Devices and methods for reducing paravalvular leakage

Abstract

The present disclosure is directed to a docking device for a prosthetic heart valve. The docking device includes an inflow end, an outflow end, a support structure disposed between the inflow and outflow ends, and an expandable sleeve. The support structure includes an inflow section and an outflow section configured to be positioned on the inflow and outflow sides of a native heart valve, respectively. The outflow section includes a first portion, a second portion, and a third portion, the first portion being disposed closer to the inflow section than the second portion, and the third portion being disposed between the first and second portions. The expandable sleeve can extend at least 100 degrees over the first portion of the outflow section of the support structure. Additionally or alternatively, the first portion of the outflow section of the support structure can have a different geometric shape than the third portion.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 107,245, filed October 29, 2020, which is incorporated herein by reference.

[0002] The present disclosure relates to systems and devices for reducing paravalvular leakage, and in particular to a docking device for a prosthetic valve configured to improve the seal between the tissue of a native heart valve and the prosthetic valve. [Background technology]

[0003] Native heart valves (e.g., aortic, pulmonary, tricuspid, and mitral valves) regulate blood flow in the human body by temporarily opening to allow forward blood flow and then closing to prevent backward blood flow (or backflow). However, various congenital, inflammatory, infectious, and / or other pathological conditions can cause these native heart valves to malfunction. For example, a defective native heart valve may not close completely as it should, thereby resulting in some degree of unwanted backflow of blood. As another example, calcium deposits can accumulate around a native heart valve, thereby narrowing the valve opening (referred to as "stenosis") and restricting blood flow through the valve. Such a condition ultimately leads to serious malfunction of the heart, necessitating repair and / or replacement of the native valve. For many years, physicians have attempted to repair and / or replace defective heart valves through open-heart surgery.

[0004] However, due to the risks and complications of open-heart surgery, less invasive transcatheter procedures have been developed that access the heart indirectly via blood vessels. Typically, these transcatheter procedures replace a defective native heart valve with a prosthetic valve advanced into the heart through a vein or artery. Therefore, instead of opening the entire chest cavity as in open-heart surgery, these transcatheter procedures require only a small incision in or near a blood vessel. For example, in one transcatheter technique, a user (e.g., a surgeon) may make a small incision in the patient's groin to access the femoral vein or artery and advance a transcatheter heart valve (THV) on a catheter through the blood vessel until the THV reaches the defective native heart valve. Once the THV reaches the defective native valve, it can then be expanded to its functional size. The prosthetic heart valve can be expanded to its functional size using various methods, including an inflatable balloon, a self-expanding frame, and / or a mechanically expandable frame. Such transcatheter approaches are much less invasive than open-heart surgery and can reduce and / or avoid the risks and complications associated with open-heart surgery.

[0005] However, in some cases, the implantation or deployment site (e.g., the annulus of the native heart valve) itself may not provide a good valve seat for the THV. Additionally or alternatively, in some cases, the shape of the native annulus may differ from the shape of the prosthetic heart valve. As a result, the prosthetic heart valve may not be securely fixed to the native tissue and / or paravalvular leak (PVL) may occur between the prosthetic heart valve and the native tissue. Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, devices and methods for anchoring prosthetic heart valves to native tissue and / or reducing PVL are desirable. [Means for solving the problem]

[0007] The present disclosure relates to devices and methods for reducing paravalvular leakage. In particular, the present disclosure is directed to a docking device for a prosthetic heart valve configured to reduce PVL between the prosthetic heart valve and native tissue.

[0008] In one exemplary embodiment, a docking device for a prosthetic heart valve includes an inflow end, an outflow end, a support structure, and an expandable sleeve covering at least a portion of the support structure. The support structure is disposed between the inflow and outflow ends of the docking device and includes an inflow section and an outflow section. The inflow section extends from the inflow end of the docking device toward the outflow end of the docking device and is configured to be positioned on the inflow side of the native heart valve. The outflow section extends between the outflow end of the docking device and the inflow section of the support structure and is configured to be positioned on the outflow side of the native heart valve. The outflow section includes a first portion, a second portion, and a third portion. The first portion of the outflow section extends distally from the inflow section to the third portion, the third portion extends distally from the first portion to the second portion, and the second portion extends distally from the third portion to the outflow end of the docking device. The expandable sleeve is movable from a compressed position to an expanded position when the crimping pressure is released, wherein in the expanded position the expandable sleeve extends at least 100 degrees over a first portion of the outflow section of the support structure.

[0009] In another exemplary embodiment, a docking device for a prosthetic heart valve includes an atrial end, a ventricular end, a support structure disposed between the atrial end and the ventricular end, and an expandable sleeve covering at least a portion of the support structure. The support structure includes an atrial section and a ventricular section. The atrial section extends from the atrial end of the docking device toward the ventricular end of the docking device and is configured to be positioned on the atrial side of the native mitral valve. The ventricular section extends from the ventricular end of the docking device toward the atrial end of the docking device and is configured to be positioned on the ventricular side of the native mitral valve. The ventricular section further includes a first rotating portion, a second rotating portion, and one or more intermediate rotating portions. The first rotating portion is disposed closer to the atrial section than the second rotating portion, and the one or more intermediate rotating portions are disposed between the first rotating portion and the second rotating portion. The support structure is further configured to move from a delivery configuration to a deployed configuration when the support structure is released from a delivery device of the docking device. In the deployed configuration, the first rotating section has a different geometry than one or more of the intermediate rotating sections.

[0010] In yet another exemplary embodiment, a prosthetic heart valve assembly includes a docking device and a prosthetic heart valve disposed within the docking device. The docking device includes an atrial end, a ventricular end, a support structure, and an expandable sleeve covering at least a portion of the support structure. The support structure is disposed between the atrial and ventricular ends of the docking device and includes an atrial section and a ventricular section. The atrial section extends from the atrial end of the docking device toward the ventricular end of the docking device and is configured to be positioned on the atrial side of the native mitral valve. The ventricular section extends between the ventricular end of the docking device and the atrial section of the support structure and is configured to be positioned on the ventricular side of the native mitral valve. The ventricular section includes a first portion, a second portion, and a third portion. The first portion extends distally from the atrial section to the third portion, the third portion extends distally from the first portion to the second portion, and the second portion extends distally from the third portion to the ventricular end of the docking device. The expandable sleeve is movable from a compressed position to an expanded position when the crimping pressure is released, wherein in the expanded position, the expandable sleeve extends at least 100 degrees over a first portion of the ventricular section of the support structure. The prosthetic heart valve includes a radially expandable and compressible frame and a plurality of valve leaflets coupled to the frame. The plurality of valve leaflets are configured to selectively open to allow blood to flow through the prosthetic heart valve.

[0011] In yet another exemplary embodiment, a prosthetic heart valve assembly includes a docking device and a prosthetic heart valve disposed within the docking device. The docking device includes an atrial end, a ventricular end, a support structure, and an expandable sleeve covering at least a portion of the support structure. The support structure is disposed between the atrial and ventricular ends of the docking device and includes an atrial section and a ventricular section. The atrial section extends from the atrial end of the docking device toward the ventricular end of the docking device and is configured to be positioned on the atrial side of the native mitral valve. The ventricular section extends from the ventricular end of the docking device toward the atrial end of the docking device and is configured to be positioned on the ventricular side of the native mitral valve. The ventricular section includes a first rotating portion, a second rotating portion, and one or more intermediate rotating portions. The first rotating portion is disposed closer to the atrial section than the second rotating portion, and the one or more intermediate rotating portions are disposed between the first rotating portion and the second rotating portion. The support structure is movable from a delivery configuration to a deployed configuration, and in the deployed configuration, the first rotor includes a different geometry than the one or more intermediate rotors when the first rotor and the one or more intermediate rotors are released from the delivery device of the docking device and deployed at the native mitral valve. The prosthetic heart valve includes a radially expandable and compressible frame configured to be radially expanded from a compressed position within the docking device to an expanded position, and a plurality of valve leaflets coupled to the frame. The plurality of valve leaflets are configured to selectively open to allow blood to flow through the prosthetic heart valve.

[0012] In yet another exemplary embodiment, the method includes wrapping at least one complete turn of the coil around the outflow side of two or more leaflets of the native heart valve, the at least one complete turn including a first geometric shape; wrapping a second turn of the coil around the outflow side of two or more leaflets of the native heart valve, the second turn including a second geometric shape different from the first geometric shape; and radially expanding an expandable sleeve around at least a portion of the second turn of the coil.

[0013] The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings. [Brief explanation of the drawings]

[0014] [Figure 1] FIG. 1 illustrates a schematic diagram of a docking device delivery device for implanting a docking device for a prosthetic heart valve into a patient's mitral valve, according to one embodiment. [Figure 2] FIG. 2 shows a schematic representation of the docking device of FIG. 1 fully implanted in a patient's mitral valve after the docking device's delivery device has been removed from the patient. [Figure 3] FIG. 3 is a schematic illustration of a prosthetic heart valve delivery device for implanting the prosthetic heart valve in the implanted docking device of FIG. 2 into a patient's mitral valve, according to one embodiment. [Figure 4] FIG. 4 shows a perspective view of a docking device according to an embodiment. [Figure 5] FIG. 5 shows a top view of the docking device of FIG. [Figure 6] FIG. 6 illustrates a perspective view of a docking device according to an embodiment. [Figure 7] FIG. 7 shows a top view of the docking device of FIG. [Figure 8] FIG. 8 illustrates a perspective view of a docking device according to an embodiment. [Figure 9] FIG. 9 shows a top view of the docking device of FIG. [Figure 10] FIG. 10 illustrates a perspective view of a docking device according to an embodiment. [Figure 11] FIG. 11 shows a top view of the docking device of FIG. [Figure 12] FIG. 12 illustrates a perspective view of a docking device according to an embodiment. [Figure 13] FIG. 13 shows a top view of the docking device of FIG. [Figure 14]FIG. 14 shows a cross-sectional view of any one of the exemplary docking devices of FIGS. 3-13 taken along line AA with the expandable sleeve of the docking device in a compressed position, such as when the docking device is held within the docking device delivery device prior to implantation. [Figure 15] FIG. 15 shows a cross-sectional view of any one of the exemplary docking devices of FIGS. 3-13 taken along section plane AA with the expandable sleeve of the docking device in an expanded position, such as when the docking device is removed from the docking device delivery device after implantation. [Figure 16] FIG. 16 shows an internal perspective view of the bottom of the left atrium of the heart, including the atrial side of the mitral valve, with an exemplary docking device implanted in the mitral valve. [Figure 17] FIG. 17 shows an internal perspective view of the heart of FIG. 16 with the docking device of FIG. 16 implanted in the mitral valve. [Figure 18] FIG. 18 shows an internal perspective view of the top of the left ventricle of the heart of FIGS. 16 and 17, including the ventricular side of the mitral valve, with the docking device of FIGS. 16 and 17 implanted in the mitral valve. [Figure 19] FIG. 19 shows a side view of a prosthetic heart valve according to one embodiment. [Figure 20] FIG. 20 shows a perspective view of an exemplary prosthetic heart valve system including the docking device of FIGS. 16-18 and the prosthetic heart valve of FIG. 19 received therein. [Figure 21] FIG. 21 shows a perspective view of the prosthetic heart valve system of FIG. 20, in which the prosthetic heart valve of FIGS. 19 and 20 is fully assembled in a docking device. [Figure 22] FIG. 22 shows a perspective view of the heart of FIGS. 16-18 with the prosthetic heart valve system of FIGS. 20 and 21, in which the prosthetic heart valve of FIGS. 19-21 has been implanted and expanded within the docking device of FIGS. 16-18. [Figure 23] FIG. 23 shows a perspective view of the heart of FIGS. 16-18 and 22 after the prosthetic heart valve has been fully expanded and assembled within the docking device to the mitral valve. [Figure 24]FIG. 24 shows an internal perspective view of the top of the left ventricle of the heart of FIGS. 16-18 and 22 and 23 after the prosthetic heart valve has been fully expanded and assembled within the docking device to the mitral valve. [Figure 25] FIG. 25 shows an internal perspective view of the bottom of the left atrium of the heart of FIGS. 16-18 and 22-24, including the atrial side of the mitral valve, after the prosthetic heart valve has been fully expanded and assembled within the docking device to the mitral valve. DETAILED DESCRIPTION OF THE INVENTION

[0015] General Considerations For purposes of this description, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The described methods, systems, and devices should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel, non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations with each other. The disclosed methods, systems, and devices are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed methods, systems, and devices require that any one or more specific advantages exist or problems be solved.

[0016] It is understood that any feature, integer, property, compound, chemical moiety, or group described in connection with a particular aspect, embodiment, or example of the present disclosure may be applied to any other aspect, embodiment, or example described herein, to the extent that it is not incompatible with that other aspect, embodiment, or example. All features disclosed in this specification (including any accompanying claims, abstract, and drawings), and / or all steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. The present disclosure is not limited to the details of any foregoing embodiment. The present disclosure extends to any novel or any novel combination of features disclosed in this specification (including any accompanying claims, abstract, and drawings), and to any novel or any novel combination of steps of any method or process so disclosed.

[0017] Although some operations of the disclosed methods are described in a particular order for convenient presentation, it should be understood that this description style encompasses rearrangement unless a particular order is required by specific terminology described below. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Moreover, for simplicity, the accompanying figures may not show the various ways in which the disclosed methods, systems, and devices can be used in conjunction with other systems, methods, and devices.

[0018] As used herein, the terms "a," "an," and "at least one" include one or more of the specified elements. That is, where two of the specified elements are present, one of these elements is also present, and therefore "an" element is present. The terms "plurality" and "plurality" refer to two or more of the specified elements.

[0019] As used herein, the term "and / or" used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase "A, B, and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."

[0020] As used herein, the term "coupled" generally means physically connected or joined and does not exclude the presence of intermediate elements between the connected items, unless specifically termed to the contrary.

[0021] Directions and other relative references (e.g., inside, outside, upper, lower, etc.) may be used to facilitate discussion of the figures and principles herein but are not intended to be limiting. For example, specific terms such as "inside," "outside," "upper," "lower," "internal," "external," and the like may be used. Such terms are used, where applicable, to provide a degree of clarity of description when dealing with relative relationships, particularly with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" part can become a "lower" part simply by flipping the object. This is still the same part, and the object remains the same. As used herein, "and / or" means "and" or "or," as well as "and" and "or."

[0022] In the context of this application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow," respectively. Thus, for example, the lower end of a valve is its inflow end and the upper end of a valve is its outflow end.

[0023] As used herein, with reference to prosthetic medical devices (e.g., heart valves), capsules, and delivery devices, "proximal" refers to a location, direction, or portion of a component that is closer to the handle of the delivery device, which is external to the user and / or patient, while "distal" refers to a location, direction, or portion of a component that is further away from the user and / or handle of the delivery device and closer to the implantation site. The terms "longitudinal" and "axial," unless expressly defined otherwise, refer to an axis that extends in the proximal and distal directions. Additionally, the term "radial" refers to a direction that is disposed perpendicular to an axis and points along a radius from the center of the object (where an axis, such as the longitudinal axis of a prosthetic valve, is centrally positioned).

[0024] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are merely preferred examples of the invention and should not be considered as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. We therefore claim as our invention all inventions that come within the scope and spirit of these claims. Overview of the disclosed technology

[0025] Defective native heart valves can be replaced with transcatheter heart valves (THVs). However, in some cases, it can be difficult to fix the prosthetic heart valve to the native tissue (e.g., the leaflets and / or annulus of the native heart valve) and / or to control the PVL at the implantation location.

[0026] The present disclosure generally relates to a docking device that can be used with an expandable prosthetic valve at the annulus of a native valve (e.g., the annulus of a mitral, tricuspid, pulmonary, and / or aortic valve), for example, to secure the prosthetic valve against native tissue. As another example, the docking device of the present disclosure can also reduce or eliminate PVL. In particular, the docking device of the present disclosure can reduce and / or eliminate paravalvular leakage at and / or near the commissures of the native heart valve. In some embodiments, the docking device includes an expandable sleeve configured to provide a seal between the tissue of the native valve and the prosthetic valve. However, the docking device of the present disclosure includes an expandable sleeve configured to extend farther along the outflow side of the docking device than conventional docking devices. As an example, the expandable sleeve can be configured to extend at least 100 degrees from the location where the docking device is configured to cross from the inflow side to the outflow side of the valve leaflet (e.g., the posteromedial commissure of the mitral valve). Thus, when implanted in a prosthetic valve, the expandable sleeve can be configured to extend from the posteromedial commissure to the anterior lateral commissure. By extending farther along the outflow side of the native heart valve leaflets, the expandable sleeve may help seal the commissures and / or other areas of the native valve leaflets that typically contribute to paravalvular leakage.

[0027] In some embodiments, the expandable sleeve is configured to be shaped and / or sized to minimize obstruction to the inflow and / or outflow tracts (e.g., the left ventricular outflow tract (LVOT)). For example, a portion of the expandable sleeve configured to be positioned adjacent to and / or proximal to the inflow and / or outflow tracts may be tapered. As another example, the expandable sleeve may include two or more expandable sleeves separated from one another by a gap, which may be configured to be positioned adjacent to and / or proximal to the inflow and / or outflow tracts. By way of example only, if the docking device is implanted in the mitral valve, the expandable sleeve may be tapered and / or absent in the portion of the docking device positioned adjacent to and / or proximal to the LVOT to minimize blockage of blood through the aortic valve. In this manner, the expandable sleeve may provide an improved seal between the tissue of the native valve and the prosthetic valve without impeding blood flow through the other native heart valve.

[0028] In some embodiments, the portion of the docking device configured to be positioned most superior and / or most proximal to the fixed edge of the native heart valve on the outflow side of the native heart valve (i.e., if the docking device is implanted on a mitral valve, the top ventricular portion of the docking device) has a different geometry (e.g., shape and / or size) than one or more of the portions of the docking device configured to be positioned farther away from the annulus of the native heart valve on the outflow side of the native heart valve. In some such embodiments, this top ventricular portion of the docking device is larger than the adjacent outflow portion of the docking device. Additionally or alternatively, the top ventricular portion of the docking device is non-circular, substantially D-shaped, substantially crescent-shaped, and / or otherwise comprises a shape identical to or similar to the annulus of the native valve. By more closely conforming to the size and / or shape of the annulus of the native valve, the top ventricular portion of the docking device may more securely hold the prosthetic valve in place (i.e., reduce shifting of the prosthetic valve relative to the native heart valve) and / or otherwise provide an improved seal between the tissue of the native valve and the prosthetic valve.

[0029] Further information and examples are provided below with reference to the accompanying drawings.

[0030] 1-3 illustrate an exemplary transcatheter heart valve replacement procedure utilizing a docking device, according to one embodiment. During the procedure, a user first uses a docking device delivery device (FIG. 1) to deliver and implant the docking device into a patient's native heart valve, then removes the docking device delivery device from the patient after implanting the docking device (FIG. 2), and finally implants a prosthetic valve into the implanted docking device using a prosthetic valve delivery device (FIG. 3).

[0031] FIG. 1 shows the first step in an exemplary mitral valve replacement procedure in which a docking device 10 is implanted into the mitral valve 12 of a heart 14 of a patient 16 using a docking device delivery device 18 (which may also be referred to herein as a "catheter" and / or a "docking device delivery device").

[0032] Generally, the docking device delivery device 18 includes a delivery shaft 20, a handle 22, and a pusher assembly 24. The delivery shaft 20 is configured to extend within the patient's vasculature and provide a passageway for the docking device 10 to reach the implantation site (e.g., the mitral valve 12). Specifically, the delivery shaft 20 may be configured to be advanced through the patient's vasculature to the implantation site and may be configured to receive and / or retain the docking device 10 therein. In some embodiments, the delivery shaft 20 may include an outer sheath or shaft defining a lumen, and the pusher assembly 24 and / or the docking device 10 may be configured to be received and / or advanced within the lumen.

[0033] The handle 22 is configured to be grasped and / or otherwise held by a user to advance the delivery shaft 20 through the patient's vasculature. Specifically, the handle 22 is coupled to the proximal end 26 of the delivery shaft 20 and is configured to remain accessible to the user (e.g., outside the patient 16) during the docking device implantation procedure. In this manner, the user can advance the delivery shaft 20 through the patient's vasculature by exerting a force (e.g., pushing) on ​​the handle 22. In some embodiments, the delivery shaft 20 can be configured to carry the pusher assembly 24 and / or the docking device 10 therewith as it advances through the patient's vasculature. In this manner, the docking device 10 and / or the pusher assembly 24 can advance through the patient's vasculature in the same direction and at the same speed as the delivery shaft 20 as the user grasps the handle 22 and pushes the delivery shaft 20 deeper into the patient's vasculature.

[0034] In some embodiments, the handle 22 may include one or more articulation members 28 configured to aid in navigating the delivery shaft 20 through a patient's vasculature. Specifically, the articulation members 28 may include one or more knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to flex, bend, twist, rotate, and / or otherwise articulate the distal end 30 of the delivery shaft 20 to aid in navigating the delivery shaft 20 through a patient's vasculature.

[0035] The pusher assembly 24 is configured to deploy and / or implant the docking device 10 at an implantation site (e.g., a native valve). Specifically, the pusher assembly 24 is configured to be adjusted by a user to advance the docking device 10 through the delivery shaft 20 and push the docking device 10 out of the distal end 30 of the delivery shaft 20. As described above, the pusher assembly 24 may be configured to extend through the delivery shaft 20, into an internal lumen defined by the outer sheath of the delivery shaft 20. The pusher assembly 24 may also be coupled to the docking device 10 such that the pusher assembly 24 pushes the docking device 10 through and / or out of the delivery shaft 20 as the pusher assembly 24 advances through the delivery shaft 20. In other words, the docking device 10 is maintained, held, and / or otherwise coupled to the pusher assembly 24 so that it can advance through and / or out of the delivery shaft 20 in the same direction and at the same speed as the pusher assembly 24.

[0036] The pusher assembly 24 comprises a pusher shaft 32 and, in some embodiments, may include a sleeve shaft 34. The pusher shaft 32 is configured to advance the docking device 10 through the delivery shaft 20 and out the distal end 30 of the delivery shaft 20, while the sleeve shaft 34, if included, may be configured to deploy an expandable sleeve of the docking device 10. Specifically, the sleeve shaft 34 may be configured to cover the docking device 10 within the delivery shaft 20, while the pusher shaft 32 pushes the docking device 10 out of the delivery shaft 20 and positions the docking device 10 at the implantation site.

[0037] In some embodiments, the pusher assembly 24 may include a pusher handle 36 (which may also be referred to herein as a "hub assembly 36") coupled to the pusher shaft 32 and configured to be grasped and pushed by a user to move the pusher shaft 32 axially relative to the delivery shaft 20 (e.g., push the pusher shaft 32 into and / or out of the distal end 30 of the delivery shaft 20). The sleeve shaft 34 may be configured to be retracted and / or withdrawn from the docking device 10 after positioning the docking device 10 at the implantation site. For example, the pusher assembly 24 may include a sleeve handle 38 coupled to the sleeve shaft 34 and configured to be withdrawn by a user to retract (e.g., axially move) the sleeve shaft 34 relative to the pusher shaft 32.

[0038] The pusher assembly 24 may be removably coupled to the docking apparatus 10 and thus may be configured to release, detach, separate, and / or otherwise detach from the docking apparatus 10 once the docking apparatus 10 is deployed at the implantation site. By way of example only, the pusher assembly 24 (e.g., the pusher shaft 32) may be removably coupled to the docking apparatus 10 via thread, string, twine, suture, or other suitable material that is bonded or sutured to the docking apparatus 10.

[0039] In some embodiments, the pusher assembly 24 includes a suture lock assembly 40 configured to receive and / or retain a thread or other suitable material coupled to the docking apparatus 10 via a suture. Thus, the thread or other suitable material forming the suture may extend from the docking apparatus 10, through the pusher assembly 24, and to the suture lock assembly 40. The suture lock assembly 40 may also be configured to cut the thread to release, detach, separate, and / or otherwise remove the docking apparatus 10 from the pusher assembly 24. For example, the suture lock assembly 40 may include a cutting mechanism configured to be adjusted by a user to cut the thread.

[0040] Further details of the docking device delivery device and variations thereof are described in International Publication No. WO2020 / 247907, the entire contents of which are incorporated herein by reference.

[0041] Before inserting the delivery device 18 of the docking device into the vascular system of the patient 16, the user may first make an incision in the patient's body to access a blood vessel 42. For example, in the embodiment shown in FIG. 1 , the user makes an incision in the patient's groin to access the femoral vein. Thus, in such an embodiment, the blood vessel 42 may be the femoral vein.

[0042] After making an incision in the blood vessel 42, the user may insert an introducer device 44, a guidewire 46, and / or other devices (e.g., delivery shaft 20, pusher shaft 32, and / or sleeve shaft 34 of a delivery device 18 of a docking device, a catheter and / or other delivery device, docking device 10, a prosthetic valve, etc.) through the incision and into the blood vessel 42. The introducer device 44 (which may include an introducer sheath) is configured to facilitate percutaneous introduction of the guidewire 46 and / or other devices (e.g., delivery device 18 of a docking device) into and through the blood vessel 42, and even when fully inserted by the user, may extend only partially through the blood vessel 42 (i.e., may extend through the blood vessel 42 toward but stop short of the heart 14). Meanwhile, the guidewire 46 is configured to guide delivery devices (e.g., docking device delivery device 18, prosthetic valve delivery device, catheter, etc.) and their associated devices (e.g., docking device, prosthetic heart valve, etc.) to an implantation site within the heart 14, and thus may extend through the blood vessel 42 all the way to the left atrium 48 of the heart 14. Specifically, the user may advance the guidewire 46 through the blood vessel 42 (e.g., through the femoral vein and inferior vena cava) to the right atrium 50 of the heart 14. The user may make a small incision in the atrial septum 52 of the heart 14, pass the guidewire 46 from the right atrium 50 to the left atrium 48 of the heart 14, and then advance the guidewire 46 through the incision in the atrial septum 52 and into the left atrium 48. Thus, the guidewire 46 may provide a path that the docking device delivery device 18 can follow to ensure that it does not perforate the walls of the blood vessel 42 and / or other vascular tissue as it advances through the patient's vasculature.

[0043] After positioning the guidewire 46 within the left atrium 48, the user may insert the docking device delivery device 18 (e.g., delivery shaft 20) into the patient 16 by advancing the docking device delivery device 18 through the introducer device 44 and over the guidewire 46. The user may then continue to advance the docking device delivery device 18 along the guidewire 46 through the patient's vasculature until the docking device delivery device 18 reaches the left atrium 48, as shown in FIG. 1 . Specifically, the user may advance the delivery shaft 20 of the docking device delivery device 18 by grasping and exerting force (e.g., pushing) on ​​the handle 22 of the docking device delivery device 18. The user may adjust one or more articulation members 28 of the handle 22 while advancing the delivery shaft 20 through the patient's mitral vasculature to navigate various turns, angles, stenoses, and / or other obstacles within the patient's vasculature.

[0044] Once the delivery shaft 20 reaches the left atrium 48, the user can use the handle 22 (e.g., articulation member 28) to position the distal end 30 of the delivery shaft 20 at and / or near the posteromedial commissure of the mitral valve 12. The user can then use the pusher assembly 24 to push the docking device 10 out of the distal end 30 of the delivery shaft 20 to deploy and / or implant the docking device 10 into the mitral valve 12. For example, the user can actuate the pusher handle 36, axially moving the pusher shaft 32 distally relative to the delivery shaft 20, such that the docking device 10 (which may be covered by a sleeve shaft 34) is deployed out of the delivery shaft 20 and moved to a desired location at the implantation site.

[0045] In some embodiments, docking device 10 may be constructed from, formed from, and / or include a shape memory material so that it can return to its original preformed shape when it exits delivery shaft 20 and is no longer constrained by delivery shaft 20. As an example, docking device 10 may originally be formed as a coil and thus wrap around the ventricular side of the valve leaflet as it exits delivery shaft 20 and returns to its original coiled configuration. This process is described in more detail below with reference to FIGS. 17 and 18.

[0046] After pushing the ventricular portion of the docking device 10 (i.e., the portion of the docking device 10 configured to be positioned / placed within the left ventricle 56 and / or on the ventricular side of the mitral valve leaflets), the user can release the remaining portion of the docking device 10 (the atrial portion of the docking device 10) from the delivery shaft 20 within the left atrium 48. Specifically, the user can retract the delivery shaft 20 relative to the docking device 10, away from the lateral side of the posteromedial commissure of the mitral valve 12. In some embodiments, the user can maintain the position of the pusher shaft 32 (e.g., by exerting a holding and / or pushing force on the pusher shaft 32) while retracting the delivery shaft 20 such that the delivery shaft 20 withdraws and / or otherwise retracts relative to the docking device 10 and the pusher shaft 32. In this manner, the pusher shaft 32 can hold the docking device 10 in place while the user retracts the delivery shaft 20, thereby releasing the docking device 10 from the delivery shaft 20. In some embodiments, the user may also retract the sleeve shaft 34 from the docking apparatus 10, exposing the docking apparatus 10 and, in some embodiments, deploying the expandable sleeve of the docking apparatus.

[0047] After deploying and / or implanting the docking device 10, the user may separate and / or otherwise remove the docking device delivery device 18 from the docking device 10, for example, by cutting the threads sutured to the docking device 10. By way of example only, the user may cut the threads using the cutting mechanism of the suture lock assembly 40. Once the docking device 10 is detached from the docking device delivery device 18, the user can retract the entire docking device delivery device 18 (delivery shaft 20, handle 22, and pusher assembly 24) from the patient 16, thereby enabling the user to deliver and implant the THV into the mitral valve 12. For example, the docking device 10 and the THV may be delivered with two different and separate delivery devices, and thus the user may need to remove the docking device delivery device 18 from the patient 16 to make room for the THV delivery device. As another example, the user may need to remove the docking device delivery device 18 from the patient 16 and load the THV onto the delivery device. In either embodiment, the user may need to remove the delivery device 18 of the docking device from the patient 16 before implanting the THV.

[0048] 2 illustrates this second stage in the mitral valve replacement procedure, with the docking device 10 fully deployed and implanted in the mitral valve 12 and the docking device's delivery device 18 (including the delivery shaft 20) removed from the patient 16, leaving only the guidewire 46 and introducer device 44 inside the patient 16. The introducer device 44 may remain inside the patient 16 and aid in percutaneously inserting the THV and valve delivery device into the patient 16, while the guidewire 46 may remain within the patient's vasculature and aid in advancing the THV and valve delivery device through the patient's vasculature. Specifically, the guidewire 46 may ensure that the THV and valve delivery device do not perforate the walls of the blood vessel 42 and / or other vascular tissue as they advance through the patient's vasculature. In some embodiments, the user may advance the guidewire 46 through the mitral valve 12 and into the left ventricle 56, allowing the guidewire 46 to consistently and reliably guide the THV and valve delivery device within the docking device 10 to the mitral valve 12.

[0049] 2 , the docking device 10 may be configured to wrap around the ventricular side of the leaflets of the mitral valve 12 and squeeze the leaflets radially inward (i.e., radially compress the leaflets) to adjust the size and / or shape of the opening between the two leaflets of the mitral valve 12. For example, the docking device 10 may be configured to reduce the size and / or change the shape of the opening in the mitral valve 12 (e.g., make the opening more circular for a cylindrical THV) to more closely match the cross-sectional shape and / or contour of the THV. By constricting the mitral valve 12 in this manner, the docking device 10 may provide a tighter fit, i.e., a better seal, between the THV and the valve 12.

[0050] 3 illustrates a third stage in a prosthetic valve replacement procedure in which a user delivers and / or implants a prosthetic heart valve 54 (which may also be referred to herein as a “heart valve,” “transcatheter heart valve,” or simply “THV,” “replacement heart valve,” and / or “prosthetic mitral valve”) into the docking device 10 and / or into the mitral valve 12 using a prosthetic heart valve delivery device 58. Thus, the docking device 10 and the prosthetic heart valve 54 may be delivered on different delivery devices at different stages in a mitral valve replacement procedure. Specifically, the docking device 10 may be delivered to the mitral valve 12 by the docking device delivery device 18 during the first stage of the mitral valve replacement procedure, and the prosthetic heart valve 54 may then be delivered by the prosthetic heart valve delivery device 58.

[0051] The prosthetic heart valve delivery device 58 includes a delivery shaft 60 and a handle 62 coupled to a proximal end 64 of the delivery shaft 60. The delivery shaft 60 is configured to extend into a patient's vasculature to deliver, implant, expand, and / or otherwise deploy the prosthetic heart valve 54 within the docking device 10 for the mitral valve 12. The handle 62 may be the same as or similar to the handle 22 of the docking device delivery device 18 and is similarly configured to be grasped and / or otherwise held by a user to advance the delivery shaft 60 through the patient's vasculature.

[0052] In some embodiments, the handle 62 may include one or more articulation members 66 configured to aid in navigating the delivery shaft 60 through a patient's vasculature. Specifically, the articulation members 66 may include one or more knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to flex, bend, twist, rotate, and / or otherwise articulate the distal end 68 of the delivery shaft 60 to aid in navigating the delivery shaft 60 through a patient's vasculature.

[0053] In some embodiments, the prosthetic heart valve delivery device 58 may include an expansion mechanism 70 configured to radially expand and deploy the prosthetic heart valve 54. For example, the expansion mechanism 70 may include an inflatable balloon configured to be inflated to radially expand the prosthetic heart valve 54 within the docking device 10. The expansion mechanism 70 may be included within and / or coupled to the delivery shaft 60, at and / or proximal to the distal end 68 of the delivery shaft 60. In other embodiments, the prosthetic heart valve 54 may be self-expanding and configured to radially expand by itself without the expansion mechanism 70. In other embodiments, the prosthetic heart valve 54 may be mechanically expandable, and the prosthetic heart valve delivery device 58 may include one or more mechanical actuators configured to radially expand the prosthetic heart valve 54.

[0054] The prosthetic heart valve 54 may be coupled to the delivery shaft 60 at and / or proximal to the distal end 68 of the delivery shaft 60. In embodiments in which the prosthetic heart valve delivery device 58 includes an expansion mechanism 70, the prosthetic heart valve 54 may be mounted on the expansion mechanism 70 in a radially compressed configuration. In some embodiments, the prosthetic heart valve 54 may be removably coupled to the delivery shaft 60 such that after the prosthetic heart valve 54 is radially expanded and deployed from the prosthetic heart valve delivery device 58, the prosthetic heart valve delivery device 58 may be stowed away from the implanted prosthetic heart valve 54 and removed from the patient 16.

[0055] The prosthetic heart valve 54 is configured to be received and / or retained within the docking device 10. That is, the docking device 10 is configured to receive the prosthetic heart valve 54 and help secure the prosthetic heart valve 54 to the mitral valve 12. As described in further detail below, the docking device 10 is also configured to provide a seal between the prosthetic heart valve 54 and the leaflets of the mitral valve to reduce paravalvular leakage around the prosthetic heart valve 54. Specifically, as described above, the docking device 10 may initially contract the leaflets of the mitral valve 12. Thereafter, as the prosthetic heart valve 54 radially expands within the docking device 10 (e.g., by inflation of the expansion mechanism 70), the leaflets may be pressed against the docking device 10. Thus, the docking device 10 and the prosthetic heart valve 54 may be configured to sandwich the leaflets of the mitral valve 12 when the prosthetic heart valve 54 is expanded within the docking device 10. In this manner, the docking device 10 can provide a seal between the leaflets of the mitral valve 12 and the prosthetic heart valve 54 .

[0056] As described in more detail below, the docking device 10 may include an expandable sleeve and / or coil structure that extends at least partially around the outflow side of the native valve to provide a seal between the mitral valve 12 and the prosthetic heart valve 54 (thereby reducing paravalvular leakage around the prosthetic heart valve 54). The expandable sleeve may extend farther along the outflow side of the native valve (toward the distal end of the coil) than a conventional sleeve. For example, the expandable sleeve may extend at least 100 degrees around the outflow side of the native valve. As another example, the expandable sleeve may be configured to extend around the outflow side of the native valve up to the anterolateral commissure of the mitral valve 12 to reduce paravalvular leakage at the anterolateral commissure.

[0057] Additionally or alternatively, when the docking device is implanted in the mitral valve 12, a portion of the coil structure configured to be the uppermost portion of the coil on the ventricular side of the mitral valve 12 may be shaped and / or sized to extend farther toward the anterior-lateral and / or posteromedial commissures of the mitral valve 12 than other portions of the coil on the ventricular side of the mitral valve 12. In this manner, tailoring the shape and / or size of this uppermost ventricular portion of the docking device 10 (i.e., more closely matching the shape and / or size of the mitral valve annulus) may help seal openings in the mitral valve 12 near the commissures of the mitral valve 12 and therefore reduce paravalvular leakage at and / or near these commissures. More generally, the uppermost ventricular portion of the docking device 10 may help close and / or otherwise seal openings in the mitral valve 12 that lie beyond the edges of the prosthetic heart valve 54 (i.e., radially outward from the prosthetic heart valve 54).

[0058] In some embodiments, one or more of the docking device delivery devices 18, the prosthetic heart valve delivery device 58, and / or the introducer device 44 may include a flushing port 72 (FIG. 1) configured to supply a flushing fluid to its lumen (e.g., the delivery shaft 20 of the docking device delivery device 18, the delivery shaft 60 of the prosthetic heart valve delivery device 58, and / or the lumen of the introducer device 44) to reduce the likelihood of blood clot (e.g., thrombus) formation.

[0059] Similar to delivering the docking device 10, the user may insert the prosthetic heart valve delivery device 58 (e.g., delivery shaft 60) into the patient 16 by advancing the prosthetic heart valve delivery device 58 through the introducer device 44 and over the guidewire 46. The user may continue to advance the prosthetic heart valve delivery device 58 along the guidewire 46 (through the patient's vasculature) until the prosthetic heart valve delivery device 58 reaches the mitral valve 12, as shown in FIG. 3 . Specifically, the user may advance the delivery shaft 60 of the prosthetic heart valve delivery device 58 by grasping and exerting force (e.g., pushing) on ​​the handle 62 of the prosthetic heart valve delivery device 58. The user may adjust one or more articulation members 66 of the handle 62 while advancing the delivery shaft 60 through the patient's mitral vasculature to navigate various turns, angles, stenoses, and / or other obstacles within the patient's vasculature.

[0060] The user may advance the delivery shaft 60 along the guidewire 46 until the prosthetic heart valve 54 and / or the expansion mechanism 70 are positioned / located within the docking device 10 and / or mitral valve 12. For example, the user may advance the delivery shaft 60 along the guidewire 46 until the delivery shaft 60 extends through the mitral valve 12 so that the distal end 68 of the delivery shaft 60 is positioned / located within the left ventricle 56. Once the prosthetic heart valve 54 is properly positioned / located within the docking device 10, the user may radially expand the prosthetic heart valve 54, such as with the expansion mechanism 70, to its fully expanded position or configuration. In some examples, the user may lock the prosthetic heart valve 54 in its fully expanded position (e.g., with a locking mechanism) to prevent the valve from collapsing. After expanding and deploying the prosthetic heart valve 54, the user may detach and / or otherwise detach the delivery shaft 60 from the prosthetic heart valve 54 and remove the delivery shaft 60 from the patient.

[0061] 1-3 specifically illustrate valve replacement procedures, it should be understood that the same and / or similar procedures may be utilized to replace other heart valves (e.g., tricuspid, pulmonary, and / or aortic valves). Furthermore, the same and / or similar delivery devices (e.g., docking device delivery device 18, prosthetic heart valve delivery device 58, introducer device 44, and / or guidewire 46), docking devices (e.g., docking device 10), replacement heart valves (e.g., prosthetic heart valve 54), and / or components thereof may be utilized to replace these other heart valves.

[0062] For example, when replacing a native tricuspid valve, the user may also access the right atrium 50 via the femoral vein, but without needing to cross the atrial septum 52 into the left atrium 48. Instead, the user can leave the guidewire 46 in the right atrium 50 and perform the same and / or similar docking device implantation process at the tricuspid valve. Specifically, the user pushes the docking device 10 out of the delivery shaft 20 around the ventricular side of the tricuspid valve leaflets, releases the remaining portion of the docking device 10 from the delivery shaft 20 in the right atrium 50, and then removes the delivery shaft 20 of the docking device delivery device 18 from the patient 16. The user can then advance the guidewire 46 through the tricuspid valve and into the right ventricle, and perform the same and / or similar prosthetic heart valve implantation process within the docking device 10 at the tricuspid valve. Specifically, a user may advance the delivery shaft 60 of the prosthetic heart valve delivery device 58 along the guidewire 46 and through the patient's vasculature until the prosthetic heart valve 54 is positioned / placed within the docking device 10 and tricuspid valve. The user may then expand the prosthetic heart valve 54 within the docking device 10 before removing the prosthetic heart valve delivery device 58 from the patient 16. In another example, a user may perform the same and / or similar process to replace an aortic valve, but access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0063] 1-3 illustrate a valve replacement procedure in which the left atrium 12 is accessed from the left atrium 48 via the right atrium 50 and the femoral vein, it should be understood that the mitral valve 12 may alternatively be accessed from the left ventricle 56. For example, a user may access the mitral valve 12 from the left ventricle 56 through the aortic valve by advancing one or more delivery devices through an artery to the aortic valve and then through the aortic valve into the left ventricle 56.

[0064] Exemplary Embodiments of the Disclosed Technology Figures 4-13 illustrate various exemplary docking devices configured to receive, retain, and / or secure a prosthetic heart valve and provide a seal between the prosthetic heart valve and native tissue. Specifically, Figures 4-9 illustrate various exemplary expandable sleeves that can cover the coils of exemplary docking devices to provide an improved seal between the leaflets of the native valve and the prosthetic heart valve. Specifically, the exemplary expandable sleeves can extend at least 100 degrees along the outflow side of the native valve to reduce paravalvular leakage (PVL) around the prosthetic heart valve. In this manner, the expandable sleeves disclosed herein can also be referred to as "PVL guards." Figures 10-13 illustrate alternative geometries (sizes and / or shapes) of the coils of the docking devices that can also provide an improved seal between the native tissue and the prosthetic heart valve.

[0065] Figures 4-13 show an exemplary docking device in a deployed configuration. The exemplary docking device is configured to move from a delivery configuration to this deployed configuration when deployed from a docking device delivery device (e.g., docking device delivery device 18 described above). However, as described in more detail below, the exemplary docking device is configured to move from the deployed configuration to an assembled configuration when a prosthetic heart valve is expanded within the docking device. Figures 20 and 21 and 24 and 25 show the exemplary docking device in this final assembled configuration.

[0066] 4 and 5 illustrate a docking device 100 according to one embodiment. Specifically, FIG. 4 illustrates a side perspective view of the docking device 100, and FIG. 5 illustrates a top view of the docking device 100. The docking device 100 includes a coil 102 (which may also be referred to herein as a “support structure 102”) having multiple turns and / or bends and defining an internal lumen 103, and an expandable sleeve 104 (which may also be referred to herein as an “expandable guard 104” and / or a “PVL guard 104”). The expandable sleeve 104 is configured to extend farther along the outflow side of the native heart valve (thus covering a majority of the outflow side of the coil 102) than conventional expandable sleeves to provide an improved seal between the tissue of the native heart valve and the prosthetic heart valve. In this manner, the expandable sleeve 104 may reduce and / or eliminate PVL around the prosthetic heart valve.

[0067] The docking device 100 also has a first end 106 and a second end 108 opposite the first end 106. Because the second end 108 is configured to exit the delivery shaft (e.g., the delivery shaft 20 described above) of the docking device's delivery device (e.g., the delivery device 18 of the docking device described above) before the first end 106 and / or extend farther from the delivery shaft than the first end 106, the second end 108 of the docking device 100 may also be referred to herein as the "distal end 108," and the first end 106 may also be referred to herein as the "proximal end 106."

[0068] The coil 102 extends from a first end 106 to a second end 108, and thus may form and / or otherwise define the first end 106 and the second end 108. The coil 102 comprises a first section 110 and a second section 112, where the first section 110 extends distally from the first end 106 to the second section 112 and the second section 112 extends proximally from the second end 108 to the first section 110. In some embodiments, the first section 110 may be configured to extend distally from the first end 106 and terminate at a location where the docking device 100 crosses the side of the native heart valve. The second section 112 may be configured to begin at a location where the first section 110 terminates (e.g., where the docking device 100 crosses the side of the native heart valve) and extend distally from the first section 110 to the second end 108. Thus, the first section 110 and the second section 112 may be joined at the location where the docking device 100 crosses the side of the native heart valve.

[0069] As one example, the first section 110 may be configured to be included in and / or positioned / disposed on the inflow side of the native heart valve (e.g., on the inflow side of the native heart valve leaflets), and the second section 112 may be configured to be included in and / or positioned / disposed on the outflow side of the native heart valve (e.g., on the outflow side of the native heart valve leaflets) when the docking device 100 is implanted into the native heart valve. For example, the first section 110 may terminate, and the second section 112 may begin at a location where the docking device 100 crosses from the inflow side of the native heart valve leaflets to the outflow side of the native heart valve leaflets (e.g., at a commissure of the native heart valve). As such, the first section 110 may also be referred to herein as the "inflow section 110," and the second section 112 may also be referred to herein as the "outflow section 112." Accordingly, the first end 106 of the docking apparatus 10 may also be referred to herein as the "inflow end 106," and the second end 108 may also be referred to herein as the "outflow end 108."

[0070] As another example, the first section 110 may be configured to be included and / or positioned / placed on the atrial side of the native heart valve (e.g., on the atrial side of the native heart valve leaflets in the atrium), and the second section 112 may be configured to be included and / or positioned / placed on the ventricular side of the native heart valve (e.g., on the ventricular side of the native heart valve leaflets in the ventricle), such as when the docking device is implanted in a tricuspid valve and / or mitral valve. Specifically, the first section 110 may terminate and the second section 112 may begin at the location where the docking device 100 crosses from the atrial side of the native heart valve leaflets to the ventricular side of the native heart valve leaflets (e.g., at the commissures of the native heart valve). As such, the first section 110 may also be referred to herein as the "atrial section 110" because the first section 110 may be positioned / placed within the atrium, and the second section 112 may also be referred to herein as the "ventricular section 112" because the second section 112 may be positioned / placed within the ventricle. Furthermore, the first end 106 of the docking device 10 may also be referred to herein as the "atrial end 106," and the second end 108 may also be referred to herein as the "ventricular end 108."

[0071] In one particular embodiment in which the docking device 100 is included in a native mitral valve (described in more detail below), the junction of the first section 110 and the second section 112 (where the first section 110 and the second section 112 meet) can be configured such that the coil 102 is positioned / placed at a location that crosses between the atrial / inflow side and the ventricular / outflow side of the mitral valve leaflets, such as at and / or near the A3 / P3 position and / or the posteromedial commissure of the native mitral valve.

[0072] The first section 110 may comprise a first portion 114 (also referred to herein as the “first rotating portion 114”) and a second portion 116 (also referred to herein as the “second rotating portion 116” and / or the “atrial functional rotating portion 116”). If included, the first portion 114 extends distally from the first end 106 of the docking device 100 to the second portion 116, which in turn extends distally from the first portion 114 to the second section 112 of the coil 102. Thus, the first section 110 may define and / or form the first end 106 of the docking device 100. The first portion 114 may flare and / or extend radially outward from the second portion 116 and may be configured to stabilize the docking device 100 with the native heart valve. Accordingly, first portion 114 may also be referred to herein as a "flange 114" and / or a "stabilizing rotation 114." In some embodiments, first portion 114 may be configured to extend parallel to the plane of the annulus of the native heart valve, and in some such embodiments, may be configured to extend beyond the annulus to the lateral shelves of the native heart valve and / or other atrial tissue. First portion 114 may be configured to hold itself substantially parallel to the annulus of the native heart valve by extending radially outward toward, to, and / or beyond the shelves of the native heart valve in the plane of the annulus, thereby helping to secure docking device 100 to the native tissue.

[0073] In some embodiments, first portion 114 may extend axially / longitudinal away from second portion 116. In some such embodiments, first portion 114 may be axially separated from the remainder of coil 102 by an amount greater than the other turns of coil 102 are axially separated from one another. Thus, first portion 114 may be axially separated from the remainder of coil 102 by a gap 118 that is greater than any axial gap that may exist between the other turns of coil 102.

[0074] In some embodiments, first portion 114 may be configured to be removably coupled to a delivery device of a docking device (e.g., delivery device 18 of the docking device described above), for example, by suturing. In some such embodiments, sutures or other suitable material may be sewn to first portion 114 at and / or adjacent first end 106 of coil 102, and a user may cut the sutures to separate and / or otherwise remove docking device 100 from the delivery device of the docking device.

[0075] In some embodiments, the first portion 114 may be configured to be sutured to the native heart valve and / or other surrounding vasculature tissue. For example, after deploying the docking device 100 to the native heart valve, the user may suture the first end 106 of the coil 102 to the native heart valve and / or other surrounding vasculature tissue.

[0076] Second portion 116 of first section 110 may be deflected radially inward from first portion 114 and extend from first portion 114 to second section 112. In some embodiments, second portion 116 may comprise a substantially circular turn when viewed from above at first end 106 of coil 102 in a plane perpendicular to longitudinal axis 119 of lumen 103 (such as in FIG. 5 ). However, in other embodiments, second portion 116 may include other non-circular curved contours.

[0077] The second section 112 comprises a first portion 120 (also referred to herein as the “first rotating portion 120,” “top ventricular side portion 120,” “top ventricular side rotating portion 120,” “proximal ventricular side rotating portion 120,” and / or “proximal ventricular side portion 120”), a second portion 122 (also referred to herein as the “second rotating portion 122”), and a third portion 124 (also referred to herein as “one or more intermediate rotating portions 124” and / or “one or more ventricular side functional rotating portions 124”) disposed between the first portion 120 and the second portion 122. Thus, first portion 120 extends distally from first section 110 of coil 102 to third portion 124 of second section 112, which extends distally from first portion 120 to second portion 122, which extends distally from third portion 124 to second end 108 of docking device 100. Thus, third portion 124 may form and / or otherwise define second end 108 of docking device 100. Because first portion 120 extends directly from first section 110 of coil 102, it may be the most proximal portion of second section 112 and, therefore, may be configured to be positioned closer to the annulus and / or commissures of the native heart valve than other portions of second section 112. Furthermore, in embodiments in which the coil 102 is implanted in the tricuspid or mitral valve, the first portion 120 may be at the top of the second section 112 on the ventricular side of the native valve (i.e., the first portion 120 may be at a higher position within the ventricle than other portions of the second section 112).

[0078] 4 and 5, the first portion 120 and the third portion 124 may have substantially the same shape when viewed from above (looking down the first end 106) or below (looking up the second end 108) of the docking apparatus 100 in a plane perpendicular to the longitudinal axis 119. Additionally or alternatively, the first portion 120 and the third portion 124 may be substantially the same size. In some such embodiments, the first portion 120 and the third portion 124 may have a circular turn and / or may have substantially the same radius (and thus define circular planes having substantially the same surface area) when viewed from above (looking down the first end 106) or below (looking up the second end 108) of the docking apparatus 100 in a plane perpendicular to the longitudinal axis 119. Thus, the first portion 120 and the third portion 124 may substantially fit together such that they coincide with one another when viewed superimposed from above or below in a plane perpendicular to the longitudinal axis 119. In other words, first portion 120 and third portion 124 may comprise substantially the same geometry (i.e., the same size and shape) when viewed from above or below. That said, third portion 124 may be longer than first portion 120. For example, first portion 120 may comprise only one full rotation (i.e., a 360-degree rotation), while third portion 124 may comprise at least one full rotation, and in some examples, two or more full rotations. Thus, in some embodiments, third portion 124 may be at least 1.1 times, at least 1.2 times, at least 1.4 times, at least 1.6 times, at least 1.8 times, at least 2 times, at least 2.5 times, at least 3 times, at most 10 times, at most 8 times, and 6 times, and / or at most 4 times the length of first portion 120.

[0079] 4 and 5 depict first portion 120 and third portion 124 as having the same circular cross-section, it should be understood that in other embodiments, first portion 120 and third portion 124 may comprise different geometric shapes (e.g., different sizes, non-circular shapes, etc.). As an example, first portion 120 may comprise one or more of an oval, a crescent, a D-shape, and / or other irregularly curved shapes when viewed in a plane perpendicular to longitudinal axis 119. Additionally or alternatively, first portion 120 may comprise a different geometric shape than third portion 124 (i.e., first portion 120 may be shaped and / or sized differently than third portion 124). For example, FIGS. 10-13 depict alternative geometric shapes for the first portion in which the first portion is shaped and / or sized differently from the third portion.

[0080] Second portion 122 may extend and / or flare radially outward from third portion 124 and / or first portion 120. In some embodiments, second portion 122 extends and / or flares radially outward from third portion 124 and first portion 120, but does not reach first portion 114 of first section 110. However, in other embodiments, second portion 122 may extend and / or flare radially outward beyond first portion 114 of first section 110.

[0081] In some embodiments, the pitch of the coil 102 (the distance between the centers of adjacent turns of the coil 102) and / or the coil pitch angle (the angle defined between the turns of the coil 102 and a plane orthogonal to the longitudinal axis 119) may be substantially consistent / uniform across at least two portions of the second section 112 of the coil 102 and / or the second portion 116 of the first section 110. That is, the pitch of two or more of the first portion 120, the second portion 122, the third portion 124, and / or the second portion 116 may be substantially the same. In this manner, the axial distance between adjacent turns of the second section 112 of the coil 102 and / or the second portion 116 of the first section 110 may be substantially the same, and / or the turns of two or more of the first portion 120, the second portion 122, the third portion 124, and / or the second portion 116 may be substantially parallel to one another. In some such embodiments, the pitch and / or coil angle of the coil 102 may be substantially consistent / uniform throughout the second section 112 and the second portion 116 of the first section 110 .

[0082] In other embodiments, the pitch and / or coil angle of first portion 120 of second section 112 may be different from other portions of second section 112. By way of example, first portion 120 of second section 112 may be substantially bowl-shaped when viewed from the side of coil 102 (in a plane parallel to longitudinal axis 119) and may extend axially farther toward first portion 114 of first section 110 than other portions of second section 112. In this manner, first portion 120 may be configured to extend upward toward the annulus, atrium, and / or commissures when positioned on the ventricular side of the native mitral valve.

[0083] With regard to the relative lengths of the various portions of the coil 102, the first portion 114 of the first section 110 may extend at least 90 degrees, at least 110 degrees, at least 130 degrees, at least 150 degrees, at least 160 degrees, at least 170 degrees, at least 180 degrees, at least 190 degrees, at least 200 degrees, at least 210 degrees, at least 220 degrees, up to 360 degrees, up to 330 degrees, up to 300 degrees, up to 270 degrees, up to 240 degrees, up to 210 degrees and / or up to 180 degrees. The second portion 116 of the first section 110 may extend at least 50 degrees, at least 70 degrees, at least 90 degrees, at least 110 degrees, at least 130 degrees, at least 150 degrees, at least 170 degrees, at least 180 degrees, at least 190 degrees, at least 200 degrees, up to 270 degrees, up to 250 degrees, up to 230 degrees, up to 210 degrees, up to 190 degrees, and / or up to 180 degrees. The first portion 120 of the second section 112 may extend at least 180 degrees, at least 220 degrees, at least 260 degrees, at least 300 degrees, at least 320 degrees, at least 340 degrees, at least 360 degrees, at least 380 degrees, at least 400 degrees, at least 420 degrees, up to 540 degrees, up to 500 degrees, up to 460 degrees, up to 420 degrees, up to 380 degrees, up to 360 degrees, up to 340 degrees, and / or up to 320 degrees. The second portion 122 of the second section 112 may extend at least 50 degrees, at least 70 degrees, at least 90 degrees, at least 100 degrees, at least 110 degrees, at least 120 degrees, at least 130 degrees, at least 140 degrees, at least 150 degrees, at least 160 degrees, up to 270 degrees, up to 240 degrees, up to 210 degrees, up to 180 degrees, up to 170 degrees, up to 160 degrees, up to 150 degrees, up to 140 degrees, up to 130 degrees, up to 120 degrees, up to 110 degrees, up to 110 degrees, and / or up to 90 degrees.The third portion 124 of the second section 112 may extend at least 360 degrees (one full rotation), at least 405 degrees, at least 450 degrees, at least 495 degrees, at least 540 degrees, at least 585 degrees, at least 630 degrees, at least 675 degrees, at least 720 degrees (two full rotations), up to 1,440 degrees, up to 1,260 degrees, up to 1,080 degrees, up to 900 degrees, up to 720 degrees, and / or up to 540 degrees.

[0084] In some embodiments, the junction of the second portion 116 of the first section 110 and the first portion 120 of the second section 112 of the coil 102 is configured to be positioned / positioned at or proximate to the posteromedial commissure of the mitral valve, the posteromedial side of the mitral valve opening, and / or the A3 / P3 position of the mitral valve. For example, the junction of the second portion 116 of the first section 110 and the first portion 120 of the second section 112 of the coil 102 can be configured to be positioned / positioned 80 degrees or less, 70 degrees or less, 60 degrees or less, 50 degrees or less, 40 degrees or less, 30 degrees or less, 20 degrees or less, 10 degrees or less, 5 degrees or less, 3 degrees or less, 2 degrees or less, and / or 1 degree or less from the posteromedial commissure, the posteromedial side of the mitral valve opening, and / or the A3 / P3 position of the mitral valve.

[0085] In some embodiments, the coil 102 may be deformable, substantially linear, or otherwise configured to be unwound to fit within a delivery shaft (e.g., the delivery shaft 20 described above) of a delivery device (e.g., the delivery device 18 of the docking device described above). However, attempting to unwind the coil 102 within the delivery shaft does not permanently unwind the coil 102. In particular, the coil 102 may include a shape memory material configured to return from a temporarily deformed shape (e.g., the unwound configuration, the delivery configuration) to its original, permanent shape (e.g., the coiled configuration, the deployed configuration) in response to a stimulus (e.g., a temperature change, an electrical current, electromagnetic radiation, a mechanical stress, etc.) and / or when not constrained by the delivery shaft of the delivery device of the docking device. By way of example, the shape memory material may include a shape memory alloy (e.g., nitinol) and / or a shape memory polymer. Thus, the coil 102 can be wound and / or unwound between the coiled configurations shown in Figures 4 and 5 (also referred to as the "deployed configuration" and "spiral configuration") and the non-coiled configurations (also referred to as the "delivery configuration" and "substantially straight configuration").

[0086] In some embodiments, the coil 102 is configured to return to its original coiled configuration when released from the delivery shaft within the patient's heart. In some such embodiments, the coil 102 may be configured to return to its original coiled shape due to the warmth experienced within the patient's body and / or due to being released from the delivery shaft. Specifically, the coil 102 may have a transformation temperature (the temperature above which the coil 102 exhibits its shape memory effect and behaves superelastically) that is the same as or close to (e.g., slightly lower than) human body temperature (e.g., 37°C). In this manner, the coil 102 may be mechanically unwound to fit within the delivery shaft, for example, at temperatures below human body temperature. Once heated to its transformation temperature by the patient's body heat, the coil 102 may automatically and passively wind itself back into its original coiled configuration when released and / or removed from the delivery shaft within the patient's vasculature.

[0087] 4 and 5 show the coil 102 in its original, permanent shape (coiled configuration). As described above, the docking device 100 may have this coiled shape / structure before being loaded onto the delivery shaft and / or after being pushed and / or otherwise released from the delivery shaft, such as after deployment and / or implantation in the native heart valve. However, the coiled configuration shown in FIGS. 4 and 5 is not the final shape of the coil 102. The coil 102 may expand radially when the prosthetic heart valve is expanded within the docking device 100. Specifically, as described in more detail below, the third portion 124 of the second section 112 may expand radially such that the second portion 122 no longer extends radially outward from the third portion 124 and / or no longer flares radially outward. For example, the third portion 124 and the second portion 122 may substantially match after the prosthetic heart valve is expanded within the docking device 100. 20 and 21 and 23-35 show an exemplary coil in this final assembled configuration with the prosthetic heart valve expanded within the docking device.

[0088] The lumen 103 is defined by the coil 102 and is configured to receive a prosthetic heart valve. For example, the lumen 103 may be sized and / or shaped to receive the prosthetic heart valve. In some embodiments, the lumen 103 may be sized and / or shaped to receive the prosthetic heart valve when the prosthetic heart valve is in a radially compressed position (i.e., a delivery configuration) and configured to radially expand when the prosthetic heart valve is radially expanded therein. When a prosthetic heart valve is not deployed within the docking device 100 and the docking device 100 is not positioned within a patient, the lumen 103 may comprise a hollow or empty space within the coil 102. The lumen 103 may extend between the inner surfaces (radially inward-facing surfaces) of the coil 102 from the first end 106 to the second end 108 of the docking device 100.

[0089] The expandable sleeve 104 is configured to cover at least a portion of the coil 102 and provide a seal between the prosthetic heart valve and the tissue of the native heart valve to reduce PVL. As described above, the expandable sleeve 104 is configured to extend over the outflow section 112 of the coil 102 along the outflow side of the native valve. By positioning the PVL guard on the outflow (ventricular) side of the mitral valve, hemodynamic pressure (e.g., systolic blood pressure) can urge the PVL guard against and / or into (as opposed to away from) the native tissue, thereby providing a seal between the tissue of the native heart valve and the prosthetic heart valve. In some examples, the expandable sleeve 104 is configured to extend at least 100 degrees around the ventricular side of the anterior leaflet of the mitral valve toward and / or up to the anterolateral commissure of the mitral valve. By extending farther along the ventricular side of the mitral valve in this manner, the expandable sleeve 104 may reduce and / or prevent PVL around the prosthetic heart valve, particularly at and / or near the anterior-lateral and / or posteromedial commissures.

[0090] The expandable sleeve 104 includes a first end 126 (which may also be referred to herein as the "proximal end 126") and a second end 128 (which may also be referred to herein as the "distal end 128"). The expandable sleeve 104 covers at least a portion of the coil 102, as shown in Figures 4 and 5. Accordingly, the portions of the coil 102 that are covered by the expandable sleeve 104 are shown with dashed lines in Figures 4 and 5 to indicate that these portions of the coil 102 are not visible from outside the docking device 100.

[0091] In some embodiments, the expandable sleeve 104 may have a generally tubular shape that surrounds and completely covers the coil 102 along the length of the expandable sleeve 104 (from the first end 126 to the second end 128 of the expandable sleeve). That being said, the expandable sleeve 104 may be shorter than the coil 102 and, therefore, may not cover the entire length of the coil 102. For example, the expandable sleeve 104 may extend distally from the second portion 116 of the first section 110 of the coil 102 and / or the first portion 114 of the first section 110 of the coil 102 to the first portion 120 of the second section 112 of the coil 102.

[0092] In some such embodiments, the expandable sleeve 104 extends from at least the point where the first section 110 and the second section 112 intersect (where the second portion 116 of the first section 110 ends and the first portion 120 of the second section 112 begins) to a more distal position on the first portion 120 of the second section 112. Specifically, the expandable sleeve 104 can extend distally from the second portion 116 of the first section 110 to where it terminates at the first portion 120 of the second section 112 (i.e., at the second end 128) at least 90 degrees, at least 100 degrees, at least 110 degrees, at least 120 degrees, at least 130 degrees, at least 140 degrees, at least 150 degrees, at least 160 degrees, at least 170 degrees, at least 180 degrees, at least 190 degrees, at least 200 degrees, at least 210 degrees, at least 240 degrees, at least 270 degrees, at least 300 degrees, at least 330 degrees, at least 360 degrees, up to 540 degrees, up to 450 degrees, up to 360 degrees, up to 270 degrees, up to 240 degrees, up to 210 degrees, up to 180 degrees, and / or up to 150 degrees. Thus, in other words, the second end 128 of the expandable sleeve 104 can be positioned / located at least 90 degrees, at least 100 degrees, at least 110 degrees, at least 120 degrees, at least 130 degrees, at least 140 degrees, at least 150 degrees, at least 160 degrees, at least 170 degrees, at least 180 degrees, at least 190 degrees, at least 200 degrees, at least 210 degrees, at least 240 degrees, at least 270 degrees, at least 300 degrees, at least 330 degrees, at least 360 degrees, at most 540 degrees, at most 450 degrees, at most 360 degrees, at most 270 degrees, at most 240 degrees, at most 210 degrees, at most 180 degrees, and / or at most 150 degrees away from the second portion 116 of the first section 110 of the coil 102.

[0093] In some embodiments, the second end 128 of the expandable sleeve 104 is configured to be positioned at or proximate the anterior-lateral commissure, anterolateral, and / or A1 / P1 position of the mitral valve when implanted in the mitral valve. For example, the second end 128 of the expandable sleeve 104 can be positioned at 90 degrees or less, 80 degrees or less, 70 degrees or less, 60 degrees or less, 50 degrees or less, 40 degrees or less, 30 degrees or less, 20 degrees or less, 10 degrees or less, and / or 5 degrees or less from the anterior-lateral commissure and / or A1 / P1 position of the native mitral valve.

[0094] From the above, it should be clear that the expandable sleeve 104 extends proximally from its second end 128 of the docking device 100 over the coil 102 toward the first end 106 . In some embodiments, the expandable sleeve 104 extends from its second end 128 to its first end 126 at least 210 degrees, at least 230 degrees, at least 250 degrees, at least 270 degrees, at least 280 degrees, at least 290 degrees, at least 300 degrees, at least 310 degrees, at least 320 degrees, at least 330 degrees, at least 340 degrees, at least 350 degrees, at least 360 degrees, at least 370 degrees, at least 380 degrees, at least 390 degrees, at least 400 degrees, up to 720 degrees, up to 630 degrees, up to 540 degrees, up to 450 degrees, up to 420 degrees, up to 390 degrees, up to 380 degrees, up to 370 degrees, and / or up to 360 degrees. In other words, the expandable sleeve 104 can cover and / or surround at least 10%, at least 12%, at least 14%, at least 16%, at least 18%, at least 20%, at least 22%, at least 24%, at least 25%, at least 30%, at least 35%, up to 50%, up to 40%, up to 30%, and / or up to 25% of the length of the coil 102.

[0095] Thus, the expandable sleeve 104 can extend proximally from its second end 128 over the first portion 120 of the second section 112 of the coil 102, and over at least a portion or all of the second portion 116 of the first section 110. In some embodiments, the expandable sleeve 104 extends all the way to and / or over the first portion 114 of the first section 110. However, in other embodiments, the expandable sleeve 104 stops short of the first portion 114 of the first section 110 and does not extend the entire length of the second portion 116 of the first section 110 of the coil 102.

[0096] In some embodiments, the expandable sleeve 104 may be coupled to the coil 102 at its second end 128. In some such embodiments, the second end 128 may be fixedly attached and / or otherwise permanently secured to the coil 102 via one or more stitches, adhesive, and / or other bonding means. For example, U.S. Provisional Patent Application No. 63 / 105,099, filed October 23, 2020, entitled "PROSTHETIC VALVE DOCKING DEVICE," which is incorporated herein by reference in its entirety, describes various exemplary methods for attaching the expandable sleeve 104 to the coil 102.

[0097] In some such embodiments, only the second end 128 of the expandable sleeve 104 is fixedly coupled to the coil 102, with the remainder of the expandable sleeve 104 being free to float around, expand away from, and / or move axially relative to the coil 102. In some such embodiments, the expandable sleeve 104 may be configured to slide toward the second end 128 relative to the coil 102 when it radially expands after the crimping pressure is released, such as when the coil 102 is released from the delivery device of the docking device. However, in other embodiments, the first end 126 of the expandable sleeve 104 and / or other portions of the expandable sleeve 104 may also or alternatively be coupled to the coil 102 via stitching, adhesive, and / or other bonding means.

[0098] The expandable sleeve 104 is deformable and configured to radially expand when the crimping pressure is released, such as when the sleeve shaft (e.g., the sleeve shaft 34 described above) is retracted, removed, and / or otherwise withdrawn from the expandable sleeve 104. That is, the expandable sleeve 104 may be self-expanding and configured to radially expand when not constrained by a sleeve. In particular, the expandable sleeve 104 may be configured to expand and / or contract between an expanded position (e.g., FIG. 15) and a compressed position (e.g., FIG. 14). For example, the expandable sleeve 104 may include a shape memory material (e.g., nitinol and / or memory foam) configured to return to its original, permanent shape (expanded position) in response to a stimulus (e.g., temperature change, electrical current, electromagnetic radiation, mechanical stress, etc.) and / or upon removal of the crimping pressure (e.g., when not constrained by the sleeve shaft).

[0099] In some such embodiments, the expandable sleeve 104 may be configured to return to its original expanded position due to warming experienced within the patient's body and / or upon removal of the crimping pressure (e.g., when released from the sleeve shaft). Specifically, the expandable sleeve 104 may have a transformation temperature (the temperature above which the coil 102 exhibits its shape memory effect and behaves superelastically) that is the same as or close to (e.g., slightly lower than) human body temperature (e.g., 37°C). In this manner, the expandable sleeve 104 may be radially compressed and extended (longitudinal / axially stretched) within the sleeve shaft, for example, at temperatures below human body temperature. Once heated to its transformation temperature by the patient's body heat, the expandable sleeve 104 may automatically and passively radially expand and longitudinally / axially compress (i.e., shorten) to its original expanded position when released and / or removed from the sleeve shaft within the patient's vasculature. As another example, expandable sleeve 104 comprises memory foam configured to radially expand to a preset shape upon removal of the crimping pressure (e.g., when removed from the delivery device of the docking device and / or the sleeve shaft of the docking device). When expanding sleeve 104 moves from the compressed position to the expanded position, it shortens axially so that it can slide axially over coil 102 toward second end 108 of coil 102.

[0100] 4 and 5 show the expandable sleeve 104 in its original, permanent shape (expanded position). As mentioned above, the expandable sleeve 104 may be in this expanded position before being loaded onto the sleeve shaft and / or after being pushed and / or otherwise released from the sleeve shaft, such as after being deployed and / or implanted into the native heart valve.

[0101] In some embodiments, the expandable sleeve 104 may be tapered at and / or proximate the second end 128. That is, the expandable sleeve 104 may narrow (expand radially inward toward the coil 102) near and / or at the second end 128. In some such embodiments, the expandable sleeve 104 may be narrowest at the second end 128, such that the second end 128 is narrower than the remainder of the expandable sleeve 104.

[0102] 6 and 7 illustrate a docking apparatus 200 according to another embodiment. Specifically, FIG. 6 illustrates a side perspective view of the docking apparatus 200, and FIG. 7 illustrates a top view of the docking apparatus 200. The docking apparatus 200 may include one or more components that are generally similar to one or more components of the docking apparatus 100. Therefore, for the sake of brevity, components of the docking apparatus 200 that are similar to components of the docking apparatus 100 are similarly labeled and may not include additional description. For example, the docking apparatus 200 includes a coil 202 and an expandable sleeve 204, having a first end 206 and a second end 208 (corresponding to the coil 102, expandable sleeve 104, first end 106, and second end 108 of the docking apparatus 100, respectively).

[0103] However, in the embodiment of FIGS. 6 and 7 , the expandable sleeve 204 comprises two separate sleeves, a first expandable sleeve 230 and a second expandable sleeve 232, separated from one another over the coil 202 by a gap 234. Thus, in the embodiment of FIGS. 6 and 7 , the expandable sleeve 204 does not cover and / or surround the coil 202 at the gap 234, and thus the coil 202 may be exposed where the gap 234 is present. As an example, the first expandable sleeve 230 may be positioned on the inflow side of the native valve (and thus may cover at least a portion of the first section 210 of the coil 202), and the second expandable sleeve 232 may be positioned on the outflow side of the native valve (and thus may cover at least a portion of the second section 212 of the coil 202). In this manner, the sleeves 230, 232 can reduce or eliminate PVL.

[0104] The first expandable sleeve 230 has a first end 236 (which may also be referred to herein as the “proximal end 236”) and a second end 238 (which may also be referred to herein as the “distal end 238”). Similarly, the second expandable sleeve 232 has a first end 240 (which may also be referred to herein as the “proximal end 240”) and a second end 242 (which may also be referred to herein as the “distal end 242”). The first end 236 of the first expandable sleeve 230 may be similar to and / or correspond to the first end 126 of the expandable sleeve 104 of the docking device 10 and may be positioned / disposed at the same and / or similar location on the coil 202. For example, the first end 236 of the first expandable sleeve 230 may be positioned / located at the first portion 214 of the first section 210, at the junction of the first portion 214 and the second portion 216 of the first section 210, and / or at the second portion 216 of the first section 210. Additionally or alternatively, the second end 242 of the second expandable sleeve 232 may be similar to and / or correspond to the second end 128 of the expandable sleeve 104 of the docking device 100 and may be positioned / located at the same and / or similar location on the coil 202. For example, the second end 242 can be positioned / disposed distally at least 90 degrees, at least 100 degrees, at least 110 degrees, at least 120 degrees, at least 130 degrees, at least 140 degrees, at least 150 degrees, at least 160 degrees, at least 170 degrees, at least 180 degrees, at least 190 degrees, at least 200 degrees, at least 210 degrees, at least 240 degrees, at least 270 degrees, at least 300 degrees, at least 330 degrees, at least 360 degrees, up to 540 degrees, up to 450 degrees, up to 360 degrees, up to 270 degrees, up to 240 degrees, up to 210 degrees, up to 180 degrees, and / or up to 150 degrees away from the junction of the first section 210 and the second section 212. Thus, the length of the coil 202 existing between the first end 236 of the first expandable sleeve 230 and the second end 242 of the second expandable sleeve 232 may be the same as and / or similar to the length of the coil 202 existing between the first end 126 and the second end 128 of the expandable sleeve 104.

[0105] The gap 234 may be in the first portion 220 of the second section 212 of the coil 202 and may extend distally from and / or near the junction of the first portion 220 and the first section 210 toward the second end 208 of the docking device 200. Thus, the first portion 220 of the second section 212 of the coil 202 may be exposed by the gap 234. The gap 234 may be configured to be positioned at, adjacent to, and / or proximal to the inflow and / or outflow tracts of an adjacent heart valve. For example, the gap 234 may be positioned at, adjacent to, and / or proximal to the anterior leaflet of the native mitral valve and / or the left ventricular outflow tract (LVOT) of the left ventricle when the docking device 200 is implanted in a native mitral valve. In this manner, the docking device 200 may reduce and / or prevent blockage to blood flow through the aortic valve.

[0106] The gap 234 separates the first expandable sleeve 230 from the second expandable sleeve 232 so that the first expandable sleeve 230 and the second expandable sleeve 232 do not directly contact each other, at least when the first expandable sleeve 230 and the second expandable sleeve 232 are in the expanded positions shown in FIGS. 6 and 7 . That said, the second expandable sleeve 232 may be in direct physical contact with the first expandable sleeve 230 when the second expandable sleeve 232 is radially compressed and extended (axially stretched) in a compressed position, such as when constrained within a sleeve shaft. Thus, the length of the gap 234 may vary depending on whether the second expandable sleeve 232 is in a compressed or expanded position. In particular, the length of the gap 234 may increase when the second expandable sleeve 232 radially expands (and shortens longitudinally / axially) from its compressed position to its expanded position, such as when released from the sleeve shaft.

[0107] In the expanded position shown in Figures 6 and 7, the gap 234 can extend at least 10 degrees, at least 20 degrees, at least 30 degrees, at least 40 degrees, at least 50 degrees, at least 60 degrees, at least 70 degrees, at least 80 degrees, at least 90 degrees, up to 180 degrees, up to 160 degrees, up to 140 degrees, up to 120 degrees, up to 110 degrees, up to 100 degrees, up to 90 degrees, up to 80 degrees, up to 70 degrees, and / or up to 60 degrees and / or separate the first expandable sleeve 230 and the second expandable sleeve 232.

[0108] The second expandable sleeve 232 may extend proximally from its second end 242 toward the first section 210 but may stop short of the first section 210. Additionally or alternatively, the first expandable sleeve 230 may extend distally from its first end 236 toward the second section 212 but may stop short of the second section 212. By way of example, the second expandable sleeve 232 may extend proximally from the second end 242 and / or the first expandable sleeve 230 may extend at least 30 degrees, at least 60 degrees, at least 80 degrees, at least 90 degrees, at least 100 degrees, at least 110 degrees, at least 120 degrees, at least 130 degrees, at least 140 degrees, at least 150 degrees, at least 160 degrees, at least It may extend distally by at least 170 degrees, at least 180 degrees, at least 190 degrees, at least 200 degrees, up to 270 degrees, up to 250 degrees, up to 230 degrees, up to 210 degrees, up to 200 degrees, up to 190 degrees, up to 180 degrees, up to 170 degrees, up to 160 degrees, up to 150 degrees, up to 140 degrees, up to 130 degrees, up to 120 degrees, up to 110 degrees, up to 110 degrees, and / or up to 100 degrees.

[0109] In some embodiments, the second expandable sleeve 232 can be coupled to the coil 202 at its second end 242. For example, the second end 242 can be fixedly attached and / or otherwise permanently secured to the coil 202 via one or more stitches, adhesive, and / or other suitable coupling mechanisms, similar to the second end 128 of the expandable sleeve 104. Additionally or alternatively, the first expandable sleeve 230 can be coupled to the coil 202 at its second end 238. For example, the second end 238 can be fixedly attached and / or otherwise permanently secured to the coil 202 via one or more stitches, adhesive, and / or other suitable coupling mechanisms, similar to the second end 128 of the expandable sleeve 104.

[0110] In some such embodiments, only the second end 238 of the first expandable sleeve 230 and / or the second end 242 of the second expandable sleeve 232 are coupled to the coil 202, with the remainder of the first expandable sleeve 230 and / or the second expandable sleeve 232 being free to float around, expand away from, and / or move axially relative to the coil 202. However, in other embodiments, the first end 236 of the first expandable sleeve 230, the first end 240 of the second expandable sleeve 232, and / or other portions of the first expandable sleeve 230 and / or the second expandable sleeve 232 may also or alternatively be coupled to the coil 202 via stitching, adhesive, and / or other suitable coupling mechanisms.

[0111] In some embodiments, the second end 238 of the first expandable sleeve 230 is configured to be positioned at the junction of the first section 210 and the second section 212 of the coil 202 (i.e., at the distal end of the first section 210). In some embodiments, the second end 242 of the second expandable sleeve 232 is configured to be positioned at least 120 degrees, at least 130 degrees, at least 140 degrees, at least 150 degrees, at least 160 degrees, at least 170 degrees, at least 180 degrees, at least 190 degrees, at least 200 degrees, at least 210, at least 220, at most 360 degrees, at most 270 degrees, at most 230 degrees, at most 210 degrees, at most 200 degrees, at most 190 degrees, and / or at most 180 degrees from the first section 210.

[0112] In some embodiments, first expandable sleeve 230 and / or second expandable sleeve 232 may be tapered at and / or adjacent second end 238 and / or second end 242, respectively. That is, first expandable sleeve 230 may be narrower (extending radially inward toward coil 202) and / or at second end 238 and / or second expandable sleeve 232 may be narrower (extending radially inward toward coil 202) and / or at second end 242. In some such embodiments, first expandable sleeve 230 and / or second expandable sleeve 232 may be narrowest at second end 238 and / or second end 242, respectively, such that second end 238 and / or second end 242 are narrower than the remainder of first expandable sleeve 230 and / or second expandable sleeve 232, respectively.

[0113] In some embodiments, first expandable sleeve 230 and / or second expandable sleeve 232 may additionally or alternatively be tapered (extending radially inward toward coil 202) at and / or adjacent first end 236 and / or first end 240, respectively. That is, first expandable sleeve 230 may narrow near and / or at first end 236, and / or second expandable sleeve 232 may narrow near and / or at first end 240.

[0114] Specifically, first expandable sleeve 230 may comprise a first portion 244 extending distally from first end 236, a second portion 246 extending proximally from second end 238, and a third portion 248 disposed between first portion 244 and second portion 246 and thicker (i.e., extending radially farther from coil 202) than first portion 244 and second portion 246. For example, third portion 248 may extend radially at least 1.2 times, at least 1.4 times, at least 1.6 times, at least 1.8 times, at least 2 times, at least 2.5 times, at least 3 times, at most 10 times, at most 9 times, at most 8 times, at most 7 times, at most 6 times, at most 5 times, at most 4 times, and / or at most 3 times further radially from coil 202 than first portion 244 and / or second portion 246. In some such embodiments, first portion 244 and / or second portion 246 may be tapered such that first portion 244 narrows monotonically toward first end 236 and / or second portion 246 narrows monotonically toward second end 238.

[0115] Similarly, second expandable sleeve 232 may include a first portion 250 extending distally from first end 240, a second portion 252 extending proximally from second end 242, and a third portion 254 disposed between first portion 250 and second portion 252 and thicker than first portion 250 and second portion 252. For example, third portion 254 may extend radially at least 1.2 times, at least 1.4 times, at least 1.6 times, at least 1.8 times, at least 2 times, at least 2.5 times, at least 3 times, up to 10 times, up to 9 times, up to 8 times, up to 7 times, up to 6 times, up to 5 times, up to 4 times, and / or up to 3 times farther from coil 302 than first portion 250 and / or second portion 252. As another example, the cross-sectional area of ​​third portion 254 (e.g., when viewed in an orthogonal cross-section such as cross-section AA) can be at least 1.5 times, at least 2 times, at least 2.5 times, at least 3 times, at least 3.5 times, at least 4 times, at most 50 times, at most 40 times, at most 30 times, at most 20 times, at most 10 times, at most 8 times, and / or at most 6 times the cross-sectional area of ​​first portion 250 and / or second portion 252.

[0116] In some such embodiments, first portion 250 and / or second portion 252 may be tapered such that first portion 250 narrows monotonically toward first end 240 and / or second portion 252 narrows monotonically toward second end 242.

[0117] First portion 244 and / or first portion 250 can comprise at least 5%, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at most 60%, at most 55%, at most 50%, at most 45%, at most 40%, and / or at most 35% of the length of first expandable sleeve 230 and / or second expandable sleeve 232, respectively. Second portion 246 and / or second portion 252 can comprise at least 5%, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at most 60%, at most 55%, at most 50%, at most 45%, at most 40%, and / or at most 35% of the length of first expandable sleeve 230 and / or second expandable sleeve 232, respectively. Third portion 248 and / or third portion 254 may comprise at least 20%, at least 30%, at least 40%, at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, up to 90%, up to 85%, up to 80%, up to 75%, up to 70%, up to 65%, up to 60%, up to 55%, and / or 50% of the length of first expandable sleeve 230 and / or second expandable sleeve 232, respectively.

[0118] 8 and 9 illustrate a docking apparatus 300 according to another embodiment. Specifically, FIG. 8 illustrates a side perspective view of the docking apparatus 300, and FIG. 9 illustrates a top view of the docking apparatus 300. The docking apparatus 300 may include one or more components that are generally similar to one or more components of the docking apparatus 100. Therefore, for the sake of brevity, components of the docking apparatus 300 that are similar to components of the docking apparatus 100 are similarly labeled and may not include additional description. For example, the docking apparatus 300 includes a coil 302 and an expandable sleeve 304, having a first end 306 and a second end 308 (corresponding to the coil 102, expandable sleeve 104, first end 106, and second end 108 of the docking apparatus 100, respectively).

[0119] 8 and 9, the midsection of the coil 302 is tapered, which may be configured to be positioned at and / or proximate to the inflow and / or outflow tracts of an adjacent heart valve (e.g., at and / or near the LVOT if the docking device is implanted in a native mitral valve). Thus, the expandable sleeve 304 may reduce and / or prevent obstruction to blood flow through the adjacent native heart valve.

[0120] Expandable sleeve 304 may include a first portion 330 extending distally from first end 326, a second portion 332 extending proximally from second end 328, and a third portion 334 (which may also be referred to herein as “tapered portion 334,” “intermediate tapered portion 334,” and / or “intermediate portion 334”) disposed between first portion 330 and second portion 332 and narrower than first portion 330 and second portion 332. For example, first portion 330 and / or second portion 332 may extend at least 1.2 times, at least 1.4 times, at least 1.6 times, at least 1.8 times, at least 2 times, at least 2.5 times, at least 3 times, up to 10 times, up to 9 times, up to 8 times, up to 7 times, up to 6 times, up to 5 times, up to 4 times, and / or up to 3 times radially farther from coil 302 than third portion 334. As another example, the cross-sectional area of ​​first portion 330 and / or second portion 332 (e.g., when viewed in an orthogonal cross-section such as cross-section AA) can be at least 1.5 times, at least 2 times, at least 2.5 times, at least 3 times, at least 3.5 times, at least 4 times, at most 50 times, at most 40 times, at most 30 times, at most 20 times, at most 10 times, at most 8 times, and / or at most 6 times the cross-sectional area of ​​third portion 334.

[0121] The third portion 334 may cover, surround, and / or be disposed at the junction between the first section 310 and the second section 312 of the coil 302 (which may be configured to be positioned at or proximal to the posteromedial and / or A3 / P3 position of the native mitral valve). In some such embodiments, the third portion 334 of the coil 302 is configured to be positioned at or proximal to the inflow and / or outflow tract of an adjacent native heart valve. For example, the third portion 334 of the coil 302 may be configured to be positioned at or proximal to the left ventricular outflow tract (LVOT). In this manner, the intermediate tapered portion 334 may reduce and / or prevent obstruction to blood flow through the native aortic valve.

[0122] The third portion 334 may comprise at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at least 45%, at least 50%, up to 75%, up to 65%, up to 55%, up to 50%, up to 45%, and / or up to 40% of the length of the expandable sleeve 304.

[0123] 10-13 illustrate exemplary docking devices according to other embodiments in which a first portion of the second section of the coil (e.g., the uppermost ventricular turn) includes a different geometry (shape and / or size) than a third portion of the second section (e.g., the ventricular-side functional turn of the coil). Specifically, the first portion of the second section may define a larger cross-sectional area and / or may be non-circular than the third portion of the second section. By extending radially outward beyond the third portion and / or more closely conforming to the shape of the native valve annulus, the first portion of the second section of the coil may help secure the docking device and / or prosthetic heart valve in place against the tissue of the native heart valve, thereby reducing and / or preventing PVL.

[0124] 10 and 11 illustrate a docking device 400 according to yet another embodiment. Specifically, FIG. 10 illustrates a side perspective view of the docking device 400, and FIG. 11 illustrates a top view of the docking device 400. The docking device 400 may include one or more components that are generally similar to one or more components of the docking device 100. Therefore, for the sake of brevity, components of the docking device 400 that are similar to components of the docking device 100 are similarly labeled and may not include additional description. For example, the docking device 400 includes a coil 402 and an expandable sleeve 404, having a first end 406 and a second end 408 (corresponding to the coil 102, expandable sleeve 104, first end 106, and second end 108 of the docking device 100, respectively).

[0125] 10 and 11 , the coil 402 comprises a different geometry (shape and / or size) than the coil 102 of the docking apparatus 100. Specifically, in the embodiments of FIGS. 10 and 11 , the first portion 420 of the second section 412 may comprise a larger turn than the first portion 120 of the second section 112 of the coil 102. Thus, in the embodiments of FIGS. 10 and 11 , the first portion 420 of the second section 412 extends radially outward from the third portion 424 of the second section 412. In some such embodiments, the first portion 420 may still be substantially the same shape (e.g., circular when viewed from above in a plane perpendicular to the longitudinal axis 419) as the first portion 120 of the docking apparatus 100 and, therefore, substantially the same shape as the third portion 424 of the second section 412.

[0126] First portion 420 may comprise a first segment 436, a second segment 438, and a third segment 440 disposed between first segment 436 and second segment 438. The first segment extends distally from second portion 416 of first section 410, the third segment 440 extends distally from first segment 436, and the second segment 438 extends distally from third segment 440. First segment 436 flares and / or extends radially outward from second portion 416 of first section 410 of coil 402. Third segment 440 may then extend distally from first segment 436 in a generally circular pattern (and may maintain a substantially consistent radial distance from third portion 424 of second section 412 of coil 402). Second segment 438 may flare and / or extend radially inward from third segment 440 toward third portion 424 of second section 412 of coil 402 and may merge with third portion 424 .

[0127] The first portion 420, like the first portion 120, may extend at least 180 degrees, at least 220 degrees, at least 260 degrees, at least 300 degrees, at least 320 degrees, at least 340 degrees, at least 360 degrees, at least 380 degrees, at least 400 degrees, at least 420 degrees, at most 540 degrees, at most 500 degrees, at most 460 degrees, at most 420 degrees, at most 380 degrees, at most 360 degrees, at most 340 degrees, and / or at most 320 degrees between the second portion 416 of the first section 410 of the coil 402 and the third portion 424 of the second section 412 of the coil 402. In some embodiments, the third segment 440 comprises at least 50%, at least 60%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, up to 99%, up to 97%, up to 95%, up to 90%, up to 85%, up to 80%, and / or up to 75% of the angular length (e.g., radians, degrees, etc.) of the first portion 420.

[0128] In some embodiments, the radial distance (i.e., the shortest linear radial distance) between first portion 420 and third portion 424 may be at least 5%, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, at least 100%, at most 500%, at most 400%, at most 300%, at most 200%, at most 150%, at most 100%, and / or at most 75% of the radius of rotation of third portion 424. Stated differently, the cross-sectional area defined by first portion 420 (in a plane perpendicular to longitudinal axis 419) can be at least 5%, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 85%, at least 100%, at least 150%, at least 200%, at least 250%, at least 300%, at least 400%, at least 500%, up to 2500%, up to 2000%, up to 1000%, up to 600%, up to 500%, up to 400%, up to 300%, up to 200%, and / or up to 100% greater than the cross-sectional area defined by third portion 424. In other words, the cross-sectional area defined by first portion 420 (in a plane perpendicular to longitudinal axis 419) can be at least 1.2 times, at least 1.4 times, at least 1.6 times, at least 1.8 times, at least 2 times, at least 2.5 times, at least 3 times, at least 3.5 times, at least 4 times, at least 4.5 times, at least 5 times, up to 25 times, up to 20 times, up to 15 times, up to 10 times, up to 5 times, and / or up to 4 times greater than the cross-sectional area defined by third portion 424.

[0129] 10 and 11 depict first portion 420 as being circular when viewed from above in a plane perpendicular to longitudinal axis 419, it should be understood that first portion 420 may include shapes different from those depicted in FIGS. 10 and 11 , such as one or more of an oval, a crescent, a D-shape, and / or other non-circular curved shapes. In some embodiments, first portion 420 may be shaped the same as and / or similar to the annulus of a native heart valve. For example, when implanted in a mitral valve, first portion 420 may be substantially D-shaped and / or crescent-shaped (as shown in FIGS. 12 and 13 ), since the annulus of the mitral valve may be substantially D-shaped and / or crescent-shaped.

[0130] 8 and 9 and / or may include one or more components generally similar to one or more components of expandable sleeve 304. Thus, for brevity, components of expandable sleeve 404 that are similar to components of expandable sleeve 304 will be labeled similarly and may not include additional description. For example, expandable sleeve 404 may include a tapered mid-section. More specifically, the expandable sleeve 404 may include a first portion 430 extending distally from a first end 426 of the expandable sleeve 404, a second portion 432 extending proximally from a second end 428 of the expandable sleeve 404, and a third portion 434 (which may also be referred to herein as a "tapered portion 434," an "intermediate tapered portion 434," and / or an "intermediate portion 434") disposed between the first portion 430 and the second portion 432 and which may be narrower than the first portion 430 and the second portion 432 (corresponding to the first portion 330, the second portion 332, and the third portion 334 of the expandable sleeve 304).

[0131] 12 and 13 illustrate a docking apparatus 500 according to another embodiment. Specifically, FIG. 12 illustrates a side perspective view of the docking apparatus 500, and FIG. 13 illustrates a top view of the docking apparatus 500. The docking apparatus 500 may include one or more components that are generally similar to one or more components of the docking apparatus 100. Therefore, for the sake of brevity, components of the docking apparatus 500 that are similar to components of the docking apparatus 100 are similarly labeled and may not include additional description. For example, the docking apparatus 500 includes a coil 502 and an expandable sleeve 504, having a first end 506 and a second end 508 (corresponding to the coil 102, expandable sleeve 104, first end 106, and second end 108, respectively, of the docking apparatus 100).

[0132] 12 and 13, however, the coil 502 comprises a different geometry (shape and / or size) than the coil 102 of the docking apparatus 100. Specifically, in the embodiment of FIGS. 12 and 13, the first portion 520 of the second section 512 may comprise a turn of a significantly different shape than the first portion 120 of the second section 112 of the coil 102. The first portion 520 may be substantially D-shaped and / or crescent-shaped when viewed from above in a plane perpendicular to the longitudinal axis 519. Furthermore, the first portion 520 may be larger than the third portion 524 of the second section 512 of the coil 502 and may extend radially outward from the third portion 524.

[0133] In particular, the cross-sectional area defined by first portion 520 (in a plane perpendicular to longitudinal axis 519) can be at least 5%, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 85%, at least 100%, at least 150%, at least 200%, at least 250%, at least 300%, at least 400%, at least 500%, up to 2500%, up to 2000%, up to 1000%, up to 600%, up to 500%, up to 400%, up to 300%, up to 200%, and / or up to 100% greater than the cross-sectional area defined by third portion 524. In other words, the cross-sectional area defined by first portion 520 (in a plane perpendicular to longitudinal axis 519) can be at least 1.2 times, at least 1.4 times, at least 1.6 times, at least 1.8 times, at least 2 times, at least 2.5 times, at least 3 times, at least 3.5 times, at least 4 times, at least 4.5 times, at least 5 times, up to 25 times, up to 20 times, up to 15 times, up to 10 times, up to 5 times, and / or up to 4 times greater than the cross-sectional area defined by third portion 524. In other words, the radial distance (i.e., the shortest straight-line radial distance) between first portion 520 and third portion 524 may be at least 5%, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, at least 100%, at most 500%, at most 400%, at most 300%, at most 200%, at most 150%, at most 100%, and / or at most 75% of the radius of turn of third portion 524. However, because first portion 520 may be substantially D-shaped and / or crescent-shaped, the radial distance between first portion 520 and third portion 524 may not be uniform (i.e., the radial distance between third portion 524 and first portion 520 may vary along the length of first portion 520).

[0134] In some embodiments, first portion 520 comprises a first segment 536, a second segment 538, and a third segment 540 disposed between first segment 536 and second segment 538. The first segment extends distally from second portion 516 of first section 510, the third segment 540 extends distally from first segment 536, and the second segment 538 extends distally from third segment 540. First segment 536 flares and / or extends radially outward from second portion 516 of first section 510 of coil 502. Third segment 540 may then extend distally from first segment 536 in a generally non-circular, curved manner (thereby having a variable radial distance to third portion 524 of second section 512 of coil 502). Second segment 538 may flare and / or extend radially inward from third segment 540 toward third portion 524 of second section 512 of coil 502 and may merge with third portion 524 .

[0135] In this manner, first segment 536, second segment 538, and third segment 540 may create a substantially D-shaped and / or crescent-shaped profile for first portion 520 when viewed from above in a plane perpendicular to longitudinal axis 519. In particular, first segment 536 and second segment 538 may form a concave surface 542 when viewed from above in a plane perpendicular to longitudinal axis 519, and third segment 540 may form a convex surface 544 when viewed from above in a plane perpendicular to longitudinal axis 519. Accordingly, first segment 536 and third segment 540 may form a first corner angle 546 (which may also be referred to herein as a “first shoulder 546”) where they meet, and similarly, second segment 538 and third segment 540 may form a second corner angle 548 (which may also be referred to herein as a “second shoulder 548”) where they meet. In some embodiments, first portion 520 is radially furthest from third portion 524 at corners 546 and 548. That is, corners 546 and 548 are positioned radially farther from third portion 524 than the remainder of first portion 520.

[0136] In some embodiments, angles 546 and 548 are configured to be positioned at, adjacent to, and / or proximate to the anterolateral (and / or A1 / P1 location) and posteromedial (and / or A3 / P3 location) commissures of the native mitral valve, respectively. In this manner, first portion 520 can extend closer to the commissures of the native heart valve, thereby providing an improved seal between the prosthetic heart valve and the tissue of the native heart valve and reducing paravalvular leakage at and / or near the commissures.

[0137] The first portion 520, like the first portion 120, may extend at least 180 degrees, at least 220 degrees, at least 260 degrees, at least 300 degrees, at least 320 degrees, at least 340 degrees, at least 360 degrees, at least 380 degrees, at least 400 degrees, at least 420 degrees, at most 540 degrees, at most 500 degrees, at most 460 degrees, at most 420 degrees, at most 380 degrees, at most 360 degrees, at most 340 degrees, and / or at most 320 degrees between the second portion 516 of the first section 510 of the coil 502 and the third portion 524 of the second section 512 of the coil 502.

[0138] 8 and 9 and / or may include one or more components generally similar to one or more components of expandable sleeve 304. Thus, for brevity, components of expandable sleeve 504 that are similar to components of expandable sleeve 304 will be labeled similarly and may not include additional description. For example, expandable sleeve 504 may include a mid-section that is tapered. More specifically, the expandable sleeve 504 may include a first portion 530 extending distally from a first end 526 of the expandable sleeve 504, a second portion 532 extending proximally from a second end 528 of the expandable sleeve 504, and a third portion 534 (which may also be referred to herein as a "tapered portion 534," an "intermediate tapered portion 534," and / or an "intermediate portion 534") disposed between the first portion 530 and the second portion 532 and which may be narrower than the first portion 530 and the second portion 532 (corresponding to the first portion 330, the second portion 332, and the third portion 334 of the expandable sleeve 304, respectively).

[0139] Although Figures 4-13 illustrate three different coil geometries (the first coil geometry in Figures 4-9, the second coil geometry in Figures 10 and 11, and the third coil geometry in Figures 12 and 13) and three different expandable sleeve geometries (the first sleeve geometry in Figures 4 and 5, the second sleeve geometry in Figures 6 and 7, and the third sleeve geometry in Figures 8-13), it should be understood that the coil and / or the expandable sleeve may comprise other geometries. For example, the first portion of the second section of the coil may include and / or define a shape and / or size different from the circular and D- or crescent-shaped geometries shown in Figures 4-13. For example, the first portion may be elliptical when viewed from above in a plane perpendicular to the longitudinal axis of the lumen and / or may include other curved geometries.

[0140] Additionally, although the second coil geometry shown in FIGS. 10 and 11 and the third coil geometry shown in FIGS. 12 and 13 are illustrated as having the third sleeve geometry shown in FIGS. 8 and 9, it should be understood that the docking device may include other sleeve geometries in place of the third sleeve geometry. For example, docking devices 400 and / or 500 shown in FIGS. 10 and 11 and 12 and 13, respectively, may include two separate expandable sleeves, such as first expandable sleeve 230 and second expandable sleeve 232 of FIGS. 6 and 7. As another example, the expandable sleeves of docking devices 400 and / or 500 may not be tapered at their midsections. For example, docking devices 400 and / or 500 may include expandable sleeve 104 shown in FIGS. 4 and 5. Thus, while Figures 4-13 show particular pairings of exemplary coil and sleeve geometries, it should be understood that these coil and / or sleeve geometries may be modified, varied, and / or used in combinations other than those shown in Figures 4-13.

[0141] Additionally, it should be understood that, apart from the first portion of the second section, the coils of the docking device (100, 200, 300, 400, 500) can have substantially the same geometric shape. That is, the first section of the coil, and the second and third portions of the second section can be substantially the same size and / or shape. Accordingly, descriptions of these portions of the coil 102 of the docking device 100 (i.e., first section 110, second portion 122, and third portion 124) can equally apply to similarly numbered portions of the coils 202, 302, 402, and / or 502. Similarly, apart from the midsection (which may be tapered or absent in the docking devices of FIGS. 6-13), the expandable sleeve can have substantially the same geometric shape. Therefore, other geometric configurations of expandable sleeve 104 shown in Figures 4 and 5, such as the overall length of expandable sleeve 104 (the angular length from first end 126 to second end 128 of the expandable sleeve), the maximum thickness of expandable sleeve 104, and the taper at second end 128 of the expandable sleeve, may be equally applied to expandable sleeves 204, 304, 404, and / or 504.

[0142] 14 and 15 show cross-sectional views of docking device 600 (which may include any one or more of docking devices 100, 200, 300, 400, and / or 500 shown in FIGS. 4-13) taken along section plane AA shown in FIGS. 5, 7, 9, 11, and 13. Specifically, FIG. 14 shows the expandable sleeve of docking device 600 in a compressed position (radially compressed and axially stretched), and FIG. 15 shows the expandable sleeve in an expanded position (radially expanded and axially shortened). As mentioned above, the expandable sleeve may be in the compressed position when docking device 600 is still retained within a docking device delivery device (e.g., docking device delivery device 18 described above) and / or prior to retraction of the sleeve shaft (e.g., sleeve shaft 34 described above). The expandable sleeve may be radially expanded to an expanded position after being removed from the docking device delivery device and / or after removal of the crimping pressure (such as after retraction of the sleeve shaft), one or both of which may occur during and / or after implantation and / or deployment of the docking device 600.

[0143] Docking apparatus 600 may include one or more components generally similar to one or more components of docking apparatuses 100, 200, 300, 400, and 500. Accordingly, for the sake of brevity, components of docking apparatus 600 that are similar to components of docking apparatuses 100, 200, 300, 400, and 500 will be similarly labeled and may not include additional description. Specifically, docking apparatus 600 includes a coil 602 and an expandable sleeve 604 (corresponding to coil 102, coil 202, coil 302, coil 402, and / or coil 502 and expandable sleeve 104, expandable sleeve 204, expandable sleeve 304, expandable sleeve 404, and / or expandable sleeve 504, respectively, of docking apparatuses 100, 200, 300, 400, and / or 500).

[0144] In the embodiment of Figures 14 and 15, the coil 602 comprises a core 650 and optionally includes a first cover 652, and the expandable sleeve 604 comprises an expandable member 654 and optionally includes a second cover 656.

[0145] Core 650 may include a shape memory material (e.g., nitinol) configured to respond to a stimulus (e.g., temperature change, electrical current, electromagnetic radiation, mechanical stress, etc.) and / or return to its original, permanent shape (e.g., coiled configuration) from a temporarily deformed shape (e.g., unrolled configuration) when unconstrained by a delivery shaft (e.g., delivery shaft 20 described above) of a delivery device of a docking device. As described above, core 650 may be initially set, formed, and / or otherwise constructed to have a generally coiled configuration, such as any one or more of the coiled geometries described above in FIGS. 4-13. The shape memory material may include a shape memory alloy (e.g., nitinol) and / or a shape memory polymer.

[0146] The first cover 652 can radially surround and / or encase the core 650, as shown in FIGS. 14 and 15 , and can be configured to provide cushioning and / or padding between the core 650 and the expandable member 654 to protect the core 650. In some embodiments, the first cover 652 can cover and / or encase the entire length of the core 650 (from the first end to the second end of the coil 602). However, in other embodiments, the first cover 652 can cover only a selected portion(s) of the core 650. In some embodiments, the first cover 652 can be formed and / or constructed from a variety of natural and / or synthetic materials. In one particular embodiment, the first cover can be formed and / or constructed from expanded polytetrafluoroethylene (ePTFE).

[0147] As described above, the expandable sleeve 604 may be configured to expand radially to provide an improved seal between the prosthetic heart valve and the tissue of the native valve and to reduce and / or prevent paravalvular leakage. Specifically, the expandable sleeve 604 may be configured to expand to cover and / or fill any openings in the leaflets of the native heart valve that may be present around the edges of the prosthetic heart valve.

[0148] The expandable member 654 may comprise a shape memory material (e.g., nitinol, memory foam, etc.) configured to respond to a stimulus (e.g., temperature change, electrical current, electromagnetic radiation, mechanical stress, etc.) and / or return from a temporarily deformed shape (e.g., compressed position) to its original, permanent shape (e.g., expanded position) when not subjected to crimping pressure (e.g., when the sleeve shaft (e.g., sleeve shaft 34 described above) of the delivery device of the docking device is removed from the expandable member 654). For example, as described above, the expandable member 654 may initially be set, formed, and / or otherwise constructed to be in the expanded position (shown in FIG. 15 ), but may be radially compressed and axially stretched to the compressed position (shown in FIG. 14 ), e.g., to fit within the delivery device of the docking device. However, the expandable member 654 is configured to radially expand and axially shorten to the expanded position when released from the delivery device of the docking device. In this manner, a gap 658 can be formed between the expandable member 654 and the coil 602 when the expandable member 654 expands radially away from the coil 602, as shown in FIG.

[0149] In some embodiments, the expandable member 654 may comprise a braided structure, such as a braided wire mesh or lattice. For example, the expandable member 654 may have a braided structure containing a metal alloy with shape memory properties, such as Nitinol. In another embodiment, the expandable member 654 may comprise a foam structure. For example, the expandable member may include an expandable memory foam that can expand to a particular shape or a particular preset shape upon removal of the crimping pressure (e.g., removal of the sleeve shaft of the delivery device of the docking device).

[0150] The second cover 656 may radially surround and / or cover the expandable member 654, as shown in FIGS. 14 and 15, and may be configured to be in direct physical contact with the tissue of the native heart valve (e.g., the native valve leaflets) and / or the prosthetic heart valve to provide a seal between the prosthetic heart valve and the tissue of the native heart valve, thereby reducing paravalvular leakage around the prosthetic heart valve.

[0151] In some embodiments, the second covering 656 can be configured to be atraumatic to native tissue and / or to promote tissue ingrowth into the second covering 656 to further improve the seal between the prosthetic heart valve and the tissue of the native heart valve. For example, the second covering 656 can have pores to promote tissue ingrowth. In another example, the second covering 656 can be impregnated with a growth factor to stimulate or promote tissue ingrowth, such as transforming growth factor alpha (TGF-alpha), transforming growth factor beta (TGF-beta), basic fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF), and / or combinations thereof.

[0152] One or more of the expandable member 654, the second covering 656, and / or the first covering 652 may be coupled to the core 650 via a suitable attachment means, such as one or more of a textured surface, sutures, adhesives, and thermal bonding. In some embodiments, the expandable member 654, the second covering 656, and / or the first covering 652 may be sewn to the core 650 via sutures. In some embodiments, the expandable member 654, the second covering, and / or the first covering 652 may be coated, sprayed, dipped, and / or laminated onto the core 650. For example, the first covering 652 and / or the second covering 656 may comprise a sprayed, dipped, and / or laminated thermoplastic polyurethane.

[0153] The second cover 656 may be formed and / or constructed from any suitable material, including foam, cloth, fabric, and / or polymer, that is sufficiently flexible to allow compression and expansion of the expandable member 654 and / or that promotes tissue ingrowth into the second cover 656. For example, the second cover 656 may include a fabric layer constructed from a thermoplastic polymeric material such as polyethylene terephthalate (PET). Thus, the second cover 656 may be configured to be sufficiently resilient to allow the expandable member 654 to move to a radially compressed (and axially stretched) state between a compressed position and an expanded position. In this manner, the entire expandable sleeve 604 (including the expandable member 654 and the second cover 656) moves between the compressed and expanded positions.

[0154] In some embodiments, the expandable cover 654 and / or second cover 656 may be coupled at their distal end(s) to the core 650. In some such embodiments, the proximal end(s) of the expandable member 654 and / or second cover 656 are not directly coupled to the core 650 and may be free to slide axially relative to the core 650. In this manner, the proximal end(s) of the expandable member 654 and / or second cover 656 may move axially toward the distal end(s) of the expandable member 654 and / or second cover 656 as the expandable sleeve 604 radially expands and axially contracts when moving from a compressed position to an expanded position, such as during deployment of the expandable sleeve 604.

[0155] When the expandable sleeve 604 is in the compressed position ( FIG. 14 ), the expandable member 654 may be in direct physical contact with the first cover 652 surrounding the core 650, such that no gap or void exists between the first cover 652 (and / or core 650) and the expandable member 654, as shown in FIG. 14 . However, when the expandable sleeve radially expands and axially shortens to the compressed position (e.g., after the sleeve shaft of a delivery device of a docking device is detached from the expandable sleeve 604), a gap or void 658 may be created between the first cover 652 and the expandable member 654, as shown in FIG.

[0156] The expandable sleeve 604 (e.g., the second cover 656) may be configured to directly physically contact the leaflets of the prosthetic and / or native heart valve when in the expanded position. For example, a portion of the expandable sleeve 604 configured to be positioned on the outflow (e.g., ventricular) side of the native heart valve may be in direct physical contact with the outflow side of the leaflet of the native heart valve (e.g., the ventricular side of the anterior leaflet of a native mitral valve). Additionally or alternatively, a portion of the expandable sleeve 604 configured to be positioned on the inflow (e.g., atrial) side of the native heart valve may be in direct physical contact with the inflow side of the leaflet of the native heart valve (e.g., the atrial side of the posterior leaflet of a native mitral valve) and / or the outward-facing surface of a prosthetic heart valve disposed within the docking device 600. For example, the outward-facing surface of the atrial portion of the expandable sleeve 604 may be in direct physical contact with the inflow side of the leaflet(s) of the native heart valve, while the opposite inward-facing surface of the atrial portion of the expandable sleeve 604 may be in direct physical contact with the outward-facing surface of the prosthetic heart valve.

[0157] In some embodiments, docking device 600 may include at least one radiopaque marker (not shown) configured to provide a visual indication regarding the position and / or amount of radial expansion of docking device 600 under fluoroscopy (e.g., when a prosthetic valve is subsequently deployed within docking device 600). In one embodiment, one or more radiopaque markers (not shown) may be disposed on core 650. In another embodiment, one or more radiopaque markers (not shown) may be disposed on first cover 652, expandable member 654, and / or second cover 656.

[0158] An exemplary docking device implanted in a native mitral valve 16-18 show the docking device 700 implanted on the native mitral valve 800 of a heart 802 in a deployed configuration. Specifically, the docking device delivery device 900, and more specifically the docking device delivery device delivery shaft 902, is in the process of implanting and deploying the docking device 700 of FIG. 16 and retracting it away from the docking device 700. FIG. 17 shows the docking device 700 after the docking device delivery device 900 has been completely removed from the heart 802, leaving only the guidewire 904 in the heart 802.

[0159] Docking device 700 may include one or more components that are generally similar to one or more components of docking device 500. Accordingly, for the sake of brevity, components of docking device 700 that are similar to components of docking device 500 are similarly labeled and may not include additional description. For example, docking device 700 includes a coil 702 and an expandable sleeve 704, where coil 702 includes a first section 710 configured to be positioned on the inlet side of a native heart valve (e.g., the atrial side of a mitral valve) and a second section 712 configured to be positioned on the outlet side of the native heart valve (e.g., the ventricular side of the mitral valve), corresponding to coil 502, expandable sleeve 504, first section 510, and second section 512 of docking device 500, respectively.

[0160] Figure 16 shows a perspective view of the docking device 700 from a superior position relative to the mitral valve 800 (thus looking down on the mitral valve 800) within the left atrium 804 of the heart 802. Figure 17 shows a perspective view of the heart 802 showing the docking device 700 implanted and deployed on the mitral valve 800 so that it wraps around the ventricular side of the leaflets of the mitral valve 800. Figure 18 shows a perspective view of the left ventricle 806 of the heart 802 from an inferior position below the mitral valve 800, looking up on the mitral valve 800.

[0161] 16 , a first portion 714 of a first section 710 of a coil 702 of a docking device 700 is configured to extend radially outward toward the edge 810 of a mitral valve 800, on the atrial side of an anterior leaflet 808 of the mitral valve 800. In some embodiments, the first portion 714 extends beyond the edge 810 of the mitral valve 800 onto a shelf 812 or other native valve tissue surrounding and / or immediately adjacent to the mitral valve 800. The expandable sleeve 704 covers a second portion 716 of the first section 710 of the coil 702 and is in direct physical contact with the atrial side of the posterior leaflet 814 of the mitral valve 800. The coil 702 is configured to cross through an opening 819 in the mitral valve 800 formed between the anterior and posterior leaflets (i.e., cross from the atrial side of the mitral valve 800 to the ventricular side of the mitral valve 800) from the left atrium 804 to the left ventricle 806 of the heart 802. In some embodiments, the coil 702 is configured to cross from the atrial side of the mitral valve 800 to the ventricular side of the mitral valve 800 at and / or near the posteromedial commissure 818 and / or the A3 / P3 position of the mitral valve 800. Specifically, the junction of the first section 710 and the second section 712 of the coil 702 can be configured to be positioned at a location where the coil 702 crosses from the atrial side of the mitral valve 800 to the ventricular side of the mitral valve 800.

[0162] 17 and 18 , the first portion 720 of the second section 712 of the coil 702 begins where the coil 702 crosses from the atrial side of the mitral valve 800 to the ventricular side of the mitral valve 800, extends distally over the ventricular side of the anterior leaflet 808, and then continues beyond the ventricular side of the posterior leaflet 814. As described above, the first portion 720 of the second section 712 of the coil 702 can be configured to extend radially outward relative to the third portion 724 of the second section 712 of the coil 702 toward the anterior-lateral commissure 820 and / or A1 / P1 locations of the mitral valve 800. In some embodiments, the coil 702 can extend radially outward toward, up to, and / or beyond the anterior-lateral commissure 820 on the ventricular side of the mitral valve leaflet.

[0163] The expandable sleeve 704 may also extend through the opening 819 of the mitral valve 800 between the atrium 804 and the ventricle 806. That is, the expandable sleeve 704 may extend over the coil 702 in the region where the coil 702 crosses from the atrial side to the ventricular side of the mitral valve leaflets. As shown in FIG. 18 , the intermediate tapered portion 734 of the expandable sleeve 704 may be configured to be positioned at, adjacent to, and / or near the left ventricular outflow tract (LVOT) 822 of the ventricle 806. The LVOT 822 is a conduit for blood to exit the ventricle 806 and connects the ventricle 806 to the aorta. Thus, when the aortic valve 824 opens and / or the ventricle 806 contracts, blood flows through the LVOT 822 to the aorta.

[0164] Specifically, the intermediate tapered portion 734 can be configured to extend over a portion of the ventricular side of the anterior leaflet 808 adjacent the LVOT 822. For example, the intermediate tapered portion 734 can be configured to extend distally from the location where the coil 702 and / or expandable sleeve 704 crosses over the anterior leaflet 808 from the atrial side of the mitral valve 800 to the ventricular side of the mitral valve 800 (e.g., at the posteromedial commissure) toward the anterior lateral commissure 820 and / or A1 / P1 position. In other examples, the intermediate tapered portion 734 can begin (and the first portion 730 of the expandable sleeve 704 can terminate) after the expandable sleeve 704 crosses from the atrial side of the mitral valve leaflet to the ventricular side of the mitral valve leaflet, away from this crossover point. By way of example, the intermediate tapered portion 734 may begin at least 5 degrees, at least 10 degrees, at least 15 degrees, at least 20 degrees, at most 60 degrees, at most 50 degrees, at most 40 degrees, at most 30 degrees, at most 20 degrees, and / or at most 10 degrees from the location where the expandable sleeve 704 crosses from the atrial side of the mitral valve leaflet to the ventricular side of the mitral valve leaflet (e.g., the posteromedial commissure). The expandable sleeve 704 may provide an improved seal between the mitral valve tissue and the prosthetic heart valve by extending the first portion 730 of the expandable sleeve 704 distally to and / or beyond the A3 / P3 position and / or the posteromedial commissure and / or positioning the intermediate tapered portion 734 distal from the posteromedial commissure and / or A3 / P3 position.

[0165] In some embodiments, the intermediate tapered portion 734 may terminate (and the second portion 732 of the expandable sleeve 704 may begin) before reaching the anterolateral commissure 820 and / or the A1 / P1 position. By way of example, the intermediate tapered portion 734 may extend distally from the first portion 730 of the expandable sleeve 704 at least 10 degrees, at least 20 degrees, at least 30 degrees, at least 40 degrees, at least 50 degrees, at least 60 degrees, at least 80 degrees, at least 90 degrees, up to 170 degrees, up to 160 degrees, up to 150 degrees, up to 140 degrees, up to 130 degrees, up to 120 degrees, up to 110 degrees, up to 100 degrees, up to 90 degrees, up to 80 degrees, up to 70 degrees, and / or up to 60 degrees onto the ventricular side of the anterior leaflet 808.

[0166] By including an intermediate tapered portion 734 at and / or near the LVOT 822, the expandable sleeve 704 may not excessively block, obstruct, and / or otherwise constrict / narrow the LVOT 822, thereby ensuring adequate blood flow through the LVOT 822 even when the docking device 700 is implanted in the mitral valve 800. In embodiments where the expandable sleeve includes two separate sleeves, the gap separating the two sleeves (e.g., gap 234) may be positioned in the same and / or similar location as the intermediate tapered portion 734 and, therefore, may similarly serve to ensure adequate blood flow through the LVOT 822.

[0167] The second portion 732 of the expandable sleeve 704 is configured to extend distally from the intermediate tapered portion 734 to and / or beyond the anterolateral commissure 820, the anterolateral side of the mitral valve 800, and / or the A1 / P1 position of the mitral valve 800. By way of example, the second portion 732 may extend distally from the intermediate tapered portion 734 of the expandable sleeve 704 above the ventricular side of the anterior leaflet 808 by at least 10 degrees, at least 20 degrees, at least 30 degrees, at least 40 degrees, at least 50 degrees, at least 60 degrees, at least 80 degrees, at least 90 degrees, at least 100 degrees, at least 110 degrees, at least 120 degrees, up to 180 degrees, up to 170 degrees, up to 160 degrees, up to 150 degrees, up to 140 degrees, up to 130 degrees, up to 120 degrees, up to 110 degrees, up to 100 degrees, up to 90 degrees, up to 80 degrees, up to 70 degrees, and / or up to 60 degrees. The expandable sleeve 704 may provide an improved seal between the tissue of the native valve and the prosthetic heart valve by extending up to and / or beyond the A1 / P1 location and / or the anterolateral commissure 820, thereby reducing paravalvular leakage around the prosthetic heart valve. Specifically, the expandable sleeve 704 may close the opening of the mitral valve 800 near and / or at the A1 / P1 location and / or the anterolateral commissure 820, thereby reducing paravalvular leakage at and / or near the A1 / P1 location and / or the anterolateral commissure 820.

[0168] 17 and 18 , the expandable sleeve 704 may extend radially outward from the coil 702. In the embodiment of FIGS. 17 and 18 , the expandable sleeve 704 may extend radially outward toward the third portion 724 of the second section 712 of the coil 702, and in some such embodiments, may physically contact the third portion 724 of the second section 712 of the coil 702. However, in some such embodiments, the expandable sleeve 704 may not physically contact the third portion 724 of the coil 702 prior to expansion of the prosthetic valve, and may physically contact the third portion 724 only after the prosthetic valve has expanded within the docking device 700 and forced the third portion 724 of the coil 702 into contact with the expandable sleeve 704. In this manner, even though the first portion 720 of the second section 712 of the coil 702 may extend radially outward relative to the third portion 724 of the coil 702 (such that it may be separated from the third portion 724 by a radial gap), the expandable sleeve 704 may extend between the first portion 720 and the third portion 724 of the second section 712 of the coil 702, closing and / or sealing any radial gap that may exist between these two portions of the coil 702, thereby ensuring that paravalvular leakage does not occur between these two portions of the coil 702.

[0169] 16-18 show the docking device 700 in a first deployed position (which may also be referred to as the "deployed configuration"). As described in more detail below with reference to FIGS. 22-25, the docking device 700 is configured to move between the first deployed position and a second deployed position (which may also be referred to as the "final assembled configuration" and / or the "expanded deployed configuration") when a prosthetic heart valve is expanded within the docking device 700. Thus, the docking device 700 may be in the first deployed position before expansion of the prosthetic heart valve and in the second deployed position after the prosthetic heart valve is expanded within the docking device 700. Specifically, the third portion 724 of the docking device 700 is configured to radially expand to move the docking device 700 from the first deployed position to the second deployed position (e.g., when the prosthetic heart valve is expanded within the docking device 700). In some embodiments, the third portion 724 is configured to radially expand until the third portion 724 and the second portion 722 substantially fit (as described above).

[0170] As described above, the coil 702 and / or the expandable sleeve 704 are configured to directly physically contact the leaflets of the native valve and / or the prosthetic heart valve to provide a seal between the leaflets of the native valve and the prosthetic heart valve. In particular, when the prosthetic heart valve is expanded within the docking device 700, the coil 702 and / or the expandable sleeve 704 are configured to sandwich the leaflets of the native valve between the docking device 700 and the prosthetic heart valve to provide a seal therebetween.

[0171] Exemplary Prosthetic Heart Valves 19-21 show an exemplary prosthetic heart valve 910 that can be expanded and deployed within a docking device (e.g., the docking devices 10, 100, 200, 300, 400, 500, 600, and / or 700 described above). FIG. 19 shows the prosthetic heart valve 910 by itself, while FIGS. 20 and 21 show the prosthetic heart valve 910 deployed within the docking device 700. While FIGS. 19 and 20 show the prosthetic heart valve 910 without the optional cover, FIG. 21 shows the prosthetic heart valve 910 including the optional cover. Many of the components of the prosthetic heart valve 910 (such as the valve structure, leaflets, commissures, and / or other valve components) have been omitted from FIGS. 20 and 21 for simplicity and clarity. 20 and 21 therefore show simplified representations of a prosthetic heart valve 910, with only the general frame structure shown in FIG. 20 and only the frame structure covered with an optional cover shown in FIG.

[0172] The prosthetic heart valve 910 may include a stent or frame 912, a valve structure 914 (shown only in FIG. 19 ), and a valve cover 916 (shown only in FIG. 21 ). The valve structure 914 may include three leaflets 940 (shown only in FIG. 19 ), collectively forming a leaflet structure that may be arranged to collapse in a tricuspid valve arrangement (although more or less than this number of leaflets may be used). The leaflets 940 are configured to permit blood flow from the inflow end 922 to the outflow end 924 of the prosthetic heart valve 910 and to block blood flow from the outflow end 924 to the inflow end 922 of the prosthetic heart valve 910. The leaflets 940 may be secured to each other at their adjacent sides, forming commissures 926 (shown only in FIG. 19 ) of the leaflet structure. The valve leaflets 940 may be formed from pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or a variety of other suitable natural or synthetic materials known in the art and described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0173] The frame 912 may be formed with a plurality of circumferentially spaced slots or commissural windows 920 (three in the embodiment shown in FIG. 19 ) adapted to mount the commissures 926 of the valve structure 914 to the frame. The frame 912 may be made of any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol) known in the art. If constructed from a plastically expandable material, the frame 912 (and thus the prosthetic heart valve 910) may be crimped to a radially compressed state on a delivery device and then expanded within the patient by an inflatable balloon or equivalent expansion mechanism. If constructed from a self-expandable material, the frame 912 (and thus the prosthetic heart valve 910) may be crimped to a radially compressed state and constrained in the compressed state by insertion into a sheath or equivalent mechanism of the delivery device. Once inside the body, the prosthetic heart valve 910 may be advanced from the delivery sheath, allowing the prosthetic heart valve 910 to expand to its functional size.

[0174] Suitable plastically expandable materials that can be used to form the frame 912 include, but are not limited to, stainless steel, nickel-based alloys (e.g., cobalt-chromium or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In certain embodiments, the frame 912 can be made from a nickel-cobalt-chromium-molybdenum alloy such as MP35N™ (a trademark of SPS Technologies), which is equivalent to UNS R30035 alloy (coated per ASTM F562-02). MP35N™ alloy / UNS R30035 alloy contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. It has been found that using MP35N to form the frame 912 can provide superior structural results than stainless steel. In particular, when MP35N is used as the frame material, less material is required to achieve the same or better performance in radial and crushing force resistance, fatigue resistance, and corrosion resistance. Additionally, because less material is required, the crimp profile of the frame may be reduced, thereby providing a lower profile valve assembly for percutaneous delivery to a treatment location within the body.

[0175] For illustrative purposes, FIG. 21 shows the cover 916 covering the entire frame 912. However, it should be understood that the cover 916, in some embodiments, covers only a portion of the frame 912. In the embodiment shown in FIG. 21 , the valve cover 916 can include an outer surface 918 that can cover the entire exterior surface of the frame 912. In some examples, the valve cover 916 can also include an inner portion 928 that can cover the entire interior surface of the frame 912 or can cover only a selected portion of the interior surface of the frame 912. The valve cover 916 can be secured to the frame 912 by various means, such as via sutures 930 (shown only in FIG. 21 ).

[0176] The valve cover 916 may be configured to make direct physical contact with the native valve leaflets and / or the docking device (e.g., docking device 700) to provide a seal between the native valve leaflets and the prosthetic heart valve 910. Additionally, the valve cover 916 may be configured to prevent paravalvular leakage between the prosthetic heart valve 910 and the native valve, to facilitate tissue migration, to protect the native anatomy, among other purposes. For mitral valve replacement, the valve cover 916 may act as a seal around the prosthetic heart valve 910 due to the typical D-shape of the mitral valve and its relatively large annulus compared to the aortic valve (e.g., when the prosthetic heart valve 910 is sized smaller than the annulus), allowing for smooth coaptation of the native valve leaflets against the prosthetic heart valve 910.

[0177] In various embodiments, the valve cover 916 may be crimped for transcatheter delivery of the prosthetic heart valve 910 and may include an expandable material to prevent paravalvular leakage around the prosthetic heart valve 910. Examples of possible materials include foam, cloth, fabric, one or more synthetic polymers (e.g., polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), ePTFE, etc.), organic tissue (e.g., bovine pericardium, porcine pericardium, equine pericardium, etc.), and / or encapsulated materials (e.g., encapsulated hydrogels).

[0178] In certain embodiments, the valve cover 916 may be made of a woven cloth or fabric having multiple raised strand sections (e.g., protruding or expanding sections, hereinafter also referred to as "floats"). Details of exemplary covered valves having multiple floats are further described in U.S. Patent Application Publication No. 2019 / 0374337 and U.S. Patent Nos. 11,013,600 and 11,013,595, which are incorporated herein by reference in their entireties.

[0179] Further details of the prosthetic heart valve 910 and its components are described, for example, in U.S. Patent Nos. 9,393,110 and 9,339,384, which are incorporated herein by reference. Further embodiments of the valve cover are described in International Patent Application Publication No. WO2020 / 247907.

[0180] Exemplary Prosthetic Heart Valve System 20 and 21 , the prosthetic heart valve 910 can be deployed within a docking device (e.g., the docking device 700) to form a prosthetic heart valve system 950 (which may also be referred to herein as a "prosthetic heart valve assembly 950"). Specifically, the prosthetic heart valve 910 can be radially expanded and securely secured within the docking device 700. Thus, the prosthetic heart valve system 950 comprises the prosthetic heart valve 910 and the docking device 700. In some embodiments, the prosthetic heart valve 910 is positioned within the lumen 703 of the docking device 700.

[0181] 20 and 21 show the prosthetic heart valve 910 after it has been fully expanded within the docking device 700. Thus, in FIGS. 20 and 21, the docking device 700 is in the second deployed position, and the third portion 724 of the coil 702 has radially expanded to substantially match the second portion 722. That is, the third portion 724 may have a larger diameter in the second deployed position shown in FIGS. 20 and 21 than it does in the first deployed position shown in FIGS. 16-18.

[0182] However, first portion 720 of coil 702, even in its final assembled configuration (as in FIGS. 20 and 21 ), may still comprise a different geometric shape when viewed in a plane perpendicular to longitudinal axis 719 than third portion 724. In some embodiments, first portion 720, when in its final assembled configuration, may include a different shape than third portion 724. For example, third portion 724 may be circular when viewed in a plane perpendicular to longitudinal axis 719, and first portion 720 may be non-circular when viewed in a plane perpendicular to longitudinal axis 719, such as one or more of an oval, a D-shape, and / or a crescent shape.

[0183] In some embodiments, first portion 720 may still be larger than third portion 724, even when coil 702 is in its final assembled configuration. For example, first portion 720 may extend radially outward beyond third portion 724 when coil 702 is in its final assembled configuration. Specifically, corners 746 and / or 748 may remain radially spaced outward from third portion 724 in the final assembled configuration. As another example, the cross-sectional area defined by first portion 720 (in a plane perpendicular to longitudinal axis 719) can be at least 2%, at least 3%, at least 4%, at least 5%, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 85%, at least 100%, at least 150%, at least 200%, at least 250%, at least 300%, up to 1000%, up to 600%, up to 500%, up to 400%, up to 300%, up to 200%, up to 100%, up to 75%, up to 50%, and / or up to 25% greater than the cross-sectional area defined by third portion 524 when docking device 700 is in its final assembled configuration.

[0184] In some embodiments, the prosthetic heart valve 910 may be coupled to the docking device 700. For example, the prosthetic heart valve 910 may be locked in an expanded position and coupled to the prosthetic heart valve 910 by frictional forces between the tissue of the native heart valve and the prosthetic heart valve 910 and the docking device 700. Additionally or alternatively, the prosthetic heart valve 910 may be coupled to the docking device 700 after the prosthetic heart valve 910 has been expanded within the docking device 700 via one or more suitable coupling mechanisms, such as sutures, fasteners, adhesives, etc.

[0185] Although the prosthetic heart valve 910 shown in Figures 20 and 21 is expanded within the docking device 700, it should be understood that the prosthetic heart valve 910 may be expanded within any of the other docking devices described herein (e.g., docking devices 10, 100, 200, 300, 400, 500, and / or 600).

[0186] An exemplary prosthetic heart valve system implanted into a native mitral valve 22-25 show the prosthetic heart valve system 950 implanted in the native mitral valve 800. Specifically, Fig. 22 shows the prosthetic heart valve 910 only partially expanded within the docking device 700 of the native mitral valve 800, while Figs. 23-25 ​​show the prosthetic heart valve 910 in its fully expanded (functional) position within the docking device 700.

[0187] Figure 22 shows the prosthetic heart valve 910 being expanded within the docking device 700. In Figure 22, the prosthetic heart valve 910 has already been delivered to and positioned within the docking device 700 by a prosthetic heart valve delivery device 1000 (e.g., the prosthetic heart valve delivery device 58 described above). The prosthetic heart valve 910 may be mounted on the distal end of a delivery shaft 1002 (e.g., the delivery shaft 60 described above) of the prosthetic heart valve delivery device 1000, and in Figure 22 is in the process of being expanded by the inflatable balloon 1004 of the prosthetic heart valve delivery device 1000. Thus, the prosthetic heart valve 910 is in the partially expanded position of Figure 22, between its compressed position and fully expanded (functional) position.

[0188] The prosthetic heart valve 910 and second section 712 of the docking device 700 are configured to be positioned substantially on opposite sides of the mitral valve leaflets, sandwiching the mitral valve leaflets therebetween. Specifically, the prosthetic heart valve 910 is configured to be positioned on the atrial side of the mitral valve leaflets, while the second section 712 of the coil 702 of the docking device 700 is configured to be positioned on the ventricular side of the mitral valve leaflets. The first section 710 of the coil 702 is configured to be positioned on the atrial side of the mitral valve leaflets and, therefore, may be in direct physical contact with the atrial side of the mitral valve leaflet(s) and / or an exterior-facing surface of the prosthetic heart valve 910 (e.g., the outer portion 918 of the valve cover 916).

[0189] When the inflatable balloon 1004 radially expands the prosthetic heart valve 910 to its expanded (functional) position, the prosthetic heart valve 910 radially expands the third portion 724 of the second section 712 of the coil 702 of the docking device 700. Thus, as shown in FIGS. 23-25 ​​, when the prosthetic heart valve 910 radially expands to its functional position, the docking device 700 is in its second, deployed position. Specifically, in FIGS. 23-25 ​​, the third portion 724 of the second section 712 of the coil 702 radially expands and substantially conforms with the second portion 722 of the second section 712 of the coil 702. As the third portion 724 radially expands, the second portion 722 may retract proximally toward the posteromedial commissure 818 and / or the A3 / P3 position accordingly. Thus, the second portion 722 may extend over less of the anterior leaflet 808 when the docking apparatus 700 is in the second deployed position than in the first deployed position.

[0190] 24 , the anterior leaflet 808 and the posterior leaflet 814 may be compressed between the docking device 700 and the prosthetic heart valve 910 when the prosthetic heart valve 910 is fully expanded to its functional size. Specifically, the anterior leaflet 808 may be crimped between the expandable sleeve 704 and / or the second section 712 of the coil 702 and the valve cover 916 of the prosthetic heart valve 910, such that the valve cover 916 of the prosthetic heart valve 910 is in direct physical contact with the atrial side of the anterior leaflet 808 and / or the expandable sleeve 704 and / or the second section 712 of the coil 702 is in direct physical contact with the ventricular side of the anterior leaflet 808. The posterior leaflet 814 may be similarly crimped between the valve cover 916 and the docking device 700, except that the expandable sleeve 704 may, in some examples, not be in direct physical contact with the posterior leaflet 814. However, in other embodiments, the expandable sleeve 704 may extend past the anterolateral commissure 820 and thus directly physically contact at least a portion of the posterior leaflet 814 .

[0191] The docking device 700 may provide a seal between the prosthetic heart valve 910 and the leaflets of the native mitral valve 800 by compressing the leaflets between the prosthetic heart valve 910 and the coil 702 and / or expandable sleeve 704 so that, when the prosthetic heart valve assembly 950 is implanted into the mitral valve 800, blood flows only through the leaflets 940 of the prosthetic heart valve 910. Furthermore, because the first portion 720 of the second section 712 of the coil 702 extends radially outward from other portions of the second section 712 of the coil 702 toward one or more of the commissures of the native mitral valve 800, the docking device 700 may reduce paravalvular leakage around the prosthetic heart valve 910. Specifically, the first portion 720 of the coil 702 and the expandable sleeve 704 may cover and / or seal openings in the native mitral valve 800 that may exist beyond the edges of the prosthetic heart valve 910, such as at and / or near the commissures of the native mitral valve 800.

[0192] In Figures 23-25, the prosthetic heart valve delivery device 1000 has been removed, with only the guide wire 904 remaining in Figure 23. In Figures 24 and 25, the guide wire 904 has also been removed, and the prosthetic heart valve system 950 is fully functional. [Example]

[0193] Additional Examples of the Disclosed Technology Example 1 A docking device for a prosthetic heart valve includes an inflow end, an outflow end, a support structure, and an expandable sleeve. The support structure is disposed between the inflow end and the outflow end and includes an inflow section and an outflow section. The inflow section extends from the inflow end of the docking device toward the outflow end of the docking device and is configured to be positioned on the inflow side of a native heart valve. The outflow section extends between the outflow end of the docking device and the inflow section of the support structure and is configured to be positioned on the outflow side of the native heart valve. The outflow section includes a first portion, a second portion, and a third portion. The first portion extends distally from the inflow section to the third portion, the third portion extends distally from the first portion to the second portion, and the second portion extends distally from the third portion to the outflow end of the docking device. The expandable sleeve covers at least a portion of the support structure. The expandable sleeve is movable from a compressed position to an expanded position when crimping pressure is released. In the expanded position, the expandable sleeve extends at least 100 degrees over a first portion of the outflow section of the support structure.

[0194] Example 2. The docking device of any of the embodiments herein, particularly embodiment 1, wherein the expandable sleeve extends over a first portion of the outflow section, at least 100 degrees from the inflow section of the support structure toward the outflow end of the docking device, and is configured to extend to and be in direct physical contact with a third portion of the outflow section of the support structure when the expandable sleeve is in the expanded position.

[0195] Example 3 The docking device of any of the embodiments herein, particularly any of Embodiments 1 or 2, wherein the expandable sleeve extends over the inflow section of the support structure and from the outflow section of the support structure toward the inflow end of the docking device by at least 100.

[0196] Example 4. The docking device of any embodiment herein, particularly any one of embodiments 1-3, wherein the expandable sleeve comprises a single continuous sleeve extending between the inflow section and the outflow section of the support structure.

[0197] Example 5. The docking device of any of the embodiments herein, particularly embodiment 4, wherein the expandable sleeve comprises a first portion extending over the inflow section of the support structure, a second portion extending over the outflow section of the support structure, and an intermediate portion disposed between the first and second portions.

[0198] Example 6 The docking device of any example herein, particularly example 5, wherein the expandable sleeve is tapered at a midsection such that the midsection is narrower than the first and second sections of the expandable sleeve.

[0199] Example 7 The docking device of any embodiment herein, particularly any of embodiment 5 or embodiment 6, wherein the intermediate portion extends at least 45 degrees from the inflow section of the support structure over the first portion of the outflow section of the support structure toward the outflow end of the support structure.

[0200] Example 8 The docking device described in any of the embodiments herein, particularly any one of embodiments 1-7, wherein the expandable sleeve has a proximal end and a distal end, the expandable sleeve extends from the distal end to the proximal end toward the inflow end of the docking device, and the expandable sleeve is coupled to a support structure at the distal end.

[0201] Example 9. The docking device of any embodiment herein, particularly embodiment 8, wherein the expandable sleeve is tapered at the distal end.

[0202] Example 10. The docking device of any embodiment herein, particularly embodiment 1, wherein the expandable sleeve comprises two separate sleeves separated from each other by a gap.

[0203] Example 11 A docking device described in any of the embodiments herein, particularly embodiment 10, wherein the expandable sleeve comprises a first sleeve extending along the inflow section of the support structure and a second sleeve extending along the outflow section of the support structure.

[0204] Example 12 The docking device of any embodiment herein, particularly embodiment 11, wherein the gap is at least 45 degrees.

[0205] Example 13 A docking device described in any of the examples herein, particularly Example 11 or Example 12, wherein the first sleeve has a proximal end and a distal end, the first sleeve extends from the distal end to the proximal end toward the inflow end of the docking device, and the first sleeve is coupled to a support structure at the distal end.

[0206] Example 14. The docking device of any embodiment herein, particularly embodiment 13, wherein the first sleeve is tapered at the distal end.

[0207] Example 15. A docking device described in any of the embodiments herein, particularly any one of embodiments 11 to 14, wherein the second sleeve has a proximal end and a distal end, the second sleeve extends from the distal end to the proximal end toward the inflow end of the docking device, and the second sleeve is coupled to a support structure at the distal end.

[0208] Example 16. The docking device of any embodiment herein, particularly embodiment 15, wherein the second sleeve is tapered at one or more of the distal end and the proximal end.

[0209] Example 17. The docking device of any embodiment herein, particularly any one of embodiments 1-16, wherein the first portion of the support structure has a different geometric shape than the third portion of the support structure.

[0210] Example 18. The docking device of any embodiment herein, particularly embodiment 17, wherein the first portion has a different shape than the third portion of the support structure when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0211] Example 19. A docking device described in any of the examples herein, particularly Example 17 or Example 18, wherein the first portion has a different size than the third portion of the support structure when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0212] Example 20. The docking device of any embodiment herein, particularly embodiment 19, wherein the first portion is larger than the third portion of the support structure when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0213] Example 21. A docking device for a prosthetic heart valve includes an atrial end, a ventricular end, a support structure, and an expandable sleeve. The support structure is disposed between the atrial end and the ventricular end and includes an atrial section and a ventricular section. The atrial section extends from the atrial end of the docking device toward the ventricular end of the docking device and is configured to be positioned on the atrial side of the native mitral valve. The ventricular section extends between the ventricular end of the docking device and the atrial section of the support structure and is configured to be positioned on the ventricular side of the native mitral valve. The ventricular section includes a first portion, a second portion, and a third portion. The first portion extends distally from the atrial section to the third portion, the third portion extends distally from the first portion to the second portion, and the second portion extends distally from the third portion to the ventricular end of the docking device. The expandable sleeve covers at least a portion of the support structure and is configured to extend at least 100 degrees above the ventricular side of the anterior leaflet of the native mitral valve when the docking device is implanted in the native mitral valve.

[0214] Example 22. The docking device of any embodiment herein, particularly embodiment 21, wherein the expandable sleeve comprises a single continuous sleeve extending between the atrial and ventricular sections of the support structure.

[0215] Example 23. A docking device as described in any of the embodiments herein, particularly embodiment 22, wherein the expandable sleeve comprises a first portion extending over the atrial section of the support structure, a second portion extending over the ventricular section of the support structure, and an intermediate portion disposed between the first and second portions.

[0216] Example 24. The docking device of any example herein, particularly example 23, wherein the expandable sleeve is tapered at the middle portion such that the middle portion is narrower than the first and second portions of the expandable sleeve.

[0217] Example 25. A docking device described in any embodiment herein, particularly any of embodiment 23 or embodiment 24, wherein the intermediate portion extends at least 45 degrees from the atrial section of the support structure over the first portion of the ventricular section of the support structure toward the ventricular end of the support structure.

[0218] Example 26. A docking device described in any of the examples herein, particularly any one of Examples 21 to 25, wherein the expandable sleeve has a proximal end and a distal end, the expandable sleeve extends from the distal end to the proximal end toward the atrial end of the docking device, and the expandable sleeve is coupled to a support structure at the distal end.

[0219] Example 27. The docking device of any embodiment herein, particularly embodiment 26, wherein the expandable sleeve is tapered at the distal end.

[0220] Example 28. The docking device of any embodiment herein, particularly embodiment 21, wherein the expandable sleeve comprises two separate sleeves separated from each other by a gap.

[0221] Example 29. A docking device described in any of the embodiments herein, particularly embodiment 28, wherein the expandable sleeve comprises a first sleeve extending along the atrial section of the support structure and a second sleeve extending along the ventricular section of the support structure.

[0222] Example 30. The docking device of any embodiment herein, particularly embodiment 29, wherein the gap is at least 45 degrees.

[0223] Example 31. A docking device described in any of the examples herein, particularly any of Example 29 or Example 30, wherein the first sleeve has a proximal end and a distal end, the first sleeve extends from the distal end to the proximal end toward the atrial end of the docking device, and the first sleeve is connected to a support structure at the distal end.

[0224] Example 32. The docking device of any embodiment herein, particularly embodiment 31, wherein the first sleeve is tapered at the distal end.

[0225] Example 33. A docking device described in any of the examples herein, particularly any one of Examples 29 to 32, wherein the second sleeve has a proximal end and a distal end, the second sleeve extends from the distal end to the proximal end toward the atrial end of the docking device, and the second sleeve is coupled to a support structure at the distal end.

[0226] Example 34. The docking device of any embodiment herein, particularly embodiment 33, wherein the second sleeve is tapered at one or more of the distal end and the proximal end.

[0227] Example 35. The docking device of any embodiment herein, particularly any one of embodiments 21-34, wherein the first portion of the support structure has a different geometric shape than the third portion of the support structure.

[0228] Example 36. The docking device of any embodiment herein, particularly embodiment 35, wherein the first portion has a different shape than the third portion of the support structure when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0229] Example 37. A docking device described in any of the examples herein, particularly Example 35 or Example 36, wherein the first portion has a different size than the third portion of the support structure when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0230] Example 38. The docking device of any embodiment herein, particularly embodiment 37, wherein the first portion is larger than the third portion of the support structure when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0231] Example 39. A docking device described in any of the embodiments herein, particularly any one of embodiments 21 to 38, wherein the expandable sleeve is configured to extend over the first portion of the support structure up to the anterior-lateral commissure of the native mitral valve.

[0232] Example 40. The docking device of any of the embodiments herein, particularly any one of embodiments 21 to 39, wherein the expandable sleeve is movable from a compressed position to an expanded position and is configured to move from the compressed position to the expanded position when crimping pressure is released from the expandable sleeve, wherein in the expanded position the expandable sleeve extends at least 100 degrees over the first portion of the ventricular section of the support structure.

[0233] Example 41. A docking device as described in any of the embodiments herein, particularly embodiment 40, wherein the expandable sleeve is configured to extend to and be in direct physical contact with a third portion of the ventricular section of the support structure when the expandable sleeve is in an expanded position.

[0234] Example 42. A docking device for a prosthetic heart valve includes an atrial end, a ventricular end, a support structure, and an expandable sleeve. The support structure is disposed between the atrial end and the ventricular end and includes an atrial section and a ventricular section. The atrial section extends from the atrial end of the docking device toward the ventricular end of the docking device and is configured to be positioned on the atrial side of the native mitral valve. The ventricular section extends from the ventricular end of the docking device toward the atrial end of the docking device and is configured to be positioned on the ventricular side of the native mitral valve. The ventricular section includes a first rotating portion, a second rotating portion, and one or more intermediate rotating portions. The first rotating portion is disposed closer to the atrial section than the second rotating portion, and the one or more intermediate rotating portions are disposed between the first rotating portion and the second rotating portion. The support structure is configured to move from a delivery configuration to a deployed configuration when the support structure is released from a delivery device of the docking device. In the deployed configuration, the first rotating portion has a different geometric shape than the one or more intermediate rotating portions. The expandable sleeve covers at least a portion of the support structure.

[0235] Example 43. A docking device described in any of the embodiments herein, particularly embodiment 42, wherein when the support structure is in the deployed configuration, the first rotating portion is larger than one or more intermediate rotating portions when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0236] Example 44. A docking device described in any embodiment herein, particularly any of embodiment 42 or embodiment 43, wherein the first rotating portion extends radially outward beyond one or more intermediate rotating portions when the support structure is in the deployed configuration.

[0237] Example 45. A docking device described in any of the embodiments herein, particularly any one of embodiments 42-44, wherein when the support structure is in the deployed configuration, the first rotating portion defines a cross-sectional area of ​​the docking device that is at least 15% larger than the cross-sectional area defined by the one or more intermediate rotating portions.

[0238] Example 46. A docking device described in any of the examples herein, particularly any one of Examples 42 to 45, wherein when the support structure is in the deployed configuration, the first rotating portion has a different shape than one or more intermediate rotating portions when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0239] Example 47. A docking device described in any of the examples herein, particularly any one of Examples 42 to 46, wherein when the support structure is in the deployed configuration, the first rotating portion is substantially D-shaped when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0240] Example 48. A docking device described in any of the embodiments herein, particularly any one of embodiments 42 to 46, wherein when the support structure is in the deployed configuration, the first rotating portion is substantially crescent-shaped when viewed in a plane perpendicular to the longitudinal axis of the docking device and comprises a convex edge configured to contact the ventricular side of the posterior leaflet of the native mitral valve and a concave edge configured to contact the ventricular side of the anterior leaflet of the native mitral valve.

[0241] Example 49. A docking device described in any of the examples herein, particularly any one of Examples 42 to 46, wherein when the support structure is in the deployed configuration, the first rotating portion has substantially the same shape as the annulus of a native mitral valve when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0242] Example 50. A docking device described in any of the examples herein, particularly any one of Examples 42 to 46, wherein when the support structure is in the deployed configuration, the first rotating portion is circular when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0243] Example 51. A docking device described in any of the embodiments herein, particularly any one of embodiments 42 to 50, wherein when the support structure is in the deployed configuration, one or more intermediate rotating portions are circular when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0244] Example 52. A docking device described in any of the embodiments described herein, particularly any one of embodiments 42 to 51, wherein the support structure is configured to move from a deployed configuration to a final assembled configuration when the prosthetic heart valve is expanded within the docking device, and wherein one or more intermediate rotating portions expand radially when the support structure moves from the deployed configuration to the final assembled configuration.

[0245] Example 53. The docking device of any embodiment herein, particularly embodiment 52, wherein the first rotating section maintains a different geometric shape than the one or more intermediate rotating sections in the final assembled configuration.

[0246] Example 54. A docking device described in any of the embodiments herein, particularly embodiment 52 or embodiment 53, wherein when the support structure is in its final assembled configuration, the first rotating portion is larger than one or more intermediate rotating portions when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0247] Example 55. A docking device described in any of the embodiments herein, particularly any one of embodiments 52 to 54, wherein when the support structure is in its final assembled configuration, the first rotating portion extends radially outward beyond the one or more intermediate rotating portions.

[0248] Example 56. A docking device described in any of the examples herein, particularly any one of Examples 52 to 55, wherein when the support structure is in its final assembled configuration, the first rotating portion comprises a different shape than one or more intermediate rotating portions when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0249] Example 57. A docking device described in any of the examples herein, particularly any one of Examples 52 to 56, wherein when the support structure is in its final assembled configuration, one or more intermediate rotating portions are circular when viewed in a plane perpendicular to the longitudinal axis of the docking device, and the first rotating portion is non-circular when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0250] Example 58. A docking device described in any of the embodiments herein, particularly any one of embodiments 52 to 57, wherein when the support structure is in its final assembled configuration, the first rotating portion is substantially D-shaped when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0251] Example 59. A docking device described in any of the embodiments herein, particularly any one of embodiments 52 to 57, wherein when the support structure is in its final assembled configuration, the first rotating portion is substantially crescent-shaped when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0252] Example 60. A docking device described in any of the examples herein, particularly any one of Examples 52 to 57, wherein when the support structure is in its final assembled configuration, the first rotating portion has substantially the same shape as the annulus of a native mitral valve when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0253] Example 61. A docking device described in any of the embodiments herein, particularly any one of embodiments 52 to 60, wherein the second rotating portion extends radially outward beyond the one or more intermediate rotating portions when the support structure is in the deployed configuration.

[0254] Example 62. The docking device of any embodiment herein, particularly any one of embodiments 52-61, wherein the one or more intermediate rotating sections and the second rotating section are substantially compatible when the support structure is in a final assembled configuration.

[0255] Example 63. A docking device described in any of the embodiments herein, particularly any one of embodiments 42 to 62, wherein the first rotating portion is configured to extend from the posteromedial commissure of the native mitral valve onto the ventricular side of the anterior leaflet of the native mitral valve to the anterior lateral commissure of the native mitral valve.

[0256] Example 64. A docking device described in any of the embodiments herein, particularly any one of embodiments 42 to 63, wherein the first rotating portion extends at least 180 degrees, one or more intermediate rotating portions extend at least 360 degrees, and the second rotating portion extends at least 90 degrees.

[0257] Example 65. The docking device of any embodiment herein, particularly any one of embodiments 42 to 64, wherein the expandable sleeve extends at least 100 degrees along the first turn of the support structure.

[0258] Example 66. A docking device described in any of the embodiments herein, particularly any one of embodiments 42 to 65, wherein the expandable sleeve is movable between a compressed position and an expanded position, and the expandable sleeve expands radially and shortens axially when moving from the compressed position to the expanded position.

[0259] Example 67. A docking device for a prosthetic heart valve, comprising an inflow end, an outflow end, a support structure, and an expandable sleeve covering at least a portion of the support structure. The support structure is disposed between the inflow end and the outflow end and comprises an inflow section and an outflow section. The inflow section extends from the inflow end of the docking device toward the outflow end of the docking device and is configured to be positioned on the inflow side of a native heart valve. The outflow section extends from the outflow end of the docking device toward the inflow end of the docking device and is configured to be positioned on the outflow side of a native heart valve. The outflow section comprises a first portion, a second portion, and a third portion. The first portion is disposed closer to the inflow section than the second portion, and the third portion is disposed between the first and second portions. The support structure is movable from a delivery configuration to a deployed configuration. In the deployed configuration, the first portion has a different geometric shape than the third portion.

[0260] Example 68. A docking device described in any of the embodiments herein, particularly embodiment 67, wherein when the support structure is in the deployed configuration, the first portion is larger than the third portion when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0261] Example 69. A docking device described in any of the embodiments herein, particularly any of embodiment 67 or embodiment 68, wherein the first portion extends radially outward beyond the third portion when the support structure is in the deployed configuration.

[0262] Example 70. A docking device described in any embodiment herein, particularly any one of embodiments 67-69, wherein when the support structure is in the deployed configuration, the first portion defines a cross-sectional area of ​​the docking device that is at least 15% larger than the cross-sectional area defined by the third portion.

[0263] Example 71. A docking device described in any of the examples herein, particularly any one of Examples 67 to 70, wherein when the support structure is in the deployed configuration, the first portion has a different shape than the third portion when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0264] Example 72. A docking device described in any of the embodiments herein, particularly any one of embodiments 67 to 71, wherein when the support structure is in the deployed configuration, the first portion is substantially D-shaped when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0265] Example 73. A docking device described in any of the examples herein, particularly any one of examples 67 to 71, wherein when the support structure is in the deployed configuration, the first portion is substantially crescent-shaped when viewed in a plane perpendicular to the longitudinal axis of the docking device and has a convex edge configured to contact the ventricular side of the posterior leaflet of the native heart valve and a concave edge configured to contact the ventricular side of the anterior leaflet of the native heart valve.

[0266] Example 74. A docking device described in any of the examples herein, particularly any one of Examples 67 to 71, wherein when the support structure is in the deployed configuration, the first portion has substantially the same shape as the annulus of a native heart valve when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0267] Example 75. A docking device described in any of the embodiments herein, particularly any one of embodiments 64 to 71, wherein when the support structure is in the deployed configuration, the first portion is circular when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0268] Example 76. A docking device described in any of the embodiments herein, particularly any one of embodiments 67 to 75, wherein when the support structure is in the deployed configuration, the third portion is circular when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0269] Example 77. A docking device described in any of the embodiments herein, particularly any one of embodiments 67 to 76, wherein the support structure is configured to move from the deployed configuration to the final assembled configuration when the prosthetic heart valve is expanded within the docking device, and the third portion expands radially when the support structure moves from the deployed configuration to the final assembled configuration.

[0270] Example 78. The docking device of any embodiment herein, particularly embodiment 77, wherein the first portion maintains a different geometric shape than the third portion in the final assembled configuration.

[0271] Example 79. A docking device described in any of the embodiments herein, particularly any of embodiment 77 or embodiment 78, wherein when the support structure is in its final assembled configuration, the first portion is larger than the third portion when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0272] Example 80. A docking device described in any embodiment herein, particularly any one of embodiments 77 to 79, wherein the first portion extends radially outward beyond the third portion when the support structure is in its final assembled configuration.

[0273] Example 81. The docking device of any of the embodiments herein, particularly any one of embodiments 77-80, wherein when the support structure is in its final assembled configuration, the first portion comprises a different shape than the third portion when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0274] Example 82. A docking device described in any of the examples herein, particularly any one of Examples 77 to 81, wherein when the support structure is in its final assembled configuration, the third portion is circular when viewed in a plane perpendicular to the longitudinal axis of the docking device and the first portion is non-circular when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0275] Example 83. A docking device described in any of the embodiments herein, particularly any one of embodiments 77 to 82, wherein when the support structure is in its final assembled configuration, the first portion is substantially D-shaped when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0276] Example 84. A docking device described in any of the examples herein, particularly any one of examples 77 to 82, wherein when the support structure is in its final assembled configuration, the first portion is substantially crescent-shaped when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0277] Example 85. A docking device described in any of the examples herein, particularly any one of Examples 77 to 82, wherein when the support structure is in its final assembled configuration, the first portion has substantially the same shape as the annulus of a native heart valve when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0278] Example 86. A docking device described in any embodiment herein, particularly any one of embodiments 77 to 85, wherein the second portion extends radially outward beyond the third portion when the support structure is in the deployed configuration.

[0279] Example 87. The docking device of any embodiment herein, particularly any one of embodiments 77 to 86, wherein the third portion and the second portion substantially match when the support structure is in a final assembled configuration.

[0280] Example 88. A docking device described in any of the embodiments herein, particularly any one of embodiments 77 to 87, wherein the first portion extends at least 180 degrees, the third portion extends at least 360 degrees, and the second portion extends at least 90 degrees.

[0281] Example 89. The docking device of any embodiment herein, particularly any one of embodiments 77-88, wherein the expandable sleeve extends at least 100 degrees along the first portion of the support structure.

[0282] Example 90. A docking device described in any of the examples herein, particularly any one of Examples 77 to 89, wherein the expandable sleeve is movable between a compressed position and an expanded position, and the expandable sleeve expands radially and shortens axially when moving from the compressed position to the expanded position.

[0283] Example 91. A prosthetic heart valve assembly comprising a docking device and a prosthetic heart valve. The docking device comprises an atrial end, a ventricular end, a support structure disposed between the atrial end and the ventricular end, and an expandable sleeve covering at least a portion of the support structure. The support structure comprises an atrial section and a ventricular section. The atrial section extends from the atrial end of the docking device toward the ventricular end of the docking device and is configured to be positioned on the atrial side of the native mitral valve. The ventricular section extends from the ventricular end of the docking device toward the atrial end of the docking device and is configured to be positioned on the ventricular side of the native mitral valve. The ventricular section comprises a first rotating portion, a second rotating portion, and one or more intermediate rotating portions. The first rotating portion is disposed closer to the atrial section than the second rotating portion, and the one or more intermediate rotating portions are disposed between the first rotating portion and the second rotating portion. The support structure is movable from a delivery configuration to a deployed configuration. In the deployed configuration, the first rotor includes a different geometry than the one or more intermediate rotors when the first rotor and the one or more intermediate rotors are released from the delivery device of the docking device and deployed to the native mitral valve. The prosthetic heart valve is configured to be disposed within the docking device and includes a frame and a plurality of valve leaflets coupled to the frame. The frame is configured to be radially expanded from a compressed position to an expanded position within the docking device. The plurality of valve leaflets are configured to selectively open to allow blood to flow through the prosthetic heart valve.

[0284] Example 92. A prosthetic heart valve assembly as described in any of the embodiments herein, particularly embodiment 91, wherein the docking device and the prosthetic heart valve are configured to capture the leaflets of the native mitral valve therebetween when the prosthetic heart valve is in an expanded position.

[0285] Example 93. The prosthetic heart valve assembly of any of the embodiments herein, particularly embodiment 92, wherein the expandable sleeve is configured to be in direct physical contact with the ventricular side of the native mitral valve leaflets and the atrial side of the native mitral valve leaflets.

[0286] Example 94. A prosthetic heart valve assembly described in any of the embodiments herein, particularly any one of embodiments 91 to 93, wherein the expandable sleeve is configured to extend at least 100 degrees over the ventricular side of the anterior leaflet of the native mitral valve toward the anterior-lateral commissure of the native mitral valve.

[0287] Example 95. A prosthetic heart valve assembly described in any of the embodiments herein, particularly any one of embodiments 91 to 94, wherein the prosthetic heart valve is configured to be in direct physical contact with the atrial side of the native mitral valve when in an expanded position, and the ventricular section of the support structure of the docking device is configured to be in direct physical contact with the ventricular side of the native mitral valve.

[0288] Example 96. The prosthetic heart valve assembly of any of the embodiments herein, particularly any one of embodiments 91-95, wherein the support structure is configured to cross between the atrial and ventricular sides of the native mitral valve at the posteromedial commissure of the native mitral valve.

[0289] Example 97. A prosthetic heart valve assembly described in any of the embodiments herein, particularly any one of embodiments 91 to 96, wherein the expandable sleeve is configured to extend to and be in direct physical contact with one or more intermediate turns of the ventricular section of the support structure.

[0290] Example 98. A prosthetic heart valve assembly described in any of the embodiments herein, particularly any one of embodiments 91 to 96, wherein the prosthetic heart valve is configured to move the docking device from the deployed configuration to the final assembled configuration when the prosthetic heart valve is expanded to the expanded position.

[0291] Example 99. A prosthetic heart valve assembly as described in any embodiment herein, particularly embodiment 98, wherein one or more intermediate rotations of the ventricular section of the support structure are configured to radially expand when the docking device moves from the deployed configuration to the final assembled configuration.

[0292] Example 100. A prosthetic heart valve assembly as described in any of the embodiments herein, particularly embodiment 99, wherein when the docking device is in its final assembled configuration, the first rotating portion extends radially outward beyond one or more intermediate rotating portions.

[0293] Example 101. A prosthetic heart valve assembly described in any of the embodiments herein, particularly any of embodiment 99 or embodiment 100, wherein when the docking device is in its final assembled configuration, the first rotating portion defines a larger cross-sectional area than one or more intermediate rotating portions.

[0294] Example 102. A prosthetic heart valve assembly described in any of the examples herein, particularly any one of Examples 99 to 101, wherein when the docking device is in a final assembled configuration, the first rotating portion has a different shape from one or more intermediate rotating portions when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0295] Example 103. A prosthetic heart valve assembly described in any of the embodiments herein, particularly any one of embodiments 99 to 102, wherein when the docking device is in its final assembled configuration, the first rotating portion is substantially D-shaped when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0296] Example 104. A prosthetic heart valve assembly described in any of the embodiments herein, particularly any one of embodiments 99 to 102, wherein when the docking device is in its final assembled configuration, the first rotating portion is substantially crescent-shaped when viewed in a plane perpendicular to the longitudinal axis of the docking device and has a convex edge configured to contact the ventricular side of the posterior leaflet of the native mitral valve and a concave edge configured to contact the ventricular side of the anterior leaflet of the native mitral valve.

[0297] Example 105. A prosthetic heart valve assembly described in any of the embodiments herein, particularly any one of embodiments 99 to 102, wherein when the docking device is in its final assembled configuration, the first rotating portion has substantially the same shape as the annulus of a native mitral valve when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0298] Example 106. A prosthetic heart valve assembly comprising a docking device and a prosthetic heart valve configured to be disposed within the docking device. The docking device comprises an atrial end, a ventricular end, a support structure disposed between the atrial end and the ventricular end, and an expandable sleeve covering at least a portion of the support structure. The support structure comprises an atrial section and a ventricular section. The atrial section extends from the atrial end of the docking device toward the ventricular end of the docking device and is configured to be positioned on the atrial side of the native mitral valve. The ventricular section extends between the ventricular end of the docking device and the atrial section of the support structure and is configured to be positioned on the ventricular side of the native mitral valve. The ventricular section comprises a first portion, a second portion, and a third portion. The first portion extends distally from the atrial section to the third portion, the third portion extends distally from the first portion to the second portion, and the second portion extends distally from the third portion to the ventricular end of the docking device. The expandable sleeve is movable from a compressed position to an expanded position when the crimping pressure is released. In the expanded position, the expandable sleeve extends at least 100 degrees over a first portion of the ventricular section of the support structure. The prosthetic heart valve includes a radially expandable and compressible frame and a plurality of leaflets coupled to the frame and configured to selectively open to allow blood to flow through the prosthetic heart valve.

[0299] Example 107. The prosthetic heart valve assembly of any embodiment herein, particularly embodiment 106, wherein the expandable sleeve comprises a single continuous sleeve extending between the atrial section and the ventricular section of the support structure.

[0300] Example 108. A prosthetic heart valve assembly as described in any of the embodiments herein, particularly embodiment 107, wherein the expandable sleeve comprises a first portion extending over the atrial section of the support structure and configured to be in direct physical contact with the atrial side of the native mitral valve, a second portion extending over the ventricular section of the support structure and configured to be in direct physical contact with the ventricular side of the native mitral valve, and an intermediate portion disposed between the first and second portions.

[0301] Example 109. The prosthetic heart valve assembly of any of the embodiments herein, particularly embodiment 108, wherein the expandable sleeve is tapered at the intermediate portion such that the intermediate portion is narrower than the first and second portions of the expandable sleeve.

[0302] Example 110. A prosthetic heart valve assembly as described in any of the embodiments herein, particularly any of embodiment 108 or embodiment 109, wherein the intermediate portion extends at least 45 degrees from the atrial section of the support structure over the first portion of the ventricular section of the support structure toward the ventricular end of the support structure and is configured to be in direct physical contact with the ventricular side of the anterior leaflet of the native mitral valve and positioned adjacent to the left ventricular outflow tract.

[0303] Example 111. A prosthetic heart valve assembly described in any of the embodiments herein, particularly any one of embodiments 106 to 110, wherein the expandable sleeve has a proximal end and a distal end, the expandable sleeve extends from the distal end to the proximal end toward the atrial end of the docking device, and the expandable sleeve is connected to a support structure at the distal end.

[0304] Example 112. The prosthetic heart valve assembly of any embodiment herein, particularly embodiment 111, wherein the expandable sleeve is tapered at the distal end.

[0305] Example 113. A prosthetic heart valve assembly as described in any of the embodiments herein, particularly embodiment 106, wherein the expandable sleeve comprises two separate sleeves separated from each other by a gap, the gap being configured to be positioned adjacent to the ventricular side of the anterior leaflet of the mitral valve and the left ventricular outflow tract.

[0306] Example 114. A prosthetic heart valve assembly as described in any of the embodiments herein, particularly embodiment 113, wherein the expandable sleeve comprises a first sleeve extending along the atrial section of the support structure and a second sleeve extending along the ventricular section of the support structure.

[0307] Example 115. The prosthetic heart valve assembly of any embodiment herein, particularly embodiment 114, wherein the gap is at least 45 degrees.

[0308] Example 116. A prosthetic heart valve assembly as described in any of the embodiments herein, particularly any of embodiment 114 or embodiment 115, wherein the first sleeve has a proximal end and a distal end, the first sleeve extends from the distal end to the proximal end toward the atrial end of the docking device, and the first sleeve is connected to a support structure at the distal end.

[0309] Example 117. The prosthetic heart valve assembly of any embodiment herein, particularly embodiment 116, wherein the first sleeve is tapered at the distal end.

[0310] Example 118. A prosthetic heart valve assembly as described in any of the embodiments herein, particularly any one of embodiments 114 to 117, wherein the second sleeve has a proximal end and a distal end, the second sleeve extends from the distal end to the proximal end toward the atrial end of the docking device, and the second sleeve is coupled to a support structure at the distal end.

[0311] Example 119. The prosthetic heart valve assembly of any embodiment herein, particularly embodiment 118, wherein the second sleeve is tapered at one or more of the distal end and the proximal end.

[0312] Example 120. The prosthetic heart valve assembly of any of the embodiments herein, particularly any one of embodiments 106-119, wherein the first portion of the support structure has a different geometric shape than the intermediate portion of the support structure.

[0313] Example 121. A prosthetic heart valve assembly as described in any of the embodiments herein, particularly embodiment 120, wherein the first portion has a different shape than the third portion of the support structure when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0314] Example 122. A prosthetic heart valve assembly described in any of the examples herein, particularly any of Example 120 or Example 121, wherein the first portion has a different size than the third portion of the support structure when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0315] Example 123. The prosthetic heart valve assembly described in any embodiment herein, particularly embodiment 122, wherein the first portion is larger than the third portion of the support structure when viewed in a plane perpendicular to the longitudinal axis of the docking device.

[0316] Example 124. 1. A method comprising: wrapping at least one complete turn of a coil around an outflow side of two or more leaflets of a native heart valve, the at least one complete turn comprising a first geometric shape; wrapping a second turn of the coil around the outflow side of two or more leaflets of the native heart valve, the second turn comprising a second geometric shape different from the first geometric shape; and radially expanding an expandable sleeve around at least a portion of the second turn of the coil.

[0317] Example 125. The method described in any of the embodiments herein, particularly embodiment 124, wherein wrapping the second rotation of the coil around the outflow side of two or more leaflets of the native heart valve includes extending the second rotation radially outward for at least one complete rotation.

[0318] Example 126. The method described in any of the embodiments herein, particularly any of embodiment 124 or embodiment 125, wherein wrapping the second rotation of the coil around the outflow side of two or more leaflets of the native heart valve comprises wrapping the second rotation of the coil around the outflow side of two or more leaflets of the native heart valve in a substantially D-shaped pattern when viewed from a plane perpendicular to the longitudinal axis of the coil.

[0319] Example 127. The method described in any of the embodiments herein, particularly embodiment 124 or embodiment 125, wherein wrapping the second rotation of the coil around the outflow side of two or more leaflets of the native heart valve comprises wrapping the second rotation of the coil around the outflow side of two or more leaflets of the native heart valve in a substantially crescent-shaped pattern when viewed from a plane perpendicular to the longitudinal axis of the coil.

[0320] Example 128. The method of any of the embodiments herein, particularly any of embodiment 124 or embodiment 125, wherein the native heart valve is a native mitral valve, and wrapping the second rotation of the coil around the outflow sides of two or more leaflets of the native heart valve comprises wrapping the second rotation around the ventricular side of the anterior leaflet of the mitral valve below the anterior-lateral commissure of the native mitral valve.

[0321] Example 129. The method of any embodiment herein, particularly any one of embodiments 124-127, wherein the second turn is larger than at least one complete turn when viewed in a plane perpendicular to the longitudinal axis of the coil.

[0322] Example 130. The method of any of the embodiments herein, particularly any of embodiments 124 to 129, wherein the second turn has a different shape than the at least one complete turn when viewed in a plane perpendicular to the longitudinal axis of the coil.

[0323] Example 131. The method described in any of the embodiments herein, particularly any one of embodiments 124 to 130, wherein radially expanding the expandable sleeve includes releasing the expandable sleeve from the delivery shaft of the delivery device of the docking device.

[0324] Example 132. A method described in any of the embodiments herein, particularly any one of embodiments 124 to 130, wherein radially expanding the expandable sleeve includes retracting the sleeve shaft of the docking device delivery device from the expandable sleeve.

[0325] Example 133. The method described in any of the examples herein, particularly any one of Examples 124-132, wherein radially expanding the expandable sleeve comprises radially expanding the expandable sleeve around at least 100 degrees of the outflow side of two or more leaflets of the native heart valve such that the expandable sleeve is in direct physical contact with the outflow side of the two or more leaflets.

[0326] 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 represent examples of the disclosed technology and should not be construed as limiting the scope of the disclosure or the claims. Rather, the scope of claimed subject matter is defined by the following claims and their equivalents. [Explanation of symbols]

[0327] 10 Docking Device 12 valves 14 Heart 16 patients 18 Delivery device 20 Delivery shaft 20 Insertion shaft 22 Handle 24 Pusher assembly 26 Proximal end 28 Joint members 30 distal end 32 Pusher shaft 34 Sleeve shaft 36 Pusher handle, hub assembly 38 Sleeve Handle 40 Suture Lock Assembly 42 Blood vessels 44 Introducer device 46 Guidewire 48 Left atrium 50 Right atrium 52 Atrial septum 54 Artificial Heart Valves 56 Left ventricle 58 Delivery device 60 Delivery shaft 62 Handle 64 proximal end 66 Joint members 68 Distal end 70 Expansion Mechanism 72 Flushing Port 100 Docking Device 102 Coil, support structure 103 Lumen 104 Expandable sleeve, guard 106 Proximal end, first end, inflow end 108 distal end, second end, outflow end 110 First section, inflow section, atrial section 112 Second section, outflow section, ventricular section 114 First Rotating Part 116 Second Rotating Part 118 Gap 119 Longitudinal Axis 120 Proximal ventricular portion 120 First rotating part, ventricular part 122 Second part, second rotating part 124 Third part, intermediate rotating part 126 proximal end, first end 128 distal end, second end 200 Docking Device 202 Coil 204 Expandable Sleeve 206 First End 208 Second End 210 First Section 212 Second Section 214 First Part 216 Second Part 220 First Part 230 first expandable sleeve 232 Second Expandable Sleeve 234 Gap 236 Proximal end, first end 238 Distal end, second end 240 proximal end, first end 242 distal end, second end 242 Second End, First Part 246 Second Part 248 Third Part 250 First Part 252 Second Part 254 Third Part 300 Docking Device 302 Coil 304 Expandable Sleeve 306 First End 308 Second End 310 First Section 312 Second Section 326 First End 328 Second End 330 First Part 332 Second Part 334 Third Part 334 Intermediate tapered section 400 Docking Device 402 Coil 404 Expandable Sleeve 406 First End 408 Second End 410 First Section 412 Second Section 416 Second Part 419 Longitudinal Axis 420 First Part 424 Third Part 426 First End 428 Second End 430 First Part 432 Second Part 434 Third section, intermediate section, intermediate tapered section 436 First Segment 438 Second Segment 440 Third Segment 500 Docking Device 502 Coil 504 Expandable Sleeve 506 First End 508 Second End 510 First Section 512 Second Section 516 Second Part 519 Longitudinal Axis 520 First Part 524 Third Part 526 First End 528 Second End 530 First Part 532 Second Part 534 Third section, intermediate tapered section 536 First Segment 538 Second Segment 540 Third Segment 542 Concave 544 Convex 546 First angle 548 Second Angle 600 Docking Device 602 Coil 604 Expandable Sleeve 650 cores 652 First Cover 654 Expandable member, expandable cover 656 Second Cover 658 Gap, Cavity 700 Docking Device 702 Coil 703 Lumen 704 Expandable Sleeve 710 First Section 712 Second Section 714 First Part 716 Second Part 719 Longitudinal Axis 720 First Part 722 Second Part 724 Third Part 730 First Part 732 Second Part 734 Intermediate tapered section 746 Corner 800 Native mitral valve 800 Mitral valve 802 Heart 804 Left atrium 806 Left ventricle 808 Anterior leaflet 810 En 812 shelves 814 Posterior apex 818 Posteromedial commissure 819 Opening 820 Anterolateral commissure 822 Left ventricular outflow tract (LVOT) 824 Aortic valve 900 Delivery Device 902 Delivery shaft 904 Guidewire 910 Artificial Heart Valves 912 Frame 914 Valve structure 916 Valve cover 918 Exterior 920 Commissural window 922 Inflow end 924 Outflow end 926 commissure 928 Inner part 930 Sutures 940 Valve Leaflet 950 Prosthetic Heart Valve System 1000 delivery device 1002 Delivery shaft 1004 Balloon

Claims

1. 1. A docking device for a prosthetic heart valve, comprising: an inlet end; an outflow end; a support structure disposed between the inlet end and the outlet end, an inflow section extending from the inflow end of the docking device toward the outflow end of the docking device and configured to be positioned on the inflow side of a native heart valve; a support structure comprising: an outflow section extending between the outflow end of the docking device and the inflow section of the support structure and configured to be positioned on the outflow side of a native heart valve, the outflow section comprising a first portion, a second portion, and a third portion, the first portion extending distally from the inflow section to the third portion, the third portion extending distally from the first portion to the second portion, and the second portion extending distally from the third portion to the outflow end of the docking device; an expandable sleeve covering at least a portion of the support structure, the expandable sleeve being movable from a compressed position to an expanded position upon release of crimping pressure, wherein in the expanded position the expandable sleeve extends at an angle of at least 100 degrees over the first portion of the outflow section of the support structure; The docking device wherein the expandable sleeve comprises a single continuous sleeve extending between the inflow section and the outflow section of the support structure.

2. 2. The docking device of claim 1, wherein the expandable sleeve extends over the first portion of the outflow section at an angle of at least 100 degrees from the inflow section of the support structure toward the outflow end of the docking device, and is configured to extend to and be in direct physical contact with the third portion of the outflow section of the support structure when the expandable sleeve is in the expanded position.

3. 3. The docking device of claim 1, wherein the expandable sleeve extends over the inflow section of the support structure at an angle of at least 100 degrees from the outflow section of the support structure toward the inflow end of the docking device.

4. 4. The docking device of claim 3, wherein the expandable sleeve comprises a first portion extending over the inflow section of the support structure, a second portion extending over the outflow section of the support structure, and an intermediate portion disposed between the first and second portions.

5. The docking apparatus of claim 4 , wherein the expandable sleeve is tapered at the intermediate portion such that the intermediate portion is narrower than the first and second portions of the expandable sleeve.

6. 6. The docking apparatus of claim 4, wherein the intermediate portion extends from the inlet section of the support structure over the first portion of the outlet section of the support structure toward the outlet end of the support structure at an angle of at least 45 degrees.

7. The docking device of any one of claims 1 to 6, wherein the expandable sleeve has a proximal end and a distal end, the expandable sleeve extends from the distal end to the proximal end toward the inflow end of the docking device, and the expandable sleeve is connected to the support structure at the distal end.

8. The docking apparatus of claim 7 , wherein the expandable sleeve is tapered at the distal end.

9. A docking device for a prosthetic heart valve, comprising: an inlet end; an outflow end; a support structure disposed between the inlet end and the outlet end, an inflow section extending from the inflow end of the docking device toward the outflow end of the docking device and configured to be positioned on the inflow side of a native heart valve; a support structure comprising: an outflow section extending between the outflow end of the docking device and the inflow section of the support structure and configured to be positioned on the outflow side of a native heart valve, the outflow section comprising a first portion, a second portion, and a third portion, the first portion extending distally from the inflow section to the third portion, the third portion extending distally from the first portion to the second portion, and the second portion extending distally from the third portion to the outflow end of the docking device; an expandable sleeve covering at least a portion of the support structure, the expandable sleeve being movable from a compressed position to an expanded position upon release of crimping pressure, wherein in the expanded position the expandable sleeve extends at an angle of at least 100 degrees over the first portion of the outflow section of the support structure; The docking device wherein the expandable sleeve comprises two separate sleeves separated from each other by a gap.

10. The docking apparatus of claim 9 , wherein the expandable sleeve comprises a first sleeve extending along the inflow section of the support structure and a second sleeve extending along the outflow section of the support structure.

11. The docking apparatus of claim 10 , wherein the gap is at an angle of at least 45 degrees.

12. 12. The docking device of claim 10 or 11, wherein the first sleeve has a proximal end and a distal end, the first sleeve extends from the distal end to the proximal end toward the inflow end of the docking device, and the first sleeve is connected to the support structure at the distal end.

13. The docking apparatus of claim 12 , wherein the first sleeve is tapered at the distal end.

14. A docking device as described in any one of claims 10 to 13, wherein the second sleeve has a proximal end and a distal end, the second sleeve extends from the distal end to the proximal end toward the inflow end of the docking device, and the second sleeve is connected to the support structure at the distal end.

15. The docking apparatus of claim 14 , wherein the second sleeve is tapered at one or more of the distal end and the proximal end.

16. The docking apparatus of any one of claims 1 to 15, wherein the first portion of the support structure has a different geometric shape than the third portion of the support structure.

17. 17. The docking device of claim 16, wherein the first portion has a different shape than the third portion of the support structure when viewed in a plane perpendicular to a longitudinal axis of the docking device.

18. 18. The docking device of claim 16 or 17, wherein the first portion has a different size than the third portion of the support structure when viewed in a plane perpendicular to a longitudinal axis of the docking device.

19. 20. The docking device of claim 18, wherein the first portion is larger than the third portion of the support structure when viewed in the plane perpendicular to the longitudinal axis of the docking device.

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