Artificial medical device delivery assembly

Abstract

The support can be configured to stabilize a delivery device having three independently operable shafts extending axially. The support can comprise an axially extending track, a first cart coupled to the track and configured to coupled to a first shaft, and a second cart coupled to the track and configured to coupled to a second shaft. The rack can be fixedly coupled to the first cart and to the second cart. The second cart can comprise a locking assembly operable between the first and second modes. In the first mode, the second cart is slidably coupled to the track and fixedly coupled to the rack. In the second mode, the second cart is fixedly coupled to the track and slidably coupled to the rack.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 489,832, filed on March 13, 2023, which is hereby incorporated by reference in its entirety.

[0002] This disclosure relates to a delivery assembly for artificial medical devices.

Background Art

[0003] The human heart is susceptible to various valvular diseases. These valvular diseases can lead to severe heart dysfunction and may ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are several known repair devices (such as stents) and artificial valves, as well as several known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver artificial medical devices to locations within the body that are not easily accessible surgically or where access without surgery is desirable. In a specific example, an artificial heart valve can be attached to the distal end of a delivery device in a crimped state and advanced through the patient's vasculature (such as through the femoral artery and aorta) until the artificial heart valve reaches the implantation site in the heart. Thereafter, the artificial heart valve is expanded to its functional size, for example, by inflating a balloon to which the artificial heart valve is attached, activating a mechanical actuator that applies an expanding force to the artificial heart valve, or deploying the artificial heart valve from the sheath of the delivery device such that the artificial heart valve can self - expand to its functional size.

[0004] A docking device delivery system can be used to deliver an artificial medical device such as a docking device used in conjunction with the above - mentioned artificial heart valve. The docking device can be positioned at the implantation site by the docking device delivery system and can provide a better seal between the implantation site and the artificial heart valve.

Summary of the Invention

[0005] The aforementioned and other objects, configurations, and advantages of the present invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings.

[0006] This disclosure describes an artificial heart valve, a delivery device, a delivery system, and a method for implanting an artificial heart valve. The disclosed artificial heart valve, delivery device, delivery assembly, and method can, for example, provide an improved positioning of a docking device for use with an artificial heart valve. The docking device can be positioned using a docking device delivery device comprising three independently operable shafts. The docking device delivery device can be coupled to a stabilizer assembly that enables improved positioning of the docking device by better stabilizing the docking device delivery device during the docking device implantation procedure. Thus, the devices and methods disclosed herein can overcome one or more of the defects of typical artificial heart valves, and their delivery devices, and delivery systems.

[0007] An assembly for implanting an artificial medical device may comprise a handle and one or more shafts coupled to the handle.

[0008] In some embodiments, the assembly may comprise three shafts.

[0009] In some embodiments, one or more shafts can act independently in the axial direction.

[0010] In some embodiments, the assembly may further comprise a stabilizer assembly for stabilizing one or more shafts.

[0011] In some embodiments, the stabilizer assembly may comprise an axially extending track, a first cart, and a second cart, the first and second carts being configured to be slidably coupled to the track, the first cart being configured to be coupled to a first shaft of one or more shafts, and the second cart being configured to be coupled to a second shaft of one or more shafts.

[0012] In some embodiments, the stabilizer assembly may further comprise a rack gear fixedly coupled to a first cart and slidably coupled to a second cart.

[0013] In some embodiments, the second cart can be configured to slide along both the track and the rack gear.

[0014] In some embodiments, the second cart may include a locking assembly configured to selectively engage with the track and rack gear.

[0015] In some embodiments, the lock assembly can be operable between a first mode and a second mode, configured to engage with the rack gear and disengage the track in the first mode, and configured to disengage the rack gear and engage with the track in the second mode.

[0016] In some embodiments, the lock assembly may include a track lock configured to engage with the track and a rack gear lock configured to engage with the rack gear.

[0017] In some embodiments, the lock assembly may further include a rotatable knob operably coupled to both the track lock and the rack gear lock, and both the track lock and the rack gear lock are activated by rotating the knob.

[0018] In some embodiments, a track may include a single structure.

[0019] In some embodiments, the track may include an extruded structure.

[0020] In some embodiments, the track may comprise a first rail having a first height and a second rail having a second height, where the first height is not equal to the second height.

[0021] In some embodiments, the docking device delivery assembly may comprise a delivery device and a support for the delivery device. The delivery device may comprise a first shaft extending distally and a second shaft coaxial with the first shaft. The support may comprise a track extending axially and a first cart slidably coupled to the track, the first cart being configured to be coupled to the first shaft of the delivery device, a guide member fixedly coupled to the first cart, and a second cart operable between a first mode and a second mode, the second cart being configured to be coupled to a second shaft, the second cart being slidably coupled to the track and fixedly coupled to the guide member in the first mode, and the second cart being fixedly coupled to the track and slidably coupled to the guide member in the second mode.

[0022] In some embodiments, a support for use with a delivery device may comprise an axially extending track, a first cart configured to slide along the track and be coupled to a first part of the delivery device, a guide rail fixedly coupled to the axial end portion of the first cart and extending in the axial direction, and a second cart configured to slide along the track and be coupled to a second part of the delivery device. The second cart may comprise a locking assembly that is operable between a first mode and a second mode, in which the locking assembly engages with the guide rail and disengages the track, and in which mode the locking assembly disengages the guide rail and engages with the track.

[0023] In some embodiments, the support assembly may comprise a rack gear having a first axial end portion and a second axial end portion, a first cart fixedly coupled to the first axial end portion, a second cart configured to slide along the rack gear between the first and second axial end portions, and a locking assembly. The locking assembly may comprise a lock configured to lock the second cart to the rack gear, and a rotatable knob configured to actuate the locking assembly.

[0024] In some embodiments, the hub assembly support for the delivery device may include a first post configured to be slidably coupled to an axially extending track, a guide rail fixedly coupled to the axial end portion of the first post, the guide rail extending axially from the axial end portion of the first post, and a second post slidably coupled to both the track and the guide rail.

[0025] In some embodiments, a method of implanting an artificial medical device can include coupling a delivery device to a stabilizer assembly. The delivery device can include first and second coaxial shafts that are independently operable. The stabilizer assembly can include axially oriented rails, a first post slidably coupled to the rails, wherein the first shaft is configured to couple to the first post, a second post slidably coupled to the rails, wherein the second shaft is configured to couple to the second post, a guide member fixedly coupled to the first post and slidably coupled to the second post, and a lock assembly disposed on the second post and configured to selectively engage the rails and the guide member. The method can further include integrally sliding the first and second posts distally along the rails, actuating the lock assembly to engage the rails and disengage the guide member, and sliding the first post proximally relative to the second post.

[0026] In some embodiments, the assembly can include one or more of the components listed in Examples 1 - 46 below.

[0027] The various innovations of the present disclosure can be used in combination or individually. This summary is provided to introduce, in simplified form, a selection of concepts that are further described in the detailed description below. The summary of the invention is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The above and other objects, features, and advantages of the present disclosure will become more apparent from the following detailed description, from the claims, and from the accompanying drawings.

[0028] The above method can be carried out on a living animal or on a simulation such as a cadaver, the heart of a cadaver, an anthropomorphic ghost, a simulator (e.g., where a part of the body, the heart, tissue, etc. are simulated).

Brief Description of the Drawings

[0029] [Figure 1] Illustrates schematically the steps in an exemplary mitral valve replacement where a guide catheter and a guide wire are inserted into the blood vessel of a patient and navigated through the blood vessel into the patient's heart towards the native mitral valve of the heart. [Figure 2A] Illustrates schematically another step in an exemplary mitral valve replacement where a docking device delivery device extending through the guide catheter implants a docking device for an artificial heart valve at the location of the native mitral valve. [Figure 2B] Illustrates schematically another step in an exemplary mitral valve replacement where the docking device of FIG. 2A is fully implanted at the location of the patient's native mitral valve and the docking device delivery device is removed from the patient. [Figure 3A] Illustrates schematically another step in an exemplary mitral valve replacement where an artificial heart valve delivery device extending through the guide catheter implants an artificial heart valve within the implanted docking device at the native mitral valve. [Figure 3B] Illustrates schematically another step in an exemplary mitral valve replacement where the artificial heart valve is fully implanted within the docking device at the native mitral valve and the artificial heart valve delivery device is removed from the patient. [Figure 4] Illustrates schematically another step in an exemplary mitral valve replacement where the guide catheter and the guide wire are removed from the patient. [Figure 5] Illustrates schematically the steps of a docking device implantation procedure according to one embodiment where a guide catheter is inserted into the blood vessel of a patient and navigated through the blood vessel into the patient's heart. [Figure 6]This schematic illustrates another stage of an exemplary docking device implantation procedure, in which the distal end portion of the docking device delivery device advances from the guide catheter into the left ventricle of the heart. [Figure 7] This schematic illustrates another stage of an exemplary docking device implantation procedure, in which the distal end portion of the docking device delivery device is coiled around several valve leaflets of the heart. [Figure 8] This schematic illustrates an optional step in an exemplary docking device implantation procedure in which the radius of curvature of the distal end portion of the docking device delivery device is increased to surround the chordae tendineae of the heart in a variable encircling turn. [Figure 9] This schematically illustrates another optional step of an exemplary docking device implantation procedure, in which the sleeve shaft of the docking device delivery device is retracted proximally to de-cover the guard member of the docking device. [Figure 10] This schematically illustrates another optional step of the exemplary docking device implantation procedure, in which the sleeve shaft advances distally to shorten the guard member axially. [Figure 11] This section schematically illustrates another stage of exemplary mitral valve replacement surgery in which the docking device delivery device is detached from the docking device. [Figure 12] This is a perspective view of a docking device delivery assembly configured for use during the docking device implantation procedure shown in Figures 5 to 11, according to one embodiment. [Figure 13] This is a side view of a delivery device for use in the docking device delivery assembly shown in Figure 12, according to one embodiment. [Figure 14] This is a cross-sectional view of the stabilizer track of the docking device delivery assembly shown in Figure 12, according to one embodiment. [Figure 15] This is a perspective view of a hub assembly support for use in the docking device delivery assembly shown in Figure 12, according to one embodiment. [Figure 16A] This is a cross-sectional view of the hub assembly support in the first mode according to one embodiment. [Figure 16B] This is a cross-sectional view of the hub assembly support in the second mode according to one embodiment, as shown in Figure 15. [Figure 17A] Figures 5 to 11 are side views of a docking device delivery assembly during the docking device implantation procedure, according to one embodiment. [Figure 17B] Figures 5 to 11 are side views of a docking device delivery assembly during the docking device implantation procedure, according to one embodiment. [Figure 17C] Figures 5 to 11 are side views of a docking device delivery assembly during the docking device implantation procedure, according to one embodiment. [Figure 17D] Figures 5 to 11 are side views of a docking device delivery assembly during the docking device implantation procedure, according to one embodiment. [Figure 17E] Figures 5 to 11 are side views of a docking device delivery assembly during the docking device implantation procedure, according to one embodiment. [Figure 18] This is a cross-sectional view of the stabilizer track of the docking device delivery assembly shown in Figure 12, according to a second embodiment. [Figure 19] This is a perspective view of the hub assembly support according to the second embodiment. [Figure 20] This is a side view of a guide catheter for use in the docking device delivery system shown in Figure 12, according to one embodiment. [Figure 21] This is a side view of a guide catheter and a docking device delivery device according to one embodiment. [Figure 22] This is a side view of the guide catheter and docking device delivery device according to the second embodiment. [Figure 23] This is a perspective view of a docking device for use in the docking device delivery system shown in Figure 12, according to one embodiment. [Figure 24] This is a perspective view of an artificial heart valve delivery device according to one embodiment. [Figure 25]This is a perspective view of an artificial heart valve configured for use with the artificial heart valve delivery device shown in Figure 24, according to one embodiment. [Modes for carrying out the invention]

[0030] General Considerations For the purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, this disclosure covers all novel and non-obvious features and aspects of the various disclosed embodiments, individually, in various combinations of each other, and in various subcombinations of each other. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require the existence of any one or more particular advantages or the resolution of any problem.

[0031] While some of the operations of the disclosed embodiments are described in a specific sequential order for the sake of presentation, it should be understood that this style of description is inclusive of reordering unless a specific order is required by the specific wording described below. For example, operations described sequentially may, in some cases, be reordered or performed simultaneously. Also, for the sake of simplification, the accompanying drawings may not show various ways in which the disclosed methods can be used in combination with other methods. In addition, the description sometimes uses terms such as “provides” or “achieves” to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may differ depending on the specific implementation and will be readily apparent to those skilled in the art.

[0032] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural form unless the context clearly specifies otherwise. Additionally, the term "includes" means "comprises." Furthermore, the term "coupled" generally means to be joined or linked physically, mechanically, chemically, magnetically, and / or electrically, and does not exclude the presence of an intermediate element between the joined or associated items unless otherwise specified.

[0033] As used herein, the term “proximal” refers to a location, orientation, or part of the device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a location, orientation, or part of the device that is further away from the user and closer to the implantation site. For example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., toward the patient's body). The terms “longitudinal” and “axial” refer to axes extending in the proximal and distal directions, respectively, unless otherwise explicitly defined.

[0034] The terms "lateral" and "radial" refer to axes perpendicular to the longitudinal axis. When referring to "lateral" in the context of stabilizer assemblies for docking device delivery systems, the term "lateral" refers to an axis perpendicular to the longitudinal axis and parallel to the plane defined by the stabilizer tracks of the stabilizer assembly.

[0035] As used herein, "e.g." means "for example," and "ie.g." means "that is."

[0036] Introduction of the disclosed technologies This specification discloses embodiments of delivery systems that can be used to navigate the target vascular system to deliver artificial medical devices (such as docking devices used in conjunction with artificial heart valves), tools, drugs, or other therapies to a target implantation site within the target body.

[0037] In connection therewith, in some embodiments, various systems are described in this disclosure that can stabilize and operate various components of the delivery system to better improve the positioning of the prosthesis.

[0038] The delivery system may comprise multiple shafts that can operate independently of each other. In some embodiments, the delivery system may comprise a delivery shaft comprising a delivery shaft lumen, a sleeve shaft positioned within the delivery shaft lumen and including a sleeve shaft lumen, and a pusher shaft positioned within the sleeve shaft lumen. The prosthesis can be positioned at the target implantation site by acting the pusher shaft relative to the delivery shaft and the sleeve shaft.

[0039] In particular, this disclosure discloses exemplary devices and / or methods that can facilitate the operation (e.g., axial movement) of one or more components of a delivery system relative to one or more other components of the delivery system.

[0040] Examples of the disclosed technology Figures 1 to 4 illustrate an example of transcatheter heart valve replacement (such as mitral valve replacement) using a docking device 52 and an artificial heart valve 62 according to one embodiment. During the procedure, the user first uses a guide catheter 30 to create a pathway to the patient's natural heart valve (Figure 1). Then, the user uses a delivery device 50 to deliver and implant the docking device 52 in the patient's natural heart valve (Figure 2A), and after implanting the docking device 52, removes the delivery device 50 from the patient 10 (Figure 2B). Subsequently, the user uses an artificial valve delivery device 60 to implant the artificial heart valve 62 inside the implanted docking device 52 (Figure 3A). After that, the user removes the artificial valve delivery device 60 from the patient 10 (Figure 3B), and also removes the guide catheter 30 (Figure 4).

[0041] Figure 1 illustrates a step in a mitral valve replacement procedure according to one embodiment, in which a guide catheter 30 and a guide wire 40 are inserted into a blood vessel 12 of the patient 10 and navigated through the blood vessel 12 into the patient 10's heart 14 and toward the natural mitral valve 16. Together, the guide catheter 30 and guide wire 40 can provide a pathway through which and along which the delivery device 50 and the prosthetic valve delivery device 60 should be navigated toward the implantation site (natural mitral valve 16 or natural mitral annulus). As shown, the heart 14 is schematically illustrated. For example, the anterior leaflet and chordae tendineae of the natural mitral valve 16 are omitted for illustrative purposes, so that only a portion of the posterior leaflet of the natural mitral valve 16 is illustrated.

[0042] Initially, the user may first make an incision in the patient's body to access the blood vessel 12. For example, in the embodiment illustrated in Figure 1, the user may make an incision in the patient's groin to access the femoral vein. Therefore, in such an embodiment, the blood vessel 12 may be the femoral vein.

[0043] After incising in the blood vessel 12, the user may insert a guide catheter 30, a guide wire 40, and / or additional devices (such as an introducer device or a transseptal puncture device) into the blood vessel 12 through the incision. The guide catheter 30 (which may also be referred to as the “introducer device,” “introducer,” or “guide sheath”) is configured to facilitate the percutaneous introduction of various implant delivery devices (such as the delivery device 50 and the artificial valve delivery device 60) into and through the blood vessel 12, and may extend through the blood vessel 12 into the heart 14, but may stop before the natural mitral valve 16. The guide catheter 30 may comprise a handle 32 and a shaft 34 (which may also be referred to as the catheter shaft 34) extending distally from the handle 32. The shaft 34 can extend into the heart 14 through the blood vessel 12, while the handle 32 remains outside the patient's body, allowing the user to operate the handle 32 to manipulate the shaft 34 (Figure 1).

[0044] The guidewire 40 is configured to guide the delivery device (such as the guide catheter 30, delivery device 50, artificial valve delivery device 60, additional catheter, or the like) and related devices (such as a docking device, artificial heart valve, and the like) to the implantation site within the heart 14, and may extend throughout into the left atrium 18 (Figure 1) of the heart 14 through the blood vessels 12, and, in some embodiments, into the left ventricle 26 of the heart 14 through the natural mitral valve 16.

[0045] In some cases, a transseptal puncture device or transseptal puncture catheter can be used to first access the left atrium 18 before inserting the guidewire 40 and guide catheter 30. For example, after creating an incision in a blood vessel 12, the user may insert the transseptal puncture device into the blood vessel 12 through the incision. The user may guide the transseptal puncture device into the heart 14 through the blood vessel 12 (e.g., into the right atrium 20 through the femoral vein). The user can then create a small incision in the atrial septum 22 of the heart 14 to allow access from the right atrium 20 to the left atrium 18. The user can then insert and advance the guidewire 40 into the left atrium 18 through the transseptal puncture device in the blood vessel 12 and through the incision in the atrial septum 22. After positioning the guidewire 40 in the left atrium 18 and / or left ventricle 26, the transseptal puncture device can be removed from the patient 10. Subsequently, the user can insert the guide catheter 30 into the blood vessel 12 and advance the guide catheter 30 into the left atrium 18 along the guide wire 40 (Figure 1).

[0046] In some cases, the introducer device can be inserted through the lumen of the guide catheter 30 before inserting the guide catheter 30 into the blood vessel 12. In some cases, the introducer device may include a tapered end extending from the distal end of the guide catheter 30 and configured to guide the guide catheter 30 into the left atrium 18 over the guidewire 40. Additionally, in some cases, the introducer device may include a proximal end portion extending from the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user can remove the introducer device from inside the guide catheter 30 and the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain inside the patient 10. The guide catheter 30 is then positioned to receive the implant delivery device and help guide it into the left atrium 18, as will be further described below.

[0047] Figure 2A depicts another stage in an exemplary mitral valve replacement, in which a docking device 52 is implanted into the natural mitral valve 16 of the patient's heart 14 using a delivery device 50 (which may also be referred to as “implant catheter”, “dock delivery system”, “docking device delivery device”, and / or “docking device delivery device”).

[0048] Generally, the delivery device 50 comprises a delivery shaft 54 ​​(which may also be referred to as the “dock delivery system shaft”), a handle 56 (which may also be referred to as the “dock delivery system handle”), and a pusher assembly 58. The delivery shaft 54 ​​is configured to be advanced by the user through the patient’s vascular system (blood vessels 12) and toward the implantation site (such as the natural mitral valve 16), and may be configured to hold the docking device 52 within the distal end portion 53 of the delivery shaft 54. In some embodiments, the distal end portion 53 of the delivery shaft 54 ​​holds the docking device 52 internally in a linear delivery configuration.

[0049] The handle 56 of the delivery device 50 is configured to be grasped by a user and / or otherwise held by a user outside the patient 10's body in order to advance the delivery shaft 54 ​​through the patient's vascular system (such as blood vessels 12).

[0050] In some embodiments, the handle 56 may include one or more articulated members 57 (or rotatable knobs) configured to assist in navigating the delivery shaft 54 ​​through the blood vessels 12. For example, one or more articulated members 57 may include one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members, which are configured to be adjusted by the user to flex, bend, twist, rotate, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 ​​to assist in navigating the delivery shaft 54 ​​through the blood vessels 12 and within the heart 14.

[0051] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at a graft site (such as the natural mitral valve 16). For example, the pusher assembly 58 is configured to be adjusted by the user to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54. The shaft of the pusher assembly 58 (which may also be referred to as the “pusher shaft”) can extend through the delivery shaft 54 ​​and be positioned adjacent to the docking device 52 within the delivery shaft 54. In some embodiments, the docking device 52 can be releasably coupled to the shaft of the pusher assembly 58 via a connection mechanism of the delivery device 50 so that the docking device 52 can be released after it has been deployed in the natural mitral valve 16.

[0052] Further details of the docking device delivery apparatus and its variations are described in PCT Publications WO2020 / 247907 and WO2023 / 205076, and PCT Application PCT / US2023 / 33745, each of which is incorporated herein by reference in its entirety.

[0053] Referring again to Figure 2A, after the guide catheter 30 is positioned in the left atrium 18, the user may insert the delivery device 50 (including the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 ​​of the delivery device 50 through the guide catheter 30 and over the guidewire 40. In some embodiments, the guidewire 40 can be moved away from the left atrium 18 and at least partially retracted onto the guide catheter 30. The user may then continue to advance the delivery shaft 54 ​​of the delivery device 50 along the guidewire 40 through the blood vessel 12 until the delivery shaft 54 ​​reaches the left atrium 18, as illustrated in Figure 2A. Specifically, the user may advance the delivery shaft 54 ​​of the delivery device 50 by grasping the handle 56 of the delivery device 50 and applying force (e.g., pushing) toward the patient 10. While advancing the delivery shaft 54 ​​through the blood vessels 12 and the heart 14, the user may adjust one or more joint members 57 of the handle 56 to navigate various bends, corners, narrows, and / or other obstacles in the blood vessels 12 and the heart 14.

[0054] Once the delivery shaft 54 ​​reaches the left atrium 18 and extends outward from the distal end of the guide catheter 30, the user can use the handle 56 (such as the articulating member 57) to position the distal end portion 53 of the delivery shaft 54 ​​at and / or near the posteromedial commissure of the natural mitral valve 16. The user can then use the shaft of the pusher assembly 58 to push the docking device 52 outward from the distal end portion 53 of the delivery shaft 54 ​​in order to deploy and / or implant the docking device 52 within the annulus of the natural mitral valve 16.

[0055] In some embodiments, the docking device 52 may be constructed from, formed from, and / or contain a shape memory material, so that it can return to its original preformed shape when it exits the delivery shaft 54 ​​and is released from its constraint by the delivery shaft 54. In one embodiment, the docking device 52 may be originally formed as a coil and, as it exits the delivery shaft 54 ​​and returns to its original coiled configuration, it may wrap around the valve leaflets 24 of the natural mitral valve 16.

[0056] After pushing the ventricular portion of the docking device 52 (such as the portion of the docking device 52 shown in Figure 2A, which is configured to be positioned within the left ventricle 26 and / or on the ventricular side of the natural mitral valve 16), the user can then deploy the remaining portion of the docking device 52 (such as the atrial portion of the docking device 52) from the delivery shaft 54 ​​in the left atrium 18 by retracting the delivery shaft 54 ​​away from the posteromedial commissure of the natural mitral valve 16.

[0057] After deploying and implanting the docking device 52 in the natural mitral valve 16, the user may detach the delivery device 50 from the docking device 52. Once the docking device 52 is detached from the delivery device 50, the user can retract the delivery device 50 from the blood vessel 12 and move it away from the patient 10, so that the user can deliver the artificial heart valve 62 in the implanted docking device 52 and implant it in the natural mitral valve 16.

[0058] Figure 2B depicts this stage of mitral valve replacement, where the docking device 52 is fully deployed and implanted in the natural mitral valve 16, and the delivery device 50 (including the delivery shaft 54) is removed from the patient 10, so that only the guidewire 40 and guide catheter 30 remain inside the patient 10. In some embodiments, after removal of the delivery device 50, the guidewire 40 can be advanced from the guide catheter 30 through the docking device 52 implanted in the natural mitral valve 16 into the left ventricle 26 (Figure 2A). Thus, the guidewire 40 can help guide the prosthetic valve delivery device 60 through the annulus of the natural mitral valve 16 into the left ventricle 26, at least partially.

[0059] As illustrated in Figure 2B, the docking device 52 may have multiple turns (or coils) that wrap around the leaflets 24 of the natural mitral valve 16 (in the left ventricle 26). The implanted docking device 52 has a more cylindrical shape than the annulus of the natural mitral valve 16, thereby providing a geometric shape that more closely matches the shape or profile of the artificial heart valve to be implanted. As a result, the docking device 52 can provide a tighter fit and, consequently, a better seal between the artificial heart valve and the natural mitral valve 16, as will be further described below.

[0060] Figure 3A depicts another stage in mitral valve replacement, in which the user uses an artificial valve delivery device 60 to deliver and / or implant an artificial heart valve 62 (which may also be referred to herein as a “transcatheter heart valve,” or more concisely as “THV,” “replacement heart valve,” and / or “artificial mitral valve”) into a docking device 52.

[0061] As shown in Figure 3A, the artificial valve delivery device 60 may comprise a delivery shaft 64 and a handle 66, the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into the patient's vascular system to deliver, implant, expand, and / or otherwise deploy the artificial heart valve 62 in the docking device 52 to the natural mitral valve 16. The handle 66 is configured to be grasped and / or otherwise held by the user to advance the delivery shaft 64 through the patient's vascular system.

[0062] In some embodiments, the handle 66 may include one or more articulated members 68 configured to assist in navigating the delivery shaft 64 through the blood vessels 12 and the heart 14. Specifically, the articulated members 68 may comprise one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members, which are configured to be adjusted by the user to flex, bend, twist, rotate, and / or otherwise articulate the distal end portion of the delivery shaft 64 in order to assist in navigating the delivery shaft 64 through the blood vessels 12 to the left atrium 18 and left ventricle 26 of the heart 14.

[0063] In some embodiments, the artificial valve delivery device 60 may include an expansion mechanism 65 configured to radially expand and deploy the artificial heart valve 62 at the implantation site. In some cases, as shown in Figure 3A, the expansion mechanism 65 may include an inflatable balloon configured to inflate in order to radially expand the artificial heart valve 62 within the docking device 52. The inflatable balloon may be coupled to the distal end portion of the delivery shaft 64.

[0064] In other embodiments, the artificial heart valve 62 may be self-expanding and configured to expand radially on its own when the sheath or capsule covering the radially compressed artificial heart valve 62 on the distal end portion of the delivery shaft 64 is removed. In yet another embodiment, the artificial heart valve 62 may be mechanically expandable and the artificial valve delivery device 60 may include one or more mechanical actuators (such as an expansion mechanism) configured to expand the artificial heart valve 62 radially.

[0065] As shown in Figure 3A, the artificial heart valve 62 is mounted on the distal end of the delivery shaft 64 in a radially compressed configuration around the expansion mechanism 65 (inflatable balloon).

[0066] To maneuver the distal end of the delivery shaft 64 to the implantation site, the user can insert the prosthetic valve delivery device 60 (delivery shaft 64) into the patient 10 via the guide catheter 30 and along the guide wire 40. The user can continue to advance the prosthetic valve delivery device 60 along the guide wire 40 (through the blood vessel 12) until the distal end of the delivery shaft 64 reaches the natural mitral valve 16, as illustrated in Figure 3A. More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery device 60 by grasping the handle 66 and applying force (e.g., pushing). While advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the user can adjust one or more articulated members 68 of the handle 66 to navigate various bends, corners, stenoses, and / or other obstacles within the blood vessel 12 and the heart 14.

[0067] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed artificial heart valve 62, which is mounted around the distal end of the delivery shaft 64, is positioned within the docking device 52 and the natural mitral valve 16. In some embodiments, as shown in Figure 3A, the distal end of the delivery shaft 64 and at least a portion of the radially compressed artificial heart valve 62 can be positioned within the left ventricle 26.

[0068] Once the radially compressed artificial heart valve 62 is properly positioned within the docking device 52 (Figure 3A), the user can operate one or more operating mechanisms on the handle 66 of the artificial valve delivery device 60 to activate the expansion mechanism 65 (for example, by inflating an inflatable balloon), thereby expanding the artificial heart valve 62 radially within the docking device 52.

[0069] Figure 3B shows another stage of mitral valve replacement, in which the artificial heart valve 62 is in its radially expanded configuration and implanted within the docking device 52 of the natural mitral valve 16. As shown in Figure 3B, the artificial heart valve 62 is received and held within the docking device 52. Thus, the docking device 52 helps to anchor the artificial heart valve 62 within the natural mitral valve 16. The docking device 52 allows for a good seal between the artificial heart valve 62 and the leaflets 24 of the natural mitral valve 16, and can reduce perivalvular leakage around the artificial heart valve 62.

[0070] Furthermore, as shown in Figure 3B, after the artificial heart valve 62 has been fully deployed and implanted within the docking device 52 in the natural mitral valve 16, the artificial valve delivery device 60 (including the delivery shaft 64) is removed from the patient 10, so that only the guide wire 40 and guide catheter 30 remain inside the patient 10.

[0071] Figure 4 illustrates another stage of mitral valve replacement surgery, with the guidewire 40 and guide catheter 30 removed from patient 10.

[0072] Figures 1-4 specifically depict mitral valve replacement, but it should be understood that the same and / or similar procedures can be used to replace other heart valves (such as the tricuspid valve, pulmonary valve, and / or aortic valve). Furthermore, the same and / or similar delivery devices (such as the delivery device 50, prosthetic valve delivery device 60, guide catheter 30, and / or guidewire 40), docking devices (such as the docking device 52), replacement heart valves (such as the prosthetic heart valve 62), and / or their components can be used to replace these other heart valves.

[0073] For example, when replacing a natural tricuspid valve, the user may also have access to the right atrium 20 via the femoral vein, but may not need to cross the atrial septum 22 to enter the left atrium 18. Instead, the user may leave the guidewire 40 in the right atrium 20 and perform the same and / or similar docking device implantation process at the tricuspid valve. Specifically, the user may push the docking device 52 out of the delivery shaft 54 ​​around the ventricular side of the tricuspid valve leaflets, freeing the rest of the docking device 52 from the delivery shaft 54 ​​in the right atrium 20, and then remove the delivery shaft 54 ​​of the delivery device 50 from the patient 10. The user may then advance the guidewire 40 through the tricuspid valve into the right ventricle and perform the same and / or similar artificial heart valve implantation process at the tricuspid valve inside the docking device 52. Specifically, the user may advance the delivery shaft 64 of the prosthetic valve delivery device 60 along the guidewire 40 through the patient's vascular system until the prosthetic heart valve 62 is positioned / placed within the docking device 52 and the tricuspid valve. The user may then expand the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery device 60 from the patient 10. In another embodiment, the user may perform the same and / or similar process to replace the aortic valve, but access the aortic valve from the outflow side via the femoral artery.

[0074] Furthermore, while Figures 1-4 depict mitral valve replacement surgery accessing the natural mitral valve 16 from the left atrium 18 via the right atrium 20 and femoral vein, it should be understood that the natural mitral valve 16 can be alternatively accessed from the left ventricle 26. For example, a user may access the natural mitral valve 16 from the left ventricle 26 via the aortic valve by advancing one or more delivery devices through the arteries to the aortic valve, and then through the aortic valve to the left ventricle 26.

[0075] Figures 5 to 11 schematically illustrate procedures for implanting an artificial medical device at a target implantation site in a subject (such as patient 10). In some embodiments, the procedure is a docking device implantation procedure for implanting a docking device 152 into the annular portion of the patient 10's natural mitral valve 16. In some embodiments, one exemplary difference between the docking device 52 in Figures 1 to 4 and the docking device 152 in Figures 5 to 11 is that the docking device 152 may optionally include a guard member 180 coupled to the docking device 152, the guard member 180 may be configured to further reduce the possibility of perivalvular leakage between the annular portion of the natural mitral valve 16 and the artificial heart valve (such as the artificial heart valve 62) positioned in the docking device 152.

[0076] The procedures shown in Figures 5 to 11 can be carried out using a delivery device 150 (which may also be referred to as a “docking device delivery device”). In some embodiments, one exemplary difference between the delivery device 150 and the delivery device 50 in Figures 1 to 4 is that the delivery device 150 may comprise three independently operable shafts: a delivery shaft 154 (which may also be referred to as a “dock delivery system shaft”), a sleeve shaft 182, and a pusher shaft 184 (which may also be referred to as a “dock shaft”). The pusher shaft 184 may be located within the sleeve shaft 182, which in turn may be located within the delivery shaft 154. In some embodiments, the delivery shaft 154, the sleeve shaft 182, and the pusher shaft 184 may be coaxial. The delivery shaft 154, sleeve shaft 182, and pusher shaft 184 operate independently of each other axially during the docking device implantation procedure to better position the docking device 152 within the annular portion of the natural mitral valve 16 so that the implanted docking device 152 better surrounds one or more chordae tendineae 27 of the heart 14 and provides a better seal between the implantation site and the artificial heart valve (such as the artificial heart valve 62).

[0077] During the procedure, the user of the delivery device 150 first uses the guide catheter 30 to create a pathway to the patient's natural heart valve (Figure 5). Next, the user advances the distal end portion of the delivery device 150 distally to advance the docking device 152 to the target implantation site (Figures 6 and 7). In some embodiments of the procedure, the user can operate the delivery system to change or adjust the curvature of the distal end portion of the delivery device 150 (see, for example, the leading turn 187 of the delivery device 150 in Figures 7 and 8). This adjustable radius of curvature may be referred to as a “variable encircling turn” (VET). The VET can facilitate encircling one or more chordae tendineae 27 that connect the valve leaflets 24 to the papillary muscles 28 of the heart 14, for example, by retracting the pusher shaft 184 proximal to the sleeve shaft 182.

[0078] In some embodiments where the docking device 152 further includes a guard member 180, the user can then retract the delivery shaft 154 and sleeve shaft 182 proximal to expose the guard member 180 (Figure 9) from the sleeve shaft 182. In some embodiments, the user can then advance the sleeve shaft 182 distally to apply an axial compressive force to the guard member 180, thereby shortening the guard member 180 axially and expanding it radially (Figure 10). Finally, the user can detach the docking device 152 from the pusher shaft 184 and remove the delivery device system 150 from the patient 10 (Figure 11).

[0079] Figure 5 illustrates the steps of a procedure in which a guide catheter 30 advances distally through the patient's vascular system into the left atrium 18 of the heart 14. The guide catheter 30 comprises a catheter shaft 34 including a distal end 72, a bent region 74, and a luminal outlet 76 on the distal end 72 of the catheter shaft 34. The luminal outlet 76 is connected to the catheter shaft lumen located within the catheter shaft 34. A delivery device (such as either an artificial device delivery device or an implant catheter as described in this disclosure) is configured to be located within the catheter shaft lumen. The catheter shaft lumen extends from the proximal end portion of the catheter shaft 34 (such as the portion of the catheter shaft 34 coupled to the handle 32) to the luminal outlet 76. The guide catheter 30 is positioned so that the distal end 72 of the catheter shaft 34 is located within the left atrium 18 of the heart 14.

[0080] In some embodiments, the catheter shaft 34 may include one or more pull wires for adjusting the curvature of the bent region 74 of the catheter shaft 34. In some embodiments, the pull wires may extend through a lumen connected to a lumen outlet 76 and may be connected to a portion of the catheter shaft 34, such as a pull wiring, at or adjacent to the distal end 72. In some embodiments, the pull wires may extend through one or more pull wire lumens embedded in the catheter shaft 34. In some embodiments, the curvature of the bent region 74 of the catheter shaft 34 can be adjusted by adjusting the tension of the pull wires. In some cases, the catheter shaft 34 (including its bent region 74) may be formed integrally as a single, single component. In some cases, the catheter shaft 34 may include one or more segments (e.g., the bent region 74, other regions, etc.) formed as separate components that are joined together (e.g., via fasteners, adhesives, mating features, and / or other means for joining). In some embodiments, the flexure region 74 may include a material that is more prone to bending, curving, and twisting than the rest of the catheter shaft 34 (e.g., a polymer with a relatively low durometer hardness). This allows the curvature of the flexure region 74 to be adjusted or increased at a different rate than the rest of the catheter shaft 34 when tension is applied to the pull wire. For example, the curvature of the flexure region 74 may change at a rate that increases relative to the proximal portion of the catheter shaft 34 as the tension of the pull wire increases. The catheter shaft 34 may also include one or more reinforcing blades or jackets to make the catheter shaft 34 more resistant to bending, curving, and twisting, for example, to prevent one or more of the lumens from twisting or collapsing when the catheter shaft 34 is manipulated.

[0081] During this stage, the docking device 152 is positioned within the sleeve shaft 182, which in turn is positioned within the delivery shaft 154, which in turn is positioned within the catheter shaft 34. The pusher shaft 184 is positioned proximal to and adjacent to the docking device 152 within the sleeve shaft 182. In some embodiments, the docking device 152, sleeve shaft 172, delivery shaft 154, and catheter shaft 34 can be coaxially aligned. During this stage, the docking device 152 is in a generally linear delivery configuration (i.e., without coiled or looped portions, but capable of bending or flexing) so as to maintain a small radial profile as it moves through the patient's vascular system.

[0082] Figure 6 illustrates the steps of the procedure in which the docking device 152, delivery shaft 154, sleeve shaft 182, and pusher shaft 184 advance distally through the luminal outlet 76 of the catheter shaft 34, through the left atrium 18, and to the natural mitral valve 16. The docking device 152 is located within the lumen of the sleeve shaft 182, which in turn is located within the lumen of the delivery shaft 154. The pusher shaft 184 is located proximal to and adjacent to the docking device 152 within the sleeve shaft 182.

[0083] In some embodiments, a delivery shaft 154, which may be similar to a delivery shaft 54, comprises a delivery shaft lumen into which a sleeve shaft 182 and a pusher shaft 184 can extend. The delivery shaft lumen is configured to extend axially along the length of the delivery shaft 154 between the handle of the delivery device 150 and the distal end portion 153 of the delivery shaft 154. The sleeve shaft 182 and the pusher shaft 184 are configured to exit the delivery shaft lumen through an opening in the distal end portion 153.

[0084] The sleeve shaft 182 extends through the delivery shaft 154 and is configured to cover at least a portion of the docking device 152 and the pusher shaft 184 as the docking device 152 is navigated through the patient's vascular system to the natural mitral valve 16. The sleeve shaft 182 has a sleeve shaft lumen that extends along the length of the sleeve shaft 182 between the handle of the delivery device 150 and the distal end portion 186 of the sleeve shaft 182. In some embodiments, a portion of the sleeve shaft 182 (e.g., the proximal end portion) may have a substantially U-shaped axial cross-section or other shape that allows the proximal end portion of the pusher shaft 184 to exit the sleeve shaft 182. The distal end portion of the pusher shaft 184 can exit the sleeve shaft 182 through an opening in the distal end portion 186 of the sleeve shaft 182.

[0085] The distal end portion 186 of the sleeve shaft 182 is configured to capture natural tissue (e.g., natural valve leaflets 24 and chordae tendineae 27). The sleeve shaft 182 may have a relatively low-friction and / or lubricating outer surface to reduce the possibility of the sleeve shaft 182 getting caught in natural tissue.

[0086] In some embodiments, the sleeve shaft 182 may include multiple layers. For example, the sleeve shaft 182 may include an innermost polymer layer, a braided or other type of flexible reinforcing layer, and an outermost polymer layer. In some embodiments, the reinforcing layer is a shape memory material and / or an elastic material (e.g., nitinol and / or stainless steel).

[0087] In some cases, the distal end portion 186 of the sleeve shaft 182 can be curved to facilitate the capture of natural tissue. This can be achieved by forming the distal end portion 186 of the sleeve shaft 182 in a curved configuration, and / or by forming the sleeve shaft 182 of a material that is relatively more flexible than the docking device 152, and by advancing the curved docking device 152 into the sleeve shaft 182, so that the sleeve shaft 182 takes on a curved configuration and / or the curvature of the sleeve shaft 182 is altered by the docking device 152.

[0088] In this way, the distal end portion 186 of the sleeve shaft 182 can form a leading turn 187 of the sleeve shaft, configured to capture the aponeurosis 27 as the sleeve shaft 182 advances around the leaflets 24 of the natural mitral valve 16. The leading turn 187 of the sleeve shaft is a portion of the sleeve shaft 182 located in the distal end portion 186, which has a curved portion of the sleeve shaft 182 having a radius of curvature, or adjacent to the distal end portion 186. When the docking device 152 is not covered within the portion of the sleeve shaft 182 corresponding to the leading turn 187 of the sleeve shaft, the leading turn 187 of the sleeve shaft has a radius of curvature equal to a first radius of curvature (r1). As will be discussed later in this application, particularly with reference to Figures 7 and 8, the radius of curvature of the leading turn 187 of the sleeve shaft can be changed by the relative motion between the sleeve shaft 182 and the docking device 152. In some embodiments, where the sleeve shaft 182 is made of, formed from, and / or can include a shape memory material, the sleeve shaft 182 may be originally formed such that the leading turn 187 of the sleeve shaft has a first radius of curvature (r1). The leading turn 187 of the sleeve shaft may be forced into another configuration having a different radius of curvature (e.g., a second radius of curvature (r2)), but can return to its original configuration having the first radius of curvature (r1) when the force is removed. In some embodiments, the second radius of curvature (r2) may be smaller than the first radius of curvature (r1).

[0089] In some embodiments, the leading turn 187 of the sleeve shaft can conform to the shape or curvature of another component (such as the docking device 152) covered by the leading turn 187 of the sleeve shaft, so that the radius of curvature of the leading turn 187 of the sleeve shaft is equal to the corresponding radius of curvature of the other component. Thus, the distal end portion 186 of the sleeve shaft 182 can have a smaller radius of curvature when the distal end portion (such as the leading turn 189) of the docking device 152 is positioned at or close to the distal end portion 186 of the sleeve shaft 182. This allows the docking device 152 to have a smaller radius of curvature than the sleeve shaft 182 and be relatively rigid. In some embodiments, the radius of curvature of the distal end portion 186 of the sleeve shaft 182 can be increased by moving the distal end of the docking device 152 proximal to the distal end portion 186 of the sleeve shaft 182, so that the sleeve shaft 182 can take on its predetermined configuration. This can be done by moving the docking device 152 proximal to the sleeve shaft 182 while maintaining the position of the sleeve shaft 182, by moving the sleeve shaft 182 distal to the docking device 152, or by a combination of both.

[0090] The pusher shaft 184 is configured to extend through the delivery shaft 154 and the sleeve shaft 182. The pusher shaft 184 is configured to be positioned proximal and adjacent to the docking device 152 within the sleeve shaft 182 while the docking device 152 is navigated through the patient's vascular system to the natural mitral valve 16. As the pusher shaft 184 moves axially relative to the sleeve shaft 182, the pusher shaft 184 can exert force on the docking device 152, causing it to move axially. In some embodiments, the docking device 152 can be detachably coupled to the pusher shaft 184 via a connection mechanism of the delivery device 150 so that it can be released after the docking device 152 has been deployed to the natural mitral valve 16.

[0091] In some embodiments, the distal end portion 153 of the delivery shaft 154 can be positioned between the leaflets 24 of the natural mitral valve 16 during this stage (e.g., at or near the posteromedial commissure). In some embodiments, the distal end portion 153 of the delivery shaft 154 can extend distally through the natural mitral valve 16 and be positioned adjacent to the natural mitral valve 16 in the left ventricle 26. In some embodiments, the distal end portion 153 of the delivery shaft 154 can be positioned adjacent to the natural mitral valve 16 in the left atrium 18.

[0092] Once the distal end portion 153 of the delivery shaft 154 is positioned, the docking device 152, sleeve shaft 182, and pusher shaft 184 advance distally from the opening in the distal end portion 153 of the delivery shaft 154 through the natural mitral valve 16 into the left ventricle 26.

[0093] Figure 7 illustrates the steps of the procedure in which the docking device 152 (located within the sleeve shaft 182), the sleeve shaft 182, and the pusher shaft 184 (located within the sleeve shaft 182 and adjacent to the docking device 152) wrap around or surround the valve leaflet 24 on the ventricular side of the natural mitral valve 16. As the docking device 152 exits the delivery shaft 154, the docking device 152 takes on a coiled configuration configured to wrap around or surround the valve leaflet 24 on the ventricular side of the natural mitral valve 16. In some embodiments in which the docking device 152 is constructed from, formed from, and / or can include shape memory material, the docking device 152 may originally be formed in a coiled configuration but may be forced into a linearized delivery configuration by the delivery shaft 154. The docking device 152 can revert to its original coiled configuration once it is no longer covered by the delivery shaft 154.

[0094] As mentioned above, the portion of the sleeve shaft 182 covering the docking device 152 can conform to or have the shape and / or curvature of the corresponding portion of the docking device 152. For example, the leading turn 187 of the sleeve shaft can conform to the leading turn 189 of the docking device 152, and the leading turn 189 has a radius of curvature equal to the second radius of curvature (r2). Thus, the leading turn 187 of the sleeve shaft can have a configuration having the second radius of curvature (r2). In other words, the variable encircling turn may be equal to the second radius of curvature (r2).

[0095] Figure 8 illustrates an optional step in a procedure to better capture the chordae tendineae 27 within the leading turn 189 of the docking device by increasing the radius of curvature of the leading turn 187 of the sleeve shaft (in other words, the variable encircling turn) from a second radius of curvature (r2) to a first radius of curvature (r1). In some embodiments, the radius of curvature of the leading turn 187 of the sleeve shaft can be increased by retracting the pusher shaft 184 proximal to the sleeve shaft 182, so that the leading turn 189 of the docking device and / or the docking device 152 are no longer covered by the leading turn 187 of the sleeve shaft. In some embodiments, the radius of curvature of the leading turn 187 of the sleeve shaft can be increased by advancing the distal end portion 186 of the sleeve shaft distal to the docking device 152. When the leading turn 187 of the sleeve shaft is no longer compelled to conform to the curvature of the leading turn 189 of the docking device having a second radius of curvature (r2), the leading turn 187 of the sleeve shaft can revert to its original configuration having a first radius of curvature (r1) that is greater than the second radius of curvature (r2). Since the chordae tendineae 27 are trapped within the leading turn 187 of the sleeve shaft, increasing the variable encircling turn to a larger first radius of curvature (r1) is beneficially possible, as the leading turn 187 of the sleeve shaft advances around the leaflet 24, more portions of the chordae tendineae 27 are trapped by the leading turn 187 of the sleeve shaft.

[0096] During the steps illustrated in Figure 8, the delivery shaft 154 can be kept stationary to maintain the position of the distal end portion 153 of the delivery shaft 154 relative to the natural mitral valve 16 (such as at or near the posteromedial commissure). In some embodiments, the sleeve shaft 182 can be kept stationary to maintain the position and / or radial orientation of the sleeve shaft 182 relative to the natural mitral valve 16. In some embodiments, the docking device 152 and / or the pusher shaft 184 can be kept stationary while the sleeve shaft 182 moves during this step. In some embodiments, neither the sleeve shaft nor the pusher shaft 184 is stationary at this stage.

[0097] As shown in Figure 8, the variable encircling turn can be adjusted after the sleeve shaft 182 has made one helical rotation around the leaflet 24. However, in some embodiments, the variable encircling turn can be adjusted after the sleeve shaft 182 has formed multiple helical turns around the valve leaflet 24. In some embodiments, the variable encircling turn may be adjusted before any helical turns are formed around the valve leaflet 24.

[0098] Figure 9 illustrates an optional "uncovering" step in the procedure, in which the delivery shaft 154 and sleeve shaft 182 are retracted proximal to uncover the guard member 180. The docking device 152 comprises a coil 188 defining a central region 190 having multiple helical turns wound around the valve leaflet 24, and a leading turn 189 of the docking device extending from the distal end portion of the central region 190.

[0099] The docking device 152 may further comprise a guard member 180 positioned on the docking device 152 such that when the docking device 152 is implanted in the natural mitral valve 16, the guard member 180 is positioned in or near the natural mitral valve 16 (for example, at or near the posteromedial commissure). In some embodiments, the guard member 180 may be positioned proximal adjacent to a central region (Figure 22), the central region may comprise a plurality of helical turns when the docking device 152 is wrapped around the valve leaflets 24. The guard member 180 may extend between a distal end portion 191 fixedly coupled to the docking device 152 and a movable proximal end portion 193 that can move axially along at least a portion of the docking device 152. In some embodiments, the distal end portion 191 of the guard member 180 may abut against the central region 190.

[0100] During the docking device implantation procedures shown in Figures 5 to 8, the guard member 180 can be covered by the delivery shaft 154 and the sleeve shaft 182. However, during the procedure illustrated in Figure 9, relative movement between the delivery shaft 154, the sleeve shaft 182, and the pusher shaft 184 can discover the guard member 180. In some embodiments, the sleeve shaft 182 can be retracted proximal from the left ventricle 26 through the mitral valve 16 into the left atrium 18 such that the distal end portion 186 of the sleeve shaft 182 is closer to the user than the proximal end portion 193 of the guard member 180. In some embodiments, the distal end portion 186 of the sleeve shaft 182 can be positioned distal to the lumen outlet 76. In some embodiments, the guard member 180 can be discovered by advancing the pusher shaft 184 distal to the sleeve shaft 182.

[0101] In some embodiments, the delivery shaft 154 can be retracted proximally through the left atrium 18 such that the distal end portion 153 of the delivery shaft 154 is closer to the user than the proximal end portion 193 of the guard member 180. In some embodiments, the delivery shaft 154 can be retracted into the catheter shaft lumen of the catheter shaft 34 through the lumen outlet 76. In some embodiments, the pusher shaft 184 can be advanced distally relative to the delivery shaft 154 such that the distal end portion 153 of the delivery shaft 154 is positioned proximal to the guard member 180.

[0102] Figure 10 illustrates an optional “seating” stage in the procedure in which the sleeve shaft 182 advances distally relative to the docking device 152 to shorten the guard member 180 axially and expand it radially. In some embodiments, the sleeve shaft 182 can advance distally such that the distal end portion 186 of the sleeve shaft 182 abuts and contacts the proximal end portion 193 of the guard member 180. In some embodiments, the pusher shaft 184 (and the docking device 152 coupled to the pusher shaft 184) can retract proximal such that the distal end portion 186 of the sleeve shaft 182 abuts and contacts the proximal end portion 193 of the guard member 180. The sleeve shaft 182 exerts force on the guard member 180, causing the proximal end portion 193 of the guard member 180 to advance distally relative to the docking device 152. Since the distal end portion 191 of the guard member 180 is fixedly coupled to the docking device 152, an axial force is applied to the guard member 180, causing it to radially expand into a deployed configuration. When in the deployed configuration, the guard member 180 further reduces the possibility of perivalvular leakage between the natural mitral valve 16 and the artificial heart valve (such as the artificial heart valve 62). The frictional engagement between the proximal end of the guard member 180 and the docking device 152 allows the guard member 180 to maintain its position relative to the docking device 152 when the sleeve shaft 182 retracts from the proximal end of the guard member 180. In some embodiments, the method may further include an optional “atrial exposure” stage between an optional de-covering stage and a seating stage, in which the handle 156 retracts proximal to the sleeve shaft 182.

[0103] Figure 11 illustrates a step in the procedure in which a delivery device 150, including a delivery shaft 154 and a sleeve shaft 182, retracts through the lumen of the catheter shaft 34. In some embodiments, the docking device 152 can be connected to the pusher shaft 184 via a release suture 194 which can be configured to be tied to the docking device 152. The release suture 194 can be cut during this step to release the docking device 152 from the delivery device 150.

[0104] Figure 12 illustrates an exemplary delivery assembly 100 (which may also be referred to as the “docking device delivery assembly,” “docking device delivery system,” or “delivery system”) that can be used in a procedure for implanting an artificial medical device, as described above with reference to Figures 5 to 11. The delivery system 100 includes a delivery device 150, a guide catheter 30, and a stabilizer assembly 200 (which may also be referred to as the “stabilization device”) configured to stabilize the delivery device 150 and / or the guide catheter 30 during the procedure.

[0105] Figure 13 illustrates a delivery device 150 according to one embodiment. The delivery device 150 may also be referred to as a "dock delivery device," "dock delivery catheter," or "dock delivery system." The delivery device 150 comprises a delivery shaft 154, a handle 156 (which may also be referred to as a "dock delivery system handle" or "dock handle") coupled to the proximal end of the delivery shaft 154, a sleeve shaft 182 configured to extend through the delivery shaft 154 and the handle 156, a hub assembly 158 (which may also be referred to as a "dock handle") coupled to the proximal end of the sleeve shaft 182, a pusher shaft 184 configured to extend through the handle 156 and the sleeve shaft 182, and a sleeve handle 196 coupled to the proximal end of the sleeve shaft 182.

[0106] The delivery shaft 154 may, in some embodiments, be similar to the delivery shaft 54 ​​and is configured to be advanced by the user through the patient's vascular system (blood vessels 12) to the implantation site (such as the natural mitral valve 16), and may be configured to hold a docking device 152 at the distal end portion 153 of the delivery shaft 154. During the docking device implantation procedure, the delivery shaft 154 advances through the catheter shaft 34 of the guide catheter 30 (for example, through its central lumen) to the target implantation site.

[0107] The handle 156 may, in some embodiments, be similar to the handle 56 and is configured to be grasped and / or otherwise held by a user outside the patient 10 to advance the delivery shaft 154 through the patient's vascular system (e.g., a blood vessel 12). In some embodiments, the handle 156 may include one or more articulated members 157 (e.g., a rotatable knob) configured to assist in navigating the delivery shaft 154 through the blood vessel 12 by maneuvering or controlling the bending of the delivery device 150 (e.g., the delivery shaft 154). Some embodiments of the articulated members 157 may be similar to the articulated members 57. The handle 156 has a handle lumen extending through the length of the handle 156, and the sleeve shaft 182 and pusher shaft 184 are configured to be located within the handle lumen. Since the sleeve and pusher shafts 182, 184 extending through the handle lumen also extend through the delivery shaft 154, the handle lumen can be aligned coaxially with the delivery shaft 154. In some embodiments, the handle 156 may further include a locking assembly 198 configured to lock a device (e.g., a sleeve shaft 182) inserted through the handle lumen to selectively prevent the device from moving relative to the handle 156 of the delivery device 150. In some embodiments, the locking assembly 198 may be located on the proximal end portion of the handle 156.

[0108] The hub assembly 158 is configured to be grasped and / or otherwise held by the user outside the patient 10's body in order to advance the pusher shaft 184 through the patient's vascular system. The distal end portion of the hub assembly 158 is coupled to the proximal end portion of the pusher shaft 184. The axial position of the pusher shaft 184 is controlled by moving the hub assembly 158 axially relative to the handle 156 and / or the sleeve handle 196. The hub assembly 158 is positioned proximal to the user relative to the handle 156, but distal to the user relative to the sleeve handle 196. The hub assembly 158 has a lumen that extends through the length of the hub assembly 158. The pusher shaft 184 is configured to be positioned within the lumen of the hub assembly and is coaxial with the sleeve shaft 182 coupled to the distal end portion of the hub assembly 158. In some embodiments, the hub assembly 158 further comprises a suture lock assembly 159 configured to be removably coupled to the proximal end of the release suture 194.

[0109] The sleeve handle 196 is configured to be grasped and / or otherwise held by the user outside the patient's body to advance the sleeve shaft 182 through the patient's vascular system. The sleeve handle 196 is coupled to the proximal end portion of the sleeve shaft 182 and is positioned proximal to the user, closer to the handle 156 and the hub assembly 158. The axial position of the sleeve shaft 182 is controlled by moving the sleeve handle 196 axially relative to the handle 156 and / or the hub assembly 158.

[0110] Further details regarding delivery devices / catheters / systems (including various embodiments of handle assemblies) configured to deliver a docking device to a target implantation site can be found in PCT Publications WO2020 / 247907 and WO2022 / 072509, and U.S. Patent Publications 2018 / 0318079 and 2018 / 0263764, all of which are incorporated herein by reference in their entirety.

[0111] Since the variable encircling turn can be adjusted based on the relative movement between the pusher shaft 184 and the sleeve shaft 182, the user of the docking device 150 can adjust the radius of curvature of the variable encircling turn (as shown in Figures 7 and 8) by moving the pusher shaft 184 axially relative to the sleeve shaft 182, or vice versa. Since the pusher shaft 184 is coupled to the hub assembly 158 and the sleeve shaft is coupled to the sleeve handle 196, in some embodiments the variable encircling turn can be adjusted by moving the hub assembly 158 distally relative to the sleeve handle 196 while the sleeve handle 196 remains stationary. In some embodiments the sleeve handle 196 can be moved proximal while the hub assembly 158 remains stationary. In some embodiments both the sleeve handle 196 and the hub assembly 158 can be moved axially. In some embodiments the handle 156 can remain stationary or can be moved relative to at least one of the sleeve handle 196 and the hub assembly 158.

[0112] Referring again to Figure 12, the guide catheter 30 and the delivery device 150 are configured to be coupled to a stabilizer assembly 200, which, among other things, can support and stabilize the guide catheter 30 and the delivery device 150 during the procedure. The stabilizer assembly 200 includes a platform 202, a stabilizer track 206 mounted on the platform 202, one or more supports 242 (e.g., clips, clamps, braces, etc.) that can be slidably coupled to the stabilizer track 206, and a hub assembly support 244 that can be slidably coupled to the stabilizer track 206.

[0113] The platform 202 is a table configured to support the stabilizer track 206. The platform 202 is configured to have an adjustable height and / or orientation, which can be adjusted relative to the surface on which the platform 202 rests (e.g., a ground surface or a table surface). In some embodiments, the platform 202 may include one or more articulated members 204 (e.g., rotatable knobs) for adjusting the height or orientation of the platform 202.

[0114] Figure 14 is an axial cross-sectional view of a stabilizer track 206 according to one embodiment. The stabilizer track 206 comprises an axially extending upper portion 208 (also referred to herein as the “upper plate”), an axially extending bottom portion 210 (also referred to herein as the “bottom plate”), and at least one axially extending reinforcing beam 212 (also referred to herein as the “reinforcing plate”, “reinforcing web”, or “reinforcing brace”). The reinforcing beam 212 can, in particular, increase the rigidity of the stabilizer track 206 and reduce vertical deflection along the length of the stabilizer track 206. The reinforcing beam 212 extends along the axial length of the stabilizer track 206. In some embodiments, the reinforcing beam 212 can extend along the entire axial length of the stabilizer track 206. In some embodiments, the reinforcing beam 212 can extend from the upper portion 208 toward the bottom portion 210. In some embodiments, the reinforcing beam 212 can extend from the bottom portion 210 toward the top portion 208. In some embodiments, the reinforcing beam 212 can be perpendicular to the top portion 208 and / or the bottom portion 210. In some embodiments, the reinforcing beam 212 can extend from the top portion 208 toward the bottom portion 210. In some embodiments, the reinforcing beam 212 can extend from the top portion 208 and only partway toward the bottom portion 210. In some embodiments in which the stabilizer track 206 comprises multiple reinforcing beams 212, a first reinforcing beam 212a can extend from the top portion 208 toward the bottom portion 210, and a second reinforcing beam 212b can extend from the top portion 208 and only partway toward the bottom portion 210.

[0115] In some embodiments, at least one reinforcing beam 212c may comprise an upper end portion 214 coupled to an upper portion 208, a lower end portion 216 coupled to a lower portion 210, and an intermediate portion 218 between the upper end portion 214 and the lower end portion 216. In some embodiments, the intermediate portion 218 may include an axial cross-section having an annular shape (such as an O-shape) or a semi-annular shape (such as a C-shape) to increase the second area moment of the reinforcing beam 212c, thereby making the reinforcing beam 212c more resistant to axial bending. In some embodiments in which the stabilizer track 206 comprises multiple reinforcing beams, at least one reinforcing beam 212c may include an intermediate portion 218 having an annular or semi-annular cross-section.

[0116] The stabilizer track 206 comprises a first rail 219a including a first web 220 and a first head 224, and a second rail 219b including a second web 222 and a second head 226. Although the illustrated stabilizer track 206 comprises two rails, the stabilizer track 206 may comprise any preferred number of rails (e.g., one rail, three rails, four rails, five rails, etc.). The first web 220 and the second web 222 each comprise a vertically oriented flange extending from the upper portion 208 along the axial length of the stabilizer track 206. In some embodiments, at least one of the first web 220 and the second web 222 may extend along the entire axial length of the stabilizer track 206. The first head 224 comprises a laterally oriented flange extending laterally from the upper end portion of the first web 220. In some embodiments, the first head 224 may extend laterally inward from the first web 220 toward the second head 226. The second head 226 includes a laterally oriented flange extending laterally from the upper end portion of the second web 222. In some embodiments, the second head 226 may extend laterally inward from the second web 222 toward the first head 224. In some embodiments, the first web 220 may include a first height 228 in the vertical direction, and the second web 222 may include a second height 230 in the vertical direction. In some embodiments, the first height 228 may be greater than the second height 230. In some embodiments, the first height 228 may be equal to the second height 230. In some embodiments, the first height 228 may be less than the second height 230.

[0117] In some embodiments, the stabilizer track 206 may further include at least one protrusion 232 extending from the upper portion 208 along the axial length of the stabilizer track 206. The at least one protrusion 232 is configured to improve frictional engagement between the brake pad of the stabilizer track lock 257 and the stabilizer track 206.

[0118] In some embodiments, the stabilizer track 206 can be formed from a polymer (such as acrylonitrile butadiene styrene ("ABS")), a metal (such as aluminum), and / or any other suitable material. In some embodiments, it may be preferable to form the stabilizer track 206 from a low-density or lightweight material to reduce the weight of the stabilizer track 206. In some embodiments, the entire stabilizer track 206 (including the top surface 208, bottom surface 210, first web 220, second web 222, first head 224, second head 226, and reinforcing beam 212) can be extruded as a single structure. Extruding the stabilizer track 206 as a single structure can improve the manufacturability of the delivery system by beneficially reducing the number of additional components, such as fasteners, required to assemble the stabilizer track 206.

[0119] In some embodiments, the stabilizer track 206 may further comprise one or more end caps configured to be coupled to the ends of the stabilizer track 206. In some embodiments, the end caps may be press-fitted to the ends of the stabilizer track 206.

[0120] Referring again to Figure 12, the stabilizer assembly 200 optionally includes a screw 233 (also referred to herein as a “clamp”) that can secure the stabilizer track 206 to the platform 202. The screw 233 comprises a first base plate 234 and a second base plate 236. Each of the first and second base plates 236 includes a cradle 238 extending from the upper portion of the respective base plates 234, 236, the cradle 238 being configured to receive a portion of the stabilizer track 206. In some embodiments, the screw 233 may include a mechanical fastener for coupling the first and second base plates 234 and 236 to the stabilizer track 206. Each of the first and second base plates 234 and 236 includes a jaw 240 extending from the bottom portion of the respective base plates 234, 236. When the first base plate 234 and the second base plate 236 are coupled to the stabilizer track 206, the jaws 240 of the first base plate 234 and the second base plate 236 form a vise that clamps the platform 202 between the jaws 240, thereby securing the stabilizer track 206 to the platform 204. In some embodiments, the jaws 240 can be aligned axially. In some embodiments, the vise 233 may further include a biasing member positioned on at least one of the first base plate 234 and the second base plate 236 to bias the jaws 240 to engage with the platform 202.

[0121] The support 242 can, in particular, hold or grasp the guide catheter 30 and handle 156 of the delivery device 150. Each of the support 242 includes a post configured to be repositioned or re-located axially on the stabilizer track 204, the post being configured to be coupled to a portion (such as the distal portion) of the guide catheter 30 or the handle 156. In some embodiments, at least one of the support 242 may include a position lock 243 configured to prevent the support 242 from moving axially along the stabilizer track 206. In some embodiments, the position lock 243 may include a threaded shaft that is movable between a locked configuration and an unlocked configuration. When the position lock 243 is in the locked configuration, the threaded shaft is in frictional contact with the stabilizer track 206, and this frictional contact prevents the support 242 from moving axially relative to the stabilizer track 206.

[0122] Figure 15 is a perspective view of a hub assembly support 244 (also referred to herein as the “hub assembly support assembly,” “hub assembly stabilizer,” or “hub assembly stabilizer assembly”) according to one embodiment. The hub assembly support 244 can, in particular, receive a hub assembly 158 and a sleeve handle 196. In some embodiments, the hub assembly support 244 can be configured to support, stabilize, and / or align the hub assembly 158 and the sleeve handle 196 during docking device implantation procedures, thereby supporting, stabilizing, and / or aligning the sleeve shaft 182 and the pusher shaft 184. The hub assembly support 244 comprises a pusher cart 246 coupled to a stabilizer track 206, a sleeve cart 260 coupled to the stabilizer track 206, and a rack 272 extending between the pusher cart 246 and the sleeve cart 260.

[0123] The pusher cart 246 (also referred herein as the “pusher post,” “pusher shaft support,” or “dock cart”) can, among other things, be coupled to the stabilizer track 206 for a first portion of the delivery device 150. In some embodiments, the first portion of the delivery device 150 may be a pusher shaft (such as a pusher shaft 184) or a hub assembly (such as a hub assembly 158) coupled to the proximal end of the pusher shaft. The pusher cart 246 may comprise a pusher cart chassis 248 (also referred herein as a “column” or “post”), a clamp 250 extending from the pusher cart chassis 248, and first and second rail engagement flanges 254, 256 positioned on the bottom portion of the pusher cart chassis 248. The clamp 250 is configured to receive a first portion of the delivery device 150 (such as a pusher shaft 184) (see, for example, Figure 12) so that the first portion of the delivery device 150 is releasably coupled to the pusher cart 246. In some embodiments, the clamp 250 may extend from the upper portion of the pusher cart chassis 248. First and second rail engagement flanges 254, 256 are configured to connect the pusher cart 246 to the stabilizer track 206. The first rail engagement flange 254 extends in a first lateral direction from the pusher cart chassis 248, and the second rail engagement flange 256 extends in a second lateral direction opposite to the first lateral direction from the pusher cart chassis 248. The first rail engagement flange 254 is configured to fit below the first head 224 and laterally adjacent to the first web 220 of the stabilizer track 206, thereby engaging with the first rail 219a of the stabilizer track 206. The second rail engagement flange 256 is configured to fit below the second head 226 and laterally adjacent to the second web 222 of the stabilizer track 206, thereby engaging with the second rail 219b of the stabilizer track 206.In some embodiments, where the height 228 of the first web 220 is greater than the height 230 of the second web 222, the first rail engagement flange 254 may have a vertical thickness greater than the vertical thickness of the second rail engagement flange 256.

[0124] In some embodiments, rail engagement flanges (such as a first rail engagement flange 254 or a second rail engagement flange 256) are laterally movable to facilitate coupling and / or uncoupling of the pusher cart 246 to and from the stabilizer track 206. In some embodiments, the rail engagement flanges can be slidably coupled to the pusher cart chassis 248 so that they can move laterally between a locked configuration and an unlocked configuration. In the locked configuration, the rail engagement flanges extend laterally outward from the pusher cart chassis 248 and are positioned below the heads (such as a first head 224 or a second head 226) and adjacent to the rail webs (such as a first web 220 or a second web 222), thereby engaging with the rails and locking the pusher cart 246 to the stabilizer track 206. In the unlocked configuration, the rail engagement flange retracts at least partially into the pusher cart chassis 248 to disengage the rail, thereby allowing the pusher cart 246 to be disengaged from the stabilizer track 206. In some embodiments, the rail engagement flange can be biased in the locked configuration by at least one biasing member. In some embodiments, the biasing member may be a spring. In some embodiments, the pusher cart 246 may further include a button coupled to the lateral flange. When pressed, the button can actuate the rail engagement flange between the locked and unlocked configurations.

[0125] In some embodiments, the pusher cart 246 may further comprise a stabilizer track lock 257 (also referred to herein as the “brake”) configured to lock the pusher cart 246 to the stabilizer track 206. The stabilizer track lock 257 comprises a brake pad, a cam, and a rotatable knob 258 that is operable between a locked configuration and an unlocked configuration. In the locked configuration, the brake pad extends from the pusher cart chassis 248 and frictionally engages with the stabilizer track 206. In some embodiments, the brake pad may extend from the bottom portion of the pusher cart chassis 248. The brake pad is coupled to the knob 258 via a cam. When the knob 258 rotates (e.g., vertically), the rotational motion of the knob 258 is converted by the cam into linear motion (e.g., vertically) to cause the brake pad to frictionally contact a portion of the stabilizer track 206 (e.g., the upper portion 208 of the stabilizer track 206). In some embodiments, the pusher cart 246 may further include a marking 259 indicating whether the pusher cart 246 is locked to the stabilizer track 206 (i.e., whether the stabilizer track lock 257 is engaged). In some embodiments, the brake pad may be formed from silicone. In some embodiments, the brake pad may be formed from any material having a coefficient of friction sufficient to prevent the pusher cart 246 from moving along the stabilizer track 206.

[0126] The sleeve cart 260 (also referred to herein as “sleeve post” or “sleeve shaft support”) can, in particular, be coupled to the stabilizer track 206 for a second portion of the delivery device 150. In some embodiments, the second portion of the delivery device 150 may be a sleeve shaft (e.g., sleeve shaft 182). In some embodiments, the second portion of the delivery device 150 may be a sleeve handle (e.g., sleeve handle 196) coupled to the sleeve shaft. In some embodiments, the sleeve cart 260 may be positioned proximal to the pusher cart 246 on the stabilizer track 206. The sleeve cart 260 comprises a sleeve cart chassis 262, a clamp 264 extending from the upper portion of the sleeve cart chassis 262, and first and second rail engagement flanges 268, 270 positioned on the bottom portion of the sleeve cart chassis 262. The clamp 264 is configured to receive the second portion of the delivery device 150. In some embodiments, the clamp 264 may extend from the upper portion of the sleeve cart chassis 262. However, the clamp 264 can extend from any preferred portion of the sleeve cart 260. The first rail engagement flange 268 and the second rail engagement flange 270 are configured to connect the sleeve cart 260 to the stabilizer track 206. The first rail engagement flange 268 extends in a first lateral direction from the sleeve cart chassis 262, and the second rail engagement flange 270 extends in a second lateral direction from the sleeve cart chassis 262, with the first lateral direction being opposite to the second lateral direction. The first rail engagement flange 268 is configured to fit below the first head 224 and laterally adjacent to the first web 220 of the stabilizer track 206, thereby engaging with the first rail 219a of the stabilizer track 206. The second rail engagement flange 270 is configured to fit below the second head 226 and laterally adjacent to the second web 222 of the stabilizer track 206, thereby engaging with the second rail 219b of the stabilizer track 206.In some embodiments, where the height 228 of the first web 220 is greater than the height 230 of the second web 222, the first rail engagement flange 268 may have a vertical thickness greater than the vertical thickness of the second rail engagement flange 270.

[0127] In some embodiments, rail engagement flanges (such as a first rail engagement flange 268 or a second rail engagement flange 270) are laterally movable to facilitate coupling and / or uncoupling of the sleeve cart 260 to and from the stabilizer track 206. In some embodiments, the rail engagement flanges can be slidably coupled to the sleeve cart chassis 262 so that they can move laterally between a locked configuration and an unlocked configuration. In the locked configuration, the rail engagement flanges extend laterally outward from the sleeve cart chassis 262 and settle beneath the heads (such as a first head 224 or a second head 226) and adjacent to the rail webs (such as a first web 220 or a second web 222), thereby locking the sleeve cart 260 to the stabilizer track 206. In the unlocked configuration, the rail engagement flanges retract at least partially into the sleeve cart chassis 262 to disengage the heads, thereby allowing the sleeve cart 260 to be uncoupled from the stabilizer track 206. In some embodiments, the rail engagement flange can be biased in a configuration locked by at least one biasing member. In some embodiments, the biasing member may be a spring. In some embodiments, the sleeve cart 260 may further include a button coupled to the lateral flange. When pressed, the button can actuate the rail engagement flange between a locked configuration and an unlocked configuration.

[0128] The rack 272 (also referred to herein as “rack gear,” “guide member,” “guide rack,” “guide rail,” or “linear gear”) can, in particular, help to adjust the axial distance between the pusher cart 246 and the sleeve cart 260. The rack 272 comprises an axially elongated beam 274 that extends axially, including a first axial end portion 276 (such as a distal end portion) and a second axial end portion 278 (such as a proximal end portion). In some embodiments, the first axial end portion 276 can be fixedly coupled to the pusher cart 246. In some embodiments, the sleeve cart 260 can be configured to be slidably coupled to the rack 272 so that the sleeve cart 260 can selectively slide along either the length of the rack 272 or the length of the stabilizer track 206. In some embodiments, the sleeve cart 260 can slide between the first axial end portion 276 and the second axial end portion 278 along the length of the rack 272. In some embodiments, the rack 272 may include a stopper 279 coupled to the second axial end portion 278 to prevent the sleeve cart 260 from sliding off the rack 272 and passing through the second axial end portion 278. The rack 272 includes a plurality of teeth 280 arranged axially along the beam 274. In some embodiments, the sleeve cart 260 may include a slot 282 extending axially through the sleeve cart chassis 262. The slot 282 may be configured to receive a portion of the rack 272.

[0129] In some embodiments, the hub assembly support 244 may include a rod extending between the pusher cart 246 and the sleeve cart 260 instead of the rack 272. One exemplary difference between the rod and the rack 272 is that the rod does not have multiple teeth 280.

[0130] In some embodiments, the rack 272 can be replaced with a linear actuator configured to adjust the axial separation of the pusher cart 246 and the sleeve cart 260. The linear actuator may comprise a first axial end portion (such as a distal end portion) coupled to the pusher cart 246 and a second axial end portion (such as a proximal end portion) coupled to the sleeve cart 260. The linear actuator may be configured to extend or retract axially. When the linear actuator extends or retracts, it can move the pusher cart 246 relative to the sleeve cart 260, or the sleeve cart 260 relative to the pusher cart 246, or both the pusher cart 246 and the sleeve cart 260 relative to each other. In some embodiments, the linear actuator may comprise a piston (such as a hydraulic, pneumatic, or piezoelectric piston), an extendable cylinder, a screw, a pulley, or any other suitable coupling capable of linear motion.

[0131] Figures 16A and 16B show a cross-sectional view of a sleeve cart 260 according to one embodiment (more specifically, a cross-sectional view of a sleeve cart chassis 262). The sleeve cart 260 includes a lock assembly 284 configured to selectively engage (or lock) a stabilizer track 206 and a rack 272. The lock assembly 284 includes a stabilizer track lock 286 configured to frictionally engage with the stabilizer track 206, a rack lock 288 configured to engage with the rack 272, and a rotatable knob 290 configured to actuate both the stabilizer track lock 286 and the rack lock 288.

[0132] The lock assembly 284 is operable between a first mode (also referred to herein as the "VET OFF mode") and a second mode (also referred to as the "variable encircling turn mode", "VET mode", or "VET ON mode").

[0133] When the lock assembly 284 is in the first mode (Figure 16A), the stabilizer track lock 286 (Figure 16B) disengages the stabilizer track 206, and the rack lock 288 engages with the teeth 280 of the rack 272, thereby maintaining a constant axial separation distance between the pusher cart 246 and the sleeve cart 260. The lock assembly 284 prevents relative movement between the pusher cart 246 and the sleeve cart 260 (and consequently, relative movement between the pusher shaft 184 and the sleeve shaft 182), thereby allowing the pusher cart 246 and the sleeve cart 260 to move along the stabilizer track 206 at the maintained relative distance. Thus, when the lock assembly 284 is in the first "VET OFF" mode, the lock assembly 284 prevents the variable circling turn from being adjusted.

[0134] When the lock assembly 284 is in the second mode (Figure 16B), the stabilizer track lock 286 on the sleeve cart 260 engages with the stabilizer track 206, and the rack lock 288 on the sleeve cart 260 disengages the teeth 280 of the rack 272. Thus, when the lock assembly 284 is in the second "VET ON" mode, the pusher cart 246 and the rack 272 can move axially relative to the sleeve cart 260, thereby allowing adjustment of the radius of curvature of the variable encircling turn, as shown in Figures 7 and 8. Since the variable encircling turn is adjusted based on the relative movement between the independently operable shafts, it should be understood that the lock assembly 284 can alternatively be configured so that the sleeve cart 260 moves relative to the pusher cart 246, or so that both the pusher cart 246 and the sleeve cart 260 move relative to each other in the second "VET ON" mode.

[0135] In some embodiments, the lock assembly 284 can be operated between a first mode and a second mode by rotating the knob 290 between a first rotational position and a second rotational position, respectively. As illustrated in Figure 15, the first rotational position is a horizontal position (parallel to the axial direction), and the second rotational position is a vertical position (perpendicular to both the axial and transverse directions). Therefore, the first and second rotational positions of the knob 290 are separated by approximately 90 degrees. However, in some embodiments, the first and second rotational positions can be oriented in any preferred direction with respect to the axial direction. The sleeve cart 260 further includes markings 291 for indicating the first and second rotational positions. However, some embodiments of the lock assembly 284 may include a button, switch, lever, slider, keypad, or any other preferred control interface instead of the knob 290 to operate the lock assembly 284 between the first and second modes.

[0136] The stabilizer track lock 286 (also referred to herein as “rail lock,” “rail position lock,” or “track lock”) can, in particular, releasably couple the sleeve cart 260 to the stabilizer track 206 to prevent axial movement of the sleeve cart 260 relative to the stabilizer track 206. The stabilizer track lock 286 comprises a brake pad 292 extending from the bottom portion of the sleeve cart chassis 262 and a cam operably coupling the brake pad 292 to a knob 290. When the knob 290 rotates from a first rotational position (corresponding to the first or “VET OFF” mode) to a second rotational position (corresponding to the second or “VET ON” mode), the knob 290 rotates the cam, which converts the rotational motion of the knob 290 into linear motion, causing the brake pad 292 to frictionally engage with a portion of the stabilizer track 206 (e.g., the upper portion 208 of the stabilizer track 206).

[0137] The rack lock 288 (also referred to herein as the "rack gear lock," "guide member lock," or "guide rail lock") can, in particular, fix the sleeve cart 260 to the rack 272, preventing axial movement of the sleeve cart 260 relative to the rack 272 and the pusher cart 246 fixedly coupled to the rack 272. The rack lock 288 comprises a rotatable disk 293 operably coupled to the knob 290 and a pin 294 extending laterally from the disk. The pin 294 extends laterally from the disk 293 and includes an off-axis pin radially offset from the center of rotation of the disk 293. When the knob 290 rotates from a second rotation position (corresponding to the second mode or "VET ON" mode) to a first rotation position (corresponding to the first mode or "VET OFF" mode), the disk 293 rotates with the knob 90 such that the pin 294 engages with at least one of the multiple teeth 280 of the rack 272. Therefore, when the lock assembly 284 is in the first mode, the rack lock 288 prevents the sleeve cart 260 from sliding axially along the rack 272 relative to the pusher cart 246, thereby preventing the radius of curvature of the variable encircling turn from being adjusted.

[0138] In some embodiments, when the rack 272 is replaced with a rod lacking several teeth 280, the rack lock 288 is replaced with a friction brake configured to frictionally engage with the rod, thereby locking the sleeve cart 260 onto the rod. The friction brake can be operably coupled to the knob 290.

[0139] In some embodiments, the cam of the stabilizer track lock 286 can be coupled to the disc 293 of the rack lock 288 instead of the knob 290.

[0140] In some embodiments, the lock assembly 284 may further include a hard stop configured to prevent the knob 290 from rotating beyond a first or second rotation position.

[0141] By coupling both the stabilizer track lock 286 and the rack lock 288 to a single control unit (such as the knob 290), the user can configure the hub assembly support 244 in a single step, action, or motion to adjust the variable encircling turn illustrated in Figures 7 and 8, thereby making the use of the hub assembly support 244 during any selected variable encircling turn step of the exemplary docking device implantation procedure easier and more intuitive.

[0142] Because the variable encircling turn can be adjusted based on the relative movement between the sleeve shaft 182 and the pusher shaft 184, some embodiments of the hub assembly support 244 feature a lock assembly 284 located in the pusher cart 246 rather than the sleeve cart 260, such that the pusher cart 246 is slidably coupled to the rack 272 and the sleeve cart 260 is fixedly coupled to the rack 272. In some embodiments, both the pusher cart 246 and the sleeve cart 260 are slidably coupled to the rack 272 so that both the pusher cart 246 and the sleeve cart 260 can move relative to each other in a second mode ("VET ON" mode). In such embodiments, both the pusher cart 246 and the sleeve cart 260 may be equipped with a rack lock 288, or one (or both) of the pusher cart 246 and the sleeve cart 260 may be equipped with a stabilizer track lock 286.

[0143] Figures 17A to 17E illustrate the configuration of the delivery system 100 during the exemplary docking device delivery procedure illustrated in Figures 5 to 11. More specifically, Figures 17A to 17E illustrate the relative axial positions of the handle 156, hub assembly 158, hub assembly support 244, and sleeve handle 196 during various stages of the exemplary procedure. The docking device delivery assembly 100 may further comprise other components such as a guide catheter 30, but these components are omitted in Figures 17A to 17E for clarity.

[0144] Figure 17A illustrates the configuration of the docking device delivery assembly 100 during a stage of the exemplary docking device delivery procedure illustrated in Figure 5. After the guide catheter 30 is deployed, the handle 156, pusher cart 246, and sleeve cart 260 advance integrally axially (indicated by arrow 295) along the stabilizer track 206. Since the delivery shaft 154 is coupled to the handle 156, the sleeve shaft 182 is coupled to the sleeve cart 260 (e.g., via clamp 264), and the pusher shaft 184 is coupled to the pusher cart 246 (e.g., via clamp 250), and by advancing the handle 156, pusher cart 246, and sleeve cart 260, the delivery shaft 154, pusher shaft 184, and sleeve shaft 182 are similarly advanced integrally toward the target implantation site. During this stage, the lock assembly 284 is in a first mode (indicated by the horizontal orientation of the knob 290) to lock the sleeve cart 260 to the rack 272 and unlock the sleeve cart 260 from the stabilizer track 206, thereby maintaining a constant axial separation between the pusher cart 246 and the sleeve cart 260 as the pusher cart 246 and the sleeve cart 260 slide along the stabilizer track 206. In some embodiments in which the pusher cart 246 further includes a stabilizer track lock 257, the stabilizer track lock 257 can be unlocked (as indicated by the horizontal orientation of the knob 258) to allow the pusher cart 246 to slide freely along the stabilizer track 206.

[0145] Figure 17B illustrates the configuration of the docking device delivery assembly 100 during the stages of the exemplary docking device delivery procedure illustrated in Figure 6. After the delivery shaft 154 is advanced to the natural mitral valve 16, the sleeve shaft 182 and pusher shaft 184 are advanced integrally from the delivery shaft 154 by advancing the pusher cart 246 and sleeve cart 260 integrally distally (indicated by arrow 296) along the stabilizer track 206. The handle 156 remains in an axial position fixed to the stabilizer track 206. During this stage, the lock assembly 284 is in a first mode (indicated by the horizontal orientation of the knob 290) to lock the sleeve cart 260 to the rack 272 and unlock the sleeve cart 260 from the stabilizer track 206, thereby maintaining a constant axial separation between the pusher cart 246 and the sleeve cart 260 as the pusher cart 246 and the sleeve cart 260 slide along the stabilizer track 206. In some embodiments in which the pusher cart 246 further includes a stabilizer track lock 257, the stabilizer track lock 257 can be unlocked (as indicated by the horizontal orientation of the knob 258) to allow the pusher cart 246 to slide freely along the stabilizer track 206.

[0146] Figure 17C illustrates the configuration of the delivery assembly 100 during an optional stage of the exemplary docking device delivery procedure illustrated in Figures 7 and 8, when the variable encircling turn is adjusted. During this stage, the lock assembly 284 is activated from a first mode ("VET OFF" mode) to a second mode ("VET ON" mode) to disengage the sleeve cart 260 from the rack 272 and lock and / or fixate the sleeve cart 260 to the stabilizer track 206. Once the sleeve cart 260 and rack 272 are disengaged, the pusher cart 246 moves along the stabilizer track 206 proximal to the sleeve cart 260 (indicated by arrow 297) to retract the pusher shaft 184 relative to the sleeve shaft 182. In some embodiments, the pusher cart 246 further comprises a stabilizer track lock 257, which can be unlocked (as indicated by the horizontal orientation of the knob 258) to allow the pusher cart 246 to slide freely along the stabilizer track 206 during adjustment of the variable encircling turn. In some embodiments, the pusher cart 246 can move along the stabilizer track 206 distal to the sleeve cart 260 (opposite to the direction of arrow 297) to advance the pusher shaft 184 relative to the sleeve shaft 182, thereby reducing the radius of curvature of the variable encircling turn.

[0147] Naturally, the variable encircling turn is adjusted based on the relative movement between the sleeve shaft 182 and the pusher shaft 184. Therefore, Figure 17C illustrates that the pusher cart 246 is moving axially relative to the sleeve cart 260, and some embodiments of this stage may include moving the sleeve cart 260 distally (opposite to the direction of arrow 297). In such embodiments, the pusher cart 246 may be locked to the stabilizer track 206. Alternatively, some embodiments of this stage may include moving both the pusher cart 246 and the sleeve cart 260 relative to each other such that the pusher cart 246 moves proximal (in the direction of arrow 297) and the sleeve cart 260 moves distally (opposite to the direction of arrow 297). In such embodiments, neither the pusher cart 246 nor the sleeve cart 260 is locked to the stabilizer track 206.

[0148] Figure 17D illustrates the configuration of the docking device delivery system 100 during an optional stage of the exemplary docking device delivery procedure illustrated in Figure 9, when the sleeve shaft 182 retracts to discover the guard member 180. During this stage, the sleeve handle 196 is actuated independently by removing or disengaging the sleeve handle 196 from the sleeve cart 260 (for example, by removing the sleeve handle from the clamp 264) and moving the sleeve handle 196 proximal (indicated by arrow 298) relative to the handle 156, hub assembly 158 and hub assembly support 244. During this stage, the lock assembly 284 is actuated from a second mode ("VET ON" mode) to a first mode ("VET OFF" mode, indicated by the horizontal orientation of the knob 290) to lock the sleeve cart 260 to the rack 272, thereby preventing the pusher cart 246 from moving axially relative to the sleeve cart 260. In some embodiments, the pusher cart 246 further comprises a stabilizer track lock 257, which locks the pusher cart 246 onto the stabilizer track 206 (indicated by the vertical orientation of the knob 258), thereby preventing the pusher shaft 184 from moving during this stage.

[0149] Since the guard member 180 is uncovered by the relative movement between the sleeve shaft 182 and the pusher shaft 184, some embodiments of the steps illustrated in Figure 17D may include moving the hub assembly 158 distally (opposite direction to the arrow 298) relative to the sleeve handle 196. For example, the lock assembly 284 may be set to a second mode so that the pusher cart 246 and the hub assembly 158 can move distally relative to the sleeve cart 260 and the sleeve handle 196. In some embodiments, the pusher shaft 184 can be disengaged from the pusher cart 246 so that the hub assembly 158 can move freely axially relative to the sleeve shaft 182 and the sleeve handle 196. In some embodiments, the hub assembly support 244 may be configured so that both the pusher cart 246 and the sleeve cart 260 move relative to each other during this step to uncover the guard member 180. In some embodiments where the docking device delivery procedure includes an optional atrial exposure step, the handle 156 can be retracted proximally while the pusher cart 246 is locked to the stabilizer track 206.

[0150] Figure 17E illustrates the configuration of the docking device delivery assembly 100 during an optional step of the exemplary docking device delivery procedure illustrated in Figure 10, when the distal end portion 186 of the sleeve shaft 182 is advanced distally, thereby applying force to the proximal end portion 193 of the guard member 180 and shortening the guard member 180 axially. The distal end portion 186 of the sleeve shaft 182 is advanced by advancing the sleeve handle 196 distally (indicated by arrow 299). In some embodiments in which the pusher cart 246 further comprises a stabilizer track lock 257, the stabilizer track lock 257 is locked to lock the pusher cart 246 to the stabilizer track 206 (indicated by the vertical orientation of the knob 258), thereby preventing the pusher shaft 184 from moving during this step.

[0151] Since the guard member 180 is shortened axially by the relative movement between the sleeve shaft 182 and the pusher shaft 184, some embodiments of the steps illustrated in Figure 17E may include moving the hub assembly 158 proximal to the sleeve handle 196 (in the opposite direction to the arrow 299). For example, the lock assembly 284 may be set to a second mode so that the pusher cart 246 and the hub assembly 158 can move proximal to the sleeve cart 260 and the sleeve handle 196. In some embodiments, the pusher shaft 184 can be discoupled from the pusher cart 246 so that the hub assembly 158 can move freely axially relative to the sleeve shaft 182 and the sleeve handle 196. In some embodiments, the hub assembly support 244 may be configured so that both the pusher cart 246 and the sleeve cart 260 move relative to each other during this step, shortening the guard member 180 axially.

[0152] Figure 18 shows a stabilizer track 306 according to a second embodiment.

[0153] Figure 19 shows a hub assembly support 344 according to a second embodiment. One exemplary difference between the hub assembly support 344 and the hub assembly support 244 of Figure 15 is that the pusher cart 346 is cantilevered from the sleeve cart 260 and is not directly coupled to the stabilizer track 206. Therefore, the pusher cart 346 lacks the first and second rail engagement flanges 254, 256 because it is not configured to be directly coupled to the stabilizer track 206. In some embodiments, the cantilevered design of the hub assembly support 344 can be reversed so that the sleeve cart 260 can be cantilevered from the pusher cart 346. In some embodiments, cantilevering either the pusher cart 346 or the sleeve cart 260 allows for a beneficial reduction in the length of the stabilizer track 206, as the hub assembly support 344 is coupled to the stabilizer track 206 at only one point.

[0154] Figure 20 illustrates a guide catheter 30 (which may be referred to herein as the “introducer device”) according to one embodiment. In some embodiments, the guide catheter 30 can be used in artificial valve implantation procedures as described above with reference to Figures 1 to 4. In some embodiments, the guide catheter 30 can be used in docking device implantation procedures as described above with reference to Figures 5 to 11. The guide catheter 30 can be inserted into the patient’s vascular system to introduce the implant catheter into the patient’s vascular system and to at least partially guide the implant catheter within it to the target implantation site, and can be configured to receive the implant catheter (and / or delivery device) therein. Embodiments of implant catheters for artificial medical devices (hereinafter referred to as “delivery device 150” and “delivery device 400”) that can be received within the guide catheter 30 are shown in Figures 13 and 24, respectively.

[0155] The illustrated guide catheter 30 comprises a handle 32, a catheter shaft 34 extending distally from the handle 32, and a longitudinal axis 36. In some embodiments, the catheter shaft 34 may extend proximal to the handle 32. In some embodiments, the catheter shaft 34 may be coupled to the distal end portion of the handle 32. The handle 32 includes a catheter handle lumen (not shown) extending through the length of the handle 32. The catheter handle lumen is axially aligned with the catheter shaft lumen and coupled to the distal end portion of the catheter shaft 34 so that a delivery shaft 154, a sleeve shaft 182, and a pusher shaft 184 may extend through the catheter handle lumen and the catheter shaft lumen. In some embodiments, the catheter shaft lumen and the delivery shaft 154 may be aligned with the longitudinal axis 36.

[0156] Figure 21 illustrates a guide catheter 30 coupled to a delivery device 150 according to one embodiment.

[0157] Figure 22 illustrates a guide catheter 30 coupled to a docking device delivery device 350 according to a second embodiment. The docking device delivery device 350 comprises a handle 356 (which may be the same as the handle 156), a hub assembly 358 (which may be the same as the hub assembly 158) with a suture lock assembly 359, and a sleeve handle 196.

[0158] Figure 23 illustrates a docking device 152 according to one embodiment. As depicted in Figure 23, the unfolded coiled docking device 152 is configured to receive and fix an artificial valve (such as an artificial heart valve 62) inside the docking device 152, thereby fixing the artificial valve to the annular portion of the natural mitral valve 16.

[0159] The docking device 152 includes a coil 188. In some embodiments, the coil 188 may include a shape memory material (e.g., nickel-titanium alloy, or "nitinol") so that the docking device 152 (and the coil 188) can transition from a substantially linear configuration (or delivery configuration) when placed inside the delivery shaft 154 to a helical unfolded configuration after being removed from the delivery shaft 154.

[0160] The coil 188 has a proximal end 188p and a distal end 188d (which also define the proximal and distal ends of the docking device 152, respectively). When positioned within the delivery shaft 154 (for example, during the delivery of the docking device 152 into the patient's vascular system), the body of the coil 188 between the proximal end 188p and the distal end 188d forms a generally straight delivery configuration (having no coiled or looped portions, but being bent or curved) to maintain a small radial profile as it moves through the patient's vascular system. After being removed from the delivery shaft 154 and unfolded at the implantation site, the coil 188 transitions from a delivery configuration to a helical unfolded configuration and wraps around the natural tissue adjacent to the implantation site. For example, the coil 188 can be configured to surround the natural valve leaflets (and the chordae tendineae connecting the natural valve leaflets to the adjacent papillary muscles) when the docking device is implanted at the location of the natural valve.

[0161] The unfolded coiled coil 188 includes a docking device leading turn 189, a central region 190, and a stabilizing turn 195 (or "stabilizing coil") around a central longitudinal axis.

[0162] In the unfolded coil configuration, the central region 190 comprises one or more helical turns formed around the central longitudinal axis of the docking device 152, the helical turns having substantially equal radii of curvature configured to surround the leaflets 24 of the natural mitral valve 16. The docking device leading turn 189 extends from the distal end of the central region 190 and has a larger radius of curvature than the helical turns of the central region 190. In some embodiments, the radius of curvature of the docking device leading turn 189 of the docking device 152 is equal to the second inner radius of curvature, and the second inner radius of curvature is smaller than the first inner radius of curvature of the sleeve shaft leading turn 187.

[0163] In the illustrated embodiment, the stabilizing turn 195 extends from the proximal end of the central region 190 and has a radius of curvature greater than that of the central region 190. Alternatively, the stabilizing turn 195 may have a radius of curvature equal to, approximately equal to, or smaller than (as opposed to) that of the central region 190, and / or the stabilizing turn may include fewer turns than the complete turn depicted in Figure 23.

[0164] In some embodiments, the docking device 152 may further include a guard member 180 positioned on the coil 188. The guard member is configured to reduce the possibility of perivalvular leakage between the natural mitral valve 16 and the artificial heart valve. In some embodiments, the guard member 180 may include a braided portion positioned between the distal end portion 191 and the proximal end portion 193 of the guard member 180. The braided portion is configured to shorten into an unfolded configuration when the proximal end portion 193 is forced distally, and the braided portion has increased radial thickness in the shortened unfolded configuration.

[0165] Further details regarding the docking device and its variations are described in PCT Publication WO2022 / 087336, which is incorporated herein by reference in its entirety.

[0166] Figure 24 illustrates a delivery device 400 (which may also be referred to in this disclosure as “implant catheter” and / or “heart valve delivery device”) that can be used to implant an expandable artificial heart valve according to one embodiment. In some embodiments, the delivery device 400 is particularly adapted for use in introducing an artificial heart valve into the heart. For example, the delivery device 400 can be used as an artificial valve delivery device 60 in an artificial valve implantation procedure, as described above with reference to Figure 3A.

[0167] The delivery device 400 in the illustrated embodiment in Figure 24 is a balloon catheter comprising a handle 402 and a maneuverable outer shaft 404 extending distally from the handle 402. The delivery device 400 further comprises an intermediate shaft 406 (which may also be called a balloon shaft) extending proximal and distally from the handle 402, the portion of which extends distally from the handle 402 also extends coaxially through the outer shaft 404. In some embodiments, the delivery device 400 may further comprise an inner shaft that extends coaxially distally from the handle 402 through the intermediate shaft 406 and the outer shaft 404, and that extends coaxially proximal from the handle 402 through the intermediate shaft.

[0168] The outer shaft 404 and the intermediate shaft 406 can be configured to translate (e.g., move) longitudinally relative to each other along the central longitudinal axis 420 of the delivery device 400 in order to facilitate the delivery and positioning of the artificial valve at the implantation site in the patient's body.

[0169] The intermediate shaft 406 may include a proximal end portion that extends proximal from the proximal end of the handle 402 to the adapter 412. The adapter 412 may include a first port 438 configured to receive a guidewire through its interior, and a second port 440 configured to receive fluid (e.g., expansion fluid) from a fluid source. The second port 440 may be fluidically coupled to the inner lumen of the intermediate shaft 406.

[0170] In some embodiments, the intermediate shaft 406 may further include a distal end portion that extends distally beyond the distal end of the outer shaft 404 when the distal end of the outer shaft 404 is positioned away from the inflatable balloon 418 of the delivery device 400. The distal end portion of the inner shaft may extend distally beyond the distal end portion of the intermediate shaft 406 toward or to the nose cone 422 at the distal end of the delivery device 400.

[0171] In some embodiments, the distal end of the balloon 418 can be coupled to the distal end of the delivery device 400, such as a nose cone 422 (as shown in Figure 24), or to an alternative component at the distal end of the delivery device 400 (e.g., the distal shoulder). The middle portion of the balloon 418 can cover the valve mounting portion 424 of the distal end of the delivery device 400, and the distal portion of the balloon 418 can cover the distal shoulder of the delivery device 400. As shown in Figure 24, the artificial heart valve 450 can be mounted around the balloon 418 at the valve mounting portion 424 of the delivery device 400 in a radially compressed state. The artificial heart valve 450 can be configured to expand radially by the inflation of the balloon 418 at the natural valve annulus, as described above with reference to Figure 3A.

[0172] The balloon shoulder assembly of the delivery device 400, including the distal shoulder, is configured to maintain the artificial heart valve 450 (or other medical device) in a fixed position on the balloon 418 during delivery through the patient's vascular system.

[0173] The outer shaft 404 may include a distal tip portion 428 mounted on its distal end. In some embodiments, the outer shaft 404 and the intermediate shaft 406 can be axially translated relative to each other to position the distal tip portion 428 adjacent to the proximal end of the valve mounting portion 424 when the prosthetic valve 450 is mounted radially compressed on the valve mounting portion 424 (for example, as shown in Figure 24) and during delivery of the prosthetic valve to the target implantation site. Thus, the distal tip portion 428 can be configured to resist the movement of the prosthetic valve 450 axially relative to the balloon 418, proximal to the balloon 418, when the distal tip portion 428 is positioned adjacent to the proximal side of the valve mounting portion 424.

[0174] An annular space can be defined between the outer surface of the inner shaft and the inner surface of the intermediate shaft 406, and can be configured to receive fluid from a fluid source via the second port 440 of the adapter 412. The annular space can be fluid-coupled to a fluid passage formed between the outer surface of the distal end portion of the inner shaft and the inner surface of the balloon 418. Thus, fluid from the fluid source can flow from the annular space into the fluid passage, inflating the balloon 418 and radially expanding and deploying the artificial valve 450.

[0175] The inner lumen of the inner shaft can be configured to receive a guidewire through which the distal end of the delivery device 400 is passed to the target implantation site.

[0176] The handle 402 may include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 400. In the illustrated embodiment, for example, the handle 402 includes an adjustment member, such as the illustrated rotatable knob 460, which is operably coupled to the proximal end portion of the pull wire. The pull wire may extend distally from the handle 402 through the outer shaft 404 and has a distal end portion fixed to the outer shaft 304 at or near the distal end of the outer shaft 404. By rotating the knob 460, the tension of the pull wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 400. Further details relating to a steering or bending mechanism for the delivery device can be found in U.S. Patent No. 9,339,384, which has been incorporated by reference previously.

[0177] The handle 402 may further include an adjustment mechanism 461, which includes an adjustment member such as the illustrated rotatable knob 462, and an associated locking mechanism, which includes another adjustment member configured as a rotatable knob 478. The adjustment mechanism 361 is configured to adjust the axial position of the intermediate shaft 406 relative to the outer shaft 404 (for example, for fine positioning at the implant site).

[0178] The artificial valves disclosed herein (e.g., artificial heart valve 450, artificial heart valve 62) may be radially compressible and expandable between a radially compressed state and a radially expanded state. Therefore, the artificial valve can be crimped or held by the implant delivery device (e.g., delivery device 400, artificial valve delivery device 60, etc.) in a radially compressed state during delivery, and then expand to a radially expanded state after the artificial valve has reached the implantation site. It will be understood that the artificial valves disclosed herein can be used with various implant delivery devices and implanted via various delivery procedures, and such embodiments will be discussed in more detail below.

[0179] Figure 25 illustrates an artificial valve 450 in a radially expanded position. The artificial valve 450 can be used as an artificial heart valve 62 in an artificial valve implantation procedure, as described above with reference to Figures 1 to 4. Although all of the artificial valves disclosed herein are adapted to be implanted in the natural aortic annulus, in other embodiments they can be adapted to be implanted in other natural annulus of the heart (pulmonary valve, mitral valve, and tricuspid valve). The disclosed artificial valves can also be implanted in the pulmonary artery (to replace the function of an affected pulmonary valve), or in the superior or inferior vena cava (to replace the function of an affected tricuspid valve), or in blood vessels communicating with the heart, including various other veins, arteries, and blood vessels of the patient. The disclosed artificial valves can also be implanted in a valve-in-valve procedure within a previously implanted artificial valve (which may be an artificial surgical valve or an artificial transcatheter heart valve).

[0180] In some embodiments, the disclosed prosthetic valve can be implanted within a docking device or anchoring device (e.g., docking device 152) implanted inside a natural heart valve or blood vessel. For example, in one embodiment, the disclosed prosthetic valve can be implanted within a docking device implanted in a pulmonary artery to replace the function of an affected pulmonary artery, as disclosed in U.S. Publication No. 2017 / 0231756, incorporated herein by reference. In another embodiment, the disclosed prosthetic valve can be implanted within a natural mitral valve or within a docking device implanted in a natural mitral valve, as disclosed in PCT Publication No. WO2020 / 247907, incorporated herein by reference, etc. In yet another embodiment, the disclosed prosthetic valve can be implanted within a docking device implanted in the superior or inferior vena cava to replace the function of an affected tricuspid valve, as disclosed in U.S. Publication No. 2019 / 0000615, incorporated herein by reference, etc.

[0181] The artificial valve 450 can be used as an artificial heart valve 62 in an artificial valve implantation procedure, as described above with reference to Figures 1 to 4. As shown in Figure 25, the artificial valve 450 may include a frame 452, and a plurality of valve leaflets 454 may be at least partially located within the frame 452. The artificial valve 450 may also include an outer cover 456 located around the frame 452. As shown in Figure 25, the artificial valve 450 includes an inlet end 457 and an outlet end 458. The terms “inlet” and “outlet” relate to the normal direction of blood flow through the artificial valve 450 (e.g., antegrade blood flow). For example, the valve leaflets 454 can allow blood flow through the valve 450 in the direction from the inlet end 457 to the outlet end 458 and prevent backflow (e.g., prevent flow in the direction from the inlet end 458 to the inlet end 457).

[0182] The frame 452 can be made of either a variety of suitable plastically expandable materials (e.g., stainless steel) or a self-expanding material (e.g., nitinol), as is known in the art. If constructed from a plastically expandable material, the frame 452 (and thus the valve 450) can be crimped into a radially compressed state on the delivery catheter and then expanded in the patient's body by an inflatable balloon or an equivalent expansion mechanism. If made of a self-expanding material, the frame 452 (and thus the valve 450) can be crimped into a radially compressed state and confined in a compressed state by insertion into the sheath of the delivery catheter or an equivalent mechanism. Once inside the body, the valve can be advanced from the delivery sheath, thereby allowing the valve to expand to its functional size.

[0183] Suitable plastically expandable materials that can be used to form the frames disclosed herein (e.g., frame 452) include metallic alloys, polymers, or combinations thereof. Exemplary metallic alloys may include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some embodiments, frame 452 may include stainless steel. In some embodiments, frame 452 may include cobalt-chromium. In some embodiments, frame 452 may include nickel-cobalt-chromium. In some embodiments, frame 452 includes a nickel-cobalt-chromium-molybdenum alloy such as MP35N® (a trade name of SPS Technologies), which is equivalent to UNS R30035 (coated by ASTM F562-02). MP35N® / UNS R30035 contains 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium, and 10 wt% molybdenum.

[0184] The outer cover 456 may be formed entirely or partially from any suitable biological material, synthetic material (e.g., any of the various polymers), or a combination thereof. In some embodiments, the outer cover 456 may include a fabric having woven yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some embodiments, the fabric may have a plush nap or pile. Exemplary fabrics having a plush nap or pile include velour, velvet, velveteen, corduroy, terrycloth, and fleece. In some embodiments, the outer cover 456 may include a fabric without woven yarns or fibers, such as felt or electrospun fabric. Exemplary materials that can be used to form such fabrics (with or without woven yarns or fibers) include, but are not limited to, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), stretched polytetrafluoroethylene (ePTFE), and polyamide. In some embodiments, the outer cover 456 may include non-woven or non-fabric materials, such as films containing any of the various crystalline or semi-crystalline polymer materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), or polyurethane (such as thermoplastic polyurethane (TPU)). In some embodiments, the outer cover 456 may include sponge materials or foams, such as polyurethane foam. In some embodiments, the outer cover 456 may include natural tissues, such as pericardium (e.g., bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0185] Further details of artificial heart valves and their modifications are described in U.S. Patent No. 11,185,406, which is incorporated herein by reference in its entirety.

[0186] delivery technique To implant a prosthetic valve into the natural aortic valve via a transfemoral delivery approach, the prosthetic valve is fitted in a radially compressed state along the distal end of the delivery device. The prosthetic valve and the distal end of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned inside the natural aortic valve and expanded radially (for example, by inflating a balloon, driving one or more actuators of the delivery device, or by deploying the prosthetic valve from the sheath to allow self-expansion of the prosthetic valve). Alternatively, the prosthetic valve can be implanted inside the natural aortic valve via a transapical procedure, in which the prosthetic valve (on the distal end of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned inside the natural aortic valve. As an alternative configuration, in transaortic procedures, the prosthetic valve (on the distal end of the delivery device) is introduced into the aorta through a surgical incision of the ascending aorta, such as through a partial J-sternotomy or a small right parasternal thoracotomy, and then advanced through the ascending aorta toward the natural aortic valve.

[0187] To implant the prosthetic valve into the natural mitral valve via a transseptal delivery approach, the prosthetic valve is fitted in a radially compressed state along the distal end of the delivery device. The prosthetic valve and the distal end of the delivery device are inserted into the femoral vein, into and through the inferior vena cava into the right atrium, across the atrial septum (through a puncture performed within the atrial septum) into the left atrium, and advanced toward the natural mitral valve. Alternatively, the prosthetic valve can be implanted into the natural mitral valve via a transapical approach, in which the prosthetic valve (on the distal end of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and at the apex of the heart, and the prosthetic valve is positioned within the natural mitral valve.

[0188] To implant a prosthetic valve into the natural tricuspid valve, the prosthetic valve is fitted in a radially compressed state along the distal end of the delivery device. The prosthetic valve and the distal end of the delivery device are inserted into the femoral vein, advanced into the inferior vena cava, and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned within the natural tricuspid valve. A similar approach can be used to implant a prosthetic valve into the natural pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the natural tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0189] Another delivery approach is the transatrial approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through a chest incision and an incision formed through the atrial wall (of the right or left atrium) to access one of the natural heart valves. Atrial delivery can also be performed intravascularly, for example, through the pulmonary vein. Yet another delivery approach is the transventricular approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through a chest incision and an incision formed through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve into the natural tricuspid valve, natural pulmonary valve, or pulmonary artery.

[0190] In all delivery approaches, the delivery device can be advanced along a guidewire previously inserted into the patient's vascular system. Furthermore, the disclosed delivery approaches are not intended to be limiting. Any of the artificial valves disclosed herein can be implanted using any of the various delivery procedures and devices known in the art.

[0191] sterile Any system, device, apparatus, etc. described herein can be sterilized (e.g., by heating / heat, pressure, steam, radiation, and / or chemicals) to ensure safety for patient use, and any method described herein may include sterilization of the relevant system, device, apparatus, etc. as one of its steps. Examples of thermal / heat sterilization include steam sterilization and autoclave. Examples of radiation for sterilization include, but are not limited to, gamma rays, ultraviolet rays, and electron beams. Examples of chemicals for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization using hydrogen peroxide may be achieved, for example, by using hydrogen peroxide plasma.

[0192] simulation Therapeutic techniques, methods, steps, etc. described or suggested in this specification or in references incorporated herein may be performed in living animals or in non-living simulations, such as cadavers, cadaveric hearts, anthropomorphic ghosts, or simulators (in which body parts, tissues, etc., are simulated).

[0193] Additional examples of the disclosed technology In consideration of the above-mentioned implementation of the disclosed subject matter, this application discloses the following additional embodiments. It should be noted that one feature of a single embodiment, or two or more features of an embodiment taken in combination with one or more features of one or more further embodiments of any choice, are further embodiments that also fall within the disclosure of this application.

[0194] Example 1. A docking device delivery assembly, A delivery device, A first shaft extending distally, and A delivery device comprising a second shaft coaxial with a first shaft, A support for a delivery device, comprising, Tracks that extend in the axial direction, A first cart slidably coupled to a track, wherein the first cart is configured to be coupled to a first shaft of a delivery device, A guide member fixedly attached to the first cart, A second cart that is operable between a first mode and a second mode, The second cart is configured to be coupled to the second shaft. In the first mode, the second cart is slidably coupled to the track and fixedly coupled to the guide member. In a second mode, a docking device delivery assembly is provided, in which a second cart is fixedly coupled to a track and slidably coupled to a guide member.

[0195] Example 2. Any embodiment of this specification, in particular the docking device delivery assembly of Example 1, further comprising a locking assembly configured to selectively engage with a track and guide member, wherein the second cart further comprises a locking assembly.

[0196] Example 3. Any embodiment of the specification, in particular the docking device delivery assembly of Example 2, wherein the lock assembly comprises a track lock.

[0197] Example 4. Any embodiment of this specification, in particular the docking device delivery assembly of Example 3, wherein the track lock is locked to the track in the second mode and unlocked from the track in the first mode.

[0198] Example 5. Any embodiment of this specification, in particular the docking device delivery assembly of Example 3, wherein the track lock comprises a brake pad configured to frictionally engage with the track.

[0199] Example 6. Any embodiment of this specification, in particular the docking device delivery assembly of Example 2, wherein the lock assembly comprises a guide member lock.

[0200] Example 7. Any embodiment of this specification, in particular the docking device delivery assembly of Example 6, wherein the guide member lock is locked to the guide member in a first mode and unlocked from the guide member in a second mode.

[0201] Example 8. Any embodiment of the specification, in particular the docking device delivery assembly of Example 6, wherein the guide member comprises a plurality of teeth extending axially along the guide member, and the guide member lock comprises a pin configured to engage with at least one of the plurality of teeth.

[0202] Example 9. Any embodiment of this specification, in particular the docking device delivery assembly of Example 6, wherein the guide member lock comprises a friction brake configured to frictionally engage with the guide member.

[0203] Example 10. A support for a delivery device, wherein the support is Tracks that extend in the axial direction, A first cart configured to slide along a track and to connect to a first part of a delivery device, A guide rail is fixedly connected to the axial end portion of the first cart and extends in the axial direction, A second cart is configured to slide along a track and to be coupled to a second part of the delivery device, and the second cart is It features a lock assembly that can be operated between a first mode and a second mode, In the first mode, the lock assembly engages with the guide rail and disengages the track. In the second mode, the lock assembly disengages the guide rail and engages the track with the support.

[0204] Example 11. A support of any embodiment of this specification, particularly of Example 10, wherein the lock assembly comprises a track lock and a guide rail lock.

[0205] Example 12. Any embodiment of this specification, in particular the support of Example 11, comprising a brake pad configured to frictionally engage with the track lock.

[0206] Example 13. Any embodiment of this specification, in particular the support of Example 11, wherein the guide rail comprises a plurality of teeth extending axially along the guide rail, and the guide rail lock comprises a pin configured to engage with at least one of the plurality of teeth.

[0207] Example 14. Any embodiment of this specification, in particular the support of Example 11, wherein the guide rail lock comprises a friction brake configured to frictionally engage with the guide rail.

[0208] Example 15. Any embodiment of this specification, in particular the support of Example 11, wherein the lock assembly further comprises a rotatable knob for operating the lock assembly between a first mode and a second mode.

[0209] Example 16. A support of any embodiment of this specification, in particular the support of Example 15, wherein a rotatable knob is configured to actuate both the track lock and the guide rail lock.

[0210] Example 17. Any embodiment of this specification, in particular any one of Examples 10 to 16, wherein the first cart further comprises a clamp configured to receive the first part of the delivery device.

[0211] Example 18. Any embodiment of the specification, in particular any one of Examples 10 to 17, in which the first knob of the delivery device is a pusher shaft.

[0212] Example 19. Any embodiment of this specification, in particular any one of Examples 10 to 18, wherein the second cart further comprises a clamp configured to receive a second portion of the delivery device.

[0213] Example 20. A support in any embodiment of this specification, particularly any one of Examples 10 to 19, in which the second knob of the delivery device is a sleeve shaft.

[0214] Example 21. Support assembly, A rack gear comprising a first axial end portion and a second axial end portion, A first cart fixedly coupled to the first axial end portion, A second cart configured to slide along a rack gear between a first axial end portion and a second axial end portion, It is a lock assembly, A lock configured to lock the second cart to the rack gear, and A support comprising a lock assembly having a rotatable knob configured to actuate the lock assembly.

[0215] Example 22. Any embodiment of this specification, in particular the support assembly of Example 21, wherein the rack gear comprises a plurality of teeth extending in the axial direction.

[0216] Example 23. Any embodiment of this specification, in particular the support assembly of Example 22, wherein the lock assembly comprises a disk rotatable between a locked configuration and an unlocked configuration, and a pin extending from the disk, wherein the pin is configured to engage with at least one of a plurality of teeth.

[0217] Example 24. Any embodiment of this specification, in particular the support assembly of Example 23, wherein the pins are off-axis pins extending from the side of the disk.

[0218] Example 25. Any embodiment of this specification, in particular any one of Examples 21-24, of a support assembly in which a rotatable knob is rotatable between a first rotation position and a second rotation position.

[0219] Example 26. Any embodiment of this specification, in particular the support assembly of Example 25, further comprising a hard stop that prevents a rotatable knob from rotating beyond at least one of a first rotation position and a second rotation position.

[0220] Example 27. Any embodiment of this specification, in particular any one of Examples 21 to 26, wherein the support assembly further comprises a hard stop on the second axial end portion of the rack gear.

[0221] Example 28. Any embodiment of this specification, in particular any one of Examples 21-27, of the support assembly, wherein the first cart is cantilevered from the second cart.

[0222] Example 29. A stabilizer assembly for a delivery device, wherein the stabilizer assembly is Tracks that extend in the axial direction, The first post attached to the track, A rack gear comprising a proximal end portion and a distal end portion, wherein the distal end portion is fixedly coupled to the proximal end portion of a first post, A second post attached to the track, and the second post is A second post comprising a slot extending axially through the second post and configured to receive at least a portion of a rack gear, A locking assembly that is operable between a first position and a second position, In the first position, the lock assembly disengages the rack gear and engages the track. In the second position, the stabilizer assembly engages with the rack gear and disengages the track.

[0223] Example 30. Any embodiment of this specification, in particular the stabilizer assembly of Example 29, wherein the track comprises a first web having a first height and a second web having a second height.

[0224] Example 31. Any embodiment of this specification, in particular the stabilizer assembly of Example 30, wherein the first height is greater than the second height.

[0225] Example 32. A stabilizer assembly of any embodiment of this specification, in particular any one of Examples 29-31, in which the track comprises a single structure.

[0226] Example 33. Any embodiment of the specification, in particular any one of Examples 29-32, of a stabilizer assembly in which the rail is an extruded structure.

[0227] Example 34. A stabilizer assembly of any embodiment of this specification, in particular any one of Examples 29-33, in which the rail is formed of ABS.

[0228] Example 35. A stabilizer assembly of any embodiment of this specification, in particular any one of Examples 29-34, wherein the rail is formed of aluminum.

[0229] Example 36. Any embodiment of this specification, in particular any one of Examples 29-35, wherein the rail comprises a top surface, a bottom surface, and at least one reinforcing web extending between the top surface and the bottom surface.

[0230] Example 37. Any embodiment of this specification, in particular the stabilizer assembly of Example 36, wherein at least one reinforcing web comprises an upper end portion bonded to the upper surface, a lower end portion bonded to the bottom surface, and an intermediate portion.

[0231] Example 38. Any embodiment of this specification, in particular the stabilizer assembly of Example 37, wherein the intermediate portion has a C-shaped axial cross-section.

[0232] Example 39. Any embodiment of this specification, in particular the stabilizer assembly of Example 37, wherein the intermediate portion has an O-shaped axial cross-section.

[0233] Example 40. Hub assembly support for a delivery device, A first post configured to be slidably coupled to an axially extending track, A guide rail fixedly coupled to the axial end portion of the first post, the guide rail extending axially from the axial end portion of the first post, A hub assembly support comprising a second post slidably coupled to both the track and the guide rail.

[0234] Example 41. A hub assembly support of any embodiment of this specification, in particular Example 40, wherein the second post further comprises a locking assembly, the locking assembly being configured to selectively engage with the track and guide rails and to restrict the relative movement of the first post along the track with respect to the second post.

[0235] Example 42. A track for a delivery device stabilizer assembly, wherein the track is An upper surface extending along the length of the track, A bottom surface that extends along the length of the track, A first web extending from the top surface along the length of the track, wherein the first web has a first height, A second web extending from the top surface along the length of the track, The first web has a second height, The first height is different from the second height. A track is formed as a single structural unit.

[0236] Example 43. A method for implanting an artificial medical device, The delivery device is coupled to the stabilizer assembly, The delivery device comprises first and second coaxial shafts, and the first and second coaxial shafts are capable of operating independently. The stabilizer assembly, Rails oriented in the axial direction, A first post slidably coupled to a rail, wherein a first shaft is configured to be coupled to the first post, A second post slidably coupled to a rail, wherein a second shaft is configured to be coupled to the second post, A guide member fixedly coupled to the first post and slidably coupled to the second post, A coupling comprising a lock assembly positioned on a second post and configured to selectively engage with rails and guide members, The first post and the second post are made to slide integrally along the rail in the distal direction, Activating the lock assembly to engage with the rail and disengaging the guide member, A method comprising sliding a first post axially relative to a second post.

[0237] Example 44. Any embodiment of this specification, in particular the method of Example 43, further comprising the step of sliding the first post proximal to the second post, then acting the lock assembly to disengage the rail and engage it with the guide member.

[0238] Example 45. Any embodiment of this specification, in particular the method of Example 44, further comprising the steps of: acting the lock assembly to disengage the rail and engage it with the guide member, then disengaging the second shaft from the second post and acting the second shaft in the proximal direction.

[0239] Example 46. Any embodiment of this specification, in particular the method of Example 45, further comprising the step of acting the second shaft distally after acting the second shaft proximal.

[0240] Example 47. Any embodiment of this specification, in particular the method of Example 46, further comprising the step of operating the handle of the delivery device in the proximal direction after disengaging the second shaft from the second post and operating the second shaft in the proximal direction, and before operating the second shaft in the distal direction.

[0241] With respect to any embodiment, the features described in this disclosure can be combined with other features described in any one or more of the other embodiments, unless otherwise specified. For example, any one or more features of a hub assembly support can be combined with any one or more features of another hub assembly support. In another embodiment, any one or more features of one docking device delivery device can be combined with any one or more features of another docking device delivery device.

[0242] Given the many possible ways in which the principles of this disclosure may be applied, it should be recognized that the illustrated configurations describe embodiments of the disclosed technology and should not be considered as limiting the scope of this disclosure or the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A docking device delivery assembly, A delivery device, A first shaft extending distally, and A delivery device comprising a second shaft coaxial with the first shaft, The delivery device comprises a support for the delivery device, wherein the support is Tracks that extend in the axial direction, A first cart slidably coupled to the track, wherein the first cart is configured to be coupled to the first shaft of the delivery device, A guide member fixedly attached to the first cart, A second cart that is operable between a first mode and a second mode, The second cart is configured to be coupled to the second shaft, In the first mode, the second cart is slidably coupled to the track and fixedly coupled to the guide member. A docking device delivery assembly in the second mode, wherein the second cart is fixedly coupled to the track and slidably coupled to the guide member.

2. The docking device delivery assembly according to claim 1, further comprising a locking assembly configured to selectively engage with the track and the guide member of the second cart.

3. The docking device delivery assembly according to claim 2, wherein the lock assembly comprises a track lock.

4. The docking device delivery assembly according to claim 3, wherein the track lock is locked to the track in the second mode and unlocked from the track in the first mode.

5. The docking device delivery assembly according to claim 3, wherein the track lock comprises a brake pad configured to frictionally engage with the track.

6. The docking device delivery assembly according to claim 2, wherein the lock assembly comprises a guide member lock.

7. The docking device delivery assembly according to claim 6, wherein the guide member lock is locked to the guide member in the first mode and unlocked from the guide member in the second mode.

8. The docking device delivery assembly according to claim 6, wherein the guide member comprises a plurality of teeth extending along the guide member in the axial direction, and the guide member lock comprises a pin configured to engage with at least one of the plurality of teeth.

9. The docking device delivery assembly according to claim 6, wherein the guide member lock comprises a friction brake configured to frictionally engage with the guide member.

10. A stabilizer assembly for a delivery device, wherein the stabilizer assembly is Tracks that extend in the axial direction, A first post coupled to the aforementioned track, A rack gear comprising a proximal end portion and a distal end portion, wherein the distal end portion is fixedly coupled to the proximal end portion of the first post, A second post coupled to the aforementioned track, wherein the second post is A second post having a slot extending axially through the second post and configured to receive at least a portion of the rack gear, A locking assembly that is operable between a first position and a second position, In the first position, the lock assembly disengages the rack gear and engages with the track. A stabilizer assembly in which, in the second position, the lock assembly engages with the rack gear and disengages the track.

11. The stabilizer assembly according to claim 10, wherein the track comprises a first web having a first height and a second web having a second height.

12. The stabilizer assembly according to claim 11, wherein the first height is greater than the second height.

13. The stabilizer assembly according to any one of claims 10 to 12, wherein the track comprises a single structure.

14. The stabilizer assembly according to any one of claims 10 to 13, wherein the rail is an extruded structure.

15. The stabilizer assembly according to any one of claims 10 to 14, wherein the rail comprises an upper surface, a lower surface, and at least one reinforcing web extending between the upper surface and the lower surface.

16. The stabilizer assembly according to claim 15, wherein the at least one reinforcing web comprises an upper end portion bonded to the upper surface, a lower end portion bonded to the bottom surface, and an intermediate portion.

17. The stabilizer assembly according to claim 16, wherein the intermediate portion has a C-shaped axial cross-section.

18. The stabilizer assembly according to claim 16, wherein the intermediate portion has an O-shaped axial cross-section.

19. A method of implanting artificial medical devices, The delivery device is coupled to the stabilizer assembly, The delivery device comprises a first and a second coaxial shaft, and the first and second coaxial shafts are independently operable. The stabilizer assembly, Rails oriented in the axial direction, A first post slidably coupled to the rail, wherein the first shaft is configured to be coupled to the first post, A second post slidably coupled to the rail, wherein the second shaft is configured to be coupled to the second post, A guide member fixedly coupled to the first post and slidably coupled to the second post, A lock assembly positioned on the second post and configured to selectively engage with the rail and the guide member, comprising: The first post and the second post are slid integrally along the rail in the distal direction, The lock assembly is activated to engage with the rail and the guide member is disengaged. A method comprising sliding the first post relative to the second post in the axial direction.

20. The method according to claim 19, further comprising the step of sliding the first post axially relative to the second post, then acting the lock assembly to disengage the rail and engage it with the guide member.

21. The method according to claim 20, further comprising the steps of: acting the lock assembly to disengage the rail, engaging it with the guide member, then disengaging the second shaft from the second post, and acting the second shaft in the proximal direction.

22. The method according to claim 21, further comprising the step of moving the second shaft in the distal direction after moving the second shaft in the proximal direction.

23. The method according to claim 22, further comprising the step of disengaging the second shaft from the second post, operating the second shaft in the proximal direction, and before operating the second shaft in the distal direction, operating the handle of the delivery device in the proximal direction.

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