Prosthetic medical device delivery system

Abstract

A delivery system may include a delivery device and a stabilizer assembly. The delivery device may include 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, the sleeve shaft, and the pusher shaft may be independently actuatable. The stabilizer assembly may include a hub assembly bracket configured to receive the hub assembly, a sleeve handle bracket configured to receive the sleeve handle, and a linear actuator configured to move the hub assembly bracket relative to the sleeve handle bracket in the axial direction. The stabilizer assembly may be configured to actuate the hub assembly relative to the sleeve handle while keeping the sleeve handle stationary, thereby stabilizing the delivery device in a manner that allows independent actuation of the delivery shaft, the sleeve shaft, and the pusher shaft.

Description

[0001] Cross-reference to related applications This application claims the benefit of U.S. Provisional Application No. 63 / 481,577, filed January 25, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0002] The present disclosure relates to delivery systems for prosthetic medical devices. Background Art

[0003] The human heart can be susceptible to various valvular diseases. These valvular diseases can lead to significant cardiac dysfunction and ultimately require repair of the native valve or replacement with a prosthetic valve. There are many known prosthetic devices (such as stents) and prosthetic valves, as well as many known methods for implanting these devices and valves in the human body. Percutaneous and minimally invasive surgical methods are used in various procedures to deliver prosthetic medical devices to locations within the body that are not easily accessible surgically or that are desired to be accessible without surgery. In one embodiment, 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 vasculature (e.g., through the femoral artery and aorta) until the prosthetic heart valve reaches its implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon mounted on the prosthetic heart valve, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by unrolling the prosthetic heart valve from a sheath of the delivery device, allowing the prosthetic heart valve to self-expand to its functional size.

[0004] The docking device delivery system can be used to deliver a prosthetic medical device, such as a docking device for use in conjunction with the above-mentioned prosthetic heart valve. 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

[0005] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description made 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, for example, provide improved positioning of a docking device for use with a prosthetic heart valve. The docking device can be positioned using a docking device delivery device that includes three independently actuatable axes. The docking device delivery device can 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, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery devices and delivery systems.

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

[0008] In some examples, the delivery system can comprise three axes.

[0009] In some examples, the one or more shafts can be actuated independently relative to each other.

[0010] In some examples, the one or more axes may be coaxially aligned.

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

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

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

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

[0015] In some examples, at least one of the hub assembly bracket and the sleeve handle bracket may be actuatable relative to the hub assembly support.

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

[0017] In some instances, a delivery system can include a delivery shaft, a sleeve shaft disposed within the delivery shaft, and a pusher shaft disposed within the sleeve shaft. The delivery shaft, the sleeve shaft, and the pusher shaft can be independently actuable relative to each other. The proximal end portion of the delivery shaft can be coupled to a distal end portion of a handle, the handle being configured to control the axial position of the delivery shaft. The proximal end portion of the sleeve shaft can be coupled to a distal end portion of a sleeve handle, the sleeve handle being configured to control the axial position of the sleeve shaft. The proximal end portion of the pusher shaft can be coupled to a distal end portion of a hub assembly, the hub assembly being configured to control the axial position of the pusher shaft.

[0018] In some examples, a delivery system comprising 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 at a native heart valve. The delivery system can be configured to perform a variable wraparound turn during which the radius of curvature of a distal portion of the delivery system can be changed by actuating the pusher shaft in an axial direction relative to the delivery shaft and the sleeve shaft. Increasing the radius of curvature of the distal portion of the delivery system can allow the delivery system to better wrap around the chordae tendineae of a native heart valve, thereby better positioning the docking device between the implantation site and the prosthetic heart valve to further reduce the likelihood of paravalvular leak.

[0019] In some instances, 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 to be used during a prosthetic medical device implantation operation. The stabilizer assembly may include a hub assembly support, which is configured to stabilize the hub assembly and the sleeve handle during the prosthetic medical device implantation operation. The hub assembly support may include a hub assembly bracket, a sleeve handle bracket, and a linear actuator configured to move the hub assembly bracket in an axial direction relative to the sleeve handle bracket. When the hub assembly is positioned in the hub assembly bracket and the sleeve handle is positioned in the sleeve handle bracket, the hub assembly support may advantageously actuate the hub assembly relative to the sleeve handle while keeping the sleeve handle stationary, thereby further improving the stability of the delivery device during the prosthetic medical device implantation operation.

[0020] In some examples, a delivery system for delivering the 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 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 portion of the handle; a sleeve shaft disposed within the delivery shaft lumen, wherein the sleeve shaft includes 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 the proximal portion of the sleeve shaft; and a hub assembly coupled to the proximal portion of the pusher shaft. The stabilizer assembly may be configured to stabilize the delivery device and may include: a stabilizer rail configured to be oriented in an axial direction; and a hub assembly support configured to be slidingly coupled to the stabilizer rail. The hub assembly support may include: a sleeve handle bracket, which is configured to accommodate the sleeve handle; a hub assembly bracket, which is configured to accommodate the hub assembly, wherein the hub assembly bracket is movable in an axial direction relative to the sleeve handle bracket; and a linear actuator, which is connected to the hub assembly, wherein the linear actuator is configured to actuate the hub assembly bracket in an axial direction relative to the sleeve handle bracket.

[0021] In some instances, a hub assembly support configured for use with a delivery system may include: a base portion; a shell disposed on the base portion and including an axially oriented slot; a sleeve handle bracket disposed on the shell and configured to accommodate 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 bracket coupled to the traveler, wherein the hub assembly bracket is configured to accommodate a hub assembly of the delivery system, and wherein the linear actuator is configured to actuate the hub assembly bracket relative to the sleeve handle bracket in the axial direction.

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

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

[0024] The various innovations of this disclosure may be used in combination or individually. This summary is provided to introduce a series of concepts further described in the detailed description below in a simplified form. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the present disclosure will become more apparent from the following detailed description, claims, and accompanying drawings.

[0025] The above methods can be performed on live animals or on simulated objects, such as cadavers, cadaver hearts, anthropomorphic ghosts, phantoms (eg, with simulated body parts, hearts, tissues, etc.). BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 Stages in an example mitral valve replacement procedure are schematically illustrated in which a guide catheter and guidewire are inserted into a patient's blood vessel and guided through the vessel and into the patient's heart toward the heart's native mitral valve.

[0027] Figure 2A Another stage in an example mitral valve replacement procedure is schematically illustrated in which a docking device delivery apparatus extending through a guide catheter is implanting a docking device for a prosthetic heart valve at the native mitral valve.

[0028] Figure 2B Another stage in an example mitral valve replacement procedure is schematically shown, wherein Figure 2A The docking device is fully implanted at the patient's native mitral valve and the docking device delivery apparatus is removed from the patient.

[0029] Figure 3A Another stage in an example mitral valve replacement procedure is schematically illustrated in which a prosthetic heart valve delivery device extending through a guide catheter is implanting a prosthetic heart valve into an implanted docking device at the native mitral valve.

[0030] Figure 3B Another stage in an example mitral valve replacement procedure is schematically illustrated, wherein the prosthetic heart valve is fully implanted within a docking device at the native mitral valve and the prosthetic heart valve delivery device has been removed from the patient.

[0031] Figure 4 Another stage in an example mitral valve replacement procedure is schematically illustrated, wherein the guide catheter and guidewire have been removed from the patient.

[0032] Figure 5 Schematically illustrates a stage in a docking device implantation procedure according to one example, wherein a guide catheter is inserted into a patient's blood vessel and guided through the vessel and into the patient's heart.

[0033] Figure 6 Another stage in an example docking device implantation procedure is schematically illustrated, in which a distal portion of a docking device delivery apparatus is advanced from a guide catheter and into the left ventricle of a heart.

[0034] Figure 7 Another stage in an example docking device implantation procedure is schematically illustrated, in which a distal portion of a docking device delivery apparatus is coiled around multiple leaflets of a heart.

[0035] Figure 8 Another stage in an example docking device implantation procedure is schematically illustrated, wherein the radius of curvature of a distal portion of a docking device delivery apparatus is increased to encircle the chordae tendineae of the heart with variable encircling turns.

[0036] Figure 9 Another stage in an example docking device implantation procedure is schematically illustrated, wherein a sleeve shaft of a docking device delivery apparatus is retracted in a proximal direction to extract a guard member of the docking device.

[0037] Figure 10 Another stage in an example docking device implantation procedure is schematically illustrated, wherein the sleeve shaft is advanced in a distal direction to shorten the guard member.

[0038] Figure 11 Another stage in an example mitral valve replacement procedure is schematically illustrated in which the docking device delivery apparatus is decoupled from the docking device.

[0039] Figure 12 is configured according to an instance Figure 5-11 A perspective view of a docking device delivery system used during a docking device implantation procedure.

[0040] Figure 13 Based on an example Figure 12 A top view of a docking device delivery apparatus used in conjunction with the docking device delivery system.

[0041] Figures 14A-14B Based on an example Figure 12 A perspective view of a hub assembly support used in conjunction with a docking device delivery system.

[0042] Figure 15 is an interior view of a hub assembly support according to one example.

[0043] Figures 16A-16E is Figure 5-11 Example of Mitral Valve Replacement During Surgery Figure 12 Side view of a docking device delivery system.

[0044] Figure 17 is a perspective view of a hub assembly support according to a second example.

[0045] Figure 18 is a perspective view of a hub assembly support according to a third example.

[0046] Figure 19 Based on an example Figure 12 Side view of a guide catheter used with the docking device delivery system.

[0047] Figure 20 is a side view of a guide catheter and docking device delivery apparatus according to one example.

[0048] Figure 21 is a side view of a guide catheter and docking device delivery apparatus according to a second example.

[0049] Figure 22 Based on an example Figure 12 A perspective view of a docking device used in conjunction with a docking device delivery system.

[0050] Figure 23 is a perspective view of a prosthetic heart valve delivery device according to one example.

[0051] Figure 24 is configured according to an instance Figure 23 A perspective view of a prosthetic heart valve used in conjunction with a prosthetic heart valve delivery device. DETAILED DESCRIPTION

[0052] General considerations For the purposes of this specification, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and subcombinations with one another. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed examples require the presence of any one or more specific advantages or problems solved.

[0053] Although the operations of some of the disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this description encompasses rearrangement unless the specific language set forth below requires a particular ordering. For example, in some cases, the operations described in sequence may be rearranged or performed simultaneously. In addition, for the sake of simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, this specification sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific embodiment and are readily discernible by those of ordinary skill in the art.

[0054] As used in this application and the claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Further, the term "coupled" generally means a physical, mechanical, chemical, magnetic, and / or electrical connection or coupling, and does not exclude the presence of intervening elements between the coupled or associated items absent specific language to the contrary.

[0055] As used herein, the term "proximal" refers to a location, direction, or portion of a device that is closer to the user and further from the implantation site. As used herein, the term "distal" refers to a location, direction, or portion of a device that is further 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 the 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" refer to axes extending in the proximal and distal directions, unless expressly defined otherwise.

[0056] The terms "lateral" and "radial" refer to axes perpendicular to the longitudinal axis. When referring to a "lateral" direction with respect 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 rails of the stabilizer assembly.

[0057] As used herein, "such as" means "for example," and "ie" means "that is to say."

[0058] Introduction to public technology Disclosed herein are examples of delivery systems that can be used to navigate a subject's vasculature to deliver a prosthetic medical device (such as a docking device used in conjunction with a prosthetic heart valve), tools, medications, or other therapies to a target implantation site within the subject.

[0059] Relatedly, various systems are described herein that, in some examples, can stabilize and actuate various components of a delivery system to better improve positioning of a prosthesis.

[0060] The delivery system can include multiple shafts that can be independently actuated relative to each other. In some examples, the delivery system can include a delivery shaft including a delivery shaft lumen, a cannula shaft disposed within the delivery shaft lumen and including 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 the sleeve shaft.

[0061] Disclosed herein are exemplary devices and / or methods that may, among other things, make it easier to actuate (eg, axially move) one or more components of a delivery system relative to one or more other components of the delivery system.

[0062] Examples of the disclosed technology Figure 1-4 An example of a transcatheter heart valve replacement procedure (such as a mitral valve replacement procedure) according to one example is depicted, which utilizes a docking device 52 and a prosthetic heart valve 62. During the procedure, the user first uses a guide catheter 30 ( Figure 1 ) creates a path to the patient's natural heart valve. The user then uses the delivery device 50 to deliver and implant the docking device 52 at the patient's natural heart valve ( Figure 2A ), and then removing the delivery device 50 from the patient 10 after implantation of the docking device 52 ( Figure 2B The user then uses the prosthetic valve delivery device 60 to implant the prosthetic heart valve 62 within the implanted docking device 52 ( Figure 3A Thereafter, the user removes the prosthetic valve delivery device 60 from the patient 10 ( Figure 3B ) and the guide catheter 30 ( Figure 4 ).

[0063] Figure 1A stage in a mitral valve replacement procedure according to one example is depicted, wherein a guide catheter 30 and a guidewire 40 are inserted into a blood vessel 12 of a patient 10 and guided 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 guided through and along to the implantation site (the native mitral valve 16 or the native mitral valve annulus). As shown, the heart 14 is schematically illustrated. For example, for illustrative purposes, the anterior leaflet and chordae of the native mitral valve 16 are omitted, such that only a portion of the posterior leaflet of the native mitral valve 16 is shown.

[0064] Initially, the user may first make an incision in the patient's body to access the blood vessel 12. For example, Figure 1 In the example shown, a user can make an incision in the patient's groin to access the femoral vein. Thus, in such an example, the blood vessel 12 can be the femoral vein.

[0065] After forming an incision at the blood vessel 12, the user can insert a guide catheter 30, a guide wire 40, and / or another device (such as an introducer device or a transseptal puncture device) through the incision and into the blood vessel 12. The guide catheter 30 (which may also be referred to as an "introducer device," "introducer," or "introducer sheath") is configured to facilitate the percutaneous introduction of various implant delivery devices (such as a delivery device 50 and a prosthetic valve delivery device 60) through the blood vessel 12, and can extend through the blood vessel 12 and into the heart 14, but can stop before the native mitral valve 16. The guide catheter 30 can include a handle 32 and a shaft 34 (which may also be referred to as a catheter shaft 34) extending distally from the handle 32. The shaft 34 can extend through the blood vessel 12 and into the heart 14 while the handle 32 remains outside the patient's 10 and can be operated by the user to manipulate the shaft 34 ( Figure 1 ).

[0066] 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, etc.) and its associated devices (e.g., docking device, prosthetic heart valve, etc.) to an implantation site within the heart 14 and, therefore, may extend through the blood vessel 12 and into the left atrium 18 of the heart 14. Figure 1 ), and in some instances, through the native mitral valve 16 and into the left ventricle 26 of the heart 14.

[0067] In some cases, a transseptal puncture device or catheter can be used to initially access the left atrium 18 prior to inserting the guidewire 40 and guide catheter 30. For example, after making an incision in the blood vessel 12, the user can insert the transseptal puncture device through the incision and into the blood vessel 12. The user can 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 can 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 can 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. Once the guidewire 40 is positioned within the left atrium 18 and / or left ventricle 26, the transseptal puncture device can be removed from the patient 10. The user can then insert the guide catheter 30 into the blood vessel 12 and advance the guide catheter 30 over the guidewire 40 into the left atrium 18 ( Figure 1 ).

[0068] In some cases, before the guide catheter 30 is inserted into the blood vessel 12, an introducer device can be inserted through the lumen of the guide catheter 30. In some cases, the introducer device can include a tapered end that extends beyond the distal tip of the guide catheter 30 and is configured to guide the guide catheter 30 into the left atrium 18 over the guidewire 40. Additionally, in some cases, the introducer device can include a proximal portion that extends beyond 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 the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain within the patient 10. The guide catheter 30 is then in place to house the implant delivery device and help guide it to the left atrium 18, as described further below.

[0069] Figure 2A Another stage in an example mitral valve replacement procedure is depicted in which a docking device 52 is being implanted at 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," "docking delivery system," "docking device delivery device," and / or "docking device delivery device").

[0070] Generally speaking, the delivery device 50 includes a delivery shaft 54 ​​(which may also be referred to as a "docking delivery system shaft"), a handle 56 (which may also be referred to as a "docking delivery system handle"), and a pusher assembly 58. The delivery shaft 54 ​​is configured to be advanced by a user through the patient's vasculature (blood vessel 12) and to an implantation site (e.g., the native mitral valve 16), and can be configured to retain the docking device 52 in the distal portion 53 of the delivery shaft 54. In some examples, the distal portion 53 of the delivery shaft 54 ​​retains the docking device 52 therein in a straightened delivery configuration.

[0071] 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 to advance the delivery shaft 54 ​​through the patient's vasculature (eg, blood vessel 12 ).

[0072] In some examples, the handle 56 can include one or more articulating members 57 (or rotatable knobs) configured to facilitate guiding the delivery shaft 54 ​​through the blood vessel 12. For example, the one or more articulating members 57 can include one or more of a knob, button, wheel, and / or other type of physically adjustable control member configured to be adjusted by a user to cause the distal portion 53 of the delivery shaft 54 ​​to flex, bend, twist, rotate, and / or otherwise articulate to facilitate guiding the delivery shaft 54 ​​through the blood vessel 12 and within the heart 14.

[0073] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at an implantation site, such as the native mitral valve 16. For example, the pusher 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 of the pusher assembly 58 (which can also be referred to as a "pusher shaft") can extend through the delivery shaft 54 ​​and can be positioned adjacent to the docking device 52 within the delivery shaft 54. In some instances, the docking device 52 can be releasably coupled to the shaft of the pusher assembly 58 via a connection mechanism of the delivery apparatus 50, such that the docking device 52 can be released after being deployed at the native mitral valve 16.

[0074] Additional details of the docking device delivery apparatus and variations thereof are described in International Publication No. WO 2020 / 247907 and U.S. Provisional Patent Application Nos. 63 / 363,162 and 63 / 380,796, which are incorporated herein by reference in their entireties.

[0075] Reference again Figure 2A After positioning the guide catheter 30 within the left atrium 18, the user can insert the delivery device 50 (e.g., delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 ​​of the delivery device 50 through the guide catheter 30 and over the guidewire 40. In some examples, the guidewire 40 can be at least partially retracted away from the left atrium 18 and into the guide catheter 30. The user can then continue to advance the delivery shaft 54 ​​of the delivery device 50 along the guidewire 40 through the blood vessel 12 until the delivery shaft 54 ​​reaches the left atrium 18, e.g., Figure 2ASpecifically, a user can advance the delivery shaft 54 ​​of the delivery device 50 toward the patient 10 by grasping the handle 56 of the delivery device 50 and applying force thereon (e.g., by pushing on the handle). When advancing the delivery shaft 54 ​​through the blood vessel 12 and the heart 14, the user can adjust one or more hinged members 57 of the handle 56 to navigate various turns, corners, constrictions, and / or other obstacles in the blood vessel 12 and the heart 14.

[0076] Once the delivery shaft 54 ​​reaches the left atrium 18 and extends out of the distal end of the guide catheter 30, the user can use the handle 56 (e.g., hinge member 57) to position the distal portion 53 of the delivery shaft 54 ​​at and / or near the posteromedial commissure of the native mitral valve 16. The user can then use the shaft of the pusher assembly 58 to push the docking device 52 out of the distal portion 53 of the delivery shaft 54 ​​to deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0077] In some examples, the docking device 52 can be constructed from, formed from, and / or include a shape memory material and, thus, can return to its initial pre-formed shape when the docking device is free of and no longer constrained by the delivery shaft 54. As one example, the docking device 52 can be initially shaped as a coil and, thus, can wrap around the leaflets 24 of the native mitral valve 16 when it is free of the delivery shaft 54 ​​and returns to its initial coiled configuration.

[0078] When pushing the ventricular portion of the docking device 52 (such as Figure 2A After deploying the portion of the docking device 52 shown in the figure 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 can then deploy the remainder of the docking device 52 (such as the atrial portion of the docking device 52) by retracting the delivery shaft 54 ​​away from the posteromedial commissure of the native mitral valve 16 from within the left atrium 18.

[0079] After deploying and implanting the docking device 52 at the native mitral valve 16, the user can disconnect the delivery apparatus 50 from the docking device 52. Once the docking device 52 is disconnected from the delivery apparatus 50, the user can retract the delivery apparatus 50 from the blood vessel 12 and away from the patient 10, allowing the user to deliver and implant the prosthetic heart valve 62 within the implanted docking device 52 at the native mitral valve 16.

[0080] Figure 2BThis stage in a mitral valve replacement procedure is shown in which the docking device 52 has been fully deployed and implanted at the native mitral valve 16, and the delivery apparatus 50 (including the delivery shaft 54) has been removed from the patient 10, such that only the guidewire 40 and the guide catheter 30 remain within the patient 10. In some examples, after the delivery apparatus 50 is removed, the guidewire 40 can be advanced out of the guide catheter 30, through the implanted docking device 52 at the native mitral valve 16, and into the left ventricle 26 ( Figure 2A ). Thus, the guidewire 40 can help guide the prosthetic valve delivery device 60 through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.

[0081] like Figure 2B As shown, the docking device 52 can include a plurality of turns (or coils) that wrap around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The shape of the implanted docking device 52 is more cylindrical than the shape of the annulus of the native mitral valve 16, thereby providing a geometry that more closely matches the shape or contour of the prosthetic heart valve to be implanted. As a result, the docking device 52 can provide a tighter fit and a better seal between the prosthetic heart valve and the native mitral valve 16, as described further below.

[0082] Figure 3A Another stage in a mitral valve replacement procedure is depicted in which a user uses a prosthetic valve delivery device 60 to deliver and / or implant a prosthetic heart valve 62 (which may also be referred to herein as a "transcatheter heart valve" or simply "THV," a "replacement heart valve," and / or a "prosthetic mitral valve") within a docking device 52.

[0083] like Figure 3A As shown, prosthetic valve delivery device 60 can include a delivery shaft 64 and a handle 66, with delivery shaft 64 extending distally from handle 66. Delivery shaft 64 is configured to extend into the patient's vasculature to deliver, implant, expand, and / or otherwise deploy prosthetic heart valve 62 within docking device 52 at native mitral valve 16. Handle 66 is configured to be grasped and / or otherwise held by a user to advance delivery shaft 64 through the patient's vasculature.

[0084] In some examples, the handle 66 can include one or more articulating members 68 configured to facilitate guiding the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulating member 68 can include one or more of a knob, button, wheel, and / or other type of physically adjustable control member configured to be adjusted by a user to flex, bend, twist, rotate, and / or otherwise articulate the distal portion of the delivery shaft 64 to facilitate guiding the delivery shaft 64 through the blood vessel 12 and into the left atrium 18 and left ventricle 26 of the heart 14.

[0085] In some instances, 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. Figure 3A As shown, 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 portion of the delivery shaft 64.

[0086] In other examples, the prosthetic heart valve 62 can be self-expanding and can be configured to radially expand upon removal of a sheath or capsule covering the radially compressed prosthetic heart valve 62 on the distal portion of the delivery shaft 64. In still other examples, the prosthetic heart valve 62 can be mechanically expandable, and the prosthetic valve delivery apparatus 60 can include one or more mechanical actuators (e.g., expansion mechanisms) configured to radially expand the prosthetic heart valve 62.

[0087] like Figure 3A As shown, a prosthetic heart valve 62 is mounted in a radially compressed configuration about an expansion mechanism 65 (an inflatable balloon) on a distal portion of a delivery shaft 64 .

[0088] To guide the distal portion of delivery shaft 64 to the implantation site, the user may insert prosthetic valve delivery device 60 (delivery shaft 64) through guide catheter 30 and over guidewire 40 into patient 10. The user may continue to advance prosthetic valve delivery device 60 along guidewire 40 (through blood vessel 12) until the distal portion of delivery shaft 64 reaches the native mitral valve 16, as shown. Figure 3A More specifically, a user can advance delivery shaft 64 of prosthetic valve delivery device 60 by grasping handle 66 and applying force thereon (e.g., by pushing on the handle). As delivery shaft 64 is advanced through vessel 12 and heart 14, the user can adjust one or more hinged members 68 of handle 66 to navigate various turns, corners, constrictions, and / or other obstacles in vessel 12 and heart 14.

[0089] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted around the distal portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some instances, such as Figure 3A As shown, 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 .

[0090] Once the radially compressed prosthetic heart valve 62 is properly positioned within the docking device 52 ( Figure 3A), the user can manipulate one or more actuators of the handle 66 of the prosthetic valve delivery device 60 to actuate the expansion mechanism 65 (e.g., by inflating an inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52.

[0091] Figure 3B Another stage in the mitral valve replacement procedure is shown, wherein the prosthetic heart valve 62 is in its radially expanded configuration and implanted within the docking device 52 in the native mitral valve 16. Figure 3B As shown, the prosthetic heart valve 62 is housed and retained 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 can enable a better seal between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16 to reduce paravalvular leakage around the prosthetic heart valve 62.

[0092] Also like Figure 3B As shown, after the prosthetic heart valve 62 has been fully deployed and implanted within the docking device 52 at the native mitral valve 16 , the prosthetic valve delivery apparatus 60 (including the delivery shaft 64 ) is removed from the patient 10 , leaving only the guidewire 40 and the guide catheter 30 within the patient 10 .

[0093] Figure 4 Another stage in the mitral valve replacement procedure is depicted, wherein the guidewire 40 and guide catheter 30 have been removed from the patient 10 .

[0094] although Figure 1-4 A mitral valve replacement procedure is specifically described, but it should be understood that the same and / or similar procedures can be used to replace other heart valves (e.g., the tricuspid valve, the pulmonary valve, and / or the aortic valve). 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 can be used to replace these other heart valves.

[0095] For example, when replacing a native tricuspid valve, the user may also access the right atrium 20 via the femoral vein, but may not need to pass through the atrial septum 22 to enter the left atrium 18. Instead, the user may leave the guidewire 40 in the right atrium 20 and perform the same and / or similar docking device implantation procedure 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 remainder of the docking device 52 from the delivery shaft 54 ​​within the right atrium 20, and then remove the delivery shaft 54 ​​of the delivery device 50 from the patient 10. The user may then advance the guidewire 40 through the tricuspid valve into the right ventricle and perform the same and / or similar prosthetic heart valve implantation procedure at the tricuspid valve within the docking device 52. Specifically, the user may advance the delivery shaft 64 of the prosthetic valve delivery device 60 along the guidewire 40 through the patient's vasculature until the prosthetic heart valve 62 is positioned / positioned within the docking device 52 and the tricuspid valve. The user can then expand the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery apparatus 60 from the patient 10. In another example, the user can perform the same and / or similar procedure to replace the aortic valve, but can access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0096] In addition, despite Figure 1-4 A mitral valve replacement procedure is depicted accessing the native mitral valve 16 from the left atrium 18 via the right atrium 20 and the femoral vein, but it should be appreciated 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 via the aortic valve by advancing one or more delivery devices through the arteries to the aortic valve and then through the aortic valve into the left ventricle 26.

[0097] Figure 5-11 A procedure for implanting a prosthetic medical device at a target implantation site in a subject, such as patient 10, is schematically illustrated. In some instances, the procedure is a docking device implantation procedure for implanting a docking device 152 at the annulus of the native mitral valve 16 of patient 10. In some instances, Figure 1-4 The docking device 52 and Figure 5-11 An exemplary difference between the docking device 152 can be that the docking device 152 optionally includes a protective member 180 coupled to the docking device 152, wherein the protective member 180 can be configured to further reduce the possibility of paravalvular leakage between the annulus of the native mitral valve 16 and a prosthetic heart valve (such as the prosthetic heart valve 62) positioned in the docking device 152.

[0098] Figure 5-11 The procedure can be performed using a delivery device 150 (which may also be referred to as a "docking device delivery device"). In some instances, the delivery device 150 is coupled to the Figure 1-4One exemplary difference between the delivery devices 50 of FIGURE 1 is that the delivery device 150 can include three independently actuatable shafts: a delivery shaft 154 (which can also be referred to as a "docking delivery system shaft"), a sleeve shaft 182, and a pusher shaft 184 (which can also be referred to as a "docking shaft"). The pusher shaft 184 can be disposed within the sleeve shaft 182, which can in turn be disposed within the delivery shaft 154. In some instances, the delivery shaft 154, the sleeve shaft 182, and the pusher shaft 184 can be coaxial. During a docking device implantation procedure, the delivery shaft 154, the sleeve shaft 182, and the pusher shaft 184 can be independently actuatable in an axial direction relative to one another 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 encircle one or more chordae tendineae 27 of the heart 14 and provide a better seal between the implantation site and a prosthetic heart valve, such as the prosthetic heart valve 62.

[0099] During the procedure, the user of the delivery device 150 first uses the guide catheter 30 ( Figure 5 ) creates access to the patient's native heart valve. The user then distally advances the distal portion of the delivery device 150 to advance the docking device 152 to the target implantation site ( Figure 6-7 In some examples of the procedure, the user can actuate the delivery system to change or adjust the curvature of the distal portion of the delivery device 150 (see, e.g., Figure 7-8 18). This adjustable radius of curvature may be referred to as a "variable encircling turn" (VET). For example, by proximally retracting the pusher shaft 184 relative to the sleeve shaft 182, the VET may make it easier to encircle one or more chordae tendineae 27 connecting the leaflets 24 to the papillary muscles 28 of the heart 14.

[0100] In some instances where the docking device 152 further includes a guard member 180, the user may then retract the delivery shaft 154 and the sleeve shaft 182 in a proximal direction to expose the guard member 180 from the sleeve shaft 182 ( Figure 9 In some instances, the user may then advance sleeve shaft 182 in a distal direction to apply an axial compressive force to guard member 180, thereby axially shortening and radially expanding guard member 180 ( Figure 10 Finally, the user can decouple the docking device 152 from the pusher shaft 184 and remove the delivery device system 150 from the patient 10 ( Figure 11 ).

[0101] Figure 51. A stage in the procedure is shown in which a guide catheter 30 is advanced in a distal direction through the patient's vasculature and into the left atrium 18 of the heart 14. The guide catheter 30 includes a catheter shaft 34 comprising a distal end 72 of the catheter shaft 34, a flexure zone 74, and a lumen outlet 76 on the distal end 72. The lumen outlet 76 is connected to a catheter shaft lumen disposed within the catheter shaft 34. A delivery device (such as a prosthetic device delivery device or an implant catheter as described herein) is configured to be disposed within the catheter shaft lumen. The catheter shaft lumen extends from a proximal portion of the catheter shaft 34 (such as the 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.

[0102] In some examples, the catheter shaft 34 may include one or more pull wires for adjusting the curvature of the flexure zone 74 of the catheter shaft 34. In some examples, 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 loop at or near the distal end 72. In some examples, the pull wires may extend through one or more pull wire lumens embedded in the catheter shaft 34. In some examples, adjusting the tension of the pull wires may adjust the curvature of the flexure zone 74 of the catheter shaft 34. In some cases, the catheter shaft 34 (including its flexure zone 74) may be integrally formed as a single, unitary component. In some cases, the catheter shaft 34 may include one or more sections (e.g., the flexure zone 74, other regions, etc.) formed as separate components coupled together (e.g., via fasteners, adhesives, mating features, and / or other coupling means). In some examples, the flexure zone 74 may include a material (e.g., a polymer having a relatively low durometer hardness) that is more easily flexed, bent, twisted, etc. than the remainder of the catheter shaft 34. This can enable the curvature of the flexure zone 74 to adjust or increase at a different rate than the rest of the catheter shaft 34 as the pull wire is tensioned. For example, as the tension in the pull wire increases, the curvature of the flexure zone 74 can change at a rate that increases relative to the proximal portion of the catheter shaft 34. The catheter shaft 34 can also include one or more reinforcing braids or sleeves that make the catheter shaft 34 more resistant to flexing, bending, twisting, etc., such as to prevent one or more of the lumens from kinking or collapsing when the catheter shaft 34 is manipulated.

[0103] During this stage, the docking device 152 is positioned within the sleeve shaft 182, which is in turn positioned within the delivery shaft 154, which is in turn positioned within the catheter shaft 34. The pusher shaft 184 is positioned proximally adjacent to the docking device 152 within the sleeve shaft 182. In some examples, the docking device 152, sleeve shaft 172, delivery shaft 154, and catheter shaft 34 can be coaxially aligned. During this stage, the docking device 152 is in a generally straight delivery configuration (i.e., without any coiled or looped portions, but can flex or bend) so as to maintain a small radial profile while moving through the patient's vasculature.

[0104] Figure 6 A stage in the procedure is shown in which the docking device 152, delivery shaft 154, sleeve shaft 182, and pusher shaft 184 are advanced in a distal direction through the lumen exit 76 of the catheter shaft 34, through the left atrium 18, and to the native mitral valve 16. The docking device 152 is positioned within the sleeve shaft lumen of the sleeve shaft 182, which in turn is 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.

[0105] The delivery shaft 154, which in some instances can be similar to the delivery shaft 54, includes a delivery shaft lumen through which a sleeve shaft 182 and a pusher shaft 184 can extend. The delivery shaft lumen is configured to extend in an axial direction along the length of the delivery shaft 154 between the handle of the delivery device 150 and the distal end portion 153 of the delivery shaft 154. The sleeve shaft 182 and the pusher shaft 184 are configured to exit the delivery shaft lumen through an opening at the distal end portion 153.

[0106] The sleeve shaft 182 is configured to extend through the delivery shaft 154 and encase the docking device 152 and at least a portion of the pusher shaft 184 when the docking device 152 is guided through the patient's vasculature to the native mitral valve 16. The sleeve shaft 182 includes a sleeve shaft lumen that extends along the length of the sleeve shaft 182 between the handle of the delivery device 150 and the distal end portion 186 of the sleeve shaft 182. In some examples, a portion of the sleeve shaft 182 (e.g., the proximal end portion) can have a generally 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 at the distal end portion 186 of the sleeve shaft 182.

[0107] The distal end portion 186 of the sleeve shaft 182 is configured to capture native tissue (eg, native leaflets 24 and cords 27). The sleeve shaft 182 can have a relatively low friction and / or lubricated outer surface to reduce the likelihood of the sleeve shaft 182 snagging on native tissue.

[0108] In some examples, the sleeve shaft 182 can include multiple layers. For example, the sleeve shaft 182 can include an innermost polymer layer, a braided or other type of flexible reinforcement layer, and an outermost polymer layer. In some examples, the reinforcement layer is a shape memory material and / or an elastic material (e.g., nitinol and / or stainless steel).

[0109] In some cases, the distal portion 186 of the sleeve shaft 182 can be curved to help facilitate capture of native tissue. This can be accomplished by forming the distal portion 186 of the sleeve shaft 182 in a curved configuration and / or by forming the sleeve shaft 182 from a relatively more flexible material than the docking device 152 and advancing the curved docking device 152 into the sleeve shaft 182, which can cause the sleeve shaft 182 to assume the curved configuration and / or cause the curvature of the sleeve shaft 182 to be altered by the docking device 152.

[0110] In this manner, the distal portion 186 of the sleeve shaft 182 can form a sleeve shaft forward turn 187 that is configured to capture the chordae tendineae 27 as the sleeve shaft 182 is advanced around the leaflets 24 of the native mitral valve 16. The sleeve shaft forward turn 187 is a portion of the sleeve shaft 182 disposed at or near the distal portion 186 that includes a curved portion of the sleeve shaft 182 having a radius of curvature. When the docking device 152 is not nested within the portion of the sleeve shaft 182 corresponding to the sleeve shaft forward turn 187, the radius of curvature of the sleeve shaft forward turn 187 is equal to the first radius of curvature ( r 1 ). As discussed later in this application, specific reference is made to Figure 7-8 The radius of curvature of the quill forward turn 187 can be varied by relative movement between the quill 182 and the docking device 152. In some examples where the quill 182 can be constructed from, formed of, and / or include a shape memory material, the quill 182 can initially be formed such that the quill forward turn 187 has a first radius of curvature ( r 1 ). The quill forward turn 187 may be forced into a curve having another radius of curvature (eg, a second radius of curvature ( r 2 )) but can return to its first radius of curvature when the force is removed ( r 1 ) of the initial configuration. In some examples, the second radius of curvature ( r 2 ) can be smaller than the first radius of curvature ( r 1 ).

[0111] In some examples, quill forward bend 187 can conform to the shape or curvature of another component (e.g., docking device 152) that is encased by quill forward bend 187, such that the radius of curvature of quill forward bend 187 is equal to the corresponding radius of curvature of the other component. Consequently, when the distal portion (e.g., forward bend 189) of docking device 152 is positioned at or near distal portion 186 of quill 182, distal portion 186 of quill 182 can have a smaller radius of curvature. This is because docking device 152 can have a smaller radius of curvature and can be relatively more rigid than quill 182. In some examples, the radius of curvature of distal portion 186 of quill 182 can be increased by moving the distal end of dock 152 proximally relative to distal portion 186 of quill 182, allowing quill 182 to assume its predetermined configuration. This may be accomplished by moving the dock 152 proximally while maintaining the position of the quill 182, by moving the quill 182 distally relative to the dock 152, or a combination of both.

[0112] 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 when the docking device 152 is guided through the patient's vasculature to the native mitral valve 16. When the pusher shaft 184 moves in an axial direction relative to the sleeve shaft 182, the pusher shaft 184 can exert a force on the docking device 152 to move the docking device 152 in the axial direction. In some examples, the docking device 152 can be releasably coupled to the pusher shaft 184 via a connection mechanism of the delivery device 150 such that the docking device 152 can be released after being deployed at the native mitral valve 16.

[0113] In some examples, during this stage, the distal portion 153 of the delivery shaft 154 can be positioned between the leaflets 24 of the native mitral valve 16 (e.g., at or near the posteromedial commissure). In some examples, the distal portion 153 of the delivery shaft 154 can extend distally past the native mitral valve 16 and be positioned near the native mitral valve 16 in the left ventricle 26. In some examples, the distal portion 153 of the delivery shaft 154 can be positioned adjacent to the native mitral valve 16 in the left atrium 18.

[0114] Once the distal portion 153 of the delivery shaft 154 is positioned, the docking device 152 , sleeve shaft 182 , and pusher shaft 184 are advanced in a distal direction away from the opening at the distal portion 153 of the delivery shaft 154 , through the native mitral valve 16 , and into the left ventricle 26 .

[0115] Figure 7A stage in the procedure is shown 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) are wrapped or looped around the leaflets 24 on the ventricular side of the native mitral valve 16. When the docking device 152 is free from the delivery shaft 154, the docking device 152 assumes a coiled configuration that is configured to wrap or loop around the leaflets 24 on the ventricular side of the native mitral valve 16. In some examples in which the docking device 152 may be constructed from, formed from, and / or include a shape-memory material, the docking device 152 may initially be formed in a coiled configuration but may be forced into a straightened delivery configuration by the delivery shaft 154. Once the docking device 152 is no longer trapped by the delivery shaft 154, the docking device 152 may assume its initial coiled configuration.

[0116] As previously described, the portion of the quill 182 that is enclosed by the docking device 152 can conform to or assume the shape and / or curvature of a corresponding portion of the docking device 152. For example, the quill forward bend 187 can conform to the forward bend 189 of the docking device 152, wherein the radius of curvature of the forward bend 189 is equal to the second radius of curvature ( r 2 Therefore, the sleeve shaft forward turning portion 187 may have a second curvature radius ( r 2 ) configuration. In other words, the variable surrounding turning portion can be equal to the second curvature radius ( r 2 ).

[0117] Figure 8 An optional stage in the procedure is shown in which the radius of curvature of the sleeve shaft forward turn 187 (in other words, the variable wraparound turn) is changed from a second radius of curvature ( r 2 ) increases to the first radius of curvature ( r 1 ) to better capture the chordae tendineae 27 within the docking device forward bend 189. In some instances, the radius of curvature of the quill forward bend 187 can be increased by retracting the pusher shaft 184 in the proximal direction relative to the quill 182 so that the docking device forward bend 189 and / or the docking device 152 are no longer trapped by the quill forward bend 187. In some instances, the radius of curvature of the quill forward bend 187 can be increased by advancing the distal end portion 186 of the quill 182 in the distal direction relative to the docking device 152. When the quill forward bend 187 is no longer forced to conform to the second radius of curvature ( r 2) of the forward turning portion 189 of the docking device, the forward turning portion 187 of the sleeve shaft can be restored to a curvature greater than the second curvature radius ( r 2 ) of the first radius of curvature ( r 1 ) initial configuration. Since the tendon 27 is captured within the sleeve shaft forward bend 187, the variable wraparound bend is increased to a larger first radius of curvature ( r 1 ) advantageously allows more of the chordae tendineae 27 to be captured by the forward turn 187 of the sleeve shaft as it is advanced around the leaflet 24.

[0118] exist Figure 8 During the illustrated step, the delivery shaft 154 can remain 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 examples, the sleeve shaft 182 can remain stationary to maintain the circumferential position and / or radial orientation of the sleeve shaft 182 relative to the native mitral valve 16. In some examples, during this step, the docking device 152 and / or the pusher shaft 184 can remain stationary while the sleeve shaft 182 moves. In some examples, neither the sleeve shaft nor the pusher shaft 184 remains stationary during this step.

[0119] like Figure 8 As shown, the variable surround turn may be adjusted after the sleeve shaft 182 has formed one helical turn around the leaflet 24. However, in some instances, the variable surround turn may be adjusted after the sleeve shaft 182 has formed multiple helical turns around the leaflet 24. In some instances, the variable surround turn may be adjusted before any helical turns have been formed around the leaflet 24.

[0120] Figure 9 An optional stage in the procedure is shown in which the delivery shaft 154 and sleeve shaft 182 are retracted in a proximal direction to withdraw the guard member 180. The docking device 152 includes a coil 188 defining a central region 190 including a plurality of helical turns wrapped around the leaflet 24 and a docking device forward turn 189 extending from a distal portion of the central region 190.

[0121] The docking device 152 can further include a protective member 180 disposed on the docking device 152 such that when the docking device 152 is implanted at the native mitral valve 16, the protective member 180 is positioned at or near the native mitral valve 16 (e.g., at or near the posteromedial commissure). In some examples, the protective member 180 can be disposed proximally adjacent to the central region ( Figure 22), wherein the central region 190 can include a plurality of spiral turns when the docking device 152 is wrapped around the leaflet 24. The guard member 180 can extend between a distal portion 191 fixedly coupled to the docking device 152 and a movable proximal portion 193 that can move in an axial direction along at least a portion of the docking device 152. In some examples, the distal portion 191 of the guard member 180 can be proximate to the central region 190.

[0122] exist Figure 5-8 During the illustrated stage of the docking device implantation procedure, the protective member 180 may be covered by the delivery shaft 154 and the sleeve shaft 182. However, during Figure 9 During the illustrated stages, relative movement between the delivery shaft 154, sleeve shaft 182, and pusher shaft 184 can withdraw the guard member 180. In some examples, the sleeve shaft 182 can be retracted in a proximal direction 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 proximally closer to the user than the proximal end portion 193 of the guard member 180. In some examples, the distal end portion 186 of the sleeve shaft 182 can be positioned distally relative to the lumen outlet 76. In some examples, the guard member 180 can be withdrawn by advancing the pusher shaft 184 distally relative to the sleeve shaft 182.

[0123] In some examples, the delivery shaft 154 can be retracted in a proximal direction through the left atrium 18 such that the distal end portion 153 of the delivery shaft 154 is proximally closer to the user than the proximal end portion 193 of the guard member 180. In some examples, the delivery shaft 154 can be retracted through the lumen exit 76 and into the catheter shaft lumen of the catheter shaft 34. In some examples, 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 proximally relative to the guard member 180.

[0124] Figure 10An optional "deployment" stage of the procedure is shown, in which sleeve shaft 182 is advanced distally relative to docking device 152 to axially shorten and radially expand guard member 180. In some examples, sleeve shaft 182 can be advanced in a distal direction such that distal end portion 186 of sleeve shaft 182 abuts and contacts proximal end portion 193 of guard member 180. In some examples, pusher shaft 184 (and docking device 152 coupled thereto) can be retracted proximally such that distal end portion 186 of sleeve shaft 182 abuts and contacts proximal end portion 193 of guard member 180. Sleeve shaft 182 applies a force to guard member 180 to distally advance proximal end portion 193 of guard member 180 relative to docking device 152. Because distal end portion 191 of guard member 180 is fixedly coupled to docking device 152, the force applied to guard member 180 causes guard member 180 to axially shorten and radially expand to its deployed configuration. When in the expanded configuration, guard member 180 further reduces the likelihood of paravalvular leakage between native mitral valve 16 and a prosthetic heart valve, such as prosthetic heart valve 62. When sleeve shaft 182 is retracted from the proximal end of guard member 180, frictional engagement between the proximal end of guard member 180 and docking device 152 can maintain the position of guard member 180 relative to docking device 152.

[0125] Figure 11 A stage in the procedure is shown in which the delivery device 150, including the delivery shaft 154 and sleeve shaft 182, is retracted through the catheter shaft lumen of the catheter shaft 34. In some examples, the docking device 152 can be connected to the pusher shaft 184 via a release suture 194, which can be configured to be tied to the docking device 152. During this stage, the release suture 194 can be cut to release the docking device 152 from the delivery device 150.

[0126] Figure 12 An example delivery system 100 (which may also be referred to as a "docking device delivery system") is shown that may be used in a procedure to implant a prosthetic medical device, as described above with reference to FIG. Figure 5-11 The delivery system 100 includes a delivery device 150, a guide catheter 30, and a stabilizer assembly 200 (which may also be referred to as a "stabilization tower" or "stabilization device") configured to stabilize the delivery device 150 and / or the guide catheter 30 during a procedure.

[0127] Figure 13A delivery device 150 is shown according to one example. The delivery device 150 may also be referred to as a "docking delivery device," a "docking delivery catheter," or a "docking delivery system." The delivery device 150 includes a delivery shaft 154, a handle 156 coupled to a proximal portion of the delivery shaft 154 (which may also be referred to as a "docking delivery system handle"), a sleeve shaft 182 configured to extend through the delivery shaft 154 and the handle 156, a hub assembly 158 coupled to the proximal portion of the sleeve shaft 182 (which may also be referred to as a "docking handle"), a pusher shaft 184 configured to extend through the handle 156 and the sleeve shaft 182, and a sleeve handle 196 coupled to the proximal portion of the sleeve shaft 182.

[0128] The delivery shaft 154, which in some instances can be similar to the delivery shaft 54, is configured to be advanced by a user through the patient's vasculature (blood vessel 12) and to an implantation site (e.g., native mitral valve 16), and can be configured to retain the docking device 152 within the distal end portion 153 of the delivery shaft 154. During a docking device implantation procedure, the delivery shaft 154 is advanced through the catheter shaft 34 of the guide catheter 30 (e.g., through its central lumen, etc.) and to the target implantation site.

[0129] Handle 156, which in some examples can be similar to handle 56, is configured to be grasped and / or otherwise held by a user outside the body of patient 10 to advance delivery shaft 154 through the patient's vasculature (e.g., blood vessel 12). In some examples, handle 156 can include one or more articulation members 157 (e.g., rotatable knobs) configured to assist in guiding delivery shaft 154 through blood vessel 12 by steering or controlling the flexure of delivery device 150 (e.g., delivery shaft 154, etc.). Some examples of articulation members 157 can be similar to articulation member 57. Handle 156 includes a handle lumen extending through the length of handle 156, with sleeve shaft 182 and pusher shaft 184 configured to be positioned within the handle lumen. Because sleeve shaft 182 and pusher shaft 184 extending through the handle lumen also extend through delivery shaft 154, the handle lumen can be coaxially aligned with delivery shaft 154. In some examples, the handle 156 can further include a locking assembly 198 configured to lock a device (e.g., the sleeve 182) inserted through the lumen of the handle so as to selectively prevent the device from moving relative to the handle 156 of the delivery apparatus 150. In some examples, the locking assembly 198 can be disposed on a proximal portion of the handle 156.

[0130] 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. The distal portion of the hub assembly 158 is coupled to the proximal portion of the pusher shaft 184. The axial position of the pusher shaft 184 is controlled by moving the hub assembly 158 in an axial direction relative to the handle 156 and / or the sleeve handle 196. The hub assembly 158 is positioned proximally closer to the user relative to the handle 156, but distally farther 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 positioned within the hub assembly lumen and is coaxial with the sleeve shaft 182 coupled to the distal portion of the hub assembly 158. In some examples, the hub assembly 158 further includes a suture locking assembly 159 configured to releasably couple to the proximal end of the release suture 194 .

[0131] The sleeve handle 196 is configured to be grasped and / or otherwise held by a user outside the body of the patient 10 to advance 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 the hub assembly 158. The axial position of the sleeve shaft 182 is controlled by moving the sleeve handle 196 in an axial direction relative to the handle 156 and / or the hub assembly 158.

[0132] Additional details regarding delivery devices / catheters / systems (including various examples of handle assemblies) configured to deliver a docking device to a target implantation site can be found in PCT Publication Nos. WO 2020 / 247907 and WO 2022 / 072509, and U.S. Patent Publication Nos. 2018 / 0318079 and 2018 / 0263764, all of which are incorporated herein by reference in their entirety.

[0133] Because the variable circumferential turn can be adjusted based on the relative movement between the pusher shaft 184 and the sleeve shaft 182, a user of the docking device 150 can adjust the variable circumferential turn (e.g., Figure 7-8), and vice versa. Because pusher shaft 184 is coupled to hub assembly 158 and sleeve shaft is coupled to sleeve handle 196, in some examples, the variable wraparound turn can be adjusted by moving hub assembly 158 in a distal direction relative to sleeve handle 196 while sleeve handle 196 remains stationary. In some examples, sleeve handle 196 can be moved in a proximal direction while hub assembly 158 remains stationary. In some examples, both sleeve handle 196 and hub assembly 158 can be moved in an axial direction. In some examples, handle 156 can remain stationary or can be moved relative to at least one of sleeve handle 196 and hub assembly 158.

[0134] Return Reference Figure 12 , the guide catheter 30 and the delivery device 150 are configured to be coupled to a stabilizer assembly 200 that supports and stabilizes the guide catheter 30 and the delivery device 150 during surgery. The stabilizer assembly 200 includes a universal platform 202, a stabilizer rail 204 mounted to the universal platform 202, one or more supports 206 (e.g., clips, clamps, brackets, etc.) that can be slidably coupled to the stabilizer rail 204, and a hub assembly support 208 that can be slidably coupled to the stabilizer rail 204.

[0135] The universal platform 202 is a platform configured to support stabilizer rails 204. The universal platform 202 is configured to have an adjustable height and / or orientation, wherein the height and / or orientation can be adjusted relative to a surface (e.g., the ground or a tabletop) on which the universal platform 202 rests. In some examples, the universal platform 202 can include one or more hinged members 203 (e.g., rotatable knobs) for adjusting the height or orientation of the universal platform 202.

[0136] The stabilizer rail 204 is coupled to the top surface of the universal platform 202. When mounted to the universal platform 202, the stabilizer rail 204 is configured to be oriented in an axial direction, such that the support member 206 and the hub assembly support member 208 can slide in the axial direction along the stabilizer rail 204. In some examples, the stabilizer rail 204 may include one or more rails 205 extending in the axial direction along the stabilizer rail 204. In the illustrated example, the stabilizer rail 204 includes a first rail 205a and a second rail 205b, but the stabilizer rail 204 may include one, three, or any other suitable number of rails 205. In some examples, each of the rails 205 may include an axially extending vertical flange (also referred to herein as a "web") and an axially extending horizontal flange (also referred to herein as a "head") coupled to a topmost portion of the vertical flange, such that the rail 205 has a "C," "I," or "T" shaped cross-section. However, the rail 205 may comprise any suitable cross-section configured to couple to the support 206 and the hub assembly support 208 .

[0137] The supports 206 are configured to hold or grasp the guide catheter 30 and handle 156 of the delivery device 150. Each of the supports 206 includes a post configured to migrate or reposition axially on the stabilizer rail 204, wherein the post is configured to couple to a portion (e.g., a distal portion) of the guide catheter 30 or handle 156. In some examples, 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 rail 204. In some examples, 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 rail 204, wherein the frictional contact prevents the support 206 from moving axially relative to the stabilizer rail 204.

[0138] Figures 14A-14B A perspective view of a hub assembly support 208 is shown according to one example. The hub assembly support 208 is configured to be slidably coupled to the stabilizer rail 204 and 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 bracket 214, a sleeve handle bracket 216, and an actuation control 218. In some examples, the hub assembly support 208 can further include an indicator 220 and a brake 227.

[0139] The base portion 210 is configured to rest on and be slidingly coupled to the stabilizer rail 204. In some examples, the base portion 210 can include a plate extending from a proximal portion 224 of the hub assembly support 208 to a distal portion 226 of the hub assembly support 208.

[0140] In some examples, the base portion 210 can further include a groove 228 disposed on a first lateral surface of the base portion 210. In some examples, the groove 228 can extend from the proximal portion 224 to the distal portion 226 of the base portion 210. The groove 228 can be configured to facilitate sliding coupling of the base portion 210 to the stabilizer rail 204 and to limit vertical movement of the hub assembly support 208. In some examples, the groove 228 can be configured to receive a head of one of the axially extending rails 205 (e.g., the first rail 205a).

[0141] In some examples, the base portion 210 may further include a stabilizer rail lock 230 configured to slidably couple the base portion 210 to the stabilizer rail 204. The stabilizer rail lock 230 may be positioned on a second lateral surface of the base portion 210, where the second lateral surface is opposite the first lateral surface. In some examples, the stabilizer rail lock 230 may include a locking flange 232 and a toggle 234 coupled to the locking flange 232, the locking flange extending laterally from the second lateral surface of the base portion 210. The locking flange 232 may be slidably coupled to the base portion 210 such that actuating the toggle 234 moves the locking flange 232 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 rail 204. In the unlocked configuration, the locking flange 232 can be at least partially retracted into the base portion 210 or the housing 212, thereby allowing the hub assembly support 208 to be decoupled from the stabilizer rail 204. In some examples, the stabilizer rail lock 230 can be biased in the locked configuration by coupling the laterally extending flange to the base portion 210 via one or more biasing springs. Figure 15 ).

[0142] 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 examples, the housing 212 can be placed on top of the base portion 210. The housing 212 covers the base portion 210 from the proximal portion 224 to the distal portion 226. The housing 212 includes an axially oriented slot 236 that is configured to receive the advancer ( Figure 15), which couples the hub assembly bracket 214 to a linear actuator ( Figure 15 ). The traveler is also referred to herein as a "sled". Although the slot 236 is Figures 14A-14B 236 as being disposed on the top surface of the housing 212 , the slot 236 may alternatively be disposed on one of the lateral surfaces of the housing 212 .

[0143] In some examples, the base portion 210 and the housing may be formed as a unitary component (eg, a chassis).

[0144] The hub assembly bracket 214 is configured to receive the hub assembly 158. In some examples, the hub assembly bracket 214 can include a laterally extending base flange 240 having a first lateral edge portion 242a and a second lateral edge portion 242b disposed on opposite lateral edges of the base flange 240. The hub assembly bracket 214 can include a first lateral flange 244a extending upward from the first lateral edge portion 242a and a second lateral flange 244b extending upward from the second lateral edge portion 242b. In some examples, the curvature of the first lateral edge portion 242a and the second lateral edge portion 242b can follow the curvature of the side portions of the hub assembly 158 to ensure that the hub assembly 158 is securely received within the hub assembly bracket 214. In some examples, at least one of the base flange 240 , the first lateral flange 244 a , and the second lateral flange 244 b can further include a cutout 246 to accommodate features of the hub assembly 158 (eg, features of the suture locking assembly 159 ).

[0145] In some instances, such as Figure 14B As best shown, the hub assembly bracket 214 can further include one or more gripping elements 248 disposed on a lateral inward surface of one or more of the lateral flanges 244a, 244b. The gripping element 222 can be configured to be disposed between one of the lateral flanges 244a, 244b and the hub assembly 158, thereby frictionally securing the hub assembly 158 in the hub assembly bracket 214. The gripping element 222 can be formed of rubber, a polymer material, or any material having a sufficient coefficient of friction to frictionally engage the hub assembly 158.

[0146] The hub assembly bracket 214 is configured to be actuatable in an axial direction relative to the other components of the hub assembly support 208, such as the base portion 210, the housing 212, and the sleeve handle bracket 216. The hub assembly bracket 214 is coupled to a linear actuator ( Figure 15 ), wherein the linear actuator is configured to move the hub assembly bracket 214 in an axial direction along the length of the slot 236. In the illustrated example, the bottom surface of the base flange 240 is moved by the traveler ( Figure 15) is coupled to a linear actuator ( Figure 15 ), the traveler extends through the slot 236 between the base flange 240 and the linear actuator. However, any suitable portion of the hub assembly bracket 214, including the first lateral flange 244a and the second lateral flange 244b, can be coupled to the linear actuator and / or the traveler.

[0147] The sleeve handle bracket 216 is configured to receive the sleeve handle 196. The sleeve handle bracket 216 is disposed on the housing 212 and is positioned proximally on the housing 212 relative to the hub assembly bracket 214. In some examples, the sleeve handle bracket 216 can 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 example, the sleeve handle bracket 216 includes 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 better ensure that the sleeve handle 196 is securely received within the recess, the first cutout 252 can have the same shape as the cross-section of the sleeve handle 196 (e.g., a bell shape), such that the edge of the first cutout 252 is flush with the surface of the sleeve handle 196. In some examples, the sleeve handle bracket 216 can further include a third cutout 256 disposed distally relative to the first and second cutouts 252 , 254 , the third cutout being configured to receive the sleeve shaft 182 extending from a distal portion of the sleeve handle 196 toward the hub assembly 158 .

[0148] In some examples where the quill 182 is additionally or alternatively movable relative to the pusher shaft 184 to adjust the variable surround turn, the quill handle bracket 216 may be actuatable relative to other components of the hub assembly support 208 (e.g., the base portion 210, the hub assembly bracket 214, etc.). In some examples, the quill 182 may additionally or alternatively be coupled to a linear actuator (which may be similar to the linear actuator 264).

[0149] The actuation control 218 is operably coupled to the linear actuator ( Figure 15 ), and is configured to control the degree of actuation of the hub assembly carrier 214 relative to the hub assembly support 208. In some examples, the actuation control 218 can be a rotatable knob. However, the actuation control 218 can be any suitable interface or control for controlling a linear actuator (e.g., a button, a slider, a switch, a crank, etc.). In some examples, a user can actuate the hub assembly carrier 214 by grasping the hub assembly 158 and sliding the hub assembly 158 in an axial direction relative to other components of the hub assembly support 208.

[0150] In some examples, the hub assembly support 208 can further include an indicator 220 configured to indicate the magnitude of the variable wraparound turn. Because the radius of curvature of the quill forward turn 187 is related to the axial position of the pusher shaft 184 relative to the quill shaft 182, and the axial position of the pusher shaft 184 relative to the quill shaft 182 is related to the axial position of the hub assembly bracket 214 relative to the quill handle bracket 216, the radius of curvature of the quill forward turn 187 can be determined based on the relative axial positioning of the hub assembly bracket 214 and the quill handle bracket 216. In some examples, the indicator 220 can include one or more markings positioned along the length of the slot 236. A first marking 258 positioned toward the proximal end of the slot 236 can indicate that the radius of curvature of the quill forward turn 187 (in other words, the variable wraparound turn) is equal to the first radius of curvature ( r 1 ), and a second mark 260 disposed toward the distal end of the slot 236 may indicate that the radius of curvature of the quill forward turn 187 is equal to the second radius of curvature ( r 2 ).

[0151] The brake 227 is configured to limit the movement of the hub assembly support 208 relative to the stabilizer rail 204. In some examples, the brake 227 can include a knob 262, a cam ( Figure 15 ) and a brake pad, wherein the brake 227 can 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 can frictionally engage the stabilizer rail 204, thereby locking the hub assembly support 208 on the stabilizer rail 204 or in a fixed axial position relative to the stabilizer rail.

[0152] Figure 15 The hub assembly support 208 is shown with the housing 212 and the hub assembly bracket 214 removed. The interior of the hub assembly support 208 contains a linear actuator 264, a traveler 266 (also referred to herein as a "sled") coupled to the linear actuator 264, and a first bevel gear 268 and a second bevel gear 270 that operably couple the linear actuator 264 to the actuation control 218. In some examples where 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.

[0153] The linear actuator 264 is configured to actuate the hub assembly bracket 214 relative to the sleeve handle bracket 216, which is disposed in a fixed axial position on the housing 212. The linear actuator 264 is configured to actuate the hub assembly bracket 214 in an axial direction along the length of the slot 236. In some examples, the linear actuator 264 can include a threaded shaft 274. The threaded shaft 274 can couple a first actuator post 276 and a second actuator post 278 that are axially aligned with each other and coupled to the base portion 210. The threaded shaft 274 can be oriented in an axial direction between the first actuator post 276 and the second actuator post 278. Although the linear actuator 264 is Figure 15 Although shown as a threaded shaft 274, some examples 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 examples, the extent of actuation of the linear actuator 264 may correspond to the length of the slot 236 disposed on the housing 212.

[0154] The threaded shaft 274 can have a thread pitch that defines the distance between adjacent threads on the threaded shaft 274. The speed at which the hub assembly carrier 214 is actuated in the axial direction relative to the rest of the hub assembly support 208 can depend in part on the thread pitch. For example, if the threaded shaft 274 has a relatively high thread pitch, the hub assembly carrier 214 will actuate more slowly in the axial direction than if the threaded shaft 274 has a relatively low thread pitch. Therefore, the thread pitch of the threaded shaft 274 can be selected based in part on the desired actuation speed of the hub assembly carrier 214.

[0155] The traveler 266 is configured to extend through the slot 236 to couple the hub assembly carrier 214 to the linear actuator 264. When the threaded shaft 274 is rotated, the rotation can move the traveler 266 proximally or distally in an axial direction along the length of the slot 236, thereby also moving the hub assembly carrier 214 in an axial direction.

[0156] First bevel gear 268 and second bevel gear 270 are configured to translate torque between actuation control 218 and linear actuator 264. In embodiments where linear actuator 264 includes a threaded shaft 274, first bevel gear 268 may be coupled to an end portion (e.g., a proximal end portion) of threaded shaft 274. Second bevel gear 270 may be coupled to actuation control 218. First bevel gear 268 and second bevel gear 270 may be positioned at right angles to each other. Because first bevel gear 268 and second bevel gear 270 are in meshing contact with each other, first bevel gear 268 and second bevel gear 270 can translate torque or rotational motion of actuation control 218 to threaded shaft 274.

[0157] In some examples where the hub assembly support 208 includes a stabilizer rail lock 230, the hub assembly support 208 can further include one or more bias springs 272 configured to bias the stabilizer rail lock 230 into the locked configuration. The bias springs 272 can include laterally oriented springs disposed between the locking flange 232 or toggle 234 and the base portion 210. The bias springs 272 can bias the locking flange 232 into the locked configuration by forcing the locking flange 232 laterally outward from the base portion 210.

[0158] In some examples where the hub assembly support 208 includes a brake 227, the brake 227 can 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 can be retracted within the hub assembly support 208 so that the brake pad does not directly contact the stabilizer rail 204. When the knob 262 is rotated to a locked configuration, the cam can engage the brake pad, causing it to extend through the cutout in the base portion 210 to frictionally engage or contact the stabilizer rail 204. In some examples, the brake 227 can further include at least one biasing member to bias the brake pad into contact with the stabilizer rail 204. In some examples, the biasing member can include a spring. In some examples, the brake pad can be formed from silicone. However, the brake pad can be formed from any material having a sufficient coefficient of friction to frictionally engage the stabilizer rail 204.

[0159] Figures 16A-16E Shown in Figure 5-11 The configuration of the delivery system 100 during an example docking device delivery procedure is shown. More specifically, Figures 16A-16E The relative axial positioning of the handle 156, hub assembly 158, hub assembly support 208, and sleeve handle 196 during various stages of an example procedure are shown. Although the delivery system 100 may further include other components, such as a guide catheter 30, for clarity, Figures 16A-16E These components are omitted.

[0160] Figures 16A-16E The hub assembly 158 is shown moving relative to the hub assembly support 208 during adjustment of the variable circumferential turn. However, since adjustment of the variable circumferential turn is caused by relative movement between the hub assembly 158 and the sleeve handle 196, it should be understood that in some instances, the hub assembly 158, the sleeve handle 196, or both components can be moved relative to each other to adjust the variable circumferential turn. Furthermore, the handle 156 can remain stationary or can be moved during various instances of the steps for adjusting the variable circumferential turn.

[0161] Figure 16A Shown in Figure 5 The configuration of the delivery system 100 during a stage of an example docking device delivery procedure is shown. After deploying the guide catheter 30, the delivery shaft 154, sleeve shaft 182, and pusher shaft 184 are advanced distally and in unison out of the guide catheter 30 by advancing the handle 156 and hub assembly support 208 in unison along the stabilizer rail 204 (indicated by arrow 282). In some examples where the hub assembly support 208 includes a brake 227, the brake 227 is actuated to an unlocked configuration during this stage to allow the hub assembly support 208 to move relative to the stabilizer rail 204.

[0162] Figure 16B Shown in Figure 6-7 The configuration of the delivery system 100 during a stage of an example docking device delivery procedure is shown. After the delivery shaft 154 is advanced to the native mitral valve 16, the sleeve shaft 182 and the pusher shaft 184 are simultaneously advanced away from the delivery shaft 154 by advancing the hub assembly support 208 in a distal direction (indicated by arrow 284) along the stabilizer rail 204. The handle 156 remains in a fixed axial position on the stabilizer rail 204 while the hub assembly support 208 is advanced distally along the stabilizer rail 204 toward the handle 156. In some examples where the hub assembly further includes a brake 227, the brake 227 can be actuated to an unlocked configuration during this stage to allow relative axial movement between the hub assembly support 208 and the stabilizer rail 204.

[0163] Figure 16C As the delivery device 150 adjusts the variable surround turn, Figure 8The configuration of delivery system 100 during an optional stage of an example docking device delivery procedure is shown. During this stage, a user activates actuation control 218 (e.g., by turning a knob), thereby causing linear actuator 264 to move hub assembly bracket 214 in a proximal direction (indicated by arrow 286) relative to sleeve handle bracket 216 to increase the radius of curvature of sleeve shaft forward turn 187. In some examples, where hub assembly support 208 includes brake 227, brake 227 can be actuated into a locking configuration to lock hub assembly support 208 to stabilizer rail 204, such that brake pads of brake 227 frictionally engage stabilizer rail 204. In some examples, position lock 207 can be used to lock support 206, which holds handle 156, to stabilizer rail 204 to prevent axial movement of delivery shaft 154 during this stage. However, because adjustment of the variable wraparound turn is caused by relative movement between the hub assembly 158 and the sleeve handle 196, some instances of this stage may involve advancing the sleeve handle 196 relative to the hub assembly 158 in a distal direction (in the direction opposite to arrow 286) or moving both the hub assembly 158 and the sleeve handle 196.

[0164] Figure 16D When the sleeve shaft 182 is retracted to extract the protective member 180, Figure 9 The configuration of the delivery system 100 during an optional stage of an example docking device delivery procedure is shown. During this stage, the sleeve handle 196 can be independently actuated by removing or decoupling the sleeve handle 196 from the sleeve handle bracket 216 and moving the sleeve handle 196 in a proximal direction relative to the handle 156, the hub assembly 158, and the hub assembly support 208 (indicated by arrow 288). In some examples, the hub assembly support 208 can be locked to the stabilizer rail 204 (e.g., using brake 227) to prevent axial movement of the hub assembly support 208 relative to the stabilizer rail 204 during this stage. However, as the guard member 180 is withdrawn due to relative movement between the docking device 152 and the sleeve shaft 182 and / or handle 156, some instances of this stage may involve advancing the handle 156 and / or hub assembly 158 in a distal direction relative to the sleeve handle 196 (in the opposite direction of arrow 288) or moving any combination of the handle 156, hub assembly 158 and sleeve handle 196.

[0165] Figure 16E As the guard member 180 is axially shortened by advancing the distal end portion 186 of the sleeve shaft 182 in the distal direction (indicated by arrow 290) to apply a force to the proximal end portion 193 of the guard member 180, the guard member 180 is shown. Figure 10The configuration of delivery system 100 during an optional stage of an example docking device delivery procedure is shown. In some examples, when proximal portion 193 is advanced in a distal direction, proximal portion 193 can frictionally engage docking device 152 after axially shortening guard member 180, such that guard member 180 remains in its deployed configuration after sleeve shaft 182 is removed from the patient's vasculature. However, due to the axial shortening of guard member 180 caused by relative movement between docking device 152 and sleeve shaft 182, some examples of this stage can involve retracting hub assembly 158 relative to sleeve handle 196 in a proximal direction (in the direction opposite to arrow 290) or moving both hub assembly 158 and sleeve handle 196.

[0166] In some instances, a position lock 207 may be used to lock the support 206 holding the handle 156 to the stabilizer rail 204 to prevent movement of the delivery shaft 154 during this phase. Figures 16A-16E The movement shown is relative movement, so the handle 156 can move relative to at least one of the hub assembly 158 and the sleeve handle 196 in any of the stages shown. In some examples, the hub assembly support 208 can be locked to the stabilizer rail 204 (e.g., using the brake 227).

[0167] Figure 17 A hub assembly support 308 is shown according to a second example. The hub assembly support 308 is depicted as the hub assembly 158 housed within the hub assembly carrier 214. Figures 14A-14B The hub assembly support 208 and Figure 17 One exemplary difference of the hub assembly support 308 is that the hub assembly support 308 can include a cam lock 316 instead of the sleeve handle bracket 216 for securing the sleeve handle 196. The cam lock 316 can be actuatable 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, which is coupled to the sleeve shaft 182, from moving in an axial position relative to the hub assembly bracket 214. When the cam lock 316 is in the unlocked configuration, the sleeve handle 196 can freely move in an axial direction relative to the hub assembly bracket 214 (e.g., in an unlocked configuration). Figures 16D-16E An example docking device is shown during the delivery phase of the procedure).

[0168] Figures 14A-14B The hub assembly support 208 and Figure 17A second exemplary difference in the hub assembly support 308 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 in an axial direction along the length of the slot 236. An indicator 320, visible to a user, may be positioned 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 be correlated with the axial position of the hub assembly 158 and the pusher shaft 184. Thus, as the hub assembly carrier 214 is actuated along the length of the slot 236, the indicator 320 may align with one or more markings disposed on the viewport 298 to indicate the radius of curvature of the quill forward turn 187 based on the axial position of the hub assembly carrier 214.

[0169] Figure 18 FIG. 4 is a hub assembly support 408 according to a third example. One exemplary difference between the hub assembly support 408 and the previously illustrated hub assembly supports 208 and 308 is that the hub assembly support 408 may include a sleeve handle bracket 216 and a housing 312 having a chamfer 296 .

[0170] Figure 19 A guide catheter 30 (which may be referred to herein as an "introducer device") according to one example is shown. In some examples, the guide catheter 30 may be used in a prosthetic valve implantation procedure, as described above with reference to Figure 1-4 In some embodiments, the guide catheter 30 may be used for a docking device implantation procedure, as described above with reference to Figure 5-11 The guide catheter 30 is configured to be inserted into the patient's vasculature and to receive the implant catheter (and / or other delivery device) therein to introduce the implant catheter into the patient's vasculature and at least partially guide the implant catheter to a target implantation site. Figure 13 and 23 Examples of implant catheters for prosthetic medical devices (hereinafter referred to as "delivery apparatus 150" and "delivery apparatus 400") that can be housed within guide catheter 30 are shown, respectively.

[0171] The guide catheter 30 in the illustrated example includes a handle 32, a catheter shaft 34 extending distally from the handle 32, and a longitudinal axis 36. In some examples, the catheter shaft 34 can extend proximally into the handle 32. In some examples, the catheter shaft 34 can be coupled to a distal 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 portion of the catheter shaft 34 such that the delivery axis 154, the sleeve shaft 182, and the pusher shaft 184 can extend through the catheter handle lumen and the catheter shaft lumen. In some examples, the catheter shaft lumen and the delivery axis 154 can be aligned with the longitudinal axis 36.

[0172] Figure 20 A guide catheter 30 is shown coupled to a delivery device 150 according to one example.

[0173] Figure 21 The guide catheter 30 is shown coupled to a docking device delivery apparatus 350 according to a second example. The docking device delivery apparatus 350 can include a handle 356 (which can be similar to handle 156), a hub assembly 358 (which can be similar to hub assembly 158) including a suture locking assembly 359, and a sleeve handle 196.

[0174] Figure 22 FIG. 1 shows a docking device 152 according to one example. Figure 22 As depicted, the docking device 152 in its expanded, coiled configuration is configured to receive and secure a prosthetic valve, such as the prosthetic heart valve 62 , within the docking device 152 , thereby securing the prosthetic valve at the annulus of the native mitral valve 16 .

[0175] The docking device 152 includes a coil 188. In some examples, the coil 188 can include a shape memory material (e.g., nickel titanium alloy or "nitinol") such that the docking device 152 (and the coil 188) can move from a substantially straight configuration (or delivery configuration) when positioned within the delivery shaft 154 to a helically expanded configuration after being removed from the delivery shaft 154.

[0176] The coil 188 has a proximal end 188p and a distal end 188d (which also define the proximal and distal ends of the docking device 152, respectively). When positioned within the delivery shaft 154 (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 (i.e., without any coiled or annular portions, but can be flexed or bent) so as to maintain a low radial profile while moving through the patient's vasculature. After being removed from the delivery shaft 154 and deployed at the implantation site, the coil 188 can be moved from the delivery configuration to a helically expanded configuration and wrapped around native tissue adjacent to the implantation site. For example, when the docking device is implanted at the site of a native valve, 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).

[0177] The coil 188 in the expanded coiled configuration may include a docking device forward turn 189 about a central longitudinal axis, a central region 190, and a stabilizing turn 195 (or "stabilizing coil").

[0178] In the deployed coiled configuration, the central region 190 includes one or more helical turns formed about a central longitudinal axis of the docking device 152, wherein the helical turns have a substantially equal radius of curvature configured to encircle the leaflets 24 of the native mitral valve 16. A docking device forward turn 189 extends from a distal end of the central region 190 and has a radius of curvature that is greater than the radius of curvature of the helical turns of the central region 190. In some examples, the radius of curvature of the docking device forward turn 189 of the docking device 152 is equal to a second radius of curvature, wherein the second radius of curvature is less than the first radius of curvature of the sleeve shaft forward turn 187.

[0179] In the example shown, the stabilizing turn 195 can extend from the proximal end of the central region 190 and have a diameter that is larger than the diameter of the central region 190. Alternatively, the stabilizing turn 195 can have a diameter that is equal to, approximately equal to, or smaller than the diameter of the central region 190 (as opposed to a larger diameter), and / or the stabilizing turn can include a diameter that is larger than the diameter of the central region 190. Figure 22 The full turn depicted in FIG is a full turn with fewer parts.

[0180] In some examples, the docking device 152 can 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 examples, the guard member 180 can include a braided portion disposed between a distal portion 191 and a proximal portion 193 of the guard member 180. The braided portion is configured to shorten to an expanded configuration when the proximal portion 193 is forced in a distal direction, wherein the braided portion has an increased radial thickness in the shortened expanded configuration.

[0181] Additional details of the docking device and its variations are described in PCT Publication No. WO2022 / 087336, which is incorporated herein by reference in its entirety.

[0182] Figure 23 A delivery device 400 (also referred to herein as an "implant catheter" and / or a "prosthetic heart valve delivery device") that can be used to implant an expandable prosthetic heart valve is shown according to one example. In some examples, the delivery device 400 is particularly suitable for introducing a prosthetic heart valve into the heart. For example, the delivery device 400 can be used as the prosthetic valve delivery device 60 in a prosthetic valve implantation procedure, as described above with reference to FIG. Figure 3A As stated.

[0183] Figure 23 The delivery device 400 in the illustrated example is a balloon catheter comprising a handle 402 and a steerable outer shaft 404 extending distally from the handle 402. The delivery device 400 may further comprise an intermediate shaft 406 (which may also be referred to as a balloon shaft) extending proximally from the handle 402 and extending distally from the handle 402, with the portion extending distally from the handle 402 also coaxially extending through the outer shaft 404. In some examples, the delivery device 400 may further comprise an inner shaft extending distally from the handle 402 coaxially through the intermediate shaft 406, and the outer shaft 404 extending proximally from the handle 402 coaxially through the intermediate shaft.

[0184] Outer shaft 404 and intermediate shaft 406 may be configured to longitudinally translate (eg, move) relative to each other along a central longitudinal axis 420 of delivery apparatus 400 to facilitate delivery and positioning of a prosthetic valve at an implantation site within a patient's body.

[0185] The intermediate shaft 406 may include a proximal portion extending proximally from the proximal end of the handle 402 to the proximal end of the adapter 412. The adapter 412 may include a first port 438 configured to receive a guidewire therethrough and a second port 440 configured to receive a fluid (e.g., an inflation fluid) from a fluid source. The second port 440 may be fluidly coupled to the inner lumen of the intermediate shaft 406.

[0186] In some examples, the intermediate shaft 406 can further include a distal portion that extends distally beyond the distal end of the outer shaft 404 when the distal end of the outer shaft 404 is positioned distal to the inflatable balloon 418 of the delivery device 400. The distal portion of the inner shaft can extend distally beyond the distal portion of the intermediate shaft 406 toward or to a nose cone 422 at the distal end of the delivery device 400.

[0187] In some examples, the distal end of the balloon 418 can be coupled to the distal end of the delivery device 400, such as to the nose cone 422 (e.g., Figure 23 ), or an alternative component (e.g., a distal shoulder) coupled to the distal end of the delivery device 400. The middle portion of the balloon 418 can cover the valve mounting portion 424 of the distal portion of the delivery device 400, and the distal portion of the balloon 418 can cover the distal shoulder of the delivery device 400. Figure 23 As shown in FIG, the prosthetic heart valve 450 can be mounted in a radially compressed state around the balloon 418 at the valve mounting portion 424 of the delivery device 400. The prosthetic heart valve 450 can be configured to expand radially by inflation of the balloon 418 at the native valve annulus, as described above with reference to FIG. Figure 3A As stated.

[0188] The balloon shoulder assembly of the delivery apparatus 400 , including the distal shoulder, is configured to maintain a prosthetic heart valve 450 (or other medical device) in a fixed position on the balloon 418 during delivery through the patient's vasculature.

[0189] The outer shaft 404 may include a distal tip portion 428 mounted on its distal end. In some examples, when the prosthetic valve 450 is mounted on the valve mounting portion 424 in a radially compressed state (e.g., Figure 23 ) and during delivery of the prosthetic valve to a target implantation site, outer shaft 404 and middle shaft 406 can be axially translated relative to each other to position distal tip portion 428 adjacent the proximal end of valve mounting portion 424. Thus, when distal tip portion 428 is disposed adjacent the proximal side of valve mounting portion 424, distal tip portion 428 can be configured to resist proximal movement of prosthetic valve 450 relative to balloon 418 in an axial direction.

[0190] An annular space can be defined between the outer surface of the inner shaft and the inner surface of the intermediate shaft 406 and can be configured to receive fluid from a fluid source via the second port 440 of the adapter 412. The annular space can be fluidly coupled to a fluid passage formed between the outer surface of the distal portion of the inner shaft and the inner surface of the balloon 418. Thus, fluid from the fluid source can flow from the annular space to the fluid passage to inflate the balloon 418 and radially expand and deploy the prosthetic valve 450.

[0191] The inner lumen of the inner shaft can be configured to receive a guidewire therethrough for guiding the distal portion of the delivery device 400 to the target implantation site.

[0192] The handle 402 can include a steering mechanism configured to adjust the curvature of the distal portion of the delivery device 400. In the illustrated example, for example, the handle 402 includes an adjustment member, such as a rotatable knob 460 as shown, which is in turn operably coupled to a proximal portion of a pull wire. The pull wire can extend distally from the handle 402 through the outer shaft 404 and have a distal portion secured to the outer shaft 404 at or near the distal end of the outer shaft 404. Rotating the knob 460 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal portion of the delivery device 400. Additional details regarding steering or flexing mechanisms for delivery devices can be found in U.S. Patent No. 9,339,384, as previously incorporated by reference above.

[0193] The handle 402 can further include an adjustment mechanism 461 including an adjustment member, such as a rotatable knob 462 as shown, and an associated locking mechanism including 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 an implantation site).

[0194] The prosthetic valves disclosed herein (e.g., prosthetic heart valve 450, prosthetic heart valve 62, etc.) can be radially compressible and radially expandable between a radially compressed state and a radially expanded state. Thus, during delivery, 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 and then expanded to a radially expanded state once the prosthetic valve reaches the implantation site. It should be understood that the prosthetic valves disclosed herein can be used with a variety of implant delivery devices and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0195] Figure 24 The prosthetic valve 450 is shown in a radially expanded position. The prosthetic valve 450 can be used as a prosthetic heart valve 62 in a prosthetic valve implantation procedure, as described above with reference to FIG. Figure 1-4Any of the prosthetic valves disclosed herein is suitable for implantation in the native aortic valve annulus, but in other instances, the prosthetic valves may be suitable for implantation in other native valve annuli of the heart (pulmonary valve, mitral valve, and tricuspid valve). The disclosed prosthetic valves may also be implanted in blood vessels connected to the heart, including the patient's pulmonary artery (to replace the function of a diseased pulmonary valve), or the superior vena cava or inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels. The disclosed prosthetic valves may also be implanted in a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) during a valve-in-valve procedure.

[0196] In some examples, the disclosed prosthetic valve can be implanted within a docking or anchoring device (e.g., docking device 152, etc.) implanted within a native heart valve or blood vessel. For example, in one example, the disclosed prosthetic valve can be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another example, the disclosed prosthetic valve can be implanted within a docking device implanted within or at the native mitral valve, as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valve can be implanted within a docking device implanted within the superior vena cava or inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0197] 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 FIG. Figure 1-4 As described. Figure 24 As shown, the prosthetic valve 450 can include a frame 452, and a plurality of leaflets 454 can be at least partially located within the frame 452. The prosthetic valve 450 can also include an outer cover 456 located around the frame 452. Figure 12 As shown, prosthetic valve 450 includes an inflow end 457 and an outflow end 458. The terms "inflow" and "outflow" relate to the normal direction of blood flow (e.g., antegrade blood flow) through prosthetic valve 450. For example, leaflets 454 can allow blood to flow through valve 450 in a direction from inflow end 457 to outflow end 458 and prevent reverse flow (e.g., preventing flow in a direction from outflow end 458 to inflow end 457).

[0198] Frame 452 can be made of 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. When constructed of a plastically expandable material, frame 452 (and therefore valve 450) can be crimped to a radially compressed state on a delivery catheter and then expanded within the patient's body by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, frame 452 (and therefore valve 450) can be crimped to a radially compressed state and retained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once within the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0199] Suitable shapable expandable materials that can be used to form the frames disclosed herein (e.g., frame 452) include metal alloys, polymers, or combinations thereof. Example metal alloys may include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some instances, frame 452 may include stainless steel. In some instances, frame 452 may include cobalt chromium. In some instances, frame 452 may include nickel-cobalt-chromium. In some instances, frame 452 may include a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (a trade name of SPS Technologies), which is equivalent to UNSR30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight.

[0200] Outer cover 456 can be formed in whole or in part from any suitable biomaterial, synthetic material (e.g., any of a variety of polymers), or a combination thereof. In some examples, outer cover 456 can comprise a fabric having interwoven yarns or fibers, such as in the form of a woven, woven, or knitted fabric. In some examples, the fabric can have a plush pile or suede surface. Exemplary fabrics having a plush pile or suede surface include velvet, velvet, velveteen, corduroy, terry, fleece, etc. In some examples, outer cover 456 can comprise a fabric without interwoven yarns or fibers, such as felt or 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, etc. In some examples, the skirt can comprise a non-woven or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the outer cover 456 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the outer cover 456 can comprise natural tissue, such as pericardium (e.g., bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0201] Additional details of prosthetic heart valves and variations thereof are described in US Patent No. 11,185,406, which is incorporated herein by reference in its entirety.

[0202] Delivery Technology To implant a prosthetic valve within the native aortic valve via a transfemoral delivery method, the prosthetic valve is mounted in a radially compressed state along the distal portion of the delivery device. The prosthetic valve and the distal 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, actuating one or more actuators of the delivery device, or 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 in a transapical procedure, whereby the prosthetic valve (on the distal 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 portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or a right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0203] To implant a prosthetic valve within the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted in a radially compressed state along the distal portion of a delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (through a puncture created 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 in a transapical procedure, whereby the prosthetic valve (on the distal 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.

[0204] To implant a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava and into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar method 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.

[0205] Another delivery method is a transatrial approach, whereby the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision in the atrial wall (right or left atrium) for access to any native heart valve. Atrial delivery can also be performed intravascularly, such as from the pulmonary veins. Yet another delivery method is a transventricular approach, whereby the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision in the right ventricle wall (usually at or near the base of the heart) for implantation into the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0206] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery methods are not intended to be limiting. Any prosthetic valve disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0207] Sterilization Any one of the system, device, equipment etc. herein can be sterilized (for example, with heating / heat, pressure, steam, radiation and / or chemicals etc.) to ensure that it is safe for use for the patient, and as a step in the step of the method, any method in the method herein can include the sterilization of the associated system, device, equipment etc. The example of heating / thermal sterilization includes steam sterilization and autoclaving. The example of radiation for sterilization includes but is not limited to gamma radiation, ultraviolet radiation and electron beam. The example of chemicals for sterilization includes but is not limited to ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde and glutaraldehyde. For example, the sterilization carried out with hydrogen peroxide can use hydrogen peroxide plasma to complete.

[0208] simulation The therapeutic techniques, methods, steps, etc. described or suggested herein or in the references incorporated herein can be performed on living animals or on non-living simulated objects, such as cadavers, cadaver hearts, anthropomorphic pseudo-targets, simulated bodies (e.g., having simulated body parts, tissues, etc.).

[0209] Additional Examples of the Disclosed Technology In view of the above-described embodiments of the disclosed subject matter, the present application discloses the additional examples listed below. It should be noted that one feature of a separate example or more than one feature of an example adopted in combination and optionally combined with one or more features of one or more additional examples are additional examples that also fall within the disclosure of the present application.

[0210] Example 1. A delivery system for delivering a prosthetic medical device, the delivery system comprising: a delivery apparatus, the delivery apparatus comprising: a handle; a delivery shaft extending from a distal portion of the handle and comprising a delivery shaft lumen extending along the length of the delivery shaft; a hub assembly extending from a proximal portion of the handle; a sleeve shaft disposed within the delivery shaft lumen, the sleeve shaft comprising 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 the proximal portion of the sleeve shaft; and a hub assembly coupled to the proximal portion of the pusher shaft; and a stabilizer assembly The stabilizer assembly is configured to stabilize the delivery device, the stabilizer assembly comprising: a stabilizer rail, the stabilizer rail being configured to be oriented in an axial direction; and a hub assembly support, the hub assembly support being configured to be slidingly connected to the stabilizer rail, the hub assembly support comprising: a sleeve handle bracket, the sleeve handle bracket being configured to accommodate the sleeve handle; a hub assembly bracket, the hub assembly bracket being configured to accommodate the hub assembly, wherein the hub assembly bracket is movable in an axial direction relative to the sleeve handle bracket; and a linear actuator connected to the hub assembly, wherein the linear actuator is configured to actuate the hub assembly bracket relative to the sleeve handle bracket in the axial direction.

[0211] Example 2. The delivery system according to any example herein, particularly example 1, wherein the delivery system further comprises a guide catheter.

[0212] Example 3. A delivery system according to any example herein, particularly Example 2, wherein the guide catheter comprises a handle, a catheter shaft extending from a distal portion of the handle, and a catheter shaft lumen extending along the length of the catheter shaft, wherein the catheter shaft lumen is configured to accommodate the delivery shaft, the sleeve shaft, and the pusher shaft.

[0213] Example 4. The delivery system of any example herein, particularly any one of examples 2 to 3, wherein the stabilizer assembly further comprises a support configured to stabilize the guide catheter.

[0214] Example 5. The delivery system of any example herein, particularly any one of examples 1 to 4, wherein the stabilizer assembly further comprises a support configured to stabilize the handle.

[0215] Example 6. The delivery system of any example herein, particularly any one of examples 1 to 5, wherein at least one of the sleeve shaft and the pusher shaft has a generally U-shaped axial cross-section.

[0216] Example 7. The delivery system of any example herein, particularly any one of examples 1 to 6, wherein the delivery shaft, the sleeve shaft, and the pusher shaft are independently actuatable relative to each other.

[0217] Example 8. The delivery system of any example herein, particularly any one of examples 1 to 7, wherein the hub assembly support further comprises an indicator.

[0218] Example 9. The delivery system of any example herein, particularly Example 8, wherein the indicator is configured to indicate a magnitude of a radius of curvature of a distal portion of the delivery system.

[0219] Example 10. A delivery system according to any example herein, in particular Example 9, wherein the radius of curvature of the distal portion of the delivery system is measured at a forward turn of a sleeve shaft, wherein the forward turn of the sleeve shaft is positioned at or near the distal portion of the sleeve shaft.

[0220] Example 11. A delivery system according to any example herein, particularly any one of Examples 9 to 10, wherein the indication of the magnitude of the radius of curvature of the distal portion of the delivery system is based on the relative axial positioning of the pusher shaft relative to the sleeve shaft.

[0221] Example 12. The delivery system of any example herein, particularly example 11, wherein the relative axial positioning of the pusher shaft is based on the relative axial positioning of the hub assembly bracket relative to the sleeve handle bracket.

[0222] Example 13. The delivery system of any example herein, particularly 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.

[0223] Example 14. The delivery system of any example herein, particularly example 13, wherein the first marker is positioned in a proximal direction relative to the second marker.

[0224] Example 15. A stabilizer assembly configured for use with a delivery apparatus, the stabilizer assembly comprising: a stabilizer rail configured to be oriented in an axial direction; and a hub assembly support configured to be slidingly coupled to the stabilizer rail, the hub assembly support comprising: a sleeve handle bracket configured to receive a sleeve handle of the delivery device; a linear actuator configured to move a traveler in an axial direction relative to the sleeve handle bracket; and a hub assembly bracket coupled to the traveler, wherein the hub assembly bracket is configured to receive a hub assembly of the delivery device.

[0225] Example 16. A stabilizer assembly according to any example herein, in particular Example 15, wherein the hub assembly support further includes a stabilizer rail lock, wherein the stabilizer rail lock is configured to connect the hub assembly support to the stabilizer rail, wherein the stabilizer rail lock is actuatable between a locked configuration and an unlocked configuration.

[0226] Example 17. The stabilizer assembly of any example herein, particularly example 16, wherein the stabilizer rail lock comprises a locking flange extending in a laterally outward direction from the hub assembly support.

[0227] Example 18. The stabilizer assembly of any example herein, particularly example 17, wherein the locking flange is configured to frictionally engage the stabilizer rail in the locked configuration.

[0228] Example 19. The stabilizer assembly of any example herein, particularly any one of examples 16 to 18, wherein the stabilizer track lock is biased in the locked configuration.

[0229] Example 20. The stabilizer assembly of any example herein, particularly any one of examples 16 to 19, wherein the hub assembly support further comprises a groove disposed on a lateral surface of the hub assembly support.

[0230] Example 21. A stabilizer assembly according to any example herein, in particular Example 20, wherein the groove is disposed on a first lateral surface of the hub assembly support and the stabilizer track lock is disposed on a second lateral surface of the hub assembly support, wherein the first lateral surface is opposite to the second lateral surface.

[0231] Example 22. A hub assembly support configured for use with a delivery system, the hub assembly support comprising: a base portion; a shell disposed on the base portion and comprising an axially oriented slot; a sleeve handle bracket disposed on the shell and configured to accommodate a sleeve handle of the delivery system; a linear actuator coupled to the base portion; a mover coupled to the linear actuator and extending through the axially oriented slot; and a hub assembly bracket coupled to the mover, wherein the hub assembly bracket is configured to accommodate a hub assembly of the delivery system, and wherein the linear actuator is configured to actuate the hub assembly bracket in the axial direction relative to the sleeve handle bracket.

[0232] Example 23. The hub assembly support of any example herein, particularly example 22, wherein the sleeve handle bracket includes a recess in the base portion configured to receive the sleeve handle.

[0233] Example 24. The hub assembly support of any example herein, particularly example 23, wherein the recess comprises a bell-shaped cutout.

[0234] Example 25. The hub assembly support of any example herein, particularly any of examples 23-24, wherein the recess includes a cutout configured to accommodate a quill of the delivery system.

[0235] Example 26. The hub assembly support according to any example herein, particularly any one of examples 22 to 25, wherein the hub assembly support further comprises an indicator.

[0236] Example 27. The hub assembly support of any example herein, particularly Example 26, wherein the indicator is configured to indicate a magnitude of a radius of curvature of a forward turn of a quill coupled to the hub assembly.

[0237] Example 28. The hub assembly support of any example herein, particularly Example 27, wherein the indication of the magnitude of the radius of curvature of the forward turn of the sleeve shaft is based on an axial position of the advancer relative to the sleeve shank bracket.

[0238] Example 29. The hub assembly support of any example herein, particularly example 28, wherein the indicator comprises a rod coupled to the traveler.

[0239] Example 30. The hub assembly support of any example herein, particularly Example 29, wherein the housing further comprises a viewport extending in the axial direction along the length of the axially-oriented slot, and wherein the rod is visible through the viewport.

[0240] Example 31. The hub assembly support of any example herein, particularly any 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 forward turn of the quill.

[0241] Example 32. A hub assembly support for use with a delivery system, the hub assembly support comprising: a base portion; a linear actuator disposed on the base portion, the linear actuator comprising: a threaded shaft oriented in an axial direction; a slide operably connected to the threaded shaft, wherein the linear actuator is configured to actuate the slide in the axial direction; a hub assembly bracket connected to the slide, wherein the hub assembly bracket is configured to accommodate a hub assembly of the delivery system; and a sleeve handle bracket disposed on the base portion, wherein the sleeve handle bracket is configured to accommodate a sleeve handle of the delivery system, wherein the linear actuator is configured to actuate the hub assembly bracket in an axial direction relative to the sleeve handle bracket.

[0242] Example 33. The hub assembly support of any example herein, particularly Example 32, wherein the hub assembly support further comprises an actuation control configured to control the linear actuator.

[0243] Example 34. The hub assembly support of any example herein, particularly Example 33, wherein the actuation control comprises a rotatable knob.

[0244] Example 35. The hub assembly support of any example herein, particularly Example 34, wherein the hub assembly support further comprises a plurality of bevel gears operably coupling the rotatable knob to the threaded shaft.

[0245] Example 36. A hub assembly support according to any example herein, particularly any one of Examples 32 to 35, wherein the hub assembly support further includes a brake configured to limit movement of the hub assembly support relative to a stabilizer rail coupled to the hub assembly support.

[0246] Example 37. The hub assembly support of any example herein, particularly any of Examples 32 to 36, wherein the extent of actuation of the linear actuator corresponds to the length of an axially extending slot in the hub assembly support.

[0247] Example 38. A method for implanting a prosthetic medical device, the method comprising: connecting a delivery device to a stabilizer assembly, wherein: 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 the proximal portion of the sleeve shaft, and a hub assembly coupled to the proximal portion of the pusher shaft, the stabilizer assembly comprises a hub assembly support, the hub assembly support comprises a hub assembly bracket configured to accommodate the hub assembly, a sleeve handle bracket configured to accommodate the sleeve handle, and a linear actuator configured to actuate the hub assembly bracket in an axial direction relative to the sleeve handle bracket, and connecting the delivery device to the stabilizer assembly comprises connecting the hub assembly to the hub assembly bracket and connecting the sleeve handle to the sleeve handle bracket; advancing the hub assembly support in a distal direction; and actuating the linear actuator to move the hub assembly bracket in an axial direction relative to the sleeve handle bracket.

[0248] Example 39. The method of any example herein, particularly Example 38, wherein the prosthetic medical device is a docking device configured for use with a prosthetic heart valve.

[0249] Example 40. The method of any example herein, particularly example 39, wherein the docking device further comprises a protective member.

[0250] Example 41. A method according to any example herein, particularly Example 40, wherein the method further comprises decoupling the sleeve handle from the sleeve handle bracket, retracting the sleeve handle in a proximal direction relative to the hub assembly, and advancing the sleeve handle in a distal direction relative to the hub assembly.

[0251] Example 42. A method according to any example herein, particularly any one of Examples 38 to 41, wherein moving the hub assembly bracket in the axial direction relative to the sleeve handle bracket changes the magnitude of the radius of curvature of the forward turn of the sleeve shaft connected to the hub assembly.

[0252] Example 43. The method of any example herein, particularly any one of Examples 38 to 42, wherein the linear actuator is configured to move the hub assembly carrier in a distal direction relative to the sleeve handle.

[0253] Example 44. A method according to any example described herein, particularly any one of Examples 38 to 43, wherein the delivery device further includes a handle connected to the proximal portion of the sleeve shaft, the stabilizer assembly further includes a support configured to stabilize the handle, and the hub assembly support is advanced in unison with the support in the distal direction.

[0254] Unless otherwise stated, features described herein with respect to any example can be combined with other features described in any one or more of the other examples. For example, any one or more features of a hub assembly support can be combined with any one or more features of another hub assembly support. As another example, any one or more features of one docking device delivery device can be combined with any one or more features of another docking device delivery device.

[0255] In view of the many possible ways in which the principles of the present disclosure can be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure, nor should they be taken as limiting the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A delivery system for delivering a prosthetic medical device, the delivery system comprising: A delivery device, comprising: handle; a delivery shaft extending from a distal 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 portion of the handle; a quill disposed within the delivery shaft lumen, the quill comprising a quill lumen extending along a length of the quill; a pusher shaft, the pusher shaft being disposed in the tubular cavity of the sleeve shaft; a sleeve handle coupled to a proximal end portion of the sleeve shaft; as well as a hub assembly coupled to a proximal end portion of the pusher shaft; as well as a stabilizer assembly configured to stabilize the delivery device, the stabilizer assembly comprising: a stabilizer rail configured to be oriented in an axial direction; and a hub assembly support configured to be slidingly coupled to the stabilizer rail, the hub assembly support comprising: a sleeve handle bracket configured to receive the sleeve handle; a hub assembly bracket configured to receive the hub assembly, wherein the hub assembly bracket is movable in an axial direction relative to the sleeve shank bracket; as well as A linear actuator is coupled to the hub assembly, wherein the linear actuator is configured to actuate the hub assembly carrier relative to the sleeve shank carrier in the axial direction.

2. The delivery system of claim 1, wherein the delivery system further comprises a guide catheter.

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

4. The delivery system of any one of claims 2 to 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 rail.

7. The delivery system of any one of claims 1 to 6, wherein the delivery shaft, the sleeve shaft, and the pusher shaft are independently actuatable relative to 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 a magnitude of a radius of curvature of a distal portion of the delivery system.

10. The delivery system of claim 9, wherein the radius of curvature of the distal portion of the delivery system is measured at a quill forward turn, wherein the quill forward turn is disposed at or near the distal portion of the quill.

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

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

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. The delivery system of claim 13 , wherein the first marker is positioned in a proximal direction relative to the second marker.

15. A stabilizer assembly configured for use with a delivery device, the stabilizer assembly comprising: a stabilizer rail configured to be oriented in an axial direction; and a hub assembly support configured to be slidingly coupled to the stabilizer rail, the hub assembly support comprising: a sleeve handle bracket configured to receive a sleeve handle of the delivery device; a linear actuator configured to move a traveler in an axial direction relative to the sleeve shank bracket; as well as A hub assembly bracket is coupled to the traveler, wherein the hub assembly bracket is configured to house a hub assembly of the delivery apparatus.

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

17. The stabilizer assembly of claim 16, wherein the stabilizer rail lock includes a locking flange extending in a laterally outward direction from the hub assembly support.

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

19. A stabiliser assembly according to any one of claims 16 to 18, wherein the stabiliser rail lock is biased in the locked configuration.

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

21. The stabilizer assembly of claim 20, wherein the groove is disposed on a first lateral surface of the hub assembly support and the stabilizer rail lock is disposed on a second lateral surface of the hub assembly support, wherein the first lateral surface is opposite the second lateral surface.

22. A hub assembly support configured for use with a delivery system, the hub assembly support comprising: base part; a housing disposed on the base portion and including an axially oriented slot; a sleeve handle bracket 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; as well as A hub assembly carrier is coupled to the traveler, wherein the hub assembly carrier is configured to house a hub assembly of the delivery system, and wherein the linear actuator is configured to actuate the hub assembly carrier in the axial direction relative to the sleeve handle carrier.

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

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

25. The hub assembly support of any one of claims 23 to 24, wherein the recess includes a cutout configured to receive a quill of the delivery system.

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

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

28. The hub assembly support of claim 27, wherein the indication of the magnitude of the radius of curvature of the forward turn of the quill is based on an axial position of the runner relative to the quill shank bracket.

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

30. The hub assembly support of claim 29, wherein the housing further comprises a viewport extending in the axial direction along the length of the axially-oriented slot, and wherein the rod is visible through the viewport.

31. The hub assembly support of any one of claims 29 to 30, wherein the rod is configured to align with markings indicating the magnitude of the radius of curvature of the forward turn of the quill.

32. A hub assembly support for use with a delivery system, the hub assembly support comprising: base part; a linear actuator disposed on the base portion, the linear actuator comprising: a threaded shaft oriented in an axial direction; a carriage operably coupled to the threaded shaft, wherein the linear actuator is configured to actuate the carriage in the axial direction; a hub assembly bracket coupled to the carriage, wherein the hub assembly bracket is configured to house a hub assembly of the delivery system; as well as a sleeve handle bracket disposed on the base portion, wherein the sleeve handle bracket is configured to receive a sleeve handle of the delivery system, Wherein the linear actuator is configured to actuate the hub assembly bracket in an axial direction relative to the sleeve handle bracket.

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. The hub assembly support of 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 rail 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 corresponds to the length of an axially extending slot in the hub assembly support.

38. A method for implanting a prosthetic medical device, the method comprising: A delivery device is coupled to the stabilizer assembly, wherein: The delivery apparatus includes 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 includes a hub assembly support including a hub assembly bracket configured to receive the hub assembly, a sleeve shank bracket configured to receive the sleeve shank, and a linear actuator configured to actuate the hub assembly bracket in an axial direction relative to the sleeve shank bracket, and Coupling the delivery apparatus to the stabilizer assembly includes coupling the hub assembly into the hub assembly bracket, and coupling the sleeve handle to the sleeve handle bracket; advancing the hub assembly support in a distal direction; as well as The linear actuator is actuated to move the hub assembly carrier in an axial direction relative to the sleeve shank carrier.

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

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

41. The method of claim 40, wherein the method further comprises decoupling the sleeve handle from the sleeve handle bracket, retracting the sleeve handle in a proximal direction relative to the hub assembly, and advancing the sleeve handle in a distal direction relative to the hub assembly.

42. The method of any one of claims 38 to 41, wherein moving the hub assembly carrier relative to the quill shank carrier in the axial direction changes the magnitude of the radius of curvature of a forward turn of a quill 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 carrier in a distal direction relative to the sleeve handle.

44. A method according to any one of claims 38 to 43, wherein the delivery device further includes a handle connected to the proximal portion of the sleeve shaft, the stabilizer assembly further includes a support configured to stabilize the handle, and the hub assembly support is advanced in unison with the support in the distal direction.

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