Artificial valve docking device

Abstract

Certain embodiments of the present disclosure relate to a guard member for a docking device configured to receive a prosthetic valve. The guard member can include an expandable member and a resilient member extending along an axial length of the expandable member. The expandable member can be movable between a radially compressed state and a radially expanded state. When the expandable member is in the radially compressed state, the resilient member can be in an axially expanded state. The resilient member in the axially expanded state can be configured to return to a resting state, thereby moving the expandable member from the radially compressed state to the radially expanded state.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 363,382, filed April 21, 2022, and U.S. Provisional Application No. 63 / 264,354, filed November 19, 2021, both of which are incorporated herein by reference.

[0002] The present disclosure relates to embodiments of docking devices configured to secure a prosthetic valve to a native heart valve, as well as methods of assembling such devices. [Background technology]

[0003] Prosthetic valves can be used to treat valvular heart disease. Natural heart valves (e.g., aortic, pulmonary, tricuspid, and mitral) function to allow forward flow while preventing reverse or regurgitation. These heart valves can become less effective due to congenital, inflammatory, infectious conditions, and the like. These conditions can ultimately lead to severe cardiovascular defects or death. For many years, physicians have attempted to treat such disorders with surgical repair or replacement of the valves during open-heart surgery.

[0004] A transcatheter technique for introducing and implanting a prosthetic heart valve using a catheter in a less invasive manner than open-heart surgery can reduce complications associated with open-heart surgery. In this technique, the prosthetic valve can be mounted in a compressed state onto the end portion of a catheter and advanced through the patient's blood vessels until the valve reaches the implantation site. The valve at the catheter tip can then be expanded to its functional size at the site of the defective native valve, such as by inflating a balloon on which the valve is mounted, or, for example, the valve can have a resilient self-expanding frame that expands the valve to its functional size when the valve is advanced from a delivery sheath at the distal end of the catheter. Optionally, the valve can have a balloon-expandable, self-expanding, mechanically expandable frame, and / or a frame that is expandable in multiple or combination of ways.

[0005] In some cases, a transcatheter heart valve (THV) may be appropriately sized to be placed inside a particular native valve (e.g., a native aortic valve). As such, the THV may not be suitable for implantation in a patient with another native valve (e.g., a native mitral valve) and / or a larger native valve. Additionally or alternatively, the native tissue at the implantation site may not provide sufficient structure to secure the THV in place relative to the native tissue. As a result, improvements to THVs and related transcatheter delivery devices are desirable. Summary of the Invention [Problem to be solved by the invention]

[0006] The present disclosure relates to methods and devices for treating valvular regurgitation and / or other valvular problems. In particular, the present disclosure is directed to a docking device configured to receive a prosthetic valve, as well as methods of assembling and implanting the docking device. [Means for solving the problem]

[0007] A docking device for securing a prosthetic valve to a native valve can include a coil comprising a plurality of helical turns when deployed on the native valve. In addition to these features, the docking device can further comprise one or more of the components disclosed herein.

[0008] In certain embodiments, the docking device can include a guard member that includes an expandable member and a resilient member.

[0009] In certain embodiments, a first end portion of the expandable member can be fixedly attached to a segment of the coil and a second end portion of the expandable member can be axially movable relative to the coil.

[0010] In certain embodiments, the expandable member can be movable between a radially compressed state and a radially expanded state.

[0011] In certain embodiments, the elastic member can be coupled to and extend along an axial length of the expandable member and can be movable between an axially extended state and a rest state, and the elastic member can be biased toward the rest state.

[0012] In certain embodiments, when the expandable member is in a radially compressed state, the elastic member can be in an axially elongated state and can be configured to assist in moving the expandable member from the radially compressed state to the radially expanded state.

[0013] In certain embodiments, the elastic member can be in a quiescent state when the expandable member is in a radially expanded state.

[0014] In one particular embodiment, a guard member for a docking device can include an expandable member and a resilient member extending along an axial length of the expandable member.

[0015] In certain embodiments, the expandable member can be movable between a radially compressed state and a radially expanded state.

[0016] In certain embodiments, the elastic member can be in an axially elongated state when the expandable member is in a radially compressed state.

[0017] In certain embodiments, the elastic member in an axially elongated state can be configured to return to a resting state, thereby moving the expandable member from a radially compressed state to a radially expanded state.

[0018] In one particular embodiment, a guard member for a docking device can include an expandable member having a woven material.

[0019] In certain embodiments, the expandable member can include multiple expandable portions connected by one or more constricted portions.

[0020] In certain embodiments, the constricted portion may have a higher weave density than the expandable portion.

[0021] In certain embodiments, the expandable portion can be movable between a first diameter and a second diameter, and the second diameter can be greater than the first diameter.

[0022] In certain embodiments, the constricted portion can be configured to remain at a constant diameter, or at least a substantially constant diameter, as the expandable portion moves between the first diameter and the second diameter.

[0023] Certain embodiments of the present disclosure relate to a docking device for securing a prosthetic valve to a native valve. The docking device may include a coil having a plurality of helical turns when deployed in the native valve, and a guard member including an expandable member and a resilient member. A first end portion of the expandable member may be fixedly attached to a segment of the coil, and a second end portion of the expandable member may be axially movable relative to the coil. The second end portion is opposite the first end portion. The expandable member may be movable between a radially compressed state and a radially expanded state. The resilient member may be coupled to the expandable member and extend along its axial length, and may be movable between an axially extended state and a rest state, and the resilient member may be biased to the rest state. When the expandable member is in the radially compressed state, the resilient member may be in an axially extended state and may be configured to assist in moving the expandable member from the radially compressed state to the radially expanded state. When the expandable member is in the radially expanded state, the resilient member may be in a rest state.

[0024] Certain embodiments of the present disclosure also relate to a guard member for a docking device configured to receive a prosthetic valve. The guard member can include an expandable member and a resilient member extending along an axial length of the expandable member. The expandable member can be movable between a radially compressed state and a radially expanded state. When the expandable member is in the radially compressed state, the resilient member can be in an axially expanded state. The resilient member in the axially expanded state can be configured to return to a resting state, thereby moving the expandable member from the radially compressed state to the radially expanded state.

[0025] According to certain embodiments, a guard member for a docking device configured to receive a prosthetic valve can include an expandable member having a woven material. The expandable member can include a plurality of expandable portions connected by one or more clamped portions. The clamped portions can have a higher weave density than the expandable portions. The expandable portions can be movable between a first diameter and a second diameter, the second diameter being greater than the first diameter. The clamped portions can be configured to remain at a constant diameter or at least a substantially constant diameter as the expandable portions move between the first diameter and the second diameter.

[0026] Certain aspects of the present disclosure relate to a method for assembling a docking device configured to receive a prosthetic valve. The method can include attaching a guard member to a coil. The coil can be configured to surround native tissue when deployed in the native valve. The guard member can include an expandable member and an elastic member extending along an axial length of the expandable member. The elastic member can move from a resting state to an axially extended state, and the elastic member can be biased to the resting state. The expandable member can be in a radially compressed state when the elastic member moves to the axially extended state. The expandable member can be in a radially expanded state when the elastic member returns to the resting state.

[0027] Certain aspects of the present disclosure also relate to methods for implanting a prosthetic valve. The method can include deploying a docking device at a native valve and deploying a prosthetic valve within the docking device. The docking device can include a coil and a guard member attached to the coil. The guard member can include an expandable member and a resilient member extending along an axial length of the expandable member. The resilient member can move from a resting state to an axially extended state, and the resilient member can be biased to the resting state. The expandable member can be in a radially compressed state when the resilient member moves to the axially extended state. The expandable member can be in a radially expanded state when the resilient member returns to the resting state.

[0028] The above methods can be performed on live animals or on simulations (such as on cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., simulated body parts, hearts, tissues, etc.), etc.).

[0029] Certain embodiments of the present disclosure relate to a medical assembly including any of the docking devices described above, or a docking device having any of the guard members described above, and a radially expandable and compressible prosthetic valve configured to be received within the docking device.

[0030] Certain aspects of the present disclosure also relate to a medical assembly including any of the above-described docking devices or a docking device having any of the above-described guard members, and a delivery apparatus configured to deliver the docking device to a target implantation site in a patient.

[0031] According to certain embodiments, a docking device for securing a prosthetic valve in a native valve can include a coil comprising a plurality of helical turns when deployed in the native valve, and an expandable member extending radially outward from the coil. The expandable member can be movable between a radially compressed state and a radially expanded state. A first end of the expandable member can be fixedly attached to the coil, and a second end of the expandable member can be axially movable relative to the coil, where the second end is opposite the first end.

[0032] According to one particular embodiment, the expandable member can include a braided wire frame.

[0033] According to certain embodiments, the expandable member can include a polymeric material.

[0034] According to one particular embodiment, the expandable member can include a braided metal wire frame coated with an elastomer.

[0035] According to one particular embodiment, the expandable member can include one or more metal wires interwoven with one or more polymeric fibers.

[0036] According to certain aspects of the present disclosure, a guard member for a docking device configured to receive a prosthetic valve can include an expandable member having a braided wire mesh and an elastic member extending along an axial length of the expandable member. The expandable member can be movable between a radially compressed state, a first radially expanded state, and a second radially expanded state. A diameter of the expandable member in the first radially expanded state is larger than the expandable member in the radially compressed state and smaller than the expandable member in the second radially expanded state. When the elastic member is not coupled to the expandable member, the expandable member can be biased toward the first radially expanded state. When the elastic member is coupled to the expandable member, the expandable member can be biased toward the second radially expanded state.

[0037] According to certain aspects of the present disclosure, a docking device for securing a prosthetic valve in a native valve can include a coil having a plurality of helical turns when deployed in the native valve, a guard member including an expandable member, and a coil spring coupled to the expandable member. The coil can extend through the coil spring. The expandable member can be movable between a radially compressed state and a radially expanded state. The coil spring can extend axially to a first length when the expandable member is in the radially compressed state and can return to a second length when the expandable member is in the radially expanded state, the second length being shorter than the first length. The coil spring can be biased toward the second length.

[0038] According to certain aspects of the present disclosure, a docking device for securing a prosthetic valve in a native valve can include a coil having a plurality of helical turns when deployed in the native valve, a guard member including an expandable member, and a coil spring wound around the coil and coupled to the expandable member. The expandable member can be movable between a radially compressed state and a radially expanded state. The coil spring can be movable between an axially extended state and a resting state, and the coil spring can be biased toward the resting state. When the expandable member is in the radially compressed state, the coil spring can be in an axially extended state and can be configured to assist in moving the expandable member from the radially compressed state to the radially expanded state. When the expandable member is in the radially expanded state, the coil spring can be in a resting state.

[0039] In some embodiments, the docking device includes one or more of the components listed in Examples 1-20, 89-108, and 122-128 described in the "Additional Examples of the Disclosed Technology" section below.

[0040] In some embodiments, the guard member comprises one or more of the components listed in Examples 21-70 and 109-121 described in the "Additional Examples of the Disclosed Technology" section below.

[0041] The above 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 description of the drawings]

[0042] [Figure 1A] FIG. 1A is a side perspective view of a docking device in a spiral configuration, according to one embodiment. [Figure 1B] FIG. 1B is a top view of the docking device illustrated in FIG. 1A. [Figure 1C] FIG. 1C is a cross-sectional view of a docking device taken along line 1C-1C illustrated in FIG. 1B, according to one embodiment. [Figure 1D] FIG. 1D is a cross-sectional view of the docking device taken along the same line as in FIG. 1C, except that the docking device is in a substantially straight delivery configuration in FIG. 1D. [Figure 1E] FIG. 1E is a cross-sectional view of a docking device taken along line 1C-1C illustrated in FIG. 1B according to another embodiment. [Figure 1F] FIG. 1F is a cross-sectional view of the docking device taken along the same line as in FIG. 1E, except that the docking device is in a substantially straight delivery configuration in FIG. 1F. [Figure 1G] FIG. 1G is a schematic diagram illustrating the docking device in a substantially straight configuration. [Figure 2A] FIG. 2A is a perspective view of an artificial valve, according to one embodiment. [Figure 2B] FIG. 2B is a perspective view of the prosthetic valve of FIG. 2A with an outer covering, according to one embodiment. [Figure 3A] 3A is a perspective view of an exemplary prosthetic implant assembly including the docking device illustrated in FIG. 1A and the prosthetic valve of FIG. 2B held within the docking device. [Figure 3B] 3B is a side elevational view of the prosthetic implant assembly of FIG. 3. [Figure 4A] FIG. 4A illustrates an expandable member coupled to an elastic member, according to one embodiment. [Figure 4B] FIG. 4B illustrates an expandable member coupled to an elastic member according to another embodiment. [Figure 4C] FIG. 4C illustrates an expandable member coupled to another elastic member in the form of a coil spring, according to one embodiment, where the coil spring is in a resting state. [Figure 4D] FIG. 4D illustrates the expandable member coupled to the coil spring of FIG. 4C, with the coil spring in an axially extended state. [Figure 5A] FIG. 5A is a top view of a docking device with a textured woven guard member, according to one embodiment. [Figure 5B] FIG. 5B is a side elevational view of the docking device of FIG. 5A. [Figure 6A] FIG. 6A illustrates a textured woven guard member in a radially compressed and axially stretched configuration. [Figure 6B] FIG. 6B illustrates the textured woven guard member of FIG. 6A in a radially expanded and axially contracted configuration. [Figure 6C] FIG. 6C illustrates a portion of the guard member of FIG. 6A that is textured and woven. [Figure 7A] FIG. 7A is a schematic top view of a docking device with a textured woven guard member and a prosthetic valve expanded within the coil of the docking device, according to one embodiment. [Figure 7B] FIG. 7B is an illustration of a textured woven guard member after it has been cut along its longitudinal axis and flattened, according to one embodiment. [Figure 7C] FIG. 7C is a cross-sectional view of a portion of the textured woven guard member taken along the longitudinal axis, where, according to one embodiment, an inner portion of the expandable portion is radially compressed by the prosthetic valve and contacts the coil. [Figure 8] FIG. 8 is a side view of a delivery assembly including a delivery apparatus and the docking device of FIG. 1A, according to one embodiment. [Figure 9A] FIG. 9A is a side cross-sectional view of a sleeve shaft according to one embodiment. [Figure 9B] FIG. 9B is a side cross-sectional view of a pusher shaft according to one embodiment. [Figure 10A] FIG. 10A is a side cross-sectional view of an assembly including the sleeve shaft of FIG. 9A, the pusher shaft of FIG. 9B, and a delivery sheath, where the sleeve shaft covers a docking device. [Figure 10B] FIG. 10B is a side cross-sectional view of the same assembly of FIG. 10A, except that the docking device is not covered by the sleeve shaft. [Figure 11] FIG. 11 is a schematic cross-sectional view of a distal end portion of a delivery system illustrating fluid flow through lumens within the delivery system. [Figure 12A] FIG. 12A illustrates a perspective view of one embodiment of a sleeve shaft that covers the docking device and extends outside the delivery sheath of the delivery system. [Figure 12B] FIG. 12B illustrates the sleeve shaft surrounding the pusher shaft after deployment of the docking device from the delivery system of FIG. 12A and removal of the sleeve shaft from the docking device. [Figure 13] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 14] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 15] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 16] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 17] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 18A] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 18B] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 18C] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 19] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 20] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 21] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 22] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 23] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 24]13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Diagram 25] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 26] 13-26 illustrate various portions of an exemplary implantation procedure in which the delivery device of FIG. 8 is used to implant the prosthetic implant assembly of FIG. 3A in place of the native mitral valve using a transseptal delivery approach. [Figure 27] FIG. 27 is an atrial side view of another docking device implanted in the mitral valve, according to one embodiment. [Figure 28] FIG. 28 is an atrial side view of the docking device of FIG. 27 after a prosthetic valve has been received within the docking device, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0043] General Considerations It will be appreciated that the disclosed embodiments can be adapted to deliver and implant prosthetic devices into any of the heart's native annulus (e.g., the pulmonary, mitral, and tricuspid annulus) and can be used with any of a variety of delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0044] For purposes of this specification, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any manner. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations with each other, and in various subcombinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature, or combination thereof, nor do the disclosed embodiments require that any one or more particular advantages exist or problems be solved. Techniques from any embodiment can be combined with the techniques described in any one or more of the other embodiments. In view of the numerous possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are only preferred embodiments and should not be taken as limiting the scope of the disclosed technology.

[0045] Although some operations of the disclosed embodiments are described in a particular sequential order for convenient presentation, it is understood that this manner of description encompasses reordering unless a particular ordering is required by specific language described below. For example, operations described sequentially may be reordered or performed simultaneously in some cases. Furthermore, for purposes of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0046] As used in this application and the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. In addition, the term "comprises" means "comprising." Furthermore, the terms "coupled" and "connected" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked and do not exclude the presence of intermediate elements between coupled or associated items, unless specifically stated to the contrary.

[0047] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and farther away from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is farther away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is the movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of a device is the movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless expressly defined otherwise.

[0048] As used herein, the terms "approximately" and "about" refer to the recited value and any value within 10% of the recited value. For example, "about 1 mm" refers to any value from about 0.9 mm to about 1.1 mm, inclusive.

[0049] Directions and other relative references (e.g., inside, outside, above, below, etc.) may be used to facilitate discussion of the figures and principles herein, but are not intended to be limiting. For example, certain terms may be used, such as "inside," "outside," "top," "down," "interior," and "exterior," and the like. Such terms are used, where applicable, to provide some descriptive clarity with respect to the specifically illustrated embodiments when dealing with relative relationships. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" portion may become a "lower" portion by simply flipping the object over. Nevertheless, it is still the same portion and the object remains the same. As used herein, "and / or" means "and" or "or," as well as "and" and "or." Introduction to the disclosed technology

[0050] Disclosed herein are various systems, apparatus, methods, etc., including anchoring or docking devices that can be used in conjunction with an expandable prosthetic valve at a native valve annulus (e.g., native mitral and / or tricuspid annulus) to more securely implant and retain the prosthetic valve at the implantation site. Anchoring / docking devices according to embodiments of the present disclosure can provide, for example, a stable anchoring site, landing zone, or implantation zone at the implantation site where the prosthetic valve can be expanded or otherwise implanted. Many of the disclosed docking devices include a circular or cylindrical portion, which (for example) can enable a prosthetic heart valve with a circular or cylindrical valve frame to be expanded or otherwise implanted into a native location having a natural circular cross-sectional profile and / or into a native location having a natural non-circular cross-section. In addition to providing an anchoring site for the prosthetic valve, the anchoring / docking device can be sized and shaped to grip or retract radially inwardly into the anatomy of the native valve (e.g., mitral, tricuspid, etc.). In this way, one of the major causes of valve regurgitation (e.g., functional mitral regurgitation) can be at least partially counteracted or countered, specifically, cardiac hypertrophy (e.g., left ventricular hypertrophy, etc.) and / or valve annulus enlargement and the resulting outward stretching of the native valve (e.g., mitral valve, etc.) from the annulus. Some embodiments of the anchoring or docking device further include features that are shaped and / or modified to better retain the position or shape of the docking device, for example, during and / or after expansion of the prosthetic valve therein. By providing such an anchoring or docking device, the replacement valve can be more securely implanted and retained in various valve annuli, including mitral annuli that do not have a natural circular cross-section.

[0051] In some cases, the docking device can include a paravalvular leak (PVL) guard (also referred to herein as a "guard member"), which can help, for example, to reduce reflux between the native tissue and the docking device and / or promote tissue ingrowth.

[0052] The PVL guard, in some embodiments, can be movable between a delivery configuration and a deployed configuration. When the PVL guard is in the delivery configuration, the outer edge of the PVL guard can extend along and adjacent to the coil. When the PVL guard is in the deployed configuration, the outer edge of the PVL guard can form a helical shape that rotates about a central longitudinal axis of the coil, and at least a segment of the outer edge of the PVL guard can extend radially away from the coil.

[0053] In certain embodiments, the PVL guard can cover or encase a portion of the coil of the docking device, and as described more fully below, such a PVL guard can be movable from a radially compressed (and axially elongated) state to a radially expanded (and axially shortened) state, and a proximal end portion of the PVL guard can be axially movable relative to the coil.

[0054] Also disclosed herein are exemplary methods of attaching the PVL guard to a docking device and exemplary methods of limiting axial movement of the PVL guard. Exemplary Docking Devices

[0055] 1A-1G illustrate a docking device 100 according to one embodiment. The docking device 100 can be implanted, for example, within a native valve annulus (see, for example, FIG. 15). As shown in FIGS. 3A-3B and 26, the docking device can be configured to receive and secure a prosthetic valve within the docking device, thereby securing the prosthetic valve to the native valve annulus.

[0056] 1A-1G, docking device 100 can include a coil 102 and a guard member 104 that covers at least a portion of coil 102. In certain embodiments, coil 102 can include a shape memory material (e.g., a nickel-titanium alloy or "nitinol") that allows docking device 100 (and coil 102) to move from a substantially straight configuration (also referred to as the "delivery configuration") when disposed within a delivery sheath of a delivery device (as described more fully below), to a helical configuration (also referred to as the "deployed configuration") after removal from the delivery sheath, as shown in FIGS. 1A-1B.

[0057] In certain embodiments, when the guard member 104 is in the deployed configuration, the guard member 104 can extend circumferentially 180 degrees to 400 degrees, or 210 degrees to 330 degrees, or 250 degrees to 290 degrees, or 260 degrees to 280 degrees relative to the central longitudinal axis 101 of the docking device 100. In one particular embodiment, when the guard member 104 is in the deployed configuration, the guard member 104 can extend circumferentially 270 degrees relative to the central longitudinal axis 101. In other words, the guard member 104 can extend circumferentially from about half a rotation around the central longitudinal axis 101 (e.g., 180 degrees) in some embodiments to more than a full rotation around the central longitudinal axis 101 (e.g., 400 degrees) in other embodiments, including various ranges therebetween. As used herein, ranges (eg, 180 to 400 degrees, from 180 degrees to 400 degrees, and between 180 degrees and 400 degrees) include the endpoints of the range (eg, 180 degrees and 400 degrees).

[0058] In some examples, the docking device 100 can also include a retention element 114 that surrounds at least a portion of the coil 102 and is at least partially covered by the guard member 104. In some cases, the retention element 114 can include a braided material. Additionally, the retention element 114 can provide a surface area that encourages or promotes tissue ingrowth and / or attachment and / or reduces trauma to native tissue. For example, in certain cases, the retention element 114 can have a textured outer surface configured to promote tissue ingrowth. In certain cases, the retention element 114 can be impregnated with growth factors to stimulate or promote tissue ingrowth.

[0059] In one embodiment, as illustrated in Figures 1A-1B and 3A-3B, at least a proximal end portion of the retaining element 114 can extend outside the proximal end of the guard member 104. In another embodiment, the retaining element 114 can be completely covered by the guard member 104.

[0060] As described further below, the retaining element 114 can be designed to interact with the guard member 104 to limit or resist movement of the guard member 104 relative to the coil 102. For example, the proximal end 105 of the guard member 104 can have an inner diameter that is approximately the same as the outer diameter of the retaining element 114. As such, the inner surface of the guard member 104 at the proximal end 105 can frictionally interact or engage with the retaining element 114 such that a frictional force exerted by the retaining element 114 can impede axial movement of the proximal end 105 of the guard member 104 relative to the coil 102.

[0061] The coil 102 has a proximal end 102p and a distal end 102d (which also define the proximal and distal ends, respectively, of the docking device 100). When disposed within a delivery sheath (e.g., during delivery of the docking device into the patient's vasculature), the body of the coil 102 between the proximal end 102p and the distal end 102d can form a generally straight delivery configuration (i.e., does not have any coiled or looped portions, but can be bent or curved) to maintain a small radial profile as it moves through the patient's vasculature. After removal from the delivery sheath and deployment at the implantation location, the coil 102 can move from the delivery configuration to a helical deployed configuration and wrap around native tissue adjacent the implantation location. For example, when implanting the docking device in the location of a native valve, the coil 102 can be configured to surround the native leaflets of the native valve (and the chordae tendineae, if present, connecting the native leaflets to the adjacent papillary muscles), as described further below.

[0062] The docking device 100 can be releasably coupled to a delivery apparatus. For example, in certain embodiments, the docking device 100 can be coupled to a delivery apparatus (as described further below) via a release suture, which can be configured to be tied to the docking device 100 and cut for removal. In one embodiment, the release suture can be tied to the docking device 100 through an eyelet or peephole 103 located adjacent the proximal end 102p of the coil. In another embodiment, the release suture can be tied around a peripheral recess located adjacent the proximal end 102p of the coil 102.

[0063] In some embodiments, the docking device 100 in the deployed configuration can be configured to conform at the mitral valve. In other embodiments, the docking device can also be shaped and / or conformed for implantation at other native valve locations, such as the tricuspid valve. As described herein, the geometry of the docking device 100 can be configured to engage with the native anatomical structure, which can provide, for example, increased stability and reduced relative movement between the docking device 100, the prosthetic valve docked therein, and / or the native anatomical structure. Such reduced relative movement can, among other things, prevent material degradation of the docking device 100 and / or components of the prosthetic valve docked therein, and / or prevent damage or trauma to the native tissue.

[0064] As shown in FIGS. 1A-1B, the coil 102 in the deployed configuration can include a leading turn 106 (or "leading coil"), a central region 108, and a stabilizing turn 110 (or "stabilizing coil") about a central longitudinal axis 101. The central region 108 can have one or more helical turns having substantially equal inner diameters. The leading turn 106 can extend from a distal end of the central region 108 and has a diameter larger than the diameter of the central region 108 (in one or more configurations). The stabilizing turn 110 can extend from a proximal end of the central region 108 and has a diameter larger than the diameter of the central region 108 (in one or more configurations).

[0065] In certain embodiments, the central region 108 may include multiple helical turns, such as a proximal turn 108p connected to the stabilizing turn 110, a distal turn 108d connected to the leading turn 106, and one or more intermediate turns 108m disposed between the proximal turn 108p and the distal turn 108d. In the embodiment shown in FIG. 1A, there is only one intermediate turn 108m between the proximal turn 108p and the distal turn 108d. In other embodiments, there are two or more intermediate turns 108m between the proximal turn 108p and the distal turn 108d. Some of the helical turns in the central region 108 may be full turns (i.e., rotate 360 ​​degrees). In some embodiments, the proximal turn 108p and / or the distal turn 108d may be partial turns (e.g., rotate less than 360 degrees, such as 180 degrees, 270 degrees, etc.).

[0066] The size of the docking device 100 can generally be selected based on the size of the desired prosthetic valve to be implanted into the patient. In certain embodiments, the central region 108 can be configured to hold a radially expandable prosthetic valve (as shown in FIGS. 3A-3B and described further below). For example, the inner diameter of the helical turns in the central region 108 can be configured to be smaller than the outer diameter of the prosthetic valve such that when the prosthetic valve is radially expanded, additional radial forces can act between the central region 108 and the prosthetic valve to hold the prosthetic valve in place. As described herein, the helical turns (e.g., 108p, 108m, 108d) in the central region 108 are also referred to herein as "functional turns."

[0067] The stabilizing turns 110 can be configured to help stabilize the docking device 100 in a desired position. For example, the radial dimension of the stabilizing turns 110 can be significantly larger than the radial dimension of the coils in the central region 108 so that the stabilizing turns 110 can flare or extend outwardly enough to abut or press against the wall of the circulatory system, thereby improving the ability of the docking device 100 to remain in a desired position prior to implantation of the prosthetic valve. In some embodiments, it is desirable for the diameter of the stabilizing turns 110 to be larger than the native annulus, native valve plane, and / or native heart chamber for better stabilization. In some embodiments, the stabilizing turns 110 can be a full turn (i.e., about a 360 degree turn). In some embodiments, the stabilizing turns 110 can be a partial turn (e.g., about a 180 degree to about a 270 degree turn).

[0068] In one particular example, when the docking device 100 is implanted in place of the native mitral valve, the functional turn in the central region 108 can be disposed substantially within the left ventricle and the stabilizing turn 110 can be disposed substantially within the left atrium. The stabilizing turn 110 can be configured to provide one or more contact points or areas between the docking device 100 and the left atrial wall, such as at least three contact points within the left atrium or complete contact on the left atrial wall. In one particular example, the contact points between the docking device 100 and the left atrial wall can form a plane that is approximately parallel to the plane of the native mitral valve.

[0069] In some embodiments, the stabilizing turn 110 can have an atrial portion 110a that connects with a proximal turn 108p of the central region 108, a stabilizing portion 110c that is adjacent to the proximal end 102p of the coil 102, and an ascending portion 110b that is located between the atrial portion 110a and the stabilizing portion 110c. Both the atrial portion 110a and the stabilizing portion 110c can be generally parallel to the helical turns in the central region 108, while the ascending portion 110b can be angled relative to the atrial portion 110a and the stabilizing portion 110c. For example, in certain embodiments, the ascending portion 110b and the stabilizing portion 110c can form an angle between about 45 degrees and about 90 degrees, inclusive. In certain embodiments, the stabilizing portion 110c can define a plane that is substantially parallel to the plane defined by the atrial portion 110a. A boundary 107 (marked by a dashed line in FIG. 1A) between the ascending portion 110b and the stabilizing portion 110c can be determined as where the ascending portion 110b intersects with a plane defined by the stabilizing portion 110c. The curvature of the stabilizing turn 110 can be configured such that when the docking device 100 is fully expanded, the atrial portion 110a and the stabilizing portion 110c are disposed in approximately opposite sides. When the docking device 100 is implanted in the place of the native mitral valve, the atrial portion 110a can be configured to abut the posterior wall of the left atrium, and the stabilizing portion 110c can be configured to flare outward and press against the anterior wall of the left atrium (see, e.g., FIGS. 18-19 and 26).

[0070] As described above, the leading turn 106 can have a larger radial dimension than the helical turns in the central region 108. As described herein, the leading turn 106 can help to more easily navigate the coil 102 around and / or through the chordae tendineae and / or around all of the native leaflets of a native valve (e.g., native mitral valve, tricuspid valve, etc.). For example, once the leading turn 106 is navigated around a desired native anatomy, the remaining coils (e.g., functional turns) of the docking device 100 can also be navigated around the same feature. In some embodiments, the leading turn 106 can be a full turn (i.e., rotates about 360 degrees). In some embodiments, the leading turn 106 can be a partial turn (e.g., rotates about 180 degrees to about 270 degrees). 24, when the prosthetic valve expands radially within the central region 108 of the coil, the functional turns within the central region 108 can expand further radially. As a result, the leading turns 106 can be pulled proximally and become part of the functional turns within the central region 108.

[0071] In certain embodiments, at least a portion of the coil 102 can be surrounded by a first cover 112. As shown in FIGS. 1C-1F, the first cover 112 can have a tubular shape and therefore can be referred to as a "tubular member." In certain embodiments, the tubular member 112 can cover the entire length of the coil 102. In certain embodiments, the tubular member 112 covers only a selected portion of the coil 102.

[0072] In certain embodiments, the tubular member 112 can be coated and / or bonded onto the coil 102. In certain embodiments, the tubular member 112 can be a cushioned, padded type layer that protects the coil. The tubular member 112 can be constructed of a variety of natural and / or synthetic materials. In one particular embodiment, the tubular member 112 can include expanded polytetrafluoroethylene (ePTFE). In certain embodiments, the tubular member 112 is configured to be fixedly attached to the coil 102 (e.g., by a textured surface resist, sutures, glue, thermal bonding, or any other means) such that relative axial movement between the tubular member 112 and the coil 102 is restricted or prevented.

[0073] 1C-1D, at least a portion of tubular member 112 can be surrounded by retaining element 114. In some embodiments, tubular member 112 can extend through the entire length of retaining element 114. Exemplary methods of attaching retaining element 114 to tubular member 112 are described further below.

[0074] In some embodiments, a distal end portion of the retaining element 114 can extend axially beyond the distal end of the guard member 104 (i.e., positioned distally relative to the distal end of the guard member 104) and a proximal end portion of the retaining element 114 can extend axially beyond the proximal end 105 of the guard member 104 (i.e., positioned proximal to the proximal end 105 of the guard member 104) to aid in retaining the prosthetic valve and tissue ingrowth. In one embodiment, the distal end of the retaining element 114 can be positioned adjacent to the leading turn 106 (e.g., near the location marked by dashed line 109 in FIG. 1A). In another embodiment, the distal end of the retaining element 114 can be positioned at or adjacent to the distal end of the coil 102. In one embodiment, the proximal end of the retaining element 114 can be positioned at or adjacent to the ascending portion 110b of the coil 102. In one embodiment, at least a portion of tubular member 112 may not be surrounded by retaining element 114, as illustrated in FIGS. 1E-1F.

[0075] In certain embodiments, the docking device 100 can have one or more placement markers. For example, FIGS. 1A-1B show a proximal placement marker 121p and a distal placement marker 121d, where the proximal placement marker 121p is positioned proximally relative to the distal placement marker 121d. Both the proximal placement marker 121p and the distal placement marker 121d can have predefined locations relative to the coil 102. As shown, both the proximal placement marker 121p and the distal placement marker 121d can be positioned distal to the ascending portion 110b of the coil 102, for example, at the atrial portion 110a. Additionally, a proximal end portion of the retention element 114 can extend into and / or be positioned at the ascending portion 110b.

[0076] In certain embodiments, both the proximal placement marker 121p and the distal placement marker 121d can include a radiopaque material such that the placement markers can be visible under fluoroscopy, such as during an implantation procedure. As described further below, the placement markers 121p, 121d can be used to mark the proximal and distal boundaries of a segment of the coil 102 at which the proximal end 105 of the guard member 104 can be positioned when the docking device 100 is deployed.

[0077] In certain embodiments, the placement markers 121p, 121d can be disposed on the tubular member 112 and can be covered by the retaining element 114. In some embodiments, the placement markers 121p, 121d can be disposed on the atrial portion 110a of the coil 102 and can be covered by the tubular member 112. In certain embodiments, the placement markers 121p, 121d can be disposed directly on the retaining element 114. In yet alternative embodiments, the placement markers 121p, 121d can be disposed on different layers relative to each other. For example, one of the placement markers (e.g., 121p) can be disposed on the outside of the tubular member 112 and covered by the retaining element 114, while another placement marker (e.g., 121d) can be disposed directly on the coil 102 and covered by the tubular member 112.

[0078] In certain embodiments, the segment of coil 102 located between proximal placement marker 121p and distal placement marker 121d can have an axial length of about 2 mm to about 7 mm, or about 3 mm to about 5 mm. In one specific embodiment, the axial length of the coil segment between proximal placement marker 121p and distal placement marker 121d is about 4 mm.

[0079] In certain embodiments, the axial distance between the proximal placement marker 121p and the distal end of the ascending portion 110b is about 10 mm to about 30 mm, or about 15 mm to about 25 mm. In one specific embodiment, the axial distance between the proximal placement marker 121p and the distal end of the ascending portion 110b is about 20 mm.

[0080] Although two placement markers 121p, 121d are shown in FIGS. 1A-1B, it should be understood that the number of placement markers can be three or more or less than two. For example, in one embodiment, the docking device 100 can have only one placement marker (e.g., 121p). In another embodiment, one or more additional placement markers can be positioned between the proximal placement marker 121p and the distal placement marker 121d. As described above, the proximal end 105 of the guard member can be positioned between the proximal placement marker 121p and the distal placement marker 121d when the docking device 100 is deployed. As such, these additional placement markers can function as a scale to indicate the precise location of the proximal end 105 of the guard member 104 relative to the coil 102.

[0081] As described herein, the guard member 104 can form part of a cover assembly 120 for the docking device 100. In some embodiments, the cover assembly 120 can also include the tubular member 112. In some embodiments, the cover assembly 120 can further include a retaining element 114.

[0082] 1A-1B, when the docking device 100 is in a deployed configuration, the guard member 104 can be configured to cover a portion of the stabilization turns 110 (e.g., atrial portion 110a) of the coil 102. In certain embodiments, the guard member 104 can be configured to cover at least a portion of the central region 108 of the coil 102, such as a portion of the proximal turns 108p. In certain embodiments, the guard member 104 can extend across the entire coil 102.

[0083] As described herein, the guard member 104 can expand radially to help prevent and / or reduce paravalvular leakage. Specifically, the guard member 104 can be configured to expand radially such that an improved seal is formed closer to and / or against a prosthetic valve deployed within the docking device 100. In some examples, the guard member 104 can be configured to prevent and / or inhibit leakage at the location where the docking device 100 crosses between the leaflets of the native valve (e.g., at the commissures of the native leaflets). For example, without the guard member 104, the docking device 100 may push the native leaflets apart at the point where it crosses the native leaflets, allowing leakage at that point (e.g., along or to the side of the docking device). However, the guard member 104 can be configured to expand to cover and / or fill any openings at that point, inhibiting leakage along the docking device 100.

[0084] In another embodiment, when the docking device 100 is deployed in the native atrioventricular valve, the guard member 104 primarily covers a portion of the stabilizing turn 110 and / or a portion of the central region 108. In one embodiment, the guard member 104 can primarily cover the atrial portion 110a of the stabilizing turn 110 that is distal to the ascending portion 110b. Thus, the guard member 104 does not extend into the ascending portion 110b when the docking device 100 is in the deployed configuration (or at least, the guard member 104 can terminate before the anterolateral commissure 419 of the native valve, see, e.g., FIGS. 18-19). In certain circumstances, the guard member 104 can extend over the ascending portion 110b. This may cause kinking of the guard member 104, which may (in some cases) reduce the performance and / or durability of the guard member. Thus, the retaining member 114 may improve the functionality and / or lifespan of the guard member 104 by, among other things, preventing the guard member 104 from extending into the ascending portion 110 b of the coil 102 .

[0085] Still further, in alternative embodiments, the guard member 104 can not only cover the atrial portion 110a, but can also extend outside the ascending portion 110b of the stabilizing turn 110. This may occur, for example, in situations where the docking device is implanted in other anatomical locations and / or the guard member 104 is reinforced to reduce the risk of wire breakage.

[0086] In various embodiments, the guard member 104 can cover the atrial side of the atrioventricular valve to help prevent and / or inhibit blood from leaking through the native leaflets, commissures, and / or the outer periphery of the prosthetic valve by blocking blood from flowing within the atrium in the direction toward the ventricle other than through the prosthetic valve (i.e., antegrade blood flow). Positioning the guard member 104 on the atrial side of the valve can additionally or alternatively help reduce blood from flowing within the ventricle in the direction from the ventricle to the atrium (i.e., retrograde blood flow).

[0087] In some examples, the guard member 104 can be positioned on the ventricular side of the atrioventricular valve to prevent and / or inhibit blood from leaking through the native leaflets, commissures, and / or the outer periphery of the prosthetic valve by blocking blood from flowing within the ventricle in a direction from the ventricle to the atrium (i.e., retrograde blood flow). Positioning the guard member 104 on the ventricular side of the valve can additionally or alternatively help reduce blood in the atrium from flowing within the atrium in a direction toward the ventricle (i.e., antegrade blood flow) other than through the prosthetic valve.

[0088] The guard member 104 can include an expandable member 116 and a cover member 118 (also referred to as a "second cover" or "outer cover") that surrounds an outer surface of the expandable member 116. In certain embodiments, the expandable member 116 surrounds at least a portion of the tubular member 112. In certain embodiments, the tubular member 112 can extend (completely or partially) through the expandable member 116.

[0089] The expandable member 116 can extend radially outward from the coil 102 (and tubular member 112) and can be moved between a radially compressed (and axially elongated) state and a radially expanded (and axially shortened) state, i.e., the expandable member 116 can be axially shortened when moving from a radially compressed state to a radially expanded state, and can be axially extended when moving from a radially expanded state to a radially compressed state.

[0090] In certain embodiments, the expandable member 116 can include a braided structure, such as a braided wire mesh or lattice. In certain embodiments, the expandable member 116 can include a shape memory material that is shaped and / or preconfigured to expand into a particular shape and / or size when unconstrained (e.g., deployed at the location of the native valve). For example, the expandable member 116 can have a braided structure that includes a shape memory alloy with superelastic properties, such as Nitinol. In certain embodiments, the expandable member 116 can have a braided structure that includes a ternary shape memory alloy with superelastic properties, such as NiTiX, where X can be chromium (Cr), cobalt (Co), zirconium (Zr), hafnium (Hf), etc. In certain embodiments, the expandable member 116 can include a metallic material that does not have shape memory properties. Examples of such metallic materials include cobalt chrome, stainless steel, etc. In one specific embodiment, the expandable member 116 can include a nickel-free austenitic stainless steel, where the nickel can be fully replaced by nitrogen. In another specific embodiment, the expandable member 116 can include a cobalt-chromium or cobalt-nickel-chromium-molybdenum alloy with a significantly lower density of titanium. The number of wires (or fibers, strands, or the like) forming the braided structure can be selected to achieve a desired elasticity and / or strength of the expandable member 116. In certain embodiments, the number of wires used to braid the expansion member 116 can range from 16 to 128 (e.g., 32 wires, 48 ​​wires, 64 wires, 96 wires, etc.). In certain embodiments, the braid density can range from 20 picks per inch (PPI) to 70 PPI, or 25 PPI to 65 PPI. In one specific embodiment, the braid density is about 36 PPI. In another specific embodiment, the braid density is about 40 PPI. In certain embodiments, the wire diameter can range from about 0.002 inches to about 0.004 inches. In one specific embodiment, the wire diameter may be approximately 0.003 inches.In another embodiment, the expandable member 116 can be a combination of braided wire (which can include a shape memory material or a non-shape memory material) and a polymeric material and / or fabric (e.g., polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), thermoplastic polyurethane (TPU), etc.). For example, the expandable member 116 can include a braided wire frame embedded within a polymeric material.

[0091] In some examples, the expandable member 116 can include a braided metal wire frame coated with an elastomer (e.g., ePTFE, TPU, or the like), which can elastically deform as the braided wire frame expands and / or compresses. In some examples, the expandable member 116 can comprise a braid and / or weave including one or more metal wires and one or more polymeric fibers. In other words, the metal wires and the polymeric fibers can be woven together to define a braided structure. In some cases, the polymeric fibers can have the same or approximately the same diameter as the metal wires. In other cases, the polymeric fibers can have a smaller diameter (e.g., microfibers) than the metal wires, or vice versa.

[0092] In yet another embodiment, the expandable member 116 can include a polymeric material, such as a thermoplastic material (e.g., PET, polyetheretherketone (PEEK), thermoplastic polyurethane (TPU), etc.), without a braided wire frame.

[0093] In certain embodiments, the expandable member 116 can include a foam structure. For example, the expandable member can include an expandable memory foam that can expand into a particular shape or a particular pre-set shape upon removal of the crimping pressure prior to delivery of the docking device (e.g., removal of the docking device 100 from the delivery sheath).

[0094] As described herein, the cover member 118 can be configured to be elastic such that when the expandable member 116 moves from a radially compressed (and axially stretched) state to a radially expanded (and axially shortened) state, the cover member 118 can also radially expand and axially shorten with the expandable member 116. In other words, the guard member 104 as a whole can move from a radially compressed (and axially stretched) state to a radially expanded (and axially shortened) state. As described herein, the radially expanded (and axially shortened) state is also referred to as the "relaxed state" and the radially compressed (and axially stretched) state is also referred to as the "folded state."

[0095] In certain examples, the covering member 118 can be configured to be atraumatic to native tissue and / or promote tissue ingrowth into the covering member 118. For example, the covering member 118 can have pores to encourage tissue ingrowth. In another example, the covering member 118 can be impregnated with growth factors 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 combinations thereof. The covering member 118 can be constructed of any suitable material, including foam, cloth, fabric, and / or polymer, which is flexible to allow for compression and expansion of the covering member 118. In one example, the covering member 118 can include a layer of fabric constructed from a thermoplastic polymeric material, such as polyethylene terephthalate (PET).

[0096] As described herein, the distal end portion 104d of the guard member 104 (including the distal end portion of the expandable member 116 and the distal end portion of the cover member 118) can be fixedly coupled (e.g., via sutures, glue, or the like) to the coil 102, and the proximal end portion 104p of the guard member 104 (including the proximal end portion of the expandable member 116 and the proximal end portion of the cover member 118) can be axially movable relative to the coil 102. Further, the proximal end portion of the expandable member 116 can be fixedly coupled (e.g., via sutures, glue, thermal compression, laser fusing, etc.) to the proximal end portion of the cover member 118.

[0097] Alternatively, the proximal end portion 104p of the guard member 104 can be fixedly coupled to the coil 102, while the distal end portion 104d of the guard member 104 can be axially movable relative to the coil 102.

[0098] When the docking device 100 is retained within the delivery sheath in a substantially straight configuration, the expandable member 116 can be radially compressed by the delivery sheath and remain in a radially compressed (and axially stretched) state. The radially compressed (and axially stretched) expandable member 116 can contact the retaining element 114 (see, e.g., FIG. 1C ) or the tubular member 112 (see, e.g., FIG. 1E ) such that no gaps or cavities exist between the retaining element 114 and the expandable member 116, or between the tubular member 112 (and / or coil 102) and the expandable member 116.

[0099] After the docking device 100 is removed from the delivery sheath and transformed from the delivery configuration to the deployed configuration, the guard member 104 can also be moved from the delivery configuration to the deployed configuration. In certain embodiments, a docking sleeve (described more fully below) can be configured to cover and hold the docking device 100 within the delivery sheath when navigating the delivery sheath through the patient's native valve. The docking sleeve can also serve to guide the docking device around the native valve leaflets and tendons, for example. Retraction of the docking sleeve relative to the docking device 100 can expose the guard member 104, allowing the guard member 104 to be moved from the delivery configuration to the deployed configuration. Specifically, without the constraints of the delivery sheath and dock sleeve, the expandable member 116 can radially expand (and axially contract) such that a gap or cavity 111 can be created between the retaining element 114 and the expandable member 116 (see, e.g., FIG. 1C ) and / or between the tubular member 112 and the expandable member 116 (see, e.g., FIG. 1E ). Thus, when the guard member 104 is in the delivery configuration, the outer edge of the guard member 104 can extend along and adjacent to the coil 102 (as shown in FIGS. 1D and 1F , there is no gap 111, and only the retaining element 114 and / or the tubular member 112 separate the coil 102 from the expandable member 116). When the guard member 104 is in the deployed configuration, the outer edge of the guard member 104 can form a helical shape rotating about the central longitudinal axis 101 (see, e.g., Figures 1A-1B and 3A-3B), and at least a segment of the guard member's outer edge can extend radially away from the coil 102 (e.g., due to the creation of a gap 111 between the expandable member 116 and the retention element 114 or tubular member 112).

[0100] The distal end portion 104d of the guard member 104 may be fixedly coupled to the coil 102, and the proximal end portion 104p of the guard member 104 may be axially movable relative to the coil 102 such that the proximal end portion 104p of the guard member 104 may slide axially outside the tubular member 112 and toward the distal end 102d of the coil 102 when the expandable member 116 moves from a radially compressed state to a radially expanded state. As a result, the proximal end portion 104p of the guard member 104 may be disposed closer to the proximal end 102p of the coil 102 when the expandable member 116 is in the radially compressed state than in the radially expanded state.

[0101] In certain examples, the covering member 118 can be configured to engage a prosthetic valve deployed within the docking device 100 when the expandable member 116 is in a radially expanded state to form a seal between the prosthetic valve and the docking device 100 and to reduce paravalvular leakage between the prosthetic valve and the docking device 100. The covering member 118 can also be configured to engage native tissue (e.g., the native annulus and / or the native leaflets) to reduce PVL between the docking device and / or prosthetic valve and the native tissue.

[0102] In certain embodiments, when the expandable member 116 is in a radially expanded state, the proximal end portion 104p of the guard member 104 can have a tapered shape, as shown in FIGS. 1A-1B, such that the diameter of the proximal end portion 104p gradually increases from the proximal end 105 of the guard member 104 to the distal body portion of the guard member 104. This can be useful, for example, to facilitate loading and / or retrieving and / or repositioning the docking device into a delivery sheath of a delivery device during an implantation procedure. Additionally, due to its small diameter, the proximal end 105 of the guard member 104 can frictionally engage the retaining element 114 such that the retaining element 114 can reduce or prevent axial movement of the proximal end portion 104p of the guard member 104 relative to the coil 102.

[0103] In certain embodiments, the docking device 100 can include at least one radiopaque marker configured to provide a visual indication under fluoroscopy of the location of the docking device 100 relative to its surrounding anatomical structures and / or the amount of radial expansion of the docking device 100 (e.g., when a prosthetic valve is subsequently deployed within the docking device 100). For example, one or more radiopaque markers can be placed on the coil 102. In one particular embodiment, the radiopaque marker (which can be larger than the placement markers 121p, 121d) can be located in the central region 108 of the coil. In another embodiment, the one or more radiopaque markers can be placed on the tubular member 112, the expandable member 116, and / or the cover member 118. As noted above, the docking device 100 can also have one or more radiopaque markers (e.g., 121p and / or 121d) located distal to the ascending portion 110b of the coil 102. Radiopaque markers used to provide a visual indication of the location and / or amount of radial expansion of docking device 100 can be added to the placement markers described above (eg, 121p, 121d).

[0104] FIG. 1G illustrates generally some example dimensions of the docking device 100 when the coil 102 is in a substantially straight configuration (e.g., as compared to the helical configuration illustrated in FIG. 1). The guard member 104 surrounding the coil 102 is shown in both a folded state (shown in solid outline) and a relaxed state (shown in dashed outline). In certain embodiments, the guard member 104 in the relaxed state can have a maximum outer diameter (D1) in the range of about 4 mm to about 8 mm (e.g., about 6 mm in one particular embodiment), and the guard member 104 in the folded state can have a maximum outer diameter (D2) in the range of about 1 mm to about 3 mm (e.g., about 2 mm in one particular embodiment). The expansion of the guard member 104 from the folded state to the relaxed state can be characterized by an expansion ratio defined as D1 / D2. In certain embodiments, the expansion ratio can range from about 1.5 to about 8, or from about 2 to about 6, or from about 2.5 to about 4. In one specific embodiment, the expansion ratio is about 3.

[0105] A distal end portion 104d of the guard member 104 may be fixedly attached to the coil 102 via, for example, sutures, glue, or other means. The portion of the guard member 104 that is fixedly attached to the coil 102 may define a distal attachment region 123 having a proximal end 127 and a distal end 129. Thus, only the portion of the guard member 104 proximal to the distal attachment region 123 is movable relative to the coil 102.

[0106] Returning again to FIG. 1G, in certain embodiments, when the guard member 104 is in a relaxed state, its movable portion (i.e., the portion extending from the proximal end 105 of the guard member 104 to the proximal end 127 of the distal attachment region 123) can have an axial length (A2) in the range of about 30 mm to about 100 mm. In one specific embodiment, A2 is about 51 mm. In another specific embodiment, A2 is about 81 mm. When the guard member 104 is in a folded state, its movable portion can have an axial length (A1) in the range of about 50 mm to about 120 mm. In one specific embodiment, A1 is about 72 mm. In another specific embodiment, A1 is 105 mm to 106.5 mm. The extension of the guard member 104 from the relaxed state to the folded state can be characterized by an extension ratio defined as A1 / A2. In certain embodiments, the stretch ratio can range from about 1.05 to about 1.7, or from about 1.1 to about 1.6, or from about 1.2 to about 1.5, or from 1.3 to about 1.4. In one specific embodiment, the stretch ratio is about 1.47. In another specific embodiment, the stretch ratio is about 1.31.

[0107] In certain embodiments, the axial length (A3) measured from the proximal end 102p of the coil 102 to the distal end 129 of the distal attachment region 123 can range from about 130 mm to about 200 mm, or from about 140 mm to about 190 mm. In one specific embodiment, A3 is 133 mm to 135 mm (e.g., 134 mm). In another specific embodiment, A3 is 178 mm to 180 mm (e.g., 179 mm). In certain embodiments, the axial length (A4) measured from the proximal end 102p of the coil 102 to the proximal end 105 of the guard member 104 when the guard member 104 is in the folded state can range from about 40 mm to about 90 mm, or from about 50 mm to about 80 mm. In certain embodiments, A4 is 60 mm to 70 mm (e.g., 61 mm).

[0108] Further details of the docking device and its variations, including various embodiments of the coil, first cover (or tubular member), second cover (or cover member), expandable member, and other components of the docking device, are described in PCT Patent Application Publication No. WO / 2020 / 247907, which is incorporated by reference in its entirety. Exemplary Prosthetic Valves

[0109] 2A-2B show a prosthetic valve 10 according to one embodiment. The prosthetic valve 10 can be adapted to be implanted within a native valve annulus, such as a native mitral valve annulus, a native aortic valve annulus, or a native pulmonary valve annulus, with or without a docking device. The prosthetic valve 10 can include a frame 12, a valvular structure 14, and a valve cover 16 (the valve cover 16 has been removed in FIG. 2A to show the frame structure).

[0110] The valvular structure 14 may include three leaflets 40, which collectively form a leaflet structure (although a greater or lesser number of leaflets may be used), which may be arranged to fold in a tricuspid arrangement. The leaflets 40 are configured to permit blood flow from the inflow end 22 to the outflow end 24 of the prosthetic valve 10, and to block blood flow from the outflow end 24 to the inflow end 22 of the prosthetic valve 10. The leaflets 40 may be secured to one another on their adjacent sides to form a commissure 26 of the leaflet structure. The lower edge of the valvular structure 14 desirably has an undulating, curved, wavy shape. By forming the leaflets 40 with this wavy geometry, stresses on the leaflets 40 may be reduced, which in turn may improve the durability of the prosthetic valve 10. Additionally, the wavy shape may eliminate or at least minimize folding and rippling in the abdomen of each leaflet 40 (the central region of each leaflet) that may cause premature calcification in those areas. The undulating geometry may also reduce the amount of tissue material used to form the leaflet structure, thereby allowing for a smaller, more uniform crimp profile at the inflow end of the prosthetic valve 10. The leaflets 40 may be formed of 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.

[0111] The frame 12 can be formed with a plurality of circumferentially spaced slots or commissure windows 20 (three in the illustrated embodiment) adapted to mount the commissures 26 of the valvular structure 14 to the frame. The frame 12 can be made of any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol) as known in the art. When constructed of a plastically expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially compressed state on a delivery device and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a valve sheath or equivalent mechanism of the delivery device. Once inside the body, the prosthetic valve 10 can be advanced out of the delivery sheath, which allows the prosthetic valve 10 to expand to its functional size.

[0112] Suitable plastically expandable materials that can be used to form the frame 12 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 a particular embodiment, the frame 12 can be made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (a trade name of SPS Technologies), which is equivalent to UNS R30035 (applied by ASTM F562-02). MP35N™ / UNS R30035 includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. It has been found that the use of MP35N to form the frame 12 can provide superior structural results over stainless steel. Specifically, when MP35N is used as the frame material, less material is required to achieve the same or better performance in radial crush resistance, fatigue resistance, and corrosion resistance. Additionally, because less material is required, the crimp profile of the frame can be reduced, thereby providing a lower profile valve assembly for percutaneous delivery to a treatment location within the body.

[0113] As shown in FIG. 2B, the valve cover 16 can include an outer portion 18 that can cover the entire exterior surface of the frame 12. In certain embodiments, as shown in FIG. 3A, the valve cover 16 can also include an inner portion 28. The inner portion 28 can cover the entire interior surface of the frame 12 or, alternatively, cover only selected portions of the interior surface of the frame 12. In the illustrated embodiment, the inner portion 28 is formed by folding the valve cover 16 over the outflow end 24 of the frame 12. In certain embodiments, a protective cover 36 comprising a highly wear-resistant material (e.g., ePTFE, etc.) can be placed over the fold of the valve cover 16 at the outflow end 24. In certain embodiments, a similar protective cover 36 can be placed over the inflow end 22 of the frame. The valve cover 16 and protective cover 36 can be affixed to the frame 12 by various means, such as via stitching 30.

[0114] As described herein, the valve cover 16 can be configured to prevent paravalvular leakage between the prosthetic valve 10 and the native valve, to protect the native anatomy and promote tissue ingrowth, among other purposes. For mitral valve replacement, due to the generally D-shape and relatively large annulus of the mitral valve compared to the aortic valve, the valve cover 16 can act as a seal around the prosthetic valve 10 (e.g., when the prosthetic valve 10 is sized to be smaller than the annulus) and allow smooth coaptation of the native leaflets to the prosthetic valve 10.

[0115] In various embodiments, the valve cover 16 can include a material that can be crimped for transcatheter delivery of the prosthetic valve 10 and that is expandable to prevent paravalvular leakage around the prosthetic valve 10. Examples of possible materials include foams, fabrics, textiles, one or more synthetic polymers (e.g., polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), etc.), organic tissues (e.g., bovine pericardium, porcine pericardium, equine pericardium, etc.), and / or encapsulated materials (e.g., encapsulated hydrogels).

[0116] In certain embodiments, the valve cover 16 can be made of a woven fabric or textile having a plurality of raised strand sections 32 (e.g., protruding or bulging sections, hereinafter also referred to as "floats"). Details of an exemplary valve covered with a plurality of floats 32 are further described in U.S. Patent Publication Nos. US2019 / 0374337, US2019 / 0192296, and US2019 / 0046314, the disclosures of which are incorporated herein in their entirety for all purposes. In certain embodiments, the float strand sections 32 are separated by one or more horizontal bands 34. In some embodiments, the horizontal bands 34 can be constructed via a leno weave, which can improve the strength of the woven structure. In some embodiments of a woven fabric, the vertical fibers (e.g., extending along the longitudinal axis of the prosthetic valve 10) can include strands or other fibers with a high level of expansion, such as textured weft yarns, while the horizontal fibers (e.g., extending circumferentially around the prosthetic valve 10) in a leno weave can include strands or fibers with a low expansion.

[0117] In some embodiments, the valve cover 16 may comprise a woven fabric that resembles an untextured fabric when assembled and under tension (e.g., when stretched longitudinally over a compressed valve prior to delivery of the prosthetic valve 10). When the prosthetic valve 10 is deployed and expanded, the tension on the floats 32 is released, allowing the floats 32 to expand. In some embodiments, the valve cover 16 may be heat set to allow the floats 32 to return to their enlarged, or inflated, space-filling configuration. In some embodiments, the number and size of the floats 32 may be optimized to provide a level of expansion (e.g., to have a higher level of expanded thickness) that prevents paravalvular leakage across the mitral valve plane, and / or a lower profile of crimp (e.g., for delivery of the prosthetic valve). Additionally, the horizontal bands 34 may be optimized to allow attachment of the valve cover 16 to the frame 12 based on the particular size or location of the struts or other structural elements on the prosthetic valve 10.

[0118] Further details of the prosthetic valve 10 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. Additional examples of valve covers are described in PCT Patent Application Publication No. WO / 2020 / 247907.

[0119] As described above and illustrated in FIGS. 3A-3B, the prosthetic valve 10 can be radially expanded and securely anchored within the docking device 100. As shown in FIG.

[0120] In certain embodiments, and as described further below with reference to Figures 23-24, the coil 102 of the docking device 100 in the deployed configuration may be movable between a first radially expanded configuration before the prosthetic valve 10 has radially expanded within the coil 102, and a second radially expanded configuration after the prosthetic valve 10 has radially expanded within the coil 102. In the embodiment illustrated in Figures 3A-3B, the prosthetic valve 10 is shown in a radially expanded state, such that the coil 102 is in the second radially expanded configuration.

[0121] As described herein, at least a portion of the coil 102, such as the central region 108, can have a larger diameter in the second radially expanded configuration than in the first radially expanded configuration (i.e., the central region 108 can be further radially expanded by radially expanding the prosthetic valve 10). As the coil 102 moves from the first radially expanded configuration to the second radially expanded configuration, the functional turn in the central region 108 and the leading turn 106 can rotate circumferentially (e.g., clockwise or counterclockwise when viewed from the stabilizing turn 110) as the diameter of the central region 108 increases. The circumferential rotation of the functional turn in the central region 108 and the leading turn 106, which can also be referred to as "clocking," can slightly unwind the helical coil in the central region 108. Generally, the unwinding can be less than one turn, or less than half a turn (i.e., 180 degrees). For example, the unwind can be about 60 degrees, and in certain circumstances may be up to 90 degrees. As a result, the distance between the proximal end 102p and the distal end 102d of the coil 102, as measured along the central longitudinal axis of the coil 102, can be shortened.

[0122] 3A-3B (and FIG. 26), the proximal end 105 of the guard member 104 is shown positioned distally relative to the proximal placement marker 121p. In other embodiments, after the prosthetic valve 10 is radially expanded within the coil 102, the proximal end 105 of the guard member 104 can be positioned proximally relative to the proximal placement marker 121p (i.e., the proximal placement marker 121p is covered by the guard member 104), but remains distal relative to the ascending portion 110b. Exemplary Cover Assembly

[0123] As mentioned above, the docking device 100 can have a cover assembly 120 that includes the tubular member 112 and the guard member 104, and in some cases the retaining element 114. The guard member 104 can further include an expandable member 116 and a cover member 118. As described herein, the cover member 118 can be fixedly coupled to the expandable member 116 such that the cover member 118 can radially expand and axially shorten together with the expandable member 116.

[0124] In one embodiment, the cover assembly 120 can be assembled by fixedly attaching the distal end portion 104d of the guard member 104 to the coil 102 (and the tubular member 112 surrounding the coil 102) while leaving the proximal end portion 104p of the guard member 104 unattached to the coil 102 (and the tubular member 112 surrounding the coil 102). Thus, the proximal end portion 104p can be axially movable relative to the coil 102 and the tubular member 112. As a result, when the coil 102 moves from the delivery configuration to the deployed configuration (e.g., during initial deployment of the docking device 100), the proximal end portion 104p of the guard member 104 can slide distally outside the coil 102 causing the guard member 104 to contract axially (i.e., have a decrease in axial length) while expanding radially (i.e., have an increase in diameter).

[0125] On the other hand, the retaining element 114 can limit the extent of distal movement of the proximal end portion 104p relative to the coil 102 by applying a frictional force (e.g., a frictional interaction between the retaining element 114 and the proximal end 105 of the guard member 104). For example, if the proximal end portion 104p of a fully expanded guard member 104 (i.e., expanded to its maximum diameter) can slide distally outside the coil 102 to a first location in the absence of the retaining element 114, the presence of the retaining element 114 can cause the proximal end portion 104p to slide distally outside the coil 102 to a second location that is proximal to the first location. In other words, the retaining element 114 can prevent the guard member 104 from expanding to its maximum diameter and / or contracting to its minimum axial length.

[0126] Similarly, the retaining element 114 can limit the extent of proximal movement of the proximal end portion 104p relative to the coil 102 by exerting a frictional force (e.g., frictional interaction between the retaining element 114 and the proximal end 105 of the guard member 104). As described above and further below, the coil 102 of the docking device 100 in a deployed configuration can further radially expand (e.g., move from a first radially expanded configuration to a second radially expanded configuration) when the prosthetic valve 10 radially expands within the coil 102, and the radial expansion of the coil 102 can cause a corresponding circumferential rotation of the coil 102. The radially expanded prosthetic valve 10 can push against the guard member 104, causing the guard member 104 to radially compress and axially extend. Because the distal end portion 104d of the guard member 104 is fixedly attached to the coil 102 and the proximal end portion 104p of the guard member 104 is not tethered to the coil 102, the proximal end portion 104p of the guard member 104 may have a tendency to move proximally relative to the coil 102 when the prosthetic valve 10 is radially expanded within the coil 102. However, the presence of the retaining element 114 may prevent the proximal end portion 104p of the guard member 104 from moving proximally outside the coil 102. In particular embodiments, the presence of the retaining element 114 may prevent the proximal end 105 of the guard member 104 from extending above the ascending portion 110b of the coil 102. This may improve the functionality and / or durability of the guard member 104, for example, as discussed above.

[0127] The guard member 104 can be coupled to the coil 102 and / or tubular member 112 in a variety of ways, such as adhesives, fasteners, welding, and / or other means for coupling. For example, in some embodiments, attachment of the cover member 118 to the expandable member 116 or attachment of the guard member distal end portion 104d to the coil 102 and tubular member 112 can be accomplished by using one or more sutures. However, there are several technical challenges when using sutures. First, when the expandable member 116 has a mesh-like wire frame made of certain metals or metal alloys (e.g., Nitinol), sewing the sutures with needles can scratch the surface of the metal or metal alloy and increase the risk of corrosion to the wire frame when exposed to bodily fluids, especially if the needle is also made of metal. Sewing sutures using non-metallic needles (e.g., plastic needles) has its own disadvantages, as non-metallic needles typically have lower strength compared to metallic needles, thus making it difficult to thread the thread through the various layers of the cover assembly 120. Furthermore, even non-metallic needles can damage the metal or metal alloy surface of the wire frame. Secondly, routing the sutures can be difficult, as the sutures must not only ensure a firm attachment between the components of the cover assembly 120, but also must not significantly increase the radial profile of the guard member 104 so that the docking device 100 can be retained within the delivery sheath of a delivery apparatus for transcatheter implantation.

[0128] An exemplary method of assembling the guard member 104 is described in U.S. Provisional Patent Application No. 63 / 252,524, the entirety of which is incorporated herein by reference. The method described therein (hereinafter also referred to as the "stitching method") overcomes the above-mentioned challenges by forming multiple knots and wraps with sutures at both the proximal end portion 104p and the distal end portion 104d of the guard member 104.

[0129] For example, in the stitching method, two separate processes can be used to prepare the expandable member 116 and the cover member 118. Specifically, to prepare the expandable member 116, a wire (e.g., Nitinol) is first braided onto a straight mandrel, and then heat is applied to shape-set the braided wire into a straight configuration. Such straight-shaped braided wire can be reconfigured to produce a tapered proximal end portion (such that the proximal end portion 104p of the guard member 104 can have a tapered shape, as shown in FIGS. 1A-1B). Such reconfiguration can be achieved by transferring the braided wire to a tapered mandrel (i.e., one end of the mandrel has a tapered shape), and then applying heat again to shape-set the braided wire to produce a tapered end portion. To prepare the cover member 118, the same steps as described above for the expandable member 116 can be repeated. In other words, the cover material (e.g., PET) is first braided onto a straight mandrel and then heat is applied to shape-set the braided cover into a straight configuration. The straight-shaped braided cover is then transferred to a tapered mandrel and heat is again applied to shape-set the braided cover to create tapered end portions that match those of the expandable member 116. These two separate processes prepare the expandable member 116 and the cover member 118.

[0130] Another exemplary method of assembling the guard member 104 is described in U.S. Provisional Patent Application No. 63 / 253,995, the entirety of which is incorporated herein by reference. The method described therein (hereinafter also referred to as the "fusing method") includes braiding a first layer onto the outside of a mandrel, braiding a second layer onto the outside of the first layer to form a multi-layer structure, shaping the multi-layer structure so that it conforms to the shape of the mandrel, and laser cutting the multi-layer structure to form proximal and distal ends. The laser cutting can fuse the second layer to the first layer at the proximal and distal ends. Exemplary PVL Guard with Elastic Members

[0131] 4A-B, the guard member 104 can further include a resilient member 122 coupled to and extending along the axial length of the expandable member 116. In the illustrated embodiment, the cover member 118 is detached from the expandable member 116, thus exposing the mesh-like wire frame of the expandable member 116.

[0132] As described herein, the elastic member 122 can be movable between an axially expanded state and a rest state, and the elastic member 122 is biased to the rest state. When the expandable member 116 is in a radially compressed (and axially expanded) state, for example, when the docking device 100 is held within a delivery sheath (e.g., 204) and / or a dock sleeve (e.g., 222), the elastic member 122 can be in an axially expanded state. After the docking device is removed from the delivery sheath and dock sleeve, the elastic member 122 tends to return to its rest state, and thus can assist the expandable member 116 in moving from a radially compressed (and axially expanded) state to a radially expanded (and axially contracted) state. When the expandable member 116 is in a radially expanded (and axially contracted) state, the elastic member 122 can be in a rest state.

[0133] In certain embodiments, the elastic member 122 can include a polymeric material, such as a thermoplastic material (eg, TPU, etc.).

[0134] In certain embodiments, the elastic member 122 can extend from the proximal end portion 116p of the expandable member 116 to the distal end portion 116d of the expandable member 116. For example, the proximal end 122p of the elastic member 122 can be attached to the proximal end portion 116p of the expandable member 116 and the distal end 122d of the elastic member 122 can be attached to the distal end portion 116d of the expandable member 116. In certain embodiments, the elastic member 122 can be a strip of elastic band that extends parallel to the central longitudinal axis 126 of the expandable member 116.

[0135] 1A-1B and 3A-3B, the distal end portion 116d of the expandable member 116 can be fixedly attached to a segment of the coil 102, and the proximal end portion 116p of the expandable member 116 can be axially movable relative to the coil 102. Alternatively, the proximal end portion 116p of the expandable member 116 can be fixedly attached to a segment of the coil 102, and the distal end portion 116d of the expandable member 116 can be axially movable relative to the coil 102.

[0136] In certain embodiments, the elastic member 122 can be stitched to the expandable member 116. For example, the elastic member 122 can be attached to the expandable member 116 via a continuous suture 124 that extends along the axial length of the expandable member 116. In certain embodiments, the length of the suture 124 can be equal to or greater than the length of the elastic member 122 in its axially extended state, such that when the elastic member 122 is in its rest state, the suture 124 has slack and therefore does not impede the expandable member 116 from moving to a radially compressed (and axially extended) state.

[0137] In one embodiment, as shown in Figures 4A-4B, the elastic member 122 can be connected to the expandable member 116 via a suture 124 routed in a spiral path.

[0138] As described herein, it should be understood that the elastic member 122 can be attached to the expandable member 116 in a number of different ways and the position of the elastic member 122 relative to the expandable member 116 can also vary. For example, in certain cases, the elastic member 122 can extend along the outer surface of the expandable member 116. In one specific embodiment, the elastic member 122 can form a sheath that surrounds the expansion member 116. In certain cases, the elastic member 122 can extend through an inner lumen of the expandable member 116. In one specific embodiment, the elastic member 122 can extend along an inner surface of the expansion member 116. In certain cases, the elastic member 122 can be woven in and out of the expandable member 116 (e.g., the spiral suture 124 illustrated in FIG. 4B can be replaced with the elastic member 122). For example, the elastic member 122 can be a strip of elastic band (e.g., TPU) that is woven in and out of the expandable member 116 and attached to both the proximal end portion 116p and the distal end portion 116d, without stitching along the length of the elastic band (i.e., no stitching is required between 116p and 116d).

[0139] If the guard member 104 does not have the elastic member 122, the inherent bias of the expandable member 116 to move from a radially compressed (and axially stretched) state to a radially expanded (and axially shortened) state may be limited. Therefore, after deploying the docking device 100, the guard member 104 (without the elastic member 122) may inadvertently extend over the ascending portion 110b of the coil 102 (see, e.g., FIG. 18B). As described below, in such a situation, a procedure may be required to reposition the proximal end 105 of the guard member 104 until the proximal end 105 is located distal to the ascending portion 110b (e.g., distal to the proximal placement marker 121p).

[0140] By coupling the elastic member 122 to the expandable member 116, as described herein, the elastic force of the elastic member 122 can assist the expandable member 116 to move from a radially compressed (and axially elongated) state to a radially expanded (and axially shortened) state. Thus, after deploying the docking device 100, the proximal end 105 of the guard member 104 can more easily retract (e.g., under the greater force generated by both the expandable member 116 and the elastic member 122) to a position distal to the ascending portion 110b. As a result, the above-mentioned repositioning procedure can be avoided.

[0141] 4C-4D, the resilient member can be configured as a coil spring 132 (e.g., a compression spring) coupled to the expandable member 116. In certain embodiments, the coil spring 132 can include a shape memory material, such as Nitinol.

[0142] The coil spring 132 can expand and recoil together with the expandable member 116. For example, the coil spring 132 can expand axially to a first length when the expandable member 116 is in a radially compressed state (see, e.g., FIG. 4D) and return to a second length when the expandable member 116 is in a radially expanded state (see, e.g., FIG. 4C). The second length is shorter than the first length and the coil spring 132 is biased toward the second length. Thus, similar to the elastic member 122, the coil spring 132 can assist the expandable member 116 in moving from a radially compressed state to a radially expanded state.

[0143] As shown, the coil 102 of the docking device can extend through the coil spring 132. In some embodiments, the proximal end 132p of the coil spring 132 can be connected to the proximal end portion 116p of the expandable member 116, and the distal end 132d of the coil spring 132 can be connected to the distal end portion 116d of the expandable member 116. In certain embodiments, the proximal end 132p of the coil spring 132 can be configured with less than a full turn (e.g., half a turn, a quarter turn, etc.) to facilitate axial elongation of the coil spring 132. In certain embodiments, the proximal end 132p of the coil spring 132 can be configured with a full turn or more than a full turn (e.g., 1.5 turns) and with a reduced outer diameter (relative to the body portion of the coil spring 132) to fit within a delivery sheath (e.g., 204) and / or a dock sleeve (e.g., 222) during the delivery process. In certain embodiments, the proximal end 132p and / or distal end 132d of the coil spring 132 can have respective hooks connected to mesh-like wires at the proximal end portion 116p and / or distal end portion 116d of the expandable member 116.

[0144] In certain embodiments, as shown in Figures 4C-4D, the coil spring 132 can be disposed within the lumen of the expandable member 116. In other embodiments, the coil spring 132 can be disposed outside the exterior surface of the expandable member 116.

[0145] The pitch of the coil spring 132 can be greater than the pitch of the braided wire mesh of the expandable member 116. In one particular embodiment, the pitch of the coil spring 132 can be in the range of 3 mm to 9 mm, or 5 mm to 7 mm, inclusive. In one particular embodiment, the pitch of the coil spring 132 can be about 6 mm. The wire forming the coil spring 132 can have a larger diameter than the wire forming the braided wire mesh of the expandable member 116. In one particular embodiment, the wire forming the coil spring 132 can have a diameter in the range of 0.15 mm to 0.22 mm, inclusive.

[0146] The coil spring 132 can be configured to assist the expandable member 116 in radially expanding to a degree that the expandable member 116 alone (e.g., without the coil spring 132) would not be able to achieve. For example, without the coil spring 132, the expandable member 116 may be able to self-expand (under its inherent biasing force) to a first radially expanded state. With the coil spring 132, the expandable member 116 may be able to expand to a second, greater radially expanded state (e.g., as a result of forces generated by both the expandable member 116 and the coil spring 132). The diameter of the expandable member 116 in the first radially expanded state is larger than the expandable member 116 in the radially compressed state and smaller than the expandable member 116 in the second radially expanded state.

[0147] Similar to the elastic member 122, the coil spring 132 can assist in moving the proximal end 105 of the guard member 104 to a more distal position relative to the ascending portion 110b after initial deployment of the docking device 100, as described above and in more detail below, and therefore, in at least some cases, can reduce or eliminate the need to reposition the proximal end of the guard member 104 with the dock sleeve.

[0148] As a result, the elastic members 122 and / or coil springs 132 can pre-bundle the guard member 104 into a more axially compact configuration (i.e., having a larger diameter than the guard member without the elastic members or coil springs) after initial deployment of the docking device. Besides reducing repositioning procedures, such pre-bundling may also help maintain the relatively large diameter of the guard member 104 during and / or after valve deployment so as to reduce paravalvular leakage.

[0149] For example, when a prosthetic valve (e.g., 10) is radially expanded within a central region (e.g., 108) of the docking device 100, the coil 102 of the docking device can move from a first radially expanded configuration to a second radially expanded configuration, as described above. Such further radial expansion can slightly unwind the functional turn of the docking device 100. As a result, the distal end of the guard member 104 can move slightly to a more distal position, thus axially stretching the guard member 104 and reducing its diameter. In addition, radial expansion of the prosthetic valve 100 can press the guard member 102 against the native annulus, thus further causing axial stretching and a reduction in diameter of the guard member 104. Pre-bundling the guard member can compensate for such effects; for example, if radial expansion of the prosthetic valve causes axial stretching of the guard member 104, the guard member 104 can still achieve a desirably large diameter effective in reducing paravalvular leakage after the prosthetic valve is deployed within the docking device. Exemplary Textured Woven PVL Guard

[0150] 5A-5B show a docking device 300 configured to receive a prosthetic valve (e.g., 10) according to another embodiment. The docking device 300 includes a coil 302 that can be moved from a substantially straight, or delivery, configuration, to a helical, or deployed, configuration, similar to the coil 102. The docking device 300 also includes a textured, woven PVL guard (or guard member) 304 attached to the coil 302, as further illustrated in FIGS. 6A-6C and 7A-7C.

[0151] 6C, the guard member 304 includes an expandable member 306 and a resilient member 308 coupled to the expandable member 306. Similar to the expandable member 116 described in FIGS. 1A-1B and 3A-3B, a distal end portion 306d of the expandable member 306 can be fixedly attached to a segment of the coil 302, and a proximal end portion 306p of the expandable member 306 can be axially movable relative to the coil 302. Alternatively, a proximal end portion 306p of the expandable member 306 can be fixedly attached to a segment of the coil 302, and a distal end portion 306d of the expandable member 306 can be axially movable relative to the coil 302.

[0152] Similarly, the guard member 304 (and expandable member 306) can move from a radially compressed (and axially elongated) state (see, e.g., FIG. 6A) to a radially expanded (and axially shortened) state (see, e.g., FIG. 6B). For example, the guard member 304 can be constrained in the radially expanded (and axially shortened) state by retaining the docking device 300 within a delivery sheath (e.g., 204) and / or a dock sleeve (e.g., 222). After the docking device 300 is removed from the delivery sheath and dock sleeve, as described further below, the guard member 304 can return to the radially expanded (and axially shortened) state under the biasing force of the expandable member 306 and / or the biasing force of the elastic member 308.

[0153] As shown, the expandable member 306 in a radially expanded state can include a plurality of enlarged portions 310 (also referred to as “expandable portions” or “floats”) and one or more constricted portions 312 connecting the plurality of expandable portions 310.

[0154] In certain embodiments, the expandable member 306 can have a proximal constricted portion 312p located at the proximal end portion 306p and a distal constricted portion 312d located at the distal end portion 306d (see, e.g., FIG. 7B). In other words, 312p is connected to and positioned proximally relative to the most proximal expandable portion, and 312d is connected to and positioned distally relative to the most distal expandable portion.

[0155] As described herein, the expandable member 306 can include a woven material such as polyethylene terephthalate (PET) strands. Other types of strands, such as polyimide, ultra-high molecular weight polyethylene (UHMWPE), low density polyethylene (LDPE), high density polyethylene (HDPE), nylon, etc., can also be textured and woven into the form or shape of the illustrated expandable member 306. As described herein, textured (or textured) strands refer to continuous filament strands whose smooth, straight fibers have been displaced from their closely packed, parallel position by the formation of crimps, curls, loops, and / or coils. Compared to flat (i.e., non-textured) strands, textured strands have increased volume and / or stretching capabilities.

[0156] In certain embodiments, the constricted portion 312 and the expandable portion 310 can be made of the same material (e.g., PET). In one specific embodiment, a textured 68 denier 36 filament yarn is used to weave the expandable member 306. In another specific embodiment, the expandable member 306 can be woven using both a textured 68 denier 36 filament yarn and a flat 40 denier 24 filament yarn. In other embodiments, yarns having different denier and / or filament counts can also be used. For example, the yarns used to weave the expandable member 306 can have a density ranging from 10 denier to 100 denier.

[0157] As described herein, the pinched portion 312 can have a first weave density that is greater than the second weave density of the expandable portion 310. In certain embodiments, the weave density of the expandable member 306 can range from 20 to 100 picks per inch (PPI), or 20 to 80 PPI. In certain embodiments, the number of picks (or wefts, fills, insertions) can remain constant or substantially constant throughout the woven expandable member 306. The different weave densities of the pinched portion 312 and the expandable portion 310 can be achieved by using different numbers of ends per unit length necessary to create the corresponding structures. In certain embodiments, the pinched portion 312 can be woven using a plain weave or a leno weave.

[0158] The expandable portion 310, including the textured strands, can be heat sealed to create an increased volume (compared to the pinched portion 312). In certain embodiments, the expandable portion 310 can be configured to be dense enough so as not to create voids therein. This can be accomplished, for example, by using thicker strands and increasing the PPI of the strands as described above, which can prevent the strands from separating.

[0159] In certain embodiments, the number of expandable portions 310 in the expandable member 306 can range from 2 to 20, or 6 to 12, or 8 to 10, inclusive. In certain embodiments, the number of constricted portions 312 (including 312p and 312d) in the expandable member 306 can be one more than the number of expandable portions 310. In other embodiments, the number of constricted portions 312 (e.g., excluding one or both of 312p and 312d) in the expandable member 306 can be the same as the number of expandable portions 310 or one less than the number of expandable portions 310.

[0160] As described herein, when the expandable member 306 is in a radially expanded state, the clamped portion 312 can wrap around the coil 302 and the expandable portion 310 can expand radially from the coil 302. In addition, the clamped portion 312 can be configured to slide axially outside the coil 302 (except for 312d or 312p, if present, which are fixedly attached to the coil 302). Thus, the clamped portion 312 can radially anchor the expandable member 306 such that the expandable member 306 is generally symmetric about the coil 302 when no prosthetic valve is radially expanded within the coil. Meanwhile, the slidable clamped portion 312 allows for axial movement (e.g., lengthening or shortening) of the expandable member 306 outside the coil 302.

[0161] As described herein, when expandable member 306 is in a radially expanded state, expandable portion 310 has a larger radial profile than constricted portion 312. In the illustrated embodiment, when expandable member 306 is in a radially expanded state, expandable portion 310 has the same or substantially similar size. In other embodiments, expandable portion 310 can have different sizes when expandable member 306 is in a radially expanded state.

[0162] As described herein, the pinched portion 312 can maintain a constant or substantially constant radial profile as the expandable member 306 moves from a radially compressed state to a radially expanded state. Thus, as the expandable member 306 moves from a radially compressed state (see, e.g., FIG. 6A) to a radially expanded state (see, e.g., FIG. 6B), the expandable portion 310 can expand radially and shorten axially, while the pinched portion 312 can remain wrapped around the coil 302 without a significant change in either the radial or axial dimensions.

[0163] As an example, the radial diameter of the expandable portion 310 can increase from d1 to d2 (i.e., d2>d1), while the radial diameter of the pinched portion 312 can remain approximately constant at d3, where d2>d3, as the expandable member 306 moves from a radially compressed state to a radially expanded state. In certain embodiments, d1 is approximately the same as d3. In certain embodiments, d1 can be greater than d3.

[0164] In certain embodiments, when the expandable member 306 is in a radially expanded state, adjacent expandable portions 310 can contact one another to shield the pinched portion 312. For example, as illustrated in FIG. 6C, when the expandable member 306 is in a radially expanded state, at least a portion of two adjacent expanded portions 310 can form direct contact at a radially outward location P of the pinched portion 312 that connects the two adjacent expanded portions 310.

[0165] As illustrated in FIG. 7A, when the expandable member 306 is in a radially expanded state and the prosthetic valve 10 expands radially within the coil 302, the inner portion 310a of the expandable portion 310 can be radially compressed by the prosthetic valve 10 such that the inner portion 306a contacts the coil 302. Meanwhile, the outer portion 310b of the expandable portion 310 can extend radially outward relative to the coil 302 and press against the native wall to create a seal to reduce paravalvular leakage when deployed in the native valve. The radial distance (T) measured from the inner portion 310a to the outermost edge of the outer portion 310b is (d2+d0) / 2, where d0 represents the diameter of the coil 302. If the thickness of the woven guard member 304 at the pinched portion 312 is negligible, d0 is approximately the same as d3. When d2>>d0, T is approximately half of d2, i.e., T≒d2 / 2.

[0166] In certain embodiments, d1 can range from 1 mm to 4 mm, or from 2 mm to 3 mm, and in one specific embodiment, d1 is from 2.0 mm to 2.6 mm.

[0167] In a particular embodiment, d2 is between 4 mm and 10 mm, or between 7 mm and 9 mm. In one specific embodiment, d2 is between 7.5 mm and 8 mm.

[0168] In a specific embodiment, d3 is between 0.3 mm and 3 mm, or between 0.5 mm and 2.6 mm. In one specific embodiment, d3 is between 1.5 mm and 2.4 mm.

[0169] The expansion of the expandable member 306 from a radially compressed state to a radially expanded state can be characterized by an expansion ratio, defined as d2 / d1. In certain embodiments, the expansion ratio can range from 1.5 to 10, or from 2 to 6. In one specific embodiment, the expansion ratio is from 3 to 4.

[0170] In certain embodiments, when the expandable member 306 is in a radially expanded state, each expandable portion 310 can have an axial length (a1) of 6 mm to 16 mm, or 8 mm to 14 mm. In one specific embodiment, a1 is 10 mm to 12 mm. Additionally, when the expandable member 306 is in a radially expanded state, each pinched portion 312 located between 312p and 312d can have an axial length (a2) of 0.1 mm to 2 mm, or 0.3 mm to 1.5 mm. In one specific embodiment, a2 is 0.5 mm to 1.0 mm. In the embodiment illustrated in FIG. 7B, the axial length of 312p and 312d is greater than a2. In other embodiments, the axial length of 312p and 312d can be the same as a2, or even less than a2.

[0171] In certain embodiments, when the expandable member 306 is in a radially expanded state, the expandable member 306 can have an axial length (L1) (e.g., measured from the proximal end portion 306p to the distal end portion 306d) in the range of 60 mm to 120 mm, or 70 mm to 100 mm. In one specific embodiment, L1 is 75 mm to 85 mm.

[0172] In certain embodiments, when the expandable member 306 is in a radially compressed state, the expandable member 306 can have an axial length (L2) ranging from 80 mm to 200 mm, or from 100 mm to 160 mm. In one specific embodiment, L2 is from 120 mm to 140 mm.

[0173] The stretch of the expandable member 306 from a radially expanded state to a radially compressed state can be characterized by a stretch ratio, defined as L2 / L1. In certain embodiments, the stretch ratio can range from 1.1 to 1.6, or from 1.2 to 1.5. In one specific embodiment, the stretch ratio is from 1.3 to 1.4.

[0174] As described herein, the expandable member 306 can be biased to a radially expanded state (i.e., the expandable portion 310 is biased to a larger diameter d2). This can be accomplished, for example, by shape setting the expandable portion 310 (e.g., by applying heat thereto). Additionally, the elastic member 308 can be configured to assist the expandable member 306 in moving from a radially compressed state to a radially expanded state.

[0175] The elastic member 308 can be similar to the elastic member 122. For example, the elastic member 308 can include a thermoplastic material (e.g., TPU) and can move between an axially extended state and a resting state. When the expandable member 306 is in a radially compressed state, the elastic member 308 can be in an axially extended state. The elastic member 308 can be biased toward the resting state. Thus, the tendency of the elastic member 308 to return to its resting state can exert a biasing force on the expandable member 306, assisting the expandable member 306 in moving from the radially compressed state to the radially expanded state. When the expandable member 306 is in a radially expanded state, the elastic member 308 can be in a resting state.

[0176] As described herein, after deploying the docking device 300, the proximal end portion 306p of the expandable member 306 can retract to a distal position relative to the ascending portion 110b (e.g., under the combined biasing forces generated by both the expandable member 306 and the elastic member 308).

[0177] In certain embodiments, the elastic member 308 can extend along the axial length of the expandable member 306. For example, as shown in FIG. 7B, the elastic member 308 can include strips of elastic bands that extend parallel to the central longitudinal axis 314 of the expandable member 306. In certain embodiments, the elastic member 308 can form a sheath that surrounds the segment of the coil 302 covered by the expandable member 306.

[0178] As shown in FIG. 7B, in certain embodiments, the proximal end 308p of the elastic member 308 can be attached to the proximal end portion 306p (e.g., 312p) of the expandable member 306, and the distal end 308d of the elastic member 308 can be attached to the distal end portion 306d (e.g., 312d) of the expandable member 306.

[0179] In certain embodiments, the elastic member 308 can be attached to the expandable member 306 via a continuous suture 316 that extends along the axial length of the expandable member 306. For example, as illustrated in FIG. 7B, a suture 316 can connect the elastic member 308 to each of the pinched portions 312, including 312p and 312d, located at the proximal and distal end portions 306p and 306d, respectively. In such a situation, the length of the suture 316 can be equal to or greater than the length of the elastic member 308 in its axially extended state, such that the suture 316 has slack when the elastic member 308 is in its resting state.

[0180] In other embodiments, the elastic member 308 can be attached to the expandable member 306 via sutures 316 only at 312p and 312d, while no suture connections are made to the clamped portion 312 located between 312p and 312d.

[0181] In yet other embodiments, elastic member 308 can be attached to expandable member 306 via sutures 316 at both 312p and 312d, as well as at selected clamped portions 312 located between 312p and 312d (e.g., every other clamped portion can be connected by sutures 316).

[0182] In certain embodiments, the sutures 316 may not be continuous extending along the axial length of the expandable member 306. For example, discontinuous sutures 316 may be used to connect the elastic members 308 to their respective pinched portions 312. Exemplary Delivery Devices

[0183] 8 illustrates a delivery apparatus 200 configured to implant a docking device, such as the docking device 100 described above or other docking devices, to a target implantation site within a patient, according to one embodiment. As such, the delivery apparatus 200 may also be referred to as a "dock delivery catheter" or a "dock delivery system."

[0184] As shown, delivery device 200 can include a handle assembly 202 and a delivery sheath 204 (also referred to as a "delivery shaft" or "outer shaft" or "outer sheath") extending distally from the handle assembly 202. The handle assembly 202 can include a handle 206 that includes one or more knobs, buttons, wheels, and / or other means for controlling and / or actuating one or more components of the delivery device 200. For example, in some embodiments, as shown in FIG. 8, the handle 206 can include knobs 208 and 210 that can be configured to steer or control bending of the delivery device 200, such as the delivery sheath 204 and / or sleeve shaft 220, described below.

[0185] In certain embodiments, the delivery device 200 can also include a pusher shaft 212 (see, e.g., FIG. 9B ) and a sleeve shaft 220 (see, e.g., FIG. 9A ), both of which can extend through the inner lumen of the delivery sheath 204 and have respective proximal end portions extending into the handle assembly 202.

[0186] As described below, the distal end portion (also referred to as the "distal section") of the sleeve shaft 220 can include a smooth docking sleeve 222 configured to cover (e.g., surround) the docking device 100. For example, the docking device 100 (including the guard member 104) can be retained inside the docking sleeve 222, which is further retained by the distal end portion 205 of the delivery sheath 204 as it navigates through the patient's vasculature. As described above, the docking device 100 retained within the delivery sheath 204 can remain in a delivery configuration. Similarly, the guard member 104 retained within the docking sleeve 222 can also remain in a delivery configuration.

[0187] In addition, the distal end portion 205 of the delivery sheath 204 can be configured to be steerable. In one embodiment, by rotating a knob (e.g., 208 or 210) on the handle 206, the curvature of the distal end portion 205 of the delivery sheath 204 can be adjusted so that the distal end portion 205 of the delivery sheath 204 can be oriented at a desired angle. For example, as shown in FIG. 14 and described below, to implant the docking device 100 at the location of the native mitral valve, the distal end portion 205 of the delivery sheath 204 can be steered within the left atrium so that the docking sleeve 222 and the docking device 100 retained therein can extend through the native mitral valve annulus at a location adjacent the posteromedial commissure.

[0188] In certain embodiments, the pusher shaft 212 and the sleeve shaft 220 can be coaxial with one another, at least within the delivery sheath 204. Additionally, the delivery sheath 204 can be configured to be axially movable relative to the sleeve shaft 220 and the pusher shaft 212. As described further below, the distal end of the pusher shaft 212 can be inserted into the lumen of the sleeve shaft 220 and pushed against the proximal end (e.g., 102d) of the docking device 100, which is held inside the dock sleeve 222.

[0189] After reaching the target implantation site, the docking device 100 can be deployed from the delivery sheath 204 by manipulating the pusher shaft 212 and the sleeve shaft 220 using the hub assembly 218, as described further below. For example, by pushing the pusher shaft 212 distally while holding the delivery sheath 204 in place, or by retracting the delivery sheath 204 proximally while holding the pusher shaft 212 in place, or by simultaneously retracting the delivery sheath 204 proximally and pushing the pusher shaft 212 distally, the docking device 100 can be pushed out of the distal end 204d of the delivery sheath 204, and thus changed from the delivery configuration to the deployed configuration. In certain embodiments, the pusher shaft 212 and the sleeve shaft 220 can be actuated independently of one another.

[0190] In certain embodiments, the pusher shaft 212 and the sleeve shaft 220 can be configured to move axially with the docking device 100 when deploying the docking device 100 from the delivery sheath 204. For example, actuation of the pusher shaft 212 to push against the docking device 100 and move it out of the delivery sheath 204 can also cause the sleeve shaft 220 to move with the pusher shaft 212 and the docking device 100. As such, the docking device 100 can remain covered by the docking sleeve 222 of the sleeve shaft 220 during the procedure of pushing the docking device 100 via the pusher shaft 212 into position at the target implantation site. Thus, when the docking device 100 is initially deployed at the target implantation site, the smooth docking sleeve 222 can facilitate the covered docking device 100 surrounding the native anatomy.

[0191] During delivery, the docking device 100 can be coupled to the delivery apparatus 200 via a release suture 214 (or other retrieval line including string, twine, or other material that can be configured to be tied around the docking device 100 and cut for removal) that extends through the pusher shaft 212. In one specific example, the release suture 214 can extend through the delivery apparatus 200, for example, through an inner lumen of the pusher shaft 212, to a suture lock assembly 216 of the delivery apparatus 200.

[0192] The handle assembly 202 can further include a hub assembly 218 to which the suture lock assembly 216 and the sleeve handle 224 are attached. The hub assembly 218 can be configured to independently control the pusher shaft 212 and the sleeve shaft 220, while the sleeve handle 224 can control the axial position of the sleeve shaft 220 relative to the pusher shaft 212. In this manner, operation of the various components of the handle assembly 202 can actuate and control operation of components disposed within the delivery sheath 204. In some embodiments, the hub assembly 218 can be coupled to the handle 206 via a connector 226.

[0193] The handle assembly 202 may further include one or more flushing ports (e.g., three flushing ports 232, 236, 238 are shown in FIG. 8 ) for supplying flush fluid to one or more lumens disposed within the delivery device 200 (e.g., annular lumens disposed between coaxial components of the delivery device 200), as described below.

[0194] Further details regarding delivery apparatus / catheters / systems (including various embodiments of handle assemblies) configured to deliver the docking device to a target implantation site can be found in U.S. Patent Publication Nos. 2018 / 0318079 and 2018 / 0263764, all of which are incorporated by reference in their entireties herein. Exemplary sleeve shaft

[0195] 9A illustrates a sleeve shaft 220 according to one embodiment. In some embodiments, the sleeve shaft 220 can have a smooth distal section 222 (also referred to herein as a "dock sleeve") configured to cover a docking device (e.g., 100) during deployment, a proximal section 228 used to manipulate or actuate the position of the distal section 222, and a middle section 230 connecting the distal section 222 and the proximal section 228.

[0196] In some embodiments, the dock sleeve 222 can be flexible, have a lower durometer than the remainder of the sleeve shaft 220, and can be configured with a hydrophilic coating, which can act as a smooth surface to improve ease of encirclement of native anatomy and reduce risk of damage to native tissue. In some embodiments, the dock sleeve 222 can form a tubular structure with an inner diameter sufficient to encircle the docking device 100 and an outer diameter small enough to be retained within the delivery sheath 204 and to be axially movable within the delivery sheath 204. In some embodiments, the outer diameter of the dock sleeve 222 can be slightly larger than the outer diameter of the middle section 230. In some embodiments, the length of the dock sleeve 222 is sufficient or longer to cover the entire length of the docking device 100 when the dock device 100 is retained inside the dock sleeve 222.

[0197] Dock sleeve 222 can have a body portion 221 and a tip portion 223 located at a distal end of body portion 221. In some embodiments, tip portion 223 can extend distally from the distal end of body portion 221 about 1-4 mm (e.g., about 2 mm). In some embodiments, tip portion 223 can taper radially inwardly, such that it has a smaller diameter than body portion 221. In some embodiments, tip portion 223 can extend past the distal end (e.g., 102d) of the docking device during delivery, thereby providing dock sleeve 222 with a more atraumatic tip that can bend, crush, deform, or the like, as dock sleeve 222 is navigated around the native architecture of the implantation site for the docking device.

[0198] Additional embodiments of the dog sleeve, including various features of the body and tip portions of the dog sleeve, are further described in US Provisional Application No. 63 / 138,910, which is incorporated herein by reference in its entirety.

[0199] In some embodiments, the middle section 230 of the sleeve shaft 220 can be configured to provide sufficient column strength to push the dock sleeve 222 (along with the docking device 100) out of the distal end 204d of the delivery sheath 204 and / or retract the dock sleeve 222 after the docking device 100 is deployed at the target implantation site. The middle section 230 can also be configured to have sufficient flexibility to facilitate navigating the patient's anatomy from the insertion point of the delivery apparatus 200 to the heart. In certain embodiments, the dock sleeve 222 and the middle section 230 can be formed as a single continuous unit having properties (e.g., dimensions, polymer, braid, etc.) that vary along the length of the single unit.

[0200] In some embodiments, a proximal portion of the proximal section 228 can be disposed within the handle assembly 202. The proximal section 228 of the sleeve shaft 220 can be configured to be more rigid and provide column strength for actuating the position of the dock sleeve 222 by pushing the middle section 230 and the dock sleeve 222 with the docking device 100 and retracting the dock sleeve 222 after the docking device 100 is deployed at the target implantation site.

[0201] In some embodiments, the proximal portion of the proximal section 228 can include a cut portion 229 having a cross-section (in a plane perpendicular to the central longitudinal axis of the sleeve shaft 220) that is not a perfect circle (e.g., is open and does not form a closed tube). An end surface 225 can be formed between the cut portion 229 and the remainder of the proximal section 228. As described further below, the end surface 225 can be configured perpendicular to the central longitudinal axis of the sleeve shaft 220 and can be configured to contact a stop element (e.g., plug 254) of the pusher shaft 212.

[0202] The cutting portion 229 can extend into the hub assembly 218 of the handle assembly 202. As described below, the proximal extension 256 of the pusher shaft 212 can extend along an inner surface of the cutting portion 229. The cut (e.g., open) profile of the cutting portion 229 can allow the proximal extension 256 of the pusher shaft 212 to extend out of a space 227 formed in the cutting portion 229 and branch off at an angle relative to the cutting portion 229 into the suture lock assembly 216 of the hub assembly 218 (see, e.g., FIG. 8 ). As such, the pusher shaft 212 and the sleeve shaft 220 can operate parallel to one another and the overall length of the delivery device 200 incorporating the sleeve shaft 220 and the pusher shaft 212 can be maintained similar to, or only minimally longer than, a delivery system not incorporating the sleeve shaft 220.

[0203] Additional embodiments of the sleeve shaft are further described in PCT Patent Application Publication No. WO / 2020 / 247907. Exemplary Pusher Shaft

[0204] 9B illustrates a pusher shaft 212 according to one embodiment. As shown, the pusher shaft 212 can include a main tube 250, a shell 252 surrounding a proximal end portion of the main tube 250, a plug 254 connecting the main tube 250 to the shell 252, and a proximal extension 256 extending from the proximal end of the main tube 250.

[0205] The main tube 250 can be configured to accommodate a release suture (e.g., 214) that advances and retracts a docking device (such as one of the docking devices described herein) and secures the docking device to the pusher shaft 212. The main tube 250 can extend from the distal end 204d of the delivery sheath 204 to the handle assembly 202 of the delivery device 200. For example, in certain cases, a proximal end portion of the pusher shaft 212, including the interface between the main tube 250, the shell 252, the plug 254, and the proximal extension 256, can be disposed within or adjacent to the hub assembly 218 of the handle assembly 202. Thus, the main tube 250 can be an elongated tube that extends along most of the delivery device 200.

[0206] The main tube 250 can be a relatively stiff tube that provides column strength to actuate the deployment of the docking device. In some embodiments, the main tube 250 can be a hypotube. In some embodiments, the main tube 250 can include a biocompatible metal, such as stainless steel. The main tube 250 can have a distal end 250d configured to interface with a docking device and a proximal end 250p to which a proximal extension 256 is attached. In some embodiments, the distal section 258 of the main tube 250 can be relatively more flexible (e.g., via having one or more cuts in the outer surface of the main tube and / or a durometer material) than the remainder of the main tube 250. Thus, the distal section 258 can bend and / or flex with the delivery sheath 204 of the delivery apparatus 200 as it is navigated through the patient's vasculature to the target implantation site.

[0207] In some embodiments, the shell 252 can be configured to lock the main tube 250 and provide a hemostatic seal on the pusher shaft 212 without interfering with movement of the sleeve shaft 220. As shown in FIG. 9B, the inner diameter of the shell 252 can be larger than the outer diameter of the main tube 250, thereby forming an annular cavity 260 between the main tube 250 and the shell 252. As such, the proximal section 228 of the sleeve shaft 220 can slide within the annular cavity 260, as described further below. Additionally, flush fluid provided into a lumen on the exterior of the proximal extension 256 in the hub assembly 218 can flow through the annular cavity 260 and exit at the distal end of the shell 252 (as shown by arrow 262) into the lumen between the sleeve shaft 220 and the delivery sheath 204 of the delivery device, as discussed further below with reference to FIG. 11.

[0208] The plug 254 can be configured to be disposed within the annular cavity 260 at the proximal end 252p of the shell 252. In some embodiments, the plug 254 can be configured to "plug" or fill a portion of the annular cavity 260 located at the proximal end 252p of the shell 252, while leaving the remaining portion of the annular cavity 260 open to receive the cut portion 229 of the sleeve shaft 220 therein. In some embodiments, the shell 252 and the plug 254 can be fixedly coupled (e.g., by welding) to the main tube 250 to allow the cut portion 229 of the sleeve shaft 220 to slide between the main tube 250 and the shell 252. As described below, the plug 254 can also act as a stop for the sleeve shaft 220.

[0209] As described above, the proximal extension 256 can extend from the proximal end 250p of the main tube 250 and the shell 252. The proximal extension 256 can provide a certain flexibility to the pusher shaft 212 such that the pusher shaft 212 can be routed from the inside of the sleeve shaft 220 (e.g., at the cut portion 229) to the outside of the sleeve shaft 220, thereby allowing the pusher shaft 212 and the sleeve shaft 220 to be actuated in parallel, reducing the overall length of the delivery device. In certain embodiments, the proximal extension 256 can be made of a flexible polymer.

[0210] Additional embodiments of the pusher shaft are further described in PCT Patent Application No. PCT / US20 / 36577. Exemplary Sleeve Shaft and Pusher Shaft Assembly

[0211] 10A-10B illustrate an example arrangement of the pusher shaft 212 and sleeve shaft 220 within the delivery sheath 204 of the delivery apparatus 200, before and after deployment of a docking device such as 100. As shown, the main tube 250 of the pusher shaft 212 can extend through the lumen of the sleeve shaft 220, which can extend through the lumen of the delivery sheath 204. The pusher shaft 212 and the sleeve shaft 220 can share a central longitudinal axis 211 of the delivery sheath 204.

[0212] FIG. 11 illustrates various lumens that may be formed between the docking device 100, the pusher shaft 212, the sleeve shaft 220, and the delivery sheath 204 that are configured to receive flush fluid during a delivery and implantation procedure. In addition, FIG. 12A illustrates a first configuration in which the docking device 100 is deployed from the delivery sheath 204 while still covered by the dock sleeve 222 of the sleeve shaft 220. The dock sleeve 222 in the first configuration is also referred to as being in a "covered state." When the dock sleeve 222 is in the covered state, the guard member 104 (not shown for clarity purposes) may remain in the delivery configuration (i.e., radially compressed by and held within the dock sleeve 222). FIG. 12B illustrates a second configuration in which the docking device 100 is not covered by the dock sleeve 222 after the sleeve shaft 220 has been retracted back into the delivery sheath 204. The dog sleeve 222 in the second configuration is also referred to as being in an “uncovered state.” When the dog sleeve 222 is in an uncovered state, the guard member 104 (not shown for purposes of clarity) can radially expand and move to the deployed configuration.

[0213] 10A illustrates a first configuration of the pusher shaft 212 and sleeve shaft 220 assembly before or during deployment of the docking device 100, according to one embodiment. As shown, the dock sleeve 222 can be configured to cover the docking device 100, while the end face 225 of the sleeve shaft 220 is positioned away from the plug 254. Additionally, the distal end 250d of the pusher shaft 212 can extend into the dock sleeve 222 and can contact the proximal end 102p of the docking device 100.

[0214] During deployment of the docking device 100 from the delivery sheath 204, the pusher shaft 212 and the sleeve shaft 220 can be configured to move axially together with the docking device 100. For example, actuation of the pusher shaft 212 to push against the docking device 100 and move it out of the delivery sheath 204 can also cause the sleeve shaft 220 to move with the pusher shaft 212 and the docking device 100. As such, the docking device 100 can remain covered by the dock sleeve 222 of the sleeve shaft 220 during the procedure of pushing the docking device 100 via the pusher shaft 212 into position at the target implantation site, as illustrated in FIG.

[0215] Additionally, as shown in FIG. 12A, during delivery and implantation of the covered docking device 100 at the target implantation site, the tip portion 223 of the sleeve shaft 220 can extend distally relative to the distal end 102d of the docking device 100, thereby providing a more atraumatic tip for the dock sleeve 222.

[0216] In some examples, one or more radiopaque markers 231 can be placed on the docking sleeve 222 to enhance the ability to visualize the docking sleeve 222 during deployment of the docking device (e.g., 100). In certain examples, at least one radiopaque marker 231 can be placed at the intersection between the body portion 221 and the tip portion 223. In certain examples, at least one radiopaque marker 231 can be placed on the tip portion 223. In some examples, the distal end 102d of the docking device 100 can be disposed proximal to the radiopaque marker 231 of the docking sleeve 222 or just distal to the radiopaque marker 231 of the docking sleeve 222.

[0217] In some embodiments, the radiopaque marker 231 can include a radiopaque material such as platinum iridium, In other embodiments, the radiopaque material included in the radiopaque marker 231 can be barium sulfate (BaSO4), bismuth subcarbonate ((BiO)2CO3), bismuth oxychloride (BiOCl), or the like.

[0218] In some embodiments, the tip portion 223 of the dog sleeve 222 can be made from a polymeric material rich in any one of the radiopaque materials described above such that the distal most edge of the tip portion 223 can be visible under fluoroscopy.

[0219] 10B illustrates a second configuration of the pusher shaft 212 and sleeve shaft 220 assembly after deployment of the docking device 100 from the delivery sheath 204 at the target implantation site and removal of the dock sleeve 222 from the implanted docking device 100, according to one embodiment. As shown, after implantation of the docking device 100 at the target implantation site and in its desired position, the sleeve shaft 220 can be pulled out of the docking device 100 and retracted back into the delivery sheath 204 while holding the pusher shaft 212 constant such that the distal end 250d of the pusher shaft 212 pushes against the proximal end 102p of the docking device 100. Alternatively, the docking device 100 can be exposed by pushing the pusher shaft 212 distally while holding the sleeve shaft 220 constant. In some embodiments, as shown in FIG. 10B, the sleeve shaft 220 can stop further retraction into the delivery device as the end face 225 contacts the plug 254.

[0220] 12B illustrates the sleeve shaft 220 removed from the docking device 100, leaving the docking device 100 uncovered by the dock sleeve 222. As shown, the tip portion 223 of the sleeve shaft 220 can be disposed proximally (e.g., back past) the distal end of the pusher shaft 212, which can still be connected to the proximal end 102p of the docking device 100 via the release suture 214. As described further below, after implanting the docking device 100 at the target implantation site and removing the dock sleeve 222 covering the docking device 100, the docking device 100 can be disconnected from the delivery apparatus by severing the release suture 214, for example, by using the suture lock assembly 216 of the delivery apparatus 200.

[0221] 11, a first pusher shaft lumen 212i can be formed within the interior of the pusher shaft 212 (e.g., within the interior of the main tube 250). The pusher shaft lumen 212i can receive flush fluid from a first fluid source, which can be fluidly coupled to a portion of the handle assembly 202. A flush fluid flow 264 through the pusher shaft lumen 212i can proceed along a length of the main tube 250 of the pusher shaft 212 to a distal end 250d of the main tube 250 of the pusher shaft 212. In some embodiments, the distal end 250d of the main tube 250 can be spaced away from the proximal end 102p of the docking device 100. Thus, at least a portion of the flush fluid flow 264 can flow as a flush fluid flow 268 into a distal portion of a second sleeve shaft lumen 220i disposed between an outer surface of the docking device 100 and an inner surface of the dock sleeve 222 of the sleeve shaft 220. Further, in some embodiments, a portion of flush fluid flow 264 can also flow as flush fluid flow 266 back into a proximal portion of sleeve shaft lumen 220i disposed between an outer surface of pusher shaft 212 and an inner surface of sleeve shaft 220 proximal to dog sleeve 222. Thus, the same first fluid source may provide flush fluid via pusher shaft lumen 212i to pusher shaft lumen 212i and sleeve shaft lumen 220i (including both the distal portion outside dog sleeve 222 and the proximal portion proximal to dog sleeve 222).

[0222] 11 also shows a third delivery sheath lumen 204i disposed between an inner surface of the delivery sheath 204 and an outer surface of the sleeve shaft 220. The delivery sheath lumen 204i may be fluidly coupled to a portion of the handle assembly 202 and may receive flush fluid from one or more second fluid sources, which may result in a flush fluid flow (as indicated by arrow 262) through the delivery sheath lumen 204i and to the distal end 204d of the delivery sheath 204.

[0223] Flushing the aforementioned lumens can help prevent or reduce thrombus formation on and around the docking device 100 and other concentric components of the delivery device 200 during deployment of the docking device 100 from the delivery device 200 and during implantation of the docking device 100 at the target implantation site. In one example, as shown in FIG. 8 , the first fluid source and / or the second fluid source can be connected to one or more flushing ports (e.g., 232, 236, 238) disposed on and / or coupled to the handle assembly 202 of the delivery device 200 to provide flush fluid to the aforementioned lumens.

[0224] Additional embodiments of the sleeve shaft and pusher shaft assemblies are further described in PCT Patent Application No. PCT / US20 / 36577. Exemplary Transplantation Procedures

[0225] An exemplary method of delivering a docking device (such as docking device 100 described above) and implanting a prosthetic valve (such as prosthetic valve 10 described above) within the docking device is illustrated in Figures 13-26. In this example, the target implantation site is at the native mitral valve 422. Following the same principles described herein, the same method, or variations thereof, can also be used for implantation of the docking device and prosthetic valve at other target implantation sites.

[0226] 13 illustrates the introduction of a guide catheter 400 into a patient's heart over a previously inserted guide wire 240. Specifically, the guide catheter 400 and guide wire 240 are inserted through the interatrial septum 406 (e.g., via a previously punctured hole 403 in the interatrial septum 406) from the right atrium 402 into the left atrium 404. To facilitate navigation through the patient's vasculature and transseptal insertion, a nosecone 242 having a tapered distal tip may be placed at the distal end of the guide catheter 400. After the distal end of the guide catheter 400 enters the left atrium 404, the nosecone 242 and guide wire 240 may be retracted back into the guide catheter 400, for example, by operating a handle connected to the proximal end of the guide catheter 400. Guide catheter 400 can remain in place (ie, extending through interatrial septum 406 ) such that the distal end of guide catheter 400 remains within left atrium 404 .

[0227] 14 illustrates introducing a delivery device (such as delivery device 200 described above) through a guide catheter 400. Specifically, a delivery sheath 204 can be inserted through the lumen of the guide catheter 400 until a distal end portion 205 of the delivery sheath 204 extends distally out the distal end of the guide catheter 400 and into the left atrium 404.

[0228] As described above, the delivery apparatus 200 can have a sleeve shaft 220 and a pusher shaft 212, both of which can extend through a lumen of the delivery sheath 204. As shown in FIGS. 15-17 , a distal end portion of the sleeve shaft 220 can have a docking sleeve 222 that surrounds the docking device 100. As described herein, the docking sleeve 222 can be retained within the distal end portion 205 of the delivery sheath 204.

[0229] As mentioned above, the distal end portion 205 of the delivery sheath 204 can be steerable, for example, by operating a knob located on the handle assembly 202. Because the dock sleeve 222 and the docking device 100 are also flexible, bending of the distal end portion 205 of the delivery sheath 204 can also bend the dock sleeve 222 and the docking device 100 held therein. As shown in FIG. 14 , the distal end portion 205 of the delivery sheath 204 (along with the dock sleeve 222 holding the docking device 100) can be bent in a desired angular direction such that the distal end 204d of the delivery sheath 204 can extend adjacent the posteromedial commissure 420 and through the native mitral valve annulus 408 into the left ventricle 414.

[0230] 15 illustrates the deployment of the docking device 100 at the mitral valve location. As shown, the distal portion of the docking device 100, including the leading turn 106 and central region 108 of the coil, can be deployed out of the distal end 204d of the delivery sheath 204 and can extend into the left ventricle 414. Note that the deployed distal portion of the docking device 100 is still covered by the dock sleeve 222. This can be accomplished, for example, by retracting the delivery sheath 204 proximally while holding both the pusher shaft 212 and the sleeve shaft 220 in place, thus extending the distal portion of the docking device 100 distally out of the delivery sheath 204 while it remains covered by the dock sleeve 222. Retraction of the delivery sheath 204 can continue until the delivery sheath 204 moves up to the stabilizing turn 110 and proximally relative to the expandable member 116.

[0231] Unconstrained by the distal end portion 205 of the delivery sheath 204, the distal portion of the docking device 100 can move from a delivery configuration to a deployed (i.e., helical) configuration. Specifically, as shown in FIG. 15 , the coil of the docking device 100 (covered by the dock sleeve 222) can form not only a leading turn 106 that extends into the left ventricle 414, but also multiple functional turns in a central region 108 that wrap around the native leaflets 410 and chordae tendineae 412 of the native valve.

[0232] The dock sleeve 222 has a smooth surface, which can prevent or reduce the possibility of the tubular member 112 (which surrounds the coil 102 of the docking device) directly contacting and catching (or adhering to) the native tissue, and can help ensure that the covered docking device 100 surrounds the native anatomy. In addition, the soft tip portion 223 of the dock sleeve 222 (which can have a tapered shape) can also facilitate atraumatic surrounding of the native tissue. As mentioned above, flush fluid (see, e.g., 264 in FIG. 11 ) can flow through the dock sleeve 222 and around the docking device 100 during deployment of the docking device 100 to prevent or reduce thrombus formation on and around the docking device 100 and other concentric components of the delivery apparatus 200.

[0233] As shown in FIG. 16, after the functional turns of the docking device 100 have been successfully wrapped around the native leaflets 410 and chordae tendineae 412, the dock sleeve 222 can be retracted proximally relative to the docking device 100. This can be accomplished, for example, by holding the pusher shaft 212 constant while pulling the sleeve shaft 220 proximally so that the distal end of the pusher shaft 212 can push against the proximal end of the docking device 100, as described above with reference to FIG. 10B. As described above, the dock sleeve 222 can be retracted back into the delivery sheath 204. FIG. 17 shows the docking device 100 surrounding the native leaflets and chordae tendineae that are not covered by the dock sleeve 222.

[0234] 18A illustrates stabilizing the docking device 100 from the atrial side. As shown, the delivery sheath 204 can be retracted into the guide catheter 400 to expose the atrial side (i.e., proximal portion) of the docking device 100, including the stabilizing turn 110 of the coil. The stabilizing turn 110 can be configured to provide one or more contact points or areas between the docking device 100 and the left atrial wall, such as at least three contact points within the left atrium or complete contact on the left atrial wall. The stabilizing turn 110 can be flared or biased outward toward both the posterior wall 416 and the anterior wall 418 of the left atrium to prevent the docking device 100 from dropping into the left ventricle prior to deploying the prosthetic valve within the docking device 100.

[0235] Free of the constraints of the delivery sheath 204 and dock sleeve 222, the guard member 104 can move (due to the radial expansion of the expandable member 116) to a deployed configuration. As shown, the guard member 104 of the docking device 100 can be configured to contact the native annulus in the left atrium to create a sealed and atraumatic interface between the docking device 100 and the native tissue. The guard member proximal end portion 104p can be configured to be positioned adjacent to (but not reaching) the anterolateral commissure 419 of the native valve. In the deployed configuration, the guard member proximal end 105 can be configured to be positioned within the atrial portion 110a or ascending portion 110b of the stabilizing turn, but distal to the boundary 107 between the ascending portion 110b and the stabilizing portion 110c (see, e.g., FIG. 1A). For example, after initial deployment of the docking device 100 and prior to deployment of a prosthetic valve (e.g., 10) within the docking device 100, the proximal end 105 of the guard member can be configured in certain circumstances to be positioned between the proximal placement marker 121p and the distal placement marker 121d or slightly distal to the distal placement marker 121d. In certain embodiments, the distal end portion 104d of the guard member can be positioned within the left ventricle 414 or at least adjacent the posteromedial commissure 420 of the native valve to prevent or reduce leakage at that location.

[0236] In the illustrated embodiment, the proximal end portion of the retaining element 114 extends into the ascending portion 110b of the coil. Additionally, the proximal end 105 of the guard member 104 is located distal to the proximal placement marker 121p, which is located distal to the ascending portion 110b. In one particular embodiment, the proximal end 105 of the guard member 104 is located between the proximal placement marker 121p and the distal placement marker 121d (which is covered by the guard member 104 and is not shown in FIG. 18A ). As discussed above, such a configuration can advantageously improve the sealing and / or durability of the guard member 104.

[0237] In certain instances, after initial deployment of the docking device 100, the proximal end 105 of the guard member 104 may inadvertently extend over the ascending portion 110b, as illustrated in FIG. 18B. Under such circumstances, the dock sleeve 222 may be used to "reposition" the proximal end 105 of the guard member 104 away from the ascending portion 110b. According to one embodiment, the dock sleeve 222 may be pushed out of the delivery sheath 204 until its tapered tip portion 223 contacts the tapered proximal end 105 of the guard member 104 (see, e.g., FIG. 18B). The location of the tip portion 223 of the dock sleeve 222 may be determined, for example, based on visualization of a radiopaque marker 231 on the dock sleeve 222 under fluoroscopy. Thus, by pushing the dock sleeve 222 further in the distal direction, the proximal end 105 of the guard member 104 can be moved distally until it is repositioned distally relative to the proximal placement marker 121p (see, e.g., FIG. 18C). Such positioning can be confirmed, for example, by observing that the radiopaque marker 231 on the dock sleeve 222 is located distally relative to the proximal placement marker 121p. The dock sleeve 222 can then be retracted back into the delivery sheath 204. As discussed above, the retaining element 114 can prevent axial movement of the proximal end portion 104p of the guard member 104 relative to the coil by applying a frictional force (e.g., frictional interaction between the retaining element 114 and the proximal end 105 of the guard member 104). Thus, the retaining element 114 can hold the proximal end 105 of the guard member 104 at a repositioned location that is distal to the ascending portion 110b.

[0238] 19 illustrates a fully deployed docking device 100. The release suture 214, which extends through the pusher shaft 212 and connects the coil proximal end 102p to the suture lock assembly 216, can then be cut so that the docking device 100 can be released from the delivery apparatus 200. The delivery apparatus 200 can then be removed from the guide catheter 400 to prepare for implantation of the prosthetic valve.

[0239] FIG. 20 illustrates the insertion of a guidewire catheter 244 through the guiding catheter 400, through the docking device 100, across the native mitral annulus, and into the left ventricle 414.

[0240] 21 illustrates the insertion of valve guidewire 246 through the inner lumen of guidewire catheter 244 and into left ventricle 414. Guidewire catheter 244 can then be retracted back into guiding catheter 400, and guiding catheter 400 and guidewire catheter 244 can be removed, leaving valve guidewire 246 in place.

[0241] 22 illustrates transseptal delivery of a prosthetic valve (such as prosthetic valve 10) into the left atrium 404. A prosthetic valve delivery device 450 can be introduced over the valve guidewire 246. During delivery, the prosthetic valve 10 can be crimped over a deflated balloon 460 located between the distal end of an outer shaft 452 and a nose cone 454 of the delivery device 450. In some examples, prior to transseptal delivery of the prosthetic valve 10, the hole 403 on the interatrial septum 406 can be further widened by inserting a balloon catheter through the hole 403 and radially expanding a balloon mounted on the balloon shaft.

[0242] 23 illustrates placing the prosthetic valve 10 within the docking device 100. Specifically, the prosthetic valve 10 can be positioned within and substantially coaxial with the functional turn in the central region 108 of the docking device 100. In some embodiments, the outer shaft 452 can be slightly retracted such that the balloon 460 is located outside of the outer shaft 452.

[0243] 24 illustrates radial expansion of the prosthetic valve 10 within the docking device 100. Specifically, the balloon 460 can be radially expanded by injecting an inflation fluid into the balloon through the delivery device 450, thereby causing radial expansion of the prosthetic valve 10. As the prosthetic valve 10 is radially expanded within the central region 108 of the coil, the functional turns within the central region 108 can be further radially expanded (i.e., as described above, the coil 102 of the docking device can move from a first radially expanded configuration to a second radially expanded configuration). To compensate for the increased diameter of the functional turns, the leading turns 106 can be retracted proximally and become part of the functional turns within the central region 108.

[0244] 25 illustrates deflation of the balloon 460 after radial expansion of the prosthetic valve 10 within the docking device 100. The balloon 460 can be deflated by withdrawing inflation fluid from the balloon through the delivery apparatus 450. The delivery apparatus 450 can then be retracted out of the patient's vasculature and the valve guidewire 246 can also be removed.

[0245] 26 illustrates the final placement of the docking device 100 and the prosthetic valve 10 received within the docking device 100 in the mitral valve. As discussed above, radial tension between the prosthetic valve 10 and the central region 108 of the docking device can hold the prosthetic valve 10 securely in place. Additionally, the guard member 104 can act as a seal between the docking device 100 and the prosthetic valve 10 disposed therein to prevent or reduce paravalvular leakage around the prosthetic valve 10.

[0246] As described above, radial expansion of the prosthetic valve 10 within the docking device 100 can cause the guard member 104 to radially compress and axially extend, and as a result, the proximal end 105 of the guard member 104 can have a tendency to move proximally relative to the coil. However, the presence of the retention element 114 can frictionally prevent the proximal end 105 of the guard member 104 from moving proximally outside the coil. In addition, the proximal placement marker 121p (which sets the proximal boundary of the proximal end 105 of the guard member 104 after initial deployment of the docking device 100) can be configured to be located sufficiently far from the ascending portion 110b of the coil. Thus, even if the proximal end 105 of the guard member 104 does move proximally due to radial expansion of the prosthetic valve 10 within the docking device 100, such movement can be limited to the extent that the proximal end 105 of the guard member 104 does not extend into the ascending portion 110b of the coil 102.

[0247] When the prosthetic heart valve 10 is fully expanded within the docking device 100, it contacts the guard member 104 and urges the guard member 104 against the coil 102, thereby restricting further axial movement of the guard member 104 against the native anatomy (e.g., the left atrial wall). In this manner, the retention member 114 can function to temporarily hold the proximal end of the guard member in a desired position from the time the docking device is deployed until the prosthetic heart valve is expanded therein. The prosthetic heart valve can then fix the positioning of the guard member relative to the coil.

[0248] In the method described above, the prosthetic valve 10 is radially expanded using an inflatable balloon 460, however, it should be understood that alternative methods can be used to radially expand the prosthetic valve 10.

[0249] For example, in some cases, the prosthetic valve can be configured to be self-expandable. During delivery, the prosthetic valve can be radially compressed and held within a valve sheath located at the distal end portion of the delivery apparatus. When the valve sheath is disposed within the central region 108 of the docking device, the valve sheath can be retracted to expose the prosthetic valve, which can then self-expand and securely engage with the central region 108 of the docking device. Additional details regarding exemplary self-expandable prosthetic valves and associated delivery apparatus / catheters / systems are described in U.S. Patent Nos. 8,652,202 and 9155,619, which are incorporated herein by reference in their entireties.

[0250] In another example, in certain cases, the prosthetic valve can be mechanically expanded. Specifically, the prosthetic valve can have a frame with multiple interconnected struts such that an axial force applied to the frame (e.g., pushing the inflow and outflow ends of the frame toward each other or pulling the inflow and outflow ends of the frame away from each other) can radially expand or compress the prosthetic valve. Additional details regarding exemplary mechanically expandable prosthetic valves and associated delivery devices / catheters / systems are described in U.S. Patent Application Publication No. 2018 / 0153689 and PCT Patent Application Publication No. WO / 2021 / 188476, which are incorporated herein by reference in their entireties.

[0251] The therapeutic techniques, methods, processes, etc. described or suggested in this specification or the references incorporated herein may be performed on living animals or on non-living simulations such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., simulated using body parts, tissues, etc.). Exemplary Methods of Deploying Textured Woven PVL Guards

[0252] The procedure for delivering the docking device 300 to the implantation site and implanting an artificial valve (such as the artificial valve 10 described above) within the docking device 300 can be generally similar to the procedure described above with reference to Figures 13-26, with exceptions as described below.

[0253] As described above, after the functional turns of the docking device have been successfully wrapped around the native leaflets and chordae tendineae (see, e.g., FIGS. 16-17), the docking sleeve 222 can be retracted proximally until it is retracted back into the delivery sheath 204. FIG. 27 illustrates the docking device 300 fully deployed. As shown, without being constrained by the docking sleeve 222, the guard member 304 can extend radially outward from the coil 302 as the expandable member 306 moves from a radially compressed state to a radially expanded state, for example, under the biasing force of the expandable member 306 and / or the biasing force of the elastic member 308. As described above, the proximal end portion 306p of the expandable member 306 can be moved to a position distal to the ascending portion 318 of the coil 302. Similarly, the release suture 214 can be cut to release the docking device 300 from the delivery apparatus 200.

[0254] As shown in FIG. 27, the distal end portion 306d of the expandable member 306 can be configured to extend to a location adjacent the posteromedial commissure 420. In certain embodiments, the distal end portion 306d of the expandable member 306 can extend through the native mitral valve annulus 408 and into the left ventricle 414. The proximal end portion 306p of the expandable member 306 can be configured to be positioned adjacent the anterior-lateral commissure 419 of the native valve. As described above, the outer portion 310b of the expandable portion 310 can press against the posterior wall 416 of the left atrium 404. In addition, adjacent expandable portions 310 can contact each other for shielding over the pinched portion 312. Therefore, the guard member 304 can form a stable seal between the docking device 300 and the native wall of the left atrium to reduce paravalvular leakage.

[0255] After the docking device 300 is deployed, an artificial valve (e.g., 10) can be delivered into the left atrium 404, positioned within the docking device 300, and then radially expanded following similar steps described above with reference to Figures 20-25.

[0256] 28 illustrates the final placement of the docking device 300 and the prosthetic valve 10 received within the docking device 300 in the mitral valve. As discussed above, radial tension between the prosthetic valve 10 and the central region of the docking device 300 can hold the prosthetic valve 10 securely in place. Additionally, the guard member 304 can act as a seal between the docking device 300 and the native wall to prevent or reduce paravalvular leakage around the prosthetic valve 10. sterile

[0257] Any of the systems, devices, apparatus, etc. herein may be sterilized (e.g., using heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure that they are safe for use on patients, and any of the methods herein may include sterilizing the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclave sterilization. Examples of radiation for use in sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beam. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization using hydrogen peroxide may be accomplished, for example, using hydrogen peroxide plasma. Additional Examples of the Disclosed Technique

[0258] In view of the above implementations of the disclosed subject matter, the present application discloses additional embodiments, which are listed below. It should be noted that one feature of an embodiment in isolation, or two or more features of that embodiment taken in combination, and optionally in combination with one or more features of one or more additional embodiments, are also further embodiments that fall within the disclosure of the present application.

[0259] Example 1. A docking device for securing a prosthetic valve in a native valve, comprising: a coil including a plurality of helical turns when deployed in the native valve; and a guard member comprising an expandable member and a resilient member, wherein a first end portion of the expandable member is fixedly attached to a segment of the coil and a second end portion of the expandable member is axially movable relative to the coil, the second end portion being opposite the first end portion, the expandable member being movable between a radially compressed state and a radially expanded state, the resilient member being coupled to the expandable member and extending along an axial length of the expandable member and being movable between an axially extended state and a resting state, the resilient member being biased to a resting state, the resilient member being in an axially extended state when the expandable member is in the radially compressed state and configured to assist in moving the expandable member from the radially compressed state to the radially expanded state, and the resilient member being in a resting state when the expandable member is in the radially expanded state.

[0260] Example 2. The docking device of certain Example 1 of any embodiment herein, wherein the elastic member comprises thermoplastic polyurethane (TPU).

[0261] Example 3. The docking device of any of the embodiments herein, specifically any one of Examples 1-2, wherein the elastic member is stitched to the expandable member.

[0262] Example 4. The docking device of any of the embodiments herein, specifically any one of Examples 1-3, wherein the elastic member is connected to the expandable member via a suture routed in a spiral path.

[0263] Example 5. The docking device of any of the embodiments herein, specifically any one of Examples 1-4, wherein the elastic member extends from the first end portion of the expandable member to the second end portion of the expandable member.

[0264] Example 6. The docking device of any of the embodiments herein, specifically any one of Examples 1-5, wherein the expandable member comprises a shape memory material.

[0265] Example 7. The docking device of any embodiment herein, particularly Example 6, wherein the expandable member comprises Nitinol.

[0266] Example 8. The docking device of any of the embodiments herein, specifically any one of Examples 1-7, wherein the expandable member comprises a woven material.

[0267] Example 9. The docking device of any embodiment herein, specifically Example 8, wherein the expandable member comprises woven polyethylene terephthalate (PET).

[0268] Example 10. A docking device of any of the embodiments herein, specifically any one of Examples 1-9, wherein the expandable member in a radially expanded state comprises a plurality of enlarged portions and one or more constricted portions connecting the plurality of enlarged portions, the enlarged portions having a larger radial profile than the constricted portions.

[0269] Example 11. The docking device of any of the embodiments herein, specifically Example 10, wherein the constricted portion and the expanded portion are made of the same material.

[0270] Example 12. The docking device of any of the examples herein, specifically any one of Examples 10-11, wherein the constricted portion has a first weave density that is greater than the second weave density of the expanded portion.

[0271] Example 13. A docking device of any of the embodiments herein, specifically any one of Examples 10-12, wherein when the expandable member is in a radially expanded state, the constricted portion wraps around the coil and the expanded portion expands radially from the coil.

[0272] Example 14. The docking device of any of the embodiments herein, specifically any one of Examples 10-13, wherein the fastened portion is configured to slide axially outside the coil.

[0273] Example 15. The docking device of any of the embodiments herein, specifically any one of Examples 10-14, wherein the enlarged portions have approximately the same size.

[0274] Example 16. The docking device of any of the embodiments herein, specifically any one of Examples 10-14, wherein the multiple enlarged portions have different sizes.

[0275] Example 17. A docking device of any of the embodiments herein, specifically any one of Examples 10-16, wherein when the expandable member is in a radially expanded state, at least a portion of two adjacent expanded portions form direct contact at a radially outward location of the clamped portion connecting the two adjacent expanded portions.

[0276] Example 18. The docking device of any of the examples herein, specifically any one of Examples 1-17, wherein the elastic member comprises a strip of elastic band extending parallel to the central longitudinal axis of the expandable member.

[0277] Example 19. A docking device of any of the embodiments herein, specifically any one of Examples 1-18, configured such that when the expandable member is in a radially expanded state and the prosthetic valve is radially expanded within the coil, the inner portion of the expandable member is radially compressed by the prosthetic valve such that the inner portion of the expandable member contacts the coil.

[0278] Example 20. A docking device of any of the embodiments herein, specifically any one of Examples 1-19, wherein when the expandable member is in a radially expanded state, at least a portion of the guard member extends radially outward relative to the coil, thereby reducing paravalvular leakage around the prosthetic valve when the guard member is deployed in the native valve.

[0279] Example 21. A guard member for a docking device configured to receive an artificial valve, comprising an expandable member and an elastic member extending along an axial length of the expandable member, the expandable member being movable between a radially compressed state and a radially expanded state, the elastic member being in an axially extended state when the expandable member is in the radially compressed state, and the elastic member in the axially extended state being configured to return to a resting state, thereby moving the expandable member from the radially compressed state to the radially expanded state.

[0280] Example 22. A guard member of any of the embodiments herein, specifically Example 21, wherein the expandable member in a radially expanded state is axially longer than the expandable member in a radially compressed state.

[0281] Example 23. A guard member of any of the embodiments herein, specifically any one of Examples 21-22, wherein the proximal end of the elastic member is attached to the proximal end portion of the expandable member and the distal end of the elastic member is attached to the distal end portion of the expandable member.

[0282] Example 24. The guard member of any of the embodiments herein, specifically any one of Examples 21-23, wherein the elastic member is attached to the expandable member via a continuous suture extending along the axial length of the expandable member.

[0283] Example 25. A guard member of any of the embodiments herein, specifically Example 24, wherein the length of the suture is equal to or greater than the length of the elastic member in its axially extended state, such that the suture has slack when the elastic member is in its rest state.

[0284] Example 26. The guard member of any of the embodiments herein, particularly any one of Examples 21-25, wherein the expandable member comprises a mesh-like wire frame.

[0285] Example 27. The guard member of any of the embodiments herein, particularly Example 26, wherein the elastic member extends along an outer surface of the expandable member.

[0286] Example 28. The guard member of any of the embodiments herein, particularly example 27, wherein the elastic member forms a sheath surrounding the expansion member.

[0287] Example 29. The guard member of any of the embodiments herein, particularly Example 26, wherein the elastic member extends through the inner lumen of the expandable member.

[0288] Example 30. The guard member of any of the embodiments herein, particularly example 29, wherein the elastic member extends along the inner surface of the expandable member.

[0289] Example 31. The guard member of any embodiment herein, particularly Example 26, wherein the elastic member is woven in and out of the expandable member.

[0290] Example 32 The guard member of any of the embodiments herein, particularly any one of Examples 21-25, wherein the expandable member comprises a woven material.

[0291] Example 33. The guard member of any of the embodiments herein, specifically Example 32, wherein the expandable member comprises a plurality of expandable portions connected by one or more constricted portions, the constricted portions having a higher weave density than the expandable portions.

[0292] Example 34. The guard member of any of the embodiments herein, particularly example 33, wherein the elastic member is connected to one or more fastened portions.

[0293] Example 35. The guard member of any of the embodiments herein, specifically any one of Examples 33-34, wherein the constricted portion maintains a generally constant diameter as the expandable member moves from a radially compressed state to a radially expanded state.

[0294] Example 36. The guard member of any of the examples herein, specifically any one of Examples 33-35, wherein the expandable portion has a first diameter when the expandable member is in a radially compressed state and a second diameter when the expandable member is in a radially expanded state, the second diameter being greater than the first diameter.

[0295] Example 37. The guard member of any of the embodiments herein, particularly example 36, wherein the first diameter of the expandable portion is about the same as the diameter of the pinched portion.

[0296] Example 38. The guard member of any of the embodiments herein, specifically any one of Examples 33-37, wherein adjacent expandable portions are configured to contact each other to shield the constricted portions when the expandable member is in a radially expanded state.

[0297] Example 39. The guard member of any of the embodiments herein, specifically any one of Examples 36-38, wherein the expandable portion is biased to the second diameter.

[0298] Example 40. The guard member of any of the embodiments herein, specifically any one of Examples 21-39, wherein the elastic member extends parallel to a central longitudinal axis of the expandable member.

[0299] Example 41. A guard member for a docking device configured to receive a prosthetic valve, comprising an expandable member including a woven material, the expandable member comprising a plurality of expandable portions connected by one or more clamped portions, the clamped portions having a higher weave density than the expandable portions, the expandable portions being movable between a first diameter and a second diameter, the second diameter being greater than the first diameter, and the clamped portions configured to remain at a constant, or at least substantially constant, diameter as the expandable portions move between the first diameter and the second diameter.

[0300] Example 42. The guard member of any of the embodiments herein, particularly example 41, wherein the first diameter of the expandable portion is about the same as the diameter of the pinched portion.

[0301] Example 43 The guard member of any of the embodiments herein, particularly example 41, wherein the first diameter of the expandable portion is greater than the diameter of the pinched portion.

[0302] Example 44. The guard member of any of the embodiments herein, specifically any one of embodiments 41-43, wherein the expandable portion is configured to extend axially when moving from the second diameter to the first diameter.

[0303] Example 45. The guard member of any of the embodiments herein, specifically any one of Examples 41-44, wherein the expandable member comprises 2-20 expandable portions.

[0304] Example 46 The guard member of any of the embodiments herein, particularly Example 45, wherein the expandable member comprises 6 to 12 expandable portions.

[0305] Example 47. The guard member of any of the embodiments herein, particularly Example 46, wherein the expandable member comprises 8-10 expandable portions.

[0306] Example 48. The guard member of any of the Examples herein, specifically any one of Examples 41-47, wherein the first diameter of the expandable portion is between 1 mm and 4 mm.

[0307] Example 49. The guard member of any of the embodiments herein, particularly Example 48, wherein the first diameter of the expandable portion is between 2 mm and 3 mm.

[0308] Example 50. The guard member of any of the embodiments herein, specifically Example 49, wherein the first diameter of the expandable portion is between 2.0 mm and 2.6 mm.

[0309] Example 51. The guard member of any of the Examples herein, specifically any one of Examples 41-50, wherein the second diameter of the expandable portion is between 4 mm and 10 mm.

[0310] Example 52. The guard member of any of the embodiments herein, particularly Example 51, wherein the second diameter of the expandable portion is between 7 mm and 9 mm.

[0311] Example 53. The guard member of any of the embodiments herein, specifically Example 52, wherein the second diameter of the expandable portion is between 7.5 mm and 8 mm.

[0312] Example 54. The guard member of any of the Examples herein, specifically any one of Examples 41 to 53, wherein the diameter of the fastened portion is 0.3 mm to 3 mm.

[0313] Example 55. The guard member of any of the examples herein, specifically Example 54, wherein the diameter of the fastened portion is 0.5 mm to 2.6 mm.

[0314] Example 56. The guard member of any of the examples herein, specifically Example 55, wherein the diameter of the fastened portion is 1.5 mm to 2.4 mm.

[0315] Example 57. The guard member of any of the Examples herein, specifically any one of Examples 41-56, wherein each expandable portion at the second diameter has an axial length of between 6 mm and 16 mm.

[0316] Example 58. The guard member of any of the examples herein, specifically Example 57, wherein each expandable portion at the second diameter has an axial length of between 8 mm and 14 mm.

[0317] Example 59. The guard member of any of the examples herein, specifically example 58, wherein each expandable portion at the second diameter has an axial length of 10 mm to 12 mm.

[0318] Example 60. The guard member of any of the embodiments herein, specifically any one of Examples 41-59, wherein when the expandable portion is at the second diameter, the expandable member has an axial length of 60 mm to 120 mm.

[0319] Example 61. The guard member of any of the embodiments herein, specifically Example 60, wherein the expandable member has an axial length of 70 mm to 100 mm when the expandable portion is at the second diameter.

[0320] Example 62. The guard member of any of the embodiments herein, specifically Example 60, wherein the expandable member has an axial length of 75 mm to 85 mm when the expandable portion is at the second diameter.

[0321] Example 63. The guard member of any of the Examples herein, specifically any one of Examples 41-62, wherein each clamped portion has an axial length of 0.1 mm to 2 mm.

[0322] Example 64. The guard member of any of the Examples herein, specifically Example 63, wherein each clamped portion has an axial length of 0.3 mm to 1.5 mm.

[0323] Example 65. The guard member of any of the examples herein, specifically Example 64, wherein each clamped portion has an axial length of 0.5 mm to 1.0 mm.

[0324] Example 66. The guard member of any of the embodiments herein, specifically any one of Examples 41-65, wherein the expandable member has an elongation budget of 1.1 to 1.6.

[0325] Example 67. The guard member of any embodiment herein, particularly Example 66, wherein the expandable member has an elongation budget of 1.2 to 1.5.

[0326] Example 68. A guard member of any of the embodiments herein, specifically any one of Examples 41-67, further comprising an elastic member extending along the axial length of the expandable member, the elastic member being movable between a resting state and an axially extended state, the elastic member being biased towards the resting state, and the expandable portion having a first diameter when the elastic member is in the axially extended state and a second diameter when the elastic member is in the resting state.

[0327] Example 69. A guard member of any of the embodiments herein, specifically Example 68, wherein the proximal end of the elastic member is attached to the proximal end portion of the expandable member and the distal end of the elastic member is attached to the distal end portion of the expandable member, whereby axial expansion or contraction of the elastic member causes corresponding axial expansion or contraction of the expandable member.

[0328] Example 70. A guard member of any of the embodiments herein, specifically any one of Examples 68-69, wherein the elastic member extends parallel to the central longitudinal axis of the expandable member and is connected to one or more constricted portions.

[0329] Example 71. A method for assembling a docking device configured to receive a prosthetic valve, comprising attaching a guard member to a coil, the coil configured to surround native tissue when deployed on the native valve, the guard member comprising an expandable member and an elastic member extending along an axial length of the expandable member, the elastic member being movable from a resting state to an axially extended state, the elastic member being biased to the resting state, the expandable member being in a radially compressed state when the elastic member is moved to the axially extended state, and the expandable member being in a radially expanded state when the elastic member returns to the resting state.

[0330] Example 72. The method of any of the embodiments herein, specifically Example 71, further comprising assembling a guard member, where assembling the guard member comprises attaching an elastic member to the expandable member.

[0331] Example 73. The method of any of the examples herein, specifically Example 72, wherein attaching the elastic member to the expandable member includes attaching a proximal end of the elastic member to a proximal end portion of the expandable member, and attaching a distal end of the elastic member to a distal end portion of the expandable member.

[0332] Example 74. The method of any of the embodiments herein, specifically any one of Examples 72-73, wherein attaching the elastic member to the expandable member comprises suturing the elastic member to the expandable member along the axial length of the expandable member.

[0333] Example 75. The method of any of the examples herein, specifically any one of Examples 72-74, wherein assembling the guard member includes braiding the expandable member using metal wire to form a mesh-like wire frame.

[0334] Example 76 The method of any of the embodiments herein, specifically Example 75, wherein attaching the elastic member to the expandable member comprises weaving the elastic member onto a mesh-like wire frame.

[0335] Example 77. The method of any of the examples herein, specifically any one of Examples 72-74, wherein assembling the guard member includes weaving a fabric to form a plurality of expandable portions connected by one or more constricted portions, the constricted portions having a higher weave density than the expandable portions.

[0336] Example 78. The method of any of the examples herein, specifically example 77, wherein attaching the elastic member to the expandable member includes connecting the elastic member to one or more constricted portions.

[0337] Example 79. The method of any of the embodiments herein, specifically any one of Examples 77-78, wherein assembling the guard member further comprises shape setting the plurality of expandable portions.

[0338] Example 80. The method of any of the embodiments herein, specifically any one of embodiments 71-79, wherein attaching the guard member to the coil includes fixedly attaching a distal end of the guard member to the coil and allowing a proximal end of the guard member to move axially relative to the coil.

[0339] Example 81. The method of any of the embodiments herein, specifically any one of Examples 71-80, further comprising retaining the guard member within the delivery sheath such that the expandable member is in a radially compressed state and the elastic member is in an axially extended state.

[0340] Example 82. A method for implanting a prosthetic valve, comprising: deploying a docking device at a native valve; and deploying the prosthetic valve within the docking device, wherein the docking device comprises a coil and a guard member attached to the coil, wherein the guard member comprises an expandable member and an elastic member extending along an axial length of the expandable member, wherein the elastic member is movable from a resting state to an axially extended state, wherein the elastic member is biased to the resting state, wherein the expandable member is in a radially compressed state when the elastic member moves to the axially extended state, and wherein the expandable member is in a radially expanded state when the elastic member returns to the resting state.

[0341] Example 83. The method of any of the examples herein, specifically Example 82, further comprising delivering a docking device to the native valve, wherein delivering the docking device comprises holding the docking device within a delivery sheath in a substantially straight configuration.

[0342] Example 84. The method of any of the examples herein, specifically Example 83, wherein retaining the docking device within the delivery sheath includes radially compressing the expandable member to a radially compressed state and axially stretching the elastic member within the delivery sheath to an axially extended state.

[0343] Example 85. The method of any of the embodiments herein, specifically any one of Examples 82-84, wherein deploying the docking device includes removing the delivery sheath from the guard member and allowing the elastic member to return to a resting state to move the expandable member from a radially compressed state to a radially expanded state.

[0344] Example 86. The method of any of the examples herein, specifically any one of Examples 82-85, wherein deploying the prosthetic valve includes radially expanding the prosthetic valve such that an inner portion of the expandable member is radially compressed by the prosthetic valve and contacts the coil.

[0345] Example 87. A medical assembly comprising a docking device according to any one of Examples 1 to 20 or a docking device having a guard member according to any one of Examples 21 to 70, and a radially expandable and compressible prosthetic valve configured to be received within the docking device.

[0346] Example 88. A medical assembly comprising a docking device according to any one of Examples 1 to 20 or a docking device having a guard member according to any one of Examples 21 to 70, and a delivery device configured to deliver the docking device to a target implantation site in a patient.

[0347] Example 89. A docking device for securing a prosthetic valve in a native valve, comprising: a coil having a plurality of helical turns when deployed in the native valve; and an expandable member extending radially outward from the coil, the expandable member being movable between a radially compressed state and a radially expanded state, a first end of the expandable member fixedly attached to the coil and a second end of the expandable member being axially movable relative to the coil, the second end being opposite the first end, the expandable member comprising a braided wire frame.

[0348] Example 90 The docking device of particular Example 89 of any embodiment herein, wherein the braided wire frame comprises a metal alloy having shape memory properties.

[0349] Example 91 The docking device of specific Example 90 of any embodiment herein, wherein the metal alloy comprises nickel titanium.

[0350] Example 92 The docking device of any particular Example 89 of any embodiment herein, wherein the metal alloy comprises a metallic material.

[0351] Example 93 The docking device of particular Example 92 of any embodiment herein, wherein the metallic material comprises cobalt chrome or stainless steel.

[0352] Example 94 The docking device of any of the embodiments herein, specifically any one of Examples 89-93, wherein the expandable member comprises a polymeric material.

[0353] Example 95 The docking device of particular Example 94 of any embodiment herein, wherein the braided wire frame is embedded within a polymeric material.

[0354] Example 96. The docking device of any of the examples herein, specifically any one of Examples 94-95, wherein the polymeric material comprises any one of polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyether ether ketone (PEEK), and thermoplastic polyurethane (TPU).

[0355] Example 97. The docking device of any of the examples herein, specifically any one of Examples 89-96, wherein the braided wire frame comprises between 16 wires and 128 wires (inclusive).

[0356] Example 98. The docking device of particular Example 97 of any embodiment herein, wherein the braided wire frame comprises between 32 wires and 96 wires (inclusive).

[0357] Example 99. The docking device of particular Example 98 of any embodiment herein, wherein the braided wire frame comprises between 48 wires and 64 wires (inclusive).

[0358] Example 100. The docking device of any of the embodiments herein, specifically any one of Examples 89-99, wherein the braided wire frame has a braid density in the range of 20 to 70 picks per inch (inclusive).

[0359] Example 101. The docking device of particular Example 100 of any embodiment herein, wherein the braided wire frame has a braid density in the range of 25 to 65 picks per inch (inclusive).

[0360] Example 102. The docking device of particular Example 101 of any embodiment herein, wherein the braided wire frame has a braid density in the range of 36 to 40 picks per inch (inclusive).

[0361] Example 103. The docking device of any of the examples herein, specifically any one of Examples 89-102, wherein the braided wire frame comprises wires having a wire diameter in the range of 0.002 inches to 0.004 inches (inclusive).

[0362] Example 104 The docking device of particular Example 103 of any example herein, wherein the wire diameter is 0.003 inches.

[0363] Example 105. A docking device for securing a prosthetic valve in a native valve, comprising: a coil having a plurality of helical turns when deployed in the native valve; and an expandable member extending radially outward from the coil, the expandable member being movable between a radially compressed state and a radially expanded state, a first end of the expandable member fixedly attached to the coil and a second end of the expandable member being axially movable relative to the coil, the second end being opposite the first end, the expandable member comprising a polymeric material.

[0364] Example 106 The docking device of particular Example 105 of any embodiment herein, wherein the polymeric material comprises PET, PEEK, or TPU.

[0365] Example 107. A docking device for securing a prosthetic valve in a native valve, comprising: a coil having a plurality of helical turns when deployed in the native valve; and an expandable member extending radially outward from the coil, the expandable member being movable between a radially compressed state and a radially expanded state, a first end of the expandable member fixedly attached to the coil and a second end of the expandable member being axially movable relative to the coil, the second end being opposite the first end, the expandable member comprising a braided metal wire frame coated with an elastomer.

[0366] Example 108. A docking device for securing a prosthetic valve in a native valve, comprising: a coil having a plurality of helical turns when deployed in the native valve; and an expandable member extending radially outward from the coil, the expandable member being movable between a radially compressed state and a radially expanded state, a first end of the expandable member being fixedly attached to the coil and a second end of the expandable member being axially movable relative to the coil, the second end being opposite the first end, the expandable member comprising one or more metal wires interwoven with one or more polymeric fibers.

[0367] Example 109. A guard member for a docking device configured to receive a prosthetic valve, comprising: an expandable member comprising a braided wire mesh; and an elastic member extending along an axial length of the expandable member, wherein the expandable member is movable between a radially compressed state, a first radially expanded state, and a second radially expanded state, wherein a diameter of the expandable member in the first radially expanded state is larger than that of the expandable member in the radially compressed state and smaller than that of the expandable member in the second radially expanded state, wherein when the elastic member is not coupled to the expandable member, the expandable member is biased toward the first radially expanded state, and when the elastic member is coupled to the expandable member, the expandable member is biased toward the second radially expanded state.

[0368] Example 110. The guard member of specific example 109 of any of the examples herein, wherein the resilient member comprises a coil spring.

[0369] Example 111. The guard member of certain example example 110 of any example herein, wherein the pitch of the coil spring is greater than the pitch of the braided wire mesh.

[0370] Example 112. The guard member of specific Example 111 of any of the embodiments herein, wherein the pitch of the coil spring is in the range of 3 mm to 9 mm.

[0371] Example 113. The guard member of specific Example 112 of any of the embodiments herein, wherein the pitch of the coil spring is in the range of 5 mm to 7 mm.

[0372] Example 114. The guard member of any of the examples herein, specifically any one of Examples 110-113, wherein the coil spring comprises a first wire and the braided wire mesh comprises a second wire, the first wire having a larger diameter than the second wire.

[0373] Example 115. The guard member of specific Example 114 of any of the embodiments herein, wherein the diameter of the first wire is in the range of 0.15 mm to 0.22 mm.

[0374] Example 116. The guard member of any of the embodiments herein, specifically any one of Examples 109-115, wherein the elastic member comprises a shape memory material.

[0375] Example 117 The guard member of any of the embodiments herein, particularly any one of Examples 109-116, wherein the braided wire mesh comprises a shape memory material.

[0376] Example 118. A guard member of any of the embodiments herein, specifically any one of Examples 109-117, wherein the elastic member is in an axially extended state when the expandable member is in a radially compressed state and is in a stationary state when the expandable member is in a second radially expanded state, and the elastic member is biased toward the stationary state.

[0377] Example 119. A guard member of any of the embodiments herein, specifically any one of Examples 109-118, wherein a first end of the elastic member is connected to a first end of the expandable member and a second end of the elastic member is connected to a second end of the expandable member.

[0378] Example 120. The guard member of any of the embodiments herein, particularly any one of Examples 109-119, wherein the elastic member is disposed within the lumen of the expandable member.

[0379] Example 121 The guard member of any of the embodiments herein, specifically any one of Examples 109-119, wherein the elastic member is disposed outside the outer surface of the expandable member.

[0380] Example 122. A docking device for securing a prosthetic valve in a native valve, comprising: a coil having a plurality of helical turns when deployed in the native valve; and a guard member comprising an expandable member and a coil spring coupled to the expandable member, wherein the coil extends through the coil spring, the expandable member is movable between a radially compressed state and a radially expanded state, the coil spring axially stretched to a first length when the expandable member is in the radially compressed state and returned to a second length when the expandable member is in the radially expanded state, the second length being shorter than the first length, and the coil spring being biased toward the second length.

[0381] Example 123. A docking device of specific example 122 of any of the examples herein, wherein a first end portion of the expandable member is fixedly attached to a segment of the coil and a second end portion of the expandable member is axially movable relative to the coil.

[0382] Example 124 The docking device of any of the embodiments herein, specifically any one of Examples 122-123, wherein the expandable member comprises a nickel titanium alloy.

[0383] Example 125. The docking device of any of the embodiments herein, specifically any one of embodiments 122-124, wherein the coil spring comprises a nickel-titanium alloy.

[0384] Example 126 The docking device of any of the embodiments herein, specifically any one of Examples 122-125, wherein the expandable member comprises a braided wire mesh.

[0385] Example 127. A docking device of any of the embodiments herein, specifically any one of Examples 122-126, wherein a first end of the coil spring is connected to a first end of the expandable member and a second end of the coil spring is connected to a second end of the expandable member.

[0386] Example 128. A docking device for securing a prosthetic valve in a native valve, comprising: a coil including a plurality of helical turns when deployed in the native valve; and a guard member comprising an expandable member and a coil spring coiled around the coil and connected to the expandable member, wherein the expandable member is movable between a radially compressed state and a radially expanded state, and the coil spring is movable between an axially extended state and a resting state, the coil spring being biased to the resting state, the coil spring being in the axially extended state when the expandable member is in the radially compressed state, and configured to assist the expandable member in moving from the radially compressed state to the radially expanded state, and the coil spring being in the resting state when the expandable member is in the radially expanded state.

[0387] Example 129. A method comprising sterilizing a docking device of any of the embodiments herein, specifically any one of Examples 1-20, 89-108, and 122-128, sterilizing a guard member of any of the embodiments herein, specifically any one of Examples 21-70 and 109-121, or sterilizing a medical assembly of any of the embodiments herein, specifically any one of Examples 87-88.

[0388] Example 130. A method of treating a heart on a simulation, comprising: deploying a docking device at a target location; and deploying an artificial valve within the docking device, wherein the docking device comprises a coil and a guard member attached to the coil, wherein the guard member comprises an expandable member and an elastic member extending along an axial length of the expandable member, wherein the elastic member is movable from a resting state to an axially extended state, wherein the elastic member is biased to the resting state, wherein the expandable member is in a radially compressed state when the elastic member moves to the axially extended state, and wherein the expandable member is in a radially expanded state when the elastic member returns to the resting state.

[0389] Unless otherwise specified, features described herein with respect to any embodiment may be combined with other features described in any one or more of the other embodiments. For example, any one or more of the features of one docking device may be combined with any one or more of the features of another docking device. As another example, any one or more of the features of one guard member may be combined with any one or more of the features of another guard member.

[0390] In view of the numerous possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are merely preferred embodiments of the technology and should not be taken as limiting the scope of the present disclosure. Rather, the scope of the claimed subject matter is defined by the following claims, and their equivalents.

Claims

1. 1. A docking device for securing a prosthetic valve to a native valve, comprising: a coil comprising a plurality of helical turns when deployed in the native valve; a guard member comprising an expandable member and an elastic member; a first end portion of the expandable member fixedly attached to a segment of the coil and a second end portion of the expandable member axially movable relative to the coil, the second end portion opposite the first end portion; the expandable member is movable between a radially compressed state and a radially expanded state; the elastic member is coupled to the expandable member and extends along an axial length of the expandable member, the elastic member being movable between an axially extended state and a resting state, the elastic member being biased toward the resting state; the elastic member is in the axially extended state when the expandable member is in the radially compressed state and is configured to assist in moving the expandable member from the radially compressed state to the radially expanded state; A docking device wherein the elastic member is in the resting state when the expandable member is in the radially expanded state.

2. The docking device of claim 1 , wherein the elastic member comprises thermoplastic polyurethane (TPU).

3. The docking device of any one of claims 1 to 2, wherein the elastic member is stitched to the expandable member.

4. The docking device of any one of claims 1 to 3, wherein the elastic member is connected to the expandable member via a suture routed in a spiral path.

5. The docking device of any one of claims 1 to 4, wherein the elastic member extends from the first end portion of the expandable member to the second end portion of the expandable member.

6. The docking device of any one of claims 1 to 5, wherein the expandable member comprises a shape memory material.

7. The docking device of claim 6 , wherein the expandable member comprises nitinol.

8. The docking device of any one of claims 1 to 7, wherein the expandable member comprises a woven material.

9. The docking device of claim 8 , wherein the expandable member comprises woven polyethylene terephthalate (PET).

10. 10. The docking device of claim 1, wherein the expandable member in the radially expanded state comprises a plurality of enlarged portions and one or more constricted portions connecting the enlarged portions, the enlarged portions having a larger radial profile than the constricted portions.

11. The docking device of claim 10 , wherein the constricted portion and the enlarged portion are made of the same material.

12. The docking device of any one of claims 10 to 11, wherein the constricted portion has a first weave density that is greater than a second weave density of the expanded portion.

13. 13. The docking device of claim 10, wherein when the expandable member is in the radially expanded state, the constricted portion wraps around the coil and the expanded portion expands radially from the coil.

14. The docking device of any one of claims 10 to 13, wherein the clamped portion is configured to slide axially outside the coil.

15. 1. A guard member for a docking device configured to receive a prosthetic valve, comprising: an expandable member; a resilient member extending along the axial length of the expandable member; the expandable member is movable between a radially compressed state and a radially expanded state; when the expandable member is in the radially compressed state, the elastic member is in an axially expanded state; A guard member, wherein the resilient member in the axially extended state is configured to return to a resting state, thereby moving the expandable member from the radially compressed state to the radially expanded state.

16. 16. The guard member of claim 15, wherein the elastic member is woven in and out of the expandable member.

17. 16. The guard member of claim 15, wherein the expandable member comprises a plurality of expandable portions connected by one or more constricted portions, the constricted portions having a higher weave density than the expandable portions.

18. 18. The guard member of claim 17, wherein the elastic member is connected to the one or more fastened portions.

19. 1. A guard member for a docking device configured to receive a prosthetic valve, comprising: an expandable member comprising a woven material; the expandable member comprises a plurality of expandable portions connected by one or more constricted portions, the constricted portions having a higher weave density than the expandable portions; the expandable portion is movable between a first diameter and a second diameter, the second diameter being greater than the first diameter; A guard member configured such that the pinched portion remains at a constant or at least substantially constant diameter as the expandable portion moves between the first diameter and the second diameter.

20. 20. The guard member of claim 19, further comprising a resilient member extending along an axial length of the expandable member, the resilient member being movable between a resting state and an axially extended state, the resilient member being biased toward the resting state, the expandable portion having the first diameter when the resilient member is in the axially extended state and the second diameter when the resilient member is in the resting state.

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