Artificial medical device delivery systems

Abstract

The delivery system includes a delivery device and a stabilizer assembly. The delivery device includes a delivery shaft, a sleeve shaft, a pusher shaft, a hub assembly coupled to the pusher shaft, and a sleeve handle coupled to the sleeve shaft. The delivery shaft, sleeve shaft, and pusher shaft may be configured to be independently actuable. The stabilizer assembly includes a hub assembly cradle that receives the hub assembly, a sleeve handle cradle that receives the sleeve handle, and an actuator that axially moves the hub assembly cradle relative to the sleeve handle cradle. The stabilizer assembly is configured to actuate the hub assembly relative to the sleeve handle while keeping the sleeve handle stationary, thereby stabilizing the delivery device to enable independent actuation of the delivery shaft, sleeve shaft, and pusher shaft.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 481,577, filed January 25, 2023, which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to delivery systems for artificial medical devices. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can lead to serious cardiac dysfunction and ultimately require repair of the native valve or replacement of the native valve with a prosthetic valve. There are several known repair devices (such as stents) and prosthetic valves, as well as several known methods for implanting these devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations within the body that are not easily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) to reach the implantation site within the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted and activating a mechanical actuator that applies an expansive force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of a delivery device so that the prosthetic heart valve can self-expand to its functional size.

[0004] A docking device delivery system can be used to deliver prosthetic medical devices, such as the docking devices used in conjunction with the prosthetic heart valves described above. The docking device can be positioned at the implantation site by the docking device delivery system to provide a better seal between the implantation site and the prosthetic heart valve. Summary of the Invention [Means for solving the problem]

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

[0006] Prosthetic heart valves, delivery devices, delivery systems, and methods for implanting prosthetic heart valves are described herein. The disclosed prosthetic heart valves, delivery devices, delivery systems, and methods can provide, for example, improved positioning of docking devices for use with prosthetic heart valves. The docking devices can be positioned using a docking device delivery device comprising three independently actuable shafts. The docking device delivery device may be coupled to a stabilizer assembly that allows for 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 address, among other issues, one or more deficiencies associated with typical prosthetic heart valves, their delivery devices, and delivery systems.

[0007] A delivery system for a prosthetic medical device can include a handle and one or more shafts coupled to the handle.

[0008] In some embodiments, the delivery system may include three shafts.

[0009] In some embodiments, one or more shafts may be actuated independently relative to one another.

[0010] In some embodiments, one or more shafts may be coaxially aligned.

[0011] In some examples, the delivery system may include a stabilizer assembly for stabilizing one or more shafts.

[0012] In some embodiments, the stabilizer assembly may include a hub assembly support.

[0013] In some embodiments, the stabilizer assembly may include a stabilizer track coupled to the hub assembly support.

[0014] In some examples, the hub assembly support may include a hub assembly cradle and a sleeve handle cradle.

[0015] In some embodiments, at least one of the hub assembly cradle and the sleeve handle cradle may be configured to be operable relative to the hub assembly support.

[0016] In some embodiments, the hub assembly support may include a brake configured to prevent relative movement between the hub assembly support and the stabilizer track.

[0017] In some embodiments, the delivery system may include a delivery shaft, a sleeve shaft disposed within the delivery shaft, and a pusher shaft disposed within the sleeve shaft. The delivery shaft, sleeve shaft, and pusher shaft may be actuated independently of one another. A proximal end portion of the delivery shaft may be coupled to a distal end portion of a handle configured to control the axial position of the delivery shaft. A proximal end portion of the sleeve shaft may be coupled to a distal end portion of a sleeve handle configured to control the axial position of the sleeve shaft. A proximal end portion of the pusher shaft may be coupled to a distal end portion of a hub assembly configured to control the axial position of the pusher shaft.

[0018] In some embodiments, a delivery system including a delivery shaft, a sleeve shaft disposed within the delivery shaft, and a pusher shaft disposed within the sleeve shaft can be configured to implant a docking device into a native heart valve. The delivery system can be configured to perform a variable encircling turn, during which a radius of curvature of a distal end portion of the delivery system is varied by actuating the pusher shaft axially relative to the delivery shaft and the sleeve shaft. Increasing the radius of curvature of the distal end portion of the delivery system can allow the delivery system to better encircle the chordae tendineae of the native heart valve, thereby better positioning the docking device between the implantation site and the prosthetic heart valve and further reducing the likelihood of paravalvular leakage.

[0019] In some examples, a delivery system may include a delivery device and a stabilizer assembly. The delivery device may include a hub assembly and a sleeve handle and may be configured for use during a prosthetic medical device implantation procedure. The stabilizer assembly may include a hub assembly support configured to stabilize the hub assembly and the sleeve handle during the prosthetic medical device implantation procedure. The hub assembly support may include a hub assembly cradle, a sleeve handle cradle, and a linear actuator configured to axially move the hub assembly cradle relative to the sleeve handle cradle. When the hub assembly is disposed within the hub assembly cradle and the sleeve handle is disposed within the sleeve handle cradle, the hub assembly support may beneficially actuate the hub assembly relative to the sleeve handle while keeping the sleeve handle stationary, thereby further improving stability of the delivery device during the prosthetic medical device implantation procedure.

[0020] In some embodiments, a delivery system for delivering a prosthetic medical device includes a delivery device and a stabilizer assembly. The delivery device may include a handle, a delivery shaft extending from a distal end portion of the handle and including a delivery shaft lumen extending along the length of the delivery shaft, a hub assembly extending from a proximal end portion of the handle, a sleeve shaft disposed within the delivery shaft lumen, the sleeve shaft including a sleeve shaft lumen extending along the length of the sleeve shaft, a pusher shaft disposed within the sleeve shaft lumen, a sleeve handle coupled to a proximal end portion of the sleeve shaft, and a hub assembly coupled to the proximal end portion of the pusher shaft. The stabilizer assembly is configured to stabilize the delivery device and may include a stabilizer track configured to be axially oriented and a hub assembly support configured to slidably couple to the stabilizer track. The hub assembly support may include a sleeve handle cradle configured to receive the sleeve handle, a hub assembly cradle configured to receive the hub assembly, the hub assembly cradle being axially movable relative to the sleeve handle cradle, and a linear actuator coupled to the hub assembly, the linear actuator being configured to actuate the hub assembly cradle axially relative to the sleeve handle cradle.

[0021] In some examples, a stabilizer assembly configured for use with a delivery system may include a stabilizer track configured to be axially oriented, a hub assembly support configured to slidably couple to the stabilizer track, the hub assembly support comprising: a sleeve handle cradle configured to receive a sleeve handle of the delivery system; a linear actuator configured to move a traveler axially relative to the sleeve handle cradle; and a hub assembly cradle coupled to the traveler, the hub assembly cradle configured to receive a hub assembly of the delivery system.

[0022] In some examples, a hub assembly support for use in a delivery system may include a base portion and a linear actuator disposed on the base portion, the linear actuator comprising: an axially oriented threaded shaft; a carriage operably coupled to the threaded shaft, the linear actuator configured to actuate the carriage in the axial direction; a hub assembly cradle coupled to the carriage, the hub assembly cradle configured to receive a hub assembly of the delivery system; and a sleeve handle cradle disposed on the base portion, the sleeve handle cradle configured to receive a sleeve handle of the delivery system, the linear actuator configured to actuate the hub assembly cradle in the axial direction relative to the sleeve handle cradle.

[0023] In some embodiments, the delivery device comprises one or more of the components listed in Examples 1-44 below.

[0024] The various innovations in this disclosure can be used in combination or separately. This Summary is provided to introduce in a simplified form a selection of various concepts that are further described in the Detailed Description below. This Summary 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. These 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.

[0025] One or more of the methods described above can be performed on a live animal or on a simulation, such as a cadaver, a cadaver heart, an anthropomorphic ghost, a simulator (e.g., a simulated body part, heart, tissue, etc.), etc. [Brief explanation of the drawings]

[0026] [Figure 1] FIG. 1 schematically illustrates a step in an exemplary mitral valve replacement procedure in which a guide catheter and guidewire are inserted into a patient's blood vessels and navigated through the blood vessels into the patient's heart and toward the heart's native mitral valve. [Figure 2A] FIG. 2A schematically illustrates another stage in an exemplary mitral valve replacement procedure, in which a docking device delivery device extending through a guide catheter implants a docking device for a prosthetic heart valve at the native mitral valve. [Figure 2B] FIG. 2B schematically illustrates another stage in an exemplary mitral valve replacement procedure in which the docking device of FIG. 2A has been fully implanted in the patient's native mitral valve and the docking device delivery device has been removed from the patient. [Figure 3A] FIG. 3A schematically illustrates another stage in an exemplary mitral valve replacement procedure, in which a prosthetic heart valve delivery device extending through a guide catheter implants a prosthetic heart valve within an implanted docking device at the native mitral valve. [Figure 3B] FIG. 3B schematically illustrates another stage in an exemplary mitral valve replacement procedure, in which the prosthetic heart valve is fully implanted within the docking device with the native mitral valve and the prosthetic heart valve delivery device has been removed from the patient. [Figure 4] FIG. 4 shows a schematic diagram of another stage in an exemplary mitral valve replacement procedure, in which the guide catheter and guidewire have been removed from the patient. [Figure 5] FIG. 5 illustrates, in accordance with one embodiment, a schematic diagram of a stage of a docking device implantation procedure in which a guide catheter is inserted into a patient's blood vessel and navigated through the vessel into the patient's heart. [Figure 6] FIG. 6 schematically illustrates another stage of an exemplary docking device implantation procedure in which the distal end portion of the docking device delivery device is advanced from the guide catheter into the left ventricle of the heart. [Figure 7] FIG. 7 schematically 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 multiple lobes of the heart. [Figure 8] FIG. 8 schematically illustrates another stage of 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 encircle the chordae tendineae of the heart with variable encircling turns. [Figure 9] FIG. 9 schematically illustrates another stage in an exemplary docking device implantation procedure, in which the sleeve shaft of the docking device delivery device is retracted proximally to unsheath the guard member of the docking device. [Figure 10] FIG. 10 schematically illustrates another stage in an exemplary docking device implantation procedure in which the sleeve shaft is advanced distally to shorten the guard member. [Figure 11] FIG. 11 illustrates schematically another stage in an exemplary mitral valve replacement procedure in which the docking device delivery device is separated from the docking device. [Figure 12] FIG. 12 is a perspective view of a docking device delivery system configured for use during the docking device implantation procedure of FIGS. 5-11, according to one embodiment. [Figure 13] 13 is a top view of a docking device delivery device for use in the docking device delivery system of FIG. 12, according to one embodiment. [Figure 14] 14A-14B are perspective views of a hub assembly support for use in the docking device delivery system of FIG. 12, according to one embodiment. [Figure 15] FIG. 15 is an internal view of a hub assembly support, according to one embodiment. [Figure 16] 16A-16E are side views of the docking device delivery system of FIG. 12 during the exemplary mitral valve replacement procedure of FIGS. 5-11. [Figure 17] FIG. 17 is a perspective view of a hub assembly support according to the second embodiment. [Figure 18] FIG. 18 is a perspective view of a hub assembly support according to a third embodiment. [Figure 19] 19 is a side view of a guide catheter for use in the docking device delivery system of FIG. 12, according to one example. [Figure 20] FIG. 20 is a side view of a guide catheter and docking device delivery device, according to one example. [Figure 21] FIG. 21 is a side view of a guide catheter and docking device delivery apparatus according to a second example. [Figure 22] 22 is a perspective view of a docking device for use in the docking device delivery system of FIG. 12, according to one example. [Figure 23] FIG. 23 is a perspective view of a delivery device for a prosthetic heart valve, according to one example. [Figure 24] 24 is a perspective view of a prosthetic heart valve configured for use with the prosthetic heart valve delivery device of FIG. 23, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0027] Basic premise For purposes of description, certain aspects, advantages, and novel configurations of examples of the disclosure are described in this disclosure. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Instead, the disclosure covers all novel and non-obvious configurations and aspects of the various disclosed examples, alone, in various combinations with each other, and in various subcombinations with each other. The methods, apparatus, and systems are not limited to any particular aspect, configuration, or combination thereof, nor do the disclosed embodiments require that any one or more particular advantages be present or problems be solved.

[0028] Although some operations in the disclosed embodiments are described in a particular sequential order for convenience of presentation, it should be understood that aspects of the description encompass reordering unless a specific order is required by specific language set forth below. For example, operations described sequentially may, in some cases, be reordered or performed simultaneously. Also, for simplicity, the accompanying drawings may not show various aspects in which the disclosed methods can be used in combination with other methods. Also, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual actions that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0029] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Furthermore, the term "coupled" generally means to physically, mechanically, chemically, magnetically, and / or electrically join or link, and does not exclude the presence of intervening elements between coupled or associated members, unless specific language to the contrary exists.

[0030] As used herein, the term "proximal" refers to a position, orientation, or portion of a device that is closer to the user and farther away from the implantation site. As used herein, the term "distal" refers to a position, orientation, or portion of a device that is located away from the user and closer to the implantation site. Thus, for example, proximal movement of a 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 a device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial," unless expressly defined otherwise, refer to axes extending in a proximal-distal direction.

[0031] The terms "lateral" and "radial" refer to axes perpendicular to the longitudinal axis. When referring to a stabilizer assembly for a docking device delivery system, the term "lateral" refers to an axis perpendicular to the longitudinal axis and parallel to a plane defined by the stabilizer track of the stabilizer assembly.

[0032] As used herein, "eg" means "for example," and "ie" means "that is."

[0033] Introduction to the Disclosed Technology Disclosed herein are examples of delivery systems that can be used to navigate a subject's vasculature and deliver prosthetic medical devices (such as docking devices used in conjunction with prosthetic heart valves), tools, drugs, or other therapies to a target implantation site within a subject's body.

[0034] In that regard, in some embodiments, various systems are described in the present disclosure that can stabilize and actuate various components of the delivery system to better improve positioning of the prosthesis.

[0035] The delivery system can include multiple shafts that can be actuated independently of each other. In some embodiments, the delivery system can include a delivery shaft having a delivery shaft lumen, a sleeve shaft disposed within the delivery shaft lumen and having a sleeve shaft lumen, and a pusher shaft disposed within the sleeve shaft lumen. The prosthesis can be positioned at a target implantation site by actuating the pusher shaft relative to the delivery shaft and sleeve shaft.

[0036] The present disclosure discloses, among other things, exemplary devices and / or methods that can facilitate actuating (e.g., axially moving) one or more components of a delivery system relative to one or more other components of the delivery system.

[0037] Examples of the disclosed technology

[0038] 1-4 illustrate an exemplary transcatheter heart valve replacement procedure (e.g., a mitral valve replacement procedure) utilizing a docking device 52 and a prosthetic heart valve 62, according to one embodiment. During the procedure, a user first uses a guide catheter 30 to create a pathway to a patient's native heart valve ( FIG. 1 ). The user then uses a delivery device 50 to deliver and implant a docking device 52 to the patient's native heart valve ( FIG. 2A ), and then removes the delivery device 50 from the patient 10 after implanting the docking device 52 ( FIG. 2B ). The user then uses a prosthetic valve delivery device 60 to implant a prosthetic heart valve 62 within the implanted docking device 52 ( FIG. 3A ). The user then removes the prosthetic valve delivery device 60 from the patient 10 ( FIG. 3B ), and then removes the guide catheter 30 ( FIG. 4 ).

[0039] 1 illustrates a stage in a mitral valve replacement procedure, according to one example, in which a guide catheter 30 and a guidewire 40 are inserted into a blood vessel 12 of a patient 10 and navigated through the blood vessel 12, into the heart 14 of the patient 10, and toward the native mitral valve 16. Together, the guide catheter 30 and the guidewire 40 can provide a path for a delivery device 50 and a prosthetic valve delivery device 60 to be navigated to, through, and along the implantation site (the native mitral valve 16 or the native mitral valve annulus). As shown, the heart 14 is depicted schematically. For example, the anterior leaflet and tendon of the native mitral valve 16 are omitted for illustrative purposes, such that only a portion of the posterior leaflet of the native mitral valve 16 is shown.

[0040] Initially, a user may first make an incision in a patient's body to access blood vessel 12. For example, in the example shown in Figure 1, a user may make an incision in the patient's groin to access the femoral vein. Thus, in such an example, blood vessel 12 may be the femoral vein.

[0041] After making the incision in blood vessel 12, a user may insert guide catheter 30, guidewire 40, and / or additional devices (such as an introducer apparatus or transseptal puncture device) through the incision and into blood vessel 12. Guide catheter 30 (which may also be referred to as an "introducer apparatus," "introducer," or "guide sheath") is configured to facilitate percutaneous introduction of various implant delivery apparatuses (e.g., delivery apparatus 50 and prosthetic valve delivery apparatus 60) into and through blood vessel 12 and may extend through blood vessel 12 into heart 14, but may stop short of native mitral valve 16. Guide catheter 30 may include a handle 32 and a shaft 34 (which may also be referred to as catheter shaft 34) extending distally from handle 32. The shaft 34 can extend through the blood vessel 12 into the heart 14, while the handle 32 remains outside the body of the patient 10 and can be manipulated by a user to operate the shaft 34 (FIG. 1).

[0042] The guidewire 40 is configured to guide a delivery device (e.g., guide catheter 30, delivery device 50, prosthetic valve delivery device 60, additional catheters, or the like) and associated devices (e.g., docking devices, prosthetic heart valves, or the like) to an implantation site within the heart 14, and thus may extend entirely through the blood vessels 12 into the left atrium 18 (FIG. 1) of the heart 14 and, in some embodiments, through the native mitral valve 16 into the left ventricle 26 of the heart 14.

[0043] In some cases, a transseptal puncture device or transseptal puncture catheter may be used to initially access the left atrium 18 before inserting the guidewire 40 and guide catheter 30. For example, after making an incision in the blood vessel 12, a user may insert a transseptal puncture device into the blood vessel 12 through the incision. The user may guide the transseptal puncture device through the blood vessel 12 and into the heart 14 (e.g., through the femoral vein and into the right atrium 20). The user may then make 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 may then insert and advance the guidewire 40 through the transseptal puncture device in the blood vessel 12 and through the incision in the atrial septum 22 into the left atrium 18. After the guidewire 40 is positioned within the left atrium 18 and / or left ventricle 26, the transseptal puncture device may be removed from the patient 10. The user may then insert a guide catheter 30 into the blood vessel 12 and advance the guide catheter 30 over the guidewire 40 into the left atrium 18 (FIG. 1).

[0044] In some cases, an 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 can include a tapered end protruding from the distal tip of the guide catheter 30 and configured to guide the guide catheter 30 over the guidewire 40 and into the left atrium 18. Additionally, in some cases, the introducer device can 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 the guide catheter 30 and from inside the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain inside the patient 10. The guide catheter 30 is then in a position to receive an implant delivery device and help guide it into the left atrium 18, as described further below.

[0045] FIG. 2A shows another stage in an exemplary mitral valve replacement procedure in which a docking device 52 is implanted into the native mitral valve 16 of the heart 14 of the patient 10 using a delivery device 50 (which may also be referred to as an "implant catheter" or "dock delivery system," "docking device delivery system," and / or "docking device delivery device").

[0046] Generally, delivery device 50 includes a delivery shaft 54 ​​(which may also be referred to as a dock delivery system shaft), a handle 56 (which may also be referred to as a dock delivery system handle), and a pusher assembly 58. Delivery shaft 54 ​​is configured to be advanced by a user through the patient's vasculature (blood vessel 12) to an implantation site (e.g., native mitral valve 16) and may be configured to retain docking device 52 within a distal end portion 53 of delivery shaft 54. In some embodiments, distal end portion 53 of delivery shaft 54 ​​retains docking device 52 therein in a straightened delivery configuration.

[0047] The handle 56 of the delivery device 50 is configured to be grasped and / or otherwise held by a user outside the body of the patient 10 for advancing the delivery shaft 54 ​​through the patient's vascular system (e.g., blood vessel 12).

[0048] In some embodiments, the handle 56 may include one or more articulation members 57 (or rotatable knobs) configured to assist in steering the delivery shaft 54 ​​through the blood vessel 12. For example, the one or more articulation members 57 may include one or more knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to bend, curve, twist, rotate, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 ​​to assist in steering the delivery shaft 54 ​​through the blood vessel 12 and within the heart 14.

[0049] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at an implantation site (e.g., the native mitral valve 16). For example, the pushing assembly 58 can be configured to be adjusted by a user to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54. The shaft (sometimes referred to as a pusher shaft) of the pusher assembly 58 can extend through the delivery shaft 54 ​​and can be positioned adjacent to the docking device 52 within the delivery shaft 54. In some examples, 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 such that the docking device 52 can be released after being deployed at the native mitral valve 16.

[0050] Further details of the docking device delivery device and variations thereof are described in International Patent Application No. WO2020 / 247907 and U.S. Provisional Applications Nos. 63 / 363,162 and 63 / 380,796, the entire contents of which are incorporated herein by reference.

[0051] 2A , after the guide catheter 30 is positioned within the left atrium 18, the user may insert the docking device delivery device 50 (e.g., delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 ​​of the docking device delivery device 50 through the guide catheter 30 and over the guidewire 40. In some examples, the guidewire 40 may be at least partially retracted into the guide catheter 30, away from the left atrium 18. 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, thereby reaching the left atrium 18, as illustrated in FIG. 2A . Specifically, the user may advance the delivery shaft 54 ​​of the docking device delivery device 50 by grasping the handle 56 of the docking device delivery device 50 and exerting a force (e.g., pushing) toward the patient 10. As the delivery shaft 54 ​​is advanced through the blood vessel 12 and the heart 14, the user may maneuver through various bends, corners, narrowings, and / or other obstacles within the blood vessel 12 and within the heart 14 by adjusting one or more articulation members 57 of the handle 56.

[0052] Once the delivery shaft 54 ​​reaches the left atrium 18 and extends out from the distal end of the guide catheter 30, the user can use the handle 56 (e.g., articulation member 57) to position the distal end portion 53 of the delivery shaft 54 ​​at and / or near the posteromedial commissure of the native mitral valve 16. The user can then push the docking device 52 out from the distal end portion 53 of the delivery shaft 54 ​​with the shaft of the pusher assembly 58 to deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0053] In some embodiments, the docking device 52 may be constructed from, formed of, and / or include a shape memory material such that it returns to its original pre-formed shape upon being extracted from the delivery shaft 54 ​​and thus released from constrainment by the delivery shaft 54. As an example, the docking device 52 may be originally formed as a coil and thus wrapped around the leaflets 24 of the native mitral valve 16 upon exiting the delivery shaft 54 ​​and returning to its original coiled configuration.

[0054] After pressing the ventricular portion of the docking device 52 (e.g., the portion of the docking device 52 shown in FIG. 2A that is configured to be positioned within the left ventricle 26 and / or on the ventricular side of the native mitral valve 16), the user may then deploy the remaining portion of the docking device 52 (e.g., the atrial portion of the docking device 52) from the delivery shaft 54 ​​within the left atrium 18 by retracting the delivery shaft 54 ​​away from the posteromedial commissure of the native mitral valve 16.

[0055] After the docking device 52 is deployed and implanted into the native mitral valve 16, the user may disconnect the docking device delivery device 50 from the docking device 52. After the docking device 52 is disconnected from the delivery device 50, the user may retract the delivery device 50 from the blood vessel 12, away from the patient 10, allowing the user to deliver and implant the prosthetic heart valve 62 in the implanted docking device 52 at the native mitral valve 16.

[0056] 2B illustrates this stage in the mitral valve replacement procedure, where the docking device 52 is fully deployed and implanted in the native mitral valve 16 and the docking device delivery device 50 (including the delivery shaft 54) is removed from the patient 10, leaving only the guidewire 40 and guide catheter 30 inside the patient 10. In some examples, after removing the delivery device 50, the guidewire 40 may be advanced out of the guide catheter 30, through the docking device 52 implanted in the native mitral valve 16, and into the left ventricle 26 ( FIG. 2A ). The guidewire 40 may thus help guide the prosthetic valve delivery device 60 at least partially through the annulus of the native mitral valve 16 and into the left ventricle 26.

[0057] 2B, the docking device 52 can include multiple turns (or coils) wrapped around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has a more cylindrical shape compared to the annulus of the native mitral valve 16, thereby providing a closer conformance to the shape or profile of the prosthetic heart valve into which it is to be implanted. As a result, the docking device 52 can be fitted more tightly between the prosthetic heart valve and the native mitral valve, as described further below, thereby providing a better seal between the prosthetic heart valve and the native mitral valve 16.

[0058] FIG. 3A shows another stage in the mitral valve replacement procedure, in which a user is using a prosthetic valve delivery device 60 to deliver and / or implant a prosthetic heart valve 62 (which may also be referred to in this disclosure as a "transcatheter heart valve," or simply a "THV," a "replacement heart valve," and / or a "prosthetic mitral valve") into a docking device 52.

[0059] 3A , the prosthetic valve delivery device 60 can include a delivery shaft 64 and a handle 66, with the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into a patient's vasculature to deliver, implant, expand, and / or otherwise deploy the prosthetic heart valve 62 within the docking device 52 at the native mitral valve 16. The handle 66 is configured to be grasped and / or otherwise held by a user for advancing the delivery shaft 64 through the patient's vasculature.

[0060] In some embodiments, the handle 66 can include one or more articulation members 68 configured to assist in steering the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulation members 68 can include one or more knobs, buttons, wheels, and / or other types of physically adjustable control members that are configured to be adjusted by a user to bend, curve, twist, rotate, and / or otherwise articulate a distal end portion of the delivery shaft 64 to assist in steering the delivery shaft 64 through the blood vessel 12 and into the left atrium 18 and into the left ventricle 26 of the heart 14.

[0061] In some embodiments, the prosthetic valve delivery device 60 can include an expansion mechanism 65 configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. In some cases, as shown in FIG. 3A , the expansion mechanism 65 can include an inflatable balloon configured to be inflated to radially expand the prosthetic heart valve 62 within the docking device 52. The inflatable balloon can be coupled to a distal end portion of the delivery shaft 64.

[0062] In other examples, the prosthetic heart valve 62 may be self-expanding and configured to radially expand on its own upon removal of a sheath or capsule covering the radially compressed prosthetic heart valve 62 on the distal end portion of the delivery shaft 64. In yet other examples, the prosthetic heart valve 62 may be mechanically expandable and the prosthetic valve delivery device 60 may include one or more mechanical actuators (e.g., expansion mechanisms) configured to radially expand the prosthetic heart valve 62.

[0063] As shown in FIG. 3A, the prosthetic heart valve 62 is mounted on the distal end portion of the delivery shaft 64 around an expansion mechanism 65 (an inflatable balloon) in a radially compressed configuration.

[0064] To navigate the distal end portion of the delivery shaft 64 to the implantation site, the user can insert the prosthetic valve delivery device 60 (delivery shaft 64) through the guide catheter 30, over the guidewire 40, and into the patient 10. The user can continue to advance the prosthetic valve delivery device 60 along the guidewire 40 (through the blood vessel 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as shown in FIG. 3A . More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery device 60 by grasping the handle 66 and exerting force (e.g., pushing). When advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the user can navigate through various turns, corners, stenoses, and / or other obstacles within the blood vessel 12 and the heart 14 by adjusting one or more articulation members 68 of the handle 66.

[0065] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted around the distal end portion of the delivery shaft 64 is positioned within the docking device 52 and within the native mitral valve 16. In some examples, as shown in FIG. 3A , the distal end of the delivery shaft 64 and at least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.

[0066] Once the radially compressed prosthetic heart valve 62 is properly positioned within the docking device 52 (FIG. 3A), the user can manipulate one or more actuation mechanisms on the handle 66 of the prosthetic valve delivery device 60 to actuate the expansion mechanism 65 (e.g., inflate the inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52.

[0067] 3B shows another stage in the mitral valve replacement procedure, in which the prosthetic heart valve 62 is in its radially expanded configuration and is implanted within the docking device 52 of the native mitral valve 16. As shown in FIG. 3B, the prosthetic heart valve 62 is received and held within the docking device 52. Thus, the docking device 52 helps anchor the prosthetic heart valve 62 within the native mitral valve 16. The docking device 52 may enable a better seal between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16, thereby reducing paravalvular leakage around the prosthetic heart valve 62.

[0068] Also, as shown in FIG. 3B, after the prosthetic heart valve 62 is fully deployed and implanted within the docking device 52 at the native mitral valve 16, the prosthetic valve delivery device 60 (including the delivery shaft 64) is removed from the patient 10, thereby leaving only the guidewire 40 and the guide catheter 30 inside the patient 10.

[0069] FIG. 4 shows another stage in the mitral valve replacement procedure, in which the guidewire 40 and guide catheter 30 have been removed from the patient 10.

[0070] 1-4 specifically illustrate a mitral valve replacement procedure, it should be understood that the same and / or similar procedures may be utilized to replace other heart valves (e.g., tricuspid, pulmonary, and / or aortic valves). Furthermore, the same and / or similar delivery devices (e.g., delivery device 50, prosthetic valve delivery device 60, guide catheter 30, and / or guidewire 40), docking devices (e.g., docking device 52), replacement heart valves (e.g., prosthetic heart valve 62), and / or components thereof may be utilized to replace these other heart valves.

[0071] For example, if replacing a native tricuspid valve, a user may also access the right atrium 20 via the femoral vein, but would not need to cross the atrial septum 22 into 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, release the remaining portion of the docking device 52 from the delivery shaft 54 ​​in the right atrium 20, and then remove the delivery shaft 54 ​​of the docking device 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 prosthetic heart valve implantation process at the tricuspid valve within the docking device 52. Specifically, a user may advance the delivery shaft 64 of the prosthetic valve delivery device 60 along the guidewire 40 through the patient's vasculature, thereby positioning / deploying the prosthetic heart valve 62 within the tricuspid valve and onto the docking device 52. The user may then expand the prosthetic heart valve 62 within the docking device 52, after which the prosthetic valve delivery device 60 may be removed from the patient 10. In another example, a user may perform the same and / or similar process to replace an aortic valve, but access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0072] 1-4 illustrate a mitral valve replacement procedure in which the native mitral valve 16 is accessed from the left atrium 18 via the right atrium 20 and femoral vein, it should be understood that the native mitral valve 16 may alternatively be accessed from the left ventricle 26. For example, a user may access the native mitral valve 16 from the left ventricle 26 through the aortic valve by advancing one or more delivery devices through an artery to the aortic valve, and then through the aortic valve into the left ventricle 26.

[0073] 5-11 schematically illustrate a procedure for implanting a prosthetic medical device at a target implantation site in a subject (e.g., patient 10). In some embodiments, the procedure is a docking device implantation procedure for implanting a docking device 152 into the annulus of a native mitral valve 16 of patient 10. In some embodiments, one exemplary difference between the docking device 52 of FIGS. 1-4 and the docking device 152 of FIGS. 5-11 may be that the docking device 152 optionally includes a guard member 180 coupled to the docking device 152, which may be configured to further mitigate the possibility of paravalvular leakage between the annulus of the native mitral valve 16 and a prosthetic heart valve (e.g., prosthetic heart valve 62) positioned within the docking device 152.

[0074] The procedures of Figures 5-11 may be performed using a delivery device 150 (which may also be referred to as a docking device delivery device). In some embodiments, one exemplary difference between delivery device 150 of Figures 1-4 and delivery device 50 is that delivery device 150 may include three independently actuable shafts: a delivery shaft 154 (which may also be referred to as a docking delivery system shaft), a sleeve shaft 182, and a pusher shaft 184 (which may also be referred to as a docking shaft). Pusher shaft 184 may be disposed within sleeve shaft 182, which may in turn be disposed within delivery shaft 154. In some embodiments, delivery shaft 154, sleeve shaft 182, and pusher shaft 184 may be configured to be coaxial. The delivery shaft 154, sleeve shaft 182, and pusher shaft 184 can move axially and independently relative to one another during the docking device implantation procedure to better position the docking device 152 within the annulus of the native mitral valve 16 so that the implanted docking device 152 can better surround one or more chordae tendineae 27 of the heart 14 and provide a better seal between the implantation site and the prosthetic heart valve (e.g., the prosthetic heart valve 62).

[0075] During a procedure, a user of the delivery device 150 first uses the guide catheter 30 to create a pathway to the patient's native heart valve (FIG. 5). Next, the user distally advances the distal end portion of the delivery device 150 to advance the docking device 152 toward the target implantation site (FIGS. 6-7). In some examples of the procedure, the user can move the delivery system to change or adjust the curvature of the distal end portion of the delivery device 150 (see, e.g., the leading turn 187 of the delivery device 150 in FIGS. 7-8). This adjustable curvature radius may be referred to as a "variable encircling turn" (VET). VET can facilitate encircling one or more chordae 27 connecting the valve leaflets 24 to the papillary muscles 28 of the heart 14, for example, by retracting the pusher shaft 184 proximally relative to the sleeve shaft 182.

[0076] In some embodiments where the docking device 152 further comprises a guard member 180, the user can then retract the delivery shaft 154 and the sleeve shaft 182 proximally to expose the guard member 180 ( FIG. 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 axially shortening and radially expanding the guard member 180 ( FIG. 10 ). Finally, the user can separate the docking device 152 from the pusher shaft 184 and remove the delivery device system 150 from the patient 10 ( FIG. 11 ).

[0077] FIG. 5 illustrates a procedural stage in which a guide catheter 30 is advanced distally through the patient's vasculature and into the left atrium 18 of the heart 14. The guide catheter 30 comprises a catheter shaft 34 including a distal end 72, a bending region 74, and a lumen outlet 76 on the distal end 72 of the catheter shaft 34. The lumen outlet 76 is connected to a catheter shaft lumen disposed within the catheter shaft 34. A delivery device (such as any of the prosthesis delivery devices or implant catheters described in this disclosure) is configured to be disposed within the catheter shaft lumen. The catheter shaft lumen extends from a proximal end portion of the catheter shaft 34 (such as a portion of the catheter shaft 34 coupled to the handle 32) to the lumen outlet 76. The guide catheter 30 is positioned such that the distal end 72 of the catheter shaft 34 is disposed within the left atrium 18 of the heart 14.

[0078] In some embodiments, the catheter shaft 34 may include one or more pull wires for adjusting the curvature of the bending region 74 of the catheter shaft 34. In some embodiments, the pull wires may extend through a lumen coupled to the lumen outlet 76 and may be coupled to a portion of the catheter shaft 34, such as a pull wire ring, at or adjacent 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 bending 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 bending region 74) may be integrally formed as a single, unitary component. In some cases, the catheter shaft 34 may include one or more segments (e.g., the bending region 74, other regions, etc.) that are connected together and in some cases formed as separate components (e.g., via fasteners, adhesives, mating features, and / or other connection means). In some embodiments, the bending region 74 may comprise a material that is more susceptible to bending, curving, kinking, etc. than the remainder of the catheter shaft 34 (e.g., a polymer having a relatively low durometer). This allows the curvature of the bending region 74 to adjust or increase at a different rate than the remainder of the catheter shaft 34 when the pull wire is under tension. For example, the curvature of the bending region 74 may be configured to change at an increased rate relative to the proximal portion of the catheter shaft 34 as the tension on the pull wire increases. The catheter shaft 34 may also include one or more reinforcing braids or jackets that make the catheter shaft 34 more resistant to bending, curving, kinking, etc., for example, to prevent one or more lumens from kinking or collapsing when the catheter shaft 34 is manipulated.

[0079] During this stage, the docking device 152 is disposed within the sleeve shaft 182, which is in turn disposed within the delivery shaft 154, which is in turn disposed within the catheter shaft 34. The pusher shaft 184 is disposed proximally 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 may be in a coaxially aligned configuration. During this stage, the docking device 152 is in a generally straight delivery configuration (i.e., has no coiled or looped portions, but can be bent or flexed) so as to maintain a low radial profile as it moves through the patient's vasculature.

[0080] 6 illustrates a stage in the procedure in which the docking device 152, delivery shaft 154, sleeve shaft 182, and pusher shaft 184 are advanced distally through the lumen outlet 76 of the catheter shaft 34, through the left atrium 18, and into the native mitral valve 16. The docking device 152 is positioned within the sleeve shaft lumen of the sleeve shaft 182, which is in turn positioned within the delivery shaft lumen of the delivery shaft 154. The pusher shaft 184 is positioned proximally adjacent to the docking device 152 within the sleeve shaft 182.

[0081] In some embodiments, the delivery shaft 154, which may be similar to the delivery shaft 54, includes a delivery shaft lumen through which the sleeve shaft 182 and the 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 openings in the distal end portion 153.

[0082] 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 vasculature and toward the native mitral valve 16. The sleeve shaft 182 comprises a sleeve shaft lumen that extends along the length of the sleeve shaft 182 between the handle of the delivery device 150 and a 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 at an opening in the distal end portion 186 of the sleeve shaft 182.

[0083] The distal end portion 186 of the sleeve shaft 182 is configured to capture natural tissue (e.g., the natural valve leaflets 24 and tendons 27). The sleeve shaft 182 may be configured with a relatively low friction and / or lubricious outer surface to reduce the likelihood of the sleeve shaft 182 getting caught on the natural tissue.

[0084] In some embodiments, sleeve shaft 182 can include multiple layers. For example, sleeve shaft 182 can 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 and / or elastic material (e.g., nitinol and / or stainless steel).

[0085] In some cases, the distal end portion 186 of the sleeve shaft 182 may be curved to help facilitate capture of natural tissue. This may 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 relatively more flexible material than the docking device 152 and advancing the curved docking device 152 into the sleeve shaft 182, which may result in the sleeve shaft 182 assuming a curved configuration and / or the curvature of the sleeve shaft 182 is altered by the docking device 152.

[0086] In this manner, the distal end portion 186 of the sleeve shaft 182 can form a sleeve shaft leading turn 187 configured to capture the chordae tendineae 27 as the sleeve shaft 182 advances around the leaflets 24 of the native mitral valve 16. The sleeve shaft leading turn 187 is a portion of the sleeve shaft 182 disposed at or adjacent to the distal end portion 186, which comprises a curved portion of the sleeve shaft 182 having a radius of curvature. When the docking device 152 is not sheathed within the portion of the sleeve shaft 182 corresponding to the sleeve shaft leading turn 187, the sleeve shaft leading turn 187 has a radius of curvature equal to the first radius of curvature (r1). As discussed later in this application, and with particular reference to FIGS. 7-8 , the radius of curvature of the sleeve shaft leading turn 187 can be changed by relative movement between the sleeve shaft 182 and the docking device 152. In some embodiments in which the sleeve shaft 182 may be constructed from, formed from, and / or include a shape memory material, the sleeve shaft 182 may be originally formed such that the sleeve shaft leading turn 187 has a first radius of curvature (r1). The sleeve shaft leading turn 187 may be forced into another configuration having a different radius of curvature (e.g., a second radius of curvature (r2)), but may 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).

[0087] In some embodiments, the sleeve shaft leading turn 187 can conform to the shape or curvature of another component (such as the docking device 152) covered by the sleeve shaft leading turn 187, such that the radius of curvature of the sleeve shaft leading turn 187 is equal to the corresponding radius of curvature of the other component. In this manner, the distal end portion 186 of the sleeve shaft 182 can have a smaller radius of curvature when the distal end portion of the docking device 152 (such as the leading turn 189) is disposed at or proximate to the distal end portion 186 of the sleeve shaft 182. This is because the docking device 152 can have a smaller radius of curvature than the sleeve shaft 182 and can be relatively stiff. 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 proximally relative to the distal end portion 186 of the sleeve shaft 182, so that the sleeve shaft 182 can assume its preset configuration. This can be done by moving the docking device 152 proximally while maintaining the position of the sleeve shaft 182, by moving the sleeve shaft 182 distally relative to the docking device 152, or by a combination of the two.

[0088] 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 proximally adjacent to the docking device 152 within the sleeve shaft 182 while the docking device 152 is navigated through the patient's vasculature and toward the native mitral valve 16. As the pusher shaft 184 moves axially relative to the sleeve shaft 182, the pusher shaft 184 can apply a force to the docking device 152, causing the docking device 152 to move axially. In some examples, the docking device 152 can be removably coupled to the pusher shaft 184 via a connection mechanism of the docking device delivery device 150 such that the docking device 152 can be released after being deployed into the native mitral valve 16.

[0089] In some embodiments, the distal end portion 153 of the delivery shaft 154 may be positioned between the leaflets 24 of the native 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 may be configured to extend distally through the native mitral valve 16 and be positioned adjacent the native mitral valve 16 in the left ventricle 26. In some embodiments, the distal end portion 153 of the delivery shaft 154 may be configured to be positioned adjacent the native mitral valve 16 in the left atrium 18.

[0090] Once the distal end portion 153 of the delivery shaft 154 is positioned, the docking device 152, sleeve shaft 182, and pusher shaft 184 are advanced distally from the opening in the distal end portion 153 of the delivery shaft 154, through the native mitral valve 16, and into the left ventricle 26.

[0091] 7 illustrates a procedural step in which the docking device 152 (disposed within the sleeve shaft 182), the sleeve shaft 182, and the pusher shaft 184 (disposed within the sleeve shaft 182 and proximally adjacent to the docking device 152) wrap around or encircle the leaflets 24 on the ventricular side of the native mitral valve 16. As the docking device 152 exits the delivery shaft 154, the docking device 152 assumes a coiled configuration configured to wrap around or encircle the leaflets 24 on the ventricular side of the native mitral valve 16. In some embodiments in which the docking device 152 may be constructed from, formed from, and / or include a shape memory material, the docking device 152 may be originally formed in a coiled configuration but may be configured to be forced into a straight delivery configuration by the delivery shaft 154. The docking device 152 can assume its original coiled configuration once the docking device 152 is no longer covered by the delivery shaft 154.

[0092] As previously described, the portion of the sleeve shaft 182 that covers the docking device 152 can conform to or assume the shape and / or curvature of the corresponding portion of the docking device 152. For example, the sleeve shaft leading turn 187 can conform to the leading turn 189 of the docking device 152, with the leading turn 189 having a radius of curvature equal to the second radius of curvature (r2). Thus, the sleeve shaft leading turn 187 can be configured with the second radius of curvature (r2). In other words, the variable encircling turn can be equal to the second radius of curvature (r2).

[0093] 8 illustrates an optional step in the procedure of increasing the radius of curvature of the sleeve shaft leading turn 187 (i.e., the variable encircling turn) from a second radius of curvature (r2) to a first radius of curvature (r1) to better capture the chordae tendineae 27 within the docking device leading turn 189. In some embodiments, the radius of curvature of the sleeve shaft leading turn 187 can be increased by retracting the pusher shaft 184 proximally relative to the sleeve shaft 182, such that the docking device leading turn 189 and / or the docking device 152 are no longer covered by the sleeve shaft leading turn 187. In some embodiments, the radius of curvature of the sleeve shaft leading turn 187 can be increased by advancing the distal end portion 186 of the sleeve shaft 182 distally relative to the docking device 152. When the sleeve shaft leading turn 187 is no longer forced to conform to the curvature of the docking device leading turn 189, which has a second radius of curvature (r2), the sleeve shaft leading turn 187 can return to its original configuration having a first radius of curvature (r1) greater than the second radius of curvature (r2). Because the chordae tendineae 27 are trapped within the sleeve shaft leading turn 187, leading to rotation 187, increasing the variable encircling turn to a larger first radius of curvature (r1) beneficially allows a greater portion of the chordae tendineae 27 to be captured by the sleeve shaft as it advances around the leaflet 24.

[0094] 8 , the delivery shaft 154 may be held stationary to maintain the position of the distal end portion 153 of the delivery shaft 154 relative to the native mitral valve 16 (e.g., at or near the posteromedial commissure). In some embodiments, the sleeve shaft 182 may be held stationary to maintain the surrounding position and / or radial orientation of the sleeve shaft 182 relative to the native mitral valve 16. In some embodiments, the docking device 152 and / or the pusher shaft 184 may be held stationary while the sleeve shaft 182 moves during this step. In some embodiments, either the sleeve shaft or the pusher shaft 184 remains stationary during this step.

[0095] 8, the variable encircling turn can be adjusted after the sleeve shaft 182 has made one helical turn around the valve leaflet 24. However, in some embodiments, the variable encircling turn can be adjusted after the sleeve shaft 182 has made multiple helical turns around the valve leaflet 24. In some embodiments, the variable encircling turn can be adjusted before any helical turns have been made around the valve leaflet 24.

[0096] 9 illustrates an optional stage in the procedure in which the delivery shaft 154 and sleeve shaft 182 are retracted proximally to hide the guard member 180. The docking device 152 comprises a coil 188 defining a central region 190 comprising a plurality of helical turns wrapped around the valve leaflet 24, and a docking device leading turn 189 extending from a distal end portion of the central region 190.

[0097] The docking device 152 can further include a guard member 180 disposed on the docking device 152 such that the guard member 180 is positioned at or near the native mitral valve 16 (e.g., at or near the posteromedial commissure) when the docking device 152 is implanted on the native mitral valve 16. In some embodiments, the guard member 180 can be disposed proximally adjacent to a central region ( FIG. 22 ), which can comprise multiple helical turns when the docking device 152 is wrapped around the valve leaflet 24. The guard member 180 can 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 can abut the central region 190.

[0098] During the stages of the docking device implantation procedure illustrated in FIGS. 5-8 , the guard member 180 can be sheathed by the delivery shaft 154 and the sleeve shaft 182. However, during the stage illustrated in FIG. 9 , relative movement between the delivery shaft 154, the sleeve shaft 182, and the pusher shaft 184 can unsheath the guard member 180. In some embodiments, the sleeve shaft 182 can be retracted proximally from the left ventricle 26, through the mitral valve 16, and 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 configured to be disposed distally relative to the lumen outlet 76. In some embodiments, the guard member 180 can be unsheathed by distally advancing the pusher shaft 184 relative to the sleeve shaft 182.

[0099] 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 configured to 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 relative to the guard member 180.

[0100] 10 illustrates an optional "seating" step in the procedure in which the sleeve shaft 182 is advanced distally relative to the docking apparatus 152 to axially shorten and radially expand the guard member 180. In some embodiments, the sleeve shaft 182 can be advanced 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 apparatus 152 coupled to the pusher shaft 184) can be retracted proximally 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 applies a force to the guard member 180, advancing the proximal end portion 193 of the guard member 180 distally relative to the docking apparatus 152. The distal end portion 191 of the guard member 180 is fixedly coupled to the docking device 152, thereby applying an axial force 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 likelihood of paravalvular leakage between the native mitral valve 16 and the prosthetic heart valve (such as the prosthetic heart valve 62). The frictional engagement between the proximal end of the guard member 180 and the docking device 152 can maintain the position of the guard member 180 relative to the docking device 152 when the sleeve shaft 182 is retracted from the proximal end of the guard member 180.

[0101] 11 shows a stage of the procedure in which the delivery device 150, including the delivery shaft 154 and the sleeve shaft 182, is retracted through the catheter shaft lumen of the catheter shaft 34. In some embodiments, the docking device 152 may be connected to the pusher shaft 184 via a release suture 194, which may be configured to be tied to the docking device 152. The release suture 194 may be cut to release the docking device 152 from the delivery device 150 at this stage.

[0102] Figure 12 illustrates an example of a delivery system 100 (which may also be referred to as a docking device delivery system) that may be used in a procedure for implanting a prosthetic medical device, as described above with reference to Figures 5-11. Delivery system 100 includes a delivery device 150, a guide catheter 30, and a stabilizer assembly 200 (which may also be referred to as a "stabilization tower" or "stabilizer") configured to stabilize delivery device 150 and / or guide catheter 30 during the procedure.

[0103] 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 includes a delivery shaft 154, a handle 156 (also referred to as a "dock delivery system handle") coupled to a proximal end portion 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 (also referred to as a "dock handle") coupled to a proximal end portion of the sleeve shaft 182, the 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 portion of the sleeve shaft 182.

[0104] Delivery shaft 154, in some embodiments, may be similar to delivery shaft 54 ​​and may be configured to be advanced by a user through the patient's vasculature (blood vessel 12) to an implantation site (e.g., native mitral valve 16) and configured to retain docking device 152 within distal end portion 153 of delivery shaft 154. During a docking device implantation procedure, delivery shaft 154 is advanced through catheter shaft 34 of guide catheter 30 (e.g., through its central lumen, etc.) to the target implantation site.

[0105] The handle 156, which may be similar to the handle 56 in some embodiments, is configured to be grasped and / or otherwise held by a user outside the body of the patient 10 for advancing the delivery shaft 154 through the patient's vasculature (e.g., the blood vessel 12). In some embodiments, the handle 156 may include one or more articulation members 157 (or rotatable knobs) configured to manipulate or control the bending of the delivery device 150 (e.g., the delivery shaft 154) to assist in steering the delivery shaft 154 through the blood vessel 12. Some embodiments of the articulation member 157 may be similar to the articulation member 57. The handle 156 includes a handle lumen extending through the length of the handle 156, and the sleeve shaft 182 and the pusher shaft 184 are configured to be disposed within the handle lumen. The sleeve and pusher shafts 182, 184 extending through the handle lumen also extend through the delivery shaft 154, such that the handle lumen may be coaxially aligned 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., sleeve shaft 182) inserted through the handle lumen to selectively prevent movement of the device relative to the handle 156 of the delivery device 150. In some embodiments, the locking assembly 198 may be disposed on a proximal end portion of the handle 156.

[0106] The hub assembly 158 is configured to be grasped and / or otherwise held by a user outside the body of the patient 10 to advance the pusher shaft 184 through the patient's vasculature. A distal end portion of the hub assembly 158 is coupled to a proximal end portion of the pusher shaft 184. The axial position of the pusher shaft 184 is controlled by axially moving the hub assembly 158 relative to the handle 156 and / or the sleeve handle 196. The hub assembly 158 is positioned proximally near the user relative to the handle 156 but distally away from the user relative to the sleeve handle 196. The hub assembly 158 includes a hub assembly lumen extending through the length of the hub assembly 158. The pusher shaft 184 is configured to be disposed within the hub assembly lumen and is coaxial with the sleeve shaft 182, which is 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 removably couple to the proximal end of the release suture 194 .

[0107] The sleeve handle 196 is configured to be grasped and / or otherwise held by a user outside the body of the patient 10 for advancing the sleeve shaft 182 through the patient's vasculature. The sleeve handle 196 is coupled to a proximal end portion of the sleeve shaft 182 and is positioned proximally closer to the user relative to the handle 156 and hub assembly 158. The axial position of the sleeve shaft 182 is controlled by axially moving the sleeve handle 196 relative to the handle 156 and / or hub assembly 158.

[0108] Further details regarding delivery devices / catheters / systems (including various embodiments of handle assemblies) configured to deliver the docking device to the target implantation site can be found in PCT International Publication Nos. WO 2020 / 247907 and WO 2022 / 072509, U.S. Patent Publication Nos. 2018 / 0318079 and 2018 / 0263764, all of which are incorporated herein by reference in their entirety.

[0109] Because the variable encircling turn can be adjusted based on relative movement between the pusher shaft 184 and the sleeve shaft 182, a user of the docking device 150 can adjust the variable encircling turn (as shown in FIGS. 7-8 ) by moving the pusher shaft 184 axially relative to the sleeve shaft 182, or vice versa. Because 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 move proximally while the hub assembly 158 remains stationary. In some embodiments, both the sleeve handle 196 and the hub assembly 158 can move axially. In some embodiments, the handle 156 can remain stationary or can move relative to at least one of the sleeve handle 196 and the hub assembly 158.

[0110] 12 , the guide catheter 30 and delivery device 150 can be coupled to a stabilizer assembly 200 that can support and stabilize the guide catheter 30 and delivery device 150 during a procedure. The stabilizer assembly 200 includes a universal platform 202, a stabilizer track 204 attached to the universal platform 202, one or more supports 206 (e.g., clips, clamps, braces, etc.) that can be slidably coupled to the stabilizer track 204, and a hub assembly support 208 that can be slidably coupled to the stabilizer track 204.

[0111] Universal platform 202 is a platform configured to support stabilizer track 204. Universal platform 202 is configured to have an adjustable height and / or orientation, which may be adjusted relative to a surface (e.g., a ground surface or a table surface) on which universal platform 202 is placed. In some embodiments, universal platform 202 may include one or more articulation members 203 (e.g., rotatable knobs) for adjusting the height or orientation of universal platform 202.

[0112] The stabilizer track 204 is coupled to an upper surface of the universal platform 202. The stabilizer track 204 is configured to be axially oriented when attached to the universal platform 202, such that the support 206 and the hub assembly support 208 can slide axially along the stabilizer track 204. In some embodiments, the stabilizer track 204 may include one or more rails 205 extending axially along the stabilizer track 204. In the illustrated embodiment, the stabilizer track 204 includes first and second rails 205 a, 205 b, although the stabilizer track 204 may include one, three, or any suitable number of rails 205. In some embodiments, each of the rails 205 may include an axially extending vertical flange (also referred to in this disclosure as a "web") and an axially extending horizontal flange (also referred to in this disclosure as a "head") connected to an uppermost portion of the vertical flange such that the rails 205 have a "C", "I", or "T" shaped cross section. However, the rails 205 may include any suitable cross section configured to connect to the supports 206 and the hub assembly supports 208.

[0113] The supports 206 are configured to hold or grip the guide catheter 30 and the handle 156 of the delivery device 150. Each of the supports 206 comprises a post configured to be repositioned or relocated axially on the stabilizer track 204, the post configured to couple to a portion (e.g., a distal portion) of the guide catheter 30 or the handle 156. In some embodiments, at least one of the supports 206 may include a position lock 207 configured to prevent the support 206 from moving axially along the stabilizer track 204. In some embodiments, the position lock 207 may include a threaded shaft movable between a locked configuration and an unlocked configuration. When the position lock 207 is in the locked configuration, the threaded shaft is in frictional contact with the stabilizer track 204, and the frictional contact prevents the support 206 from moving axially relative to the stabilizer track 204.

[0114] 14A-14B show perspective views of a hub assembly support 208, according to one embodiment. The hub assembly support 208 is slidably coupled to the stabilizer track 204 and is configured to hold or grip the hub assembly 158 and the sleeve handle 196. The hub assembly 158 includes a base portion 210, a housing 212, a hub assembly cradle 214, a sleeve handle cradle 216, and an actuation control 218. In some embodiments, the hub assembly support 208 may further include an indicator 220 and a brake 227.

[0115] The base portion 210 is configured to rest on and slidably couple to the stabilizer track 204. In some embodiments, the base portion 210 may comprise a plate that extends from a proximal end portion 224 of the hub assembly support 208 to a distal end portion 226 of the hub assembly support 208.

[0116] In some embodiments, base portion 210 can further include a groove 228 disposed on a first outer surface of base portion 210. In some embodiments, groove 228 can extend from proximal end portion 224 to distal end portion 226 of base portion 210. Groove 228 can be configured to facilitate sliding coupling of base portion 210 to stabilizer track 204 and to limit vertical movement of hub assembly support 208. In some embodiments, groove 228 can be configured to receive a head of one of axially extending rails 205 (e.g., first rail 205a).

[0117] In some embodiments, base portion 210 may further include a stabilizer track lock 230 configured to slidably couple base portion 210 to stabilizer track 204. Stabilizer track lock 230 may be disposed on a second outer surface of base portion 210, the second outer surface being opposite the first outer surface. In some embodiments, stabilizer track lock 230 may include a locking flange 232 extending laterally from the second outer surface of base portion 210 and a toggle 234 coupled to locking flange 232. Locking flange 232 may be slidably coupled to base portion 210 such that actuation of toggle 234 causes locking flange 232 to move laterally between a locked configuration and an unlocked configuration. In the locked configuration, the locking flange 232 may extend laterally outward from the base portion 210 and below the head of the second rail 205b, thereby coupling the base portion 210 to the stabilizer track 204. In the unlocked configuration, the locking flange 232 may be at least partially retracted within the base portion 210 or the housing 212, thereby allowing the hub assembly support 208 to be decoupled from the stabilizer track 204. In some examples, the stabilizer track lock 230 may be biased in the locked configuration by coupling the laterally extending flange to the base portion 210 via one or more biasing springs ( FIG. 15 ).

[0118] The housing 212 is coupled to the base portion 210 and is configured to cover one or more internal components of the hub assembly support 208. In some embodiments, the housing 212 may be disposed on top of the base portion 210. The housing 212 covers the base portion 210 from the proximal end portion 224 to the distal end portion 226. The housing 212 includes an axially oriented slot 236 configured to receive a traveler (FIG. 15) that couples the hub assembly cradle 214 to a linear actuator (FIG. 15) disposed within the housing 212. The traveler is also referred to herein as a "carriage." While the slot 236 is illustrated in FIGS. 14A-14B as being disposed on the top surface of the housing 212, the slot 236 may alternatively be disposed on one of the exterior surfaces of the housing 212.

[0119] In some embodiments, the base portion 210 and the housing may be formed as a single component (eg, a chassis).

[0120] The hub assembly cradle 214 is configured to receive the hub assembly 158. In some embodiments, the hub assembly cradle 214 may include a laterally extending base flange 240 having a first outer edge portion 242a and a second outer edge portion 242b disposed on opposite outer edges of the base flange 240. The hub assembly cradle 214 may include a first outer flange 244a extending upwardly from the first outer edge portion 242a and a second outer flange 244b extending upwardly from the second outer edge portion 242b. In some embodiments, the curvature of the first and second outer edge portions 242a, 242b may be configured to follow the curvature of the outer portion of the hub assembly 158 to ensure that the hub assembly 158 is securely received within the hub assembly cradle 214. In some embodiments, at least one of the base flange 240, the first outer flange 244a, and the second outer flange 244b may further include a cutout 246 for accommodating features of the hub assembly 158 (such as features of the suture lock assembly 159).

[0121] 14B, the hub assembly cradle 214 may further include one or more gripping elements 248 disposed on a laterally inwardly facing surface of one or more of the outer flanges 244a, 244b. The gripping element 222 may be configured to be disposed between one of the outer flanges 244a, 244b and the hub assembly 158, thereby frictionally securing the hub assembly 158 within the hub assembly cradle 214. The gripping element 222 may be formed of rubber, a polymeric material, or any material having a sufficient coefficient of friction to frictionally engage the hub assembly 158.

[0122] The hub assembly cradle 214 is configured to be axially actuable relative to other components of the hub assembly support 208 (such as the base portion 210, the housing 212, and the sleeve handle cradle 216). The hub assembly cradle 214 is coupled to a linear actuator (FIG. 15) disposed within the housing 212, which is configured to axially move the hub assembly cradle 214 along the length of the slot 236. In the illustrated embodiment, the bottom surface of the base flange 240 is coupled to the linear actuator (FIG. 15) via a traveler (FIG. 15) that extends through the slot 236 between the base flange 240 and the linear actuator. However, any suitable portion of the hub assembly cradle 214, including the first and second outer flanges 244a, 244b, may be coupled to the linear actuator and / or traveler.

[0123] The sleeve handle cradle 216 is configured to receive the sleeve handle 196. The sleeve handle cradle 216 is disposed on the housing 212 and positioned proximally on the housing 212 relative to the hub assembly cradle 214. In some embodiments, the sleeve handle cradle 216 may include one or more cutouts 252, 254, 256 that define a recess 250 configured to receive at least a portion of the sleeve handle 196. In the illustrated embodiment, the sleeve handle cradle 216 comprises the recess 250 defined by a first bell-shaped cutout 252 on the top surface of the housing 212 and a second semicircular cutout 254 on the proximal surface of the housing 212. To further ensure that the sleeve handle 196 is securely received within the recess, the first cutout 252 may be configured to have the same shape (e.g., bell-shaped) as the cross-section of the sleeve handle 196 such that the edge of the first cutout 252 is flush with the surface of the sleeve handle 196. In some embodiments, the sleeve handle cradle 216 may further include a third cutout 256 positioned distally relative to the first cutout 252 and the second cutout 254, configured to accommodate the sleeve shaft 182 extending from the distal end portion of the sleeve handle 196 toward the hub assembly 158.

[0124] In some embodiments, the sleeve handle cradle 216 may be configured to be actuable relative to other components of the hub assembly support 208 (e.g., base portion 210, hub assembly cradle 214, etc.) to additionally or alternatively move the sleeve shaft 182 relative to the pusher shaft 184 to adjust the variable encircling turn. In some embodiments, the sleeve shaft 182 may additionally or alternatively be configured to couple to a linear actuator (which may be similar to linear actuator 264).

[0125] The actuation control 218 is operably coupled to the linear actuator ( FIG. 15 ) and is configured to control the degree of actuation of the hub assembly cradle 214 relative to the hub assembly support 208. In some embodiments, the actuation control 218 may be a rotatable knob. However, the actuation control 218 may be any suitable interface or control (e.g., a button, slider, switch, crank, etc.) for controlling a linear actuator. In some embodiments, a user may actuate the hub assembly cradle 214 by grasping the hub assembly 158 and sliding the hub assembly 158 axially relative to the other components of the hub assembly support 208.

[0126] In some embodiments, the hub assembly support 208 may further include an indicator 220 configured to indicate the magnitude of the variable encircling turn. Because the radius of curvature of the sleeve shaft leading turn 187 correlates with the axial position of the pusher shaft 184 relative to the sleeve shaft 182, which in turn correlates with the axial position of the hub assembly cradle 214 relative to the sleeve handle cradle 216, the radius of curvature of the sleeve shaft leading turn 187 may be determined based on the relative axial positions of the hub assembly cradle 214 and the sleeve handle cradle 216. In some embodiments, the indicator 220 may include one or more markings disposed along the length of the slot 236. A first marking 258 located toward the proximal end of the slot 236 may indicate that the radius of curvature of the sleeve shaft leading turn 187 (in other words, the variable encircling turn) is equal to a first radius of curvature (r1), and a second marking 260 located toward the distal end of the slot 236 may indicate that the radius of curvature of the sleeve shaft leading turn 187 is equal to a second radius of curvature (r2).

[0127] The brake 227 is configured to limit movement of the hub assembly support 208 relative to the stabilizer track 204. In some embodiments, the brake 227 may include a knob 262, a cam ( FIG. 15 ), and a brake pad, and the brake 227 may be configured to be movable between a locked configuration and an unlocked configuration. When a user actuates the knob 262 to move the brake 227 to the locked configuration, the brake pad frictionally engages the stabilizer track 204, thereby locking the hub assembly support 208 in a fixed axial position on or relative to the stabilizer track 204.

[0128] 15 shows the hub assembly support 208 with the housing 212 and hub assembly cradle 214 removed. The interior of the hub assembly support 208 comprises a linear actuator 264, a traveler 266 (also referred to herein as a "carriage") coupled to the linear actuator 264, and first and second bevel gears 268, 270 operably coupling the linear actuator 264 to the actuation control 218. In some embodiments in which the hub assembly support 208 comprises the stabilizer track lock 230, the hub assembly support 208 may further comprise one or more biasing springs 272.

[0129] The linear actuator 264 is configured to actuate the hub assembly cradle 214 relative to the sleeve handle cradle 216, which is disposed at a fixed axial position on the housing 212. The linear actuator 264 is configured to actuate the hub assembly cradle 214 axially along the length of the slot 236. In some embodiments, the linear actuator 264 may comprise a threaded shaft 274. The threaded shaft 274 may be coupled to a first actuator post 276 and a second actuator post 278 that are axially aligned with one another and coupled to the base portion 210. The threaded shaft 274 may be axially oriented between the first actuator post 276 and the second actuator post 278. Although the linear actuator 264 is shown in FIG. 15 as a threaded shaft 274, some embodiments of the linear actuator 264 may include a hydraulic linear actuator, a pneumatic linear actuator, a rack and pinion linear actuator, a belt-driven linear actuator, or any suitable mechanical or electromechanical linear actuator device. In some embodiments, the extent of actuation of the linear actuator 264 may be the same as the length of the slot 236 located on the housing 212 .

[0130] The threaded shaft 274 may have a thread pitch that defines the distance between adjacent threads on the threaded shaft 274. The speed at which the hub assembly cradle 214 is actuated axially relative to the remainder of the hub assembly support 208 may be configured to depend in part on the thread pitch. For example, if the threaded shaft 274 has a relatively high thread pitch, the hub assembly cradle 214 will actuate axially at a slower speed than if the threaded shaft 274 has a relatively low thread pitch. Thus, the thread pitch of the threaded shaft 274 may be selected based in part on the desired speed at which the hub assembly cradle 214 is actuated.

[0131] The traveler 266 is configured to extend through the slot 236 to couple the hub assembly cradle 214 to the linear actuator 264. When the threaded shaft 274 rotates, the rotation causes the traveler 266 to move axially proximally or distally along the length of the slot 236, thereby also moving the hub assembly cradle 214 axially.

[0132] The first bevel gear 268 and the second bevel gear 270 are configured to translate torque between the actuation control 218 and the linear actuator 264. In examples in which the linear actuator 264 includes a threaded shaft 274, the first bevel gear 268 may be coupled to an end portion (e.g., a proximal end portion) of the threaded shaft 274. The second bevel gear 270 may be coupled to the actuation control 218. The first bevel gear 268 and the second bevel gear 270 may be disposed perpendicular to one another. Because the first bevel gear 268 and the second bevel gear 270 mesh with one another, the first bevel gear 268 and the second bevel gear 270 can translate the torque or rotational motion of the actuation control 218 to the threaded shaft 274.

[0133] In some embodiments in which the hub assembly support 208 includes the stabilizer track lock 230, the hub assembly support 208 may further include one or more biasing springs 272 configured to bias the stabilizer track lock 230 in the locked configuration. The biasing springs 272 may comprise laterally oriented springs disposed between the locking flange 232 or toggle 234 and the base portion 210. The biasing springs 272 may bias the locking flange 232 in the locked configuration by forcing the locking flange 232 laterally outward from the base portion 210.

[0134] In some embodiments in which the hub assembly support 208 includes a brake 227, the brake 227 may include a cam 280 coupled to the rotatable knob 262 and a brake pad configured to selectively extend through a cutout in the base portion 210. When the knob 262 is rotated to an unlocked configuration, the brake pad may be retracted within the hub assembly support 208 such that the brake pad does not directly contact the stabilizer track 204. When the knob 262 is rotated to a locked configuration, the cam may engage the brake pad such that the brake pad extends through the cutout in the base portion 210 and frictionally engages or contacts the stabilizer track 204. In some embodiments, the brake 227 may further include at least one biasing member for biasing the brake pad into contact with the stabilizer track 204. In some embodiments, the biasing member may include a spring. In some embodiments, the brake pad may be formed from silicone. However, the brake pad may be formed from any material having a sufficient coefficient of friction to frictionally engage the stabilizer track 204.

[0135] 16A-16E illustrate the configuration of delivery system 100 during the exemplary docking device delivery procedure illustrated in FIGS. 5-11. More specifically, FIGS. 16A-16E show the relative axial positions of handle 156, hub assembly 158, hub assembly support 208, and sleeve handle 196 during various stages of the exemplary procedure. Delivery system 100 may further include other components, such as guide catheter 30, as illustrated in FIGS. 16A-16E.

[0136] 16A-16E show the hub assembly 158 as moving relative to the hub assembly support 208 during adjustment of the variable encircling turn. However, because adjustments to the variable encircling turn are caused by relative movement between the hub assembly 158 and the sleeve handle 196, it should be understood that in some embodiments, either the hub assembly 158, the sleeve handle 196, or both components can be moved relative to one another to adjust the variable encircling turn. Additionally, the handle 156 can be held static or moved during various embodiments of the steps to adjust the variable encircling turn.

[0137] 16A illustrates the configuration of delivery system 100 during the stage of the exemplary docking device delivery procedure illustrated in FIG. 5. After guide catheter 30 is deployed, delivery shaft 154, sleeve shaft 182, and pusher shaft 184 are advanced distally in unison from guide catheter 30 by advancing handle 156 along stabilizer track 204 (indicated by arrow 282) in unison with hub assembly support 208. In some embodiments in which hub assembly support 208 includes brake 227, brake 227 is actuated to an unlocked configuration at this stage to allow hub assembly support 208 to move relative to stabilizer track 204.

[0138] 16B illustrates the configuration of delivery system 100 during the stage of the exemplary docking device delivery procedure illustrated in FIGS. 6-7. After delivery shaft 154 is advanced into native mitral valve 16, sleeve shaft 182 and pusher shaft 184 are advanced together from delivery shaft 154 by advancing hub assembly support 208 distally along stabilizer track 204 (indicated by arrow 284). Handle 156 remains in a fixed axial position on stabilizer track 204, while hub assembly support 208 advances distally along stabilizer track 204 toward handle 156. In some embodiments in which the hub assembly further comprises brake 227, brake 227 can be actuated to an unlocked configuration at this stage to allow relative axial movement between hub assembly support 208 and stabilizer track 204.

[0139] 16C shows the configuration of the delivery system 100 during an optional stage of the exemplary docking device delivery procedure illustrated in FIG. 8 , in which the delivery device 150 adjusts the variable encircling turn. During this stage, the user activates the actuation control 218 (e.g., by rotating a knob), thereby causing the linear actuator 264 to move the hub assembly cradle 214 proximally (indicated by arrow 286) relative to the sleeve handle cradle 216 to increase the radius of curvature of the sleeve shaft leading turn 187. In some embodiments, in which the hub assembly support 208 includes a brake 227, the brake 227 can be actuated to a locked configuration to lock the hub assembly support 208 to the stabilizer track 204 such that the brake pads of the brake 227 frictionally engage the stabilizer track 204. In some embodiments, the support 206 holding the handle 156 can be locked to the stabilizer track 204 using a position lock 207 to prevent axial movement of the delivery shaft 154 during this stage. However, because the adjustment of the variable encircling turn is caused by relative movement between the hub assembly 158 and the sleeve handle 196, some embodiments of this step may involve advancing the sleeve handle 196 distally relative to the hub assembly 158 (opposite the direction of arrow 286) or moving both the hub assembly 158 and the sleeve handle 196.

[0140] 16D illustrates the configuration of delivery system 100 during an optional stage of the exemplary docking device delivery procedure illustrated in FIG. 9 in which sleeve shaft 182 is retracted to unsheath guard member 180. During this stage, sleeve handle 196 can be independently actuated by removing or separating sleeve handle 196 from sleeve handle cradle 216 and moving sleeve handle 196 in a proximal direction (indicated by arrow 288) relative to handle 156, hub assembly 158, and hub assembly support 208. In some examples, hub assembly support 208 can be locked to stabilizer track 204 (e.g., using brake 227) to prevent axial movement of hub assembly support 208 relative to stabilizer track 204 during this stage. However, because the guard member 180 is not covered due to the relative movement between the docking device 152 and the sleeve shaft 182 and / or handle 156, some embodiments of this step may involve advancing the handle 156 and / or hub assembly 158 distally relative to the sleeve handle 196 (opposite the direction of arrow 288), or moving any combination of the handle 156, hub assembly 158, and sleeve handle 196.

[0141] 16E illustrates the configuration of delivery system 100 during an optional stage of the exemplary docking device delivery procedure illustrated in FIG. 10 , when guard member 180 is axially shortened by advancing distal end portion 186 of sleeve shaft 182 distally (indicated by arrow 290) to apply a force to proximal end portion 193 of guard member 180. In some embodiments, when proximal end portion 193 is advanced distally, proximal end portion 193 can frictionally engage docking device 152 after guard member 180 is axially shortened, such that guard member 180 is retained in its deployed configuration after sleeve shaft 182 is removed from the patient's vasculature. However, because the guard member 180 shortens axially due to the relative movement between the docking device 152 and the sleeve shaft 182, some embodiments of this step may involve retracting the hub assembly 158 proximally relative to the sleeve handle 196 (opposite the direction of arrow 290) or moving both the hub assembly 158 and the sleeve handle 196.

[0142] In some embodiments, the support 206 that holds the handle 156 may be configured to lock to the stabilizer track 204 using a position lock 207 to prevent movement of the delivery shaft 154 at this stage. However, Figures 16A-16E show relative movement, and the handle 156 may move relative to at least one of the hub assembly 158 and sleeve handle 196 at any of the stages shown. In some embodiments, the hub assembly support 208 may be configured to lock to the stabilizer track 204 (e.g., using a brake 227).

[0143] FIG. 17 illustrates a hub assembly support 308 according to a second embodiment. The hub assembly support 308 is shown with the hub assembly 158 received within the hub assembly cradle 214. One exemplary difference between the hub assembly support 208 of FIGS. 14A-14B and the hub assembly support 308 of FIG. 17 is that the hub assembly support 308 may include a cam lock 316 instead of the sleeve handle cradle 216 for securing the sleeve handle 196. The cam lock 316 may be configured to be operable between a locked configuration and an unlocked configuration. When the cam lock 316 is in the locked configuration, the cam lock 316 can frictionally contact the sleeve shaft 182, thereby preventing the sleeve handle 196 coupled to the sleeve shaft 182 from moving axially relative to the hub assembly cradle 214. When the cam lock 316 is in the unlocked configuration, the sleeve handle 196 is free to move axially relative to the hub assembly cradle 214 (e.g., during the docking device delivery procedure of the embodiment illustrated in Figures 16D-16E).

[0144] A second exemplary difference between the hub assembly support 208 of FIGS. 14A-14B and the hub assembly support 308 of FIG. 17 is that the hub assembly support 308 may include a housing 312 having a chamfer 296. The chamfer 296 may include a viewport 298 extending axially along the length of the slot 236. A user-visible indicator 320 may be located behind the viewport 298. The indicator 320 may include a rod coupled to the traveler 266. Because the indicator 320 is coupled to the traveler 266 and the hub assembly is indirectly coupled to the traveler 266, the axial position of the indicator 320 may correlate to the axial position of the hub assembly 158 and the pusher shaft 184. Thus, as the hub assembly cradle 214 moves along the length of the slot 236, the indicator 320 may align with one or more markings located on the viewport 298 to indicate the radius of curvature of the sleeve shaft leading turn 187, which is determined based on the axial position of the hub assembly cradle 214.

[0145] 18 illustrates a third embodiment of a hub assembly support 408. One exemplary difference between the hub assembly support 408 and the previously described hub assembly supports 208, 308 is that the hub assembly support 408 may include a sleeve handle cradle 216 and a housing 312 having a chamfered portion 296.

[0146] FIG. 19 illustrates a guide catheter 30 (which may also be referred to herein as an introducer device) according to one embodiment. In some embodiments, the guide catheter 30 may be used in a prosthetic valve implantation procedure, as described above with reference to FIGS. 1-4. In some embodiments, the guide catheter 30 may be used in a docking device implantation procedure, as described above with reference to FIGS. 5-11. The guide catheter 30 may be configured to be inserted into a patient's vasculature and to receive an implant catheter (and / or delivery device) therein for introducing the implant catheter into the patient's vasculature and at least partially guiding the implant catheter therein to a target implantation site. Examples of implant catheters for prosthetic medical devices (hereinafter referred to as delivery device 150 and delivery device 400) that may be received within the guide catheter 30 are illustrated in FIGS. 13 and 23, respectively.

[0147] The guide catheter 30 of the illustrated embodiment 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 proximally within the handle 32. In some embodiments, the catheter shaft 34 may be coupled to a 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 such that the delivery shaft 154, sleeve shaft 182, and pusher shaft 184 may extend through the catheter handle lumen and the catheter shaft lumen. In some embodiments, the catheter shaft lumen and delivery shaft 154 may be aligned with the longitudinal axis 36.

[0148] FIG. 20 illustrates a guide catheter 30 coupled to a delivery device 150, according to one example.

[0149] 21 illustrates a guide catheter 30 coupled to a docking device delivery device 350 according to a second embodiment. The docking device delivery device 350 may include a handle 356 (which may be similar to the handle 156), a hub assembly 358 (which may be similar to the hub assembly 158) including a suture lock assembly 359, and a sleeve handle 196.

[0150] Figure 22 illustrates an example docking device 152. As shown in Figure 22, the docking device 152 in its deployed, coiled configuration can be configured to receive and secure a prosthetic valve (such as the prosthetic heart valve 62) therein, thereby securing the prosthetic valve at the annulus of the native mitral valve 16.

[0151] The docking device 152 comprises a coil 188. In some embodiments, the coil 188 may comprise a shape memory material (e.g., a nickel-titanium alloy, or "nitinol") such that the docking device 152 (and the coil 188) may transition from a substantially straight configuration (or delivery configuration) when disposed within the delivery shaft 154 to a spirally deployed configuration after being removed from the delivery shaft 154.

[0152] The coil 188 has a proximal end 188p and a distal end 188d (which also define the proximal and distal ends, respectively, of the docking device 152). When disposed within the delivery shaft 154 (e.g., during delivery of the docking device 152 into the patient's vasculature), the body of the coil 188 between the proximal end 188p and the distal end 188d can form a generally straight delivery configuration (without any coiled or looped portions, but can be bent or curved) to maintain a low radial profile as it moves through the patient's vasculature. After being removed from the delivery shaft 154 and deployed at the implantation location, the coil 188 can transition from the delivery configuration to a helical deployed configuration and can wrap around native tissue adjacent the implantation location. For example, the coil 188 can be configured to surround the native leaflets of the native valve (and the chordae tendineae connecting the native leaflets to the adjacent papillary muscles) when the docking device is implanted at the native valve location.

[0153] The deployed coiled configuration of the coil 188 may include, about a central longitudinal axis, a docking device leading turn 189, a central region 190, and a stabilizing turn 195 (or "stabilizing coil").

[0154] In the deployed, coiled configuration, the central region 190 comprises one or more helical turns formed about a 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 native mitral valve 16. A docking device leading turn 189 extends from the distal end of the central region 190 and has a radius of curvature greater than the radius of curvature of the helical turns of the central region 190. In some embodiments, the radius of curvature of the docking device that connects to the docking device leading turn 189 of the docking device 152 is equal to a second radius of curvature that is less than the first radius of curvature of the sleeve shaft leading turn 187.

[0155] The stabilizing turns 195, in the illustrated example, may extend from the proximal end of the central region 190 and have a diameter greater than the diameter of the central region 190. Alternatively, the stabilizing turns 195 may have a diameter equal to, approximately equal to, or smaller than (as opposed to larger than) the diameter of the central region 190, and / or the stabilizing turns may include fewer than the full turns illustrated in FIG.

[0156] In some embodiments, the docking device 152 may further include a guard member 180 disposed over the coil 188. The guard member is configured to reduce the likelihood of paravalvular leakage between the native mitral valve 16 and the prosthetic heart valve. In some embodiments, the guard member 180 may include a braided portion disposed 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 a deployed configuration when the proximal end portion 193 is forced distally, the braided portion having an increased radial thickness in the shortened, deployed configuration.

[0157] Further details regarding the docking device and variations thereof are described in PCT International Publication No. WO2022 / 087336, which is incorporated herein by reference in its entirety.

[0158] 23 illustrates a delivery device 400 (which may also be referred to in this disclosure as an "implant catheter" and / or a "prosthetic heart valve delivery device") that may be used to implant an expandable prosthetic heart valve, according to one example. In some embodiments, the delivery device 400 is particularly adapted for use in introducing a prosthetic heart valve into the heart. For example, the delivery device 400 may be used as the prosthetic valve delivery device 60 in a prosthetic valve implantation procedure, as described above with reference to FIG. 3A.

[0159] 23 is a balloon catheter including a handle 402 and a steerable outer shaft 404 extending distally from the handle 402. The delivery device 400 may further include a mid-shaft 406 (which may also be referred to as a balloon shaft) extending proximally and distally from the handle 402, the portion extending distally from the handle 402 extending coaxially through the outer shaft 404. In some embodiments, the delivery device 400 may further include an inner shaft extending coaxially distally from the handle 402 through the mid-shaft 406 and the outer shaft 404, and extending proximally from the handle 402 coaxially through the mid-shaft 406 and the outer shaft 404.

[0160] The outer shaft 404 and the intermediate shaft 406 can be configured to translate (e.g., move) longitudinally relative to one another along a central longitudinal axis 420 of the delivery device 400 to facilitate delivery and positioning of the prosthetic valve to an implantation site within a patient's body.

[0161] The midshaft 406 can include a proximal end portion that extends proximally from the proximal end of the handle 402 to an adapter 412. The adapter 412 can include a first port 438 configured to receive a guidewire therethrough and a second port 440 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 440 can be fluidly coupled to the inner lumen of the midshaft 406.

[0162] In some embodiments, the midshaft 406 can 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 can extend distally beyond the distal end portion of the midshaft 406 toward or to a nosecone 422 at the distal end of the delivery device 400.

[0163] 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 nosecone 422 (as shown in FIG. 23 ), or to an alternative component (e.g., a distal shoulder) at the distal end of the delivery device 400. An intermediate portion of the balloon 418 can be configured to cover a valve mounting portion 424 at the distal end of the delivery device 400, and the distal end portion of the balloon 418 can be configured to cover the distal shoulder of the delivery device 400. As shown in FIG. 23 , a prosthetic 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 prosthetic heart valve 450 can be configured to be radially expanded by inflation of the balloon 418 at the native valve annulus, as described above with reference to FIG. 3A .

[0164] The balloon shoulder assembly of the delivery device 400, including the distal shoulder, is configured to maintain the prosthetic heart valve 450 (or other medical device) in a fixed position on the balloon 418 during delivery through the patient's vasculature.

[0165] The outer shaft 404 can include a distal tip portion 428 mounted on its distal end. In some embodiments, the outer shaft 404 and the midshaft 406 can be axially translated relative to one another to position the distal tip portion 428 adjacent the proximal end of the valve mounting portion 424 when the prosthetic valve 450 is mounted in a radially compressed state on the valve mounting portion 424 (e.g., as shown in FIG. 23 ) and during delivery of the prosthetic valve to the target implantation site. Thus, the distal tip portion 428 can be configured to resist movement of the prosthetic valve 450 axially relative to the balloon 418 and proximally relative to the balloon 418 when the distal tip portion 428 is positioned adjacent the proximal side of the valve mounting portion 424.

[0166] An annular space may be defined between the outer surface of the inner shaft and the inner surface of the midshaft 406 and may be configured to receive fluid from a fluid source via the second port 440 of the adapter 412. The annular space may be fluidly connected to a fluid passageway 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 may flow from the annular space into the fluid passageway, inflating the balloon 418 and radially expanding and deploying the prosthetic valve 450.

[0167] The inner lumen of the inner shaft may be configured to receive a guidewire therethrough for navigating the distal end portion of the delivery device 400 to the target implantation site.

[0168] The handle 402 can 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, that is operably coupled to a proximal end portion of a pull wire. The pull wire can extend distally from the handle 402 through the outer shaft 404 and have a distal end portion secured to the outer shaft 404 at or near the distal end of the outer shaft 404. By rotating the knob 460, the tension in the pull wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 400. Further details regarding steering or bending mechanisms for delivery devices can be found in U.S. Pat. No. 9,339,384, previously incorporated by reference above.

[0169] The handle 402 may further include an adjustment mechanism 461 that includes an adjustment member, such as the illustrated rotatable knob 462, and an associated locking mechanism that includes another adjustment member configured as a rotatable knob 478. The adjustment mechanism 461 is configured to adjust the axial position of the intermediate shaft 406 relative to the outer shaft 404 (e.g., for fine positioning at the implantation site).

[0170] The prosthetic valves disclosed in the present disclosure (e.g., prosthetic heart valve 450, prosthetic heart valve 62, etc.) may be configured to be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be crimped onto or held by an implant delivery device (e.g., delivery device 400, prosthetic valve delivery device 60, etc.) in a radially compressed state during delivery, and then expanded to a radially expanded state after the prosthetic valve reaches the implantation site. It will be appreciated that the prosthetic valves disclosed in the present disclosure can be used with a variety of implant delivery devices and implanted via a variety of delivery procedures, examples of which are discussed in more detail below.

[0171] FIG. 24 shows the prosthetic valve 450 in a radially expanded position. The prosthetic valve 450 can be used as the prosthetic heart valve 62 in a prosthetic valve implantation procedure, as described above with reference to FIGS. 1-4. While all of the prosthetic valves disclosed in the present disclosure are configured to be implanted in the native aortic valve annulus, in other embodiments, they may be adapted to be implanted in other native valve annulus of the heart (such as the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves can also be implanted within blood vessels communicating with the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), the superior vena cava, or the inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of the patient. The disclosed prosthetic valves can also be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0172] In some embodiments, the disclosed prosthetic valves can be implanted within a docking apparatus or anchoring device (e.g., docking apparatus 152, etc.) that is implanted within a native heart valve or blood vessel. For example, in one embodiment, the disclosed prosthetic valves can be implanted within a docking apparatus implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another embodiment, the disclosed prosthetic valves can be implanted within a docking apparatus implanted within a native mitral valve or within a docking apparatus implanted within a native mitral valve, such as disclosed in PCT Publication No. WO 2020 / 247907, which is incorporated herein by reference. In another embodiment, the disclosed prosthetic valves can be implanted within a docking apparatus implanted within the superior vena cava or inferior vena cava to replace the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0173] The prosthetic valve 450 can be used as the prosthetic heart valve 62 in a prosthetic valve implantation procedure, as described above with reference to FIGS. 1-4. As shown in FIG. 24, the prosthetic valve 450 can include a frame 452, and multiple valve leaflets 454 can be at least partially positioned within the frame 452. The prosthetic valve 450 can also include an outer cover 456 positioned around the frame 452. As shown in FIG. 12, the prosthetic valve 450 includes an inflow end 457 and an outflow end 458. The terms "inflow" and "outflow" refer to the normal direction of blood flow (e.g., antegrade blood flow) through the prosthetic valve 450. For example, the valve leaflets 454 can allow blood flow through the valve 450 in a direction from the inflow end 457 to the outflow end 458 and prevent backflow (e.g., prevent flow from the inflow end 458 to the inflow end 457).

[0174] Frame 452 can be formed from any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol), as known in the art. If constructed from a plastically expandable material, frame 452 (and thus valve 450) can be crimped into a radially compressed state on a delivery catheter and then expanded within the patient's body by an inflatable balloon or equivalent expansion mechanism. If constructed from a self-expandable material, frame 452 (and thus valve 450) can be constrained in a compressed state by insertion into a sheath or equivalent mechanism on a delivery catheter that is crimped into a radially compressed state. Once introduced into the body, the valve can be advanced from the delivery sheath, allowing the valve to expand to its functional size.

[0175] Suitable plastically expandable materials that can be used to form the frames (e.g., frame 452) disclosed herein include metal alloys, polymers, or combinations thereof. Exemplary metal alloys can include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some embodiments, frame 452 can include stainless steel. In some embodiments, frame 452 can include cobalt-chromium. In some embodiments, frame 452 can include nickel-cobalt-chromium. In some embodiments, frame 452 can include a nickel-cobalt-chromium alloy, such as MP35N™ (a trade name of SPS Technologies), which is equivalent to UNS R30035 (certified per ASTM F562-02). MP35N™ / UNS R30035 includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight.

[0176] The outer cover 456 may be constructed entirely or partially from any suitable biological material, synthetic material (e.g., any of a variety of polymers), or combinations thereof. In some embodiments, the outer cover 456 may include a fabric having interwoven 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, bettin, corduroy, terry cloth, fleece, and the like. In some embodiments, the outer cover 456 may include a fabric without interwoven yarns or fibers, such as a felt or an electrospun fabric. Exemplary materials that can be used to form such fabrics (with or without interwoven yarns or fibers) include, but are not limited to, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide, and the like. In some examples, the skirt may comprise a non-fibrous or non-woven material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (e.g., thermoplastic polyurethane (TPU)), etc. In some examples, the outer cover 456 may comprise a sponge material or foam, such as polyurethane foam. In some examples, the outer cover 456 may comprise natural tissue, such as pericardial tissue (e.g., bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0177] Further details regarding prosthetic heart valves and their components are provided in US Patent Publication No. 11,185,406, which is incorporated herein by reference.

[0178] delivery technology To implant a prosthetic valve into the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery device. The prosthetic valve and the distal end portion 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 within the native aortic valve and radially expanded (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted within the native aortic valve via a transapical procedure, in which the prosthetic valve (on the distal end portion 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 within the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a right parasternal minithoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0179] To implant a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted within the native mitral valve via a transapical procedure, in which the prosthetic valve (on the distal end portion 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 within the native mitral valve.

[0180] To implant a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used to implant a prosthetic valve within the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0181] Another delivery approach is the transatrial approach, whereby the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (of the right or left atrium) to access either of the native heart valves. Atrial delivery can also be performed intravascularly, for example, from a pulmonary vein. Yet another delivery approach is the transventricular approach, where the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve within the native tricuspid valve, within the native pulmonary valve, or within the pulmonary artery.

[0182] In all delivery approaches, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed in this disclosure can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0183] sterile Any system, device, apparatus, etc. of the present disclosure can be sterilized (e.g., using heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use on patients, and any method of the present disclosure can include sterilizing the associated system, device, apparatus, etc. as a step in the method. Examples of heat sterilization include steam sterilization and autoclave sterilization. Examples of radiation for use in sterilization include, but are not limited to, gamma rays, ultraviolet light, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Hydrogen peroxide sterilization may be achieved, for example, using hydrogen peroxide plasma.

[0184] simulation The therapeutic techniques, methods, processes, etc. described or suggested in this disclosure or the references incorporated herein may be performed on live animals or on non-living simulations such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., simulated using body parts, tissues, etc.).

[0185] Additional Examples of the Disclosed Technology In view of the implementations described above with respect to the disclosed subject matter, the present application discloses the following additional examples: It should be noted that one feature individually in an example, or two or more features in combination in that example, and optionally in combination with one or more features in one or more additional examples, are also further examples falling within the disclosure of the present application.

[0186] Example 1. A delivery system for delivering a prosthetic medical device, comprising: a delivery device comprising: a handle; a delivery shaft extending from a distal end portion of the handle and comprising a delivery shaft lumen extending along a length of the delivery shaft; a hub assembly extending from a proximal end portion of the handle; a sleeve shaft disposed within the delivery shaft lumen, the sleeve shaft comprising a sleeve shaft lumen extending along a length of the sleeve shaft; a pusher shaft disposed within the sleeve shaft lumen; a sleeve handle coupled to a proximal end portion of the sleeve shaft; and a hub assembly coupled to the proximal end portion of the pusher shaft; and a stabilizer assembly configured to stabilize the delivery device, the stabilizer assembly configured to stabilize the delivery device in an axial direction. a hub assembly support configured to slidably couple to the stabilizer track, the hub assembly support comprising: a stabilizer track configured to be oriented in the axial direction relative to the sleeve handle; a sleeve handle cradle configured to receive the sleeve handle; a hub assembly cradle configured to receive the hub assembly, the hub assembly cradle being movable in the axial direction relative to the sleeve handle cradle; and a linear actuator coupled to the hub assembly, the linear actuator configured to actuate the hub assembly cradle in the axial direction relative to the sleeve handle cradle.

[0187] Example 2. The delivery system of any example of the present disclosure, particularly example 1, further comprising a guide catheter.

[0188] Example 3. A delivery system according to any of the embodiments of the present disclosure, particularly Example 2, wherein the guide catheter comprises a handle, a catheter shaft extending from a distal end portion of the handle, and a catheter shaft lumen extending along the length of the catheter shaft, the catheter shaft lumen configured to receive the delivery shaft, the sleeve shaft, and the pusher shaft.

[0189] Example 4. A delivery system according to any of the embodiments of the present disclosure, particularly any one of Examples 2-3, wherein the stabilizer assembly further comprises a support configured to stabilize the guide catheter.

[0190] Example 5. A delivery system according to any of the embodiments of the present disclosure, particularly any one of Examples 1-4, wherein the stabilizer assembly further comprises a support configured to stabilize the handle.

[0191] Example 6. A delivery system of any embodiment of the present disclosure described in any one of Examples 1 to 5, wherein at least one of the sleeve shaft and the pusher shaft has a substantially U-shaped axial cross section.

[0192] Example 7. A delivery system according to any of the embodiments of the present disclosure, particularly any one of Examples 1-6, wherein the delivery shaft, the sleeve shaft, and the pusher shaft are capable of operating independently of each other.

[0193] Example 8. A delivery system according to any of the embodiments of the present disclosure, particularly any one of Examples 1-7, wherein the hub assembly support further comprises an indicator.

[0194] Example 9. The delivery system of any embodiment of the present disclosure, particularly Example 8, wherein the indicator is configured to indicate the magnitude of the radius of curvature of the distal end portion of the delivery system.

[0195] Example 10. Any embodiment of the present disclosure, particularly a delivery system described in Example 9, wherein the radius of curvature of the distal end portion of the delivery system is measured at a sleeve shaft leading turn, and the sleeve shaft leading turn is located at or adjacent to the distal end portion of the sleeve shaft.

[0196] Example 11. A delivery system described in any one of Examples 9 to 10, wherein the indication of the magnitude of the radius of curvature of the distal end portion of the delivery system is based on the relative axial position of the pusher shaft with respect to the sleeve shaft.

[0197] Example 12. A delivery system as described in any of the embodiments of the present disclosure, particularly Example 11, wherein the relative axial position of the pusher shaft is based on the relative axial position of the hub assembly cradle relative to the sleeve handle cradle.

[0198] Example 13. A delivery system described in any one of Examples 9 to 12, wherein the indicator comprises a first marking indicating that the radius of curvature is equal to a first radius of curvature and a second marking indicating that the radius of curvature is equal to a second radius of curvature.

[0199] Example 14. A delivery system according to any of the presently disclosed embodiments, particularly example 13, wherein the first marking is disposed proximally relative to the second marking.

[0200] Example 15. A stabilizer assembly configured for use with a delivery device, comprising: a stabilizer track configured to be axially oriented; and a hub assembly support configured to slidably couple to said stabilizer track; a hub assembly support comprising: a sleeve handle cradle configured to receive a sleeve handle of the delivery device; a linear actuator configured to move a traveler axially relative to the sleeve handle cradle; and a hub assembly cradle coupled to the traveler, the hub assembly cradle configured to receive a hub assembly of the delivery device.

[0201] Example 16. The stabilizer assembly of any of the embodiments of the present disclosure, particularly example 15, wherein the hub assembly support further comprises a stabilizer track lock configured to couple the hub assembly support to the stabilizer track, the stabilizer track lock being operable between a locked configuration and an unlocked configuration.

[0202] Example 17. The stabilizer bar assembly of any of the embodiments of the present disclosure, particularly example 16, wherein the stabilizer track lock comprises a locking flange extending laterally outward from the hub assembly support.

[0203] Example 18. The stabilizer bar assembly of any example of the present disclosure, particularly example 17, wherein the locking flange is configured to frictionally engage the stabilizer track in the locked configuration.

[0204] Example 19. The stabilizer assembly of any of the embodiments of the present disclosure, particularly any one of Examples 16-18, wherein the stabilizer track lock is biased in the locked configuration.

[0205] Example 20. A stabilizer assembly of any embodiment of the present disclosure described in any one of Examples 16 to 19, wherein the hub assembly support further comprises a groove disposed on an outer surface of the hub assembly support.

[0206] Example 21. Any embodiment of the present disclosure, particularly example 20, of a stabilizer assembly, wherein the groove is disposed on a first outer surface of the hub assembly support, the stabilizer track lock is disposed on a second outer surface of the hub assembly support, and the first outer surface is opposite the second outer surface.

[0207] Example 22. A hub assembly support configured for use with a delivery system, comprising: a base portion; a housing disposed on the base portion and having an axially oriented slot; a sleeve handle cradle disposed on the housing and configured to receive a sleeve handle of the delivery system; a linear actuator coupled to the base portion; a traveler coupled to the linear actuator and extending through the axially oriented slot; and a hub assembly cradle coupled to the traveler, the hub assembly cradle configured to receive a hub assembly of the delivery system, the linear actuator configured to actuate the hub assembly cradle in the axial direction relative to the sleeve handle cradle.

[0208] Example 23. The hub assembly support of any of the embodiments of the present disclosure, particularly example 22, wherein the sleeve handle cradle comprises a recess in the base portion configured to receive the sleeve handle.

[0209] Example 24. The hub assembly support of any embodiment of the present disclosure, particularly example 23, wherein the recess has a bell-shaped cutout.

[0210] Example 25. A hub assembly support described in any of the embodiments of the present disclosure, particularly any one of Examples 23-24, wherein the recess has a cutout configured to accommodate the sleeve shaft of the delivery system.

[0211] Example 26. A hub assembly support according to any of the embodiments of the present disclosure, particularly any one of Examples 22-25, wherein the hub assembly support further comprises an indicator.

[0212] Example 27. The hub assembly support of any embodiment of the present disclosure, particularly example 26, wherein the indicator is configured to indicate the magnitude of the radius of curvature of the leading rotation of a sleeve shaft coupled to the hub assembly.

[0213] Example 28. A hub assembly support of any embodiment of the present disclosure, particularly Example 27, wherein the indication of the magnitude of the radius of curvature of the leading turn of the sleeve shaft is based on the axial position of the traveler relative to the sleeve handle cradle.

[0214] Example 29. The hub assembly support of any embodiment of the present disclosure, particularly example 28, wherein the indicator comprises a rod coupled to the traveler.

[0215] Example 30. The hub assembly support of any embodiment of the present disclosure, particularly example 29, wherein the housing further comprises a viewport extending in the axial direction along the length of the axially oriented slot, and the rod is visible through the viewport.

[0216] Example 31. A hub assembly support described in any one of Examples 29 to 30, wherein the rod is configured to align with a marking indicating the magnitude of the radius of curvature of the leading turn of the sleeve shaft.

[0217] Example 32. A hub assembly support for use with a delivery system, comprising: a base portion; a linear actuator disposed on the base portion, the linear actuator having an axially oriented threaded shaft; a carriage operably coupled to the threaded shaft, the linear actuator configured to actuate the carriage in the axial direction; a hub assembly cradle coupled to the carriage, the hub assembly cradle configured to receive a hub assembly of the delivery system; and a sleeve handle cradle disposed on the base portion, the sleeve handle cradle configured to receive a sleeve handle of the delivery system, the linear actuator configured to actuate the hub assembly cradle in the axial direction relative to the sleeve handle cradle.

[0218] Example 33. The hub assembly support of any example of the present disclosure, particularly example 32, wherein the hub assembly support further comprises an actuation control configured to control the linear actuator.

[0219] Example 34. The hub assembly support of any embodiment of the present disclosure, particularly example 33, wherein the actuation control comprises a rotatable knob.

[0220] Example 35. The hub assembly support of any embodiment of the present disclosure, particularly example 34, wherein the hub assembly support further comprises a plurality of bevel gears operably coupling the rotatable knob to the threaded shaft.

[0221] Example 36. A hub assembly support described in any one of Examples 32 to 35, wherein the hub assembly support further comprises a brake configured to limit movement of the hub assembly support relative to a stabilizer track coupled to the hub assembly support.

[0222] Example 37. A hub assembly support described in any embodiment of the present disclosure, particularly any one of Examples 32 to 36, wherein the degree of actuation of the linear actuator is the same as the length of the axially extending slot in the hub assembly support.

[0223] Example 38. A method for implanting a prosthetic medical device, comprising: coupling a delivery apparatus to a stabilizer assembly, the delivery apparatus comprising: a delivery shaft, a sleeve shaft disposed within the delivery shaft, a pusher shaft disposed within the sleeve shaft, a sleeve handle coupled to a proximal end portion of the sleeve shaft, and a hub assembly coupled to the proximal end portion of the pusher shaft, the stabilizer assembly comprising: a hub assembly cradle configured to receive the hub assembly, a sleeve handle cradle configured to receive the sleeve handle, and a linear actuator configured to actuate the hub assembly cradle axially relative to the sleeve handle cradle; coupling the hub assembly to the hub assembly cradle and coupling the sleeve handle to the sleeve handle cradle; coupling the delivery apparatus to the stabilizer assembly; advancing the hub assembly support distally; and actuating the linear actuator to move the hub assembly cradle axially relative to the sleeve handle cradle.

[0224] Example 39. The method of any embodiment of the present disclosure, particularly example 38, wherein the prosthetic medical device is a docking device configured for use with a prosthetic heart valve.

[0225] Example 40. The method of any of the disclosed embodiments, particularly example 39, wherein the docking device further comprises a guard member.

[0226] Example 41. A method according to any of the embodiments of the present disclosure, particularly example 40, further comprising: separating the sleeve handle from the sleeve handle cradle; storing the sleeve handle proximally relative to the hub assembly; and advancing the sleeve handle distally relative to the hub assembly.

[0227] Example 42. A method described in any one of Examples 38 to 41, wherein moving the hub assembly cradle axially relative to the sleeve handle cradle changes the magnitude of the radius of curvature of the sleeve shaft leading turn coupled to the hub assembly.

[0228] Example 43. A method according to any of the embodiments of the present disclosure, particularly any one of Examples 38 to 42, wherein the linear actuator is configured to move the hub assembly cradle distally relative to the sleeve handle.

[0229] Example 44. A method described in any one of Examples 38 to 43, wherein the delivery device further comprises a handle connected to a proximal end portion of the sleeve shaft, the stabilizer assembly further comprises a support configured to stabilize the handle, and the hub assembly support advances in the distal direction integrally with the support.

[0230] Any feature described in this disclosure with respect to any embodiment may be combined with any other feature described in one or more of the other embodiments, unless otherwise specified. For example, any one or more features of one hub assembly support may be combined with any one or more features of another hub assembly support. As another example, any one or more features of one docking device delivery device may be combined with any one or more features of another docking device delivery device.

[0231] In view of the many possible manners to which the principles of the present disclosure may be applied, it will be understood that the illustrated configurations illustrate some examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure and the claims that follow. Rather, the scope of claimed subject matter is defined by the following claims and their equivalents.

Claims

1. 1. A delivery system for delivering a prosthetic medical device, comprising:

1. A delivery device comprising: The handle and a delivery shaft extending from a distal end portion of the handle and including a delivery shaft lumen extending along the length of the delivery shaft; a hub assembly extending from a proximal end portion of the handle; a sleeve shaft disposed within the delivery shaft lumen, the sleeve shaft comprising a sleeve shaft lumen extending along a length of the sleeve shaft; a pusher shaft disposed within the sleeve shaft bore; a sleeve handle coupled to a proximal end portion of the sleeve shaft; a hub assembly coupled to a proximal end portion of the pusher shaft; a stabilizer assembly configured to stabilize the delivery device, a stabilizer track configured to be axially oriented; a hub assembly support configured to slidably couple to the stabilizer track, a sleeve handle cradle configured to receive the sleeve handle; a hub assembly cradle configured to receive the hub assembly, the hub assembly cradle being movable in the axial direction relative to the sleeve handle cradle; a hub assembly support comprising: a linear actuator coupled to the hub assembly, the linear actuator configured to actuate the hub assembly cradle in the axial direction relative to the sleeve handle cradle; and a stabilizer assembly comprising:

2. The delivery system of claim 1 further comprising a guide catheter.

3. 3. The delivery system of claim 2, wherein the guide catheter comprises a handle, a catheter shaft extending from a distal end portion of the handle, and a catheter shaft lumen extending along the length of the catheter shaft, the catheter shaft lumen configured to receive the delivery shaft, the sleeve shaft, and the pusher shaft.

4. The delivery system of any one of claims 2-3, wherein the stabilizer assembly further comprises a support configured to stabilize the guide catheter.

5. The delivery system of any one of claims 1 to 4, wherein the stabilizer assembly further comprises a support configured to stabilize the handle.

6. The delivery system of any one of claims 1 to 5, wherein the hub assembly support further comprises a brake configured to lock the hub assembly support to the stabilizer track.

7. The delivery system of any one of claims 1 to 6, wherein the delivery shaft, the sleeve shaft, and the pusher shaft are operable independently of each other.

8. The delivery system of any one of claims 1 to 7, wherein the hub assembly support further comprises an indicator.

9. The delivery system of claim 8 , wherein the indicator is configured to indicate the magnitude of the radius of curvature of the distal end portion of the delivery system.

10. 10. The delivery system of claim 9, wherein the radius of curvature of the distal end portion of the delivery system is measured at a sleeve shaft leading turn, the sleeve shaft leading turn being located at or adjacent to the distal end portion of the sleeve shaft.

11. 11. A delivery system according to any one of claims 9 to 10, wherein the indication of the magnitude of the radius of curvature of the distal end portion of the delivery system is based on the relative axial position of the pusher shaft with respect to the sleeve shaft.

12. The delivery system of claim 11 , wherein the relative axial position of the pusher shaft is based on the relative axial position of the hub assembly cradle relative to the sleeve handle cradle.

13. 13. The delivery system of any one of claims 9 to 12, wherein the indicator comprises a first marking indicating that the radius of curvature is equal to a first radius of curvature and a second marking indicating that the radius of curvature is equal to a second radius of curvature.

14. The delivery system of claim 13 , wherein the first marking is disposed proximally relative to the second marking.

15. 1. A stabilizer assembly configured for use with a delivery device, comprising: a stabilizer track configured to be axially oriented; a hub assembly support configured to slidably couple to the stabilizer track, a sleeve handle cradle configured to receive a sleeve handle of the delivery device; a linear actuator configured to move a traveler axially relative to the sleeve handle cradle; a hub assembly cradle coupled to the traveler, the hub assembly cradle configured to receive a hub assembly of the delivery device; and a hub assembly support comprising:

16. 16. The stabilizer assembly of claim 15, wherein the hub assembly support further comprises a stabilizer track lock configured to couple the hub assembly support to the stabilizer track, the stabilizer track lock being actuatable between a locked configuration and an unlocked configuration.

17. The stabilizer bar assembly of claim 16, wherein the stabilizer track lock comprises a locking flange extending laterally outward from the hub assembly support.

18. The stabilizer bar assembly of claim 17 , wherein the locking flange is configured to frictionally engage the stabilizer track in the locked configuration.

19. The stabilizer bar assembly of any one of claims 16 to 18, wherein the stabilizer track lock is biased in the locked configuration.

20. The stabilizer bar assembly according to any one of claims 16 to 19, wherein the hub assembly support further comprises a groove disposed on an outer surface of the hub assembly support.

21. 21. The stabilizer bar assembly of claim 20, wherein the groove is located on a first outer surface of the hub assembly support and the stabilizer track lock is located on a second outer surface of the hub assembly support, the first outer surface being opposite the second outer surface.

22. 1. A hub assembly support configured for use with a delivery system, comprising: The base part and a housing disposed on the base portion and including an axially oriented slot; a sleeve handle cradle disposed on the housing and configured to receive a sleeve handle of the delivery system; a linear actuator coupled to the base portion; a traveler coupled to the linear actuator and extending through the axially oriented slot; a hub assembly cradle coupled to the traveler, the hub assembly cradle configured to receive a hub assembly of the delivery system, the linear actuator configured to actuate the hub assembly cradle in the axial direction relative to the sleeve handle cradle.

23. The hub assembly support of claim 22, wherein the sleeve handle cradle includes a recess in the base portion configured to receive the sleeve handle.

24. The hub assembly support of claim 23 wherein the recess has a bell-shaped cutout.

25. A hub assembly support according to any one of claims 23 to 24, wherein the recess has a cutout configured to accommodate a sleeve shaft of the delivery system.

26. A hub assembly support according to any one of claims 22 to 25, wherein the hub assembly support further comprises an indicator.

27. 27. The hub assembly support of claim 26, wherein the indicator is configured to indicate a magnitude of a radius of curvature of a sleeve shaft leading turn coupled to the hub assembly.

28. 28. The hub assembly support of claim 27, wherein the indication of the magnitude of the radius of curvature of the leading turn of the sleeve shaft is based on an axial position of the traveler relative to the sleeve handle cradle.

29. The hub assembly support of claim 28, wherein the indicator comprises a rod coupled to the traveler.

30. 30. The hub assembly support of claim 29, wherein the housing further comprises a viewport extending axially along the length of the axially oriented slot, the rod being visible through the viewport.

31. A hub assembly support according to any one of claims 29 to 30, wherein the rod is configured to align with a marking indicating the magnitude of the radius of curvature of the leading turn of the sleeve shaft.

32. 1. A hub assembly support for use with a delivery system, comprising: The base part and a linear actuator disposed on the base portion, an axially oriented threaded shaft; a carriage operably coupled to the threaded shaft, the linear actuator configured to actuate the carriage in the axial direction; a hub assembly cradle coupled to the carriage, the hub assembly cradle configured to receive a hub assembly of the delivery system; a sleeve handle cradle disposed on the base portion, the sleeve handle cradle configured to receive a sleeve handle of the delivery system; a linear actuator configured to actuate the hub assembly cradle in the axial direction relative to the sleeve handle cradle.

33. The hub assembly support of claim 32, wherein the hub assembly support further comprises an actuation control configured to control the linear actuator.

34. The hub assembly support of claim 33, wherein the actuation control comprises a rotatable knob.

35. The hub assembly support of claim 34, wherein the hub assembly support further comprises a plurality of bevel gears operably coupling the rotatable knob to the threaded shaft.

36. A hub assembly support according to any one of claims 32 to 35, wherein the hub assembly support further comprises a brake configured to limit movement of the hub assembly support relative to a stabilizer track coupled to the hub assembly support.

37. A hub assembly support according to any one of claims 32 to 36, wherein the extent of actuation of the linear actuator is the same as the length of an axially extending slot in the hub assembly support.

38. 1. A method for implanting an artificial medical device, comprising: coupling a delivery device to a stabilizer assembly, the delivery device comprises a delivery shaft, a sleeve shaft disposed within the delivery shaft, a pusher shaft disposed within the sleeve shaft, a sleeve handle coupled to a proximal end portion of the sleeve shaft, and a hub assembly coupled to a proximal end portion of the pusher shaft; the stabilizer assembly comprises a hub assembly support comprising a hub assembly cradle configured to receive the hub assembly, a sleeve handle cradle configured to receive the sleeve handle, and a linear actuator configured to actuate the hub assembly cradle axially relative to the sleeve handle cradle; coupling the delivery device to the stabilizer assembly, comprising: coupling the hub assembly to the hub assembly cradle; and coupling the sleeve handle to the sleeve handle cradle; advancing the hub assembly support distally; and actuating the linear actuator to axially move the hub assembly cradle relative to the sleeve handle cradle.

39. 39. The method of claim 38, wherein the prosthetic medical device is a docking apparatus configured for use with a prosthetic heart valve.

40. 40. The method of claim 39, wherein the docking device further comprises a guard member.

41. 41. The method of claim 40, further comprising: separating the sleeve handle from the sleeve handle cradle; retracting the sleeve handle proximally relative to the hub assembly; and advancing the sleeve handle distally relative to the hub assembly.

42. 42. The method of any one of claims 38 to 41, wherein axially moving the hub assembly cradle relative to the sleeve handle cradle changes the magnitude of the radius of curvature of a sleeve shaft leading turn coupled to the hub assembly.

43. The method of any one of claims 38 to 42, wherein the linear actuator is configured to move the hub assembly cradle distally relative to the sleeve handle.

44. 44. The method of any one of claims 38 to 43, wherein the delivery device further comprises a handle coupled to a proximal end portion of the sleeve shaft, and wherein the stabilizer assembly further comprises a support configured to stabilize the handle, and wherein the hub assembly support advances in the distal direction integrally with the support.

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