Release mechanism for a prosthetic implant delivery apparatus

Abstract

A release mechanism for a delivery apparatus is disclosed, where the release mechanism is configured to release a prosthetic implant from the delivery apparatus. The delivery apparatus comprises a shaft with a lumen and a sidewall, where the sidewall has an aperture therethrough. A release member is disposed within the lumen and a securing member having a distal loop extends distally from a distal end of the shaft. The delivery apparatus is movable from a first to a second arrangement. In the first arrangement, the securing member extends through the aperture such that the loop is disposed inside the lumen and the release member is in a distal state extending through the loop. In the second arrangement, the release member is in a proximal state removed from the loop and the securing member is removable from the lumen. A method of using the release mechanism is also disclosed.

Description

RELEASE MECHANISM FOR A PROSTHETICIMPLANT DELIVERY APPARATUSCROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U. S. Provisional Application No. 63 / 712,719, filed October 28, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to a release mechanism 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 inplace 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. Docking devices can be delivered to the implantation site by a delivery apparatus.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 disclosed herein are release mechanisms that are configured to quickly and reliably decouple a prosthetic implant from a delivery apparatus for implantation at a target site in a body. In a particular example, the prosthetic implant can be a docking device for a prosthetic heart valve. The disclosed release mechanisms can comprise a securing member that couples the docking device to the delivery apparatus for advancement through the body. The release mechanisms can be arranged to disconnect a distal portion of the securing member from the delivery apparatus in a location adjacent the docking device at a distal end of the delivery apparatus. The distal portion of the securing member can be removed from the docking device as the delivery apparatus is removed from the body, thus saving time. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic implants, prosthetic heart valves, and their delivery apparatuses.

[0007] A delivery apparatus for a prosthetic implant can comprise a shaft with a sidewall having an inner surface defining a lumen. In addition to this component, a delivery apparatus for a prosthetic implant can further comprise one or more of the components disclosed herein.

[0008] In some examples, an aperture can extend through a distal end portion of the sidewall from an outer surface to the inner surface of the shaft.

[0009] In some examples, the delivery apparatus can comprise a release member disposed within the lumen of the shaft, where the release member is configured to axially translate relative to the lumen from a distal state to a proximal state.

[0010] In some examples, the delivery apparatus can comprise a securing member arranged within the lumen and extending distally from a distal end of the shaft.

[0011] In some examples, the securing member can have a proximal end fixedly attached to the delivery apparatus and a distal end movable in relation to the delivery apparatus.

[0012] In some examples, the delivery apparatus can comprise a first arrangement and a second arrangement.

[0013] In some examples, in the first arrangement, the release member can be in the distal state and the distal end of the securing member can extend through the aperture from outside the shaft and be secured inside the lumen by a distal end portion of the release member.

[0014] In some examples, in the second arrangement, the release member can be in the proximal state and the distal end of the securing member can be removable from the lumen.

[0015] In some examples, the distal tip of the release member can be distal to the aperture when the release member is in the distal state and proximal to the aperture when the release member is in the proximal state.

[0016] In some examples, the distal end of the securing member can comprise a loop.

[0017] In some examples, the distal end portion of the release member can extend through the loop when the delivery apparatus is in the first arrangement.

[0018] In some examples, the securing member can comprise a length of material doubled over to form the loop extending between two legs.

[0019] In some examples, the securing member can comprise a length of material with the loop integrally formed into a distal end of a single leg.

[0020] In some examples, the delivery apparatus can comprise an actuator disposed at a proximal end portion of the delivery apparatus, where the actuator is configured to axially translate the release member from the distal state to the proximal state.

[0021] In some examples, the actuator can comprise a sliding mechanism configured to axially translate the release member from the distal state to the proximal state.

[0022] In some examples, the actuator can comprise a lock movable from a locked state to an unlocked state.

[0023] In some examples, the securing member can be secured to a proximal end portion of the prosthetic implant when the delivery apparatus is in the first configuration.

[0024] In some examples, the securing member can be releasable from the prosthetic implant when the delivery apparatus is in the second configuration.

[0025] In some examples, the prosthetic implant can be a docking device for a prosthetic valve.

[0026] In some examples, the release member can be configured to extend proximally from a proximal end of the delivery apparatus through an orifice when the release member is in the proximal state.

[0027] In some examples, the securing member can be a suture.

[0028] In some examples, the orifice can be sealed around the release member.

[0029] In some examples, the release member can be a wire, a rod, a shaft, or a tube.

[0030] In some examples, a delivery apparatus for a prosthetic implant comprises a shaft with a sidewall having an inner surface defining a lumen and an aperture extending through a distal end portion of the sidewall from an outer surface to the inner surface of the shaft; a release member disposed within the lumen of the shaft, wherein the release member is configured to axially translate relative to the lumen from a distal state to a proximal state; and a securing member arranged within the lumen and extending distally from a distal end of the shaft, wherein the securing member has a proximal end fixedly attached to the delivery apparatus and a distal end movable in relation to the delivery apparatus, wherein the delivery apparatus comprises a first arrangement and a second arrangement, wherein in the first arrangement, the release member is in the distal state and the distal end of the securing member extends through the aperture from outside the shaft and is secured inside the lumen by a distal end portion of the release member, and wherein in the second arrangement, the release member is in the proximal state and the distal end of the securing member is removable from the lumen.

[0031] In some examples, a delivery apparatus for a prosthetic implant comprises a shaft with a sidewall having an inner surface defining a lumen and an aperture extending through a distal end portion of the sidewall from an outer surface to the inner surface of the shaft; a release member disposed within the lumen of the shaft; and a securing member extending distally from a distal end of the shaft, wherein the securing member has a distal end movable in relation to the delivery apparatus, wherein the delivery apparatus is transformable from afirst configuration to a second configuration, wherein in the first configuration the distal end of the securing member extends through the aperture from outside the shaft and is secured inside the lumen by a distal end portion of the release member, and wherein in the second configuration the distal end of the securing member is removable from the lumen.

[0032] In some examples, a delivery apparatus for a prosthetic implant comprises one or more of the components recited in Examples 1-31 and 51 below.

[0033] A release mechanism for a delivery apparatus having a shaft can comprise a release member and a securing member. In addition to these components, a release mechanism for a delivery apparatus can further comprise one or more of the components disclosed herein.

[0034] In some examples, the release member can be disposed within a lumen of the shaft, where the shaft has a sidewall defining the lumen and an aperture can extend through the sidewall adjacent a distal end of the shaft.

[0035] In some examples, the securing member can be arranged within the lumen and can extend distally from a distal end of the shaft, where the securing member can have a distal end movable in relation to the shaft and comprising a loop.

[0036] In some examples, the mechanism can comprise a first configuration and a second configuration.

[0037] In some examples, in the first configuration, a distal end portion of the securing member can extend through the aperture from outside the shaft, the loop can be disposed in the lumen, and the release member can be in a distal state extending through the loop.

[0038] In some examples, in the second configuration, the release member can be in a proximal state and the loop can be removable from the lumen.

[0039] In some examples, the release member can extend substantially parallel to a portion of the securing member inside the lumen along a length of the shaft.

[0040] In some examples, the release member can be in overlapping arrangement with the aperture inside the lumen when the release member is in the distal state and can be in nonoverlapping arrangement with the aperture when the release member is in the proximal state.

[0041] In some examples, the securing member can have a proximal end fixedly attached to a distal portion of the shaft.

[0042] In some examples, the securing member can have a proximal end fixedly attached to a proximal end portion of the delivery apparatus.

[0043] In some examples, the release member can be a wire, a rod, a shaft, or a tube.

[0044] In some examples, the securing member can be a suture.

[0045] In some examples, a release mechanism for a delivery apparatus having a shaft comprises a release member disposed within a lumen of the shaft, wherein the shaft has a sidewall defining the lumen and an aperture extending through the sidewall adjacent a distal end of the shaft; and a securing member arranged within the lumen and extending distally from a distal end of the shaft, wherein he securing member has a distal end movable in relation to the shaft and comprising a loop, wherein the mechanism comprises a first configuration and a second configuration, wherein in the first configuration, a distal end portion of the securing member extends through the aperture from outside the shaft, the loop is disposed in the lumen, and the release member is in a distal state extending through the loop, and wherein in the second configuration, the release member is in a proximal state and the loop is removable from the lumen.

[0046] In some examples, a mechanism for releasing a prosthetic implant from a delivery apparatus comprises a release member disposed within a lumen of the delivery apparatus, wherein the release member is axially movable relative to the lumen from a distal state to a proximal state and wherein the lumen is defined by a sidewall of a shaft having an aperture extending through the sidewall; and a securing member arranged within the lumen and extending distally from a distal end of the shaft, wherein the securing member has a distal end with a loop, and wherein the mechanism is movable from a first configuration to a second configuration, wherein in the first configuration a proximal end of the prosthetic implant is secured in abutment with a distal end of the shaft, the securing member extends through the aperture from outside the shaft, the loop is disposed in the lumen, and the release member is in the distal state extending through the loop, and wherein in the second configuration, the release member is in a proximal state, the loop is removable from the lumen, and the prosthetic implant is releasable from the delivery apparatus.

[0047] In some examples, a mechanism comprises one or more of the components recited in Examples 32-41 below.

[0048] A method of releasing a prosthetic implant from a delivery apparatus can comprise advancing the prosthetic implant to an implantation site with the delivery apparatus and retracting the delivery apparatus. In addition to these steps, a method of releasing a prosthetic implant from a delivery apparatus can further comprise one or more of the steps disclosed herein.

[0049] In some examples, the method can further comprise moving the delivery apparatus from a first configuration to a second configuration by translating a release member axially relative to a lumen of a shaft from a distal state to a proximal state in which the release member is decoupled from a distal end of a securing member inside the lumen.

[0050] In some examples, the method can further comprise retracting the delivery apparatus to release the prosthetic implant from the delivery apparatus, where releasing the prosthetic implant comprises removing the securing member from an aperture in a sidewall of the shaft.

[0051] In some examples, releasing the prosthetic implant can further comprise detaching the securing member from the prosthetic implant.

[0052] In some examples, the act of translating the release member axially can further comprise moving a distal tip of the release member proximal to the aperture.

[0053] In some examples, the act of translating the release member can comprise engaging an actuator to axially translate the release member from the distal state to the proximal state.

[0054] In some examples, the method can further comprise moving a lock from a locked state to an unlocked state prior to moving the delivery apparatus from the first configuration to the second configuration.

[0055] In some examples, the act of engaging the actuator can comprise moving the slider mechanism from the distal arrangement to the proximal arrangement.

[0056] A method of releasing a prosthetic implant from a delivery apparatus comprises advancing the prosthetic implant to an implantation site with the delivery apparatus in a first configuration; moving the delivery apparatus from the first configuration to a second configuration by translating a release member axially relative to a lumen of a shaft from adistal state to a proximal state in which the release member is decoupled from a distal end of a securing member inside the lumen; and retracting the delivery apparatus to release the prosthetic implant from the delivery apparatus, wherein releasing the prosthetic implant comprises removing the securing member from an aperture in a sidewall of the shaft.

[0057] In some examples, a method comprises one or more of the steps recited in Examples 42-50 below.

[0058] 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).

[0059] 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

[0060] FIG. 1 A schematically illustrates a first stage in an exemplary mitral valve replacement procedure where a guide catheter and a guidewire are inserted into a blood vessel of a patient and navigated through the blood vessel and into a heart of the patient, towards a native mitral valve of the heart.

[0061] FIG. IB 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.

[0062] FIG. 1C schematically illustrates a third stage in the exemplary mitral valve replacement procedure where the docking device of FIG. IB is fully implanted at the native mitral valve of the patient and the docking device delivery apparatus has been removed from the patient.

[0063] FIG. ID 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.

[0064] FIG. IE 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.

[0065] FIG. IF 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.

[0066] FIG. 2 is a perspective view of a prosthetic heart valve, according to an example.

[0067] FIG. 3 is a perspective view of a docking device for a prosthetic heart valve, according to an example.

[0068] FIG. 4 is a perspective view of a docking device for a prosthetic heart valve, according to another example.

[0069] FIGS. 5-6 are detail views of a distal portion of a delivery apparatus for the docking device of FIG. 3, where the delivery apparatus comprises a release mechanism and a suture of the release mechanism is shown coupled to the docking device, according to an example.

[0070] FIGS. 7A-7C are schematic views of the distal portion of the delivery apparatus and the release mechanism of FIGS. 5-6, where steps for releasing the docking device are illustrated.

[0071] FIG. 8 is a side view schematically showing a suture for the release mechanism of FIGS. 7A-7C, according to an example.

[0072] FIG. 9A is a side view of a braided suture for a release mechanism, according to an example.

[0073] FIG. 9B is a side view of a twisted suture for a release mechanism, according to another example.

[0074] FIG. 10 is a side view of a delivery apparatus for a docking device, according to an example, where a proximal portion of the delivery apparatus is configured with an actuator for a release mechanism.DETAILED DESCRIPTIONGeneral Considerations

[0075] 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 constmed 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.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0080] 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 delivery apparatus can be additionally used to orient the docking device in relation to anatomical features at the implantation site, after which the docking device can be released from the delivery apparatus, and the delivery apparatus can be removed from the body leaving the docking device in place.

[0081] 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. It is understood that the prosthetic implants disclosed herein may be prosthetic valves, grafts, or stents which may be used with a variety of implant delivery apparatuses and implanted via various delivery procedures, examples of which will be discussed in more detail below.

[0082] In some examples, the delivery apparatus can comprise a shaft with a suture extending distally therefrom. The suture can be arranged to couple the docking device to the deliveryapparatus. For example, the suture can extend from the shaft of the delivery apparatus, through a hole in a proximal end portion of the docking device, and back into the shaft of the delivery apparatus. The suture can be releasably secured relative to the shaft and docking device, thereby constraining the docking device to the delivery apparatus via a snare-like mechanism. In such examples, the suture can be removed from the docking device to detach the docking device from the delivery apparatus for implantation.

[0083] It is advantageous, in some examples, to minimize the number of steps and time needed to release the docking device from the delivery apparatus. Described herein are examples of a release mechanism for a delivery apparatus in which the release mechanism comprises a securing member (for example, a suture) that can be disconnected from the delivery apparatus in a location adjacent the docking device such that the docking device can be quickly released from the delivery apparatus. Although the prosthetic implants described herein are directed towards docking devices for prosthetic valves, it is understood that the release mechanism and delivery apparatus can be used with any prosthetic implant such as a stent or a graft.

[0084] In some examples, the release mechanism can comprise a release member (for example, a wire or other similar structure such as a rod, shaft, tube, etc.) that secures a distal portion of the securing member in a location adjacent the docking device at a distal end of the delivery apparatus when the release member is in a first configuration. The release member can release the distal portion of the securing member from the delivery apparatus when the release member is in a second configuration. By detaching the securing member from the delivery apparatus in a location adjacent the docking device at the distal end of the delivery apparatus, the securing member can be removed from the docking device as the delivery apparatus is removed from the body. In this way, the act of removing the securing member from the docking device occurs simultaneously with the act of removing the delivery apparatus from the body, i.e., without having to remove the securing member in a separate step. Accordingly, the time to decouple the docking device from the delivery apparatus is reduced. An additional advantage is that introduction of air into the shaft (or body) during suture removal is minimized or eliminated.Examples of the Disclosed Technology

[0085] 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. 1 A-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.

[0086] During the example procedure depicted in FIGS. 1 A-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. IB) 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 52 using a prosthetic valve delivery apparatus 60 (FIG. ID). Thereafter, the user removes the prosthetic valve delivery apparatus 60 from the patient 10 (FIG. IE), as well as the guide catheter 30 (FIG. IF).

[0087] 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).

[0088] 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. 1A, 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.

[0089] 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.

[0090] 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. 1A.

[0091] 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. 1).

[0092] 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.

[0093] FIG. IB 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").

[0094] 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 distal end portion 53 of the delivery shaft 54. In some examples, the distal end portion 53 of the delivery shaft 54 retains the docking device 52 therein in a straightened delivery configuration.

[0095] 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).

[0096] 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 areconfigured 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).

[0097] 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. 5-10. Further details of the docking device delivery apparatus and its variants are described in PCT No. W02020 / 247907, which is incorporated by reference herein in its entirety.

[0098] Referring again to FIG. IB, 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 guide catheter 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.

[0099] 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.

[0100] 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. 3-4.

[0101] 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.

[0102] 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 12 and 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.

[0103] FIG. 1C 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 guide wire 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. IB). 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.

[0104] 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.

[0105] FIG. ID 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.

[0106] As shown in FIG. ID, 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.

[0107] 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 and the 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.

[0108] 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. ID, 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.

[0109] In other examples, the prosthetic heart valve 62 can be self-expanding and can be configured to radially expand on its own upon removal of a sheath or capsule 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.

[0110] As shown in FIG. ID, 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.

[0111] 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. ID. 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.

[0112] 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 ofthe radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.

[0113] Once the radially compressed prosthetic heart valve 62 is appropriately positioned within the docking device 52 (FIG. ID), 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.

[0114] FIG. IE 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. IE, 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.

[0115] As also shown in FIG. IE, 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.

[0116] FIG. IF 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.

[0117] Although FIGS. 1 A-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 be utilized for replacing these other heart valves. Additional details regarding implantationprocedures for docking devices and prosthetic heart valves are described in PCT Publication No. W02023 / 205076, which is incorporated by reference herein.

[0118] 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.

[0119] 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.

[0120] 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.

[0121] 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 108 and an outflow end portion 110, and an intermediate portion 112 extending therebetween.

[0122] 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.

[0123] 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.

[0124] 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 -cobaltchromium. 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.

[0125] 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 someexamples, 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 plush nap 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).

[0126] 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. 1A-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.

[0127] 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 embodiments, 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 (e.g., the delivery shaft 404) of a delivery apparatus to a helical configuration (also referred to as “deployed configuration”) after being advanced out of the delivery shaft.

[0128] The coil 202 has a proximal end 210 and a distal end 212. When being 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 from the 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 as described above.

[0129] 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 (or “stabilization coil”). The central region 216 can possess one or more helical turns having substantially equal inner diameters. 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.

[0130] The docking device 200 can be releasably coupled to a delivery apparatus. For example, in certain examples, the docking device 200 can be coupled to a delivery apparatus, as will be described further below in connection with FIGS. 5-10, 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.

[0131] 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 as well, such as at the tricuspid valve. As described herein, the geometry of the docking device 200 can beconfigured 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.

[0132] 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” or 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 (or “leading coil”), each of which are 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 lumen diameters. The leading turn 308 can extend from a distal end of the central region 306 and, in some examples, can have a lumen diameter substantially equal to the lumen diameter of the central region 306. In some examples, the leading turn 308 can comprise a distal end portion 314 that extends radially outward. In some examples, the stabilization turn 304 can extend from a proximal end of the central region 306 and can have a lumen diameter substantially equal to the lumen diameter of the central region 306. In some examples, the lumen diameter of the stabilization turn can be different than the lumen diameter of the central region 306. 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.

[0133] In some examples, a guard member can be used with the stabilization turn 304 and configured to provide increased stability to the docking device as it is positioned in the mitral valve. As seen in the depicted example, the coil 302 can be similar to the coil 202 depicted in FIG. 3, however, the coil 302 excludes the ascending portion 217.

[0134] The attachment portion 316 can be configured to releasably couple the coil 302 to a delivery apparatus, as will be described in more detail below in connection with FIGS. 5-10. 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 one or more eyelets or holes 318.

[0135] FIGS. 5-10 show a docking device delivery apparatus (also referred to herein as a “dock delivery apparatus,” a “dock delivery catheter”, “dock delivery system,” or a “delivery apparatus”) 400, according to an example, configured to advance a docking device to an implantation site. In some examples, the delivery apparatus 400 can be used in lieu of the delivery apparatus 50, as described above with reference to the procedure schematically shown in FIGS. 1A-1F. Although the delivery apparatus 400 is shown coupled to the docking device 200 in FIGS. 5-10, it is understood that the delivery apparatus 400 can be used with any docking device or prosthetic implant described herein, as well as other compatible docking devices and / or prosthetic implants.

[0136] Referring to FIG. 10, the delivery apparatus 400 can comprise a handle assembly 402, a delivery shaft 404 extending distally from the handle assembly 402, a sleeve shaft 420 disposed within a delivery shaft 404, and a pusher shaft 412 disposed within the sleeve shaft 420. The pusher shaft 412 and the sleeve shaft 420 can have portions extending into the handle assembly 402. The sleeve shaft 420 can be configured to cover (e.g., surround) the docking device 200 and, together, the pusher shaft 412 and sleeve shaft 420 can be configured to deploy the docking device 200 from the delivery shaft 404, upon reaching the target implantation site. Further details of the docking device delivery apparatus and its components are described in PCT publication Nos. WO2022 / 087336 and W02020 / 0247907.

[0137] As shown in FIGS. 5-10, according to an example, the delivery apparatus 400 can comprise a release mechanism 500 arranged to couple and decouple the docking device 200 from a distal end of the delivery apparatus 400. More specifically, in some examples, the mechanism 500 can secure the proximal end 210 of the docking device 200 in abutment with a distal end 413 of the pusher shaft 412 such that the proximal end 210 of the docking device 200 is disposed immediately distal the pusher shaft 412. In this way, the delivery apparatus 400 can push and advance the docking device 200 through a body to an implantation site.

[0138] FIGS. 5-6 depict a close-up view of a distal end portion of the pusher shaft 412 coupled to the docking device 200 after the distal end of the sleeve shaft 420 has been retracted into the delivery shaft 404, revealing the docking device 200. More specifically, as shown in FIGS. 5-6, the distal end portion of the pusher shaft 412 of the delivery apparatus 400 is shown coupled to the docking device 200, for example, with a securing member in the form of a suture 504 in the mechanism 500. The suture 504 is shown in FIGS. 5-6 such thatthe proximal end 210 of the docking device 200 is spaced from the distal end 413 of the pusher shaft 412 for illustration purposes. As described above, the proximal end 210 of the docking device 200 can be held in abutment to the distal end 413 of the pusher shaft 412 by the suture 504.

[0139] FIGS. 7A-7C schematically illustrate the distal end portion of the pusher shaft 412 and portions of the mechanism 500. The mechanism 500 can comprise the suture 504 and a release member in the form of a wire 508. Although the release member is shown in FIGS.7A-7C as the wire 508, it is understood that the release member can take other forms such as for example a rod, shaft, tube, etc. The pusher shaft comprises a sidewall 414 with an inner surface 415 and an outer surface 417, where the inner surface 415 defines a lumen 419. The wire 508 can be disposed within the lumen 419 of the pusher shaft 412 and configured to be axially movable relative to the lumen 419. In some examples, a proximal end of the wire 508 can extend distally from an actuator in the handle assembly 402 as described in more detail below in connection with FIG. 10.

[0140] An aperture 421 can extend through the sidewall 414 from the outer surface 417 to the inner surface 415, where a distal edge of the aperture 421 is disposed a distance dl from the distal end 413 of the pusher shaft 412. In some examples, the aperture 421 may be drilled, laser ablated, cut, punched, and / or otherwise fonned through the sidewall 414. In some examples, the aperture 421 can be reinforced (e.g., with a grommet and / or a hypotube having an opening formed therein).

[0141] As seen in FIG. 8, the suture 504 can have a two ends 509a, 509b and a loop 516 formed as the suture 504 is doubled upon itself. The suture 504 can be arranged to extend through the lumen 419 of the pusher shaft 412, in some examples, and be oriented substantially parallel to the wire 508. The suture 504 can extend distally from the distal end 413 of the pusher shaft 412. In some examples, the suture 504 can extend through an aperture 423 in the distal end 413, where the aperture 423 is sealed around the suture 504 extending therethrough. In some examples, the distal end 413 of the pusher shaft 412 is open and the suture 504 can extend through the opening.

[0142] In some examples, the ends 509a, 509b of the suture 504 can be fixedly secured (for example, crimped, tied, glued, pinned, etc.) to the pusher shaft 412 and / or to the handleassembly 402. For example, the suture 504 can be fixedly secured to the pusher shaft 412 at any location within the lumen 419 between the distal end 413 and a proximal end of the pusher shaft 412. In some examples, the proximal end 509 of the suture 504 can be fixedly secured to the handle assembly 402. In some examples, the ends 509a, 509b of the suture 504 can be fixedly secured to distal portion of the pusher shaft 412 inside the lumen 419 or to an outer surface of the pusher shaft 412.

[0143] In the example shown in FIGS. 7A-7C, the suture 504 is configured as a length of material (e.g., thread, yarn, cord, etc.) doubled over to form a loop 516 at a distal region 510 as depicted in FIG. 8. That is, the suture 504 comprises a first leg 520 and a second leg 522 substantially parallel to the first leg 520, where distal portions of the first and second legs 520, 522 are connected to each other to form the loop 516. In some examples, the suture material can comprise a plurality of twisted or braided strands 524. In some examples, the suture 504 shown in FIG. 8 can be formed from a single filament.

[0144] To secure the docking device 200 to the delivery apparatus 400, the delivery apparatus 400 can be arranged in a first configuration 525a as shown in FIG. 7A. In the first configuration 525a, the distal region 510 of the suture 504 (i.e., the loop 516) extending distally from the distal end 413 of the pusher shaft 412 can be fed through the hole 220 adjacent the proximal end 210 of the coil 202 as shown in FIG. 7A. The distal region 510 of the suture 504 can be extended from outside the pusher shaft 412 through the aperture 421 in the sidewall 414 such that the loop 516 is disposed within the lumen 419.

[0145] Referring still to FIG. 7A, the wire 508 can extend distally within the lumen 419 of the pusher shaft 412 from a proximal end of the delivery apparatus 400. The wire 508 can be arranged to translate axially from a proximal to a distal state within the lumen 419. In the first configuration 525a, the wire 508 is in the distal state within the lumen 419 and a distal end portion of the wire 508 can extend through the loop 516 of the suture 504. That is, when the distal region 510 of the suture 504 is arranged through the aperture 421 such that the loop 516 of the suture 504 is disposed in the lumen 419, the wire 508 can be moved into the distal state in which the distal end 530 of the wire 508 is distal to the aperture 421 in the sidewall 414. Stated another way, a distal end portion of the wire 508 extends through the loop 516 and is in overlapping arrangement with the aperture 421 in the distal state such that the wire 508 extends distally beyond the aperture 421 inside the lumen 419 in the distal state.

[0146] When the distal end portion of the wire 508 extends through the loop 516 and the distal end 530 of the wire 508 extends distal to the aperture 421, the loop 516 is prevented from pulling out through the aperture 421. In this way, the distal end portion of the wire 508 captures or secures the distal region 510 of the suture 504 inside the lumen 419 in a snare-like manner. Thus, the distal region 510 of the suture 504 is secured to the pusher shaft 412, thereby securing the docking device 200 to the delivery apparatus 400.

[0147] In some examples, the distal end 530 of the wire 508 can be arranged in abutment with an inner surface 425 of the distal end 413 of the pusher shaft 412 when the wire 508 is in the distal state. In some examples, the distal end 530 of the wire 508 can be disposed a distance from the inner surface 425 of the distal end 413 of the pusher shaft 412 when the wire 508 is in the distal state, provided the distance is less than the distance dl (FIG. 7C). The distance dl and the location of the distal end 530 of the wire 508 in the distal state can be arranged to minimize the likelihood that the loop 516 can be pulled through the aperture 421 when the delivery apparatus is in the first configuration 525a.

[0148] Referring now to FIG. 7B, the release mechanism 500 of the delivery apparatus 400 can be moved to a second configuration 525b to release the distal region 510 of the suture 504 from the delivery apparatus 400 such that the suture 504 can be removed from the hole 220 in the coil 202 of the docking device 200 (i.e., for implantation at the target site in the body). To move the release mechanism 500 to the second configuration 525b, the wire 508 can be translated axially from the distal state to the proximal state. In the proximal state (e.g., FIGS. 7B-7C), the distal end 530 of the wire 508 is positioned proximal to the aperture 421 and the wire 508 is in nonoverlapping arrangement with the aperture 421. In other words, the distal end 530 of the wire 508 in the proximal state no longer extends distally beyond the aperture 421 inside the lumen 419, and the distal end portion of the wire 508 no longer extends through the loop 516 at the distal region 510 of the suture 504. As such, the distal region 510 (i.e., the loop 516) of the suture 504 can be removed from the lumen 419 through the aperture 421.

[0149] As shown in FIG. 7C, when the pusher shaft 412 (either alone or together with other components of the delivery apparatus 400) is retracted in a proximal direction, the suture 504 also moves proximally. As such, the suture loop 516 withdraws from the lumen 419 through the aperture 421 in the sidewall 414. As the pusher shaft 412 continues to move proximally,the suture 504 withdraws from the hole 220 of the docking device 200, thus releasing the docking device 200 from the delivery apparatus 400.

[0150] In this way, the suture 504 can be withdrawn from the docking device 200 as the delivery apparatus 400 is removed from the body without having to remove the suture 504 from the docking device 200 in a separate step (e.g., prior to withdrawing the delivery apparatus 400 from the patient’s vasculature). Accordingly, time to decouple the docking device from the delivery device is reduced. Additionally (or alternatively), in some examples, releasing a portion of the suture 504 at a distal end of the delivery apparatus 400 without otherwise displacing the suture 504 with respect to the pusher shaft 412 eliminates or reduces the likelihood of introducing air into the pusher shaft 412.

[0151] The suture 504 can be arranged in relation to the pusher shaft 412 such that the distal region 510 of the suture 504 extends a length LI from the distal end 413 of the pusher shaft 412 as seen in FIG. 7C. The length LI can be specified to ensure enough suture length for the distal region 510 of the suture 504 to extend through the hole 220 in the coil 202, through the aperture 421, and into the lumen 419. In some examples, the distance d2 can be specified such that the proximal end 210 of the coil 202 is held in abutment or contacts the distal end 413 of the pusher shaft 412. In some examples, the distance d2 can be specified according to the distance dl. For example, the greater the distance dl, the longer the length LI, and vice-versa.

[0152] Although the suture 504 is shown in FIGS 7A-8 and described above as a doubled over material forming the loop 516, in some examples, the suture 504 can take other forms. FIG. 9A illustrates an example of a suture 604 comprising a proximal end 609, a distal end region 610, a loop 616 disposed at the distal end region 610, and a single leg 620 extending from the proximal end 609 to the loop 616. The suture 604 can be formed of braided strands 624, where the loop 616 is braided integrally into the leg 620.

[0153] FIG. 9B illustrates a suture 704, according to another example, comprising a proximal end 709, a distal end region 710, a loop 716 disposed at the distal end region 710, and a single leg 720 extending from the proximal end 709 to the loop 716. The suture 704 can be formed of twisted strands 724, where the loop 716 is twisted integrally with the leg 720.

[0154] Referring to FIG. 10, the handle assembly 402 can include a handle 406 including one or more knobs, buttons, wheels, or the like. For example, in some embodiments, as shown in FIG. 10, the handle 406 can include knobs 408 and 410 which can be configured to steer or control flexing of the delivery apparatus 400 such as the delivery shaft 404 and / or the sleeve shaft 420 described above. The handle assembly 402 can optionally include a hub assembly 418 to which a suture tension mechanism 416 and a sleeve handle 424 are attached. In some instances, the suture tension mechanism can be omitted. In some examples, the hub assembly 418 can be coupled to the handle 406 via a connector 426. The hub assembly 418 can be configured to control the pusher shaft 412 and the sleeve shaft 420 while the sleeve handle 424 can control a position of the sleeve shaft 420 relative to the pusher shaft 412. Further details regarding the sleeve shaft 420 are described in PCT publication No.W02023 / 205076.

[0155] The handle assembly 402 can further include one or more flushing ports (e.g., three flushing ports 432, 436, 438 are shown in FIG. 10) to supply flush fluid to one or more lumens arranged within the delivery apparatus 400 (e.g., annular lumens arranged between coaxial components of the delivery apparatus 400).

[0156] Operation of the various components of the handle assembly 402 can actuate and control operation of the components arranged within the delivery shaft 404. For example, the hub assembly 418 can comprise an actuator 440 configured to move the wire 508 of the release mechanism 500 between the distal and proximal states. In some examples, the proximal end of the wire 508 can extend through the pusher shaft 412 and to the hub assembly 418, coupling to the actuator 440. In some examples, the actuator 440 can comprise a lock 442 configured to move the actuator 440 between a locked and an unlocked state. In some examples, the lock 442 can take the form of a knob that can be twisted between the locked and unlocked states. In some examples, the actuator 440 can further comprise a slider mechanism 444 arranged to translate a distance in the direction of arrow 446 which, in turn, translates the wire 508 between the distal and proximal states. The lock 442 can be configured to prevent the slider mechanism 444 from translating the wire 508 when the lock 442 is in the locked state. When the lock 442 is in the unlocked state, the slider mechanism 444 can be engaged to translate the wire 508 as described above.

[0157] In use, in some instances, the wire 508 can be translated such that a portion of the wire 508 can be disposed outside of the hub assembly 418 when the wire 508 is in the proximal state. To create a hemostatic and / or air seal, one or more seal members (e.g., o-rings, flapper seals, etc.) may be implemented where the wire 508 exits the handle assembly 402.

[0158] 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 all incorporated by reference herein in their entireties. Additional embodiments of the delivery apparatus 400 and its components, including the pusher shaft 412 and the sleeve shaft 420, are described further in PCT Patent Application No. W02020 / 247907.Delivery Techniques

[0159] 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 (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.

[0160] 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 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 mitral valve.

[0161] 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.

[0162] 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 transventricular 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 the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0163] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approachesare 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

[0164] 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

[0165] 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

[0166] 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.

[0167] Example 1. A delivery apparatus for a prosthetic implant, the delivery apparatus comprising: a shaft with a sidewall having an inner surface defining a lumen and an aperture extending through a distal end portion of the sidewall from an outer surface to the inner surface of the shaft; a release member disposed within the lumen of the shaft, wherein the release member is configured to axially translate relative to the lumen from a distal state to a proximal state; and a securing member arranged within the lumen and extending distally from a distal end of the shaft, wherein the securing member has a proximal end fixedly attached tothe delivery apparatus and a distal end movable in relation to the delivery apparatus, wherein the delivery apparatus comprises a first arrangement and a second arrangement, wherein in the first arrangement, the release member is in the distal state and the distal end of the securing member extends through the aperture from outside the shaft and is secured inside the lumen by a distal end portion of the release member, and wherein in the second arrangement, the release member is in the proximal state and the distal end of the securing member is removable from the lumen.

[0168] Example 2. The delivery apparatus of any example herein, particularly example 1, wherein a distal tip of the release member is distal to the aperture when the release member is in the distal state and proximal to the aperture when the release member is in the proximal state.

[0169] Example 3. The delivery apparatus of any example herein, particularly any one of examples 1-2, wherein the distal end of the securing member comprises a loop and the distal end portion of the release member extends through the loop when the delivery apparatus is in the first arrangement.

[0170] Example 4. The delivery apparatus of any example herein, particularly example 3, wherein the securing member comprises a length of material doubled over to form the loop extending between two legs.

[0171] Example 5. The delivery apparatus of any example herein, particularly example 3, wherein the securing member comprises a length of material with the loop integrally formed into a distal end of a single leg.

[0172] Example 6. The delivery apparatus of any example herein, particularly any one of examples 1-5, wherein the securing member is braided or twisted.

[0173] Example 7. The delivery apparatus of any example herein, particularly any one of examples 1-6, wherein the aperture extending through the sidewall is reinforced.

[0174] Example 8. The delivery apparatus of any example herein, particularly any one of examples 1-7, further comprising an actuator disposed at a proximal end portion of the delivery apparatus, wherein the actuator is configured to axially translate the release member from the distal state to the proximal state.

[0175] Example 9. The delivery apparatus of any example herein, particularly example 8, wherein the actuator comprises a sliding mechanism configured to axially translate the release member from the distal state to the proximal state.

[0176] Example 10. The delivery apparatus of any example herein, particularly example 9, wherein the actuator comprises a lock movable from a locked state to an unlocked state, and wherein the sliding mechanism is arranged to axially translate the release member from the distal state to the proximal state when the lock is in the unlocked state.

[0177] Example 11. The delivery apparatus of any example herein, particularly any one of examples 1-10, wherein the prosthetic implant is a docking device for a prosthetic valve.

[0178] Example 12. The delivery apparatus of any example herein, particularly any one of examples 1-11, wherein the release member is a wire, a rod, a shaft, or a tube.

[0179] Example 13. The delivery apparatus of any example herein, particularly any one of examples 1-12, wherein the securing member is a suture.

[0180] Example 14. A delivery apparatus for a prosthetic implant, the delivery apparatus comprising: a shaft with a sidewall having an inner surface defining a lumen and an aperture extending through a distal end portion of the sidewall from an outer surface to the inner surface of the shaft; a release member disposed within the lumen of the shaft; and a securing member extending distally from a distal end of the shaft, wherein the securing member has a distal end movable in relation to the delivery apparatus, wherein the delivery apparatus is transformable from a first configuration to a second configuration, wherein in the first configuration, the distal end of the securing member extends through the aperture from outside the shaft and is secured inside the lumen by a distal end portion of the release member, and wherein in the second configuration, the distal end of the securing member is removable from the lumen.

[0181] Example 15. The delivery apparatus of any example herein, particularly example 14, wherein the securing member is secured to a proximal end portion of the prosthetic implant when the delivery apparatus is in the first configuration.

[0182] Example 16. The delivery apparatus of any example herein, particularly example 15, wherein the securing member is releasable from the prosthetic implant when the delivery apparatus is in the second configuration.

[0183] Example 17. The delivery apparatus of any example herein, particularly any one of examples 14-16, wherein a distal end of the delivery apparatus abuts a proximal end of the prosthetic implant when the delivery apparatus is in the first configuration.

[0184] Example 18. The delivery apparatus of any example herein, particularly any one of examples 14-17, wherein the distal end of the securing member comprises a loop and the distal end portion of the release member extends through the loop when the delivery apparatus is in the first configuration.

[0185] Example 19. The delivery apparatus of any example herein, particularly example 18, wherein the securing member comprises a length of material doubled over to form the loop extending between two legs.

[0186] Example 20. The delivery apparatus of any example herein, particularly example 18, wherein the securing member comprises a length of material with the loop integrally formed into a distal end of a single leg.

[0187] Example 21. The delivery apparatus of any example herein, particularly any one of examples 14-20, wherein the securing member is braided or twisted.

[0188] Example 22. The delivery apparatus of any example herein, particularly any one of examples 14-21, wherein the release member is configured to axially translate relative to the lumen from a distal state in the first configuration to a proximal state in the second configuration.

[0189] Example 23. The delivery apparatus of any example herein, particularly example 22, wherein the release member is in overlapping arrangement with the aperture inside the lumen when the release member is in the distal state and is in nonoverlapping arrangement with the aperture when the release member is in the proximal state.

[0190] Example 24. The delivery apparatus of any example herein, particularly any one of examples 14-23, further comprising an actuator disposed at a proximal end portion of the delivery apparatus, wherein the actuator is configured to axially translate the release member from the distal state to the proximal state.

[0191] Example 25. The delivery apparatus of any example herein, particularly example 24, wherein the actuator comprises a lock.

[0192] Example 26. The delivery apparatus of any example herein, particularly any one of examples 24-25, wherein the actuator comprises a sliding mechanism.

[0193] Example 27. The delivery apparatus of any example herein, particularly any one of examples 14-26, wherein the release member is configured to extend proximally from a proximal end of the delivery apparatus through an orifice when the release member is in the proximal state.

[0194] Example 28. The delivery apparatus of any example herein, particularly example 27, wherein the orifice is sealed around the release member.

[0195] Example 29. The delivery apparatus of any example herein, particularly any one of examples 14-28, wherein the prosthetic implant is a docking device for a prosthetic valve.

[0196] Example 30. The delivery apparatus of any example herein, particularly any one of examples 14-29, wherein the release member is a wire, a rod, a shaft, or a tube.

[0197] Example 31. The delivery apparatus of any example herein, particularly any one of examples 14-30, wherein the securing member is a suture.

[0198] Example 32. A release mechanism for a delivery apparatus having a shaft, the mechanism comprising: a release member disposed within a lumen of the shaft, wherein the shaft has a sidewall defining the lumen and an aperture extending through the sidewall adjacent a distal end of the shaft; and a securing member arranged within the lumen and extending distally from a distal end of the shaft, wherein the securing member has a distal end movable in relation to the shaft and comprising a loop, wherein the mechanism comprises a first configuration and a second configuration, wherein in the first configuration, a distal end portion of the securing member extends through the aperture from outside the shaft, the loop is disposed in the lumen, and the release member is in a distal state extending through the loop, and wherein in the second configuration, the release member is in a proximal state and the loop is removable from the lumen.

[0199] Example 33. The release mechanism of any example herein, particularly example 32, wherein the release member extends substantially parallel to a portion of the securing member inside the lumen along a length of the shaft.

[0200] Example 34. The release mechanism of any example herein, particularly any one of examples 32-33, wherein a distal tip of the release member is distal to the aperture when the release member is in the distal state and proximal to the aperture when the release member is in the proximal state.

[0201] Example 35. The delivery apparatus of any example herein, particularly any one of examples 32-34, wherein the release member is a wire, a rod, a shaft, or a tube.

[0202] Example 36. The delivery apparatus of any example herein, particularly any one of examples 32-35, wherein the securing member is a suture.

[0203] Example 37. A mechanism for releasing a prosthetic implant from a delivery apparatus, the mechanism comprising: a release member disposed within a lumen of the delivery apparatus, wherein the release member is axially movable relative to the lumen from a distal state to a proximal state and wherein the lumen is defined by a sidewall of a shaft having an aperture extending through the sidewall; and a securing member arranged within the lumen and extending distally from a distal end of the shaft, wherein the securing member has a distal end with a loop, and wherein the mechanism is movable from a first configuration to a second configuration, wherein in the first configuration, a proximal end of the prosthetic implant is secured in abutment with a distal end of the shaft, the securing member extends through the aperture from outside the shaft, the loop is disposed in the lumen, and the release member is in the distal state extending through the loop, and wherein in the second configuration, the release member is in a proximal state, the loop is removable from the lumen, and the prosthetic implant is releasable from the delivery apparatus.

[0204] Example 38. The mechanism of any example herein, particularly example 37, further comprising an actuator disposed at a proximal end portion of the delivery apparatus, wherein the actuator is configured to move the release member from the distal state to the proximal state.

[0205] Example 39. The mechanism of any example herein, particularly any one of examples 37-38, wherein the securing member has a proximal end fixedly attached to a distal portion of the shaft.

[0206] Example 40. The mechanism of any example herein, particularly any one of examples 37-38, wherein the securing member has a proximal end fixedly attached to a proximal end portion of the delivery apparatus.

[0207] Example 41. The mechanism of any example herein, particularly any one of examples 39-40, wherein the proximal end of the securing member is crimped, tied, bonded, or pinned to the delivery apparatus.

[0208] Example 42. A method of releasing a prosthetic implant from a delivery apparatus, the method comprising: advancing the prosthetic implant to an implantation site with the delivery apparatus in a first configuration; moving the delivery apparatus from the first configuration to a second configuration by translating a release member axially relative to a lumen of a shaft from a distal state to a proximal state in which the release member is decoupled from a distal end of a securing member inside the lumen; and retracting the delivery apparatus to release the prosthetic implant from the delivery apparatus, wherein releasing the prosthetic implant comprises removing the securing member from an aperture in a sidewall of the shaft.

[0209] Example 43. The method of any example herein, particularly example 42, wherein the securing member is secured to the prosthetic implant when the delivery apparatus is in the first configuration, and wherein releasing the prosthetic implant further comprises detaching the securing member from the prosthetic implant.

[0210] Example 44. The method of any example herein, particularly any one of examples 42-43, wherein a distal tip of the release member is distal to the aperture when the release member is in the distal state and the act of translating the release member axially comprises moving the distal tip of the release member proximal to the aperture.

[0211] Example 45. The method of any example herein, particularly any one of examples 42-44, wherein the delivery apparatus further comprises an actuator, and wherein the act of translating the release member comprises engaging the actuator to axially translate the release member from the distal state to the proximal state.

[0212] Example 46. The method of any example herein, particularly example 45, wherein the actuator comprises a lock movable from a locked state to an unlocked state, and wherein the method further comprises moving the lock from the locked state to the unlocked stateprior to moving the delivery apparatus from the first configuration to the second configuration.

[0213] Example 47. The method of any example herein, particularly any one of examples 45-46, wherein actuator comprises a slider mechanism movable from a distal arrangement to a proximal arrangement, and wherein the act of engaging the actuator comprises moving the slider mechanism from the distal arrangement to the proximal arrangement.

[0214] Example 48. The method of any example herein, particularly any one of examples 42-47, wherein the prosthetic implant is a docking device for a prosthetic valve.

[0215] Example 49. A method comprising sterilizing the prosthetic heart valve, delivery apparatus, docking device, release mechanism, apparatus, and / or assembly of any example.

[0216] Example 50. A method comprising performing on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, or simulator the prosthetic heart valve, delivery apparatus, docking device, release mechanism, apparatus, and / or assembly of any example.

[0217] Example 51. A prosthetic implant and / or delivery apparatus of any one of examples 1-49, wherein the prosthetic implant, delivery apparatus, release mechanism, and / or docking device is sterilized.

[0218] 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 docking device can be combined with any one or more features of another docking device. As another example, any one or more features of one release mechanism or delivery apparatus can be combined with any one or more features of another release mechanism or delivery apparatus.

[0219] 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 prosthetic implant, the delivery apparatus comprising:a shaft with a sidewall having an inner surface defining a lumen and an aperture extending through a distal end portion of the sidewall from an outer surface to the inner surface of the shaft;a release member disposed within the lumen of the shaft, wherein the release member is configured to axially translate relative to the lumen from a distal state to a proximal state; anda securing member arranged within the lumen and extending distally from a distal end of the shaft, wherein the securing member has a proximal end fixedly attached to the delivery apparatus and a distal end movable in relation to the delivery apparatus,wherein the delivery apparatus comprises a first arrangement and a second arrangement,wherein in the first arrangement, the release member is in the distal state and the distal end of the securing member extends through the aperture from outside the shaft and is secured inside the lumen by a distal end portion of the release member, andwherein in the second arrangement, the release member is in the proximal state and the distal end of the securing member is removable from the lumen.

2. The delivery apparatus of claim 1, wherein a distal tip of the release member is distal to the aperture when the release member is in the distal state and proximal to the aperture when the release member is in the proximal state.

3. The delivery apparatus of any one of claims 1-2, wherein the distal end of the securing member comprises a loop and the distal end portion of the release member extends through the loop when the delivery apparatus is in the first arrangement.

4. The delivery apparatus of claim 3, wherein the securing member comprises a length of material doubled over to form the loop extending between two legs.

5. The delivery apparatus of claim 3, wherein the securing member comprises a length of material with the loop integrally formed into a distal end of a single leg.

6. The delivery apparatus of any one of claims 1-5, wherein the securing member is braided or twisted.

7. The delivery apparatus of any one of claims 1-6, wherein the aperture extending through the sidewall is reinforced.

8. The delivery apparatus of any one of claims 1-7, further comprising an actuator disposed at a proximal end portion of the delivery apparatus, wherein the actuator is configured to axially translate the release member from the distal state to the proximal state.

9. The delivery apparatus of claim 8, wherein the actuator comprises a sliding mechanism configured to axially translate the release member from the distal state to the proximal state.

10. The delivery apparatus of claim 9, wherein the actuator comprises a lock movable from a locked state to an unlocked state, and wherein the sliding mechanism is arranged to axially translate the release member from the distal state to the proximal state when the lock is in the unlocked state.

11. The delivery apparatus of any one of claims 1-10, wherein the prosthetic implant is a docking device for a prosthetic valve.

12. The delivery apparatus of any one of claims 1-11, wherein the release member is a wire, a rod, a shaft, or a tube.

13. The delivery apparatus of any one of claims 1-12, wherein the securing member is a suture.

14. A delivery apparatus for a prosthetic implant, the delivery apparatus comprising:a shaft with a sidewall having an inner surface defining a lumen and an aperture extending through a distal end portion of the sidewall from an outer surface to the inner surface of the shaft;a release member disposed within the lumen of the shaft; anda securing member extending distally from a distal end of the shaft, wherein the securing member has a distal end movable in relation to the delivery apparatus, wherein the delivery apparatus is transformable from a first configuration to a second configuration,wherein in the first configuration, the distal end of the securing member extends through the aperture from outside the shaft and is secured inside the lumen by a distal end portion of the release member, andwherein in the second configuration, the distal end of the securing member is removable from the lumen.

15. The delivery apparatus of claim 14, wherein the securing member is secured to a proximal end portion of the prosthetic implant when the delivery apparatus is in the first configuration.

16. The delivery apparatus of claim 15, wherein the securing member is releasable from the prosthetic implant when the delivery apparatus is in the second configuration.

17. The delivery apparatus of any one of claims 14-16, wherein a distal end of the delivery apparatus abuts a proximal end of the prosthetic implant when the delivery apparatus is in the first configuration.

18. The delivery apparatus of any one of claims 14-17, wherein the release member is configured to axially translate relative to the lumen from a distal state in the first configuration to a proximal state in the second configuration.

19. The delivery apparatus of claim 18, wherein the release member is configured to extend proximally from a proximal end of the delivery apparatus through an orifice when the release member is in the proximal state.

20. The delivery apparatus of claim 19, wherein the orifice is sealed around the release member.

21. A release mechanism for a delivery apparatus having a shaft, the mechanism comprising:a release member disposed within a lumen of the shaft, wherein the shaft has a sidewall defining the lumen and an aperture extending through the sidewall adjacent a distal end of the shaft; anda securing member arranged within the lumen and extending distally from a distal end of the shaft, wherein the securing member has a distal end movable in relation to the shaft and comprising a loop,wherein the mechanism comprises a first configuration and a second configuration, wherein in the first configuration, a distal end portion of the securing member extends through the aperture from outside the shaft, the loop is disposed in the lumen, and the release member is in a distal state extending through the loop, andwherein in the second configuration, the release member is in a proximal state and the loop is removable from the lumen.

22. The release mechanism of claim 21, wherein the release member extends substantially parallel to a portion of the securing member inside the lumen along a length of the shaft.

23. A method of releasing a prosthetic implant from a delivery apparatus, the method comprising:advancing the prosthetic implant to an implantation site with the delivery apparatus in a first configuration;moving the delivery apparatus from the first configuration to a second configuration by translating a release member axially relative to a lumen of a shaft from a distal state to aproximal state in which the release member is decoupled from a distal end of a securing member inside the lumen; andretracting the delivery apparatus to release the prosthetic implant from the delivery apparatus, wherein releasing the prosthetic implant comprises removing the securing member from an aperture in a sidewall of the shaft.

24. The method of claim 23, wherein the securing member is secured to the prosthetic implant when the delivery apparatus is in the first configuration, and wherein releasing the prosthetic implant further comprises detaching the securing member from the prosthetic implant.

25. The method of any one of claims 23-24, wherein a distal tip of the release member is distal to the aperture when the release member is in the distal state and the act of translating the release member axially comprises moving the distal tip of the release member proximal to the aperture.

26. The method of any one of claims 23-25, wherein the delivery apparatus further comprises an actuator, and wherein the act of translating the release member comprises engaging the actuator to axially translate the release member from the distal state to the proximal state.

27. The method of claim 26, wherein the actuator comprises a lock movable from a locked state to an unlocked state, and wherein the method further comprises moving the lock from the locked state to the unlocked state prior to moving the delivery apparatus from the first configuration to the second configuration.

28. The method of any one of claims 26-27, wherein actuator comprises a slider mechanism movable from a distal arrangement to a proximal arrangement, and wherein the act of engaging the actuator comprises moving the slider mechanism from the distal arrangement to the proximal arrangement.

Images