Handle for implant delivery device

Abstract

Disclosed are devices and methods for a handle for a delivery device for a prosthetic medical device. In one example, the handle for the delivery device includes an outer housing and a spine positioned within the outer housing. The spine includes a central lumen, an axially extending recess radially depressed into the spine from an outer surface of the spine toward the central lumen, and a support wall separating the central lumen and the axially extending recess. The handle further includes a pull wire extending through the recess and out from a proximal end portion of the recess to a wire wrap coupled to the outer surface of the spine.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 480,676, filed January 19, 2023, which is incorporated herein by reference in its entirety.

[0002] SUMMARY The present disclosure relates to a handle for a delivery device for a prosthetic medical device. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can lead to serious cardiac dysfunction and ultimately require repair of the native valve or replacement of the native valve with a prosthetic valve. There are several known repair devices (e.g., stents) and prosthetic valves, as well as several known methods for implanting these devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations within the body that are not easily accessible by surgery or where non-surgical access is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site within the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon to which the prosthetic valve is mounted, activating a mechanical actuator that applies an expansive force to the prosthetic valve, or deploying the prosthetic valve from a sheath in the delivery device, allowing the prosthetic valve to self-expand to its functional size.

[0004] A delivery device for delivering a prosthetic medical device, such as the prosthetic heart valve delivery device described above, can include an elongated shaft that is inserted into a patient's vascular system. The delivery device can also include a handle that remains outside the patient and can be used to manipulate the shaft. Summary of the Invention

[0005] Described herein are prosthetic heart valves, delivery devices, and methods for implanting prosthetic heart valves. The disclosed prosthetic heart valves, delivery devices, and methods can be configured, for example, to transmit torque applied to a handle of the delivery device via a spine assembly to the distal end of a shaft extending distally from the delivery device. In some embodiments, the spine assembly can include a spine having one or more axially extending recesses recessed radially into the spine from its outer surface. Each axially extending recess is configured to receive a pull wire of an adjustment mechanism therethrough, allowing the pull wire to be routed externally of the spine. The pull wires can be configured to adjust the amount of curvature of the distal end portion of the shaft of the delivery device. The recesses can extend only radially through a portion of the spine, which can increase the strength of the spine. As such, the devices and methods disclosed herein can overcome, among other things, one or more deficiencies of typical delivery devices.

[0006] A handle for a delivery device for a prosthetic implant may include an outer housing and a spine positioned within the outer housing.

[0007] In some examples, a handle for a delivery device may include a spine positioned within an outer housing of the handle, the spine having a central lumen and an axially extending recess that is depressed radially into the spine from an outer surface of the spine toward the central lumen, the axially extending recess being spaced from the central lumen by a support wall of the spine.

[0008] In some embodiments, a handle for a delivery device includes an outer housing and a spine positioned within the outer housing. The spine includes a central lumen, an axially extending recess radially depressed into the spine from an outer surface of the spine toward the central lumen, and a support wall separating the central lumen and the axially extending recess. The handle further includes a pull wire extending through the recess and out a proximal end portion of the recess to a wire wrap coupled to the outer surface of the spine.

[0009] In some embodiments, a handle for a delivery device comprises one or more of the components listed in Examples 1-16 below.

[0010] A delivery device for a prosthetic implant may include a handle and one or more shafts coupled to the handle.

[0011] In some examples, the delivery device may include a handle including a spine positioned within an outer housing of the handle, the spine having a central lumen and an axially extending recess radially depressed into the spine from an outer surface of the spine toward the central lumen, the axially extending recess being spaced from the central lumen by a support wall of the spine.

[0012] In some examples, the delivery device may include a handle including a spine positioned within an outer housing of the handle, the spine having a central lumen and axially extending recesses that are depressed radially into the spine from an outer surface of the spine, at least one recess being depressed only partially into a wall thickness of the spine defined between the outer surface and the central lumen.

[0013] In some embodiments, a delivery device comprises a handle including an outer housing and a spine positioned within the outer housing. The spine comprises a central lumen and at least one axially extending recess radially recessed into the spine from an outer surface of the spine, the at least one recess being only partially recessed into a wall thickness of the spine defined between the outer surface and the central lumen. The delivery device further comprises a shaft positioned within the central lumen of the spine and extending distally from the handle. The delivery device further comprises an adjustment mechanism configured to adjust the curvature of a distal end of the shaft, the adjustment mechanism comprising a pull wire connected between the distal end of the shaft and a wire wrap coupled to the outer surface of the spine, a proximal end portion of the pull wire extending from inside the at least one recess to an exterior of the spine and connecting to the wire wrap.

[0014] In some embodiments, a delivery device includes a handle including an outer housing and a spine positioned within the outer housing. The spine includes a central lumen, a first axially extending recess radially depressed into the spine from an outer surface of the spine, and a second axially extending recess radially depressed into the spine from an outer surface of the spine and positioned circumferentially spaced from the first axially extending recess. Each of the first axially extending recess and the second axially extending recess includes a base offset from the central lumen by a respective support wall of the spine. The delivery device further includes a shaft positioned within the central lumen of the spine and extending distally from the handle, and an adjustment mechanism configured to adjust the curvature of the distal end of the shaft, the adjustment mechanism including a first pull wire routed through the first axially extending recess and a second pull wire routed through the second axially extending recess.

[0015] In some embodiments, a delivery device includes a handle, a delivery shaft extending distally from the handle, a pusher shaft extending through the delivery shaft and the handle, and a hub assembly extending proximally from the handle. The hub assembly includes an adapter coupled to the handle, the adapter including a first section and a second section branching from the first section, a portion of the pusher shaft extending into the second section, and a gasket disposed around a portion of the pusher shaft within the second section such that a fluid seal is created around the portion of the pusher shaft. The hub assembly further includes a suture lock assembly coupled to a proximal end of the second section and configured to adjust tension on a suture extending from the suture lock assembly and through the pusher shaft, the suture lock assembly including a release bar configured to removably couple to the second section of the adapter, the release bar including an inner lumen configured to receive a suture therethrough and a sealing element disposed around an outer surface of the release bar and configured to seal against an inner surface of the second section of the adapter. The hub assembly further includes a first flush port coupled to the second section proximal to the gasket and fluidly coupled to a first fluid flow lumen disposed within the interior of the pusher shaft.

[0016] In some embodiments, the delivery device comprises one or more of the components listed in Examples 17-54 below.

[0017] The various innovations of this disclosure may be used in combination or individually. This Summary is provided to introduce in a simplified form a selection of various concepts that are further described in the Detailed Description below. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. These and other objects, features, and advantages of the present disclosure will become more apparent from the following Detailed Description, the claims, and the accompanying drawings. [Brief explanation of the drawings]

[0018] [Figure 1] FIG. 1 schematically illustrates the first step in an exemplary mitral valve replacement procedure, in which a guide catheter and guidewire are inserted into a patient's blood vessels and navigated through the vessels into the patient's heart toward the heart's native mitral valve. [Figure 2A] FIG. 2A schematically illustrates the second step in an exemplary mitral valve replacement procedure, in which a docking device delivery device extending through a guide catheter implants a docking device for a prosthetic heart valve into the native mitral valve. [Figure 2B] FIG. 2B schematically illustrates a third stage in an exemplary mitral valve replacement procedure, in which the docking device of FIG. 2A has been fully implanted into the patient's native mitral valve and the docking device delivery device has been removed from the patient. [Figure 3A] FIG. 3A schematically illustrates a fourth step in an exemplary mitral valve replacement procedure, in which a prosthetic heart valve delivery device extending through a guide catheter implants a prosthetic heart valve into a docking device already implanted with the native mitral valve. [Figure 3B] FIG. 3B schematically illustrates a fifth stage in an exemplary mitral valve replacement procedure, in which the prosthetic heart valve is fully implanted within the docking device with the native mitral valve and the prosthetic heart valve delivery device has been removed from the patient. [Figure 4] FIG. 4 shows a schematic representation of a sixth stage in an exemplary mitral valve replacement procedure, in which the guide catheter and guidewire have been removed from the patient. [Figure 5] FIG. 5 is a side view of a delivery device configured to deliver a prosthetic medical device to a target implantation site in a patient, according to one embodiment. [Figure 6] 6 is a side cross-sectional view of the delivery device of FIG. 5. FIG. [Figure 7] 7 is a perspective view of the delivery device of FIG. 5 with a distal portion of the housing removed to show the internal components of the delivery device. [Figure 8] FIG. 8 is a perspective view of a spine extension of the delivery device of FIG. 5 according to one embodiment. [Figure 9]FIG. 9 is a perspective view of a distal portion of the housing of the delivery device of FIG. 5 according to one embodiment. [Figure 10] 10 is a proximal end view of the spine extension of FIG. 8 positioned within the distal portion of the housing of FIG. 9. FIG. [Figure 11] 11 is a perspective view of the delivery device of FIG. 5 showing the shaft of the delivery device with the distal portion of the housing and spine extension removed. [Figure 12] 12 is another perspective view of the delivery device of FIG. 5 with a distal portion of the housing removed. [Figure 13] 13 is a perspective view of the spine assembly of the delivery device of FIG. 5 positioned about the shaft of the delivery device of FIG. 5, the spine assembly including the spine extension of FIG. 9. FIG. [Figure 14] 14 is a perspective view of the distal spine of the spine assembly of FIG. 13. FIG. [Figure 15] 15 is a perspective view of the proximal spine of the spine assembly of FIG. 13. FIG. [Figure 16] 16 is a perspective view of the components of the adjustment mechanism positioned on the spine assembly of FIG. 13. FIG. [Figure 17] 17 is a perspective view of additional components of the adjustment mechanism positioned on the spine assembly of FIG. 13. FIG. [Figure 18] 18 is a perspective view of an upper segment of the middle portion of the housing of the delivery device of FIG. 5. FIG. [Figure 19] 19 is a perspective view of a lower segment of the middle portion of the housing of the delivery device of FIG. 5. FIG. [Figure 20] 20 is a top view of the middle section of the delivery device of FIG. 5 with the upper segment of the middle portion of the housing of FIG. 18 removed. [Figure 21] 21 is a perspective view of the mid-section of the delivery device of FIG. 5 with the upper segment of the mid-portion of the housing of FIG. 18 removed, showing the components of the indicator assembly. [Figure 22]22 is a perspective view of the middle portion of the delivery device of FIG. 5 with the upper segment of the middle portion of the housing and the window of the indicator assembly of FIG. 18 removed. [Figure 23] 23 is another perspective view of the delivery device of FIG. 5. FIG. [Figure 24] 24 is a perspective view of the delivery device of FIG. 5 with a proximal portion of the housing removed to show the internal components of the delivery device. [Figure 25] 25 is a side cross-sectional view of the proximal section of the delivery device of FIG. 5. FIG. [Figure 26] FIG. 26 is a perspective view of a seal housing of the delivery device of FIG. 5 according to one embodiment. [Figure 27] FIG. 27 is a perspective view of a sealing compression member of the delivery device of FIG. 5, according to one embodiment. [Figure 28] 28 is a perspective view of a seal assembly of the delivery device of FIG. 5 including the seal housing of FIG. 26 and the seal compression member of FIG. 27 according to one embodiment. [Figure 29] FIG. 29 is a side view of another delivery device configured to deliver a prosthetic medical device to a target implantation site in a patient, according to one embodiment. [Figure 30] 30 is a side view of an exemplary delivery system including the delivery device of FIG. [Figure 31] FIG. 31 is a perspective view of a spine for the delivery device of FIG. 5, the spine including an axially extending recess that receives a pull wire of the adjustment mechanism therethrough. [Figure 32A] 32A is a side view of a portion of the spine of FIG. 31 showing a first axially extending recess. [Figure 32B] FIG. 32B is a side cross-sectional view of a portion of the spine of FIG. 32A. [Figure 33A] 33A is a side view of a portion of the spine of FIG. 31 showing a second axially extending recess. [Figure 33B] FIG. 33B is a side cross-sectional view of a portion of the spine of FIG. 33A. [Figure 33C]FIG. 33C is an end cross-sectional view taken along a first section of the spine shown in FIG. 33A, the first section showing both the first axially extending recess and the second axially extending recess. [Figure 33D] FIG. 33D is a cross-sectional end view taken along the second section of the spine shown in FIG. 33A, the second section showing a proximal portion of the second axially extending recess. [Figure 34] FIG. 34 is a side view of a delivery device configured to deliver a prosthetic medical device to a target implantation site in a patient, according to one embodiment. [Figure 35] 35 is a perspective view of a spine for the delivery device of FIG. 34, the spine including an axially extending recess that receives a pull wire of the adjustment mechanism therethrough. [Figure 36A] FIG. 36A is a side view of a portion of the spine of FIG. 35 showing a first axially extending recess. [Figure 36B] FIG. 36B is a side cross-sectional view of a portion of the spine of FIG. 36A. [Figure 37A] FIG. 37A is a side view of a portion of the spine of FIG. 35 showing a second axially extending recess. [Figure 37B] FIG. 37B is a side cross-sectional view of a portion of the spine of FIG. 37A. [Figure 37C] FIG. 37C is a cross-sectional end view taken along a first section of the spine shown in FIG. 37A, the first section showing both the first axially extending recess and the second axially extending recess. [Figure 37D] FIG. 37D is a cross-sectional end view taken along the second section of the spine shown in FIG. 37A, the second section showing a proximal portion of the second axially extending recess. [Figure 38A] 38A is a side view of the hub assembly of the delivery device of FIG. 34. FIG. [Figure 38B] FIG. 38B is a side view of the hub assembly of FIG. 38A, with the Y-connector of the hub assembly shown as transparent, revealing the underlying components. [Figure 38C] FIG. 38C is an end view of the hub assembly of FIG. 38A. [Figure 38D] FIG. 38D shows a side cross-sectional view of the hub assembly of FIG. 38A taken along the section shown in FIG. 38C, showing the flushing port of the Y-connector located proximal to the gasket disposed inside the Y-connector. [Figure 39] FIG. 39 is a side view of the suture lock assembly of the hub assembly of FIG. 38A, with the suture lock assembly disconnected from the Y-connector. [Figure 40] FIG. 40 is a simplified schematic diagram of the delivery device of FIG. 34 showing the fluidly coupled flow lumens of the delivery device. DETAILED DESCRIPTION OF THE INVENTION

[0019] General Considerations For purposes of description, certain aspects, advantages, and novel configurations of examples of the disclosure are described in this disclosure. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone, in various combinations with each other, and in various subcombinations with each other. The methods, apparatus, and systems are not limited to any particular aspect, feature, or combination thereof, nor do the disclosed embodiments require that any one or more particular advantages be present or problems be solved.

[0020] Although some operations in the disclosed embodiments are described in a particular sequential order for convenience of presentation, it should be understood that aspects of the description encompass reordering unless a specific order is required by specific language set forth below. For example, operations described sequentially may, in some cases, be reordered or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods can be used in combination with other methods. Also, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0021] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Furthermore, the term "coupled" generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intervening elements between coupled or associated members unless specific language to the contrary exists.

[0022] The term "proximal," as used in this disclosure, refers to a position, direction, or portion of a device that is closer to the user and farther from the implantation site. The term "distal," as used in this disclosure, refers to a position, direction, or portion of a device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of a device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial," unless expressly defined otherwise, refer to axes extending in the proximal and distal directions.

[0023] As used herein, "eg" means "for example" and "ie" means "that is."

[0024] Overview of the Disclosed Technology Described herein are various systems, devices, methods, etc. that, in some embodiments, may be used within or with a delivery device for a prosthetic medical device (such as a prosthetic heart valve or docking device). In some embodiments, the delivery devices disclosed herein may be used to deliver a docking device for a transcatheter prosthetic heart valve within a patient's vasculature at a target implantation site. For example, Figures 1-4 schematically illustrate an exemplary transcatheter heart valve replacement procedure utilizing a guide catheter to guide a docking device delivery device toward the native valve annulus and then a prosthetic heart valve delivery device toward the native valve annulus. A docking device delivery device is used to deliver the docking device to the native valve annulus, and then a prosthetic heart valve delivery device is used to deliver the transcatheter prosthetic heart valve within the docking device.

[0025] As described above, a defective native heart valve can be replaced with a transcatheter prosthetic heart valve. However, such a prosthetic heart valve may not be able to adequately conform to the shape of the native tissue (e.g., to the leaflets and / or annulus of the native heart valve) and may move undesirably relative to the native tissue, which may result in paravalvular leakage. Therefore, a docking device may be first implanted into the native valve annulus, and then the prosthetic heart valve may be implanted within the docking device, which helps anchor the prosthetic heart valve to the native tissue and provide a seal between the native tissue and the prosthetic heart valve.

[0026] An exemplary delivery device for delivering a docking device at a native heart valve is shown in more detail in FIGS. 5-30. In some embodiments, as shown in FIGS. 5-22, the delivery device can include a spine assembly within the handle of the delivery device configured to transmit torque applied to the handle to the shaft of the delivery device. Additional details of an exemplary spine assembly are shown in FIGS. 8 and 13-15. The delivery device can also include an adjustment mechanism for manipulating (e.g., controlling, steering, bending, etc.) the distal end of the shaft. Further details of an exemplary spine assembly are shown in FIGS. 11 and 12 and 16 and 17. In some embodiments, as shown in FIGS. 5 and 20-22, the handle of the delivery device can include an indicator to visually indicate manipulation of the distal end of the shaft. The delivery device can also include a sealing assembly including one or more seals that can be uniformly compressed axially (e.g., without the use of fasteners such as screws or bolts), as shown in FIGS. 24-28. Additionally, the delivery device may include a locking mechanism configured to lock a device inserted through the delivery device (FIGS. 29 and 30) so that the device is selectively prevented from moving relative to the delivery device. Additional details of an exemplary locking mechanism are shown in FIGS. 23-25.

[0027] In some embodiments, a spine assembly of a delivery device, such as the delivery device of FIGS. 5-30 or the delivery device of FIG. 34, can include a spine having one or more recesses recessed radially from the outer surface of the spine partially into the spine (as shown in FIGS. 31-33D and 35-37D). Such recesses can allow pull wires of an adjustment mechanism to be routed from the interior to the exterior of the spine and to wire wraps of the adjustment mechanism disposed on the outer surface of the spine. By including recesses that do not extend all the way through the spine to its central lumen, the strength of the spine can be increased, thereby allowing torque to be effectively transmitted from the handle to the distal end of the delivery device shaft.

[0028] In some embodiments, a Y-shaped connector or adapter can extend proximally from the handle of the delivery device (FIG. 34). As shown in FIGS. 38A-38D and 39, the suture lock assembly can connect to a branch of the adapter, which can include an irrigation port disposed proximal to a gasket within the branch configured to seal around the shaft of the delivery device (e.g., a pusher shaft). The suture lock assembly can connect to the branch with a release bar extending within the branch (FIGS. 38B and 38D). The release bar can include a sealing element (e.g., an O-ring) extending around the outer surface of the release bar and creating a fluid seal between the release bar and the inner surface of the adapter branch (FIGS. 38D and 39). The sealing element can be disposed proximal to the irrigation port, and the suture can extend from the suture lock assembly, through the interior of the release bar, through the handle, and to the distal end portion of the delivery device. This arrangement of the Y-shaped connector of the delivery device can simplify desiccation and irrigation of the delivery device.

[0029] Examples of the disclosed technology 1-4 illustrate an exemplary transcatheter heart valve replacement procedure (e.g., mitral valve replacement) utilizing a prosthetic implant including a docking device 52 and a prosthetic heart valve 62 according to one embodiment. During the procedure, a user first uses a guide catheter 30 to create a pathway to a patient's native heart valve (FIG. 1). The user uses a docking device delivery device 50 (FIG. 2A) to deliver and implant a docking device 52 at the patient's native heart valve, and after implanting the docking device 52, removes the docking device delivery device 50 from the patient 10 (FIG. 2B). The user can then use a prosthetic valve delivery device 60 to implant a prosthetic heart valve 62 within the implanted docking device 52 (FIG. 3A). The user then removes the prosthetic valve delivery device 60 from the patient 10 (FIG. 3B) and removes the guide catheter 30 (FIG. 4).

[0030] 1 illustrates the first step in a mitral valve replacement procedure, according to one embodiment, in which a guide catheter 30 and a guidewire 40 are inserted into a blood vessel 12 of a patient 10 and navigated through the blood vessel 12, into the heart 14 of the patient 10, and toward the native mitral valve 16. Together, the guide catheter 30 and the guidewire 40 may provide a pathway for a docking device delivery device 50 and a prosthetic valve delivery device 60 to be navigated through and along the implantation site (the native mitral valve 16 or the native mitral valve annulus) to the implantation site.

[0031] Initially, a user may first create an incision in a patient's body to access blood vessel 12. For example, in the embodiment shown in Figure 1, a user may create an incision in the patient's groin to access the femoral vein. Thus, in such an embodiment, blood vessel 12 may be the femoral vein.

[0032] After making the incision in the blood vessel 12, a user may insert a guide catheter 30, a guidewire 40, and / or additional devices (such as an introducer device or a transseptal puncture device) through the incision and into the blood vessel 12. The guide catheter 30 (which may also be referred to as an "introducer device," "introducer," or "guide sheath") is configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., a docking device delivery device 50 and a prosthetic valve delivery device 60) into and through the blood vessel 12 and may extend through the blood vessel 12 into the heart 14, but may stop short of the native mitral valve 16. The guide catheter 30 may include a handle 32 and a shaft 34 extending distally from the handle 32. While the shaft 34 may extend through the blood vessel 12 into the heart 14, the handle 32 remains outside the body of the patient 10 and may be manipulated by a user to operate the shaft 34 ( FIG. 1 ).

[0033] The guidewire 40 is configured to guide a delivery device (e.g., a guide catheter 30, a docking device delivery device 50, a prosthetic valve delivery device 60, an additional catheter, or the like) and associated devices (e.g., a docking device, a prosthetic heart valve, or the like) to an implantation site within the heart 14, and thus may extend entirely through the blood vessels 12 into the left atrium 18 of the heart 14 (and, in some embodiments, through the native mitral valve 16 and into the left ventricle of the heart 14) (FIG. 1).

[0034] In some instances, a transseptal puncture device or transseptal puncture catheter may be used to initially access the left atrium 18 before inserting the guidewire 40 and guide catheter 30. For example, after making an incision in the blood vessel 12, a user may insert the transseptal puncture device through the incision and into the blood vessel 12. The user may guide the transseptal puncture device through the blood vessel 12 and into the heart 14 (e.g., through the femoral vein and into the right atrium 20). The user may make a small incision in the atrial septum 22 of the heart 14, allowing access from the right atrium 20 to the left atrium 18. The user may insert and advance the guidewire 40 through the transseptal puncture device in the blood vessel 12 and through the incision in the atrial septum 22 into the left atrium 18. Once the guidewire 40 is positioned within the left atrium 18 and / or left ventricle 26, the transseptal puncture device may be removed from the patient 10. A user may insert guide catheter 30 into blood vessel 12 and advance guide catheter 30 over guidewire 40 into left atrium 18 (FIG. 1).

[0035] In some instances, the introducer device may be inserted through the lumen of the guide catheter 30 prior to inserting the guide catheter 30 into the blood vessel 12. In some instances, the introducer device may include a tapered end that protrudes from the distal tip of the guide catheter 30 and is configured to guide the guide catheter 30 over the guidewire 40 and into the left atrium 18. Additionally, in some instances, the introducer device may include a proximal end portion that extends from the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user can remove the introducer device from the guide catheter 30 and from inside the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain inside the patient 10. The guide catheter 30 is then in a position to receive an implant delivery device and help guide the implant delivery device into the left atrium 18, as described further below.

[0036] FIG. 2A shows the second step in an exemplary mitral valve replacement procedure, in which a docking device 52 is implanted into the native mitral valve 16 of the heart 14 of the patient 10 using a docking device delivery device 50 (which may also be referred to as an "implant catheter" and / or a "docking device delivery device").

[0037] Generally, docking device delivery device 50 includes a delivery shaft 54, a handle 56, and a pusher assembly 58. Delivery shaft 54 ​​is configured to be advanced by a user through a patient's vasculature (blood vessel 12) to an implantation site (e.g., native mitral valve 16) and can be configured to retain docking device 52 within a distal end portion 53 of delivery shaft 54. In some embodiments, distal end portion 53 of delivery shaft 54 ​​retains docking device 52 therein in a straight delivery configuration.

[0038] The handle 56 of the docking device delivery device 50 is configured to be grasped and / or otherwise held by a user outside the body of the patient 10 to advance the delivery shaft 54 ​​through the patient's vasculature (e.g., blood vessel 12).

[0039] In some embodiments, the handle 56 may include one or more articulation members 57 (or rotatable knobs) configured to assist in positioning the delivery shaft 54 ​​within the heart 14. For example, the one or more articulation members 57 may include one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to flex, bend, twist, turn, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 ​​to assist in positioning the delivery shaft 54 ​​within the heart 14 for deployment of the docking device 52 at an implantation site (e.g., the native mitral valve 16).

[0040] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at an implantation site (e.g., the native mitral valve 16). For example, the pusher assembly 58 can be configured to be adjusted by a 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 can extend through the delivery shaft 54 ​​and can be positioned adjacent to the docking device 52 within the delivery shaft 54. In some examples, the docking device 52 can be removably coupled to the shaft of the pusher assembly 58 via a connection mechanism of the docking device delivery apparatus 50 such that the docking device 52 can be released after being deployed at the native mitral valve 16.

[0041] Further details of the delivery device of the docking device, and variations thereof, are described in International Publication No. WO2020 / 247907, which is incorporated herein by reference in its entirety.

[0042] Referring again to FIG. 2A , after the guide catheter 30 is positioned within the left atrium 18, the user may insert the docking device delivery device 50 (e.g., delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 ​​of the docking device delivery device 50 through the guide catheter 30 and over the guidewire 40. In some embodiments, the guidewire 40 may be at least partially housed within the guide catheter 30, away from the left atrium 18. In other embodiments, the guidewire 40 may be completely removed from the guide catheter 30 prior to insertion of the docking device delivery device 50. The user may continue to advance the delivery shaft 54 ​​of the docking device delivery device 50 through the blood vessel 12 within the guide catheter 30 until the delivery shaft 54 ​​reaches the left atrium 18, as shown in FIG. 2A . Specifically, the user may advance the delivery shaft 54 ​​of the docking device delivery device 50 by grasping the handle 56 of the docking device delivery device 50 and applying force (e.g., pushing) on ​​the handle 56 toward the patient 10. While advancing the delivery shaft 54 ​​through the blood vessel 12 and the heart 14, the user may adjust one or more articulation members 57 of the handle 56 to navigate various turns, corners, narrowings, and / or other obstacles within the blood vessel 12 and the heart 14.

[0043] Once the delivery shaft 54 ​​reaches the left atrium 18 and extends out of the distal end of the guide catheter 30, the user can use the handle 56 (e.g., articulation member 57) to position the distal end portion 53 of the delivery shaft 54 ​​at and / or near the posteromedial commissure of the native mitral valve 16. The user can push the docking device 52 out of the distal end portion 53 of the delivery shaft 54 ​​with the shaft of the pusher assembly 58, deploying and / or embedding the docking device 52 within the annulus of the native mitral valve 16.

[0044] In some examples, the docking device 52 may be constructed from, formed from, and / or include a shape memory material so that the docking device can return to its original pre-formed shape when it exits the delivery shaft 54 ​​and is no longer constrained by the delivery shaft 54. As an example, the docking device 52 may originally be formed as a coil and thus may be wrapped around the leaflets 24 of the native mitral valve 16 when it exits the delivery shaft 54 ​​and returns to its original coiled configuration.

[0045] After pressing the ventricular portion of the docking device 52 (e.g., the portion of the docking device 52 shown in FIG. 2A that is configured to be positioned within the left ventricle 26 and / or on the ventricular side of the native mitral valve 16), the user can deploy the remaining portion of the docking device 52 (e.g., the atrial portion of the docking device 52) from the delivery shaft 54 ​​within the left atrium 18 by retracting the delivery shaft 54 ​​away from the posteromedial commissure of the native mitral valve 16.

[0046] After deploying and implanting the docking device 52 at the native mitral valve 16, the user may disconnect the docking device delivery device 50 from the docking device 52. Once the docking device 52 is disconnected from the docking device delivery device 50, the user may store the docking device delivery device 50 out of the blood vessel 12 and away from the patient 10 so that the user can deliver and implant the prosthetic heart valve 62 into the docking device 52 implanted at the native mitral valve 16.

[0047] 2B illustrates this third stage in the mitral valve replacement procedure, in which the docking device 52 is fully deployed and implanted in the native mitral valve 16 and the docking device delivery device 50 (including the delivery shaft 54) is removed from the patient 10, leaving only the guide catheter 30 inside the patient 10. In some embodiments, both the guide catheter 30 and the guidewire 40 remain inside the patient 10. After removing the docking device delivery device 50, the guidewire 40 may be advanced through and / or out of the guide catheter 30, through the docking device 52 implanted in the native mitral valve 16, and into the left ventricle 26 ( FIG. 2A ). The guidewire 40 may thus help guide the prosthetic valve delivery device 60 through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.

[0048] 2B, the docking device 52 may include multiple turns (or coils) that wrap around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has a more cylindrical shape than the annulus of the native mitral valve 16, thereby providing a geometry that more closely matches the shape or profile of the prosthetic heart valve into which it is to be implanted. As a result, the docking device 52 may provide a tighter fit, and therefore a better seal, between the prosthetic heart valve and the native mitral valve 16, as described further below.

[0049] FIG. 3A shows a fourth stage in the mitral valve replacement procedure, in which a user uses a prosthetic valve delivery device 60 to deliver and / or implant a prosthetic heart valve 62 (which may also be referred to herein as a "transcatheter heart valve," or simply "THV," "replacement heart valve," and / or "prosthetic mitral valve") into a docking device 52.

[0050] 3A , the prosthetic valve delivery device 60 may include a delivery shaft 64 and a handle 66, with the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into the patient's vasculature to deliver, implant, expand, and / or otherwise deploy the prosthetic heart valve 62 within the docking device 52 at the native mitral valve 16. The handle 66 is configured to be grasped and / or otherwise held by a user to advance the delivery shaft 64 through the patient's vasculature.

[0051] In some embodiments, the handle 66 may include one or more articulation members 68 configured to assist in steering the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulation members 68 may include one or more knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to flex, bend, twist, turn, and / or otherwise articulate a distal end portion of the delivery shaft 64 to assist in steering the delivery shaft 64 through the blood vessel 12 and into the left atrium 18 and into the left ventricle 26 of the heart 14.

[0052] In some embodiments, the prosthetic valve delivery device 60 may include an expansion mechanism 65 configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. In some cases, as shown in FIG. 3A , the expansion mechanism 65 may include an inflatable balloon configured to be inflated to radially expand the prosthetic heart valve 62 within the docking device 52. The inflatable balloon may be coupled to a distal end portion of the delivery shaft 64.

[0053] In other embodiments, the prosthetic heart valve 62 may be self-expanding and configured to radially expand on its own upon removal of a sheath or capsule covering the radially compressed prosthetic heart valve 62 on the distal end portion of the delivery shaft 64. In yet other embodiments, the prosthetic heart valve 62 may be mechanically expandable and the prosthetic valve delivery device 60 may include one or more mechanical actuators (e.g., expansion mechanisms) configured to radially expand the prosthetic heart valve 62.

[0054] As shown in FIG. 3A, the prosthetic heart valve 62 is mounted on the distal end portion of the delivery shaft 64 and around an expansion mechanism 65 (an inflatable balloon) in a radially compressed configuration.

[0055] To navigate the distal end portion of the delivery shaft 64 to the implantation site, a user can insert the prosthetic valve delivery device 60 (delivery shaft 64) through the guide catheter 30, over the guidewire 40, and into the patient 10. The user can continue to advance the prosthetic valve delivery device 60 along the guidewire 40 (through the blood vessel 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as shown in FIG. 3A . More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery device 60 by grasping the handle 66 and applying force (e.g., pushing) on ​​the handle 66. While advancing the delivery shaft 64 through the blood vessel 12 and heart 14, the user can adjust one or more articulation members 68 of the handle 66 to navigate various turns, corners, stenoses, and / or other obstacles within the blood vessel 12 and heart 14.

[0056] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted around the distal end portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some examples, as shown in FIG. 3A , the distal end of the delivery shaft 64 and at least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.

[0057] Once the prosthetic heart valve 62 in a radially compressed state is properly positioned within the docking device 52 (FIG. 3A), the user can manipulate one or more actuation mechanisms on the handle 66 of the prosthetic valve delivery device 60 to actuate the expansion mechanism 65 (e.g., inflate the inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52.

[0058] 3B illustrates a fifth stage of the mitral valve replacement procedure, in which the prosthetic heart valve 62 is in a radially expanded configuration and is implanted within the docking device 52 within the native mitral valve 16. As shown in FIG. 3B, the prosthetic heart valve 62 is received and held within the docking device 52. Thus, the docking device 52 helps anchor the prosthetic heart valve 62 within the native mitral valve 16. The docking device 52 may enable a better seal between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16, reducing paravalvular leakage around the prosthetic heart valve 62.

[0059] Also, as shown in FIG. 3B, after the prosthetic heart valve 62 is fully deployed and implanted within the docking device 52 at the native mitral valve 16, the prosthetic valve delivery device 60 (including the delivery shaft 64) is removed from the patient 10, so that only the guidewire 40 and the guide catheter 30 remain inside the patient 10.

[0060] FIG. 4 shows a sixth stage of the mitral valve replacement procedure, in which the guidewire 40 and guide catheter 30 have been removed from the patient 10.

[0061] 1-4 specifically illustrate mitral valve replacement, it will be understood that the same and / or similar procedures may be utilized to replace other heart valves (e.g., tricuspid, pulmonary, and / or aortic valves). Furthermore, the same and / or similar delivery devices (e.g., docking device delivery device 50, prosthetic valve delivery device 60, guide catheter 30, and / or guidewire 40), docking devices (e.g., docking device 52), replacement heart valves (e.g., prosthetic heart valve 62), and / or components thereof may be utilized to replace these other heart valves.

[0062] For example, a user may also access the right atrium 20 via the femoral vein when replacing a native tricuspid valve, but would not need to cross the atrial septum 22 into the left atrium 18. Instead, a user may leave the guidewire 40 in the right atrium 20 and perform the same and / or similar docking device implantation process in the tricuspid valve. Specifically, a user may push the docking device 52 out of the delivery shaft 54 ​​around the ventricular side of the tricuspid valve leaflets, release the remaining portion of the docking device 52 from the delivery shaft 54 ​​in the right atrium 20, and remove the delivery shaft 54 ​​of the docking device delivery device 50 from the patient 10. A user may advance the guidewire 40 through the tricuspid valve and into the right ventricle, and perform the same and / or similar prosthetic heart valve implantation process in the tricuspid valve within the docking device 52. Specifically, a user may advance the delivery shaft 64 of the prosthetic valve delivery device 60 through the patient's vasculature along the guidewire 40 until the prosthetic heart valve 62 is positioned / placed within the docking device 52 and tricuspid valve. The user may expand the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery device 60 from the patient 10. In another example, a user may perform the same and / or similar process to replace an aortic valve, but access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0063] 1-4 illustrate a mitral valve replacement procedure in which the native mitral valve 16 is accessed from the left atrium 18 via the right atrium 20 and femoral vein, it should be understood that the native mitral valve 16 may alternatively be accessed from the left ventricle 26. For example, a user may access the native mitral valve 16 from the left ventricle 26 through the aortic valve by advancing one or more delivery devices up an artery to the aortic valve, through the aortic valve, and into the left ventricle 26.

[0064] Certain embodiments are directed to delivery systems and / or devices for delivering a prosthetic medical device (such as the docking device 52 and / or prosthetic heart valve 62 described above with reference to FIGS. 1-4 ) to the heart and / or native valve of an animal, human, cadaver, cadaver heart, anthropomorphic ghost, and / or simulation / simulator. Such devices include transcatheter devices that can be used to guide the delivery of the docking device through the vascular system.

[0065] An exemplary delivery device 1000 configured to deliver a docking device to a target implantation site is shown in Figures 5 and 6. In some embodiments, the delivery device 1000 may be used as the docking device delivery device 50 in a prosthetic valve implantation procedure, as described above with reference to Figures 1-4. The delivery device 1000 may also be referred to as a "docking device delivery device," "dock delivery device," "dock delivery catheter," or "dock delivery system."

[0066] The delivery device 1000 may include a handle assembly 1002 and a delivery shaft 1004 (also referred to as a "delivery catheter," "outer shaft," "delivery sheath," or "outer sheath") extending distally from the handle assembly 1002. The delivery shaft 1004 may be coaxial with a central longitudinal axis 1003 of the delivery device 1000. The handle assembly 1002 may include a handle 1006 that includes one or more knobs, buttons, wheels, and / or other means for controlling and / or actuating one or more components of the delivery device 1000. For example, in some embodiments, as shown in FIG. 5 , the handle 1006 may include knobs 1008a and 1008b that may be configured to steer or control bending of the delivery device 1000 (e.g., the delivery shaft 1004, etc.).

[0067] The delivery shaft 1004 has a main (or primary) lumen 1010 defined by the inner surface of the wall of the delivery shaft 1004 ( FIG. 6 ). The main lumen 1010 is configured to receive one or more devices therein (such as any of the docking devices and pusher assemblies described herein). In some embodiments, as shown in FIG. 6 , the delivery shaft 1004 can extend into the handle 1006. Further, in some embodiments, the main lumen 1010 can extend through the handle 1006 to a locking mechanism 1020 disposed at the proximal end of the handle 1006. For example, in these cases, the inner surface of the locking mechanism 1020 can comprise a lumen coaxial with the main lumen 1010 of the delivery shaft 1004. Thus, the delivery device 1000 comprises a lumen extending from the locking mechanism 1020 to the distal end portion 1005 of the delivery shaft 1004.

[0068] In certain embodiments, the handle 1006 may also include an outer housing 1012. Within the housing 1012, the handle 1006 may include a spine assembly 1014, an adjustment mechanism 1016 including knobs 1008a, 1008b, an indicator assembly 1017, a seal assembly 1018, and a locking mechanism 1020. In some cases, the housing 1012 may be integrally formed as a single, one-piece component. In other cases, as shown, the housing 1012 may include one or more segments formed as separate components that are joined together (e.g., via fasteners, adhesive, mating mechanisms, and / or other joining means). For example, the housing 1012 may include a distal segment 1012a, a middle segment 1012b proximal to the distal segment 1012a, and a proximal segment 1012c proximal to the middle segment 1012b. In some embodiments, the housing 1012 may be manufactured using one or more molding processes (eg, injection molding, etc.).

[0069] In the illustrated embodiment, a distal segment 1012a (which may also be referred to as a "nose cone") of the housing 1012 is distal to the knob 1008a and may include a portion of the spine assembly 1014, as described in more detail below. An intermediate segment 1012b (which may also be referred to as a "main housing") of the housing 1012 is positioned between the knobs 1008a, 1008b. The main housing 1012b may also include a portion of the spine assembly 1014, as well as an adjustment mechanism 1016 and an indicator assembly 1017, as described in more detail below. A proximal segment 1012c (which may also be referred to as a "proximal housing") of the housing 1012 is proximal to the knob 1008b and may include a seal assembly 1018 and a locking mechanism 1020, as described in more detail below. In some embodiments, the portion of the handle 1006 proximal to the nose cone 1012a (e.g., the main housing 1012b, the proximal housing 1012c, and / or the components contained therein) may also be referred to herein as the "body" of the handle 1006.

[0070] The spine assembly 1014 may be configured to partially cover (e.g., surround) the delivery shaft 1004. The spine assembly 1014 may support the delivery shaft 1004 when torque is applied to the handle 1006. Specifically, the spine assembly 1014 may be connected to the housing 1012 and may transmit torque exerted on the handle 1006 from the housing 1012 of the handle 1006 to the delivery shaft 1004, including the distal end portion 1005 of the delivery shaft 1004. Thus, in some embodiments, the spine assembly 1014 may also be referred to as a support member.

[0071] In some cases, the spine assembly 1014 may be integrally formed as a single, one-piece component. In other cases, as shown, the spine assembly 1014 may comprise one or more segments formed as separate components that are joined together (e.g., via fasteners, adhesives, mating mechanisms, and / or other joining means). For example, the spine assembly 1014 may include a spine extension 1022, a distal spine 1024, and a proximal spine 1026. The spine extension 1022 (also referred to herein as a "nose bridge") is connected to and extends distally from the distal spine 1024. The proximal spine 1026 is connected to and extends proximally from the distal spine 1024. As shown in FIG. 6, the spine extension 1022 is positioned within the nosecone 1012a, and the distal spine 1024 and the proximal spine 1026 are positioned within the main housing 1012b. It should be understood that in some embodiments, the distal spine 1024 and the proximal spine 1026 may be integrally formed as a single, unitary component. In some instances, the distal spine 1024 and the proximal spine 1026 may be collectively referred to as a "spine" or a "main spine."

[0072] The handle assembly 1002 may also include an irrigation conduit 1027 connected to the housing 1012 distal to the seal of the seal assembly 1018. In some embodiments, as shown, the irrigation conduit 1027 is connected to the proximal housing 1012c.

[0073] FIG. 7 shows the delivery device 1000 with the nosecone 1012a removed. As shown, the spine extension 1022 can extend distally from the handle 1006 along the length of the delivery shaft 1004. The spine extension 1022 can partially surround (e.g., partially cover) the delivery shaft 1004 circumferentially. As described in more detail below, the delivery shaft 1004 can include a distal section 1004d and a proximal section 1004p. In some examples, the distal section 1004d of the delivery shaft 1004 can include a reinforcing braid to strengthen the delivery shaft 1004 and help transmit torque to the distal end portion 1005 of the delivery shaft 1004. As shown, the distal section 1004d can have a relatively large outer diameter (e.g., due to the presence of a reinforcing braid), and the proximal section 1004p can have a relatively small outer diameter. The spine extension 1022 may partially surround the delivery shaft 1004 at the transition from the distal section 1004d to the proximal section 1004p, providing additional support and strength to the delivery shaft 1004, and particularly the proximal section 1004p of the delivery shaft 1004.

[0074] The spine extension 1022 may include radial protrusions 1028 spaced axially apart from one another along the length of the spine extension 1022. The radial protrusions 1028 of the spine extension 1022 may be configured to mate with the nosecone 1012a (FIG. 10). In some examples, as shown, the radial protrusions 1028 may include a mating feature or element 1030, such as a slot, notch, or the like. The mating element 1030 may be configured to engage with an internal mating element 1032 of the nosecone 1012a (FIG. 9).

[0075] It should be understood that each radial protrusion 1028 can include one or more mating elements 1030 of the same or different configurations. For example, as best shown in FIG. 8 , a first radial protrusion 1028a can include one notch 1030a, and a second radial protrusion 1028b can include two notches 1030a and one slot 1030b. In some cases, as shown, the notches 1030a on axially adjacent radial protrusions 1028a and 1028b can form corresponding halves of a slot. As shown, radial protrusion 1028b can be spaced circumferentially and axially from radial protrusion 1028a. In some embodiments, multiple radial protrusions 1028a can be located at the same axial location. As a result, the radial protrusions 1028a are spaced apart only circumferentially. It should be understood that the radial protrusions 1028 may be configured in other configurations and / or at other spacings (eg, only axially, etc.) on the mating element 1030 .

[0076] As shown in FIG. 9 , the nosecone 1012a may include a mating element 1032 that protrudes from an inner surface 1034 of the nosecone 1012a. The mating element 1032 may extend axially along the length of the inner surface 1034 of the nosecone 1012a. In this manner, the mating element 1032 may also be referred to as an “axial runner.” In the illustrated embodiment, the nosecone 1012a includes three axial runners 1032. The nosecone 1012a may include a different number of axial runners 1032 (e.g., fewer than three axial runners 1032, more than three axial runners 1032, etc.). As shown, each axial runner 1032 may include a primary segment or panel 1036 that protrudes radially from the inner surface 1034. Each axial runner 1032 may also include two secondary segments or panels 1038 that may protrude at an angle from the inner surface 1034 and intersect or contact the primary segment 1036. Each tip 1040 of the primary segment 1036 may extend radially (e.g., toward the center of the nosecone 1012a) beyond the secondary segment 1038. Each tip 1040 may be configured to engage with an axial slot or groove defined by the mating element 1030 of the spine extension 1022.

[0077] The axial runners 1032 may be configured to mate with mating elements 1030 of the spine extension 1022. As shown in FIG. 10 , the mating elements 1030 of each radial protrusion 1028 may be axially aligned and correspond to the axial runners 1032 of the nosecone 1012a. This alignment allows the spine extension 1022 to be inserted into the nosecone 1012a and moved axially relative to the nosecone 1012a (e.g., during assembly of the delivery device 1000). Furthermore, the axial runners 1032 may be configured to prevent rotational movement of the nosecone 1012a relative to the spine extension 1022. In this manner, torque exerted on the nosecone 1012a may be transmitted from the nosecone 1012a to the spine extension 1022 via the radial protrusions 1028 and the axial runners 1032. Additionally, the spine extension 1022 can be configured to transmit torque to the delivery shaft 1004 .

[0078] 8-9 , the spine extension 1022 can include a distal end portion 1042 that partially circumferentially surrounds the delivery shaft 1004 (e.g., surrounding half of the circumference of the delivery shaft 1004). The nosecone 1012a can also include a distal end portion 1044 that partially circumferentially surrounds the delivery shaft 1004 (e.g., surrounding the other half of the circumference of the delivery shaft 1004). Thus, when the nosecone 1012a is mated with the spine extension 1022, the distal end portion 1042 of the nosecone 1012a and the distal end portion 1044 of the spine extension 1022 can be axially aligned and can completely circumferentially surround the delivery shaft 1004. In some examples, a cylindrical cap 1046 can be positioned over the distal end portions 1042, 1044 of the spine extension 1022 and the nosecone 1012a ( FIGS. 5 and 6 ). The cylindrical cap 1046 can be configured to prevent movement (e.g., axial movement, etc.) of the spine extension 1022 relative to the nosecone 1012a. In some cases, the cap 1046 can include an elastomeric material.

[0079] In some cases, as shown, the outer surface of the nosecone 1012a may include six sides to define a hexagonal cross-section. The distal end portion 1042 of the nosecone 1012a may include three sides, and the distal end portion 1044 of the spine extension 1022 may include three sides, such that the distal end portions 1042, 1044 may also define a hexagonal cross-section. The hexagonal cross-section may help to facilitate gripping of the handle 1006. In other cases, the outer surface of the nosecone 1012a and / or the distal end portions 1042, 1044 may include a different number of sides to define different cross-sectional shapes (e.g., circular, square, octagonal, etc.). Other segments of the housing 1012 (e.g., the main housing 1012b and the proximal housing 1012c) may also have the same cross-sectional shape (e.g., hexagonal, etc.) as the nosecone 1012a and / or a different cross-sectional shape to help facilitate gripping the handle 1006. In some cases, the cylindrical cap 1046 may include an interior shape (e.g., hexagonal, etc.) that is complementary to the exterior shape (e.g., hexagonal, etc.) of the distal end portions 1042, 1044 to limit or prevent rotation of the cap 1046 relative to the spine extension 1022 and nosecone 1012a.

[0080] Although the cap 1046 is shown as cylindrical in the illustrated embodiment, in other embodiments, the cap 1046 can have a non-cylindrical shape, including, for example, a hexagon, a square, an octagon, or the like.

[0081] Instead of, or in addition to, the cylindrical cap 1046, the delivery device 1000, in some embodiments, may include one or more other components configured to couple the spine extension 1022 to the nosecone 1012a. For example, the spine extension 1022 and / or the nosecone 1012a may include a mating feature configured to mate the spine extension 1022 with the nosecone 1012a to prevent relative movement therebetween.

[0082] As described above, the distal end portion 1005 of the delivery shaft 1004 can be configured to be steerable via the knobs 1008 a, 1008 b and the adjustment mechanism 1016. In one embodiment, by rotating a knob (e.g., 1008 a or 1008 b) on the handle 1006, the curvature of the distal end portion 1005 can be adjusted so that the distal end portion 1005 of the delivery shaft 1004 can be oriented at a desired angle. For example, to implant a docking device (e.g., docking device 52) at the location of the native mitral valve, the distal end portion 1005 of the delivery shaft 1004 can be steered so that the docking device can be positioned at the target implantation location.

[0083] In some examples, the knob 1008a can be coupled to a first pull wire (e.g., the first pull wire 1282a or the second pull wire 1282b of FIG. 31 ) of an adjustment mechanism that can control the forward bending of the delivery shaft 1004 (e.g., based on tension in the first pull wire, etc.). The knob 1008b can be coupled via the adjustment mechanism 1016 to a second pull wire (e.g., the first pull wire 1282a or the second pull wire 1282b of FIG. 31 ) that can control the backward bending of the delivery shaft 1004 (e.g., based on tension in the second pull wire, etc.). The first and second pull wires can be connected to the distal end portion 1005 of the delivery shaft 1004 and can extend proximally into the handle 1006 (e.g., into the main housing 1012b of the handle 1006, etc.).

[0084] 11 , in some embodiments, the first and second pull wires must pass from a location inside or within the delivery shaft 1004 to a location outside the delivery shaft 1004. As such, the proximal section 1004p of the delivery shaft 1004 may include two axially extending slots 1047 (also referred to as "openings") configured to allow the first and second pull wires to exit from a location inside or within the distal section 1004d of the delivery shaft 1004 and pass along the outside of the proximal section 1004p of the delivery shaft 1004. Because the pull wires must pass from a location inside or within the delivery shaft 1004 to a location outside the delivery shaft 1004, the reinforcing braid included in the distal section 1004d of the delivery shaft 1004 cannot extend along the entire length of the delivery shaft 1004. In this manner, the spine extension 1022 may provide additional strength to the delivery shaft 1004 while allowing the pull wire to pass through the slot 1047 in the delivery shaft 1004 .

[0085] Following the proximal pull wire, after the pull wire passes through slot 1047, the first and second pull wires can pass through openings 1048 in the distal end 1024d of the distal spine 1024, as shown in FIG. 12. After passing through openings 1048, the pull wires can connect to other components of the adjustment mechanism 1016, which may be located within the main housing 1012b of the handle 1006, as described in more detail below.

[0086] The distal end 1024d of the distal spine 1024 may be coupled to the spine extension 1022. Specifically, the inner surface of the spine extension 1022 may include a step 1052 that defines a seat for the distal end 1024d of the distal spine 1024 (see also FIG. 8 ). For example, during assembly of the spine assembly 1014, the distal spine 1024 may be inserted into the spine extension 1022 and moved axially relative to the spine extension 1022 until the distal end 1024d contacts the step 1052 of the spine extension 1022. In this manner, the spine extension 1022 can partially surround the distal end 1024d of the distal spine 1024 such that the distal end 1024d of the distal spine 1024 is positioned within the spine extension 1022.

[0087] 13 shows the delivery shaft 1004 positioned within the central lumen 1050 of the spine assembly 1014. The central lumen 1050 may be coaxial with the central longitudinal axis 1003 and may be defined by the inner surfaces of the spine extension 1022, the distal spine 1024, and the proximal spine 1026.

[0088] The distal spine 1024 may be coupled to the proximal spine 1026. As shown in FIGS. 14 and 15 , the distal spine 1024 may include a mating feature 1054 (e.g., a socket, etc.) that corresponds to a (complementary) mating feature 1056 (e.g., a pin, etc.) on the proximal spine 1026. The distal spine 1024 and the proximal spine 1026 may also include holes 1058 that may be configured to couple the spine assembly 1014 to the housing 1012. Specifically, when the distal spine 1024 is coupled (e.g., mated, etc.) to the proximal spine 1026, the holes 1058 of the distal spine 1024 and the proximal spine 1026 may be aligned such that a fastener (e.g., fastener 1106 shown in FIG. 20 , a screw, a bolt, etc.) may be inserted through the holes 1058 to attach the spine assembly 1014 to the main housing 1012b.

[0089] The distal spine 1024 may include a spine shaft 1060 and a base 1062. The spine shaft 1060 may be generally cylindrical and parallel to the central longitudinal axis 1003 of the delivery device 1000. The base 1062 may be connected to the spine shaft 1060 or may be radially spaced or offset from the spine shaft 1060. In the illustrated example, the base 1062 is located at the proximal end 1024p of the distal spine 1024. The base 1062 may be positioned within the main housing 1012b and may contact an inner surface of the main housing 1012b, as described in more detail below. In some cases, the base 1062 may be the only component of the spine assembly 1014 that contacts the housing 1012b (e.g., other than fasteners 1106 inserted through holes 1058, etc.). In this manner, the base 1062 can be configured to align the spine assembly 1014 relative to the housing 1012 so that the central lumen 1050 of the spine assembly 1014 is coaxial with the central longitudinal axis 1003 of the delivery device 1000. In this manner, the base 1062 can generate alignment data (e.g., radial, vertical, axial, etc.) for the handle assembly 1002. In some cases, the holes 1058 of the distal spine 1024 and / or the proximal spine 1026 can also contact the housing 1012 (e.g., such as with the holes 1104 shown in FIGS. 19 and 20 ).

[0090] The distal spine 1024 can include a first slot 1064 having a distal end 1064d and a proximal end 1064p. The distal spine 1024 can also include a second axially extending slot 1066 having a distal end 1066d and a proximal end 1066p. The first slot 1064 can be circumferentially spaced apart from the second slot 1066. In the illustrated embodiment, the first slot 1064 and the second slot 1066 are circumferentially spaced apart by 90 degrees. As best shown in FIG. 12 , the distal end 1064d of the first slot 1064 and the distal end 1066d of the second slot 1066 can be positioned distally of the main housing 1012b such that the distal ends 1064d, 1066d are positioned within the nosecone 1012a.

[0091] 14 , the first slot 1064 can extend axially along the length of the spine shaft 1060 (e.g., less than the entire length of the spine shaft 1060). In particular, the proximal end 1064p of the first slot 1064 can be axially spaced apart from the proximal end 1024p of the spine 1024 (e.g., the proximal end 1064p of the first slot 1064 is distal to the proximal end 1024p of the spine 1024). The proximal end 1066p of the second slot 1066 can be positioned at or adjacent to the proximal end 1024p of the spine 1024. In this manner, the first slot 1064 can have a shorter axial length than the second slot 1066.

[0092] The spine shaft 1060 of the distal spine 1024 may also include radial grooves 1068 configured to receive clips, spacers, or the like. The radial grooves 1068 may be spaced along the length of the spine shaft 1060.

[0093] As shown in FIG. 15 , the proximal spine 1026 may include a spine shaft 1070 that may be generally cylindrical and parallel to the central longitudinal axis 1003 of the delivery device 1000. The spine shaft 1070 may include an axially extending slot 1072 positioned toward the distal end 1026d of the spine 1026. When the distal spine 1024 and the proximal spine 1026 are coupled (e.g., mated), the slot 1072 may be aligned with the second slot 1066 of the distal spine 1024. The spine shaft 1070 of the proximal spine 1026 may also include radial grooves 1074 configured to receive clips, spacers, or the like. The radial grooves 1074 may be spaced along the length of the spine shaft 1070 and may be positioned toward the proximal end 1026p of the spine 1026.

[0094] Although distal spine 1024 is shown as including base 1062, it should be understood that in some embodiments, proximal spine 1026 can include base 1062 instead of distal spine 1024. For example, base 1062 can be connected to spine shaft 1070 and can be radially spaced or offset from spine shaft 1070. In these embodiments, base 1062 can be located at distal end 1026d of proximal spine 1026.

[0095] The spine assembly 1014 may also include a wire shaft 1076, as shown in FIG. 13. In some cases, the wire shaft 1076 may comprise a hollow cylindrical tube, as shown. The wire shaft 1076 may be positioned within the slot 1066 of the distal spine 1024 and the slot 1072 of the proximal spine 1026. One of the pull wires of the adjustment mechanism 1016 may be positioned within the lumen of the wire shaft 1076.

[0096] As mentioned above, the adjustment mechanism 1016 (also referred to herein as a “flexion assembly”) may be configured to manipulate the distal end portion 1005 of the delivery shaft 1004 via the knobs 1008 a, 1008 b and the pull wires (not shown) by increasing or decreasing the tension in the pull wires. In addition to the knobs 1008 a, 1008 b and the pull wires, the adjustment mechanism 1016 may also include a sliding nut 1078, a wire wrap 1080, and a barrel 1082, as shown in FIGS. 16 and 17 . The sliding nut 1078 may be positioned around the spine assembly 1014 and configured to move axially relative to the spine assembly 1014. Specifically, a first sliding nut 1078 may be positioned around the distal spine 1024, and a second sliding nut 1078 may be positioned around the proximal spine 1026. The sliding nut 1078 may include male threads that engage with the female threads of the barrel 1082.

[0097] Each wire wrap 1080 can be positioned adjacent to and proximal to one of the sliding nuts 1078. The wire wrap 1080 can be configured to secure the distal end of one of the pull wires thereto (e.g., by wrapping the end of the pull wire around the wire wrap 1080). As discussed with reference to FIG. 12 , the pull wire can be secured to the distal end portion 1005 of the delivery shaft 1004 and pass through an opening 1048 in the distal end 1024d of the distal spine 1024.

[0098] After passing through opening 1048, one of the pull wires may be positioned within slot 1064 of distal spine 1024 and routed outside slot 1064 (on the outside or exterior of the spine) to connect to a wire wrap 1080 positioned around distal spine 1024. The other pull wire, after passing through opening 1048, may pass through wire shaft 1076 and be routed outside slot 1066 and / or slot 1072 (on the outside or exterior of the spine) to connect to a wire wrap 1080 positioned around proximal spine 1026.

[0099] The barrel 1082 may be coupled to the knobs 1008a, 1008b such that rotating one of the knobs 1008a, 1008b rotates one of the barrels 1082. To adjust the distal end portion 1005 of the delivery shaft, one of the knobs (e.g., 1008a or 1008b) may be rotated, which in turn rotates its corresponding barrel 1082. Rotation of the barrel 1082 may drive the sliding nut 1078 axially via the threaded engagement between the barrel 1082 and the sliding nut 1078. As the sliding nut 1078 moves axially, the sliding nut 1078 may change the tension in the pull wire attached to the wire wrap 1080, thereby pushing the wire wrap 1080 axially, which adjusts the curvature or bend of the distal end portion 1005 of the delivery shaft 1004.

[0100] Each wire wrap 1080 may include a notch 1084 that may be configured to prevent rotational movement of the wire wrap 1080 when the sliding nut 1078 presses against the wire wrap 1080. In particular, the notch 1084 of the wire wrap 1080 located on the distal spine 1024 may engage with the wire shaft 1076 when the wire wrap 1080 is moved axially by the sliding nut 1078. In this manner, the wire shaft 1076 may be configured as a guide for the wire wrap 1080 that prevents rotational movement of the wire wrap 1080 while allowing the wire wrap 1080 to move axially relative to the distal spine 1024. 16 , the proximal spine 1026 may include one or more guides 1086 that may be molded into the proximal spine 1026 and may be configured (e.g., similar to the wire shaft 1076) to guide axial movement of the corresponding wire wrap 1080 relative to the proximal spine 1026 while preventing rotational movement of the wire wrap 1080 relative to the proximal spine 1026. The guides 1086 may be protrusions from the outer surface of the spine shaft 1070 that extend along the length of the proximal spine 1026. Although not shown, in some embodiments, the distal spine 1024 may also include one or more guides 1086 in addition to the wire shaft 1076. The wire shaft 1076 and guides 1086 may also be configured to guide movement of the sliding nut 1078 (e.g., to allow axial movement and prevent rotational movement).

[0101] In some cases, the spine assembly 1014 may include stops 1088 extending radially from the distal spine 1024 and the proximal spine 1026 to limit axial movement of the sliding nut 1078 and wire wrap 1080 relative to the spine assembly 1014. In some cases, as shown, the stops 1088 (e.g., clips, etc.) may be removably coupled to and positioned about the spine assembly 1014. In this manner, the stops 1088 may also limit the amount of curvature or bending of the distal end portion 1005 of the delivery shaft 1004 (e.g., by limiting the amount of tension that can be applied to the pull wires, etc.). Additionally, the amount of curvature or bending may be visually indicated by an indicator assembly 1017, as described in more detail below.

[0102] Further details of steerable catheters, adjustment mechanisms, and variations thereof are described in US Pat. No. 10,076,638, which is incorporated herein by reference in its entirety.

[0103] The sliding nut 1078, wire wrap 1080, and barrel 1082 of the adjustment mechanism 1016 may be positioned within the main housing 1012b. In some cases, the main housing 1012b may be integrally formed as a single, one-piece component. In other cases, as shown in FIGS. 18 and 19, the main housing 1012b may comprise one or more segments formed as separate components that are coupled together (e.g., via fasteners, adhesive, mating mechanisms, and / or other coupling means). For example, the main housing 1012b may include an upper segment 1090a ( FIG. 18 ) and a lower segment 1090b ( FIG. 19 ) that may be coupled together.

[0104] The upper segment 1090a may include a mating feature 1092a connected to an inner surface 1094a of the upper segment 1090a. The lower segment 1090b may include a corresponding mating feature 1092b connected to an inner surface 1094b of the lower segment 1090b. The mating feature 1092b of the lower segment 1090b may be configured to mate with the mating feature 1092a of the upper segment 1090a. In the illustrated example, the mating feature 1092a may include a pin, and the corresponding mating feature 1092b may include a socket. It should be understood that other mating mechanisms are contemplated for the upper segment 1090a and the lower segment 1090b, including, but not limited to, clips and corresponding clip tabs, and / or hooks and corresponding hinges, etc. In some cases, the mating feature 1092a on the upper segment 1090a may comprise a socket, and the corresponding mating feature 1092b on the lower segment 1090b may include a pin. In some cases, as shown, all of the mating features on one of the segments (e.g., the upper segment 1090a) may include one type of mating feature (e.g., a pin). In other cases, the mating features on one of the segments (e.g., 1090a or 1090b) may include a combination of different types of mating features. Furthermore, in the illustrated embodiment, six mating features 1092a, 1092b are included on each segment 1090a, 1090b, respectively. In other embodiments, a different number of mating features (e.g., less than six, more than six, etc.) may be included on each segment.

[0105] The upper segment 1090a may include a groove 1096a and an internal rib 1098a configured to receive and retain components of the indicator assembly 1017, as described in more detail below. The groove 1096a may be included in an outer wall 1100a of the upper segment 1090a. The internal rib 1098a may be positioned radially inward of the groove 1096a (e.g., within the outer wall 1100a). The rib 1098a may define an opening or slot, and the components of the indicator assembly 1017 may be positioned within the slot defined by the rib 1098a. In the illustrated example, the rib 1098a may be positioned adjacent to the mating feature 1092a and may extend axially from the mating feature 1092a.

[0106] The upper segment 1090a may include a platform 1102a (which may also be referred to herein as an “alignment platform”) extending from the inner surface 1094a. The platform 1102a may be positioned in a central region of the upper segment 1090a (e.g., axially midway between the ends of the upper segment 1090a, etc.). The platform 1102a may be configured to position the spine assembly 1014 relative to the housing 1012. Specifically, the platform 1102a may align the distal spine 1024 and the proximal spine 1026 relative to the upper segment 1090a of the main housing 1012b. In some cases, the platform 1102a may include a notch to accommodate the barrel 1082 ( FIG. 6 ).

[0107] Similar to the upper segment 1090a, the lower segment 1090b may include a groove 1096b and an internal rib 1098b configured to receive and retain components of the indicator assembly 1017. The groove 1096b may be included in an outer wall 1100b of the lower segment 1090b. The internal rib 1098b may be positioned radially inward of the groove 1096b (e.g., within the outer wall 1100b). The rib 1098b may define an opening or slot, and the components of the indicator assembly 1017 may be positioned within the slot defined by the rib 1098b. In the illustrated example, the rib 1098b may be positioned adjacent to the mating feature 1092b and may extend axially from the mating feature 1092b.

[0108] The lower segment 1090b may include a platform 1102b (which may also be referred to herein as an “alignment platform”) extending from the inner surface 1094b. The platform 1102b may be positioned in a central region of the lower segment 1090b (e.g., axially midway between the ends of the lower segment 1090b, etc.). The platform 1102b may be configured to position the spine assembly 1014 relative to the housing 1012. Specifically, the platform 1102b may align the spine assembly 1014 relative to the lower segment 1090b of the main housing 1012b. In some cases, as best shown in FIG. 6 , the platform 1102b may contact the base 1062 of the distal spine 1024 to achieve this alignment. In some examples, the spine assembly 1014 may be configured such that the spine assembly 1014 can only be assembled in one direction or orientation within the housing 1012 based on a mating feature of the housing 1012. For example, the base 1062 and platform 1102b of the spine assembly 1014 may be configured such that the base 1062 can only be aligned or mated with the platform 1102b in one direction (e.g., the spine shaft 1060 extends distally from the base 1062).

[0109] The lower segment 1090b may include holes 1104 (e.g., screw holes, etc.) configured to receive fasteners 1106 (e.g., screws, bolts, etc.). With further reference to FIG. 20 , when the spine assembly 1014 and the housing 1012 are coupled (e.g., secured, etc.) together, the holes 1104 in the lower segment 1090b of the main housing 1012b and the holes 1058 in the distal spine 1024 and the proximal spine 1026 may align. In this manner, the fasteners 1106 may be inserted through the holes 1058 and into the holes 1104 to attach the spine assembly 1014 to the housing 1012.

[0110] 20-22, indicator assembly 1017 (also referred to herein as a "flexion indicator assembly") may be positioned within main housing 1012b. Indicator assembly 1017 may be configured to indicate the amount of flex applied to distal end portion 1005 of delivery shaft 1004 by adjustment mechanism 1016. Indicator assembly 1017 may be positioned within main housing 1012b and may include window 1108 and indicator 1110 (also referred to herein as a "flexion indicator" or "flexion measurement device") that may be viewable through (e.g., adjacent to) window 1108.

[0111] The window 1108 may be positioned within grooves 1096a, 1096b in the upper and lower segments 1090a, 1090b of the main housing 1012b. The window 1108 may include a frame 1112 and a pane 1114 that may be coupled to the frame 1112. For example, the pane 1114 may be retained within the frame 1112 via a snap and / or friction fit. In some cases, as shown in FIG. 21 , the frame 1112 may include a retaining member 1116, such as a tab, clip, or the like, extending radially from the frame 1112 and capable of engaging a corresponding opening 1118 in the pane 1114. The pane 1114 may be transparent, translucent, etc., to allow a user to view the indicator 1110 through the window 1108.

[0112] In the illustrated embodiment, the indicator assembly 1017 may include frames 1112 disposed on opposite sides of the handle assembly 1002. Each frame 1112 may be coupled to one pane 1114 and may define a distal viewing area 1120d and a proximal viewing area 1120p (collectively referred to as viewing areas 1120). In the illustrated embodiment, the retaining member 1116 of the frame 1112 and the opening 1118 of the pane 1114 are positioned between the viewing areas 1120.

[0113] The indicator assembly 1017 may also include four indicators 1110, as shown. Two of the indicators 1110 may be positioned on each side of the handle assembly 1002. In some examples, the two distal indicators 1110 may indicate one type of curvature or amount of bending (e.g., a particular direction as controlled by knob 1008a), and the two proximal indicators 1110 may indicate a different type of curvature or amount of bending (e.g., a different direction as controlled by knob 1008b, etc.). The distal indicators 1110 may be viewable through a distal viewing region 1120d of the window 1108, and the proximal indicators 1110 may be viewable through a proximal viewing region 1120p of the window 1108.

[0114] Each indicator 1110 includes a slider 1122 and a background member 1124, as best shown in FIG. 22 . The background member 1124 may be positioned within the internal ribs 1098a, 1098b of the upper and lower segments 1090a, 1090b of the main housing 1012b. In this manner, the background member 1124 may be fixed relative to the housing 1012 (e.g., prevented from moving axially relative to the housing 1012, etc.). The slider 1122 may be configured to slide axially relative to the background member 1124. In particular, the slider 1122 may include an opening 1126 through which the background member 1124 may pass. In this manner, the slider 1122 may include an outer portion 1122a that is visible or viewable through the viewing area 1120 and an inner portion 1122b that is not visible or viewable through the viewing area 1120. In particular, the outer portion 1122a may be positioned radially outside the background member 1124, and the inner portion 1122b may be positioned radially inside the background member 1124. The outer portion 1122a may also be referred to as the “visible portion” or “viewable portion” of the slider 1122.

[0115] The slider 1122 may also include at least one protrusion 1128 (e.g., one or more tabs, pins, etc.) extending from the inner portion 1122b of the slider 1122. The protrusion 1128 may be configured to engage with a corresponding barrel 1082. In this manner, when the barrel 1082 is rotated by one of the knobs (e.g., 1008a or 1008b, etc.), the threads of the barrel 1082 may move the slider 1122 axially relative to the background member 1124 via the protrusion 1128.

[0116] In the illustrated embodiment, the viewable portion 1122a of the slider 1122 may be configured as a bar. As such, the slider 1122 may also be referred to as a "slider bar." It should be understood that in other cases, the viewable portion 1122a of the slider 1122 may include other configurations, such as, for example, a tab that extends in front of only a portion of the background member 1124, etc.

[0117] In some cases, one background member 1124 may be used for two indicators 1110. For example, in these cases, the background member 1124 may extend axially such that the extended background member 1124 is visible through both the distal viewing region 1120d and the proximal viewing region 1120p. Additionally, two sliders 1122 may be positioned on the extended background member 1124.

[0118] The background member 1124 may include indicia 1130 (e.g., markings, hash marks, etc.) to indicate the amount and / or measurement of flexion. For example, in some cases, as the slider 1122 moves proximally relative to the background member 1124, the position of the slider 1122 relative to the indicia 1130 may indicate an increased amount of flexion. Conversely, in some cases, as the slider 1122 moves distally relative to the background member 1124, the position of the slider 1122 relative to the indicia 1130 may indicate a decreased amount of flexion. It should be understood that axial movement of the slider 1122 relative to the background member 1124 may indicate either an increased or decreased amount of flexion.

[0119] In some cases, the indicator assembly 1017 may include additional indicia (e.g., color, marking, etc.) to distinguish the distal indicator 1110 (e.g., indicating one type of curvature or bend, etc.) from the proximal indicator 1110 (e.g., indicating another type of curvature or bend, etc.). For example, the slider 1122, the background member 1124, and / or the indicia 1130 of the distal indicator 1110, a portion of the frame 1112 surrounding the distal viewing region 1120d, and / or the corresponding knob 1008a may include a first color, marking, etc. to indicate that these components are related (e.g., to indicate that a bend caused by rotation of the knob 1008a is visible through the distal viewing region 1120d and is indicated by the distal indicator 1110, etc.). Similarly, in some cases, the slider 1122, background member 1124, and / or indicia 1130 of the proximal indicator 1110, a portion of the frame 1112 surrounding the proximal viewing area 1120p, and / or corresponding knob 1008b may comprise a second color, markings, etc. to distinguish from the first color. Other components may include additional indicia to distinguish different types of curvature or bend provided by the adjustment mechanism 1016 and indicated by the indicator assembly 1017.

[0120] As described above, the seal assembly 1018 and locking mechanism 1020 may be positioned within the proximal housing 1012c. In some cases, the proximal housing 1012c may be integrally formed as a single, one-piece component. In other cases, as shown in FIGS. 23-25, the proximal housing 1012c may comprise one or more segments formed as separate components that are coupled together (e.g., via fasteners, adhesive, mating mechanisms, and / or other means for coupling). For example, the proximal housing 1012c may include two segments configured to be coupled together with a mating mechanism 1132 (e.g., a pin, socket, etc.). FIG. 24 shows the delivery device 1000 with one of the segments of the proximal housing 1012c removed.

[0121] The seal assembly 1018 may be configured to surround (e.g., cover) the proximal spine 1026 and the delivery shaft 1004, as shown in FIG. 25. Specifically, the seal assembly 1018 may be positioned around the proximal end 1026p of the proximal spine 1026 and the proximal end 1007 of the delivery shaft 1004. The seal assembly 1018 may include a seal housing 1134, a seal 1136, and a seal compression member 1138.

[0122] The seal housing 1134 may include a shaft portion 1135 and a head portion 1137. The shaft portion 1135 may be positioned at a distal end 1134d of the seal housing 1134, and the head portion 1137 may be positioned at a proximal end 1134p of the seal housing 1134. Additionally, the seal 1136 may be positioned within the seal housing 1134. In particular, as best shown in FIG. 26 , the head portion 1137 of the seal housing 1134 may include a seat 1140 of the seal 1136. The seat 1140 may be defined by an inner surface of the head portion 1137 of the seal housing 1134. The seat 1140 may be configured to prevent the seal 1136 from moving relative to the seal housing 1134.

[0123] The head portion 1137 may include a distal flange 1142d and a proximal flange 1142p. The proximal flange 1142p may be positioned at the proximal end 1134p of the seal housing 1134. The proximal flange 1142p may include an opening 1144 having a shape corresponding to the seal compression member 1138. In this manner, the seal compression member 1138 may be inserted into the head portion 1137 of the seal housing 1134 through the opening 1144. The seal housing 1134 may also include a locking channel 1146 positioned within the head portion 1137 and in fluid communication with the opening 1144. The locking channel 1146 may be defined in part by the flanges 1142d, 1142p. In the illustrated embodiment, the seal housing 1134 includes four locking channels 1146, although the seal housing 1134 may include a different number of locking channels 1146 in other embodiments. The locking channel 1146 can be configured to receive and removably retain the sealing compression member 1138 after the sealing compression member 1138 is inserted into the seal housing 1134 .

[0124] 27 , the sealing compression member 1138 can include a base 1148 and pins 1150 extending radially outward from the base 1148. In the illustrated embodiment, the sealing compression member 1138 includes four pins 1150 corresponding to the four locking channels 1146 of the seal housing 1134. However, it should be understood that in other embodiments, the sealing compression member 1138 can include a different number of pins 1150 (e.g., more or less than four). The sealing compression member 1138 can also include one or more ribs 1152. In some cases, the ribs 1152 can be configured to be grasped by a user (e.g., to rotate the sealing compression member 1138 about the central longitudinal axis 1003).

[0125] The seal assembly 1018 can be configured to axially compress the seal 1136 within the seal housing 1134 (e.g., without the use of screws or the like). In particular, the seal compression member 1138 can be inserted into the opening 1144 at the proximal end 1134p of the seal housing 1134 and positioned adjacent to the seal 1136. Specifically, the distal surface 1154 of the seal compression member 1138 can contact the seal 1136. To axially compress the seal 1136, an axial force can be applied to the seal compression member 1138. In this manner, the seal 1136 is compressed between the seat 1140 of the seal housing 1134 and the distal surface 1154 of the seal compression member 1138. When compressed, the seal 1136 can be configured to slightly pinch or squeeze the shaft of a delivery device (e.g., such as any of the pusher assemblies described herein) inserted radially through the main lumen 1010 of the delivery device 1000 ( FIG. 25 ).

[0126] When the seal 1136 is compressed by the sealing compression member 1138, the pin 1150 of the sealing compression member 1138 can be distal to the flange 1142p and positioned within the locking channel 1146. In this position, the sealing compression member 1138 can be rotated relative to the seal housing 1134 (e.g., about the axis 1003) to lock the sealing compression member 1138 in place, as shown in FIG. 28 . In particular, the pin 1150 of the sealing compression member 1138 can be guided through the locking channel 1146 to a locked position. In the locked position, the pin 1150 can contact a surface of the flange 1142p, thereby allowing a force to be maintained on the seal 1136. This applies a constant axial pressure to the seal 1136.

[0127] In some cases, as shown, the seal housing 1134 may include an irrigation port 1156. As shown, the irrigation port 1156 may be distal to the seal 1136 and may extend radially from the shaft portion 1135. The irrigation tube 1027 may be coupled to the irrigation port 1156 (e.g., to the inner surface of the irrigation port 1156, etc.). In some cases, the irrigation tube 1027 may comprise a flexible or semi-flexible material, and the proximal housing 1012c may comprise a rigid material. To stiffen the irrigation tube 1027 where it passes through the proximal housing 1012c, a support 1158 may be positioned around the irrigation tube 1027 and coupled to the proximal housing 1012c. The support 1158 may comprise a flexible or semi-flexible material (e.g., rubber, etc.).

[0128] FIG. 29 illustrates a delivery device 1000 having a pusher assembly 1180 (e.g., similar to pusher assembly 58) extending proximally therefrom. Specifically, the pusher assembly 1180 may be positioned within the main lumen 1010 of the delivery device 1000 (e.g., within the delivery shaft 1004). In some embodiments, the delivery device 1000 may include the pusher assembly 1180 such that the delivery device 1000 includes the handle assembly 1002, the delivery shaft 1004, and the pusher assembly 1180. As described above, the pusher assembly 1180 may be used to deploy and / or implant the docking device at the implantation site. To do so, the pusher assembly 1180 may, in some cases, be required to move or slide axially relative to the delivery device 1000. In other cases, the pusher assembly 1180 may be required to remain stationary relative to the delivery device 1000.

[0129] The locking mechanism 1020 may be configured to prevent movement of the pusher assembly 1180 relative to the delivery device 1000 when the locking mechanism 1020 is in the locked configuration. In the unlocked configuration, the locking mechanism 1020 may be configured to allow such movement. Referring again to FIGS. 23-25 ​​, the locking mechanism 1020 may include a rotatable knob 1160 (also referred to herein as a “lock”) and a collet 1162. The knob 1160 includes two tabs 1164 extending radially outward from the knob 1160 and a shaft 1166 extending axially distally from the knob 1160. The shaft 1166 may be configured to receive the collet 1162. In the illustrated example, the shaft 1166 may include a threaded region 1168 having internal threads and a tapered region 1170. Tapered region 1170 includes an inner surface 1172 that may taper proximally from a larger inner diameter to a smaller inner diameter.

[0130] The collet 1162 may include external threads 1174 configured to engage with internal threads in the threaded region 1168 of the shaft 1166. The collet 1162 may also include a protrusion 1176 (also referred to herein as a "cantilever arm") extending axially from the proximal end 1162p of the collet 1162. In some cases, as shown, the collet 1162 may include four protrusions 1176. It should be understood that in other cases, the collet 1162 may include a different number of protrusions 1176. The collet 1162 may also include a central lumen 1178 extending from the distal end 1162d to the proximal end 1162p of the collet 1162. The central lumen 1178 may be coaxial with the main lumen 1010 of the delivery device 1000.

[0131] As shown in FIG. 25 , when the locking mechanism 1020 is in the unlocked configuration, the protrusion 1176 extends straight from the collet 1162. In other words, the diameter of the central lumen 1178 is uniform from the distal end 1162d to the proximal end 1162p of the collet 1162. In the unlocked configuration, the diameter of the central lumen 1178 may be the same as the diameter of the main lumen 1010. Rotating the knob 1160 a particular amount (e.g., one-quarter turn) relative to the central longitudinal axis 1003 may change the locking mechanism 1020 from the unlocked configuration to the locked configuration. As such, in some instances, the locking mechanism 1020 may also be referred to as a “quarter-turn locking mechanism.”

[0132] As the knob 1160 is rotated, the collet 1162 may move axially relative to the knob 1160 toward the tapered region 1170 of the shaft 1166. When the locking mechanism 1020 is in the locked configuration, the protrusions 1176 may contact the inner surface 1172 of the shaft 1166 and may be pushed or bent radially inward by the taper of the inner surface 1172. In other words, in the locked configuration, the diameter of the central lumen 1178 is smaller at the proximal end 1162p of the collet 1162 than at the distal end 1162d of the collet 1162 due to the tapered inner surface 1172. In this manner, the protrusions 1176 may be configured to fasten around a device inserted through the delivery device 1000 (e.g., pusher assembly 1180, etc.) to lock the device in place. In this manner, the protrusions 1176 can be configured to prevent movement of the device relative to the delivery device 1000 (eg, relative to the main lumen 1010, the handle 1006, etc.).

[0133] Further details of the docking device delivery device and variations thereof are described in International Patent Application No. PCT / US2021 / 052669, which is incorporated herein by reference in its entirety.

[0134] Referring again to FIG. 23 , in some cases, as shown, the proximal housing 1012c may include a proximal extension 1182 (e.g., an axial extension or protrusion, etc.) that may extend axially over the knob 1160. The extension 1182 may be configured to prevent the knob 1160 from rotating more than a certain angular amount (e.g., more than a quarter turn, etc.). In particular, the extension 1182 may protrude axially over the knob 1160 between the tabs 1164. Furthermore, the tabs 1164 may extend radially outward further than the extension 1182. In this manner, the tabs 1164 may contact the extension 1182 and prevent additional rotation. The extension 1182 may be sized and / or spaced such that a full rotation (e.g., a quarter turn, etc.) of the knob 1160 between the extensions 1182 can transition the locking mechanism 1020 from the unlocked configuration to the locked configuration (and vice versa).

[0135] FIG. 30 illustrates an exemplary delivery system 2000 including a delivery device 1000, a pusher assembly 1180, a guide catheter 2002 (e.g., similar to guide catheter 30), and a stabilizer 2004 (also referred to herein as a "stabilization tower" or "stabilizer"). The delivery system 2000 may be used in transcatheter heart valve replacement procedures, for example, as described above with reference to FIGS. 1-4. Specifically, the delivery system 2000 illustrated in FIG. 30 may be used during the second stage of the procedure described above with reference to FIG. 2A. As shown in FIG. 30, the delivery device 1000 and the pusher assembly 1180 may be inserted through the guide catheter 2002. Specifically, the delivery shaft 1004 of the delivery device 1000 may be advanced through the guide catheter 2002 (e.g., through its central lumen). The shaft of pusher assembly 1180 may be inserted through delivery device 1000 and may extend distally through delivery device 1000 into delivery shaft 1004. As described above, locking mechanism 1020 may be configured to selectively allow movement (e.g., axial and / or rotational movement, etc.) of pusher assembly 1180 relative to delivery device 1000.

[0136] The guide catheter 2002 and delivery device 1000 may be coupled to a stabilizer 2004 that can support and stabilize the guide catheter 2002 and delivery device 1000 (e.g., during a procedure). The stabilizer 2004 may include a support 2006 (e.g., a clip, clamp, brace, etc.) that may be configured to hold or grip the guide catheter 2002 and delivery device 1000. In some cases, the support 2006 may be slidably coupled to the stabilizer 2004 and may be axially repositioned or repositioned on the stabilizer 2004. In some examples, as shown, the support 2006 may be configured to engage with a cap 1046 of the delivery device 1000. For example, as described above, the cap 1046 may be fixed relative to the remainder of the delivery device 1000 (e.g., the spine extension 1022 and the nosecone 1012a, etc.). In some examples, torque can be applied to the handle assembly 1002 of the delivery device 1000 while the delivery device 1000 is coupled to the stabilizer 2004. This torque can be transmitted to the delivery shaft 1004 via the spine assembly 1014, as described above.

[0137] In some examples, the spine assembly 1014 of the handle 1006 may include recesses (having walls formed between the recesses and the central lumen 1050 of the spine assembly) instead of slots (e.g., through slots) in the distal and proximal spines configured to receive pull wires therethrough. In this manner, the spine 1014 may be referred to as a "reinforced spine." A reinforced spine may, for example, improve the torsional stiffness of the spine. For example, when the handle 1006 is rotated or otherwise manipulated by a user during an implantation procedure, a reinforced spine may more effectively transmit torque to the distal end portion of the delivery device (e.g., torque applied to the handle 1006 is transmitted to the distal end portion of the delivery device).

[0138] For example, Figures 31-33D show various views of a distal spine 1224 and a proximal spine 1226 that may be used in place of the distal spine 1024 and the proximal spine 1026 in the spine assembly of the handle 1006. Figure 31 shows a perspective view of the distal spine 1224 and the proximal spine 1226 coupled together and defining a central lumen 1250 extending therethrough. Figures 32A-33D show various side and cross-sectional views of different portions of the distal spine 1224 and the proximal spine 1226, as described further below. In some examples, the distal spine 1224 and the proximal spine 1226 may be similar to the distal spine 1024 and the proximal spine 1026 described above, except that they include axially extending recesses instead of slots, as described below.

[0139] 31 and 33A-33B, the distal spine 1224 includes a spine shaft 1260 and a base 1262. The spine shaft 1260 may be generally cylindrical and may be parallel to the central longitudinal axis 1003 of the delivery device 1000. The base 1262 may be connected to the spine shaft 1260 or may be radially spaced or offset from the spine shaft 1260. In the illustrated example, the base 1262 is located at the proximal end of the distal spine 1224 and may be the same as or similar to the base 1062, as described above for the distal spine 1024. The base 1262 may be positioned within the main housing 1012b and may contact the inner surface of the main housing 1012b, similar to that described above for the distal spine 1024.

[0140] Distal spine 1224 can include a first axially extending recess 1264 (also referred to as first recess 1264) having a distal end 1264d and a proximal end 1264p (FIGS. 31-32B). First recess 1264 extends axially along a portion of the length of spine shaft 1260 (e.g., less than the entire length of spine shaft 1260).

[0141] In particular, the distal end 1264d of the first recess 1264 may be positioned adjacent (or close to) but offset from the distal end 1224d of the distal spine 1224, and the proximal end 1264p of the first recess 1264 may be further axially spaced apart (compared to the spacing between the distal ends 1264d and 1224d) from the proximal end 1224p of the distal spine 1224 (Figures 31-32B).

[0142] In some embodiments, the first recess 1264 has a first axial length 1263 that is at least ¼ of the total length of the distal spine 1224. In some embodiments, the first recess 1264 has a first axial length 1263 that is ¼ to ½ of the total length of the distal spine 1224.

[0143] The first axial length 1263 of the first recess 1264 can be based at least in part on the path of the pull wire extending therethrough when the wire wrap 1280 is in the fully retracted position.

[0144] Distal spine 1224 may also include a second axially extending recess 1266 (also referred to as second recess 1266) having a distal end 1266d and a proximal end 1266p (FIG. 31 and FIGS. 33A-33D). Second recess 1266 extends axially along the length of spine shaft 1260. Proximal end 1266p of second recess 1266 may be positioned at or adjacent to proximal end 1224p of distal spine 1224, and distal end 1266d of second recess 1266 may be disposed adjacent (or near) but offset from distal end 1224d of distal spine 1224 (FIG. 33B).

[0145] In some embodiments, second recess 1266 has a second axial length 1267 that is a majority of the overall length of distal spine 1224. In some embodiments, second axial length 1267 of second recess 1266 is 80-95% of the overall length of distal spine 1224.

[0146] Thus, the first recess 1264 can have a shorter axial length (first axial length 1263) than the second recess 1266 (second axial length 1267). In some embodiments, the second recess 1266 can be at least twice as long as the first recess 1264.

[0147] The first recess 1264 is circumferentially spaced apart from the second recess 1266. In the illustrated embodiment, the first recess 1264 and the second recess 1266 are circumferentially spaced apart by 90 degrees. In some embodiments, the first recess 1264 and the second recess 1266 are circumferentially spaced apart by 80-100 degrees or 85-95 degrees.

[0148] The spine shaft 1260 may also include radial grooves 1268 configured to receive clips, spacers, or the like. The radial grooves 1268 may be spaced apart along the length of the spine shaft 1260.

[0149] 31 , the proximal spine 1226 may include a spine shaft 1270 that may be generally cylindrical and parallel to the central longitudinal axis 1003 of the delivery device 1000. The spine shaft 1270 may include an axially extending recess 1272 positioned toward the distal end 1226d of the proximal spine 1226. When the distal spine 1224 and the proximal spine 1226 are coupled (e.g., mated) together, the recess 1272 may be aligned with and contiguous with the second recess 1266 of the distal spine 1224. Thus, in some embodiments, the second recess 1266 and the recess 1272 may be referred to as a continuous, axially extending recess of one of the spines of the handle (e.g., the distal spine 1224 and the proximal spine 1226 coupled together).

[0150] The spine shaft 1270 of the proximal spine 1226 may also include radial grooves 1274 configured to receive clips, spacers, etc. (FIG. 31). The radial grooves 1274 may be spaced apart along the length of the spine shaft 1270 and may be positioned toward the proximal end 1226p of the spine 1226 (FIG. 31).

[0151] Both the first recess 1264 and the second recess 1266 are recessed radially into the spine shaft 1260 of the distal spine 1224, from the outer surface 1212 of the spine shaft 1260 toward the central lumen 1250. Furthermore, both the first recess 1264 and the second recess 1266 are recessed only partially into the total wall thickness 1228 of the distal spine 1224 defined between the outer surface 1212 and the central lumen 1250. As a result, the first and second recesses 1264, 1266 do not extend all the way through the wall of the distal spine 1224 to the central lumen 1250, as described further below with reference to FIGS.

[0152] Similarly, the recess 1272 is depressed radially into the spine shaft 1270 of the proximal spine 1226, from the outer surface 1214 of the spine shaft 1270 toward the central lumen 1250. Furthermore, the recess 1272 is depressed only partially into the total wall thickness of the proximal spine 1226 defined between the outer surface 1214 and the central lumen 1250. As a result, the recess 1272 does not extend all the way through the wall of the proximal spine 1226 to the central lumen 1250, as further shown and described below with reference to FIGS.

[0153] 32A and 32B, the first recess 1264 may include a first recess portion 1264a extending from its distal end 1264d and a second recess portion 1264b extending from the first recess portion 1264a to the proximal end 1264p of the first recess 1264 (FIGS. 32A and 32B). The first recess 1264a may be disposed adjacent to and connect to a first channel 1210 that extends axially through the wall of the distal spine 1224 from the first recess 1264a to the distal end 1224d of the distal spine 1224.

[0154] In some embodiments, the first recess 1264a can be shorter (axially) than the second recess 1264b (FIGS. 32A and 32B).

[0155] In some embodiments, the first recess 1264a can have a first width 1230 that is smaller than the second width 1232 of the second recess 1264b. In some embodiments, the first recess 1264a can narrow from the first width 1230 at the exterior surface 1212 to a narrower width at the base 1234 of the first recess 1264a.

[0156] In some embodiments, the second recess 1264b can have a second depth 1238 that is greater than the first depth 1236 of the first recess 1264a.

[0157] In some embodiments, the first depth 1236 and the second depth 1238 may be the same.

[0158] The first depth 1236 and the second depth 1238 can be specified such that the support wall 1240 separating the central lumen 1250 and the first recess 1264 has a minimum thickness 1242 that is at least 10% of the total wall thickness 1228 of the distal spine 1224.

[0159] For example, in some cases, the first depth 1236 and the second depth 1238 may be ½ to ¾ of the total wall thickness 1229 .

[0160] First depth 1236 and second depth 1238 may additionally or alternatively be specified such that a pull wire extending through first channel 1210 may extend out of first channel 1210 and into first recess 1264.

[0161] 33A and 33B, second recess 1266 may include a first recess portion 1266a extending from its distal end 1266d, a second recess portion 1266b extending from first recess portion 1266a, and a third recess portion 1266b extending from second recess portion 1266b to proximal end 1266p of second recess 1266 (FIGS. 33A and 33B). First recess 1264a may be disposed adjacent to and connect to second channel 1216 that extends axially through the wall of distal spine 1224 from first recess 1266a to distal end 1224d of distal spine 1224 (FIG. 33B).

[0162] In some embodiments, the first recess 1266a can be shorter (axially) than the second recess 1266b and the third recess 1266c (FIGS. 32A and 32B). In some embodiments, the third recess 1266c can be longer than the second recess 1266b.

[0163] The first recess 1266a may have a first width 1244a, the second recess 1266b may have a second width 1244b, and the third recess 1266c may have a third width 1244c (FIG. 33A).

[0164] In some embodiments, first width 1244a can be smaller than second width 1244b and third width 1244c. In some embodiments, first recess 1266a can narrow from first width 1244a at outer surface 1212 to a narrower width at base 1235 of first recess 1266a.

[0165] In some embodiments, second width 1244b can be greater than third width 1244c. In some embodiments, second recess 1266b can narrow from second width 1244b at outer surface 1212 to a narrower width at base 1237 of second recess 1266b.

[0166] The first recess 1266a can have a first depth 1246a, the second recess 1266b can have a second depth 1246b, and the third recess 1266c can have a third depth 1246c (Figure 33B).

[0167] In some embodiments, the second depth 1246b may be greater than the first depth 1246a. In some embodiments, the first and second depths 1246a, 1246b may be the same.

[0168] In some embodiments, third depth 1246c can be less than second depth 1246b. In some embodiments, third depth 1246c can be less than first depth 1246a. In this manner, support wall 1248 separating central lumen 1250 and second recess portion 1266 can have a first thickness 1252 ( FIG. 33C ) between central lumen 1250 and second recess portion 1266b and a second thickness 1254 ( FIG. 33D ) between central lumen 1250 and third recess portion 1266c, where second thickness 1254 is greater than first thickness 1252.

[0169] In some embodiments, the first depth 1246a, the second depth 1246b, and the third depth 1246c can be specified such that the support wall 1248 separating the central lumen 1250 and the second recess 1266 has a minimum thickness (e.g., the first thickness 1252) that is at least 10% of the total wall thickness 1228 of the distal spine 1224.

[0170] In some embodiments, the first depth 1246a, the second depth 1246b, and the third depth 1246c can be between 1 / 2 and 4 / 5 of the total wall thickness.

[0171] In some embodiments, the first depth 1246a, the second depth 1246b, and the third depth 1246c are additionally or alternatively specified such that the entrance of the wire shaft 1276 into the lumen can be aligned with the second channel 1216 and such that the wire shaft 1276 can act as rails for the wire wrap 1280 and sliding nut 1284 on the distal spine 1224 to slide along.

[0172] In some embodiments, the second recess portion 1266b of the second recess 1266 may have a circular cross-section 1253 (as shown in FIG. 33C), which may allow the wire shaft 1276 to align with the second channel 1216 while maintaining the maximum possible wall thickness to increase the torsional resistance of the distal spine 1224.

[0173] The varying widths and depths of first recess 1264 and second recess 1266 are shown in cross sections in Figures 33C and 33D, which are taken along the section of distal spine 1224 shown in Figure 33A. The section shown in Figure 33C is taken along a more distal portion of distal spine 1224 and therefore shows both first recess 1264 (second recess portion 1264b) and second recess 1266 (second recess portion 1266b). The section shown in Figure 33D is taken along a central portion of distal spine 1224 and therefore shows third recess portion 1266c of second recess 1266.

[0174] In some embodiments, the recess 1272 of the proximal spine 1226 can have a width and depth similar to the third width 1244c and third depth 1246c of the third recess portion 1266c of the second recess 1266 (Figures 33A and 33B).

[0175] Returning to FIG. 31, in some embodiments, a wire shaft 1276 comprising a hollow cylindrical tube can be positioned within the second recess 1266 of the distal spine 1224 and the recess 1272 of the proximal spine 1226 .

[0176] In some examples, an additional wire shaft or tube 1275 can extend through a distal portion of the first recess 1264 and the second recess 1266 (e.g., the first recess portion 1266a and the wire shaft 1276). In some cases, the tube 1275 can extend proximally from the distal spine 1224 through at least a portion of the delivery shaft 1004.

[0177] The pull wires of the adjustment mechanism 1016 may extend through the tube 1275, into and through the lumen of the wire shaft 1276, or into and through the first recess 1264. As mentioned above, the adjustment mechanism 1016 (also referred to herein as a "flexion assembly") may be configured to steer the distal end portion 1005 of the delivery shaft 1004 via the knobs 1008a, 1008b and the pull wires by increasing or decreasing the tension in the pull wires. In addition to the knobs 1008a, 1008b and the pull wires, the adjustment mechanism 1016 may also include a sliding nut (e.g., sliding nut 1078 shown in FIG. 16 ), a wire wrap 1280, and a barrel (e.g., barrel 1082 shown in FIG. 17 ).

[0178] As described above, the pull wires 1282a, 1282b (shown in FIG. 31) are secured to the distal end portion 1005 of the delivery shaft 1004 and can pass through the tube 1275 and into the distal end 1024d of the distal spine 1024 (or directly into the first channel 1210 and second channel 1216 of the distal spine 1024 if the tube 1275 is omitted).

[0179] For example, a first pull wire 1282a can pass through the first channel 1210 and into and through the first recess 1264 ( FIG. 31 ). The first pull wire 1282a is routed outside the first recess 1264 (to the exterior or outer surface 1212 of the spine shaft 1260 of the distal spine 1224) and connects to a wire wrap 1280 positioned around the distal spine 1224. As shown in FIG. 31 , the proximal end of the first pull wire 1282a can wrap around, thereby securing it to, the wire wrap 1280.

[0180] Similarly, second pull wire 1282b can pass through second channel 1216, enter the distal end of second recess 1266, and through the lumen of wire shaft 1276 disposed inside second recess portion 1266b and third recess portion 1266c of second recess 1266 (FIG. 31). Second pull wire 1282b is routed into recess 1272 adjacent to second recess 1266 and outside recess 1272 (the outside or outer surface 1214 of spine shaft 1270 of proximal spine 1226) to connect to wire wrap 1280 positioned around proximal spine 1226. As shown in FIG. 31, the proximal end of second pull wire 1282b can wrap around, thereby securing it to wire wrap 1280.

[0181] Note that sliding nuts that may be positioned adjacent the wire wraps 1280 are omitted from FIG. 31 for clarity. However, in some embodiments, the first and second pull wires 1282a, 1282b may extend through openings or channels in respective sliding nuts positioned adjacent the respective wire wraps 1280, similar to that shown in FIG. 35 (and described below).

[0182] 34 illustrates an exemplary delivery device 1300 configured to deliver a docking device to a target implantation site. In some embodiments, the delivery device 1300 may be used as the docking device delivery device 50 in a prosthetic valve implantation procedure, as described above with reference to FIGS. 1-4. The delivery device 1000 may also be referred to as a "docking device delivery device," "dock delivery device," "dock delivery catheter," or "dock delivery system."

[0183] Delivery device 1300 may be similar to (e.g., have similar components and functions with) delivery device 1000. For example, delivery device 1300 may include a handle assembly 1302 and a delivery shaft 1304 (also referred to as a “delivery catheter,” “outer shaft,” “delivery sheath,” or “outer sheath”) extending distally from handle assembly 1302.

[0184] The handle assembly 1302 may include a handle 1306 that includes one or more knobs, buttons, wheels, and / or other means for controlling and / or actuating one or more components of the delivery device 1300. For example, in some embodiments, as shown in FIG. 34 , the handle 1306 may include knobs 1308 and 1310 that may be configured to steer or control bending of the delivery device 1300 (e.g., delivery shaft 1304, similar to knobs 1008a and 1008b, as described above).

[0185] In certain embodiments, the delivery device 1300 may also include a pusher shaft 1312 and a sleeve shaft 1320, both of which may extend through the lumen of the delivery shaft 1304 and have respective proximal end portions extending within the handle assembly 1302.

[0186] As described below, the distal end portion (also referred to as the "distal section") of the sleeve shaft 1320 can be configured to cover (e.g., surround) a docking device (e.g., docking device 52 of FIGS. 2A-4 or docking device 1358 shown schematically in FIG. 40). For example, the docking device can be retained within the sleeve shaft 1320, which is further retained by the distal end portion 1305 of the delivery shaft 1304, as it is maneuvered through the patient's vasculature.

[0187] Additionally, the distal end portion 1305 of the delivery shaft 1304 can be configured to be steerable. In one embodiment, by rotating a knob (e.g., knob 1308 or knob 1310) on the handle 1306, the curvature of the distal end portion 1305 can be adjusted so that the distal end portion 1305 of the delivery shaft 1304 can be oriented at a desired angle. For example, to implant a docking device at the location of the native mitral valve, the distal end portion 1305 of the delivery shaft 1304 can be steered within the left atrium so that at least a portion of the sleeve shaft 1320 and the docking device held therein can extend through the annulus of the native mitral valve adjacent the posteromedial commissure.

[0188] Knobs 1308 and / or 1310 may be part of an adjustment mechanism disposed within handle 1306, which may be the same as or similar to adjustment mechanism 1016 of delivery device 1000 (as described above).

[0189] In certain embodiments, the pusher shaft 1312 and the sleeve shaft 1320 can be coaxial with one another, at least within the interior of the delivery shaft 1304. Additionally, the delivery shaft 1304 can be configured to be axially movable relative to the sleeve shaft 1320 and the pusher shaft 1312. As described further below, the distal end of the pusher shaft 1312 can be inserted into the lumen of the sleeve shaft 1320 and can press against the proximal end of a docking device held within the sleeve shaft 1320.

[0190] After reaching the target implantation site, the docking device can be deployed from the delivery shaft 1304 by manipulating the pusher shaft 1312 and sleeve shaft 1320 using the hub assembly 1318, as described further below. For example, by pushing the pusher shaft 1312 distally while holding the delivery shaft 1304 in place, or by retracting the delivery shaft 1304 proximally while holding the pusher shaft 1312 in place, or by pushing the pusher shaft 1312 distally while simultaneously retracting the delivery shaft 1304 proximally, the docking device can be pushed out the distal end 1304d of the delivery shaft 1304, thereby transitioning the docking device from the delivery configuration to the deployed configuration. In certain embodiments, the pusher shaft 1312 and the sleeve shaft 1320 can be actuated independently of one another.

[0191] During delivery, the docking device may be coupled to the delivery device 1300 via a release suture extending through the pusher shaft 1312 or other retrieval line including a string, twine, or other material that may be configured to be tied around the docking device and cut for removal. In an example, the release suture may extend through the delivery device 1300, for example, through a lumen of the pusher shaft 1312, to the suture lock assembly 1316 of the delivery device 1300 (as shown in FIGS. 38B and 39, as described further below).

[0192] The handle assembly 1302 can further include a hub assembly 1318 to which the suture lock assembly 1316 and the sleeve handle 1324 are attached. The hub assembly 1318 can be configured to independently control the pusher shaft 1312 and the sleeve shaft 1320, while the sleeve handle 1324 can control the axial position of the sleeve shaft 1320 relative to the pusher shaft 1312. In this manner, operation of various components of the handle assembly 1302 can actuate and control operation of components disposed within the delivery shaft 1304. In some embodiments, the hub assembly 1318 can be coupled to the handle 1306 via a connector 1326.

[0193] The handle assembly 1302 can further include one or more irrigation ports for supplying irrigation fluid to one or more lumens disposed within the delivery device 1300 (e.g., annular lumens disposed between coaxial components of the delivery device 1300). For example, a first irrigation port 1330 (or first irrigation port) and a second irrigation port 1332 (or second irrigation port) are shown in FIG. 34 (and described further below with reference to FIGS. 38A-39).

[0194] The handle 1306 may be similar to the handle 1006 of the delivery device 1000. For example, the handle 1306 may include an outer housing 1311 and a spine assembly disposed within the outer housing 1311. The spine assembly may be similar to the spine assembly 1014 of the handle 1006. However, the spine assembly of the handle 1306 may include a distal spine 1424 and a proximal spine 1426 that include recesses configured to receive pull wires (instead of through slots) of an adjustment mechanism, similar to the distal spine 1224 and the proximal spine 1226 of FIGS. 31-33D. In this manner, the spine 1424 may also be referred to as a "reinforced spine."

[0195] Figure 35 shows a perspective view of the distal spine 1424 and the proximal spine 1426, which are coupled together and define a central lumen 1450 extending therethrough. Figures 36A-37D show various side views and cross-sectional views of different portions of the distal spine 1424 and the proximal spine 1426, as further described below.

[0196] 35 and 37A-37B , the distal spine 1424 includes a spine shaft 1460 and a base 1462. The spine shaft 1460 can be generally cylindrical and can be parallel to the central longitudinal axis of the delivery device 1300. The base 1462 can be connected to the spine shaft 1460 or can be radially spaced or offset from the spine shaft 1460. In the illustrated embodiment, the base 1462 is located at the proximal end of the distal spine 1424. The base 1462 can be positioned within the housing 1311 and can contact the inner surface of the housing 1311, similar to that described above for the distal spine 1024 of the delivery device 1000.

[0197] The distal spine 1424 can include a first axially extending recess 1464 (also referred to as first recess 1464) having a distal end 1464d and a proximal end 1464p (FIGS. 35-36B). The first recess 1464 extends axially along a portion of the length of the spine shaft 1460 (e.g., less than the entire length of the spine shaft 1460).

[0198] In particular, the distal end 1464d of the first recess 1464 may be positioned adjacent (or close to) but offset from the distal end 1424d of the distal spine 1424, and the proximal end 1464p of the first recess 1464 may be axially spaced further away (compared to the spacing between the distal ends 1464d and 1424d) from the proximal end 1424p of the distal spine 1424 (Figures 35-36B).

[0199] In some embodiments, the first recess 1464 has a first axial length 1463 that is at least ¼ of the overall length of the distal spine 1424. In some embodiments, the first recess 1464 has a first axial length 1463 that is ¼ to ½ of the overall length of the distal spine 1424. The first axial length 1463 of the first recess 1464 can be based at least in part on the path of the pull wire extending therethrough when the wire wrap 1480 is in the fully retracted position.

[0200] Distal spine 1424 may also include a second axially extending recess 1466 (also referred to as second recess 1466) having a distal end 1466d and a proximal end 1466p (FIGS. 35 and 37A-37D). Second recess 1466 extends axially along the length of spine shaft 1460. Proximal end 1466p of second recess 1466 may be positioned at or adjacent to proximal end 1424p of distal spine 1424, and distal end 1466d of second recess 1466 may be disposed adjacent (or near) but offset from distal end 1424d of distal spine 1424 (FIGS. 37A and 37B).

[0201] In some embodiments, the second recess 1466 has a second axial length 1467 that is a majority of the total length of the distal spine 1424 (FIG. 37B). In some embodiments, the second axial length 1467 of the second recess 1466 is 80-95% of the total length of the distal spine 1424.

[0202] In this manner, the first recess 1464 can have a shorter axial length than the second recess 1466. In some embodiments, the second recess 1466 can be at least twice as long as the first recess 1464.

[0203] The first recess 1464 is circumferentially spaced apart from the second recess 1466. In the illustrated embodiment, the first recess 1464 and the second recess 1466 are circumferentially spaced apart by 90 degrees. In some embodiments, the first recess 1464 and the second recess 1466 are circumferentially spaced apart by 80-100 degrees or 85-95 degrees.

[0204] The spine shaft 1460 may also include radial grooves 1468 configured to receive clips, spacers, or the like. The radial grooves 1468 may be spaced apart along the length of the spine shaft 1460.

[0205] As shown in FIG. 35 , the proximal spine 1426 can include a spine shaft 1470 that can be generally cylindrical and parallel to a central longitudinal axis of the delivery device 1300. The spine shaft 1470 can include an axially extending recess 1472 positioned toward the distal end 1426d of the proximal spine 1426. When the distal spine 1424 and the proximal spine 1426 are coupled (e.g., mated) together, the recess 1472 can be aligned and continuous with the second recess 1466 of the distal spine 1424 (as shown in FIG. 37B ). Thus, in some embodiments, the second recess 1466 and the recess 1472 can be referred to as one continuous, axially extending recess of the spine (e.g., the distal spine 1424 and the proximal spine 1426 coupled together).

[0206] The spine shaft 1470 of the proximal spine 1426 may also include radial grooves 1474 configured to receive clips, spacers, etc. (FIG. 35). The radial grooves 1474 may be spaced along the length of the spine shaft 1470 and may be positioned toward the proximal end 1426p of the proximal spine 1426 (FIG. 35).

[0207] Both the first recess 1464 and the second recess 1466 are recessed radially into the spine shaft 1460 of the distal spine 1424, from the outer surface 1412 of the spine shaft 1460 toward the central lumen 1450. Furthermore, both the first recess 1464 and the second recess 1466 are recessed only partially into the total wall thickness 1428 of the distal spine 1424 defined between the outer surface 1412 and the central lumen 1450 ( FIGS. 36B and 37B ). As a result, the first and second recesses 1464, 1466 do not extend all the way through the wall of the distal spine 1424 to the central lumen 1450, as described further below with reference to FIGS. 36A-37D .

[0208] Similarly, the recess 1472 is depressed radially into the spine shaft 1470 of the proximal spine 1426, from the outer surface 1414 of the spine shaft 1470 toward the central lumen 1450. Furthermore, the recess 1472 is depressed only partially into the total wall thickness of the proximal spine 1426 defined between the outer surface 1414 and the central lumen 1450. As a result, the recess 1472 does not extend all the way through the wall of the proximal spine 1426 to the central lumen 1450, as further shown and described below with reference to FIGS.

[0209] As shown in FIG. 36B, a distal end 1464d of the recess 1464 may be positioned adjacent to and connect to a first channel 1410 that extends axially through the wall of the distal spine 1424.

[0210] In some embodiments, the first channel 1410 extends from the first recess 1464 to a wider second channel 1411 that extends through the wall of the distal spine 1424 to the distal end 1424d of the distal spine 1424. The first channel 1410 can be configured to receive a pull wire of an adjustment mechanism therethrough. The pull wire can further extend through the second channel 1411 (and, in some embodiments, through a compression coil disposed within the second channel 1411).

[0211] In some embodiments, first channel 1410 can extend from first recess 1464 all the way to distal end 1424 d of distal spine 1424 and can have a width similar to the width of second channel 1411 .

[0212] The first recess 1464 can have a first width 1430 (FIG. 36A) and a first depth 1436 (FIGS. 36B and 37C).

[0213] The first depth 1436 may be specified such that the support wall 1440 separating the central lumen 1450 and the first recess 1464 has a minimum thickness 1442 that is at least 10% of the total wall thickness 1428 of the distal spine 1424. The first depth 1436 may additionally or alternatively be specified such that a pull wire extending through the first channel 1410 may extend out of the first channel 1410 and into the first recess 1464.

[0214] In some embodiments, the first depth 1436 can be between ½ and ¾ of the total wall thickness 1428 .

[0215] 37A and 37B, the second recess 1466 can include a first recess portion 1466a extending from its distal end 1466d, a second recess portion 1466b extending from the first recess portion 1466a, and a third recess portion 1466b extending from the second recess portion 1466b to a proximal end 1466p of the second recess 1466. The first recess 1466a can be disposed adjacent to and connect to a first channel 1416 extending axially through the wall of the distal spine 1424.

[0216] In some embodiments, first channel 1416 extends from first recess 1466a to a wider second channel 1417 that extends through the wall of distal spine 1424 to the distal end 1424d of distal spine 1424. First channel 1416 can be configured to receive a pull wire of an adjustment mechanism therethrough. The pull wire can further extend through second channel 1417 (and, in some embodiments, through a compression coil disposed within second channel 1417).

[0217] In some embodiments, first channel 1416 can extend from first recess 1466a all the way to distal end 1424d of distal spine 1424 and can have a width similar to the width of second channel 1417.

[0218] In some embodiments, the first recess 1466a can be shorter (axially) than the second recess 1466b (FIGS. 37A and 37B). In some embodiments, the second recess 1466b can be longer than the third recess 1466c.

[0219] The first recess 1466a may have a first width 1444a, the second recess 1466b may have a second width 1444b, and the third recess 1466c may have a third width 1444c (FIG. 37A).

[0220] In some embodiments, second width 1444b can be greater than first width 1444a. In some embodiments, second width 1444b can be less than third width 1444c. In some embodiments, first recess 1466a can narrow from first width 1444a at outer surface 1412 to a narrower width at base 1435 of first recess 1466a.

[0221] The first recess 1466a can have a first depth 1446a, the second recess 1466b can have a second depth 1446b, and the third recess 1466c can have a third depth 1446c (Figure 37B).

[0222] In some embodiments, first depth 1446a may be greater than second depth 1446b, and in some embodiments, third depth 1446c may be greater than second depth 1446b.

[0223] In some embodiments, the first and second depths 1446a, 1446b may be the same.

[0224] In some embodiments, the support wall 1448 separating the central lumen 1450 and the second recess 1466 may have a first thickness 1452 (FIG. 37C) between the central lumen 1450 and the first recess 1466a and a second thickness 1454 (FIG. 37D) between the central lumen 1450 and the second recess 1466b, wherein the second thickness 1454 is greater than the first thickness 1452.

[0225] In some embodiments, the first depth 1446a, the second depth 1446b, and the third depth 1446c can be specified such that the support wall 1448 separating the central lumen 1450 and the second recess 1466 has a minimum thickness (e.g., the first thickness 1452) that is at least 10% of the total wall thickness 1428 of the distal spine 1424.

[0226] In some embodiments, the first depth 1446a, the second depth 1446b, and the third depth 1446c can be between 1 / 3 and 5 / 6 of the total wall thickness 1428.

[0227] In some embodiments, the first depth 1446a, the second depth 1446b, and the third depth 1446c are additionally or alternatively specified such that the entrance of the wire shaft 1476 into the lumen can be aligned with the first channel 1416 and such that the wire shaft 1476 can act as rails for the wire wrap 1480 and sliding nut 1484 on the distal spine 1424 and slide along them.

[0228] In some embodiments, the first recess portion 1466a of the second recess 1466 may have a circular cross-section 1453 (as shown in FIG. 37C), which may allow the wire shaft 1476 to align with the first channel 1416 while maintaining the maximum possible wall thickness to increase the torsional resistance of the distal spine 1424.

[0229] The varying widths and depths of the first recess 1464 and the second recess 1466 are shown in cross sections in Figures 37C and 37D, which are taken along the section of the distal spine 1424 shown in Figure 37A. The section shown in Figure 37C is taken along a more distal portion of the distal spine 1424 and therefore shows both the first recess 1464 and the second recess 1466 (first recess portion 1466a). The second, shown in Figure 37D, is taken along a central portion of the distal spine 1424 and therefore shows the second recess portion 1466b of the second recess 1466.

[0230] In some embodiments, the recess 1472 of the proximal spine 1426 can have a width and depth similar to the second width 1444b and second depth 1446b of the second recess portion 1466b and the third width 1444c and third depth 1446c of the third recess portion 1466c of the second recess 1466 (Figures 37A and 37B).

[0231] For example, recess 1472 may comprise a first recess 1472a having a first width and a first depth that are the same as or similar to second width 1444b and second depth 1446b of second recess 1466b of second recess 1466, and a second recess portion 1472b having a second width and a second depth that are the same as or similar to third width 1444c and third depth 1446c of third recess 1466c of second recess 1466.

[0232] Returning to FIG. 35, in some embodiments, a wire shaft 1476 comprising a hollow cylindrical tube can be positioned within at least a portion of the second recess 1466 of the distal spine 1424 and a portion of the recess 1472 of the proximal spine 1426.

[0233] In some examples, an additional wire shaft or tube 1475 can extend through a distal portion (e.g., first recess portion 1466a) of the first recess 1464 and the second recess 1466. In some cases, the tube 1475 can extend proximally from the distal spine 1424 through at least a portion of the delivery shaft 1304.

[0234] The pull wires 1482a, 1482b of an adjustment mechanism (e.g., an adjustment mechanism the same as or similar to adjustment mechanism 1016) of the delivery device 1300 may extend through the tube 1475 and into and through the first recess 1464 and the second recess 1466 (which may include extending through a lumen of a wire shaft 1476 disposed inside the second recess 1466). As mentioned above, the adjustment mechanism (also referred to herein as a “flexion assembly”) may be configured to manipulate the distal end portion 1304d of the delivery shaft 1304 via the knobs 1308, 1310 and the pull wires by increasing or decreasing the tension in the pull wires. In addition to the knobs 1308, 1310 and the pull wires, the adjustment mechanism may also include a sliding nut 1484, a wire wrap 1480, and a barrel (e.g., barrel 1082 shown in FIG. 17 ).

[0235] Pull wires 1482a, 1482b (shown in FIG. 35) are fixed to the distal end portion 1304d of the delivery shaft 1304 and can pass through the tube 1475 and into the distal end 1424d of the distal spine 1424 (or directly into the second channels 1411, 1417 and first channels 1410, 1416 of the distal spine 1424 if the tube 1475 is omitted).

[0236] For example, the first pull wire 1482a can pass through the second channel 1411, through the first channel 1410, into and through the first recess 1464. The first pull wire 1482a passes through a channel 1486 in the sliding nut 1484 and is routed outside the first recess 1464 (to the outside or outer surface 1412 of the spine shaft 1460 of the distal spine 1424) for connection to a wire wrap 1480 positioned around the distal spine 1424 ( FIG. 35 ). As shown in FIG. 35 , the proximal end of the first pull wire 1482a can wrap around, thereby securing it to, the wire wrap 1480.

[0237] Similarly, second pull wire 1482b can pass through the lumen of wire shaft 1476 disposed inside second recess portion 1466b and third recess portion 1466c of second recess 1466, through second channel 1417, through first channel 1416, to the distal end of second recess 1466. Second pull wire 1482b is routed into recess 1472 adjacent to second recess 1466 and outside recess 1472 (the outside or outer surface 1414 of spine shaft 1470 of proximal spine 1426), passes through channel 1486 of sliding nut 1484, and connects to wire wrap 1480 positioned around proximal spine 1426 ( FIG. 35 ). As shown in FIG. 35 , the proximal end of second pull wire 1482b can wrap around, thereby securing it to wire wrap 1480.

[0238] In some examples, the reinforced spine may be additionally or alternatively reinforced by adding intermittent bridges or laterally extending support portions within the pullwire slots (e.g., slots 1064 and 1066) or recesses (e.g., recesses 1264 and 1266 or recesses 1464 and 1466).

[0239] In some examples, the reinforced spine may additionally or alternatively be reinforced by adhering (e.g., by adhesive or mechanical fixation) the spine to a delivery shaft disposed within the spine, thereby fixing the rotation of the spine to the delivery shaft.

[0240] 38A-39 illustrate an embodiment of the hub assembly 1318 of FIG. 34 in more detail. In FIGS. 38A-39, the hub assembly 1318 is shown alone, without the pusher shaft 1312 and the proximal portion of the sleeve shaft 1320 extending therethrough. As shown, the hub assembly 1318 can include a Y-shaped connector 1340 (also referred to as an "adapter") having a straight section 1342 (e.g., a straight conduit) and a bifurcated portion 1344 (e.g., a bifurcated conduit), although in some embodiments, the hub assembly 1318 can include two or more bifurcated portions. In some embodiments, the suture lock assembly 1316 can be attached to the bifurcated portion 1344 ( FIGS. 38A-38C ), and a sleeve handle (e.g., a sleeve actuation handle) 1324 can extend proximally from the proximal end of the straight section 1342 (as shown in FIG. 34 ).

[0241] As shown in FIGS. 38A-38D, the hub assembly 1318 may include one or more flushing ports to allow for flushing and / or degassing of one or more lumens within the delivery device 1300 to reduce thrombus formation between components of the delivery device, remove air from one or more lumens or components, and / or sterilize the delivery device 1300.

[0242] In some examples, the suture lock assembly 1316 can include an irrigation port 1315 located at its end. The irrigation port 1315 can deliver fluids to various lumens of the delivery device 1300 during an implantation procedure to allow degassing of the suture lock assembly 1316 and / or reduce thrombus formation before and / or during an implantation procedure using the delivery device 1300.

[0243] 38A-38D, the first flushing port 1330 is located on a branch 1344 of a Y-connector 1340 proximal to a gasket 1346 configured to seal around an extension of the pusher shaft 1312 (as shown in the schematic diagram of FIG. 40, described below). The gasket 1346 is visible in the side view of FIG. 38B, in which the Y-connector 1340 is shown as transparent (so that the components extending inside the Y-connector 1340 are visible), and in the cross-sectional view of FIG. 38D.

[0244] 38B and 38D , the gasket 1346 is positioned within the bifurcation 1344 closer to the straight section 1342 than the first flushing port 1330. The first flushing port 1330 is disposed on the bifurcation 1344 closer to the suture lock assembly 1316 than the gasket 1346. As such, the first flushing port 1330 is said to be positioned proximal to the gasket 1346 on the bifurcation 1344.

[0245] In some embodiments, the gasket 1346 can have a T-shaped cross section with a wider diameter portion and a smaller diameter portion.

[0246] The first flushing port 1330 can provide flushing fluid to the lumen of the pusher shaft 1312 before and / or during an implantation procedure using the delivery device. For example, FIG. 40 is an exemplary simplified diagram of the delivery device 1300 showing multiple lumens formed between the exemplary docking device (which may be the same as or similar to docking device 52), the pusher shaft 1312, the sleeve shaft 1320, and the delivery shaft 1304 configured to receive fluids. More specifically, a first pusher shaft lumen 1328 can be formed within the interior of the pusher shaft 1312. A second sleeve shaft lumen 1334 can be formed within the sleeve shaft 1320. Additionally, a third delivery shaft lumen 1338 can be formed within the annular space formed between the inner surface of the delivery shaft 1304 and the outer surface of the sleeve shaft 1320.

[0247] 40 , the pusher shaft lumen 1328 can receive fluid directly from a first flushing port 1330 positioned on the Y-connector 1340 proximal to the gasket 1346 (as described above with reference to FIGS. 38B and 38D ). The flushing fluid flow 1348 from the first flushing port 1330 can travel through the pusher shaft lumen 1328, along the length of the pusher shaft 1312, to the distal end 1350 of the pusher shaft 1312. The flushing fluid flow 1348 can flow from the distal end 1350 of the pusher shaft 1312 into and through the sleeve shaft lumen 1334 (indicated by arrow 1352) and / or through a portion of the docking apparatus 1358 (such as through a guard member 1360 of the docking apparatus 1358, as indicated by arrow 1356). In some embodiments, the irrigation fluid flow 1348 can continue through the sleeve shaft lumen 1334, into the shell portion 1364 of the pusher shaft 1312, and into the delivery shaft lumen 1338 (as shown by arrow 1352).

[0248] 40, one or more lumens of the delivery device 1300 (e.g., delivery shaft lumen 1338) can also receive fluid from a second flushing port 1332 as flushing fluid stream 1366 that flows through the delivery shaft lumen 1338 to the distal end 1304d of the delivery shaft 1304. As shown in FIG. 34, the second flushing port 1332 can be coupled to the handle 1306 of the delivery device 1300.

[0249] In some embodiments, prior to an implantation procedure using the delivery device 1300, the delivery device 1300 can receive a flushing fluid via the first flushing port 1330 and the second flushing port 1332 to flush and degas the lumen of the delivery device 1300 described above.

[0250] For example, in some cases, while the flush port 1315 on the suture lock assembly 1316 is open (e.g., uncapped), a first amount of flush fluid may be pushed through the first flush port 1330. In this manner, the first amount of flush fluid may pass through and flush the lumen of the suture lock assembly 1316 (e.g., due to the flush port 1315 being fluidly coupled to the first flush port 1330 via one or more lumens of the suture lock assembly 1316).

[0251] In some cases, after closing (e.g., capping or otherwise sealing) the flushing port 1315, a second amount of flushing fluid can be pushed through the first flushing port 1330 to flush the pusher shaft lumen 1328 (and any additional lumens fluidly connected thereto, as described above with reference to FIG. 40).

[0252] In some embodiments, while supplying the first amount of flushing fluid, the sleeve lock cap located at the proximal end of the straight section 1342 of the Y-shaped connector 1340 can be unlocked, thereby unlocking the sleeve gasket 1345 (or seal) disposed therein and around the sleeve shaft 1320 ( FIG. 40 ), allowing fluid to flow proximally through the shell portion 1364 of the pusher shaft 1312, into the Y-shaped connector 1340, and out the proximal end of the straight section 1342 of the Y-shaped connector 1340.

[0253] In some cases, a third amount of flushing fluid may be pushed through the second flushing port 1332 to flush the delivery shaft lumen 1338 as described above.

[0254] During an implantation procedure while the delivery device 1300 is being guided to the target implantation site and / or the docking device is being deployed from the delivery device 1300, irrigation fluid may be continuously provided to the first irrigation port 1330 and the second irrigation port 1332. For example, a fluid pump may be coupled to the first irrigation port 1330 and the second irrigation port 1332 to supply fluid to the lumen of the delivery device 1300 at a set fluid flow rate, thereby preventing clot formation within the delivery device 1300.

[0255] The above-described placement of the flushing ports of the delivery device 1300 may simplify operation of the delivery device 1300 both before and during the implantation procedure.

[0256] 38A-38D and 39, further details are provided of the configuration of the suture lock assembly 1316 of the delivery device 1300. The suture lock assembly 1316 may include a rotator 1372 (which may also be referred to as a "rotatable handle"), which, as described above, may extend from the suture lock assembly 1316, through a branch 1344, through the handle 1322 and the delivery shaft 1304 to increase or decrease tension on the release suture 1336 (shown in dashed lines in FIGS. 38B and 39) that connects to the docking device.

[0257] In certain embodiments, the release suture 1336 may be wrapped around a spool of the suture lock assembly 1316 such that by rotating the rotator 1372 in a given direction, the tension of the release suture 1336 across the delivery device 1300 may be adjusted (e.g., increased or decreased). Rotating the rotator 1372 may apply tension or slack to the release suture 1336, causing the docking device to move closer or further away from the delivery device 1300, respectively.

[0258] In certain embodiments, the suture lock assembly 1316 may include a connector or connecting portion for attaching the suture lock assembly 1316 to a handle assembly (e.g., handle assembly 1302). For example, the suture lock assembly 1316 may include a release bar 1382 that extends into and couples with the housing 1362 of the suture lock assembly 1316 (see, e.g., FIG. 39 ). In some embodiments, the release bar 1382 may be adhered to the housing 1362 (e.g., via adhesive, welding, or other non-removable fastening means). As shown in FIG. 38D , a release knob 1384 may be disposed around a portion of the release bar 1382 adjacent to the connecting portion 1386 of the housing 1362. The release knob 1384 may be configured to connect the suture lock assembly 1316 to the Y-shaped connector 1340. For illustrative purposes, the release knob 1384 is removed in FIG. 38B to show the threaded portion 1385 of the branch 1344 of the Y-shaped connector 1340 to which the release knob 1384 can be coupled (and thus the suture lock assembly 1316 can be secured to the branch 1344).

[0259] In certain embodiments, when a release knob 1384 is coupled to each of the threaded portion 1385 of the Y-shaped connector 1340 and the release bar 1382, the suture lock assembly 1316 may be coupled to the delivery device 1300, and the suture cutting section 1354 of the release bar 1382 may be covered by the prong 1344 of the Y-shaped connector 1340 ( FIGS. 38B and 38D ). In some embodiments, once the docking device (or other implant) is positioned in a desired position for release from the delivery device 1300, the release knob 1384 may be unthreaded from the threaded portion 1385 of the Y-shaped connector 1340, releasing the suture lock assembly 1316 from the Y-shaped connector 1340, and the suture lock assembly 1316 may be pulled proximally away from the Y-shaped connector 1340, exposing the suture cutting section 1354 ( FIG. 39 ).

[0260] The suture cutting section 1354 may be configured to allow a user or medical professional to cut the release suture 1336 that traverses the length of the delivery device 1300 to allow the docking device to be decoupled from the delivery device 1300 upon deployment at the target implantation site.

[0261] In some embodiments, once the release suture 1336 is wrapped around the docking device or implant and routed through the delivery device, through the release bar 1382 (including traversing the suture cutting section 1354), and into the housing 1362, the two suture ends of the release suture 1336 can be threaded through two openings disposed in the lower end of the spool and then tied together to complete the suture loop.

[0262] 39 , the release suture 1336 extends longitudinally through the release bar 1382, and the two strands of the release suture 1336 are split across a divider 1388 disposed within the suture cutting section 1354. In some cases, the divider 1388 separates the strands of the release suture 1336 such that only one strand can be cut by a user or medical professional to release the docking device from the delivery device. For example, as shown in FIG. 39 , the exposed portion of the release suture 1336 can be cut by a cutting mechanism. Once the release suture 1336 is cut, it can be removed from the delivery device 1300, and the suture lock assembly 1316 can be reinstalled onto the Y-connector 1340.

[0263] In some embodiments, one or more sealing elements may be disposed about an outer surface of the release bar 1382 such that a fluid seal may be created between the release bar 1382 and the prong 1344 of the Y-connector 1340. For example, as shown in FIGS. 38D and 39 , a sealing element 1390 (e.g., an O-ring) is disposed around the circumference of a portion of the exterior of the release bar 1382 proximal to the suture cutting section 1354 of the release bar 1382. Thus, the release suture 1336 extends through the interior (lumen) of the release bar 1382, while the sealing element 1390 seals around the outer surface of the release bar 1382 (e.g., between the outer surface of the release bar 1382 and the inner surface of the threaded portion 1385 of the prong 1344).

[0264] The components and functions of suture lock assemblies (such as suture lock assembly 1316), as well as delivery devices including such suture lock assemblies, are described in International Publication No. WO2020 / 247907, the disclosure of which is incorporated herein by reference.

[0265] delivery technology To implant a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath to allow it to self-expand). Alternatively, the prosthetic valve can be implanted within the native aortic valve transapically, whereby the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native aortic valve. Alternatively, in the transaortic approach, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a mini-thoracotomy in the right parasternal region, and then advanced through the ascending aorta toward the native aortic valve.

[0266] To implant a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted within the native mitral valve transapically, 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 the apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0267] To implant a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used to implant a prosthetic valve within the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0268] Another delivery approach is the transatrial approach, whereby the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (of the right or left atrium) to access either of the native heart valves. Atrial delivery can also be performed intravascularly, such as through a pulmonary vein. Yet another delivery approach is the transventricular approach, whereby the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0269] In all delivery approaches, the delivery device may be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed herein may be implanted using any of a variety of delivery techniques and any of a variety of delivery devices known in the art.

[0270] Any of the systems, devices, instruments, etc. herein can be sterilized (e.g., using heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use on patients, and any of the methods herein can include sterilizing the associated system, device, instrument, etc. as one of the steps in the method. Examples of heat sterilization include steam sterilization and autoclave sterilization. Examples of radiation for use in sterilization include, but are not limited to, gamma rays, ultraviolet light, and electron beams. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization by hydrogen peroxide can be achieved, for example, using hydrogen peroxide plasma.

[0271] Additional Examples of the Disclosed Techniques In view of the above-described implementations of the disclosed subject matter, the present application discloses the following additional embodiments: It should be noted that one feature of an embodiment in isolation, or two or more features of that embodiment taken in combination, and optionally in combination with one or more features of one or more additional embodiments, are additional embodiments that also fall within the disclosure of the present application.

[0272] Example 1 1. A handle for a delivery device, comprising: an outer housing; a spine positioned within the outer housing, the spine including a central lumen, an axially extending recess radially depressed into the spine from an outer surface of the spine toward the central lumen, and a support wall separating the central lumen and the axially extending recess; and a pull wire extending through the axially extending recess and out from a proximal end portion of the axially extending recess to a wire wrap coupled to the outer surface of the spine.

[0273] Example 2. The handle of any embodiment herein, particularly embodiment 1, wherein the support wall has a minimum thickness that is at least 10% of the total wall thickness of the spine, the total wall thickness being defined between the outer surface of the spine and the central lumen.

[0274] Example 3 The handle of any of the embodiments herein, particularly Example 1, wherein the support wall has a minimum thickness of 1 / 6 to 1 / 2 of the total wall thickness of the spine, the total wall thickness being defined between the outer surface of the spine and the central lumen.

[0275] Example 4. A handle according to any embodiment herein, particularly any one of embodiments 1-3, wherein the axially extending recess has an axial length that is at least ¼ of the total length of the spine.

[0276] Example 5. A handle as described in any of the embodiments herein, particularly any one of embodiments 1-4, wherein the distal end of the axially extending recess is disposed in a radial position disposed between the central lumen and the outer surface of the spine, adjacent to a channel extending axially through the spine toward the distal end of the spine, and the pull wire extends proximally through the channel into the axially extending recess.

[0277] Example 6 The handle of any of the embodiments herein, particularly any one of embodiments 1-5, wherein the pull wire is part of an adjustment mechanism configured to adjust the curvature of the distal end of the shaft of the delivery device, and the adjustment mechanism is disposed within the outer housing of the handle.

[0278] Example 7 A handle as described in any of the embodiments herein, particularly any one of embodiments 1-6, wherein the spine comprises a spine shaft and a base, the base being connected to and disposed on the end of the spine shaft, an axially extending recess being disposed within the spine shaft, and the base contacting the inner surface of the outer housing.

[0279] Example 8 10. The handle of any embodiment herein, particularly any one of embodiments 1-7, wherein the axially extending recess is a first axially extending recess, the pull wire is a first pull wire, the wire wrap is a first wire wrap, the spine comprises a second axially extending recess circumferentially spaced from the first axially extending recess, and the handle comprises a second pull wire extending through the second axially extending recess and out from a proximal end portion of the second axially extending recess to a second wire wrap coupled to an outer surface of the spine.

[0280] Example 9. The handle of any embodiment herein, particularly embodiment 8, wherein the first axially extending recess is positioned within the spine between 80 degrees and 100 degrees away from the second axially extending recess.

[0281] Example 10. The handle of any embodiment herein, particularly any of embodiment 8 or embodiment 9, wherein the second axially extending recess is longer than the first axially extending recess.

[0282] Example 11 A handle as described in any of the examples herein, particularly any one of Examples 8-10, wherein the second axially extending recess extends from a position adjacent the distal end of the spine to a proximal end of the spine, and the first axially extending recess extends from a position adjacent the distal end of the spine towards a central portion of the spine that is disposed between the distal and proximal ends of the spine.

[0283] Example 12 A handle described in any of the embodiments herein, particularly any one of embodiments 8 to 11, wherein the spine comprises a distal spine portion and a proximal spine portion that are joined together at their respective bases, and each base is joined to the outer housing.

[0284] Example 13 The handle of any embodiment herein, particularly embodiment 12, wherein the first axially extending recess is disposed in the distal spine portion and the second axially extending recess extends from the distal spine portion into the proximal spine portion.

[0285] Example 14. The handle of any embodiment herein, particularly any one of embodiments 8-13, wherein the first wire wrap and the second wire wrap are axially spaced apart from each other.

[0286] Example 15. The handle of any embodiment herein, particularly any one of embodiments 1-14, wherein the axially extending recess has a depth and a length, and the depth varies along the length of the axially extending recess.

[0287] Example 16. The handle of any embodiment herein, particularly any one of embodiments 1-14, wherein the axially extending recess has a depth and a length, and the depth is constant along the length of the axially extending recess.

[0288] Example 17. 1. A delivery device comprising: a handle including an outer housing; a spine positioned within the outer housing, the spine comprising a central lumen and at least one axially extending recess radially recessed into the spine from an outer surface of the spine, the at least one recess being only partially recessed into a wall thickness of the spine defined between the outer surface and the central lumen; a shaft positioned within the central lumen of the spine and extending distally from the handle; and an adjustment mechanism configured to adjust the curvature of a distal end of the shaft, the adjustment mechanism comprising a pull wire connected between the distal end of the shaft and a wire wrap coupled to the outer surface of the spine, a proximal end portion of the pull wire extending from inside the at least one recess to an exterior of the spine and connecting to the wire wrap.

[0289] Example 18. A delivery device described in any example herein, particularly Example 17, wherein the depth of at least one radially defined recess is less than the wall thickness of the spine such that the base of the at least one recess is spaced from the central lumen.

[0290] Example 19. The delivery device of any example herein, particularly example 18, wherein the depth of the at least one recess is between 1 / 3 and 5 / 6 of the wall thickness of the spine.

[0291] Example 20. The delivery device of any example herein, particularly example 18, wherein the depth of the at least one recess is between ½ and ¾ of the wall thickness of the spine.

[0292] Example 21. A delivery device described in any of the embodiments herein, particularly any one of embodiments 18-20, wherein the depth of the at least one recess varies along the length of the at least one recess, the length being defined between the distal end and the proximal end of the at least one recess.

[0293] Example 22. A delivery device described in any of the embodiments herein, particularly any one of embodiments 18-20, wherein the depth of the at least one recess is constant along the length of the at least one recess, the length being defined between the distal end and the proximal end of the at least one recess.

[0294] Example 23. The delivery device of any embodiment herein, particularly any one of embodiments 17-22, wherein at least one recess has an axial length that is at least ¼ of the total length of the spine.

[0295] Example 24. The delivery device of any embodiment herein, particularly any one of embodiments 17-23, wherein the at least one recess extends axially along the spine along a majority of the length of the spine.

[0296] Example 25. A delivery device described in any of the embodiments herein, particularly any one of embodiments 17-24, wherein the distal end of at least one recess is positioned in a radial position disposed between the central lumen and the outer surface of the spine, adjacent to a channel extending axially through the spine toward the distal end of the spine, and the pull wire extends proximally through the channel into the at least one recess.

[0297] Example 26. A delivery device described in any of the embodiments herein, particularly any one of embodiments 17 to 25, wherein the spine comprises a spine shaft and a base, the base being connected to and disposed at the end of the spine shaft, at least one recess being disposed within the spine shaft, and the base contacting the inner surface of the outer housing.

[0298] Example 27. A delivery device described in any example herein, particularly any one of Examples 17-26, wherein the spine comprises a first axially extending recess and a second axially extending recess that are radially depressed into the spine from an outer surface of the spine, both of the first and second recesses being only partially depressed into a wall thickness of the spine defined between the outer surface and a central lumen, and the first and second recesses being circumferentially spaced apart from each other.

[0299] Example 28. The delivery device of any of the embodiments herein, particularly embodiment 27, wherein the pull wire is a first pull wire, the wire wrap is a first wire wrap, the adjustment mechanism comprises a second pull wire connected between the distal end of the shaft and a second wire wrap coupled to the outer surface of the spine, and a proximal end portion of the second pull wire extends from inside the second recess to the outside of the spine and connects to the second wire wrap.

[0300] Example 29. The delivery device of any embodiment herein, particularly embodiment 28, wherein the first wire wrap and the second wire wrap are axially spaced apart from each other.

[0301] Example 30. The delivery device of any embodiment herein, particularly any one of embodiments 27-29, wherein the first recess is positioned within the spine between 80 degrees and 100 degrees away from the second recess.

[0302] Example 31. The delivery device of any of the examples herein, particularly any one of Examples 27-30, wherein the first recess has a first axial length and the second recess has a second axial length, the second axial length being longer than the first axial length.

[0303] Example 32. A delivery device described in any example herein, particularly any one of Examples 27-31, wherein the second recess extends from a position adjacent to the distal end of the spine to the proximal end of the spine, and the first recess extends from a position adjacent to the distal end of the spine toward a central portion of the spine that is disposed between the distal and proximal ends of the spine.

[0304] Example 33. A delivery device described in any of the embodiments herein, particularly any one of embodiments 27 to 32, wherein the spine comprises a distal spine and a proximal spine that are joined together at their respective bases, and each base is joined to the outer housing.

[0305] Example 34. The delivery device of any example herein, particularly example 33, wherein the first recess is disposed only in the distal spine and the second recess extends from the distal spine into the proximal spine.

[0306] Example 35. The delivery device of any embodiment herein, particularly any one of embodiments 17-34, wherein the wire wrap extends around the circumference of the spine.

[0307] Example 36. A delivery device described in any embodiment herein, particularly any one of embodiments 17 to 35, further comprising a sliding nut disposed adjacent to the wire wrap around the outer surface of the spine, the sliding nut comprising a channel, and the pull wire extending from the at least one recess, through the channel in the sliding nut, to the wire wrap and secured around the wire wrap.

[0308] Example 37. The delivery device of any of the embodiments herein, particularly any one of embodiments 17-36, wherein the delivery device is configured to deliver a docking device disposed within a distal end portion of the shaft.

[0309] Example 38. 1. A delivery device comprising: a handle including an outer housing; a spine positioned within the outer housing, the spine comprising: a central lumen; a first axially extending recess radially depressed into the spine from an outer surface of the spine; and a second axially extending recess radially depressed into the spine from an outer surface of the spine and positioned circumferentially spaced from the first axially extending recess, wherein the first axially extending recess and the second axially extending recess each comprise a base offset from the central lumen by a respective support wall of the spine; a shaft positioned within the central lumen of the spine and extending distally from the handle; and an adjustment mechanism configured to adjust a curvature of a distal end of the shaft, the adjustment mechanism comprising a first pull wire routed through the first axially extending recess and a second pull wire routed through the second axially extending recess.

[0310] Example 39. The delivery device of any example herein, particularly example 38, wherein the second axially extending recess is axially longer than the first axially extending recess.

[0311] Example 40. A delivery device as described in any example herein, particularly any of Example 38 or Example 39, wherein the adjustment mechanism comprises a first wire wrap disposed around the outer surface of the spine and a second wire wrap disposed around the outer surface of the spine at a position axially spaced from the first wire wrap, wherein a first pull wire is routed through the first axially extending recess, out of the proximal end of the first axially extending recess, to the exterior of the spine and coupled to the first wire wrap, and a second pull wire is routed through the second axially extending recess, out of the proximal end of the second axially extending recess, to the exterior of the spine and coupled to the second wire wrap.

[0312] Example 41. 10. The delivery device of any embodiment herein, particularly embodiment 40, further comprising: a first sliding nut disposed about an outer surface of the spine adjacent to the first wire wrap; and a second sliding nut disposed about the outer surface of the spine adjacent to the second wire wrap, wherein the first sliding nut comprises a channel, and the first pull wire extends from the first axially extending recess through the channel in the first sliding nut to the first wire wrap; and the second sliding nut comprises a channel, and the second pull wire extends from the second axially extending recess through the channel in the second sliding nut to the second wire wrap.

[0313] Example 42. A delivery device described in any embodiment herein, particularly any one of embodiments 38-41, wherein the first axially extending recess is positioned within the spine 80 degrees to 100 degrees away from the second axially extending recess.

[0314] Example 43. A delivery device described in any embodiment herein, particularly any one of embodiments 38-42, wherein the first axially extending recess is positioned within the spine 85 degrees to 95 degrees away from the second axially extending recess.

[0315] Example 44. A delivery device described in any of the embodiments herein, particularly any one of embodiments 38 to 43, wherein the spine comprises a distal spine and a proximal spine that are joined together at their respective bases, and each base contacts the outer housing.

[0316] Example 45. A delivery device as described in any example herein, particularly example 44, wherein the first axially extending recess extends from a position adjacent the distal end of the distal spine toward a central portion of the distal spine, and the second axially extending recess extends from a position adjacent the distal end of the distal spine, along the distal spine, and into the proximal spine.

[0317] Example 46. The delivery device described in any of the embodiments herein, particularly any one of embodiments 38 to 45, wherein the delivery device is configured to deliver a docking device disposed within a distal end portion of the shaft.

[0318] Example 47. a delivery device including a handle, a delivery shaft extending distally from the handle, a pusher shaft extending through the delivery shaft and the handle, a hub assembly extending proximally from the handle, the adapter coupled to the handle and including a first section and a second section branching from the first section, a portion of the pusher shaft extending into the second section, a gasket disposed around a portion of the pusher shaft within the second section such that a fluid seal is created around the portion of the pusher shaft, and a suture lock assembly coupled to a proximal end of the second section. a suture lock assembly configured to adjust tension on a suture extending from the article through a pusher shaft, the suture lock assembly including a release bar configured to removably couple to the second section of the adapter, the release bar including a lumen configured to receive the suture therethrough and a sealing element disposed about an outer surface of the release bar and configured to seal against an inner surface of the second section of the adapter; and a hub assembly including a first flushing port coupled to the second section proximal to the gasket and fluidly coupled to a first fluid flow lumen disposed within the interior of the pusher shaft.

[0319] Example 48. A delivery device as described in any of the examples herein, particularly example 47, wherein when the suture lock assembly is coupled to the proximal end of the second section of the adapter, the sealing element is disposed proximal to the first flushing port on the second section.

[0320] Example 49. The delivery device of any example herein, particularly any of example 47 or example 48, wherein the sealing element is an O-ring.

[0321] Example 50. A delivery device described in any of the embodiments herein, particularly any one of embodiments 47 to 49, further comprising: a sleeve shaft disposed around at least a portion of the pusher shaft and extending from the first section of the adapter through the delivery shaft; and a second flushing port coupled to the handle and fluidly coupled to a second fluid flow lumen disposed between the delivery shaft and the sleeve shaft.

[0322] Example 51. A delivery device described in any of the embodiments herein, particularly any one of embodiments 47-50, wherein the release bar comprises a suture cutting section extending into the second section of the adapter adjacent to the first flushing port.

[0323] Example 52. The delivery device of any embodiment herein, particularly any one of embodiments 47-51, wherein the first flushing port is the only flushing port located on the second section of the adapter.

[0324] Example 53. A delivery device described in any of the embodiments herein, particularly any one of embodiments 47 to 52, wherein the suture lock assembly comprises a third flushing port disposed at its proximal end, the third flushing port being fluidly coupled to the second flushing port via an inner lumen of the suture lock assembly.

[0325] Example 54. A delivery device described in any of the embodiments herein, particularly any one of embodiments 47 to 53, wherein the sleeve gasket is disposed within the first section of the adapter and around a sleeve shaft extending out from the proximal end of the first section, and the sleeve shaft is disposed around a pusher shaft inside the delivery shaft.

[0326] Example 55. A method comprising sterilizing the handle, delivery device, and / or assembly of any embodiment.

[0327] Example 56. The delivery device of any one of Examples 1 to 54, wherein the delivery device is sterilized.

[0328] Any feature described in this disclosure with respect to any embodiment may be combined with any other feature described in any one or more of the other embodiments, unless expressly stated otherwise. For example, any one or more features of one delivery device may be combined with any one or more features of another delivery device. As another example, any one or more features of one handle may be combined with any one or more features of another handle.

[0329] In view of the many possible manners to which the principles of this disclosure may be applied, it will be understood that the illustrated configurations represent examples of the disclosed technology and should not be taken as limiting the scope of the disclosure and the claims that follow. Rather, the scope of claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A handle for a delivery device, comprising: An outer housing; a spine positioned within the outer housing, a central lumen; an axially extending recess radially depressed into the spine from an outer surface of the spine toward the central lumen; a support wall separating the central lumen and the axially extending recess; a pull wire extending through the axially extending recess and out a proximal end portion of the axially extending recess to a wire wrap coupled to the outer surface of the spine.

2. 2. The handle of claim 1, wherein the support wall has a minimum thickness that is at least 10% of a total wall thickness of the spine, the total wall thickness being defined between the outer surface and the central lumen of the spine.

3. 2. The handle of claim 1, wherein the support wall has a minimum thickness that is 1 / 6 to 1 / 2 of the total wall thickness of the spine, the total wall thickness being defined between the outer surface of the spine and the central lumen.

4. A handle according to any one of claims 1 to 3, wherein the axially extending recess has an axial length that is at least ¼ of the overall length of the spine.

5. 5. The handle of claim 1, wherein a distal end of the axially extending recess is disposed at a radial position disposed between the central lumen and the outer surface of the spine adjacent a channel extending axially through the spine toward the distal end of the spine, the pull wire extending through the channel and proximally into the axially extending recess.

6. 6. The handle of claim 1, wherein the spine comprises a spine shaft and a base, the base being connected to and disposed on an end of the spine shaft, the axially extending recess being disposed within the spine shaft, and the base contacting an inner surface of the outer housing.

7. A handle according to any preceding claim, wherein the axially extending recess has a depth and a length, the depth varying along the length of the axially extending recess.

8. A handle according to any preceding claim, wherein the axially extending recess has a depth and a length, the depth being constant along the length of the axially extending recess.

9. 1. A delivery device comprising: a handle including an outer housing; a spine positioned within the outer housing, a central lumen; a spine comprising at least one axially extending recess radially depressed into the spine from an outer surface thereof, the at least one axially extending recess only partially depressed into a wall thickness of the spine defined between the outer surface and the central lumen; a shaft positioned within the central lumen of the spine and extending distally from the handle; an adjustment mechanism configured to adjust the curvature of the distal end of the shaft, the adjustment mechanism comprising a pull wire connected between the distal end of the shaft and a wire wrap coupled to the outer surface of the spine, a proximal end portion of the pull wire extending from inside the at least one recess to the exterior of the spine and connecting to the wire wrap.

10. 10. The delivery device of claim 9, wherein the depth of the at least one recess is between 1 / 3 and 5 / 6 of the wall thickness of the spine.

11. 11. The delivery device of claim 9 or 10, wherein the at least one recess extends axially along the spine along a majority of the length of the spine.

12. 12. The delivery device of claim 9, wherein the spine comprises a first axially extending recess and a second axially extending recess radially depressed into the spine from the outer surface of the spine, both of the first and second recesses being only partially depressed into the wall thickness of the spine defined between the outer surface and the central lumen, and the first and second recesses being circumferentially spaced apart from one another.

13. 13. The delivery device of claim 12, wherein the pull wire is a first pull wire, the wire wrap is a first wire wrap, and the adjustment mechanism comprises a second pull wire connected between the distal end of the shaft and a second wire wrap coupled to the outer surface of the spine, a proximal end portion of the second pull wire extending from inside the second recess to the exterior of the spine and connecting to the second wire wrap.

14. 1. A delivery device comprising: a handle including an outer housing; a spine positioned within the outer housing, a central lumen; a first axially extending recess radially depressed into the spine from an outer surface of the spine; a spine comprising: a second axially extending recess radially depressed into the spine from the outer surface thereof and positioned circumferentially spaced apart from the first axially extending recess, the first axially extending recess and the second axially extending recess each comprising a base offset from the central lumen by a respective support wall of the spine; a shaft positioned within the central lumen of the spine and extending distally from the handle; an adjustment mechanism configured to adjust a curvature of the distal end of the shaft, the adjustment mechanism comprising a first pull wire routed through the first axially extending recess and a second pull wire routed through the second axially extending recess.

15. The delivery device of claim 14 , wherein the second axially extending recess is axially longer than the first axially extending recess.

16. 16. The delivery device of claim 14 or 15, wherein the adjustment mechanism comprises a first wire wrap disposed around the outer surface of the spine and a second wire wrap disposed around the outer surface of the spine at a location axially spaced from the first wire wrap, the first pull wire being routed through the first axially extending recess, out a proximal end of the first axially extending recess, to the exterior of the spine, and coupled to the first wire wrap, and the second pull wire being routed through the second axially extending recess, out a proximal end of the second axially extending recess, to the exterior of the spine, and coupled to the second wire wrap.

17. 17. The delivery device of claim 16, further comprising: a first sliding nut disposed about the outer surface of the spine adjacent to the first wire wrap; and a second sliding nut disposed about the outer surface of the spine adjacent to the second wire wrap, wherein the first sliding nut comprises a channel, and the first pull wire extends from the first axially extending recess through the channel in the first sliding nut to the first wire wrap; and the second sliding nut comprises a channel, and the second pull wire extends from the second axially extending recess through the channel in the second sliding nut to the second wire wrap.

18. 18. The delivery device of any one of claims 14 to 17, wherein the first axially extending recess is positioned within the spine between 80 degrees and 100 degrees away from the second axially extending recess.

19. 19. The delivery device of any one of claims 14-18, wherein the spine comprises a distal spine and a proximal spine joined together at their respective bases, the respective bases contacting the outer housing, the first axially extending recess extending from a location adjacent the distal end of the distal spine toward a central portion of the distal spine, and the second axially extending recess extending from the location adjacent the distal end of the distal spine along the distal spine into the proximal spine.

20. 1. A delivery device comprising: The handle and a delivery shaft extending distally from the handle; a pusher shaft extending through the delivery shaft and the handle; a hub assembly extending proximally from the handle, an adapter coupled to the handle, the adapter including a first section and a second section branching from the first section, a portion of the pusher shaft extending into the second section; a gasket disposed around the portion of the pusher shaft within the second section such that a fluid seal is created around the portion of the pusher shaft; a suture lock assembly coupled to a proximal end of the second section and configured to adjust tension on a suture extending from the suture lock assembly and through the pusher shaft, the suture lock assembly including a release bar configured to removably couple with the second section of the adapter, the release bar including an inner lumen configured to receive the suture therethrough, and a sealing element disposed about an outer surface of the release bar and configured to seal against an inner surface of the second section of the adapter; a hub assembly coupled to the second section proximal to the gasket and fluidly coupled to a first fluid flow lumen disposed within the interior of the pusher shaft.

Images