Shaft for a prosthetic implant delivery apparatus

Abstract

A delivery apparatus comprising a pusher shaft for a prosthetic implant is disclosed. A pusher shaft can comprise a tube having a first flexibility and an extension fixed to an end of the tube, wherein the extension has a second flexibility that is greater than the first flexibility. The extension can comprise a first extension fixed to a distal end of the tube, a second extension fixed to the proximal end of the tube, or both a first extension fixed to distal end of the tube and a second extension fixed to the proximal end of the tube. The first extension, the second extension, or both the first and second extensions can comprise a coil, a braid, a separate tube, or a unitary structure formed with the tube.

Description

SHAFT FOR A PROSTHETIC IMPLANT DELIVERY APPARATUSCROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent ApplicationNo. 63 / 759,809, filed February 18, 2025, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to a shaft for a prosthetic implant delivery apparatus.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable.

[0004] In a specific example, the prosthetic medical device can be a prosthetic heart valve mounted in a crimped state on a distal end of a delivery apparatus and advanced through the patient’s vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches an implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size.

[0005] An anchoring or docking device can be used in conjunction with an expandable prosthetic implant, for example a prosthetic valve, at an implantation site such as a native heart valve. The anchoring device can be used to securely hold the prosthetic implant in place at the implantation site when the prosthetic implant is expanded. Docking devices can, for example, provide a stable anchoring site, landing zone, or implantation zone at the implant site in which prosthetic implants can be expanded or otherwise secured. A dockingdevice can be delivered to the implantation site by a delivery apparatus comprising a shaft. The docking device can be releasably coupled to the shaft.SUMMARY

[0006] Described herein are prosthetic implants (such as, for example, docking devices and prosthetic heart valves), delivery apparatuses, and methods for implanting prosthetic implants. Also described herein are shafts (for example, pusher shafts) for delivery apparatuses for docking devices, where the shafts can have portions with increased flexibility. In some examples, the portions of the shafts having increased flexibility can include an extension on a distal end, a proximal end, or both a distal and a proximal end of the shafts. In some examples, pusher shafts for a delivery apparatus can have a distal extension, where the distal extension can have a reduced outer diameter for increased flexibility. These flexible, distal extensions can, in some instances, elongate the pusher shaft distally and more easily adapt to accommodate docking devices having varying configurations and features.Additionally or alternatively, pusher shafts can, in some instances, have a proximal extension with increased flexibility for bending inside a delivery apparatus. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic implants and their delivery apparatus.

[0007] A delivery apparatus for a docking device can comprise a pusher shaft comprising a tube and an extension fixed to an end of the tube. In addition to these components, a delivery apparatus can further comprise one or more of the components disclosed herein.

[0008] In some examples, the tube can have a first inner lumen and a first flexibility and the extension can have a second inner lumen coaxially arranged with the first inner lumen and a second flexibility that is greater than the first flexibility.

[0009] In some examples, a delivery apparatus can comprise a liner disposed within the first and second inner lumens and configured to extend from a proximal end of the pusher shaft to a distal end of the pusher shaft.

[0010] In some examples, a delivery apparatus can comprise a polymer layer arranged over the extension and at least a portion of the tube.

[0011] In some examples, the extension fixed to the end of the tube can comprise a first extension fixed to a distal end of the tube.

[0012] In some examples, the extension fixed to the end of the tube can comprise a second extension fixed to the proximal end of the tube.

[0013] In some examples, the extension fixed to the end of the tube can comprise both a first extension fixed to distal end of the tube and a second extension fixed to the proximal end of the tube.

[0014] In some examples, the first extension, the second extension, or both the first and second extensions can comprise a coil having a plurality of turns defining the second inner lumen.

[0015] In some examples, the first extension, the second extension, or both the first and second extensions can comprise a braid forming a cylindrical shape defining the second inner lumen.

[0016] In some examples, the first extension, the second extension, or both the first and second extensions can be formed as a unitary structure with the tube.

[0017] In some examples, the unitary structure can comprise a plurality of slits.

[0018] In some examples, tube can have a first outer diameter and the first extension can have a second outer diameter that is less than the first outer diameter.

[0019] In some examples, the polymer layer can be arranged over a proximal end portion of the tube and the second extension.

[0020] In some examples, the second extension can extend a first distance proximally from the proximal end of the tube and the polymer layer can extend a second distance proximally from the proximal end of the tube, where the second distance is greater than the first distance.

[0021] In some examples, the polymer layer arranged over the second extension can have a third outer diameter and taper in a proximal direction from the third outer diameter to a fourth outer diameter that is less than the third outer diameter.

[0022] In some examples, the polymer layer can be arranged over a distal end portion of the tube and the first extension.

[0023] In some examples, a delivery apparatus can further comprise a handle assembly including a first handle and a connector, wherein the pusher shaft can extend through a bend in the connector.

[0024] In some examples, the second extension can be received in the bend in the connector.

[0025] In some examples, a distal end portion of the pusher shaft can be configured to couple to a docking device.

[0026] In some examples, the polymer layer can be arranged over at least a distal end portion of the tube and an entire length of the first extension.

[0027] In some examples, the polymer layer can have a constant or at least substantially constant radial thickness along its entire length.

[0028] In some examples, the tube can have a first outer diameter and the first extension can have a second outer diameter that is less than the first outer diameter.

[0029] In some examples, a portion of the polymer layer arranged over the tube can have a third outer diameter and a portion of the polymer layer arranged over the first extension can have a fourth outer diameter that is less than the third outer diameter.

[0030] In some examples, the fourth outer diameter can be configured to receive a brim of a docking device.

[0031] In some examples, a liner can be arranged to extend from a distal end of the tube to a proximal end of the polymer layer.

[0032] In some examples, a liner can be arranged to extend from a proximal end of the pusher shaft to the distal end of the pusher shaft.

[0033] In some examples, a delivery apparatus for a docking device comprises a pusher shaft comprising: a tube having a first inner lumen and a first flexibility; an extension fixed to an end of the tube, wherein the extension has a second inner lumen coaxially arranged with the first inner lumen and a second flexibility that is greater than the first flexibility; a liner disposed within the first and second inner lumens and configured to extend from a proximal end of the pusher shaft to a distal end of the pusher shaft; and a polymer layer arranged over the extension and at least a portion of the tube.

[0034] In some examples, a delivery apparatus for a docking device comprises a pusher shaft comprising: a tube extending a length from a proximal end of the tube to a distal end of the tube, wherein the tube has a first inner lumen and a first flexibility; and an extension fixed to the distal end of the tube, wherein the extension has a second inner lumen coaxially arranged with the first inner lumen and a second flexibility that is greater than the first flexibility.

[0035] In some examples, a delivery apparatus for a docking device comprises a pusher shaft comprising: a tube extending a length from a proximal end of the tube to a distal end of thetube, wherein the tube has a first lumen and a first flexibility; and a support extension fixed to the proximal end of the tube, wherein the support extension has a second lumen coaxially arranged with the first lumen and a second flexibility that is greater than the first flexibility.

[0036] In some examples, a delivery apparatus comprises one or more of the components recited in Examples 1-12, 22-40, 57 below.

[0037] A delivery system for delivering a docking device to a native heart valve can comprise a handle assembly comprising a first handle and a guide shaft mounted to and extending distally from the first handle. In addition to these components, a delivery system can further comprise one or more of the components disclosed herein.

[0038] In some examples, the delivery system can comprise a sleeve shaft at least partially arranged within the guide shaft.

[0039] In some examples, the delivery system can comprise a pusher shaft at least partially arranged within the sleeve shaft and extending distally and proximally from the first handle.

[0040] In some examples, the pusher shaft can comprise a tube having a first inner lumen and a first flexibility and an extension fixed to an end of the tube, wherein the extension has a second inner lumen coaxially arranged with the first inner lumen and a second flexibility that is greater than the first flexibility.

[0041] In some examples, the delivery system can further comprise a polymer layer arranged over the extension and at least a portion of the tube,

[0042] In some examples, a first portion of the polymer layer that is arranged over the tube can have a first outer diameter and a second portion of the polymer layer that is arranged over the distal extension can have a second outer diameter that is less than the first outer diameter.

[0043] In some examples, the second outer diameter can be configured to receive a brim of the docking device when the docking device and the pusher shaft are disposed within the sleeve shaft.

[0044] In some examples, the handle assembly can further comprise second handle with a connector disposed proximal to the first handle.

[0045] In some examples, the connector can comprise a first branch aligned with the first handle and a second branch extending at an oblique angle relative to the first branch.

[0046] In some examples, the pusher shaft can extend through a bend in the connector.

[0047] In some examples, the proximal extension can be arranged in the bend and can extend into the second branch.

[0048] In some examples, a delivery system for delivering a docking device to a native heart valve comprises a handle assembly comprising a first handle; a guide shaft mounted to and extending distally from the first handle; a sleeve shaft at least partially arranged within the guide shaft; and a pusher shaft at least partially arranged within the sleeve shaft and extending distally and proximally from the first handle, wherein the pusher shaft comprises: a tube having a first inner lumen and a first flexibility; and an extension fixed to an end of the tube, wherein the extension has a second inner lumen coaxially arranged with the first inner lumen and a second flexibility that is greater than the first flexibility.

[0049] In some examples, a delivery system comprises one or more of the components recited in Examples 13-21, 57 below.

[0050] A method of forming a shaft for a docking device delivery apparatus can comprise fixing an extension to an end of a tube or forming an extension with a length on an end portion of the tube, wherein the tube has a first lumen and a first flexibility and the extension has a second lumen coaxially arranged with the first lumen and a second flexibility that is greater than the first flexibility. In addition to this step, a method can further comprise one or more of the steps disclosed herein.

[0051] In some examples, the method can further comprise arranging a liner within the first and second lumens.

[0052] In some examples, the method can further comprise forming a polymer layer over the extension and at least a portion of the tube.

[0053] In some examples, the act of fixing the extension to the end of the tube can comprise welding or bonding.

[0054] In some examples the distal extension, the proximal extension, or both the distal and proximal extensions can comprise a coil having a plurality of turns defining the second lumen.

[0055] In some examples, the distal extension, the proximal extension, or both the distal and proximal extensions can comprise a braid forming a cylindrical shape defining the second lumen.

[0056] In some examples, the act of forming the extension can comprise reducing the end portion of the tube in diameter along the length from a first outer diameter to a second outer diameter.

[0057] In some examples, the act of reducing the end portion of the tube can comprise grinding or turning the tube.

[0058] In some examples, the extension can comprise a distal extension on a distal end of the tube, a proximal extension on the proximal end of the tube, or both a distal extension on the distal end of the tube and a proximal extension on the proximal end of the tube.

[0059] In some examples, a method of forming a shaft for a docking device delivery apparatus comprises fixing an extension to an end of a tube, wherein the tube has a first lumen and a first flexibility and the extension has a second lumen coaxially arranged with the first lumen and a second flexibility that is greater than the first flexibility.

[0060] In some examples, a method of forming a shaft for a docking device delivery apparatus comprises forming an extension with a length on an end portion of a tube having an inner lumen, wherein the tube has a first flexibility and the extension has a second flexibility that is greater than the first flexibility.

[0061] In some examples, a method comprises one or more of the steps recited in Examples 41-56 below.

[0062] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, or simulator (e.g., with body parts, heart, tissue, etc. being simulated).

[0063] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0064] FIG. 1A schematically illustrates a first stage in an exemplary mitral valve replacement procedure where a guide catheter and a guidewire are inserted into a bloodvessel of a patient and navigated through the blood vessel and into a heart of the patient, towards a native mitral valve of the heart.

[0065] FIG. 1B schematically illustrates a second stage in the exemplary mitral valve replacement procedure where a docking device delivery apparatus extending through the guide catheter is implanting a docking device for a prosthetic heart valve at the native mitral valve.

[0066] FIG. 1C schematically illustrates a third stage in the exemplary mitral valve replacement procedure where the docking device of FIG. 1B is fully implanted at the native mitral valve of the patient and the docking device delivery apparatus has been removed from the patient.

[0067] FIG. 1D schematically illustrates a fourth stage in the exemplary mitral valve replacement procedure where a prosthetic heart valve delivery apparatus extending through the guide catheter is implanting a prosthetic heart valve in the implanted docking device at the native mitral valve.

[0068] FIG. 1E schematically illustrates a fifth stage in the exemplary mitral valve replacement procedure where the prosthetic heart valve is fully implanted within the docking device at the native mitral valve and the prosthetic heart valve delivery apparatus has been removed from the patient.

[0069] FIG. 1F schematically illustrates a sixth stage in the exemplary mitral valve replacement procedure where the guide catheter and the guidewire have been removed from the patient.

[0070] FIG. 2 is a perspective view of a prosthetic heart valve, according to an example.

[0071] FIG. 3 is a perspective view of a docking device for a prosthetic heart valve, according to an example.

[0072] FIG. 4 is a perspective view of a docking device for a prosthetic heart valve, according to another example.

[0073] FIG. 5 is a perspective view of a docking device for a prosthetic heart valve, according to another example, where the docking device comprises a brim.

[0074] FIG. 6 is a side view of a delivery apparatus for a docking device, according to an example.

[0075] FIG. 6A is a detail view of a proximal end portion of the delivery apparatus of FIG. 6.

[0076] FIG. 6B is a detail view of a distal end portion of the delivery apparatus of FIG. 6, according to an example, showing a pusher shaft having a distal extension coupled to the docking device of FIG. 5.

[0077] FIG. 7 is a cross-sectional side view of a pusher shaft for a docking device delivery apparatus, according to an example, where the pusher shaft has a tube with a proximal extension and a distal extension.

[0078] FIG. 8A is a side view of a tube for the pusher shaft of FIG. 7, according to an example, where the tube has a distal extension formed as a unitary portion of the tube.

[0079] FIG. 8B is a side view of a tube for the pusher shaft of FIG. 7, according to another example, where the tube has a distal extension formed as a braid.

[0080] FIG. 8C is a side view of a tube for the pusher shaft of FIG. 7, according to another example, where the tube has a distal extension formed as a coil.

[0081] FIG. 9A is a detail view of the distal end portion of the pusher shaft of FIG. 7 comprising the tube and distal extension of FIG. 8A.

[0082] FIG. 9B is a detail view of the distal end portion of the pusher shaft of FIG. 7 comprising the tube and distal extension of FIG. 8B.

[0083] FIG. 9C is a detail view of the distal end portion of the pusher shaft of FIG. 7 comprising the tube and distal extension of FIG. 8C.

[0084] FIG. 10A is a side view of a tube for the pusher shaft of FIG. 7, according to an example, where the tube has a proximal extension formed as a unitary portion of the tube.

[0085] FIG. 10B is a side view of a tube for the pusher shaft of FIG. 7, according to another example, where the tube has a proximal extension formed as a braid.

[0086] FIG. 10C is a side view of a tube for the pusher shaft of FIG. 7, according to another example, where the tube has a proximal extension formed as a coil.

[0087] FIG. 11A is a detail view of the proximal end portion of the pusher shaft of FIG. 7 comprising the tube and proximal extension of FIG. 10A.

[0088] FIG. 11B is a detail view of the proximal end portion of the pusher shaft of FIG. 7 comprising the tube and proximal extension of FIG. 10B.

[0089] FIG. 11C is a detail view of the proximal end portion of the pusher shaft of FIG. 7 comprising the tube and proximal extension of FIG. 10C.

[0090] FIG. 12 is a side view of a tube for the pusher shaft of FIG. 7, according to another example, where the tube has a proximal extension and a distal extension formed as a unitary portion of the tube.DETAILED DESCRIPTIONGeneral Considerations

[0091] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0092] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0093] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0094] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0095] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0096] As introduced above, docking devices for prosthetic implants (for example, prosthetic heart valves) can be used to securely hold prosthetic implants in place at an implantation site. Docking devices can be delivered to the implantation site by a docking device delivery apparatus to which the docking device can be coupled for advancement through a body. In some examples, the docking device can be coupled to a distal end portion of a pusher shaft of the delivery apparatus. The pusher shaft and the coupled docking device can be sheathed (e.g., covered) inside a sleeve shaft during advancement through the body to the implantation site then unsheathed for deployment. In some examples, the pusher shaft can be additionally used to orient the docking device in relation to native anatomical features at the implantation site.

[0097] In some examples, it can be advantageous for a pusher shaft to have sufficient rigidity or column strength for guiding the docking device to an implantation site and orienting the docking device in relation to a surrounding native anatomy. Conversely, it can be advantageous for the pusher shaft to have portions of increased flexibility for improved adaptability and resiliency during bending. For example, a pusher shaft comprising a distal portion with increased flexibility can, in some instances, more easily accommodate docking devices having various configurations. For example, docking devices having shorter proximal end portions may be more easily implanted when coupled to pusher shafts having elongated distal end portions that can more easily bend. Additionally, in some examples, these flexible distal portions can have reduced outer diameters that, when used with dockingdevices having a brim, advantageously provide radial space for storing the brim when sheathed within a sleeve shaft as described above.

[0098] Additionally (or alternatively), proximal end portions of a pusher shaft can be arranged within regions of a delivery apparatus having bends or curves. It can be desirable, in some instances, for the proximal end portions of the pusher shaft to have supportive, proximal extensions arranged within these curves. These proximal extensions can be configured with additional, flexible support that can reduce the likelihood of kinking or damage to the shaft when bent. In other words, proximal end portions of a pusher shaft extending through bends in a delivery apparatus can be configured with a flexible extension which can, in some examples, improve reliability and shaft integrity when under strain.

[0099] Described herein are examples of a pusher shaft for an implant delivery apparatus, such as for the delivery of a docking device, where the pusher shaft comprises portions of increased flexibility. In some examples, the flexible portions of the shafts can include an extension on a distal end, a proximal end, or both a distal and a proximal end of the pusher shaft.Examples of the Disclosed Technology

[0100] Prosthetic implants disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic implants can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus. The prosthetic implants can be expanded to the radially expanded state once the prosthetic implants reach the implantation site. Although prosthetic valves are primarily described herein, it is understood that any the delivery apparatuses described herein can be used with any types of prosthetic implant, such as, for example, stents, grafts, or prosthetic valves. It is also understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0101] FIGS. 1A-1B show an exemplary prosthetic implant in the form of a prosthetic valve 100, according to an example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in some examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicatingwith the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0102] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated by reference herein in its entirety. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907, which is incorporated by reference herein in its entirety. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No.2019 / 0000615, which is incorporated by reference herein in its entirety.

[0103] In some examples, the expandable prosthetic implant can be a prosthetic heart valve. FIGS. 1A-1F depict one example of a transcatheter heart valve replacement procedure (e.g., a mitral valve replacement procedure) which utilizes a docking device 52 and a prosthetic heart valve 62. As described above, the docking device 52 can be used to securely hold the prosthetic heart valve 62 in place at the native mitral valve, where the prosthetic heart valve 62 can be radially expanded inside the docking device 52 within the annulus of the native mitral valve. Although FIG. 1A-1F show the procedure using the docking device 52 and the prosthetic heart valve 62, it is understood that any docking device or prosthetic heart valve described herein can be used.

[0104] During the example procedure depicted in FIGS. 1A-1F, a user first creates a pathway to a patient’s native heart valve using a guide catheter 30 (FIG. 1 A). The user then delivers and implants the docking device 52 at the patient’s native heart valve using a docking device delivery apparatus 50 (FIG. 1B) and then removes the docking device delivery apparatus 50 from the patient 10 after implanting the docking device 52 (FIG. 1C). The user then implants the prosthetic heart valve 62 within the implanted docking device 52using a prosthetic valve delivery apparatus 60 (FIG. 1D). Thereafter, the user removes the prosthetic valve delivery apparatus 60 from the patient 10 (FIG. 1E), as well as the guide catheter 30 (FIG. 1F).

[0105] FIG. 1 A depicts a first stage in a mitral valve replacement procedure, according to an example, where the guide catheter 30 and a guidewire 40 are inserted into a blood vessel 12 of a patient 10 and navigated through the blood vessel 12, into a heart 14 of the patient 10, and toward the native mitral valve 16. Together, the guide catheter 30 and the guidewire 40 can provide a path for the docking device delivery apparatus 50 and the prosthetic valve delivery apparatus 60 to be navigated through and along, to the implantation site (the native mitral valve 16 or native mitral valve annulus).

[0106] Initially, the user may first make an incision in the patient’s body to access the blood vessel 12. For example, in the example illustrated in FIG. 1 A, the user may make an incision in the patient’s groin to access a femoral vein. Thus, in such examples, the blood vessel 12 may be a femoral vein.

[0107] After making the incision at the blood vessel 12, the user may insert the guide catheter 30, the guidewire 40, and / or additional devices (such as an introducer device or transseptal puncture device) through the incision and into the blood vessel 12. The guide catheter 30 (which can also be referred to as an “introducer device,” “introducer,” or “guide sheath”) is configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., the docking device delivery apparatus 50 and the prosthetic valve delivery apparatus 60) into and through the blood vessel 12 and may extend through the blood vessel 12 and into the heart 14 but may stop short of the native mitral valve 16. The guide catheter 30 can comprise a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 can extend through the blood vessel 12 and into the heart 14 while the handle 32 remains outside the body of the patient 10 and can be operated by the user in order to manipulate the shaft 34.

[0108] The guidewire 40 is configured to guide the delivery apparatuses (e.g., the guide catheter 30, the docking device delivery apparatus 50, the prosthetic valve delivery apparatus 60, additional catheters, or the like) and their associated devices (e.g., docking device, prosthetic heart valve, and the like) to the implantation site within the heart 14, and thus may extend all the way through the blood vessel 12 and into a left atrium 18 of the heart 14 (and in some examples, through the native mitral valve 16 and into a left ventricle of the heart 14) as shown in FIG. 1 A.

[0109] In some examples, a transseptal puncture device or catheter can be used to initially access the left atrium 18, prior to inserting the guidewire 40 and the guide catheter 30. For example, after making the incision to the blood vessel 12, the user may insert a transseptal puncture device through the incision and into the blood vessel 12. The user may guide the transseptal puncture device through the blood vessel 12 and into the heart 14 (e.g., through the femoral vein and into the right atrium 20). The user can then make a small incision in an atrial septum 22 of the heart 14 to allow access to the left atrium 18 from the right atrium 20. The user can then insert and advance the guidewire 40 through the transseptal puncture device within the blood vessel 12 and through the incision in the atrial septum 22 into the left atrium 18. Once the guidewire 40 is positioned within the left atrium 18 and / or the left ventricle 26, the transseptal puncture device can be removed from the patient 10. The user can then insert the guide catheter 30 into the blood vessel 12 and advance the guide catheter 30 into the left atrium 18 over the guidewire 40 (FIG. 1A).

[0110] In some examples, an introducer device can be inserted through a lumen of the guide catheter 30 prior to inserting the guide catheter 30 into the blood vessel 12. In some instances, the introducer device can include a tapered end that extends out a distal tip of the guide catheter 30 and that is configured to guide the guide catheter 30 into the left atrium 18 over the guidewire 40. Additionally, in some instances, the introducer device can include a proximal end portion that extends out a proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user can remove the introducer device from inside the guide catheter 30 and the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain inside the patient 10. The guide catheter 30 is then in position to receive an implant delivery apparatus and help guide it to the left atrium 18, as described further below.

[0111] FIG. 1B depicts a second stage in the exemplary mitral valve replacement procedure where the docking device 52 is being implanted at the native mitral valve 16 of the heart 14 of the patient 10 using the docking device delivery apparatus 50 (which may also be referred to as an “implant catheter,” a “delivery apparatus,” and / or a “docking device delivery device”).

[0112] In general, the docking device delivery apparatus 50 comprises a delivery shaft 54, a handle 56, and a pusher assembly 58. The delivery shaft 54 is configured to be advanced through the patient’s vasculature (blood vessel 12) and to the implantation site (e.g., native mitral valve 16) by the user and may be configured to retain the docking device 52 at a distalend portion 53 of the delivery shaft 54. In some examples, the distal end portion 53 of the delivery shaft 54 retains the docking device 52 therein in a straightened delivery configuration.

[0113] The handle 56 of the docking device delivery apparatus 50 is configured to be gripped and / or otherwise held by the user, outside the body of the patient 10, to advance the delivery shaft 54 through the patient’s vasculature (e.g., blood vessel 12).

[0114] In some examples, the handle 56 can comprise one or more articulation members 57 (or rotatable knobs) that are configured to aid in positioning the delivery shaft 54 within the heart 14. For example, the one or more articulation members 57 can comprise one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 to aid in positioning the delivery shaft 54 within the heart 14 for deployment of the docking device 52 at the implantation site (e.g., the native mitral valve 16).

[0115] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at the implantation site (e.g., the native mitral valve 16). For example, the pusher assembly 58 can be configured to be adjusted by the user to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54. A pusher shaft of the pusher assembly 58 can extend through the delivery shaft 54 and can be disposed adjacent to the docking device 52 within the delivery shaft 54. In some examples, the docking device 52 can be releasably coupled to the pusher shaft of the pusher assembly 58 via a connection mechanism of the docking device delivery apparatus 50 such that the docking device 52 can be released after being deployed at the native mitral valve 16. An example of a connection mechanism will be described in more detail below in connection with FIGS. 6 and 6B. Further details of the docking device delivery apparatus and its variants are described in PCT Publication No. W02020 / 247907.

[0116] Referring again to FIG. 1B, after the guide catheter 30 is positioned within the left atrium 18, the user may insert the docking device delivery apparatus 50 (e.g., the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 of the docking device delivery apparatus 50 through the guide catheter 30 and over the guidewire 40. In some examples, the guidewire 40 can be at least partially retracted away from the left atrium 18 and into the guide catheter 30. In other examples, the guidewire 40 can be fully removed from the guidecatheter 30 prior to insertion of the docking device delivery apparatus 50. The user may then continue to advance the delivery shaft 54 of the docking device delivery apparatus 50 through the blood vessel 12 within the guide catheter 30 until the delivery shaft 54 reaches the left atrium 18, as illustrated in FIG. IB. Specifically, the user may advance the delivery shaft 54 of the docking device delivery apparatus 50 by gripping and exerting a force on (e.g., pushing) the handle 56 of the docking device delivery apparatus 50 toward the patient 10. While advancing the delivery shaft 54 through the blood vessel 12 and the heart 14, the user may adjust the one or more articulation members 57 of the handle 56 to navigate the various turns, corners, constrictions, and / or other obstacles in the blood vessel 12 and the heart 14.

[0117] Once the delivery shaft 54 reaches the left atrium 18 and extends out of a distal end of the guide catheter 30, the user can position the distal end portion 53 of the delivery shaft 54 at and / or near the posteromedial commissure of the native mitral valve 16 using the handle 56 (e.g., the articulation members 57). The user may then push the docking device 52 out of the distal end portion 53 of the delivery shaft 54 with the shaft of the pusher assembly 58 to deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0118] In some examples, the docking device 52 may be constructed from, formed of, and / or comprise a shape memory material, and as such, may return to its original, pre-formed shape when it exits the delivery shaft 54 and is no longer constrained by the delivery shaft 54. As one example, the docking device 52 may originally be formed as a coil, and thus may wrap around leaflets 24 of the native mitral valve 16 as it exits the delivery shaft 54 and returns to its original coiled configuration. Examples of docking devices will be described in more detail below in connection with FIGS. 3-5.

[0119] After pushing a ventricular portion of the docking device 52 (e.g., the portion of the docking device 52 shown in FIG. IB that is configured to be positioned within a left ventricle 26 and / or on the ventricular side of the native mitral valve 16), the user may then deploy the remaining portion of the docking device 52 (e.g., an atrial portion of the docking device 52) from the delivery shaft 54 within the left atrium 18 by retracting the delivery shaft 54 away from the posteromedial commissure of the native mitral valve 16.

[0120] After deploying and implanting the docking device 52 at the native mitral valve 16, the user may disconnect the docking device delivery apparatus 50 from the docking device 52. Once the docking device 52 is disconnected from the docking device delivery apparatus 50, the user may retract the docking device delivery apparatus 50 out of the blood vessel 12and away from the patient 10 so that the user can deliver and implant a prosthetic heart valve 62 within the implanted docking device 52 at the native mitral valve 16.

[0121] FIG. 1 C depicts a third stage in the mitral valve replacement procedure, where the docking device 52 has been fully deployed and implanted at the native mitral valve 16 and the docking device delivery apparatus 50 (including the delivery shaft 54) has been removed from the patient 10, such that only the guide catheter 30 remains inside the patient 10. In some examples, both the guide catheter 30 and the guidewire 40 remain inside the patient 10. After removing the docking device delivery apparatus 50, the guidewire 40 can be advanced through and / or out of the guide catheter 30, through the implanted docking device 52 at the native mitral valve 16, and into the left ventricle 26 (FIG. 1B). As such, the guidewire 40 can help to guide the prosthetic valve delivery apparatus 60 through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.

[0122] As illustrated in FIG. 1C, the docking device 52 can comprise a plurality of turns (or coils) that wrap around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has a more cylindrical shape than the annulus of the native mitral valve 16, thereby providing a geometry that more closely matches the shape or profile of the prosthetic heart valve to be implanted. As a result, the docking device 52 can provide a tighter fit, and thus a better seal, between the prosthetic heart valve and the native mitral valve 16.

[0123] FIG. 1D depicts a fourth stage in the mitral valve replacement procedure where the user is delivering and / or implanting a prosthetic heart valve 62 (which can also be referred to herein as a “transcatheter heart valve” or “THV” for short, “replacement heart valve,” and / or “prosthetic mitral valve”) within the docking device 52 using a prosthetic valve delivery apparatus 60.

[0124] As shown in FIG. 1D, the prosthetic valve delivery apparatus 60 can comprise a delivery shaft 64 and a handle 66, the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into the patient’s vasculature to deliver, implant, expand, and / or otherwise deploy the prosthetic heart valve 62 within the docking device 52 at the native mitral valve 16. The handle 66 is configured to be gripped and / or otherwise held by the user to advance the delivery shaft 64 through the patient’s vasculature.

[0125] In some examples, the handle 66 can comprise one or more articulation members 68 that are configured to aid in navigating the delivery shaft 64 through the blood vessel 12 andthe heart 14. Specifically, the articulation member(s) 68 can comprise one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and / or otherwise articulate a distal end portion of the delivery shaft 64 to aid in navigating the delivery shaft 64 through the blood vessel 12 and into the left atrium 18 and left ventricle 26 of the heart 14.

[0126] In some examples, the prosthetic valve delivery apparatus 60 can include an expansion mechanism 65 that is configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. In some instances, as shown in FIG. 1D, the expansion mechanism 65 can comprise an inflatable balloon that is configured to be inflated to radially expand the prosthetic heart valve 62 within the docking device 52. The inflatable balloon can be coupled to the distal end portion of the delivery shaft 64.

[0127] In other examples, the prosthetic heart valve 62 can be self-expanding and can be configured to radially expand on its own upon removable of a sheath or capsule covering the radially compressed prosthetic heart valve 62 on the distal end portion of the delivery shaft 64. In still other examples, the prosthetic heart valve 62 can be mechanically expandable and the prosthetic valve delivery apparatus 60 can include one or more mechanical actuators (e.g., the expansion mechanism) configured to radially expand the prosthetic heart valve 62.

[0128] As shown in FIG. 1D, the prosthetic heart valve 62 can be mounted around the expansion mechanism 65 (the inflatable balloon) on the distal end portion of the delivery shaft 64, in a radially compressed configuration.

[0129] To navigate the distal end portion of the delivery shaft 64 to the implantation site, the user can insert the prosthetic valve delivery apparatus 60 (the delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guidewire 40. The user can continue to advance the prosthetic valve delivery apparatus 60 along the guidewire 40 (through the blood vessel 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as illustrated in FIG. 1D. More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery apparatus 60 by gripping and exerting a force on (e.g., pushing) the handle 66. While advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the user can adjust the one or more articulation members 68 of the handle 66 to navigate the various turns, comers, constrictions, and / or other obstacles in the blood vessel 12 and heart 14.

[0130] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted around the distal end portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some examples, as shown in FIG. ID, a distal end of the delivery shaft 64 and a least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.

[0131] Once the radially compressed prosthetic heart valve 62 is appropriately positioned within the docking device 52 (FIG. 1D), the user can manipulate one or more actuation mechanisms of the handle 66 of the prosthetic valve delivery apparatus 60 to actuate the expansion mechanism 65 (e.g., inflate the inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52.

[0132] FIG. 1E shows a fifth stage in the mitral valve replacement procedure where the prosthetic heart valve 62 is in its radially expanded configuration and implanted within the docking device 52 in the native mitral valve 16. As shown in FIG. 1E, the prosthetic heart valve 62 is received and retained within the docking device 52. Thus, the docking device 52 aids in anchoring the prosthetic heart valve 62 within the native mitral valve 16. In some examples, the docking device 52 can enable better sealing between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16 to reduce paravalvular leakage around the prosthetic heart valve 62.

[0133] As also shown in FIG. 1E, after the prosthetic heart valve 62 has been fully deployed and implanted within the docking device 52 at the native mitral valve 16, the prosthetic valve delivery apparatus 60 (including the delivery shaft 64) can be removed from the patient 10 such that only the guidewire 40 and the guide catheter 30 remain inside the patient 10.

[0134] FIG. 1F depicts a sixth stage in the mitral valve replacement procedure, where the guidewire 40 and the guide catheter 30 have been removed from the patient 10.

[0135] Although FIGS. 1A-1F specifically depict a mitral valve replacement procedure, it should be appreciated that a similar procedure may be utilized to replace other heart valves (e.g., tricuspid, pulmonary, and / or aortic valves). Further, the same and / or similar delivery apparatuses (e.g., docking device delivery apparatus 50, prosthetic valve delivery apparatus 60, guide catheter 30, and / or guidewire 40), docking devices (e.g., docking device 52, or any other docking device described herein), replacement heart valves (e.g., prosthetic heart valve 62, or any other prosthetic valve described herein), and / or components thereof may beutilized for replacing these other heart valves. Additional details regarding implantation procedures for docking devices and prosthetic heart valves are described in PCT Publication No. W02023 / 205076, which is incorporated by reference herein in its entirety.

[0136] Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0137] FIG. 2 shows an exemplary prosthetic implant in the form of a prosthetic valve 100, according to another example. The prosthetic valve 100 can be implanted within the docking device 52 in lieu of the prosthetic valve 62, as described above in connection with FIGS. 1D-1F.

[0138] In some examples, the disclosed prosthetic valves (for example, prosthetic valves 62 and 100) can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated by reference herein.

[0139] Referring back to FIG. 2, the prosthetic valve 100 can comprise a frame 102, a valvular structure 104, and a peri valvular outer sealing member or outer skirt 106. The prosthetic valve 100 can have an inflow end portion 110 and an outflow end portion 108, and an intermediate portion 112 extending therebetween.

[0140] The valvular structure 104 can comprise a plurality of leaflets 114 collectively forming a leaflet structure. In some examples, the valvular structure 104 can comprise three leaflets 114 arranged in a tricuspid arrangement. However, there can be a greater or fewer number of leaflets 114. The leaflets 114 can be secured to one another at their adjacent sides to form commissures of the valvular structure 104. The lower edge of the valvular structure 104 can have an undulating, curved scalloped shape. In some examples, the leaflets 114 can be formed of pericardial tissue (such as bovine pericardial tissue), biocompatible synthetic materials, or other various suitable natural or synthetic materials as known in the art and described in U. S. Patent No. 6,730,118, which is incorporated by reference herein.

[0141] The frame 102 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol). When constructed of a plastically-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable catheter balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size, as introduced above.

[0142] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 102) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 102 can comprise stainless steel. In some examples, the frame 102 can comprise cobalt-chromium. In some examples, the frame 102 can comprise nickel-cobalt-chromium. In some examples, the frame 102 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0143] The outer skirt 106 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirt 106 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plushnap or pile, Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the skirt 106 can comprise a fabric without interlaced yarns or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirt 106 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirt 106 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirt 106 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0144] FIG. 3 shows a docking device 200, according to an example. The docking device 200 can, for example, be implanted within a native valve annulus and configured to receive and secure a prosthetic valve (such as, for example, the prosthetic valves 62 and 100) within the docking device 200, thereby securing the prosthetic valve at the native valve annulus. The docking device 200 can be implanted in lieu of the docking device 52 as described above in connection with FIGS. 1 A-1F. Although described primarily for use herein with a prosthetic valve, any docking device described herein can be used with a variety of prosthetic implants, such as, for example, prosthetic valves, grafts, or stents.

[0145] The docking device 200 can comprise two main components: a coil 202 and a guard member 204 covering at least a portion of the coil 202. In certain examples, the coil 202 can include a shape memory material (e.g., Nitinol) such that the docking device 200 (and the coil 202) can move from a substantially straight configuration (also referred to as “delivery configuration”) when disposed within a delivery shaft of a delivery apparatus to a helical configuration (also referred to as “deployed configuration”) after being advanced out of the delivery shaft.

[0146] The coil 202 has a proximal end 210 and a distal end 212. When disposed within the delivery shaft (e.g., during delivery of the docking device into the vasculature of a patient), a body of the coil 202 between the proximal end 210 and distal end 212 can form a generally straight delivery configuration (i.e., without any coiled or looped portions) so as to maintain a small radial profile when moving through a patient’s vasculature. After being removed fromthe delivery shaft and deployed at an implant position, the coil 202 can move from the delivery configuration to the helical deployed configuration and wrap around native tissue adjacent the implant position. For example, when implanting the docking device at the location of a native valve, the coil 202 can be configured to surround native leaflets of the native valve.

[0147] The coil 202 in the deployed configuration can include a leading turn 214 (or “leading coil”), a central region 216, an ascending portion 217, and stabilization turn 218 (also referred to herein as a “stabilization coil” or an “atrial turn”). The central region 216 can have one or more helical turns having substantially equal inner diameters, in some examples. The leading turn 214 can extend from a distal end of the central region 216 and have a diameter greater than the diameter of the central region 216 (in one or more configurations). The stabilization turn 218 can extend from a proximal end of the central region 216 and have a diameter greater than the diameter of the central region 216 (in one or more configurations). The docking device 200 can comprise additional features as disclosed in PCT Publication No. WO2022 / 087336, which is incorporated by reference herein.

[0148] The docking device 200 can be releasably coupled to a delivery apparatus. For example, the docking device 200 can be coupled to a delivery apparatus, as will be described further below in connection with FIGS. 6 and 6 A, via a release suture. For example, the release suture can be tied to the docking device 200 through an eyelet, eyehole, or hole 220 located adjacent the proximal end 210 of the coil. In another example, the release suture can be tied around a circumferential recess that is located adjacent the proximal end 210 of the coil 202.

[0149] In some examples, the docking device 200 in the deployed configuration can be configured to fit at the mitral valve position. In other examples, the docking device can also be shaped and / or adapted for implantation at other native valve positions, such as at the tricuspid valve. As described herein, the geometry of the docking device 200 can be configured to engage the native anatomy, which can, for example, provide for increased stability and reduction of relative motion between the docking device 200, the prosthetic valve docked therein, and / or the native anatomy. Reduction of such relative motion can, among other things, prevent material degradation of components of the docking device 200 and / or the prosthetic valve docked therein and / or prevent damage or trauma to the native tissue.

[0150] FIG. 4 shows a docking device 300 in a deployed configuration, according to another example. The docking device 300 comprises a coil 302 having a stabilization turn 304 (also referred to as a “stabilization coil,” an “atrial most functional turn,” or a “first coil region”), a central region 306 (also referred to as “functional turns” or a “second coil region”), and a leading turn 308 (also referred to as a “leading coil”). The stabilization turn 304, the central region 306 and the leading turn 308 are each disposed around a longitudinal axis 310 which extends through a central lumen 312 of the coil 302. The central region 306 can comprise one or more helical turns having substantially equal diameters, in some instances.

[0151] The leading turn 308 can extend from a distal end of the central region 306 and, in some examples, can have a diameter substantially equal to the diameter of the central region 306. In some examples, the leading turn 308 can comprise a distal end portion 314 that extends radially outward.

[0152] In some examples, the stabilization turn 304 can extend from a proximal end of the central region 306 and can have a diameter substantially equal to the diameter of the central region 306. In some examples, the diameter of the stabilization turn can be different than the diameter of the central region 306.

[0153] In some examples, the coil 302 of docking device 300 can comprise turns having different coil pitches, where the coil pitch can be defined as a distance between two successive turns of the coil. In some examples, the coil 302 of docking device 300 can comprise turns having the same coil pitch from coil to coil.

[0154] An attachment portion 316 can extend from the stabilization turn 304 and can have one or more eyelets, eyeholes, or holes 318 adjacent a proximal end 320 of the coil 302. The attachment portion 316 can be configured to releasably couple the coil 302 to a delivery apparatus. In some examples, the coil 302 can be coupled to the delivery apparatus via a release suture that can be configured to be tied to the coil 302 through the one or more eyelets or holes 318.

[0155] In some examples, a guard member can be used with the stabilization turn 304, where the guard member can be configured to provide increased stability to the docking device as it is deployed. As seen in the depicted example, the coil 302 can be similarly configured as the coil 202 depicted in FIG. 3, with the exception of the ascending portion 217.

[0156] FIG. 5 shows a docking device 400 in a deployed configuration, according to another example. The docking device 400 can comprise a coil 402 that can include a stabilizationturn 404 (also referred to as a “stabilization coil,” an “atrial most functional turn,” or a “first coil region”), a central region 406 (also referred to as “functional turns” or a “second coil region”), and a leading turn 408 (also referred to as a “leading coil”), each of which are disposed around a longitudinal axis 410 that extends through a central lumen 420. The stabilization turn 404 can have a proximal end 405. The coil 402 can be arranged with the same configuration as the coil 302 and, as such, the description of the coil 302 applies to the coil 402 and is incorporated herein in connection to the coil 402. Some features of the coil 402 may not be repeated here for sake of brevity. In some examples, however, the docking device 400 need not include all of the components described above for the docking device 300.

[0157] In contrast to the docking device 300 shown in FIG. 4, the docking device 400 comprises a guard member (also referred to herein as a “brim”) 430. The brim 430 can move between a radially compressed state and a radially expanded state. The brim 430 can include a plurality of anus defining panels that can be radially expandable and compressible. The brim 430 can also comprise terminal lobes. In the depicted example, the brim 430 can have arms 432 with panels 434 and two terminal lobes 436. In some examples, the brim 430 can comprise a flap sheet. In some examples, the flap sheet is folded over the ends of the arms 432 to provide increased protection to native tissue. Any of the docking devices described herein can comprise a guard member which is substantially similar to the brim 430.

[0158] FIG. 6 shows a docking device delivery apparatus (also referred to herein as a “dock delivery apparatus,” a “dock delivery catheter,” a “dock delivery system,” or a “delivery apparatus”) 500, according to an example, configured to advance a docking device to an implantation site. In some examples, the delivery apparatus 500 can be used in lieu of the delivery apparatus 50, described above with reference to the procedure schematically shown in FIGS. 1 A-1F. Although the delivery apparatus 500 is shown coupled to the docking device 400 of FIG. 5, it is understood that the delivery apparatus 500 can be used with any docking device or prosthetic implant described herein, as well as other compatible docking devices and / or prosthetic implants.

[0159] Referring to FIG. 6, the delivery apparatus 500 can comprise a handle assembly 502, a delivery shaft (also referred to herein as an “outer shaft” or a “guide shaft”) 504 extending distally from the handle assembly 502, a sleeve shaft 506 disposed within the delivery shaft 504 (see FIG. 6B), and a pusher shaft 512 disposed within the sleeve shaft 506 and coupled to the docking device 400.

[0160] The handle assembly 502 can comprise a first handle 514 comprising knobs 516 and 518 which can be configured to steer and / or control flexing of the delivery apparatus 500, such as the delivery shaft 504 and / or the sleeve shaft 506. The pusher shaft 512 and the sleeve shaft 506 can have portions extending into the handle assembly 502. The sleeve shaft 506 can be configured to cover (e.g., surround or sheath) the docking device 400 and, together, the pusher shaft 512 and sleeve shaft 506 can be configured to deploy the docking device 400 from the delivery shaft 504, upon reaching the target implantation site. Further details regarding the sleeve shaft 506 are described in PCT Publication No. W02023 / 205076.

[0161] Further, the delivery apparatus 500 can be configured to adjust an axial position of the sleeve shaft 506 to remove a sleeve portion (e.g., a distal section) of the sleeve shaft 506 from the docking device 400, after implantation at the target implantation site. As shown in FIG.6, during delivery, the docking device 400 can be coupled to the delivery system via a release suture 520 (or other retrieval line comprising a string, yam, or other material that can be configured to be tied around the docking device and cut for removal) that extends through the pusher shaft 512. The suture 520 can extend through the delivery apparatus 500, through an inner lumen of the pusher shaft 512, to a suture lock assembly 522 of the delivery apparatus 500. In some examples, the delivery apparatus 500 can additionally or alternatively comprise a release mechanism 524 for the dock 400 as described in U. S. Provisional Application No.63 / 712,719, which is incorporated herein in its entirety. After removing the sleeve shaft 506 from covering the docking device 400 and implanting the docking device 400 at the target implantation site, the docking device 400 can be disconnected from the delivery system by cutting the suture 520 via the suture lock assembly 522 of the delivery system and / or by using the release mechanism 524.

[0162] An example of a portion of the handle assembly 502 is shown in FIG. 6A, where the handle assembly 502 comprises a hub assembly (also referred to herein as a “second handle”) 526, which in some examples, can comprise a Y-shaped connector (e.g., adaptor) 527. The connector 527 can have a straight section (e.g., straight conduit) 528 and at least one branch (e.g., branch conduit) 530 disposed at an angle (e.g., an oblique angle) with respect to the straight section 528. Although one branch is shown in the example of FIG. 6A, in some examples, the connector 527 can include more than one branch. In some examples, the hub assembly 526 can be coupled to the first handle 514 via a locking mechanism 532.

[0163] The suture lock assembly (e.g., suture lock) 522 can be attached to the branch 530 and a sleeve actuating handle 534 can be arranged at a proximal end of the straight section 528.The hub assembly 526 can be adapted and configured to allow a proximal end portion 540 of the pusher shaft 512 (or any other pusher shaft disclosed herein) to extend to the suture lock assembly 522 arranged at the end of the branch 530 while a cut, proximal portion 506p of the sleeve shaft 506 can extend to the sleeve actuating handle 534 arranged at the end of the straight section 528.

[0164] As seen in FIG. 6A, the proximal end portion 540 of the pusher shaft 512 is arranged to extend from the straight section 528 into the branch 530 and thus assumes a curved or bent configuration through the Y-shaped connector 527. Accordingly, as introduced above, it may be advantageous to configure the proximal end portion 540 of the pusher shaft with a supporting extension (also referred to herein as a “proximal extension” or a “second extension”) of increased flexibility, the details of which are provided below in connection with FIGS. 10A-11C, where the supporting extension can reduce the likelihood of kinking or damage to the shaft 512 when bent as described above and shown in FIG. 6 A.

[0165] Referring again to FIG. 6, a medical professional can deploy the docking device 400, or any other docking device such as the docking devices 52, 200, 300 described herein, by manipulating the position of the handle assembly 502 (e.g., moving it in the axial direction) and also retracting the sleeve shaft 506 (off of and away from the implanted docking device) by pulling back, in the axial direction, on the sleeve actuating handle 534.

[0166] The sleeve shaft 506 and pusher shaft 512 assembly can be configured to work together such that they can be moved simultaneously together when deploying and positioning the docking device at the native valve (e.g., by moving the entire hub assembly 526 distally and / or proximally, in the axial direction), but can also to move independently so the pusher shaft 512 can hold the docking device in position while the sleeve shaft 506 is retracted off of the docking device (e.g., by holding the hub assembly 526 in place relative to the guide shaft 504 of the delivery system and / or other parts of the delivery system and / or docking device while pulling proximally on the sleeve actuating handle 534 to withdraw the sleeve shaft 506). As introduced above and shown in FIG. 6, the sleeve shaft 506 and pusher shaft 512 can be coaxial along some, all, or a majority of the delivery system to facilitate this working together.

[0167] The handle assembly 502 can further include one or more flushing ports (e.g., three flushing ports 542, 544, 546 are shown in FIG. 6) to supply flush fluid to one or more lumens arranged within the delivery apparatus 500 (e.g., annular lumens arranged between coaxial components of the delivery apparatus 500).

[0168] Operation of the various components of the handle assembly 502 can actuate and control the components arranged within the delivery shaft 504. Further details on delivery apparatuses, catheters, and systems that are configured to deliver a docking device to a target implantation site can be found in U. S. Patent Publication Nos. 2018 / 0318079 and 2018 / 0263764, which are incorporated by reference herein in their entireties. Additional examples of the delivery apparatus 500 and its components, including the pusher shaft 512 and the sleeve shaft 506, are described further in PCT Patent Application Nos.W02020 / 247907 and WO2022 / 087336.

[0169] In some examples, as described above, a docking device (for example, the docking device 200), can have a stabilization turn and an ascending portion (such as the stabilization turn 218 and the ascending portion 217, shown in FIG. 3) that can aid in locating the docking device in position before a coupled pusher shaft is removed and a prosthetic valve is implanted therein. Docking devices having an ascending portion, a stabilization turn, and / or other structures (e.g., atrial structures) can, in some instances, extend further proximally from a native annulus (for example, into an atrium).

[0170] In other examples, a docking device (for example, the docking devices 300, 400) can be configured without an ascending portion or additional structures extending proximally. In such examples, proximal ends of these docking devices can, in some instances, be situated closer to a native annulus when implanted. That is, in some examples, proximal ends of docking devices without additional proximal structures (e.g., ascending portions) may minimally extend into an atrium. As such, it may be desirable for a pusher shaft to have an elongated distal end portion capable of extending further distally toward a native annulus to accordingly accommodate and deliver docking devices with such configurations.

[0171] Additionally, before decoupling a suture coupled to a docking device, in some examples, the stability and position of a docking device can be evaluated by retracting a surrounding sleeve shaft (such as, for example, the sleeve shaft 506 of the delivery apparatus 500) off of the docking device and adding slack to the suture (such as, for example, the release suture 520) to allow the docking device to freely deploy at the implantation site without influence from the pusher shaft. In this way, the position of the docking device at the implantation site can be evaluated before the pusher shaft is removed. As such, it may be advantageous in some instances for a pusher shaft to have a distal end portion that is not only elongated as described above, but also more flexible. In other words, by increasing the flexibility of a distal end portion of a pusher shaft, influence from the pusher shaft on thedocking device can be reduced which can, in some instances, allow the docking device to relax into position before it is decoupled from the pusher shaft. The user can thus evaluate if adjustment is necessary.

[0172] FIG. 6B shows a distal end portion of the delivery apparatus 500 shown in FIG. 6, where the delivery apparatus 500 comprises a pusher shaft 600 according to another example. The pusher shaft 600 can be used in lieu of the pusher shaft 512 in the delivery apparatus 500 or any other delivery apparatus disclosed herein. The pusher shaft 600 is shown in FIG. 6B coupled to the docking device 400 of FIG. 5, although the pusher shaft 600 can be arranged to couple to any prosthetic implant.

[0173] As shown in FIG. 6B, the sleeve shaft 506 is removed from covering the docking device 400, leaving the docking device 400 uncovered for deployment and / or release. In other words, a distal tip 550 of the sleeve shaft 506 can be positioned proximal to the proximal end 405 of the docking device 400. A distal end portion of the pusher shaft 600 is coupled to the docking device 400 via the suture 520 and curved to allow the proximal end of the docking device 400 to assume its resting, undeflected state.

[0174] FIG. 7 illustrates a side view of the pusher shaft 600 of FIG. 6B in cross-section. As shown in FIG. 7, the pusher shaft 600 can comprise a tube 602, a shell 604, a plug 606 that connects the tube 602 to the shell 604, a liner 608, and an outer layer (also referred to herein as an “outer covering,” a “polymer outer layer,” or a “polymer layer”) 610 that extends over portions of the tube 602.

[0175] In some examples, the tube 602 can have a central, longitudinal axis 601 and can be arranged to extend a length LI from a distal end 612 of the tube 602 to a proximal end 614 of the tube. The tube 602 can have an inner lumen 615 extending from the distal end 612 to the proximal end 614 with a constant or substantially constant diameter in a range of about 1.0 mm to about 1.34 mm along the length LI. The liner 608 can be arranged within the inner lumen 615 of the tube 602 as shown in FIG. 7. As shown in FIGS. 8A-8C and 10A-10C, the tube 602 can be configured with an outer diameter dl between the distal end 612 and the proximal end 614 in a range of approximately 1.5 to 2.0 mm (e.g., +0.25 mm).

[0176] In some examples, the tube 602 can be a hypotube. Hypotubes are components that can be utilized for deploying docking devices and have been previously described in U.S. Publication No. 2018 / 0318079, which is incorporated by reference herein in its entirety. In some examples, the tube 602 can comprise a biocompatible metal, such as stainless steel. In various examples, the tube 602 can be a relatively rigid tube having a first flexibility thatprovides column strength for actuating deployment of a docking device. In some examples, the tube 602 can be configured with a plurality of cuts or slits 621 (shown in FIGS. 8A-8C and 10A-10C) to vary the flexibility along its length LI. Additional details regarding the shell, the plug, and the slits are described in U.S. Publication No. 2022 / 0079749, which is incorporated by reference herein.

[0177] In some examples, the pusher shaft 600 can further comprise a distal extension (also referred to herein as a “first extension”) 620 having a proximal end 622 fixed to the distal end 612 of the tube 602 and a distal end 626 disposed a length L2 from the proximal end 622. The distal extension 620 can be configured with a flexibility that is greater than the first flexibility (i.e., the flexibility of the tube 602) to form a flexible distal end portion 628 of the pusher shaft 600.

[0178] According to an example, the distal extension 620 can be formed as a unitary structure with the tube 602. That is, the distal extension 620 can be combined or formed integrally as part of the tube 602 as a single, uniform piece, described as tube 602a.

[0179] FIG. 8A shows a side view of the tube 602a having an integrated, unitary distal extension 620a. The distal extension 620a can be arranged to extend the length L2 which is added to the length LI. In other words, in some examples, the tube 602a can be configured to extend a length L3 that is defined as the length LI plus the length L2 of the distal extension 620a. In this way, the tube 602 can be lengthened or elongated from the length LI to the length L3 by the length L2 of the distal extension 620a to form the tube 602a.

[0180] The inner lumen 615 (FIG. 7) can extend from the distal end 626 of the distal extension 620a to the proximal end 614 of the tube 602, 602a. In some instances, the inner lumen 615 (i.e., the inner diameter of the tube 602a) can have a constant or substantially constant diameter (e.g., within + / - 5%) along the length L3. In other words, an inner lumen of the extension 620a is continuous with the inner lumen 615 along the tube 602a. In some examples, the tube 602a can be configured with a plurality of cuts or slits 621 as described above in relation to the tube 602 and in U.S. Publication No. 2022 / 0079749.

[0181] To increase the flexibility of the distal extension 620a such that the distal extension 620a has a greater flexibility than other portions of the tube 602a, the distal extension 620a can be configured with an outer diameter d2 that is smaller than the outer diameter of the other portions of the tube 602a (i.e., smaller than the diameter dl). That is, the distal extension 620a can be configured with a reduced wall thickness in comparison to the otherportions of the tube 602a to increase the flexibility in the distal extension 620a (see, e.g., FIG.7). In some examples, the tube 602a can have an outer diameter dl which can be machined, ground, turned, and / or otherwise reduced to the outer diameter d2 in the region of the distal extension 620a. The smaller outer diameter d2 with a reduced wall thickness in the region of the distal extension 620a increases the flexibility of the distal section 620a compared to the remainder the tube 602a (i.e., the portions having the diameter dl and a greater wall thickness).

[0182] In some examples, to minimize stress concentrations that may arise due to abrupt changes in diameter, the tube 602a can have a tapered transition region 630 that extends between the outer diameter d2 and the outer diameter dl. The length, angle, and / or degree of the tapered transition region 630 along the axis 601 can be arranged to reduce stress concentrations.

[0183] In some examples, the distal extension 620a can additionally include a plurality of slits (also referred to herein as “cuts”) 632 that can provide the distal extension 620a with further increased flexibility. In some examples, the slits 632 can be laser cuts formed by laser cutting into a surface (e.g., outer surface) of the distal extension 620a. In alternate examples, the slits 632 can be another type of cut formed by another cutting process (e.g., via etching, scoring, through-cutting, etc., into the outer surface of the distal extension 620a). A width, depth, and spacing of the slits 632 can be configured to add flexibility to the distal extension 620a. In some examples, each of the slits 632 can be through cuts that penetrate through an entirety of the distal extension 620a (e.g., through the wall thickness), from one side to the other, in a direction perpendicular to the central longitudinal axis 601. In some examples, the width of each slit 632 can be approximately 0.05 mm. In some examples, the width of each slit 632 can be in a range of 0.01 mm to 0.08 mm. The number of slits 632 and spacing between adjacent slits 632 can be selected to yield a desired flexibility.

[0184] According to another example, the distal extension 620 can be formed as a separate tube that is coupled to the distal end 612 of the tube 602. In some examples, the separate tube can include a plurality of slits that can provide the separate tube with further increased flexibility. This separate tube can in some instances resemble the distal extension 620a described above, but be welded (e.g., laser welded), soldered, bonded, or otherwise secured to the distal end 612 of the tube 602.

[0185] According to another example, as shown in FIG. 8B, the distal extension 620 can be formed as a braid that is coupled to the distal end 612 of the tube 602. FIG. 8B shows a side view of the tube 602 having a distal extension 620b configured as a braid 634, where the braid 634 is formed into a cylindrical configuration having an inner lumen 635 that is coaxially arranged with the inner lumen 615 of the tube 602. In other words, the braid 634 can have an annular arrangement that extends a full 360 degrees around the longitudinal axis 601 and the length L2 in a direction of the longitudinal axis 601. In some examples, the inner lumen 635 can have the same or substantially same diameter as the inner lumen 615 and thus be arranged to receive the liner 608 therethrough. The braid 634 can be configured with an outer diameter d2 that is smaller than the outer diameter dl of the tube 602. In some examples, the proximal end 622 of the distal extension 620b (i.e., the braid 634) can be welded (e.g., laser welded), soldered, bonded, or otherwise secured to the distal end 612 of the tube 602.

[0186] The tube 602 having the distal extension 620b fixed to its distal end 612 can extend the length L3 which is the sum of the length LI of the tube 602 and the length L2 of the distal extension 620b. In some examples, the lengths L2 and L3 for the pusher shaft in FIG. 8B are the same as the lengths L2 and L3 for the pusher shaft in FIG. 8A. In some examples, the lengths L2 and L3 for the pusher shaft in FIG. 8B are different than the lengths L2 and L3 for the pusher shaft in FIG. 8A.

[0187] The braid 634 can comprise a plurality of strands or filaments 636 made of a polymer, metal, or metal alloy such as, for example, stainless steel. The strands 636 can have any of various cross-sectional shapes (wherein the cross-sectional shape is in plane perpendicular to the length of the strand), such as circular, rectangular, square, etc.

[0188] In some examples, each strand 636 can have a width W1 and a thickness Tl, where T1 can be 0.0005 - 0.003 inches and W1 can be 0.004 - 0.006 inches. In some examples, Tl can be 0.001 inches. In some examples, W1 can be 0.005 inches. In some examples, Tl can be the same as W1 (e.g., having a circular or square cross-section).

[0189] The strands 636 can be crossed, interlaced, or woven with each other to form a lattice pattern of cells or openings. The lattice pattern can be arranged to extend the entire length L2 of the distal extensions 620b. In some examples, the braid 634 can be configured with a density or picks per inch (PPI), where a pick is defined as a distance along the longitudinal axis 601 from a first vertex of intersecting strands 636 to a second, opposing vertex ofintersecting strands 636 of the same opening. In some examples, a higher PPI can correlate to a more rigid braid 634, and conversely, a lower PPI can correlate to a more flexible braid 634, assuming other parameters are constant. The material of the strands 636, as well as the width Wl, the thickness Tl, and the density (e.g., PPI) of the strands 636 can be specified to yield a desired flexibility such that the second flexibility (e.g., braid flexibility) that is greater than the first flexibility (i.e., the flexibility of the tube 602).

[0190] According to another example, as shown in FIG. 8C, the distal extension 620 can be formed as a coil that is coupled to the distal end 612 of the tube 602. FIG. 8C shows a side view of the tube 602 having a distal extension 620c configured as a coil 640, where the coil 640 comprises a plurality of helical turns arranged around the longitudinal axis 601 to form a cylindrical configuration with an inner lumen 641 coaxially arranged with the inner lumen 615 of the tube 602. In other words, the coil 640 can have an annular arrangement that extends a full 360 degrees around the longitudinal axis 601 to form a cylindrical or at least substantially cylindrical shape with the length L2 in the direction of the longitudinal axis 601. In some examples, the inner lumen 641 can have the same or substantially same diameter as the inner lumen 615 and thus be arranged to receive the liner 608 therethrough. The coil 640 can be configured with an outer diameter d2 that is smaller than the outer diameter dl of the tube 602 as shown in FIG. 8C. In some examples, the proximal end 622 of the distal extension 620c (i.e., the coil 640) can be welded (e.g., laser welded), soldered, bonded, and / or otherwise secured to the distal end 612 of the tube 602.

[0191] Like the distal extensions 620a, 620b described above, the tube 602 having the distal extension 620c can extend the length L3 which is the sum of the length LI of the tube 602 and the length L2 of the distal extension 620c. In some examples, the lengths L2 and L3 for the pusher shaft in FIG. 8C are the same as the lengths L2 and L3 for the pusher shafts in FIG. 8 A and 8B. In some examples, the lengths L2 and L3 for the pusher shaft in FIG. 8C are different than the lengths L2 and L3 for the pusher shafts in FIG. 8 A and / or FIG. 8B.

[0192] The coil 640 can comprise a wire or filament 642 with the helical configuration described above, where the filament 642 is made of a polymer, metal, or metal alloy such as, for example, stainless steel. The filament 642 can have any of various cross-sectional shapes (wherein the cross-sectional shape is in plane perpendicular to the length of the strand), such as circular, rectangular, square, etc. In some examples, the filament 642 can have a width W2 and a thickness T2, where T2 can be 0.0005 - 0.003 inches and W2 can be 0.004 - 0.006 inches. In some examples, T2 can be 0.001 inches. In some examples, W2 can be 0.005inches. In some examples, T2 can be the same as W2 (e.g., having a circular or square crosssection).

[0193] The filament 642 forming the coil 640 can have helical turns forming a pitch between each adjacent turn along the length L2, where the pitch is defined as an axial distance or spacing between adjacent turns along the central longitudinal axis 601. In some examples, the spacing between turns of the coil 640 can be the same or substantially the same (for example, + / - 5%) between adjacent turns along the length L2. In some examples, the spacing between turns of the coil 640 can vary between adjacent turns along the length L2. Although the coil 640 is depicted with gaps between adjacent coil for purposes of illustration, in some examples, the coil can be formed such that adjacent coils contact each other (or have a relatively small amount of space) when the coil is in a straight configuration.

[0194] The material of the filament 642 forming the coil 640 as well as the width W2, the thickness T2, and the pitch of the filament 642 can be specified to yield a desired second flexibility (e.g., coil flexibility) that is greater than the first flexibility (i.e., the flexibility of the tube 602).

[0195] In some examples, the length L2 can be selected to accommodate docking devices of different configurations. In some implementations, the length L2 can be in a range of 25 mm to 60 mm, 35 mm to 55 mm, or about 55 mm.

[0196] FIGS. 9A-9C show an end portion of the pusher shaft 600 having the distal extensions 620a, 620b, 620c respectively illustrated in cross-section. As introduced above, the liner 608 arranged within the inner lumen 615 of the tube 602 can be configured to extend to the distal end 626 of the distal extension 620, for example the distal extensions 620a, 620b, 620c as illustrated in FIGS. 9A-9C. In some examples, the inner liner 608 can comprise PTFE. Further, in some examples, a thickness of the inner liner 608 can be in a range of 0.012 mm to 0.064 mm.

[0197] FIGS. 9A-9C also show the outer layer 610 extending over at least a distal end region of the tube 602, forming an outer diameter d3 over the tube 602, where diameter d3 is greater than both of the outer diameters dl and d2. The outer layer 610 can also be arranged to extend over the distal extension 620, for example the distal extensions 620a, 620b, 620c, forming an outer diameter d4 over the distal extension 620, where the diameter d4 is less than the diameter d3. The outer layer 610 can be made of a flexible polymer, as explained further below. In some examples, the outer layer 610 can be arranged over a portion of the tube 602distal to the shell 604 and configured to extend at least to the distal end 626 of the distal extension 620. In some examples, the outer layer 610 can be configured to extend distally beyond the distal end 626 of the distal extension 620. In some examples, the outer layer 610 can also be arranged over a portion of the tube 602 proximal to the shell 604, as will be described in more detail below in connection with FIGS. 11 A-l 1C.

[0198] In some examples, the outer layer 610 can be reflowed over the slits 621 and any apertures in the tube 602. Additionally, as shown schematically in FIGS. 9A-9C, the outer layer 610 can be reflowed over any voids or openings in the distal extension 620 such that the outer layer 610 can fill into the voids to bond with the inner liner 608. For example, as shown in FIG. 9 A, the outer layer 610 can be reflowed over the slits 632 in the distal extension 620a such that the polymeric material of the outer layer 610 fills into the slits 632 and contacts the liner 608 inside the lumen 615 for bonding thereto.

[0199] In some examples, the outer layer 610 can be reflowed only over the distal extension 620.

[0200] In some examples, the outer layer 610 can be reflowed over openings in the braid 634 in the distal extension 620b such that the polymeric material of the outer layer 610 fills into any openings in the lattice of the braid 634 and contacts the liner 608.

[0201] The outer layer 610 can likewise be reflowed over openings between turns in the coil 640 in the distal extension 620c as shown in FIG. 9C such that the polymeric material of the outer layer 610 fills within the open portions between turns of the coil 640 and bonds to the inner liner 608.

[0202] In some examples, the outer layer 610 can be arranged to extend over at least a portion of the tube 602 without filling in openings, apertures, and / or slits 621. In some examples, the outer layer 610 can be only reflowed over the tube 602 without flowing or filling in voids or openings in the distal extension 620 (e.g., slits 632).

[0203] In some examples, the outer layer 610 can be arranged to extend over at least a portion of the tube 602 and the distal extension 620 without flowing into or filling in voids or openings in the tube 602 and / or distal extension 620. For example, the outer layer 610 can be disposed around at least a portion of the tube 602 and / or the distal extension 620 without flowing or filling in some or all of the voids or openings (e.g., apertures, slits 621 and / or slits 632).

[0204] In certain examples, the outer layer 610 can comprise a polyether-amide block copolymer or a blend of two or more polyether-amide block copolymers. The polymer of the polymer outer layer 610 can have a Shore D hardness measured according to ISO 868:2003 of between about 60 and about 75, between about 50 and about 75, between about 50 and about 65, or about 55. In some examples, the polymer outer layer 610 can have a flexural modulus measured according to ISO 178:2010 of between about 350 MPa and about 550 MPa, between about 450 MPa and about 550 MPa, between about 500 MPa and about 550 MPa, between about 500 MPa and about 525 MPa, between about 510 MPa and about 520 MPa, about 500 MPa, about 505 MPa, about 510 MPa, about 515 MPa, about 520 MPa, or about 525 MPa. In certain examples, the polymer outer layer 610 can be one of or a blend of two or more of PEBAX® grades 7033 and 7233 (Arkema S. A., France) and VESTAMID® grades E62, E72, and EX9200 (Evonik Industries AG, Germany). In some examples, the polymer outer layer 610 can be PEBAX®, such as PEBAX® 7233. In other examples, the polymer outer layer 610 can be VESTAMID® EX9200.

[0205] In some examples, the polymer layer 610 can vary in thickness along the length of the pusher shaft 600. In some examples, the polymer layer 610 can vary in durometer from softer to harder or harder to softer along the length of the pusher shaft 600 (e.g., in gradations). For example, a distal region of the polymer layer 610 can be made of a softer or more flexible material than a central region of the polymer layer 610. In another example, a proximal region of the polymer layer 610 can be made of a softer or more flexible material than a central region of the polymer layer 610, or vice versa. In some examples, any portion of the polymer layer 610 can be made of a flexible polymer, such for example, a polyether-amide block copolymer or a blend of two or more polyether-amide block copolymers, such as PEBAX® grades 2533, 3533, 4033, 4533, 5533, 6333, and 7033, and 7233 (Arkema S. A., France) and VESTAMID® grades E40, E47, E55, E62, E72, and EX9200 (Evonik Industries AG, Germany).

[0206] In this way, the distal extension 620, for example the distal extensions 620a, 620b, 620c, in conjunction with the flexible polymer layer 610 can be arranged to not only distally elongate the pusher shaft 600, but also provide greater flexibility to accordingly accommodate docking devices with varied configurations as described above.

[0207] Additionally, as introduced above, the smaller outer diameter d4 of the pusher shaft 600 in the region of the distal extension 620 (e.g., along the length L2) can provide an annular space in which a brim (such as, for example the brim 430) of a sheathed dockingdevice (such as the docking device 400) can be stored when the pusher shaft 600 is within a sleeve shaft (for example, the sleeve shaft 506). That is, an annular pocket can be formed between the flexible distal portion 628 of the pusher shaft 600 and a surrounding sleeve shaft, for example during advancement to an implantation site, in which a brim or other component of a docking device can be retained.

[0208] Referring back to FIG. 7, in some examples, the pusher shaft 600 can further comprise a proximal extension (also referred to herein as a “second extension” or a “support extension”) 650 having a distal end 652 fixed to the proximal end 614 of the tube 602 and a proximal end 654 disposed a length L4 from the distal end 652 along the axis 601. The pusher shaft 600 can be arranged such that the proximal extension 650 extends through curved portions of a delivery apparatus, such as the connector 527 of the delivery apparatus 500. In some instances, the proximal extension 650 can be positioned in the connector 527 of the delivery apparatus 500, such as, for example through the straight section 528 and the branch 530 forming a bend. In other instances, the proximal extension 650 can terminate at or distal to the bend between the straight section 528 and the branch 530 of the connector 527. As will be described further below, the proximal extension 650 can be configured with a third flexibility that is greater than the first flexibility (i.e., the flexibility of the tube 602). This support extension 650 with increased flexibility can be configured to reduce the likelihood of kinking or damage when bent through curved portions of a delivery apparatus.

[0209] Although the proximal extension 650 is shown in FIG. 7 having the same outer diameter as the tube 602, it is understood that the proximal extension 650 and any proximal extension described herein (such as, for example, proximal extensions 650a, 650b, 650c) can be configured with an outer diameter that is smaller than the outer diameter of the other portions of the tube 602 (i.e., smaller than the diameter dl) in a similar manner as described above in connection with the distal extensions 620a, 620b, 620c in FIGS. 8A-8C.

[0210] According to an example, the proximal extension 650 can be formed as a unitary structure with the tube 602. That is, the proximal extension 650 can be combined or formed integrally as part of the tube 602 as a single, uniform component, described as tube 602b in FIG. 10A.

[0211] FIG. 10A shows a side view of the tube 602b having an integrated, unitary proximal extension 650a. The proximal extension 650a can be arranged to extend the length L4 which is added to the length LI. In other words, in some examples, the tube 602b can be configuredto extend a length L5 that is defined as the length LI plus the length L4 of the proximal extension 650a. In this way. the tube 602 can be lengthened or elongated from a length LI to a length L5 by the length L4 of the proximal extension 650a to form the tube 602b. In some examples, as shown in FIG. 10A, the proximal extension 650a can have the same outer diameter as other portions of the tube 602b, namely dl. In some examples, the length L4 can be in a range of 5 mm to 35 mm, 5 mm to 15 mm, or 5-10 mm.

[0212] The inner lumen 615 can extend from the distal end 612 to the proximal end 654 of the proximal extension 650a, where the inner lumen 615 has a constant or substantially constant diameter (e.g., within + / - 5%) along the length L5. Stated another way, an inner lumen of the extension 650a extends from and is the same as the inner lumen 615 of the tube 602b. In some examples, the tube 602b can be configured with a plurality of cuts or slits 621 as described above in relation to the slits 621 in the tube 602.

[0213] In some examples, the proximal extension 650a can additionally comprise a plurality of cuts or slits 656 that provide the proximal extension 650a with further increased flexibility. In some examples, the cuts 656 can be laser cuts formed by laser cutting into a surface (e.g., outer surface) of the proximal extension 650a. In alternate examples, the cuts 656 can be another type of cut formed by another cutting process (e.g., via etching, scoring, through-cutting, etc., into the outer surface of the proximal extension 650a). A width, depth, and spacing of the cuts 656 can be configured to add flexibility to the proximal extension 650a. In some examples, each of the cuts 656 can be through cuts that penetrate through an entirety of the proximal extension 650a (e.g., through the wall thickness), from one side to the other, in a direction perpendicular to the central longitudinal axis 601. In some examples, the width of each cut 656 can be approximately 0.05 mm. In some examples, the width of each cut 656 can be in a range of 0.03 mm to 0.08 mm. The number of cuts 656 and spacing between adjacent slits 656 can be selected to yield a specified flexibility.

[0214] According to an example, the proximal extension 650 can be formed as a separate tube that is coupled to the proximal end 614 of the tube 602. In some examples, the separate tube can include a plurality of slits that can provide the separate tube with increased flexibility. This separate tube can, in some instances, resemble the proximal extension 650a described above, but be welded (e.g., laser welded), soldered, bonded, or otherwise secured to the proximal end 614 of the tube 602.

[0215] According to another example, as shown in FIG. 10B, the proximal extension 650 can be formed as a braid that is coupled to the proximal end 614 of the tube 602. FIG. 10B shows a side view of the tube 602 having a proximal extension 650b configured as a braid 658, where the braid 658 is formed into a cylindrical configuration having an inner lumen 660 that is coaxially arranged with the inner lumen 615 of the tube 602. That is, the braid 658 can have an annular arrangement that extends full 360 degrees around the longitudinal axis 601 and the length L4 in the direction of the longitudinal axis 601. In some examples, the inner lumen 660 can have the same or substantially same diameter as the inner lumen 615 and thus be arranged to receive the liner 608 therethrough. In some examples, as shown in FIG. 10B, the braid 658 can be configured with an outer diameter dl that is the same size as the outer diameter dl of the tube 602. In other examples, braid 658 can be configured with an outer diameter that is smaller than the outer diameter dl of the tube 602.

[0216] The braid 658 can be arranged to extend from the proximal end 614 of the tube 602 to the proximal end 654 of the proximal extension 650b such that the tube 602 with the proximal extension 650b extends the length L5. In some examples, the lengths L4 and L5 for the pusher shaft in FIG. 10B are the same as the lengths L4 and L5 for the pusher shaft in FIG. 10A. In some examples, the lengths L4 and L5 for the pusher shaft in FIG. 10B can be different than the lengths L4 and L5 for the pusher shaft in FIG. 10A. In some examples, the distal end 652 of the proximal extension 650b can be welded (e.g., laser welded), soldered, bonded, and / or otherwise secured to the proximal end 614 of the tube 602.

[0217] The braid 658 can comprise a plurality of strands or filaments 662 made of a polymer, metal, or metal alloy such as, for example, stainless steel. The strands 662 can have any of various cross-sectional shapes (wherein the cross-sectional shape is in plane perpendicular to the length of the strand), such as circular, rectangular, square, etc.

[0218] In some examples, each strand 662 can have a width W3 and a thickness T3, where T3 can be 0.0005 - 0.003 inches and W3 can be 0.004 - 0.006 inches. In some examples, T3 can be 0.001 inches. In some examples, W3 can be 0.005 inches. In some examples, T3 can be the same as W3 (e.g., having a circular or square cross-section). In some examples, T3 can be the same as Tl. In some examples, W3 can be the same as Wl. The strands 662 can be crossed, interlaced, or woven with each other to form a lattice pattern of cells or openings. The lattice pattern can be arranged to extend the entire length L4 of the proximal extension 650b.

[0219] In some examples, the braid 658 can be configured with a density or picks per inch (PPI), where a pick is defined as a distance along the longitudinal axis 601 from a vertex of intersecting strands 662 to an opposing vertex of intersecting strands 662 of the same opening. In some examples, a greater PPI can correlate to a more rigid braid 658.Conversely, a smaller PPI can correlate to a more flexible braid 658. The material of the strands 662 as well as the width W3, the thickness T3, and the density (e.g., PPI) of the strands 662 can be selected to yield a specified flexibility that is greater than the first flexibility (i.e., the flexibility of the tube 602).

[0220] According to another example, as shown in FIG. 10C, the proximal extension 650 can be formed as a coil that is coupled to the proximal end 614 of the tube 602. FIG. 10C shows a side view of the tube 602 having a proximal extension 650c configured as a coil 670, where the coil 670 comprises a plurality of helical turns arranged around the longitudinal axis 601 to form a cylindrical configuration having an inner lumen 671 that is coaxially arranged with the inner lumen 615 of the tube 602. In other words, the coil 670 can have an annular arrangement that extends full 360 degrees around the longitudinal axis 601 to form a cylindrical or at least substantially cylindrical shape and the length L4 in the direction of the longitudinal axis 601. In some examples, the inner lumen 671 can have the same or substantially same diameter as the inner lumen 615 and thus be arranged to receive the liner 608 therethrough. In some examples, as shown in FIG. 10C, the coil 670 can be configured with an outer diameter dl that is the same as the outer diameter dl of the tube 602. In other examples, the coil 670 can be configured with an outer diameter that is smaller than the outer diameter dl of the tube 602.

[0221] Like the proximal extensions 650a, 650b described above, the coil 670 can be arranged to extend from the proximal end 614 of the tube 602 to the proximal end 654 of the proximal extension 650c such that the tube 602 with the proximal extension 650c extends the length L5. In some examples, the lengths L4 and L5 for the pusher shaft in FIG. 10C are the same as the lengths L4 and L5 for the pusher shafts in FIGS. 10A and / or FIG. 10B. In some examples, the lengths L4 and L5 for the pusher shaft in FIG. 10C can be different than the lengths L4 and L5 for the pusher shafts in FIG. 10A and / or FIG. 10B. In some examples, the distal end 652 of the proximal extension 650c can be welded (e.g., laser welded), soldered, bonded, or otherwise secured to the proximal end 614 of the tube 602.

[0222] The coil 670 can comprise a wire or filament 672 with the helical configuration described above, where the filament 672 is made of a polymer, metal, or metal alloy such as,for example, stainless steel. The filament 672 can have any of various cross-sectional shapes (wherein the cross-sectional shape is in plane perpendicular to the length of the strand), such as circular, rectangular, square, etc. In some examples, the filament 672 can have a width W4 and a thickness T4, where T4 can be 0.0005 - 0.003 inches and W4 can be 0.004 - 0.006 inches. In some examples, T4 can be 0.001 inches. In some examples, W4 can be 0.005 inches. In some examples, T4 can be the same as W4 (e.g., having a circular or square crosssection). In some examples, T4 can be the same as T2. In some examples, W4 can be the same as W2.

[0223] The filament 672 forming the coil 670 can have helical turns forming a pitch between each adjacent turn along the length L4, where the pitch is defined as an axial distance or spacing between adjacent turns along the central longitudinal axis 601. In some examples, the spacing between turns of the coil 670 can be the same or substantially the same (for example, + / - 5%) between adjacent turns along the length L4. In some examples, the spacing between turns of the coil 670 can vary between adjacent turns along the length L4. Although the coil 670 is depicted with gaps between adjacent coil for purposes of illustration, in some examples, the coil can be formed such that adjacent coils contact each other (or have a relatively small amount of space) when the coil is in a straight configuration.

[0224] The material of the filament 672 forming the coil 670 as well as the width W4, the thickness T4, and the pitch of the filament 672 can be selected to yield a specified flexibility that is greater than the first flexibility (i.e., the flexibility of the tube 602).

[0225] FIGS. 11 A-l 1C show a proximal end portion of the pusher shaft 600 having the proximal extensions 650a, 650b, 650c respectively illustrated in cross-section. The liner 608 arranged within the inner lumen 615 of the tube 602 can be configured to extend to at least the proximal end 654 of the proximal extension 650. In some examples, as will be described in more detail below, the liner 608 can be configured to extend proximally beyond the proximal end 654 of the proximal extension 650.

[0226] FIGS. 11 A-l 1C also show the outer layer 610 extending over a proximal region of the tube 602, forming an outer diameter d5 that is greater than the diameter dl. The outer layer 610 can also be arranged to extend over the proximal extension 650, for example the proximal extensions 650a, 650b, 650c, forming an outer diameter that is the same or substantially the same as the outer diameter d5 of the outer layer 610 extending over the proximal region of the tube 602, as shown in FIGS. 11 A-l 1C. In some examples, the outerdiameter d5 can be the same as the outer diameter d3. In some examples, the outer diameter d5 can be different than the outer diameter d3. In some examples, the outer layer 610 can be arranged over a portion of the tube 602 proximal to the shell and configured to extend to at least the proximal end 654 of the proximal extension 650.

[0227] In some examples, as shown in FIGS. 11 A-l 1 C, the outer layer 610 can be arranged to extend a length or distance L6 in a proximal direction (i.e., proximally) from the proximal end 614 of the tube 602 and have a proximal end 680, where the length L6 is greater than the length L4. That is, the outer layer 610 can be configured to extend proximally beyond the proximal end 654 of the proximal extension 650, for example the proximal extensions 650a, 650b, 650c, by a length or distance L7 that is defined by the difference between L6 and L4. The proximal end 680 of the outer layer 610 can define the proximal end of the pusher shaft 600.

[0228] In some examples, the portion of the outer layer 610 defined by the length L7 can have an outer diameter d6 that is smaller than the outer diameter d5 and an inner lumen 682 that is the same or substantially the same diameter as the inner lumen 615, as shown in FIGS.11 A-l 1C. In other words, a portion of the outer layer 610 arranged over the proximal extension 650, such as the proximal extensions 650a, 650b, 650c, can have the diameter d5 which can taper proximally (i.e., in a proximal direction toward the proximal end 680) from the outer diameter d5 to the outer diameter d6, where the outer diameter d6 is smaller than the outer diameter d5.

[0229] As introduced above, and shown in FIGS. 11 A-l 1C, the liner 608 arranged within the inner lumen 615 of the tube 602 can be configured to extend to the proximal end 680 through the lumen 682 of the polymer outer layer 610.

[0230] In some examples, as shown schematically in FIGS. 11A-11C, the outer layer 610 can be reflowed over any voids or openings in the proximal extension 650 such that the outer layer 610 can bond to the inner liner 608. More specifically, as shown in FIG. 11A, the outer layer 610 can be reflowed over the cuts 656 in the proximal extension 650a such that the polymeric material of the outer layer 610 fills into the cuts 656 and contacts with the liner 608 for bonding thereto.

[0231] In some examples, the outer layer 610 can be reflowed only over the proximal extension 650.

[0232] Similarly, the outer layer 610 can be reflowed over openings in the braid 658 in the proximal extension 650b such that the polymeric material of the outer layer 610 fills any openings in the lattice of the braid 658 and contacts the liner 608.

[0233] The outer layer 610 can likewise be reflowed over openings between turns in the coil 670 in the proximal extension 650c as shown in FIG. 11 C such that the polymeric material of the outer layer 610 fills between open portions of the coil 670 and contacts the liner 608 for bonding thereto.

[0234] In some examples, the outer layer 610 can be arranged to extend over at least a portion of the tube 602 without filling in openings, apertures, and / or slits 621. In some examples, the outer layer 610 can be only reflowed over the tube 602 without flowing or filling in voids or openings in the proximal extension 650 (e.g., cuts 656).

[0235] In some examples, the outer layer 610 can be arranged to extend over at least a portion of the tube 602 and the proximal extension 650 without flowing into or filling in voids or openings in the tube 602 and / or the proximal extension 650. For example, the outer layer 610 can be disposed around at least a portion of the tube 602 and / or the proximal extension 650 without flowing or filling in some or all of the voids or openings (e.g., apertures, slits 621, and / or cuts 656).

[0236] The outer layer 610 extending over the proximal region of the tube 602 and the proximal extension 650 can be made of the same material as described above in connection with the layer 610 extending over the distal region of the tube 602 and the distal extension 620. In some examples, the outer layer 610 extending over the proximal region of the tube 602 and the proximal extension 650 can be made of a flexible polymer that is a different material or a different durometer than the outer layer 610 extending over the distal region of the tube 602 and the distal extension 620. That is, in some examples as introduced above, the polymer layer 610 can be gradated in durometer along a length of the pusher shaft 600. Stated another way, any region of the polymer layer 610 can vary from softer to harder or harder to softer.

[0237] In this way, the proximal extension 650, for example the proximal extensions 650a, 650b, 650c, in conjunction with the flexible polymer layer 610 can be arranged to provide greater flexibility to accordingly reduce the likelihood of kinking or stresses in portions of the pusher shaft 600 extending through bends or curves in a delivery apparatus.

[0238] Although FIGS. 9A-9C show the pusher shaft 600 comprising the tube 602 configured with the distal extension 620 and FIGS. 11A-11C show the pusher shaft 600 comprising the tube 602 configured with the proximal extension 650, it is understood that the pusher shaft 600 can comprise the tube 602 configured with the distal extension 620, the proximal extension 650, or both the distal extension 620 and the proximal extension 650.

[0239] In some examples, the tube 602 can be configured with only the distal extension 620.

[0240] In some examples, the tube 602 can be configured with only the proximal extension 650.

[0241] In some examples, the tube 602 can be configured with both the distal extension 620 and the proximal extension 650.

[0242] For example, the tube 602 can be configured with the distal extension 620, the proximal extension 650, or both the distal and proximal extensions 620, 650 formed as a unitary structure with the tube 602. That is, the tube 602 can comprise the distal extension 620a, the proximal extension 650a, or both the distal and proximal extensions 620a, 650a as shown in FIG. 12. In some examples, the tube 602 can be lengthened or elongated from a length LI to a length L8 by both the length L2 of the distal extension 620a and the length L4 of the proximal extension 650a to form a tube 602c as shown in FIG. 12, where the length L8 is equal to the sum of the lengths LI, L2, L4.

[0243] In some examples, the tube 602 can be configured with the distal extension 620, the proximal extension 650, or both the distal and proximal extensions 620, 650 each formed as a separate tube that is coupled respectively to the distal and proximal ends 612, 614 of the tube 602. These separate tubes can, in some instances, resemble the distal and proximal extensions 620a, 650a described above, but be welded (e.g., laser welded), soldered, bonded, or otherwise secured to the tube 602.

[0244] In another example, the tube 602 can be configured with the distal extension 620, the proximal extension 650, or both the distal and proximal extensions 620, 650 comprising a braid such as, for example, the braids 634, 658. In other words, the tube 602 can comprise the distal extension 620b, the proximal extension 650b, or both the distal and proximal extensions 620b, 650b.

[0245] In another example, the distal extension 620, the proximal extension 650, or both the distal and proximal extensions 620, 650 can comprise a coil such as, for example, the coils640, 670. In other words, the tube 602 can comprise the distal extension 620c, the proximal extension 650c, or both the distal and proximal extensions 620c, 650c.

[0246] For examples of the tube 602 configured with both the distal extension 620 and the proximal extension 650, the distal and proximal extensions 620, 650 can be formed in the same manner as each other. That is, the distal and proximal extensions 620, 650 can both comprise coils (such as, for example, coils 640, 670), braids (such as, for example braids 634, 658), separate tubes, or unitary formed extension structures.

[0247] Alternatively, the distal and proximal extensions 620, 650 can be formed in a different manner as each other and can be any combination of a coil (such as, for example, coils 640, 670), a braid (such as, for example braids 634, 658), a separate tube, or a unitary formed extension structure. For example, the distal extension 620 can be the distal extension 620a (i.e., a unitary formed structure) while the proximal extension 650 can be the proximal extension 650c (i.e., comprising the coil 670).

[0248] In another example, the distal extension 620 can be the distal extension 620b (i.e., comprising the braid 634) while the proximal extension 650 can be the proximal extension 650a (i.e., a unitary formed structure), and so on. In this way, the distal and proximal extensions 620, 650 can be any combination of a coil, a braid, or a unitary formed extension structure.

[0249] In this way, the pusher shaft 600 can be configured accordingly to more easily adapt and accommodate docking devices having varying configurations and features and / or have improved resiliency and reliability when proximal end portions are strained or bent in a delivery apparatus.Delivery Techniques

[0250] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Additionally and / or alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the deliveryapparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0251] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve, A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0252] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Additionally and / or alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery- apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aorticvalve. Additionally and / or alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini -thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0253] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a trans ventricular approach whereby aprosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the nati e tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0254] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.Sterilization

[0255] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.Simulation

[0256] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc.Additional Examples of the Disclosed Technology

[0257] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0258] Example 1. A delivery apparatus for a docking device, the delivery apparatus comprising: a pusher shaft comprising: a tube having a first inner lumen and a first flexibility;an extension fixed to an end of the tube, wherein the extension has a second inner lumen coaxially arranged with the first inner lumen and a second flexibility that is greater than the first flexibility; a liner disposed within the first and second inner lumens and configured to extend from a proximal end of the pusher shaft to a distal end of the pusher shaft; and a polymer layer arranged over the extension and at least a portion of the tube.

[0259] Example 2. The delivery apparatus of any example herein, particularly example 1, wherein the extension fixed to the end of the tube comprises a first extension fixed to a distal end of the tube, a second extension fixed to a proximal end of the tube, or both a first extension fixed to the distal end of the tube and a second extension fixed to the proximal end of the tube.

[0260] Example 3. The delivery apparatus of any example herein, particularly example 2, wherein the first extension, the second extension, or both the first and second extensions comprise a coil having a plurality of turns defining the second inner lumen.

[0261] Example 4. The delivery apparatus of any example herein, particularly example 2, wherein the first extension, the second extension, or both the first and second extensions comprise a braid forming a cylindrical shape defining the second inner lumen.

[0262] Example 5. The delivery apparatus of any example herein, particularly example 2, wherein the first extension, the second extension, or both the first and second extensions are formed as a unitary structure with the tube and comprise a plurality of slits.

[0263] Example 6. The delivery apparatus of any example herein, particularly any of examples 2-5, wherein the tube has a first outer diameter and the first extension has a second outer diameter that is less than the first outer diameter.

[0264] Example 7. The delivery apparatus of any example herein, particularly any of examples 2-6, wherein the polymer layer is arranged over a proximal end portion of the tube and the second extension.

[0265] Example 8. The delivery apparatus of any example herein, particularly example 7, wherein the second extension extends a first distance proximally from the proximal end of the tube and the polymer layer extends a second distance proximally from the proximal end of the tube, wherein the second distance is greater than the first distance.

[0266] Example 9. The delivery apparatus of any example herein, particularly example 8, wherein the polymer layer arranged over the second extension has a third outer diameter andtapers in a proximal direction from the third outer diameter to a fourth outer diameter that is less than the third outer diameter.

[0267] Example 10. The delivery apparatus of any example herein, particularly any of examples 2-9, wherein the polymer layer is arranged over a distal end portion of the tube and the first extension.

[0268] Example 11. The delivery apparatus of any example herein, particularly any of examples 2-10, further comprising a handle assembly including a connector, wherein the pusher shaft extends through a bend in the connector and the second extension is received in the bend.

[0269] Example 12. The delivery apparatus of any example herein, particularly any of examples 1-11, wherein a distal end portion of the pusher shaft is configured to couple to the docking device.

[0270] Example 13. A delivery system for delivering a docking device to a native heart valve, the delivery system comprising: a handle assembly comprising a first handle; a guide shaft mounted to and extending distally from the first handle; a sleeve shaft at least partially arranged within the guide shaft; and a pusher shaft at least partially arranged within the sleeve shaft and extending distally and proximally from the first handle, wherein the pusher shaft comprises: a tube having a first inner lumen and a first flexibility; and an extension fixed to an end of the tube, wherein the extension has a second inner lumen coaxially arranged with the first inner lumen and a second flexibility that is greater than the first flexibility.

[0271] Example 14. The delivery system of any example herein, particularly example 13, wherein the extension fixed to the end of the tube comprises a distal extension fixed to a distal end of the tube, a proximal extension fixed to a proximal end of the tube, or both a distal extension fixed to the distal end of the tube and a proximal extension fixed to the proximal end of the tube.

[0272] Example 15. The delivery system of any example herein, particularly example 14, wherein the distal extension, the proximal extension, or both the distal extension and the proximal extension comprise a coil having a plurality of turns defining the second inner lumen.

[0273] Example 16. The delivery system of any example herein, particularly example 14, wherein the distal extension, the proximal extension, or both the distal extension and theproximal extension comprise a braid forming a cylindrical shape defining the second inner lumen.

[0274] Example 17. The delivery system of any example herein, particularly example 14, wherein the distal extension, the proximal extension, or both the distal extension and the proximal extension are formed as a unitary structure with the tube and comprise a plurality of slits.

[0275] Example 18. The delivery system of any example herein, particularly any of examples 13-17, further comprising a polymer layer arranged over the distal extension, the proximal extension, or both the distal extension and the proximal extension and at least a portion of the tube, wherein a distal end of the pusher shaft is configured to couple with the docking device.

[0276] Example 19. The delivery system of any example herein, particularly example 18, wherein a first portion of the polymer layer that is arranged over the tube has a first outer diameter and a second portion of the polymer layer that is arranged over the distal extension has a second outer diameter that is less than the first outer diameter and is configured to receive a brim of the docking device when the docking device and the pusher shaft are disposed within the sleeve shaft.

[0277] Example 20. The delivery system of any example herein, particularly any of examples 15-19, wherein the handle assembly further comprises second handle with a connector disposed proximal to the first handle, wherein the connector comprises a first branch aligned with the first handle and a second branch extending at an oblique angle relative to the first branch, and wherein the pusher shaft extends through a bend in the connector.

[0278] Example 21. The delivery system of any example herein, particularly example 20, wherein the proximal extension is arranged in the bend and extends into the second branch.

[0279] Example 22. A delivery apparatus for a docking device, the delivery apparatus comprising: a pusher shaft comprising: a tube extending a length from a proximal end of the tube to a distal end of the tube, wherein the tube has a first inner lumen and a first flexibility; and an extension fixed to the distal end of the tube, wherein the extension has a second inner lumen coaxially arranged with the first inner lumen and a second flexibility that is greater than the first flexibility.

[0280] Example 23. The delivery apparatus of any example herein, particularly example 22, further comprising a polymer layer arranged over at least a distal end portion of the tube and an entire length of the extension.

[0281] Example 24. The delivery apparatus of any example herein, particularly any of examples 22-23, wherein the extension comprises a coil having a plurality of turns defining the second inner lumen.

[0282] Example 25. The delivery apparatus of any example herein, particularly any of examples 22-23, wherein the extension comprises a braid forming a cylindrical shape defining the second inner lumen.

[0283] Example 26. The delivery apparatus of any example herein, particularly any of examples 22-23, wherein the extension is formed as a unitary structure with the tube and comprises a plurality of slits.

[0284] Example 27. The delivery apparatus of any example herein, particularly any of examples 22-26, wherein a distal end portion of the pusher shaft is configured to couple to the docking device.

[0285] Example 28. The delivery apparatus of any example herein, particularly any of examples 22-27, wherein the polymer layer has a constant or at least substantially constant radial thickness along its entire length.

[0286] Example 29. The delivery apparatus of any example herein, particularly any of examples 22-28, wherein the tube has a first outer diameter and the extension has a second outer diameter that is less than the first outer diameter.

[0287] Example 30. The delivery apparatus of any example herein, particularly any of examples 22-29, wherein a portion of the polymer layer arranged over the tube has a third outer diameter and a portion of the polymer layer arranged over the extension has a fourth outer diameter that is less than the third outer diameter and is configured to receive a brim of the docking device.

[0288] Example 31. The delivery apparatus of any example herein, particularly any of examples 22-30, further comprising a liner disposed within the first and second inner lumens and extending from a proximal end of the pusher shaft to a distal end of the pusher shaft.

[0289] Example 32. A delivery apparatus for a docking device, the delivery apparatus comprising: a pusher shaft comprising: a tube extending a length from a proximal end of thetube to a distal end of the tube, wherein the tube has a first lumen and a first flexibility; and a support extension fixed to the proximal end of the tube, wherein the support extension has a second lumen coaxially arranged with the first lumen and a second flexibility that is greater than the first flexibility.

[0290] Example 33. The delivery apparatus of any example herein, particularly example 32, further comprising a polymer layer arranged over the support extension and at least a proximal end portion of the tube.

[0291] Example 34. The delivery apparatus of any example herein, particularly any of examples 32-33, wherein the support extension comprises a coil having a plurality of turns defining the second lumen.

[0292] Example 35. The delivery apparatus of any example herein, particularly any of examples 32-33, wherein the support extension comprises a braid forming a cylindrical shape defining the second lumen.

[0293] Example 36. The delivery apparatus of any example herein, particularly any of examples 32-33, wherein the support extension comprises a plurality of slits and is formed as a unitary structure with the tube.

[0294] Example 37. The delivery apparatus of any example herein, particularly any of examples 32-36, wherein the support extension extends a first distance proximally from the proximal end of the tube and the polymer layer extends a second distance proximally from the proximal end of the tube, wherein the second distance is greater than the first distance.

[0295] Example 38. The delivery apparatus of any example herein, particularly example 37, wherein a portion of the polymer layer arranged over the support extension has a first outer diameter and tapers in a proximal direction from the first outer diameter to a second outer diameter that is less than the first outer diameter.

[0296] Example 39. The delivery apparatus of any example herein, particularly any of examples 32-38, further comprising a liner disposed within the first and second lumens and arranged to extend from a distal end of the tube to a proximal end of the polymer layer.

[0297] Example 40. The delivery apparatus of any example herein, particularly any of examples 32-38, further comprising a liner disposed within the first and second lumens and arranged to extend from a proximal end of the pusher shaft to the distal end of the pusher shaft.

[0298] Example 41. A method of forming a shaft for a docking device delivery apparatus, the method comprising: fixing an extension to an end of a tube, wherein the tube has a first lumen and a first flexibility and the extension has a second lumen coaxially arranged with the first lumen and a second flexibility that is greater than the first flexibility.

[0299] Example 42. The method of any example herein, particularly example 41, further comprising arranging a liner within the first and second lumens.

[0300] Example 43. The method of any example herein, particularly any of examples 41-42, further comprising forming a polymer layer over the extension and at least a portion of the tube.

[0301] Example 44. The method of any example herein, particularly any of examples 41-43, wherein the act of fixing the extension to the end of the tube comprises welding or bonding.

[0302] Example 45. The method of any example herein, particularly any of examples 41-44, wherein the extension comprises a distal extension fixed to a distal end of the tube, a proximal extension fixed to a proximal end of the tube, or both a distal extension fixed to the distal end of the tube and a proximal extension fixed to the proximal end of the tube.

[0303] Example 46. The method of any example herein, particularly example 45, wherein the distal extension, the proximal extension, or both the distal extension and the proximal extension comprise a coil having a plurality of turns defining the second lumen.

[0304] Example 47. The method of any example herein, particularly example 45, wherein the distal extension, the proximal extension, or both the distal extension and the proximal extension comprise a braid forming a cylindrical shape defining the second lumen.

[0305] Example 48. A method of forming a shaft for a docking device delivery apparatus, the method comprising: forming an extension with a length on an end portion of a tube having an inner lumen, wherein the tube has a first flexibility and the extension has a second flexibility that is greater than the first flexibility.

[0306] Example 49. The method of any example herein, particularly example 48, further comprising arranging a liner within the inner lumen.

[0307] Example 50. The method of any example herein, particularly any of examples 48-49, further comprising forming a polymer layer over the extension and at least a portion of the tube.

[0308] Example 51. The method of any example herein, particularly any of examples 48-50, further comprising creating slits in the extension.

[0309] Example 52. The method of any example herein, particularly any of examples 48-51, wherein the act of forming the extension comprises reducing the end portion of a tube in diameter along the length from a first outer diameter to a second outer diameter.

[0310] Example 53. The method of any example herein, particularly example 52, wherein the act of reducing the end portion of the tube comprises grinding or turning the tube.

[0311] Example 54. The method of any example herein, particularly any of examples 48-51, wherein the extension comprises a proximal extension formed on a proximal end potion of the tube.

[0312] Example 55. The method of any example herein, particularly any of examples 48-54, wherein the extension comprises a distal extension formed on a distal end portion of the tube.

[0313] Example 56. A method comprising sterilizing the delivery apparatus, and / or assembly of any example.

[0314] Example 57. A delivery apparatus or system of any one of examples 1-55, wherein the delivery apparatus or system is sterilized.

[0315] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one shaft can be combined with any one or more features of another shaft. As another example, any one or more features of one delivery apparatus or system can be combined with any one or more features of another delivery apparatus or system.

[0316] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

CLAIMS:

1. A delivery apparatus for a docking device, the delivery apparatus comprising: a pusher shaft comprising:a tube having a first inner lumen and a first flexibility;an extension fixed to an end of the tube, wherein the extension has a second inner lumen coaxially arranged with the first inner lumen and a second flexibility that is greater than the first flexibility;a liner disposed within the first and second inner lumens and configured to extend from a proximal end of the pusher shaft to a distal end of the pusher shaft; and a polymer layer arranged over the extension and at least a portion of the tube.

2. The delivery apparatus of claim 1, wherein the extension fixed to the end of the tube comprises a first extension fixed to a distal end of the tube, a second extension fixed to a proximal end of the tube, or both a first extension fixed to the distal end of the tube and a second extension fixed to the proximal end of the tube.

3. The delivery apparatus of claim 2, wherein the first extension, the second extension, or both the first and second extensions comprise a coil having a plurality of turns defining the second inner lumen.

4. The delivery apparatus of claim 2, wherein the first extension, the second extension, or both the first and second extensions comprise a braid forming a cylindrical shape defining the second inner lumen.

5. The delivery apparatus of claim 2, wherein the first extension, the second extension, or both the first and second extensions are formed as a unitary structure with the tube and comprise a plurality of slits.

6. The delivery apparatus of any of claims 2-5, wherein the tube has a first outer diameter and the first extension has a second outer diameter that is less than the first outer diameter.

7. The delivery apparatus of any of claims 2-6, wherein the polymer layer is arranged over a proximal end portion of the tube and the second extension.

8. The delivery apparatus of claim 7, wherein the second extension extends a first distance proximally from the proximal end of the tube and the polymer layer extends a second distance proximally from the proximal end of the tube, wherein the second distance is greater than the first distance.

9. The delivery apparatus of claim 8, wherein the polymer layer arranged over the second extension has a third outer diameter and tapers in a proximal direction from the third outer diameter to a fourth outer diameter that is less than the third outer diameter.

10. The delivery apparatus of any of claims 2-9, wherein the polymer layer is arranged over a distal end portion of the tube and the first extension.

11. The delivery apparatus of any of claims 1-10, wherein a distal end portion of the pusher shaft is configured to couple to the docking device.

12. A delivery system for delivering a docking device to a native heart valve, the delivery system comprising:a handle assembly comprising a first handle;a guide shaft mounted to and extending distally from the first handle;a sleeve shaft at least partially arranged within the guide shaft; anda pusher shaft at least partially arranged within the sleeve shaft and extending distally and proximally from the first handle, wherein the pusher shaft comprises:a tube having a first inner lumen and a first flexibility; andan extension fixed to an end of the tube, wherein the extension has a second inner lumen coaxially arranged with the first inner lumen and a second flexibility that is greater than the first flexibility.

13. The delivery system of claim 12, wherein the extension fixed to the end of the tube comprises a distal extension fixed to a distal end of the tube, a proximal extension fixed to a proximal end of the tube, or both a distal extension fixed to the distal end of the tube and a proximal extension fixed to the proximal end of the tube.

14. The delivery system of claim 13, wherein the distal extension, the proximal extension, or both the distal extension and the proximal extension comprise a coil having a plurality of turns defining the second inner lumen.

15. The delivery system of claim 13, wherein the distal extension, the proximal extension, or both the distal extension and the proximal extension comprise a braid forming a cylindrical shape defining the second inner lumen.

16. The delivery system of claim 13, wherein the distal extension, the proximal extension, or both the distal extension and the proximal extension are formed as a unitary structure with the tube and comprise a plurality of slits.

17. The delivery system of any of claims 14-16, wherein the handle assembly further comprises second handle with a connector disposed proximal to the first handle, wherein the connector comprises a first branch aligned with the first handle and a second branch extending at an oblique angle relative to the first branch, and wherein the pusher shaft extends through a bend in the connector.

18. The delivery system of claim 17, wherein the proximal extension is arranged in the bend and extends into the second branch.

19. A method of forming a shaft for a docking device delivery apparatus, the method comprising:fixing an extension to an end of a tube, wherein the tube has a first lumen and a first flexibility and the extension has a second lumen coaxially arranged with the first lumen and a second flexibility that is greater than the first flexibility.

20. The method of claim 19, further comprising arranging a liner within the first and second lumens.

21. The method of any of claims 19-20, further comprising forming a polymer layer over the extension and at least a portion of the tube.

22. The method of any of claims 19-21, wherein the act of fixing the extension to the end of the tube comprises welding or bonding.

23. The method of any of claims 19-22, wherein the extension comprises a distal extension fixed to a distal end of the tube, a proximal extension fixed to a proximal end of the tube, or both a distal extension fixed to the distal end of the tube and a proximal extension fixed to the proximal end of the tube.

24. The method of claim 23, wherein the distal extension, the proximal extension, or both the distal extension and the proximal extension comprise a coil having a plurality of turns defining the second lumen.

25. The method of claim 23, wherein the distal extension, the proximal extension, or both the distal extension and the proximal extension comprise a braid forming a cylindrical shape defining the second lumen.

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