Artificial medical device delivery device

Abstract

A method for a delivery device for a device and a docking device is disclosed. As an example, the delivery device may include a housing and a linear actuator coupled to the housing, the linear actuator comprising a traveler and an articulated member coupled to the traveler, wherein the traveler moves axially relative to the housing based on the rotation of the articulated member relative to the housing; a first shaft extending through the housing and configured to move axially relative to the housing; a second shaft extending through the first shaft and coupled to the traveler of the linear actuator, wherein the second shaft and the traveler are configured to move together axially; 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 is movable relative to the housing in an unlocked configuration.

Description

Technical Field

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

[0002] The present disclosure relates to a delivery device for artificial medical devices.

Background Art

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

[0004] In some cases, the docking device may be initially implanted within the natural valve, receiving the prosthetic valve and fixing (e.g., anchoring) the prosthetic valve in a desired position within the natural valve. For example, the docking device may form a more rounded and / or stable fixation site on the annulus of the natural valve into which the prosthetic valve can be expanded and implanted. A transcatheter delivery device may be used to deliver the docking device to the implantation site. [Overview of the project]

[0005] Artificial heart valves, docking devices, delivery devices, and methods for implanting artificial heart valves are described herein. The disclosed artificial heart valves, docking devices, delivery devices, and methods can provide improved positioning of the docking device, for example, by the independent operation of multiple shafts of the delivery device. Thus, the devices and methods disclosed herein can overcome, among other things, one or more of the shortcomings of typical artificial heart valves, docking devices, and associated delivery devices.

[0006] The delivery device may include a handle and one or more shafts coupled to the handle.

[0007] In some embodiments, the delivery device may include a handle, a shaft coupled to the handle, and a linear actuator coupled to the shaft, the linear actuator being configured to move the shaft axially relative to the handle.

[0008] In some embodiments, the delivery device may include a housing, a linear actuator coupled to the housing, the linear actuator comprising a traveler and an articulated member coupled to the traveler, wherein the traveler moves axially relative to the housing based on the rotation of the articulated member relative to the housing, a first shaft extending through the housing and configured to move axially relative to the housing, a second shaft extending through the first shaft and coupled to the traveler of the linear actuator, wherein the second shaft and the traveler are configured to move together axially, 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 is movable relative to the housing in an unlocked configuration.

[0009] In some embodiments, the delivery device comprises a housing having an opening at its distal end, a first shaft extending through the housing and configured to move relative to the housing, a second shaft extending through the first shaft, and a linear actuator coupled to the housing, wherein the linear actuator comprises a traveler and an articulated member coupled to the traveler, the traveler comprises a linear actuator coupled to the housing relative to the housing, the linear actuator comprises a traveler and an articulated member coupled to the traveler, the traveler moves axially relative to the housing between a first axial position and a second axial position based on the rotation of the articulated member relative to the housing, the second shaft and the traveler are configured to move together, and the traveler protrudes at least partially from the opening of the housing at the second axial position.

[0010] In some embodiments, the delivery device may include a housing defining an internal region; a linear actuator connected to the housing and configured to move axially relative to the housing, comprising a lead screw and a chassis connected to the lead screw, the chassis being positioned within the internal region of the housing; a pusher shaft extending through the housing and connected to the lead screw, configured such that the pusher shaft and the lead screw move together relative to the housing; and a cap coupled to the housing and at least partially removable from the housing, selectively exposing the internal region.

[0011] In some embodiments, the delivery device further comprises a housing, a sleeve shaft extending through the housing, the sleeve shaft having a U-shaped or C-shaped axial cross-section, and a locking mechanism connected to the housing and including a collet having a lumen, wherein the sleeve shaft extends through the lumen having a non-circular cross-section, the sleeve shaft is prevented from moving relative to the housing in a locked configuration, and the sleeve shaft is movable relative to the housing in an unlocked configuration.

[0012] A method for implanting an artificial medical device at a target implantation site may include moving the pusher shaft of the delivery device axially relative to the sleeve shaft and hub assembly of the delivery device.

[0013] In some embodiments, a method for implanting an artificial medical device at a target implantation site includes: advancing an artificial medical device, which is connected to the distal end of a pusher shaft of a delivery device and held within a sleeve shaft of the delivery device, toward the target implantation site by moving the sleeve shaft and pusher shaft distally relative to the handle of the delivery device; locking the position of the sleeve shaft relative to the hub assembly of the delivery device using a locking mechanism connected to the hub assembly of the delivery device; and acting on a linear actuator of the hub assembly to move the pusher shaft axially relative to the sleeve shaft and hub assembly.

[0014] The various innovations in this disclosure can be used in combination or individually. This summary is provided in a simplified form to introduce a selection of concepts that will be further described in the following detailed description. This summary of the invention is not intended to identify any major or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The above and other purposes, structures, and advantages of this disclosure will become clearer from the following detailed description, the claims, and the accompanying drawings. [Brief explanation of the drawing]

[0015] [Figure 1] Figure 1 schematically illustrates the steps in an exemplary mitral valve replacement procedure, in which a guide catheter and guidewire are inserted into the patient's blood vessels and navigated through the vessels into the patient's heart towards the heart's own mitral valve. [Figure 2A] Figure 2A schematically illustrates another stage in an exemplary mitral valve replacement surgery in which a docking device delivery device extending through a guide catheter implants a docking device for an artificial heart valve at the site of the patient's own mitral valve. [Figure 2B]Figure 2B schematically illustrates another stage in an exemplary mitral valve replacement surgery, where the docking device shown in Figure 2A has been fully implanted in the patient's own mitral valve and the docking device delivery device has been removed from the patient. [Figure 3A] Figure 3A schematically illustrates another stage in an exemplary mitral valve replacement, in which an artificial heart valve delivery device extending through a guide catheter implants the artificial heart valve into the implanted docking device at the site of the patient's own mitral valve. [Figure 3B] Figure 3B schematically shows another stage in an exemplary mitral valve replacement, where the artificial heart valve has been fully implanted within the docking device at the site of the patient's own mitral valve, and the artificial heart valve delivery device has been removed from the patient. [Figure 4] Figure 4 schematically shows another stage in an exemplary mitral valve replacement procedure, where the guide catheter and guidewire have been removed from the patient. [Figure 5] Figure 5 schematically illustrates the steps of a docking device implantation procedure in one embodiment, in which a guide catheter is inserted into the patient's blood vessel and navigated through the vessel into the patient's heart. [Figure 6] Figure 6 schematically illustrates another stage of an exemplary docking device implantation procedure, in which the distal end portion of the docking device delivery device advances from the guide catheter into the left ventricle of the heart. [Figure 7] Figure 7 schematically shows another stage of an exemplary docking device implantation procedure, in which the distal end portion of the docking device delivery device is coiled around several valve leaflets of the heart. [Figure 8] Figure 8 schematically illustrates another stage of an exemplary docking device implantation procedure in which the radius of curvature of the distal end portion of the docking device delivery device is increased to surround the chordae tendineae of the heart in a variable encircling turn. [Figure 9] Figure 9 schematically illustrates another step in an exemplary docking device implantation procedure, in which the sleeve shaft of the docking device delivery device is retracted proximally to de-cover the guard member of the docking device. [Figure 10]Figure 10 schematically shows another stage in an exemplary docking device implantation procedure where the sleeve shaft advances distally to shorten the guard member. [Figure 11] Figure 11 schematically shows another stage in an exemplary mitral valve replacement where the docking device delivery apparatus is separated from the docking device. [Figure 12] Figure 12 is a side view of a delivery apparatus for a docking device according to one example. [Figure 13] Figure 13 is a side view of the dock handle of the delivery apparatus of Figure 12. [Figure 14] Figure 14 is a perspective view of the dock handle of Figure 13 with the cover partially removed from the handle. [Figure 15] Figure 15 is a perspective view of the dock handle of Figure 13, with the cover omitted for purposes of illustration. [Figure 16] Figure 16 is a cross-sectional side view of the dock handle of Figure 13. [Figure 17A] Figures 17A - 17C are perspective views of the dock handle of Figure 13 in various configurations. [Figure 17B] Figures 17A - 17C are perspective views of the dock handle of Figure 13 in various configurations. [Figure 17C] Figures 17A - 17C are perspective views of the dock handle of Figure 13 in various configurations. [Figure 18] Figure 18 is a perspective view of a collet of a locking mechanism according to one embodiment. [Figure 19A] Figure 19A is an end view of a collet of a locking mechanism according to one embodiment. [Figure 19B] Figure 19B is a perspective view of the collet of Figure 19A. [Figure 20] Figure 20 is a perspective view of a docking device for use with a docking device delivery apparatus according to one example. [Figure 21] Figure 21 is a perspective view of the shaft of the delivery apparatus of Figure 12.

DETAILED DESCRIPTION OF THE INVENTION

[0016] General Considerations For the purposes of this description, specific aspects, aspects, advantages, and novel configurations of the examples disclosed herein are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, this disclosure covers all novel and non-obvious features and aspects relating to the various examples disclosed, individually, in various combinations of each other, and in various subcombinations of each other. The methods, apparatus, and systems are not limited to any specific aspects, features, or combinations thereof, and the disclosed examples do not require the existence of any one or more specific advantages or the resolution of any problem.

[0017] While some of the operations in the disclosed examples are described in a specific sequential order for the sake of presentation, it should be understood that this style of description is inclusive of reordering unless a specific order is required by the specific wording described below. For example, operations described sequentially may, in some cases, be reordered or performed simultaneously. Also, for the sake of simplification, the accompanying drawings may not show various ways in which the disclosed methods can be used in combination with other methods. Furthermore, the description sometimes uses terms such as “provides” or “achieves” to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may differ depending on the specific implementation and will be readily apparent to those skilled in the art.

[0018] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural form unless the context clearly specifies otherwise. Additionally, the term “includes” means “comprises.” Furthermore, the term “coupled” generally means being coupled or linked physically, mechanically, chemically, magnetically, and / or electrically, and does not exclude the existence of intermediate elements between the coupled or associated items unless there is a specific antonym.

[0019] As used herein, the term “proximal” refers to a location, orientation, or part of the device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a location, orientation, or part of the device that is further away from the user and closer to the implantation site. For example, proximal movement of the device is the movement of the device away from the implantation site and toward the user (e.g., away from the patient's body), while distal movement of the device is the movement of the device away from the user and toward the implantation site (e.g., toward the patient's body). The terms “longitudinal” and “axial” refer to axes extending in the proximal and distal directions, respectively, unless otherwise explicitly defined.

[0020] As used herein, "eg" means "for example," and "ie" means "that is."

[0021] Implementation of the disclosed technologies This specification discloses examples of delivery systems that may be used to navigate the target vascular system to deliver artificial medical devices (such as docking devices used in conjunction with artificial heart valves), tools, drugs, or other therapies to target implantation sites within the subject's body. In this regard, in some embodiments, the delivery devices described herein may include a plurality of shafts that act independently of each other to improve the positioning of the artificial medical device within the subject's body. This specification discloses, in particular, exemplary devices and / or methods that can facilitate the actuation (e.g., axial movement) of one or more components of a delivery device relative to one or more other components of the delivery device.

[0022] Examples of the disclosed technology Figures 1 to 4 illustrate an exemplary transcatheter heart valve replacement procedure (e.g., mitral valve replacement) using a docking device 52 and an artificial heart valve 62 according to one embodiment. During the procedure, the user first uses a guide catheter 30 to create a pathway to the patient's own heart valve (Figure 1). The user then uses a delivery device 50 to deliver and implant the docking device 52 to the patient's own heart valve (Figure 2A), and after implanting the docking device 52, removes the delivery device 50 from the patient 10 (Figure 2B). The user then uses an artificial valve delivery device 60 to implant the artificial heart valve 62 inside the implanted docking device 52 (Figure 3A). The user then removes the artificial valve delivery device 60 from the patient 10 (Figure 3B), and further removes the guide catheter 30 (Figure 4).

[0023] Figure 1 illustrates one step in a mitral valve replacement procedure, in which a guide catheter 30 and a guide wire 40 are inserted into a blood vessel 12 of the patient 10 and navigated through the blood vessel 12 into the patient 10's heart 14, and further toward the patient's own mitral valve 16. Together, the guide catheter 30 and guide wire 40 can provide a pathway through and along which a delivery device 50 and an artificial valve delivery device 60 should be navigated toward the implantation site (the patient's own mitral valve 16 or the patient's own mitral annulus). As shown, the heart 14 is illustrated schematically. For example, the anterior leaflet and chordae tendineae of the patient's own mitral valve 16 are omitted for illustrative purposes so that only a portion of the posterior leaflet of the patient's own mitral valve 16 is illustrated.

[0024] Initially, the user may first make an incision in the patient's body to access the blood vessel 12. For example, in the example shown in Figure 1, the user may make an incision in the patient's groin to access the femoral vein. Thus, in such an embodiment, the blood vessel 12 may be the femoral vein.

[0025] After an incision has been made in the blood vessel 12, the user may insert a guide catheter 30, a guide wire 40, and / or additional devices (such as an introducer device or a transseptal puncture device) into the blood vessel 12 through the incision. The guide catheter 30 (which may also be referred to as the “introducer device,” “introducer,” or “guide sheath”) is configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., delivery device 50 and prosthetic valve delivery device 60) further into the blood vessel 12 through the blood vessel 12, and may extend into the heart 14 through the blood vessel 12, but may stop before reaching the progenitor mitral valve 16. The guide catheter 30 may comprise a handle 32 and a shaft 34 (which may also be referred to as the catheter shaft 34) extending distally from the handle 32. The shaft 34 can extend into the heart 14 through the blood vessel 12, while the handle 32 remains outside the patient's body, and the user can operate the handle 32 for the purpose of manipulating the shaft 34 (Figure 1).

[0026] The guidewire 40 is configured to guide the delivery device (e.g., guide catheter 30, delivery device 50, artificial valve delivery device 60, additional catheter, or similar) and associated devices (e.g., docking device, artificial heart valve, or similar) to the implantation site within the heart 14, and may extend entirely through the blood vessel 12 into the left atrium 18 (Figure 1) of the heart 14, and, in some embodiments, through the native mitral valve 16 into the left ventricle 26 of the heart 14.

[0027] In some cases, a transseptal puncture device or transseptal puncture catheter can be used to initially access the left atrium 18 before inserting the guidewire 40 and guide catheter 30. For example, after creating an incision in a blood vessel 12, the user may insert the transseptal puncture device into the blood vessel 12 through the incision. The user may guide the transseptal puncture device into the heart 14 through the blood vessel 12 (for example, into the right atrium 20 through the femoral vein). The user can then create a small incision in the atrial septum 22 of the heart 14 to allow access from the right atrium 20 to the left atrium 18. The user can then insert and advance the guidewire 40 into the left atrium 18 through the transseptal puncture device in the blood vessel 12 and further through the incision in the atrial septum 22. After positioning the guidewire 40 in the left atrium 18 and / or left ventricle 26, the transseptal puncture device can be removed from the patient 10. Subsequently, the user can insert the guide catheter 30 into the blood vessel 12 and advance the guide catheter 30 into the left atrium 18 along the guide wire 40 (Figure 1).

[0028] In some examples, an introducer device can be inserted through the lumen of the guide catheter 30 before inserting the guide catheter 30 into the blood vessel 12. In some examples, the introducer device may include a tapered end protruding from the distal end of the guide catheter 30 and configured to guide the guide catheter 30 into the left atrium 18 along the guidewire 40. In addition, in some examples, the introducer device may include a proximal end portion protruding from the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user can remove the introducer device from inside the guide catheter 30 and the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain inside the patient 10. The guide catheter 30 is then positioned to receive the implant delivery device and assist in guiding it into the left atrium 18, as will be further described below.

[0029] Figure 2A shows another stage in an exemplary mitral valve replacement, in which a docking device 52 is implanted into the patient's own mitral valve 16 in the heart 14 using a delivery device 50 (which may also be referred to as “implant catheter” or “dock delivery system,” “docking device delivery device” and / or “docking device delivery device”).

[0030] Generally, the delivery device 50 comprises a delivery shaft 54 ​​(which may also be called the “dock delivery system shaft”), a handle 56 (which may also be called the “dock delivery system handle”), and a pusher assembly 58. The delivery shaft 54 ​​is configured to be advanced by the user through the patient’s vascular structure (blood vessels 12) to the implantation site (e.g., the patient’s own mitral valve 16), and the docking device 52 may be configured to be held within the distal end portion 53 of the delivery shaft 54. In some embodiments, the distal end portion 53 of the delivery shaft 54 ​​holds the docking device 52 internally in a linear delivery configuration.

[0031] The handle 56 of the delivery device 50 is for advancing the delivery shaft 54 ​​through the patient's vascular system (e.g., blood vessel 12) and is configured to be grasped by a user and / or held by a user outside the patient's body 10.

[0032] In some embodiments, the handle 56 may include one or more articulated members 57 (or rotatable knobs) configured to assist in maneuvering the delivery shaft 54 ​​through the blood vessels 12. For example, one or more articulated members 57 may include one or more knobs, buttons, wheels, and / or other types of physically adjustable control members, which are configured to bend, curve, twist, rotate, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 ​​in order to assist in maneuvering the delivery shaft 54 ​​inside the heart 14 through the blood vessels 12.

[0033] The pusher assembly 58 may be configured to deploy and / or embed the docking device 52 into an implantation site (e.g., the patient's own mitral valve 16). For example, the pusher assembly 58 may be configured to be adjusted by the user to push the docking device 52 out from the distal end portion 53 of the delivery shaft 54. The shaft of the pusher assembly 58 (sometimes also referred to as the “pusher shaft”) may extend through the delivery shaft 54 ​​and be positioned adjacent to the docking device 52 within the delivery shaft 54. In some embodiments, the docking device 52 may be releasably coupled to the shaft of the pusher assembly 58 via a connection mechanism of the delivery device 50 so that the docking device 52 can be released after it has been deployed into the patient's own mitral valve 16.

[0034] Further details of the docking device delivery apparatus and its variations are described in International Patent Publication WO2020 / 247907, International Patent Application 2023 / 205076, and International Patent Application PCT / US2023 / 033745, which are incorporated herein by reference in their entirety.

[0035] Referring again to Figure 2A, after the guide catheter 30 is positioned within the left atrium 18, the user may 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 over the guide wire 40. In some embodiments, the guide wire 40 may be located away from the left atrium 18 and at least partially housed within the guide catheter 30. The user may then continue to advance the delivery shaft 54 ​​of the delivery device 50 along the guide wire 40 through the blood vessel 12, thereby bringing the delivery shaft 54 ​​into the left atrium 18, as illustrated in Figure 2A. Specifically, the user may advance the delivery shaft 54 ​​of the delivery device 50 by grasping the handle 56 of the delivery device 50 and applying force (e.g., pushing) toward the patient 10. When advancing the delivery shaft 54 ​​through the blood vessels 12 and the heart 14, the user may adjust one or more joint members 57 of the handle 56 to steer through various bends, corners, narrows, and / or other obstacles within the blood vessels 12 and the heart 14.

[0036] Once the delivery shaft 54 ​​has reached the left atrium 18 and extends outward from the distal end of the guide catheter 30, the user can use the handle 56 (e.g., the articulating member 57) to position the distal end portion 53 of the delivery shaft 54 ​​to and / or near the posteromedial commissure of the patient's own mitral valve 16. In some embodiments, the user can fine-tune the positioning of the distal end 53 of the delivery shaft 54 ​​using the procedure described below in relation to Figures 5-11. After the delivery shaft 54 ​​is positioned, the user can use the shaft of the pusher assembly 58 to push the docking device 52 out from the distal end 53 of the delivery shaft 54, deploying and / or embedding the docking device 52 into the annulus of the patient's own mitral valve 16.

[0037] In some embodiments, the docking device 52 may be constructed from, formed from, and / or contain a shape memory material, so that it may return to its original preformed shape when it exits the delivery shaft 54 ​​and is released from constraint by the delivery shaft 54. For example, the docking device 52 may be originally formed as a coil, so that it can wrap the valve leaflets 24 of the mitral valve 16 when it exits the delivery shaft 54 ​​and returns to its original coiled configuration.

[0038] After pushing the ventricular portion of the docking device 52 (for example, the portion of the docking device 52 shown in Figure 2A, which is configured to be positioned within the left ventricle 26 and / or on the ventricular side of the patient's own mitral valve 16), the user may then deploy the remaining portion of the docking device 52 (for example, the atrial portion of the docking device 52) from the delivery shaft 54 ​​in the left atrium 18 by retracting the delivery shaft 54 ​​away from the posteromedial commissure of the patient's own mitral valve 16.

[0039] After deploying and implanting the docking device 52 into the patient's own mitral valve 16, the user may disconnect the delivery device 50 from the docking device 52. After the docking device 52 is disconnected from the delivery device 50, the user may move the delivery device 50 away from the blood vessel 12 so that it is separated from the patient 10, thereby allowing the user to deliver and implant the artificial heart valve 62 in the implanted docking device 52 into the patient's own mitral valve 16.

[0040] Figure 2B illustrates this stage in mitral valve replacement, where the docking device 52 is fully deployed and implanted in the patient's own mitral valve 16, and the delivery device 50 (including the delivery shaft 54) is removed from the patient 10, leaving only the guidewire 40 and guide catheter 30 inside the patient 10. In some embodiments, after removal of the delivery device 50, the guidewire 40 may be advanced out of the guide catheter 30 through the docking device 52 implanted in the patient's own mitral valve 16 into the left ventricle 26 (Figure 2A). Thus, the guidewire 40 may help guide the prosthetic valve delivery device 60 through the annulus of the patient's own mitral valve 16 into the left ventricle 26, at least partially.

[0041] As illustrated in Figure 2B, the docking device 52 may include multiple turns (or coils) that wrap around the leaflets 24 of the patient's own mitral valve 16 (in the left ventricle 26). The implanted docking device 52 has a more cylindrical shape than the annulus of the patient's own mitral valve 16, thereby providing a geometric shape that more closely matches the shape or profile of the implanted prosthetic valve. As a result, the docking device 52 can be fitted more tightly between the prosthetic valve and the patient's own mitral valve 16, as will be further described below, thereby providing a better seal between the prosthetic valve and the patient's own mitral valve 16.

[0042] Figure 3A shows another stage in mitral valve replacement, in which the user uses an artificial valve delivery device 60 to deliver and / or implant an artificial heart valve 62 (which may also be referred to herein as a “transcatheter heart valve,” or more concisely, “THV,” “replacement heart valve,” and / or “artificial mitral valve”) into a docking device 52.

[0043] As shown in Figure 3A, the artificial valve delivery device 60 may 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 vascular structure to deliver, implant, expand, and / or otherwise deploy the artificial heart valve 62 in the docking device 52 to the patient's own mitral valve 16. The handle 66 is for advancing the delivery shaft 64 through the patient's vascular structure and is configured to be grasped and / or otherwise held by the user.

[0044] In some embodiments, the handle 66 may include one or more articulated members 68 configured to assist in maneuvering the delivery shaft 64 through the blood vessels 12 and the heart 14. Specifically, the articulated members 68 may include one or more knobs, buttons, wheels, and / or other types of physically adjustable control members, which are configured to be adjusted by the user to bend, curve, twist, rotate, and / or otherwise articulate the distal end portion of the delivery shaft 64 in order to assist in maneuvering the delivery shaft 64 through the blood vessels 12 into the left atrium 18 and further into the left ventricle 26 of the heart 14.

[0045] In some embodiments, the artificial valve delivery device 60 may include an expansion mechanism 65 configured to radially expand and deploy the artificial heart valve 62 at the implantation site. In some examples, as shown in Figure 3A, the expansion mechanism 65 may include an inflatable balloon configured to inflate in order to radially expand the artificial heart valve 62 within the docking device 52. The inflatable balloon may be connected to the distal end portion of the delivery shaft 64.

[0046] In other embodiments, the artificial heart valve 62 may be self-expanding and configured to expand radially on its own when the sheath or capsule covering the radially compressed artificial heart valve 62 on the distal end portion of the delivery shaft 64 is removed. In yet another embodiment, the artificial heart valve 62 may be mechanically expandable, and the artificial valve delivery device 60 may include one or more mechanical actuators (e.g., expansion mechanisms) configured to expand the artificial heart valve 62 radially.

[0047] As shown in Figure 3A, the artificial heart valve 62 is mounted on the distal end portion of the delivery shaft 64 in a configuration that is radially compressed around the expansion mechanism 65 (inflatable balloon).

[0048] To maneuver the distal end of the delivery shaft 64 towards the implantation site, the user can insert the prosthetic valve delivery device 60 (delivery shaft 64) into the patient 10 via the guide catheter 30 and along the guide wire 40. As illustrated in Figure 3A, the user can continue to advance the prosthetic valve delivery device 60 along the guide wire 40 (through the blood vessel 12) until the distal end of the delivery shaft 64 reaches the patient's own mitral valve 16. More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery device 60 by grasping the handle 66 and applying force (e.g., pushing). When advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the user can maneuver it through various bends, corners, stenoses, and / or other obstacles within the blood vessel 12 and the heart 14 by adjusting one or more articulated members 68 of the handle 66.

[0049] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed artificial heart valve 62, which is mounted around the distal end portion of the delivery shaft 64, is positioned within the docking device 52 and within the patient's own mitral valve 16. In some embodiments, as shown in Figure 3A, the distal end of the delivery shaft 64 and at least a portion of the radially compressed artificial heart valve 62 can be positioned within the left ventricle 26.

[0050] Once the radially compressed artificial heart valve 62 is properly positioned within the docking device 52 (Figure 3A), the user can operate one or more operating mechanisms of the handle 66 of the artificial valve delivery device 60 to activate the expansion mechanism 65 (for example, by inflating an inflatable balloon), thereby radially expanding the artificial heart valve 62 within the docking device 52.

[0051] Figure 3B shows another stage in mitral valve replacement surgery, in which the artificial heart valve 62 is in its radially extended configuration and is embedded within the docking device 52 of the patient's own mitral valve 16. As shown in Figure 3B, the artificial heart valve 62 is received and held inside the docking device 52. Thus, the docking device 52 assists in anchoring the artificial heart valve 62 inside the patient's own mitral valve 16. The docking device 52 can enable better sealing between the artificial heart valve 62 and the leaflets 24 of the patient's own mitral valve 16, thereby reducing paravalvular regurgitation around the artificial heart valve 62.

[0052] Furthermore, as shown in Figure 3B, after the artificial heart valve 62 has been fully deployed and implanted inside the docking device 52 at the site of the patient's own mitral valve 16, the artificial valve delivery device 60 (including the delivery shaft 64) is removed from the patient 10, leaving only the guidewire 40 and guide catheter 30 inside the patient 10.

[0053] Figure 4 shows another stage in mitral valve replacement surgery, where the guidewire 40 and guide catheter 30 have been removed from patient 10.

[0054] Figures 1-4 specifically illustrate mitral valve replacement, but it should be understood that the same and / or similar procedures can be used to replace other heart valves (e.g., tricuspid valve, pulmonary valve, and / or aortic valve). Furthermore, the same and / or similar delivery devices (e.g., delivery device 50, prosthetic valve delivery device 60, guide catheter 30, and / or guidewire 40), docking devices (e.g., docking device 52), replacement heart valves (e.g., prosthetic heart valve 62), and / or components can be used to replace these other heart valves.

[0055] For example, when a user replaces their own tricuspid valve, they may also have access to the right atrium 20 via the femoral vein, but it would not be necessary to cross the atrial septum 22 to enter the left atrium 18. Instead, the user can leave the guidewire 40 inside the right atrium 20 and perform the same and / or similar docking device implantation process 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 leaflets, freeing the rest of the docking device 52 from the delivery shaft 54 ​​inside the right atrium 20, and then remove the delivery shaft 54 ​​of the docking device delivery unit 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 artificial heart valve implantation process at the tricuspid valve inside the docking device 52. Specifically, the user may advance the delivery shaft 64 of the prosthetic valve delivery device 60 along the guidewire 40 through the patient's vascular structure until the prosthetic heart valve 62 is positioned / placed within the docking device 52 and the tricuspid valve. The user may then expand the prosthetic heart valve 62 inside the docking device 52, and then remove the prosthetic valve delivery device 60 from the patient 10. In another embodiment, the user may perform the same and / or similar process to replace the aortic valve, but access the aortic valve from the outflow side via the femoral artery.

[0056] Furthermore, while Figures 1-4 illustrate mitral valve replacement surgery accessing the patient's own mitral valve 16 from the left atrium 18 via the right atrium 20 and femoral vein, it should be understood that the patient's own mitral valve 16 can be alternatively accessed from the left ventricle 26. For example, a user may access the patient's own mitral valve 16 from the left ventricle 26 via the aortic valve by advancing one or more delivery devices through the arteries to the aortic valve, and then through the aortic valve to the left ventricle 26.

[0057] Figures 5 to 11 schematically illustrate the procedure for implanting an artificial medical device at a target implantation site in a subject (such as patient 10). In some embodiments, the procedure is a docking device implantation procedure for implanting a docking device 152 into the annular portion of the patient 10's own mitral valve 16. In some embodiments, one exemplary difference between the docking device 52 in Figures 1 to 4 and the docking device 152 in Figures 5 to 11 may be that the docking device 152 optionally includes a guard member 180 connected to the docking device 152, the guard member 180 may be configured to further reduce the possibility of paravalvular regurgitation between the annular portion of the patient's own mitral valve 16 and an artificial heart valve (such as an artificial heart valve 62) positioned within the docking device 152.

[0058] The procedures shown in Figures 5 to 11 may be carried out using a delivery device 150 (sometimes also called a “docking device delivery device”). In some embodiments, the delivery device 150 may be used as a docking device delivery device 50 in the artificial valve implantation procedure, as described above with reference to Figures 1 to 4. The delivery device 150 may comprise three independently operable shafts: a delivery shaft 154 (may also be called a “dock delivery system shaft”), a sleeve shaft 182, and a pusher shaft 184 (may also be called a “dock shaft”) (Figure 12). The pusher shaft 184 may be located within the sleeve shaft 182, which may then be located within the delivery shaft 154. In some embodiments, the delivery shaft 154, the sleeve shaft 182, and the pusher shaft 184 may be configured to be coaxial. The delivery shaft 154, sleeve shaft 182, and pusher shaft 184 operate independently of each other axially during the docking device implantation procedure to better position the docking device 152 within the annular portion of the progenitor mitral valve 16, so that the implanted docking device 152 better surrounds one or more chordae tendineae 27 of the heart 14 and provides a better seal between the implantation site and the progenitor valve (e.g., the progenitor valve 62).

[0059] During the procedure, the user of the delivery device 150 first uses the guide catheter 30 to create a pathway to the patient's own heart valve (Figure 5). Next, the user advances the distal end portion of the delivery device 150 distally to advance the docking device 152 to the target implantation site (Figures 6-7). In some embodiments of the procedure, the user can move the delivery system to change or adjust the curvature of the distal end portion of the delivery device 150 (see, for example, the leading turn 187 of the delivery device 150 in Figures 7-8). This adjustable radius of curvature may be referred to as a “variable encircling turn” (VET). The VET can facilitate the encircling of one or more chordae tendineae 27 that connect the valve leaflets 24 to the papillary muscles 28 of the heart 14, for example, by retracting the pusher shaft 184 proximal to the sleeve shaft 182.

[0060] In some embodiments where the docking device 152 further includes a guard member 180, the user can then retract the delivery shaft 154 and sleeve shaft 182 proximal to expose the guard member 180 (Figure 9) from the sleeve shaft 182. In some embodiments, the user can then advance the sleeve shaft 182 distally to apply an axial compressive force to the guard member 180, thereby shortening the guard member 180 axially and expanding it radially (Figure 10). Finally, the user can separate the docking device 152 from the pusher shaft 184 and remove the delivery device 150 from the patient 10 (Figure 11).

[0061] Figure 5 illustrates the steps of the procedure in which the guide catheter 30 advances distally through the patient's vascular structure into the left atrium 18 of the heart 14. The guide catheter 30 comprises a catheter shaft 34 including a distal end 72, a bent region 74, and a luminal outlet 76 on the distal end 72 of the catheter shaft 34. The luminal outlet 76 is connected to the catheter shaft lumen located within the catheter shaft 34. The delivery device (such as either an artificial device delivery device or an implantable catheter as described herein) is configured to be located within the catheter shaft lumen. The catheter shaft lumen extends from the proximal end portion of the catheter shaft 34 (such as the portion of the catheter shaft 34 coupled to the handle 32) to the luminal outlet 76. The guide catheter 30 is positioned so that the distal end 72 of the catheter shaft 34 is located within the left atrium 18 of the heart 14.

[0062] In some embodiments, the catheter shaft 34 may include one or more pull wires for adjusting the curvature of the bent region 74 of the catheter shaft 34. In some embodiments, the pull wires may extend through a lumen connected to a lumen outlet 76 and may be configured to be connected at or adjacent to the distal end 72 to a portion of the catheter shaft 34, such as a pull wiring. In some embodiments, the pull wires may extend through one or more pull wire lumens embedded in the catheter shaft 34. In some embodiments, the curvature of the bent region 74 of the catheter shaft 34 can be adjusted by adjusting the tension of the pull wires. In some cases, the catheter shaft 34 (including its bent region 74) may be configured to be formed integrally as a single, single component. In some cases, the catheter shaft 34 may be configured to have one or more segments (e.g., the bent region 74, other regions, etc.) that are connected together and in some cases as separate components (e.g., via fasteners, adhesives, fitting functions, and / or other connecting means). In some embodiments, the flexure region 74 may include a material that is more prone to bending, curving, and twisting than the rest of the catheter shaft 34 (e.g., a polymer with a relatively low durometer hardness). This allows the curvature of the flexure region 74 to be adjusted or increased at a different rate than the rest of the catheter shaft 34 when the pull wire is subjected to tension. For example, the curvature of the flexure region 74 may be configured to change at an increasing rate relative to the proximal portion of the catheter shaft 34 as the tension of the pull wire increases. The catheter shaft 34 may also include one or more reinforcing braids or jackets to make the catheter shaft 34 more resistant to bending, curving, and twisting, for example, to prevent one or more lumens from twisting or collapsing when the catheter shaft 34 is manipulated.

[0063] During this stage, the docking device 152 is positioned within the sleeve shaft 182, which is then positioned within the delivery shaft 154, which is then positioned within the catheter shaft 34. The pusher shaft 184 is positioned proximal to and adjacent to the docking device 152 within the sleeve shaft 182. In some embodiments, the docking device 152, sleeve shaft 172, delivery shaft 154, and catheter shaft 34 may be configured to be coaxially aligned. During this stage, the docking device 152 is in a generally linear delivery configuration (i.e., without coiled or looped portions, but capable of bending or flexing) so as to maintain a small radial profile as it moves through the patient's vascular structure.

[0064] Figure 6 illustrates the steps of the procedure in which the docking device 152, delivery shaft 154, sleeve shaft 182, and pusher shaft 184 advance distally through the luminal outlet 76 of the catheter shaft 34, through the left atrium 18, and toward the progenitor mitral valve 16. The docking device 152 is positioned within the sleeve shaft lumen of the sleeve shaft 182, which is then positioned within the delivery shaft lumen of the delivery shaft 154. The pusher shaft 184 is positioned proximal to the docking device 152 within the sleeve shaft 182.

[0065] In some embodiments, a delivery shaft 154, which may be similar to a delivery shaft 54, comprises a delivery shaft lumen into which a sleeve shaft 182 and a pusher shaft 184 can extend. The delivery shaft lumen is configured to extend axially along the length of the delivery shaft 154 between the handle of the delivery device 150 and the distal end portion 153 of the delivery shaft 154. The sleeve shaft 182 and the pusher shaft 184 are configured to exit the delivery shaft lumen through an opening in the distal end portion 153.

[0066] The sleeve shaft 182 extends through the delivery shaft 154 and is configured to cover at least a portion of the docking device 152 and the pusher shaft 184 as the docking device 152 is navigated through the patient's vascular structure to the patient's own mitral valve 16. The sleeve shaft 182 has a sleeve shaft lumen that extends along the length of the sleeve shaft 182 between the handle of the delivery device 150 and the distal end portion 186 of the sleeve shaft 182. In some embodiments, a portion of the sleeve shaft 182 (e.g., the proximal end portion) may have a substantially U-shaped axial cross-section, or other shape that allows the proximal end portion of the pusher shaft 184 to exit the sleeve shaft 182 at a position distal to the proximal end of the sleeve shaft 182. The distal end portion of the pusher shaft 184 can exit the sleeve shaft 182 at an opening in the distal end portion 186 of the sleeve shaft 182.

[0067] The distal end portion 186 of the sleeve shaft 182 is configured to capture the patient's own tissue (e.g., the patient's valve leaflets 24 and chordae tendineae 27). The sleeve shaft 182 may have a relatively low-friction and / or lubricating outer surface to reduce the possibility of the sleeve shaft 182 getting caught on the patient's own tissue.

[0068] In some embodiments, the sleeve shaft 182 may comprise multiple layers. For example, the sleeve shaft 182 may comprise an innermost polymer layer, a braid or other type of flexible reinforcing layer, and an outermost polymer layer. In some embodiments, the reinforcing layer is a shape memory material and / or an elastic material (e.g., nitinol and / or stainless steel).

[0069] In some cases, the distal end portion 186 of the sleeve shaft 182 may be curved to facilitate the capture of self-tissue. This can be achieved by forming the distal end portion 186 of the sleeve shaft 182 in a curved configuration, and / or by forming the sleeve shaft 182 of a material that is relatively more flexible than the docking device 152, and by advancing the curved docking device 152 into the sleeve shaft 182, which may result in the sleeve shaft 182 having a curved configuration and / or the curvature of the sleeve shaft 182 being modified by the docking device 152.

[0070] In this way, the distal end portion 186 of the sleeve shaft 182 can form a sleeve shaft leading turn 187 configured to capture the chordae tendineae 27 as the sleeve shaft 182 advances around the leaflets 24 of the mitral valve 16. The sleeve shaft leading turn 187 is a portion of the sleeve shaft 182 located in or adjacent to the distal end portion 186, which has a curved portion of the sleeve shaft 182 having a radius of curvature. If the docking device 152 is not covered within the portion of the sleeve shaft 182 corresponding to the sleeve shaft leading turn 187, the sleeve shaft leading turn 187 has a radius of curvature equal to a first radius of curvature (r1). As will be discussed later in this application, particularly with reference to Figures 7-8, the radius of curvature of the sleeve shaft leading turn 187 can be varied by the relative motion between the sleeve shaft 182 and the docking device 152. In some embodiments, the sleeve shaft 182 may be constructed from, formed from, and / or contain a shape memory material, and the sleeve shaft 182 may be originally formed such that the sleeve shaft leading turn 187 has a first radius of curvature (r1). The sleeve shaft leading turn 187 may be forced into another configuration having a different radius of curvature (e.g., a second radius of curvature (r2)), but can return to its original configuration having the first radius of curvature (r1) when the force is removed. In some embodiments, the second radius of curvature (r2) may be smaller than the first radius of curvature (r1).

[0071] In some embodiments, the sleeve shaft leading turn 187 can conform to the shape or curvature of another component (such as the docking device 152) covered by the sleeve shaft leading turn 187, so that the radius of curvature of the sleeve shaft leading turn 187 is equal to the corresponding radius of curvature of the other component. Thus, the distal end portion 186 of the sleeve shaft 182 can have a smaller radius of curvature when the distal end portion of the docking device 152 (such as the leading turn 189) is positioned in close proximity to or adjacent to the distal end portion 186 of the sleeve shaft 182. This is because the docking device 152 can have a smaller radius of curvature than the sleeve shaft 182 and may be relatively rigid. In some embodiments, the radius of curvature of the distal end portion 186 of the sleeve shaft 182 can be increased by moving the distal end of the docking device 152 proximal to the distal end portion 186 of the sleeve shaft 182, so that the sleeve shaft 182 can assume its predetermined configuration. This can be done by moving the docking device 152 proximal to the sleeve shaft 182 while maintaining the position of the sleeve shaft 182, by moving the sleeve shaft 182 distal to the docking device 152, or by a combination of both.

[0072] The pusher shaft 184 is configured to extend through the delivery shaft 154 and the sleeve shaft 182. The pusher shaft 184 is configured to be positioned proximal and adjacent to the docking device 152 within the sleeve shaft 182 while the docking device 152 is navigated through the patient's vascular structure to the patient's own mitral valve 16. As the pusher shaft 184 moves axially relative to the sleeve shaft 182, the pusher shaft 184 can apply force to the docking device 152, causing the docking device 152 to move axially. In some embodiments, the docking device 152 may be detachably coupled to the pusher shaft 184 via a connection mechanism of the delivery device 150 of the docking device, so that the docking device 152 can be released after it has been deployed to the patient's own mitral valve 16.

[0073] In some embodiments, the distal end portion 153 of the delivery shaft 154 may be positioned between the leaflets 24 of the native mitral valve 16 during this stage (e.g., at or near the posteromedial commissure). In some embodiments, the distal end portion 153 of the delivery shaft 154 may extend distally past the native mitral valve 16 and be positioned adjacent to the native mitral valve 16 of the left ventricle 26. In some embodiments, the distal end portion 153 of the delivery shaft 154 may be positioned adjacent to the native mitral valve 16 of the left atrium 18.

[0074] Once the distal end portion 153 of the delivery shaft 154 is positioned, the docking device 152, sleeve shaft 182, and pusher shaft 184 advance distally through the opening of the distal end portion 153 of the delivery shaft 154, through the progenitor mitral valve 16, and into the left ventricle 26.

[0075] Figure 7 shows the steps of the procedure in which the docking device 152 (located within the sleeve shaft 182), the sleeve shaft 182, and the pusher shaft 184 (located within the sleeve shaft 182 and adjacent to the docking device 152) wrap around or surround the valve leaflet 24 on the ventricular side of the native mitral valve 16. As the docking device 152 exits the delivery shaft 154, the docking device 152 takes on a coiled configuration configured to wrap around or surround the valve leaflet 24 on the ventricular side of the native mitral valve 16. In some embodiments in which the docking device 152 may be constructed from, formed from, and / or contain a shape memory material, the docking device 152 may be originally formed in a coiled configuration but may be forced into a linear delivery configuration by the delivery shaft 154. The docking device 152 can revert to its original coiled configuration once it is no longer covered by the delivery shaft 154.

[0076] As mentioned above, the portion of the sleeve shaft 182 covering the docking device 152 can be adapted to or assumed to conform to the shape and / or curvature of the corresponding portion of the docking device 152. For example, the sleeve shaft leading turn 187 can conform to the leading turn 189 of the docking device 152, and the leading turn 189 has a radius of curvature equal to the second radius of curvature (r2). Thus, the sleeve shaft leading turn 187 can be configured to have the second radius of curvature (r2). In other words, the variable circulating turn may be equal to the second radius of curvature (r2).

[0077] Figure 8 illustrates an optional step in the procedure for better capturing the chordae tendineae 27 within the docking device leading turn 189 by increasing the radius of curvature of the sleeve shaft leading turn 187 (in other words, the variable encircling turn) from a second radius of curvature (r2) to a first radius of curvature (r1). In some embodiments, the radius of curvature of the sleeve shaft leading turn 187 can be increased by retracting the pusher shaft 184 proximal to the sleeve shaft 182, thereby so that the docking device leading turn 189 and / or the docking device 152 are no longer covered by the sleeve shaft leading turn 187. In some embodiments, the radius of curvature of the sleeve shaft leading turn 187 can be increased by advancing the distal end portion 186 of the sleeve shaft 182 distal to the docking device 152. If the sleeve shaft leading turn 187 is no longer forced to conform to the curvature of the docking device leading turn 189 having a second radius of curvature (r2), the sleeve shaft leading turn 187 can revert to its original configuration having a first radius of curvature (r1) that is larger than the second radius of curvature (r2). The chordae tendineae 27 are trapped within the sleeve shaft leading turn 187, and by increasing the variable encircling turn to a larger first radius of curvature (r1), it becomes beneficially possible for more of the chordae tendineae 27 to be trapped by the sleeve shaft leading turn 187 as it advances around the valve leaflet 24.

[0078] During the steps shown in Figure 8, the delivery shaft 154 may be kept stationary to maintain the position of its distal end portion 153 relative to the mitral valve 16 (e.g., at or near the posteromedial commissure). In some embodiments, the sleeve shaft 182 may be kept stationary to maintain its position and / or radial orientation surrounding the mitral valve 16. In some embodiments, the docking device 152 and / or pusher shaft 184 may be kept stationary while the sleeve shaft 182 moves during this step. In some embodiments, either the sleeve shaft or the pusher shaft 184 is kept stationary during this step.

[0079] As shown in Figure 8, the variable encircling turn can be adjusted after the sleeve shaft 182 has made one helical rotation around the valve leaflet 24. However, in some embodiments, the variable encircling turn can be adjusted after the sleeve shaft 182 has formed multiple helical turns around the valve leaflet 24. In some embodiments, the variable encircling turn can be adjusted before any helical turn is formed around the valve leaflet 24.

[0080] Figure 9 illustrates an arbitrary step in the procedure in which the delivery shaft 154 and sleeve shaft 182 retract proximally to uncover the guard member 180. The docking device 152 comprises a coil 188 defining a central region 190 having a plurality of helical turns wound around the valve leaflet 24, and a docking device leading turn 189 extending from the distal end portion of the central region 190.

[0081] The docking device 152 may further comprise a guard member 180 positioned on the docking device 152 such that when the docking device 152 is implanted on the mitral valve 16, the guard member 180 is positioned on or near the mitral valve 16 (for example, on or near the posteromedial commissure). In some embodiments, the guard member 180 may be positioned proximal to a central region (Figure 22), which may comprise a plurality of helical turns when the docking device 152 is wrapped around the valve leaflets 24. The guard member 180 may extend between a distal end portion 191 fixedly connected to the docking device 152 and a movable proximal end portion 193 that can move axially along at least a portion of the docking device 152. In some embodiments, the distal end portion 191 of the guard member 180 may abut against the central region 190.

[0082] During the docking device implantation steps shown in Figures 5 to 8, the guard member 180 can be covered by the delivery shaft 154 and the sleeve shaft 182. However, during the step shown in Figure 9, the relative movement between the delivery shaft 154, the sleeve shaft 182, and the pusher shaft 184 can uncover the guard member 180. In some embodiments, the sleeve shaft 182 can retract proximally from the left ventricle 26 through the mitral valve 16 into the left atrium 18 such that the distal end portion 186 of the sleeve shaft 182 is closer to the user than the proximal end portion 193 of the guard member 180. In some embodiments, the distal end portion 186 of the sleeve shaft 182 may be configured to be positioned distal to the lumen outlet 76. In some embodiments, the guard member 180 may be configured to be uncovered by advancing the pusher shaft 184 distal to the sleeve shaft 182.

[0083] In some embodiments, the delivery shaft 154 can be retracted proximally through the left atrium 18 so that the distal end portion 153 of the delivery shaft 154 is closer to the user than the proximal end portion 193 of the guard member 180. In some embodiments, the delivery shaft 154 may be configured to be housed within the catheter shaft lumen of the catheter shaft 34 through the lumen outlet 76. In some embodiments, the pusher shaft 184 can be advanced distally relative to the delivery shaft 154 so that the distal end portion 153 of the delivery shaft 154 is positioned proximal to the guard member 180.

[0084] Figure 10 illustrates an optional “seating” step in the procedure of advancing the sleeve shaft 182 distally relative to the docking device 152 to shorten the guard member 180 axially and expand it radially. In some embodiments, the sleeve shaft 182 can be advanced distally such that the distal end portion 186 of the sleeve shaft 182 abuts and contacts the proximal end portion 193 of the guard member 180. In some embodiments, the pusher shaft 184 (and the docking device 152 connected to the pusher shaft 184) can be retracted proximally such that the distal end portion 186 of the sleeve shaft 182 abuts and contacts the proximal end portion 193 of the guard member 180. The sleeve shaft 182 applies force to the guard member 180, advancing 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 connected to the docking device 152, an axial force is applied to the guard member 180, causing it to radially expand into a deployed configuration. When in the deployed configuration, the guard member 180 further reduces the possibility of paravalvular regurgitation between the natural mitral valve 16 and the artificial heart valve (such as the artificial heart valve 62). The frictional engagement between the proximal end of the guard member 180 and the docking device 152 allows the guard member 180 to maintain its position relative to the docking device 152 when the sleeve shaft 182 retracts from the proximal end of the guard member 180.

[0085] Figure 11 shows the steps of the procedure in which the delivery device 150, including the delivery shaft 154 and the sleeve shaft 182, retracts through the lumen of the catheter shaft 34. In some embodiments, the docking device 152 may be connected to the pusher shaft 184 via a release suture 194 which may be configured to tie to the docking device 152. The release suture 194 may be cut at this stage to release the docking device 152 from the delivery device 150.

[0086] Figure 12 shows a delivery device 150 according to one embodiment. The delivery device 150 may also be referred to as a "dock delivery device," "dock delivery catheter," or "dock delivery system." The delivery device 150 comprises a delivery shaft 154, a handle 156 connected to the proximal end of the delivery shaft 154 (sometimes also called a "dock delivery system handle"), a sleeve shaft 182 configured to extend through the delivery shaft 154 and the handle 156, a hub assembly 200 connected to the proximal end of the sleeve shaft 182 (sometimes also called a "dock handle"), a pusher shaft 184 configured to extend through the handle 156 and the sleeve shaft 182, and a sleeve handle 196 connected to the proximal end of the sleeve shaft 182.

[0087] The delivery shaft 154, which in some embodiments may be similar to the delivery shaft 54, is configured by the user to advance through the patient's vascular structure (blood vessel 12) to the implantation site (e.g., the patient's own mitral valve 16), and the docking device 152 may be configured to be held within the distal end portion 153 of the delivery shaft 154. During the docking device implantation procedure, the delivery shaft 154 advances through the catheter shaft 34 of the guide catheter 30 (e.g., through its central lumen) to the target implantation site.

[0088] The handle 156, which may be similar to the handle 56 in some embodiments, is for advancing the delivery shaft 154 through the patient's vascular system (e.g., blood vessel 12) and is configured to be grasped by a user and / or held by a user outside the patient's body 10. In some embodiments, the handle 156 may include one or more articulated members 157 (or rotatable knobs) configured to assist in maneuvering the delivery shaft 154 through the blood vessel 12 by manipulating or controlling the bending of the delivery device 150 (e.g., the delivery shaft 154). Some embodiments of the articulated members 157 may be similar to the articulated members 57. The handle 156 has a handle lumen (not shown) extending through the length of the handle 156, the handle lumen configured to receive a sleeve shaft 182 and a pusher shaft 184. The sleeve shaft and pusher shafts 182, 184 extending through the handle lumen also extend through the delivery shaft 154, so the handle lumen can be aligned coaxially with the delivery shaft 154. In some embodiments, the handle 156 may further include a locking assembly 198 configured to lock a device (e.g., a sleeve shaft 182) inserted through the handle lumen, thereby selectively preventing the device from moving relative to the delivery device 150. In some embodiments, the locking assembly 198 may be located on the proximal end portion of the handle 156.

[0089] The sleeve handle 196 is for advancing the sleeve shaft 182 through the patient's vascular system and is configured to be grasped and / or otherwise held by the user outside the patient's body. The sleeve handle 196 is connected to the proximal end portion of the sleeve shaft 182 and is positioned proximal to the user, closer to the handle 156 and the hub assembly 200. The axial position of the sleeve shaft 182 can be controlled by moving the sleeve handle 196 axially relative to the handle 156 and / or the hub assembly 200.

[0090] The hub assembly 200 is configured to be grasped and / or otherwise held by the user outside the patient 10's body in order to advance the pusher shaft 184 through the patient's vascular system. The proximal end portion of the pusher shaft 184 is connected to the hub assembly 200 and may extend at least partially within the hub assembly 200. The hub assembly 200 is axially positioned between the handle 156 and the sleeve handle 196. In some cases, the axial position of the pusher shaft 184 may be controlled by axially moving the entire hub assembly 200 relative to the handle 156 and / or the sleeve handle 196.

[0091] Further details regarding delivery devices / catheters / systems (including various embodiments of handle assemblies) configured to deliver a docking device to a target implantation site can be found in PCT International Publications WO2020 / 247907 and WO2022 / 072509, U.S. Patents 10,940,000 and 11,065,111, all of which are incorporated herein by reference in their entirety.

[0092] A user of the docking device delivery device 150 can perform a variable encircling turn by moving the pusher shaft 184 axially relative to the delivery shaft 154 and the sleeve shaft 182 (Figures 7-8). 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, a variable encircling turn can be performed by moving the entire hub assembly 200 distally relative to the sleeve handle 196 while the handle 156 and the sleeve handle 196 are stationary.

[0093] The hub assembly 200 of this disclosure may be configured to advance the pusher shaft 184 into the patient's vascular structure without requiring movement of the hub assembly 200 relative to the sleeve shaft 182. As will be described in more detail below, the hub assembly 200 may include a linear actuator 202 configured to advance the pusher shaft 184 relative to the hub assembly 200 (and sleeve shaft 182) to perform a variable encircling turn as needed (Figures 7-8). The linear actuator 202, in particular, allows the user to fine-tune the relative position of the pusher shaft (and therefore the coil) and the sleeve shaft.

[0094] The hub assembly 200 comprises an outer housing 204, and the linear actuator 202 may be at least partially located within the housing 204. For example, as shown in Figures 13 to 16, the linear actuator 202 may comprise an articulated member 206 (e.g., a rotatable knob) connected to the housing 204 and a traveler 208 (e.g., a lead screw) located within the housing 204. The knob 206 is operably connected to the traveler 208, and the operation of the knob 206 (e.g., rotation relative to the housing 204) causes the traveler 208 to move in parallel with respect to the housing 204. For example, the knob 206 may have a threaded inner surface 210, and the traveler 208 may have a threaded outer surface 212 operably connected to the threaded inner surface 210 (e.g., a threaded connection). Thus, the operation of the knob 206 (e.g., rotation) can facilitate the linear motion of the traveler 208 via the threaded connection between surfaces 210 and 212.

[0095] 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 along the length of the hub assembly 200 (Figure 16). The sleeve shaft 182 extends proximal to 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) relative to the housing 204 within the hub assembly lumen 214, for example, by moving the sleeve handle 196 relative to the hub assembly 200.

[0096] The pusher shaft 184 is at least partially located within the sleeve shaft 182 and partially extends within the hub assembly 200. The pusher shaft 184 is configured to move (e.g., translate) relative to and / or within the sleeve shaft 182 relative to the hub assembly housing 204. The pusher shaft 184 is coupled to the traveler 208 such that the pusher shaft 184 and the traveler 208 are configured to move together axially. In this way, the operation of the linear actuator 202 causes the movement (e.g., translation) of the pusher shaft 184 relative to the hub assembly 200.

[0097] As described above, the pusher shaft 184 extends from the sleeve shaft 182 at a position distal to the proximal end of the sleeve shaft 182 (e.g., proximal to the sleeve handle 196). For example, as shown in Figure 21, the proximal end portion of the sleeve shaft 182 may have a partially annular (e.g., substantially U-shaped or C-shaped) axial cross-section that allows the proximal segment 185 of the pusher shaft 184 to extend from the sleeve shaft 182 at an angle to the sleeve shaft 182 (e.g., branching away from 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 internal region of the housing 204 (e.g., at the end of the traveler 208), while the proximal portion of the sleeve shaft 182 extends to the sleeve handle 196 located proximal to and outside the housing 204. This configuration allows medical personnel to deploy the docking device (e.g., docking device 152 in Figure 20) by manipulating the position of the hub assembly 200 (e.g., moving the hub assembly 200 axially) and / or manipulating the position of the traveler 208 (e.g., rotating the knob 206 relative to the housing 204), and to retract and detach the device by pulling the sleeve shaft 182 out of the implanted docking device by pulling the sleeve handle 196 axially.

[0098] Thus, the sleeve shaft 182 and the pusher shaft 184 may be configured to move together when deploying and positioning the docking device on the natural valve (for example, by moving the entire hub assembly 200 axially forward), but they may also move independently, for example, to fine-tune the positioning of the docking device on the natural valve (for example, by performing VET as described above in relation to Figures 7-8), and / or to withdraw the sleeve shaft 182 from the docking device while the pusher shaft 184 holds the docking device in place (e.g., by pulling the sleeve handle 196 proximally to retract the sleeve shaft 182 while the hub assembly 200 is held in place relative to the delivery shaft 154 of the delivery device 150 and / or other parts of the delivery device 150 and / or the docking device).

[0099] As shown in Figure 21, the proximal portion 197 of the sleeve shaft 182 may define an open channel. For example, the channel of the sleeve shaft 182 may be radially open, so that the proximal segment 185 of the pusher shaft 184 can extend outward from the open channel and move away from the sleeve shaft 182 at an angle to the longitudinal axis of the sleeve shaft 182. In some embodiments, the proximal portion 197 of the sleeve shaft 182 may also be referred to herein as the “open channel”. The open channel 197 may have a substantially U or C-shaped cross-section. In some embodiments, as shown, the open channel 197 has a curved outer surface, so that the open channel 197 has a partially annular cross-section (e.g., a C-shaped cross-section). Specifically, the open channel 197 may be a partially annular structure having an inwardly facing concave surface and an outwardly facing convex surface. In this way, the inwardly facing concave surface of the open channel 197 can form a void space in which the pusher shaft 184 can be at least partially positioned (Figure 21). In various embodiments, the open channel 197 can be cut using a laser, but other means can be used to form the open channel (e.g., by removing part of the tubular structure).

[0100] The distal segment of the sleeve shaft 182 may have a closed channel or lumen such that the channel closes radially (e.g., in an annular cross-section) (Figure 12). The pusher shaft 184 may extend through the closed channel of the sleeve shaft 182. For example, the pusher shaft 184 may be coaxial with the sleeve shaft 182 along part or most of the delivery device 150, such as through the closed channel of the sleeve shaft 182. The open channel 197 may extend, for example, from an intermediate axial position of the sleeve shaft 182 to the proximal end of the sleeve shaft 182, for example, to the sleeve handle 196. In other embodiments, the open channel 197 of the sleeve shaft 182 may extend proximal from the intermediate axial position without extending to the proximal end of the sleeve shaft 182. In these embodiments, the open channel 197 forms an axially extending window or slot, which allows the proximal segment 185 of the pusher shaft 184 to project outward at an angle from the sleeve shaft 182.

[0101] In some embodiments, due to frictional forces within the delivery device 150, the movement of the pusher shaft 184 based on the operation of the linear actuator 202 may also cause movement of the sleeve shaft 182 within the lumen 214 of the hub assembly. However, in order to perform a variable encircling turn (Figures 7-8), the pusher shaft 184 must move axially relative to the sleeve shaft 182, not together with it. To overcome the frictional forces present between the sleeve shaft 182 and the pusher shaft 184 when performing a variable encircling turn, the hub assembly 200 further includes a locking mechanism 216 in some embodiments. The locking mechanism 216 is configured to lock the sleeve shaft 182 relative to the hub assembly 200 so as to selectively prevent the sleeve shaft 182 from moving relative to the hub assembly 200. Therefore, when the locking mechanism 216 is in a locked configuration, the linear actuator 202 may be operated to move the pusher shaft 184 axially while the locking mechanism 216 holds the sleeve shaft 182 stationary relative to the hub assembly 200. In this way, the operation of the linear actuator 202 causes the pusher shaft 184 to move relative to the hub assembly 200 (for example, relative to the housing 204 and the sleeve shaft 182). In some embodiments, instead of a locking mechanism, the user of the delivery device 150 can perform a variable encircling turn by holding the sleeve shaft 182 stationary (for example, by holding the sleeve handle 196) while operating the linear actuator 202.

[0102] The locking mechanism 216 may be configured to prevent the sleeve shaft 182 from moving relative to the hub assembly 200 when the locking mechanism 216 is in a locked configuration. In an unlocked configuration, the locking mechanism 216 may be configured to allow such movement. Referring to Figures 16 and 18, the locking mechanism 216 may comprise a rotatable knob 218 (also referred herein as the “locking 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 embodiment, the shaft 224 may include a threaded region 226 having an internal thread and a tapered region 228. The tapered region 228 includes an inner surface 230 which may be tapered proximal to a smaller internal diameter.

[0103] As shown in Figure 18, the collet 220 may include a male thread 232 configured to engage with a female thread in the threaded region 226 of the shaft 224. The collet 220 may also include a projection 234 (also referred to herein as a “cantilever arm”) extending axially from the proximal end of the collet 220. In some cases, as shown, the collet 220 may include four projections 234. In other cases, it should be understood that the collet 220 may include a different number of projections 234. The collet 220 may also include a central lumen 236 extending from the distal end to the proximal end of the collet 220. The central lumen 236 may be coaxial with the hub assembly lumen 214 of the hub assembly 200.

[0104] When the locking mechanism 216 is in the unlocked configuration, the projection 234 extends straight from the collet 220. In other words, the diameter of the central lumen 236 is uniform from the distal end to the proximal end of the collet 220. In the unlocked configuration, the diameter of the central lumen 236 may be the same as the diameter of the hub assembly lumen 214. The locking mechanism 216 can be configured to switch from an unlocked configuration to a locked configuration by rotating the knob 218 relative to the hub assembly 200 by a predetermined amount (e.g., 1 / 4 turn, 1 / 2 turn, 1 turn, multiple turns, etc.).

[0105] As the knob 218 rotates, the collet 220 may move axially relative to the knob 218 toward the tapered region 228 of the shaft 224. When the locking mechanism 216 is in a locked configuration, the projection 234 may contact the inner surface 230 of the shaft 224 and may be pushed radially inward or bent by the tapered inner surface 230. In other words, in the locked configuration, the tapered inner surface 230 causes the diameter of the central lumen 236 at the proximal end of the collet 220 to be smaller than the diameter at the distal end of the collet 220. In this way, the projection 234 may clamp around a device (e.g., a sleeve shaft 182) inserted through the hub assembly 200 to lock the device in place. Thus, the projection 234 may be configured to prevent the device from moving relative to the hub assembly 200 (e.g., a housing 204).

[0106] As shown in Figure 18, the central lumen 236 of the collet 220 may have a circular cross-section, as defined by the projection 234. Figures 19A and 19B show a collet 320 of another embodiment that may be included in the locking mechanism 216 instead of the collet 220. The collet 320 is similar to the collet 220. For example, the collet 320 includes a male thread 332 configured to engage with the female thread of the knob 218. However, the central lumen 336 of the collet 320 has a different cross-sectional shape from the central lumen 236 of the collet 220, as defined by the extension 334. As described above, the proximal portion 197 of the sleeve shaft 182 may have a partial annular cross-section (e.g., a U-shaped cross-section, a C-shaped cross-section, etc.) in some embodiments. To allow the collet 320 to engage with more surfaces of the partial annular sleeve shaft 182 and provide sufficient locking force (e.g., enough force to overcome frictional forces between the sleeve shaft 182 and the pusher shaft 184), the central lumen 336 of the collet 320 can be configured to accommodate the partial annular cross-section of the sleeve shaft 182. As shown, the extensions 334 each have different shapes and / or sizes, with some extensions (e.g., extension 334a) having a smaller cross-sectional area compared to others (e.g., extensions 334b-334d), and extensions (e.g., extension 334b) having a curved inner surface and / or a flat inner surface (e.g., extensions 334a, 334c, 334d). In some embodiments, as shown in Figure 19A, the central lumen 336 can be slit from the distal end to the proximal end of the collet 320, thereby allowing the sleeve shaft 182 to be inserted into the collet 320 in both radial and axial directions. In some embodiments, the extension 334 defines a slotless, partially annular central lumen 336. For example, the extension 334 may define a central lumen 336 having a D-shaped cross-section that surrounds a partially annular cross-section of the sleeve shaft 182. The central lumen 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.

[0107] Referring to Figures 14 to 16, the chassis 238 (Figure 16) may be connectable to the proximal end of the traveler 208 and configured to move axially with the traveler 208. The suture locking assembly 240 and one or more seals 242 may be coupled to the chassis 238. The hub assembly 200 may further include one or more flush ports (e.g., flush port 244) for supplying cleaning fluid to one or more lumens located within the delivery device 150 (e.g., annular lumens located between coaxial components of the delivery device 150) for maintaining hemostasis within the delivery device 150. The flush port 244 may be coupled to the chassis 238 for supplying cleaning fluid to the distal end of the seal 242.

[0108] In some embodiments, the proximal end portion of the pusher shaft 184 may extend to the chassis 238 and be operably connected to a suture locking assembly 240. As described above, the proximal end portion of the pusher shaft 184 may branch off or be angled away from the sleeve shaft 182 so as to extend toward the suture locking assembly 240, for example, in some embodiments. In some embodiments, the suture locking assembly 240 is configured to be detachably connected to the proximal end of the release suture 194. In some embodiments, the suture locking assembly 240 may include a rotor 241 (which may also be called a “rotatable handle”) for increasing and decreasing the tension of the release suture 194, which may extend from the suture locking assembly 240 through the lumen of the pusher shaft 184 to the docking device 152. The suture locking assembly 240 may be configured, for example, to cut the release suture 194 at the end of the procedure for implanting the docking device 152, thereby releasing the docking device 152 from the delivery device 150. Further details of the suture locking assembly that may be used with the hub assembly 200 are described in International Patent Applications PCT / US2023 / 025726 and PCT / US2023 / 025730, which are incorporated herein by reference in their entirety.

[0109] In some embodiments, the user may operate the suture locking assembly 240 for a limited time during a procedure (for example, at the end of a procedure to release the docking device 152 from the delivery device 150). Thus, it may be useful to have the suture locking assembly 240 accessible to the user during those specific times, but otherwise inaccessible to the user (for example, to prevent accidental operation of the suture locking assembly 240). To ensure that the suture locking assembly 240 is accessible only when the user intends to operate it, the housing 204 of the hub assembly 200 may have a cap 246 (or cover) that is connected to the rest of the housing 204 and is at least partially removable from the housing 204. As shown in Figure 14, the cap 246 can be partially removed from the housing 204 to expose the internal area of ​​the housing 204 that houses the suture locking assembly 240. Therefore, with the internal area of ​​the housing 204 exposed, the user can operate the suture locking assembly 240 and / or other components located within the housing 204. In some embodiments, the cap 246 may include a tab 248 that is operable to release the cap 246 from the rest of the housing 204. In some embodiments, as shown, the cap 246 is hinged to the housing 204. For example, after the user presses the tab 248, the user can lift the cap 246 away from the housing 204, thereby making the internal area accessible to the user and allowing the user to operate the suture locking assembly 240. In some embodiments, the cap 246 is connectable to the housing 204 via a spring, and after the tab 248 is pressed in, the cap 246 is biased toward moving away from the housing 204. In some embodiments, the cap 246 may be slidably mounted to the housing 204 so that the user can slide the cap 246 against the housing 204 to expose the internal area within the housing 204.In some embodiments, the housing 204 does not include a cap 246 so that the suture locking assembly 240 is exposed to the user throughout the procedure.

[0110] As described above, one or more seals 242 may be positioned within the chassis 238 such that the chassis 238 defines at least partially 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 may be positioned at the proximal end of the chassis 238 and around the outer surface of the sleeve shaft 182. As described above, the proximal portion 197 of the sleeve shaft 182 may have a partial annular cross-section, and the seals 242 may be configured to seal around the partial annular cross-section. Further details of the seals and seal assemblies for the shafts are described in U.S. Provisional Patent Application No. 63 / 482,210, which is incorporated herein by reference in its entirety.

[0111] The cap 246 and / or housing 204 may define a slot 250 between the cap 246 and the rest of the housing 204. The slot 250 extends axially along the length of the cap 246. As shown in Figure 13, the slot 250 defines an opening to the housing 204, and the flush port 244 may extend outward from the chassis 238 and through the slot 250 to the outside of the housing 204. Thus, the flush port 244 is accessible to the user when the cap 246 is closed, as well as when the user operates the linear actuator 202 to perform a variable encircling turn as described below.

[0112] As shown in Figures 17A to 17C, the axial position of the traveler 208 relative to the hub assembly 200 can be adjusted by operating the linear actuator 202 (for example, by rotating the knob 206). The connection between the traveler 208 and the pusher shaft 184 causes the movement of the traveler 208 to result in the movement of the pusher shaft 184. Figures 17A to 17C show a configuration in which the locking mechanism 216 is locked, thereby preventing the sleeve shaft 182 from moving relative to the hub assembly 200. As described above, by adjusting the axial position of the pusher shaft 184 relative to the sleeve shaft 182, the magnitude of the radius of curvature of the sleeve shaft leading turn 187 (for example, the VET described above in relation to Figures 7 to 8) can be changed. In particular, the radius of curvature of the sleeve shaft leading turn 187 correlates with the axial position of the pusher shaft 184 relative to the sleeve shaft 182.

[0113] In some embodiments, the traveler 208 can at least partially protrude from the housing 204 in a portion of its axial position, thereby allowing the traveler 208 to travel a greater axial distance without increasing the size of the hub assembly 200. For example, the traveler 208 may extend through an opening 247 at the distal end of the housing 204. In this way, the hub assembly 200 can be designed to an ergonomic size that allows for user operation and can achieve a wider range of radii of curvature for the sleeve shaft leading turn 187. Figure 17A shows the traveler 208 (and therefore the pusher shaft 184) in a first axial position relative to the hub assembly 200. In the first position, the traveler 208 is fully positioned within the housing 204. Rotating the knob 206 in a first direction (e.g., clockwise) relative to the housing 204 moves the traveler 208 and the pusher shaft 184 distal to the housing 204. For example, moving from the first axial position to a second axial position (Figure 17B). In some embodiments, as shown, the distal end of the traveler 208 may partially extend from the housing 204 in a second axial position. When the traveler 208 is in the second axial position, the traveler 208 and pusher shaft 184 can be further moved distally to the housing 204 to a third axial position by rotating the knob 206 in a first direction relative to the housing 204 (Figure 17C). In the third axial position, a larger portion of the traveler 208 extends outside the housing 204. By rotating the knob 206 in a second direction (e.g., counterclockwise), the traveler 208 and pusher shaft 184 can be moved proximal to the housing 204, for example, from the third axial position to the second axial position. The first, second, and third axial positions each correspond to different radii of curvature of the sleeve shaft leading turn 187. In this way, the radius of curvature of the sleeve shaft leading turn 187 can be adjusted by operating the linear actuator 202 to move the traveler 208 and pusher shaft 184 between the axial positions shown in Figures 17A and 17C.In other embodiments, the traveler 208 may be held and housed within the housing 204 in all axial positions.

[0114] In some embodiments, the hub assembly 200 (e.g., housing 204, knob 206, and / or traveler 208) may further include an indicator configured to show the magnitude of the variable encircling turn. The radius of curvature of the sleeve shaft leading 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 traveler 208; therefore, the radius of curvature of the sleeve shaft leading turn 187 can be determined based on the relative axial positions of the housing 204 and the traveler 208 and / or components connected thereto (e.g., flush port 244). In some embodiments, the indicator may include one or more markings positioned along the length of the slot 250. A first marking positioned towards the proximal end of slot 250 may indicate that the radius of curvature of the sleeve shaft leading turn 187 (i.e., the variable encircling turn) is equal to the first radius of curvature (r1), and a second marking positioned towards the distal end of slot 250 may indicate that the radius of curvature of the sleeve shaft leading turn 187 is equal to the second radius of curvature (r2). In some embodiments, the indicator may be configured to indicate the magnitude of the variable encircling turn based on the amount of rotation of the knob 206 relative to the housing 204. The indicator may consist of a visual representation of the coil (e.g., various curvatures), words (e.g., "greater" and / or "smaller"), and / or other indicator means.

[0115] When the axial position of the traveler 208 is adjusted, the axial positions of the components connected to the traveler 208 are adjusted accordingly. For example, the chassis 238, suture locking assembly 240, seal 242, and flush port 244 can all move together with the traveler 208. As described above, the flush port 244 may extend outward from the chassis 238 and outward from the housing 204 through the slot 250. Thus, when the linear actuator 202 is operated to move the traveler 208, the flush port 244 may move along the length of the slot 250. In the first axial position (Figure 17A), the flush port 244 is positioned adjacent to the proximal end of the hub assembly 200, for example, at the proximal end of the slot 250. In the third axial position (Figure 17C), the flush port 244 is positioned adjacent to the distal end of the hub assembly 200, for example, at the distal end of the slot 250.

[0116] As shown in Figures 16 and 17C, the traveler 208 may comprise a pair of axially extending rails 252 and a plurality of supports 254 extending between the rails 252. Each rail 252 has a threaded outer surface 212 that can engage with a threaded inner surface 210 of the knob 206. To change the linear operating speed, the thread pitch of the threaded inner surface 210 can be changed. For example, a smaller thread pitch of the threaded inner surface 210 results in slower operation of the pusher shaft 184 relative to the housing 204, while a larger thread pitch increases the travel speed of the pusher shaft 184. In other words, when the knob 206 rotates a predetermined amount (e.g., 1 / 4 turn) relative to the housing 204, the traveler 208 can move axially by different amounts based on the thread pitch of the threaded inner surface 210.

[0117] The sleeve shaft 182 and the pusher shaft 184 may extend through and / or between the support 254 (for example, through an opening in the support 254). In some embodiments, the pusher shaft 184 may be fixedly coupled to the traveler 208 at one or more of the support 254 so that the traveler 208 and the pusher shaft 184 move together axially. In some embodiments, the pusher shaft 184 may be fixedly coupled to the chassis 238. The sleeve shaft 182 may be configured to move relative to the traveler 208 (for example, axially) through an opening defined by the support 254.

[0118] Figure 20 illustrates an example of a docking device 152. As shown in Figure 20, the unfolded coil-shaped docking device 152 is configured to receive and secure an artificial valve (e.g., an artificial heart valve 62) within the docking device 152, thereby securing the artificial valve to the annulus of the native mitral valve 16.

[0119] The docking device 152 includes a coil 188. In some embodiments, the coil 188 may include a shape memory material (e.g., nickel-titanium alloy, or "nitinol") so that the docking device 152 (and the coil 188) can transition from a substantially linear configuration (or delivery configuration) when placed inside the delivery shaft 154 to a helical unfolding configuration after being removed from the delivery shaft 154.

[0120] The coil 188 has a proximal end 188p and a distal end 188d (which also define the proximal and distal ends of the docking device 152, respectively). When positioned within the delivery shaft 154 (for example, during the delivery of the docking device 152 into the patient's vascular system), the body of the coil 188 between the proximal end 188p and the distal end 188d can form a generally straight delivery configuration (having no coiled or looped portions, but being bent or curved) to maintain a small radial profile as it moves through the patient's vascular system. After being removed from the delivery shaft 154 and unfolded at the implantation site, the coil 188 can transition from a delivery configuration to a helical unfolded configuration and can be wound around the patient's own tissue adjacent to the implantation site. For example, when the docking device is implanted at the site of a proximal valve, the coil 188 may be configured to surround the proximal valve leaflets (and the chordae tendineae connecting the proximal valve leaflets to the adjacent papillary muscles).

[0121] The unfolded coiled coil 188 may include a docking device leading turn 189, a central region 190, and a stabilizing turn 195 (or "stabilizing coil") around the central longitudinal axis.

[0122] In the unfolded coiled configuration, the central region 190 comprises one or more helical turns formed around the central longitudinal axis of the docking device 152, the helical turns having substantially equal radii of curvature configured to surround the valve leaflets 24 of the self-mitral valve 16. The docking device leading turn 189 extends from the distal end of the central region 190 and has a larger radius of curvature than the helical turns of the central region 190. In some embodiments, the radius of curvature of the docking device leading turn 189 of the docking device 152 is equal to the second radius of curvature, and the second radius of curvature is smaller than the first radius of curvature of the sleeve shaft leading turn 187.

[0123] In the illustrated example, the stabilizing turn 195 may extend from the proximal end of the central region 190 and have a diameter larger than the diameter of the central region 190. Alternatively, the stabilizing turn 195 may have a diameter equal to, approximately equal to, or smaller than (as opposed to) the diameter of the central region 190, and / or the stabilizing turn may contain fewer turns than the complete turn illustrated in Figure 22.

[0124] In some embodiments, the docking device 152 may further include a guard member 180 positioned on the coil 188. The guard member is configured to reduce the possibility of paravalvular regurgitation between the patient's own mitral valve 16 and the artificial heart valve. In some embodiments, the guard member 180 may include a braided portion positioned between the distal end portion 191 and the proximal end portion 193 of the guard member 180. The braided portion is configured to shorten into an unfolded configuration when the proximal end portion 193 is forced distally, and the braided portion has increased radial thickness in the shortened unfolded configuration.

[0125] Further details relating to the docking device and its variations are described in International Patent Publication WO2022 / 087336, which is incorporated herein by reference in its entirety.

[0126] Any system, device, apparatus, etc. described herein may be sterilized (e.g., using heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use for patients, and any method described herein may include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of sterilization by heating / heat include steam sterilization and autoclave sterilization. Examples of radiation used for sterilization include, but are not limited to, gamma rays, ultraviolet rays, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization by hydrogen peroxide may be carried out, for example, using hydrogen peroxide plasma.

[0127] Treatment techniques, methods, steps, etc., described or suggested herein, or described or suggested in references incorporated herein, can be performed on living animals or on non-living simulations such as corpses, corpse hearts, anthropomorphic ghosts, simulators (in which parts of the body, tissues, etc., are simulated), etc.

[0128] delivery technology To implant a prosthetic valve into the patient's own aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned inside the patient's own aortic valve and expanded radially (for example, by inflating a balloon, by activating one or more actuators of the delivery device, or by deploying the prosthetic valve from its sheath to make it self-expandable). Alternatively, the prosthetic valve may be implanted inside the patient's own aortic valve via a transapical procedure, thereby introducing the prosthetic valve (on the distal end portion of the delivery device) into the left ventricle through surgical openings in the chest and the apex of the heart, and positioning the prosthetic valve inside the patient's own aortic valve. As an alternative configuration, in the transaortic procedure, the prosthetic valve (on the distal end of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, by a partial J-sternotomy or a small right parasternal thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0129] To implant the prosthetic valve into the patient's own mitral valve via a transseptal delivery approach, the prosthetic valve is fitted in a radially compressed state along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into the inferior vena cava, and through the inferior vena cava to the right atrium, across the interatrial septum (through the puncture site made within the interatrial septum) to the left atrium, and toward the patient's own mitral valve. Alternatively, the prosthetic valve may be implanted within the patient's own mitral valve via a transapical procedure, in which case the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and at the apex of the heart, and the prosthetic valve is positioned within the patient's own mitral valve.

[0130] To implant a prosthetic valve within the patient's own tricuspid valve, the prosthetic valve is fitted in a radially compressed state along the distal end of the delivery device. The prosthetic valve and the distal end of the delivery device are inserted into the femoral vein, advanced into the inferior vena cava and through the inferior vena cava into the right atrium, and the prosthetic valve is positioned within the patient's own tricuspid valve. A similar approach can be used to implant a prosthetic valve into the patient's own pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the patient's own tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0131] Another delivery approach is the transatrial approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through a chest incision and through an incision formed through the atrial wall (the atrial wall of the right or left atrium) to access one of the patient's own heart valves. Atrial delivery can also be performed intravascularly, for example, through the pulmonary vein. Yet another delivery approach is the transventricular approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through a chest incision and through an incision formed through the wall of the right ventricle (typically the base of the heart or nearby) to implant the prosthetic valve inside the patient's own tricuspid valve, or inside the patient's own pulmonary valve, or inside the pulmonary artery.

[0132] In all delivery approaches, the delivery device can be advanced along a guidewire previously inserted into the patient's vascular system. Furthermore, the disclosed delivery approaches are not intended to be limiting. Any artificial valve disclosed herein can be implanted using any variety of delivery procedures and any variety of delivery devices known in the art.

[0133] Additional examples of the disclosed technology In consideration of the above-mentioned implementation of the disclosed subject matter, this application discloses the following additional embodiments. It should be noted that two or more features of an embodiment, taken as one feature or combination of features of a separated embodiment, and in combination with one or more features of one or more further embodiments of any choice, are further embodiments that similarly fall within the disclosure of this application.

[0134] Example 1. A delivery device for a docking device, comprising: a housing; a linear actuator coupled to the housing, the linear actuator comprising: a traveler; an articulated member coupled to the traveler, wherein the traveler moves axially relative to the housing based on the rotation of the articulated member relative to the housing; a first shaft extending through the housing and configured to move axially relative to the housing; a second shaft extending through the first shaft and coupled to the traveler of the linear actuator, wherein the second shaft and the traveler are configured to move together axially; 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 the first shaft is movable relative to the housing in an unlocked configuration.

[0135] Example 2. A delivery device according to any embodiment of this specification, particularly the one described in Example 1, wherein the proximal portion of the first shaft has a partially annular axial cross-section.

[0136] Example 3. A delivery device according to any embodiment of this specification, particularly Example 1 or Example 2, wherein the locking mechanism includes a collet having a lumen, and a first shaft extends through the lumen.

[0137] Example 4. A delivery device according to any embodiment of this specification, particularly Example 3, wherein the lumen has a non-circular cross-section.

[0138] Example 5. A delivery device according to any embodiment of this specification, particularly Example 3 or Example 4, wherein the collet comprises an extension configured to clamp around a first shaft in a locked configuration, and the extension is of a non-uniform shape and / or size.

[0139] Example 6. A delivery device according to any embodiment of this specification, in particular any one of Examples 1 to 5, wherein the second shaft extends distal to the proximal end of the first shaft.

[0140] Example 7. A delivery device for a docking device, comprising: a housing having an opening at its distal end; a first shaft extending through the housing and configured to move relative to the housing; a second shaft extending through the first shaft; and a linear actuator connected to the housing, wherein the linear actuator comprises a traveler and an articulated member coupled to the traveler, wherein the traveler moves axially relative to the housing between a first axial position and a second axial position based on the rotation of the articulated member relative to the housing, and the second shaft and the traveler move together, and the traveler protrudes at least partially from the opening of the housing at the second axial position.

[0141] Example 8. A delivery device according to any embodiment of this specification, particularly Example 7, wherein the traveler has a threaded outer surface and the joint member has a threaded inner surface.

[0142] Example 9. A delivery device according to any embodiment of this specification, particularly Example 7 or Example 8, wherein the housing comprises a cap, the cap being coupled to the housing and at least partially removable from the housing.

[0143] Example 10. A delivery device according to any embodiment of this specification, in particular any one of Examples 7 to 9, further comprising a locking mechanism connected to a housing, wherein the first shaft is prevented from moving relative to the housing in a locked configuration and is movable relative to the housing in an unlocked configuration.

[0144] Example 11. A delivery device according to any embodiment of this specification, particularly any one of Examples 7 to 10, wherein the second shaft extends distal to the proximal end of the first shaft.

[0145] Example 12. A delivery device for a docking device, comprising: a housing defining an internal region; a linear actuator connected to the housing and configured to move axially relative to the housing, comprising a lead screw and a chassis connected to the lead screw, the chassis being positioned within the internal region of the housing; a pusher shaft extending through the housing and connected to the lead screw, configured such that the pusher shaft and the lead screw move together relative to the housing; and a cap coupled to the housing and at least partially removable from the housing, selectively exposing the internal region.

[0146] Example 13. A delivery device according to any embodiment of this specification, particularly the one described in Example 12, wherein the cap is rotatably connected to the housing.

[0147] Example 14. A delivery device according to any embodiment of this specification, particularly the one described in Example 12, wherein the cap is slidably connected to the housing.

[0148] Example 15. A delivery device according to any embodiment of this specification, in particular any one of Examples 12 to 14, further comprising a suture extending through a pusher shaft and a suture locking assembly connected to a chassis, wherein the suture is removably connected to the suture locking assembly.

[0149] Example 16. A delivery device according to any embodiment of this specification, particularly Example 15, wherein the suture locking assembly is located within an internal region and is accessible when the cap is partially removed from the housing.

[0150] Example 17. A delivery device according to any embodiment of this specification, particularly the one described in Example 16, wherein the housing and cap define a slot that extends axially along the length of the housing.

[0151] Example 18. A delivery device according to any embodiment of this specification, in particular Example 17, further comprising a flush port coupled to a chassis, wherein the flush port extends from an internal area of ​​the housing through a slot so that the flush port can be accessed when the cap is closed on the housing.

[0152] Example 19. A delivery device according to any embodiment of this specification, in particular any one of Examples 12 to 18, further comprising a sleeve shaft extending through a housing, a pusher shaft extending through the sleeve shaft, and the pusher shaft exiting the sleeve shaft within an internal region of the housing.

[0153] Example 20. A delivery device for a docking device, comprising a housing, a sleeve shaft extending through the housing, the sleeve shaft having a U-shaped or C-shaped axial cross-section, and a locking mechanism connected to the housing and including a collet having a lumen, wherein the sleeve shaft extends through the lumen, the lumen having a non-circular cross-section, the sleeve shaft is prevented from moving relative to the housing in a locked configuration, and the sleeve shaft is movable relative to the housing in an unlocked configuration.

[0154] Example 21. A delivery device according to any embodiment of this specification, in particular Example 20, comprising an extension configured to clamp around a sleeve shaft in a collet-locked configuration, wherein the extension is of a non-uniform shape and / or size.

[0155] Example 22. A delivery device according to any embodiment of this specification, particularly Example 20 or Example 21, further comprising a pusher shaft extending through a sleeve shaft.

[0156] Example 23. A delivery device according to any embodiment of this specification, particularly Example 22, wherein the pusher shaft exits from the sleeve shaft distal to the proximal end of the sleeve shaft.

[0157] Example 24. A delivery device according to any embodiment herein, particularly Example 22 or Example 23, comprising a linear actuator connected to a housing, wherein the linear actuator comprises a traveler and an articulated member coupled to the traveler, the traveler moves axially relative to the housing based on the rotation of the articulated member relative to the housing, and a pusher shaft is connected to the traveler of the linear actuator, the pusher shaft and the traveler move together axially.

[0158] Example 25. A delivery device according to any example of this specification, in particular any one of Examples 1 to 24, wherein the delivery device is sterilized.

[0159] Example 26. A method for implanting an artificial medical device at a target implantation site, comprising: advancing an artificial medical device, which is connected to the distal end of a pusher shaft of a delivery device and held within a sleeve shaft of a delivery device, toward the target implantation site by moving the sleeve shaft and pusher shaft distally relative to the handle of the delivery device; locking the position of the sleeve shaft relative to the hub assembly of the delivery device using a locking mechanism connected to the hub assembly of the delivery device; and operating a linear actuator of the hub assembly to move the pusher shaft axially relative to the sleeve shaft and hub assembly.

[0160] Example 27. Any embodiment of this specification, particularly the method of Example 26, comprising releasing the lock of the sleeve shaft and moving the sleeve shaft proximal to the pusher shaft and hub assembly to withdraw the sleeve shaft from the artificial medical device.

[0161] With respect to any embodiment, the features described in this disclosure may be combined with other features described in any one or more of the other embodiments, unless otherwise specified. For example, any one or more features of one delivery device may be combined with any one or more features of another delivery device.

[0162] Given the many possible ways in which the principles of this disclosure may be applied, it will be recognized that the illustrated configurations illustrate examples of the disclosed technology and should not be considered as limiting the scope of this disclosure or the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A delivery device for docking devices, Housing and A linear actuator connected to the housing, wherein the linear actuator comprises a traveler and an articulated member coupled to the traveler, and the traveler moves axially relative to the housing based on the rotation of the articulated member relative to the housing. A first shaft extending through the housing and configured to move axially relative to the housing, A second shaft extending through the first shaft and connected to the traveler of the linear actuator, wherein the second shaft and the traveler are configured to move together in the axial direction, A delivery device comprising a locking mechanism connected to the housing, wherein the first shaft is prevented from moving relative to the housing in a locked configuration, and the first shaft is movable relative to the housing in an unlocked configuration.

2. The delivery device according to claim 1, wherein the proximal portion of the first shaft has a partially annular axial cross-section.

3. The delivery device according to claim 1 or 2, wherein the locking mechanism includes a collet having a lumen, and the first shaft extends through the lumen.

4. The delivery device according to claim 3, wherein the lumen has a non-circular cross-section.

5. The delivery device according to claim 3 or 4, wherein the collet comprises an extension configured to clamp around the first shaft in the locked configuration, the extension having a non-uniform shape and / or size.

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

7. A delivery device for docking devices, A housing having an opening at the distal end, A first shaft extending through the housing and configured to move relative to the housing, A second shaft extending through the first shaft, A delivery device comprising a linear actuator connected to the housing, wherein the linear actuator comprises a traveler and an articulated member coupled to the traveler, wherein the traveler moves axially relative to the housing between a first axial position and a second axial position based on the rotation of the articulated member relative to the housing, and the second shaft and the traveler move together, and the traveler protrudes at least partially from an opening in the housing at the second axial position.

8. The delivery device according to claim 7, wherein the traveler has a threaded outer surface and the joint member has a threaded inner surface.

9. The delivery device according to claim 7 or 8, wherein the housing comprises a cap, the cap is connected to the housing and is at least partially removable from the housing.

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

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

12. A delivery device for docking devices, A housing that defines the internal area, A linear actuator connected to the housing and configured to move axially relative to the housing, comprising a lead screw and a chassis connected to the lead screw, wherein the chassis is positioned within the internal region of the housing, A pusher shaft extending through the housing and connected to the lead screw, wherein the pusher shaft and the lead screw are configured to move together relative to the housing, A delivery device comprising a cap coupled to the housing and at least partially removable from the housing, which selectively exposes the internal region.

13. The delivery device according to claim 12, wherein the cap is rotatably connected to the housing.

14. The delivery device according to claim 12, wherein the cap 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 pusher shaft and a suture locking assembly connected to the chassis, wherein the suture is detachably connected to the suture locking assembly.

16. The delivery device according to claim 15, wherein the suture locking assembly is positioned within the internal region and is accessible when the cap is partially removed from the housing.

17. The delivery device according to claim 16, wherein the housing and the cap define a slot that extends axially along the length of the housing.

18. The delivery device according to claim 17, further comprising a flash port coupled to the chassis, wherein the flash port extends from the internal region of the housing through a slot so as to be accessible when the cap is closed on 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 the pusher shaft exits the sleeve shaft within the internal region of the housing.

20. A method for implanting an artificial medical device into a target transplant site, The artificial medical device, which is connected to the distal end of the pusher shaft of the delivery device and held within the sleeve shaft of the delivery device, is advanced toward the target implantation site by moving the sleeve shaft and pusher shaft distally relative to the handle of the delivery device. 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, A method comprising acting a linear actuator of the hub assembly to move the pusher shaft axially relative to the sleeve shaft and the hub assembly.

Images