a cover over the paddle and the abutment member or spacer. [Figure 26] FIG. 26 shows a top perspective view of the implantable device or implant of FIG. 22 in an open position. [Figure 27] FIG. 27 shows a bottom perspective view of the implantable device or implant of FIG. 22 in an open position. [Figure 28] FIG. 28 shows a clasp for use in an implantable device or implant. [Figure 29] FIG. 29 shows a portion of native valve tissue grasped by a clasp. [Diagram 30] FIG. 30 illustrates a side view of an exemplary implantable device or implant in a partially open position with the clasp in a closed position. [Diagram 31] FIG. 31 illustrates a side view of an exemplary implantable device or implant in a partially open position with the clasp in the open position. [Diagram 32]FIG. 32 illustrates a side view of an exemplary implantable device or implant in a semi-open position with the clasp in a closed position. [Diagram 33] FIG. 33 illustrates a side view of an exemplary implantable device or implant in a semi-open position with the clasp in the open position. [Diagram 34] FIG. 34 shows a side view of an exemplary implantable device or implant in a three-quarters open position with the clasp in a closed position. [Diagram 35] FIG. 35 illustrates a side view of an exemplary implantable device or implant in a three-quarters open position with the clasps in the open position. [Diagram 36] FIG. 36 shows a side view of an exemplary implantable device in a fully open or fully extended position with the clasps in the closed position. [Figure 37] FIG. 37 illustrates a side view of an exemplary implantable device in a fully open or fully extended position with the clasps in the open position. [Figure 38] FIG. 38 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, shown delivered and implanted within the native valve. [Figure 39] FIG. 39 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, shown delivered and implanted within the native valve. [Diagram 40] FIG. 40 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, shown delivered and implanted within the native valve. [Diagram 41] FIG. 41 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, shown delivered and implanted within a native valve. [Diagram 42]FIG. 42 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, shown delivered and implanted within the native valve. [Diagram 43] FIG. 43 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, shown delivered and implanted within a native valve. [Diagram 44] FIG. 44 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, shown delivered and implanted within the native valve. [Diagram 45] FIG. 45 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, shown delivered and implanted within the native valve. [Diagram 46] FIG. 46 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, shown delivered and implanted within a native valve. [Figure 47] FIG. 47 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, shown delivered and implanted within the native valve. [Figure 48] FIG. 48 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, shown delivered and implanted within the native valve. [Figure 49] FIG. 49 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, shown delivered and implanted within the native valve. [Figure 50] FIG. 50 is a schematic diagram illustrating the path of the native valve leaflets along each side of a coaptation member or spacer in an exemplary valve repair device or implant. [Figure 51]FIG. 51 is a schematic diagram from above illustrating the path of the leaflets of a native valve around a coaptation member or spacer in an exemplary valve repair device or implant. [Figure 52] FIG. 52 illustrates a coaptation member or spacer positioned within the gap of the native valve as viewed from the atrial side of the native valve. [Diagram 53] FIG. 53 illustrates a valve repair device or implant attached to the leaflets of a native valve with the coaptation members or spacers positioned within the gaps of the native valve when viewed from the ventricular side of the native valve. [Figure 54] FIG. 54 is a perspective view of a valve repair device or implant attached to the leaflets of a native valve with a coaptation member or spacer positioned within the interstices of the native valve when viewed from the ventricular side of the native valve. [Figure 55] FIG. 55 shows a perspective view of an exemplary implantable device or implant in an occluded position. [Figure 56] FIG. 56 illustrates a perspective view of an exemplary clasp on an exemplary implantable device or implant in a closed position. [Figure 57] FIG. 57 illustrates the valve repair device with the paddles in the open position. [Figure 58] FIG. 58 illustrates the valve repair device of FIG. 57 with the paddle in an open position and the gripping member actuated to create a wider gap between the gripping member and the paddle. [Figure 59] FIG. 59 illustrates the valve repair device of FIG. 57 in the position shown in FIG. 57 with the valve tissue disposed between the grasping members and the paddles. [Figure 60] FIG. 60 illustrates the valve repair device of FIG. 57 where the gripping members have been actuated to reduce the gap between the gripping members and the paddles. [Figure 61A] FIG. 61A illustrates the paddles on the valve repair device of FIG. 57 being actuated from an open position to a closed position. [Figure 61B] FIG. 61B illustrates the paddles on the valve repair device of FIG. 57 being actuated from an open position to a closed position. [Figure 62] FIG. 62 illustrates the valve repair device of FIG. 57 in an occluded position with the gripping members engaged against the valve tissue. [Figure 63] FIG. 63 illustrates the valve repair device of FIG. 57 after being detached from the delivery device and attached to the valve tissue, where the valve repair device is in an occluded and locked state. [Figure 64] FIG. 64 illustrates the distal end of an exemplary system or assembly including a delivery system and an implantable device. [Figure 65] FIG. 65 illustrates the proximal end of the exemplary system or assembly of FIG. [Figure 66] FIG. 66 illustrates an exemplary implant catheter assembly for use in a delivery system coupled to an implantable device. [Figure 67] FIG. 67 illustrates a schematic diagram of an exemplary implant catheter assembly coupled to an implantable device, with each of the clasp drive lines coupled to a clasp control member positioned on the handle and the drive member coupled to a control member or knob positioned on the handle. [Figure 68] FIG. 68 is a perspective view of an exemplary handle of an implant catheter assembly. [Figure 69] FIG. 69 is a cross section of the handle in FIG. 68 perpendicular to the plane defined by line AA, where one of the clasp control tubes is bisected. [Figure 70] FIG. 70 is another cross-section of the handle in FIG. 68 perpendicular to the plane defined by line BB, where the release knob is bisected. [Figure 70A] FIG. 70A is an enlarged portion of FIG. [Figure 71]FIG. 71 is another cross-section of the handle in FIG. 68 perpendicular to the plane defined by line CC, which bisects the release knob and suture lock. [Figure 71A] FIG. 71A is another perspective view of the handle in FIG. 68 with the clasp setting spacer supporting the clasp control tube. [Figure 72] FIG. 72 is another perspective view of the handle of FIG. 68, where the housing includes a pair of detents for locking the clasp control member in place. [Figure 73] FIG. 73 is a perspective view of an exemplary proximal end of a handle with the release knob in a distal position. [Figure 74] FIG. 74 is a perspective view of an exemplary proximal end of a handle with the release knob in a proximal position. [Figure 75] FIG. 75 is a cutaway perspective view of a handle including an exemplary release knob with a ratchet mechanism. [Figure 76] FIG. 76 is a perspective view of the release knob of FIG. 75 with a ratchet mechanism. [Figure 77] FIG. 77 is a cross-sectional view of the release knob in FIGS. 75-76 taken perpendicular to the plane defined by line DD, with the pawl shown in cross-section. [Figure 78] FIG. 78 is a cross-sectional view of an exemplary suture lock in which a clasp drive line is fixed to a post at one end and extends between a suture lock body and a suture lock body receptacle at a second end after being coupled to an implantable device. [Figure 79] FIG. 79 is a perspective view of an exemplary nose grip for coupling a delivery system or component thereof to a stabilization system. [Figure 80] FIG. 80 is a cross-sectional view of an exemplary clamp in a stabilization system that surrounds the nose grip of a delivery system or catheter assembly. [Figure 81]FIG. 81 is another cross-sectional view of an exemplary clamp in a stabilization system that surrounds the nose grip of a delivery system or catheter assembly. [Fig. 82A] FIG. 82A is a perspective view of an exemplary steerable catheter assembly including a nose grip coupled to a clamp of a stabilization system. [Fig. 82B] FIG. 82B is a perspective view of the exemplary steerable catheter assembly of FIG. 82A with the clamp closed. [Fig. 82C] FIG. 82C illustrates axial movement of the steerable catheter assembly and clamp of FIGS. 82A-B relative to the base plate of the stabilization system. [Figure 83A] FIG. 83A is a perspective view of an exemplary implant catheter assembly including a nose grip. [Figure 83B] FIG. 83B is a perspective view of the exemplary implant catheter assembly of FIG. 83A coupled to a clamp of a stabilization system. [Figure 83C] FIG. 83C is a perspective view of the exemplary implant catheter assembly of FIGS. 83A-B with the clamp closed. [Figure 84] FIG. 84 is a perspective view of the proximal end of a stabilization system coupled to a steerable catheter assembly and an implant catheter assembly illustrating axial movement of the steerable catheter assembly and the implant catheter assembly relative to a base plate of the stabilization system. [Fig. 85A] FIG. 85A illustrates the outer diameter of the nose grip of the steerable catheter assembly and the implant catheter assembly. [Fig. 85B] FIG. 85B illustrates the outer diameter of the nose grip of the steerable catheter assembly and the implant catheter assembly. [Figure 86]FIG. 86 is a cross-sectional view of a shaft of an implant catheter assembly having a reduced outer diameter portion and a low friction coating positioned within a steerable portion of the shaft of a steerable catheter assembly. [Figure 87] FIG. 87 is another illustration of an implant catheter assembly with a shaft having a reduced outer diameter section and a low friction coating. [Fig. 88A] FIG. 88A illustrates a sheath having a reduced outer diameter portion of an implant catheter assembly positioned within the sheath of a steerable catheter assembly in a retracted position. [Fig. 88B] FIG. 88B illustrates the sheath of the implant catheter assembly of FIG. 88A positioned within the sheath of the steerable catheter assembly in the extended position. [Figure 89A] FIG. 89A illustrates a proximal portion of a sheath of a steerable catheter assembly that includes a reinforcing material. [Figure 89B] FIG. 89B illustrates a proximal portion of the sheath of the implant catheter assembly that includes a reinforcing material. [Figure 89C] FIG. 89C illustrates a proximal portion of the sheath of the steerable catheter assembly and a proximal portion of the sheath of the implant catheter assembly that includes a reinforcing material. [Figure 90] FIG. 90 illustrates a sheath of a steerable catheter assembly having a stiffened length between the proximal end of the steerable catheter sheath and the steerable portion. [Figure 91] FIG. 91 illustrates a steerable catheter assembly having two hypotubes of different stiffness. [Figure 92] FIG. 92 illustrates a steerable catheter assembly having a laser cut hypotube positioned over a braided, mesh, or woven material to increase the stiffness of a portion of the steerable catheter assembly. [Figure 93] FIG. 93 illustrates four segments of laser cut hypotube. [Figure 94] FIG. 94 illustrates a hypotube with an interrupted spiral cut. [Figure 95] 95A and 95B are radial cross-sectional views of an exemplary multi-layer sheath. [Figure 96A] FIG. 96A is a longitudinal cross-sectional view of another exemplary multi-layer sheath. [Figure 96B] FIG. 96B is a longitudinal cross-sectional view of a proximal portion of the multi-layer sheath of FIG. 96A. [Figure 97] FIG. 97 illustrates an exemplary catheter assembly with portions removed to show the internal components. [Figure 98] FIG. 98 illustrates an exemplary catheter assembly with portions removed to show the internal components. [Figure 99A] FIG. 99A illustrates an exemplary braid pattern having tubes for housing the flexion members woven within. [Figure 99B] FIG. 99B illustrates an exemplary braid pattern having tubes for housing the flexion members woven within. [Figure 99C] FIG. 99C illustrates an exemplary braid pattern having tubes for housing the flexion members woven within. [Figure 99D] FIG. 99D is a longitudinal cross-sectional view of an exemplary multi-layer sheath having any of the braids in FIGS. 99A-99C. [Figure 99E] FIG. 99E illustrates an exemplary braid pattern having tubes for housing the flexion members woven within. [Fig. 99F] FIG. 99F is a longitudinal cross-sectional view of an exemplary multi-layer sheath having the braid of FIG. 99E. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0093] In the following description, reference is made to the accompanying drawings which illustrate example implementations of the present disclosure. Other implementations having different structure and operation do not depart from the scope of the present disclosure.

[0094] Exemplary implementations of the present disclosure are directed to systems, devices, methods, etc., for repairing defective heart valves. For example, various implementations of implantable devices, valve repair devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components in the disclosed devices and systems can be combined unless mutually exclusive or physically impossible. Furthermore, the techniques and methods herein can be performed on live animals or can be performed on simulations, such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0095] As described herein, when one or more components are described as being connected, joined, fastened, coupled, attached, or otherwise interconnected, such interconnection can be direct, such as between the components, or can be indirect, such as through the use of one or more intermediate components. Also, as described herein, references to a "member," "component," or "portion" are not 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 including) (preferably within 10%, more preferably within 1%, and most preferably within 0.1%) a given value or condition.

[0096] 1 and 2 are cross-sectional views of a human heart H during diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., atrioventricular valves, respectively. In addition, an aortic valve AV separates the left ventricle LV from the ascending aorta AA, and a pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in Figs. 3-6 and leaflets 30, 32, 34 shown in Fig. 7) that extend inwardly across their respective valve openings and that flow together or "coapt" to form a unidirectional fluid-occluding surface. The native valve repair system of the present application is frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomy of the left atrium LA and the left ventricle LV will now be described in more detail. However, the devices described herein may also be used in the repair of other native valves, for example, the devices may be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0097] The left atrium LA receives oxygen-rich blood from the lungs. During the expansion phase, or diastole, as seen in FIG. 1, blood already collected in the left atrium LA (during the contraction phase) moves into the left ventricle LV through the mitral valve MV due to the expansion of the left ventricle LV. During the contraction phase, or systole, as seen in FIG. 2, the left ventricle LV contracts to pump blood through the aortic valve AV and the ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV are closed to prevent blood from flowing back from the left ventricle LV into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some implementations, the devices described in this application are used to restore the function of a defective mitral valve MV. That is, the devices are configured to assist in the closure of the leaflets of the mitral valve to prevent or block blood from flowing back from the left ventricle LV into the left atrium LA. Although many of the devices described in this application are designed to easily grasp and secure the native leaflets around a coaptation member or spacer that beneficially acts as a filler in the regurgitant opening to prevent or inhibit backflow during systole, this is not required.

[0098] Referring now to Figures 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24, which is a variably dense, fibrous ring of tissue surrounding the leaflets 20, 22. Referring to Figures 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., muscles located at the base of the chordae tendineae CT and in the wall of the left ventricle LV) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM function to limit the movement of the leaflets 20, 22 of the mitral valve MV and to prevent the mitral valve MV from everting. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and in the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, they support and brace the leaflets 20, 22 against the high pressures required to circulate blood throughout the body. Together, the papillary muscles PM and chordae tendineae CT are known as the subvalvular tissue, which functions to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve MV is occluded. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in FIG. 3, the anatomy of the leaflets 20, 22 is such that the inner surfaces of the leaflets meet at their free ends and the leaflets 20, 22 begin to retract and spread apart from each other. The leaflets 20, 22 spread apart toward the atrium until each leaflet contacts the mitral annulus.

[0099] Various disease processes can impair the proper function of one or more native valves in the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber deficiency, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or right ventricle RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathies, etc.) can distort the shape of the native valve, which can cause the native valve to malfunction. However, the majority of patients undergoing valve surgery, such as mitral valve MV surgery, suffer from a degenerative disease that causes the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV) to malfunction, resulting in prolapse and regurgitation.

[0100] In general, native valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when the native valve does not open completely, causing obstruction of blood flow. Typically, valve stenosis is due to the accumulation of calcified material on the valve leaflets, which thicken and impair the valve's ability to open completely to allow forward blood flow. Valve regurgitation occurs when the valve leaflets do not close completely, allowing blood to leak back into the previous chamber (e.g., blood leaks from the left ventricle into the left atrium).

[0101] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier Type I, Type II, and Type III insufficiencies. Carpentier Type I insufficiency involves dilatation of the valve annulus, which causes normally functioning leaflets to move apart and not form a tight seal (i.e., the leaflets do not coapt properly). Type I insufficiencies include leaflet perforation, such as occurs in endocarditis. Carpentier Type II insufficiency involves deviation of one or more native valve leaflets above the plane of coaptation. Carpentier Type III insufficiency involves restricted movement of one or more native valve leaflets, resulting in abnormal restriction of the leaflets below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or by ventricular dilation (IIIb).

[0102] With reference to FIG. 5, when a healthy mitral valve MV is in the occluded position, the anterior leaflets 20 and posterior leaflets 22 coapt, thereby preventing blood from leaking from the left ventricle LV into the left atrium LA. With reference to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflets 20 and / or posterior leaflets 22 of the mitral valve MV are displaced into the left atrium LA during systole such that the edges of the leaflets 20, 22 no longer contact each other. This failure to coapt results in a gap 26 between the anterior leaflets 20 and posterior leaflets 22, which allows blood to flow regurgitantly from the left ventricle LV into the left atrium LA during systole, as illustrated by the mitral regurgitation MR flow path shown in FIG. 3. With reference to FIG. 6, the gap 26 can have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, the gap 26 can have a width W greater than 15 mm. As discussed above, there are several different ways in which a valve leaflet (e.g., the leaflets 20, 22 of the mitral valve MV) can become incompetent, causing valve regurgitation.

[0103] In any of the above situations, a valve repair device or implant that can engage the anterior leaflet 20 and posterior leaflet 22 to occlude the gap 26 and prevent or inhibit backflow of blood through the mitral valve MV is desirable. As can be seen in Fig. 4, an abstract representation of an implantable device, valve repair device, or implant 10 is shown implanted between the leaflets 20, 22 to prevent backflow during systole (compare Fig. 3 with Fig. 4). In some implementations, the coaptation members (e.g., spacers, bonding members, gap fillers, etc.) of the device 10 have a generally tapered or triangular shape to naturally conform to the shape of the native valve and the nature of its expanded (towards the annulus) leaflets. In this application, the terms spacer, coaptation member, connecting member, and gap filler are used interchangeably to refer to members that fill a portion of the space between the leaflets of a native valve and / or are configured to engage or "coapt" the leaflets of a native valve (e.g., to connect the native leaflets not only to each other but also to the coaptation member, connecting member, spacer, etc.).

[0104] Although stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve AV or the pulmonary valve PV, and regurgitation has been found to primarily affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the burden on the heart H and, if left untreated, can lead to very serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. The left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) is primarily responsible for circulating blood flow throughout the body. Therefore, since pressures are substantially higher in the left side of the heart, malfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening.

[0105] A dysfunctional native heart valve can be either repaired or replaced. Repair typically involves preserving and modifying the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Since the stenotic damage sustained by the valve leaflets is irreversible, a procedure for a stenotic aortic valve or pulmonary valve can involve removing the valve and replacing it with a surgically implanted heart valve or a transcatheter heart valve. The mitral valve MV and tricuspid valve TV are more prone to deformation of the leaflets and / or surrounding tissue, which, as described above, can prevent the mitral valve MV or tricuspid valve TV from closing properly, allowing blood to regurgitate or backflow from the ventricle into the atrium (e.g., a deformed mitral valve MV can allow blood to regurgitate or backflow from the left ventricle LV into the left atrium LA, as shown in FIG. 3). Regurgitation or backflow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. In addition, regurgitation can occur due to incompetence of the chordae tendineae CT (e.g., the chordae tendineae CT can stretch or rupture), allowing the anterior leaflet 20 and the posterior leaflet 22 to evertate, allowing blood to flow back into the left atrium LA. Problems caused by incompetent chordae tendineae CT can be repaired by repairing the chordae tendineae CT or by repairing the structure of the mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0106] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it is understood that the devices and concepts provided herein may be used in repairing any native valve, as well as in repairing any component of a native valve. Such devices may be used between the leaflets 20, 22 of the mitral valve MV to prevent or block the backflow of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts provided herein may be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or block the backflow of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein may be used together on all three leaflets 30, 32, 34 to prevent or block the backflow of blood from the right ventricle into the right atrium. That is, the valve repair device or implant provided herein may be centrally positioned between the three leaflets 30, 32, 34.

[0107] An exemplary implant or implantable device (e.g., an implantable prosthetic device, etc.) can optionally include a coaptation member (e.g., a spacer, a bonding member, a gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, an implantable device or implant can include any combination or subcombination of the features disclosed herein without a coaptation member. When included, the coaptation member (e.g., a bonding member, a spacer, etc.) is configured to be positioned within the native heart valve opening to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing the backflow discussed above. The coaptation member can have a structure that is impermeable to blood (or resists blood flow therethrough) and can have a structure that allows the native leaflets to close around the coaptation member during ventricular systole, thereby blocking backflow of blood from the left ventricle into the left atrium and from the right ventricle into the right atrium. The device or implant can be configured to seal against two or three native leaflets, i.e., the device can be used in native mitral (bicuspid) and native tricuspid valves. The coaptation members are sometimes referred to herein as spacers because they can fill the space between native leaflets (e.g., mitral 20, 22 or tricuspid 30, 32, 34) that are not completely occluded and functioning properly.

[0108] The optional coaptation members (e.g., spacers, bonding members, etc.) can have a variety of shapes. In some implementations, the coaptation members can have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation members can have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some implementations, the coaptation members can have an atrial portion positioned within or adjacent to the atrium, a ventricular or lower portion positioned within or adjacent to the ventricle, and lateral sides extending between the native leaflets. In some implementations configured for use in a tricuspid valve, the atrial or upper portion is positioned within or adjacent to the right atrium, the ventricular or lower portion is positioned within or adjacent to the right ventricle, and the lateral sides extend between the native tricuspid valve leaflets.

[0109] In some implementations, the anchors can be configured to secure the device to one or both of the native leaflets such that the coaptation member is positioned between two native leaflets. In some implementations configured for use in a tricuspid valve, the anchors are configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation member is positioned between three native leaflets. In some implementations, the anchors can be attached to the coaptation member at a location adjacent to the ventricular portion of the coaptation member. In some implementations, the anchors can be attached to a drive member, such as a shaft or drive wire, to which the coaptation member is also attached. In some implementations, the anchors and coaptation members can be independently positioned relative to one another by separately moving each of the anchors and coaptation members along a longitudinal axis of the drive member (e.g., drive shaft, drive rod, drive tube, drive wire, etc.). In some implementations, the anchors and coaptation members can be simultaneously positioned by moving the anchors and coaptation members together along a longitudinal axis of the drive member (e.g., shaft, drive wire, etc.). The anchors can be configured to be positioned behind the native leaflets when implanted such that the leaflets are grasped by the anchors.

[0110] The device or implant can be configured to be implanted via a delivery system or other delivery means. The delivery system can include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. The coaptation member and anchor can be compressible to a radially compressed state and can be self-expandable to a radially expanded state when the compressive pressure is released. The device can be configured such that the anchor expands radially away from the coaptation member, which is initially still compressed, to form a gap between the coaptation member and the anchor. A native leaflet can then be positioned within the gap. The coaptation member can expand radially to occlude the gap between the coaptation member and the anchor, thereby capturing the leaflet between the coaptation member and the anchor. In some implementations, the anchor and coaptation member are optionally configured to be self-expanding. The implantation methods for various implementations can be different and are described more fully below for each implementation. Additional information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication No. 2014 / 0222136, U.S. Patent Application Publication No. 2014 / 0067052, U.S. Patent Application Publication No. 2016 / 0331523, and PCT Patent Application Publication No. 2020 / 076898, which are incorporated by reference in their entireties for all purposes. These methods can be performed, mutatis mutandis, on live animals or can be performed on simulations, such as cadavers, cadaveric hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0111] The disclosed device or implant can be configured with anchors connected to the leaflets and can utilize tension from the natural chordae tendineae to resist large systolic pressures that urge the device toward the left atrium. During diastole, the device can rely on compressive and retaining forces applied to the leaflets gripped by the anchors.

[0112] 8-15, a schematic illustration of an implantable device or implant 100 (e.g., an artificial spacer device, a valve repair device, etc.) is shown in various stages of deployment. The device or implant 100, as well as other similar devices / implants, are described in more detail in PCT Patent Application Publication Nos. WO2018 / 195215, WO2020 / 076898, and WO2019 / 139904, which are incorporated by reference in their entireties. The device 100 can include any other features of an implantable device or implant described in this application or the applications cited above, and the device 100 can be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications cited above).

[0113] The device or implant 100 is deployed from a delivery system 102 or other delivery means. The delivery system 102 may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, etc. The device or implant 100 includes a joint portion 104 and an anchor portion 106.

[0114] In some implementations, the interface portion 104 of the device or implant 100 includes an interface member 110 (e.g., a spacer, plug, filler, foam, sheet, membrane, coupling member, etc.) configured to be implanted between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and slidably attached to an actuation member 112 (e.g., a drive wire, drive shaft, drive tube, etc.). The anchor portion 106 includes one or more anchors 108 that are actuable between an open state and a closed state and can take a wide variety of forms, such as, for example, a paddle, a gripping member, or the like. Actuation of the actuation means or actuation member 112 opens and closes the anchor portion 106 of the device 100 to grip the leaflets of the native valve during implantation. The drive means or member 112 (as well as other drive means and members herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a variety of configurations. As an example, the drive member can be threaded such that driving the drive member in rotation moves the anchor portion 106 relative to the interface portion 104. Alternatively, the drive member can be unthreaded such that driving the drive member 112 in a pushing or pulling manner moves the anchor portion 106 relative to the interface portion 104.

[0115] The anchor portion 106 and / or anchor of the device 100 in some implementations includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the mating means or mating member 110 by portions 124, 126, 128. The portions 124, 126, 128 can be articulated and / or flexible to move between all positions described below. The interconnection of the outer paddle 120, inner paddle 122, mating member 110, and cap 114 by portions 124, 126, 128 can constrain the device to the positions and movements illustrated herein.

[0116] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and a drive means or member 112 (e.g., a drive wire, a drive shaft, etc.), which can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the drive means or member 112 extends through the delivery catheter and through the joint means or member 110 to a distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extension and retraction of the drive member 112 increases and decreases, respectively, the spacing between the joint member 110 and the distal end of the device (e.g., a cap 114 or other attachment portion). In some implementations, a collar or other attachment member directly or indirectly removably attaches the joint member 110 to the delivery system 102 such that the actuation means or member 112 slides through the collar or other attachment member, and in some implementations, through the joint member or member 110 when actuated, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0117] In some implementations, the anchor portion 106 and / or the anchor 108 may include an attachment portion or gripping member. The illustrated gripping member may include a clasp 130 including a base or fixed arm 132, a movable arm 134, an optional barb, friction enhancing member, or other fastening means 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the joint portion 138 disposed proximate to the joining means or joining member 110. In some implementations, the clasp (e.g., a barbed clasp, etc.) has a flat surface and does not fit within a recess of the inner paddle. Rather, the flat portion of the clasp is disposed against a surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 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 member of material integrally formed with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary or substantially stationary with respect to the inner paddle 122 when the movable arm 134 opens and releases the clasp 130, turning it over and exposing the friction enhancing member, or fastening means 136.

[0118] In some implementations, the clasp 130 is opened by applying tension to a drive line 116 attached to a movable arm 134, thereby causing the movable arm 134 to articulate, bend, or pivot on a joint portion 138. The drive line 116 extends through the delivery system 102 (e.g., through a steerable catheter and / or an implant catheter). Other drive mechanisms are also possible.

[0119] The drive line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The clasp 130 can be spring loaded so that in the occluded position, the clasp 130 continues to provide a clamping force against the grasped native leaflet. This clamping force remains constant regardless of the position of the inner paddle 122. Optional barbs, friction enhancing members, or other securing means 136 of the clasp 130 can grip, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0120] During implantation, the paddles 120, 122 may open and close to, for example, grip a native leaflet (e.g., a leaflet of a native mitral valve, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation means or member 110. The clasps 130 may be used to grip and / or further secure a native leaflet by engaging the leaflet with barbs, frictional enhancements, or fixation means 136 and clamping the leaflet between the movable arm 134 and the fixation arm 132. The frictional enhancements or other fixation means 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.) on the clasps 130 may increase friction against the leaflet or partially or completely pierce the leaflet. The drive lines 116 may be individually actuated so that each clasp 130 may be individually opened and closed. Individual actuation allows for grasping one leaflet at a time, or allows for repositioning of clasp 130 on leaflets that are not adequately grasped, without altering the good grip on other leaflets. Clasp 130 can be opened and closed relative to the position of inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), allowing for grasping of leaflets in a variety of positions as a particular situation requires.

[0121] 8, the device 100 is shown in an extended or fully open state for deployment from an implant delivery catheter of a delivery system 102. In the fully open position, the device 100 is located at the end of the catheter because it takes up the least amount of space and also because the smallest catheter may be used in the fully open position (or the largest device 100 may be used for a given catheter size). In the extended state, the cap 114 is spaced away from the attachment means or attachment member 110 so that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is about 180 degrees. The clasp 130 is maintained in an occluded state during deployment through the delivery system 102 so that the optional barbs, friction enhancing members, or other fastening means 136 (FIG. 9) do not snag or damage the delivery system 102 or tissue within the patient's heart. The drive line 116 may be attached to a movable arm 134 .

[0122] 9, the device 100 is shown in an extended, uncoiled state similar to that of FIG. 8, but with the clasp 130 in a fully open position, in the range of about 140 degrees to about 200 degrees, in the range of about 170 degrees to about 190 degrees, or at about 180 degrees between the fixed portion 132 and the movable portion 134 of the clasp 130. Full opening of the paddles 120, 122 and clasp 130 has been found to improve the ease of disengagement or detachment of the device 100 from the patient's anatomical structures, such as chordae tendineae CT, upon implantation.

[0123] Referring now to FIG. 10, the device 100 is shown in a shortened or fully occluded state. The compact size of the device 100 in the shortened state allows for easier manipulation and placement inside the heart. To drive the device 100 from the extended state to the shortened state, the driving means or driving member 112 is retracted, pulling the cap 114 towards the attachment means or attachment member 110. The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained in movement such that a compressive force acting from the cap 114 onto the outer paddle 120 retracts the paddle or gripping member towards the attachment means or attachment member 110 and moves radially outward. When driven from the open position to the occluded position, the outer paddle 120 maintains an acute angle with respect to the driving means or driving member 112. The outer paddle 120 can optionally be biased towards the occluded position. The inner paddle 122 moves through a significant angle in order to orient away from the open joint means or member 110 and to fold along the side of the closed joint means or member 110 during the same movement. In some implementations, the inner paddle 122 can be thinner and / or narrower than the outer paddle 120, and the connecting portions 126, 128 (e.g., joints, flexible connections, etc.) connected to the inner paddle 122 can be thinner and / or more flexible. For example, this increased flexibility can allow for a larger movement compared to the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some implementations, the outer paddle 120 can be narrower than the inner paddle 122. The connecting portions 126, 128 connected to the inner paddle 122 can be more flexible, for example, to allow for greater movement compared to the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some implementations, the inner paddle 122 can be the same width or substantially the same width as the outer paddle.

[0124] 11-13, the device 100 is shown in a partially open state and ready to be grasped. To move from the fully occluded state to the partially open state, the actuation means or member (e.g., drive wire, drive shaft, etc.) is extended to push the cap 114 away from the attachment means or member 110, thereby pulling the outer paddle 120 and pulling the inner paddle 122 to partially open the anchor or anchor portion 106. The drive line 116 is also retracted, thereby opening the clasp 130 so that it can grasp the leaflets. In some implementations, the pair of inner and outer paddles 122, 120 are actuated together, rather than individually, by a single actuation means or member 112. Also, the position of the clasp 130 depends on the position of the paddles 122, 120. 10, closing the paddles 122, 120 also closes the clasp. In some implementations, the paddles 120, 122 can be independently controllable. For example, the device 100 can have two actuation members and two independent caps (or other mounting parts), such that one independent actuation member (e.g., wire, shaft, etc.) and cap (or other mounting part) can be used to control one paddle, and the other independent actuation member and cap (or other mounting part) can be used to control the other paddle.

[0125] 12, extending one drive line 116 can close one clasp 130. Referring now to FIG 13, extending the other drive line 116 can close the other clasp 130. By repeatedly driving one or both drive lines 116, the clasps 130 can be repeatedly opened and closed.

[0126] 14, the device 100 is shown in a fully occluded and deployed state. The delivery system 102 or delivery means and drive means or member 112 are retracted, and the paddles 120, 122 and clasp 130 remain in the fully occluded position. After deployment, the device 100 can be maintained in the fully occluded position by a mechanical latch, or it can be biased to remain occluded by using a spring material such as steel, other metals, plastics, composites, etc., or by using a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from a metal such as steel or from a shape memory alloy such as Nitinol, which can be manufactured from wire, sheet, tube, or laser sintered powder, and are biased to hold the outer paddle 120 in an occluded state around the attachment means or attachment member 110 and to clamp the clasp 130 around the native leaflets. Similarly, the fixed arm 132 and the movable arm 134 of the clasp 130 are biased to clamp the leaflets. In some implementations, the attachment or connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from a metal or any other suitable elastic material, such as a polymeric material, to maintain the device 100 in an occluded state after implantation.

[0127] Figure 15 illustrates an example where the paddles 120, 122 are independently controllable. The device 101 illustrated in Figure 15 is similar to the device 100 illustrated in Figure 11, except that the device 101 in Figure 15 includes an actuation member configured as two independent actuation members or actuation wires 111, 113 coupled to two independent caps 115, 117. To move the first inner paddle 122 and the first outer paddle 120 from a fully occluded state to a partially open state, the actuation means or actuation member 111 is extended to push the cap 115 away from the joint means or joint member 110, thereby pulling the outer paddle 120 and pulling the inner paddle 122 to partially open the first anchor 108. To move the second inner paddle 122 and the second outer paddle 120 from the fully closed state to the partially open state, the actuation means or actuation member 113 is extended to push the cap 115 away from the joining means or actuation member 110, thereby pulling the outer paddle 120 and pulling the inner paddle 122 to partially open the second anchor 108. The independent paddle control illustrated in Figure 15 can be implemented in any of the devices disclosed in this application. For comparison, in the example illustrated in Figure 11, the pair of inner and outer paddles 122, 120 are driven together by a single actuation means or single actuation member 112, rather than individually.

[0128] 16-21, the implantable device 100 of FIGS. 8-14 is shown being delivered and implanted within the native mitral valve MV of the heart H. Referring to FIG 16, a delivery sheath / catheter is inserted through the septum into the left atrium LA and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open condition as shown in FIG 16. The drive means or member 112 is then retracted to drive the implant / device into a fully occluded condition as shown in FIG 17.

[0129] As can be seen in Figure 18, the implant / device is driven into a position within the mitral valve MV and into the ventricle LV and in a partially open state to grasp the leaflets 20, 22. For example, the steerable catheter can be advanced and steered or bent to position the steerable catheter as shown in Figure 18. An implant catheter connected to the implant / device can be advanced from within the steerable catheter to position the implant as shown in Figure 18.

[0130] 19, the implant catheter is retracted into the steerable catheter to position the mitral valve leaflets 20, 22 within the clasps 130. The drive line 116 is extended to occlude one of the clasps 130 and capture the leaflet 20. FIG. 20 illustrates that the other drive line 116 is then extended to occlude the other clasp 130 and capture the remaining leaflet 22. Additionally, as can be seen in FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), drive means or member 112, and drive line 116 are then retracted to fully occlude and deploy the device or implant 100 within the native mitral valve MV.

[0131] 22-27, an example of an implantable device or implant or implants 200 is shown. The implantable device 200 is one of many different configurations that the device 100 shown generally in FIGS. 8-14 may take. The device 200 may include any other features of an implantable device or implant described herein, and the device 200 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein). The device / implant 200 may be an artificial spacer device, a valve repair device, or another type of implant that attaches to the leaflets of a native valve.

[0132] In some implementations, the implantable device or implant 200 includes an interface portion 204, a proximal or attachment portion 209, an anchor portion 206, and a distal portion 207. In some implementations, the interface portion 204 of the device optionally includes an interface member 210 (e.g., a spacer, a coupling member, a plug, a membrane, a sheet, etc.) for implantation between the 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 an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some implementations, the attachment portion 209 includes a first or proximal collar 211 (or other attachment member) for engaging a capture mechanism 213 (FIGS. 43-49) of the delivery system 202 (FIGS. 38-42 and 49). The delivery system 202 may be the same as or similar to the delivery system 102 described elsewhere and may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, and the like.

[0133] In some implementations, the junction members 210 and paddles 220, 222 can be formed from a metal fabric such as a mesh, woven fabric, braided, or any other suitable formed, or laser cut or otherwise cut flexible material. The material can be cloth, a shape memory alloy wire such as Nitinol to provide shape setting capabilities, or any other flexible material suitable for implantation within the human body.

[0134] A drive member 212 (e.g., a drive shaft, drive rod, drive tube, drive wire, drive line, etc.) extends from the delivery system 202 to engage the implantable device or implant 200 to enable driving of the implantable device or implant 200. In some implementations, the drive member 212 extends through the capture mechanism 213, the proximal collar 211, and the joint member 210 to engage a cap 214 of the distal portion 207. The drive member 212 can be configured to releasably engage the cap 214 via a threaded or similar connection such that the drive member 212 can be disengaged and removed from the device 200 after implantation.

[0135] The abutment member 210 extends from a proximal collar 211 (or other attachment member) to an inner paddle 222. In some implementations, the abutment member 210 has a generally elongated, circular shape, although other shapes and configurations are possible. In some implementations, the abutment member 210 has an elliptical shape or cross-section when viewed from above (e.g., FIG. 51), a tapered shape or cross-section when viewed from the front (e.g., FIG. 23), and a circular shape or cross-section when viewed from the side (e.g., FIG. 24). A mixture of these three geometries can result in a three-dimensional shape for the illustrated abutment member 210 that achieves the advantages described herein. It can be seen that the circular shape of the abutment member 210 also substantially conforms to or approximates the shape of the paddle frame 224 when viewed from above.

[0136] The size and / or shape of the junction member 210 can be selected to minimize the number of implants (preferably one) that a patient will need while maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the apex of the junction member is about 5 mm, and the medial-lateral distance at the widest point of the junction member is about 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and on the overall shape strategy described above. It will be readily apparent that using other anterior-posterior and medial-lateral distances as a starting point for the device will result in devices with different dimensions. Additionally, using other size and shape strategies described above will also result in devices with different dimensions.

[0137] In some implementations, the outer paddle 220 is articulably attached to the cap 214 of the distal portion 207 by connecting portion 221 and to the inner paddle 222 by connecting portion 223. The inner paddle 222 is articulably attached to the joint member by connecting portion 225. In this manner, the anchor 208 is configured similar to a leg in that the inner paddle 222 is like an upper portion of a leg, the outer paddle 220 is like a lower portion of a leg, and the connecting portion 223 is like a knee portion of a leg.

[0138] In some implementations, the inner paddle 222 is rigid, relatively rigid, stiff, has a stiff portion, and / or is stiffened by a stiffening member or fixed portion 232 of the clasp 230. The stiffening of the inner paddle allows the device to be driven into a variety of different positions as shown and described herein. The inner paddle 222, outer paddle 220, and joints can all be interconnected as described herein, thereby constraining the device 200 to the movements and positions as shown and described herein.

[0139] In some implementations, the paddle frame 224 is attached to the cap 214 at the distal portion 207 and extends to a connection portion 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is formed from a stiffer and more rigid material compared to the material forming the paddles 222, 220 such that the paddle frame 224 provides support for the paddles 222, 220.

[0140] The paddle frame 224 provides additional clamping force between the inner paddle 222 and the coaptation member 210, as can be seen in FIG. 51, and helps wrap the leaflets around the sides of the coaptation member 210 for a better seal between the coaptation member 210 and the leaflets. That is, the paddle frame 224 can be configured with a rounded three-dimensional shape that extends from the cap 214 to the connecting portion 223 of the anchor 208. The connections between the paddle frame 224, the outer and inner paddles 220 and 222, the cap 214, and the coaptation member 210 can constrain each of these members to the movements and positions described herein. In particular, the connecting portion 223 is constrained by its connections between the outer and inner paddles 220 and 222, and by its connections to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connecting portion 223 (and thus the inner paddle 222 and the outer paddle 220 ) and by its attachment to the cap 214 .

[0141] Configuring the paddle frame 224 in this manner provides an increased surface area compared to the outer paddle 220 alone, which may, for example, allow easier grasping and fixation of the native leaflets. The increased surface area may also distribute the clamping force of the paddles 220 and paddle frame 224 on the native leaflets over a larger surface area of ​​the native leaflets to further protect the native leaflet tissue. Referring again to FIG. 51, the increased surface area of ​​the paddle frame 224 may also allow the native leaflets to be clamped against the implantable device or implant 200 such that the native leaflets are generally coapted around the coaptation or joining member 210. This may, for example, improve sealing of the native leaflets 20, 22, thereby preventing or further reducing mitral regurgitation.

[0142] In some implementations, the clasp includes a movable arm coupled to the anchor. In some implementations, the clasp 230 includes a base or fixed arm 232, a movable arm 234, an optional barb 236, and a joint portion 238. The fixed arm 232 is attached to the inner paddle 222 with the joint portion 238 disposed adjacent to the joining member 210. The joint portion 238 is spring loaded such that the fixed arm 232 and the movable arm 234 are biased toward each other when the clasp 230 is in the closed state. In some implementations, the clasp 230 includes friction enhancing members or fastening means such as barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.

[0143] In some implementations, the fixed arm 232 is attached to the inner paddle 222 through a hole or slot 231 using a suture (not shown). The fixed arm 232 can be attached to the inner paddle 222 using any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, a weld, an adhesive, a clamp, a latch, or the like. The fixed arm 232 remains substantially stationary relative to the inner paddle 222 when the movable arm 234 is opened, thereby opening the clasp 230 and exposing the optional barb or other friction enhancing member 236. The clasp 230 is opened by applying tension to a drive line 216 (e.g., as shown in FIGS. 43-48 ) attached to a hole 235 in the movable arm 234, thereby causing the movable arm 234 to articulate, pivot, and / or bend on a joint portion 238.

[0144] 29, there is shown a close-up view of one of the leaflets 20, 22 being grasped by a clasp, such as clasp 230. The leaflets 20, 22 are grasped between a movable arm 232 and a fixed arm 234 of the clasp 230. Although the tissue of the leaflets 20, 22 is not pierced by the barbs or frictional enhancement members 236, in some implementations the barbs 236 may partially or completely pierce the leaflets 20, 22. The angle and height of the barbs or frictional enhancement members 236 relative to the movable arms 234 helps secure the leaflets 20, 22 within the clasp 230. In particular, the force of pulling the implant away from the native leaflets 20, 22 will encourage the barbs or frictional enhancement members 236 to further engage the tissue, thereby ensuring a better hold. Retention of the leaflets 20, 22 within the clasp 230 is further improved by the position of the fixed arm 232 located near the barb / frictional enhancement member 236 when the clasp 230 is closed. In this configuration, the tissue is molded into an S-shaped curved path by the fixed arm 232, the movable arm 234, and the barb / frictional enhancement member 236. Thus, the force pulling the leaflets 20, 22 away from the clasp 230 will encourage the tissue to further engage the barb / frictional enhancement member 236 before the leaflets 20, 22 can prolapse. For example, tension on the leaflets during diastole can encourage the barb 236 to pull towards the end of the leaflets 20, 22. Thus, the S-shaped path can take advantage of the leaflet tension during diastole to more tightly engage the leaflets 20, 22 against the barb / frictional enhancement member 236.

[0145] 25, the device or implant 200 may also include a cover 240. In some implementations, the cover 240 may be disposed on the joint members 210, on the outer paddle 220 and the inner paddle 222, and / or on the paddle frame 224. The cover 240 may be configured to prevent or reduce blood flow through the device or implant 200 and / or to promote engraftment of natural tissue. In some implementations, the cover 240 may be a cloth or fabric, such as PET, velour, or other suitable fabric. In some implementations, instead of or in addition to a cloth, the cover 240 may include a coating (e.g., a polymer) applied to the implantable device or implant 200.

[0146] During implantation, the paddles 220, 222 of the anchor 208 can be opened and closed to grip the native valve leaflets 20, 22 between the paddles 220, 222 and the coaptation member 210. The anchor 208 can be driven between a closed position (FIGS. 22-25) and various open positions (FIGS. 26-37) by extending and retracting the drive member 212. The extension and retraction of the drive member 212 increases and decreases the spacing between the coaptation member 210 and the cap 214, respectively. When actuated, the proximal collar 211 (or other attachment member) and coaptation member 210 slide along the drive member 212, thereby changing the spacing between the coaptation member 210 and the cap 214 to drive the paddles 220, 220 between different positions, thereby gripping the mitral valve leaflets 20, 22 during implantation.

[0147] To open and close the device 200, the pair of inner and outer paddles 222, 220 are actuated together, rather than individually, by a single actuating member 212. Also, the position of the clasp 230 depends on the position of the paddles 222, 220. For example, the clasp 230 is configured such that closure of the anchor 208 simultaneously closes the clasp 230. In some implementations, the device 200 can be configured with the paddles 220, 222 independently controllable in the same manner (e.g., the device 100 illustrated in FIG. 15).

[0148] In some implementations, the clasps 230 further secure the native leaflets 20, 22 by engaging the leaflets 20, 22 against optional barbs and / or other friction-enhancing members 236 and further by sandwiching the leaflets 20, 22 between the movable arm 234 and the fixed arm 232. In some implementations, the clasps 230 include barbs that increase friction with the leaflets 20, 22 and / or may partially or fully pierce the leaflets 20, 22. The drive lines 216 (FIGS. 43-48) can be individually actuated so that each clasp 230 can be individually opened and closed. Individual actuation allows for gripping one leaflet 20, 22 at a time, or allows for repositioning the clasp 230 on a leaflet 20, 22 that was not adequately gripped without altering the good grip on the other leaflets 20, 22. The clasps 230 can be fully opened and closed when the inner paddle 222 is not occluded, thereby allowing the leaflets 20, 22 to be grasped in a variety of positions as a particular situation requires.

[0149] 22-25, the device 200 is shown in an occluded position. When occluded, the inner paddle 222 is disposed between the outer paddle 220 and the coaptation member 210. The clasp 230 is disposed between the inner paddle 222 and the coaptation member 210. Upon successfully capturing the native leaflets 20, 22, the device 200 is driven to and held in the occluded position such that the leaflets 20, 22 are secured within the device 200 by the clasp 230 and pressed against the coaptation member 210 by the paddles 220, 222. The outer paddle 220 can have a wider curved shape that fits around the curved shape of the coaptation member 210 (e.g., as can be seen in FIG. 51) to more securely grip the leaflets 20, 22 when the device 200 is occluded. The curved shape and circular edges of the outer paddle 220 also prevent or inhibit tearing of the leaflet tissue.

[0150] 30-37, the implantable device or implant 200 described above is shown in various positions and configurations ranging from partially open to fully open. The paddles 220, 222 of the device 200 transition between the positions shown in FIGS. 30-37 from the closed position shown in FIGS. 22-25 to the upward extension of the drive member 212 from a fully retracted position to a fully extended position.

[0151] 30-31, the device 200 is shown in a partially open position and a ready to capture position. The device 200 is driven to the partially open position by extending the drive member 212. The extension of the drive member 212 pulls down the bottom of the outer paddle 220 and the paddle frame 224, which pulls down the inner paddle 222, to which it is connected. As the proximal collar 211 (or other attachment member) and the joint member 210 are held in place by the capture mechanism 213, the inner paddle 222 is caused to articulate, pivot, and / or bend toward the opening. The inner paddle 222, the outer paddle 220, and the paddle frame all bend to the positions shown in FIGS. 30-31. Releasing the paddles 222, 220 and frame 224 creates a gap between the coaptation member 210 and the inner paddle 222 that can receive and grip the native leaflets 20, 22. This movement also exposes the clasp 230, which can be actuated between a closed position (FIG. 30) and an open position (FIG. 31) to create a second gap for gripping the native leaflets 20, 22. The extent of the gap between the fixed arm 232 and the movable arm 234 of the clasp 230 is limited to the extent that the inner paddle 222 extends away from the coaptation member 210.

[0152] 32-33, the device 200 is shown in a laterally extended or laterally open position. The device 200 is driven into the laterally extended or laterally open position by continuing the extension of the drive member 212 as described above, thereby increasing the distance between the joint member 210 and the cap 214 of the distal portion 207. Continued extension of the drive member 212 pulls the outer paddle 220 and the paddle frame 224 downward, thereby spreading the inner paddle 222 further away from the joint member 210. In the laterally extended or laterally open position, the inner paddle 222 extends more horizontally and forms an angle of approximately 90 degrees with respect to the joint member 210 as compared to other positions of the device 200. Similarly, the paddle frame 224 are in their maximum spread position when the device 200 is in the laterally extended or laterally open position. The increased gap created between the joint member 210 and the inner paddle 222 in the laterally extended or laterally open position allows the clasp 230 to open further (FIG. 33) before engaging the joint member 210, thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0153] 34-35, the exemplary device 200 is shown in a three-quarters extended position. The device 200 is driven to the three-quarters extended position by continuing the extension of the drive member 212 as described above, thereby increasing the distance between the joint member 210 and the cap 214 of the distal portion 207. Continuing the extension of the drive member 212 pulls the outer paddle 220 and the paddle frame 224 down, thereby spreading the inner paddle 222 further away from the joint member 210. In the three-quarters extended position, the inner paddle 222 is open to an angle of more than 90 degrees, approximately 135 degrees, relative to the joint member 210. The paddle frame 224 spreads less compared to the laterally extended or laterally open positions, and begins to move inwardly toward the drive member 212 as the drive member 212 is further extended. The outer paddle 220 also bends backwards toward the drive member 212. Similar to the laterally extended or laterally open position, the increased gap formed between the joint member 210 and the inner paddle 222 in the laterally extended or laterally open position allows the clasp 230 to open even further (FIG. 35), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0154] 36-37, the exemplary device 200 is shown in a fully extended position. The device 200 is driven to the fully extended position by continuing to extend the drive member 212 as described above, thereby increasing the distance between the junction member 210 and the cap 214 of the distal portion 207 to the maximum distance allowable by the device 200. Continuing to extend the drive member 212 pulls the outer paddle 220 and the paddle frame 224 down, thereby spreading the inner paddle 222 further away from the junction member 210. The outer paddle 220 and the paddle frame 224 are driven to a position where they are closer to the drive member. In the fully extended position, the inner paddle 222 is open to an angle of approximately 180 degrees relative to the junction member 210. In the fully extended position, the inner and outer paddles 222, 220 are linearly extended to form an angle of about 180 degrees between the paddles 222, 220. The fully extended position of the device 200 provides the maximum size of the gap between the joint member 210 and the inner paddle 222, and in some implementations allows the clasp 230 to also be fully opened to about 180 degrees between the fixed arm 232 and the movable arm 234 of the clasp 230 (FIG. 37). The position of the device 200 is in its longest and narrowest configuration. Thus, the fully extended position of the device 200 may be a desired position for salvaging the device 200 from an attempted implantation, or may be a desired position for placement of the device in a delivery catheter, or the like.

[0155] Configuring the device or implant 200 such that the anchors 208 can extend into a straight or nearly straight configuration (e.g., about 120 degrees to 180 degrees relative to the coaptation member 210) can provide several advantages. For example, this configuration can reduce the radial corrugated 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 member 210 and the inner paddle 222 for grasping the native leaflets 20, 22. Additionally, the relatively narrow and straight configuration can prevent or reduce the possibility of the device or implant 200 becoming entangled in the native anatomy (e.g., the chordae tendineae CT shown in FIGS. 3 and 4) when positioning and / or retrieving the device or implant 200 within the delivery system 202.

[0156] 38-49, an exemplary implantable device 200 is shown being delivered and implanted into the native mitral valve MV of the heart H. As described above, the device 200 shown in FIGS. 38-49 includes an optional cover 240 (e.g., FIG. 25) over the coaptation member 210, the clasp 230, and the inner and / or outer paddles 222 and 220. The device 200 is deployed from a delivery system 202 (which may include, for example, a steerable catheter and / or an implant catheter extendable from a guide sheath) and is held by a capture mechanism 213 (see, for example, FIGS. 43 and 48) and actuated by extending and retracting the drive member 212. Fingers of the capture mechanism 213 releasably attach the collar 211 to the delivery system 202. In some implementations, the capture mechanism 213 is held in a closed state around the collar 211 by the drive member 212, such that after the device 200 is successfully implanted, removal of the drive member 212 allows the fingers of the capture mechanism 213 to open and release the collar 211, thereby detaching the capture mechanism 213 from the device 200.

[0157] 38, a delivery system 202 (e.g., its delivery catheter / sheath) is inserted through the septum into the left atrium LA and the device / implant 200 is deployed from the delivery system 202 in a fully open state for the reasons described above with respect to device 100 (e.g., the implant catheter holding the device / implant can be expanded to deploy the device / implant from the steerable catheter). The device 200 is then driven through a partially occluded state (FIG. 39) to a fully occluded state as shown in FIGS. 40-41 by retracting the drive member 212. The delivery system or catheter then steers the device / implant 200 towards the mitral valve MV as shown in FIG. 41. 42, when the device 200 is aligned with the mitral valve MV, the drive member 212 extends to open the paddles 220, 222 to a partially open position and the drive line 216 (FIGS. 43-48) retracts to open the clasp 230 ready to grasp the leaflets. The partially open device 200 is then inserted (e.g., by advancing an implant catheter from a steerable catheter) through the native valve until the leaflets 20, 22 are properly positioned between the inner paddle 222 and the coaptation member 210 and within the open clasp 230, as shown in FIGS. 43-44.

[0158] FIG. 45 shows the device 200 with both clasps 230 in an occluded state, but with the optional barb 236 of one clasp 230 not engaged against one leaflet 22. As can be seen from FIGS. 45-47, the misaligned clasp 230 is again opened and occluded to properly grip the escaped leaflet 22. When both leaflets 20, 22 are properly gripped, the drive member 212 is retracted to drive the device 200 to a fully occluded position, as shown in FIG. 48. With the device 200 fully occluded and implanted within the native valve, the drive member 212 can be disengaged and withdrawn from the cap 214 to release the capture mechanism 213 from the proximal collar 211 (or other attachment member), allowing the capture mechanism 213 to be withdrawn into the delivery system 202 (e.g., into a catheter / sheath), as shown in FIG. 49. After deployment, the device 200 can be maintained in a fully occluded position by mechanical means such as a latch, or can be biased to remain occluded through the use of a spring material such as steel and / or through the use of a shape memory alloy such as Nitinol. For example, the paddles 220, 222 can be formed from steel or from Nitinol shape memory alloy, where it can be manufactured from wire, sheet, tube, or laser sintered powder, and biased to hold the outer paddle 220 in an occluded state around the inner paddle 222, coaptation members 210, and / or clasps 230, which circumferentially clamp the native leaflets 20, 22.

[0159] 50-54, after the device 200 is implanted in the native valve, the coaptation member 210 functions as a gap filler in a valve regurgitation opening, such as the gap 26 in the mitral valve MV illustrated in FIG. 6 or in another native valve. In some implementations, when the device 200 is deployed between two opposing leaflets 20, 22, the leaflets 20, 22 no longer coapt to each other in the region of the coaptation member 210, but instead coapt to the coaptation member 210. This reduces the distance that the leaflets 20, 22 need to approach to occlude the mitral valve MV during systole, thereby facilitating the repair of functional valve disease that may cause mitral regurgitation. The reduction in leaflet approach distance can result in several other benefits as well. For example, the reduced approach distance required of the leaflets 20, 22 reduces or minimizes the stress experienced by the native valve. The shorter approximation distance for the leaflets 20, 22 also requires less approximation force, which may result in less tension experienced by the leaflets 20, 22 and less annular diameter reduction. Lesser annular diameter reduction, or no annular diameter reduction at all, may result in less reduction in valve opening area compared to devices without coaptation members or spacers. In this manner, the coaptation members 210 may reduce transvalvular gradients.

[0160] To adequately fill the gap 26 between the leaflets 20, 22, the device 200 and its components can have a wide variety of different shapes and sizes. For example, the outer paddle 220 and paddle frame 224 can be configured to match the shape or geometry of the coaptation member 210, as shown in FIGS. 50-54. As a result, the outer paddle 220 and paddle frame 224 can engage both the coaptation member 210 and the native valve leaflets 20, 22. In some implementations, when the leaflets 20, 22 are coapted to the coaptation member 210, the leaflets 20, 22 can completely surround or "cradle" the coaptation member 210 in its entirety, preventing small leaks at the outer and inner surfaces 201, 203 of the coaptation member 210. The interaction of the leaflets 20, 22 with the device 200 is made clear in Figure 51, which shows a schematic atrial or surgeon's eye view showing a paddle frame 224 (which would not actually be visible from a true atrial view, e.g., in Figure 52) conforming to the geometry of the coaptation member 210. The opposing leaflets 20, 22 (whose ends would also not be visible from a true atrial view, e.g., in Figure 52) are driven closer together by the paddle frame 224 to completely surround or "embrace" the coaptation member 210.

[0161] This coaptation of the leaflets 20, 22 against the lateral and medial surfaces 201, 203 of the coaptation member 210 (shown from the atrial side in FIG. 52 and from the ventricular side in FIG. 53) would seem to contradict the statement above that the presence of the coaptation member 210 minimizes the distance the leaflets must come together. However, the distance the leaflets 20, 22 must come together is still minimized if the coaptation member 210 is placed exactly at the regurgitation gap 26, and further if the regurgitation gap 26 is smaller than the width (medial minus lateral) of the coaptation member 210.

[0162] FIG. 50 illustrates the geometry of the coaptation member 210 and paddle frame 224 from the perspective of the LVOT. As can be seen from this figure, the coaptation member 210 has a tapered shape with smaller dimensions in the area close to where the inner surfaces of the leaflets 20, 22 are desired to coapt and larger dimensions as the coaptation member 210 extends toward the atrium. Thus, the challenges of the illustrated native valve geometry are addressed by the tapered coaptation member shape. Still referring to FIG. 50, the tapered coaptation member geometry, in combination with the illustrated expanded paddle frame 224 shape (towards the annulus), can help achieve capture at the inferior end of the leaflets, reduce stress, and minimize transvalvular gradients.

[0163] 54, the shapes of the coaptation member 210 and the paddle frame 224 can be defined based on the inner commissure diagram of the native valve and the device 200. The two factors for these shapes are the coaptation of the leaflets to the coaptation member 210 and the reduction of stress on the leaflets due to coaptation. With reference to FIG. 54 and FIG. 24, the coaptation member 210 can have a circular or round shape and the paddle frame 224 can have a full radius that spans almost the entirety of the paddle frame 224, both to coapt the leaflets 20, 22 to the coaptation member 210 and to reduce the stress that the coaptation member 210 and / or paddle frame 224 apply to the leaflets 20, 22. The round shape of the coaptation member 210 and / or the fully round shape of the paddle frame 224 shown distributes the stress on the leaflets 20, 22 over a large curved engagement region 205. For example, in FIG. 54, the force exerted by the paddle frame on the leaflets 20, 22 is spread along the entire rounded length of the paddle frame 224 as the leaflets 20 attempt to open during diastole.

[0164] 55, an example of an implantable device or implant 300 is shown. The implantable device 300 is one of many different configurations that the device 100 may assume, as illustrated generally in Figures 8-14. The device 300 may include any other features of an implantable device or implant described herein, and the device 300 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system, such as any of the valve repair systems disclosed herein.

[0165] The implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes an interface portion 304, which optionally includes an interface member 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles, such as an outer paddle 320, an inner paddle 322, a paddle extension member or paddle frame 324, etc. The anchors can also include and / or be coupled to a clasp 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment member) for engaging with a capture mechanism (e.g., a capture mechanism such as capture mechanism 213 shown in Figures 43-49) of a delivery system (e.g., a delivery system such as the systems shown in Figures 38-42 and 49).

[0166] The anchors 308 can be attached to other portions of the device and / or to each other in a variety of different manners (e.g., directly, indirectly, by welding, by stitching, by adhesive, by linking, by latching, by integral formation, by any or all combinations thereof, etc.) In some implementations, the anchors 308 are attached to the joining member or joining element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0167] The anchor 308 can include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. The connecting portion 323 can be attached to a paddle frame 324 that is hingedly attached to the cap 314 or to another attachment portion. In this manner, the anchor 308 is configured similar to a leg in that the inner paddle 322 is like an upper portion of a leg, the outer paddle 320 is like a lower portion of a leg, and the connecting portion 323 is like a knee portion of the leg.

[0168] In implementations having a joining member or element 310, the joining member or element 310 and the anchor 308 can be coupled together in a variety of ways. For example, as shown in the illustrated example, the joining member 310 and the anchor 308 can be coupled together by integrally forming the joining member 310 and the anchor 308 as a single, unitary component. This can be accomplished, for example, by forming the joining member 310 and the anchor 308 from a continuous strip 301 of braided or woven material, such as braided or woven Nitinol wire. In the illustrated example, the joining member 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, 325 are formed from a continuous strip of fabric 301.

[0169] Similar to the anchor 208 in the implantable device or implant 200 described above, the anchor 308 can be configured to transition 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 member, etc.), thereby moving the anchor 308 relative to a midpoint of the device. The movement can be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and proximal ends (e.g., collar 311 or other attachment member, etc.) of the device. For example, the anchor 308 can be positioned in a fully extended or fully stretched or straight configuration (e.g., similar to the configuration of device 200 shown in FIG. 36) by moving the distal end (e.g., cap 314, etc.) away from the proximal end of the device.

[0170] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight with respect to the orientation of the longitudinal axis of the device. In some implementations, the connecting portion 323 of the anchor 308 is adjacent with respect to the longitudinal axis of the joining member 310 (e.g., similar to the configuration of the device 200 shown in FIG. 36). From the fully extended or straight configuration, the anchor 308 can be driven to a fully collapsed or closed configuration (e.g., FIG. 55), for example, by driving the proximal and distal ends toward each other and / or toward the midpoint or center of the device. Initially, as the distal end (e.g., cap 314, etc.) moves toward the proximal end and / or toward the midpoint or center of the device, anchor 308 bends at connecting portions 321, 323, 325 and connecting portion 323 moves radially outward relative to the longitudinal axis of device 300 and axially toward the midpoint and / or proximal end of the device (e.g., similar to the configuration of device 200 shown in FIG. 34). As cap 314 continues to move toward the midpoint and / or proximal end of the device, connecting portion 323 moves radially inward relative to the longitudinal axis of device 300 and axially toward the proximal end of the device (e.g., similar to the configuration of device 200 shown in FIG. 30).

[0171] In some implementations, the clasp includes a movable arm coupled to the anchor. In some implementations, the clasp 330 (shown in detail in FIG. 56 ) includes a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing member 336, and a joint portion 338. The fixed arm 332 is attached to the inner paddle 322 with the joint portion 338 disposed adjacent to the joining member 310. The joint portion 338 is spring loaded such that the fixed arm 332 and the movable arm 334 are biased toward each other when the clasp 330 is in the closed state.

[0172] The fixed arm 332 is attached to the inner paddle 322 through a hole or slot 331 using a suture (not shown). The fixed arm 332 can be attached to the inner paddle 322 by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, a weld, an adhesive, or the like. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened, thereby opening the clasp 330 to expose the optional barb 336. The clasp 330 is opened by applying tension to a drive line (e.g., drive line 216 shown in FIGS. 43-48 ) attached to a hole 335 in the movable arm 334, thereby causing the movable arm 334 to articulate, pivot, and / or bend on a joint portion 338.

[0173] In summary, the implantable device or implant 300 is similar in construction and operation to the implantable device or implant 200 described above, except that the joining member 310, the outer paddle 320, the inner paddle 322, and the connecting portions 321, 323, 325 are formed from a single strip of material 301. In some implementations, the strip of material 301 is attached to the proximal collar 311, the cap 314, and the paddle frame 324 by weaving or inserting through openings in the proximal collar 311, the cap 314, and the paddle frame 324 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 overlapping layers of the strip of material 301.

[0174] For example, Figure 55 shows a joint member 310 and inner paddle 322 formed from multiple overlapping layers of the strip of material 301. The single continuous strip of material 301 can begin and end at various locations on the device 300. The ends of the strip of material 301 can be located at the same or different locations on the device 300. For example, in the example illustrated in Figure 55, the strip of material 301 begins and ends at the location of the inner paddle 322.

[0175] As with the implantable device or implant 200 described above, the size of the junction member 310 can be selected to minimize the number of implants (preferably one) required per patient while maintaining a low transvalvular gradient. In particular, forming many components of the device 300 from a strip of material 301 allows the device 300 to be smaller than device 200. For example, in some implementations, the anterior-posterior distance at the top of the junction member 310 is less than 2 mm, and the medial-lateral distance at the widest point of the device 300 (i.e., the width of the paddle frame 324, which is wider than the junction member 310) is about 5 mm.

[0176] The concepts disclosed herein can be used with a wide variety of different valve repair devices. Figures 57-63 illustrate one exemplary valve treatment system configured as a valve repair system 400 for repairing a patient's native valve to which the concepts of the present application may be applied. However, the concepts of the present application may be applied to a greater number of valve treatment systems, including a greater number of other valve repair systems, and a greater number of valve replacement systems.

[0177] The valve repair system 400 includes a delivery system or device 401 and an implant 402 configured as a valve repair device. The implant or device 402 includes a base assembly 404, a pair of paddles 406, and a pair of gripping members 408. In some implementations, the paddles 406 can be integrally formed with the base assembly. For example, the paddles 406 can be formed as an extension of a link in the base assembly. In the illustrated example, the base assembly 404 of the valve repair device 402 includes 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 paddle 406 such that movement of the coupler 405 along the shaft 403 drives the paddle between an open position and a closed position. In this manner, coupler 405 serves as a means for mechanically coupling paddles 406 to shaft 403 and, when driven along shaft 403, drives paddles 406 between their open and closed positions.

[0178] In some implementations, the gripping member 408 is pivotally connected to the base assembly 404 such that the width of the opening 414 between the paddle 406 and the gripping member 408 may be adjusted by actuating the gripping member (e.g., the gripping member 408 may be pivotally connected to the shaft 403 or to any other suitable member in the base assembly). The gripping member 408 may include an optional barb portion 409 for attaching the gripping member to the valve tissue when the implant or valve repair device 402 is attached to the valve tissue. The gripping member 408 forms a means for gripping valve tissue (particularly the tissue of the valve leaflets) using an anchoring means or portion such as the barb portion 409. When the paddle 406 is in the closed position, it engages the gripping member 408 such that when the valve tissue is attached to the barbed portion 409 of the gripping member, the paddle acts as a retention or fixation means to hold the valve tissue at the gripping member and to fix the implant 402 to the valve tissue. In some implementations, the gripping member 408 is configured to engage the paddle 406 such that the barbed portion 409 engages the valve tissue member and the paddle 406 to fix the implant 402 to the valve tissue member. For example, in certain circumstances it may be advantageous for the paddle 406 to remain in the open position and for the gripping member 408 to move outwardly toward the paddle 406 to engage the valve tissue with the paddle 406.

[0179] Although the example shown in Figures 57-63 illustrates a pair of paddles 406 and a pair of gripping members 408, it will be understood that the implant or valve repair device 402 may include any suitable number of paddles and gripping members.

[0180] In some implementations, the valve repair system 400 includes a deployment 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 the valve tissue, the deployment shaft 413 can be removed from the shaft 403, thereby removing the valve repair device 402 from the rest of the valve repair system 400, such that the valve repair device 402 can remain attached to the valve tissue and the delivery device 401 can be removed from the patient's body.

[0181] Valve repair system 400 can also include a paddle control mechanism 410, a gripping member control mechanism 411, and a lock control mechanism 412. Paddle control mechanism 410 is mechanically attached to coupler 405 to drive the coupler along the shaft, thereby driving paddle 406 between open and closed positions. Paddle control mechanism 410 can take any suitable form, such as, for example, a shaft or rod. For example, paddle control mechanism can include a hollow shaft, a catheter tube, or a sleeve that fits over deployment shaft 413 and over shaft 403 and connected to coupler 405.

[0182] The gripping member control mechanism 411 is configured to actuate the gripping member 408 to vary the width of the opening 414 between the gripping member and the paddle 406. The gripping member control mechanism 411 may take any suitable form, such as, for example, a line, a suture or wire, a rod, a catheter, etc.

[0183] The lock control mechanism 412 is configured to lock and unlock the lock. The lock 407 functions as a locking means for locking the coupler 405 in a stationary position relative to the shaft 403 and can take a wide variety of different forms, and the type of lock control mechanism 412 can be dictated by the type of lock used. In some implementations, the lock 407 takes the form of a lock often used in caulking guns; that is, the lock 407 includes a pivotable plate with a hole, and the shaft 403 of the valve repair device 402 is disposed within the hole of the pivotable plate. In this example, when the pivotable plate is in a tilted position, the pivotable plate engages the shaft 403 to maintain its position on the shaft 403, but when the pivotable plate is in a substantially non-tilted position, the pivotable plate can move along the shaft (thereby allowing the coupler 405 to move along the shaft 403). In other words, the coupler 405 is prevented from moving in the direction Y (as shown in FIG. 61A ) along the shaft 403 when the pivotable plate of the lock 407 is in the tilted (or locked) position, and the coupler is allowed to move in the direction Y along the shaft 403 when the pivotable plate is in the substantially non-tilted (or unlocked) position. In some implementations where the lock 407 includes a pivotable plate, the lock control mechanism 412 is configured to engage the pivotable plate to drive the plate between the tilted and substantially non-tilted positions. The lock control mechanism 412 can be, for example, a rod, suture, wire, or any other member capable of driving the pivotable plate of the lock 407 between the tilted and substantially non-tilted positions. In some implementations, the rotatable plate of the lock 407 is biased to a tilted position (or locked position), and using the lock control mechanism 412, the plate is driven from the tilted position to a substantially non-tilted position (or unlocked position).In some implementations, the rotatable plate of the lock 407 is biased to a substantially non-tilted position (or unlocked position), and using the lock control mechanism 412, the plate is driven from the substantially non-tilted position to the tilted position (or locked position).

[0184] 61A-61B illustrate a valve repair device 402 being actuated from an open position (shown in FIG. 61A) to a closed position (shown in FIG. 61B). The base assembly 404 includes a first link 1021 extending from point A to point B, a second link 1022 extending from point A to point C, a third link 1023 extending from point B to point D, a fourth link 1024 extending from point C to point E, and a fifth link 1025 extending from point D to point E. The coupler 405 is movably attached to the shaft 403, which is fixed relative to the fifth link 1025. The first link 1021 and the second link 1022 are pivotally attached to the coupler 405 at point A, such that movement of the coupler 405 along the shaft 403 drives the position of point A, which in turn drives the first link 1021 and the second link 1022. The first link 1021 and the third link 1023 are pivotally attached to one another at point B, and the second link 1022 and the fourth link 1024 are pivotally attached to one another at point C. One paddle 406a is attached to the first link 1021 such that movement of the first link 1021 drives the paddle 406a, and the other paddle 406b is attached to the second link 1022 such that movement of the second link 1022 drives the paddle 406b. In some implementations, the paddles 406a, 406b may be connected to the links 1023, 1024 or may be extensions of the links 1023, 1024.

[0185] To drive the valve repair device from an open position (shown in FIG. 61A ) to a closed position (shown in FIG. 61B ), driving coupler 405 along shaft 403 in direction Y drives pivot point A for first link 1021 and second link 1022 to a new position. Driving coupler 405 (and pivot point A) in direction Y drives a portion of first link 1021 located near point A in direction H and drives a portion of first link 1021 located near point B in direction J. Paddle 406a is attached to first link 1021 such that driving coupler 405 in direction Y drives paddle 406a in direction Z. In addition, third link 1023 is pivotally attached to first link 1021 at point B such that driving coupler 405 in direction Y drives third link 1023 in direction K. Similarly, driving the coupler 405 (and pivot point A) in the direction Y drives the portion of the second link 1022 located near point A in the direction L and drives the portion of the second link 1022 located near point C in the direction M. The paddle 406b is attached to the second link 1022 such that driving the coupler 405 in the direction Y drives the paddle 406b in the direction V. In addition, the fourth link 1024 is pivotally attached to the second link 1022 at point C such that driving the coupler 405 in the direction Y drives the fourth link 1024 in the direction N. FIG. 61B illustrates the final position of the valve repair device 402 after driving the coupler 405 as shown in FIG. 61A.

[0186] 58, the valve repair device 402 is shown in an open position (similar to the position shown in FIG. 61A) with the gripping member control mechanism 411 actuating the gripping members 408 to provide a wider gap at the opening 414 between the gripping members and the paddle 406. In the illustrated example, the gripping member control mechanism 411 includes a line, such as a suture, wire, etc., that is attached through an opening in the end of the gripping member 408. Both ends of the line extend through a delivery opening 516 of the delivery device 401. When the line is pulled through the delivery opening 516 in direction Y, the gripping members 408 are actuated inward in direction X to cause the opening 414 between the gripping members and the paddle 406 to become wider.

[0187] 59, the valve repair device 402 is shown with the valve tissue 20, 22 disposed into the opening 414 between the gripping member 408 and the paddle 406. With reference to FIG. 60, after the valve tissue 20, 22 is disposed between the gripping member 408 and the paddle 406, the gripping member control mechanism 411 is used to narrow the opening 414 between the gripping member and the paddle. That is, in the illustrated example, the line of the gripping member control mechanism 411 is released or pushed out of the delivery member opening 516 in a direction H, allowing the gripping member 408 to move in a direction D, thereby narrowing the opening 414. Although the gripping member control mechanism 411 is shown as actuating the gripping member 408 to widen the opening 414 between the gripping member and the paddle 406 (FIG. 59), it will be understood that actuation of the gripping member may not be necessary to position the valve tissue within the opening 414. However, in certain circumstances, it may be necessary to make the opening 414 between the paddle 406 and the gripping member 408 wider to receive the valve tissue.

[0188] 62, an implant or valve repair device 402 is in an occluded position and secured relative to the valve tissue 20, 22. The valve repair device 402 is secured relative to the valve tissue 20 by paddles 406a, 406b and gripping members 408a, 408b. In particular, the valve tissue 20, 22 is attached to the valve repair device 402 by barbed portions 409 of the gripping members 408a, 408b, and the paddles 406a, 406b engage the gripping members 408 to secure the valve repair device 402 relative to the valve tissue 20, 22.

[0189] To drive the valve repair device 402 from the open position to the closed position, the lock 407 is driven to an unlocked state by the lock control mechanism 412 (as shown in FIG. 62). After the lock 407 is in the unlocked state, the coupler 405 can be driven along the shaft 403 by the paddle control mechanism 410. In the illustrated example, the paddle control mechanism 410 drives the coupler 405 along the shaft in a direction Y, thereby driving one paddle 406a in a direction X and the other paddle 406b in a direction Z. Driving the paddle 406a in a direction X and the paddle 406b in a direction Z engages the paddles with the gripping members 408a, 408b and secures the valve repair device 402 to the valve tissue 20, 22.

[0190] 63, after the valve repair device 402 is fixed to the valve tissue 20, 22 by driving the paddle 406 to the occluded position (as shown in FIG. 62), the lock 407 is driven to a locked state by the lock control mechanism 412 (FIG. 62) to maintain the valve repair device 402 in the occluded position. After the valve repair device 402 is maintained in the locked state by the lock 407, the valve repair device 402 is removed from the delivery device 401 by decoupling the shaft 403 from the deployment shaft 413 (FIG. 62). In addition, the valve repair device 402 is removed from the paddle control mechanism 410 (FIG. 62), the gripping member control mechanism 411 (FIG. 62), and the lock control mechanism 412. Removing the valve repair device 402 from the delivery device 401 allows the valve repair device to remain fixed to the valve tissue 20, 22 while the delivery device 401 is being removed from the patient.

[0191] When implanting an implantable device or implant into a native heart valve, the actuation of the device to the implantation position may be hindered or impeded by native heart structures. For example, the articulating portion of the implantable device or implant (such as the paddle portion of the anchor used to secure the device to the native heart valve tissue) may rub, be temporarily caught, or be temporarily blocked by the chordae tendineae CT (shown in FIGS. 3 and 4) that extend to the leaflets. An exemplary implantable device or implant may be configured to reduce the likelihood that the device or implant will be temporarily caught or blocked by the CT. For example, the implantable device or implant may have a wide variety of different configurations that are configured to actively or passively constrict to reduce the width of the paddle frame at the anchor portion of the device, thereby reducing the surface area of ​​the device and facilitating the movement of the device / implant over and / or through the CT.

[0192] In some implementations, the delivery system or delivery assembly is configured to easily transition the implantable device or implant between various configurations and / or to easily implant the implantable device or implant into a native heart valve. For example, the controls of the handle used in the delivery system / assembly can be configured to allow improved control over the implantable device or implant, as described below.

[0193] 64-65 illustrate an example of a system or assembly 600 (e.g., a valve treatment system or assembly, a valve repair system or assembly, a valve replacement system or assembly, etc.) and its components. With reference to FIG. 64, the system or assembly 600 can include a delivery assembly or system 602 and an implantable device or implant 604. The delivery system 602 can include multiple catheter assemblies. The delivery system 602 can also include one or more optional catheter stabilization members or stabilization systems / devices (not shown in FIGS. 64 and 65).

[0194] In some implementations, as shown in the illustrated example in FIG. 65, the delivery system 602 includes a first catheter assembly 606, a second catheter assembly 608, and a third catheter assembly 610. However, in some implementations, the delivery system 602 may include fewer or more catheter assemblies than illustrated. In some implementations, the first catheter assembly 606 is configured as a delivery catheter assembly, and is often referred to as such herein for purposes of illustration, although it may be other types of catheters or catheter assemblies. In some implementations, the second catheter assembly 608 is configured as a steerable catheter assembly, and is often referred to as such herein for purposes of illustration, although it may be other types of catheters or catheter assemblies. In some implementations, the third catheter assembly 610 is configured as an implant catheter assembly, and is often referred to as such herein for purposes of illustration, although it may be other types of catheters or catheter assemblies.

[0195] In some implementations, a second or steerable catheter assembly 608 extends coaxially through the first or delivery catheter assembly 606, and a third or implant catheter assembly 610 extends coaxially through the second catheter assembly 608 and through the first catheter assembly 606. The implantable device 604 can be removably coupled to a distal portion of the third or implant catheter assembly 610, as described further below. It will be understood that the implantable device 604 can be any device described herein.

[0196] 65, each catheter assembly (e.g., delivery catheter assembly 606, steerable catheter assembly 608, and implant catheter assembly 610) includes a sheath or shaft 607, 609, 611 extending from a corresponding handle 612, 614, 616. The handles 612, 614, 616 are disposed at the proximal end of each corresponding sheath or shaft and include one or more control members that allow a user to manipulate the catheter assembly (e.g., bend or rotate the sheath or shaft of the catheter assembly) or control a component coupled to the corresponding catheter assembly (e.g., control wires extending through the shaft of the catheter assembly).

[0197] The delivery catheter assembly 606 and the steerable catheter assembly 608 can be used, for example, to access an implantation location (e.g., the native mitral valve region of the heart) and / or to position the implant catheter assembly 610 at the implantation location. Thus, in some implementations, the delivery catheter assembly 606 and the steerable catheter assembly 608 are configured to be steerable. The catheter assemblies or features of the catheter assemblies disclosed by U.S. Pat. Nos. 10,653,862 and 10,646,342 can be used as or in the catheter assemblies 606, 608, 610. U.S. Pat. Nos. 10,653,862 and 10,646,342 are incorporated herein by reference in their entireties.

[0198] 66 and 67 illustrate examples of implant catheter assemblies 610. FIG. 66 illustrates a generalized implant catheter assembly 610, while FIG. 67 is a schematic illustration of an exemplary implant catheter assembly 610, in which each of the clasp drive lines 624 is coupled to a clasp control member positioned on a handle 616, and the drive member 112 is coupled (directly or indirectly) to a control member positioned on the handle (e.g., a knob 626, although the control member can also be a button, switch, slider, motor, a button controlling a motor, combinations thereof, etc.). In each example illustrated in FIG. 66 and 67, the implant catheter assembly 610 can include an inner member or drive member 112, a coupler 620, an outer shaft 611, a handle 616 (shown diagrammatically), and a clasp drive line 624. A proximal end portion 622a of the outer shaft 611 can be coupled to extend distally from the handle 616, and a distal end portion 622b of the outer shaft 611 can be coupled to the coupler 620. The drive member 112 can extend distally from a control member or knob 626 (shown diagrammatically in FIG. 66 ), through the handle 616, through the outer shaft 611, and through the coupler 620. The drive member 112 can be movable (e.g., axially and / or rotationally) relative to the outer shaft 611 and relative to the handle 616. A clasp drive line 624 can extend through the handle 616 and the outer shaft 611, and can be axially movable relative to the handle 616 and the outer shaft 611. The clasp drive line 624 can also be axially movable relative to the drive member 112.

[0199] In some implementations, the outer shaft 611 of the implant catheter assembly 610 can be configured to be steerable. For example, although not shown, the implant catheter assembly 610 can include a drive member, such as a pull wire, and a flexible, axially incompressible pull wire sleeve (e.g., a helical coil).

[0200] 66, the drive member 112 of the implant catheter assembly 610 can be releasably coupled to the cap 114 of the device 604. For example, in some implementations, a distal end portion 112b of the drive member 112 can include external threads configured to releasably engage with internal threads of the cap 114 of the device 604. Thus, by driving the drive member 112 in a first direction (e.g., clockwise) relative to the cap 114 of the device 604, the drive member 112 becomes releasably secured to the cap 114, while by driving the drive member 112 in a second direction (e.g., counterclockwise) relative to the cap 114 of the device 604, the drive member 112 becomes disengaged from the cap 114.

[0201] In the example of FIGS. 66 and 67, the outer shaft 611 of the implant catheter assembly 610 is an elongate shaft extending axially between a proximal end portion 622a coupled to the handle 616 and a distal end portion 622b coupled to the coupler 620. The outer shaft 611 may also include an intermediate portion 622c disposed between the proximal end portion 622a and the distal end portion 622b. The outer shaft 611 may be formed from a variety of materials, including metals and polymers. For example, in some implementations, the proximal end portion 622a may include stainless steel, and the distal portion 622b and the intermediate portion 622c may include polyether block amide (PEBA). The outer shaft 611 may also include an outer cover or coating, such as a polymer reflowed onto the portions 622a, 622b, and 622c.

[0202] 66 and 67, the clasp drive line 624 is coupled to the clasp 130 through the hole 235 in the clasp 130 and extends axially through the outer shaft 611 between the clasp 130 and the handle 616. In some implementations, as shown in FIG. 67, for example, at a proximal end of the clasp drive line 624, each of the multiple clasp drive lines 624 is operatively and / or physically coupled to a clasp control member 628. Each clasp control member 628 is configured such that actuation of each clasp control member 628 can cause axial movement of the clasp drive line 624 relative to the handle 616, relative to the outer shaft 611, and / or relative to the drive member 112. As will be described in more detail, in some implementations, each of the clasp control members 628 can be driven / operated independently of the other clasp control members such that each clasp drive line 624 is driven independently relative to the handle 616, relative to the outer shaft 611, relative to the drive member 112, and / or relative to other clasp drive lines 624. In some implementations, the clasp control members 628 can be operatively or physically fixed (or synchronized) relative to one another (e.g., locked) such that the multiple clasp drive lines 624 are driven axially together relative to the outer shaft 611 and relative to the drive member 112. In some applications, the clasp control members 628 are configured such that an end user can switch between being independently operable and being operable together (e.g., synchronized).

[0203] The clasp control members 628 can be configured in a variety of manners. In some implementations, one or more of the clasp control members 628 are axially driven controls or sliders coupled to corresponding clasp drive lines 624, which drive the clasp drive lines 624 axially relative to the outer shaft 611 and relative to the drive member 112. In some implementations, one or more of the clasp control members 628 include buttons, switches, latches, gears, etc.

[0204] As mentioned above, in some implementations, the drive member 112 is coupled at a distal end to the cap 114 of the device 604. The drive member 112 extends axially through the outer shaft 611 to the handle 616 and is coupled at a proximal end portion 112a to a control member or knob 626. Although described with respect to the various figures herein as being configured as a knob, it will be understood that the drive member 112 may be coupled to any other type of control member, such as another type of rotational control member rotatable about the axis of the handle 616.

[0205] As will be described in more detail, in some implementations, when the knob 626 is rotationally driven about the axis of the handle 616, the rotation is translated into axial movement of the drive member 112, effective to axially advance or retract the drive member, such as a rod or wire, thereby opening and closing the valve repair device. Optionally, the knob can also drive a paddle release knob 630 (sometimes referred to as an indicator member) between a proximal or extended position (as shown in FIG. 74) and a distal or retracted position (as shown in FIG. 73). In some implementations, the control member can be a button, switch, or the like, such as a shaft, gear, screw, or other component driven in rotation by a motor, which can cause axial movement of the drive member 112.

[0206] Turning now to Figure 68, there is shown one example of a handle 616 for an implant catheter assembly 610. In Figure 68, the handle 616 includes a housing 632 to which various controls are coupled.

[0207] In some implementations, an optional nose grip 634 extends axially from the distal end of the housing 632 to facilitate releasably coupling the implant catheter assembly to the stabilizing member (shown in FIGS. 82A-C and 83B-D) during use. In some implementations, the nose grip 634 extends between the housing 632 and a distal flange 636, which limits axial movement of the handle relative to the stabilizing member. The housing 632 and nose grip 634 may be formed from a variety of materials, including polymers such as polycarbonate, and may be formed as a unitary body (e.g., by injection molding) or may be secured together in any of a variety of manners, including by fasteners, pins, adhesives, or the like.

[0208] In some implementations, as shown for example in Figures 69-71, the housing 632 can include an open area or multiple lumens through which the clasp drive line 624 and drive member 112 extend.

[0209] In some implementations, the handle 616 further includes a flushing port 638, as shown in FIGS. 68-70. The flushing port 638 is configured to flush the outer shaft 611 (e.g., with saline) prior to inserting the outer shaft 611 into the patient's vasculature. Additionally, the flushing port 638 can remove air present in the outer shaft 611 as fluid is drawn into the proximal end of the outer shaft 611. Additional information regarding flushing ports available in the handle 616 can be found, for example, in WO 2020 / 112622, the entire contents of which are incorporated herein by reference.

[0210] 68-70, the housing 632 includes an opening for receiving a marker / indicator 640 (e.g., a marking pin, a tactile marker, a visual marker, a tag, etc.). The marker / indicator 640 can visually and / or tactilely indicate which clasp control member is which to aid the end user in tracking when the handle is rotationally actuated.

[0211] In some implementations, the marker / indicator 640 can be a marking pin that is removably coupled to an opening in the housing 632 for storing the marking pin 640. In use, the marking pin 640 can be removed from the opening in the housing and inserted into an opening 641 (shown in FIG. 68 ) on one of the clasp control members 628. For example, the marking pin 640 can be inserted into an opening 641 on the clasp control member 628 that controls the clasp to be coupled to the posterior leaflet of the mitral valve. Thus, when the handle 616 is rotationally driven in use, a user can easily identify the clasp control member 628 for controlling the clasp to be coupled to the posterior leaflet (e.g., a marked clasp control member 628) and the clasp to be coupled to the anterior leaflet (e.g., an unmarked clasp control member 628). Although the marking pin 640 has been described as being coupled to a clasp control member 628 that controls which clasp should be coupled to the posterior leaflet, it is envisioned that the marking pin 640 may be coupled to any clasp control member 628 to indicate any particular orientation of the implant catheter assembly.

[0212] In some implementations, a lock 642 is also included and configured such that the lock 642 can be operated or engaged to selectively physically and / or operatively lock the multiple clasp control members 628 together. The lock can be configured in a variety of manners and can take a variety of forms. In some implementations, the lock 642 is configured as a slide lock and can be operated or engaged to slide between a first position in which the slide lock 642 is coupled to one clasp control member 628 and a second position in which the slide lock 642 is coupled to both clasp control members 628. For example, each of the clasp control members 628 can include a flange 643 to which the slide lock 642 is slidably coupled.

[0213] In some implementations, the slide lock 642 can be actuated to a first position (as shown in FIG. 71A and as indicated by the arrow in FIG. 68) in which the slide lock engages the flange 643 of one clasp control member 628 (e.g., to allow independent movement of each clasp drive line relative to one another) and to a second position (as shown in FIG. 68) in which the slide lock engages the flange 643 of both clasp control members 628 (e.g., to allow simultaneous movement of the clasp drive lines) to selectively control relative movement between the clasp control members 628. When the slide lock is in the first position, each clasp control member can move axially independently relative to the other clasp control member, and when the slide lock is in the second position, the clasp control members can move axially together. Although not shown in the figures, in some implementations, each flange 643 can include a stop to limit the position of the slide lock 642 along the flange 643. Moreover, in some implementations, the slide lock 642 may include one or more detents on or near the bottom of the slide lock 642 configured to prevent or inhibit the slide lock 642 from disengaging from the flange 643.

[0214] In some implementations, each of the clasp control members 628 may include one or more tactile or visual indicators to allow a user to distinguish one clasp control member from another with improved precision. For example, one clasp control member 628 may have a different color and / or a different texture (e.g., ribbed, smooth) compared to the other clasp control member 628.

[0215] As shown in the drawings, in some implementations, each of the clasp control members 628 is wrapped about 180 degrees or otherwise in an arcuate manner around the housing 632 such that together the clasp control members 628 encircle and / or surround (which may include partially surround) the housing 632. Such an arrangement may allow the clasp control members 628 to be accessed by a user from any angle with one hand, for example. Moreover, in the example illustrated in FIG. 68 and FIG. 71A, the clasp control member 628 includes a recessed area 644 generally configured to receive and rock a user's thumb. Although the inclusion of such a recessed area is optional in some examples, it may provide comfort to the user when wrapped and may improve ease of use of the clasp control member 628.

[0216] Although various configurations and arrangements for the clasp control member 628 are possible, having a clasp control member that surrounds, encircles, or is easily accessible from a significant or majority of the handle (or even the entire circumference of the handle) provides a significant advantage over handles that have a clasp control member on only one side or only a small portion of the handle. If the clasp control member is only on one side of the handle, it can be very difficult to manipulate and use during various stages of a procedure, such as when the clasp control member ends up on the underside of the handle as the catheter handle is rotated to properly steer and / or reposition the device within the patient's body. Having a clasp control member that surrounds or is easily accessible from a significant portion of the handle (or even the entire circumference of the handle) makes it significantly easier to keep the clasp control member manipulated / operated as the handle is rotated in either direction during a procedure.

[0217] In some implementations, each clasp control member 628 can further include one or more keyed projections or tangs configured to be received by and slide along a corresponding groove or slot in the housing 632. As shown most clearly in FIG. 72, in some implementations, the housing 632 further includes a pair of detents 645. The first detent 645 is disposed at a first axial location along the path of the one clasp control member 628, and the second detent 645 is disposed at a second axial location along the path of the clasp control member 628. For example, in FIG. 72, one detent 645 protrudes from the housing 632 at a location that places the clasp control member 628 in a fully proximal position (i.e., fully open position), thereby maintaining the clasp control member 628 in the fully proximal position (i.e., fully open position) and preventing the clasp control member 628 from moving distally without the user's intention. A second detent 645 protrudes from the housing 632 at a position that places the clasp control member 628 in a fully distal position (i.e., fully closed position), thereby maintaining the clasp control member 628 in the fully distal position (i.e., fully closed position) and preventing the clasp control member 628 from moving proximally without the user's intention. To release the clasp control member 628 to operate the clasp, the user simply pushes the clasp control member 628 with enough force to depress the detent 645 and slide it past the detent 645. When the clasp control member 628 is actuated to either the proximal position (open position) or the distal position (closed position), the corresponding detent 645 provides tactile and audible feedback to the user indicating that the clasp control member 628 is in the open or closed position.

[0218] 72, the clasp control member 628 can include a coupler 646 configured to attach the clasp control member 628 to a clasp control tube 648. As described in more detail below, the clasp control tube 648 is removably coupled to the clasp drive line 624. Sliding the clasp control member 628 along the housing drives the clasp control tube 648 relative to the housing 632, thereby opening and closing the clasp.

[0219] In the example shown in Figs. 68 and 69, the coupler 646 includes at least one opening 647 into which a clasp control tube 648 is connected. The clasp control member 628 is slidably coupled to the housing 632, such as by an engagement channel 629 in the housing 632 and a protrusion 631 in the clasp control member 628 (see Fig. 68), and / or by the clasp control tube 648 extending through a guide passage 649 formed in the housing (see Fig. 71). The clasp control member, coupler 646, and clasp control tube 648 can slide together axially (i.e., distally and proximally) relative to the housing 632, thereby opening and closing the clasp. Only a single coupler 646 and clasp control tube 648 are visible in Figs. 68 and 69. 71 illustrates that each clasp control member 628 is fixedly coupled to a corresponding clasp control tube 648 and slides with such clasp control tube 648 in a similar manner. At the proximal end, the clasp control tube 648 can be secured to a suture lock 650 that is used to secure the clasp drive line 624 to the clasp control tube 648.

[0220] In some implementations, each clasp control tube 648 may include one or more optional keyed features 671 at various locations along the axial length of the clasp control tube 648 or at all. In some implementations, no keyed features are included. When included, the optional keyed features 671 are complementary to corresponding keyed features 675 formed in one or more components of the handle 616, such as in the handle housing 632. These keyed features 671, 675 may prevent or inhibit rotation of the clasp control tube 648 within the housing, thereby limiting movement of the clasp control tube to linear movement along the length of the housing 632. For example, the optional keyed feature 671 of the clasp control tube 648 may include a wire welded to an outer surface of the clasp control tube 648 (see FIG. 69). In such implementations, one or more portions of the axial pathway defined by the handle for the clasp control tube 648 may include corresponding grooves configured to receive the wires and provide a pathway through which the wires may slide. The optional keyed features 671, 675 may enhance stabilization of the clasp control member 628 by preventing or inhibiting rotation or twisting of the clasp control tube 648 within the handle 616. For example, the optional keyed features 671, 675 may prevent or inhibit rotation or twisting of the clasp control tube 648 within the handle 616 when a control line is pulled by and / or through the clasp control tube 648 to release the clasp.

[0221] The suture lock can take a variety of forms. In the example depicted in FIG. 78, the suture lock 650 includes a post 658, a suture lock body 660, and a suture lock body receptacle 662. In the illustrated example, the suture lock body 660 has external threads 665 that engage with internal threads 667 of the suture lock body receptacle 662, thereby connecting the suture lock body and the suture lock body receptacle together. The suture lock body 660 includes a central bore that extends from a first end to a second end of the suture lock body 660. In some implementations, the central bore of the suture lock body 660 has a diameter that varies from the first end to the second end of the suture lock body 660. At least a portion of the central bore is sized to receive the post 658. Thus, the diameter of the central hole of the suture lock body 660 can vary to form a flange to limit the position of the post 658 within the hole of the suture lock body 660 while still allowing the post 658 to be inserted into the first end of the suture lock body 660.

[0222] In some implementations, the suture lock body receptacle 662 includes a central bore extending from a first end to a second end of the suture lock body receptacle 662. The central bore of the suture lock body receptacle 662 is sized to receive the suture lock body 660 at the threaded end of the suture lock body receptacle 662 and is sized to receive and attach to the clasp control tube 648 at the second end of the suture lock body receptacle 662. An optional seal member or O-ring 664 is positioned around the suture lock body 660 and forms a fluid-tight seal between the suture lock body 660 and the suture lock body receptacle 662.

[0223] In some implementations, the clasp drive line 624 is fixed at one end of the clasp drive line 624 to a post 658 that is inserted into the suture lock body 660, thereby coupling the clasp drive line 624 to the suture lock body 660. In some implementations, the clasp drive line 624 can be welded, glued, or otherwise fixedly coupled to the post 658.

[0224] In some implementations, the clasp drive line 624 extends through a central lumen of the suture lock body 660, through a central lumen of the suture lock body receptacle 662, and through a clasp control tube 648. The clasp control tube 648 guides the clasp drive line 624 through the interior of the handle 616 and protects the clasp drive line 624. The clasp drive 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 implant catheter assembly 610. As described herein, the clasp drive line 624 exits the outer shaft 611 at the distal end of the outer shaft and is coupled to the device, such as by passing through one or more holes 235 in the clasp 130 (see, e.g., FIGS. 66 and 67). The clasp drive line 624 is then passed back through the outer shaft 611 from the distal end to the proximal end and through the clasp control tube 648 to form a loop within the clasp drive line 624 extending from the distal end of the outer shaft 611. The clasp drive line 624 is then routed out of the clasp control tube 648, between the suture lock body 660 and the suture lock body receptacle 662, and out of the central lumen of the suture lock body receptacle 662. The threaded connections 665, 667 between the suture lock body 660 and the suture lock body receptacle 662 allow the clasp drive line 624 to be clamped in position between the tapered nose 679 of the suture lock body 660 and the reduced diameter passage 681 of the suture lock body receptacle 662. Tightening the threaded connections 665, 667 also compresses a seal, such as an O-ring, between the suture lock body 660 and the suture lock body receptacle 662, thereby forming a fluid-tight seal between the suture lock body 660 and the suture lock body receptacle 662.

[0225] In some implementations, an optional spacer or fixation member can be used to position the clasp control tube 648 and / or the suture lock 650 when the effective length of the clasp drive line 624 is set. That is, the optional spacer or fixation member sets the proper position of the clasp drive line 624 corresponding to the clasp being in the closed position. The clasp drive line 624 can then be pulled with the clasp in the open position, and the suture lock 650 can be tightened to secure the clasp drive line 624 relative to the clasp control tube 648. The optional spacer or fixation member can take a variety of different forms. Any device that sets the position of the control tube 648 and / or the suture lock 650 relative to the handle body can be used.

[0226] 71A, an exemplary clasp set spacer 696 is shown supporting the clasp control tube 648 and suture lock 650 for each clasp in a corresponding groove 698 when the threaded connection between the suture lock body and the suture lock receptacle is tightened. Each groove 698 of the clasp set spacer 696 is sized to receive at least a portion of the clasp control tube 648 and / or the suture lock 650. The clasp set spacer 696 may also include a handle support end 800 configured to couple to and support the handle 616. In some implementations, the handle support end 800 may include a groove configured to receive a protrusion on a surface of the handle 616, thereby allowing the clasp set spacer 696 to couple to the handle 616.

[0227] 71A, the clasp setting spacer 696 can include a pair or pairs of optional feet 802. The pair of feet 802 support the handle 616, clasp control tube 648, and suture lock 650 by interacting with a surface against which the handle rests during clasp setting.

[0228] In some implementations, the clasp set spacer 696 has a length that extends between the handle support end 800 and the proximal end 804 of the clasp set spacer 696. Although the length of the clasp set spacer 696 can vary, in some implementations, the length of the clasp set spacer 696 is selected to provide a predetermined distance between the suture lock and the proximal end of the handle 616. Thus, in use, the clasp set spacer 696 receives the clasp control tube 648 and the suture lock 650 and secures them in a predetermined position relative to the handle 616 such that the path distance of the clasp control lines is constant when the clasp control lines are secured in place between the suture lock body and the suture lock receptacle. This ensures that the clasp control lines are long enough to allow the clasps to move through their full range of motion without being too long.

[0229] In some implementations, to release the clasp from the clasp drive line, the suture lock body 660 can be removed (e.g., by unscrewing) from the suture lock body receptacle 662, thereby releasing the end of the clasp drive line 624 that is sandwiched between the suture lock body 660 and the suture lock body receptacle 662. After the clasp drive line 624 is released, the clasp drive line can be pulled through the clasp control tube 648, through the outer shaft 611, through the hole 235 in the clasp, and back through the outer shaft 611 and through the clasp control tube 648. Thus, the clasp drive line 624 is no longer connected to the clasp and has been removed from the patient.

[0230] 69 , in some implementations, when the clasp control member 628 is actuated proximally, the clasp control tube 648 is also actuated proximally, thereby pushing the suture lock 650 proximally relative to the handle 616. When the suture lock 650 is actuated proximally, the loop of the clasp drive line 624 extending from the distal end of the outer shaft 611 is actuated proximally, thereby pulling the clasp 130. To release the clasp 130, such as to grasp a leaflet, the clasp control member 628 is driven distally, which in turn drives the clasp control tube 648 and the suture lock 650 distally, which in turn drives the loop of the clasp drive line 624 distally, thereby enabling the clasp 130 to move toward the inner paddle 122 and grasp a leaflet between the clasp 130 and the inner paddle 122.

[0231] As mentioned above, in some implementations, the handle 616 can further include a control member or knob 626 that can be configured to rotate about an axis of the handle 616, and the control member or knob 626 can be configured to control the position of the drive member 112 relative to the handle 616 and the outer shaft 611. As can be seen in the example of FIGS. 69-71, the knob 626 is fixedly coupled to an internally threaded tube 652 positioned within a housing 632 of the handle 616. When the knob 626 is rotationally driven about the axis of the handle 616, the internally threaded tube 652 rotates relative 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 is rotatably fixed relative to the housing 632. The externally threaded nut or retractor 654 can be rotatably secured in a variety of different manners. In the example illustrated in FIG. 70, a pair of guide rods 661 extend axially within the handle 616, with each of the pair of guide rods 661 fixed to the housing 632 at opposite ends of the guide rods 661. A mounting bracket 663 couples the pair of guide rods 661 to the housing 632 at a distal end of each of the pair of guide rods 661. Thus, when the internally threaded tube 652 is rotationally driven, the externally threaded retractor 654 is linearly driven axially (i.e., distally and proximally) forward along the pair of guide rods 661.

[0232] In some implementations, the externally threaded retractor 654 is connected to the drive member 112 such that linear movement of the externally threaded retractor 654 causes linear movement of the drive member 112 to drive the device between a fully extended configuration, an open configuration, and a closed configuration, as described herein. Translating the rotational drive of the knob 626 into linear movement of the drive member 112 provides greater control and precision, which in turn provides greater accuracy in opening and closing the device.

[0233] In some implementations, the internally threaded tube 652 includes a non-threaded portion 657. A clutch spring 656 is positioned around the non-threaded proximal portion 659 of the retractor 654. The clutch spring presses against a proximal end face 655 of the threaded portion of the retractor 654. Proximal movement of the drive member 112 after occlusion of the device 604 can result in over-occlusion or compression of the valve repair device. The location of the non-threaded portion 657 is selected to prevent or inhibit over-retraction of the drive member 112, thereby preventing or inhibiting over-occlusion 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 non-threaded 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 reaches the end of the threads of the internally threaded tube 652. Continued rotational driving of the knob 626 after the external threads of the externally threaded retractor 654 disengage from the internal threads of the internally threaded tube 652 provides an audible indication that the device is in the occluded position. Biasing the externally threaded retractor 654 can also reduce tilt in the threaded connection, thereby improving the stability of the paddle angle. Biasing the externally threaded retractor 654 toward 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 the opposite direction corresponding to the advancement of the drive member 112.

[0234] As shown in FIGS. 70, 70A, and 71, in some implementations, the externally threaded retractor 654 can include a central passage 683. A crimp assembly 668 is coupled within the central passage 683. The crimp assembly attaches the drive member 112, which is within the drive tube 669, to the paddle release knob 630. The crimp assembly 668 can take a variety of different forms. In the illustrated example, the crimp assembly 668 includes a collet 687 and a nut 670. The collet 687 includes external threads and the nut includes internal threads. The collet and the nut each have a central bore sized to receive the drive tube 669, which surrounds the drive member 112. The drive member 112 can be fixed relative to the drive tube 669 near a proximal end of the drive tube 669. The drive tube 669 is fixed relative to the crimp assembly 668, which is fixed relative to the externally threaded retractor 654. External threads on the exterior of collet 687 mate with internal threads of nut 670. When tightened, collet 687 and nut 670 secure the crimp assembly against both the drive tube 669 and a shoulder 689 at the proximal end of retractor 654. The nut is positioned within a central passage 683 of externally threaded retractor 654. A spring 672 is also positioned within a central passage 683 of externally threaded retractor 654 such that nut 670 is biased against shoulder 689. Positioning nut 670 against shoulder 689 allows collet 687 to be easily attached to nut 670.

[0235] In some implementations, in use, the knob 626 is rotationally driven, which in turn drives the internally threaded tube 652 relative to the housing 632, which in turn drives the externally threaded retractor 654 axially. Axial movement of the externally threaded retractor 654 causes axial movement of the drive member 112, which drives the device between a fully extended configuration, an open configuration, and an occluded 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 FIG. 74 ) and a distal or retracted position (shown in FIG. 73 ). Thus, in some implementations, the axial position of the release knob 630 relative to the housing 632 is a visual indicator of the configuration of the device 604.

[0236] In some implementations, when the device 604 is in an occluded configuration (e.g., as shown in FIG. 21 ), the release knob 630 is in a proximal position extended from the housing 632, as shown in FIG. 74 . To remove the device from the implant catheter assembly 610, the release knob 630 is rotationally driven in an unscrewing or loosening direction, which rotates the crimp assembly 668, the drive tube 669, and the drive member 112. Rotating the drive member 112 extends the length of the drive member to the distal end portion 112b of the drive member, which unscrewing the drive member 112 from the cap 114 of the device 604.

[0237] As shown in FIGS. 75-77, in some implementations, the release knob 630 includes an elongated shaft 673 and a number of teeth 674 extending from an outer surface of the elongated shaft 673. Each of the teeth 674 is uniform, but asymmetrical in shape, with each of the teeth 674 having a moderate slope on one edge and a much steeper slope on the other edge. A ratchet insert 676 is positioned within the housing 632 of the handle 616 between the elongated shaft 673 and the housing 632. The ratchet insert 676 includes one or more pawls 678 flexibly attached to a ratchet frame 680. In some implementations, the pawls 678 and the ratchet frame 680 are formed from a unitary member of a material that allows the pawls 678 to flex relative to the ratchet frame 680.

[0238] In some implementations, each of the pawls 678 contacts the outer surface of the elongate shaft 673. Thus, when the release knob 630 is rotated in an unscrewing or loosening direction, each pawl 678 slides over the edge of the moderately sloped tooth 674 and springs back into the area between the tooth and the adjacent tooth. In some implementations, the springback of the pawl into the area between the teeth creates an audible indication that the tooth has been passed. The steeper sloped edge of the tooth 674 captures the pawl 678, thereby preventing or preventing the release knob 630 from being rotated in the reverse tightening direction. By allowing the release knob 630 to be rotated in a single direction, twist that may accumulate as a result of the drive member 112 being twisted when the device 604 is released is prevented or prevented from unwinding the release knob 630 in the tightening direction.

[0239] After the drive member 112 is decoupled from the device 604, the drive member 112 can be retracted into the implant catheter assembly 610, which can be retracted through the steerable catheter assembly 608 and through the delivery catheter assembly 606.

[0240] Although not shown in the drawings, in some implementations a cap may be removably coupled to the proximal end of the handle and cover the release knob 630 and the suture lock 650. The cap may thus be positioned over the release knob 630 and the suture lock 650 to prevent or inhibit the release knob 630 and the suture lock 650 from accidentally contacting or catching on anything during operation of the implantable device, and may be removed to provide access to the release knob 630 and the suture lock 650.

[0241] In some implementations, one or more components of the delivery system can be coupled to a stabilization system to further improve control of the delivery system during delivery and implantation of the implantable device. As will be described in more detail, the stabilization system generally includes one or more clamps that are slidable relative to a base plate that can be fixed relative to the patient. One or more components of the delivery system (e.g., one or more catheter assemblies) are received by the one or more clamps to limit movement of the delivery system or one or more components of the delivery system (e.g., catheter assemblies, etc.) in one or more directions. For example, the stabilization system can prevent or inhibit the delivery system or one or more components of the delivery system from moving vertically and laterally while allowing the delivery system or one or more components of the delivery system to move axially. In some implementations, the clamps receive nose grips on one or more catheter assemblies of the delivery system.

[0242] 79-81, an exemplary nosegrip 634 is shown in additional detail. In FIG. 79, the nosegrip 634 extends between a distal flange 636 and a proximal flange 682. Although the examples shown in FIG. 79 and FIG. 81 include a proximal flange 682, it is contemplated that some implementations may not include the proximal flange 682, as shown in FIG. 82A and FIG. 85A. Thus, the proximal flange 682 is optional. As can be seen from FIG. 82A-84, the nosegrip 634 is coupled at its proximal end to a catheter handle, such as the handle 614 of the steerable catheter assembly 608 or the handle 616 of the implant catheter assembly 610. A passageway 684 extends through the nosegrip 634 from the proximal end to the distal end to allow a corresponding catheter sheath 609, 611 to pass through the nosegrip 634.

[0243] In some implementations, the nose grip 634 is formed from or has an exterior surface coated with a rubber or other material having a relatively high coefficient of friction to prevent the nose grip 634 from slipping when coupled to a clamp 685, such as may be incorporated into the stabilizing member. However, in some implementations, the material has a coefficient of friction that allows the nose grip 634 to rotate about an axis when coupled to the clamp 685, thereby allowing the handle to be rotated during the procedure to rotatably position the implantable device. As shown in FIG. 80, the clamp 685 generally includes a pair of jaws 686 that form an opening 688 configured to receive the nose grip 634. In some implementations, the pair of jaws 686 are coupled together via a spring 690, which biases the pair of jaws 686 toward each other while allowing the jaws 686 to open with the application of an opening force to position the nose grip 634 into or remove the nose grip 634 from the opening 688 (as shown in FIG. 80). U.S. Provisional Patent Application Serial No. 63 / 073,392, filed September 1, 2020, discloses examples of clamps that may be used as the clamp 685, as well as examples of stabilization systems and devices that may be used with the systems and devices herein. U.S. Provisional Patent Application Serial No. 63 / 073,392 is incorporated herein by reference for all purposes. Any of the devices, methods, etc. may be used in any implementation or example disclosed in this application.

[0244] 80-81, nose grip 634 is received in opening 688 between jaws 686 with distal flange 636 and proximal flange 682 disposed outside of jaws 686. Distal flange 636 has an outer diameter that is larger than the outer diameter of a central portion of nose grip 634 (e.g., the portion of the nose grip located between the distal and proximal flanges) and larger than the diameter of the opening in clamp 685, thereby preventing or inhibiting nose grip 634 from being unintentionally pulled out of clamp 685 and from being unintentionally rotated relative to clamp 685.

[0245] 82A-C illustrate an exemplary nose grip 634a in conjunction with a handle 614 of a steerable catheter assembly coupled to a clamp 685. In FIGS. 82A-C, the clamp 685 includes a movable jaw 686a and a fixed jaw 686b. The clamp 685 is opened and closed by pivoting the movable jaw 686a relative to the fixed jaw 686b. The movable jaw 686a is spring biased toward the fixed jaw 686b such that the clamp 685 remains in a closed state unless opened by application of an opening force to the movable jaw 686a as shown by arrow 691 in FIG. 82A. The nose grip 634a is positioned within the opening of the clamp 685 while the clamp is open. Referring to FIG. 62B, once the opening force 691 is removed from the movable jaw 686a, the clamp 685 closes and applies a clamp closing force to the nose grip 634a. In some implementations, the occlusion force applied by clamp 685 is sufficient to stabilize and prevent unintentional rotation of nose grip 634a, and thus handle 614 and corresponding sheath 609. However, intentional rotation of handle 614, as indicated by the rotation arrow in FIG. 82B, can apply a rotational force to nose grip 634a sufficient to overcome the occlusion force, thereby allowing handle 614 to rotate.

[0246] In some implementations, the clamp 685 is coupled to the base plate 693 via one or more mounting rails 694 extending from the base plate 693. U.S. Provisional Patent Application Serial No. 63 / 073,392 discloses examples of base plates and mounting rails that may be used as the base plate 693 and the mounting rails 694, and U.S. Provisional Patent Application Serial No. 63 / 073,392 is incorporated herein by reference for all purposes. In some implementations, the one or more mounting rails 694 extend axially (e.g., proximally and distally) along the base plate 693 and allow the clamp 685 to move axially. In some implementations, the clamp 685 is configured to slide relative to the mounting rails 694, thereby allowing axial movement of the clamp 685, and thus the steerable catheter assembly, when the nose grip 634a is positioned within an opening in the clamp 685. The locking knob 692 is rotatable between a first, locked position (shown in FIGS. 82A and 82B) and a second, unlocked position (shown in FIG. 82C) to hold the clamp 685 in a desired position along the mounting rail 694.

[0247] In some implementations, the lock knob 692 is connected to a rotating cam portion (not shown) that is rotated by driving the lock knob 692 in rotation. When the rotating cam portion rotates, an oblong portion of the rotating cam portion engages a lock foot (not shown), which moves the lock foot downward to an extended position, which moves the carriage upward relative to the mounting rail 694. Friction between the carriage and the mounting rail 694 holds the clamp 685 in the desired position. To reposition the clamp 685, the lock knob 692 is driven in rotation to disengage the lock foot, allowing the clamp 685 to slide along the mounting rail 694, as shown in FIG. 82C.

[0248] 83A-C illustrate an exemplary nose grip 634b in conjunction with the handle 616 of an implant catheter assembly coupled to a clamp 685. In FIGS. 83A-C, the clamp 685 includes a movable jaw 686a and a fixed jaw 686b. The clamp 685 is opened and closed by pivoting the movable jaw 686a relative to the fixed jaw 686b. The movable jaw 686a is spring biased toward the fixed jaw 686b such that the clamp 685 remains in a closed state unless opened by application of an opening force to the movable jaw 686a as shown by arrow 691 in FIG. 83B. The nose grip 634a is positioned within the open clamp. Once the opening force is removed from the movable jaw 686a, the clamp 685 closes and applies a clamping force to the nose grip 634a as shown in FIG. 83C. In some implementations, the occlusion force applied by clamp 685 is sufficient to stabilize and prevent unintentional rotation of nose grip 634a, and thus handle 616 and corresponding sheath 611. However, intentional rotation of handle 616, as shown by the rotation arrow in FIG. 83C, can apply a rotational force to nose grip 634a sufficient to overcome the occlusion force, thereby allowing handle 616 to rotate.

[0249] Similar to the above examples, the clamp 685 can be coupled to the base plate 693 via one or more mounting rails 694 extending from the base plate 693. In some implementations, the one or more mounting rails 694 extend axially (e.g., proximally and distally) along the base plate 693 and allow the clamp 685 to move axially. The clamp 685 is configured to slide relative to the mounting rails 694, thereby allowing axial movement of the clamp 685, and thus the implant catheter assembly, when the nose grip 634a is positioned within an opening in the clamp 685. The locking knob 692 is rotatable between a first locked position and a second unlocked position (shown in FIGS. 83B-C) to hold the clamp 685 in a desired position along the mounting rails 694.

[0250] In some implementations, the lock knob 692 is connected to a rotating cam portion (not shown) that is rotated by driving the lock knob 692 in rotation. When the rotating cam portion rotates, an oblong portion of the rotating cam portion engages a locking foot (not shown), which moves the locking foot downward to an extended position, which moves the carriage upward relative to the mounting rail 694. Friction between the carriage and the mounting rail 694 holds the clamp 685 in the desired position. To reposition the clamp 685, the lock knob 692 is driven in rotation to disengage the locking foot, allowing the clamp 685 to slide along the mounting rail 694.

[0251] FIG. 84 illustrates a portion of a stabilization system for stabilizing a system or assembly (e.g., a valve treatment system or assembly) such as the system or assembly 600 of FIGS. 64-65. For example, FIG. 84 illustrates a handle 616 and sheath 611 of a catheter assembly (e.g., an implant catheter assembly 610) that is received by a proximal end of a handle 614 of another catheter assembly (e.g., a steerable catheter assembly 608). Although only one catheter assembly (e.g., an implant catheter assembly) is shown as being coupled to the stabilization system, it will be understood that the handle 614 of the other catheter assembly (e.g., a steerable catheter assembly) may also be coupled to a clamp (not shown), e.g., via a nose grip, such as nose grip 634a. Moreover, it will be understood that the system or assembly may further include one or more additional catheter assemblies (e.g., a delivery catheter assembly 606) that may also be coupled to a clamp (not shown), e.g., via a nose grip or via other attachment points or the like.

[0252] In some implementations, the sheath 611 can be introduced into the handle 614 of the steerable catheter assembly and extended through the handle into the sheath 609 of the steerable catheter assembly as described herein above. In some implementations, the sheath 611 has a frictional engagement within the handle 614, within the sheath 609, or within both. As shown in FIG. 84 , the locking knob 692 of the clamp 685 coupled to the nose grip 634 is positioned in an unlocked position, which allows axial movement of the implant catheter assembly relative to the base plate 693. Thus, when the locking knob of the clamp coupled to the nose grip 634 of the handle 614 is in the unlocked position, axial movement of the implant catheter assembly handle 616 can also cause axial movement of the steerable catheter assembly handle 614 and axial movement of the implant catheter assembly handle 616 relative to the base plate 693. However, when the lock knob of the clamp coupled to the nose grip 634 of the handle 614 is in the locked position, axial movement of the handle 616 of the implant catheter assembly can cause axial movement of the handle 616 of the implant catheter assembly relative to the handle 614 of the steerable catheter assembly and relative to the base plate 693.

[0253] As described herein, the nose grip 634 can be incorporated into the handles 614, 616 for the steerable and implant catheter assemblies in the delivery system. It is further contemplated that in some implementations, any one or more of the catheter assemblies included in the delivery system can include a nose grip 634 to enable coupling of the catheter assembly to a stabilization system. Moreover, in some implementations in which multiple catheter assemblies in a delivery system include a nose grip 634, it is contemplated that the nose grip 634 can be the same for each catheter assembly or can be different between the catheter assemblies. For example, FIGS. 85A and 85B illustrate nose grips 634a and 634b, as described herein above. As shown in FIG. 85A, the nose grip 634a described herein as being incorporated into the handle 614 of a steerable catheter assembly does not include a proximal flange, while the nose grip 634b (FIG. 85B) described herein as being incorporated into the handle 616 of an implant catheter assembly includes both a distal flange 636 and a proximal flange 682.

[0254] In some implementations, the nose grip 634a has an outer diameter OD1 and the nose grip 634b has an outer diameter OD2. In some implementations, the outer diameter OD1 is equal to the outer diameter OD2. In some implementations, the outer diameter OD1 is different from the outer diameter OD2. For example, the outer diameter OD1 can be larger than the outer diameter OD2, or the outer diameter OD1 can be smaller than the outer diameter OD2. The difference in the outer diameters OD1, OD2 can enable a different tactile feel, for example, during rotation of the steerable catheter assembly compared to rotation of the implant catheter assembly. In some implementations, the outer diameter OD1 of the nose grip 634a of the steerable catheter assembly is larger than the outer diameter OD2 of the nose grip 634b of the implant catheter assembly, which can provide additional friction between the nose grip 634a and the opening 688 of the clamp 685 compared to the amount of friction between the nose grip 634b and the opening 688 of the clamp 685. This can give the user the feeling that it is easier to rotate the implant catheter assembly and implant compared to rotating a steerable catheter assembly within a guide sheath or delivery catheter assembly.

[0255] Although the stabilization system can be effective in stabilizing the delivery system at a proximal position, in some implementations, one or more catheter assemblies include features to further improve the accuracy of delivery of the implantable device. For example, movement of the implant catheter assembly through or within the steerable catheter assembly (e.g., rotation of the implant catheter shaft to properly orient the implantable device) can change the trajectory of the steerable catheter sheath, thereby changing the position of the implantable device coupled to the implant catheter assembly. Thus, in some implementations, features can be implemented to reduce friction between the implant catheter shaft and the steerable catheter shaft, or to stiffen the proximal portion of the steerable catheter sheath and / or the implant catheter shaft, or both.

[0256] 86 and 87, a shaft or sheath 611 of a catheter assembly, such as, for example, an implant catheter assembly 610, is shown having a portion of the shaft or sheath 611 having a reduced outer diameter portion 703. In particular, FIG. 86 shows a cross section of a shaft or sheath 611 of a catheter assembly, such as, for example, an implant catheter assembly 610, extending through a shaft or sheath 609 of another catheter assembly, such as, for example, a steerable catheter assembly 608. Although described in the context of a particular type of catheter assembly for purposes of illustration, similar features and principles may be applied in a variety of catheter assemblies.

[0257] Figure 87 shows the shaft or sheath 611 of the implant catheter assembly 610 extending from the shaft or sheath 609 of the steerable catheter assembly 608. As shown in Figure 86, the shaft or sheath 609 of the steerable catheter assembly 608 has an inner diameter ID1 through which the shaft or sheath 611 of the implant catheter assembly 611 extends. The sheath 609 of the steerable catheter assembly 608 includes a steerable portion having a length L1 over which the sheath 609 of the steerable catheter assembly 608 can bend or deform, as described in more detail above.

[0258] In some implementations, the outer shaft or sheath 611 of the implant catheter assembly 610 includes a lumen through which the drive member 112 (which may be the same or similar to other drive members herein) extends, as described in more detail above. The drive member 112 extends axially through the lumen of the sheath or shaft 611 of the implant catheter assembly 610. In some implementations, the sheath or shaft 611 of the implant catheter assembly has a portion having a first outer diameter OD1. In some implementations, the portion having the first outer diameter OD1 extends distally from the handle 616 (FIG. 66) to a reduced diameter portion 703 having a second outer diameter OD2, although this portion may extend a shorter distance in some implementations (e.g., may not extend all the way to the handle). The reduced diameter portion 703 is typically proximate to the distal end of the sheath 611 of the implant catheter assembly 610. The second outer diameter OD2 is smaller than the first outer diameter OD1 of the sheath of the implant catheter assembly.

[0259] In some implementations, the portion of the sheath 611 of the implant catheter assembly 610 having the first outer diameter OD1 has a greater length compared to the length L2 of the reduced diameter portion 703 having the second outer diameter OD2. The length L2 of the reduced diameter portion 703 is greater than the length L1 of the steerable portion of the sheath of the steerable catheter assembly 608. Although the length L2 of the reduced diameter portion 703 can vary, in some implementations, the length L2 is greater than or equal to the sum of the stroke distance (i.e., the distance that the sheath or shaft 611 of the implant catheter assembly 610 extends from the sheath or shaft 609 of the steerable catheter assembly 608 during delivery of the implantable device) and the length L1 of the steerable portion of the sheath or shaft 609 of the steerable catheter assembly 608. Thus, the system can be manipulated such that, during use of the implant catheter assembly 610 and the steerable catheter assembly 608 to position and implant the implant or valve repair device 604, only the reduced diameter portion 703 of the sheath or shaft 611 is located within the steerable portion of the sheath or shaft 609. The sheath or shaft 611 of the implant catheter assembly 610 can have a reduced outer diameter along the entire length of the sheath or shaft 611 that will be located within the steerable portion of the sheath 609 of the steerable catheter assembly 608, including when the sheath or shaft 611 of the implant catheter assembly is retracted and extended relative to the steerable catheter assembly 608, as shown in FIGS.

[0260] The difference between the first outer diameter OD1 and the second outer diameter OD2 may vary depending on the particular implementation, and may be, for example, about 0.25 mm to about 0.76 mm, or any range between 0.25 mm and 0.76 mm. In some implementations, the transition from the first outer diameter OD1 to the second outer diameter OD2 may be gradual and form a smooth taper from the first outer diameter OD1 to the second outer diameter OD2 over a distance of about 25 mm to about 50 mm. In some implementations, one or more discrete steps are defined from the first outer diameter OD1 to the second outer diameter OD2. Moreover, as shown in FIG. 86 and FIG. 87, the sheath or shaft 611 of the implant catheter assembly 610 transitions from the first outer diameter OD1 to the second outer diameter OD2 and back to the first outer diameter OD1 along the length of the sheath or shaft 611 of the implant catheter assembly 610 such that the portion having the second outer diameter OD1 is located between two portions of the implant catheter assembly having the first outer diameter OD1.

[0261] In some implementations, both outer diameters OD1 and OD2 are smaller than the inner diameter ID1 of the sheath 609 of the steerable catheter assembly 608, and as described above, the sheath 611 of the implant catheter assembly 610 has a second outer diameter OD2 along the length L1 of the steerable portion of the sheath 609 of the steerable catheter assembly 608. The reduced outer diameter OD2 of the sheath 611 of the implant catheter assembly 610 through the steerable portion of the sheath 609 of the steerable catheter assembly 608 may reduce friction between the steerable catheter sheath 609 and the implant catheter sheath 611, reducing crosstalk between the steerable catheter sheath 609 and the implant catheter sheath 611 (e.g., unintended bending of the steerable catheter sheath 609 and the implant catheter sheath 611 due to friction therebetween) and reducing the need for reorientation of the steerable catheter assembly during positioning of the implant.

[0262] As an alternative to decreasing the outer diameter of the implant catheter assembly sheath over the steerable length, it is contemplated that in some implementations, the inner diameter of the steerable catheter assembly sheath may be increased over the length L1 while the outer diameter of the implant catheter assembly sheath remains constant. The inner diameter of the bending portion of the sheath 609 may be increased by an amount of about 0.25 mm to about 0.76 mm (or any subrange therein) and / or the transition from the first inner diameter to the second inner diameter may be made over a distance of about 25 mm to about 50 mm. Moreover, in some implementations, both increasing the inner diameter of the steerable catheter assembly sheath and decreasing the outer diameter of the implant catheter assembly sheath may reduce friction between the steerable catheter assembly and the implant catheter assembly through the steerable portion.

[0263] Friction can additionally or alternatively be reduced between the implant catheter shaft and the steerable catheter sheath by the use of a lubricious coating 700, as shown in FIGS. 86 and 87. The lubricious coating can take a wide variety of different forms. The coating can be a wet coating or a dry coating, or can include both wet and dry components. In FIGS. 86 and 87, the lubricious coating 700 is applied to an outer surface of a reduced diameter portion 703 having a second outer diameter OD2 of the sheath 611 of the implant catheter assembly 610. However, it is contemplated that some implementations may include the lubricious coating 700 over a length of the sheath of the implant catheter assembly having a substantially constant outer diameter. Alternatively or additionally, the lubricious coating 700 can be applied to an inner surface of a length L1 of the steerable portion of the sheath 609 of the steerable catheter assembly 608. Moreover, although illustrated in Figures 86 and 87 as being included only along length L2, it is envisioned that the coating may be applied along any additional lengths of the sheath 611 of the implant catheter assembly 610 or the sheath 609 of the steerable catheter assembly 608.

[0264] The lubricious coating 700 can be a coating made from a wide variety of different materials. Any material that reduces friction can be used. The lubricious coating 700 can be, for example, a coating made from silicone oil, a hydrophilic material, or other material with a low coefficient of friction, such as perfluoropolyether (PFPE) or expanded polytetrafluoroethylene (ePTFE). Thus, the lubricious coating 700 can include hydrophilic coatings, coatings of PFPE lubricants, and ePTFE sleeves, such as coatings made from materials commercially available under the trade names CHRISTO-LUBE® (available from Engineered Custom Lubricants) and SURMODICS SERENE® (available from SURMODICS, Inc.).

[0265] In some implementations, the lubricious coating 700 reduces the coefficient of friction between the outer surface of the sheath 611 of the implant catheter 610 and the inner surface of the sheath 609 of the steerable catheter assembly 608 through the steerable portion of the sheath 609 of the steerable catheter assembly 608. This reduction in friction can reduce crosstalk between the steerable catheter sheath 609 and the implant catheter sheath 611 (e.g., unintended bending in the steerable catheter sheath 609 and the implant catheter sheath 611 due to friction therebetween) and can reduce the need to reorient the steerable catheter sheath during implant orientation.

[0266] Alternatively or additionally, friction between the steerable catheter sheath 609 and the implant catheter sheath 611 can be reduced by using a liner (e.g., a lubricious liner) within the lumen of the steerable catheter sheath 609. In some implementations, such a liner is formed from polyamide doped with PTFE powder. The PTFE powder can be incorporated into the molten polyamide in an amount of about 5% to about 30% by weight, depending on the particular implementation. For example, the PTFE powder can be incorporated into the polyamide in an amount of about 5% to about 30% by weight, about 5% to about 25% by weight, about 5% to about 20% by weight, about 5% to about 15% by weight, about 7.5% to about 30% by weight, about 7.5% to about 25% by weight, about 7.5% to about 20% by weight, about 7.5% to about 15% by weight, about 10% to about 30% by weight, about 10% to about 25% by weight, about 10% to about 20% by weight, or about 10% to about 15% by weight, or any range and subrange therein.

[0267] The polyamide can be a variety of different polyamides. In some implementations, the polyamide is nylon 6,6, nylon 6,12, nylon 4,6, nylon 6, nylon 12, or combinations thereof. In some implementations, the polyamide has a Shore D hardness of 70D or greater. For example, the polyamide can have a Shore D hardness of 70D or greater, 75D or greater, 80D or greater, or 85D or greater. According to various implementations, the PTFE-doped polyamide liner can exhibit a lower coefficient of friction as compared to an otherwise identical polyamide liner, and also exhibit improved adhesion to a polymer jacket (e.g., a PEBAX or nylon polymer jacket) bonded to the outer surface of the polymer liner. The PTFE-doped polyamide liner can define an inner surface of one or more lumens of a guide sheath, a steerable catheter, and / or an implant catheter in a delivery assembly described herein or in any other delivery assembly.

[0268] According to some implementations, the inner diameter ID1 of the sheath 609 of the steerable catheter assembly 608 varies along the length of the sheath 609, and more particularly, may have a larger inner diameter at or near both ends of the sheath 609 as compared to an inner diameter located toward the middle of the length of the sheath 609. For example, in some implementations, the inner diameter ID1 of the sheath 609 of the steerable catheter assembly 608 is flared at one or both of the proximal and distal ends of the sheath. The flared inner diameter ID1 of the sheath 609 is effective to create a smooth transition between the outer diameter of the sheath 611 of the implant catheter assembly 610 and the outer diameter of the sheath 609 of the steerable catheter assembly 608, thereby reducing the amount of coating (e.g., lubricious coating 700) scraped off the outer surface of the implant catheter sheath 611 by the inner surface of the sheath 609 of the steerable catheter assembly 608.

[0269] As mentioned above, another method for improving delivery accuracy of an implantable device includes stiffening the proximal portion of the sheath 609 of the steerable catheter assembly 608 (as shown in FIG. 89A), the sheath 611 of the implant catheter assembly 610 (as shown in FIG. 89B), or both (as shown in FIG. 89C). It is believed that stiffening the proximal portion of the sheath of the catheter assembly can reduce torsional deformation, which may reduce the delay between rotation of the implant catheter handle and rotation of the implant, reduce out-of-plane movement of the sheath of the steerable catheter assembly, or both, depending on the sheath of the catheter assembly that is hardened.

[0270] 89A-C, a proximal portion 611a of the sheath or shaft 611 of the implant catheter assembly 610 is shown extending through a proximal portion 609a of the sheath 609 of the steerable catheter assembly 608, and a distal portion 611b of the sheath or shaft 611 of the implant catheter assembly 610 is shown extending through a distal portion 609b of the sheath 609 of the steerable catheter assembly 608. The proximal portion 611a of the sheath or shaft 611 of the implant catheter assembly 611, the proximal portion 609a of the sheath 609 of the steerable catheter assembly 608, or both, include a reinforcing material 701, while the distal portion 611b of the sheath 611 of the implant catheter assembly 610 and the distal portion 609b of the sheath 609 of the steerable catheter assembly 608 do not include a reinforcing material. Thus, the proximal portion of the sheath or shaft of the catheter assembly, including the reinforcing material 701, is reinforced as compared to the distal portion of the sheath or shaft of the catheter assembly.

[0271] The reinforcing material 701 can take a wide variety of different forms. The reinforcing material 701 can be, for example, a laser cut hypotube, a material having a greater durometer than the material in the distal portion of the sheath or shaft of the catheter assembly, one or more braids, one or more meshes, one or more woven materials, or the like. The reinforcing material 701 can be incorporated into the catheter sheath or into the shaft as one layer of a multi-layer sheath, as shown in Figures 89A-C. In the example illustrated in Figure 89A, the reinforcing material 701 is provided on the proximal portion 609a of the steerable catheter shaft or sheath 609. In the example illustrated in Figure 89B, the reinforcing material 701 is provided on the proximal portion 611a of the implant catheter shaft or sheath 611. In the example illustrated in FIG. 89C, reinforcing material 701 is provided on the proximal portion 609 a of the steerable catheter shaft or sheath 609 as well as on the proximal portion 611 a of the implant catheter shaft or sheath 611 .

[0272] FIG. 98 is another illustration of an exemplary implant catheter. As shown in FIG. 98, the implant catheter 611 includes a reinforcing material in the form of a braided, mesh, or woven material 704 and a laser cut hypotube 702 extending over the braided, mesh, or woven material 704. As discussed above, the laser cut hypotube 702 can have a variable or constant cut pattern along the length of the implant catheter 611. The braided, mesh, or woven material 704 can extend over a polymer layer 732 (e.g., a PEBA layer) that defines one or more lumens of the implant catheter 611. Although shown in FIG. 98 as including five lumens, it is envisioned that the polymer layer 732 can include one or more lumens depending on the particular implementation. The implant catheter illustrated in FIG. 98 also includes a polymer jacket 734 that can impart lubricity, stiffness, or other properties to the implant catheter 611. One or more additional layers may also be included in some implementations, including, but not limited to, a PTFE liner, a polymer layer, an adhesive layer, or the like.

[0273] 90 and 91 illustrate an example of a steerable catheter assembly 608. The steerable catheter assembly 608 includes a steerable portion 900 and a non-steerable portion 902. In some implementations, the stiffness of the sheath of the catheter assembly is determined by the length L of the sheath. NS. In general, the non-steerable portion is configured to have a greater stiffness at the proximal end than at the distal end. The stiffness of the non-steerable portion 902 can be varied in a variety of different manners. The variable stiffness non-steerable portion 902 can be used with any implementation disclosed herein or in a delivery system that does not include any other features disclosed herein. The variable stiffness non-steerable portion can be used in conjunction with a reduced outer diameter of the distal portion of the sheath or shaft 611 of the implant catheter assembly 610 and / or a low friction coating can be provided on the reduced outer diameter portion of the sheath or shaft 611 of the implant catheter assembly 610. Additionally, the sheath 607 of the guide sheath or catheter assembly 606 can include a variable stiffness steerable portion in addition to or in place of the variable stiffness non-steerable portion of the sheath or shaft of the steerable catheter assembly 608.

[0274] 90, in some implementations, when a non-steerable portion 902 of a sheath or shaft 609 of a steerable catheter assembly 608 has a variable stiffness, such as by incorporation of a laser cut hypotube, the variable stiffness portion can extend over any length of the non-steerable portion 902. Thus, in some implementations, the variable stiffness length of a sheath 609 of a steerable catheter assembly 608 may be a length L NS In some implementations, this stiffened length can include one or more stiffnesses.

[0275] Variable stiffness can be achieved in a variety of different ways. In the example illustrated in FIG. 91, variable stiffness can be achieved, for example, by using a first laser cut hypotube 702a along a first length of the sheath 609 of the catheter assembly 608 and a second laser cut hypotube 702b along a second length of the sheath 609 of the catheter assembly, where the first laser cut hypotube 702a and the second laser cut hypotube 702b have different stiffnesses. An exemplary catheter including one or more laser cut hypotubes is disclosed in PCT Application No. PCT / US2019 / 062194, filed November 19, 2019, and published as WO2020106705A1, which is incorporated herein by reference. Any of the features of the devices and systems disclosed in PCT Application No. PCT / US2019 / 062194 may be used with any of the implementations in this application.

[0276] In FIG. 91, a drive member such as a puller wire 714 extends along the sheath 609 of the steerable catheter assembly 608 (typically embedded within the sheath material) and through a compression coil 716 (also typically embedded within the sheath material). The compression coil 716 (along with the puller wire 714) extends along (either internally or externally) the first laser cut hypotube 702a and the second laser cut hypotube 702b. In some implementations, each of the first laser cut hypotube 702a and the second laser cut hypotube 702b is formed as a jacket that covers the compression coil 716. The compression coil 716 is fixed (e.g., welded or glued) to the first ring 718a. At the first ring 718a, the pull wire 714 exits from the distal end of the compression coil 716 and extends between the first ring 718a and the second ring 718b and is fixed (e.g., welded or glued) to the second ring 718b. In some implementations, the first ring 718a and the second ring 718b are located at opposite ends of a third laser cut hypotube 702c that has a bend pattern cut into it to bend the sheath 609 of the steerable catheter assembly 608 along the length of the third laser cut hypotube 702c. Thus, to steer the sheath of the steerable catheter assembly 608, the pull wire 714 is pulled proximally to drive the second ring 718b relative to the first ring 718a.

[0277] The sheath 609 of the steerable catheter assembly 608 shown in FIG. 92, or of other catheter assemblies, can also have variable stiffness. The proximal portion 701 of the sheath of the catheter assembly can include a laser cut hypotube positioned over a braid (or other mesh or woven material) that surrounds the tube or polymeric material that makes up the sheath 609 of the catheter assembly 608. The sheath 609 of the steerable catheter assembly 608 also includes a portion 704 where the laser cut hypotube is not present and the braid surrounds the tube, and a portion 706 where the tube is not covered by the laser cut hypotube or braid. Thus, the sheath 609 of the steerable catheter assembly 608 in FIG. 92 has at least three stiffnesses along its length, with each hypotube and braid adding stiffness to the tube 706.

[0278] 96A and 97, in some implementations, the sheath 609 includes an elongate intermediate section having a braided, mesh, or woven material 704 positioned within a laser cut hypotube 702. In some implementations, the braided, mesh, or woven material 704 and the laser cut hypotube 702 are embedded within a molten tube or polymer material 706 of the sheath 609. In the example illustrated in FIG. 97, the sheath 609 also includes a steerable section 900 having another laser cut hypotube 702c. The braided, mesh, or woven material 704 and the laser cut hypotube 702 are not contained within the steerable section 900. The laser cut hypotube 702c has a bend pattern cut into it to allow the sheath 609 to bend along the length of the third laser cut hypotube 702c. Thus, the pull wire 714 is pulled proximally to steer the sheath 609. Thus, in some implementations, the sheath 609 can include multiple layers selected to provide different properties (e.g., stiffness, lubricity, etc.) to the sheath 609 (or portions thereof), and these multiple layers can extend along different lengths of the sheath 609.

[0279] Referring to Fig. 93, in some implementations, the variable stiffness sections can be formed by a single laser cut hypotube 702 having variable stiffness along its length. Fig. 93 illustrates four segments (702d, 702e, 702f, 702g) of laser cut hypotube, each with a different cut pattern resulting in different stiffness in each section. In the illustrated example, the stiffness of the first segment 702d is greater than the stiffness of the second segment 702e, which is greater than the stiffness of the third segment 702f, which is greater than the stiffness of the fourth segment 702g. In the example of FIG. 93, the non-cut area of ​​the first segment 702d is greater than the non-cut area of ​​the second segment 702e, which is greater than the non-cut area of ​​the third segment 702f, which is greater than the non-cut area of ​​the fourth segment 702g.

[0280] The cut pattern of the laser cut hypotube can take a wide variety of different forms. In the example shown in FIG. 91, the first segment 702d has a pitch of about 0.05 inches, a 40 degree cut, and a 51 degree uncut. The second segment 702e has a pitch that transitions from about 0.05 inches to about 0.02 inches, with a cut degree transitioning from 40 degrees cut to 74 degrees cut and a uncut degree transitioning from 51 degrees uncut to 28.85 degrees uncut. The third segment 702f has a pitch of about 0.02 inches, a 74 degree cut, and a 28.85 degree uncut. The fourth segment 702g has a pitch that transitions from about 0.5 mm (0.02 inches) to about 0.1 mm (0.004 inches), a cut transition from 74° cut to 94° cut, and a non-cut transition from 28.85° non-cut to 8.85° non-cut. Although four segments are illustrated in FIG. 93, it will be understood that the laser cut hypotube may have any suitable number of segments having different stiffnesses. Additionally, it is contemplated that in some implementations the stiffness of the hypotube may decrease distally (as shown in the second and fourth segments 702e and 702g) without defining distinct segments.

[0281] The stiffness of each laser cut hypotube 702 (or segment of hypotube) can be selected based on, for example, the material forming the hypotube, the pitch of the cuts, the angle around the periphery of the cuts in the laser cut hypotube, the angle around the periphery of the uncut hypotube, and the kerf width at each cut. In some implementations, the hypotubes are formed from stainless steel or nitinol, although other materials are suitable and contemplated.

[0282] Figure 94 illustrates a hypotube 702 as a rectangular sheet with interrupted spiral cuts. In Figure 94, the circumference of the hypotube is represented by the letter C and the pitch is represented by the letter P. The cut degree 708 is the length of each cut and the uncut degree 710 is the distance between a cut and an adjacent cut in the direction of the circumference C. The kerf width 712 of each cut refers to the width of the space between two adjacent laser cuts at the point where the sides of the cuts are parallel to one another.

[0283] As mentioned above, in some implementations, the reinforcing material can be incorporated in the form of a jacket for the sheath 609 of the steerable catheter assembly 608, or the reinforcing material can be incorporated into the structure of the sheath as a layer in a multi-layer sheath. Exemplary multi-layer sheaths are shown in Figures 95A, 95B, 96A, and 96B. The number and types of layers can vary from those shown. The layers can be formed by extrusion, molding, or other methods, and can be combined in various manners.

[0284] 95A is a longitudinal cross-sectional view of an exemplary multi-layer sheath including a first polymer layer 720, a laser cut hypotube 702, a second polymer layer 722, a braided, mesh, or woven material 704, and a third polymer layer 724 defining a lumen 726 (from the outer surface of the multi-layer sheath toward the lumen). Similarly, the multi-layer sheath in FIG. 95B includes a first polymer layer 720, a laser cut hypotube 702, a second polymer layer 722, a braided, mesh, or woven material 704, and a lumen 726 (from the outer surface of the multi-layer sheath toward the lumen). However, in the example illustrated in FIG. 95B, a polytetrafluoroethylene (PTFE) liner 728 defines the lumen 726. As discussed above, the use of the PTFE liner 728 can reduce friction along the inner diameter of the lumen 726. The polymer layers 720, 722, 724 can provide torque resistance based on the durometer of the polymer used, and the laser cut hypotube 702 and braid, mesh, or woven material 704 can further provide torque resistance to the multi-layer sheath. It is envisioned that the cross-section of the multi-layer sheath can vary along the length of the sheath. For example, as described herein, the laser cut hypotube 702, the braid 704, or both can be present in a proximal portion of the sheath but absent in a distal portion of the sheath to provide a variable stiffness to the sheath.

[0285] FIG. 96A illustrates a radial cross section of an exemplary multi-layer sheath. For example, the cross section illustrated in FIG. 96A can correspond to one or more portions of the sheath illustrated in FIG. 97 (e.g., a middle portion of the sheath, etc.). The example multi-layer sheath illustrated in FIG. 96A includes two lumens. For example, when the multi-layer sheath is used as a sheath 609 of a steerable catheter assembly 608, the shaft 611 of the implant catheter assembly 610 can pass through the lumen 726, and a bending member or bending control member 714, such as the illustrated pull wire, and a compression coil 716 can extend through the second lumen, as described above with respect to FIG. 91. In the example illustrated in FIG. 96A, the lumen 726 is defined by a PTFE liner 728, which is positioned within the second polymer layer 722.

[0286] In some implementations, the braid, mesh, or woven material 704 is positioned around the second polymer layer 722 and within the laser cut hypotube 702. In some implementations, the first polymer layer 720 surrounds the laser cut hypotube 702. Within the second polymer layer 722 and adjacent to the PTFE liner 728, a second liner 730 defines a second lumen through which the flexion control member or flexion member 714 (e.g., pull wire, tension suture, tension member, etc.) and compression coil 716 extend. It will be understood that in some implementations, other layers and other lumens may be present and that multiple layers may be provided in alternative sequences while still providing the torque resistance described herein.

[0287] FIG. 96B illustrates a radial cross-section of an exemplary multi-layer sheath, with the flexion member 714 and coil located outside the proximal portion of the sheath. The cross-section can correspond to various positions along the length of the sheath. For example, in some implementations, the cross-section illustrated in FIG. 96B corresponds to the proximal portion of the sheath illustrated in FIG. 97. In some implementations, the second lumen for accommodating the flexion member extends shorter compared to the full length of the multi-layer sheath. In some implementations, the lumen of the multi-layer sheath can vary along the length of the multi-layer sheath and transition, for example, from a circular cross-section to a non-circular cross-section along the length of the multi-layer sheath. The cross-section illustrated in FIG. 96B can correspond to a proximal portion of the multi-layer sheath relative to the radial cross-section illustrated in FIG. 96A, such as the cross-section along line AA in FIG. 91. As shown in FIG. 96B and FIG. 97, the flexion member 714 is located outside the multi-layer sheath, and the lumen 726 is defined by a PTFE liner 728 positioned inside the second polymer layer 722.

[0288] In some implementations, the braid 704 (or other mesh or woven material), the laser cut hypotube 702, and the first polymer layer 720 surrounding the laser cut hypotube 702 do not extend along the proximal length of the multi-layer sheath, allowing the flexure member 714 to be introduced into the second lumen of the multi-layer sheath as described above. The lumen 726 has a substantially circular cross-section. In some implementations, a groove in the mandrel used to support the PTFE liner 728 and the second polymer layer 722 is filled at a location corresponding to the proximal end of the multi-layer sheath such that the lumen 726 illustrated in FIG. 96B can be formed. In some of these implementations, reflow of the PTFE and / or polymer used to form the second polymer layer can create a gradual transition between the circular cross-section and the non-circular cross-section illustrated in FIG. 96A. It will be understood that in some implementations, other layers and other lumens may be present and that the layers may be arranged in various orders while still providing the torque resistance described herein.

[0289] In still further implementations, the braid of the multi-layer sheath can be used to facilitate passage for a bend control member or bending member (e.g., pull wire, tension suture, tension member, etc.). By incorporating a passage in the braid, a separate lumen below the braid (lumen 726) can be eliminated, and in some implementations, the compression coil 716 can be eliminated, which can reduce the outer diameter profile of the multi-layer sheath, allow for a more uniform (e.g., circular) profile, allow for a larger inner diameter profile, and / or reduce manufacturing complexity. Various braid patterns incorporating passages for bending members are illustrated in Figures 99A-C and 99E.

[0290] In Figures 99A-C, the lumen 730 is woven into the braid 704 and the lumen 730 extends longitudinally or along the length of the sheath. The lumen can extend along the length of the sheath in a variety of different ways. For example, the lumen can extend longitudinally and the braided wires 731 are disposed at two opposing angles to the lumen. In some implementations, the lumen and other wires form a triaxial braid. In some implementations, the lumen 730 and the braided wires 731 form an angle of 60 degrees or approximately 60 degrees with respect to each other.

[0291] The lumen 730 can be a tube, such as a thin walled tube, made of any suitable material. In some implementations, the lumen 730 can be a hypotube made of stainless steel or made of Nitinol. In some other implementations, the lumen 730 can be a polymer tube, such as a tube made of polyamide, PEEK, or other polymers known and used in the art. The lumen can be made of any material. In the implementation illustrated in FIGS. 99A-99C, the lumen 730 is incorporated into the braided structure and extends longitudinally along the length of the braid 704. The lumen 730 can further reinforce the braid and strength of the multi-layered sheath while providing a passage for bending members (e.g., pull wires, tension sutures, tension members, etc.). In some implementations, the lumen 730 is braided to lead in and out of every other crossover or pick of the braid 704, although other patterns are envisioned and possible. As shown in Figures 99A-C, the lumen 730 can be incorporated into any one of a variety of weave patterns, such as a triaxial weave pattern or any pattern in which the lumen extends longitudinally. For example, Figure 99A illustrates a longitudinally extending lumen 730 incorporated into a full weave pattern, Figure 99B illustrates a longitudinally extending lumen 730 incorporated into a diamond weave pattern, and Figure 99C illustrates a lumen 730 incorporated into a half diamond weave pattern.

[0292] FIG. 99D illustrates a radial cross-section of an exemplary multi-layered sheath, with a bending member 714, such as a pull wire as illustrated in the drawing, passing through a longitudinally extending lumen 730 woven into the braid 704. The bending member 714 and lumen 730 can be used in the same manner as the bending member and compression coil 716 described above to deflect or steer the sheath. For example, applying tension to the bending member 714 within the lumen 730 will deflect a portion of the sheath. The cross-sections can correspond to various locations along the length of the sheath. For example, in some implementations, the cross-section illustrated in FIG. 99D corresponds to the proximal portion of the sheath illustrated in FIG. 97. In some implementations, the lumen 730 for accommodating the bending member extends a shorter distance compared to the entire length of the multi-layered sheath.

[0293] In some implementations, the braid 704 (or other mesh or woven material), the laser cut hypotube 702, and the first polymer layer 720 surrounding the laser cut hypotube 702 do not extend along the proximal length of the multi-layer sheath, thereby allowing the bending member 714 to be introduced into the lumen 730 of the multi-layer sheath as described above. The lumen 730 can have a substantially circular cross-section. It will be understood that in some implementations, other layers and other lumens may be present and that multiple layers may be provided in alternative sequences while still providing the torque resistance described herein.

[0294] In FIG. 99E, the lumen 730 is woven into the braid 704 such that the lumen does not extend only longitudinally and does not extend only the length of the sheath. For example, the lumen 730 can wrap around or twist around the sheath (e.g., in a helical configuration) as the lumen extends along the length of the sheath. Some braids include a chase wire that runs along or parallel to another wire in the braid. In the implementation illustrated in FIG. 99E, the lumen 730 is replaced by a chase wire within the braid.

[0295] As mentioned above, the lumen 730 can be a tube, such as a thin-walled tube, made of any suitable material. In some implementations, the lumen 730 can be a hypotube made of stainless steel or made of Nitinol. In some other implementations, the lumen 730 can be a polymer tube, such as a tube made of polyamide, PEEK, or other polymers known and used in the art. The lumen 730 can be made of any material. In the implementation shown in FIG. 99E, the lumen 730 is woven into the braid 704 next to another wire in the braid. The lumen 730 can further reinforce the braid and strength of the multi-layer sheath while providing a passage for a bending member, such as the illustrated pull wire. As a chase wire type feature, the lumen can reduce bending of the multi-layer sheath when applying tension to the bending member because it spirals around the multi-layer sheath. In an implementation, the lumen 730 is incorporated as a chase wire feature in a half diamond weave pattern. However, the lumen 730 may have any helical or swirl configuration and may be incorporated into any braid pattern.

[0296] FIG. 99F illustrates a radial cross-section of an exemplary multi-layered sheath, with a flexing member 714 passing through a helical, spiral, or other wound lumen 730 woven into the braid 704. The cross-section of the lumen 730 and flexing member 714 is non-circular (e.g., elliptical or other shape) due to the helical, spiral, or other wound flexing member, such as the illustrated pull wire 714, and the lumen 730 extending therethrough. The cross-section can correspond to various positions along the length of the sheath. For example, in some implementations, the cross-section illustrated in FIG. 99F corresponds to the proximal portion of the sheath illustrated in FIG. 97. In some implementations, the lumen 730 for accommodating the flexing member extends less than the entire length of the multi-layered sheath.

[0297] In some implementations, the braid 704 (or other mesh or woven material), the laser cut hypotube 702, and the first polymer layer 720 surrounding the laser cut hypotube 702 do not extend along the proximal length of the multi-layer sheath, thereby allowing the bending member 714 to be introduced into the lumen 730 of the multi-layer sheath as described above. In contrast to the lumen illustrated in FIG. 99D, the lumen 730 illustrated in FIG. 99F has a substantially elliptical cross-section due to a coiled configuration (e.g., not extending longitudinally) within the braid 704. It will be understood that in some implementations, other layers and other lumens may be present and may be arranged in various orders while still providing the torque resistance described herein.

[0298] Although various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as embodied in combination in exemplary implementations, these various aspects, concepts, and features may be used individually or in various combinations and subcombinations thereof in many alternative implementations. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of the present application. Still further, although various alternative implementations of the various aspects, concepts, and features of the present disclosure may be described herein, for example, alternative materials, alternative structures, alternative configurations, alternative methods, alternative devices, alternative components, alternatives in form, alternatives in fit, alternatives in function, and the like, such descriptions are not intended to be a complete or exhaustive list of available alternative implementations, whether currently known or later developed. One or more of the inventive aspects, concepts, or features may be readily employed into additional implementations and uses within the scope of the present application, even if such additional implementations are not expressly disclosed herein.

[0299] Additionally, although some features, concepts, or aspects of the disclosure may be described herein as being preferred configurations or methods, such description is not intended to imply that such features are essential or essential unless expressly described. Furthermore, while exemplary or representative values, and even exemplary or representative ranges, may be included to aid in the understanding of the present application, such values ​​and ranges should not be construed in a limiting sense, and are intended to be critical values ​​or ranges only if so expressly described. Moreover, although various aspects, features, and concepts may be expressly identified herein as being inventive or forming part of the disclosure, such identification is not intended to be exclusive, and 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 particular disclosure, and the disclosure is instead defined in the appended claims. Descriptions of exemplary methods or processes are not limited to the inclusion of every step as essential in all cases, and the order in which multiple steps are presented is not to be construed as essential or essential unless expressly described. Additionally, the techniques, methods, operations, steps, etc., as described or suggested herein may be performed on live animals or on non-living simulations, such as cadavers, cadaver hearts, simulators (e.g., where a body part, tissue, etc. is simulated), etc. The terms used in the claims are to be given their entirely ordinary meaning and are not to be limited in any way by the description of implementations herein.

Claims

1. 1. A delivery system for an implantable device, comprising: a first catheter assembly having a handle and a sheath extending axially from the handle, the sheath including a steerable section; a second catheter assembly having a handle and a sheath including a proximal end and a distal end coupled to the handle; the sheath of the second catheter assembly extends coaxially through the sheath of the first catheter assembly; the sheath of the second catheter assembly has a first outer diameter along a first length and a second outer diameter along a second length; the second outer diameter is smaller than the first outer diameter, the sheath of the second catheter assembly may extend from a distal end of the sheath of the first catheter assembly by a stroke distance; A delivery system for an implantable device, wherein the second length is greater than or equal to the sum of the stroke distance and the length of the steerable section of the first catheter assembly, whereby the sheath of the second catheter assembly has the second outer diameter that passes through the steerable section of the first catheter assembly.

2. The delivery system for an implantable device of claim 1 , wherein the difference between the first outer diameter and the second outer diameter is about 0.25 mm to about 0.76 mm.

3. The delivery system for an implantable device of claim 1 or 2, wherein the transition from the first outer diameter to the second outer diameter forms a smooth taper over a distance of about 25 mm to about 50 mm.

4. The delivery system for an implantable device of any one of claims 1 to 3, further comprising a lubricious coating on an exterior surface of the sheath along the second length of the sheath.

5. The delivery system for an implantable device of claim 4 , wherein the lubricious coating comprises a hydrophilic coating.

6. The delivery system for an implantable device of any one of claims 1 to 5, wherein the first outer diameter and the second outer diameter are each smaller than an inner diameter of the sheath of the first catheter assembly.

7. The delivery system for an implantable device according to any one of claims 1 to 6, wherein the first catheter assembly is a steerable catheter assembly and the second catheter assembly is an implant catheter assembly.

8. A delivery system for an implantable device as described in any one of claims 1 to 6, wherein the sheath of the second catheter assembly is a multi-layer sheath, one or more layers of the multi-layer sheath comprising at least one laser cut hypotube having a stiffness that varies along the length of the at least one laser cut hypotube, a proximal portion of the sheath being stiffer than a distal portion of the sheath.

9. A delivery system comprising: a first catheter assembly having a handle and a sheath extending axially from the handle, the sheath including a steerable section; a second catheter assembly having a handle and a sheath including a proximal end and a distal end coupled to the handle; the sheath of the second catheter assembly extends coaxially through the sheath of the first catheter assembly; the sheath of the second catheter assembly has a first outer diameter along a first length and a second outer diameter along a second length; the second outer diameter is smaller than the first outer diameter, the sheath of the second catheter assembly may extend from a distal end of the sheath of the first catheter assembly by a stroke distance; the second length is greater than or equal to the sum of the stroke distance and a length of the steerable section of the first catheter assembly, whereby the sheath of the second catheter assembly has the second outer diameter through the steerable section of the first catheter assembly; an implantable device coupled to the second catheter assembly; A system equipped with.

10. The system of claim 9, wherein the implantable device is a heart valve replacement device.

11. The system described in claim 9, wherein the implantable device is a heart valve repair device.

12. The system described in claim 11, wherein the heart valve repair device comprises a pair of anchors configured to be attached to two native leaflets of a native heart valve.

13. The system described in claim 12, wherein the second catheter assembly is configured to open and close the pair of anchors.

14. The system described in claim 9, wherein the difference between the first outer diameter and the second outer diameter is about 0.25 mm to about 0.76 mm.

15. A system described in any one of claims 9 to 14, wherein the transition portion from the first outer diameter to the second outer diameter forms a smooth tapered shape over a distance of about 25 mm to about 50 mm.

16. The system of claim 9, further comprising a lubricous coating on an outer surface of the sheath along the second length of the sheath.

17. The system of claim 16, wherein the lubricious coating comprises a hydrophilic coating.

18. A system described in any one of claims 9 to 17, wherein the first outer diameter and the second outer diameter are each smaller than the inner diameter of the sheath of the first catheter assembly.

19. A system as described in any one of claims 9 to 18, wherein the sheath of the second catheter assembly is a multi-layer sheath, one or more layers of the multi-layer sheath including at least one laser cut hypotube having a stiffness that varies along the length of the at least one laser cut hypotube, and wherein a proximal portion of the sheath is stiffer than a distal portion of the sheath.

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