Delivery device and assembly

Abstract

The utility model relates to a delivery device and assembly. A delivery device comprises: a handle comprising a body and a nose cone positioned distally of the body, wherein the nose cone comprises at least one axial flow channel extending from an inner surface of the nose cone; a spine positioned within the body of the handle, the spine including a lumen; a shaft positioned within the lumen of the spine, the shaft extending distally from the handle; and a ridge extension positioned within the nose cone and coupled to the ridge, the ridge extension at least partially surrounding the shaft, the ridge extension including a radial protrusion, wherein each of the radial projections includes one or more mating features defining at least one slot corresponding to the at least one axial flow passage of the nose cone.

Description

[0001] This application is a divisional application. The application date of the original application is April 17, 2023, the application number is 2023208418640, and the name of the invention is “A handle of a delivery device”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 63 / 363,162, filed on April 18, 2022, which is incorporated herein by reference. Technical Field

[0004] The present disclosure relates to handles for delivery devices for prosthetic medical devices. Background Art

[0005] The human heart may suffer from various valvular diseases. These valvular diseases may cause significant dysfunction of the heart and ultimately require repairing the natural valve or replacing the natural valve with a prosthetic valve. There are many known repair devices (such as stents) and prosthetic valves, as well as many known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various surgeries to deliver prosthetic medical devices to a position that is not easily accessible by surgery or a position that is expected to be accessible without surgery. In a specific example, a prosthetic heart valve can be mounted on the distal end of a delivery device in a curled state and advance through the patient's vascular system (such as through a femoral artery or femoral vein) until the prosthetic valve reaches the implantation site in the heart. Then, for example, by inflating a balloon with a prosthetic valve mounted thereon, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying a prosthetic valve from a sheath of a delivery device so that the prosthetic valve can self-expand to its functional size, the prosthetic valve is expanded to its functional size.

[0006] A delivery device for delivering a prosthetic medical device, such as the prosthetic heart valve delivery device described above, can include an elongated shaft inserted into the patient's vasculature. The delivery device can also include a handle that remains outside the patient's body and can be used to manipulate the shaft. Utility Model Content

[0007] Prosthetic heart valves, delivery devices, and methods for implanting prosthetic heart valves are described herein. The disclosed delivery device can, for example, be configured to transmit torque applied to the handle of the delivery device to the distal end of a shaft extending distally from the delivery device via a spine assembly. In some instances, the handle can be used to manipulate the distal end of the shaft, and the delivery device can include an indicator assembly indicating manipulation of the shaft (e.g., it is located in the handle, can be observed through a window of the handle, etc.). Thus, the devices and methods disclosed herein can particularly overcome one or more defects of typical delivery devices.

[0008] In a representative example, a handle of a delivery device includes: a shell having an outer wall; at least one window connected to the outer wall of the shell, the at least one window defining at least one observation area through the outer wall; and at least one indicator positioned within the shell adjacent to the window, the at least one indicator comprising a background member and a slider, wherein the slider is configured to slide relative to the background member.

[0009] In another representative example, a delivery device includes: a handle including a body and a nose cone positioned distal to the body, wherein the nose cone includes at least one axial flow channel extending from an inner surface of the nose cone; a ridge positioned within the body of the handle, the ridge including a lumen; an axis positioned within the lumen of the ridge, the axis extending distally from the handle; and a ridge extension positioned within the nose cone and coupled to the ridge, the ridge extension at least partially surrounding the axis, the ridge extension including radial protrusions, wherein each of the radial protrusions includes one or more mating features defining at least one groove corresponding to the at least one axial flow channel of the nose cone.

[0010] In another representative example, a delivery device includes: a handle; a shaft having a distal end and a proximal end, the shaft extending distally from the handle, wherein the proximal end of the shaft is positioned in the handle, the shaft including a lumen extending from the distal end toward the proximal end; and a sealing assembly positioned in the handle and connected to the proximal end of the shaft, the sealing assembly including a sealing housing, a seal disposed within the sealing housing, and a seal compressor component connected to the sealing housing and configured to compress the seal within the sealing housing in an axial direction.

[0011] In another representative example, a delivery device includes: a handle having at least one window; a delivery shaft extending distally from the handle, the delivery shaft having a distal end and a proximal end, wherein the proximal end of the delivery shaft is positioned within the handle; a spine assembly positioned at least partially around the delivery shaft, the spine assembly being coupled to the handle; an adjustment mechanism configured to adjust the curvature of the distal end of the delivery shaft; and an indicator configured to indicate an amount of adjustment made by the adjustment mechanism, the indicator being positioned within the handle and observable through the at least one window.

[0012] In another representative example, an assembly includes: a delivery device including a handle according to any example described herein; and a prosthetic implant releasably coupled to the delivery device.

[0013] In another representative example, an assembly includes: a delivery device according to any example herein; and a prosthetic implant releasably coupled to the delivery device.

[0014] In another representative example, a method for implanting a prosthetic implant includes inserting a delivery device into a patient's vascular system, wherein the delivery device includes a delivery device according to any example described herein; and sliding a first slider within a handle of the delivery device relative to a first background member, wherein the slider indicates a first type of adjustment amount of an axis of the delivery device.

[0015] In another representative example, a method for implanting a prosthetic implant includes: inserting a shaft of a delivery device into the vasculature of a patient, wherein the delivery device includes a handle outside the patient's body, wherein the handle includes a handle according to any example described herein; and rotating the delivery device relative to the vasculature of the patient, wherein the handle includes a support member configured to transmit torque from the handle to a distal end of the shaft.

[0016] The various innovations of the present disclosure may be used in combination or alone. The present disclosure is provided to introduce some concepts in a simplified form, which will be further described in the following detailed description. The present disclosure is not intended to identify the 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. The foregoing and other objects, features and advantages of the present disclosure will become more apparent from the following detailed description, claims and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 A first stage in an exemplary mitral valve replacement procedure is schematically illustrated in which a guide catheter and guidewire are inserted into a patient's blood vessel and guided through the vessel and into the patient's heart toward the heart's native mitral valve.

[0018] Figure 2A A second stage in an exemplary mitral valve replacement procedure is schematically illustrated in which a docking device delivery apparatus extending through a guide catheter implants a docking device for a prosthetic heart valve at the native mitral valve.

[0019] Figure 2B The third stage in an exemplary mitral valve replacement procedure is schematically shown, wherein Figure 2A The docking device is fully implanted at the patient's native mitral valve and the docking device delivery apparatus is removed from the patient.

[0020] Figure 3AA fourth stage in an exemplary mitral valve replacement procedure is schematically illustrated, in which a prosthetic heart valve delivery device extending through a guide catheter implants a prosthetic heart valve into an implanted docking device at the native mitral valve.

[0021] Figure 3B A fifth stage in an exemplary mitral valve replacement procedure is schematically illustrated, wherein the prosthetic heart valve is fully implanted within a docking device at the native mitral valve and the prosthetic heart valve delivery device has been removed from the patient.

[0022] Figure 4 A sixth stage in an exemplary mitral valve replacement procedure is schematically illustrated, wherein the guide catheter and guidewire have been removed from the patient.

[0023] Figure 5 is a side view of a delivery apparatus configured to deliver a prosthetic medical device to a target implantation site in a patient according to one example.

[0024] Figure 6 yes Figure 5 Cross-sectional side view of a delivery device.

[0025] Figure 7 yes Figure 5 A perspective view of a delivery device with a distal portion of the housing removed to illustrate internal components of the delivery device.

[0026] Figure 8 Based on an example Figure 5 A perspective view of a spine extension of a delivery device.

[0027] Fig. 9 Based on an example Figure 5 A perspective view of the distal portion of the housing of the delivery device.

[0028] Fig.10 yes Figure 8 Positioning in Fig. 9 A proximal end view of a spine extension within a distal portion of a housing.

[0029] Fig.11 yes Figure 5 A perspective view of a delivery device with a distal portion of the housing and spine extension removed to illustrate the shaft of the delivery device.

[0030] Fig.12 yes Figure 5 Another perspective view of the delivery device with the distal portion of the housing removed.

[0031] Fig.13 yes Figure 5 Delivery equipment around Figure 5A perspective view of a spinal assembly positioned along an axis of a delivery device, the spinal assembly comprising Fig. 9 The ridge extension.

[0032] Fig.14 yes Fig.13 Perspective view of the distal spine of the spine assembly.

[0033] Fig.15 yes Fig.13 A perspective view of the proximal spine of the spine assembly.

[0034] Fig.16 is located in Fig.13 A perspective view of the components of the adjustment mechanism on the spine assembly.

[0035] Fig.17 is located in Fig.13 A perspective view of the additional components of the adjustment mechanism on the spine assembly.

[0036] Fig.18 yes Figure 5 A perspective view of an upper section of a mid-portion of a housing of a delivery device.

[0037] Fig.19 yes Figure 5 A perspective view of a lower section of a middle portion of a housing of a delivery device.

[0038] Fig. 20 yes Figure 5 A top view of a middle section of a delivery device, wherein Fig.18 The upper section of the middle part of the housing is removed.

[0039] Fig.21 yes Figure 5 A perspective view of a middle section of a delivery device, wherein Fig.18 An upper section of the middle portion of the housing is removed to illustrate components of the indicator assembly.

[0040] Fig. 22 yes Figure 5 A perspective view of a middle section of a delivery device, wherein Fig.18 The upper section of the middle portion of the housing and the window of the indicator assembly are removed.

[0041] Fig.23 yes Figure 5 Another perspective view of a delivery device.

[0042] Fig.24 yes Figure 5 A perspective view of a delivery device with a proximal portion of the housing removed to illustrate internal components of the delivery device.

[0043] Fig.25 yes Figure 5Cross-sectional side view of the proximal section of the delivery device.

[0044] Fig.26 Based on an example Figure 5 A perspective view of a sealed housing of a delivery device.

[0045] Fig. 27 Based on an example Figure 5 A perspective view of a seal compressor component of a delivery device.

[0046] Fig.28 Based on an example Figure 5 Delivery equipment included Fig.26 Sealed housing and Fig. 27 A perspective view of a seal assembly of a seal compressor component.

[0047] Fig.29 is a side view of another delivery apparatus configured to deliver a prosthetic medical device to a target implantation site in a patient according to one example.

[0048] Fig.30 is included Fig.29 Side view of an example delivery system of a delivery device. DETAILED DESCRIPTION

[0049] General considerations

[0050] For the purposes of this specification, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Rather, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed examples require the presence of any one or more specific advantages or solutions to problems.

[0051] Although the operations of some disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language set forth below requires a particular order. For example, the operations described in sequence may be rearranged or performed simultaneously in some cases. In addition, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, this specification sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation, and are easily discernible by those of ordinary skill in the art.

[0052] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. In addition, the term "comprising" means "including". Furthermore, the term "coupled" generally means a physical, mechanical, chemical, magnetic, and / or electrical connection or coupling, and in the absence of specific language to the contrary does not exclude the presence of intervening elements between the coupled or associated items.

[0053] As used herein, the term "proximal" refers to a position, direction or part of a device that is closer to a user and further away from an implantation site. As used herein, the term "distal" refers to a position, direction or part of a device that is further away from a user and closer to an implantation site. Therefore, for example, the proximal motion of a device is the motion of a device away from an implantation site and toward a user (e.g., leaving the patient's body), while the distal motion of a device is the motion of a device away from a user and toward an implantation site (e.g., entering the patient's body). The terms "longitudinal" and "axial" refer to an axis extending in proximal and distal directions, unless otherwise clearly defined. As used herein, other directional terms (e.g., "vertical", "horizontal", etc.) refer to the direction of a reference system relative to the accompanying drawings, and are not intended to limit potential alternative orientations.

[0054] Introduction of public technology

[0055] Various systems, devices, methods, etc. are described herein, which in some instances can be used in or with delivery devices for prosthetic medical devices (e.g., prosthetic heart valves or docking devices). In some instances, the delivery devices disclosed herein can be used to deliver a docking device for a transcatheter prosthetic heart valve to the vasculature of a patient at a target implantation site. For example, Figure 1-4 An exemplary transcatheter heart valve replacement procedure is schematically shown, which uses a guide catheter to guide a docking device delivery apparatus toward a native valve annulus, and then guides a prosthetic heart valve delivery apparatus toward the native valve annulus. The docking device delivery apparatus is used to deliver the docking device to the native valve annulus, and then the prosthetic heart valve delivery apparatus is used to deliver the transcatheter prosthetic heart valve into the docking device.

[0056] 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 fully conform to the geometry of the native tissue (e.g., conform to the leaflets and / or annulus of the native heart valve) and may be undesirably displaced relative to the native tissue, which may result in paravalvular leakage. Therefore, a docking device may first be implanted at the native valve annulus, and then the prosthetic heart valve may be implanted within the docking device to help anchor the prosthetic heart valve to the native tissue and provide a seal between the native tissue and the prosthetic heart valve.

[0057] exist Figure 5-30 An exemplary delivery device for delivering a docking device at a native heart valve is shown in more detail in FIG. Figure 5-22 As shown, a delivery device may include a spine assembly within a handle of the delivery device, the spine assembly being configured to transmit torque applied to the handle to a shaft of the delivery device. Figure 8 and 13 -15 shows additional details of an exemplary spine assembly. The delivery device may also include an adjustment mechanism for manipulating (e.g., controlling, guiding, flexing, etc.) the distal end of the shaft. Figure 11-12 Additional details of exemplary spine assemblies are shown in 16-17. In some examples, as Figure 5 and Figure 20-22 As shown, 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, the sealing assembly including one or more seals that can be uniformly compressed in the axial direction (e.g., without the use of fasteners such as screws or bolts), such as Figure 24-28 In addition, the delivery device may include a locking mechanism configured to lock a device inserted through the delivery device ( Figure 29-30 ) such that the device is selectively prevented from moving relative to the delivery device. Figure 23-25 Additional details of an exemplary locking mechanism are shown in .

[0058] Examples of Public Technology

[0059] Figure 1-4 An exemplary transcatheter heart valve replacement procedure (e.g., mitral valve replacement procedure) according to one example is depicted, the procedure utilizing a prosthetic implant including a docking device 52 and a prosthetic heart valve 62. During the procedure, the user first uses a guide catheter 30 ( Figure 1 ) creates a passage to the patient's native heart valve. The user then uses the docking device to deliver the device 50 ( Figure 2A ) delivering and implanting the docking device 52 at the patient's native heart valve, and then removing the docking device delivery apparatus 50 from the patient 10 after implanting the docking device 52 ( Figure 2B The user then uses the prosthetic valve delivery device 60 ( Figure 3A ) implants the prosthetic heart valve 62 within the implanted docking device 52. Thereafter, the user removes the prosthetic valve delivery device 60 from the patient 10 ( Figure 3B ) and a guide catheter 30 ( Figure 4 ).

[0060] Figure 1A first stage in a mitral valve replacement procedure according to one example is depicted in which a guide catheter 30 and guidewire 40 are inserted into a blood vessel 12 of a patient 10 and are guided through the blood vessel 12, into the heart 14 of the patient 10, and toward the native mitral valve 16. The guide catheter 30 and guidewire 40 together can provide a path for a docking device delivery apparatus 50 and a prosthetic valve delivery apparatus 60 to be guided through and along the path to the implantation site (the native mitral valve 16 or the native mitral valve annulus).

[0061] Initially, the user may first make an incision in the patient's body to access the blood vessel 12. For example, Figure 1 In the example shown, the user can make an incision in the patient's groin to access the femoral vein. Therefore, in such examples, the blood vessel 12 can be the femoral vein.

[0062] After forming an incision at the blood vessel 12, the user can insert the guide catheter 30, the guide wire 40 and / or an additional device (such as an introducer device or a transseptal puncture device) into the blood vessel 12 through the incision. The guide catheter 30 (which may also be referred to as an "introducer device", "introducer" or "introducer 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 can extend through the blood vessel 12 and into the heart 14, but can stop before the native mitral valve 16. The guide catheter 30 may include a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 can extend through the blood vessel 12 and into the heart 14, while the handle 32 remains outside the patient's 10 and can be operated by the user to manipulate the shaft 34 ( Figure 1 ).

[0063] 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, additional catheters, etc.) and its associated devices (e.g., a docking device, a prosthetic heart valve, etc.) to an implantation site within the heart 14, and thus may extend through the blood vessel 12 and into the left atrium 18 of the heart 14 (and, in some instances, through the native mitral valve 16 and into the left ventricle of the heart 14) ( Figure 1 ).

[0064] In some cases, a transseptal puncture device or catheter can be used to initially access the left atrium 18 prior to inserting the guidewire 40 and guide catheter 30. For example, after making an incision in the blood vessel 12, the user can insert the transseptal puncture device through the incision into the blood vessel 12. The user can guide the transseptal puncture device through the blood vessel 12 and into the heart 14 (e.g., through the femoral vein and into the right atrium 20). The user can then make a small incision in the atrial septum 22 of the heart 14 to allow access to the left atrium 18 from the right atrium 20. The user can then insert and advance the guidewire 40 through the transseptal puncture device in the blood vessel 12 and into the left atrium 18 through the incision in the atrial septum 22. Once the guidewire 40 is positioned within the left atrium 18 and / or left ventricle 26, the transseptal puncture device can be removed from the patient 10. The user can then insert the guide catheter 30 into the blood vessel 12 and ( Figure 1 ) Advance the guide catheter 30 into the left atrium 18.

[0065] In some cases, before the guide catheter 30 is inserted into the blood vessel 12, an introducer device can be inserted through the lumen of the guide catheter 30. In some cases, the introducer device can include a tapered end that extends out of the distal end of the guide catheter 30 and is configured to guide the guide catheter 30 into the left atrium 18 via the guide wire 40. In addition, in some cases, the introducer device can include a proximal end portion that extends out of the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user can remove the introducer device from the guide catheter 30 and the patient 10. Therefore, only the guide catheter 30 and the guide wire 40 remain in the patient 10. The guide catheter 30 is then in place to receive the implant delivery device and help guide it to the left atrium 18, as described further below.

[0066] Figure 2A A second stage in an exemplary mitral valve replacement procedure is depicted in which a docking device 52 is implanted at the native mitral valve 16 of the heart 14 of the patient 10 using a docking device delivery apparatus 50 (which may also be referred to as an "implantation catheter" and / or a "docking device delivery apparatus").

[0067] Generally, the docking device delivery apparatus 50 includes a delivery shaft 54, a handle 56, and a pusher assembly 58. The delivery shaft 54 ​​is configured to be advanced by a user through the patient's vasculature (blood vessel 12) and to an implantation site (e.g., native mitral valve 16), and can be configured to retain the docking device 52 in the distal end portion 53 of the delivery shaft 54. In some examples, the distal end portion 53 of the delivery shaft 54 ​​retains the docking device 52 therein in a straightened delivery configuration.

[0068] The handle 56 of the docking device delivery apparatus 50 is configured to be grasped and / or otherwise held by a user outside the body of the patient 10 to advance the delivery shaft 54 ​​through the patient's vasculature (eg, blood vessel 12 ).

[0069] In some examples, the handle 56 may include one or more articulated members 57 (or rotatable knobs) configured to facilitate positioning the delivery shaft 54 ​​within the heart 14. For example, the one or more articulated members 57 may include one or more of a knob, a button, a wheel, and / or other types of physically adjustable control members configured to be adjusted by a user to flex, bend, twist, rotate, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 ​​to facilitate positioning the delivery shaft 54 ​​within the heart 14 for deployment of the docking device 52 at the implantation site (e.g., the native mitral valve 16).

[0070] 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 is configured to be adjusted by a user to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54. The shaft of the pusher assembly 58 can extend through the delivery shaft 54 ​​and can be disposed adjacent to the docking device 52 within the delivery shaft 54. In some instances, the docking device 52 can be releasably coupled to the shaft of the pusher assembly 58 via a connection mechanism of the docking device delivery apparatus 50, such that the docking device 52 can be released after being deployed at the native mitral valve 16.

[0071] Further details of the docking device delivery apparatus and its variations are described in International Publication No. WO2020 / 247907, which is incorporated herein by reference in its entirety.

[0072] Reference again Figure 2A , after positioning the guide catheter 30 within the left atrium 18, the user can insert the docking device delivery device 50 (e.g., delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 ​​of the docking device delivery device 50 through the guide catheter 30 and over the guidewire 40. In some examples, the guidewire 40 can be at least partially retracted away from the left atrium 18 and into the guide catheter 30. In other examples, the guidewire 40 can be completely removed from the guide catheter 30 before inserting the docking device delivery device 50. The user can then continue to advance the delivery shaft 54 ​​of the docking device delivery device 50 within the guide catheter 30 through the blood vessel 12 until the delivery shaft 54 ​​reaches the left atrium 18, as shown. Figure 2ASpecifically, the user can advance the delivery shaft 54 ​​of the docking device delivery device 50 toward the patient 10 by grasping the handle 56 of the docking device delivery device 50 and applying force thereon (e.g., pushing the handle). When advancing the delivery shaft 54 ​​through the blood vessel 12 and the heart 14, the user can adjust one or more hinged members 57 of the handle 56 to guide various turns, corners, constrictions, and / or other obstacles in the blood vessel 12 and the heart 14.

[0073] Once the delivery shaft 54 ​​reaches the left atrium 18 and extends out of the distal end of the guide catheter 30, the user can use the handle 56 (e.g., hinge member 57) to position the distal end portion 53 of the delivery shaft 54 ​​at and / or near the posteromedial commissure of the native mitral valve 16. The user can then use the shaft of the pusher assembly 58 to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54 ​​to deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0074] In some examples, the docking device 52 can be constructed from, formed from, and / or include a shape memory material and, therefore, can return to its initial, pre-formed shape when it leaves the delivery shaft 54 ​​and is no longer constrained by the delivery shaft 54. As one example, the docking device 52 can be initially formed as a coil and, therefore, can wrap around the leaflets 24 of the native mitral valve 16 when it leaves the delivery shaft 54 ​​and returns to its initial coiled configuration.

[0075] When the ventricular portion (e.g., Figure 2A After the docking device 52 shown in FIG. 1 is configured to be positioned within the left ventricle 26 and / or on the ventricular side of the native mitral valve 16), the user can then deploy the 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.

[0076] After the docking device 52 is deployed and implanted at the native mitral valve 16, the user can 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 can retract the docking device delivery device 50 from the blood vessel 12 and away from the patient 10 so that the user can deliver and implant the prosthetic heart valve 62 within the implanted docking device 52 at the native mitral valve 16.

[0077] Figure 2BThis third stage in the mitral valve replacement procedure is depicted, wherein the docking device 52 has been fully deployed and implanted at the native mitral valve 16, and the docking device delivery apparatus 50 (including the delivery shaft 54) has been removed from the patient 10, such that only the guide catheter 30 remains within the patient 10. In some instances, both the guide catheter 30 and the guidewire 40 remain within the patient 10. After the docking device delivery apparatus 50 is removed, the guidewire 40 can be advanced through the guide catheter 30 and / or out of the guide catheter, through the implanted docking device 52 at the native mitral valve 16, and into the left ventricle 26 ( Figure 2A ). Thus, the guidewire 40 can help guide the prosthetic valve delivery device 60 through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.

[0078] like Figure 2B As shown, the docking device 52 can include a plurality of turns (or coils) that wrap around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The 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 contour of the prosthetic heart valve to be implanted. Thus, the docking device 52 can provide a tighter fit between the prosthetic heart valve and the native mitral valve 16, and therefore provide a better seal, as further described below.

[0079] Figure 3A The fourth stage in a mitral valve replacement procedure is depicted, in which a user uses a prosthetic valve delivery device 60 to deliver and / or implant a prosthetic heart valve 62 (which may also be referred to herein as a "transcatheter heart valve" or "THV" for short), a "replacement heart valve," and / or a "prosthetic mitral valve") within a docking device 52.

[0080] like Figure 3A As shown, 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 vasculature of the patient 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 vasculature of the patient.

[0081] In some examples, the handle 66 may include one or more articulating members 68 configured to facilitate guiding the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulating member 68 may include one or more of a knob, button, wheel, and / or other type of physically adjustable control member configured to be adjusted by a user to flex, bend, twist, rotate, and / or otherwise articulate the distal end portion of the delivery shaft 64 to facilitate guiding the delivery shaft 64 through the blood vessel 12 and into the left atrium 18 and left ventricle 26 of the heart 14.

[0082] In some instances, the prosthetic valve delivery device 60 can include an expansion mechanism 65 that is configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. Figure 3A As shown, expansion mechanism 65 can include an inflatable balloon configured to be inflated to radially expand prosthetic heart valve 62 within docking device 52. The inflatable balloon can be coupled to a distal end portion of delivery shaft 64.

[0083] In other examples, the prosthetic heart valve 62 can be self-expanding and can be configured to radially expand on its own upon removal of a sheath or capsule that radially compresses the prosthetic heart valve 62 over the distal end portion of the delivery shaft 64. In still other examples, the prosthetic heart valve 62 can be mechanically expandable, and the prosthetic valve delivery device 60 can include one or more mechanical actuators (e.g., expansion mechanisms) that are configured to radially expand the prosthetic heart valve 62.

[0084] like Figure 3A As shown, a prosthetic heart valve 62 is mounted in a radially compressed configuration about an expansion mechanism 65 (an inflatable balloon) on a distal end portion of a delivery shaft 64 .

[0085] To guide the distal end portion of the delivery shaft 64 to the implantation site, the user may insert the prosthetic valve delivery device 60 (delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guide wire 40. The user may continue to advance the prosthetic valve delivery device 60 along the guide wire 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. Figure 3A More specifically, a user can advance the delivery shaft 64 of the prosthetic valve delivery device 60 by grasping the handle 66 and applying force thereon (e.g., pushing the handle). When advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the user can adjust one or more hinged members 68 of the handle 66 to guide various turns, corners, constrictions, and / or other obstacles in the blood vessel 12 and the heart 14.

[0086] 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, such as Figure 3A As shown, the distal end of the delivery shaft 64 and at least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26 .

[0087] Once the radially compressed prosthetic heart valve 62 is properly positioned within the docking device 52 ( Figure 3A ), the user can manipulate one or more actuators of the handle 66 of the prosthetic valve delivery device 60 to actuate the expansion mechanism 65 (e.g., inflate the inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52.

[0088] Figure 3B 1 shows a fifth stage in a mitral valve replacement procedure, wherein the prosthetic heart valve 62 is in its radially expanded configuration and implanted within the docking device 52 in the native mitral valve 16. Figure 3B As shown, the prosthetic heart valve 62 is received and retained within the docking device 52. Thus, the docking device 52 helps anchor the prosthetic heart valve 62 within the native mitral valve 16. The docking device 52 can enable a better seal between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16 to reduce paravalvular leakage around the prosthetic heart valve 62.

[0089] Also like Figure 3B As shown, after the prosthetic heart valve 62 has been fully deployed and implanted within the docking device 52 at the native mitral valve 16, the prosthetic valve delivery apparatus 60 (including the delivery shaft 64) is removed from the patient 10, leaving only the guidewire 40 and the guide catheter 30 within the patient 10.

[0090] Figure 4 A sixth stage in the mitral valve replacement procedure is depicted, wherein the guidewire 40 and guide catheter 30 have been removed from the patient 10 .

[0091] although Figure 1-4 A mitral valve replacement procedure is specifically shown, but it should be appreciated that the same and / or similar procedures can be used to replace other heart valves (e.g., tricuspid valve, pulmonary valve, and / or aortic valve). In addition, 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 can be used to replace these other heart valves.

[0092] For example, when replacing a native tricuspid valve, the user may also enter the right atrium 20 via the femoral vein, but may not need to enter the left atrium 18 through the atrial septum 22. Instead, the user may leave the guidewire 40 in the right atrium 20 and perform the same and / or similar docking device implantation process at the tricuspid valve. Specifically, the user may push the docking device 52 out of the delivery shaft 54 ​​around the ventricular side of the tricuspid valve leaflet, release the remaining portion of the docking device 52 from the delivery shaft 54 ​​in the right atrium 20, and then remove the delivery shaft 54 ​​of the docking device delivery device 50 from the patient 10. The user may then advance the guidewire 40 through the tricuspid valve into the right ventricle, and perform the same and / or similar prosthetic heart valve implantation process at the tricuspid valve within the docking device 52. Specifically, the user may advance the delivery shaft 64 of the prosthetic valve delivery device 60 along the guidewire 40 through the patient's vascular system until the prosthetic heart valve 62 is positioned / set within the docking device 52 and the tricuspid valve. The user may then expand the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery apparatus 60 from the patient 10. In another example, the user may perform the same and / or similar procedure to replace the aortic valve, but may access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0093] In addition, despite Figure 1-4 A mitral valve replacement procedure is depicted in which the native mitral valve 16 is accessed from the left atrium 18 via the right atrium 20 and the femoral vein, but it should be appreciated that the native mitral valve 16 may alternatively be accessed from the left ventricle 26. For example, a user may advance one or more delivery devices through the arteries to the aortic valve, through the aortic valve into the left ventricle 26, and then from the left ventricle 26 into the native mitral valve 16 via the aortic valve.

[0094] Certain embodiments relate to delivery systems and / or apparatus for delivering a prosthetic medical device (e.g., Figure 1-4 The described docking device 52 and / or prosthetic heart valve 62) is delivered to an animal, a human, a cadaver, a cadaver heart, an anthropomorphic ghost, and / or a simulation / simulator heart and / or a natural valve. Such devices include transcatheter devices that can be used to guide the delivery of the docking device through the vasculature.

[0095] exist Figure 5-6 An example delivery device 1000 configured to deliver a docking device to a target implantation site is shown in FIG. In some examples, the delivery device 1000 can be used as a docking device delivery device 50 in a prosthetic valve implantation procedure, as described above with reference to FIG. Figure 1-4The delivery device 1000 may also be referred to as a "docking device delivery device," "docking delivery device," "docking delivery catheter," or "docking delivery system."

[0096] The delivery device 1000 can 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 can be coaxial with a central longitudinal axis 1003 of the delivery device 1000. The handle assembly 1002 can include a handle 1006 that includes one or more knobs, buttons, wheels, and / or other components for controlling and / or actuating one or more components of the delivery device 1000. For example, in some instances, such as Figure 5 As shown, the handle 1006 can include knobs 1008a and 1008b, which can be configured to direct or control the deflection of the delivery device 1000 (eg, the delivery shaft 1004, etc.).

[0097] The delivery shaft 1004 has a main (or primary) lumen 1010 ( Figure 6 ). The main lumen 1010 is configured to receive one or more devices therein (e.g., any of the docking devices and pusher assemblies described herein). In some examples, such as Figure 6 As shown, the delivery shaft 1004 can extend into the handle 1006. Additionally, in some cases, 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 include a lumen coaxial with the main lumen 1010 of the delivery shaft 1004. Thus, the delivery device 1000 includes a lumen extending from the locking mechanism 1020 to the distal end portion 1005 of the delivery shaft 1004.

[0098] In some instances, 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 formed as a single integral component. In other cases, as depicted, the housing 1012 may include one or more segments formed as separate components that are coupled together (e.g., via fasteners, adhesives, mating features, and / or other components for coupling). For example, the housing 1012 may include a distal segment 1012a, an intermediate segment 1012b proximal to the distal segment 1012a, and a proximal segment 1012c proximal to the intermediate segment 1012b. In some instances, one or more molding processes (e.g., injection molding, etc.) may be used to manufacture the housing 1012.

[0099] In the depicted example, a distal section 1012a of the housing 1012 (which may also be referred to as a "nose cone") is distal to the knob 1008a and may contain a portion of a spine assembly 1014, as described in more detail below. An intermediate section 1012b of the housing 1012 (which may also be referred to as a "main housing") is positioned between the knobs 1008a, 1008b. The main housing 1012b may also contain the spine assembly 1014 and a portion of an adjustment mechanism 1016 and an indicator assembly 1017, as described in more detail below. A proximal section 1012c of the housing 1012 (which may also be referred to as a "proximal housing") is proximal to the knob 1008b and may contain a seal assembly 1018 and a locking mechanism 1020, as described in more detail below. In some cases, the portion of the handle 1006 proximal to the nose cone 1012a (e.g., the main housing 1012b, the proximal housing 1012c and / or components contained therein, etc.) may also be referred to herein as the "body" of the handle 1006.

[0100] The spine assembly 1014 can be configured to partially cover (e.g., surround) the delivery shaft 1004. When torque is applied to the handle 1006, the spine assembly 1014 can support the delivery shaft 1004. Specifically, the spine assembly 1014 can be connected to the housing 1012, and can transfer the torque applied to the handle 1006 from the housing 1012 of the handle 1006 to the delivery shaft 1004, including to the distal end portion 1005 of the delivery shaft 1004. Therefore, in some examples, the spine assembly 1014 can also be referred to as a support member.

[0101] In some cases, spine assembly 1014 can be integrally formed as a single, unitary component. In other cases, as depicted, spine assembly 1014 can include one or more segments that are formed as separate components that are coupled together (e.g., via fasteners, adhesives, mating features, and / or other means for coupling). For example, spine assembly 1014 can include spine extension 1022, distal spine 1024, and proximal spine 1026. Spine extension 1022 (also referred to herein as a "nose bridge") is connected to distal spine 1024 and extends distally therefrom. Proximal spine 1026 is connected to distal spine 1024 and extends proximally therefrom. As shown in FIG. Figure 6 As shown, the ridge extension 1022 is positioned within the nose cone 1012a, and the distal ridge 1024 and the proximal ridge 1026 are positioned within the main housing 1012b. It should be understood that in some examples, the distal ridge 1024 and the proximal ridge 1026 can be integrally formed as a single unitary component. In some cases, the distal ridge 1024 and the proximal ridge 1026 can be collectively referred to as a "ridge" or "main ridge."

[0102] The handle assembly 1002 can also include an irrigation tube 1027 connected to the housing 1012, distal to the seal of the seal assembly 1018. In some examples, as depicted, the irrigation tube 1027 is connected to the proximal housing 1012c.

[0103] Figure 7 The delivery device 1000 is depicted with the nose cone 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 in a circumferential direction. As described in more detail below, the delivery shaft 1004 can include a distal segment 1004d and a proximal segment 1004p. In some instances, a reinforcing braid can be included in the distal segment 1004d of the delivery shaft 1004 to help strengthen the delivery shaft 1004 and transmit torque to the distal end portion 1005 of the delivery shaft 1004. As shown, the distal segment 1004d can have a relatively large outer diameter (e.g., due to the presence of a reinforcing braid, etc.), and the proximal segment 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 to provide additional support and strength to the delivery shaft 1004, specifically the proximal section 1004p of the delivery shaft 1004.

[0104] The ridge extension 1022 may include radial protrusions 1028 that are spaced apart from one another in the axial direction along the length of the ridge extension 1022. The radial protrusions 1028 of the ridge extension 1022 may be configured to mate with the nose cone 1012a ( Fig.10). In some examples, as depicted, radial protrusion 1028 can include a mating feature or element 1030, such as a slot, a notch, etc. Mating element 1030 can be configured to engage with an internal mating element 1032 of nose cone 1012a ( Fig. 9 ).

[0105] It should be appreciated that each radial protrusion 1028 may include one or more mating elements 1030 having the same or different configurations. Figure 8 , the first radial protrusion 1028a can include a notch 1030a, and the second radial protrusion 1028b can include two notches 1030a and a groove 1030b. In some cases, as depicted, the notches 1030a on the axially adjacent radial protrusions 1028a and 1028b can form the corresponding half of the groove. As shown, the radial protrusion 1028b can be spaced apart from the radial protrusion 1028a in the circumferential direction and in the axial direction. In some examples, more than one radial protrusion 1028a can be located at the same axial position. Therefore, the radial protrusion 1028a is spaced apart only in the circumferential direction. It should be understood that the radial protrusion 1028 can be constructed together with other configurations and / or other spacings (e.g., only in the axial direction, etc.) of the mating element 1030.

[0106] like Fig. 9 As shown, the nose cone 1012a can include a mating element 1032 protruding from the inner surface 1034 of the nose cone 1012a. The mating element 1032 can extend along the length of the inner surface 1034 of the nose cone 1012a in the axial direction. In this way, the mating element 1032 can also be referred to as an "axial flow channel". In the example shown, the nose cone 1012a includes three axial flow channels 1032. It should be understood that the nose cone 1012a can include a different number of axial flow channels 1032 (e.g., less than three axial flow channels 1032, more than three axial flow channels 1032, etc.). As shown, each axial flow channel 1032 can include a primary section or panel 1036 protruding from the inner surface 1034 in the radial direction. Each axial flow channel 1032 can also include two secondary sections or panels 1038, which can protrude from the inner surface 1034 at a certain angle and can intersect or contact the primary section 1036. Each end 1040 of the primary segment 1036 can extend beyond the secondary segment 1038 in a radial direction (eg, toward the center of the nose cone 1012a, etc.). Each end 1040 can be configured to engage an axial slot or groove defined by the mating element 1030 of the spine extension 1022.

[0107] The axial flow channel 1032 can be configured to mate with the mating element 1030 of the ridge extension 1022. Fig.10As shown, the mating element 1030 of each radial protrusion 1028 can be axially aligned and can correspond to the axial flow channel 1032 of the nose cone 1012a. This alignment allows the spine extension 1022 to be inserted into the nose cone 1012a and axially moved relative to the nose cone 1012a (e.g., during assembly of the delivery device 1000, etc.). In addition, the axial flow channel 1032 can be configured to prevent rotational movement of the nose cone 1012a relative to the spine extension 1022. In this way, torque applied to the nose cone 1012a can be transmitted from the nose cone 1012a to the spine extension 1022 via the radial protrusion 1028 and the axial flow channel 1032. In addition, the spine extension 1022 can be configured to transmit torque to the delivery shaft 1004.

[0108] Reference again Figure 8-9 , the spine extension 1022 can include a distal end portion 1042 that partially surrounds the delivery axis 1004 in the circumferential direction (e.g., around half of the circumference of the delivery axis 1004, etc.). The nose cone 1012a can also include a distal end portion 1044 that partially surrounds the delivery axis 1004 in the circumferential direction (e.g., around the other half of the circumference of the delivery axis 1004, etc.). Therefore, when the nose cone 1012a is mated with the spine extension 1022, the distal end portion 1042 of the nose cone 1012a and the distal end portion 1044 of the spine extension 1022 can be aligned in the axial direction and can completely surround the delivery axis 1004 in the circumferential direction. In some examples, the cylindrical cover 1046 can be positioned above the distal end portions 1042, 1044 of the spine extension 1022 and the nose cone 1012a ( Figure 5-6 ). Cylindrical cover 1046 can be configured to prevent movement (eg, axial movement, etc.) of ridge extension 1022 relative to nose cone 1012a. In some cases, cover 1046 can include an elastic material.

[0109] In some cases, as depicted, the outer surface of the nose cone 1012a can include six faces to define a hexagonal cross-section. The distal end portion 1042 of the nose cone 1012a can include three faces and the distal end portion 1044 of the ridge extension 1022 can include three faces, so that the distal end portions 1042, 1044 can also define a hexagonal cross-section. The hexagonal cross-section can help facilitate the gripping of the handle 1006. In other cases, the outer surface of the nose cone 1012a and / or the distal end portions 1042, 1044 can include a different number of faces so that different cross-sectional shapes (e.g., circular, square, octagonal, etc.) can be defined. Other sections of the housing 1012 (e.g., the main housing 1012b and the proximal housing 1012c) can also have the same cross-sectional shape (e.g., hexagonal, etc.) and / or a different cross-sectional shape as the nose cone 1012a to help facilitate the gripping of the handle 1006. In some cases, cylindrical cover 1046 may include an internal shape (e.g., hexagonal, etc.) that is complementary to the shape of the outer surface of distal end portions 1042, 1044 (e.g., hexagonal, etc.) to limit or prevent rotation of cover 1046 relative to ridge extension 1022 and nose cone 1012a.

[0110] Although the cover 1046 is shown as being cylindrical in the illustrated example, in other examples, the cover 1046 can include non-cylindrical shapes including, for example, hexagonal, square, octagonal, etc.

[0111] In some examples, the delivery device 1000 can include one or more other components configured to couple the spine extension 1022 to the nose cone 1012a in place of or in addition to the cylindrical cover 1046. For example, the spine extension 1022 and / or the nose cone 1012a can include mating features configured to mate the spine extension 1022 with the nose cone 1012a to prevent relative movement therebetween.

[0112] As described above, the distal end portion 1005 of the delivery shaft 1004 can be configured to be steerable via the knobs 1008a, 1008b and the adjustment mechanism 1016. In one example, by rotating the knobs (e.g., 1008a or 1008b) 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, in order to implant a docking device (e.g., docking device 52) at a native mitral valve location, the distal end portion 1005 of the delivery shaft 1004 can be steered so that the docking device can be positioned at a target implantation location.

[0113] In some examples, the knob 1008a can be coupled to a first pull wire (not shown) of an adjustment mechanism, which can control the front deflection of the delivery shaft 1004 (e.g., based on the tension of the first pull wire, etc.). The knob 1008b can be coupled to a second pull wire (not shown) via the adjustment mechanism 1016, which can control the rear deflection of the delivery shaft 1004 (e.g., based on the tension of the second pull wire, etc.). The first pull wire and the second pull wire can be connected to the distal end portion 1005 of the delivery shaft 1004 and extend proximally into the handle 1006 (e.g., into the main housing 1012b of the handle 1006, etc.).

[0114] Reference now Fig.11 In some instances, the first and second pull wires need to be transferred from a location inside or within the delivery shaft 1004 to a location outside the delivery shaft 1004. Therefore, the proximal section 1004p of the delivery shaft 1004 can include two axially extending slots 1047 (also referred to as "openings") that are configured to allow the first and second pull wires to leave a location inside or within the distal section 1004d of the delivery shaft 1004 and transfer along the exterior of the proximal section 1004p of the delivery shaft 1004. Because the pull wires must be transferred 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. Therefore, the ridge extension 1022 can provide additional strength to the delivery shaft 1004 while allowing the pull wires to pass through the slots 1047 of the delivery shaft 1004.

[0115] With the pull wire in the proximal direction, after the pull wire passes through the slot 1047, the first pull wire and the second pull wire can pass through the opening 1048 in the distal end 1024d of the distal ridge 1024, as shown in FIG. Fig.12 After passing through opening 1048, the pull wire can be connected to other components of adjustment mechanism 1016, which can be located within main housing 1012b of handle 1006, as described in more detail below.

[0116] The distal end 1024d of the distal ridge 1024 can be coupled to the ridge extension 1022. Specifically, the inner surface of the ridge extension 1022 can include a step 1052 that defines a seat for the distal end 1024d of the distal ridge 1024 (see also Figure 8). For example, during assembly of the spine assembly 1014, the distal spine 1024 can be inserted into the spine extension 1024 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 way, the spine extension 1022 can partially surround the distal end 1024d of the distal spine 1024 so that the distal end 1024d of the distal spine 1024 is positioned within the spine extension 1022.

[0117] Fig.13 The delivery shaft 1004 is shown positioned within a central lumen 1050 of the spine assembly 1014. The central lumen 1050 can be coaxial with the central longitudinal axis 1003 and can be defined by the inner surfaces of the spine extension 1022, the distal spine 1024, and the proximal spine 1026.

[0118] The distal ridge 1024 can be coupled to the proximal ridge 1026. Figure 14-15 As shown, the distal spine 1024 can include a mating feature 1054 (e.g., a socket, etc.) that corresponds to a mating feature 1056 (e.g., a pin, etc.) of the proximal spine 1026. The distal spine 1024 and the proximal spine 1026 can also include a hole 1058 that can be configured to couple the spine assembly 1014 to the housing 1012. Specifically, when the distal spine 1024 is coupled to the proximal spine 1026 (e.g., mated with the proximal spine, etc.), the holes 1058 of the distal spine 1024 and the proximal spine 1026 can be aligned so that a fastener (e.g., Fig. 20 Fasteners 1106 (screws, bolts, etc.) as shown may be inserted through apertures 1058 to attach the spine assembly 1014 to the main housing 1012b.

[0119] The distal spine 1024 can include a spine axis 1060 and a base 1062. The spine axis 1060 can be generally cylindrical and can be parallel to the central longitudinal axis 1003 of the delivery device 1000. The base 1062 can be connected to the spine axis 1060 and can be radially spaced apart from or offset from the spine axis 1060. In the illustrated example, the base 1062 is located at the proximal end 1024p of the distal spine 1024. The base 1062 can be positioned within the main housing 1012b and contact the inner surface of the main housing 1012b, as described in more detail below. In some cases, the base 1062 can be the only component of the spine assembly 1014 that contacts the housing 1012 (e.g., except for the fastener 1106 inserted through the hole 1058). Thus, the base 1062 can be configured to align the spine assembly 1014 relative to the housing 1012 such 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 create an alignment reference (e.g., radial, vertical, axial, etc.) for the handle assembly 1002. In some cases, the aperture 1058 of the distal spine 1024 and / or the proximal spine 1026 can also contact the housing 1012 (e.g., at Figure 19-20 hole 1104 shown, etc.).

[0120] The distal ridge 1024 can include a first groove 1064 having a distal end 1064d and a proximal end 1064p. The distal ridge 1024 can also include a second axially extending groove 1066 having a distal end 1066d and a proximal end 1066p. The first groove 1064 can be circumferentially spaced from the second groove 1066. In the example shown, the first groove 1064 and the second groove 1066 are circumferentially spaced 90 degrees apart. Fig.12 As best shown in FIG. 1 , 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 nose cone 1012a.

[0121] Reference again Fig.14 , the first groove 1064 can extend axially along the length of the spine axis 1060 (e.g., less than the entire length of the spine axis 1060, etc.). Specifically, the proximal end 1064p of the first groove 1064 can be spaced apart from the proximal end 1024p of the spine 1024 in the axial direction (e.g., the proximal end 1064p of the first groove 1064 is distal to the proximal end 1024p of the spine 1024, etc.). The proximal end 1066p of the second groove 1066 can be positioned at or near the proximal end 1024p of the spine 1024. In this way, the first groove 1064 can have a shorter axial length than the second groove 1066.

[0122] The spine shaft 1060 of the distal spine 1024 can also include radial grooves 1068 configured to receive a clamp, spacer, etc. The radial grooves 1068 can be spaced apart along the length of the spine shaft 1060.

[0123] like Fig.15 As shown, the proximal spine 1026 can include a spine axis 1070 that can be generally cylindrical and can be parallel to the central longitudinal axis 1003 of the delivery device 1000. The spine axis 1070 can include an axially extending groove 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 groove 1072 can be aligned with the second groove 1066 of the distal spine 1024. The spine axis 1070 of the proximal spine 1026 can also include radial grooves 1074 configured to receive a clamp, spacer, etc. The radial grooves 1074 can be spaced apart along the length of the spine axis 1070 and can be positioned toward the proximal end 1026p of the spine 1026.

[0124] Although the distal ridge 1024 is depicted as including the base 1062, it should be appreciated that in some examples, the proximal ridge 1026 may include the base 1062 instead of the distal ridge 1024. For example, the base 1062 may be connected to the ridge axis 1070 and may be radially spaced or offset from the ridge axis 1070. In these examples, the base 1062 may be located at the distal end 1026d of the proximal ridge 1026.

[0125] The spine assembly 1014 may also include a bobbin 1076, such as Fig.13 In some cases, as depicted, the bobbin 1076 can include a hollow cylindrical tube. The bobbin 1076 can be positioned within the groove 1066 of the distal spine 1024 and the groove 1072 of the proximal spine 1026. One of the pull wires of the adjustment mechanism 1016 can be positioned within the lumen of the bobbin 1076.

[0126] As described above, the adjustment mechanism 1016 (also referred to herein as a "flexure assembly") can be configured to guide the distal end portion 1005 of the delivery shaft 1004 via the knobs 1008a, 1008b and the pull wire (not shown) by increasing or decreasing the tension of the pull wire. In addition to the knobs 1008a, 1008b and the pull wire, the adjustment mechanism 1016 can also include a sliding nut 1078, a winding member 1080, and a barrel 1082, such as Figure 16-17 Sliding nuts 1078 can be positioned around spine assembly 1014 and configured to move axially relative to spine assembly 1014. Specifically, a first sliding nut 1078 can be positioned around distal spine 1024 and a second sliding nut 1078 can be positioned around proximal spine 1026. Sliding nuts 1078 can include external threads that engage with internal threads of barrel 1082.

[0127] Each wire wrap 1080 can be positioned adjacent to and proximate 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, etc.). Fig.12 As discussed, the pull wires are secured to the distal end portion 1005 of the delivery shaft 1004 and may be passed through an opening 1048 in the distal end 1024d of the distal spine 1024. After passing through the opening 1048, one of the pull wires may be positioned within the groove 1064 of the distal spine 1024 and connected to a wire wrap 1080 positioned around the distal spine 1024. The other pull wire may be passed through the spool 1076 and connected to a wire wrap 1080 positioned around the proximal spine 1026 after passing through the opening 1048.

[0128] The barrel 1082 can be coupled to the knobs 1008a, 1008b such that rotation of one of the knobs 1008a, 1008b causes rotation of 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) can be rotated, which in turn rotates its corresponding barrel 1082. The rotation of the barrel 1082 can drive the sliding nut 1078 in an axial direction via the threaded engagement between the barrel 1082 and the sliding nut 1078. When the sliding nut 1078 moves axially, the sliding nut 1078 can push the winding member 1080 in an axial direction, which may change the tension of the pull wire attached to the winding member 1080, thereby adjusting the curvature or deflection of the distal end portion 1005 of the delivery shaft 1004.

[0129] Each winding member 1080 may include a notch 1084 that may be configured to prevent rotational movement of the winding member 1080 when the sliding nut 1078 pushes the winding member 1080. Specifically, when the sliding nut 1078 causes the winding member 1080 to move axially, the notch 1084 of the winding member 1080 located on the distal ridge 1024 may engage with the spool 1076. In this way, the spool 1076 may be configured as a guide for the winding member 1080 that prevents rotational movement of the winding member 1080 but allows the winding member 1080 to move in the axial direction relative to the distal ridge 1024. Fig.16As shown, the proximal spine 1026 can include one or more guides 1086 that can be molded into the proximal spine 1026 and can be configured to guide axial movement of the corresponding winding member 1080 relative to the proximal spine 1026 while preventing rotational movement of the winding member 1080 relative to the proximal spine 1026 (e.g., similar to the spool 1076). The guide 1086 can be a protrusion that extends along the length of the proximal spine 1026 and protrudes from the outer surface of the spine shaft 1070. Although not shown, in some examples, the distal spine 1024 can also include one or more guides 1086 in addition to the spool 1076. The spool 1076 and the guide 1086 can also be configured to guide the movement of the sliding nut 1078 (e.g., allow axial movement but prevent rotational movement, etc.).

[0130] In some cases, the spine assembly 1014 can 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 the winding member 1080 relative to the spine assembly 1014. In some cases, as depicted, the stop 1088 (e.g., a clamp, etc.) can be removably coupled to the spine assembly 1014 and can be positioned around the spine assembly 1014. In this way, the stop 1088 can also limit the amount of curvature or deflection 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 wire, etc.). In addition, the amount of curvature or deflection can be visually indicated by the indicator assembly 1017, as described in more detail below.

[0131] Additional details of steerable catheters, adjustment mechanisms, and variations thereof are described in US Patent No. 10,076,638, which is incorporated herein by reference in its entirety.

[0132] The sliding nut 1078, the winding member 1080 and the barrel 1082 of the adjustment mechanism 1016 can be disposed within the main housing 1012b. In some cases, the main housing 1012b can be integrally formed as a single unitary component. In other cases, such as Figure 18-19 As depicted, the main housing 1012b may include one or more segments formed as separate components that are coupled together (e.g., via fasteners, adhesives, mating features, and / or other means for coupling). For example, the main housing 1012b may include an upper segment 1090a ( Fig.18 ) and lower section 1090b ( Fig.19 ), the upper section and the lower section can be connected together.

[0133] 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 features of the upper segment 1090a and the lower segment 1090b are contemplated, including but not limited to a clamp and a corresponding clip, and / or a hook and a corresponding hinge, etc. In some cases, the mating feature 1092a of the upper segment 1090a may include a socket, and the corresponding mating feature 1092b of the lower segment 1090b may include a pin. In some cases, as depicted, all mating features on one segment (e.g., upper segment 1090a) may include one type of mating feature (e.g., pins). In other cases, the mating features on one segment (e.g., 1090a or 1090b) may include a combination of different types of mating features. Additionally, in the illustrated example, six mating features 1092a, 1092b are included on each segment 1090a, 1090b, respectively. In other examples, a different number of mating features may be included on each segment (e.g., less than six, more than six, etc.).

[0134] The upper section 1090a can include a groove 1096a and an internal rib 1098a, which is configured to receive and retain the components of the indicator assembly 1017, as described in more detail below. The groove 1096a can be included in the outer wall 1100a of the upper section 1090a. The internal rib 1098a can be positioned radially inward of the groove 1096a (e.g., inside the outer wall 1100a, etc.). The rib 1098a can define an opening or groove, and the components of the indicator assembly 1017 can be positioned in the groove defined by the rib 1098a. In the illustrated example, the rib 1098a can be positioned adjacent to the mating feature 1092a and extend from the mating feature 1092a in the axial direction.

[0135] The upper section 1090a can include a platform 1102a extending from the inner surface 1094a (which can also be referred to herein as an "alignment platform"). The platform 1102a can be positioned in a central region of the upper section 1090a (e.g., positioned midway between the ends of the upper section 1090a in an axial direction, etc.). The platform 1102a can be configured to position the spine assembly 1014 relative to the housing 1012. Specifically, the platform 1102a can align the distal spine 1024 and the proximal spine 1026 relative to the upper section 1090a of the main housing 1012b. In some cases, the platform 1102a can include a recess to accommodate the barrel 1082 ( Figure 6 ).

[0136] Similar to the upper section 1090a, the lower section 1090b can include a groove 1096b and an internal rib 1098b, which is configured to receive and retain the components of the indicator assembly 1017. The groove 1096b can be included in the outer wall 1100b of the lower section 1090b. The internal rib 1098b can be positioned radially inward of the groove 1096b (e.g., inside the outer wall 1100b, etc.). The rib 1098b can define an opening or groove, and the components of the indicator assembly 1017 can be positioned in the groove defined by the rib 1098b. In the illustrated example, the rib 1098b can be positioned adjacent to the mating feature 1092b and extend from the mating feature 1092b in the axial direction.

[0137] The lower section 1090b can include a platform 1102b (which may also be referred to herein as an "alignment platform") extending from the inner surface 1094b. The platform 1102b can be positioned in a central region of the lower section 1090b (e.g., positioned midway between the ends of the lower section 1090b in an axial direction, etc.). The platform 1102b can be configured to position the spine assembly 1014 relative to the housing 1012. Specifically, the platform 1102b can align the spine assembly 1014 relative to the lower section 1090b of the main housing 1012b. In some cases, such as Figure 6 1064, the platform 1102b can contact the base 1062 of the distal spine 1024 to achieve this alignment. In some examples, the spine assembly 1014 can be configured such that the spine assembly 1014 can only be assembled within the housing 1012 in one direction or orientation based on the mating features of the housing 1012. For example, the base 1062 and platform 1102b of the spine assembly 1014 can be configured such that the base 1062 can only be aligned or mated with the platform 1102b in one direction (e.g., with the spine axis 1060 extending distally from the base 1062, etc.).

[0138] The lower section 1090b can include a hole 1104 (eg, a threaded hole, etc.) configured to receive a fastener 1106 (eg, a screw, a bolt, etc.). Fig. 20 , when the spine assembly 1014 and the housing 1012 are coupled (e.g., fastened, etc.) together, the holes 1104 of the lower section 1090b of the main housing 1012b and the holes 1058 of the distal spine 1024 and the proximal spine 1026 can be aligned. In this way, the fastener 1106 can be inserted through the hole 1058 and into the hole 1104 to attach the spine assembly 1014 to the housing 1012.

[0139] Reference now Figure 20-22, an indicator assembly 1017 (also referred to herein as a "flexure indicator assembly") can be positioned within the main housing 1012b. The indicator assembly 1017 can be configured to indicate the amount of flexure applied by the adjustment mechanism 1016 to the distal end portion 1005 of the delivery shaft 1004. The indicator assembly 1017 can include a window 1108 and an indicator 1110 (also referred to herein as a "flexure indicator" or "flexure measurement device"), which can be positioned within the main housing 1012b and can be viewed through the window 1108 (e.g., adjacent to the window 1108, etc.).

[0140] The window 1108 can be positioned in the grooves 1096a, 1096b of the upper section 1090a and the lower section 1090b of the main housing 1012b. The window 1108 can include a frame 1112 and a pane 1114 that can be coupled to the frame 1112. For example, the pane 1114 can be retained within the frame 1112 via a snap and / or friction fit. In some cases, such as Fig.21 As depicted, frame 1112 can include retaining members 1116, such as tabs, clips, etc., that extend radially from frame 1112 and can engage corresponding openings 1118 of pane 1114. Pane 1114 can be transparent, translucent, etc., to enable a user to view indicator 1110 through window 1108.

[0141] In the example shown, the indicator assembly 1017 can include frames 1112 disposed on opposite sides of the handle assembly 1002. Each frame 1112 can be coupled to a pane 1114 and can define a distal viewing area 1120d and a proximal viewing area 1120p (collectively referred to as viewing area 1120). In the example shown, the retaining member 1116 of the frame 1112 and the opening 1118 of the pane 1114 are positioned between the viewing area 1120.

[0142] The indicator assembly 1017 may also include four indicators 1110, as shown. Two indicators 1110 may be provided on each side of the handle assembly 1002. In some examples, the two distal indicators 1110 may indicate the amount of curvature or flexure of one type (e.g., in a particular direction, as controlled by the knob 1008a, etc.), and the two proximal indicators 1110 may indicate the amount of curvature or flexure of a different type (e.g., in different directions, as controlled by the knob 1008b, etc.). The distal indicators 1110 may be observed through the distal viewing area 1120d of the window 1108, and the proximal indicators 1110 may be observed through the proximal viewing area 1120p of the window 1108.

[0143] Each indicator 1110 includes a slider 1122 and a background component 1124, such as Fig. 221012a and 1090b of the main housing 1012b. In this way, the background member 1124 can be fixed relative to the housing 1012 (e.g., prevented from moving relative to the housing 1012 in an axial direction, etc.). The slider 1122 can be configured to slide axially relative to the background member 1124. Specifically, the slider 1122 can include an opening 1126, and the background member 1124 can pass through the opening 1126. In this way, the slider 1122 can include an outer portion 1122a that is visible or observable through the viewing area 1120 and an inner portion 1122b that is not visible or observable through the viewing area 1120. Specifically, the outer portion 1122a can be positioned outside the background member 1124 in a radial direction, and the inner portion 1122b can be positioned inside the background member 1124 in a radial direction. The outer portion 1122a may also be referred to as the “visible portion” or “observable portion” of the slider 1122 .

[0144] The slider 1122 may also include at least one protrusion 1128 (e.g., one or more tabs, pins, etc.) extending from the interior portion 1122b of the slider 1122. The protrusion 1128 may be configured to engage with a corresponding barrel 1082. In this way, when the barrel 1082 is rotated by a knob (e.g., 1008a or 1008b, etc.), the threads of the barrel 1082 may cause the slider 1122 to move axially relative to the background member 1124 via the protrusion 1128.

[0145] In the example shown, the observable portion 1122a of the slider 1122 can be configured as a bar. Therefore, the slider 1122 can also be referred to as a "slider". It should be understood that in other cases, the observable portion 1122a of the slider 1122 can include other configurations, such as a tab that extends only in front of a portion of the background component 1124, etc.

[0146] In some cases, one background member 1124 can be used for both indicators 1110. For example, in these cases, the background member 1124 can be extended axially so that the extended background member 1124 is visible through both the distal viewing area 1120d and the proximal viewing area 1120p. In addition, two sliders 1122 can be positioned on the extended background member 1124.

[0147] The background member 1124 may include an indicia 1130 (e.g., a marker, a hash mark, etc.) to indicate the amount and / or measure of deflection. 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 deflection. 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 deflection. It should be appreciated that movement of the slider 1122 in an axial direction relative to the background member 1124 may indicate an increased or decreased amount of deflection.

[0148] In some cases, the indicator assembly 1017 may include additional indicia (e.g., colors, markings, etc.) to distinguish the distal indicator 1110 (e.g., indicating one type of curvature or deflection, etc.) from the proximal indicator 1110 (e.g., indicating a different type of curvature or deflection, etc.). For example, the slider 1122, the background member 1124, and / or the marking 1130 of the distal indicator 1110, the portion of the frame 1112 surrounding the distal viewing area 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 deflection that can be observed through the distal viewing area 1120d and can be caused by rotation of the distal indicator 1110 indicating knob 1008a, etc.). Similarly, in some cases, the slider 1122, the background member 1124, and / or the indicia 1130 of the proximal indicator 1110, the portion of the frame 1112 surrounding the proximal viewing area 1120p, and / or the corresponding knob 1008b may include a second color, indicia, etc. to distinguish from the first color, indicia, etc. It should be appreciated that other components may include additional indicia to distinguish between different types of curvature or flexure provided by the adjustment mechanism 1016 and indicated by the indicator assembly 1017.

[0149] As described above, the seal assembly 1018 and the locking mechanism 1020 can be positioned within the proximal housing 1012c. In some cases, the proximal housing 1012c can be integrally formed as a single unitary component. In other cases, such as Figure 23-25 As depicted, the proximal housing 1012c may include one or more segments formed as separate components that are coupled together (e.g., via fasteners, adhesives, mating features, and / or other means for coupling). For example, the proximal housing 1012c may include two segments that are configured to couple together with a mating feature 1132 (e.g., a pin, a socket, etc.). Fig.24 The delivery device 1000 is depicted with a segment of the proximal housing 1012c removed.

[0150] The seal assembly 1018 can be configured to surround (eg, cover) the proximal spine 1026 and the delivery shaft 1004, such as Fig.25 Specifically, the seal assembly 1018 can 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 can include a seal housing 1134, a seal 1136, and a seal compressor member 1138.

[0151] 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. In addition, a seal 1136 may be positioned within the seal housing 1134. Specifically, as shown in FIG. Fig.26 , the head portion 1137 of the seal housing 1134 can include a seat 1140 for the seal 1136. The seat 1140 can be defined by the inner surface of the head portion 1137 of the seal housing 1134. The seat 1140 can be configured to prevent the seal 1136 from moving relative to the seal housing 1134.

[0152] 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 compressor member 1138. In this way, the seal compressor 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 in the head portion 1137 and in fluid communication with the opening 1144. The locking channel 1146 may be partially defined by the flanges 1142d, 1142p. In the illustrated example, the seal housing 1134 includes four locking channels 1146, but in other examples, the seal housing 1134 may include different numbers of locking channels 1146. The locking channel 1146 may be configured to receive and releasably retain the seal compressor component 1138 after the seal compressor component 1138 is inserted into the seal housing 1134 .

[0153] like Fig. 27As shown, the seal compressor component 1138 can include a base 1148 and a pin 1150 extending outwardly from the base 1148 in a radial direction. In the illustrated example, the seal compressor component 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 examples, the seal compressor component 1138 can include a different number of pins 1150 (e.g., more or less than four, etc.). The seal compressor component 1138 can also include one or more ribs 1152. In some cases, the rib 1152 can be configured to be grasped by a user (e.g., to rotate the seal compressor component 1138 around the central longitudinal axis 1003, etc.).

[0154] 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, etc.). Specifically, the seal compressor member 1138 can be inserted into the opening 1144 at the proximal end 1134p of the seal housing 1134 and can be positioned adjacent to the seal 1136. Specifically, the distal surface 1154 of the seal compressor member 1138 can contact the seal 1136. A force can be applied to the seal compressor member 1138 in an axial direction to axially compress the seal 1136. In this way, the seal 1136 is compressed between the seat 1140 of the seal housing 1134 and the distal surface 1154 of the seal compressor member 1138. When compressed, the seal 1136 can be configured to slightly clamp or squeeze the shaft (e.g., any of the pusher assemblies described herein, etc.) of the delivery device (e.g., any of the pusher assemblies described herein, etc.) inserted through the main lumen 1010 of the delivery device 1000 in a radial direction. Fig.25 ).

[0155] When the seal compressor member 1138 compresses the seal 1136, the pin 1150 of the seal compressor member 1138 can be located distally of the flange 1142p and positioned within the locking channel 1146. In this position, the seal compressor member 1138 can be rotated relative to the seal housing 1134 (e.g., about the axis 1003, etc.) to lock the seal compressor member 1138 into the appropriate position, such as Fig.28 Specifically, the pin 1150 of the seal compressor member 1138 can be guided through the locking channel 1146 to the locked position. In the locked position, the pin 1150 can contact the surface of the flange 1142p, which allows the force to be maintained on the seal 1136. This causes a steady-state pressure to be applied to the seal 1136 in the axial direction.

[0156] In some cases, as depicted, the seal housing 1134 can include a flushing port 1156. As depicted, the flushing port 1156 can be located distal to the seal 1136 and extend radially from the shaft portion 1135. The flushing tube 1027 can be coupled to the flushing port 1156 (e.g., coupled to an inner surface of the flushing port 1156, etc.). In some cases, the flushing tube 1027 can include a flexible or semi-flexible material, and the proximal housing 1012c can include a rigid material. In order to reinforce the flushing tube 1027 at the location where the flushing tube 1027 passes through the proximal housing 1012c, a support 1158 can be positioned around the flushing tube 1027 and coupled to the proximal housing 1012c. The support 1158 can include a flexible or semi-flexible material (e.g., rubber, etc.).

[0157] Fig.29 A delivery device 1000 is shown in which a pusher assembly 1180 (e.g., similar to pusher assembly 58, etc.) extends proximally from the delivery device 1000. Specifically, the pusher assembly 1180 can be positioned within the main lumen 1010 of the delivery device 1000 (e.g., positioned within the delivery shaft 1004, etc.). In some instances, the delivery device 1000 can include the pusher assembly 1180, so 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 can be used to deploy and / or implant a docking device at an implantation site. To this end, in some cases, the pusher assembly 1180 may need to move or slide in an axial direction relative to the delivery device 1000. In other cases, the pusher assembly 1180 may also need to remain fixed relative to the delivery device 1000.

[0158] The locking mechanism 1020 can be configured to prevent the pusher assembly 1180 from moving relative to the delivery device 1000 when the locking mechanism 1020 is in the locked configuration. In the unlocked configuration, the locking mechanism 1020 can be configured to allow such movement. Figure 23-25 , the locking mechanism 1020 can include a rotatable knob 1160 (also referred to herein as a "locker body") and a collet 1162. The knob 1160 includes two tabs 1164 extending outwardly from the knob 1160 in a radial direction and a shaft 1166 extending distally from the knob 1160 in an axial direction. The shaft 1166 can be configured to receive the collet 1162. In the example shown, the shaft 1166 can include a threaded region 1168 having internal threads and a tapered region 1170. The tapered region 1170 includes an inner surface 1172 that can taper from a larger inner diameter to a smaller inner diameter in the proximal direction.

[0159] The collet 1162 can include external threads 1174 configured to engage with internal threads in the threaded region 1168 of the shaft 1166. The collet 1162 can also include an axially extending protrusion 1176 (also referred to herein as a "cantilever") at the proximal end 1162p of the collet 1162. In some cases, as depicted, the collet 1162 can include four protrusions 1176. It should be appreciated that in other cases, the collet 1162 can include a different number of protrusions 1176. The collet 1162 can also include a central lumen 1178 extending from the distal end 1162d of the collet 1162 to the proximal end 1162p. The central lumen 1178 can be coaxial with the main lumen 1010 of the delivery device 1000.

[0160] When the locking mechanism 1020 is in the unlocked configuration, as shown Fig.25 As shown, the protrusion 1176 extends straight out 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 can be the same as the diameter of the main lumen 1010. Rotating the knob 1160 relative to the central longitudinal axis 1003 by a certain amount (e.g., a quarter turn, etc.) can change the locking mechanism 1020 from the unlocked configuration to the locked configuration. Therefore, in some cases, the locking mechanism 1020 can also be referred to as a "quarter turn locking mechanism."

[0161] When the knob 1160 is rotated, the collet 1162 can move in the axial direction relative to the knob 1160 toward the tapered region 1170 of the shaft 1166. When the locking mechanism 1020 is in a locked configuration, the protrusion 1176 can contact the inner surface 1172 of the shaft 1166 and can be pushed or deflected radially inward by the reduction of the inner surface 1172. In other words, in the locked configuration, since the inner surface 1172 is tapered, the diameter of the central lumen 1178 at the proximal end 1162p of the collet 1162 is smaller than the diameter at the distal end 1162d of the collet 1162. In this way, the protrusion 1176 can be configured to clamp the device inserted through the delivery device 1000 (e.g., the pusher assembly 1180, etc.) to lock the device in place. Therefore, the protrusion 1176 can be configured to prevent the device from moving relative to the delivery device 1000 (e.g., relative to the main lumen 1010, the handle 1006, etc.).

[0162] Additional details of the docking device delivery apparatus and variations thereof are described in International Patent Application No. PCT / US2021 / 052669, which is incorporated herein by reference in its entirety.

[0163] Reference again Fig.23In some cases, as depicted, the proximal housing 1012c can include a proximal extension 1182 (e.g., an axial extension or protrusion, etc.) that can extend in an axial direction above the knob 1160. The extension 1182 can be configured to prevent the knob 1160 from rotating beyond a certain angular amount (e.g., more than a quarter turn, etc.). Specifically, the extension 1182 can protrude axially over the knob 1160 between the tabs 1164. Additionally, the tabs 1164 can extend outwardly in a radial direction, extending further than the extension 1182. In this way, the tabs 1164 can contact the extension 1182 to prevent additional rotation. The extensions 1182 can be sized and / or spaced apart so that a full rotation of the knob 1160 between the extensions 1182 (e.g., a quarter turn, etc.) can cause the locking mechanism 1020 to transition from an unlocked configuration to a locked configuration (or vice versa).

[0164] Fig.30 An example delivery system 2000 is shown, which includes the delivery device 1000, the pusher assembly 1180, the guide catheter 2002 (e.g., similar to the guide catheter 30, etc.), and the stabilizer 2004 (also referred to herein as a "stabilization tower" or "stabilization device"). The delivery system 2000 can be used in a transcatheter heart valve replacement procedure, such as the above reference Figure 1-4 Specifically, Fig.30 The delivery system 2000 depicted in FIG. Figure 2A The second stage of the operation is used as described. Fig.30 As shown, the delivery device 1000 and the pusher assembly 1180 can be inserted through the guide catheter 2002. Specifically, the delivery shaft 1004 of the delivery device 1000 can be advanced through the guide catheter 2002 (e.g., through its central lumen, etc.). The shaft of the pusher assembly 1180 can be inserted through the delivery device 1000 and extend distally through the delivery device 1000 into the delivery shaft 1004. As described above, the locking mechanism 1020 can be configured to selectively allow movement of the pusher assembly 1180 relative to the delivery device 1000 (e.g., axial and / or rotational movement, etc.).

[0165] The guide catheter 2002 and the delivery device 1000 can be coupled to a stabilizer 2004, which can support and stabilize the guide catheter 2002 and the delivery device 1000 (e.g., during surgery, etc.). The stabilizer 2004 can include a support 2006 (e.g., a clamp, a clamp, a brace, etc.), which can be configured to hold or grasp the guide catheter 2002 and the delivery device 1000. In some cases, the support 2006 can be slidably coupled to the stabilizer 2004 and can be repositioned or repositioned on the stabilizer 2004 in an axial direction. In some examples, as depicted, the support 2006 can be configured to engage with the cover 1046 of the delivery device 1000. For example, as described above, the cover 1046 can be fixed relative to the rest of the delivery device 1000 (e.g., the spine extension 1022 and the nose cone 1012a, etc.). In some examples, when the delivery device 1000 is coupled to the stabilizer 2004, torque can be exerted on the handle assembly 1002 of the delivery device 1000. This torque can be transmitted to the delivery shaft 1004 via the spine assembly 1014, as described above.

[0166] Delivery Technology

[0167] In order to implant the prosthetic valve in the natural aortic valve via the transfemoral delivery method, the prosthetic valve is installed along the distal end portion of the delivery device under radial compression. The distal end portion of the prosthetic valve and the delivery device is 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 in the natural aortic valve and radially expanded (e.g., by inflating the balloon, actuating one or more actuators of the delivery device or deploying the prosthetic valve from the sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted in the natural aortic valve in a transapical surgery, whereby the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through the surgical opening in the chest and the apex, and the prosthetic valve is positioned in the natural aortic valve. Alternatively, in a transaortic procedure, a 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 through a partial J-shaped sternotomy or a right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0168] To implant a prosthetic valve into the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted along the distal end portion of the delivery device in a radially compressed state. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (through a perforation made in the atrial septum), into the left atrium, and advanced toward the native mitral valve. Alternatively, the prosthetic valve can be implanted into the native mitral valve in a transapical procedure, 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 mitral valve.

[0169] To implant the prosthetic valve into the native tricuspid valve, the prosthetic valve is mounted along the distal end portion of the delivery device in a radially compressed state. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar method can be used to implant the prosthetic valve into 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.

[0170] Another delivery method is a transatrial approach, in which 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) for access to any native heart valve. Atrial delivery can also be performed intravascularly, such as from the pulmonary veins. Yet another delivery method is a transventricular approach, in which 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 right ventricular wall (usually at or near the base of the heart) for implantation of the prosthetic valve into the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0171] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery methods are not intended to be limited. Any prosthetic valve disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0172] Additional Examples of Disclosed Technology

[0173] Considering the above-mentioned embodiment of the disclosed subject matter, the present application discloses the additional examples listed below. It should be noted that one feature of a separate example or one or more features of the examples adopted in combination, and optionally combined with one or more features of one or more other examples, are additional examples that also fall within the disclosure of the present application.

[0174] Example 1: A handle of a delivery device, the handle comprising: a shell having an outer wall; at least one window connected to the outer wall of the shell, the at least one window defining at least one observation area through the outer wall; and at least one indicator positioned adjacent to the window within the shell, the at least one indicator comprising a background member and a slider, wherein the slider is configured to slide relative to the background member.

[0175] Example 2: The handle according to any example herein, in particular the handle according to example 1, wherein the slider comprises an opening, and the background member extends through the opening of the slider.

[0176] Example 3: The handle according to any example herein, in particular the handle according to example 1 or example 2, wherein the slider includes an observable portion positioned between the background member and the window.

[0177] Example 4: The handle according to any example herein, in particular the handle according to example 3, wherein the observable portion of the slider is a rod.

[0178] Example 5: The handle according to any example herein, in particular the handle according to any one of examples 1 to 4, wherein the background member is fixed relative to the housing.

[0179] Example 6: The handle according to any example herein, in particular the handle according to any one of examples 1 to 5, wherein the shell further comprises a rib extending from an inner surface of the shell, wherein the rib defines a groove configured to receive the background member.

[0180] Example 7: The handle according to any example herein, in particular the handle according to any one of examples 1 to 6, wherein the at least one window comprises a frame and a pane coupled to the frame.

[0181] Example 8: The handle according to any example herein, in particular the handle according to Example 7, wherein the frame defines two viewing areas, wherein each viewing area is associated with a different measurement result indicated by the at least one indicator.

[0182] Example 9: The handle according to any example described herein, specifically the handle according to Example 7, wherein the frame includes a retaining member extending from an inner surface of the frame, wherein the retaining member connects the pane to the frame, and wherein the retaining member is positioned between the two viewing areas.

[0183] Example 10: The handle of any example herein, in particular the handle of any one of examples 1 to 9, wherein the first window is positioned on a first side of the handle, and wherein the second window is positioned on a second, opposite side of the handle.

[0184] Example 11: The handle according to any example herein, in particular the handle according to Example 10, wherein the at least one indicator includes four indicators, wherein two indicators are positioned adjacent to the first window and wherein the other two indicators are positioned adjacent to the second window.

[0185] Example 12: The handle according to any example herein, in particular the handle according to example 11, wherein the two indicators include two sliders and only one background component.

[0186] Example 13: The handle according to any example herein, in particular the handle according to Example 11, wherein the two indicators include two sliders and two background components.

[0187] Example 14: The handle according to any example herein, in particular the handle according to any one of examples 1 to 13, further comprising an adjustment mechanism operatively connected to the slider, wherein the slider is configured to indicate an amount of adjustment made by the adjustment mechanism.

[0188] Example 15: A delivery device comprising: a handle including a body and a nose cone positioned distal to the body, wherein the nose cone includes at least one axial flow channel extending from an inner surface of the nose cone; a ridge positioned within the body of the handle, the ridge including a lumen; an axis positioned within the lumen of the ridge, the axis extending distally from the handle; and a ridge extension positioned within the nose cone and connected to the ridge, the ridge extension at least partially surrounding the axis, the ridge extension including radial protrusions, wherein each of the radial protrusions includes one or more mating features defining at least one groove corresponding to the at least one axial flow channel of the nose cone.

[0189] Example 16: The delivery device of any example herein, in particular the delivery device of Example 15, wherein the spine extension partially surrounds the shaft in a circumferential direction, wherein the spine extension is configured to transmit torque to the shaft.

[0190] Example 17: A delivery device according to any of the examples herein, specifically the delivery device according to Example 15 or Example 16, wherein the nose cone includes a distal end portion extending partially around the axis in a circumferential direction, wherein the ridge extension includes a distal end portion extending partially around the axis in the circumferential direction, and wherein the nose cone and the distal end portions of the ridge extension completely surround the axis in the circumferential direction.

[0191] Example 18: The delivery device according to any example described herein, specifically the delivery device according to Example 17, further comprising a cover that is arranged around the distal end portion of the nose cone and the spine extension and is configured to limit the movement of the nose cone relative to the spine extension.

[0192] Example 19: The delivery device according to any example herein, in particular the delivery device according to Example 18, wherein the cover is configured for attachment to an external stabilization device.

[0193] Example 20: The delivery device according to any example herein, in particular the delivery device according to example 18 or example 19, wherein the cover comprises an elastic material.

[0194] Example 21: A delivery device according to any example herein, specifically according to any one of Examples 18 to 20, wherein the cover includes an inner surface defining a hexagonal shape, and wherein the distal end portions of the nose cone and the ridge extension define complementary hexagonal shapes.

[0195] Example 22: The delivery device according to any example herein, in particular the delivery device according to any one of examples 15 to 21, wherein the radial protrusions are spaced apart from each other in the axial direction and / or the circumferential direction.

[0196] Example 23: The delivery device according to any example herein, in particular the delivery device according to any one of examples 15 to 22, wherein the mating feature of the first radial protrusion and the mating feature of the second axially adjacent radial protrusion define a groove corresponding to the axial flow channel.

[0197] Example 24: A delivery device according to any example described herein, specifically a delivery device according to any one of Examples 15 to 23, wherein the axial flow channel comprises one or more panels and an end, wherein the end is configured to cooperate with the at least one groove defined by the mating feature of the radial protrusion.

[0198] Example 25: The delivery device according to any example herein, in particular the delivery device according to Example 24, wherein the axial flow channel comprises a primary panel and at least one secondary panel, the primary panel comprising the end and the at least one secondary panel is angled relative to the primary panel.

[0199] Example 26: The delivery device of any example herein, particularly any one of examples 15 to 25, wherein the proximal end of the spine extension is positioned within the body.

[0200] Example 27: The delivery device of any example herein, particularly any one of examples 15 to 26, wherein the distal end of the ridge is positioned within the nose cone.

[0201] Example 28: The delivery device of any example herein, particularly any one of Examples 15 to 27, wherein the spine comprises a distal spine and a proximal spine, wherein the distal spine is coupled to the proximal spine via a mating feature.

[0202] Example 29: The delivery device of any example herein, particularly Example 28, wherein one of the distal ridge and the proximal ridge comprises a base, wherein the base contacts an inner surface of the body.

[0203] Example 30: The delivery device of any example herein, in particular the delivery device of Example 29, wherein the base is only the portion of the ridge that directly contacts the inner surface of the body.

[0204] Example 31: The delivery device of any example herein, particularly any one of examples 15 to 30, wherein the shaft comprises a first portion having a first outer diameter and a second portion having a second, smaller outer diameter.

[0205] Example 32: The delivery device of any example herein, particularly Example 31, wherein the spine extension partially surrounds the first portion of the shaft and the second portion of the shaft.

[0206] Example 33: The delivery device according to any example herein, in particular the delivery device according to example 31 or example 32, wherein the second portion of the shaft comprises one or more openings.

[0207] Example 34: A delivery device comprising: a handle; a shaft having a distal end and a proximal end, the shaft extending distally from the handle, wherein the proximal end of the shaft is positioned in the handle, the shaft comprising a lumen extending from the distal end toward the proximal end; and a sealing assembly positioned in the handle and connected to the proximal end of the shaft, the sealing assembly comprising a sealing housing, a seal disposed within the sealing housing, and a seal compressor component connected to the sealing housing and configured to compress the seal within the sealing housing in an axial direction.

[0208] Example 35: The delivery apparatus of any example herein, particularly Example 34, wherein the seal compressor member comprises a base and a pin extending radially from the base.

[0209] Example 36: A delivery device according to any example herein, specifically the delivery device according to Example 34 or Example 35, wherein the sealing housing comprises a head portion and a shaft portion, wherein the seal is positioned within the head portion, and wherein the shaft is positioned within the shaft portion.

[0210] Example 37: The delivery device of any example herein, particularly Example 36, wherein the proximal end of the head portion includes an opening configured to receive the seal compressor member.

[0211] Example 38: A delivery device according to any of the examples herein, specifically the delivery device according to Example 36 or Example 37, wherein the head portion includes one or more flanges defining a locking channel for the seal compressor member, the locking channel being configured to maintain compression of the seal by the seal compressor member.

[0212] Example 39: The delivery device of any example herein, particularly Example 38, wherein the pin of the seal compressor member is distal to a flange at the proximal end of the head portion.

[0213] Example 40: The delivery device according to any example herein, in particular the delivery device according to example 38 or example 39, wherein the locking channel is in fluid communication with the opening and extends in a circumferential direction.

[0214] Example 41: The delivery device of any example herein, specifically the delivery device of any one of Examples 34 to 40, wherein the handle comprises the handle of any one of Examples 1 to 14.

[0215] Example 42: A delivery device comprising: a handle having at least one window; a delivery shaft extending distally from the handle, the delivery shaft having a distal end and a proximal end, wherein the proximal end of the delivery shaft is positioned within the handle; a spine assembly positioned at least partially around the delivery shaft, the spine assembly being coupled to the handle; an adjustment mechanism configured to adjust the curvature of the distal end of the delivery shaft; and an indicator configured to indicate an amount of adjustment made by the adjustment mechanism, the indicator being positioned within the handle and observable through the at least one window.

[0216] Example 43: The delivery device according to any example herein, in particular the delivery device according to Example 42, wherein the handle comprises a shell having a distal section, a middle section, and a proximal section.

[0217] Example 44: The delivery device of any example herein, particularly Example 43, wherein the spine component comprises a spine extension positioned at least partially around the delivery axis, the spine extension having a radial protrusion.

[0218] Example 45: The delivery device according to any example herein, in particular the delivery device according to Example 44, wherein the distal segment of the housing includes a mating element corresponding to the radial protrusion.

[0219] Example 46: The delivery device according to any example herein, in particular the delivery device according to Example 43, wherein the at least one window is disposed in the middle section of the shell.

[0220] Example 47: The delivery device according to any example herein, in particular according to any one of examples 43 to 46, wherein the indicator comprises a slider operatively connected to the adjustment mechanism and a background member positioned between the at least one window and the adjustment mechanism.

[0221] Example 48: The delivery device according to any example herein, in particular the delivery device according to Example 47, wherein the slider comprises an opening, wherein the background member is positioned within the opening, wherein the slider is configured to move axially relative to the background member.

[0222] Example 49: The delivery device of any example herein, in particular example 47 or example 48, wherein the background member is coupled to the middle section of the housing.

[0223] Example 50: The delivery device according to any example herein, in particular the delivery device according to any one of examples 47 to 49, wherein the background component comprises a logo.

[0224] Example 51: A delivery device according to any example described herein, specifically a delivery device according to any one of Examples 42 to 50, further comprising a sealing assembly connected to the delivery shaft, the sealing assembly comprising a sealing housing, a seal positioned within the sealing housing, and a seal compressor component configured to axially compress the seal within the sealing housing.

[0225] Example 52: The delivery device according to any example herein, in particular the delivery device according to any one of examples 42 to 51, further comprising a locking mechanism at the proximal end of the handle, the locking mechanism comprising a rotatable knob and a collet.

[0226] Example 53: The delivery device according to any example herein, in particular the delivery device according to Example 52, wherein rotation of the knob is configured to transition the locking mechanism between an unlocked configuration and a locked configuration.

[0227] Example 54: A delivery device according to any of the examples described herein, specifically the delivery device according to Example 52 or Example 53, wherein the knob includes a radial tab, and wherein the proximal segment of the shell includes an axial extension, which is configured to engage with the radial tab to limit the rotational movement of the knob relative to the shell.

[0228] Example 55: A delivery device according to any example herein, specifically according to any one of Examples 52 to 54, wherein the knob comprises a lumen having a threaded region and a tapered region, wherein the cartridge is movable within the lumen in an axial direction relative to the knob.

[0229] Example 56: The delivery device of any example herein, in particular any one of Examples 52 to 55, further comprising a pusher assembly comprising a shaft, wherein the shaft is positioned within the lumen of the delivery shaft.

[0230] Example 57: The delivery device of any example herein, particularly Example 56, wherein the locking mechanism is configured to prevent the shaft of the pusher assembly from moving relative to the handle in the locked configuration.

[0231] Example 58: An assembly comprising: a delivery device including a handle according to any one of Examples 1 to 14; and a prosthetic implant releasably coupled to the delivery device.

[0232] Example 59: A component according to any example described herein, in particular the component according to Example 58, wherein the prosthetic implant includes a docking device.

[0233] Example 60: The assembly of any example herein, in particular the assembly of Example 59, wherein the docking device comprises a coil.

[0234] Example 61: The assembly of any example herein, in particular the assembly of Example 58, wherein the prosthetic implant comprises a prosthetic valve.

[0235] Example 62: The assembly of any example herein, in particular the assembly of any one of examples 58 to 61, wherein the delivery device comprises the delivery device of any one of examples 15 to 57.

[0236] Example 63: The assembly of any example herein, particularly any one of Examples 58 to 62, further comprising a guide catheter, wherein at least a portion of the delivery device extends through a lumen of the guide catheter.

[0237] Example 64: The assembly of any example herein, in particular any one of examples 58 to 63, further comprising a stabilizer coupled to at least the delivery device.

[0238] Example 65: The assembly of any example herein, particularly any one of Examples 58 to 64, further comprising a pusher assembly, wherein at least a portion of the pusher assembly extends through the lumen of the delivery device.

[0239] Example 66: An assembly comprising: a delivery device according to any one of Examples 15 to 57; and a prosthetic implant releasably coupled to the delivery device.

[0240] Example 67: A component according to any example described herein, in particular the component according to Example 66, wherein the prosthetic implant includes a docking device.

[0241] Example 68: The component according to any example described herein, specifically the component according to Example 67, wherein the docking device includes a coil.

[0242] Example 69: An assembly according to any example herein, in particular the assembly according to Example 66, wherein the prosthetic implant comprises a prosthetic valve.

[0243] Example 70: The assembly of any example herein, particularly any one of Examples 66 to 69, further comprising a guide catheter, wherein at least a portion of the delivery device extends through a lumen of the guide catheter.

[0244] Example 71: The assembly of any example herein, in particular any one of examples 66 to 70, further comprising a stabilizer coupled to at least the delivery device.

[0245] Example 72: The assembly of any example herein, particularly any one of Examples 66 to 71, further comprising a pusher assembly, wherein at least a portion of the pusher assembly extends through the lumen of the delivery device.

[0246] Example 73: A method for implanting a prosthetic implant, the method comprising: inserting a delivery device into the vascular system of a patient, wherein the delivery device comprises a delivery device according to any one of Examples 15 to 57; and sliding a first slider within a handle of the delivery device relative to a first background member, wherein the slider indicates a first type of adjustment amount of an axis of the delivery device.

[0247] Example 74: The method according to any example herein, specifically the method according to Example 73, wherein the delivery device comprises a handle, wherein the handle comprises the handle according to any one of Examples 1 to 14.

[0248] Example 75: The method according to any example herein, in particular the method according to Example 73 or Example 74, wherein sliding the first slider comprises rotating a first knob of the delivery device.

[0249] Example 76: The method according to any example described herein, specifically the method according to any one of Examples 73 to 75, further comprising sliding a second slider relative to the first background member, wherein the second slider indicates a second type of adjustment amount of the axis of the delivery device.

[0250] Example 77: The method according to any example described herein, specifically the method according to any one of Examples 73 to 75, further comprising sliding a second slider relative to a second background member, wherein the second slider indicates a second type of adjustment amount of the axis of the delivery device.

[0251] Example 78: The method according to any example herein, in particular the method according to Example 76 or Example 77, wherein sliding the second slider comprises rotating a second knob of the delivery device.

[0252] Example 78: A method for implanting a prosthetic implant, the method comprising: inserting a shaft of a delivery device into the vascular system of a patient, wherein the delivery device comprises a handle outside the patient's body, wherein the handle comprises a handle according to any one of Examples 1 to 14; and rotating the delivery device relative to the vascular system of the patient, wherein the handle comprises a support member, the support member being configured to transmit torque from the handle to a distal end of the shaft.

[0253] Example 79: The method according to any example herein, specifically the method according to Example 78, wherein the delivery device comprises a delivery device according to any one of Examples 15 to 57.

[0254] Unless otherwise stated, features described herein with respect to any example may be combined with other features described in any one or more other examples. For example, any one or more features of one delivery device may be combined with any one or more features of another delivery device.

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

[0256] aspect

[0257] Aspect 1. A handle of a delivery device, the handle comprising:

[0258] a housing having an outer wall;

[0259] at least one window coupled to the outer wall of the housing, the at least one window defining at least one viewing area through the outer wall; and

[0260] At least one indicator is positioned within the housing adjacent to the window, the at least one indicator comprising a background member and a slider, wherein the slider is configured to slide relative to the background member.

[0261] Aspect 2. The handle of aspect 1, wherein the slider includes an opening, and wherein the background member extends through the opening of the slider.

[0262] Aspect 3. The handle of aspect 1 or aspect 2, wherein the slider includes an observable portion positioned between the background member and the window.

[0263] Aspect 4. The handle according to any one of aspects 1 to 3, wherein the background member is fixed relative to the housing.

[0264] Aspect 5. The handle according to any one of aspects 1 to 4, wherein the at least one window comprises a frame and a pane coupled to the frame.

[0265] Aspect 6. The handle of aspect 5, wherein the frame defines two viewing areas, wherein each viewing area is associated with a different measurement result indicated by the at least one indicator.

[0266] Aspect 7. The handle of any one of aspects 1 to 6, wherein the first window is positioned on a first side of the handle, and wherein the second window is positioned on a second, opposing side of the handle.

[0267] Aspect 8. The handle according to any one of aspects 1 to 7, further comprising an adjustment mechanism operatively connected to the slider, wherein the slider is configured to indicate an amount of adjustment made by the adjustment mechanism.

[0268] Aspect 9. A method for implanting a prosthetic implant, the method comprising:

[0269] inserting a shaft of a delivery device into the vasculature of a patient, wherein the delivery device comprises a handle external to the patient, wherein the handle comprises a handle according to any one of aspects 1 to 8; and

[0270] The delivery device is rotated relative to the vasculature of the patient, wherein the handle includes a support member configured to transmit torque from the handle to the distal end of the shaft.

Claims

1. A delivery device, characterized in that The delivery device includes: a handle including a body and a nose cone positioned distally of the body, wherein the nose cone includes at least one axial flow channel extending from an inner surface of the nose cone; a ridge positioned within the body of the handle, the ridge including a lumen; an axis positioned within the lumen of the ridge, the axis extending distally from the handle; and a ridge extension positioned within the nose cone and coupled to the ridge, the ridge extension at least partially surrounding the axis, the ridge extension including radial protrusions, wherein each of the radial protrusions includes one or more mating features defining at least one groove corresponding to the at least one axial flow channel of the nose cone. 2 . The delivery device of claim 1 , wherein the spine extension partially surrounds the shaft in a circumferential direction, wherein the spine extension is configured to transmit torque to the shaft.

3. A delivery device according to claim 1 or claim 2, wherein the nose cone includes a distal end portion extending partially around the axis in a circumferential direction, wherein the ridge extension portion includes a distal end portion extending partially around the axis in the circumferential direction, and wherein the nose cone and the distal end portions of the ridge extension portion completely surround the axis in the circumferential direction.

4. The delivery device according to claim 3, characterized in that It further includes a cover disposed around the nose cone and the distal end portion of the spine extension and configured to limit movement of the nose cone relative to the spine extension.

5. The delivery apparatus of claim 4, wherein the cap is configured for attachment to an external stabilization device.

6. A delivery device according to claim 4 or claim 5, wherein the cover comprises a resilient material.

7. The delivery device of any one of claims 4 to 5, wherein the cap includes an inner surface defining a hexagonal shape, and wherein the nose cone and the distal end portion of the spine extension define complementary hexagonal shapes.

8. The delivery device according to any one of claims 1 to 2 and 4 to 5, wherein the radial protrusions are spaced apart from each other in the axial direction and / or the circumferential direction.

9. The delivery device of any one of claims 1 to 2 and 4 to 5, wherein the mating feature of a first radial projection and the mating feature of a second axially adjacent radial projection define a slot corresponding to the axial flow passage.

10. The delivery device of any one of claims 1-2 and 4-5, wherein the axial flow channel comprises one or more panels and a tip, wherein the tip is configured to mate with the at least one groove defined by the mating feature of the radial protrusion.

11. The delivery apparatus of claim 10, wherein the axial flow channel comprises a primary panel and at least one secondary panel, the primary panel comprising the tip and the at least one secondary panel being angled relative to the primary panel.

12. The delivery device of any one of claims 1-2, 4-5 and 11, wherein a proximal end of the spine extension is positioned within the body.

13. The delivery device of any one of claims 1-2, 4-5 and 11, wherein a distal end of the spine is positioned within the nose cone.

14. The delivery device of any one of claims 1-2, 4-5, and 11, wherein the spine comprises a distal spine and a proximal spine, wherein the distal spine is coupled to the proximal spine via a mating feature.

15. The delivery apparatus of claim 14, wherein one of the distal ridge and the proximal ridge includes a base, wherein the base contacts an inner surface of the body.

16. The delivery device of claim 15, wherein the base is only the portion of the ridge that directly contacts the inner surface of the body.

17. The delivery device of any one of claims 1-2, 4-5, 11, and 15-16, wherein the shaft comprises a first portion having a first outer diameter and a second portion having a second, smaller outer diameter.

18. The delivery device of claim 17, wherein the spine extension partially surrounds the first portion of the shaft and the second portion of the shaft.

19. The delivery device of claim 17, wherein the second portion of the shaft comprises one or more openings.

20. A delivery device, characterized in that The delivery device includes: a handle; a shaft having a distal end and a proximal end, the shaft extending distally from the handle, wherein the proximal end of the shaft is positioned in the handle, the shaft including a lumen extending from the distal end to the proximal end; and a sealing assembly positioned in the handle and connected to the proximal end of the shaft, the sealing assembly including a sealing housing, a seal disposed in the sealing housing, and a seal compressor component connected to the sealing housing and configured to compress the seal in the sealing housing in an axial direction.

21. The delivery apparatus of claim 20, wherein the seal compressor member comprises a base and a pin extending radially from the base.

22. The delivery device of claim 21, wherein the seal housing comprises a head portion and a shaft portion, wherein the seal is positioned within the head portion, and wherein the shaft is positioned within the shaft portion.

23. The delivery device of claim 22, wherein a proximal end of the head portion includes an opening configured to receive the seal compressor member.

24. The delivery apparatus of claim 23, wherein the head portion includes one or more flanges defining a locking channel for the seal compressor member, the locking channel being configured to maintain compression of the seal by the seal compressor member.

25. The delivery device of claim 24, wherein the pin of the seal compressor member is distal to a flange at the proximal end of the head portion.

26. The delivery device of claim 24 or claim 25, wherein the locking channel is in fluid communication with the opening and extends in a circumferential direction.

27. A delivery device, characterized in that The delivery device includes: a handle having at least one window; a delivery shaft extending distally from the handle, the delivery shaft having a distal end and a proximal end, wherein the proximal end of the delivery shaft is positioned within the handle; a spine assembly positioned at least partially around the delivery shaft, the spine assembly being coupled to the handle; an adjustment mechanism configured to adjust the curvature of the distal end of the delivery shaft; and an indicator configured to indicate an amount of adjustment made by the adjustment mechanism, the indicator being positioned within the handle and observable through the at least one window.

28. The delivery device of claim 27, wherein the handle comprises a housing having a distal section, a middle section, and a proximal section.

29. The delivery device of claim 28, wherein the spine component comprises a spine extension positioned at least partially around the delivery axis, the spine extension having a radial protrusion.

30. The delivery device of claim 29, wherein the distal section of the housing includes a mating element corresponding to the radial protrusion.

31. The delivery device of claim 28, wherein the at least one window is disposed in the intermediate section of the housing.

32. The delivery device of any one of claims 28 to 31, wherein the indicator comprises a slider operatively connected to the adjustment mechanism and a background member positioned between the at least one window and the adjustment mechanism.

33. The delivery apparatus of claim 32, wherein the slider comprises an opening, wherein the background member is positioned within the opening, wherein the slider is configured to move axially relative to the background member.

34. The delivery device of claim 32, wherein the background member is coupled to the intermediate section of the housing.

35. The delivery device of claim 32, wherein the background component comprises a logo.

36. A delivery device according to any one of claims 28 to 31 and 33 to 35, characterised in that It further includes a seal assembly coupled to the delivery shaft, the seal assembly comprising a seal housing, a seal positioned within the seal housing, and a seal compressor member configured to axially compress the seal within the seal housing.

37. A delivery device according to any one of claims 28 to 31 and 33 to 35, characterised in that It further includes a locking mechanism at the proximal end of the handle, the locking mechanism comprising a rotatable knob and a collet.

38. The delivery device of claim 37, wherein rotation of the knob is configured to transition the locking mechanism between an unlocked configuration and a locked configuration.

39. The delivery device of claim 38, wherein the knob includes a radial tab, and wherein the proximal segment of the housing includes an axial extension configured to engage the radial tab to limit rotational movement of the knob relative to the housing.

40. The delivery device of any one of claims 38 to 39, wherein the knob comprises a lumen having a threaded region and a tapered region, wherein the collet is movable within the lumen in an axial direction relative to the knob.

41. A delivery device according to any one of claims 38 to 39, characterised in that It further includes a pusher assembly comprising a shaft, wherein the shaft is positioned within the lumen of the delivery shaft.

42. The delivery apparatus of claim 41 wherein the locking mechanism is configured to prevent movement of the shaft of the pusher assembly relative to the handle in the locked configuration.

43. A component characterized by The assembly comprises: a delivery device according to any one of claims 1 to 42; and a prosthetic implant releasably coupled to the delivery device.

44. The assembly of claim 43, wherein the prosthetic implant comprises a docking arrangement.

45. The assembly of claim 44, wherein the docking device comprises a coil.

46. ​​The assembly of claim 43, wherein the prosthetic implant comprises a prosthetic valve.

47. An assembly according to any one of claims 43 to 46, characterised in that It further comprises a guide catheter, wherein at least a portion of the delivery device extends through a lumen of the guide catheter.

48. An assembly according to any one of claims 43 to 46, characterised in that It further comprises a stabilizer coupled to at least the delivery device.

49. An assembly according to any one of claims 43 to 46, characterised in that It further includes a pusher assembly, wherein at least a portion of the pusher assembly extends through the lumen of the delivery device.

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