Prosthetic medical device delivery apparatus

Abstract

Devices and methods for a delivery device for docking a device are disclosed. As an example, a delivery device may include: a housing; a linear actuator coupled to the housing, the linear actuator including a slider and a hinge member coupled to the slider, where the slider axially translates relative to the housing based on rotation of the hinge member relative to the housing; a first shaft extending through the housing and configured to axially translate relative to the housing; a second shaft extending through the first shaft and coupled to the slider of the linear actuator such that the second shaft and the slider axially translate together; and a locking mechanism coupled to the housing, where movement of the first shaft relative to the housing is prevented in a locked configuration, and where the first shaft is movable relative to the housing in an unlocked configuration.

Description

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 488,511, filed March 5, 2023, which is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0002] The present disclosure relates to delivery apparatuses for prosthetic medical devices. BACKGROUND

[0003] Human hearts can suffer from a variety of valvular diseases. These valvular diseases can cause significant dysfunction of the heart and eventually require repair of the native valve or replacement of the native valve with a prosthetic valve. There are a number of known repair devices (e.g., stents) and prosthetic valves, and a number of known methods of implanting these devices and valves into 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 accessed through surgery or are desired to be accessed without surgery. In one particular example, a prosthetic heart valve can be mounted in a crimped state on a distal end of a delivery apparatus and advanced through a patient’s vasculature (e.g., through the femoral artery or femoral vein), until the prosthetic valve reaches an implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, thereby actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size. For example

[0004] In some examples, the docking device can be implanted first within the native valve and can be configured to receive and secure (e.g., anchor) the prosthetic valve at a desired location within the native valve. For example, the docking device can create a more rounded and / or stable anchoring site at the native annulus, into which the prosthetic valve can be expanded and implanted. A transcatheter delivery apparatus can be used to deliver the docking device to the implantation site. SUMMARY

[0005] Prosthetic heart valves, docking devices, delivery apparatuses, and methods for implanting prosthetic heart valves are described herein. The disclosed prosthetic heart valves, docking devices, delivery apparatuses, and methods can provide for improved positioning of the docking device, for example, through independent actuation of multiple shafts of the delivery apparatus. Thus, the devices and methods disclosed herein can overcome one or more deficiencies of typical prosthetic heart valves, docking devices, and associated delivery apparatuses, among others.

[0006] A delivery apparatus can include a handle and one or more shafts coupled to the handle.

[0007] ​In some examples, a delivery device can include a handle, a shaft coupled to the handle, and a linear actuator coupled to the shaft, wherein the linear actuator is configured to move the shaft in an axial direction relative to the handle.

[0008] In some examples, a delivery device can include a housing, a linear actuator coupled to the housing, the linear actuator including a slider and an articulating member coupled to the slider, wherein the slider is axially translated relative to the housing based on rotation of the articulating member relative to the housing, a first shaft extending through the housing and configured to be axially translated relative to the housing, a second shaft extending through the first shaft and coupled to the slider of the linear actuator such that the second shaft and the slider are axially translated together, and a locking mechanism coupled to the housing, wherein the first shaft is prevented from moving relative to the housing in a locked configuration, and wherein the first shaft is movable relative to the housing in an unlocked configuration.

[0009] In some examples, a delivery device can include a housing including an opening at a distal end, a first shaft extending through the housing and configured to be translated relative to the housing, a second shaft extending through the first shaft, and a linear actuator coupled to the housing, the linear actuator including a slider and an articulating member coupled to the slider, wherein the slider is axially translated relative to the housing between a first axial position and a second axial position based on rotation of the articulating member relative to the housing, wherein the second shaft and the slider are configured to be translated together, and wherein the slider at least partially extends out of the opening of the housing in the second axial position.

[0010] In some examples, a delivery device can include a housing defining an interior region, a linear actuator coupled to the housing and configured to be axially translated relative to the housing, the linear actuator including a lead screw and a chassis coupled to the lead screw, the chassis positioned within the interior region of the housing, a pusher shaft extending through the housing and coupled to the lead screw, wherein the pusher shaft and the lead screw are configured to be translated together relative to the housing, and a cover coupled to the housing and at least partially removable from the housing to selectively expose the interior region.

[0011] In some examples, a delivery device includes a housing, a sleeve shaft extending through the housing, wherein the sleeve shaft includes a u-shaped or c-shaped axial cross-section, and a locking mechanism coupled to the housing and including a collet having an internal cavity, wherein the sleeve shaft extends through the internal cavity, wherein the internal cavity includes a non-circular cross-section, wherein the sleeve shaft is prevented from moving relative to the housing in a locked configuration, and wherein the sleeve shaft is movable relative to the housing in an unlocked configuration.

[0012] A method for implanting a prosthetic medical device at a target implant site can include moving a pusher shaft of a delivery device in an axial direction relative to a sleeve shaft and a hub assembly of the delivery device.

[0013] In some instances, a method for implanting a prosthetic medical device at a target implant site of a subject, the method comprising: advancing a prosthetic medical device coupled to a pusher shaft of a delivery apparatus and retained within a sleeve shaft of the delivery apparatus toward the target implant site by moving the sleeve shaft and the pusher shaft relative to a handle of the delivery apparatus in a distal direction; locking a position of the sleeve shaft relative to a hub assembly of the delivery apparatus with a locking mechanism coupled to the hub assembly of the delivery apparatus; and actuating a linear actuator of the hub assembly to move the pusher shaft relative to the sleeve shaft and the hub assembly in an axial direction.

[0014] The various innovations of the present disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts that are further described below in the detailed description. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will be more readily understood upon consideration of the following detailed description, taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0015] Figure 1 Another stage in an example mitral valve replacement procedure is schematically illustrated in which a docking device delivery apparatus extending through the guide catheter implants a docking device for a prosthetic heart valve at the native mitral valve.

[0016] Figure 2A Another stage in an example mitral valve replacement procedure is schematically illustrated in which a docking device delivery apparatus extending through the guide catheter implants a docking device for a prosthetic heart valve at the native mitral valve.

[0017] Figure 2B Another stage in an example mitral valve replacement procedure is schematically illustrated in which Figure 2A the docking device is fully implanted at the native mitral valve of the patient and the docking device delivery apparatus has been removed from the patient.

[0018] Figure 3A Another stage in an example mitral valve replacement procedure is schematically illustrated in which a prosthetic heart valve delivery apparatus extending through the guide catheter implants a prosthetic heart valve into the implanted docking device at the native mitral valve.

[0019] Figure 3B Another stage in an example mitral valve replacement procedure is schematically illustrated in which the prosthetic heart valve is fully implanted within the docking device at the native mitral valve and the prosthetic heart valve delivery apparatus has been removed from the patient.

[0020] Figure 4Another stage in an example mitral valve replacement procedure is schematically illustrated in which the guide catheter and guidewire have been removed from the patient.

[0021] Figure 5 A stage in a docking device implant procedure according to one example is schematically illustrated in which a guide catheter is inserted into a blood vessel of a patient and is guided through the blood vessel and into the heart of the patient.

[0022] Figure 6 Another stage in an example docking device implant procedure is schematically illustrated in which a distal end portion of the docking device delivery apparatus is advanced from the guide catheter and into the left ventricle of the heart.

[0023] Figure 7 Another stage in an example docking device implant procedure is schematically illustrated in which the distal end portion of the docking device delivery apparatus is wrapped around a plurality of leaflets of the heart.

[0024] Figure 8 Another stage in an example docking device implant procedure is schematically illustrated in which a radius of curvature of the distal end portion of the docking device delivery apparatus is increased to wrap around the chordae tendineae of the heart in a variable loop turn.

[0025] Figure 9 Another stage in an example docking device implant procedure is schematically illustrated in which a sleeve shaft of the docking device delivery apparatus is retracted in a proximal direction to withdraw a guard member of the docking device.

[0026] Figure 10 Another stage in an example docking device implant procedure is schematically illustrated in which the sleeve shaft is advanced in a distal direction to shorten the guard member.

[0027] Figure 11 Another stage in an example mitral valve replacement procedure is schematically illustrated in which the docking device delivery apparatus is uncoupled from the docking device.

[0028] Figure 12 Side view of a docking handle for a docking device delivery apparatus according to one example.

[0029] Figure 13 Perspective view of a docking handle of the docking device delivery apparatus of Figure 12

[0030] Perspective view of a docking handle of the docking device delivery apparatus of Figure 14 Figure 13 Perspective view of a docking handle of the docking device delivery apparatus of

[0031] Figure 15 Figure 13 Perspective view of a docking handle of the docking device delivery apparatus of ​​

[0032] Figure 16 FIG. 1 is a perspective view of a docking handle according to one example. Figure 13 FIG. 2 is a cross-sectional side view of the docking handle of FIG. 1.

[0033] Figures 17A to 17C FIG. 3 is a perspective view of the docking handle of FIG. 1 in a different configuration. Figure 13 FIG. 4 is a perspective view of the docking handle of FIG. 3.

[0034] Figure 18 FIG. 5 is a perspective view of a collet of a locking mechanism according to one example.

[0035] Figure 19A FIG. 6 is an end view of the collet of the locking mechanism of FIG. 5.

[0036] Figure 19B FIG. 7 is a perspective view of the collet of FIG. 6. Figure 19A FIG. 8 is a perspective view of the collet of FIG. 7.

[0037] Figure 20 FIG. 9 is a perspective view of a docking device for use with a delivery apparatus according to one example.

[0038] Figure 21 FIG. 10 is a perspective view of a shaft of the delivery apparatus of FIG. 9. Figure 12 FIG. 11 is a perspective view of the shaft of FIG. 10. DETAILED DESCRIPTION

[0039] General Considerations For purposes of this specification, certain aspects, advantages and novel features of the examples of the present disclosure are described herein. The disclosed methods, apparatus and systems should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with each other. The methods, apparatus and systems are not limited to any particular aspect or feature or combination of aspects and features, nor do the disclosed examples require the presence of any particular advantage or resolve any problem.

[0040] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenience only, it should be understood that this manner of description encompasses rearrangement, save to the specific language set forth below. For example, operations described sequentially can be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures can not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are readily recognizable by one of ordinary skill in the art.

[0041] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically connected, or linked and does not exclude the presence of intermediate elements between coupled or associated items in the absence of a specific contrary language.

[0042] As used herein, the term “proximal” refers to a location, orientation, or portion of a device that is closer to a user and further from an implant site. As used herein, the term “distal” refers to a location, orientation, or portion of a device that is further from a user and closer to an implant site. Thus, for example, proximal movement of a device is movement of the device away from an implant site and toward a user (e.g., out of a patient’s body), while distal movement of a device is movement of the device away from a user and toward an implant site (e.g., into a patient’s body). The terms “longitudinal” and “axial” refer to an axis that extends in the proximal and distal directions, unless otherwise specifically defined.

[0043] As used herein, “for example” means “for the purpose of example,” and “that is” means “that is.”.

[0044] Introduction to the disclosed technology 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), a tool, a medicament, or other therapy to a target implant site within the subject are disclosed herein. Related thereto, in some examples, the delivery devices described herein can include multiple shafts that are independently actuated relative to one another to improve positioning of a prosthetic medical device within a subject. Exemplary devices and / or methods are disclosed herein that, among other things, can more easily actuate (e.g., axially move) one or more components of a delivery device relative to one or more other components of the delivery device.

[0045] Examples of the disclosed technology Figures 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, a user first creates access to a patient’s native heart valve using a guide catheter 30 ( Figure 1 ). The user then delivers and implants the docking device 52 at the patient’s native heart valve using a delivery apparatus 50 ( Figure 2A ), and then removes the delivery apparatus 50 from the patient 10 after implanting the docking device 52 ( Figure 2BThe user then uses the prosthetic valve delivery device 60 to implant the prosthetic heart valve 62 into the implanted docking device 52. Figure 3A Subsequently, the user removed the prosthetic valve delivery device 60 from patient 10. Figure 3B ) and guiding catheter 30 ( Figure 4 ).

[0046] Figure 1 The procedure depicts stages of a mitral valve replacement surgery according to an example, wherein a guiding catheter 30 and a guidewire 40 are inserted into a vessel 12 of the patient 10 and guided through the vessel 12 into the heart 14 of the patient 10, toward the natural mitral valve 16. The guiding catheter 30 and guidewire 40 together provide a path for a delivery device 50 and a prosthetic valve delivery device 60 to be guided through and along the path to the implantation site (natural mitral valve 16 or natural mitral valve annulus). The heart 14 is schematically shown in the figure. For example, for illustrative purposes, the anterior leaflet and chordae tendineae of the autologous mitral valve 16 are omitted, so that only a portion of the posterior leaflet of the autologous mitral valve 16 is shown.

[0047] Initially, the user can first create an incision inside the patient to access the blood vessel 12. For example, in Figure 1 In the example shown, the user can make an incision in the patient's groin to access the femoral vein. Therefore, in such an example, vessel 12 can be the femoral vein.

[0048] After an incision is made at vessel 12, the user can insert a guiding catheter 30, guidewire 40, and / or additional devices (such as a guide device or transseptal puncture device) through the incision and into vessel 12. The guiding catheter 30 (which may also be referred to as a "guide device," "guide," or "guide sheath") is configured to facilitate the percutaneous introduction and passage of various implant delivery devices (such as delivery device 50 and prosthetic valve delivery device 60) through vessel 12 and can extend through vessel 12 into heart 14, but may stop before the natural mitral valve 16. The guiding catheter 30 may include a stem 32 and a shaft 34 (which may also be referred to as catheter shaft 34) extending distally from the stem 32. The shaft 34 can extend through vessel 12 into heart 14, while the stem 32 remains outside the patient 10 and can be manipulated by the user to control the shaft 34. Figure 1 ).

[0049] The guidewire 40 is configured to guide delivery devices (such as guide catheter 30, delivery device 50, prosthetic valve delivery device 60, other catheters, etc.) and their associated devices (such as docking devices, prosthetic heart valves, etc.) to the implantation site within the heart 14, and thus can 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.

[0050] In some cases, a transseptal puncture device or catheter can be used to initially access the left atrium 18 prior to insertion of the guidewire 40 and the guide catheter 30. For example, after making an incision into the blood vessel 12, the user can insert a 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 into the left atrium 18. The user can then insert and advance the guidewire 40 through the transseptal puncture device within 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 through the guidewire 40 into the left atrium 18. Figure 1 ).

[0051] In some cases, a guide wire 40 can be inserted through the lumen of the guide catheter 30 prior to insertion of the guide catheter 30 into the blood vessel 12. In some cases, the guide wire 40 can include a tapered end that extends out of the distal tip of the guide catheter 30 and is configured to guide the guide catheter 30 into the left atrium 18 via the guide wire 40. Additionally, in some cases, the guide wire 40 can include a proximal end portion that extends out of the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user can remove the guide wire 40 from the guide catheter 30 and inside of the patient 10. Thus, only the guide catheter 30 remains inside the patient 10. The guide catheter 30 is then in position to house an implant delivery apparatus and help guide it into the left atrium 18, as further described below.

[0052] Figure 2A Another stage in an example mitral valve replacement procedure is depicted, in which a docking device 52 is implanted at the native mitral valve 16 of the heart 14 of the patient 10 using a delivery apparatus 50 (which can also be referred to as an "implant catheter," a "docking delivery system," a "docking device delivery apparatus," and / or a "docking device delivery device").

[0053] Generally, the delivery apparatus 50 includes a delivery shaft 54 (which can also be referred to as a “docking delivery system shaft”), a handle 56 (which can 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 a patient’s vasculature (vessel 12) and to a implantation site (such as native mitral valve 16), and can be configured to hold the docking device 52 in a distal end portion 53 of the delivery shaft 54. In some examples, the distal end portion 53 of the delivery shaft 54 holds the docking device 52 therein in a straightened delivery configuration.

[0054] The handle 56 of the delivery apparatus 50 is configured to be grasped and / or otherwise held by a user outside of the patient 10 to advance the delivery shaft 54 through the patient’s vasculature (such as vessel 12).

[0055] In some examples, the handle 56 can include one or more articulating members 57 (or rotatable knobs) configured to facilitate steering of the delivery shaft 54 through the vessel 12. For example, the one or more articulating members 57 can include one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to flex, bend, twist, turn, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 to facilitate steering of the delivery shaft 54 through the vessel 12 and within the heart 14.

[0056] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at the implantation site (such as the native mitral valve 16). For example, the pusher assembly 58 is 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. A 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 disposed adjacent to the docking device 52 within the delivery shaft 54. In some examples, the docking device 52 can be releasably coupled to the shaft of the pusher assembly 58 via a connection mechanism of the delivery apparatus 50 such that the docking device 52 can be released after being deployed at the native mitral valve 16.

[0057] Additional details of docking device delivery apparatuses and variations thereof are described in International Publication Nos. WO 2020 / 247907 and WO 2023 / 205076 and International Application No. PCT / US2023 / 033745, which are incorporated herein by reference in their entireties.

[0058] Referring again to Figure 2AAfter positioning the guide catheter 30 within the left atrium 18, the user can insert the delivery device 50 (e.g., the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 of the delivery device 50 through the guide catheter 30 and through the guide wire 40. In some examples, the guide wire 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 guide wire 40 through the vasculature 12 until the delivery shaft 54 reaches the left atrium 18, as shown in FIG. 18. In particular, the 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 exerting a force thereon (e.g., by pushing the handle). As the delivery shaft 54 is advanced through the vasculature 12 and the heart 14, the user can adjust one or more articulating members 57 of the handle 56 to navigate various turns, corners, constrictions, and / or other obstacles in the vasculature 12 and the heart 14. Figure 2A

[0059] 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., the articulating members 57) to position the distal end portion 53 of the delivery shaft 54 at and / or near the posterior-medial commissure of the native mitral valve 16. In some examples, the user can use the procedures described below in connection with FIGS. 20-22 to fine-tune the positioning of the distal end portion 53 of the delivery shaft 54. After positioning the delivery shaft 54, the user can then use the shaft of the pusher assembly 58 to push the docking device 52 out of the distal end 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. Figures 5 to 11

[0060] In some examples, the docking device 52 can be composed of, formed from, and / or include a shape memory material, and thus, when it exits the delivery shaft 54 and is no longer constrained by the delivery shaft 54, can return to its initial, pre-shaped shape. As one example, the docking device 52 can be initially shaped as a coil, and thus, when it exits the delivery shaft 54 and returns to its initial coiled configuration, can wrap around the leaflets 24 of the native mitral valve 16.

[0061] After pushing the ventricular portion of the docking device 52 (e.g., the portion of the docking device 52 that is configured to be positioned within the left ventricle 26 and / or the ventricular side of the native mitral valve 16), as shown in FIG. 20, the user can then deploy the remaining portion of the docking device 52 (e.g., the atrial portion of the docking device 52) from the delivery shaft 54 within the left atrium 18 by retracting the delivery shaft 54 away from the posterior-medial commissure of the native mitral valve 16. Figure 2A

[0062] ​​​After the docking device 52 is deployed and implanted 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 so that the user can deliver and implant the prosthetic heart valve 62 within the implanted docking device 52 at the native mitral valve 16.

[0063] Figure 2B This stage in the mitral valve replacement procedure is shown, where 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 so 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 apparatus 60 through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.

[0064] As shown in Figure 2B , the docking device 52 can include a plurality of turns (or coils) wrapped around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has a more cylindrical shape than the annulus of the native mitral valve 16, thereby providing a geometry that more closely matches the shape or profile of the prosthetic heart valve to be implanted. Thus, the docking device 52 can provide a tighter fit between the prosthetic heart valve and the native mitral valve 16, and thus a better seal, as further described below.

[0065] Figure 3A Another stage in the mitral valve replacement procedure is depicted, where the user delivers and / or implants the prosthetic heart valve 62 (which can also be referred to herein as a "transcatheter heart valve" or simply a "THV," a "replacement heart valve," and / or a "prosthetic mitral valve") within the docking device 52 using the prosthetic valve delivery apparatus 60.

[0066] As shown in Figure 3A , the prosthetic valve delivery apparatus 60 can include a delivery shaft 64 and a handle 66, the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into the patient's vasculature to deliver, implant, expand the prosthetic heart valve, and / or otherwise deploy the prosthetic heart valve 62 within the docking device 52 at the native mitral valve 16. The handle 66 is configured to be grasped and / or otherwise held by the user to advance the delivery shaft 64 through the patient's vasculature.

[0067] In some examples, the handle 66 can include one or more articulation members 68 configured to facilitate steering the delivery shaft 64 through the blood vessel 12 and the heart 14. In particular, the articulation members 68 can include one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to cause the distal portion of the delivery shaft 64 to flex, bend, twist, turn, and / or otherwise articulate to facilitate steering the delivery shaft 64 through the blood vessel 12 and into the left atrium 18 and left ventricle 26 of the heart 14.

[0068] In some examples, the prosthetic valve delivery apparatus 60 can include an expansion mechanism 65 configured to radially expand and deploy the prosthetic heart valve 62 at the implant site. In some cases, 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 the distal portion of the delivery shaft 64. Figure 3A

[0069] In other examples, the prosthetic heart valve 62 can be self-expanding and can be configured to radially expand on its own when a sheath or capsule that is removably covering the radially compressed prosthetic heart valve 62 over the distal portion of the delivery shaft 64 is removed. 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 configured to cause the prosthetic heart valve 62 to radially expand (e.g., an expansion mechanism).

[0070] As shown, the prosthetic heart valve 62 is mounted in a radially compressed configuration around the expansion mechanism 65 (inflatable balloon) over the distal portion of the delivery shaft 64. Figure 3A

[0071] To guide the distal portion of the delivery shaft 64 to the implant site, the user can insert the prosthetic valve delivery apparatus 60 (delivery shaft 64) into the patient 10 through the guide catheter 30 and through the guide wire 40. The user can continue to advance the prosthetic valve delivery apparatus 60 (through the blood vessel 12) along the guide wire 40 until the distal portion of the delivery shaft 64 reaches the native mitral valve 16, as shown. More particularly, the user can advance the delivery shaft 64 of the prosthetic valve delivery apparatus 60 by grasping the handle 66 and exerting a force thereon (e.g., by pushing the handle). As the delivery shaft 64 is advanced through the blood vessel 12 and the heart 14, the user can adjust one or more articulation members 68 of the handle 66 to navigate various turns, corners, constrictions, and / or other obstacles in the blood vessel 12 and the heart 14. Figure 3A

[0072] ​​​The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted about the distal end portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some examples, as shown in Figure 3A the distal end of the delivery shaft 64 and at least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.

[0073] Once the radially compressed prosthetic heart valve 62 is properly positioned within the docking device 52 (as shown in Figure 3A ), the user can manipulate one or more actuation mechanisms of the handle 66 of the prosthetic valve delivery apparatus 60 to actuate the expansion mechanism 65 (e.g., by inflating the inflatable balloon), thereby causing the prosthetic heart valve 62 to radially expand within the docking device 52.

[0074] Figure 3B Another stage in the mitral valve replacement procedure is shown, in which the prosthetic heart valve 62 is in its radially expanded configuration and implanted within the docking device 52 in the native mitral valve 16. As shown in Figure 3B the prosthetic heart valve 62 is received and held within the docking device 52. Thus, the docking device 52 helps to 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.

[0075] Also shown in Figure 3B 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, such that only the guidewire 40 and the guide catheter 30 remain within the patient 10.

[0076] Figure 4 Another stage in the mitral valve replacement procedure is depicted, in which the guidewire 40 and the guide catheter 30 have been removed from the patient 10.

[0077] Although Figures 1-4 a mitral valve replacement procedure is specifically depicted, it should be appreciated that the same and / or similar procedures can be used to replace other heart valves (such as the tricuspid valve, the pulmonary valve, and / or the aortic valve). Moreover, the same and / or similar delivery apparatuses (such as the delivery apparatus 50, the prosthetic valve delivery apparatus 60, the guide catheter 30, and / or the guidewire 40), docking devices (such as the docking device 52), replacement heart valves (such as the prosthetic heart valve 62), and / or components thereof can be used to replace these other heart valves.

[0078] For example, when replacing a natural tricuspid valve, the user can also access the right atrium 20 via the femoral vein, but it is not necessary to cross the interatrial septum 22 to access the left atrium 18. Instead, the user can 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 can push the docking device 52 out of the delivery shaft 54 ​​around the ventricular side of the tricuspid valve leaflet, 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 can 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 can advance the delivery shaft 64 of the prosthetic valve delivery device 60 along the guidewire 40 through the patient's vascular system until the prosthetic heart valve 62 is positioned / placed within the docking device 52 and the tricuspid valve. The user can then dilate the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery device 60 from the patient 10. In another instance, the user can perform the same and / or similar procedure to replace the aortic valve, but access to the aortic valve can be via the femoral artery from the outflow side of the aortic valve.

[0079] Furthermore, despite Figures 1-4 A mitral valve replacement procedure is described, with the patient's own mitral valve 16 accessed from the left atrium 18 via the right atrium 20 and the femoral vein. However, it should be understood that the own mitral valve 16 can alternatively access the patient's own mitral valve from the left ventricle 26. For example, the patient can access the natural mitral valve 16 from the left ventricle 26 via the aortic valve by advancing one or more delivery devices through an artery to the aortic valve and then through the aortic valve to the left ventricle 26.

[0080] Figures 5-11 The illustration schematically depicts a surgical procedure for implanting a prosthetic medical device at a target implantation site in a subject (e.g., patient 10). In some instances, the procedure is a docking device implantation procedure for implanting a docking device 152 at the annulus of the natural mitral valve 16 in patient 10. In some instances, Figures 1-4 docking device 52 and Figures 5-11 An exemplary difference between docking devices 152 may be that docking device 152 optionally includes a protective member 180 coupled to docking device 152, wherein the protective member 180 may be configured to further mitigate the possibility of paravalvular leakage between the annulus of the natural mitral valve 16 and a prosthetic heart valve (such as prosthetic heart valve 62) located in docking device 152.

[0081] Figures 5 to 11The surgery can be performed using delivery device 150 (which may also be referred to as a "docking device delivery device"). In some instances, delivery device 150 can be used as docking device delivery device 50 in prosthetic valve implantation surgery, as referenced above. Figures 1 to 4 As described. The delivery device 150 may include three independently actuated axes: a delivery shaft 154 (which may also be referred to as the "docking delivery system shaft"), a sleeve shaft 182, and a pusher shaft 184 (which may also be referred to as the "docking shaft"). Figure 12 The actuator shaft 184 can be housed within the sleeve shaft 182, which in turn can be housed within the delivery shaft 154. In some instances, the delivery shaft 154, sleeve shaft 182, and actuator shaft 184 can be coaxial. During docking device implantation surgery, the delivery shaft 154, sleeve shaft 182, and actuator shaft 184 can be actuated independently of each other in the axial direction to better position the docking device 152 within the annulus of the natural mitral valve 16, so that the implanted docking device 152 can better surround one or more chordae tendineae 27 of the heart 14 and provide a better seal between the implantation site and the prosthetic heart valve (such as prosthetic heart valve 62).

[0082] During the procedure, the user of delivery device 150 first uses guide catheter 30 ( Figure 5 This creates a pathway to the patient's natural heart valve. The user then advances the distal portion of the delivery device 150 to advance the docking device 152 to the target implantation site. Figures 6-7 In some surgical cases, the user can actuate the delivery system to change or adjust the curvature of the distal portion of the delivery device 150 (see, for example...). Figures 7 to 8 The forward bend 187 of the delivery device 150. This adjustable radius of curvature may be referred to as a “variable surrounding bend” (VET). For example, by retracting the pusher shaft 184 proximally relative to the sleeve shaft 182, the VET makes it easier to surround one or more chordae tendineae 27 that connect the leaflet 24 to the papillary muscle 28 of the heart 14.

[0083] In some instances where the docking device 152 further includes a protective member 180, the user can then retract the delivery shaft 154 and the sleeve shaft 182 in a proximal direction to expose the protective member 180 from the sleeve shaft 182. Figure 9 In some instances, the user can then advance the sleeve shaft 182 in the distal direction to apply an axial compressive force to the protective member 180, thereby axially shortening and radially expanding the protective member 180. Figure 10 Finally, the user can decouple the docking device 152 from the actuator shaft 184 and remove the delivery device 150 from the patient 10. Figure 11 ).

[0084] Figure 5 A stage in a procedure is shown in which a guide catheter 30 is advanced in a distal direction through a patient's vasculature and into the left atrium 18 of the heart 14. The guide catheter 30 includes a catheter shaft 34 that includes a distal end 72 of the catheter shaft 34, a flex region 74, and a lumen exit 76 on the distal end 72. The lumen exit 76 is connected to a catheter shaft lumen disposed within the catheter shaft 34. A delivery device, such as any of the prosthetic device delivery devices or implant catheters described herein, is configured to be disposed within the catheter shaft lumen. The catheter shaft lumen extends from a proximal end portion of the catheter shaft 34, such as a portion of the catheter shaft 34 coupled to the handle 32, to the lumen exit 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.

[0085] In some examples, the catheter shaft 34 can include one or more pull wires for adjusting a curvature of the flex region 74 of the catheter shaft 34. In some examples, the pull wires can extend through a lumen coupled to the lumen exit 76 and can 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 can extend through one or more pull wire lumens embedded in the catheter shaft 34. In some examples, adjusting a tension of the pull wires can adjust the curvature of the flex region 74 of the catheter shaft 34. In some cases, the catheter shaft 34, including the flex region 74 thereof, can be integrally formed as a single unitary component. In some cases, the catheter shaft 34 can include one or more segments (e.g., the flex region 74, other regions, etc.) that are formed as separate components that are coupled together, such as via fasteners, adhesives, mating features, and / or other coupling means. In some examples, the flex region 74 can include a material (e.g., a polymer having a relatively low durometer hardness) that is more easily flexed, bent, twisted, etc. than the rest of the catheter shaft 34. This can enable the curvature of the flex region 74 to adjust or increase at a different rate than the rest of the catheter shaft 34 when the pull wires are tensioned. For example, the curvature of the flex region 74 can change at a different rate relative to the proximal portion of the catheter shaft 34 as the tension of the pull wires increases. The catheter shaft 34 can also include one or more reinforcing braids or jackets 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 maneuvered.

[0086] During this stage, the docking device 152 is disposed within the sleeve shaft 182, which in turn is disposed within the delivery shaft 154, which in turn is disposed within the catheter shaft 34. The pusher shaft 184 is disposed proximally adjacent 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 be flexible or curved) so as to maintain a low profile when moving through the patient's vasculature.

[0087] 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 lumenal outlet 76 of the catheter shaft 34, through the left atrium 18, and to the native mitral valve 16. The docking device 152 is disposed within a sleeve shaft lumen of the sleeve shaft 182, which in turn is disposed within a delivery shaft lumen of the delivery shaft 154. The pusher shaft 184 is disposed proximally adjacent the docking device 152 within the sleeve shaft 182.

[0088] The delivery shaft 154, which in some examples can be similar to the delivery shaft 54, includes a delivery shaft lumen through which the sleeve shaft 182 and pusher shaft 184 can extend. The delivery shaft lumen is configured to extend in an axial direction along a length of the delivery shaft 154 between a handle of the delivery device 150 and a distal portion 153 of the delivery shaft 154. The sleeve shaft 182 and pusher shaft 184 are configured to exit the delivery shaft lumen through an opening at the distal portion 153.

[0089] The sleeve shaft 182 is configured to extend through the delivery shaft 154 and sheath the docking device 152 and at least a portion of the pusher shaft 184 as 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 a length of the sleeve shaft 182 between a handle of the delivery device 150 and a distal portion 186 of the sleeve shaft 182. In some examples, a portion of the sleeve shaft 182 (e.g., a proximal end portion) can have a substantially U-shaped axial cross-section or other shape that allows a proximal end portion of the pusher shaft 184 to exit the sleeve shaft 182 at a location distal from a proximal end of the sleeve shaft 182. A distal end portion of the pusher shaft 184 can exit the sleeve shaft 182 at an opening at the distal portion 186 of the sleeve shaft 182.

[0090] The distal end portion 186 of the sleeve shaft 182 is configured to capture autologous tissue (e.g., autologous leaflets 24 and chords 27). The sleeve shaft 182 can have a relatively low-friction and / or lubricious outer surface to reduce the likelihood of the sleeve shaft 182 catching on native tissue.

[0091] In some examples, the sleeve shaft 182 can include multiple layers. For example, the sleeve shaft 182 can include an innermost polymer layer, a woven or other type of flexible reinforcement layer, and an outermost polymer layer. In some examples, the reinforcement layer is a shape-storing material and / or an elastic material (e.g., Nitinol and / or stainless steel).

[0092] 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 of a material that is relatively more flexible than the docking device 152 and pushing the curved docking device 152 into the sleeve shaft 182, which can cause the sleeve shaft 182 to assume a curved configuration and / or cause the curvature of the sleeve shaft 182 to be altered by the docking device 152.

[0093] In this manner, the distal portion 186 of the sleeve shaft 182 can form a sleeve shaft forward bend 187 that is configured to capture chordae tendinae 27 as the sleeve shaft 182 is advanced around the leaflets 24 of the native mitral valve 16. The sleeve shaft forward bend 187 is the 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 bend 187, the radius of curvature of the sleeve shaft forward bend 187 is equal to the first radius of curvature (R1). r 1 As discussed later in this application, and with particular reference to Figures 7-8 , the radius of curvature of the sleeve shaft forward bend 187 can be varied by relative movement between the sleeve shaft 182 and the docking device 152. In some examples in which the sleeve shaft 182 can be composed of, formed from, and / or include a shape memory material, the sleeve shaft 182 can initially be formed such that the sleeve shaft forward bend 187 has a first radius of curvature (R1). r 1 The sleeve shaft forward bend 187 can be forced into another configuration having another radius of curvature (e.g., a second radius of curvature (R2)), but can return to its initial configuration having the first radius of curvature (R1) when the force is removed. In some examples, the second radius of curvature (R2) can be smaller than the first radius of curvature (R1). r 2 r 1 In some examples, the second radius of curvature (R2) can be smaller than the first radius of curvature (R1). r 2 r 1

[0094] ​​​In some examples, the sleeve shaft forward bend 187 can conform to the shape or curvature of another component (such as the docking device 152) that is sheathed by the sleeve shaft forward bend 187, such that the radius of curvature of the sleeve shaft forward bend 187 is equal to the corresponding radius of curvature of the other component. Thus, when the distal end portion of the docking device 152 (such as the forward bend 189) is disposed at or near the distal end portion 186 of the sleeve shaft 182, the distal end portion 186 of the sleeve shaft 182 can have a smaller radius of curvature. This is because the docking device 152 can have a smaller radius of curvature, and can be relatively more rigid than the sleeve shaft 182. In some examples, the radius of curvature of the distal end portion 186 of the sleeve shaft 182 can be increased by moving the distal end of the docking device 152 proximally relative to the distal end portion 186 of the sleeve shaft 182, such that the sleeve shaft 182 can assume its pre-set configuration. This can be accomplished by moving the docking device 152 proximally while holding the position of the sleeve shaft 182, by moving the sleeve shaft 182 distally relative to the docking device 152, or a combination of both.

[0095] 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 disposed proximally adjacent to the docking device 152 within the sleeve shaft 182 as the docking device 152 is guided through the patient’s vasculature to the native mitral valve 16. As the pusher shaft 184 is moved 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 apparatus 150, such that the docking device 152 can be released after being deployed at the native mitral valve 16.

[0096] In some examples, during this stage, the distal end portion 153 of the delivery shaft 154 can be positioned between the leaflets 24 of the native mitral valve 16 (such as at or near the posteromedial commissure). In some examples, the distal end portion 153 of the delivery shaft 154 can extend distally past the native mitral valve 16 and be positioned in the left ventricle 26 near the native mitral valve 16. In some examples, the distal end portion 153 of the delivery shaft 154 can be positioned adjacent to the native mitral valve 16 in the left atrium 18.

[0097] Once the distal end portion 153 of the delivery shaft 154 is positioned, the docking device 152, the sleeve shaft 182, and the pusher shaft 184 are advanced in a distal direction away from the opening at the distal end portion 153 of the delivery shaft 154, through the native mitral valve 16, and into the left ventricle 26.

[0098] Figure 7The diagram illustrates stages during surgery, where the docking device 152 (located within the sleeve shaft 182), the sleeve shaft 182, and the pusher shaft 184 (located within the sleeve shaft 182 and proximal to the docking device 152) wrap around or surround the leaflet 24 on the ventricular side of the natural mitral valve 16. When the docking device 152 leaves the delivery shaft 154, it assumes a coiled configuration configured to wrap around or surround the leaflet 24 on the ventricular side of the natural mitral valve 16. In some instances where the docking device 152 may be constructed of, formed of, and / or contain 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 enclosed by the delivery shaft 154, it can assume its initial coiled configuration.

[0099] As previously described, the portion of the sleeve shaft 182 that covers the docking device 152 can conform to or represent the shape and / or curvature of the corresponding portion of the docking device 152. For example, the forward bend 187 of the sleeve shaft 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 forward turning portion 187 of the sleeve shaft can have a second radius of curvature ( r 2 The configuration of ). In other words, the variable surrounding turning part can be equal to the second radius of curvature ( r 2 ).

[0100] Figure 8 The optional stages of the procedure are shown, wherein the radius of curvature of the forward bend 187 of the sleeve shaft (in other words, the variable surrounding bend) is changed from the second radius of curvature ( r 2 Increase to the first radius of curvature ( r 1 This is to better capture the tendineae 27 within the forward bend 189 of the docking device. In some instances, the radius of curvature of the forward bend 187 of the sleeve shaft can be increased by retracting the pusher shaft 184 relative to the sleeve shaft 182 in the proximal direction, so that the forward bend 189 of the docking device and / or the docking device 152 are no longer enclosed by the forward bend 187 of the sleeve shaft. In some instances, the radius of curvature of the forward bend 187 of the sleeve shaft can be increased by advancing the distal portion 186 of the sleeve shaft 182 relative to the docking device 152 in the distal direction. When the forward bend 187 of the sleeve shaft is no longer forced to conform to a second radius of curvature ( r 2When the curvature of the forward turning part 189 of the docking device is adjusted, the forward turning part 187 of the sleeve shaft can be restored to a curvature greater than the second radius of curvature. r 2 The first radius of curvature of ) r 1 The initial configuration of ). Since the tendineae 27 are trapped within the forward bend 187 of the sleeve shaft, the variable surrounding bend is increased to a larger first radius of curvature ( r 1 This advantageously allows for the capture of a greater portion of the tendineae 27 by the forward bend of the sleeve shaft 187 as it advances around the leaflet 24.

[0101] exist Figure 8 During the illustrated steps, delivery shaft 154 may remain stationary to maintain the position of its distal portion 153 relative to the natural mitral valve 16 (e.g., at or near the posteromedial commissure). In some instances, sleeve shaft 182 may remain stationary to maintain its circumferential position and / or radial orientation relative to the natural mitral valve 16. In some instances, during this step, docking device 152 and / or actuator shaft 184 may remain stationary while sleeve shaft 182 moves. In some instances, neither sleeve shaft nor actuator shaft 184 remains stationary during this step.

[0102] like Figure 8 As shown, the variable spiral bend can be adjusted after the sleeve shaft 182 has formed a single spiral bend around the leaflet 24. However, in some instances, the variable spiral bend can be adjusted after the sleeve shaft 182 has formed multiple spiral bends around the leaflet 24. In some instances, the variable spiral bend can be adjusted before any spiral bend has been formed around the leaflet 24.

[0103] Figure 9 An optional stage of the procedure is shown, in which the delivery shaft 154 and the sleeve shaft 182 retract in the proximal direction to withdraw the protective member 180. The docking device 152 includes a coil 188 defining a central region 190, which includes a plurality of helical turns wound around the leaflet 24 and a docking device forward turn 189 extending from the distal portion of the central region 190.

[0104] The docking device 152 may further include a protective member 180 disposed on the docking device 152 such that when the docking device 152 is implanted at the natural mitral valve 16, the protective member 180 is positioned at or near the natural mitral valve 16 (e.g., at or near the posteromedial commissure). In some instances, the protective member 180 may be disposed proximally adjacent to the central region (FIG. 22), wherein the central region may include multiple helical bends when the docking device 152 is wound around the leaflet 24. The protective member 180 may extend between a distal portion 191 fixedly coupled to the docking device 152 and a movable proximal portion 193, the movable proximal portion being movable in the axial direction along at least a portion of the docking device 152. In some instances, the distal portion 191 of the protective member 180 may be adjacent to the central region 190.

[0105] exist Figures 5-8 During the implantation phase of the docking device surgery, the protective member 180 can be covered by the delivery shaft 154 and the sleeve shaft 182. However, in Figure 9 During the phase shown, relative movement between the delivery shaft 154, the sleeve shaft 182, and the actuator shaft 184 can withdraw the protective member 180. In some instances, the sleeve shaft 182 can retract proximally from the left ventricle 26, through the mitral valve 16, and into the left atrium 18, such that the distal portion 186 of the sleeve shaft 182 is closer to the user proximally than the proximal portion 193 of the protective member 180. In some instances, the distal portion 186 of the sleeve shaft 182 can be positioned distally relative to the lumen outlet 76. In some instances, the protective member 180 can be withdrawn by distally advancing the actuator shaft 184 relative to the sleeve shaft 182.

[0106] In some instances, the delivery shaft 154 can retract proximally through the left atrium 18, such that the distal portion 153 of the delivery shaft 154 is closer to the user proximally than the proximal portion 193 of the protective member 180. In some instances, the delivery shaft 154 can retract through the lumen outlet 76 and enter the lumen of the catheter shaft 34. In some instances, the actuator shaft 184 can be advanced distally relative to the delivery shaft 154, such that the distal portion 153 of the delivery shaft 154 is positioned proximally relative to the protective member 180.

[0107] Figure 10An optional "setting" stage in the procedure is shown, in which the sleeve shaft 182 is advanced distally relative to the docking device 152 to axially shorten and radially expand the guard member 180. In some examples, the sleeve shaft 182 can be advanced in the distal direction such that the distal end portion 186 of the sleeve shaft 182 abuts and contacts the proximal end portion 193 of the guard member 180. In some examples, the pusher shaft 184 (and the docking device 152 coupled to the pusher shaft 184) can be retracted in the proximal direction such that the distal end portion 186 of the sleeve shaft 182 abuts and contacts the proximal end portion 193 of the guard member 180. The sleeve shaft 182 applies a force to the guard member 180 to advance the proximal end portion 193 of the guard member 180 distally relative to the docking device 152. Since the distal end portion 191 of the guard member 180 is fixedly coupled to the docking device 152, applying a force to the guard member 180 causes the guard member 180 to axially shorten and radially expand to a deployed configuration. When in the deployed configuration, the guard member 180 further reduces the likelihood of paravalvular leakage between the native mitral valve 16 and a prosthetic heart valve, such as the prosthetic heart valve 62. As the sleeve shaft 182 is retracted from the proximal end of the guard member 180, the frictional engagement between the proximal end of the guard member 180 and the docking device 152 can maintain the position of the guard member 180 relative to the docking device 152.

[0108] Figure 11 A stage in the procedure is shown in which the delivery apparatus 150, including the delivery shaft 154 and the sleeve shaft 182, is retracted through the catheter shaft lumen of the catheter shaft 34. In some 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 apparatus 150.

[0109] Figure 12 A delivery apparatus 150 according to one example is shown. The delivery apparatus 150 can also be referred to as a "docking delivery apparatus," a "docking delivery catheter," or a "docking delivery system." The delivery apparatus 150 includes a delivery shaft 154, a handle 156 (which can also be referred to as a "docking delivery system handle") coupled to a proximal end portion of the delivery shaft 154, a sleeve shaft 182 configured to extend through the delivery shaft 154 and the handle 156, a hub assembly 200 (which can also be referred to as a "docking handle") coupled to a proximal end portion of the sleeve shaft 182, a pusher shaft 184 configured to extend through the handle 156 and the sleeve shaft 182, and a sleeve handle 196 coupled to a proximal end portion of the sleeve shaft 182.

[0110] Delivery shaft 154 can in some instances be similar to delivery shaft 54, configured to be advanced by a user through a patient's vasculature (vessel 12) and to an implant site (e.g., native mitral valve 16), and can be configured to hold docking device 152 in a distal end portion 153 of delivery shaft 154. During a docking device implant procedure, delivery shaft 154 is advanced through catheter shaft 34 of guide catheter 30 (e.g., through a central lumen thereof, etc.) and to the target implant site.

[0111] Handle 156 can in some instances be similar to handle 56, configured to be grasped and / or otherwise held by a user outside of patient 10 to advance delivery shaft 154 through a patient's vasculature (e.g., vessel 12). In some instances, handle 156 can include one or more articulation members 157 (such as rotatable knobs) configured to help navigate delivery shaft 154 through vessel 12 by manipulating or controlling the bending of delivery apparatus 150 (e.g., delivery shaft 154, etc.). Some instances of articulation members 157 can be similar to articulation members 57. Handle 156 includes a handle lumen (not shown in the figures) extending through a length of handle 156, where the handle lumen is configured to receive sleeve shaft 182 and pusher shaft 184. Since sleeve shaft 182 and pusher shaft 184 extending through the handle lumen also extend through delivery shaft 154, the handle lumen is coaxially aligned with delivery shaft 154. In some instances, handle 156 can further include a locking assembly 198 configured to lock a device (e.g., sleeve shaft 182) inserted through the handle lumen such that selective prevention of movement of the device relative to delivery apparatus 150. In some instances, locking assembly 198 can be disposed on a proximal end portion of handle 156.

[0112] Sleeve handle 196 is configured to be grasped and / or otherwise held by a user outside of patient 10 to advance sleeve shaft 182 through a patient's vasculature. Sleeve handle 196 is coupled to a proximal end portion of sleeve shaft 182 and disposed proximally of handle 156 and hub assembly 200. The axial position of sleeve shaft 182 can be controlled by moving sleeve handle 196 in an axial direction relative to handle 156 and / or hub assembly 200.

[0113] Hub assembly 200 is configured to be grasped and / or otherwise held by a user outside of patient 10 to advance pusher shaft 184 through a patient's vasculature. A proximal end portion of pusher shaft 184 is coupled to and can extend at least partially into hub assembly 200. Hub assembly 200 is axially disposed between handle 156 and sleeve handle 196. In some instances, the axial position of pusher shaft 184 can be controlled by moving the entire hub assembly 200 in an axial direction relative to handle 156 and / or sleeve handle 196.

[0114] Further details regarding delivery devices / catheters / systems (including various examples of stem assemblies) configured to deliver docking devices to target implantation sites can be found in PCT Publications WO 2020 / 247907 and WO 2022 / 072509 and U.S. Patents 10,940,000 and 11,065,111, all of which are incorporated herein by reference in their entirety.

[0115] The user of the docking device delivery equipment 150 can perform a variable around turn by moving the pusher shaft 184 relative to the delivery shaft 154 and the sleeve shaft 182 in the axial direction. Figures 7 to 8 Since the delivery shaft 154 is connected to the handle 156, the pusher shaft 184 is connected to the hub assembly 200, and the sleeve shaft 182 is connected to the sleeve handle 196, the variable surround turning can be performed by moving the entire hub assembly 200 in the distal direction relative to the sleeve handle 196 while the handle 156 and the sleeve handle 196 remain stationary.

[0116] The hub assembly 200 of this disclosure can be configured to propel the actuator shaft 184 through the patient's vascular system without requiring movement of the hub assembly 200 relative to the sleeve shaft 182. As described in more detail below, the hub assembly 200 may include a linear actuator 202 configured to perform variable-around-turning if necessary, propel the actuator shaft 184 relative to the hub assembly 200 (and relative to the sleeve shaft 182). Figures 7 to 8 The linear actuator 202 allows users to finely adjust the relative positions of the actuator shaft (and thus the coil) and the sleeve shaft.

[0117] The hub assembly 200 includes an outer housing 204, and the linear actuator 202 may be at least partially housed within the housing 204. For example, as described... Figures 13 to 16 As shown, the linear actuator 202 may include a hinge member 206 (e.g., a rotatable knob) coupled to a housing 204 and a slider 208 (e.g., a lead screw) disposed within the housing 204. The knob 206 is operatively coupled to the slider 208 such that actuation of the knob 206 (e.g., rotation relative to the housing 204) causes the slider 208 to translate relative to the housing 204. For example, the knob 206 may have a threaded inner surface 210, and the slider 208 may have a threaded outer surface 212 operatively coupled to the threaded inner surface 210 (e.g., a threaded connection). Thus, actuation (e.g., rotation) of the knob 206 can drive linear movement of the slider 208 via the threaded connection between surfaces 210, 212.

[0118] As described above, the sleeve shaft 182 extends through the hub assembly 200 to the sleeve handle 196. In particular, the sleeve shaft 182 extends through the hub assembly lumen 214, which extends through the length of the hub assembly 200 Figure 16 . The sleeve shaft 182 extends proximally from the hub assembly 200, and the sleeve handle 196 is positioned at the proximal end of the sleeve handle 196. The sleeve shaft 182 is configured to move (e.g., translate) within the hub assembly lumen 214 relative to the housing 204, for example, by moving the sleeve handle 196 relative to the hub assembly 200.

[0119] The pusher shaft 184 is at least partially disposed within the sleeve shaft 182 and partially extends into the hub assembly 200. The pusher shaft 184 is configured to move (e.g., translate) within the sleeve shaft 182 relative to the hub assembly housing 204 and / or relative to the sleeve shaft 182. The pusher shaft 184 is coupled to the slider 208 such that the pusher shaft 184 and the slider 208 are configured to axially translate together. In this way, operation of the linear actuator 202 causes the pusher shaft 184 to move (e.g., translate) relative to the hub assembly 200.

[0120] As described above, the pusher shaft 184 exits the sleeve shaft 182 at a location distal from the proximal end of the sleeve shaft 182 (e.g., the proximal end of the sleeve handle 196). For example, as shown in Figure 21 , the proximal end portion of the sleeve shaft 182 can have a partial annular (e.g., substantially U-shaped or C-shaped, etc.) axial cross-section that allows the proximal segment 185 of the pusher shaft 184 to angularly exit the sleeve shaft 182 relative to the sleeve shaft 182 (e.g., distal from a branch of the sleeve shaft 182). The hub assembly 200 can be adapted and configured to allow the proximal segment 185 of the pusher shaft 184 to terminate within the interior region of the housing 204 (e.g., at the end of the slider 208), while the proximal portion of the sleeve shaft 182 extends to the sleeve handle 196, which is disposed proximally and externally of the housing 204. With this configuration, a medical professional can perform deployment of the docking device (e.g., the docking device 152 of Figure 20 ) by manipulating the position of the hub assembly 200 (e.g., moving the hub assembly 200 in the axial direction) and / or the slider 208 (e.g., rotating the knob 206 relative to the housing 204), and also perform retraction of the sleeve shaft 182 from and away from the implanted docking device by pulling back the sleeve handle 196 in the axial direction.

[0121] In this manner, the sleeve shaft 182 and the pusher shaft 184 can be configured to work together such that they can be moved together at the same time (e.g., by moving the entire hub assembly 200 forward and / or backward in the axial direction) when deploying and positioning the docking device at the native valve, but can also be moved independently, for example, to fine-tune the positioning of the docking device at the native valve (e.g., by performing a VET as described above in connection with Figures 7 to 8 the sleeve shaft 182 from the docking device while the pusher shaft 184 holds the docking device in place (e.g., by holding the hub assembly 200 in place relative to the delivery shaft 154 of the delivery device 150 and / or other portions of the delivery device 150 and / or the docking device while pulling the sleeve handle 196 proximally to withdraw the sleeve shaft 182).

[0122] As shown in Figure 21 the proximal portion 197 of the sleeve shaft 182 can define an open channel. For example, the channel of the sleeve shaft 182 is open in the radial direction such that the proximal segment 185 of the pusher shaft 184 can extend out of the open channel and angularly away from the sleeve shaft 182 relative to the longitudinal axis of the sleeve shaft 182. In some examples, the proximal portion 197 of the sleeve shaft 182 can also be referred to herein as an “open channel.” The open channel 197 can have a generally U-shaped or C-shaped cross-section. In some examples, as depicted, the open channel 197 has a curved outer surface such that the open channel 197 has a partially annular cross-section (e.g., a C-shaped cross-section). In particular, the open channel 197 can be partially annular with a concave, inward-facing surface and a convex, outward-facing surface. In this manner, the concave, inward-facing surface of the open channel 197 can form a void space in which the pusher shaft 184 can be at least partially disposed Figure 21 In various examples, the open channel 197 can be laser cut, but any other means for forming an open channel can be used (e.g., removing portions of a tubular structure).

[0123] The distal segment of the sleeve shaft 182 can include a closed channel or lumen such that the channel is closed in the radial direction (e.g., an annular cross-section) (see Figure 12The pusher shaft 184 can extend through a closed passage of the sleeve shaft 182. For example, the pusher shaft 184 can be coaxial with the sleeve shaft 182 along some or most of the delivery device 150, e.g., through the closed passage of the sleeve shaft 182. An open passage 197 can extend, for example, from an intermediate axial position of the sleeve shaft 182 to a proximal end of the sleeve shaft 182, e.g., to the sleeve handle 196. In other examples, the open passage 197 of the sleeve shaft 182 can extend proximally from the intermediate axial position without extending to the proximal end of the sleeve shaft 182. In these examples, the open passage 197 can form an axially extending window or slot that permits the proximal segment 185 of the pusher shaft 184 to extend out of the sleeve shaft 182 and angularly away from the sleeve shaft.

[0124] In some examples, due to frictional forces within the delivery device 150, translation of the pusher shaft 184 based on operation of the linear actuator 202 can also cause translation of the sleeve shaft 182 within the hub assembly inner cavity 214. However, to perform variable wrap turns (described below), Figures 7 to 8 In order to overcome the frictional forces that exist between the sleeve shaft 182 and the pusher shaft 184 when performing variable wrap turns, in some examples, the hub assembly 200 further includes a locking mechanism 216. The locking mechanism 216 is configured to lock the sleeve shaft 182 relative to the hub assembly 200 such that selective prevention of movement of the sleeve shaft 182 relative to the hub assembly 200 is achieved. Thus, when the locking mechanism 216 is in a locked configuration, the linear actuator 202 is operable to move the pusher shaft 184 in an axial direction while the locking mechanism 216 holds the sleeve shaft 182 stationary relative to the hub assembly 200. In this manner, operation of the linear actuator 202 causes the pusher shaft 184 to move relative to the hub assembly 200 (e.g., relative to the housing 204 and the sleeve shaft 182, etc.). In some examples, instead of the locking mechanism, a user of the delivery device 150 can hold the sleeve shaft 182 stationary (e.g., by holding the sleeve handle 196) while operating the linear actuator 202 to perform variable wrap turns.

[0125] The locking mechanism 216 can be configured to prevent movement of the sleeve shaft 182 relative to the hub assembly 200 when the locking mechanism 216 is in a locked configuration. In an unlocked configuration, the locking mechanism 216 can be configured to allow such movement. With reference to Figure 16 and 18The locking mechanism 216 may include a rotatable knob 218 (also referred to herein as the "locker body") and a collet 220. The knob 218 includes two tabs 222 extending radially outward from the knob 218 and a shaft 224 extending axially distally from the knob 218. The shaft 224 may be configured to receive the collet 220. In the illustrated example, the shaft 224 may include a threaded region 226 with internal threads and a tapered region 228. The tapered region 228 includes an inner surface 230 that tapers from a larger inner diameter to a smaller inner diameter in a proximal direction.

[0126] like Figure 18 As shown, the collet 220 may include an external thread 232 configured to engage with an internal thread in the threaded region 226 of the shaft 224. The collet 220 may also include an axially extending protrusion 234 (also referred to herein as a "cantilever") at a proximal end of the collet 220. In some cases, as depicted, the collet 220 may include four protrusions 234. It should be understood that in other cases, the collet 220 may include a different number of protrusions 234. The collet 220 may also include a central cavity 236 extending from the distal end of the collet 220 to the proximal end. The central cavity 236 may be coaxial with the hub assembly cavity 214 of the hub assembly 200.

[0127] When the locking mechanism 216 is in the unlocked configuration, the protrusion 234 extends straight from the chuck 220. In other words, the diameter of the central cavity 236 is uniform from the distal end to the proximal end of the chuck 220. In the unlocked configuration, the diameter of the central cavity 236 may be the same as the diameter of the wheel assembly cavity 214. The locking mechanism 216 may be configured such that rotating the knob 218 relative to the wheel assembly 200 by a certain amount (e.g., a quarter turn, half turn, one turn, multiple turns, etc.) changes the locking mechanism 216 from the unlocked configuration to the locked configuration.

[0128] When knob 218 is rotated, chuck 220 can move axially relative to knob 218 toward the tapered region 228 of shaft 224. When locking mechanism 216 is in locked configuration, protrusion 234 can contact inner surface 230 of shaft 224 and can be pushed or flexed radially inward by the tapering of inner surface 230. In other words, in locked configuration, because inner surface 230 is tapered, the diameter of central cavity 236 at the proximal end of chuck 220 is smaller than the diameter at the distal end of chuck 220. In this way, protrusion 234 can be configured to clamp around a device inserted through hub assembly 200 (e.g., sleeve shaft 182) to lock the device in place. Therefore, protrusion 234 can be configured to prevent movement of the device relative to hub assembly 200 (e.g., relative to housing 204, etc.).

[0129] like Figure 18As shown, the central cavity 236 of the chuck 220 may have an annular cross-section defined by the protrusion 234. Figures 19A to 19B Another example of a chuck 320, which is not chuck 220, is shown, and may be included in locking mechanism 216. Chuck 320 is similar to chuck 220. For example, chuck 320 includes external threads 332 configured to engage with the internal threads of knob 218. However, the central cavity 336 of chuck 320, defined by extension 334, has a cross-section of a different shape than that of the central cavity 236 of chuck 220. As described above, in some instances, the proximal portion 197 of sleeve shaft 182 may have a partially annular cross-section (e.g., a U-shaped cross-section, a C-shaped cross-section, etc.). To enable chuck 320 to engage more surfaces of the partially annular sleeve shaft 182 and provide sufficient locking force (e.g., sufficient to overcome friction between sleeve shaft 182 and actuator shaft 184, etc.), the central cavity 336 of chuck 320 may be configured to accommodate a portion of the annular cross-section of sleeve shaft 182. As shown, the extensions 334 may each include different shapes and / or sizes, some of which (e.g., extension 334a) have a smaller cross-section compared to other extensions (e.g., extensions 334b ​​to 334d), and one or more of the extensions have curved inner surfaces (e.g., extension 334b) and / or flat inner surfaces (e.g., extensions 334a, 334c, 334d). In some instances, such as Figure 19A As depicted, the central cavity 336 may be slotted from the distal end to the proximal end of the collet 320, allowing the sleeve shaft 182 to be inserted into the collet 320 both radially and axially. In some instances, the extension 334 defines a partially annular central cavity 336 that is not slotted. For example, the extension 334 may define a central cavity 336 having a D-shaped cross-section surrounding a partially annular cross-section of the sleeve shaft 182. The central cavity 336 may define other shapes corresponding to the cross-sectional shape of the shaft (e.g., the sleeve shaft 182) extending through the collet 320.

[0130] refer to Figures 14 to 16 Chassis 238 ( Figure 16 The suture locking assembly 240 and one or more seals 242 can be coupled to the proximal end of the slider 208 and configured to translate axially with the slider 208. The suture locking assembly 240 and one or more seals 242 can be coupled to the chassis 238. The hub assembly 200 further includes one or more flushing ports (e.g., flushing port 244) to supply flushing fluid to one or more lumens disposed within the delivery device 150 (e.g., annular lumens disposed between coaxial assemblies of the delivery device 150), for example, to maintain hemostasis within the delivery device 150. The flushing port 244 can be coupled to the chassis 238, for example, to supply flushing fluid distal to the seal 242.

[0131] In some examples, the proximal end portion of the pusher shaft 184 can extend to the chassis 238 and be operably coupled to a suture lock assembly 240. As described above, in some examples, the proximal end portion of the pusher shaft 184 can branch or angle away from the sleeve shaft 182, for example, to extend toward the suture lock assembly 240. The suture lock assembly 240 is configured to releasably couple to a proximal end of the release suture 194. In some examples, the suture lock assembly 240 can include a rotator 241 (which can also be referred to as a “rotatable handle”) to increase and decrease tension on the release suture 194, which can extend from the suture lock assembly 240 through a lumen of the pusher shaft 184 to the docking device 152. The suture lock assembly 240 can be configured to cut the release suture 194 to release the docking device 152 from the delivery apparatus 150, for example, at the end of a procedure to implant the docking device 152. Additional details of suture lock assemblies that can be used with the hub assembly 200 are described in International Application Nos. PCT / US2023 / 025726 and PCT / US2023 / 025730, both of which are incorporated herein in their entirety.

[0132] In some examples, the user can operate the suture lock assembly 240 for a limited time during a procedure (e.g., to release the docking device 152 from the delivery apparatus 150 at the end of a procedure). Accordingly, it can be useful for the suture lock assembly 240 to be accessible by the user during those particular times, but not otherwise (e.g., to prevent inadvertent operation of the suture lock assembly 240). To ensure that the suture lock assembly 240 is only accessible when the user intends to operate the suture lock assembly 240, the housing 204 of the hub assembly 200 can include a cover 246 (or cover plate) that is coupled to the rest of the housing 204 and can be at least partially removed from the housing 204. As shown in FIG. 6, the cover 246 can be coupled to the housing 204 by a hinge 248. In some examples, the hinge 248 can be a living hinge that is integrally formed with the housing 204. In other examples, the hinge 248 can be a separate component that is coupled to the housing 204. In some examples, the hinge 248 can be a living hinge that is integrally formed with the cover 246. In other examples, the hinge 248 can be a separate component that is coupled to the cover 246. Figure 14As shown, the cover 246 can be partially removed from the housing 204 to expose an interior region of the housing 204 that houses the suture locking assembly 240. Thus, with the interior region of the housing 204 exposed, a user can operate the suture locking assembly 240 and / or other components disposed within the housing 204. In some examples, the cover 246 can include a tab 248 that is operable to release the cover 246 from the rest of the housing 204. In some examples, as depicted, the cover 246 is hingedly coupled to the housing 204. For example, after the user presses the tab 248, the user can lift the cover 246 from the housing 204 so that the user can access the interior region and the user can operate the suture locking assembly 240. In some examples, the cover 246 can be coupled to the housing 204 with a spring so that the cover 246 is biased away from the housing 204 after the tab 248 is pressed. In some examples, the cover 246 can be slidably attached to the housing 204 so that the user can slide the cover 246 relative to the housing 204 to expose the interior region within the housing 204. In some examples, the housing 204 does not include a cover 246 so that the suture locking assembly 240 is exposed to the user throughout the procedure.

[0133] As described above, one or more seals 242 can be disposed within the chassis 238 so that the chassis 238 at least partially defines a housing for the seals 242. The seals 242 are configured to seal around one or more shafts of the delivery device 150 and provide hemostasis. For example, the seals 242 can be positioned at a proximal end of the chassis 238 and positioned around an outer surface of the sleeve shaft 182. As described above, the proximal portion 197 of the sleeve shaft 182 can have a partial annular cross-section, and the seals 242 can be configured to seal around the partial annular cross-section. Additional details of seals and seal assemblies for shafts are described in U.S. Provisional Patent Application No. 63 / 482,210, which is incorporated by reference herein in its entirety.

[0134] The cover 246 and / or the housing 204 can define a slot 250 between the cover 246 and the rest of the housing 204. The slot 250 extends axially along a length of the cover 246. As Figure 13 As shown, the slot 250 defines an opening into the housing 204, and the irrigation port 244 can extend outward from the chassis 238 and exit the housing 204 through the slot 250. Thus, when the cover 246 is closed, and when a user operates the linear actuator 202 to perform variable circumferential turns as described below, the user can access the irrigation port 244.

[0135] Referring to Figures 17A to 17CThe axial position of the slider 208 relative to the hub assembly 200 can be adjusted by operating the linear actuator 202 (e.g., by rotating the knob 206). Due to the connection between the slider 208 and the pusher shaft 184, translation of the slider 208 causes translation of the pusher shaft 184. The locking mechanism 216 is shown in the locked configuration in Figures 17A to 17C , such that movement of the sleeve shaft 182 relative to the hub assembly 200 is prevented. As described above, adjusting the axial position of the pusher shaft 184 relative to the sleeve shaft 182 can vary the magnitude of the radius of curvature of the sleeve shaft front bend 187 (e.g., as described above in connection with the VET). In particular, the radius of curvature of the sleeve shaft front bend 187 is related to the axial position of the pusher shaft 184 relative to the sleeve shaft 182. Figures 7 to 8

[0136] In some examples, the slider 208 can extend at least partially out of the housing 204 in some axial positions to enable the slider 208 to translate a larger axial distance without increasing the size of the hub assembly 200. For example, the slider 208 can extend through an opening 247 at the distal end of the housing 204. In this way, the hub assembly 200 can be ergonomically sized for a user to manipulate while achieving a larger range of radii of curvature of the sleeve shaft front bend 187. Figure 17A The slider 208 (and thus the pusher shaft 184) is shown in a first axial position relative to the hub assembly 200. In the first position, the slider 208 is disposed entirely within the housing 204. Rotating the knob 206 in a first direction relative to the housing 204 (e.g., clockwise) translates the slider 208 and the pusher shaft 184 in a distal direction relative to the housing 204, e.g., from the first axial position to a second axial position Figure 17B ). In some examples, as depicted, the distal end of the slider 208 can extend partially out of the housing 204 in the second axial position. When the slider 208 is in the second axial position, rotating the knob 206 in the first direction relative to the housing 204 can further translate the slider 208 and the pusher shaft 184 in a distal direction relative to the housing 204 to a third axial position Figure 17C ). In the third axial position, a larger portion of the slider 208 extends out of the housing 204. Rotating the knob 206 in a second direction (e.g., counterclockwise) can translate the slider 208 and the pusher shaft 184 in a proximal direction relative to the housing 204, e.g., from the third axial position to the second axial position. The first, second, and third axial positions each correspond to a different radius of curvature of the sleeve shaft front bend 187. In this way, the radius of curvature of the sleeve shaft front bend 187 can be varied by operating the linear actuator 202 to move the slider 208 in Figures 17A to 17C ​The slider 208 and the pusher shaft 184 are adjusted by moving between the axial positions shown in the middle. In other examples, the slider 208 can remain in all axial positions and be enclosed within the housing 204.

[0137] In some examples, the hub assembly 200 (e.g., the housing 204, the knob 206, and / or the slider 208, etc.) can further include an indicator configured to indicate a magnitude of the variable wrap turn. Because the radius of curvature of the sleeve shaft forward turn 187 is related to the axial position of the pusher shaft 184 relative to the sleeve shaft 182, and the axial position of the pusher shaft 184 relative to the sleeve shaft 182 is related to the axial position of the housing 204 relative to the slider 208, the radius of curvature of the sleeve shaft forward turn 187 can be determined based on the relative axial positions of the housing 204 and the slider 208 and / or assembly (e.g., the irrigation port 244) coupled thereto. In some examples, the indicator can include one or more markings disposed along the length of the slot 250. A first marking disposed toward the proximal end of the slot 250 can indicate that the radius of curvature of the sleeve shaft forward turn 187 (in other words, the variable wrap turn) is equal to a first radius of curvature (R1), and a second marking disposed toward the distal end of the slot 250 can indicate that the radius of curvature of the sleeve shaft forward turn 187 is equal to a second radius of curvature (R2). r 1 ), and a second marking disposed toward the distal end of the slot 250 can indicate that the radius of curvature of the sleeve shaft forward turn 187 is equal to a second radius of curvature (R2). r 2 In some examples, the indicator can be configured to indicate the magnitude of the variable wrap turn based on an amount of rotation of the knob 206 relative to the housing 204. The indicator can be a visual depiction of a coil (e.g., with various curvatures), words (e.g., “larger” and / or “smaller”), and / or any other indicia.

[0138] When adjusting the axial position of the slider 208, the axial position of the assembly coupled to the slider 208 is likewise adjusted. For example, the chassis 238, the suture lock assembly 240, the seal 242, and the irrigation port 244 can all translate with the slider 208. As described above, the irrigation port 244 can extend outward from the chassis 238 and exit the housing 204 through the slot 250. Thus, as the linear actuator 202 is operated to move the slider 208, the irrigation port 244 can translate along the length of the slot 250. In a first axial position (R1 Figure 17A ), the irrigation port 244 is positioned proximate to the proximal end of the hub assembly 200, e.g., at the proximal end of the slot 250. In a third axial position (R2 Figure 17C ), the irrigation port 244 is positioned proximate to the distal end of the hub assembly 200, e.g., at the distal end of the slot 250.

[0139] As Figure 16 and 17CAs shown, the slider 208 can include a pair of axially extending rails 252 and a plurality of supports 254 extending between the rails 252. Each rail 252 includes a threaded outer surface 212 that can engage with a threaded inner surface 210 of the knob 206. The pitch of the threaded inner surface 210 can vary to change the rate of linear actuation. For example, a smaller pitch of the threaded inner surface 210 causes the pusher shaft 184 to actuate more slowly relative to the housing 204, whereas a larger pitch will increase the travel speed of the pusher shaft 184. In other words, for a given amount of rotation of the knob 206 relative to the housing 204 (e.g., a quarter turn, etc.), the slider 208 can translate axially a different amount based on the pitch of the threaded inner surface 210.

[0140] The sleeve shaft 182 and the pusher shaft 184 can extend through and / or between the supports 254 (e.g., through openings of the supports 254). In some examples, the pusher shaft 184 can be fixedly coupled to the slider 208 at one or more of the supports 254 such that the slider 208 and the pusher shaft 184 move together in the axial direction. In some examples, the pusher shaft 184 can be fixedly coupled to the chassis 238. The sleeve shaft 182 can be configured to move relative to the slider 208 (e.g., in the axial direction) through the openings defined by the supports 254.

[0141] Figure 20 A docking device 152 according to one example is shown. As Figure 20 As depicted in its deployed, coiled configuration, the docking device 152 is configured to receive a prosthetic valve (e.g., the prosthetic heart valve 62) and secure the prosthetic valve within the docking device 152, thereby securing the prosthetic valve at the annulus of the native mitral valve 16.

[0142] 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 flat configuration (or delivery configuration) when disposed within the delivery shaft 154 to a helical deployed configuration after removal from the delivery shaft 154.

[0143] Coil 188 has a proximal end 188p and a distal end 188d (which also define the proximal and distal ends of docking device 152, respectively). When disposed within delivery shaft 154 (e.g., during delivery of docking device 152 into a patient’s vasculature), the body of coil 188 between proximal end 188p and distal end 188d can form a generally straight delivery configuration (without any windings or looped portions but can be flexible or curved) so as to maintain a small radial profile when moving through a patient’s vasculature. Upon removal from delivery shaft 154 and deployment at an implantation site, coil 188 can move from the delivery configuration to a helically unwound configuration and wrap around native tissue proximate the implantation site. For example, when docking device is implanted at the site of a native valve, coil 188 can be configured to wrap around native leaflets of the native valve (and chordae tendineae connecting the native leaflets to adjacent papillary muscles).

[0144] Coil 188 in the unwound deployed configuration can include a docking device forward turn 189, a central region 190, and a stabilizing turn 195 (or “stabilizing coil”) about a central longitudinal axis.

[0145] In the unwound deployed configuration, central region 190 includes one or more helical turns formed about the central longitudinal axis of docking device 152, where the helical turns have a substantially equal radius of curvature configured to encircle leaflets 24 of native mitral valve 16. Docking device forward turn 189 extends from a distal end of central region 190 and has a radius of curvature that is greater than the radius of curvature of the helical turns of central region 190. In some examples, the radius of curvature of docking device forward turn 189 of docking device 152 is equal to a second radius of curvature, where the second radius of curvature is less than the first radius of curvature of sleeve shaft forward turn 187.

[0146] In the illustrated example, stabilizing turn 195 can extend from a proximal end of central region 190 and have a diameter that is greater than the diameter of central region 190. Alternatively, stabilizing turn 195 can have a diameter that is equal to, approximately equal to, or less than the diameter of central region 190 (as opposed to a greater diameter), and / or the stabilizing turn can include fewer full turns than the full turns depicted in FIG. 22.

[0147] In some examples, docking device 152 can further include a guard member 180 disposed on coil 188. Guard member is configured to reduce the likelihood of paravalvular leakage between native mitral valve 16 and the prosthetic heart valve. In some examples, guard member 180 can include a braided portion disposed between a distal portion 191 and a proximal portion 193 of guard member 180. The braided portion is configured to shorten into an unwound configuration when proximal portion 193 is forced in a distal direction, where the braided portion has an increased radial thickness in the shortened unwound configuration.

[0148] Further details of docking devices and variations thereof are described in International Publication No. WO 2022 / 087336, which is incorporated herein by reference in its entirety.

[0149] Any of the systems, devices, apparatuses, etc. herein can be sterilized (e.g., with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure their safe use on patients, and as one of the steps in the methods, any of the methods herein can include sterilization of the associated systems, devices, apparatuses, etc. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beam. Examples of chemicals for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. For example, sterilization using hydrogen peroxide can be accomplished using hydrogen peroxide plasma.

[0150] The therapeutic techniques, methods, steps, etc. described or suggested herein or in the references incorporated herein can be performed on a living animal or on a non-living simulation, e.g., on a cadaver, a cadaveric heart, a mannequin, a simulator (e.g., having a simulated body part, tissue, etc.), etc.

[0151] Delivery techniques To implant a prosthetic valve within a native aortic valve via a transfemoral delivery method, the prosthetic valve is mounted in a radially compressed state along a distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a 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 apparatus, 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 a distal end portion of a delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and apex, and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on a distal end portion of a delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-shaped sternotomy or a right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0152] To implant a prosthetic valve within a native mitral valve by a transseptal delivery method, the prosthetic valve is mounted in a radially compressed state along a distal portion of a delivery apparatus. The prosthetic valve and the distal portion of the delivery apparatus are inserted into a femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (by making a puncture in the atrial septum), into the left atrium, and towards 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 apparatus) is introduced into the left ventricle through a surgical opening in the chest and apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0153] To implant a prosthetic valve within a native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along a distal portion of a delivery apparatus. The prosthetic valve and the distal portion of the delivery apparatus are inserted into a femoral vein and advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. Similar methods can be used to implant a prosthetic valve within a native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and towards the pulmonary valve / pulmonary artery.

[0154] Another delivery method is a transatrial method, whereby the prosthetic valve (on the distal portion of the delivery apparatus) is inserted through a chest incision and through an incision in the atrial wall (right atrium or left atrium) for access to any native heart valve. Transatrial delivery can also be performed intravascularly, such as from a pulmonary vein. Yet another delivery method is a transventricular method, whereby the prosthetic valve (on the distal portion of the delivery apparatus) is inserted through a chest incision and through an incision in the right ventricular wall (typically at or near the bottom of the heart) for implantation of the prosthetic valve within a native tricuspid valve, native pulmonary valve, or pulmonary artery.

[0155] In all delivery methods, the delivery apparatus can be advanced over a guidewire that is previously inserted into the patient's vasculature. Also, the disclosed delivery methods are not intended to be limiting. Any of the prosthetic valves disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0156] Additional examples of the disclosed technology In view of the embodiments of the disclosed subject matter described above, the present application discloses the following additional examples. It should be noted that an example of a single feature or combination of features of a separate example, and optionally in combination with one or more features of one or more additional examples, is an additional example that also falls within the disclosure of the present application.

[0157] Example 1 : A delivery apparatus for a docking device, the delivery apparatus comprising: a housing; a linear actuator coupled to the housing, the linear actuator comprising a slider and an articulating member coupled to the slider, wherein the slider translates axially relative to the housing based on rotation of the articulating member relative to the housing; a first shaft extending through the housing and configured to translate axially relative to the housing; a second shaft extending through the first shaft and coupled to the slider of the linear actuator such that the second shaft and the slider translate axially together; and a locking mechanism coupled to the housing, wherein the first shaft is prevented from moving relative to the housing in a locked configuration, and wherein the first shaft is movable relative to the housing in an unlocked configuration.

[0158] Example 2. The delivery apparatus of any example herein, especially Example 1, wherein a proximal portion of the first shaft comprises a partially annular axial cross-section.

[0159] Example 3. The delivery apparatus of any example herein, especially Example 1 or Example 2, wherein the locking mechanism comprises a collet having an internal cavity, wherein the first shaft extends through the internal cavity.

[0160] Example 4. The delivery apparatus of any example herein, especially Example 3, wherein the internal cavity comprises a non-circular cross-section.

[0161] Example 5. The delivery apparatus of any example herein, especially Example 3 or Example 4, wherein the collet comprises an extension portion configured to grip around the first shaft in the locked configuration, wherein the extension portion is unevenly shaped and / or sized.

[0162] Example 6. The delivery apparatus of any example herein, especially any one of Examples 1-5, wherein the second shaft is spaced apart from the first shaft distally of a proximal end of the first shaft.

[0163] Example 7. A delivery apparatus for a docking device, the delivery apparatus comprising: a housing comprising an opening at a distal end; a first shaft extending through the housing and configured to translate relative to the housing; a second shaft extending through the first shaft; and a linear actuator coupled to the housing, the linear actuator comprising a slider and an articulating member coupled to the slider, wherein the slider translates axially relative to the housing between a first axial position and a second axial position based on rotation of the articulating member relative to the housing, wherein the second shaft and the slider are configured to translate together, and wherein the slider extends at least partially out of the opening of the housing in the second axial position.

[0164] Example 8. The delivery apparatus of any example herein, especially Example 7, wherein the slider comprises a threaded outer surface, and wherein the articulating member comprises a threaded inner surface.

[0165] Example 9. The delivery device of any example herein, especially Example 7 or Example 8, wherein the housing includes a cover coupled to the housing and at least partially removable from the housing.

[0166] Example 10. The delivery device of any example herein, especially any of Examples 7-9, further comprising a locking mechanism coupled to the housing, wherein the first shaft is prevented from moving relative to the housing in a locked configuration, and wherein the first shaft is movable relative to the housing in an unlocked configuration.

[0167] Example 11. The delivery device of any example herein, especially any of Examples 7-10, wherein the second shaft is distanced from the proximal end of the first shaft.

[0168] Example 12. A delivery device for a docking device, the delivery device comprising: a housing defining an interior region; a linear actuator coupled to the housing and configured to translate axially relative to the housing, the linear actuator including a lead screw and a chassis coupled to the lead screw, the chassis positioned within the interior region of the housing; a pusher shaft extending through the housing and coupled to the lead screw, wherein the pusher shaft and the lead screw are configured to translate together relative to the housing; and a cover coupled to the housing and at least partially removable from the housing to selectively expose the interior region.

[0169] Example 13. The delivery device of any example herein, especially Example 12, wherein the cover is rotatably connected to the housing.

[0170] Example 14. The delivery device of any example herein, especially Example 12, wherein the cover is slidably connected to the housing.

[0171] Example 15. The delivery device of any example herein, especially any of Examples 12-14, further comprising a suture extending through the pusher shaft and a suture locking assembly coupled to the chassis, wherein the suture is releasably coupled to the suture locking assembly.

[0172] Example 16. The delivery device of any example herein, especially Example 15, wherein the suture locking assembly is positioned within the interior region and is accessible when the cover is partially removed from the housing.

[0173] Example 17. The delivery device of any example herein, especially Example 16, wherein the housing and the cover define a slot extending axially along a length of the housing.

[0174] Example 18. The delivery device of any example herein, especially Example 17, further comprising an irrigation port coupled to the chassis, wherein the irrigation port extends through the slot out of the interior region of the housing such that the irrigation port is accessible when the cover is closed onto the housing.

[0175] Example 19. The delivery device of any example herein, especially any of examples 12-18, further comprising a sleeve shaft extending through the housing, wherein the pusher shaft extends through the sleeve shaft, and wherein the pusher shaft exits the sleeve shaft within the interior region of the housing.

[0176] Example 20. A delivery device for a docking device, the delivery device comprising: a housing; a sleeve shaft extending through the housing, wherein the sleeve shaft comprises a u-shaped or c-shaped axial cross-section; and a locking mechanism coupled to the housing and comprising a collet having an internal cavity, wherein the sleeve shaft extends through the internal cavity, wherein the internal cavity comprises a non-circular cross-section, wherein the sleeve shaft is prevented from moving relative to the housing in a locked configuration, and wherein the sleeve shaft is movable relative to the housing in an unlocked configuration.

[0177] Example 21. The delivery device of any example herein, especially example 20, wherein the collet comprises an extension portion configured to grip around the sleeve shaft in the locked configuration, wherein the extension portion is unevenly shaped and / or sized.

[0178] Example 22. The delivery device of any example herein, especially example 20 or example 21, further comprising a pusher shaft extending through the sleeve shaft.

[0179] Example 23. The delivery device of any example herein, especially example 22, wherein the pusher shaft exits the sleeve shaft distal to a proximal end of the sleeve shaft.

[0180] Example 24. The delivery device of any example herein, especially example 22 or example 23, further comprising a linear actuator coupled to the housing, the linear actuator comprising a slider and an articulating member coupled to the slider, wherein the slider translates axially relative to the housing based on rotation of the articulating member relative to the housing, and wherein the pusher shaft is coupled to the slider of the linear actuator such that the pusher shaft and the slider translate axially together.

[0181] Example 25. The delivery device of any example herein, especially any of examples 1-24, wherein the delivery device has been sterilized.

[0182] Example 26. A method for implanting a prosthetic medical device at a target implant site of a subject, the method comprising: advancing a prosthetic medical device coupled to a pusher shaft of a delivery device and remaining within a sleeve shaft of the delivery device toward the target implant site by moving the sleeve shaft and the pusher shaft relative to a handle portion of the delivery device in a distal direction; locking a position of the sleeve shaft relative to a hub assembly of the delivery device with a locking mechanism of the hub assembly coupled to the delivery device; and actuating a linear actuator of the hub assembly to move the pusher shaft relative to the sleeve shaft and the hub assembly in an axial direction.

[0183] Example 27. The method of any example herein, including Example 26, further comprising unlocking the sleeve shaft and moving the sleeve shaft relative to the pusher shaft and the hub assembly in a proximal direction to retract the sleeve shaft from the prosthetic medical device.

[0184] Features described in relation to any example herein can be combined with other features described in relation to any one or more of the other examples, unless otherwise stated. For example, any one or more features of one delivery device can be combined with any one or more features of another delivery device.

[0185] In light of the many possible ways in which the principles of the disclosure can be applied, it should be recognized that the illustrated configurations depict example implementations of the disclosed technology and do not limit the scope of the disclosure or the claims. Rather, the scope of the claimed subject matter is limited only by the claims and their equivalents.

Claims

1. A delivery device for a docking apparatus, the delivery device comprising: case; A linear actuator coupled to the housing, the linear actuator including a slider and a hinge member coupled to the slider, wherein the slider translates axially relative to the housing based on rotation of the hinge member relative to the housing; A first axis extends through the housing and is configured to translate axially relative to the housing; A second axis extends through the first axis and is coupled to the slider of the linear actuator, such that the second axis and the slider are axially translated together. and A locking mechanism is coupled to the housing, wherein in a locking configuration the first shaft is prevented from moving relative to the housing, and wherein in an unlocking configuration the first shaft is movable relative to the housing.

2. The delivery device of claim 1, wherein the proximal portion of the first shaft comprises a partial annular axial cross section.

3. The delivery device according to claim 1 or claim 2, wherein the locking mechanism comprises a chuck having an inner cavity, wherein the first shaft extends through the inner cavity.

4. The delivery device of claim 3, wherein the cavity comprises a non-circular cross-section.

5. The delivery device according to claim 3 or claim 4, wherein the chuck includes an extension configured to clamp around the first axis in the locking configuration, wherein the extension is non-uniformly shaped and / or sized.

6. The delivery device according to any one of claims 1 to 5, wherein the proximal end of the second shaft is away from the first shaft.

7. A delivery device for a docking apparatus, the delivery device comprising: A housing having an opening at its distal end; A first axis extends through the housing and is configured to translate relative to the housing; A second axis extends through the first axis; and A linear actuator coupled to the housing, the linear actuator including a slider and a hinge member coupled to the slider, wherein the slider is axially translated relative to the housing between a first axial position and a second axial position based on rotation of the hinge member relative to the housing, wherein the second axis and the slider are configured to translate together, and wherein the slider at least partially extends out of the opening of the housing in the second axial position.

8. The delivery device of claim 7, wherein the slider includes a threaded outer surface and wherein the hinge member includes a threaded inner surface.

9. The delivery device according to claim 7 or claim 8, wherein the housing includes a cover attached to the housing and removable at least partially from the housing.

10. The delivery device according to any one of claims 7 to 9, further comprising a locking mechanism coupled to the housing, wherein in a locking configuration the first shaft is prevented from moving relative to the housing, and wherein in an unlocking configuration the first shaft is movable relative to the housing.

11. The delivery device according to any one of claims 7 to 10, wherein the proximal end of the second shaft is away from the first shaft.

12. A delivery device for a docking apparatus, the delivery device comprising: The shell, which defines the internal area; A linear actuator coupled to the housing and configured to translate axially relative to the housing, the linear actuator including a lead screw and a chassis coupled to the lead screw, the chassis being positioned within the internal region of the housing; A actuator shaft extends through the housing and is coupled to the lead screw, wherein the actuator shaft and the lead screw are configured to translate together relative to the housing; and A cover, which is attached to the housing and can be at least partially removed from the housing to selectively expose the interior area.

13. The delivery device of claim 12, wherein the cover is rotatably connected to the housing.

14. The delivery device of claim 12, wherein the cover is slidably connected to the housing.

15. The delivery device according to any one of claims 12 to 14, further comprising a suture extending through the actuator shaft and a suture locking assembly coupled to the chassis, wherein the suture is releasably coupled to the suture locking assembly.

16. The delivery device of claim 15, wherein the suture locking assembly is located within the internal area and is accessible when the cover is partially removed from the housing.

17. The delivery device of claim 16, wherein the housing and the cover define a slot extending along the length axis of the housing.

18. The delivery device of claim 17, further comprising a flushing port coupled to the chassis, wherein the flushing port extends through the slot out of the interior region of the housing such that it is accessible when the cover is closed onto the housing.

19. The delivery device according to any one of claims 12 to 18, further comprising a sleeve shaft extending through the housing, wherein the pusher shaft extends through the sleeve shaft, and wherein the pusher shaft exits the sleeve shaft within the interior region of the housing.

20. A method for implanting a prosthetic medical device at a target implantation site in a subject, the method comprising: By moving the sleeve shaft and the pusher shaft of the delivery device in the distal direction relative to the handle of the delivery device, the prosthetic medical device, which is connected to the distal end of the pusher shaft and retained in the sleeve shaft, is advanced toward the target implantation site. The position of the sleeve shaft relative to the hub assembly of the delivery device is locked using a locking mechanism connected to the hub assembly of the delivery device; and Actuate the linear actuator of the hub assembly to move the pusher shaft in the axial direction relative to the sleeve shaft and the hub assembly.

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