Implant delivery device with a telescopic shaft

Abstract

A delivery device configured to deliver an artificial implant may include a handle, a first shaft extending through the handle, and a second shaft coaxial with the first shaft and surrounding at least the proximal end portion of the first shaft. The second shaft may include an outer shaft member positioned proximal to the handle and an inner shaft member axially movable relative to the outer shaft member. The second shaft may be movable between an axially extended configuration and an axially folded configuration. When the second shaft is in the axially extended configuration, the inner shaft member may extend into the handle. When the second shaft is in the axially folded configuration, the inner shaft member may be positioned proximal to the handle.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 366,897, filed on June 23, 2022, which is hereby incorporated by reference in its entirety.

[0002] This disclosure relates to an embodiment of a delivery device for delivering an artificial implant to a patient's body and an associated handle assembly.

Background Art

[0003] Artificial valves can be used to treat valvular heart disease. Natural heart valves (e.g., aortic valve, pulmonary valve, tricuspid valve, and mitral valve) function to allow forward flow while preventing backflow. These heart valves can be impaired by congenital, inflammatory, infectious conditions, etc. Such conditions can ultimately lead to severe cardiovascular defects or death. For many years, physicians have attempted to treat such disorders by surgical repair or replacement of the valve during open - heart surgery.

[0004] Trans - catheter techniques for introducing and implanting an artificial heart valve in a less invasive manner than open - heart surgery can reduce the complications associated with open - heart surgery. In this technique, the artificial valve can be mounted in a compressed state on the distal end of a catheter and advanced through the patient's blood vessels until the valve reaches the implantation site. Thereafter, the valve at the catheter tip can be expanded to its functional size at the site of the defective natural valve, for example, by inflating a balloon, or by having the valve have an elastic self - expanding stent or frame that expands the valve to its functional size, when the valve is mounted thereon or when, for example, the valve is advanced from a delivery sheath at the distal end of the catheter. Optionally, the valve can have a balloon - expandable, self - expandable, mechanically expandable frame, and / or an expandable frame in multiple ways or in a combined way.

[0005] In some cases, a transcatheter heart valve (THV) may be appropriately sized to be placed inside a particular native valve (e.g., the native aortic valve). As such, the THV may not be suitable for implantation in patients with another native valve (e.g., the native mitral valve) and / or a larger native valve. Additionally or alternatively, the native tissue at the implantation site may not provide sufficient structure to securely fix the THV in place relative to the native tissue.

[0006] In certain embodiments, a docking device may be first implanted within the native valve, configured to receive the THV and secure (e.g., anchor) the THV at a desired location within the native valve. For example, the docking device may form a more circular and / or stable anchoring site at the annulus of the native valve where the THV can be expanded and implanted. A transcatheter delivery device may be used to deliver the docking device to the implantation site. In certain cases, the docking device may be disposed within a delivery device coaxial with additional components of the delivery device.

[0007] The operation of the delivery device for implanting the THV and / or the docking device involves complex steps and requires special skills. Therefore, it is desirable to improve the transcatheter delivery device to simplify its operation. SUMMARY OF THE INVENTION

[0008] The present disclosure relates to devices and related methods for treating valvular regurgitation and / or other valve problems. Specifically, the present disclosure is directed to a delivery device configured to deliver an artificial implant such as a THV and / or a docking device, as well as a method of implanting the artificial implant.

[0009] According to certain embodiments, a delivery device configured to deliver an artificial implant may include a handle, a first shaft extending through the handle, and a second shaft coaxial with the first shaft and surrounding at least the proximal end portion of the first shaft. The second shaft may include an outer shaft member positioned proximal to the handle and an inner shaft member axially movable relative to the outer shaft member. The second shaft may be movable between an axially extended configuration and an axially folded configuration. When the second shaft is in the axially extended configuration, the inner shaft member may extend into the handle. When the second shaft is in the axially folded configuration, the inner shaft member may be positioned proximal to the handle.

[0010] According to certain embodiments, a delivery device configured to deliver an artificial implant may include a first shaft having a lumen and including a first fluid port fluidly coupled to the lumen of the first shaft, an outer shaft member fixedly attached around a proximal portion of the first shaft, and a second telescoping shaft coaxial with the first shaft and having one or more inner shaft members axially movable relative to the first shaft. The one or more inner shaft members may include a most inner shaft member. The first shaft may extend through the lumen of the most inner shaft member. The second telescoping shaft may include a second fluid port fluidly coupled to the lumen of the most inner shaft member.

[0011] According to certain embodiments, a delivery device configured to deliver an artificial implant may include a first shaft, an outer shaft member fixedly attached around a proximal portion of the first shaft, and a second shaft having one or more nested inner shaft members configured to be axially movable relative to each other, and a sealing member configured to seal one or more annular spaces formed between the one or more inner shaft members and the outer shaft member. The one or more inner shaft members may include a most inner shaft member. The first shaft may extend through the most inner shaft member.

[0012] Certain aspects of the present disclosure relate to a system. The system can include an artificial implant and a delivery device configured to deliver the artificial implant to a target implantation location. The delivery device can include a pusher shaft positioned proximal to the artificial implant, an outer shaft member fixedly attached around a proximal portion of the pusher shaft, and a sleeve shaft having one or more inner shaft members that are coaxial with the pusher shaft and axially movable relative to the pusher shaft, and a suture lock connected to a proximal end of the pusher shaft. The suture lock can be removably connected to the artificial implant via a release suture extending through the pusher shaft. The one or more inner shaft members can include a most inner shaft member. The pusher shaft can extend through the most inner shaft member.

[0013] Certain embodiments of the present disclosure also include a method. The method can include inserting a delivery device loaded with an artificial device into a patient's vasculature and deploying the artificial device to a target location within the patient's vasculature. The delivery device can include a pusher shaft positioned proximal to the artificial implant, an outer shaft member fixedly attached around a proximal portion of the pusher shaft, and a sleeve shaft having one or more inner shaft members that are coaxial with the pusher shaft and axially movable relative to the pusher shaft, and a delivery shaft surrounding at least a distal portion of the pusher shaft and positioned distal to the outer shaft member. The one or more inner shaft members can include a most inner shaft member. The pusher shaft can extend through the most inner shaft member.

[0014] The above method can be performed on a live animal or on a simulation such as a cadaver, a cadaver heart, an anthropomorphic dummy, a simulator (e.g., where a body part, tissue, etc. is simulated).

[0015] According to certain embodiments, a delivery device configured to deliver an artificial implant may include a pusher shaft, a telescoping sleeve shaft having a fixed shaft segment and one or more movable shaft segments coaxial with the fixed shaft segment, and a dock sleeve connected to one of the one or more movable shaft segments and configured to cover the artificial implant. The fixed shaft segment may be fixedly attached around a proximal portion of the pusher shaft. The one or more movable shaft segments may be axially movable relative to the pusher shaft.

[0016] In some embodiments, the delivery device comprises one or more of the components listed in Examples 1-90 and 108-115 described in the section "Additional Examples of the Disclosed Technology" below.

[0017] The above and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description of the invention, which proceeds with reference to the accompanying drawings.

Brief Description of the Drawings

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[0019] General Considerations The disclosed embodiments can be adapted to deliver and implant an artificial device within any of the native valve annuli of the heart (e.g., pulmonary valve annulus, mitral valve annulus, and tricuspid valve annulus) and can be used with any of a variety of delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0020] For the purposes of this specification, specific aspects, advantages, and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature, or combination thereof, and the disclosed embodiments do not require that any one or more particular advantages exist or that problems be solved. The techniques from any one embodiment can be combined with the techniques described in any one or more of the other embodiments. Considering the many possible embodiments to which the principles of the disclosed techniques can be applied, it will be recognized that the exemplary embodiments are merely preferred embodiments and should not be regarded as limiting the scope of the disclosed techniques.

[0021] Although some operations of the disclosed embodiments are described in a particular sequential order for the sake of presentation, it should be understood that this mode of description encompasses permutations unless a particular order is required by the specific language set forth below. For example, operations described sequentially may, in some cases, be reordered or may be performed simultaneously. Additionally, for the sake of simplicity, the accompanying drawings may not show various aspects in which the disclosed methods can be used in combination with other methods. Additionally, in the description, terms such as "provide" or "achieve" may be used to describe the disclosed methods. These terms are high-level abstractions of the actual operations being 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.

[0022] As used in this application and 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 terms "coupled" and "connected" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or associated, and do not exclude the presence of intermediate elements between the coupled or associated items unless a specific contrary indication is given.

[0023] 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 direction" and "axial direction" refer to an axis extending in the proximal and distal directions unless otherwise explicitly defined.

[0024] Directions and other relative references (e.g., inside, outside, top, bottom, etc.) may be used to facilitate the discussion of the drawings and the principles herein, but are not intended to be limiting. For example, certain terms such as "inside", "outside", "top", "down", "interior", and "exterior" and the like may be used. Such terms, when applicable, are used to provide a degree of clarity of description with respect to the illustrated embodiments when dealing with relative relationships. However, such terms are not intended to mean absolute relationships, positions, or orientations. For example, with respect to an object, the "top" portion can become the "down" portion simply by turning the object over. Nevertheless, it remains the same portion, and the object remains the same. As used herein, "and / or" means "and" or "or", and further means "and" and "or".

[0025] The term "shaping" as used in this application and the claims may generally refer to a process of plastically deforming a material from a first configuration to a second configuration. The shaping process may result in the material being biased to the second configuration. In some embodiments, shaping may occur as a result of a physical stimulus, a chemical reaction, or a combination thereof.

[0026] In some embodiments, the shaping process can further impart shape memory properties to the material. The term "shape memory" as used in this application and the claims may generally refer to the tendency of a material to elastically deform or return from a third configuration to a second configuration after the material has been deformed from the second configuration to the third configuration. In some embodiments, the shape memory properties can be activated by an external stimulus such as a temperature change, a chemical reaction, or a physical force.

[0027] As used herein, the term "inflow" can generally refer to the location, orientation, or portion of an artificial heart valve that is closer to the inlet through which blood flow enters the artificial heart valve. As used herein, the term "outflow" can generally refer to the location, orientation, or portion of an artificial heart valve that is closer to the outlet through which blood flow exits the artificial heart valve.

[0028] Exemplary Transcatheter Heart Valve Replacement This specification describes various systems, devices, methods, etc. that can be used within or with a delivery device to deliver an artificial implant (e.g., an artificial valve, a docking device, etc.) into a patient's body.

[0029] In certain embodiments, the delivery device can be configured to deliver and implant a docking device at an implantation site such as the annulus of a native valve. The docking device can be configured to securely hold an expandable artificial valve embedded within the docking device by the annulus of the native valve. For example, the docking device can provide or form a more circular and / or stable anchor fixation site, landing zone, or implantation zone at the implant site where the artificial valve can be expanded or otherwise implanted. By providing such an anchor fixation device or docking device, the replacement artificial valve can be more securely implanted and held at the annulus of various valves, including mitral valve annuli that do not naturally have a circular cross-section.

[0030] In some embodiments, the docking device can be disposed within the outer shaft of the delivery device. A sleeve shaft can cover or surround the docking device within the delivery device during delivery to the target implantation site. A pusher shaft can be disposed within the outer shaft proximal to the docking device and can be configured to push the docking device out of the outer shaft to position the docking device at the target implantation site. The sleeve shaft can also surround the pusher shaft within the outer shaft of the delivery device. After positioning the docking device at the target implantation site, the sleeve shaft can be removed from the docking device and can be re-stored within the outer shaft of the delivery device.

[0031] A fluid (e.g., a flushing fluid such as heparinized saline) can be supplied to a pusher shaft lumen defined within the interior of the pusher shaft, a delivery shaft lumen defined between the sleeve shaft and the outer shaft of the delivery device, and a sleeve shaft lumen defined between the pusher shaft and the sleeve shaft. By providing a consistent flow of fluid through these lumens of the delivery device, stasis of blood within the delivery device can be reduced or avoided, thereby reducing the risk of thrombus formation.

[0032] An exemplary transcatheter heart valve replacement in which a first delivery device is used to deliver a docking device to the valve annulus of a native valve and then a second delivery device is used to deliver an artificial heart valve (e.g., a THV) within the docking device is shown in the schematic views of FIGS. 1-4.

[0033] A defective native heart valve can be replaced with a THV as introduced above. However, in certain cases, such a THV may not be able to adequately secure itself to native tissue (e.g., to the leaflets and / or annulus of the native heart valve), may move undesirably with respect to the native tissue, and may result in paravalvular leakage, valve malfunction, and / or other problems. Thus, a docking device can be first implanted into the valve annulus of the native valve and then the THV can be implanted within the docking device, helping to anchor the THV to the native tissue and provide a seal between the native tissue and the THV.

[0034] Figures 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 surgery, the user may create a path to the patient's native heart valve using a guide catheter 30 (Figure 1). The user may deliver and implant the docking device 52 to the patient's native heart valve using the delivery device 50 of the docking device (Figure 2A), and then, after implanting the docking device 52, remove the delivery device 50 of the docking device from the patient 10 (Figure 2B). Thereafter, the user may implant the artificial heart valve 62 into the implanted docking device 52 using the delivery device 60 of the artificial valve (Figure 3A). Thereafter, the user may remove the delivery device 60 of the artificial valve (Figure 3B), as well as the guide catheter 30 (Figure 4) from the patient 10.

[0035] Figure 1 shows the first step in a mitral valve replacement according to one embodiment. As shown, the guide catheter 30 and the guide wire 40 may be inserted into the vasculature 12 of the patient 10 and navigated through the vasculature 12 towards the native mitral valve 16 of the patient's heart 14. Together, the guide catheter 30 and the guide wire 40 may provide a path for the delivery device 50 of the docking device and the delivery device 60 of the artificial valve to navigate through and along the implantation site (the native mitral valve 16 or the annulus of the native mitral valve).

[0036] First, the user may first make an incision in the patient's body to access the vasculature 12. For example, in the embodiment shown in Figure 1, the user may make an incision in the patient's groin to access the femoral vein. Thus, in such an embodiment, the vasculature 12 may include the femoral vein.

[0037] To access the vascular system 12, after making an incision, the user may insert a guide catheter 30, a guide wire 40, and / or an additional device (e.g., an introducer device or a transseptal puncture device) through the incision into the vascular system 12. The guide catheter 30 (which may also be referred to as an “introducer device”, an “introducer”, or a “guide sheath”) may be configured to facilitate percutaneous introduction of various implant delivery devices (e.g., a delivery device 50 of a docking device and a delivery device 60 of an artificial valve) into and through the vascular system 12, and may extend through the vascular system 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 the vascular system 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).

[0038] The guide wire 40 is configured to guide a delivery device (e.g., the guide catheter 30, the delivery device 50 of the docking device, the delivery device 60 of the artificial valve, an additional catheter, or the like) and their associated devices (e.g., the docking device, the artificial heart valve, or the like) to an implantation site within the heart 14, and thus may extend continuously through the vascular system 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).

[0039] In some cases, a transseptal puncture device or catheter can be used to first access the left atrium 18 before inserting the guide wire 40 and guide catheter 20. For example, to access the vasculature 12, after making an incision, the user can insert the transseptal puncture device through the incision into the vasculature 12. The user can direct the transseptal puncture device through the vasculature 12 into the heart 14 (e.g., into the right atrium 20 through the femoral vein). Thereafter, the user can make a small incision in the atrial septum 22 of the heart 14 to provide access from the right atrium 20 to the left atrium 18. The user can then insert and advance the guide wire 40 through the transseptal puncture device within the vasculature 12, through the incision in the atrial septum 22, and into the left atrium 18. Once the guide wire 40 is positioned within the left atrium 18 and / or left ventricle 26, the transseptal puncture device can be removed from the patient 10. The user can then insert the guide catheter 30 into the vasculature 12 and advance the guide catheter 30 over the guide wire 40 into the left atrium 18 (FIG. 1).

[0040] In some cases, an introducer device can be inserted through the lumen of the guide catheter 30 before the guide catheter 30 is inserted into the vasculature 12. In some cases, the introducer device can include a tapered end that extends from the distal tip of the guide catheter 30 and is configured to direct the guide catheter 30 over the guide wire 40 into the left atrium 18. Additionally, in some cases, the introducer device can include a proximal end portion that extends from the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user can remove the introducer device from inside the guide catheter 30 and the patient 10. Thus, only the guide catheter 30 and the guide wire 40 remain inside the patient 10. The guide catheter 30 then receives the implant delivery device and is in a position to assist in directing it into the left atrium 18, as further described below.

[0041] FIG. 2A shows a second stage in an exemplary mitral valve replacement procedure in which a docking device 52 can be implanted into the native mitral valve 16 of a patient 10's heart 14 using a delivery device 50 of the docking device (which may also be referred to as an "implant catheter" or "delivery device of the docking device", or simply "delivery device").

[0042] Generally, the delivery device 50 of the docking device can include a delivery shaft 54 (which may also be referred to as an "outer shaft"), a handle 56, and a pusher assembly 58. The delivery shaft 54 can be configured to be advanced through a patient's vasculature 12 by a user to an implantation site (e.g., the native mitral valve 16), and can 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 in a substantially linear delivery configuration therein.

[0043] The handle 56 of the delivery device 50 of the docking device can be configured to be held by a user, gripped and / or otherwise, to advance the delivery shaft 54 through the patient's vasculature 12. Specifically, the handle 56 can be coupled to the proximal end of the delivery shaft 54 and can be configured to remain accessible to the user (e.g., outside the patient 10's body) during implantation of the docking device. In this way, the user can advance the delivery shaft 54 through the patient's vasculature 12 by applying a force (e.g., pushing) to the handle 56. In some embodiments, the delivery shaft 54 can be configured to convey the pusher assembly 58 and / or the docking device 52 therewith as it advances through the patient's vasculature 12. In this way, the docking device 52 and / or the pusher assembly 58 can advance through the patient's vasculature 12 in the same direction and at the same speed as the delivery shaft 54 when the user grips the handle 56 and pushes the delivery shaft 54 deeper into the patient's vasculature 12.

[0044] In some embodiments, the handle 56 may include one or more articulating members 57 configured to assist in navigating the delivery shaft 54 through the vasculature 12. For example, the one or more articulating members 57 may be configured to be joined by the 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 vasculature 12 and / or into the heart 14. The one or more articulating members 57 may include one or more of a knob, button, wheel, and / or other types of physically adjustable control members.

[0045] The pusher assembly 58 may 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 may be configured to be adjusted by the user to push the docking device 52 out from the distal end portion 53 of the delivery shaft 54. The pusher shaft of the pusher assembly 58 may extend through the delivery shaft 54 and may be disposed adjacent to the docking device 52 within the delivery shaft 54. In some embodiments, the docking device 52 may be removably coupled to the pusher shaft of the pusher assembly 58 via a connection mechanism of the delivery device 50 of the docking device such that the docking device 52 can be released after the docking device 52 is deployed at the native mitral valve 16. Since the docking device 52 is maintained, held, and / or otherwise coupled to the pusher assembly 58, the docking device 52 may advance through and / or out of the delivery shaft 54 in the same direction and at the same speed as the pusher assembly 58.

[0046] In addition to the pusher shaft, in certain cases, the pusher assembly 58 may also include a sleeve shaft. While the pusher shaft is configured to advance the docking device 52 out from the distal end portion 53 of the delivery shaft 54 through the delivery shaft 54, the sleeve shaft, if included, may have a distal dock sleeve configured to push the docking device 52 out from the delivery shaft 54 and cover the docking device 52 within the delivery shaft 54 while positioning the docking device 52 at the embedding site. In some embodiments, the pusher shaft may be at least partially covered by the sleeve shaft. In certain embodiments, the sleeve shaft may include a telescoping shaft member as further described below.

[0047] In some embodiments, the pusher assembly 58 may include a pusher handle coupled to the pusher shaft and configured to be gripped and pushed by a user to axially move the pusher shaft relative to the delivery shaft 54 (e.g., push the pusher shaft at and / or out from the distal end portion 53 of the delivery shaft 54). The dock sleeve may be configured to be retracted and / or withdrawn from the docking device 52 after positioning the docking device 52 at the embedding site. For example, the pusher assembly 58 may include a sleeve handle coupled to the sleeve shaft and configured to be retracted (e.g., axially moved) by the user relative to the pusher shaft, thereby pulling out the dock sleeve to retract it.

[0048] The pusher assembly 58 may be removably coupled to the docking device 52 and thus may be configured to be released, detached, separated, and / or otherwise removed from the docking device 52 once the docking device 52 is deployed at the embedding site. By way of example only, the pusher assembly 58 may be removably coupled to the docking device 52 via a textile thread, a cord, a twisted thread, a suture thread, or other suitable material that is tied or sutured to the docking device 52.

[0049] In some embodiments, the pusher assembly 58 may include a suture lock assembly (also referred to as a "suture lock") configured to receive and / or hold a woven thread or other suitable material coupled to the docking device 52 via a suture. Thus, the woven thread or other suitable material forming the suture may extend from the docking device 52, through the pusher assembly 58, to the suture lock assembly. The suture lock assembly may also be configured to cut the suture to release, disconnect, separate, and / or otherwise remove the docking device 52 from the pusher assembly 58. For example, the suture lock assembly may include a cutting mechanism configured to be adjusted by a user to cut the suture.

[0050] Referring again to FIG. 2A, after the guide catheter 30 is positioned within the left atrium 18, the user may insert the delivery device 50 of the docking device (e.g., the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 of the delivery device 50 of the docking device through the guide catheter 30 and onto the guide wire 40. In some embodiments, the guide wire 40 may be at least partially received within the guide catheter 30 away from the left atrium 18. The user may then continue to advance the delivery shaft 54 of the delivery device 50 of the docking device along the guide wire 40 through the vasculature 12 until the delivery shaft 54 reaches the left atrium 18, as shown in FIG. 2A. Specifically, the user may advance the delivery shaft 54 of the delivery device 50 of the docking device by gripping the handle 56 of the delivery device 50 of the docking device and applying a force (e.g., pushing) toward the patient 10. The user may adjust one or more articulation members 57 of the handle 56 while advancing the delivery shaft 54 through the vasculature 12 and the heart 14 to navigate various bends, corners, stenoses, and / or other obstructions of the vasculature 12 and the heart 14.

[0051] Once the delivery shaft 54 reaches the left atrium 18 and extends out from the distal end of the guide catheter 30, the user can use the handle 56 (e.g., the articulating member 57) to position the distal end portion 53 of the delivery shaft 54 at and / or near the posterior medial commissure of the native mitral valve 16. The user can then use the shaft of the pusher assembly 58 to push the docking device 52 out from the distal end portion 53 of the delivery shaft 54 to deploy and / or embed the docking device 52 within the annulus of the native mitral valve 16.

[0052] 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 preformed shape. As an example, the docking device 52 may originally be formed as a coil and thus can wrap around the leaflet tips 24 of the native mitral valve 16 as it exits the delivery shaft 54 and returns to its original coiled configuration.

[0053] 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 then deploy the remaining portion of the docking device 52 (e.g., the atrial portion of the docking device 52) from the delivery shaft 54 within the left atrium 18 by retracting the delivery shaft 54 away from the posterior medial commissure of the native mitral valve 16. In some embodiments, while the user can maintain the position of the pusher assembly 58 (e.g., by holding and / or applying a pushing force thereon on the pusher shaft), the delivery shaft 54 is retracted proximally such that it pulls away from and / or otherwise stows relative to the docking device 52 and the pusher assembly 58. In this way, the pusher assembly 58 can hold the docking device 52 in place while the user stows the delivery shaft 54, thereby releasing the docking device 52 from the delivery shaft 54. In some embodiments, the user can also remove the dock sleeve from the docking device 52, e.g., by stowing a sleeve shaft.

[0054] After deploying and implanting the docking device 52 into the native mitral valve 16, the user can disconnect the delivery device 50 of the docking device from the docking device 52. Once the docking device 52 is disconnected from the delivery device 50 of the docking device (e.g., by cutting the suture thread tied to the docking device 52), the user can stow the delivery device 50 of the docking device out of the blood vessel 12 and away from the patient 10, such that the user can deliver and implant the artificial heart valve 62 within the implanted docking device 52 into the native mitral valve 16.

[0055] 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 delivery device 50 (including the delivery shaft 54) of the docking device is removed from the patient 10, such that only the guide wire 40 and the guide catheter 30 remain inside the patient 10. In some embodiments, after removing the delivery device of the docking device, the guide wire 40 can be advanced out of the guide catheter 30, through the docking device 52 implanted in the native mitral valve 16, and into the left ventricle 26 (Figure 2A). Thus, the guide wire 40 can assist in guiding the delivery device 60 of the artificial valve through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.

[0056] As shown in Figure 2B, the docking device 52 can comprise a plurality of rotating portions (or coils) that are wrapped around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has a cylindrical shape that is larger than the annulus of the native mitral valve 16, thereby providing a geometric shape that more closely matches the shape or profile of the implanted artificial heart valve. 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.

[0057] Figure 3A shows the fourth stage of the mitral valve replacement procedure, where the user uses the delivery device 60 of the artificial valve to deliver and / or implant the artificial heart valve 62 into the docking device 52.

[0058] As shown in Figure 3A, the delivery device 60 of the artificial valve can comprise a delivery shaft 64 and a handle 66. The delivery shaft 64 can extend distally from the handle 66. The delivery shaft 64 can be configured to extend into the patient's vasculature 12 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 can be configured to be grasped and / or otherwise held by the user to advance the delivery shaft 64 through the patient's vasculature 12.

[0059] 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 vasculature 12 and into the heart 14. Specifically, the articulating members 68 may be configured to bend, flex, twist, rotate, and / or otherwise engage the distal end portion of the delivery shaft 64 by the user to adjust the delivery shaft 64 to assist in navigating through the vasculature 12 and into the left atrium 18 and left ventricle 26 of the heart 14. The articulating members 68 may include one or more of a knob, button, wheel, and / or other types of physically adjustable control members.

[0060] In some embodiments, the prosthetic valve delivery device 60 may include an expansion mechanism 65 configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. In some cases, as shown in FIG. 3A, the expansion mechanism 65 may include an inflatable balloon configured to be inflated to radially expand the prosthetic heart valve 62 within the docking device 52. The inflatable balloon may be coupled to the distal end portion of the delivery shaft 64.

[0061] In other embodiments, the prosthetic heart valve 62 may be self-expanding and configured to radially expand itself upon removal of a sheath or capsule that covers the prosthetic heart valve 62 radially compressed on the distal end portion of the delivery shaft 64. In yet other embodiments, the prosthetic heart valve 62 may be mechanically expandable, and the prosthetic valve delivery device 60 may include one or more mechanical actuators (e.g., an expansion mechanism) configured to radially expand the prosthetic heart valve 62.

[0062] As shown in FIG. 3A, the prosthetic heart valve 62 may be mounted in a radially compressed configuration around the expansion mechanism 65 (inflatable balloon) on the distal end portion of the delivery shaft 64.

[0063] To navigate the distal end portion of the delivery shaft 64 to the implantation site, the user may insert the artificial valve delivery device 60 (delivery shaft 64) through the guide catheter 30 and over the guide wire 40 into the patient 10. As shown in FIG. 3A, the user may continue to advance the artificial valve delivery device 60 along the guide wire 40 (through the vasculature 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16. More specifically, the user may advance the delivery shaft 64 of the artificial valve delivery device 60 by gripping the handle 66 and applying force (e.g., pushing). The user may adjust one or more articulating members 68 of the handle 66 while advancing the delivery shaft 64 through the vasculature 12 and the heart 14 to navigate various bends, corners, stenoses, and / or other obstacles within the vasculature 12 and the heart 14.

[0064] The user may advance the delivery shaft 64 along the guide wire 40 until the radially compressed artificial heart valve 62 mounted around the distal end portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some embodiments, as shown in FIG. 3A, the distal end of the delivery shaft 64 and at least a portion of the radially compressed artificial heart valve 62 may be positioned within the left ventricle 26.

[0065] Once the radially compressed artificial heart valve 62 is properly positioned within the docking device 52 (FIG. 3A), the user may operate 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 expanding the artificial heart valve 62 radially within the docking device 52. In some embodiments, the user may lock the artificial heart valve 62 in its fully expanded position (e.g., by a locking mechanism) to prevent the artificial heart valve 62 from being crushed.

[0066] Figure 3B shows the fifth stage in mitral valve replacement, where the artificial heart valve 62 is in its radially expanded configuration and is embedded within the docking device 52 of the native mitral valve 16. As shown in Figure 3B, the artificial heart valve 62 can be received and held within the docking device 52.

[0067] As also shown in Figure 3B, after the artificial heart valve 62 is fully deployed and embedded within the docking device 52 with the native mitral valve 16, the delivery device 60 of the artificial valve (including the delivery shaft 64) can be removed from the patient 10. As a result, only the guide wire 40 and the guide catheter 30 remain inside the patient 10.

[0068] Figure 4 shows the sixth stage in mitral valve replacement, where the guide wire 40 and the guide catheter 30 have been removed from the patient 10. The docking device 52 can also be configured to provide a 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. Specifically, the docking device 52 can first contract the valve leaflets 24 of the native mitral valve 16. The artificial heart valve 62 can then press the valve leaflets 24 against the docking device 52 when radially expanding within the docking device 52. Thus, the docking device 52 and the artificial heart valve 62 can be configured to sandwich the valve leaflets 24 of the native mitral valve 16 when the artificial heart valve 62 is expanded within the docking device 52. In this way, the docking device 52 can also provide a seal between the valve leaflets 24 of the native mitral valve 16 and the artificial heart valve 62 to reduce paravalvular leakage around the artificial heart valve 62.

[0069] In some embodiments, one or more of the delivery device 50 of the docking device, the delivery device 60 of the artificial valve, and / or the guide catheter 30 can include one or more fluid ports configured to supply a cleansing fluid into their lumens to prevent and / or reduce the likelihood of blood clot (e.g., thrombus) formation. Exemplary fluid ports that can be used to inject the cleansing fluid into the delivery device of the docking device are further described below.

[0070] Figures 1-4 specifically show a mitral valve replacement, but it should be understood that the same and / or similar techniques may 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., delivery device 50 of the docking device, delivery device 60 of the artificial valve, 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 may be utilized to replace these other heart valves.

[0071] For example, when replacing the native tricuspid valve, the user may access the right atrium 20 via the femoral vein, but will not need to cross the atrial septum 22 and enter the left atrium 18. Instead, the user can leave the guide wire 40 within the right atrium 20 and perform the implantation process of the same and / or similar docking device 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 valve leaflets of the tricuspid valve, release the remaining portion of the docking device 52 from the delivery shaft 54 within the right atrium 20, and then remove the delivery shaft 54 of the delivery device 50 of the docking device from the patient 10. The user can then 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 / disposed within the docking device 52 and the tricuspid valve. The user can then 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 example, the user may perform the same and / or similar process to replace the aortic valve, but may access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0072] Further, 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, it being 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.

[0073] Further details of the delivery device of the docking device are further described below with reference to FIGS. 8-17.

[0074] Additional embodiments of the delivery device of the docking device, including variations thereof, as well as methods of implanting the docking device and methods of implanting an artificial valve within the docking device are described in International Patent Application PCT / US2020 / 36577 and International Patent Application PCT / US2021 / 056150, as well as U.S. Patent Application Publication Nos. 2018 / 0318079, 2018 / 0263764, and 2018 / 0177594, all of which are hereby incorporated by reference in their entirety.

[0075] Exemplary Docking Device FIG. 5 shows an example of a docking device 100 configured to receive an artificial heart valve. For example, the docking device 100 can be implanted within the annulus of a native valve as described above with reference to FIGS. 2-4. As shown in FIGS. 2A and 2B and FIGS. 3 and 4, the docking device 100 can be configured to receive and secure an artificial valve within the docking device, thereby securing the artificial valve to the annulus of the native valve.

[0076] Referring to FIG. 5, the docking device 100 may 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) can move from a substantially linear configuration (also referred to as a "delivery configuration") when disposed within a delivery sheath of a delivery device (as 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 sheath.

[0077] The coil 102 has a proximal end 102p and a distal end 102d. The body of the 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 disposed within a delivery sleeve (e.g., during delivery of the docking device into a patient's vasculature) and when moving through the patient's vasculature. After being removed from the delivery sheath and deployed in an implantation position, the coil 102 can move from the delivery configuration to a helical deployed configuration and can be wrapped around natural tissue adjacent to the implantation position. For example, the coil 102 can be configured to surround the native leaflets of a native valve (and the chordae tendineae connecting the native leaflets to adjacent papillary muscles, if present) when implanting the docking device at the position of a native valve.

[0078] The docking device 100 can be removably coupled to a delivery device. For example, in certain embodiments, the docking device 100 can be coupled to the delivery device via a release suture that can be tied to the docking device 100 and cut for removal (as described further below with reference to FIG. 11B). In one embodiment, the release suture can be tied to the docking device 100 through an eyelet or aperture 103 located adjacent to the proximal end 102p of the coil. In another embodiment, the release suture can be tied around a circumferential recess located adjacent to the proximal end 102p of the coil 102.

[0079] In some embodiments, the docking device 100 in the deployed configuration may be configured to conform at the location of the mitral valve. In other embodiments, the docking device 100 may also be shaped and / or conformed for implantation at the location of other native valves, such as the tricuspid valve. In some embodiments, the geometric shape of the docking device 100 may be configured to engage the native anatomical structure, thereby providing, for example, improved stability and reduced relative movement between the docking device 100, the prosthetic valve docked therein, and / or the native anatomical structure. Reduction of such relative movement can prevent, among other things, material degradation of the components of the docking device 100 and / or the prosthetic valve docked therein and / or prevent damage or trauma to the native tissue.

[0080] As shown in FIG. 5, the coil 102 in the deployed configuration may include a leading rotation portion 106 (or "leading coil"), a central region 108, and a stabilizing rotation portion 110 (or "stabilizing coil"). The central region 108 may have one or more helical rotation portions having substantially equal inner diameters. The leading rotation portion 106 may extend from the distal end of the central region 108 and have a diameter greater than the diameter of the central region 108 (in one or more configurations). The stabilizing rotation portion 110 may extend from the proximal end of the central region 108 and have a diameter greater than the diameter of the central region 108 (in one or more configurations).

[0081] In certain embodiments, the central region 108 may include a plurality of helical rotating parts such as a proximal rotating part 108p connected to the stabilizing rotating part 110, a distal rotating part 108d connected to the leading rotating part 106, and one or more intermediate rotating parts 108m disposed between the proximal rotating part 108p and the distal rotating part 108d. In the embodiment shown in FIG. 5, there is only one intermediate rotating part 108m between the proximal rotating part 108p and the distal rotating part 108d. In other embodiments, there are two or more intermediate rotating parts 108m between the proximal rotating part 108p and the distal rotating part 108d. Some of the helical rotating parts in the central region 108 can be full rotating parts (i.e., rotating 360 degrees). In some embodiments, the proximal rotating part 108p and / or the distal rotating part 108d can be partial rotating parts (e.g., rotating less than 360 degrees such as 180 degrees, 270 degrees, etc.).

[0082] The size of the docking device 100 can generally be selected based on the size of the desired artificial valve to be implanted in the patient. In certain embodiments, the central region 108 can be configured to hold a radially expandable artificial valve. For example, the inner diameter of the helical rotating parts within the central region 108 can be configured to be smaller than the outer diameter of the artificial valve when the artificial valve is radially expanded such that additional radial tension can act between the central region 108 and the artificial valve to hold the artificial valve in place. The helical rotating parts (e.g., 108p, 108m, 108d) in the central region 108 are also referred to herein as "functional rotating parts".

[0083] The stabilization rotating part 110 can be configured to help stabilize the docking device 100 in a desired position. For example, the radial dimension of the stabilization rotating part 110 can be significantly larger than the radial dimension of the coil within the central region 108. As a result, the stabilization rotating part 110 can flare outwards or extend sufficiently to abut or press against the wall of the circulation system, thereby improving the ability of the docking device 100 to remain in the desired position before the implantation of the artificial valve. In some embodiments, the diameter of the stabilization rotating part 110 is desirably larger than the valve annulus, the natural valve surface, and the atrium for good stabilization. In some embodiments, the stabilization rotating part 110 can be a full rotating part (i.e., rotating approximately 360 degrees). In some embodiments, the stabilization rotating part 110 can be a partial rotating part (e.g., rotating approximately 180 degrees to approximately 270 degrees).

[0084] In one particular embodiment, when implanting the docking device 100 in the position of the natural mitral valve, the functional rotating part within the central region 108 can be disposed substantially within the left ventricle, and the stabilization rotating part 110 can be disposed substantially within the left atrium. The stabilization rotating part 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 substantially parallel to the plane of the natural mitral valve.

[0085] As described above, the leading rotating portion 106 can have a radial dimension larger than that of the helical rotating portion within the central region 108. The leading rotating portion 106 can help to more readily and appropriately 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, once the guiding rotating portion 106 is navigated around a desired native tissue, the remaining coils (such as the functional rotating portion) of the docking device 100 can also be guided around the same structure. In some embodiments, the leading rotating portion 106 can be a full rotating portion (i.e., rotating approximately 360 degrees). In some embodiments, the leading rotating portion 106 can be a partial rotating portion (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 rotating portion of the central region 108 can be further radially expanded. As a result, the leading rotating portion 106 can be pulled in the proximal direction and become part of the functional rotating portion within the central region 108.

[0086] As shown in FIGS. 5A-5D, in certain embodiments, at least a portion of the coil 102 can be surrounded by a first cover 112. In certain embodiments, the first cover 112 can cover the entire length of the coil 102. In certain embodiments, the first cover 112 can cover only a selected portion of the coil 102. In certain embodiments, the first cover 112 can be coated and / or joined onto the coil 102. In certain embodiments, the first cover 112 can be a cushioned, padded type layer that protects the coil. The first cover 112 can be composed of various natural and / or synthetic materials. In one particular embodiment, the first cover 112 can include expanded polytetrafluoroethylene (ePTFE). In certain embodiments, the first cover 112 can be attached to the coil 102 (e.g., by textured surface resistance, suture, glue, thermal bonding, or any other means) such that relative axial movement between the first cover 112 and the coil 102 is restricted or prohibited.

[0087] As shown in FIGS. 5A and 5B, in some embodiments, the docking device 100 can also include a retaining element 114 that surrounds at least a portion of the coil 102 and is at least partially covered by the guard member 104. In some cases, the retaining element 114 can include braided material. Additionally, the retaining element 114 can provide a surface area that promotes and / or facilitates in-growth and / or attachment within tissue and / or reduces trauma to natural tissue. For example, the retaining element 114 can have a textured outer surface configured to promote in-growth within tissue. In certain cases, the retaining element 114 can be impregnated with growth factors to stimulate or promote in-growth within tissue.

[0088] In certain embodiments, at least a portion of the first cover 112 can be surrounded by the retaining element 114. In some embodiments, the first cover 112 can extend throughout the entire length of the retaining element 114. In some embodiments, the distal end portion of the retaining element 114 can axially extend beyond the distal end of the guard member 104 (i.e., be positioned distally relative to the distal end of the guard member 104), and the proximal end portion of the retaining element 114 can axially extend beyond the proximal end 105 of the guard member 104 (i.e., be positioned proximally relative to the proximal end 105 of the guard member 104) to assist in retaining the artificial valve and in-growth within tissue.

[0089] The retaining element 114 can be designed to interact with the guard member 104 to limit or resist movement of the guard member 104 relative to the coil 102. For example, the proximal end 105 of the guard member 104 can have an inner diameter that is substantially the same as the outer diameter of the retaining element 114. Thus, the inner surface of the guard member 104 at the proximal end 105 can frictionally interact or engage with the retaining element 114 such that axial movement of the proximal end 105 of the guard member 104 relative to the coil 102 can be impeded by the frictional force applied by the retaining element 114.

[0090] As shown in FIGS. 5A-5D, in certain embodiments, the guard member 104 may include an expandable member 116 and a second cover 118 surrounding the outer surface of the expandable member 116. In certain embodiments, the expandable member 116 surrounds at least a portion of the first cover 112. In certain embodiments, the first cover 112 may extend (fully or partially) through the expandable member 116.

[0091] In certain embodiments, the expandable member 116 can include a braided structure, such as a braided wire mesh or lattice. In certain embodiments, the expandable member 116 is shaped and / or preconfigured to expand to a particular shape and / or size when unconstrained (e.g., when deployed in the position of a native valve), and / or can include a shape memory material having superelastic properties. For example, the expandable member 116 can have a braided structure containing a shape memory alloy having superelastic properties, such as nitinol. In certain embodiments, the expandable member 116 can have a braided structure containing a ternary shape memory alloy having superelastic properties, such as NiTiX (where X can be, for example, chromium (Cr), cobalt (Co), zirconium (Zr), hafnium (Hf), etc.). In certain embodiments, the expandable member 116 can include a metallic material that does not have shape memory properties. Examples of such metallic materials include cobalt chromium, stainless steel, and the like. In one specific embodiment, the expandable member 116 can include a nickel-free austenitic stainless steel in which nickel can be completely replaced by nitrogen. In another specific embodiment, the expandable member 116 can include a cobalt-chromium or cobalt-nickel-chromium-molybdenum alloy having a significantly low density of titanium. The number of wires (or fibers, strands, or the like) forming the braided structure can be selected to achieve the desired elasticity and / or strength of the expandable member 116. In certain embodiments, the number of wires used to braid the expansion member 116 can range from 16 to 128 (e.g., 32 wires, 48 wires, 64 wires, 96 wires, etc.). In certain embodiments, the braiding density can range from 20 picks per inch (PPI) to 70 PPI, or from 25 PPI to 65 PPI. In one specific embodiment, the braiding density is about 36 PPI. In another specific embodiment, the braiding density is about 40 PPI. In certain embodiments, the diameter of the wire can range from about 0.002 inches to about 0.004 inches. In one particular embodiment, the diameter of the wire can be about 0.003 inches.In another embodiment, the expandable member 116 can be a combination of braided wire (which can include shape memory or non-shape memory materials), and a polymer material and / or fabric (e.g., polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), thermoplastic polyurethane (TPU), etc.). For example, the expandable member 116 can include a braided wire frame embedded within a polymer material.

[0092] In some embodiments, the expandable member 116 can include a braided metal wire frame coated with an elastomer (e.g., ePTFE, TPU, or the like), which can elastically deform as the braided wire frame expands and / or compresses. In some embodiments, the expandable member 116 can comprise a braid and / or weave including one or more metal wires and one or more polymer fibers. In other words, the metal wires and polymer fibers can be woven together to define a braided structure. In some cases, the polymer fibers can have the same or approximately the same diameter as the metal wires. In other cases, the polymer fibers can have a smaller diameter (e.g., microfibers) than the metal wires, or vice versa.

[0093] In yet another embodiment, the expandable member 116 can include a polymer material such as a thermoplastic material (e.g., PET, polyetheretherketone (PEEK), thermoplastic polyurethane (TPU), etc.) without having a braided wire frame.

[0094] In certain embodiments, the expandable member 116 can include a foam structure. For example, the expandable member can include an expandable memory foam that can expand to a particular shape or a particular pre-set shape with the removal of the crimping pressure prior to delivery of the docking device (e.g., removal from the delivery sheath of the docking device 100).

[0095] The expandable member 116 can extend radially outward from the coil 102 and is movable between a radially compressed (and axially extended) state and a radially expanded (and axially shortened) state. That is, when the expandable member 116 moves from a radially compressed state to a radially expanded state, it can shorten axially, and when it moves from a radially expanded state to a radially compressed state, it can extend axially.

[0096] The second cover 118 can be configured to be elastic enough such that when the expandable member 116 moves from a radially compressed (and axially extended) state to a radially expanded (and axially shortened) state, the second cover member 118 can also expand radially together with the expandable member 116 and shorten axially. In other words, the guard member 104 can move as a whole from a radially compressed (and axially extended) state to a radially expanded (and axially shortened) state.

[0097] In certain embodiments, the second cover 118 can be configured to be non-invasive to natural tissue and / or to promote in-growth of tissue into the second cover 118. For example, the second cover 118 can have pores to promote in-growth of tissue. In another embodiment, the second cover 118 can be impregnated with growth factors to stimulate or promote in-growth of tissue. The second cover 118 can be constructed of any suitable material including foams, fabrics, textiles, and / or polymers, which are flexible to allow compression and expansion of the second cover. In one embodiment, the second cover 118 can include a fabric layer constructed from a thermoplastic polymer material such as polyethylene terephthalate (PET).

[0098] 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 the first cover 112. In some embodiments, the cover assembly can further include a retaining element 114.

[0099] In certain embodiments, when the docking device 100 is in the deployed configuration, the guard member 104 may be configured to cover a portion of the stabilizing rotation portion 110 of the coil 102. In certain embodiments, the guard member 104 may be configured to cover at least a portion of the central region 108 of the coil 102, such as a portion of the proximal rotation portion 108p. In certain embodiments, the guard member 104 may extend across the entire coil 102.

[0100] In some embodiments, the guard member 104 may expand radially to help prevent and / or reduce perivalvular leakage. Specifically, the guard member 104 may be configured to expand radially such that an improved seal is formed closer to and / or against an artificial valve deployed within the docking device 100. In some embodiments, the guard member 104 may be configured to prevent and / or inhibit leakage at a position where the docking device 100 crosses between natural valve leaflets (e.g., at the commissure of natural valve leaflets). For example, without the guard member 104, the docking device 100 may push the natural valve leaflets apart at the point where it crosses the natural valve leaflets, allowing leakage (e.g., along or to the side of the docking device) at that point. However, the guard member 104 may be configured to expand to cover and / or fill any openings at that point and to inhibit leakage along the docking device 100.

[0101] In certain embodiments, when the docking device 100 is deployed at the native atrioventricular valve, the guard member 104 may primarily cover a portion of the stabilizing rotation section 110 and / or a portion of the central region 108. Thus, the guard member 104 may assist in covering the atrial side of the atrioventricular valve by blocking blood from flowing in the ventricular direction (i.e., antegrade blood flow) within the atrium other than through the prosthetic valve, thereby preventing and / or suppressing blood leakage through the native valve leaflets, commissures, and / or around the outside of the prosthetic valve. Positioning the guard member 104 on the atrial side of the valve may additionally or alternatively help reduce blood from flowing in the ventricular-to-atrial direction (i.e., retrograde blood flow) within the ventricle.

[0102] In some embodiments, the guard member 104 may be positioned on the ventricular side of the atrioventricular valve by blocking blood from flowing in the ventricular-to-atrial direction (i.e., retrograde blood flow) to prevent and / or suppress blood leakage through the native valve leaflets, commissures, and / or around the outside of the prosthetic valve. Positioning the guard member 104 on the ventricular side of the valve may additionally or alternatively help reduce blood from flowing in the atrial-to-ventricular direction (i.e., antegrade blood flow) within the atrium other than through the prosthetic valve.

[0103] In some embodiments, the distal end portion 104d of the guard member 104 may be fixedly coupled (e.g., via a suture) to the coil 102, and the proximal end portion 104p of the guard member 104 may be axially movable relative to the coil 102.

[0104] When the docking device 100 is held within the delivery sheath in a substantially linear configuration, the expandable member 116 can be radially compressed by the delivery sheath and remain in a radially compressed (and axially extended) state. The radially compressed (and axially extended) expandable member 116 can contact the retaining element 114 (see, e.g., FIG. 5B) or the first cover 112 (see, e.g., FIG. 5D), such that there is no gap or void between the retaining element 114 and the expandable member 116, or between the first cover 112 (and / or coil 102) and the expandable member 116.

[0105] After the docking device 100 is removed from the delivery sheath and changes from the delivery configuration to the deployed configuration, the guard member 104 can also move from the delivery configuration to the deployed configuration. In certain embodiments, the dock sleeve can be configured to cover the docking device 100 and hold it within the delivery sheath when navigating the delivery sheath through the patient's native valve. The dock sleeve can also be useful, for example, to guide the docking device 100 around the native valve tip and chordae. By housing the dock sleeve relative to the docking device 100, the guard member 104 can be exposed and the guard member 104 can move from the delivery configuration to the deployed configuration. Specifically, without the restraint of the delivery sheath and the dock sleeve, the expandable member 116 can radially expand (and axially contract) such that a gap or void 111 is created between the retaining element 114 and the expandable member 116 (see, e.g., FIG. 5A), and / or between the first cover 112 and the expandable member 116 (see, e.g., FIG. 5C).

[0106] The distal end portion 104d of the guard member 104 is fixedly coupled to the coil 102, and the proximal end portion 104p of the guard member 104 can be axially movable relative to the coil 102. Therefore, when the expandable member 116 moves from a radially compressed state to a radially expanded state, the proximal end portion 104p of the guard member 104 can slide axially on the first cover member 112 toward the distal end 102d of the coil 102. As a result, the proximal end portion 104p of the guard member 104 can be disposed closer to the proximal end 102p of the coil 102 when the expandable member 116 is in a radially compressed state than in a radially expanded state.

[0107] In certain embodiments, the second cover 118 can be configured to engage an artificial valve deployed within the docking device 100 so as to form a seal between the artificial valve and the docking device 100 when the expandable member 116 is in a radially expanded state to reduce perivalvular leakage. The second cover 118 can also be configured to engage natural tissue (e.g., natural valve annulus and / or natural valve leaflets) to reduce perivalvular leakage between the docking device and / or the artificial valve and the natural tissue.

[0108] In certain embodiments, when the guard member 104 is in a radially expanded state, the proximal end portion 104p of the guard member 104 can have a tapered shape such that the diameter of the proximal end portion 104p gradually increases from the proximal end 105 of the guard member 104 to the body portion located distally of the guard member 104. This can help facilitate, for example, loading the docking device into the delivery sheath of the delivery device and / or retrieving and / or repositioning the docking device on the delivery device during the implantation procedure. Additionally, due to its small diameter, the proximal end 105 of the guard member 104 can frictionally engage the retaining element 114 such that the retaining element 114 can reduce or prevent axial movement of the proximal end portion 104p of the guard member 104 relative to the coil 102.

[0109] Additional embodiments of the docking device and guard member, as well as methods of assembling the docking device (e.g., attaching the guard member to the coil), are described in International Patent Application PCT / US2021 / 056150.

[0110] Exemplary artificial valve FIG. 6 shows a perspective view of an artificial heart valve 200 according to one embodiment. In certain embodiments, the artificial heart valve 200 can be a dry bioprosthetic heart valve.

[0111] As shown, the artificial heart valve 200 can include a frame 205, a plurality of valve leaflets 225, and an outer skirt 230. However, other embodiments of the artificial heart valve 200 can include additional and / or alternative components.

[0112] The frame 205 can comprise an annular structure such as a cylinder. The perimeter of the cylinder can form a central flow orifice through which blood can flow. The cylinder can be aligned such that the central flow orifice extends from the inflow end portion 215 at the inflow end of the frame 205 to the outflow end portion 210 at the outflow end of the frame 205. The frame 205 can be made of any suitable metal or other material. In some embodiments, the frame 205 can include a metal wire or a mesh frame. The metal wire or mesh frame can be configured to be radially expandable or compressible.

[0113] The frame 205 can include a plurality of crosslinking posts 220 (which can also be referred to as "crosslinking supports") configured to secure the plurality of valve leaflets 225 to the frame 205. The plurality of crosslinking posts 220 can be circumferentially distributed around the frame 205 and can include a plurality of upright posts extending towards the outflow end portion 210. In some embodiments, the plurality of crosslinking posts 220 can be an extension of the frame 205. The plurality of crosslinking posts 220 can include any suitable metal, polymer, plastic, bioprosthetic tissue, suture material, or other material.

[0114] The plurality of valve leaflets 225 can be configured to regulate blood flow through the artificial heart valve 200. In the illustrated embodiment, the plurality of valve leaflets 225 can include three valve leaflets arranged to be folded in a tricuspid valve configuration. However, other embodiments of the artificial heart valve 200 can include three valve leaflets arranged to be folded in a different configuration, or can include a different number of valve leaflets (e.g., two valve leaflets, etc.).

[0115] Each of the plurality of valve leaflets 225 can include two lateral portions 224. Each lateral portion 224 can define an edge that extends from the inflow end portion 215 toward the outflow end portion 210. The lateral portions 224 can be aligned with and fixed to the plurality of interconnecting posts 220. For example, each of the two lateral portions 224 can be fixed to one of the adjacent corresponding ones of the plurality of interconnecting posts 220.

[0116] Each of the plurality of valve leaflets 225 can include an inflow edge portion 226 (which can also be referred to as a biting edge portion) that extends between the two lateral portions 224 on a portion of the valve leaflet 225 closest to the inflow end portion 215. The inflow edge portion 226 can define an undulating, curved, scalloped-shaped edge that generally follows or tracks a portion of the frame 205 in the circumferential direction. The inflow edge portions 226 of the plurality of valve leaflets 225 can also be referred to as a "scallop line".

[0117] Each of the plurality of valve leaflets 225 can further include a free edge portion 228 on a portion of the valve leaflet 225 closest to the outflow end portion 210, between the two lateral portions 224. The free edge portion 228 of each of the plurality of valve leaflets 225 can extend inwardly toward the central flow orifice when the plurality of valve leaflets 225 are in a closed configuration so as to block blood flow through the central flow orifice, and can join or mate with the free edge portions 228 of other valve leaflets. When the plurality of valve leaflets 225 are in an open configuration, the free edge portion 228 of each of the plurality of valve leaflets 225 can generally follow the circumferential direction of a portion of the frame 205 so as not to block blood flow through the central flow orifice.

[0118] The plurality of valve leaflets 225 can be biased or shaped. In some embodiments, the plurality of valve leaflets 225 can be shaped into an open configuration. Shaping the plurality of valve leaflets 225 into an open configuration can beneficially reduce the amount of force required to move the plurality of valve leaflets 225 from a closed configuration to an open configuration, thereby improving the operation of the plurality of valve leaflets 225 between the open and closed configurations during normal valve operation. In other embodiments, the plurality of valve leaflets 225 can be shaped into a closed configuration or an intermediate configuration between the open and closed configurations.

[0119] In some embodiments, the plurality of valve leaflets 225 can be made from a bioprosthetic tissue such as bovine pericardium. For example, the plurality of valve leaflets 225 can be formed by cutting the valve leaflets out of a bovine pericardial sac. However, other embodiments of the plurality of valve leaflets 225 can include any other suitable tissue or material. The bioprosthetic tissue can be treated or dehydrated so that the artificial heart valve 200 can be stored in a non-aqueous environment, i.e., not stored in a liquid preservative, prior to surgical implantation. Further, the bioprosthetic tissue can be sterilized to prevent the growth of microorganisms or fungi.

[0120] In some embodiments, the artificial heart valve 200 can include one or more skirts mounted around the frame 205. For example, as shown in FIG. 6, the artificial heart valve 200 can include an outer skirt 230 mounted around the outer surface of the frame 205. In the illustrated embodiment, the outer skirt 230 can extend from the inflow end portion 215 to the outflow end portion 210 and / or can cover substantially the entire outer surface of the frame 205. In other embodiments, the outer skirt 230 can cover only a portion of the frame 205 (e.g., the inflow end portion 215). The outer skirt 230 can be configured to function as a sealing member for the artificial heart valve 200 by sealing against the tissue of the natural valve annulus (or, if the artificial valve 200 is secured within a docking device, against the docking device, e.g., 52) and serving to reduce paravalvular leakage through the artificial heart valve 200.

[0121] In some cases, an inner skirt (e.g., similar to 330 shown in FIG. 7) can be mounted around the inner surface of the frame 205. The inner skirt functions as a sealing member to prevent or reduce perivalvular leakage, fix a plurality of valve leaflets 225 to the frame 205, and / or protect the plurality of valve leaflets 225 from damage caused by contact with the frame 205 during crimping and the operating cycle of the artificial heart valve 200. In some embodiments, the inflow edge portions of the plurality of valve leaflets 225 can be sutured to the inner skirt substantially along scallop lines. The inner skirt can then be sutured to the frame 205. In other embodiments, the plurality of valve leaflets 225 can be sutured directly to the frame 205.

[0122] The inner skirt and the outer skirt can be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials, such as a fabric (e.g., a polyethylene terephthalate fabric), or natural tissue (e.g., pericardial tissue).

[0123] In certain embodiments, an identification tag (not shown) can be fixed to the frame 205, for example, by suture. The identification tag can provide a serial number representing information regarding other details of its manufacture, such as the type and date of the heart valve.

[0124] FIG. 7 shows an exemplary artificial heart valve 300 according to another embodiment. As shown, the artificial heart valve 300 can include a frame 305, a plurality of valve leaflets 325, and an inner skirt 330. The frame 305 can include a plurality of interconnecting posts 320 configured to fix the plurality of valve leaflets 325. Although three valve leaflets 325 are shown in FIG. 7, it should be understood that the artificial heart valve 300 can have a different number of valve leaflets (e.g., two valve leaflets). Other embodiments of the artificial heart valve 300 can include additional or alternative components.

[0125] In the illustrated embodiment, each of the plurality of valve leaflets 325 may include a free edge portion 328 disposed toward the outflow end portion 310 of the artificial heart valve 300, and the free edge portion is between two lateral portions 324. Each of the two lateral portions 324 extending between the inflow end portion 315 and the outflow end portion 310 of the frame 305 may be fixed to corresponding adjacent portions of the plurality of commissural posts 320, while the free edge portion 328 may remain unattached to the plurality of commissural posts 320 or the frame 305.

[0126] The inner skirt 330 may be mounted around the inner surface of the frame 305. Similarly, the inner skirt 330 may be configured to function as a sealing member to prevent or reduce paravalvular leakage, anchor the plurality of valve leaflets 325 to the frame 305, and / or protect the plurality of valve leaflets 325 from damage caused by contact with the frame 305 during crimping and during the working cycle of the artificial heart valve 300. Although not shown, the artificial valve 300 may include an outer skirt (e.g., similar to 230 shown in FIG. 6) mounted around the outer surface of the frame 305.

[0127] In the illustrated embodiment, each of the plurality of valve leaflets 325 may be biased or shaped into an open configuration in which the free edge portion of each of the plurality of valve leaflets 325 can substantially follow or track the frame 305 circumferentially. In some embodiments, each of the plurality of valve leaflets 325 may form a generally bell-shaped curve, the tip of the bell-shaped curve may extend outwardly toward the periphery of the frame 305, and each end portion of the bell-shaped curve may terminate at one of the plurality of commissural posts 320.

[0128] In some embodiments where the artificial heart valve 300 is implanted in the native mitral annulus, biasing or shaping the plurality of valve leaflets 325 in the open configuration may effectively reduce the amount of force required to open the plurality of valve leaflets 325, thereby facilitating the actuation of the plurality of valve leaflets 325 from the closed configuration to the open configuration.

[0129] However, in other embodiments, the artificial heart valve 300 can be implanted into the aortic valve annulus of a patient's heart or any other suitable valve annulus. When the artificial heart valve 300 is implanted within the aortic valve annulus, the plurality of valve leaflets 325 can be biased or shaped into a closed configuration in which each free edge portion of the plurality of valve leaflets 325 extends within a central flow orifice formed by the frame 305. The plurality of valve leaflets 325 in the closed configuration can block blood flow through the central flow orifice formed by the frame 305. In these embodiments, biasing or shaping the plurality of valve leaflets 325 in the closed configuration can help counter the pressure gradient across the aortic valve annulus that tends to force the plurality of valve leaflets 325 into an open configuration.

[0130] In any of the embodiments described herein, the artificial heart valve 200 and / or 300 can be implanted directly into the target implantation site. In other embodiments, the artificial heart valve 200 and / or 300 can be deployed and secured within a docking device (e.g., 52) that is implanted into the target implantation site. For example, the artificial heart valve 200 and / or 300 can be implanted (with or without a docking device) into the native mitral valve annulus, native aortic valve annulus, tricuspid valve annulus, pulmonary valve annulus, and / or other native valve sites.

[0131] Further details of various artificial heart valves and their components are described, for example, in U.S. Patent No. 9,393,110, U.S. Patent No. 9,339,384, U.S. Patent No. 9,155,619, U.S. Patent No. 8,652,202, and U.S. Patent No. 6,730,118, U.S. Patent Application Publication No. 2020 / 0352711, U.S. Patent Application Publication No. 2019 / 0374337, U.S. Patent Application Publication No. 2019 / 0192296, U.S. Patent Application Publication No. 2019 / 0046314, U.S. Patent Application Publication No. 2018 / 0206982, U.S. Patent Application Publication No. 2018 / 0153689, and International Publication No. 2021 / 188476 and International Publication No. 2020 / 247907, the disclosures of which are hereby incorporated by reference in their entireties for all purposes.

[0132] Exemplary Delivery Devices Figures 8-12 illustrate an exemplary delivery device 400 configured to deliver an implant device (e.g., an artificial organ such as the docking devices 52 and 100 described above) to a target implantation site (e.g., the heart and / or natural valve of an animal, human, cadaver, and / or the same species). In some embodiments, the delivery device 400 can be a transcatheter delivery device that can be used to guide the delivery of the docking device 401 through a patient's vasculature, as described above with reference to FIGS. 1-4. The docking device 401 can be the docking device 100 described above with reference to FIG. 5. In other embodiments, the delivery device 400 can be used to guide the delivery of an artificial valve (e.g., 200, 300) or other artificial implant.

[0133] Referring again to FIGS. 8-12, the delivery device 400 can include a pusher shaft 402, a sleeve shaft 404, and a delivery shaft 406, all of which are coaxial about a central longitudinal axis 408.

[0134] As shown in FIG. 8, the pusher shaft 402 can extend through the inner lumen 406i of the delivery shaft 406. The delivery shaft 406 can surround at least the distal portion of the pusher shaft 402. When navigating through a patient's vasculature, the docking device 401 can be held at the distal end portion of the delivery shaft 406 in a substantially straight delivery configuration. The pusher shaft 402 can be positioned proximal to the docking device 401. The distal end 402d of the pusher shaft 402 can abut the docking device 401 or be spaced apart from the docking device 401. After reaching the target implantation side, the pusher shaft 402 can be used to deploy the docking device 401 from the delivery shaft 406. Without restraint of the delivery shaft 406, the docking device 401 can return to the deployed configuration, as described above.

[0135] In certain embodiments, deploying the docking device 401 from the delivery shaft 406 can be accomplished by operating the pusher shaft 402 in the distal direction while holding the delivery shaft 406 in place, retracting the delivery shaft 406 in the proximal direction while holding the pusher shaft 402 in place, or pushing the pusher shaft 402 in the distal direction while retracting the delivery shaft 406 in the proximal direction. As a result, the docking device 401 can be pushed out from the distal end of the delivery shaft 406 and, thus, changes from the delivery configuration to the deployed configuration.

[0136] In certain embodiments, the delivery device 400 may further include a dock sleeve 418 that is connected to or is the distal portion of the sleeve shaft 404. The dock sleeve 418 may have a lubricious outer surface. The dock sleeve 418 may be configured to cover the docking device 401 while being held inside the delivery shaft 406. In some embodiments, the dock sleeve 418 may have a tubular structure with an inner diameter sufficient to surround the docking device 401 and an outer diameter small enough to be held within and axially movable within the delivery shaft 406. The length of the dock sleeve 418 may be configured to cover at least the entire length of the docking device 401.

[0137] In certain embodiments, when deploying the docking device 401 from the delivery sheath 406, the pusher shaft 402 and the sleeve shaft 404 can be configured to move axially together (at least initially) with the docking device 401. For example, when actuating the pusher shaft 402 to push against the docking device 401 and move it out of the delivery sheath 406, the sleeve shaft 404 can move with the pusher shaft 402 and the docking device 401. As such, the docking device 401 can remain covered by the dock sleeve 418 during the procedure of pushing the docking device 401 to the location of the target implantation site via the pusher shaft 402. Therefore, when the docking device 401 is initially deployed at the target implantation site, the smooth dock sleeve 418 can facilitate the covered docking device 401 surrounding the natural anatomical structure.

[0138] The pusher shaft 402 and the sleeve shaft 404 can also be actuated independently of each other. For example, the sleeve shaft 404 can be extended and / or folded axially over the pusher shaft 402, as further described below. Therefore, after confirming that it is desirable for the docking device 401 to be positioned at the target implantation site, the dock sleeve 418 can be retracted proximally to expose the docking device 401.

[0139] As will be further described below, the dock sleeve 418 can be connected to the sleeve shaft 404 such that by axially extending or retracting the sleeve shaft 404, the dock sleeve 418 can be moved distally to cover the docking device 401 or proximally to expose the docking device 401. In some embodiments, the sleeve shaft 404 and the dock sleeve 418 can be fixed in place. In such a situation, the docking device 401 can be moved distally or proximally relative to the sleeve shaft 404 such that the docking device is respectively exposed or covered by the dock sleeve 418. In certain embodiments, the dock sleeve 418 can be an integral part (e.g., the distal end portion) of the sleeve shaft 404.

[0140] As described herein, the sleeve shaft 404 can comprise a telescoping section that includes a plurality of nested shaft members 412, 414 (which may also be referred to as "shaft segments"). Specifically, the sleeve shaft 404 can include a fixed shaft member 412 that is fixedly attached (e.g., by welding, adhesive, mechanical fastener, or the like) around the proximal portion 402p of the pusher shaft 402. The sleeve shaft 404 can also include one or more movable shaft members 414a, 414b, 414c, 414d, etc. (collectively 414) that are coaxial with and axially movable relative to the fixed shaft member 412 and the pusher shaft 402.

[0141] As shown in FIGS. 8-12, the delivery shaft 406 can be positioned distally of the fixed shaft member 412 of the sleeve shaft 404. In certain embodiments, the proximal end 412p of the fixed shaft member 412 can be positioned distally of the proximal end 402p of the pusher shaft 402. In certain embodiments, at least a portion of one or more of the movable shaft members 414 are configured to be axially extensible within the inner lumen 406i of the delivery shaft 406 (see, e.g., FIGS. 8, 9A, 10A, and 12A and 12B).

[0142] In the embodiment shown in FIGS. 8-12, the fixed shaft member 412 is the outermost shaft member (which may also be referred to as the "outer shaft member"), and one or more movable shaft members 414 are inner shaft members that can be held within the fixed shaft member 412. That is, the fixed shaft member 412 has an inner diameter that is larger than that of one or more movable shaft members 414 (at least along most of its length).

[0143] As shown, the sleeve shaft 404 may include the innermost shaft member 414a having the minimum diameter of the movable shaft members. The pusher shaft 402 may extend through the inner lumen 415 of the innermost shaft member 414a. In the embodiment shown, the sleeve shaft 404 includes one or more intermediate shaft members (e.g., 414b, 414c, 414d, etc.) coaxially disposed between the innermost shaft member 414a and the fixed shaft member 412. In other embodiments, the sleeve shaft 404 may include only one fixed shaft member (e.g., 412) and one movable shaft member (e.g., 414a) without an intermediate shaft member disposed therebetween.

[0144] The delivery device 400 may include an actuating mechanism (more fully described below) configured to axially move one or more movable shaft members 414 relative to the fixed shaft member 412 such that the sleeve shaft 404 can move axially between an extended configuration and a folded configuration. As an example, FIGS. 9A and 9B show the sleeve shaft 404 in a fully extended configuration, FIGS. 11A-11C show the sleeve shaft 404 in a folded configuration, and FIGS. 10A and 10B show the sleeve shaft 404 in an intermediate or partially extended configuration. Accordingly, the axial length of the sleeve shaft 404 may gradually increase from the folded configuration to the partially extended configuration and then to the fully extended configuration.

[0145] As shown in FIG. 11A, when the sleeve shaft 404 is in a folded configuration, each of the one or more movable shaft members 414 can be substantially received within the fixed shaft member 412. As described herein, a movable shaft member is considered to be substantially received within the fixed shaft member 412 when the axial length of the movable shaft member covered by the fixed shaft member 412 is greater than a predetermined percentage (e.g., 80%, 90%, 95%, etc.) of the axial length of the movable shaft member. As an example, when the sleeve shaft 404 is in a folded configuration, each of the movable shaft members 414 can be completely retained within the fixed shaft member 412 such that the movable shaft members are not exposed. As another example, when the sleeve shaft 404 is in a folded configuration, only the distal tip / end of each of the respective movable shaft members 414 can be exposed while the body portion of each of the respective movable shaft members 414 is retained within the fixed shaft member 412.

[0146] As shown in FIG. 9A, when the sleeve shaft 404 is in a fully extended configuration, each of the one or more movable shaft members 414 can extend substantially outwardly from the fixed shaft member 412. For example, the one or more movable shaft members 414 can be configured such that a movable shaft member having a smaller diameter extends to a more distal position than another movable shaft member having a larger diameter.

[0147] In certain embodiments, each of the one or more movable shaft members 414 can have a lubricant coating on its outer surface. In certain embodiments, the fixed shaft member 412 and the intermediate shaft members (e.g., 414b, 414c, 414d, etc.) can each have a lubricant coating on their respective inner surfaces. The lubricant coating can facilitate the axial movement of the movable shaft member 414.

[0148] In certain embodiments, the dock sleeve 418 can be fixedly attached or joined to the distal end 413 of the innermost shaft member 414a. In certain embodiments, the dock sleeve 418 can overlap a portion of the innermost shaft member 414a (e.g., the proximal end portion of the dock sleeve 418 can cover the distal end 413 of the innermost shaft member 414a). In some embodiments, the dock sleeve 418 can have a diameter substantially the same as the innermost shaft member 414a. In other embodiments, the dock sleeve 418 can have a diameter larger or smaller than the innermost shaft member 414a. In certain embodiments, the dock sleeve 418 can be an integral part (e.g., the distal end portion) of the innermost shaft member 414a.

[0149] Accordingly, by axially extending or shortening the sleeve shaft 404 (e.g., by axially moving one or more of the movable shaft members 414), the dock sleeve 418 can cover or expose the docking device 401. Alternatively, when the sleeve shaft 404 and the dock sleeve 418 are fixed in place, by advancing the docking device 401 distally or retracting the docking device 401 proximally, the docking device 401 can be respectively exposed or covered by the dock sleeve 418.

[0150] For example, FIG. 9B shows the docking device 401 first deployed out of the delivery shaft 406. In this configuration, the sleeve shaft 404 is in the fully extended configuration as shown in FIG. 9A, and the docking device 401 is covered by the dock sleeve 418. FIG. 10B shows the deployed docking device 401 partially covered by the dock sleeve 404. In this configuration, the sleeve shaft 404 is in a partially extended configuration as shown in FIG. 10A. As a result, while the distal portion of the docking device 401 is exposed, the proximal portion of the docking device 401 remains covered by the dock sleeve 418. FIG. 11B shows the deployed docking device 401 fully exposed by the dock sleeve 418. In this configuration, the sleeve shaft 404 is in the folded configuration as shown in FIG. 11A. As a result, the dock sleeve 418 is retracted back into the delivery shaft 406, thereby exposing the docking device 401, as well as the release suture 403 connected to the docking device 401.

[0151] In certain embodiments, the dock sleeve 418 can be configured to be more flexible and / or have a lower durometer than the movable shaft member 414. If the dock sleeve 418 is an integral or distal end portion of the innermost shaft member 414a, the dock sleeve 418 can be configured to have a lower durometer than the proximal end portion of the innermost shaft member 414a. In certain embodiments, the shaft members 412, 414 can include a relatively more rigid metallic material (e.g., stainless steel, etc.) and can be constructed as a hypodermic tube. The dock sleeve 418 can include a polymeric material such as a low durometer thermoplastic elastomer (e.g., PTFE, chloroprene, santoprene, tecothane, etc.). In certain embodiments, the dock sleeve 418 can be joined to the innermost shaft member 414a through a reflow process. In some embodiments, the dock sleeve 418 can have a hydrophilic coating, which can act as a smooth surface, improve the ease of surrounding natural anatomical structures, and reduce the risk of damage to natural tissue.

[0152] An additional embodiment of the docking sleeve 418 is further described in U.S. Provisional Application No. 63 / 138,910, which is hereby incorporated by reference in its entirety.

[0153] Alternatively, the fixed shaft member may have a diameter smaller than one or more of the movable shaft members. For example, the innermost shaft member can be the fixed shaft member, while the outermost shaft member and intermediate shaft members (if any) can be the movable shaft members. In such a case, the pusher shaft 402 may extend through the lumen of the fixed shaft member. The docking sleeve 418 can be connected to the distal end of the outermost shaft member. In certain embodiments, the docking sleeve 418 can be an integral part (e.g., a distal end portion) of the outermost shaft member. Similarly, one or more movable shaft members surrounding the fixed shaft member can be moved progressively to a more distal position relative to the fixed shaft member (i.e., moved to the extended configuration), or proximally such that the movable shaft members substantially surround the fixed shaft member (i.e., moved to the folded configuration). Also, while the embodiments of FIGS. 8-12 show the outermost shaft member as the fixed shaft member and the inner shaft members as the movable shaft members, it should be understood that the same principles described herein apply when the innermost shaft member is the fixed shaft member and the outer shaft members are the movable shaft members.

[0154] In certain embodiments, the delivery device 400 can include a suture lock 410 connected to the proximal end 402p of the pusher shaft 402. The suture lock 410 can be configured to be removably connected to the docking device 401 via a release suture 403 that extends through the lumen 402i of the pusher shaft 402, for example. The suture lock 410 can also include a cutting mechanism configured to cut the release suture 403 to release, remove, disconnect, and / or otherwise separate the docking device 401 from the delivery device 400.

[0155] As shown in FIGS. 8-12, the suture lock 410 can be configured to be in line with the pusher shaft 402 and the sleeve shaft 404. In certain embodiments, the suture lock 410 can be removably connected to the pusher shaft 402 via a locking and releasing mechanism such as a rotatable release knob. When connected, the axial distance between the suture lock 410 and the fixed shaft member 412 can be fixed.

[0156] Further details regarding the suture lock are described in International Patent Application PCT / US2020 / 36577 and International Patent Application PCT / US2021 / 056150. Additional embodiments of the locking and releasing mechanism for the suture lock are described in Provisional U.S. Patent Application No. 63 / 362,996 and Provisional U.S. Patent Application No. 63 / 366,733, which are hereby incorporated by reference in their entirety.

[0157] As shown in FIGS. 9A, 10A, 11A, and FIGS. 12A and 12B, the delivery device 400 can further include a handle 420 (omitted in FIG. 8 for simplicity). The pusher shaft 402 can extend through the handle 420. The proximal portion of the delivery shaft 406 can be connected to the handle 420. In certain embodiments, the proximal end 406p of the delivery shaft 406 can extend proximally outward from the handle 420. In other embodiments, the proximal end 406p of the delivery shaft 406 can terminate inside the handle 420.

[0158] Since the fixed shaft member 412 is fixedly mounted on the pusher shaft 402, the axial distance between the suture lock 410 and the handle 420 can also remain fixed (or at least substantially fixed) unless the pusher shaft 402 moves axially relative to the handle 420. Thus, the telescoping movement of the movable shaft member 414 relative to the fixed shaft member 412 does not affect the overall length of the delivery device 400.

[0159] The fixed shaft member 412 can be positioned proximal to the handle 420, and one or more movable shaft members 414 can be configured to be axially extensible within the handle 420. For example, when the sleeve shaft 404 is in an axially extended configuration, the innermost shaft member 414a can extend into the handle 420 (and the inner lumen 406i of the delivery shaft 406). When the sleeve shaft 404 is in an axially folded configuration, the innermost shaft member 414a can be positioned proximal to the handle 420.

[0160] In certain embodiments, the handle 420 can include one or more actuators configured to adjust the position and / or curvature of the pusher shaft 402, the sleeve shaft 404, and / or the delivery shaft 406. For example, the handle 420 can include one or more rotatable knobs 422 (or buttons, wheels, etc.) configured to selectively bend the distal portion of the delivery shaft 406 to facilitate navigating the delivery shaft 406 through the patient's vasculature during an implantation procedure.

[0161] The handle 420 can further include one or more actuation mechanisms configured to adjust the axial positions of the pusher shaft 402, the sleeve shaft 404, and / or the delivery shaft 406 relative to each other. For example, as will be more fully described below, the handle 420 can include an actuation mechanism configured to move the sleeve shaft 404 between an axially folded configuration and an axially extended configuration.

[0162] As shown in FIGS. 8-12, all of the various components of the delivery device 400 including the pusher shaft 402, the sleeve shaft 404, the delivery shaft 406, the handle 420, and the suture lock 410 can be arranged to extend along the longitudinal axis 408.

[0163] In certain embodiments, the delivery device 400 can include one or more cleaning ports (e.g., 452, 454, 456) configured to supply cleaning and / or anticoagulant fluid to different parts of the delivery device 400. In certain embodiments, at least a portion of the cleaning port (e.g., 456) can be connected and / or positioned to the handle 420 as further described below.

[0164] Additional details regarding the handle of the delivery device are described in International Patent Application PCT / US2020 / 36577 and International Patent Application PCT / US2021 / 056150.

[0165] Exemplary actuation mechanisms Figures 12-14 depict several exemplary actuation mechanisms that can move one or more movable shaft members 414 distally (e.g., toward the distal end 402d of the pusher shaft 402) continuously or telescopically relative to the fixed shaft member 412 such that the dock sleeve 418 can cover the docking device 401. Further, the actuation mechanisms shown can move / retract one or more movable shaft members 414 proximally relative to the fixed shaft member 412 continuously or telescopically such that the dock sleeve 418 can be removed from the docking device 401. The actuation mechanism can be mounted on the handle 420. In certain embodiments, any of the actuation mechanisms described herein can include a motor operably coupled to one or more movable shaft members 414. In other embodiments, the actuation mechanism can be manually operated without a motor.

[0166] For example, by operating the actuation mechanism, one or more movable shaft members 414 can be continuously moved in the distal direction such that the distal ends of the one or more movable shaft members 414 move progressively further distally along and across the pusher shaft 402. As a result, the dock sleeve 418 can also be moved distally to cover the docking device 401 (see, e.g., FIGS. 9A and 9B). Conversely, the actuation mechanism can be operated to move the one or more movable shaft members 414 in the proximal direction until they are substantially received within the fixed shaft member 412. As a result, the dock sleeve 418 can also be moved proximally to expose the docking device 401 (see, e.g., FIGS. 11A and 11B).

[0167] In certain embodiments, the actuation mechanism can include at least one rotary actuator operably connected to the one or more movable shaft members 414. Rotating the at least one rotary actuator in a first direction can move the sleeve shaft 404 telescopically from an axially folded configuration to an axially extended configuration, while rotating the at least one rotary actuator in a second direction opposite the first direction can move the sleeve shaft telescopically from the axially extended configuration to the axially folded configuration.

[0168] In certain embodiments, the at least one rotary actuator can be configured to rotationally engage the sleeve shaft 404, e.g., one or more movable shaft members 414, at a distal location of the fixed shaft member 412.

[0169] As an example, FIGS. 12A and 12B show two rollers 424a, 424b that function as rotary actuators. Although two rollers 424a, 424b are shown in this embodiment, the delivery device 400 can include more or fewer rollers in other instances. In certain embodiments, the rollers 424a, 424b can be positioned distally of the fixed shaft member 412 and configured to frictionally engage the respective outer surfaces of the movable shaft members 414.

[0170] As shown in FIG. 12A, positioning rollers 424a and 424b in contact with a movable shaft member (e.g., movable shaft member 414), rotating roller 424a counterclockwise, and rotating roller 424b clockwise (as indicated by the arrow) can move the movable shaft member proximally relative to the fixed shaft member 412, and thus move the sleeve shaft 404 proximally relative to the pusher shaft 402. Conversely, as shown in FIG. 12B, positioning rollers 424a and 424b in contact with the movable shaft member, rotating roller 424b clockwise, and / or rotating roller 424a counterclockwise (as indicated by the arrow) can move the movable shaft member distally relative to the fixed shaft member 412, and thus move the sleeve shaft 404 distally relative to the pusher shaft 402.

[0171] One or more movable shaft members 414 can be moved sequentially. For example, to move the sleeve shaft 404 from a folded configuration to an extended configuration, rollers 424a and 424b can first frictionally engage and move the innermost shaft member 414a distally. After the innermost shaft member 414a is fully extended, rollers 424a and 424b can frictionally engage an intermediate shaft member (e.g., 414b, 414c, 414d, etc.) that immediately surrounds the innermost shaft member 414a and move it distally. Thereafter, rollers 424a and 424b can frictionally engage and move, one by one (e.g., in order of increasing diameter of the shaft members), other nested intermediate shaft members (if present) until all movable shaft members 414 extend to their most distal positions, respectively.

[0172] Conversely, to move the sleeve shaft 404 from the extended configuration to the folded configuration, the rollers 424a, 424b can first frictionally engage an intermediate shaft member immediately surrounded by the fixed shaft member 412 and move it in the proximal direction. After the intermediate shaft member is received in the fixed shaft member 412, the rollers 424a, 424b can then frictionally engage (one by one, for example, in the order of decreasing diameter of the shaft members) the other nested intermediate shaft members (if any) and the innermost shaft member 414a until all the movable shaft members 414 are substantially received within the fixed shaft member 412 and move them.

[0173] The rollers 424a, 424b can be configured to accommodate movable shaft members 414 of various diameters. In a particular embodiment, the biasing mechanism can be coupled to the rollers 424a, 424b such that when the rollers 424a, 424b are in a non-biased state, the radial distance between the rollers 424a, 424b is approximately the same as, or smaller than, the outer diameter of the innermost shaft member 414a. The biasing mechanism can bias the rollers 424a, 424b radially inward toward the outer diameter of any movable shaft member 414 in which they are located.

[0174] For example, when moving the innermost shaft member 414a, the rollers 424a, 424b can engage the outer surface of the innermost shaft member 414a under the biasing force. When moving an intermediate shaft member having an outer diameter larger than that of the innermost shaft member 414a (e.g., 414b, 414c, etc.), the rollers 424a, 424b can be biased into a biased state due to an increase in the radial distance between the rollers 424a, 424b. As a result, the rollers 424a, 424b can push radially inward against the outer surface of the intermediate shaft member under the biasing force. Thus, the rollers 424a, 424b can remain in contact with the outer surface of the movable shaft member 414 regardless of their various diameters.

[0175] In certain embodiments, the biasing mechanism may include springs directly attached to rollers 424a, 424b, respectively. In other embodiments, the biasing mechanism may include springs attached to respective arms that are further connected to rollers 424a, 424b.

[0176] The rotary actuator can take other forms as long as it can convert the rotational movement of one object into the axial movement of one or more movable shafts 414.

[0177] As an example, FIG. 13A shows a nut 426 that can be configured as a rotary actuator. Each of the movable shaft members 414 may have a male thread 428 configured to mate and engage with the female thread of the nut 426. The nut 426 can rotate freely but can be configured to be axially fixed at a distal position of the fixed shaft member 412. Thus, the movable shaft member 414 can function as a lead screw, and when the nut 426 rotates, a corresponding axial movement of the movable shaft member 414 can occur. In some embodiments, the nut 426 may have an elastically constricted inner bore such that the nut 426 can threadably engage one or more movable shaft members 414 having different diameters. For example, the inner bore of the nut 426 can be enlarged to threadably engage a movable shaft member having a larger diameter, or vice versa.

[0178] As another example, FIG. 13B shows a circular gear 430 (also referred to as a "pinion gear") that can be configured as a rotary actuator. Each of the movable shaft members 414 can have external teeth 432 configured to engage and mate with the teeth 431 of the gear 430. The gear 430 can be configured to rotate freely but axially fixed at a distal position of the fixed shaft member 412. Thus, the movable shaft member 414 can function as a linear gear or rack, and when the gear 430 rotates, a corresponding axial movement of the movable shaft member 414 can occur. In some embodiments, the gear 430 can be configured to bias radially inwardly towards the pusher shaft 402 such that the gear 430 can engage to fit one or more movable shaft members 414 having different diameters. For example, the gear 430 can move slightly closer to the pusher shaft 402 and engage and fit with a movable shaft member having a smaller diameter, or vice versa.

[0179] As another example, FIG. 13C shows a cam 434 that can be configured as a rotary actuator. The cam 434 can be an eccentric disk or can have other shapes and can be configured to contact the proximal end of a movable shaft member (e.g., 414). Thus, the rotational movement of the cam 434 can be converted into an axial movement of the movable shaft member.

[0180] As yet another example, FIG. 13D shows a rotatable drive shaft 436 that can be configured as a rotary actuator. The rod 438 can have a first end hingedly connected to the drive shaft 436 and another end connected to one of the movable shaft members (e.g., 414). Thus, the rotational movement of the drive shaft 436 can be converted into an axial movement of the movable shaft member.

[0181] In certain embodiments, the actuation mechanism may include at least one linear actuator operably connected to one or more movable shaft members 414. Moving or translating the at least one linear actuator in a first direction can move the sleeve shaft 404 telescopically from an axially folded configuration to an axially extended configuration, while moving or translating the at least one linear actuator in a second direction opposite the first direction can move the sleeve shaft 404 from an axially extended configuration to an axially folded configuration.

[0182] The linear actuator can take various forms as long as the linear motion of one object can cause the axial motion of one or more movable shaft members 414.

[0183] As an example, FIG. 14A shows two grippers 440a, 440b that can function as a linear actuator. In this embodiment, two grippers 440a, 440b are shown, but the delivery device 400 may include more or fewer grippers in certain cases. In certain embodiments, the grippers 440a, 440b may be positioned distally of the fixed shaft member 412 and may be axially movable relative to the fixed shaft member 412.

[0184] The grippers 440a, 440b may be configured to frictionally engage the outer surface of the movable shaft member 414 when the grippers 440a, 440b are radially compressed (as shown by the dotted lines 440a', 440b' in FIG. 14A). The grippers 440a, 440b may also be removable from the movable shaft member when the grippers 440a, 440b are not radially compressed (e.g., by a biasing spring mechanism or the like) (as shown by the solid lines 440a, 440b in FIG. 14A). The radial movement of the grippers 440a, 440b is indicated by the vertical arrows in FIG. 14A.

[0185] Accordingly, the grippers 440a, 440b contact the outer surface of the movable shaft member, and then, until the grippers 440a, 440b are moved in the distal or proximal direction, by pushing radially inward, the movable shaft member can also be moved in the distal or proximal direction. After releasing the pressure, the grippers 440a, 440b can be removed from the movable shaft member and can be moved to another axial position to move another movable shaft member. The axial movement of the grippers 440a, 440b is indicated by the horizontal arrows in FIG. 14A. For example, the distal end of the shaft 414 can move from P1 to P2 when the grippers 440a, 440b grip the shaft 414 and move in the distal direction, or can move reversely from P2 to P1 when the grippers 440a, 440b grip the shaft 414 and move in the proximal direction.

[0186] As another example, FIG. 14B shows a slider 442 that can be configured as a linear actuator. In a particular example, the slider 442 can be a thin rigid rod fixedly connected to a movable shaft member (e.g., 414) and axially movable relative to the fixed shaft member 412. Accordingly, by pushing the slider 442 in the distal direction or pulling the slider 442 in the proximal direction, the movable shaft member can also be moved distally or proximally accordingly.

[0187] In a particular example, the actuating mechanism can include at least one biasing member operably connected to one or more movable shaft members 414. In a particular example, the biasing member can be configured to elastically bias the movable shaft member (e.g., 414) axially toward the fixed shaft member 412 when the movable shaft member is positioned distally relative to the fixed shaft member. In such a case, the sleeve shaft 404 is biased to a folded configuration. In other examples, the biasing member can be configured to elastically bias the movable shaft member (e.g., 414) axially away from the fixed shaft member 412 when the movable shaft member is positioned / inserted within the fixed shaft member 412. In such a case, the sleeve shaft 404 is biased to an extended configuration.

[0188] As an example, FIG. 14C shows a spring 444 that can function as a biasing member. In a particular embodiment, one end of the spring 444 can be connected to the proximal end of a movable shaft member (e.g., 414), and another end of the spring 444 can be connected to a component 446 within the handle 420. When the spring 444 is in an un-biased state, the spring 444 can have a rest or equilibrium length.

[0189] In a particular embodiment, the spring 444 can be moved to a biased state by axially extending the spring 444 such that it has a length greater than its rest length. Axial extension of the spring 444 can push the connected movable shaft member in the distal direction. When the spring 444 returns to an un-biased state (i.e., its rest length), the connected movable shaft member can be pulled in the proximal direction.

[0190] In other embodiments, the spring 444 can be moved to a biased state by axially compressing the spring 444 such that it has a length less than its rest length. Axial compression of the spring 444 can pull the connected movable shaft member in the proximal direction. When the spring 444 returns to an un-biased state (i.e., its rest length), the connected movable shaft member can be pushed in the distal direction.

[0191] In still other embodiments, the biasing member can be configured as and / or coupled with a sealing member (e.g., 462, 464) as further described below with reference to FIGS. 15A and 15B and FIGS. 16A and 16B.

[0192] In a particular embodiment, the sleeve shaft 404 can further include a locking mechanism configured to lock the sleeve shaft 404 in an axially extended configuration. Such a locking mechanism can prevent the axially extended sleeve shaft 404 from being accidentally folded into an axially folded configuration, for example, when moving the pusher shaft 402 and the sleeve shaft 404 together during initial deployment of the docking device 401.

[0193] In some embodiments, the locking mechanism may be based on the inherent frictional force present between the movable shaft members 414. For example, the above-described sealing members (e.g., 462, 464) can provide frictional resistance to relative axial movement between the movable shaft members 414.

[0194] In some embodiments, the slider 442 shown in FIG. 14B can be configured as a locking mechanism. For example, by holding the slider 442 stationary relative to the fixed shaft member 412, the axial position of the movable shaft member 414 can be fixed relative to the fixed shaft member 412.

[0195] In some embodiments, the locking mechanism may include a peg and slot configuration. For example, the first movable shaft member may have a radially projecting peg received within a slot of the second movable shaft member. The slot may have an axial slot portion and a circumferential slot portion located at the distal end of the second movable shaft member. The peg can move within the axial slot portion such that the first movable shaft member can move axially relative to the second movable shaft member. When the sleeve shaft 404 is in an axially extended configuration, if the first movable shaft member rotates relative to the second movable shaft member, the peg can move into the circumferential slot portion, thereby preventing axial movement of the first movable shaft member relative to the second movable shaft member until the peg is moved back into the axial slot portion.

[0196] In some embodiments, the locking mechanism may include mating threads. For example, the first movable shaft member may have a proximal threaded portion, and the second movable shaft member immediately adjacent to the first movable shaft member may have a distal threaded portion. When the sleeve shaft 404 is in the axially extended configuration, the proximal threaded portion of the first movable shaft member may engage the distal threaded portion of the second movable shaft member. Thus, when the first movable shaft member is rotated relative to the second movable shaft member, the first movable shaft member and the second movable shaft member may be threadably engaged, thereby preventing the first movable shaft member from sliding axially relative to the second movable shaft member until the proximal threaded portion is disengaged from the distal threaded portion.

[0197] In addition to and / or instead of the locking mechanism described above, other locking mechanisms known in the art may be included in the sleeve shaft 404.

[0198] Exemplary fluid ports The delivery device 400 may include one or more fluid ports configured to supply a flushing fluid (e.g., saline, heparin solution, etc.) into one or more lumens disposed within the delivery device 400 (e.g., an annular lumen disposed between coaxial components of the delivery device 400) to reduce potential thrombus formation.

[0199] In the embodiments shown in FIGS. 8-12, the delivery device 400 has three fluid ports 450, 452, 454 that are fluidly coupled to the respective lumens of the pusher shaft 402, the sleeve shaft 404, and the delivery shaft 406. In some embodiments, additional fluid ports may be included to flush other portions of the delivery device 400.

[0200] For example, fluid port 450 can be fluidly coupled to the inner lumen 402i of pusher shaft 402. In certain embodiments, fluid port 450 can be located near the proximal end 402p of pusher shaft 402. In certain embodiments, a fluid source can be connected to fluid port 450 to inject a cleaning fluid into the inner lumen 402i of pusher shaft 402. The cleaning fluid can flow through the entire length of the inner lumen 402i and can exit at the distal end 402d of pusher shaft 402, as indicated by arrow 451. The flow rate of the cleaning fluid can be adjusted to form a continuous flow within the inner lumen 402i. The inner lumen 402i can be cleaned before inserting the delivery device 400 into a patient's vasculature. Further, when inserting / navigating the delivery device 400 and deploying the docking device 401, a continuous flow of cleaning fluid can be maintained within the inner lumen 402i.

[0201] In some situations, for example, when the distal end 402d of pusher shaft 402 is spaced apart from the docking device 401, the cleaning fluid exiting at the distal end 402d of pusher shaft 402 can also flow into the lumen 418i of the dock sleeve 418 and around the docking device 401 and then exit at the distal end of the dock sleeve 418. Thus, the cleaning fluid introduced through fluid port 450 can also clean the docking device 401. In particular, the fluid flow (e.g., 451) within the inner lumen 402i of pusher shaft 402 is in one direction (i.e., the distal direction) and there is no backflow.

[0202] In certain embodiments, fluid port 452 can be fluidly coupled to the inner lumen 404i of sleeve shaft 404. In certain embodiments, fluid port 452 can be located near the proximal end 412p of fixed shaft member 412. Due to the nested structure of sleeve shaft 404, the inner lumen 404i can include one or more annular spaces 416i (see, e.g., FIGS. 15C and 17) formed between the inner lumen 415 of the innermost shaft member 414a and the movable shaft member 414 and / or the fixed shaft member 412.

[0203] In certain embodiments, the fluid source may be connected to the fluid port 452 and inject a cleaning fluid into the inner lumen 404i of the sleeve shaft 404. The cleaning fluid injected through the fluid port 452 may flow through the entire length of the inner lumen 415 of the innermost shaft member 414a and across the pusher shaft 402. For example, as shown in FIG. 8, the cleaning fluid may flow through a flow path or conduit (e.g., an annular space) formed between the pusher shaft 402 and the innermost shaft member 414a, as indicated by arrow 453.

[0204] Similarly, the flow rate of the cleaning fluid introduced through the fluid port 452 may be adjusted to form a continuous flow within the inner lumen 415. The inner lumen 415 may be cleaned before the delivery device 400 is inserted into the patient's vasculature. Further, when inserting / navigating the delivery device 400 and deploying the docking device 401, a continuous flow of the cleaning fluid may be maintained within the inner lumen 415.

[0205] Since the dock sleeve 418 may be fixedly connected to or an integral part of the innermost shaft member 414a, the cleaning fluid injected into the inner lumen 415 may also flow around the docking device 401 into the lumen 418i of the dock sleeve 418 and then exit at the distal end of the dock sleeve 418. Thus, the cleaning fluid introduced through the fluid port 452 can also clean the docking device 401. Note that the fluid flow within the inner lumen 415 (e.g., 453) is also in one direction (i.e., the distal direction) and there is no backflow.

[0206] Further, the cleaning fluid injected through fluid port 452 can also clean the annular space 416i (see, e.g., FIGS. 15C and 17) formed between the movable shaft member 414 and / or the fixed shaft member 412. As will be further described below, the annular space 416i can be sealed at each distal end such that the cleaning fluid injected through fluid port 452 forms a one-dimensional flow (e.g., 453) only within the annular space formed between the pusher shaft 402 and the innermost shaft member 414a.

[0207] In certain embodiments, fluid port 454 can be fluidly coupled to the inner lumen 406i of delivery shaft 406. In certain embodiments, fluid port 454 can be located near the proximal end 406p of delivery shaft 406.

[0208] In certain embodiments, a fluid source can be connected to fluid port 454 to inject cleaning fluid into the inner lumen 406i of delivery shaft 406. The cleaning fluid injected through fluid port 454 can flow through the entire length of the inner lumen 406i of delivery shaft 406, over the movable shaft member 414 (when inserted into the inner lumen 406i) and / or the dock sleeve 418, as indicated by arrow 455, and exit through the distal end 406d of delivery shaft 406. Thus, the cleaning fluid injected through fluid port 454 can flow in one direction (e.g., distally).

[0209] Similarly, the flow rate of the cleaning fluid introduced through fluid port 454 can be adjusted to form a continuous flow within the inner lumen 406i. The inner lumen 406i can be cleaned prior to inserting the delivery device 400 into a patient's vasculature. Further, a continuous flow of cleaning fluid can be maintained within the inner lumen 406i when inserting / navigating the delivery device 400 and deploying the docking device 401.

[0210] In some embodiments, the flow rates of the cleaning fluids introduced into cleaning ports 450, 452, and 454 may be independently adjusted such that the fluid flows to 402i, 415, and 406i (e.g., as indicated by arrows 451, 453, and 455) may be the same as or different from each other.

[0211] In some embodiments, cleaning ports 450, 452, and 454 may be connected to a common fluid source.

[0212] In certain embodiments, fluid ports 450, 452, and 454 may be configured to be fluidly "separated" from each other, meaning that the fluid flows indicated by arrows 451, 453, and 455 are all confined within their respective inner lumens (e.g., 402i, 415, and 406i) before reaching their respective distal ends (e.g., 402d, 413, 406d). For example, the fluid injected into fluid port 452 can flow through a conduit formed between pusher shaft 402 and the innermost shaft member 414a, but not through the inner lumen 402i of pusher shaft 402. Similarly, the fluid injected into fluid port 454 can flow through a conduit formed between delivery shaft 406 and sleeve shaft 404, but not through the inner lumen 415 of the innermost shaft member 414a.

[0213] Further details regarding a handle of a delivery device having one or more cleaning ports configured to supply a cleaning fluid to one or more lumens disposed within the delivery device are described in International Patent Application No. PCT / US2020 / 36577 and International Patent Application No. PCT / US2021 / 059075.

[0214] Exemplary Sealing Mechanism In certain embodiments, delivery device 400 may include one or more sealing mechanisms configured to prevent leakage of blood, saline, or other fluids through the system.

[0215] As an example, the delivery device 400 may include an annular seal 460 configured to seal between the pusher shaft 402 and the delivery shaft 406. In certain instances, the annular seal 460 can be part of the delivery shaft 406. In certain instances, the annular seal 460 can be located at the proximal end 406p of the delivery shaft 406. Thus, when the sleeve shaft 404 is in an axially folded configuration (e.g., the movable shaft member does not extend into the inner lumen 406i of the delivery shaft 406), the innermost shaft member 414a can be positioned proximal to the annular seal 460.

[0216] In certain embodiments, the annular seal 460 can include an elastically constricted central opening (e.g., the central opening can be elastically biased towards a diameter smaller than the outer diameter of the innermost shaft member 414a). Thus, the annular seal 460 can elastically engage the outer surface of at least one movable shaft member (e.g., 414) when at least one movable shaft member is inserted into the inner lumen 406i of the delivery shaft 406 (e.g., when the sleeve shaft 404 is in a fully or partially extended configuration). In other words, the diameter of the central opening of the annular seal 460 can conform or match different outer diameters of the movable shaft members passing through the annular seal 460, thereby forming a seal between the delivery shaft 406 and the movable shaft members passing through the annular seal. For example, the annular seal 460 can be configured to seal against the outer surface of the innermost shaft member 414a when the innermost shaft member 414a passes through the annular seal 460, and to seal against the outer surface of the intermediate shaft members (e.g., 414b, 414c, 414d, etc.) when the intermediate shaft members pass through the annular seal 460.

[0217] In certain embodiments, the delivery device 400 may also include a sealing member (which may be part of the sleeve shaft 404) configured to seal one or more annular spaces 416i formed between one or more movable shaft members 414 and the fixed shaft member 412. As a result, the cleaning fluid injected through the fluid port 452 may be able to clean but may not exit through the annular space 416i. FIG. 15C schematically shows the annular space 416i and the inner lumen 415 formed within the sleeve shaft 404.

[0218] In certain embodiments, as shown in FIGS. 15A and 15B, the sealing member may include a sealing film 462 extending from the distal end portion 412d of the fixed shaft member 412 to the outer surface of the innermost shaft member 414a, thereby sealing between the fixed shaft member 412 and the outer surface of the innermost shaft member 414a. In the illustrated embodiment, five movable shaft members 414a - 414e are shown. The proximal end 462p of the sealing film 462 can be connected to the outer surface, inner surface, or end portion of the fixed shaft member 412. The distal end 462d of the sealing film 462 can be connected to the innermost shaft member 414a at a position adjacent to the distal end 413, or at an intermediate portion, or a proximal portion of the innermost shaft member 414a. The sealing film 462 can be connected to the fixed shaft member 412 and the innermost shaft member 414a via any means such as thermal bonding, adhesion, stitching, etc. In certain embodiments, the sealing film 462 can be a single piece surrounding the sleeve shaft 404. In other embodiments, the sealing film 462 can include two or more separate components, each of which connects the fixed shaft member 412 to the innermost shaft member 414a.

[0219] In certain embodiments, the sealing membrane 462 may include an elastic material (e.g., plastic, rubber, polytetrafluoroethylene (PTFE), polyether block amide (PEBA), etc.), such that the sealing membrane 462 can extend axially when the innermost shaft member 414a moves distally relative to the fixed shaft member 412 (e.g., when the sleeve shaft 404 moves from an axially folded configuration to an axially extended configuration). For example, compared to FIG. 15A, FIG. 15B shows that the sealing membrane 462 is more axially extended when the innermost shaft member 414a moves in a more distal direction relative to the fixed shaft member 412.

[0220] In certain embodiments, as shown in FIGS. 16A and 16B, the sealing member may include a segmented sealing membrane 464 that extends from the distal end portion 412d of the fixed shaft member 412 to the outer surface of the innermost shaft member 414a. The segmented sealing membrane 464 can be considered a special variation of the sealing membrane 462. For example, in addition to connecting to the fixed shaft member 412 and the innermost shaft member 414a, the segmented sealing membrane 464 can be further connected to one or more intermediate shaft members (e.g., 414b, 414c, 414d, 414e) so as to divide the segmented sealing membrane 464 into a plurality of sealing segments 466, each of which can be configured to seal a corresponding annular space 416i. In certain embodiments, the plurality of sealing segments 466 can be connected to the respective distal end portions of the intermediate shaft members. Similarly, each of the sealing segments 466 can be a single piece or a plurality of pieces surrounding the respective shaft member.

[0221] In certain embodiments, the segmented seal membrane 464 may include an elastic material (e.g., similar to 462) such that each seal segment 466 can axially extend when the sleeve shaft 404 moves from an axially folded configuration to an axially extended configuration. For example, compared to FIG. 16A, FIG. 16B shows that the seal segment 466 is more axially extended when the innermost shaft member 414a moves in a more distal direction relative to the fixed shaft member 412.

[0222] In certain embodiments, the seal members described above (e.g., 462, 464) may also be configured as an actuating mechanism to cause axial movement of one or more movable shaft members 414. In one embodiment, the biasing member may be embedded within or coupled to the seal member. Additionally and / or alternatively, the biasing member may be similar to the seal member but constructed independently of the seal member. For example, the biasing member (or segmented biasing member) may extend from the distal end portion 412d of the fixed shaft member 412 to the outer surface of the innermost shaft member 414a. In certain embodiments, the biasing member may include a tension spring, an elastic band, etc. As a result, the sleeve shaft 404 in the axially extended configuration may generate tension in the biasing member, whereby the sleeve shaft 404 is biased to return to the axially folded configuration. Alternatively, the biasing member may include a compression spring or the like. As a result, the sleeve shaft 404 in the axially folded configuration may generate a compressive force in the biasing member, whereby the sleeve shaft 404 is biased to return to the axially extended configuration.

[0223] In certain embodiments, as shown in FIG. 17, the sealing member may include a plurality of annular rings 468 (e.g., O-rings, gaskets, etc.) that are fixedly attached to the respective outer surfaces of one or more movable shaft members 414 and are configured to seal the respective annular spaces 416i. In the illustrated embodiment, four movable shaft members 414a - 414d are shown. As shown, one annular ring 468a may be configured to seal between the innermost shaft member 414a and an intermediate shaft member (e.g., 414b) that immediately surrounds the innermost shaft member 414a. Another annular ring 468c may be configured to seal between the fixed shaft member 412 and an intermediate shaft member (e.g., 414d) that is immediately surrounded by the fixed shaft member 412. An additional annular ring 468b may be configured to seal between any two intermediate shaft members where one is immediately surrounded by the other (e.g., 414b - 414c, 414c - 414d, etc.).

[0224] In certain embodiments, the sleeve shaft 404 may have a retaining mechanism configured to resist movement of the annular ring 468 when the movable shaft member 414 moves axially relative to the fixed shaft member 412.

[0225] In certain embodiments, the retaining mechanism may include the crimped distal end portions (e.g., 412d, 416d) of the fixed shaft member 412 and the movable shaft member 414. The crimped distal end portions (e.g., 412d, 416d) may have a diameter smaller than the respective cylindrical body portions (e.g., 412b, 416b) of the fixed shaft member 412 and the movable shaft member 414. As shown in FIG. 17, the annular ring 468 may be positioned adjacent to the respective crimped distal end portions (e.g., 412d, 416d). Thus, the annular ring 468 can prevent the crimped distal end portions (e.g., 412d, 416d) from moving distally past it when the movable shaft member 414 moves axially relative to the fixed shaft member 412.

[0226] Additionally, or alternatively, the retaining mechanism can comprise a flared proximal end portion 416p of the movable shaft member 414. The flared proximal end portion 416p can have a diameter larger than that of the respective cylindrical body portion 416b of the movable shaft member 414. The annular ring 468 can be positioned adjacent to each flared proximal end portion 416p. Thus, the annular ring 468 can prevent the flared proximal end portion 416p from moving proximally past it when the movable shaft member 414 moves axially relative to the fixed shaft member 412.

[0227] Although a particular retaining mechanism is shown in FIG. 17, it should be understood that the retaining mechanism can take other forms. For example, the outer surface of the movable shaft member 414 can have an annular groove, and the annular ring 468 can be retained within each groove. In other embodiments, the annular ring 468 can be held in place by other means such as gluing, fastening, etc.

[0228] Any of the systems, devices, instruments, etc. described herein can be sterilized (e.g., using heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use on a patient, and any of the methods described herein can include sterilizing the associated systems, devices, instruments, etc. as one of the steps of the method. Examples of sterilization by heating / heat 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 used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization by hydrogen peroxide can be carried out, for example, using hydrogen peroxide plasma.

[0229] Sterilization Any of the systems, devices, instruments, etc. described in this specification can be sterilized (e.g., using heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use for patients. Any of the methods described in this specification can include sterilizing related systems, devices, instruments, etc. as one of the steps of the method. Examples of sterilization by heating / heat 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 used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization by hydrogen peroxide can be carried out, for example, using hydrogen peroxide plasma. [Embodiment]

[0230] Additional embodiments of the disclosed technology In view of the above-described implementations of the disclosed subject matter, this application discloses the additional embodiments listed below. It should be noted that one or more features of one isolated embodiment, or a combination thereof, and optionally a combination of one or more features of one or more additional embodiments, taken in combination with two or more features of that embodiment, are further embodiments within the scope of the disclosure of this application.

[0231] Embodiment 1. A delivery device configured to deliver an artificial implant, comprising a handle, a first shaft extending through the handle, and a second shaft coaxial with the first shaft and surrounding at least the proximal end portion of the first shaft. The second shaft includes an outer shaft member positioned proximal to the handle and an inner shaft member axially movable relative to the outer shaft member. The second shaft is movable between an axially extended configuration and an axially folded configuration. When the second shaft is in the axially extended configuration, the inner shaft member extends to the handle. When the second shaft is in the axially folded configuration, the inner shaft member is positioned proximal to the handle.

[0232] Example 2. The delivery device according to any one of the embodiments herein, particularly Example 1, further comprising a suture lock connected to the proximal end of the first shaft, the suture lock being configured to connect to a release suture tied to an artificial implant.

[0233] Example 3. The delivery device according to any one of the embodiments herein, particularly Example 2, wherein the proximal end of the outer shaft member of the second shaft is positioned distal to the proximal end of the first shaft.

[0234] Example 4. The delivery device according to any one of the embodiments herein, particularly any one of Examples 1 to 3, further comprising a first fluid port fluidly coupled to the inner lumen of the first shaft.

[0235] Example 5. The delivery device according to any one of the embodiments herein, particularly any one of Examples 1 to 4, wherein the second shaft comprises a second fluid port fluidly coupled to an annular space formed between the first shaft and the inner shaft member.

[0236] Example 6. The delivery device according to any one of the embodiments herein, particularly any one of Examples 1 to 5, further comprising a third shaft connected to the handle, the first shaft extending through the lumen of the third shaft.

[0237] Example 7. The delivery device according to any one of the embodiments herein, particularly Example 6, wherein the third shaft comprises a third fluid port fluidly coupled to the lumen of the third shaft.

[0238] Example 8. The delivery device according to any one of the embodiments herein, particularly Example 6 or 7, wherein the third shaft comprises an annular seal configured to seal between the third shaft and the first shaft.

[0239] Example 9. The annular seal is located at the proximal end of the third shaft, and the inner shaft member is positioned proximal to the annular seal when the second shaft is in the axially folded configuration, for any of the embodiments described herein, particularly the delivery device described in Example 8.

[0240] Example 10. The inner shaft member extends into the lumen of the third shaft when the second shaft is in the axially extended configuration, for any of the embodiments described herein, particularly the delivery device described in Example 9.

[0241] Example 11. The proximal end of the third shaft extends proximally outward from the handle, for any of the embodiments described herein, particularly the delivery device described in Example 9 or 10.

[0242] Example 12. The second shaft comprises a sealing member configured to seal between the outer shaft member and the outer surface of the inner shaft member, for any of the embodiments described herein, particularly the delivery device described in any one of Examples 1 to 11.

[0243] Example 13. The sealing member comprises an elastic sealing film extending from the distal end portion of the outer shaft member to the outer surface of the inner shaft member, and the elastic sealing film is configured to extend axially when the second shaft moves from the axially folded configuration to the axially extended configuration, for any of the embodiments described herein, particularly the delivery device described in Example 12.

[0244] Example 14. The elastic sealing film extends from the distal end portion of the outer shaft member to the distal end portion of the inner shaft member, for any of the embodiments described herein, particularly the delivery device described in Example 13.

[0245] Example 15. The second shaft comprises one or more intermediate shaft members coaxially disposed between the inner shaft member and the outer shaft member, the delivery device described in any embodiment of the present specification, particularly embodiment 12.

[0246] Embodiment 16. The sealing member comprises an elastic sealing film extending from the distal end of a portion of the outer shaft member to the outer surface of the inner shaft member, the elastic sealing film being connected to one or more intermediate shaft members so as to divide the elastic sealing film into a plurality of elastic sealing segments, the plurality of elastic sealing segments being configured to extend axially when the second shaft moves from an axially folded configuration to an axially extended configuration, the delivery device described in any embodiment of the present specification, particularly embodiment 15.

[0247] Embodiment 17. The sealing member comprises a plurality of annular rings, each annular ring being configured to seal between the inner shaft member and an intermediate shaft member immediately surrounding the inner shaft member, or between the outer shaft member and an intermediate shaft member immediately surrounded by the outer shaft member, or between two intermediate shaft members, one of which is immediately surrounded by the other, the delivery device described in any embodiment of the present specification, particularly embodiment 15.

[0248] Embodiment 18. Each of the intermediate shaft member and the outer shaft member has a cylindrical body portion and a curled distal end portion having a diameter smaller than that of the cylindrical body portion, and the annular rings are positioned adjacent to the respective curled distal end portions, the delivery device described in any embodiment of the present specification, particularly embodiment 17.

[0249] Embodiment 19. Each of the intermediate shaft member and the inner shaft member has a cylindrical body portion and a flared proximal end portion having a diameter larger than that of the cylindrical body portion, and the annular rings are positioned adjacent to the respective flared proximal end portions, the delivery device described in any embodiment of the present specification, particularly embodiment 17.

[0250] Example 20. The delivery device according to any one of the embodiments herein, particularly any one of Embodiments 1 to 19, further comprising an operating mechanism configured to move a second shaft between an axially folded configuration and an axially extended configuration.

[0251] Example 21. The operating mechanism includes at least one rotary actuator. When the at least one rotary actuator is rotated in a first direction, the second shaft moves from an axially folded configuration to an axially extended configuration. When the at least one rotary actuator is rotated in a second direction opposite to the first direction, the second shaft moves from an axially extended configuration to an axially folded configuration. The delivery device according to any one of the embodiments herein, particularly the delivery device described in Example 20.

[0252] Example 22. The delivery device according to any one of the embodiments herein, particularly the delivery device described in Example 21, wherein the at least one rotary actuator is configured to rotationally engage with the second shaft at a distal position of an outer shaft member.

[0253] Example 23. The delivery device according to any one of the embodiments herein, particularly the delivery device described in Example 21 or 22, wherein the at least one rotary actuator includes a roller configured to frictionally engage with an outer surface of an inner shaft member so that rotational movement of the roller can be converted into axial movement of the inner shaft member.

[0254] Example 24. The delivery device according to any one of the embodiments herein, particularly the delivery device described in Example 21 or 22, wherein the at least one rotary actuator includes a nut having an internal thread configured to engage with an external thread of the inner shaft member so that rotational movement of the nut can be converted into axial movement of the inner shaft member.

[0255] Example 25. At least one rotary actuator comprises a pinion gear configured to engage a male thread of an inner shaft member such that rotational movement of the pinion gear can be converted into axial movement of the inner shaft member, for any of the embodiments herein, particularly the delivery device described in Embodiment 21 or 22.

[0256] Embodiment 26. At least one rotary actuator comprises a rotatable drive shaft hinged to an inner shaft member via a rod such that rotational movement of the drive shaft can be converted into axial movement of the inner shaft member, for any of the embodiments herein, particularly the delivery device described in Embodiment 21 or 22.

[0257] Embodiment 27. At least one rotary actuator comprises a cam rotatably connected to an inner shaft member such that rotational movement of the cam can be converted into axial movement of the inner shaft member, for any of the embodiments herein, particularly the delivery device described in Embodiment 21 or 22.

[0258] Embodiment 28. The actuating mechanism comprises at least one linear actuator, and moving at least one linear actuator in a first direction is configured to move a second shaft from an axially folded configuration to an axially extended configuration, and moving at least one linear actuator in a second direction opposite to the first direction is configured to move the second shaft from an axially extended configuration to an axially folded configuration, for any of the embodiments herein, particularly the delivery device described in Embodiment 20.

[0259] Embodiment 29. At least one linear actuator is a gripper configured to frictionally engage an outer surface of an inner shaft member when the gripper is radially compressed and to be removable from the inner shaft member when the gripper is not radially compressed, the gripper being configured to be axially movable relative to an outer shaft member, a delivery device according to any of the embodiments herein, particularly embodiment 28.

[0260] Example 30. At least one linear actuator includes a slider fixedly connected to an inner shaft member, the slider being configured to be axially movable relative to an outer shaft member, a delivery device according to any of the embodiments herein, particularly embodiment 28.

[0261] Example 31. The actuating mechanism includes at least one biasing member connected to the inner shaft member, the biasing member being configured to elastically bias the inner shaft member axially toward the outer shaft member when the inner shaft member is positioned distally relative to the outer shaft member, a delivery device according to any of the embodiments herein, particularly embodiment 20.

[0262] Example 32. The actuating mechanism includes at least one biasing member connected to the inner shaft member, the biasing member being configured to elastically bias the inner shaft member axially away from the outer shaft member when the inner shaft member is positioned within the outer shaft member, a delivery device according to any of the embodiments herein, particularly embodiment 20.

[0263] Example 33. A delivery device configured to deliver an artificial implant, comprising a first shaft having a lumen, the first shaft comprising a first fluid port fluidly coupled to the lumen of the first shaft, a first shaft, an outer shaft member fixedly mounted around a proximal portion of the first shaft, and a second telescopic shaft coaxial with the first shaft and axially movable relative to the first shaft, the one or more inner shaft members comprising the innermost shaft member, the first shaft extending through the lumen of the innermost shaft member, and the second telescopic shaft comprising a second fluid port fluidly coupled to the lumen of the innermost shaft member.

[0264] Example 34. In any of the embodiments herein, particularly the delivery device described in Example 33, the fluid injected into the second fluid port flows through a conduit formed between the first shaft and the innermost shaft member and does not flow through the lumen of the first shaft.

[0265] Example 35. In any of the embodiments herein, particularly the delivery device described in Example 33 or 34, further comprising a handle, the first shaft extending longitudinally through the handle, and the outer shaft member being positioned proximal to the handle.

[0266] Example 36. In any of the embodiments herein, particularly the delivery device described in Example 35, at least a portion of the one or more inner shaft members is configured to be axially extendable into the handle.

[0267] Example 37. In any of the embodiments herein, particularly the delivery device described in any one of Examples 33 to 36, further comprising a dock sleeve connected to the distal end of the innermost shaft member, the dock sleeve being configured to cover the artificial implant.

[0268] Example 38. The delivery device according to any one of the embodiments herein, particularly any one of embodiments 33 to 37, further comprises a suture lock connected to the proximal end of the first shaft, and the suture lock is configured to be removably connected to the artificial implant via a release suture extending through the lumen of the first shaft.

[0269] Example 39. The delivery device according to any one of the embodiments herein, particularly any one of embodiments 33 to 38, further comprises a third shaft positioned distally of the outer shaft member, and the first shaft extends through the lumen of the third shaft.

[0270] Example 40. The delivery device according to any one of the embodiments herein, particularly the delivery device according to embodiment 39, wherein the third shaft comprises a third fluid port fluidly coupled to the lumen of the third shaft.

[0271] Example 41. The fluid injected into the third fluid port flows through a conduit formed between the second telescopic shaft and the third shaft and does not flow through the lumen of the innermost shaft member. The delivery device according to any one of the embodiments herein, particularly the delivery device according to embodiment 40.

[0272] Example 42. At least a portion of one or more inner shaft members is configured to be axially extendable into the lumen of the third shaft. The delivery device according to any one of the embodiments herein, particularly any one of embodiments 39 to 41.

[0273] Example 43. The delivery device according to any one of the embodiments herein, particularly any one of embodiments 39 to 42, further comprises an annular seal configured to seal between the first shaft and the third shaft.

[0274] Example 44. The annular seal elastically engages with the outer surface of at least one inner shaft member when at least one inner shaft member is inserted into the inner cavity of the third shaft, thereby forming a seal between the third shaft and the at least one inner shaft member, and has an elastically constricted central opening, as described in any of the embodiments herein, particularly the delivery device described in Embodiment 43.

[0275] Embodiment 45. The delivery device according to any of the embodiments herein, particularly any one of Embodiments 33 to 44, further comprising a sealing member configured to seal between the outer shaft member and the outer surface of the innermost shaft member.

[0276] Embodiment 46. The sealing member includes an elastic sealing film extending from the distal end portion of the outer shaft member to the outer surface of the innermost shaft member, and the elastic sealing film is configured to axially expand when the innermost shaft member moves distally relative to the outer shaft member, as described in any of the embodiments herein, particularly the delivery device described in Embodiment 45.

[0277] Embodiment 47. The delivery device according to any of the embodiments herein, particularly Embodiment 46, wherein the elastic sealing film includes one or more elastic sealing segments respectively connected to one or more inner shaft members.

[0278] Embodiment 48. The delivery device according to any of the embodiments herein, particularly Embodiment 45 or 46, wherein the sealing member includes one or more annular rings configured to seal each annular space formed between one or more inner shaft members and the outer shaft member.

[0279] Embodiment 49. The delivery device according to any of the embodiments herein, particularly any one of Embodiments 33 to 48, wherein one or more inner shaft members include a lubricant coating.

[0280] Embodiment 50. An actuating mechanism configured to continuously move one or more inner shaft members distally towards the distal end of the first shaft, or to continuously retract one or more inner shaft members proximally towards the outer shaft member, further comprising a delivery device according to any one of the embodiments herein, particularly any one of embodiments 33-49.

[0281] Example 51. A delivery device configured to deliver an artificial implant, comprising a first shaft, an outer shaft member fixedly mounted around a proximal portion of the first shaft, and a second shaft comprising one or more inner shaft members that are nested within each other and configured to be axially movable relative to each other, and a sealing member configured to seal one or more annular spaces formed between the one or more inner shaft members and the outer shaft member, wherein the one or more inner shaft members comprise the innermost shaft member, and the first shaft extends through the innermost shaft member.

[0282] Example 52. Further comprising a handle, wherein the first shaft extends axially through the handle, a delivery device according to any one of the embodiments herein, particularly embodiment 51.

[0283] Example 53. The outer shaft member is positioned proximally relative to the handle, and at least one of the one or more inner shaft members is configured to be axially extendable relative to the handle, a delivery device according to any one of the embodiments herein, particularly embodiment 52.

[0284] Example 54. Further comprising a suture lock connected to the proximal end of the first shaft, the suture lock being configured to be removably connected to the artificial implant via a release suture extending through the first shaft, a delivery device according to any one of the embodiments herein, particularly any one of embodiments 51-53.

[0285] Example 55. A delivery device according to any one of the embodiments herein, particularly any one of embodiments 51 to 54, further comprising a first fluid port fluidly coupled to the lumen of the first shaft.

[0286] Example 56. A delivery device according to any one of the embodiments herein, particularly any one of embodiments 51 to 55, further comprising a second fluid port fluidly coupled to the lumen of the innermost shaft member.

[0287] Example 57. A delivery device according to any one of the embodiments herein, particularly any one of embodiments 51 to 56, further comprising a third shaft positioned distally of the outer shaft member, wherein the first shaft extends through the lumen of the third shaft.

[0288] Example 58. A delivery device according to any one of the embodiments herein, particularly the delivery device according to embodiment 57, further comprising a third fluid port fluidly coupled to the lumen of the third shaft.

[0289] Example 59. A delivery device according to any one of the embodiments herein, particularly the delivery device according to embodiment 57 or 58, further comprising an annular seal configured to seal between the third shaft and the first shaft when the inner shaft member is not inserted into the lumen of the third shaft, or to seal between the third shaft and the inner shaft member when the inner shaft member is inserted into the lumen of the third shaft.

[0290] Example 60. A delivery device according to any one of the embodiments herein, particularly any one of embodiments 51 to 59, wherein the second shaft is movable between an axially extended configuration and an axially folded configuration, and the second shaft has a greater axial length in the axially extended configuration than in the axially folded configuration.

[0291] Example 61. In the axial folding configuration, each of the one or more inner shaft members is substantially received within the outer shaft member, and in the axial extension configuration, each of the one or more inner shaft members substantially extends outward from the outer shaft member. A delivery device according to any embodiment herein, particularly embodiment 60.

[0292] Example 62. In the axial extension configuration, the one or more inner shaft members are configured such that an inner shaft member having a smaller diameter extends to a more distal position than an inner shaft member having a larger diameter. A delivery device according to any embodiment herein, particularly embodiment 61.

[0293] Example 63. The sealing member includes an elastic sealing film that extends from the distal end portion of the outer shaft member to the outer surface of the innermost shaft member, and the elastic sealing film is configured to axially extend when the innermost shaft member moves distally relative to the outer shaft member. A delivery device according to any embodiment herein, particularly any one of embodiments 51 - 62.

[0294] Example 64. The elastic sealing film is connected to the one or more inner shaft members so as to define one or more elastic sealing segments, and each elastic sealing segment is configured to seal a corresponding annular space. A delivery device according to any embodiment herein, particularly embodiment 63.

[0295] Example 65. The sealing member includes one or more annular rings configured to seal each annular space formed between the one or more inner shaft members and the outer shaft member. A delivery device according to any embodiment herein, particularly any one of embodiments 51 - 64.

[0296] Example 66. The second shaft comprises a holding mechanism configured to resist movement of the annular ring when the inner shaft member moves axially relative to the outer shaft member, according to any embodiment of the present specification, particularly the delivery device described in Embodiment 65.

[0297] Embodiment 67. The holding mechanism comprises a crimped distal end portion of the outer shaft member and one or more inner shaft members, the crimped distal end portion having a diameter smaller than the respective body portions of the outer shaft member and one or more inner shaft members, according to any embodiment of the present specification, particularly the delivery device described in Embodiment 66.

[0298] Embodiment 68. The holding mechanism comprises a flared proximal end portion of one or more inner shaft members, the flared proximal end portion having a diameter larger than the respective body portions of the one or more inner shaft members, according to any embodiment of the present specification, particularly the delivery device described in Embodiment 66.

[0299] Embodiment 69. The delivery device further comprises an actuating mechanism configured to move one or more inner shaft members outwardly from the outer shaft member such that the distal ends of the one or more inner shaft members move progressively further distally along the first shaft, the actuating mechanism further configured to move the one or more inner shaft members substantially into the outer shaft member, according to any embodiment of the present specification, particularly any one of Embodiments 51 to 68.

[0300] Embodiment 70. The actuating mechanism comprises a motor operably coupled to one or more inner shaft members, according to any embodiment of the present specification, particularly the delivery device described in Embodiment 69.

[0301] Embodiment 71. A system comprising an artificial implant and a delivery device configured to deliver the artificial implant to a target implantation position, the delivery device comprising a pusher shaft positioned proximal to the artificial implant, an outer shaft member fixedly attached around a proximal portion of the pusher shaft, and a sleeve shaft coaxial with the pusher shaft and comprising one or more inner shaft members axially movable relative to the pusher shaft, and a suture lock connected to a proximal end of the pusher shaft, the suture lock removably connected to the artificial implant via a release suture extending through the pusher shaft, the one or more inner shaft members comprising a most inner shaft member, the pusher shaft extending through the most inner shaft member, the system.

[0302] Example 72. The system according to any one of the examples herein, particularly the system described in Example 71, wherein the artificial implant is an artificial valve.

[0303] Example 73. The system according to any one of the examples herein, particularly the system described in Example 71, wherein the artificial implant is a docking device configured to receive an artificial valve.

[0304] Example 74. The system according to any one of the examples herein, particularly any one of Examples 71 - 73, wherein the delivery device further comprises a first fluid port fluidly coupled to a lumen of the pusher shaft.

[0305] Example 75. The system according to any one of the examples herein, particularly any one of Examples 71 - 74, wherein the delivery device further comprises a second fluid port fluidly coupled to a lumen of the most inner shaft member.

[0306] Example 76. The delivery device further comprises a handle positioned distally of the outer shaft member, and the pusher shaft extends axially through the handle, the system according to any one of Examples 71 to 75.

[0307] Example 77. The delivery device comprises a delivery shaft connected to the handle, and the pusher shaft extends through the lumen of the delivery shaft, the system according to any example herein, particularly the system described in Example 76.

[0308] Example 78. The delivery shaft is positioned distally of the outer shaft member, and at least a portion of one or more inner shaft members is configured to extend axially within the lumen of the delivery shaft, the system according to any example herein, particularly the system described in Example 77.

[0309] Example 79. The system according to any example herein, particularly the system described in Example 77 or 78, further comprises a third fluid port fluidly coupled to the lumen of the delivery shaft.

[0310] Example 80. The delivery device further comprises an annular seal configured to seal between the pusher shaft and the delivery shaft when the inner shaft member does not extend into the lumen of the delivery shaft, the system according to any example herein, particularly any one of Examples 77 to 79.

[0311] Example 81. The annular seal is configured to seal between the delivery shaft and the inner shaft member when the inner shaft member extends into the lumen of the delivery shaft, the system according to any example herein, particularly the system described in Example 80.

[0312] Example 82. The delivery device further comprises a sealing member configured to seal one or more annular spaces formed between one or more inner shaft members and an outer shaft member, a system according to any one of the embodiments herein, particularly any one of embodiments 71-81.

[0313] Embodiment 83. The sealing member comprises an elastic sealing film extending from the distal end portion of the outer shaft member to the outer surface of the innermost shaft member, and the elastic sealing film is configured to extend axially when the innermost shaft member moves distally relative to the outer shaft member, a system according to any one of the embodiments herein, particularly the system described in Embodiment 82.

[0314] Embodiment 84. The elastic sealing film comprises one or more elastic sealing segments each connected to a respective one of the one or more inner shaft members, and each elastic sealing segment is configured to seal a corresponding annular space, a system according to any one of the embodiments herein, particularly the system described in Embodiment 83.

[0315] Embodiment 85. The sealing member comprises one or more annular rings configured to seal respective annular spaces, a system according to any one of the embodiments herein, particularly any one of embodiments 82-84.

[0316] Embodiment 86. The one or more annular rings are fixedly attached to the outer surface of each of the one or more inner shaft members, a system according to any one of the embodiments herein, particularly the system described in Embodiment 85.

[0317] Embodiment 87. The delivery device further comprises an actuating mechanism configured to move one or more inner shaft members telescopically distally relative to the outer shaft member or to move one or more inner shaft members telescopically proximally toward the outer shaft member, a system according to any one of the embodiments herein, particularly any one of embodiments 71-86.

[0318] Example 88. The actuating mechanism comprises at least one rotary actuator operably connected to one or more inner shaft members, and the rotation of the at least one rotary actuator is configured to axially move one or more inner shaft members relative to the outer shaft member in a telescopic manner, according to any of the embodiments described herein, particularly the system described in Example 87.

[0319] Example 89. The actuating mechanism comprises at least one linear actuator operably connected to one or more inner shaft members, and the linear translational movement of the linear actuator is configured to axially move one or more inner shaft members relative to the outer shaft member in a telescopic manner, according to any of the embodiments described herein, particularly the system described in Example 87.

[0320] Example 90. The actuating mechanism comprises at least one biasing member operably connected to one or more inner shaft members, and when the biasing member generates a biasing force that moves the position of one or more inner shaft members relative to the outer shaft member from a biased state to an unbiased state, the biasing member is configured to axially move one or more inner shaft members relative to the outer shaft member in a telescopic manner, according to any of the embodiments described herein, particularly the system described in Example 87.

[0321] Example 91. A method comprising inserting a delivery device loaded with an artificial device into a patient's vasculature and deploying the artificial device at a target location within the patient's vasculature, the delivery device comprising a pusher shaft positioned proximal to the artificial device, an outer shaft member fixedly attached around a proximal portion of the pusher shaft, and a sleeve shaft coaxial with the pusher shaft and comprising one or more inner shaft members axially movable relative to the pusher shaft, a delivery shaft surrounding at least a distal portion of the pusher shaft and positioned distal to the outer shaft member, the one or more inner shaft members comprising a most inner shaft member, the pusher shaft extending through the most inner shaft member.

[0322] Example 92. The step of deploying the artificial device includes cutting a release suture tied to the artificial device, the release suture extending through the pusher shaft and connected to a suture lock connected to a proximal end of the pusher shaft, the method according to any example herein, particularly Example 91.

[0323] Example 93. The method according to any example herein, particularly Example 91 or 92, further comprising the step of flushing the lumen of the pusher shaft with a solution.

[0324] Example 94. The step of flushing the lumen of the pusher shaft includes injecting a solution from a first fluid port fluidly coupled to the lumen of the pusher shaft, the method according to any example herein, particularly Example 93.

[0325] Example 95. The method according to any example herein, particularly Example 93 or 94, further comprising the step of maintaining a continuous flow of solution within the lumen of the pusher shaft when inserting the delivery device and deploying the artificial device.

[0326] Example 96. The method according to any one of the embodiments herein, particularly any one of embodiments 93 to 96, further comprising the step of washing the annular space formed between the innermost shaft member and the pusher shaft with a solution.

[0327] Embodiment 97. The step of washing the annular space between the innermost shaft member and the pusher shaft includes the step of injecting a solution from a second fluid port fluidly coupled to the lumen of the innermost shaft member, according to any one of the embodiments herein, particularly the method described in embodiment 96.

[0328] Embodiment 98. The method according to any one of the embodiments herein, particularly any one of embodiments 93 to 97, further comprising the step of washing the annular space formed between the delivery shaft and the pusher shaft with a solution.

[0329] Embodiment 99. The step of washing the annular space formed between the delivery shaft and the pusher shaft includes the step of injecting a solution from a third fluid port fluidly coupled to the lumen of the delivery shaft, according to any one of the embodiments herein, particularly the method described in embodiment 98.

[0330] Embodiment 100. The step of inserting the delivery device includes the step of selectively bending the distal portion of the delivery shaft, according to any one of the embodiments herein, particularly any one of embodiments 91 to 99.

[0331] Embodiment 101. The method according to any one of the embodiments herein, particularly any one of embodiments 91 to 100, wherein the docking sleeve further includes the step of moving one or more inner shaft members distally relative to the outer shaft member so as to cover the artificial device when inserting the delivery device, and the docking sleeve is connected to the distal end of the innermost shaft member.

[0332] Embodiment 102. The step of deploying the artificial device includes moving the artificial device out from the distal end of the delivery shaft while keeping the artificial device covered by the dock sleeve, as described in any of the embodiments herein, particularly the method described in Embodiment 101.

[0333] Embodiment 103. The method of any of the embodiments herein, particularly the method of Embodiment 102, further includes moving one or more inner shaft members proximally relative to the outer shaft member such that the dock sleeve is removed from the artificial device.

[0334] Embodiment 104. The step of moving one or more inner shaft members includes operating an operating mechanism operably coupled to the one or more inner shaft members, as described in any of the embodiments herein, particularly any one of Embodiments 101 - 103.

[0335] Embodiment 105. The step of operating the operating mechanism includes rotating at least one rotary actuator. By rotating the at least one rotary actuator in a first direction, the innermost shaft member moves distally to cover the artificial device, and by rotating the at least one rotary actuator in a second direction opposite to the first direction, the innermost shaft member moves proximally to expose the artificial device, as described in any of the embodiments herein, particularly the method described in Embodiment 104.

[0336] Embodiment 106. The step of operating the operating mechanism includes translating at least one linear actuator. By translating the at least one linear actuator in a first direction, the innermost shaft member moves distally to cover the artificial device, and by translating the at least one linear actuator in a second direction opposite to the first direction, the innermost shaft member moves proximally to expose the artificial device, as described in any of the embodiments herein, particularly the method described in Embodiment 104.

[0337] Example 107. The step of actuating the actuating mechanism includes moving a biasing member connected to the innermost shaft member between a biased state and an unbiased state, the biasing member being in a biased state when the dock sleeve covers the artificial device, and the biasing member being configured to return to an unbiased state when the dock sleeve exposes the artificial device, according to any of the embodiments herein, particularly the method described in Example 104.

[0338] Example 108. A delivery device configured to deliver an artificial implant, comprising a pusher shaft, a telescopic sleeve shaft having a fixed shaft segment and one or more movable shaft segments coaxial with the fixed shaft segment, and a dock sleeve connected to one of the one or more movable shaft segments and configured to cover the artificial implant, wherein the fixed shaft segment is fixedly mounted around a proximal portion of the pusher shaft, and the one or more movable shaft segments are axially movable relative to the pusher shaft.

[0339] Example 109. The delivery device according to any of the embodiments herein, particularly Example 108, wherein the fixed shaft segment has a diameter larger than that of the one or more movable shaft segments.

[0340] Example 110. The delivery device according to any of the embodiments herein, particularly Example 109, wherein the one or more movable shaft segments include the innermost shaft segment, the pusher shaft extends through the lumen of the innermost shaft segment, and the dock sleeve is connected to the distal end of the innermost shaft segment.

[0341] Example 111. The fixed shaft segment has a diameter smaller than that of one or more movable shaft segments, and the pusher shaft extends through the lumen of the fixed shaft segment, as described in any of the embodiments herein, particularly the delivery device described in embodiment 108.

[0342] Embodiment 112. One or more movable shaft segments include the outermost shaft segment, and the dock sleeve is connected to the distal end of the outermost shaft segment, as described in any of the embodiments herein, particularly the delivery device described in embodiment 111.

[0343] Embodiment 113. The delivery device further comprises a sealing member configured to seal an annular space formed between the fixed shaft segment and the one or more movable shaft segments, as described in any of the embodiments herein, particularly any one of embodiments 108-112.

[0344] Embodiment 114. The delivery device further comprises a first fluid port fluidly coupled to the lumen of the pusher shaft and a second fluid port fluidly coupled to an annular space between the pusher shaft and the telescopic sleeve shaft, as described in any of the embodiments herein, particularly any one of embodiments 108-113.

[0345] Embodiment 115. The delivery device further comprises an actuating mechanism configured to axially move the one or more movable shaft segments relative to the fixed shaft segment, as described in any of the embodiments herein, particularly any one of embodiments 108-114.

[0346] Embodiment 116. A method comprising the step of sterilizing an apparatus, device, assembly, and / or system as described in any of the embodiments herein, particularly any one of embodiments 1-90 and 108-115.

[0347] For any of the examples described herein, the various features described can be combined with any one or more of the other features described in any of the other embodiments, unless otherwise stated. For example, any one or more of the features of one delivery device can be combined with any one or more of the features of another delivery device.

[0348] Considering the many possible embodiments to which the principles of the disclosed technology can be applied, it should be recognized that the illustrated embodiments are only preferred embodiments of the technology and should not be taken as limiting the scope of the present disclosure. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

**Claim 1** A delivery device configured to deliver an artificial implant, comprising: a handle; a first shaft extending through the handle; a second shaft coaxial with the first shaft and surrounding at least a proximal end portion of the first shaft; wherein the second shaft includes an outer shaft member positioned proximal to the handle and an inner shaft member axially movable relative to the outer shaft member; the second shaft is movable between an axially extended configuration and an axially folded configuration; when the second shaft is in the axially extended configuration, the inner shaft member extends to the handle; when the second shaft is in the axially folded configuration, the inner shaft member is positioned proximal to the handle. A delivery device. **Claim 2** The delivery device according to claim 1, further comprising a suture lock connected to a proximal end of the first shaft, the suture lock being configured to connect to a release suture tied to the artificial implant. **Claim 3** The delivery device according to claim 2, wherein a proximal end of the outer shaft member of the second shaft is positioned distal to the proximal end of the first shaft. **Claim 4** The delivery device according to any one of claims 1 to 3, further comprising a first fluid port fluidly coupled to an inner lumen of the first shaft. **Claim 5** The delivery device according to any one of claims 1 to 4, wherein the second shaft includes a second fluid port fluidly coupled to an annular space formed between the first shaft and the inner shaft member. **Claim 6** The delivery device according to any one of claims 1 to 5, further comprising a third shaft connected to the handle, the first shaft extending through a lumen of the third shaft. **Claim 7** The delivery device according to claim 6, wherein the third shaft includes a third fluid port fluidly coupled to the lumen of the third shaft. **Claim 8** The delivery device according to claim 6 or 7, wherein the third shaft includes an annular seal configured to seal between the third shaft and the first shaft. **Claim 9** The annular seal is located at the proximal end of the third shaft, and the inner shaft member is positioned proximal to the annular seal when the second shaft is in the axially folded configuration, the delivery device according to claim 8.

10. The inner shaft member extends into the inner cavity of the third shaft when the second shaft is in the axially extended configuration, the delivery device according to claim 9.

11. The proximal end of the third shaft extends proximally outward from the handle, the delivery device according to claim 9 or 10.

12. The second shaft includes a sealing member configured to seal between the outer shaft member and the outer surface of the inner shaft member, the delivery device according to any one of claims 1 to 11.

13. The sealing member includes an elastic sealing film extending from a distal end portion of the outer shaft member to the outer surface of the inner shaft member, and the elastic sealing film is configured to extend axially when the second shaft moves from the axially folded configuration to the axially extended configuration, the delivery device according to claim 12.

14. A delivery device configured to deliver an artificial implant, A first shaft having an inner cavity, the first shaft including a first fluid port fluidly coupled to the inner cavity of the first shaft, A second telescopic shaft including an outer shaft member fixedly mounted around a proximal portion of the first shaft and one or more inner shaft members coaxial with the first shaft and axially movable relative to the first shaft, Comprising, The one or more inner shaft members include a most inner shaft member, and the first shaft extends through the inner cavity of the most inner shaft member, The second telescopic shaft includes a second fluid port fluidly coupled to the inner cavity of the most inner shaft member, the delivery device.

15. The fluid injected into the second fluid port flows through a conduit formed between the first shaft and the most inner shaft member and does not flow through the inner cavity of the first shaft, the delivery device according to claim 14.

16. The delivery device according to claim 14 or 15, further comprising a handle, wherein the first shaft extends in the longitudinal direction through the handle, and the outer shaft member is positioned proximal to the handle.

17. The delivery device according to claim 16, wherein at least some of the one or more inner shaft members are configured to be axially extendable into the handle.

18. A delivery device configured to deliver an artificial implant, a first shaft; a second shaft comprising an outer shaft member fixedly mounted around a proximal portion of the first shaft, and one or more inner shaft members configured to be nested within one another and axially movable relative to one another; a sealing member configured to seal one or more annular spaces formed between the one or more inner shaft members and the outer shaft member; comprising the delivery device, wherein the one or more inner shaft members include the innermost shaft member, and the first shaft extends through the innermost shaft member.

19. The delivery device according to claim 18, further comprising a handle, wherein the first shaft extends in the longitudinal direction through the handle.

20. The delivery device according to claim 19, wherein the outer shaft member is positioned proximal to the handle, and at least one of the one or more inner shaft members is configured to be axially extendable into the handle.

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