Catheter shaft for an implant delivery device

Abstract

A catheter shaft that can be used in a delivery device for an artificial implant is disclosed. As an example, the catheter shaft can include a tube having a distal end portion with at least one axially extending slot, the slot extending proximally into the tube from the distal end of the tube and radially through the thickness of the tube. The catheter shaft further can include a polymer layer comprising a jacket portion disposed around the tube, a tip portion extending distally of the jacket portion and the tube, and a channel portion disposed within the slot, and an inner liner disposed on the inner surface of the tube and the inner surface of the tip portion, the material of the polymer layer bonding to the inner liner.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 366,683, filed on June 20, 2022, which is hereby incorporated by reference in its entirety.

[0002] The present disclosure relates to a delivery device for a docking device configured to fix an artificial valve to a natural heart valve.

Background Art

[0003] The human heart is susceptible to various valvular diseases. These valvular diseases can cause severe heart dysfunction and may ultimately require either repairing the natural valve or replacing the natural valve with an artificial valve. Numerous repair devices (e.g., stents) and artificial valves are known, and numerous methods for implanting those devices and valves into the human body are also known. By using percutaneous and minimally invasive surgical approaches in various procedures, it is possible to deliver artificial medical devices to locations within the patient's body that are not easily accessible surgically and to locations where access without surgery is desirable. In one specific example, an artificial heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and the aorta), and the artificial valve can be made to reach the implantation site within the heart. Thereafter, the artificial valve can be expanded to its functional size by, for example, inflating a balloon on which the artificial valve is mounted, or by driving a mechanical actuator that applies an expanding force to the artificial valve, or by deploying the artificial valve from the sheath of the delivery device such that the artificial valve can be naturally expanded to its functional size.

[0004] An artificial heart valve can be appropriately sized to be placed inside many native aortic valves. However, native mitral valves, and tricuspid valves can have different shapes than typical vena cava valves. The anatomical structures of the mitral valve, and tricuspid valve can also vary significantly from person to person. Thus, it can be difficult to appropriately size and shape an artificial heart valve for various patients. Further, when treating valve insufficiency, the surrounding tissue at the target implantation site (e.g., native valve annulus) may not be strong enough to hold a particular type of valve in the desired position.

[0005] In some embodiments, a docking device can be initially implanted within a native valve, configured to receive an artificial heart valve, and to secure (e.g., anchor) the artificial heart valve in a desired position within the native valve. For example, the docking device can form a more circular, and / or stable anchoring site at the native valve annulus where the artificial heart valve can be expanded and implanted. A transcatheter delivery device can be used to deliver the docking device to the implantation site. The docking device can be disposed within the distal end portion of the delivery device in a relatively straight delivery configuration. In some embodiments, the docking device can be deployed from the delivery device by a pusher shaft disposed adjacent to the docking device within the delivery device. The distal tip of the pusher shaft can be pressed against the end of the docking device to push the docking device out of the delivery device and embed the docking device in a coiled (or helical) configuration into the native valve annulus. SUMMARY OF THE INVENTION

[0006] This specification describes a docking device, an artificial heart valve, a delivery device, and a method for implanting the docking device and the artificial heart valve within the docking device. Also described herein are examples of shafts (e.g., pusher shafts) for a delivery device configured to engage with an end of a docking device within the delivery device and to push the docking device out of the delivery device to position the docking device at a target implantation site. The disclosed shaft has a distal end portion comprising, for example, a tube surrounded by a polymer outer layer and an inner liner having various bonding surfaces for increasing the contact area between the polymer outer layer around the tube and the inner liner, thereby increasing the robustness of the polymer tip of the shaft extending distally from the tube.

[0007] The catheter shaft can comprise a tube and a polymer layer comprising a jacket portion disposed around the tube and a tip portion extending distally of the jacket portion and the tube.

[0008] In some embodiments, the tube has a distal end portion that includes an axially extending channel that extends proximally into the first tube from the distal end of the first tube.

[0009] In some embodiments, the axially extending channel is a cylindrical hole disposed on the inner surface of the tube.

[0010] In some embodiments, the axially extending channel is configured as an axially extending cut that extends radially through the thickness of the first tube.

[0011] In some embodiments, the tube comprises a plurality of axially extending cuts that are circumferentially spaced from each other, extend radially through the thickness of the tube, and extend proximally into the tube from the distal end of the tube.

[0012] In some embodiments, the axially extending channel is configured as an axially extending slot that extends radially through the thickness of the first tube and has a circumferential width.

[0013] In some embodiments, the tube has a distal end portion that tapers from a larger first diameter disposed proximal to the distal end of the tube to a smaller second diameter at the distal end.

[0014] In some embodiments, the tube has a distal end portion that includes at least one window extending radially through the thickness of the tube.

[0015] In some embodiments, the catheter shaft further includes a first liner disposed on the outer surface of the tube and a second liner disposed on the inner surface of the tube and the inner surface of the tip portion.

[0016] In some embodiments, a catheter shaft for an artificial implant includes a tube having a distal end portion that tapers from a first diameter to a second diameter at the distal tip of the tube, the second diameter being distal to the first diameter, and a polymer layer. The polymer layer includes a tip portion and a cover portion, the cover portion is over the tube, the tip portion extends distally beyond the cover portion and the tube, and the thickness of the cover portion increases from the first diameter of the tube to the second diameter of the tube along the distal end portion.

[0017] In some embodiments, a catheter shaft for an artificial implant includes a first tube having a distal end portion that includes an axially extending channel extending proximally into the first tube from the distal end of the first tube, and a second tube including a tip portion and a cover portion. The tip portion extends distally beyond the first tube, and the cover portion extends over and surrounds the first tube.

[0018] In some embodiments, a catheter shaft for an artificial implant comprises a tube having a distal end portion that includes a plurality of axially extending cuts spaced circumferentially from each other. Each of the plurality of axially extending cuts extends proximally into the tube through the thickness of the tube in a radial direction from the distal end of the tube. The catheter shaft further comprises a polymer layer having a jacket portion disposed around the tube and a tip portion extending distally from the jacket portion and the tube. The catheter shaft further comprises an inner liner disposed on the inner surface of the tube and the inner surface of the tip portion, and the material of the polymer layer extends radially through the plurality of axially extending cuts such that the polymer layer binds to the inner liner.

[0019] In some embodiments, a catheter shaft for an artificial implant comprises a tube having a distal end portion that includes an axially extending hole on the inner surface of the tube that extends proximally into the tube from the distal end of the tube. The catheter shaft further comprises a polymer layer having a jacket portion disposed around the tube and a tip portion extending distally from the jacket portion and the tube. The catheter shaft further comprises an inner liner disposed on the inner surface of the tube and the inner surface of the tip portion, and the polymer layer extends into and fills a space defined by a hole disposed between the inner liner and the inner surface of the distal end portion of the tube.

[0020] In some embodiments, a catheter shaft for an artificial implant comprises a tube having a distal end portion that includes at least one window extending radially through the thickness of the tube. The catheter shaft further comprises a polymer layer having a jacket portion disposed around the tube, a tip portion extending distally from the jacket portion and the tube, and a channel portion disposed within the window. The catheter shaft further comprises an inner liner disposed on the inner surface of the tube and the inner surface of the tip portion, and the material of the polymer layer binds to the inner liner. The catheter shaft further comprises a radially extending hole that extends through the polymer layer, the window, and the inner liner.

[0021] In some embodiments, a catheter shaft for an artificial implant comprises a tube, a first liner disposed on the outer surface of the tube, a jacket portion disposed around the first liner and radially outward of the tube, and a polymer layer comprising the jacket portion and a tip portion extending distally of the tube, and a second liner disposed on the inner surface of the tube and the inner surface of the tip portion. The second liner extends distally of the first liner, and the material of the polymer layer binds to the first and second liners.

[0022] In some embodiments, a catheter shaft for an artificial implant comprises a tube having a distal end portion including at least one axially extending slot that extends radially into the tube from the distal end of the tube through the thickness of the tube. The catheter shaft further comprises a polymer layer comprising a jacket portion disposed around the tube, a tip portion extending distally of the jacket portion and the tube, and a channel portion disposed within the slot. The catheter shaft further comprises an inner liner disposed on the inner surface of the tube and the inner surface of the tip portion, and the material of the polymer layer binds to the inner liner.

[0023] In some embodiments, the catheter shaft comprises one or more of the components listed in Examples 1-92 below.

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

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0026] General Considerations For the purposes of this specification, specific aspects, advantages, and novel features in the examples of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Instead, this disclosure is directed to all novel and non-obvious features and aspects, alone and in various combinations and sub-combinations with each other, related to the various disclosed examples. The methods, apparatuses, and systems are disclosed without being limited to any particular aspect, feature, or combination thereof, and the disclosed examples do not require the presence of any one or more particular advantages or the solution of any problems.

[0027] In some of the disclosed examples, operations are described in a particular sequential order for the sake of presentation, but it should be understood that this mode of description encompasses permutations unless the specific language described below requires a particular order. For example, operations described sequentially may in some cases be permuted or may be performed concurrently. Additionally, for simplicity, the accompanying drawings may not show various aspects in which the disclosed methods may be used in combination with other methods. Additionally, in the description, terms such as "provide" or "achieve" are sometimes used to describe the disclosed methods. These terms are high-level abstractions related to the actual operations performed. The actual operations corresponding to these terms may vary depending on the particular implementation and will be readily recognizable to those of ordinary skill in the art.

[0028] As used in this application and in the claims, the singular forms "a", "an", and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises". Further, the term "coupled" generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or connecting, and does not exclude the presence of intervening elements between coupled or associated members unless specific contrary language is provided.

[0029] As used herein, the term "proximal" refers to the position, direction, or portion of a device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to the position, direction, or portion of a device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of a device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to an axis extending in the proximal direction and in the distal direction, unless otherwise explicitly defined.

[0030] As used herein, "e.g." means "for example" and "i.e." means "that is".

[0031] Introduction to the Disclosed Technology As described above, a delivery device can be used to deliver a docking device for an artificial heart valve to a target implantation site (e.g., a native valve annulus). The docking device can be disposed within a distal end portion of the outer shaft of the delivery device in a relatively straight (e.g., non-coiled) delivery configuration. The delivery device can include a pusher shaft disposed adjacent to the docking device within the outer shaft. The pusher shaft can include a main tube surrounded by a polymeric outer layer and an inner liner. The distal tip of the pusher shaft can be configured to engage and push against the end of the docking device to push the docking device out of the outer shaft and deploy the docking device at the target implantation site. Thus, the distal tip of the pusher shaft can comprise a polymer (e.g., the same polymer as the polymeric outer layer) and an inner liner, and can extend distally of the main tube of the pusher shaft, thereby providing a softer and / or more flexible distal tip for contacting the docking device. Since the distal tip of the pusher shaft is used to apply a pushing force to the docking device, the distal tip should be durable. Therefore, an improvement in the distal end portion of the pusher shaft and / or the joint surface between the main tube and the polymeric distal tip that increases the robustness of the connection between the main tube and the polymeric distal tip is desirable. Such improvements can, for example, increase the strength and durability of the pusher shaft.

[0032] As described herein, in some embodiments, various systems, devices, methods, etc. are described that can be used with or in a delivery device for an artificial medical device (such as an artificial heart valve or a docking device). In some embodiments, such systems, devices, and / or methods can provide a pusher shaft for a delivery device comprising a main tube having one or more channels, tapers, cuts, etc. in its distal end portion configured to increase the bond between an outer polymeric layer surrounding the main tube and an inner liner. As a result, the strength of the connection between the polymeric distal tip of the pusher shaft and the distal end portion of the main tube can be increased, thereby increasing the durability of the pusher shaft.

[0033] In some embodiments, the docking device delivery device disclosed herein can be used to deliver a docking device to a target implantation site of a patient. For example, FIGS. 1-4 schematically illustrate an exemplary transcatheter heart valve replacement procedure in which a docking device delivery device is guided toward a native valve annulus using a guide catheter, and an artificial heart valve delivery device is guided toward the native valve annulus. The docking device delivery device is used to deliver the docking device to the native valve annulus, and the artificial heart valve delivery device is used to deliver a transcatheter artificial heart valve inside the docking device.

[0034] As described above, a damaged native heart valve can be replaced with a transcatheter artificial heart valve. However, such artificial heart valves may not be able to sufficiently conform to the shape of native tissue (e.g., to the leaflets and / or annulus of the native heart valve), may move in an undesirable manner relative to the native tissue, and may result in paravalvular leakage. Thus, a docking device can be initially implanted in the native valve annulus, and then an artificial heart valve can be implanted within the docking device, which helps to anchor the artificial heart valve to the native tissue and provide a seal between the native tissue and the artificial heart valve. An exemplary docking device is shown in FIG. 5, and an exemplary delivery device for deploying the docking device to the native heart valve is shown in FIG. 6.

[0035] As shown in FIGS. 7-9, the docking device delivery device can include an outer shaft, a sleeve shaft that extends through the outer shaft and houses the docking device in a relatively straight delivery configuration therein, and a pusher shaft that extends through the outer shaft and is disposed adjacent to the proximal end of the docking device. The pusher shaft can include, as shown in FIGS. 10-12, a tube, an outer polymer layer surrounding the tube, an inner liner, and a polymer distal tip that extends distally of the tube and is more flexible than the tube.

[0036] In some embodiments, as shown in FIGS. 11 - 14, the distal end portion of the tube can include one or more axially extending cuts that extend proximally into the tube from the distal end of the tube and radially through the tube between the outer polymer layer and the inner liner. As a result, the bond between the outer polymer layer of the pusher shaft, the inner liner, and the polymer distal tip can be increased, and the connection between the polymer distal tip and the tube can be made more robust.

[0037] In some embodiments, as shown in FIG. 15, the distal end portion of the tube can taper such that its diameter decreases at its distal end, and the outer polymer layer increases in thickness towards the distal end, thereby creating a thicker outer polymer layer adjacent to the polymer distal tip. As a result, stress concentration at the distal end of the tube can be reduced, and the connection between the polymer distal tip and the tube can be made more robust.

[0038] In some embodiments, as shown in FIG. 16, the distal end portion of the tube can include an axially extending hole on the inner surface of the tube that extends proximally into the tube from the distal end of the tube. The hole can be filled with the polymer of the outer polymer layer and the polymer distal tip, thereby increasing the bond between the polymer and the inner liner and increasing the robustness of the connection between the polymer distal tip and the tube.

[0039] In some embodiments, as shown in FIGS. 17 - 21, the distal end portion of the tube can include one or more slots or windows that extend proximally into the tube from the distal end of the tube and radially through the tube between the outer polymer layer and the inner liner. In some examples, the radially extending holes can be made through the outer polymer layer, which extend through one or more slots or windows and the inner liner. Such through - holes can allow a cleaning fluid to pass from the inside to the outside of the pusher shaft during degassing or to provide a cleaning fluid through a delivery device during use.

[0040] In some embodiments, the window in the distal end portion of the tube can be offset from the distal end, as shown in FIGS. 22-24. In some examples, the distal end portion of the tube can additionally include an axially extending hole on the inner surface of the tube, as shown in FIG. 24.

[0041] In some embodiments, as shown in FIGS. 25-26C, an outer liner can be added outside the tube, the outer liner extending a distance into the polymeric distal tip and being covered by an outer polymeric layer, thereby further increasing the robustness of the connection between the polymeric distal tip and the tube.

[0042] Examples of the Disclosed Technology FIGS. 1-4 illustrate an exemplary transcatheter heart valve replacement (e.g., mitral valve replacement) using a docking device 52 and an artificial heart valve 62 according to one embodiment. During the procedure, the user first creates a path to the patient's native heart valve using a guide catheter 30 (FIG. 1). The user implants the docking device 52 at the patient's native heart valve using a docking device delivery apparatus 50 (FIG. 2A), and then removes the docking device delivery apparatus 50 from the patient 10 after implanting the docking device 52 (FIG. 2B). The user implants the artificial heart valve 62 into the implanted docking device 52 using an artificial valve delivery apparatus 60 (FIG. 3A). Thereafter, the user removes the artificial valve delivery apparatus 60 (FIG. 3B) as well as the guide catheter 30 (FIG. 4) from the patient 10.

[0043] FIG. 1 shows a first stage in a mitral valve replacement according to one embodiment, in which a guide catheter 30 and a guide wire 40 are inserted into a blood vessel 12 of a patient 10 and navigated through the blood vessel 12 into the heart 14 of the patient 10 towards the native mitral valve 16. Together, the guide catheter 30 and the guide wire 40 can provide a path for a docking device delivery apparatus 50 and an artificial valve delivery apparatus 60 to navigate through and along the implantation site (the native mitral valve 16 or the native mitral valve annulus).

[0044] First, the user may first make an incision in the patient's body to access blood vessel 12. For example, in the embodiment shown in FIG. 1, the user may make an incision in the patient's groin to access the femoral vein. Thus, in such an embodiment, blood vessel 12 may be the femoral vein.

[0045] After making an incision in blood vessel 12, the user may insert, through the incision, into blood vessel 12, a guide catheter 30, a guide wire 40, and / or an additional device (e.g., an introducer device, or a transseptal puncture device). The guide catheter 30 (which may also be referred to as an "introducer device", "introducer", or "guide sheath") is configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., a docking device delivery device 50, and an artificial valve delivery device 60) into and through blood vessel 12, and may extend through blood vessel 12 into the heart 14, but may stop in front of the native mitral valve 16. The guide catheter 30 may include a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 may extend through blood vessel 12 into the heart 14 while the handle 32 remains outside the patient 10's body, and may be manipulated by the user to manipulate the shaft 34 (FIG. 1).

[0046] The guide wire 40 is configured to guide a delivery device (e.g., the guide catheter 30, the docking device delivery device 50, the artificial valve delivery device 60, an additional catheter, or the like), and their associated devices (e.g., the docking device, the artificial heart valve, or the like) to the implantation site within the heart 14, and thus may extend continuously through blood vessel 12 into the left atrium 18 of the heart 14 (and, in some embodiments, through the native mitral valve 16 into the left ventricle of the heart 14) (FIG. 1).

[0047] In some cases, prior to inserting the guidewire 40 and the guide catheter 30, a transseptal puncture device, or catheter, may be used to first access the left atrium 18. For example, after making an incision in the blood vessel 12, the user may insert a transseptal puncture device through the incision into the blood vessel 12. The user may guide the transseptal puncture device through the blood vessel 12 and into the heart 14 (e.g., through the femoral vein and into the right atrium 20). The user may make a small incision in the atrial septum 22 of the heart 14 to enable access from the right atrium 20 to the left atrium 18. The user may insert and advance the guidewire 40 through the transseptal puncture device within the blood vessel 12 and through the incision in the atrial septum 22 and into the left atrium 18. Once the guidewire 40 is positioned within the left atrium 18 and / or the left ventricle 26, the transseptal puncture device may be removed from the patient 10. The user may insert the guide catheter 30 into the blood vessel 12 and advance the guide catheter 30 within the left atrium 18 over the guidewire 40 (Figure 1).

[0048] In some cases, the introducer device may be inserted through the lumen of the guide catheter 30 prior to inserting the guide catheter 30 into the blood vessel 12. In some cases, the introducer device may include a tapered end portion that extends from the distal tip of the guide catheter 30 and is configured to guide the guide catheter 30 into the left atrium 18 over the guidewire 40. Additionally, in some cases, the introducer device may include a proximal end portion that extends from the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user may remove the introducer device from within the guide catheter 30 and from inside the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain inside the patient 10. The guide catheter 30 then receives the implant delivery device and assists in guiding it into the left atrium 18 as further described below.

[0049] Figure 2A shows a second stage in an exemplary mitral valve replacement in which a docking device 52 is implanted onto the native mitral valve 16 of a patient 10's heart 14 using a docking device delivery device 50 (which may also be referred to as an "implant catheter" and / or "docking device delivery apparatus").

[0050] Generally, the docking device delivery device 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 a patient's vasculature (vessel 12) to a implantation site (e.g., the native mitral valve 16) and may be configured to hold the docking device 52 within a distal end portion 53 of the delivery shaft 54. In some embodiments, the distal end portion 53 of the delivery shaft 54 holds the docking device 52 therein in a straight delivery configuration.

[0051] The handle 56 of the docking device delivery device 50 is configured to be grasped and / or otherwise held outside of the patient 10's body by a user for advancing the delivery shaft 54 through the patient's vasculature (e.g., vessel 12).

[0052] In some embodiments, the handle 56 may include one or more articulating members 57 (or rotatable knobs) configured to assist in navigating the delivery shaft 54 through the patient's vessel 12. For example, the one or more articulating members 57 may include one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to bend, flex, twist, rotate, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 to assist in navigating the delivery shaft 54 through the patient's vessel 12 and into the heart 14.

[0053] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at the 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 from the distal end portion 53 of the delivery shaft 54. The shaft of the pusher assembly 58 can extend through the delivery shaft 54 and can be disposed adjacent to the docking device 52 within the delivery shaft 54. In some embodiments, the docking device 52 can be releasably coupled to the shaft of the pusher assembly 58 via the 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.

[0054] Further details of the docking device delivery apparatus and its variations are described in International Publication No. WO2020 / 247907, which is hereby incorporated by reference in its entirety.

[0055] Referring again to FIG. 2A, after the guide catheter 30 is positioned within the left atrium 18, the user can insert the docking device delivery device 50 (e.g., the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 of the docking device delivery device 50 over the guide wire 40 through the guide catheter 30. In some embodiments, the guide wire 40 can be at least partially retracted into the guide catheter 30 away from the left atrium 18. As shown in FIG. 2A, the user can continue to advance the delivery shaft 54 of the docking device delivery device 50 along the guide wire 40 through the blood vessel 12 until the delivery shaft 54 reaches the left atrium 18. Specifically, the user can advance the delivery shaft 54 of the docking device delivery device 50 by gripping the handle 56 of the docking device delivery device 50 and applying a force (e.g., pushing) toward the patient 10. While advancing the delivery shaft 54 through the blood vessel 12 and the heart 14, the user can adjust one or more articulating members 57 of the handle 56 to navigate various turns, corners, stenoses, and / or other obstacles in the blood vessel 12 and the heart 14.

[0056] When the delivery shaft 54 reaches the left atrium 18 and extends beyond the distal end of the guide catheter 30, the user can use the handle 56 (e.g., the articulating member 57) to position the distal end portion 53 of the delivery shaft 54 at and / or near the posterior medial commissure of the native mitral valve 16. The user can use the shaft of the pusher assembly 58 to extrude the docking device 52 out of the distal end portion 53 of the delivery shaft 54 and deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0057] In some embodiments, the docking device 52 may be constructed from, formed from, and / or include a shape memory material, such that when the docking device exits the delivery shaft 54 and is no longer constrained by the delivery shaft 54, it can return to its original pre-formed shape. As an example, the docking device 52 may originally be formed as a coil and thus can wrap around the valve tip 24 of the native mitral valve 16 when it exits the delivery shaft 54 and returns to its original coiled configuration.

[0058] After pushing the ventricular portion of the docking device 52 (e.g., the portion of the docking device 52 shown in FIG. 2A configured to be positioned within the left ventricle 26 and / or on the ventricular side of the native mitral valve 16), the user can deploy the remaining portion of the docking device 52 (e.g., the atrial portion of the docking device 52) from the delivery shaft 54 within the left atrium 18 by retracting the delivery shaft 54 away from the posterior medial commissure of the native mitral valve 16.

[0059] After deploying and implanting the docking device 52 onto the native mitral valve 16, the user can disconnect the docking device delivery apparatus 50 from the docking device 52. When the docking device 52 is disconnected from the docking device delivery apparatus 50, the user can store the docking device delivery apparatus 50 outside of the blood vessel 12 and away from the patient 10, such that the user can then deliver and implant the artificial heart valve 62 into the docking device 52 implanted onto the native mitral valve 16.

[0060] Figure 2B shows this third stage in the mitral valve replacement procedure, where the docking device 52 is fully deployed and implanted into the native mitral valve 16, and the docking device delivery apparatus 50 (including the delivery shaft 54) is removed from the patient 10, such that as a result, only the guide wire 40 and the guide catheter 30 remain within the patient 10. In some embodiments, after removing the docking device delivery apparatus, the guide wire 40 can be advanced into the left ventricle 26 outside of the guide catheter 30 and through the docking device 52 implanted in the native mitral valve 16 (Figure 2A). Thus, the guide wire 40 can assist in guiding the artificial valve delivery apparatus 60 at least partially into the left ventricle 26 through the annulus of the native mitral valve 16.

[0061] As shown in Figure 2B, the docking device 52 can comprise a plurality of wraps (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 geometric shape that more closely matches the shape, or outer profile, of the artificial heart valve to be implanted. As a result, the docking device 52 can provide a tighter fit, and thus a better seal, between the artificial heart valve and the native mitral valve 16, as further described below.

[0062] Figure 3A shows the fourth stage in the mitral valve replacement procedure, where the user is using the artificial valve delivery apparatus 60 to deliver and / or implant an artificial heart valve 62 (which may also be referred to herein as a "transcatheter heart valve", or more simply as a "THV", "replacement heart valve", and / or "artificial mitral valve").

[0063] As shown in FIG. 3A, the artificial valve delivery device 60 may include a delivery shaft 64 and a handle 66. The delivery shaft 64 extends distally from the handle 66. The delivery shaft 64 is configured to extend into the patient's vasculature to deliver, implant, expand, and / or otherwise deploy the artificial heart valve 62 within the docking device 52 to the native mitral valve 16. The handle 66 is configured to be held by the user, gripped, and / or otherwise retained to advance the delivery shaft 64 through the patient's vasculature.

[0064] In some embodiments, the handle 66 may include one or more articulating members 68 configured to assist in navigating the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulating member 68 may include one or more knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by the user to bend, flex, twist, rotate, and / or otherwise join the distal end portion of the delivery shaft 64 to assist in navigating the delivery shaft 64 through the patient's blood vessel 12 to the left atrium 18 and the left ventricle 26 of the heart 14.

[0065] In some embodiments, the artificial valve delivery device 60 may include an expansion mechanism 65 configured to radially expand and deploy the artificial heart valve 62 at the implantation site. In some cases, as shown in FIG. 3A, the expansion mechanism 65 may include an inflatable balloon configured to inflate to radially expand the artificial heart valve 62 within the docking device 52. The inflatable balloon may be coupled to the distal end portion of the delivery shaft 64.

[0066] In other embodiments, the artificial heart valve 62 can be self-expanding and can be configured to radially expand itself upon removal of a sheath or capsule covering the radially compressed artificial heart valve 62 on the distal end portion of the delivery shaft 64. In yet other embodiments, the artificial heart valve 62 can be mechanically expandable, and the artificial valve delivery device 60 can include one or more mechanical actuators (e.g., an expansion mechanism) configured to radially expand the artificial heart valve 62.

[0067] As shown in FIG. 3A, the artificial heart valve 62 is attached in a radially compressed configuration around an expansion mechanism 65 (an inflatable balloon) on the distal end portion of the delivery shaft 64.

[0068] To navigate the distal end portion of the delivery shaft 64 to the implantation site, the user can insert the artificial valve delivery device 60 (delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guide wire 40. The user can continue to advance the artificial 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. 3A. More specifically, the user can advance the delivery shaft 64 of the artificial valve delivery device 60 by gripping the handle 66 and applying force (e.g., pushing). While advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the user can adjust one or more articulating members 68 of the handle 66 to navigate various turns, corners, stenoses, and / or other obstacles in the blood vessel 12 and the heart 14.

[0069] The user can advance the delivery shaft 64 along the guide wire 40 until the radially compressed artificial heart valve 62 attached 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 embodiments, as shown in FIG. 3A, at least a portion of the distal end of the delivery shaft 64 and the radially compressed artificial heart valve 62 can be positioned within the left ventricle 26.

[0070] When the radially compressed artificial heart valve 62 is properly positioned within the docking device 52 (FIG. 3A), the user operates one or more actuation mechanisms of the handle 66 of the artificial valve delivery device 60 to activate the expansion mechanism 65 (e.g., inflate an inflatable balloon), thereby radially expanding the artificial heart valve 62 within the docking device 52.

[0071] FIG. 3B shows the fifth stage in mitral valve replacement, in which the artificial heart valve 62 is in its radially expanded configuration and implanted within the docking device 52 within the native mitral valve 16. As shown in FIG. 3B, the artificial heart valve 62 is received and held within the docking device 52. Thus, the docking device 52 aids in anchoring the artificial heart valve 62 within the native mitral valve 16. The docking device 52 allows for a better seal between the artificial heart valve 62 and the valve leaflets 24 of the native mitral valve 16 to reduce paravalvular leakage around the artificial heart valve 62.

[0072] As shown in FIG. 3B, after the artificial heart valve 62 is fully deployed and implanted within the docking device 52 with the native mitral valve 16, the artificial valve delivery device 60 (including the delivery shaft 64) is removed from the patient 10 so that only the guide wire 40 and the guide catheter 30 remain inside the patient 10.

[0073] FIG. 4 shows the sixth stage in mitral valve replacement, in which the guide wire 40 and the guide catheter 30 have been removed from the patient 10.

[0074] Figures 1-4 specifically illustrate a mitral valve replacement, but it should be understood that the same and / or similar techniques can be utilized to replace other heart valves (e.g., tricuspid valve, pulmonary valve, and / or aortic valve). Further, the same and / or similar delivery devices (e.g., docking device delivery device 50, artificial valve delivery device 60, guide catheter 30, and / or guide wire 40), docking devices (e.g., docking device 52), replacement heart valves (e.g., artificial heart valve 62), and / or their components can be utilized to replace these other heart valves.

[0075] For example, when replacing the native tricuspid valve, the user can access the right atrium 20 via the femoral vein, but does not need to cross the atrial septum 22 to enter the left atrium 18. Instead, the user can leave the guide wire 40 within the right atrium 20 and perform the same and / or similar docking device implantation process at the tricuspid valve. Specifically, the user can push the docking device 52 out from 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 within the right atrium 20, and remove the delivery shaft 54 of the docking device delivery device 50 from the patient 10. The user can advance the guide wire 40 through the tricuspid valve into the right ventricle and perform the same and / or similar artificial heart valve implantation process within the docking device 52 at the tricuspid valve. Specifically, the user can advance the delivery shaft 64 of the artificial valve delivery device 60 along the guide wire 40 through the patient's vasculature until the artificial heart valve 62 is positioned / located within the docking device 52 and the tricuspid valve. The user can expand the artificial heart valve 62 within the docking device 52 before removing the artificial valve delivery device 60 from the patient 10. In another embodiment, the user can perform the same and / or similar process to replace the aortic valve, but can access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0076] Furthermore, FIGS. 1-4 illustrate a mitral valve replacement that accesses the native mitral valve 16 from the left atrium 18 via the right atrium 20 and the femoral vein, but it should be understood that the native mitral valve 16 can alternatively be accessed from the left ventricle 26. For example, a user can access the native mitral valve 16 from the left ventricle 26 via the aortic valve by advancing one or more delivery devices through an artery to the aortic valve and then through the aortic valve into the left ventricle 26.

[0077] FIG. 5 shows an embodiment of a docking device 100 configured to receive an artificial heart valve. For example, the docking device 100 can be implanted within the native valve annulus as described above with reference to FIGS. 1-2B. As shown in FIGS. 2A-4, the docking device 100 can be used in place of the docking device 52 such that the docking device 100 is configured to receive and secure an artificial valve within the docking device, thereby securing the artificial valve to the native valve annulus.

[0078] Referring to FIG. 5, the docking device 100 can include two main components: a coil 102 and a guard member 104 that covers at least a portion of the coil 102. In certain embodiments, the coil 102 can include a shape memory material (e.g., nitinol), such that the docking device 100 (and the coil 102) is movable from a substantially linear configuration (also referred to as a "delivery configuration") when disposed within a delivery sleeve (e.g., a sleeve shaft) of a delivery device (described more fully below) to a helical configuration (also referred to as a "deployed configuration" as shown in FIG. 5) after being removed from the delivery sleeve (e.g., a sleeve shaft).

[0079] Coil 102 has a proximal end 102p and a distal end 102d. When disposed within a delivery sleeve (e.g., during delivery of a docking device to a patient's vasculature), the body of coil 102 between the proximal end 102p and the distal end 102d can form a substantially linear delivery configuration (e.g., without coiled or looped portions) so as to maintain a small radial profile when moving through the patient's vasculature. After being removed from the delivery sleeve and deployed at the implantation site, coil 102 moves from the delivery configuration to a helical deployment configuration and can wrap around native tissue adjacent to the implantation site. For example, when implanting a docking device at the location of a native valve, coil 102 can be configured to surround the native valve leaflets (and, if present, the chordae tendineae connecting the native valve leaflets to adjacent papillary muscles).

[0080] Docking device 100 can be releasably coupled to a delivery device. In certain embodiments, docking device 100 can be coupled to the delivery device via a release suture configured to be coupled to docking device 100 and severed for removal (as described further below with reference to FIGS. 6 and 9). In one embodiment, the release suture can be coupled to docking device 100 through an eyelet, or eyehole, positioned adjacent the proximal end 102p of the coil. In another embodiment, the release suture can be coupled around a circumferential recess positioned adjacent the proximal end 102p of coil 102.

[0081] In some embodiments, docking device 100 in the deployed configuration can be configured to fit at the location of the mitral valve. In other embodiments, the docking device can also be shaped and / or adapted for implantation at the location of other native valves, such as the tricuspid valve. In some embodiments, the geometric shape of docking device 100 can be configured to engage native anatomical structures, thereby providing, for example, improved stability and reduced relative movement between docking device 100, the prosthetic valve docked therein, and / or native anatomical structures.

[0082] As shown in FIG. 5, the coil 102 in the deployed configuration may include a leading turn 106 (or "leading coil"), a central region 108, and a stabilizing turn 110 (or "stabilizing coil"). The central region 108 may have one or more helical turns having substantially equal inner diameters. The leading turn 106 may extend from the distal end of the central region 108 and have a diameter larger than the diameter of the central region 108 (in one or more configurations). The stabilizing turn 110 may extend from the proximal end of the central region 108 and have a diameter larger than the diameter of the central region 108 (in one or more configurations).

[0083] In certain embodiments, the central region 108 can include a plurality of helical turns, such as a proximal turn 108p connected to the stabilizing turn 110, a distal turn 108d connected to the leading turn 106, and one or more intermediate turns 108m disposed between the proximal turn 108p and the distal turn 108d. In the embodiment shown in FIG. 5, there is only one intermediate turn 108m between the proximal turn 108p and the distal turn 108d. In other embodiments, there are two or more intermediate turns 108m between the proximal turn 108p and the distal turn 108d. Some of the helical turns in the central region 108 can be full rotations (i.e., 360-degree rotations). In some embodiments, the proximal turn 108p, and / or the distal turn 108d can be partial rotations (e.g., less than 360-degree rotations such as 180 degrees, 270 degrees, etc.).

[0084] The size of the docking device 100 can generally be selected based on the size of the desired prosthetic valve to be implanted into the patient. In certain embodiments, the central region 108 can be configured to hold a radially expandable prosthetic valve. For example, the inner diameter of the helical turns within the central region 108 can be configured to be smaller than the outer diameter of the prosthetic valve when the prosthetic valve is radially expanded such that additional radial tension acts between the central region 108 and the prosthetic valve to hold the prosthetic valve in place. The helical turns (e.g., 108p, 108m, 108d) in the central region 108 are also referred to herein as "functional turns".

[0085] The stabilization turn 110 can be configured to help stabilize the docking device 100 in a desired position within the surrounding anatomical structure at the implantation site. For example, the radial dimension of the stabilization turn 110 can be significantly larger than the radial dimension of the coil in the central region 108 such that the stabilization turn 110 can be expanded, or extended, sufficiently outwardly to abut against, or press against, the wall of the atrium of the heart, thereby improving the ability of the docking device 100 to remain in the desired position prior to implantation of the artificial valve. In some embodiments, the diameter of the stabilization turn 110 is larger than the native valve annulus, the native valve surface, and the atrium for good stabilization. In some embodiments, the stabilization turn 110 can be a full rotation (i.e., a rotation of about 360 degrees). In some embodiments, the stabilization turn 110 can be a partial rotation (e.g., a rotation of about 180 degrees to about 270 degrees).

[0086] In one particular embodiment, when implanting the docking device 100 in the location of the native mitral valve, the functional turns within the central region 108 can be disposed substantially within the left ventricle, and the stabilization turn 110 can be disposed substantially within the left atrium. The stabilization turn 110 can be configured to provide one or more contact points, or contact regions, between the docking device 100 and the left atrial wall, such as at least three contact points within the left atrium, or a complete contact on the left atrial wall. In a particular embodiment, the contact points between the docking device 100 and the left atrial wall can form a plane that is substantially parallel to the plane of the native mitral valve.

[0087] As described above, the leading turn 106 can have a larger radial dimension than the helical turns within the central region 108. The leading turn 106 can help to more readily guide the coil 102 around and / or through the geometry of the chordae tendineae and around all of the natural valve leaflets of a native valve (e.g., native mitral valve, tricuspid valve, etc.). For example, when the leading turn 106 is navigated around the desired native tissue, the remaining coils (e.g., functional turns) of the docking device 100 can also be guided around the same structure. In some embodiments, the leading turn 106 can be a full rotation (i.e., a rotation of approximately 360 degrees). In some embodiments, the leading turn 106 can be a partial turn (e.g., rotating between approximately 180 degrees and approximately 270 degrees). In some embodiments, when the prosthetic valve is radially expanded within the central region 108 of the coil, the functional turns of the central region 108 can be further radially expanded. As a result, the leading turn 106 can be pulled in the proximal direction, its diameter can decrease, and it can become part of the functional turns within the central region 108.

[0088] In certain embodiments, at least a portion of the coil 102 can be surrounded by a first cover. The first cover can be composed of various natural materials and / or synthetic materials. In one particular embodiment, the first cover can include expanded polytetrafluoroethylene (ePTFE). In certain embodiments, the first cover is configured to be fixedly attached to the coil 102 (e.g., by textured surface resistance, suture, glue, heat bonding, or any other means) such that relative axial movement between the first cover and the coil 102 is restricted or prohibited.

[0089] The guard member 104 can form part of a cover assembly for the docking device 100. In some embodiments, the cover assembly can also include a first cover.

[0090] In a typical embodiment as shown in FIG. 5, when the docking device 100 is in the deployed configuration, the guard member 104 can be configured to cover a portion of the stabilizing turns 110 of the coil 102. In certain embodiments, the guard member 104 can be configured to cover at least a portion of the central region 108 of the coil 102, such as a portion of the proximal turn 108p. In a particular embodiment, the guard member 104 can extend across the entire coil 102.

[0091] In some embodiments, the guard member 104 can be radially expanded to help prevent and / or reduce perivalvular leakage. Specifically, the guard member 104 can be configured to radially expand such that improved sealing is formed near and / or against an artificial valve deployed within the docking device 100. In some embodiments, the guard member 104 can be configured to prevent and / or impede leakage at locations where the docking device 100 crosses between native valve leaflets (e.g., at commissures of native valve leaflets).

[0092] In another embodiment, when the docking device 100 is deployed in a native atrioventricular valve (e.g., mitral or tricuspid valve) and the guard member 104 primarily covers a portion of the stabilizing turns 110 and / or a portion of the central region 108, the guard member 104 can help cover the atrial side of the atrioventricular valve and prevent and / or impede blood from leaking through the native valve leaflets, commissures, and / or around the outside of the artificial valve by preventing blood from flowing in a retrograde direction (i.e., from the ventricle to the atrium) other than through the artificial valve (i.e., antegrade blood flow).

[0093] In some embodiments, the guard member 104 can be positioned on the ventricular side of the atrioventricular valve and prevent and / or impede blood from leaking through the native valve leaflets, commissures, and / or around the outside of the artificial valve by preventing blood from flowing in a retrograde direction (i.e., from the ventricle to the atrium).

[0094] In some embodiments, the distal end portion 104d of the guard member 104 may be fixedly coupled to the coil 102 (e.g., via a distal suture), and the proximal end portion 104p of the guard member 104 may be axially movable relative to the coil 102.

[0095] In certain embodiments, when the guard member 104 is in a radially expanded state, the proximal end portion 104p of the guard member 104 may have a tapered shape as shown in FIG. 5, such that the diameter of the proximal end portion 104p gradually increases from the proximal end of the guard member 104 to the body portion located distally of the guard member 104. This may facilitate, for example, loading a docking device onto a delivery sleeve (e.g., a sleeve shaft) of a delivery device and / or retrieving and / or repositioning the docking device relative to the delivery device during a transplantation procedure.

[0096] FIGS. 6 - 9 show embodiments of a delivery device 200 (which may also be referred to as a delivery system) configured to deliver a docking device (such as the docking device 100 described above with reference to FIG. 5) to a target implantation site (e.g., an animal, a human, a cadaver, a cadaver heart, an anthropomorphic phantom, and / or a like, the heart, and / or a native valve). In some embodiments, the delivery device 200 may be a transcatheter delivery device that can be used to guide a docking device disposed therein through a patient's vasculature as described above with reference to FIGS. 1 - 2B.

[0097] The exemplary delivery device 200 is shown in FIG. 6, and the docking device 232 is at least partially deployed from the distal end of the delivery device 200 (e.g., for illustrative purposes). In some embodiments, the docking device 232 can be the docking device 100 described above with reference to FIG. 5. FIG. 7 schematically depicts the distal end portion of the delivery device 200 showing the docking device 232 disposed within the outer shaft 260 in a relatively straight delivery configuration. FIGS. 8 and 9 show the distal end portion of the delivery device 200 with the docking device 232 deployed from the outer shaft with the sleeve shaft 280 covering the docking device 232 (FIG. 8), and after the sleeve shaft 280 has been removed from the docking device 232 (but before cutting the docking device 232 from the delivery device 200) (FIG. 9).

[0098] Referring to FIG. 6, the delivery device 200 can include a handle assembly 220 and an outer shaft (e.g., a delivery catheter) 260 extending distally from the handle assembly 220. The handle assembly 220 can include a handle 222 and a hub assembly 230 extending proximally from the proximal end of the handle 222. As shown in FIG. 6, the handle assembly 220 can include a handle 222 that includes one or more knobs, buttons, wheels, etc. For example, as shown in FIG. 6, the handle 222 can include knobs 224 and 226 that can be configured to control the bending of the delivery device (e.g., the outer shaft 260). The outer shaft 260 extends distally from the handle 222, while the hub assembly 230 extends proximally from the handle 222.

[0099] The delivery device 200 may include a pusher shaft 290 (Figs. 6, 7, and 9) and a sleeve shaft 280 (Figs. 7-9) that are coaxially disposed within an outer shaft 260 (Fig. 7) and each have a portion that extends into the handle assembly 220. The pusher shaft 290 can be configured to deploy the docking device 232 from within the distal end portion of the outer shaft 260 when it reaches the target implantation site, and the sleeve shaft 280 can be configured to cover the docking device 232 while it is inside the delivery device 200 (Fig. 7) and while it is positioned at the target implantation site (Fig. 8). Further, the delivery device 200 can be configured to adjust the axial position of the sleeve shaft 280 to remove the sleeve portion (e.g., the distal section) of the sleeve shaft 280 from the docking device 232 after implantation at the target implantation site (Fig. 9). Figs. 8 and 9 are perspective views showing an exemplary docking device 232 (Fig. 8) deployed from the outer shaft 260 of the delivery device 200 and covered by the distal (or sleeve) portion 282 of the sleeve shaft 280, and an exemplary docking device 232 (Fig. 9) after the sleeve shaft 280 has been retracted back into the outer shaft 260.

[0100] Accordingly, the sleeve shaft 270 may be removable from the docking device 232. In some embodiments, the distal portion 282 of the sleeve shaft 280 may have an outer surface that includes a lubricious material, or a low friction material, that facilitates sliding the docking device 232 to a fixed position having a natural anatomical structure at the implantation site.

[0101] As shown in Figs. 6 and 9, the docking device 232 may be coupled to the delivery device 200 via a release suture (or other retrieval line including a string, yarn, or other material that may be tied around the docking device and configured to be cut for removal) 236 that may extend through the pusher shaft 290. The release suture 236 may extend through the delivery device 200, through the inner lumen of the pusher shaft 290, and to the suture locking assembly 206 of the delivery device 200.

[0102] As shown in FIG. 6, the hub assembly 230 can include a suture lock assembly (e.g., suture thread lock) 206 and a sleeve handle 234 attached thereto. While the hub assembly 230 can be configured to control (e.g., axially move together) the pusher shaft 290 and the sleeve shaft 280 of the delivery device 200, the sleeve handle 234 can control the axial position of the sleeve shaft 280 relative to the pusher shaft 290. Thus, by operating the various components of the handle assembly 220, the operation of the components disposed within the outer shaft 260 can be actuated and controlled. In some embodiments, as shown in FIG. 6, the hub assembly 230 can be coupled to the handle 222 via a connector 240.

[0103] Further details regarding the suture lock assembly and the pusher shaft and sleeve shaft assembly for a delivery device for a docking device are described in International Patent Application No. WO2020 / 247907, which is already incorporated herein by reference above. In addition, further embodiments of the pusher shaft for a delivery device such as the delivery device 200 are described further below with reference to FIGS. 10 - 16.

[0104] As shown in FIG. 6, the handle assembly 220 can further include one or more flushing ports for supplying flush fluid to one or more lumens disposed within the delivery device 200 (e.g., an annular lumen disposed between coaxial components of the delivery device 200) to reduce potential thrombus formation and / or to degas the components of the delivery device 200 prior to insertion into a patient. FIG. 6 shows one embodiment where the delivery device 200 includes three flushing ports (e.g., flushing ports 210, 216, and 218). In an alternative embodiment, the delivery device 200 may not include the flushing port 216, or alternatively, the flushing port 210 may be positioned at the end of the suture thread lock assembly 206.

[0105] In some embodiments, the hub assembly 230 can include a Y-shaped connector (e.g., an adapter) having a straight section (e.g., a straight conduit) 202 and at least one branch (e.g., a branch conduit) 204 (however, in some cases, it can include multiple branches) (FIG. 6). In some embodiments, the suture locking assembly 206 can be attached to the branch 204, and the sleeve handle 234 (e.g., a sleeve actuating handle) can be disposed at the proximal end of the straight section 202.

[0106] FIG. 7 schematically depicts a distal end portion of the delivery device 200 showing the docking device 232 disposed within the outer shaft 260 in its delivery configuration. The docking device 232 is depicted as a rectangle in FIG. 7 for ease of illustration, but the docking device 232 in its delivery configuration can be longer than depicted in FIG. 7. Inside the outer shaft 260, the docking device 232 is covered by the distal portion 282 of the sleeve shaft 280. The pusher shaft 290 extends through the sleeve shaft 280, and the distal end 293 of the pusher shaft 290 is disposed adjacent to the proximal end of the docking device 232. In some examples, when deploying the docking device 232 from the outer shaft 260, the distal end 293 of the pusher shaft 290 abuts (or contacts) the proximal end of the docking device 232 and is moved distally to push the docking device 232 out of the outer shaft 260. As further described below, the distal end 293 of the pusher shaft 290 is configured to contact and press against the docking device 232 while deploying the docking device 232 from the delivery device 200, so the pusher shaft 290 can include a polymeric distal end portion or tip.

[0107] Further details of the delivery device 200 and its variants are described in International Publication No. WO2020 / 247907, which is already incorporated by reference above. Further details regarding additional delivery systems and devices configured to deliver a docking device to a target implantation site can be found in U.S. Patent Publications Nos. US2018 / 0318079, US2018 / 0263764, and US2018 / 0177594, all of which are hereby incorporated by reference in their entirety.

[0108] Referring now to FIGS. 10 - 14, an example of a pusher shaft 300 (which may also be referred to herein as a catheter shaft) for a delivery device is shown. The pusher shaft 300 can be used in place of the pusher shaft 290 of the delivery device 200 (FIGS. 6 - 9). As shown in the side cross-sectional view of FIG. 10, the pusher shaft 300 can include a main tube 302 (or shaft), a shell 304, a plug 306, and a proximal extension 308. Only the distal end portion 312 of the main tube 302 is shown in more detail in FIG. 11. The pusher shaft 300 is described as being used in a delivery device for a docking device, but in other examples, the pusher shaft 300 can be a catheter shaft used in an alternative delivery system, such as a delivery device for another type of artificial implant.

[0109] The main tube 302 can be configured to advance a docking device (such as the docking device 100 in FIG. 5 or the docking device 232 in FIGS. 6-9) and accommodate a release suture that secures the docking device to the pusher shaft 300. The shell 304 surrounds a portion of the main tube 302, and the plug 306 can be configured to connect the main tube 302 to the shell 304 and serve as a stop for a sleeve shaft (such as the sleeve shaft 280 described above). The proximal extension 308 extends proximally from the proximal ends 311 of the shell 304 and the main tube 302. The proximal extension 308 can extend through a portion of the sleeve shaft within the outer shaft 260 and then pass outside the sleeve shaft within the hub assembly 230 (such as extending into the branch portion 204 and being controllable in parallel with the sleeve shaft), and can be configured as a more flexible component of the pusher shaft 300.

[0110] When included within a delivery device (such as the delivery device 200 in FIG. 6), the main tube 302 can extend from the distal end portion of the outer shaft of the delivery device (such as the outer shaft 260 shown in FIG. 6) into the handle assembly of the delivery device (such as the handle assembly 220 in FIG. 6). In some examples, the main tube 302 can be an elongated tube that extends along most of the delivery device.

[0111] The main tube 302 can include a relatively rigid tube that provides column strength for operating the docking device from the delivery device. In some embodiments, the main tube 302 can include a metal tube or a hypodermic tube. In some examples, the main tube 302 can include a biocompatible metal such as stainless steel.

[0112] In some embodiments, the pusher shaft 300 may include an inner liner 314 that covers the inner surface of the main tube 302, forms the inner surface of the proximal extension 308, thereby defining an inner lumen of the pusher shaft 300 having an inner lumen diameter 315 (FIG. 12). In some embodiments, the inner liner 314 can extend along the entire length of the pusher shaft 300, and the inner lumen diameter 315 can be constant along the entire length of the pusher shaft 300. In some embodiments, the inner liner 314 may be relatively thin and may include a polymeric material such as PTFE. For example, the thickness of the inner liner 314 can range from 0.012 mm to 0.064 mm.

[0113] In addition, in some embodiments, a portion of the pusher shaft 300 may include an outer polymer layer 316 (which may also be referred to as an outer polymer cover or jacket) (FIG. 12). The outer polymer layer 316 can include a flexible polymer (e.g., a material that is more flexible than the main tube 302). In some embodiments, the outer polymer layer 316 is disposed along and on the distal section 318 of the main tube 1502, while the intermediate section 320 of the main tube 302 does not include the outer polymer layer 316 (FIG. 10).

[0114] In some embodiments, the outer polymer layer 316 can also be included on the proximal section 322 of the main tube 302 and can form the outer layer of the proximal extension 308. For example, the proximal extension 308 can include the inner liner 314 and the outer polymer layer 316 (FIG. 10).

[0115] In certain embodiments, the outer polymer layer 316 may comprise a polyether - amide block copolymer, or a mixture of two or more polyether - amide block copolymers. The polymer of the outer polymer layer 316 may have a Shore D hardness measured according to ISO 868:2003 of about 60 to about 75, about 65 to about 75, about 70 to about 75, or about 72. In some embodiments, the outer polymer layer 316 may have a flexural modulus measured according to ISO 178:2010 of about 350 MPa to about 550 MPa, about 450 MPa to about 550 MPa, about 500 MPa to about 550 MPa, about 500 MPa to about 525 MPa, about 510 MPa to about 520 MPa, about 500 MPa, about 505 MPa, about 510 MPa, about 515 MPa, about 520 MPa, or about 525 MPa. In certain embodiments, the outer polymer layer 316 may be one of or a mixture of two or more of PEBAX® grades 7033 and 7233 (Arkema S.A., France), and VESTAMID® grades E62, E72, and EX9200 (Evonik Industries AG, Germany). In some embodiments, the outer polymer layer 316 may be PEBAX® 7233. In other embodiments, the outer polymer layer 316 may be VESTAMID® EX9200.

[0116] The distal end portion 310 of the pusher shaft 300 is shown in more detail in FIG. 12. As shown in FIG. 12, the distal end portion 310 of the pusher shaft 300 may include a polymer tip 324 (or polymer distal end portion) that extends distally beyond the distal end 326 of the main tube 302 and includes a polymer material that is more flexible than the main tube 302. The polymer tip 324 may be configured to engage (contact) the proximal end of the docking device (as shown, for example, in FIG. 7).

[0117] In some embodiments, the polymer tip 324 can comprise the same polymer material as the outer polymer layer 316 and can be continuous with the outer polymer layer 316. Thus, in some examples, the pusher shaft 300 can be said to have a polymer layer 340 that includes a tip portion (e.g., the polymer tip 324) and a cover portion (e.g., the outer polymer layer 316, which can also be referred to as a connection or jacket portion). In some examples, the outer polymer layer 316 and the polymer tip 324 together can be referred to as a polymer tube that surrounds the main conduit 302, and the polymer tube includes the tip portion 324 and the cover portion 316.

[0118] In some embodiments, the polymers of the outer polymer layer 316 and the polymer tip 324 can be reflowed onto the distal section 318 of the main conduit (and beyond the distal end 326 of the main conduit 302) and bonded to the inner liner 314. For example, when contacting each other (and / or in the presence of an external stimulus such as heat), the polymers of the outer polymer layer 316 and the polymer tip 324, and the material of the inner liner 314, can bond to each other (e.g., form a chemical bond) such that they are adhered together around the main conduit 302.

[0119] In some embodiments, at least a portion of the distal section 318 of the main conduit 302 can include a plurality of incisions 328 (which can also be referred to herein as slits) configured to provide the main conduit 302 with increased flexibility at its distal end portion 312 (FIGS. 11 and 12). For example, due to the presence of the incisions 328, the distal section 318 can be configured to bend and / or curve with the outer shaft of the delivery device when being navigated through a patient's vasculature to a target implantation site.

[0120] In some embodiments, the notch 328 can be a laser notch formed by laser cutting the surface (e.g., the outer surface) of the main tube 302. In an alternative embodiment, the notch 328 can be another type of notch formed by another cutting process (e.g., via etching, scoring, through-cutting, etc.) on the outer surface of the main tube 302. The width and depth of the notch 328 can be configured to add a specified amount of flexibility to the main tube 302.

[0121] In some embodiments, each of the notches 328 can be a through-notch that penetrates the entire main tube 302 (e.g., in a radial direction perpendicular to the central longitudinal axis 350 of the pusher shaft 300, from one side surface to the other side surface). In some embodiments, the width of each notch 328 can be about 0.05 mm. In some embodiments, the width of each notch 328 can be in the range of 0.03 mm to 0.08 mm.

[0122] In some embodiments, the spacing between adjacent notches 328 can vary along the length of the distal section 318. For example, adjacent notches 328 can be arranged to be closest together at the distal end 312, and then the spacing between adjacent notches 328 can increase from the distal end portion 312 towards the proximal end of the distal section 318.

[0123] In some embodiments, the notch 328 can be formed as a helical thread notch on (and through) the outer surface of the main tube 302. Thus, in these examples, the spacing or distance between adjacent notches 328 can be defined as the pitch of the notch 328.

[0124] As shown in FIG. 11, the notch 328 extends circumferentially (e.g., along the periphery of the main tube 302). In some embodiments, the notch 328 is an interrupted helical notch that extends both circumferentially and axially along the main tube 302 (e.g., as further described below and shown in FIG. 18). In both cases, the notch 328 can extend circumferentially (and in some examples, axially as well if they are helical notches). Thus, the notch 328 can be referred to herein as a circumferential, circumferentially extending, circumferentially and axially extending, or helical notch 328.

[0125] In some embodiments, the outer polymer layer 316 may be reflowed over the notch 328, and the polymer of the outer polymer layer 316 can flow at least partially through the notch 328 and bond to the inner liner 314.

[0126] As shown in FIG. 11, the notch 328 can end before the distal end 326 of the main tube 302. In other words, the notch 328 can be axially spaced from the distal end 326.

[0127] In some embodiments, the distal end portion 312 of the main tube 302 can include one or more axially extending notches 330 (which can also be called axial or longitudinal notches, slits, or channels) that extend through the thickness (radial direction) of the main tube 302 (FIGS. 11 and 12). For example, as shown in the cross-sectional end view of FIG. 14 (taken along cutting line 14-14 of FIG. 12), each notch 330 can extend through the thickness 332 of the main tube 302 from the outer surface to the inner surface of the main tube 302. As a result, the polymer of the outer polymer layer 316 can extend into and fill the notch 330 (e.g., during the reflow process during the assembly of the pusher shaft 300), thereby enabling the polymer to bond to the inner liner 314. For example, as shown in FIG. 14, the polymer layer 340 can include a channel portion 344 disposed within the notch 330.

[0128] As shown in FIGS. 11, 12, and 14, the axially extending notch 330 may have a width 334 (circumferential as labeled in FIG. 14) that is large enough for the polymer of the polymer layer 340 (outer polymer layer 316 and polymer tip 324) to flow through it and bond to the inner liner 314. The width 334 of the axially extending notch 330 may be exaggerated (larger than actual) in FIGS. 11 and 14 for illustrative purposes, and it should be noted that in some examples, the width 334 of the axially extending notch 330 may be the same as or similar to the width of the notch 328.

[0129] Each axially extending notch 330 may extend proximally into the main tube 302 from the distal end 326 of the main tube 302 and may have a length 336 (FIG. 12). However, each axially extending notch 330 ends before the circumferential notch 328 and may be spaced (axially) from the circumferential notch 328. Thus, the axially extending notch 330 does not intersect or overlap with the circumferential notch 328.

[0130] In some embodiments, one or more of the axially extending notches 330 may have a wider feature, such as a circle, square, or ellipse, extending through a thickness 332 at its distal end that allows more polymer to flow through the wider proximal end portion and bond to the inner liner 314.

[0131] The main tube 302 may include one or more axially extending notches 330. The main tube 302 is illustrated in FIGS. 11 and 14 as having five axially extending notches 330, but in alternative embodiments, more or fewer than five axially extending notches 330 are possible (e.g., two, three, four, six, seven, eight, etc.).

[0132] In this way, when the polymer material of the polymer layer 340 (e.g., the outer polymer layer 316 and the polymer tip 324) is reflowed onto the distal end portion 312 of the main tube 302, the polymer can flow over and through the axially extending notch 330 and bond to the inner liner 314. By adding additional polymer material into the notch 330 of the distal end portion 312 of the main tube 302, the contact area between the polymer (polymer layer 340) and the inner liner 314 can be increased, thereby increasing the strength of the bond between the polymer tip 324 and the outer polymer layer 316 around the main tube 302 and making the interface between the polymer tip 324 and the main tube 302 more resistant to transverse (or radial) and torsional loads. As a result, the durability of the pusher shaft 300 can be increased.

[0133] FIG. 15 shows an embodiment of the distal end portion 400 of the pusher shaft 300 (which may be used instead of the distal end portion 310, for example), where the distal end portion 402 of the main tube 302 is tapered (instead of including the axially extending cut 330). However, in some embodiments, the distal end portion can be tapered and can include one or more additional features such as an axially extending channel, as will be further described below. For example, as shown in FIG. 15, the distal end portion 402 of the main tube 302 tapers from a first diameter 404 at a first position adjacent to the notch 328 to a second diameter 406 at the distal tip 408 of the main tube 302 (at the distal end 326 of the main tube 302), and the second diameter 406 is smaller than the first diameter 404. In some examples, as shown in FIG. 15, the distal tip 408 can be rounded, curved, chamfered, or otherwise smooth so that the stress concentration of the polymer tip 324 at the distal end 326 of the main tube 302 is reduced. In some embodiments, the rounded distal tip 408 can have the shape of a bullet (e.g., a bullet head).

[0134] The tapering of the distal end portion 402 of the main tube 302 allows the thickness of the outer polymer layer 316 at the distal tip 408 to be increased, thereby increasing the robustness of the connection between the polymer tip 324 and the distal end portion 402 of the main tube 302. For example, as shown in FIG. 15, the thickness of the outer polymer layer 316 (or the cover portion of the polymer layer 340 including the cover portion and the tip portion, or the polymer tip 324) increases along the distal end portion 402 from the first diameter 404 of the main tube 302 to the second diameter 406 of the main tube 302. More specifically, the thickness of the outer polymer layer 316 can increase from a first thickness 410 at a position adjacent to the notch 328 (e.g., a proximal position of the distal tip 408) to a second thickness 412 around the distal tip 408. In some embodiments, the second thickness 412 may be the same as or slightly smaller than the third thickness 414 of the polymer tip 324.

[0135] In some embodiments, the distal end portion 400 of the pusher shaft 300 may have a relatively uniform inner lumen diameter 315 (e.g., defined by the inner liner 314) and an outer diameter 418 (defined by the outer surface of the outer polymer layer 316 and the polymer tip 324) even when the diameter of the distal end portion 402 of the main tube 302 changes (tapers).

[0136] In this way, the combination of the rounded and / or smooth distal tip 408 of the main tube and the tapering of the distal end portion 402 of the main tube 302, which allows for an increase in the thickness of the outer polymer layer 316 adjacent to the polymer tip 324, provides a stronger and more robust connection between the polymer tip 324 and the distal end portion 402 of the main tube 302. As a result, the durability of the pusher shaft 300 can be increased.

[0137] FIG. 16 shows another embodiment of the distal end portion 500 of the pusher shaft 300 (which may be used in place of, for example, the distal end portion 310), where the distal end portion 502 of the main tube 302 has an axially extending channel or hole 504 (instead of the axially extending notch 330 or tapered tip). In some embodiments, as further described below, the distal end portion may include one or more additional features such as an axially extending hole 504 and a tapered tip.

[0138] The axially extending hole 504 can be disposed on the inner surface 506 of the main tube 302 (e.g., the surface facing radially inward with respect to the central longitudinal axis 350) and can extend proximally (axially) into the main tube 302 from the distal end 326 of the main tube 302. In some examples, the axially extending hole 504 extends between the distal end 326 of the main tube 302 and a position adjacent to the first notch 328 of the plurality of notches 328, or the position of the first notch 328.

[0139] In some embodiments, the axially extending hole 504 is cylindrical and has a hole diameter 508, which can also be the inner diameter of the distal end portion 502 of the main tube 302 along the axially extending hole 504. The main tube 302 can have a second inner diameter 510 that is smaller than the hole diameter 508 and is adjacent and proximal to the axially extending hole 504.

[0140] In some embodiments, the hole diameter 508 is constant along the length of the axially extending hole 504. In other embodiments, the hole diameter 508 may not be constant along the length of the axially extending hole 504. In such embodiments, the axially extending hole 504 can have a first diameter at the distal end 326 and a second diameter at its proximal end (e.g., adjacent to the first notch 328). In some examples, the first diameter may be smaller than the second diameter, thereby tapering the axially extending hole.

[0141] In some embodiments, both the hole diameter 508 of the axially extending hole 504 and the outer diameter of the distal end portion 502 of the main tube may taper or decrease in diameter from the proximal end of the axially extending hole 504 to the distal end 326 of the main tube 302 (e.g., similar to that shown in FIG. 15). Thus, the distal end portion 502 may include both a tapered distal end portion (or tip) and the axially extending hole 504.

[0142] In some embodiments, as shown in FIG. 16, the distal end portion 502 of the main tube 302 may define a step 514 (or shoulder) of the main tube 302 where the axially extending hole 504 ends and the inner diameter of the main tube 302 increases from the hole diameter 508 to a second inner diameter 510.

[0143] In an alternative embodiment, instead of the step 514, the transition between the axially extending hole 504 and the adjacent portion of the main tube 302 (defining the second inner diameter 510) may be angled or curved such that the inner diameter of the main tube 302 gradually transitions from the larger hole diameter 508 to the smaller second inner diameter 510.

[0144] The axially extending hole 504 may be filled by the polymer layer 340. For example, as shown in FIG. 16, the polymer layer 340 may extend into and fill the space defined by the axially extending hole 504 disposed between the inner liner 314 and the inner surface 506 of the distal end portion 502 of the main tube 302. The portion of the polymer layer 340 that fills the axially extending hole 504 may be referred to as the channel or hole portion 512. The hole portion 512 of the polymer layer 340 may be coupled to the inner liner 314. Including the hole 504 filled by the polymer layer 340 increases the contact area between the polymer of the polymer layer 340 distal to the notch 328 and the inner liner 314, thereby increasing the strength of the connection between the polymer tip 324 and the outer polymer layer 316 covering the distal end portion 503 of the main tube. As a result, the durability of the pusher shaft 300 can be increased.

[0145] Figures 17-21 illustrate an embodiment of a distal end portion 600 of a pusher shaft 300 (which may be used in place of, for example, the distal end portion 310), and the distal end portion 602 of the main tube 302 has one or more windows or slots 604 that extend (radially) through the thickness 332 of the main tube 302. For example, each slot 604 may extend from the outer surface to the inner surface of the main tube 302 through the thickness 332 of the main tube 302. As a result, the polymer of the polymer layer 340 (the outer polymer layer 316 and the polymer tip 324) can extend into and fill each slot 604 (e.g., during a reflow process during the assembly of the pusher shaft 300), thereby enabling the polymer to bond to the inner liner 314. For example, as shown in FIG. 17, the polymer layer 340 may include channel portions 644 disposed within each slot 604.

[0146] Each slot 604 may extend proximally into the main tube 302 from the distal end 326 of the main tube 302 and have a length 606 (FIG. 18). In some examples, the length 606 ranges from about 0.75 mm or 0.7 - 0.8 mm.

[0147] However, each slot 604 ends before the (axial) helical (or circumferential) cut 328 and may be spaced from the (axial) helical (or circumferential) cut 328. Thus, the slot 604 does not intersect or overlap the cut 328.

[0148] In some embodiments, each slot 604 may be spaced from the cut 328 (from the most distal or first cut 328) by about 0.25 mm, or in the range of 0.15 - 0.3 mm.

[0149] Each slot may have a width 608 (circumferentially, as labeled in FIG. 18).

[0150] In some embodiments, the width 608 may be specified such that a radially extending hole 610 (which may be referred to as a "radial hole") can be made through the polymer layer 340 and the slot 604 (and the inner liner 314). For example, as shown in FIGS. 17, 19, and 20, each hole 610 may extend through the polymer layer 340 (or the jacket or outer polymer layer 316 of the polymer layer 340), the corresponding slot 604, and the inner liner 314 (thus, the hole 610 can be referred to as a through-hole). In this way, the hole 610 connects the lumen of the pusher shaft 300 defined by the inner liner 314 to the outside of the pusher shaft 300 (e.g., the outer surface of the polymer layer 340).

[0151] In some embodiments, the entire hole 610 may extend through the corresponding slot 604.

[0152] In some embodiments, a first portion of the hole 610 may extend through the corresponding slot 604 while a second portion of the hole 610 may extend through the polymer tip 324. In this way, a portion of the hole 610 may be axially offset from the distal end of the slot 604.

[0153] FIGS. 19 and 20 show perspective views of an example of the distal end portion 600 in which the polymer layer 340 is shown in solid lines and the distal end portion 602 below the main conduit 302 is shown in dashed lines, for illustrative purposes.

[0154] In some embodiments, as shown in FIG. 19, the distal end portion 602 of the main conduit 302 may include three slots 604 and the distal end portion 600 of the pusher shaft 300 may include three corresponding holes 610.

[0155] In some embodiments, as shown in FIG. 20, the distal end portion 602 of the main conduit 302 may include two slots 604 and the distal end portion 600 of the pusher shaft 300 may include two corresponding holes 610.

[0156] In some embodiments, the distal end portion 602 of the main tube 302 can include one (single) slot 604, and the distal end portion 600 of the pusher shaft 300 can include one (single) corresponding hole 610.

[0157] The hole 610 can be configured to allow fluid (e.g., a flush fluid such as saline) to pass from the interior (lumen) of the pusher shaft 300 to the exterior during deaeration or while providing flush fluid through the delivery device during use. As a result, the various lumens of the delivery device can receive flush fluid via the pusher shaft 300 during use of the delivery device.

[0158] Thus, in some examples, the size of the hole 610 and the width 608 of the slot 604 can be specified such that sufficient fluid can pass from the interior of the pusher shaft 300 to the exterior at the distal end portion 600.

[0159] In some embodiments, the width 608 and / or length 606 of each slot 604 can be further specified such that sufficient polymer of the polymer layer 340 can pass through the slot 604 to increase the robustness of the polymer tip 324 (by increasing the surface area for bonding between the polymer of the polymer layer 340 and the inner liner 314).

[0160] By extending the hole 610 through the slot 604, the length of the polymer tip 324 can be shortened, thereby increasing the strength and robustness of the polymer tip 324 (e.g., by reducing the moment arm on the polymer tip 324 at the distal end 326 of the main tube 302).

[0161] In some examples, the polymer tip 324 can have a length 612 in the range of 0.5 - 2.0 mm, 0.75 mm - 2.0 mm, 1.0 mm - 2.0 mm, or about 1.5 mm.

[0162] In some embodiments, the polymer layer 340 may include one or more of the materials described herein (e.g., PEBAX). In some examples, the polymer of the polymer layer 340 can be of a clear or transparent or translucent color that allows the user to see the slot 604 below the polymer layer 340. As a result, the slot 604 can be positioned and the holes 610 can be more easily formed (e.g., drilled) through the polymer layer 340 so as to extend through the respective slot 604.

[0163] In some embodiments, as shown in FIG. 21, the polymer tip 624 may be separately molded or extruded (and thus may be referred to as a molded or extruded polymer tip 624) and configured to couple to the distal end portion 602 of the main tube 302. For example, as shown in FIG. 21, the molded polymer tip 624 may include an annular portion 626 and one or more protruding portions 628 that axially extend from the annular portion 626. The protruding portions 628 are shaped to fit inside the slots 604 of the distal end portion 602 of the main tube 302. As a result, the polymer of the polymer tip 624 can be evenly distributed inside the slots 604.

[0164] When the molded polymer tip 624 and the distal end portion 602 are fitted together, an outer polymer layer (e.g., the outer polymer layer 316) is reflowed over both the distal end portion 602 of the main tube 302 and the molded polymer tip 624, whereby all can be joined together.

[0165] FIGS. 22 and 23 show an embodiment of the distal end portion 700 of a pusher shaft 300 (which can be used in place of, e.g., the distal end portion 310), where the distal end portion 702 of the main tube 302 has one or more windows 704 (instead of the slots 604) that extend (radially) through the thickness 332 of the main tube 302 and are offset from the distal end 326 of the main tube 302.

[0166] For example, each window 704 can extend through the thickness 332 of the main tube 302 from the outer surface to the inner surface of the main tube 302. As a result, the polymers of the polymer layer 340 (the outer polymer layer 316 and the polymer tip 324) can extend into each window and can fill each window 704 (e.g., during the reflow process during the assembly of the pusher shaft 300), thereby enabling the polymer to bond to the inner liner 314. For example, as shown in FIG. 23, the polymer layer 340 can include a channel portion 744 disposed within each window 704.

[0167] Each window 704 can be axially spaced from the distal end 326 and notch 328 of the main tube 302 and can have a length 706 and a width 708 (FIG. 22).

[0168] In some examples, the length 706 is in the range of 0.75 - 2.0 mm, 0.75 mm - 1.5 mm, at least 0.75 mm, about 1.0 mm, or about 1.5 mm (e.g., 1.5 mm ± 0.1 mm).

[0169] In some embodiments, each window 704 can be spaced from the notch 328 by about 0.25 mm, or in the range of 0.1 - 0.3 mm.

[0170] In some embodiments, the length 706 and width 708 can be specified such that a radially extending hole 710 (similar to the hole 610 described above) can be created through the polymer layer 340 and the window 704 (and the inner liner 314). For example, as shown in FIG. 23, each hole 710 can extend through the polymer layer 340, the corresponding window 704, and the inner liner 314 (thus, the hole 710 can be referred to as a through - hole).

[0171] FIG. 22 shows a side view of the distal end portion 702 of the main tube 302, and the dashed lines illustrate the position of the polymer layer 340 for illustrative purposes.

[0172] The distal end portion 702 can include one or more windows 704 (e.g., one, two, three, etc.), and one hole 710 extends through the polymer channel portion 744 of each window 704.

[0173] Similar to that described above for the slot 604, the size of the hole 710 and the width 708 of the window 704 can be specified such that sufficient fluid can pass from the inside to the outside of the pusher shaft 300 at the distal end portion 700.

[0174] In some embodiments, the width 708 and / or length 706 of each window 704 can be further specified such that sufficient polymer of the polymer layer 340 can pass through the window 704 and bond with the inner liner 314, increasing the robustness of the polymer tip 324.

[0175] By extending the hole 710 through the window 704, the length of the polymer tip 324 can be shortened, thereby increasing the strength and robustness of the polymer tip 324. In some embodiments, the window 704 can also protect the hole 710 from compressive loads.

[0176] In some examples, the polymer tip 324 can have a length 712 (FIG. 23) in the range of 0.5 to 2.0 mm, 0.5 to 1.25 mm, 0.75 mm to 1.5 mm, or 0.75 mm to 1.75 mm.

[0177] In some embodiments, the polymer layer 340 can include one or more of the materials described herein (e.g., PEBAX). In some examples, the polymer of the polymer layer 340 can be clear or transparent or translucent in color, allowing the user to see the window 704 below the polymer layer 340. As a result, the window 704 can be located, and the holes 710 can be more easily formed (e.g., drilled) through the polymer layer 340 to extend through their respective windows 704.

[0178] In some embodiments, the connection strip 714 of the distal end portion 702 of the main tube 302 between adjacent windows 704 (FIG. 22) can be laser cut to include slits or cuts (e.g., similar to cut 328) to enhance the flexibility of the distal end portion 702 of the main tube 302. For example, in some examples, the connection strip 714 can include a plurality of circumferential slits (or cuts) extending through the thickness of the main tube 302.

[0179] As an example, the first slit can extend across a portion of the connection strip 714 therebetween (e.g., 75% of the width of the connection strip 714) from the first window 704 towards the second window 704. The second slit can extend across a portion of the connection strip 714 therebetween from the second window 704 towards the third window 704. The third slit can extend across a portion of the connection strip 714 therebetween from the third window 704 towards the first window, etc. (the slits are circumferentially spaced along the distal end portion 702).

[0180] FIG. 24 shows an embodiment of the distal end portion 800 of a pusher shaft 300 (which can be used instead of, for example, the distal end portion 310), where the distal end portion 802 of the main tube 302 has one or more windows 804 that extend (radially) through the thickness 332 of the main tube 302 and are offset from the distal end 326 of the main tube 302. The windows 804 can be configured similarly to the windows 704 and are not described again here for the sake of brevity.

[0181] Similar to the distal end portion 702, the distal end portion 802 can also include holes 810 that extend through the channel portion 844 of the polymer layer 340 disposed within the window 804.

[0182] In some embodiments, the distal end portion 802 may also include an axially extending channel or hole 814 (the same or similar to the hole 504 described above with reference to FIG. 16). For example, the hole 814 may be disposed on the inner surface of the main tube 302 (e.g., the surface facing radially inward with respect to the central longitudinal axis 350), and may extend proximally (axially) into the main tube 302 from the distal end 326 of the main tube 302. In some examples, the axially extending hole 814 extends between the distal end 326 of the main tube 302 and a position adjacent to the first notch 328 of the plurality of notches 328, or the position of the first notch 328. In the region of the window 804, the hole 814 extends to and connects with the window 804.

[0183] As a result, the polymer of the polymer layer 340 can flow through the hole 814 and the window 804, thereby strengthening the bond between the polymer tip 324, the inner liner 314, and the outer polymer layer 316. For example, the channel portion 844 of the polymer layer 340 of the polymer tip 324 and the window 804 is connected on the outer and inner surfaces of the main tube 302 by the hole 814. In this way, the robustness of the polymer tip 324 can be further increased.

[0184] In some embodiments, the distal end portion of the main tube 302 of the pusher shaft 300, such as any one of the distal end portions 312, 402, 502, 602, 702, 802, or 902 described herein with reference to FIGS. 11 - 26C, may include a rough surface on the distal surface 342 (labeled in FIG. 11) of the distal end 326 of the main tube 302 and / or along a portion of the outer surface of the distal end portion of the main tube 302. In some examples, the rough surface can be created by applying a rough finish to the distal surface 342 (and / or another portion of the distal end portion of the main tube 302) through various surface roughening methods such as polishing, etching (by chemical treatment), bead blasting, etc. In other examples, score lines, small depressions, or small pores can be created on the distal surface 342. By creating a rough finish on the distal surface 342, the polymer layer 340 can adhere better to the distal surface 342.

[0185] Furthermore, in some embodiments, in order to enhance the adhesion to the distal surface 342 of the polymer layer 340, additional adhesives or layers may not be added to the distal surface 342.

[0186] In some embodiments, one or more of the features of the distal end portions 312, 402, 502, 602, 702, 802, and 902 of the main tube 302 of the pusher shaft 300 can be used in combination with each other. For example, in some instances, the distal end portion of the main tube 302 of the pusher shaft 300 can include both a tapered distal end portion (as shown in FIG. 15) and an axially extending hole (as shown in FIGS. 16 and 24). In other examples, the distal end portion of the main tube of the pusher shaft 300 can include an axially extending notch 330 (as shown in FIGS. 11, 12, and 14) and a tapered distal end portion (as shown in FIG. 15). In still other examples, the distal end portion of the main tube of the pusher shaft 300 can include both an axially extending notch 330 (as shown in FIGS. 11, 12, and 14) and an axially extending hole (as shown in FIGS. 16 and 24). As a result, the surface contact area between the polymer layer 340 and the inner liner 314 around the distal end portion of the main tube adjacent to the polymer tip (or tip portion) can be increased, thereby increasing the strength of the bond between the polymer layer 340 and the inner liner 314, and the robustness of the connection between the polymer tip 324 and the rest of the pusher shaft 300.

[0187] FIG. 25 shows an example of the distal end portion 900 of the pusher shaft 300 (which can be used, for example, instead of the distal end portion 310), where the distal end portion 902 of the main tube 302 is sandwiched between two liner layers including an inner liner 314 (first liner) and an additional outer liner 914 (second liner).

[0188] Although not shown in FIG. 25 (simply for simplicity of illustration), as shown in FIGS. 11, 12, 15, 16, 17, 18, and 22 - 24, the main tube 302 can include a notch 328.

[0189] In some embodiments, the outer liner 914 may extend beyond the distal end 326 of the main tube 302. In some embodiments, the outer liner 914 may end in front of the inner liner 314 (e.g., the inner liner 314 may extend distally beyond the distal end of the outer liner 914 to the distal end of the polymer tip 324).

[0190] As a result, the region of the polymer tip 324 that connects to the distal end 326 of the main tube 302 is strengthened due to the enhanced bond between the inner liner 314, the polymer tip 324, the outer liner 914, and the outer polymer layer 316.

[0191] In addition, by utilizing the outer liner 914, polymer from the outer polymer layer 316 is prevented from entering the notch 328 of the main tube 302 during polymer reflow. Thus, the flexibility of the distal end portion 902 of the main tube 302 can be increased.

[0192] Figures 26A - 26C illustrate an exemplary method for fabricating the distal end portion 900 shown in Figure 25.

[0193] As shown in Figure 26A, the liner 314 can be stretched over a build mandrel 904, and the main tube 302 and the first polymer tip portion 906 (which may be an extruded tip or tip portion in some examples) can be positioned over the inner liner 314 with the first polymer tip portion 906 abutting the distal end 326 of the main tube 302. The outer liner 914 can be stretched over the main tube 302 and the first polymer tip portion 906. The polymer of the first polymer tip portion 906 can be reflowed (e.g., melted via heat), thereby bonding the first polymer tip portion 906 to both the inner liner 314 and the outer liner 914.

[0194] As shown in Figure 26B, the first polymer tip portion 906 and the outer liner 914 can be cut (trimmed) while keeping the inner liner 314 intact (at its initial length).

[0195] As shown in FIG. 26C, the second polymer tip portion 908 (which in some examples may be an extruded tip or tip portion) can be positioned around the inner liner 314 at the end of the first polymer tip portion 906. The outer polymer layer 910 (or outer polymer extrusion or jacket) can be positioned over the outer liner 914 and the second polymer tip portion 908.

[0196] The outer polymer layer 910 and the second polymer tip portion 908 can be reflowed, thereby bonding together the outer polymer layer 910, the outer liner 914, the second polymer tip portion 908, the inner liner 314, and the first polymer tip portion 906. The entire assembly 920 shown in FIG. 26C can be cut to a specified length.

[0197] This results in the formed polymer tip 324 (having an outer liner 914 extending through a portion of the polymer tip 324) and the outer polymer layer 316 shown in FIG. 25.

[0198] In some embodiments, holes (similar to holes 610, 710, or 810) for fluid flow can be formed within the polymer tip 324 distal to the end of the outer liner 914.

[0199] In some embodiments, holes (similar to holes 610, 710, or 810) for fluid flow can be formed within the polymer tip 324, which extend through the outer liner 914 and the inner liner 314.

[0200] In some embodiments, radially extending holes (similar to holes 610, 710, or 810) that allow fluid to pass between the lumen of the pusher shaft and the exterior can be disposed within the polymer tip 324 of any of the embodiments described herein. For example, in some embodiments, the polymer tip 324 of the distal end portion 310 (FIG. 12), the distal end portion 400 (FIG. 15), or the distal end portion 500 (FIG. 16) can include one or more radially extending holes.

[0201] In some embodiments, a thicker inner liner 314 can be applied to one of the embodiments described above with reference to FIGS. 11-25. Delivery Technology

[0202] To implant an artificial valve into the native aortic valve via a transfemoral delivery approach, the artificial valve is mounted in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced through the descending aorta, around the aortic arch, and through the ascending aorta. The artificial valve is positioned inside the native aortic valve and expanded radially (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the artificial valve from the sheath to make the artificial valve self-expandable). Alternatively, the artificial valve can be implanted inside the native aortic valve via a transapical procedure, in which case the artificial 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 artificial valve is positioned inside the native aortic valve. Alternatively, in a transaortic procedure, the artificial valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, by a partial J sternotomy or a small right parasternal thoracotomy, and then advanced through the ascending aorta towards the native aortic valve.

[0203] To implant an artificial valve inside the native mitral valve via a transseptal delivery approach, the artificial valve is attached in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral vein, advanced into the inferior vena cava, and through the inferior vena cava into the right atrium, across the atrial septum (through a puncture made within the atrial septum), into the left atrium, and towards the native mitral valve. Alternatively, the artificial valve can be implanted inside the native mitral valve via a transapical procedure, in which case the artificial 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 artificial valve is positioned inside the native mitral valve.

[0204] To implant an artificial valve inside the native tricuspid valve, the artificial valve is attached in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral vein, advanced into the inferior vena cava, and through the inferior vena cava into the right atrium, and the artificial valve is positioned inside the native tricuspid valve. A similar approach can be used to implant the artificial valve inside the native pulmonary valve or the pulmonary artery, except that the artificial valve is advanced through the native tricuspid valve into the right ventricle and towards the pulmonary valve / pulmonary artery.

[0205] Another delivery approach is the transatrial approach, in which case the artificial valve (on the distal end portion of the delivery device) is inserted through an incision in the chest, and the incision is made through the atrial wall (the atrial wall of the right atrium or the left atrium) to access any of the native heart valves. Transatrial delivery can also be performed from within a blood vessel, such as from a pulmonary vein, for example. Yet another delivery approach is the transventricular approach, in which case the artificial valve (on the distal end portion of the delivery device) is inserted through an incision in the chest, and the incision is made through the wall of the right ventricle (typically at the base of the heart or in its vicinity) to implant the artificial valve inside the native tricuspid valve or inside the native pulmonary valve or the pulmonary artery.

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

[0207] Any of the systems, devices, apparatuses, etc. herein can be sterilized (e.g., using heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure safety for use with a patient, and any of the methods herein can include sterilization of the associated systems, devices, apparatuses, etc. as one of the method steps. Examples of sterilization by heat / thermal include sterilization by steam and sterilization by autoclave. Examples of radiation used for sterilization include, but are not limited to, gamma rays, ultraviolet rays, and electron beams. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization by hydrogen peroxide can be achieved, for example, using hydrogen peroxide plasma.

[0208] Additional Examples of the Disclosed Technology In view of the above implementations of the disclosed subject matter, this application discloses additional embodiments listed below. It should be noted that two or more features of an embodiment taken alone, or in combination, of one feature of a separate embodiment, and optionally in combination with one or more features of one or more additional embodiments, are also further embodiments that fall within the disclosure of this application.

[0209] Example 1. A catheter shaft for an artificial implant, comprising a tube having a distal end portion that tapers from a first diameter to a second diameter at the distal tip of the tube, the second diameter being distal to the first diameter, and a polymer layer including a tip portion and a cover portion, the cover portion overlapping the tube, the tip portion extending distally beyond the cover portion and the tube, and the thickness of the cover portion increasing from the first diameter of the tube to the second diameter of the tube along the distal end portion.

[0210] Example 2. The catheter shaft according to any one of the examples herein, particularly Example 1, wherein the distal tip of the tube is rounded.

[0211] Example 3. The catheter shaft according to any one of the examples herein, particularly either Example 1 or Example 2, wherein the catheter shaft has a third diameter that is constant and defined by the polymer layer along the tip portion and the cover portion.

[0212] Example 4. The catheter shaft according to any one of the examples herein, particularly any one of Examples 1 to 3, further comprising an inner liner disposed on the inner surface of the tube and the inner surface of the tip portion of the polymer layer.

[0213] Example 5. The catheter shaft according to any one of the examples herein, particularly Example 4, wherein the inner liner defines the lumen of the catheter shaft having a constant diameter.

[0214] Example 6. The catheter shaft according to any one of the examples herein, particularly either Example 4 or Example 5, wherein the tube includes a plurality of circumferentially extending cuts spaced along a portion of the tube extending proximally from the tapering distal end portion.

[0215] Example 7. The catheter shaft according to any one of the examples herein, particularly Example 6, wherein each of the plurality of circumferentially extending cuts extends through the thickness of the tube between the polymer layer and the inner liner and also extends axially to form a plurality of interrupted helical cuts.

[0216] Example 8. A catheter shaft according to any one of the examples herein, particularly any one of Examples 4 to 7, wherein the inner liner comprises polytetrafluoroethylene.

[0217] Example 9. A catheter shaft according to any one of the examples herein, particularly any one of Examples 1 to 8, wherein the tube is a metal tube.

[0218] Example 10. A catheter shaft according to any one of the examples herein, particularly any one of Examples 1 to 9, wherein the polymer layer comprises a polyether-amide block copolymer.

[0219] Example 11. A catheter shaft according to any one of the examples herein, particularly any one of Examples 1 to 10, wherein the distal end portion of the tube comprises a plurality of axially extending cuts that are circumferentially spaced from each other and extend proximally into the tube from the distal tip of the tube.

[0220] Example 12. A catheter shaft according to any one of the examples herein, particularly Example 11, wherein each of the axially extending cuts of the plurality of axially extending cuts extends radially through the thickness of the tube.

[0221] Example 13. A catheter shaft according to any one of the examples herein, particularly any one of Examples 1 to 10, wherein the distal end portion of the tube comprises an axially extending hole on the inner surface of the tube that extends proximally into the tube from the distal tip of the tube.

[0222] Example 14. A catheter shaft according to any one of the examples herein, particularly any one of Examples 1 to 13, wherein the distal surface of the distal end portion has a rough surface.

[0223] Example 15. A catheter shaft according to any one of the examples herein, particularly any one of Examples 1 to 14, wherein the catheter shaft is a pusher shaft disposed within the outer shaft of a delivery device for an artificial implant.

[0224] Example 16. A catheter shaft for an artificial implant, comprising a first tube having a distal portion with an axially extending channel that extends proximally into the first tube from the distal end of the first tube, the first tube containing metal, the first tube, and a second tube including a tip portion and a cover portion, the tip portion extending distally of the first tube, the cover portion extending over and surrounding the first tube, the second tube containing a polymeric material, the second tube.

[0225] Example 17. The catheter shaft according to any one of the examples herein, particularly Example 16, wherein the first tube is stiffer than the second tube.

[0226] Example 18. The catheter shaft according to any one of the examples herein, particularly either Example 16 or Example 17, further comprising an inner liner disposed on the inner surface of the first tube and the inner surface of the tip portion of the second tube.

[0227] Example 19. The catheter shaft according to any one of the examples herein, particularly Example 18, wherein the second tube includes a channel portion that extends into and fills the axially extending channel.

[0228] Example 20. The catheter shaft according to any one of the examples herein, particularly Example 19, wherein the axially extending channel is configured to increase contact for the coupling between the inner liner around the first tube and the second tube.

[0229] Example 21. The catheter shaft according to any one of the examples herein, particularly any one of Examples 16 to 20, wherein the axially extending channel is disposed within the first tube distally of a plurality of circumferentially extending helical cuts within the first tube, each helical cut being spaced from adjacent helical cuts of the plurality of helical cuts and extending through the thickness in the radial direction of the first tube.

[0230] Example 22. A catheter shaft according to any one of the examples herein, particularly any one of Examples 16 to 21, wherein the thickness of the tip portion in the radial direction is greater than the thickness of the cover portion.

[0231] Example 23. A catheter shaft according to any one of the examples herein, particularly any one of Examples 16 to 22, wherein the axially extending channel is cylindrical and disposed on the inner surface of the first tube.

[0232] Example 24. A catheter shaft according to any one of the examples herein, particularly any one of Examples 16 to 22, wherein the axially extending channel is configured as an axially extending cutout that extends radially through the thickness of the first tube.

[0233] Example 25. A catheter shaft according to any one of the examples herein, particularly Example 24, wherein the distal end portion includes a plurality of axially extending cutouts that are circumferentially spaced from each other and extend proximally into the first tube from the distal end of the first tube radially through the thickness of the first tube.

[0234] Example 26. A catheter shaft according to any one of the examples herein, particularly any one of Examples 16 to 25, wherein the outer diameter of the distal end portion of the first tube tapers from a larger first diameter disposed proximally of the distal end to a smaller second diameter at the distal end.

[0235] Example 27. A catheter shaft according to any one of the examples herein, particularly any one of Examples 16 to 22, wherein the axially extending channel is configured as an axially extending slot that extends radially through the thickness of the first tube and has a circumferential width.

[0236] Example 28. A catheter shaft according to any one of the examples herein, particularly Example 27, further comprising a radially extending hole that extends through the cover portion and the slot, and wherein the width of the slot is greater than the diameter of the hole.

[0237] Example 29. A catheter shaft according to any example herein, particularly either Example 27 or Example 28, wherein the distal end portion comprises two axially extending slots circumferentially spaced from each other.

[0238] Example 30. A catheter shaft according to any example herein, particularly either Example 27 or Example 28, wherein the distal end portion comprises three axially extending slots circumferentially spaced from each other.

[0239] Example 31. A catheter shaft according to any example herein, particularly any one of Examples 16 - 30, wherein the distal surface of the distal end portion of the first tube has a rough surface configured to increase adhesion to the distal surface of the tip portion of the second tube.

[0240] Example 32. A catheter shaft according to any example herein, particularly any one of Examples 16 - 31, wherein the catheter shaft is a pusher shaft disposed within the outer shaft of a delivery device for an artificial implant.

[0241] Example 33. A catheter shaft for an artificial implant, comprising a tube having a distal end portion with a plurality of axially extending cuts circumferentially spaced from each other, wherein each of the plurality of axially extending cuts extends radially proximally into the tube from the distal end of the tube and through the thickness of the tube, a jacket portion disposed around the tube, and a polymer layer comprising the jacket portion and a tip portion extending distally of the tube, and an inner liner disposed on the inner surface of the tube and the inner surface of the tip portion, wherein the material of the polymer layer extends radially through the plurality of axially extending cuts such that the polymer layer binds to the inner liner.

[0242] Example 34. A catheter shaft according to any example herein, particularly Example 33, in which the cuts extending in each axial direction extend towards a first circumferentially extending cut of a plurality of circumferentially extending cuts disposed within the tube, but are axially spaced therefrom.

[0243] Example 35. A catheter shaft according to any example herein, particularly Example 34, in which the circumferentially extending cuts of the plurality of circumferentially extending cuts are axially spaced from each other.

[0244] Example 36. A catheter shaft according to any example herein, particularly any one of Examples 33 - 35, in which the thickness of the radially distal portion is greater than the thickness of the jacket portion and the distal portion covers the distal surface of the tube at the distal end.

[0245] Example 37. A catheter shaft according to any example herein, particularly any one of Examples 33 - 36, in which the tube is more rigid than the polymer layer.

[0246] Example 38. A catheter shaft according to any example herein, particularly any one of Examples 33 - 37, in which the tube is a metal tube, the polymer layer includes a first polymer material, and the inner liner includes a second polymer material configured to bond to the first polymer material.

[0247] Example 39. A catheter shaft according to any example herein, particularly any one of Examples 33 - 38, in which the outer diameter of the distal end portion of the tube tapers from a larger first diameter disposed proximal to the distal end to a smaller second diameter at the distal end.

[0248] Example 40. A catheter shaft according to any example herein, particularly any one of Examples 33 - 38, in which the distal surface of the distal end portion of the tube has a rough surface configured to increase adhesion to the distal surface of the tip portion of the polymer layer.

[0249] Example 41. The catheter shaft according to any one of the examples herein, particularly any one of Examples 33 to 38, wherein the catheter shaft is a pusher shaft disposed within the outer shaft of a delivery device for an artificial implant.

[0250] Example 42. A catheter shaft for an artificial implant, comprising a tube having a distal end portion with an axially extending hole on the inner surface of the tube extending proximally from the distal end of the tube, a jacket portion disposed around the tube, and a polymer layer comprising the jacket portion and a tip portion extending distally of the tube, and an inner liner disposed on the inner surface of the tube and the inner surface of the tip portion, wherein the polymer layer extends into and fills a space defined by a hole disposed between the inner liner and the inner surface of the distal end portion of the tube.

[0251] Example 43. The catheter shaft according to any one of the examples herein, particularly Example 42, wherein the hole is cylindrical.

[0252] Example 44. The catheter shaft according to any one of the examples herein, particularly either Example 42 or Example 43, wherein the hole diameter of the hole is constant along the length of the hole.

[0253] Example 45. The catheter shaft according to any one of the examples herein, particularly either Example 42 or Example 43, wherein the hole has a first diameter at the distal end of the tube and a second diameter at the proximal end of the hole spaced from the distal end.

[0254] Example 46. The catheter shaft according to any one of the examples herein, particularly Example 45, wherein the first diameter is smaller than the second diameter.

[0255] Example 47. The catheter shaft according to any one of the examples herein, particularly any one of Examples 42 to 44, wherein the hole defines a step in the distal end portion where the hole ends and the inner diameter of the tube increases from the first diameter of the hole to a second diameter of the tube proximal to the hole.

[0256] Example 48. The catheter shaft according to any example herein, particularly Example 47, wherein the segment is disposed adjacent to a first circumferentially extending cutout of a plurality of circumferentially extending cutouts disposed in the tube.

[0257] Example 49. The catheter shaft according to any example herein, particularly Example 48, wherein each circumferentially extending cutout of the plurality of circumferentially extending cutouts extends radially through the thickness of the tube and is axially spaced from an adjacent circumferentially extending cutout of the plurality of circumferentially extending cutouts.

[0258] Example 50. The catheter shaft according to any example herein, particularly any one of Examples 47 - 49, wherein the catheter shaft has a third diameter that is constant and defined by a polymer layer along the tip portion and the jacket portion.

[0259] Example 51. The catheter shaft according to any example herein, particularly Example 50, wherein the inner liner defines the lumen of the catheter shaft having a constant lumen diameter.

[0260] Example 52. The catheter shaft according to any example herein, particularly any one of Examples 42 - 51, wherein the inner liner comprises polytetrafluoroethylene configured to bond to the material of the polymer layer.

[0261] Example 53. The catheter shaft according to any example herein, particularly any one of Examples 42 - 52, wherein the tube is a metal tube.

[0262] Example 54. The catheter shaft according to any example herein, particularly any one of Examples 42 - 53, wherein the polymer layer comprises a polyether - amide block copolymer.

[0263] Example 55. The outer diameter of the distal end portion of the tube tapers from a larger first diameter disposed proximal to the distal end to a smaller second diameter at the distal end, and the distal end of the tube is rounded, the catheter shaft according to any one of the embodiments herein, particularly any one of Embodiments 42 to 54.

[0264] Example 56. The distal surface of the distal end portion of the tube has a rough surface configured to increase the adhesion of the distal surface of the tip portion of the polymer layer, the catheter shaft according to any one of the embodiments herein, particularly any one of Embodiments 42 to 55.

[0265] Example 57. The catheter shaft is a pusher shaft disposed within the outer shaft of a delivery device for an artificial implant, the catheter shaft according to any one of the embodiments herein, particularly any one of Embodiments 42 to 56.

[0266] Example 58. A catheter shaft for an artificial implant, comprising a tube having a distal end portion with at least one window extending radially through the thickness of the tube, a jacket portion disposed around the tube, a tip portion extending distally of the jacket portion and the tube, and a polymer layer comprising a channel portion disposed within the window, and an inner liner disposed on the inner surface of the tube and the inner surface of the tip portion, wherein the material of the polymer layer binds to the inner liner, the inner liner, the polymer layer, the window, and a radially extending hole extending through the inner liner.

[0267] Example 59. The tube comprises a plurality of circumferentially and axially extending helical cuts disposed within the tube and spaced from the distal end of the tube, and the window is axially spaced from a first helical cut of the plurality of helical cuts, the catheter shaft according to any one of the embodiments herein, particularly Embodiment 58.

[0268] Example 60. The window is axially spaced from the distal end of the tube and disposed between the distal end of the tube and the first helical cut, the catheter shaft according to any one of the embodiments herein, particularly Embodiment 59.

[0269] Example 61. The catheter shaft according to any example herein, particularly Example 60, wherein the tube comprises an axially extending hole on the inner surface of the tube that extends proximally into the tube from the distal end of the tube.

[0270] Example 62. The catheter shaft according to any example herein, particularly Example 61, wherein the polymer layer extends into and fills a space defined by a hole disposed between the inner liner and the inner surface of the tube.

[0271] Example 63. The catheter shaft according to any example herein, particularly either Example 61 or Example 62, wherein the hole is cylindrical.

[0272] Example 64. The catheter shaft according to any example herein, particularly any one of Examples 61 - 63, wherein the hole diameter of the hole is constant along the length of the hole.

[0273] Example 65. The catheter shaft according to any example herein, particularly Example 59, wherein the window extends proximally into the tube from the distal end of the tube.

[0274] Example 66. The catheter shaft according to any example herein, particularly any one of Examples 58 - 65, wherein the length of the axial tip portion ranges from 0.5 to 2.0 mm.

[0275] Example 67. The catheter shaft according to any example herein, particularly any one of Examples 58 - 66, wherein the tube is a metal tube.

[0276] Example 68. The catheter shaft according to any example herein, particularly any one of Examples 58 - 67, wherein the polymer layer comprises a first polymer material and the inner liner comprises a second polymer material configured to bond to the first polymer material.

[0277] Example 69. A catheter shaft according to any of the examples herein, particularly any one of Examples 58 to 68, wherein the distal surface of the distal end portion of the tube and a portion of the outer surface of the distal end portion of the tube have a rough surface configured to increase the adhesion of the polymer layer to the distal end portion of the tube.

[0278] Example 70. A catheter shaft according to any of the examples herein, particularly any one of Examples 58 to 69, wherein the catheter shaft is a pusher shaft disposed within the outer shaft of a delivery device for an artificial implant.

[0279] Example 71. A catheter shaft for an artificial implant, comprising a tube, a first liner disposed on the outer surface of the tube, a jacket portion disposed around the first liner and radially outside the tube, and a polymer layer extending distally from the jacket portion and the tube to a tip portion, and a second liner disposed on the inner surface of the tube and the inner surface of the tip portion, wherein the second liner extends distally from the first liner, and the material of the polymer layer binds to the first and second liners.

[0280] Example 72. A catheter shaft according to any of the examples herein, particularly Example 71, wherein the tube is a metal tube.

[0281] Example 73. A catheter shaft according to any of the examples herein, particularly either Example 71 or Example 72, wherein the polymer layer comprises a first polymer material, and the first and second liners comprise a second polymer material configured to bind to the first polymer material.

[0282] Example 74. A catheter shaft according to any of the examples herein, particularly Example 73, wherein the first polymer material is PEBAX.

[0283] Example 75. A catheter shaft according to any of the examples herein, particularly any one of Examples 71 to 74, wherein the first liner extends distally beyond the distal end of the tube and into the tip portion.

[0284] Example 76. The catheter shaft according to any one of the embodiments herein, particularly any one of embodiments 71-75, wherein the segment of the distal portion is disposed in the space between the first liner and the second liner distal to the tube.

[0285] Example 77. The catheter shaft according to any one of the embodiments herein, particularly any one of embodiments 71-76, wherein the second liner defines the lumen of the catheter shaft having a constant lumen diameter.

[0286] Example 78. The catheter shaft according to any one of the embodiments herein, particularly any one of embodiments 71-77, wherein the catheter shaft is a pusher shaft disposed within the outer shaft of a delivery device for an artificial implant.

[0287] Example 79. A catheter shaft for an artificial implant, comprising a tube having a distal end portion with at least one axially extending slot, the slot extending proximally into the tube from the distal end of the tube and radially through the thickness of the tube, a polymer layer comprising the tube, a jacket portion disposed around the tube, a tip portion extending distally of the jacket portion and the tube, and a channel portion disposed within the slot, and an inner liner disposed on the inner surface of the tube and the inner surface of the tip portion, wherein the material of the polymer layer binds to the inner liner.

[0288] Example 80. The catheter shaft according to any one of the embodiments herein, particularly the catheter shaft according to embodiment 79, further comprising a radially extending hole extending through the polymer layer, the slot, and the inner liner.

[0289] Example 81. The catheter shaft according to any one of the embodiments herein, particularly the catheter shaft according to embodiment 80, wherein the radially extending hole connects the lumen of the catheter shaft defined by the inner liner to the outside of the catheter shaft.

[0290] Example 82. The catheter shaft according to any one of the examples herein, particularly any one of Examples 79 to 81, wherein one or more axially extending slots include a plurality of axially extending slots circumferentially spaced at the distal end portion of the tube.

[0291] Example 83. The catheter shaft according to any one of the examples herein, particularly the catheter shaft according to Example 82, wherein the plurality of axially extending slots includes three slots.

[0292] Example 84. The catheter shaft according to any one of the examples herein, particularly the catheter shaft according to Example 82, wherein the plurality of axially extending slots includes two slots.

[0293] Example 85. The catheter shaft according to any one of the examples herein, particularly any one of Examples 79 to 84, wherein the slot extends toward the first circumferential and axially extending helical cuts disposed within the tube, but is axially spaced therefrom.

[0294] Example 86. The catheter shaft according to any one of the examples herein, particularly the catheter shaft according to Example 85, wherein the helical cuts of the plurality of helical cuts are axially spaced from each other.

[0295] Example 87. The catheter shaft according to any one of the examples herein, particularly any one of Examples 79 to 86, wherein the thickness of the radially distal portion is greater than the thickness of the jacket portion, and the distal portion covers the distal surface of the tube at the distal end.

[0296] Example 88. The catheter shaft according to any one of the examples herein, particularly the catheter shaft according to Example 87, wherein the distal surface of the tube has a rough surface configured to increase the adhesion of the distal portion to the distal surface of the tube.

[0297] Example 89. The catheter shaft according to any one of the examples herein, particularly any one of Examples 79 to 88, wherein the tube is more rigid than the polymer layer.

[0298] Example 90. A catheter shaft according to any example herein, particularly any one of Examples 79 - 89, wherein the tube is a metal tube, the polymer layer comprises a first polymer material, and the inner liner comprises a second polymer material configured to bond to the first polymer material.

[0299] Example 91. A catheter shaft according to any example herein, particularly Example 90, wherein the first polymer material is PEBAX.

[0300] Example 92. A catheter shaft according to any example herein, particularly Example 91, wherein the PEBAX is transparent such that the tube is visible through the polymer layer.

[0301] Example 93. A method comprising sterilizing a catheter shaft, device, and / or assembly of any example.

[0302] For any example, the various features described herein can be combined with any one or more other features described in any one or more other examples, unless otherwise stated. For example, any one or more features of one pusher shaft can be combined with any one or more features of another pusher shaft. As another example, any one or more features of one main tube of a pusher shaft can be combined with any one or more features of another main tube of the pusher shaft.

[0303] It will be recognized that, considering the many possible aspects to which the principles of the present disclosure can be applied, the illustrated configurations are illustrative of examples related to the disclosed technology and should not be construed as limiting the scope of the present disclosure or the scope of the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A catheter shaft (290; 300) for an artificial implant (52; 232), A tube (302) having a distal end portion (293; 310; 400; 500) comprising at least one axially extending slot (604; 704; 804), wherein the slot (604; 704; 804) extends radially from the distal end of the tube (302) proximally into the tube (302) and through the thickness of the tube (302), A polymer layer (340) comprising a jacket portion (316) arranged around the tube (302), a tip portion (324) extending distally to the jacket portion (316) and the tube (302), and a channel portion arranged within the slots (604; 704; 804), An inner liner (314) disposed on the inner surface of the tube (302) and the inner surface of the tip portion (324), wherein the material of the polymer layer (340) is bonded to the inner liner (314), A catheter shaft (290; 300) equipped with [a specific feature].

2. The catheter shaft (290; 300) according to claim 1, further comprising radially extending holes extending through the polymer layer (340), the slots (604; 704; 804), and the inner liner (314).

3. The catheter shaft (290; 300) according to claim 1 or 2, wherein the at least one axially extending slot (604; 704; 804) includes a plurality of axially extending slots (604; 704; 804) spaced apart from each other in the circumferential direction at the distal end portion (293; 310; 400; 500) of the tube (302).

4. The catheter shaft (290; 300) according to any one of claims 1 to 3, wherein the slots (604; 704; 804) extend toward a first helical notch (328; 330) that extends in the circumferential and axial directions among a plurality of helical notches (328; 330) arranged within the tube (302), but are spaced apart from it in the axial direction.

5. The catheter shaft (290; 300) according to claim 4, wherein the plurality of helical notches (328; 330) are spaced apart from each other in the axial direction.

6. The catheter shaft (290; 300) according to claim 5, wherein the plurality of helical notches (328; 330) extend radially through the thickness of the tube (302).

7. A catheter shaft according to any one of claims 1 to 6, wherein the thickness of the radial tip portion (324) is greater than the thickness of the jacket portion (316).

8. The catheter shaft (290; 300) according to claim 7, wherein the tip portion (324) covers the distal surface of the tube (302) at the distal end.

9. The catheter shaft (290; 300) according to any one of claims 1 to 8, wherein the tube (302) is a metal tube (302).

10. The catheter shaft (290; 300) according to claim 9, wherein the metal is stainless steel.

11. The catheter shaft (290; 300) according to any one of claims 1 to 10, wherein the polymer layer (340) comprises a first polymer material, and the inner liner (314) comprises a second polymer material configured to bond to the first polymer material.

12. The catheter shaft according to claim 11, wherein the first polymer material is PEBAX.

13. The catheter shaft (290; 300) according to claim 12, wherein the PEBAX is transparent so that the tube (302) can be seen through the polymer layer (340).

14. The catheter shaft (290; 300) according to any one of claims 1 to 13, wherein the catheter shaft (290; 300) is a pusher shaft disposed within the outer shaft (260) of the delivery device (50; 200) for the artificial implant.

15. A delivery device (50; 200) comprising a catheter shaft (290; 300) according to any one of claims 1 to 14 as a pusher shaft.

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