Sealing members for prosthetic implant docking devices

Abstract

A docking device for a prosthetic implant is disclosed, where the docking device comprises a coil and a sealing member coupled to the coil. The coil comprises a plurality of turns defining a ventricular portion of the coil, an atrial portion of the coil, and a transition region extending from the ventricular portion of the coil to the atrial portion of the coil. The sealing member comprises a plurality of filaments and is disposed at least along the transition region of the coil, where the plurality of filaments extends radially outward from the coil. The sealing member can further comprise a sleeve or an expandable member to the which the plurality of filaments is coupled.

Description

SEALING MEMBERS FOR PROSTHETIC IMPLANT DOCKING DEVICES CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No.63 / 705,170, filed October 9, 2024, which is incorporated by reference herein in its entirety. FIELD

[0002] The present disclosure relates to sealing members for prosthetic implant docking devices. 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, prosthetic heart valves), docking devices for prosthetic implants, delivery apparatuses, and methods for implanting prosthetic implants and docking devices. Also described herein are sealing members for docking devices, where the sealing members are configured to locally conform to an adjacent native anatomy when the docking device is implanted. In some examples, the disclosed sealing members can comprise a plurality of filaments extending radially outward from the docking device. Each of the plurality of filaments can move independently of and without influence from other filaments forming the sealing member. Independent and localized movement of the plurality of filaments can, in some instances, result in greater contact with the adjacent native anatomy for improved sealing. 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 docking device for a prosthetic implant can comprise a coil and a sealing member. In addition to these components, a docking device can further comprise one or more of the components disclosed herein.

[0008] In some examples, the coil can comprise a plurality of turns.

[0009] In some examples, the plurality of turns can define a ventricular portion of the coil, an atrial portion of the coil, and a transition region extending from the ventricular portion of the coil to the atrial portion of the coil.

[0010] In some examples, the sealing member can be coupled to the coil at least along the transition region of the coil.

[0011] In some examples, the sealing member can comprise a plurality of filaments extending radially outward from the coil.

[0012] In some examples, a plurality of filaments can extend radially outward from the coil along at least a portion of the plurality of turns.

[0013] In some examples, the docking device can further comprise a cover extending over the coil from a proximal end portion of the coil to a distal end portion of the coil.

[0014] In some examples, the plurality of filaments can be coupled to the cover and can extend radially outward therefrom.

[0015] In some examples, the sealing member can further comprise a sleeve disposed over at least the transition region of the coil.

[0016] In some examples, the plurality of filaments can be coupled to the sleeve and can extend radially outward therefrom.

[0017] In some examples, the sleeve can extend over the cover and be fixedly secured thereto.

[0018] In some examples, the sealing member can further comprise an expandable member extending over at least the transition region of the coil.

[0019] In some examples, the expandable member can be configured to move from a first configuration to a second configuration.

[0020] In some examples, in the first configuration, the expandable member can form an axially lengthened and radially compacted shape.

[0021] In some examples, in the second configuration, the expandable member can form an axially foreshortened and radially extended shape defining an atrial ledge, a ventricular ledge, and a necked region extending between the atrial ledge and the ventricular ledge.

[0022] In some examples, the expandable member can form a cylindrical or an at least substantially cylindrical shape in the first configuration.

[0023] In some examples, the expandable member can form an hourglass shape or an at least substantially hourglass shape in the second configuration.

[0024] In some examples, the necked region can be disposed within a native valve commissure when the docking device is implanted.

[0025] In some examples, the plurality of filaments can be coupled to at least a portion the necked region of the expandable member and can extend radially outward from the coil.

[0026] In some examples, the plurality of turns can define a central, longitudinal axis of the coil and the plurality of filaments can extend greater than 250 degrees and less than 380 degrees circumferentially around the central, longitudinal axis of the coil.

[0027] In some examples, the plurality of filaments can be arranged to extend within a space between the docking device and an adjacent native anatomy at an implantation site to prevent leakage around the docking device.

[0028] In some examples, the implantation site can be a native valve and the adjacent native anatomy can be a native commissure of the native valve.

[0029] In some examples, the plurality of filaments can extend within the space between the docking device and the native commissure.

[0030] In some examples, a docking device for a prosthetic implant comprises a coil comprising a plurality of turns; and a sealing member coupled to the coil and comprising a plurality of filaments, wherein the plurality of filaments extends radially outward from the coil along at least a portion of the plurality of turns.

[0031] In some examples, a docking device for a prosthetic implant comprises a coil comprising a plurality of turns defining: a ventricular portion of the coil; an atrial portion of the coil; and a transition region extending from the ventricular portion of the coil to the atrial portion of the coil; and a sealing member coupled to the transition region of the coil and comprising a plurality of filaments extending radially outward from the coil.

[0032] In some examples, a docking device for securing a prosthetic implant at an implantation site comprises a coil comprising a plurality of turns; and a sealing member coupled to the coil and comprising a plurality of filaments extending radially outward from the coil, wherein the plurality of filaments is arranged to extend within a space between the docking device and an adjacent native anatomy at the implantation site to prevent leakage around the docking device.

[0033] In some examples, a docking device for a prosthetic implant comprises a coil comprising a plurality of turns defining: a ventricular portion of the coil; an atrial portion ofthe coil; and a transition region extending from the ventricular portion of the coil to the atrial portion of the coil; a cover extending over the coil from a proximal end portion of the coil to a distal end portion of the coil; and a sealing member disposed over the cover along at least the transition region of the coil, wherein sealing member comprises a plurality of filaments integrated into the cover and extending radially outward from the coil.

[0034] In some examples, a docking device for a prosthetic implant comprises a coil having a central, longitudinal axis and comprising a plurality of turns defining: a ventricular portion of the coil; an atrial portion of the coil; and a transition region extending from the ventricular portion of the coil to the atrial portion of the coil; and a sealing member disposed along at least the transition region of the coil, wherein sealing member comprises a sleeve extending over the coil and a plurality of filaments coupled to the sleeve and extending radially outward from the coil, and wherein the sleeve extends greater than 250 degrees and less than 380 degrees circumferentially around the central, longitudinal axis of the coil.

[0035] In some examples, a docking device for a prosthetic implant comprises a coil comprising a plurality of turns defining: a ventricular portion of the coil; an atrial portion of the coil; and a transition region extending from the ventricular portion of the coil to the atrial portion of the coil; and a sealing member comprising an expandable member extending over at least the transition region of the coil, wherein the expandable member is configured to move from a first configuration to a second configuration, wherein, in the first configuration, the expandable member forms an axially lengthened and radially compacted shape, and in the second configuration, the expandable member forms an axially foreshortened and radially extended shape.

[0036] In some examples, a docking device comprises one or more of the components recited in Examples 1-28 and 32 below.

[0037] A method of implanting the docking device can comprise positioning the sealing member adjacent a native commissure of a native valve.

[0038] In some examples, a method of implanting the docking device comprises one or more of the steps recited in Examples 29-31 below.

[0039] 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).

[0040] 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

[0041] FIG.1A schematically illustrates a first stage in an exemplary mitral valve replacement procedure where a guide catheter and a guidewire are inserted into a 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.

[0042] FIG.1B schematically illustrates a second stage in the exemplary mitral valve replacement procedure where a docking device delivery apparatus extending through the guide catheter is implanting a docking device for a prosthetic heart valve at the native mitral valve.

[0043] FIG.1C schematically illustrates a third stage in the exemplary mitral valve replacement procedure where the docking device of FIG.1B is fully implanted at the native mitral valve of the patient and the docking device delivery apparatus has been removed from the patient.

[0044] FIG.1D schematically illustrates a fourth stage in the exemplary mitral valve replacement procedure where a prosthetic heart valve delivery apparatus extending through the guide catheter is implanting a prosthetic heart valve in the implanted docking device at the native mitral valve.

[0045] FIG.1E schematically illustrates a fifth stage in the exemplary mitral valve replacement procedure where the prosthetic heart valve is fully implanted within the dockingdevice at the native mitral valve and the prosthetic heart valve delivery apparatus has been removed from the patient.

[0046] FIG.1F schematically illustrates a sixth stage in the exemplary mitral valve replacement procedure where the guide catheter and the guidewire have been removed from the patient.

[0047] FIG.2 is a perspective view of a docking device comprising a coil and a sealing member, according to an example, where the sealing member comprises a plurality of filaments extending radially outward from the coil.

[0048] FIG.2A is a section view of the sealing member and the coil of FIG.2, showing the filaments extending from the coil.

[0049] FIG.3 is a top view of the docking device of FIG.2 implanted in a native heart valve, where the sealing member is shown disposed within a commissure of the native valve.

[0050] FIGS.4A-4D are schematic views showing different configurations of filaments.

[0051] FIG.5 is a perspective view of a docking device comprising a coil and a sealing member, according to another example, where the sealing member comprises a sleeve and a plurality of filaments configured to extend radially outward from the sleeve.

[0052] FIG.5A is a section view of the sealing member and the coil of FIG.5, showing the sleeve disposed around the coil and the filaments extending from the sleeve.

[0053] FIG.6A is a side view of a sealing member, according to another example, shown in a first configuration in which the sealing member is axially lengthened and radially contracted into a substantially cylindrical shape.

[0054] FIG.6B is a side view of the sealing member of FIG.6A shown in a second configuration in which the sealing member is axially foreshortened and radially extended into a substantially hourglass shape.

[0055] FIG.7 is a side view of a delivery assembly comprising a delivery apparatus and the docking device of FIG.2, according to an example. DETAILED DESCRIPTION General Considerations

[0056] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0057] 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.

[0058] 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.

[0059] 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 fromthe 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.

[0060] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0061] 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. 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.

[0062] 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 delivery apparatus to which the docking device can be coupled for advancement through a body. The delivery apparatus can be removed from the body, leaving the docking device in place. A prosthetic implant can be subsequently deployed within the docking device.

[0063] In some examples, docking devices can comprise a coil and a sealing member coupled to the coil, where the coil can move from a straightened delivery configuration to a helical configuration when deployed at an implantation site. When the docking device is deployed at the implantation site, the sealing member can likewise deploy and conform to the adjacent native anatomy. Sealing members can be configured to reduce leakage between the coil of the docking device and the deployed prosthetic implant and / or the adjacent native anatomy at the implantation site.

[0064] Subsequent implantation of a prosthetic implant within the deployed docking device can introduce forces on the docking device that can affect how the sealing member conforms to the native anatomy. For example, a change in forces on one region of the sealing membercan, in some instances, result in displacement of that region. Displacement in one region, in some cases, can lead to inadvertent displacement in another region of the sealing member. In some examples, this inadvertent displacement can introduce gaps between the docking device and adjacent anatomical features which can cause leaks. Thus, it is advantageous, in at least some instances, to configure docking devices with sealing members having portions that move independently of and without influence from other portions of the sealing member. This localized and independent movement can result in a more conformal seal that can reduce or eliminate leakage.

[0065] Described herein are examples of docking devices comprising a coil with a sealing member. In some examples, the sealing member can have a plurality of filaments extending radially outward from the coil. Each of the plurality of filaments can move independently of and without influence from other filaments in the sealing member. As such, the plurality of filaments can, in some instances, conform to the native anatomy, thereby reducing or eliminating leakage. In some examples, the plurality of filaments can encourage tissue ingrowth which can aid in reducing or eliminating leakage.

[0066] In a particular example, the docking device can be used with a prosthetic heart valve and the sealing member can comprise a plurality of filaments disposed on a portion of the docking device extending through a native valve commissure. In this way, potential leakage through gaps or spaces between the native commissure and the docking device can be minimized or eliminated. Although the examples described herein are drawn toward sealing members for docking devices used with prosthetic heart valves at a native valve, the sealing members and docking devices can be used with any prosthetic implant such as, for example, a prosthetic valve, a stent, or a graft. Examples of the Disclosed Technology

[0067] In some examples, the expandable prosthetic implant can be a prosthetic heart valve. FIGS.1A-1F depict an 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 a native mitral valve, where the prosthetic heart valve 62 can be radially expanded inside the docking device 52 within the annulus of the native mitralvalve. Although FIG.1A-1F show the procedure using the docking device 52 and the prosthetic heart valve 62, it is understood that any docking device or prosthetic heart valve described herein can be used.

[0068] During the example procedure depicted in FIGS.1A-1F, a user first creates a pathway to a patient’s native heart valve using a guide catheter 30 (FIG.1A). The user then delivers and implants the docking device 52 at the patient’s native heart valve using a docking device delivery apparatus 50 (FIG.1B) and then removes the docking device delivery apparatus 50 from the patient 10 after implanting the docking device 52 (FIG.1C). The user then implants the prosthetic heart valve 62 within the implanted docking device 52 using a prosthetic valve delivery apparatus 60 (FIG.1D). Thereafter, the user removes the prosthetic valve delivery apparatus 60 from the patient 10 (FIG.1E), as well as the guide catheter 30 (FIG.1F).

[0069] FIG.1A 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).

[0070] 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.

[0071] 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 intothe 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 to manipulate the shaft 34.

[0072] 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.

[0073] 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).

[0074] 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 frominside 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.

[0075] FIG.1B depicts a second stage in the exemplary mitral valve replacement procedure where the docking device 52 is being implanted at the native mitral valve 16 of the heart 14 of the patient 10 using the docking device delivery apparatus 50 (which may also be referred to as an “implant catheter,” a “delivery apparatus,” and / or a “docking device delivery device”).

[0076] 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.

[0077] 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).

[0078] In some examples, the handle 56 can comprise one or more articulation members 57 (or rotatable knobs) that are configured to aid in positioning the delivery shaft 54 within the heart 14. For example, the one or more articulation members 57 can comprise one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 to aid in positioning the delivery shaft 54 within the heart 14 for deployment of the docking device 52 at the implantation site (e.g., the native mitral valve 16).

[0079] 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 outof 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. Further details of the docking device delivery apparatus and its variants are described in PCT publication Nos. WO2022 / 087336 and WO2020 / 247907, which are incorporated by reference herein in their entireties.

[0080] Referring again to FIG.1B, after the guide catheter 30 is positioned within the left atrium 18, the user may insert the docking device delivery apparatus 50 (e.g., the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 of the docking device delivery apparatus 50 through the guide catheter 30 and over the guidewire 40. In some examples, the guidewire 40 can be at least partially retracted away from the left atrium 18 and into the guide catheter 30. In other examples, the guidewire 40 can be fully removed from the 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.1B. 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.

[0081] 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.

[0082] 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 shapewhen 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.2 and 5.

[0083] After pushing a ventricular portion of the docking device 52 (e.g., the portion of the docking device 52 shown in FIG.1B 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.

[0084] 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.

[0085] 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 guidewire 40 remain inside the patient 10. After removing the docking device delivery apparatus 50, the guidewire 40 can be advanced through and / or out of the guide catheter 30, through the implanted docking device 52 at the native mitral valve 16, and into the left ventricle 26 (FIG.1B). As such, the guidewire 40 can help to guide the prosthetic valve delivery apparatus 60 through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.

[0086] 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 thenative 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.

[0087] FIG.1D depicts a fourth stage in the mitral valve replacement procedure where the user is delivering and / or implanting a prosthetic heart valve 62 (which can also be referred to herein as a “transcatheter heart valve” or “THV” for short, “replacement heart valve,” and / or “prosthetic mitral valve”) within the docking device 52 using a prosthetic valve delivery apparatus 60.

[0088] As shown in FIG.1D, the prosthetic valve delivery apparatus 60 can comprise a delivery shaft 64 and a handle 66, the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into the patient’s vasculature to deliver, implant, expand, and / or otherwise deploy the prosthetic heart valve 62 within the docking device 52 at the native mitral valve 16. The handle 66 is configured to be gripped and / or otherwise held by the user to advance the delivery shaft 64 through the patient’s vasculature.

[0089] 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.

[0090] In some examples, the prosthetic valve delivery apparatus 60 can include an expansion mechanism 65 that is configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. In some instances, as shown in FIG.1D, the expansion mechanism 65 can comprise an inflatable balloon that is configured to be inflated to radially expand the prosthetic heart valve 62 within the docking device 52. The inflatable balloon can be coupled to the distal end portion of the delivery shaft 64.

[0091] In other examples, the prosthetic heart valve 62 can be self-expanding and can be configured to radially expand on its own upon removable of a sheath or capsule covering theradially 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.

[0092] As shown in FIG.1D, the prosthetic heart valve 62 can be mounted around the expansion mechanism 65 (the inflatable balloon) on the distal end portion of the delivery shaft 64, in a radially compressed configuration.

[0093] To navigate the distal end portion of the delivery shaft 64 to the implantation site, the user can insert the prosthetic valve delivery apparatus 60 (the delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guidewire 40. The user can continue to advance the prosthetic valve delivery apparatus 60 along the guidewire 40 (through the blood vessel 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as illustrated in FIG.1D. More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery apparatus 60 by gripping and exerting a force on (e.g., pushing) the handle 66. While advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the user can adjust the one or more articulation members 68 of the handle 66 to navigate the various turns, corners, constrictions, and / or other obstacles in the blood vessel 12 and heart 14.

[0094] 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.1D, a distal end of the delivery shaft 64 and a least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.

[0095] Once the radially compressed prosthetic heart valve 62 is appropriately positioned within the docking device 52 (FIG.1D), the user can manipulate one or more actuation mechanisms of the handle 66 of the prosthetic valve delivery apparatus 60 to actuate the expansion mechanism 65 (e.g., inflate the inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52.

[0096] FIG.1E shows a fifth stage in the mitral valve replacement procedure where the prosthetic heart valve 62 is in its radially expanded configuration and implanted within the docking device 52 in the native mitral valve 16. As shown in FIG.1E, the prosthetic heart valve 62 is received and retained within the docking device 52. Thus, the docking device 52 aids in anchoring the prosthetic heart valve 62 within the native mitral valve 16. In some examples, the docking device 52 can enable better sealing between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16 to reduce paravalvular leakage around the prosthetic heart valve 62.

[0097] As also shown in FIG.1E, after the prosthetic heart valve 62 has been fully deployed and implanted within the docking device 52 at the native mitral valve 16, the prosthetic valve delivery apparatus 60 (including the delivery shaft 64) can be removed from the patient 10 such that only the guidewire 40 and the guide catheter 30 remain inside the patient 10.

[0098] FIG.1F depicts a sixth stage in the mitral valve replacement procedure, where the guidewire 40 and the guide catheter 30 have been removed from the patient 10.

[0099] Although FIGS.1A-1F specifically depict a mitral valve replacement procedure, it should be appreciated that a similar procedure may be utilized to replace other heart valves (e.g., tricuspid, pulmonary, and / or aortic valves). Further, the same and / or similar delivery apparatuses (e.g., docking device delivery apparatus 50, prosthetic valve delivery apparatus 60, guide catheter 30, and / or guidewire 40), docking devices (e.g., docking device 52, or any other docking device described herein), replacement heart valves (e.g., prosthetic heart valve 62, or any other prosthetic valve described herein), and / or components thereof may be utilized for replacing these other heart valves. Additional details regarding implantation procedures for docking devices and prosthetic heart valves are described in PCT Publication No. WO2023 / 205076, which is incorporated by reference herein in its entirety.

[0100] Any of the prosthetic valves disclosed herein are adapted to be implanted in the native mitral annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, aortic, 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 diseasedtricuspid 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.

[0101] As introduced above, in some examples it can be advantageous for a docking device to be configured with a seal that can conform to an adjacent anatomy at an implantation site. FIG.2 shows an example of a docking device 100 which can, for example, be implanted within a native valve annulus (e.g., a native mitral valve annulus). In some examples, the docking device 100 can be configured to receive and secure a prosthetic valve within the docking device 100, thereby securing the prosthetic valve at the native valve annulus. In some examples, the docking device 100 can be used in lieu of the docking device 52 shown in connection with the procedure illustrated in FIGS.1A-1F.

[0102] Referring to FIG.2, the docking device 100 can comprise two main components: a coil 102 and a sealing member (also may be referred to a “paravalvular leak (PVL) guard”) 104 covering at least a portion of the coil 102. In some examples, the coil 102 can include a shape memory material (e.g., Nitinol) such that the docking device 100 (and the coil 102) can move from a substantially straight configuration (also referred to as “delivery configuration”) when disposed within a shaft of a delivery apparatus to the helical configuration (also referred to as “deployed configuration,” as shown in FIG.2) after being removed from the shaft.

[0103] The coil 102 has a proximal end 102p and a distal end 102d. When disposed within the shaft (e.g., during delivery of the docking device into the vasculature of a patient), a body of the coil 102 between the proximal end 102p and distal end 102d can form a generally straight (or elongate) delivery configuration (i.e., without any coiled or looped portions) so as to maintain a small radial profile for insertion and movement through a patient’s vasculature. After removal from the shaft and deployment at an implant position, the coil 102 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 102 can be configured to surround native leaflets of the native valve (and the chordae tendineae that connects native leaflets to adjacent papillary muscles, if present). Additional details regarding the coupling and release of the dockingdevice from the delivery apparatus are described in U.S. Publication No.2023 / 0255754 and U.S. Publication No. 2023 / 0255755, as well as U.S. Provisional Application No.63 / 712,719, which are incorporated by reference herein in their entireties.

[0104] In some examples, the docking device 100 in the deployed configuration can be configured to fit at the mitral valve position. In other examples, the docking device 100 can also be shaped and / or adapted for implantation at other native valve positions, such as at the tricuspid valve. As described herein, the geometry of the docking device 100 can be configured to engage the native anatomy, which can, for example, provide for increased stability and reduction of relative motion between the docking device 100, the prosthetic valve mounted therein, and / or the native anatomy.

[0105] As shown in FIG.2, the coil 102 in the deployed configuration can include a plurality of turns defining a leading turn 106 (or “leading coil”), a central region 108, a stabilization turn 110 (or “stabilization coil”), and an ascending portion 112. The central region 108 can possess one or more helical turns having substantially equal inner diameters. The leading turn 106 can extend from a distal end of the central region 108 and have a diameter greater than the diameter of the central region 108 (in one or more configurations). The stabilization turn 110 can extend from the ascending portion 112, which extends from a proximal end of the central region 108. The stabilization turn 110 can have a diameter greater than the diameter of the central region 108 (in one or more configurations).

[0106] In some examples as shown in FIG.2, the central region 108 can include a plurality of helical turns (also referred to herein as “functional turns”), such as a proximal turn 108p in connection with the ascending portion 112, a distal turn 108d in connection with the leading turn 106, and one or more intermediate turns 108m disposed between the proximal turn 108p and the distal turn 108d. In the example shown in FIG.2, only one intermediate turn 108m is shown between the proximal turn 108p and the distal turn 108d. In other examples, more than one intermediate turn 108m can be arranged between the proximal turn 108p and the distal turn 108d. Some of the helical turns in the central region 108 can be full turns (i.e., rotating 360 degrees). In some examples, the proximal turn 108p and / or the distal turn 108d can be partial turns (e.g., rotating less than 360 degrees, such as 180 degrees, 270 degrees, etc.). The plurality of functional turns revolve around a central, longitudinal axis 109 of thecoil 102. Additional details regarding the coil 102 are described in U.S. Publication No. 2023 / 0255754 and U.S. Publication No.2023 / 0255755.

[0107] As seen in FIG.2A, in some examples, the coil 102 can comprise a wire core 130 surrounded by a foam layer 132 and a cover 134. The cover 134 can have a tubular shape and thus can also be referred to as a “tubular member.” In some examples, the foam layer 132 can be omitted. In some examples, the cover 134 can extend over a length of the wire core 130 from a distal end portion of the wire core 130 to a proximal end portion of the wire core 130. In some examples, the cover 134 can cover only selected portion(s) of the wire core 130. In some examples, the cover 134 can be coated on and / or bonded on the wire core 130. In some examples, the cover 134 can be a cushioned, padded-type layer protecting the wire core 130. In some examples, the cover 134 can be made of a fabric material as will be described in more detail below. The cover 134 can be constructed of various biocompatible materials. In some examples, the cover 134 can comprise polyethylene terephthalate (PET). In some examples, the cover 134 is configured to be fixedly attached to the wire core 130 and / or the foam layer 132 (e.g., by means of textured surface resistance, suture, glue, thermal bonding, or any other means) so that relative axial movement between the cover 134, the foam layer 132, and the core 130 is restricted or prohibited. As shown in FIG.2A, the foam layer 132 can extend between the wire core 130 and the cover 134 along the entire length of the coil 102 or along portions of the coil 102.

[0108] In some examples, the docking device 100 can be implanted at a native mitral valve such that a ventricular portion 120 of the coil 102 is disposed in the left ventricle on the outflow side of the native mitral valve and an atrial portion 122 of the coil 102 is disposed in the left atrium on the inflow side of the native mitral valve. FIG.3 shows the docking device 100 implanted at the native mitral valve 16 of the patient 10 shown in FIGS.1A-1F, where the mitral valve 16 is shown from above in the left atrium 18.

[0109] In some examples, the ventricular portion 120 disposed within the left ventricle 26 can comprise the leading turn 106 and portions of the central region 108 of the coil 102. The atrial portion 122 disposed within the left atrium 18 can comprise the stabilization turn 110 and the ascending portion 112 of the coil 102. In some examples, as shown in FIG.3, the atrial portion 122 can further comprise a portion of the central region 108 of the coil 102. As illustrated in FIGS.2 and 3, a transition region 124 of the coil 102 can extend from theventricular portion 120 of the coil 102 to the atrial portion 122 of the coil 102. The transition region 124 can be arranged to extend across or adjacent a native commissure of the native valve, such as the medial commissure 17 as shown for example in FIG.3 or, in other examples, the lateral commissure 19. In some examples, the transition region 124 can comprise at least a portion of the proximal turn 108p.

[0110] As introduced above, it is advantageous in some instances to seal gaps or spaces that can form between a native commissure and a docking device to minimize or eliminate leakage through the native commissure when the docking device is implanted. As seen in FIGS.2 and 3, the sealing member 104 can be configured to extend along at least the transition region 124 of the coil 102 and can comprise a plurality of filaments 140 extending radially outward along an outer surface of the coil 102.

[0111] The plurality of filaments 140 can be made of a flexible biocompatible material. In some examples, the filaments can be made of a polymeric material that can allow the plurality of filaments 140 to deflect and conform to adjacent structures. The polymeric material can be, for example, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide, polypropylene, polyurethane (such as thermoplastic polyurethane (TPU)), or any combination thereof. The plurality of filaments 140 can be arranged to contact adjacent tissue of the native commissure 17, as seen in FIG.3. For example, the sealing member 104 comprising filaments 140 can be arranged on a portion of the proximal turn 108p in the central region 108 of the coil 102. More specifically, as seen in FIG.2, the sealing member 104 can be arranged to extend over at least a portion of the proximal turn 108p directly adjacent the ascending portion 112 of the coil 102. In this way, as seen in FIG.3, the sealing member 104 comprising filaments 140 can be disposed within the native commissure 17 when the docking device 100 is implanted. Although the sealing member 104 is shown extending through the medial commissure in FIG. 3, the transition region 124 and thus the sealing member 104 can be configured to extend through the lateral commissure of the native valve in some instances.

[0112] The sealing member 104 can be arranged to extend at least around a portion of the coil 102 extending between the left ventricle and the left atrium (i.e., across or adjacent a native commissure). In some examples, the sealing member 104 can extend 180-400 degreesor 200-380 or 250-380 degrees around the central, longitudinal axis 109 of the coil 102 along the transition region 124.

[0113] In some examples, the sealing member can extend 320-360 degrees around the central, longitudinal axis 109 of the coil 102 along the transition region 124.

[0114] In some examples, the sealing member can extend 340-380 degrees around the central, longitudinal axis 109 of the coil 102 along the transition region 124.

[0115] In the example shown in FIGS.2 and 2A, the plurality of filaments 140 can be arranged to extend radially outward directly from the cover 134. In some examples, the cover 134 can be made from a fabric material and the plurality of filaments 140 can be part of or integrally formed with the fabric of the cover 134. Stated another way, in some examples, the plurality of filaments 140 can be fibers integrated (e.g., woven or interlaced) into the fabric of the cover 134. In other examples, the plurality of filaments 140 can be separate elements that are bonded (e.g., ultrasonically welded), glued, sutured, and / or otherwise coupled to the cover 134.

[0116] As seen schematically in FIGS.4A-4D, each of the plurality of filaments can have a base 142, a tip 144, a diameter D, and a length L extending from the base 142 to the tip 144, where the base 142 is disposed at a coupling surface S (e.g., an outer surface of the cover 134).

[0117] In some examples, as illustrated schematically in FIG.4A, a plurality of filaments 140a can have a substantially constant (i.e., within 5%) length Lc along a sealing member.

[0118] In some examples, as seen schematically in FIG.4B, a plurality of filaments 140b can have a length Lv that varies along a sealing member. For instance, the length Lv can be greatest at a central region of the sealing member and can decrease toward end regions of the sealing member. In some examples, the length Lv can be greatest at an end region of the sealing member. In some examples, the length Lv can be arranged in various patterns (e.g., long-short-long-short) or can be random.

[0119] In some examples, a diameter Dc of each of the plurality of filaments 140a, 140b can be substantially constant (i.e., within 5%) from the base 142 to the tip 144 as schematically shown in FIGS.4A-4B. In some examples, the diameter Dc of the plurality of filaments 140a, 140b can be substantially the same (i.e., within 5%) along a sealing member. In otherwords, the diameter Dc of the plurality of filaments 140a, 140b can be the same in all regions of the sealing member.

[0120] In some examples, a diameter Dt of a plurality of filaments 140c can taper from the base 142 to the tip 144 as schematically illustrated in FIG.4C.

[0121] In additional or alternative examples, a diameter Dv of a plurality of filaments 140d can vary along a sealing member as schematically shown in FIG.4D. Stated another way, each filament 140d can have the same diameter from base 142 to tip 144 but the diameter can vary from filament 140d to filament 140d. For instance, the plurality of filaments 140d can be arranged such that a filament 140d at a central region of the sealing member has the greatest diameter while a filament 140d at end regions of the sealing member has the smallest diameter.

[0122] The length L (e.g., Lc and Lv) and the diameter D (e.g., Dc, Dt, and Dv) of each of the plurality of filaments 140a-140d can be sized to facilitate the filling of any gaps or spaces that may exist between the docking device 100 and the native anatomy and to promote tissue ingrowth. For example, the length L and diameter D of each of the plurality of filaments 140a-140d can be specified such that individual filaments can fold over and deflect to fill gaps and voids.

[0123] The density of the filaments 140a-140d along a sealing member can be specified to fill gaps or spaces. In some examples, a density of the plurality of filaments 140a-140d can be substantially the same (i.e., within 5%) along the sealing member. In other examples, a density of the plurality of filaments 140a-140d can vary along the sealing member. For example, a density of filaments 140a-140d can be greatest in a central region of the sealing member and thin out toward end regions. In another example, a density of filaments 140a- 140d can be greatest in the end regions of the sealing member.

[0124] In some examples, a density of the plurality of filaments 140a-140d can be related to a diameter of the filaments 140a-140d. For example, the density of the filaments 140a-140d can be inversely related to the diameter. That is, the smaller the diameter of the filaments 140a-140d, the higher density of the filaments 140a-140d, and vice-versa. Although FIGS. 4A-4D show specific arrangements of filaments, it is appreciated that any combination of filament length, density, and / or diameter can be specified.

[0125] Referring again to FIGS.2-3, the plurality of filaments 140 of the sealing member 104 can be arranged on an exterior facing, outer surface of the coil 102 such that the filaments 140 extend in a radially outward configuration from the coil 102. The filaments 140 extending radially outward from the coil 102 can be configured to move independently of and without influence from other filaments 140 in the sealing member 104. In this way, each of the plurality of filaments 140 can individually and / or locally conform to an immediately adjacent native anatomy. More specifically, as seen in FIG.3, the plurality of filaments 140 can be configured to fill in localized gaps and spaces that may exist between the docking device 100 and the native commissure 17. As such, the plurality of filaments 140 can, as introduced above in some instances, reduce or eliminate leakage through the native commissure 17.

[0126] Although FIG.3 shows the docking device 100 comprising the sealing member 104 implanted within the mitral valve, it is understood that any sealing member described herein could be similarly implanted and result in comparable reduction or elimination of leakage. FIG.5 shows a docking device 200 comprising the coil 102 of FIG.2 and a sealing member 204, according to another example. The sealing member (also may be referred to a “paravalvular leak (PVL) guard”) 204 of FIG.5 has a similar configuration as the sealing member 104 of the example in FIG.2, except the sealing member 204 further comprises an attachment member (e.g., a sleeve 238) to which a plurality of filaments 240 is coupled. The sleeve 238 can be arranged to extend circumferentially around and axially along at least the transition region 124 described above in connection with FIGS.2 and 3. In some examples, the coil 102 comprises the cover 134 and the sleeve 238 can be arranged to extend over the cover 134 as shown in FIG.5A. In some examples, the attachment member can be a patch or a panel that does not completely circumscribe the coil.

[0127] In the example shown in FIGS.5 and 5A, the plurality of filaments 240 can be arranged to extend radially outward directly from the sleeve 238. In some examples, the sleeve 238 can be made from a fabric material and the plurality of filaments 240 can be part of or integrally formed with the fabric of the sleeve 238. Stated another way, in some examples, the plurality of filaments 240 can be fibers integrated (e.g., woven or interlaced) into the fabric of the sleeve 238. In other examples, the plurality of filaments 240 can be separate elements that are bonded (e.g., ultrasonically welded), glued or otherwise adhered tothe sleeve 238. The plurality of filaments 240 can be configured to extend radially outward therefrom as shown in FIGS.5-5A.

[0128] Each of the plurality of filaments 240 can have a base 242, a tip 244, a diameter D, and a length L extending from the base 242 to the tip 244, where the base 242 is disposed at a coupling surface S (e.g., an outer surface of the sleeve 238) as seen in FIGS.4A-4D. The length L, diameter D, and density of the plurality of filaments 240 can be arranged in the same manner as the length L, diameter D, and density of the plurality of filaments 140 described above and in connection with FIGS.4A-4D. In this way, the description regarding the plurality of filaments 140a-140d applies to a plurality of filaments 240a-240d. The length L (e.g., Lc and Lv) and diameter D (e.g., Dc, Dt, and Dv) of each of the plurality of filaments 240a-240d can be sized to facilitate the filling of any gaps or spaces that may exist between the docking device 200 and the adjacent native anatomy and to promote tissue ingrowth therebetween. For example, the length L and diameter D of each of the plurality of filaments 240a-240d can be specified such that individual filaments can fold over and deflect to fill gaps and voids. It is appreciated that any combination of filament length, density and / or diameter can be specified for the sealing member 204, or any sealing member described herein, to optimize sealing.

[0129] Because the sealing member 204 comprises the sleeve 238 to which the filaments 240 are coupled, the sealing member 204 can be fabricated separately and independently from the coil 102 and fixedly secured thereto (i.e., in some examples, secured to the cover 134) by suturing, bonding, and / or an adhesive or other means for coupling via a separate step. In this way, fabrication of the coil 102 and the sealing member 204 can be simplified. Additionally (or alternatively), by fabricating the sealing member 204 as a modular component comprising the sleeve 238 and the plurality of filaments 240, the sealing member 204 can be advantageously applied to any docking device.

[0130] In lieu of the docking device 100, the docking device 200 can be implanted at the native mitral valve 16 shown in FIG.3 such that the sealing member 204 extends across the native commissure 17 (or, alternatively, the native commissure 19). Like the sealing member 104 shown in FIGS.2-3, each of the plurality of filaments 240 of the sealing member 204 can individually and locally conform to the immediately adjacent native anatomy, filling in localized gaps and spaces that may exist between the docking device 200 and the nativecommissure 17. As such, the plurality of filaments 240 can similarly reduce or eliminate leakage through the native commissure 17 as described above.

[0131] In some examples, a sealing member extending across or adjacent a native commissure can be configured with additional conformal features arranged to adapt to the adjacent native anatomy. FIGS.6A-6B show a portion of a docking device 300 comprising a sealing member (also may be referred to a “paravalvular leak (PVL) guard”) 304 disposed over the transition region 124 of the coil 102, according to another example, where the coil is 102 depicted in a straightened or delivery configuration for illustration purposes. The sealing member 304 comprises an expandable member 338 and, in some examples, a plurality of filaments 340, as will be discussed in more detail below.

[0132] In some examples, the expandable member 338 can be made from shape set material such that the sealing member 304 can move from a first configuration as shown in FIG.6A to a second configuration as shown in FIG.6B when the coil 102 is deployed at an implantation site. In some instances, the expandable member 338 can comprise a mesh and / or braided material. In some examples, the expandable member 338 can comprise a cover (e.g., a cover made of polyethylene terephthalate (PET)). Details of the expandable member 338, including example materials, construction, and deployment, are described in U.S. Publication No. 2023 / 0255754 and U.S. Publication No.2023 / 0255755.

[0133] The expandable member 338 has a distal end 354, a proximal end 356, a central region 357, and a length 360a extending from the distal end 354 to the proximal end 356 when the expandable member 338 is in the first configuration illustrated in FIG.6A. As seen in FIG.6A, in the first configuration, the expandable member 338 forms an axially lengthened and radially compacted shape having a central diameter 358 at the central region 357 that tapers from the central diameter 358 to the distal and proximal ends 354, 356 on either side. In some examples, the expandable member 338 can have a substantially cylindrical shape when in the first configuration. Relative to the configuration depicted in FIG.6A, the expandable member 338 can be further radially compressed and axially elongated (for example, to fit within the sleeve shaft 420 of the delivery apparatus 400).

[0134] When the coil returns to its pre-formed, coiled shape as the docking device 300 is implanted at the implantation site, the expandable member 338 axially foreshortens andradially expands to the second configuration shown in FIG.6B. That is, the axial foreshortening of the expandable member 338 results in radial expansion of specified regions of the expandable member 338. In some examples, the expandable member 338 can have a substantially hourglass shape when in the second configuration.

[0135] Although the coil 102 is shown in FIG.6B in a straightened state for purposes of illustration, the coil 102 comprises a helical, deployed form when the expandable member 338 is expanded.

[0136] In the second configuration of FIG.6B, the expandable member 338 has a length 360b extending from the distal end 354 to the proximal end 356, where the length 360b is less than the length 360a in the first configuration shown in FIG.6A. In some examples, the length 360b can be 50-90% of the length 360a of the first configuration of FIG.6A. In some examples, the length 360b can be 50-75% of the length 360a of the first configuration of FIG. 6A.

[0137] In place of the docking devices 100, 200, the docking device 300 can be implanted at the native mitral valve 16 shown in FIG.3 such that the sealing member 304 extends across the native commissure 17 (or, alternatively, the native commissure 19). The radial expansion of the expandable member 338 in the second configuration of FIG.6B can result in the formation of an atrial ledge 360, a ventricular ledge 362, and a necked region 364 extending between the atrial ledge 360 and the ventricular ledge 362. The ledges 360, 362 can also be referred to as “flanges” or “shoulders.” The necked region 364 can be disposed along the native commissure 17 such that an inner surface 363 of the atrial ledge 360 contacts an atrial portion of the adjacent native tissue on the inflow side of the native commissure 17 and an inner surface 365 of the ventricular ledge 362 contacts a ventricular portion of the adjacent native tissue on the outflow side of the native commissure 17. In this way, the atrial and ventricular ledges 360, 362 can conform to and seal around contours of the native commissure.

[0138] The atrial and ventricular ledges 360, 362 can have respective diameters 366, 368 and the necked region 364 can have a diameter 370.

[0139] In some examples, the diameters 366, 368 can be the same as each other. In some examples, the diameters 366, 368 can be different from each other. In some examples, thediameter 366 can be larger than the diameter 368. In some examples, the diameter 366 can be smaller than the diameter 368.

[0140] In some examples, the diameters 366, 368 can be 1.5-2.5 times larger than the central diameter 358 of the expandable member 338 in the first configuration.

[0141] In some examples, the diameters 366, 368 can be 2-4 times the diameter 370 of the necked region 364 in the second configuration. The diameters 366, 368 of the atrial and ventricular ledges 360, 362 and the diameter 370 of the necked region 364 can be specified to maximize contact with portions of the native anatomy at the native commissure for optimal sealing. In some examples, expansion of the expandable member 338 and the diameters 366, 368, 370 can be adjusted in situ to appropriately conform to a specific native anatomy at an implantation site. In other words, the expandable member 338 can have more or less expansion according to the specific native anatomy in which it is implanted.

[0142] In some examples, the sealing member 304 can optionally comprise a plurality of filaments 340 coupled to at least a portion of the expandable member 338, as shown in FIGS. 6A-6B. The plurality of filaments 340 can be arranged on portions of the expandable member 338 that form at least one of the necked region 364, the atrial ledge 360, and / or the ventricular ledge 362 when the expandable member 338 is in the second configuration of FIG.6B.

[0143] Each of the plurality of filaments 340 can have a base 342, a tip 344, a diameter D, and a length L extending from the base 342 to the tip 344, where the base 342 is disposed at a coupling surface S (e.g., an outer surface of the expandable member 338) as seen in FIGS. 4A-4D. The length L, diameter D, and density of the plurality of filaments 340 can be arranged in the same manner as the length L, diameter D, and density of the plurality of filaments 140 described above and in connection with FIGS.4A-4D. In this way, the description regarding the plurality of filaments 140a-140d applies to a plurality of filaments 340a-340d. The length L (e.g., Lc and Lv) and the diameter D (e.g., Dc, Dt, and Dv) of each of the plurality of filaments 340a-340d can be sized to facilitate the filling of any gaps or spaces that may exist between the docking device 300 and the adjacent native anatomy and to promote tissue ingrowth therebetween. For example, the length L and diameter D of each of the plurality of filaments 340a-340d can be specified such that individual filaments can foldover and deflect to fill gaps and voids. It is appreciated that any combination of filament length, density and / or diameter can be specified for the sealing member 304, or any sealing member described herein.

[0144] In same manner, the plurality of filaments 340 can individually and locally conform to adjacent native anatomy, filling in localized gaps and spaces that may exist between the atrial and ventricular ledges 360, 362 and an adjacent native commissure. As such, the plurality of filaments can, as introduced above in some instances, further reduce or eliminate leakage through the native commissure.

[0145] Although the sealing members 104, 204, and 304 are shown and described as coupled to the coil 102, any sealing member described herein, can be applied to any coil forming a docking device. For example, a coil for a docking device can comprise one or more helical turns without any one or more of a leading turn, an ascending portion, and / or a stabilization turn. In other words, a coil for a docking device can comprise the central region 108 of the coil 102 described above, omitting any one or more of the leading turn 106, the ascending portion 112, and / or the stabilization turn 110 shown in FIGS.2 and 5. In some examples, a coil for a docking device comprising any of the sealing members described herein can be configured to extend from a proximal dashed line 150 to a distal dashed line 152, as shown in FIGS.2 and 5. Exemplary Delivery Apparatus

[0146] FIG.7 shows a delivery apparatus 400 configured to deliver and implant the docking device 100, schematically shown, at a target implantation site in a patient, according to an example. Although the docking device 100 is shown coupled to the delivery apparatus 400 in FIG.7, it is understood that the delivery apparatus 400 can be used with any docking device described herein, such as for example, docking devices 52, 200, 300 described above or other docking devices. Thus, the delivery apparatus 400 can also be referred to as a “dock delivery catheter” or “dock delivery system.” In some examples, the delivery apparatus 400 can be used in lieu of the docking device delivery apparatus 50 shown in connection with the procedure illustrated in FIG.1B.

[0147] As shown, the delivery apparatus 400 can include a handle assembly 402 and an outer shaft 404 extending distally from the handle assembly 402. The handle assembly 402 caninclude a handle 406 including one or more knobs, buttons, wheels, or the like. For example, in some examples, as shown in FIG.7, 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 outer shaft 404 and / or a sleeve shaft 420 described below.

[0148] In certain examples, the delivery apparatus 400 can also include a pusher shaft 412. The pusher shaft 412 and the sleeve shaft 420 can both extend through an inner lumen of the outer shaft 404 and have portions extending into the handle assembly 402. The sleeve shaft 420 can be configured to cover (e.g., surround) the docking device 100 and, together, the pusher shaft 412 and sleeve shaft 420 can be configured to deploy the docking device 100 from the outer shaft 404, upon reaching the target implantation site.

[0149] In certain examples, the pusher shaft 412 and sleeve shaft 420 can be coaxial with one another, at least within the outer shaft 404. In some examples, a distal end of the pusher shaft 412 can be inserted into a lumen of the sleeve shaft 420 and pressed against a proximal end of the docking device 100 retained inside the shaft 404 Thus, after reaching the target implantation site, the docking device 100 can be deployed by manipulating the pusher shaft 412 and sleeve shaft 420 using a hub assembly 418.

[0150] During delivery, the docking device 100 can be coupled to the delivery apparatus 400 via a release suture 414 (or other retrieval line comprising a string, yarn, or other material that can be configured to be tied around the docking device 100 and removed for release) that extends through the pusher shaft 412. In one specific example, the release suture 414 can extend through the delivery apparatus 400, through an inner lumen of the pusher shaft 412, to a suture lock assembly 416 of the delivery apparatus 400.

[0151] The handle assembly 402 can further include a hub assembly 418 to which the suture lock assembly 416 and a sleeve handle 424 are attached. 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. In this way, operation of the various components of the handle assembly 402 can actuate and control operation of the components arranged within the outer shaft 404. In some examples, the hub assembly 418 can be coupled to the handle 406 via a connector 426.

[0152] The handle assembly 402 can further include one or more flushing ports (e.g., three flushing ports 432, 436, 438 are shown in FIG.7) 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). Further details of the docking device delivery apparatus and its components and methods of use are described in PCT Publication Nos. WO2022 / 087336 and WO2020 / 0247907. Delivery Techniques

[0153] 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 (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.

[0154] 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 aortic valve. Additionally (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 surgicalincision 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.

[0155] 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.

[0156] 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.

[0157] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art. Sterilization

[0158] 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 / thermalsterilization 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

[0159] 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

[0160] 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.

[0161] Example 1. A docking device for a prosthetic implant, the docking device comprising: a coil comprising a plurality of turns defining: a ventricular portion of the coil; an atrial portion of the coil; and a transition region extending from the ventricular portion of the coil to the atrial portion of the coil; and a sealing member coupled to the transition region of the coil and comprising a plurality of filaments extending radially outward from the coil.

[0162] Example 2. The docking device of any example herein, particularly example 1, further comprising a cover extending over the coil from a proximal end portion of the coil to a distal end portion of the coil, wherein the plurality of filaments is coupled to the cover and extends radially outward therefrom.

[0163] Example 3. The docking device of any example herein, particularly example 1, wherein the sealing member further comprises a sleeve disposed over at least the transition region of the coil, and wherein the plurality of filaments is coupled to the sleeve and extends radially outward therefrom.

[0164] Example 4. The docking device of any example herein, particularly example 3, further comprising a cover extending over the coil from a proximal end portion of the coil to a distal end portion of the coil, wherein the sleeve extends over the cover and is fixedly secured thereto.

[0165] Example 5. The docking device of any example herein, particularly example 4, wherein the sleeve is fixedly secured to the cover by suturing, bonding, or an adhesive.

[0166] Example 6. The docking device of any example herein, particularly example 1, wherein the sealing member further comprises a expandable member extending over at least the transition region of the coil, wherein the expandable member is configured to move from a first configuration to a second configuration, wherein, in the first configuration, the expandable member forms an axially lengthened and radially compacted shape, and in the second configuration, the expandable member forms an axially foreshortened and radially extended shape defining an atrial ledge, a ventricular ledge, and a necked region extending between the atrial ledge and the ventricular ledge, and wherein the plurality of filaments is coupled to at least a portion the necked region of the expandable member and extends radially outward from the coil.

[0167] Example 7. The docking device of any example herein, particularly example 6, wherein the expandable member forms a cylindrical or an at least substantially cylindrical shape in the first configuration.

[0168] Example 8. The docking device of any example herein, particularly any one of examples 6-7, wherein the expandable member forms an hourglass shape or an at least substantially hourglass shape in the second configuration.

[0169] Example 9. A docking device for a prosthetic implant, the docking device comprising: a coil comprising a plurality of turns; and a sealing member coupled to the coil and comprising a plurality of filaments, wherein the plurality of filaments extends radially outward from the coil along at least a portion of the plurality of turns.

[0170] Example 10. The docking device of any example herein, particularly example 9, wherein the plurality of turns revolves around a central, longitudinal axis, and wherein the plurality of filaments extends greater than 250 degrees and less than 380 degrees circumferentially around the central, longitudinal axis of the coil.

[0171] Example 11. The docking device of any example herein, particularly any one of examples 9-10, wherein the plurality of filaments comprises a flexible and biocompatible polymeric material.

[0172] Example 12. A docking device for securing a prosthetic implant at an implantation site, the docking device comprising: a coil comprising a plurality of turns; and a sealing member coupled to the coil and comprising a plurality of filaments extending radially outward from the coil, wherein the plurality of filaments is arranged to extend within a space between the docking device and an adjacent native anatomy at the implantation site to prevent leakage around the docking device.

[0173] Example 13. The docking device of any example herein, particularly example 12, wherein the implantation site is a native valve and the adjacent native anatomy is an adjacent native commissure of the native valve, wherein the plurality of filaments extends within the space between the docking device and the native commissure.

[0174] Example 14. The docking device of any example herein, particularly any one of examples 12-13, wherein the plurality of turns defines a central, longitudinal axis of the coil, and wherein the plurality of filaments extends greater than 250 degrees and less than 380 degrees circumferentially around the central, longitudinal axis of the coil.

[0175] Example 15. A docking device for a prosthetic implant, the docking device comprising: a coil comprising a plurality of turns defining: a ventricular portion of the coil; an atrial portion of the coil; and a transition region extending from the ventricular portion of the coil to the atrial portion of the coil; a cover extending over the coil from a proximal end portion of the coil to a distal end portion of the coil; and a sealing member disposed over the cover along at least the transition region of the coil, wherein sealing member comprises a plurality of filaments integrated into the cover and extending radially outward from the coil.

[0176] Example 16. The docking device of any example herein, particularly example 15, wherein the cover comprises a fabric.

[0177] Example 17. The docking device of any example herein, particularly any one of examples 15-16, wherein the plurality of turns defines a central, longitudinal axis of the coil, and wherein the plurality of filaments extends greater than 250 degrees and less than 380 degrees circumferentially around the central, longitudinal axis of the coil.

[0178] Example 18. A docking device for a prosthetic implant, the docking device comprising: a coil having a central, longitudinal axis and comprising a plurality of turns defining: a ventricular portion of the coil; an atrial portion of the coil; and a transition region extending from the ventricular portion of the coil to the atrial portion of the coil; and a sealing member disposed along at least the transition region of the coil, wherein sealing member comprises a sleeve extending over the coil and a plurality of filaments coupled to the sleeve and extending radially outward from the coil, and wherein the sleeve extends greater than 250 degrees and less than 380 degrees circumferentially around the central, longitudinal axis of the coil.

[0179] Example 19. The docking device of any example herein, particularly example 18, wherein the sleeve extends 320-360 degrees circumferentially around the central, longitudinal axis of the coil.

[0180] Example 20. The docking device of any example herein, particularly any one of examples 18-21, wherein the sleeve is fixedly secured to the coil by suturing, bonding, or an adhesive.

[0181] Example 21. The docking device of any example herein, particularly any one of examples 18-20, wherein the sleeve comprises a fabric.

[0182] Example 22. A docking device for a prosthetic implant, the docking device comprising: a coil comprising a plurality of turns defining: a ventricular portion of the coil; an atrial portion of the coil; and a transition region extending from the ventricular portion of the coil to the atrial portion of the coil; and a sealing member comprising an expandable member extending over at least the transition region of the coil, wherein the expandable member is configured to move from a first configuration to a second configuration, wherein, in the first configuration, the expandable member forms an axially lengthened and radially compacted shape, and in the second configuration, the expandable member forms an axially foreshortened and radially extended shape.

[0183] Example 23. The docking device of any example herein, particularly example 22, wherein the expandable member forms a cylindrical or an at least substantially cylindrical shape in the first configuration.

[0184] Example 24. The docking device of any example herein, particularly any one of examples 22-23, wherein the expandable member forms an hourglass shape or an at least substantially hourglass shape in the second configuration.

[0185] Example 25. The docking device of any example herein, particularly any one of examples 22-24, wherein the axially foreshortened and radially extended shape defines an atrial ledge, a ventricular ledge, and a necked region extending between the atrial ledge and the ventricular ledge, and wherein the necked region is disposed along a native valve commissure when the docking device is implanted.

[0186] Example 26. The docking device of any example herein, particularly example 25, wherein the sealing member further comprises a plurality of filaments coupled to at least the necked region of the expandable member and extending radially outward from the coil.

[0187] Example 27. The docking device of any example herein, particularly any one of examples 22-26, wherein at least a portion of the expandable member is fixedly secured to the coil by suturing, bonding, or an adhesive.

[0188] Example 28. The docking device of any example herein, particularly any one of examples 25-27, wherein an outer diameter of the atrial ledge, an outer diameter of the ventricular ledge, or the outer diameters of both the atrial and ventricular ledges are 3-5 times larger than a diameter of the necked region of the expandable member.

[0189] Example 29. A method of implanting the docking device of any example herein, particularly any one of examples 1-28, comprising positioning the sealing member adjacent a native commissure of a native valve.

[0190] Example 30. A method comprising sterilizing the docking device, sealing member, apparatus, and / or assembly of any example.

[0191] Example 31. A method of implanting the docking device 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).

[0192] Example 32. A docking device of any one of examples 1-28 wherein the docking device, sealing member, apparatus, and / or assembly is sterilized.

[0193] 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 sealing member can be combined with any one or more features of another sealing member.

[0194] 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 docking device for a prosthetic implant, the docking device comprising: a coil comprising a plurality of turns defining: a ventricular portion of the coil; an atrial portion of the coil; and a transition region extending from the ventricular portion of the coil to the atrial portion of the coil; and a sealing member coupled to the transition region of the coil and comprising a plurality of filaments extending radially outward from the coil.

2. The docking device of claim 1, further comprising a cover extending over the coil from a proximal end portion of the coil to a distal end portion of the coil, wherein the plurality of filaments is coupled to the cover and extends radially outward therefrom.

3. The docking device of claim 1, wherein the sealing member further comprises a sleeve disposed over at least the transition region of the coil, and wherein the plurality of filaments is coupled to the sleeve and extends radially outward therefrom.

4. The docking device of claim 3, further comprising a cover extending over the coil from a proximal end portion of the coil to a distal end portion of the coil, wherein the sleeve extends over the cover and is fixedly secured thereto.

5. The docking device of claim 4, wherein the sleeve is fixedly secured to the cover by suturing, bonding, or an adhesive.

6. The docking device of claim 1, wherein the sealing member further comprises an expandable member extending over at least the transition region of the coil, wherein the expandable member is configured to move from a first configuration to a second configuration,wherein, in the first configuration, the expandable member forms an axially lengthened and radially compacted shape, and in the second configuration, the expandable member forms an axially foreshortened and radially extended shape defining an atrial ledge, a ventricular ledge, and a necked region extending between the atrial ledge and the ventricular ledge, and wherein the plurality of filaments is coupled to at least a portion the necked region of the expandable member and extends radially outward from the coil.

7. The docking device of claim 6, wherein the expandable member forms a cylindrical or an at least substantially cylindrical shape in the first configuration.

8. The docking device of any one of claims 6-7, wherein the expandable member forms an hourglass shape or an at least substantially hourglass shape in the second configuration.

9. A docking device for securing a prosthetic implant at an implantation site, the docking device comprising: a coil comprising a plurality of turns; and a sealing member coupled to the coil and comprising a plurality of filaments extending radially outward from the coil, wherein the plurality of filaments is arranged to extend within a space between the docking device and an adjacent native anatomy at the implantation site to prevent leakage around the docking device.

10. The docking device of claim 9, wherein the implantation site is a native valve and the adjacent native anatomy is an adjacent native commissure of the native valve, wherein the plurality of filaments extends within the space between the docking device and the native commissure.

11. The docking device of any one of claims 9-10, wherein the plurality of turns defines a central, longitudinal axis of the coil, and wherein the plurality of filaments extendsgreater than 250 degrees and less than 380 degrees circumferentially around the central, longitudinal axis of the coil.

12. A docking device for a prosthetic implant, the docking device comprising: a coil comprising a plurality of turns defining: a ventricular portion of the coil; an atrial portion of the coil; and a transition region extending from the ventricular portion of the coil to the atrial portion of the coil; and a sealing member comprising an expandable member extending over at least the transition region of the coil, wherein the expandable member is configured to move from a first configuration to a second configuration, wherein, in the first configuration, the expandable member forms an axially lengthened and radially compacted shape, and in the second configuration, the expandable member forms an axially foreshortened and radially extended shape.

13. The docking device of claim 12, wherein the expandable member forms a cylindrical or an at least substantially cylindrical shape in the first configuration.

14. The docking device of any one of claims 12-13, wherein the expandable member forms an hourglass shape or an at least substantially hourglass shape in the second configuration.

15. The docking device of any one of claims 12-14, wherein the axially foreshortened and radially extended shape defines an atrial ledge, a ventricular ledge, and a necked region extending between the atrial ledge and the ventricular ledge, and wherein the necked region is disposed along a native valve commissure when the docking device is implanted.

16. The docking device of claim 15, wherein the sealing member further comprises a plurality of filaments coupled to at least the necked region of the expandable member and extending radially outward from the coil.

17. The docking device of any one of claim 12-16, wherein at least a portion of the expandable member is fixedly secured to the coil by suturing, bonding, or an adhesive.

18. The docking device of any one of claims 15-17, wherein an outer diameter of the atrial ledge, an outer diameter of the ventricular ledge, or the outer diameters of both the atrial and ventricular ledges are 3-5 times larger than a diameter of the necked region of the expandable member.

19. A method of implanting the docking device of any one of claims 1-18 comprising positioning the sealing member adjacent a native commissure of a native valve.

Images