Docking device, protective member for docking device and medical assembly

Abstract

The utility model relates to a butt joint device, a protective component for the butt joint device and a medical assembly. Certain examples of the present disclosure relate to a guard member for a docking device configured to receive a prosthetic valve. The guard member may include an expandable member and a resilient member extending along an axial length of the expandable member. The expandable member is movable between a radially compressed state and a radially expanded state. The resilient member may be in an axially stretched state when the expandable member is in the radially compressed state. The resilient member may be configured to return to a rest state in the axially stretched state, thereby moving the expandable member from the radially compressed state to the radially expanded state.

Description

[0001] This application is a divisional application of Chinese patent application 2022226924966, entitled “Docking device and protective component”, filed on October 13, 2022.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] 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. Technical Field

[0004] The present disclosure relates to examples of docking devices configured to secure a prosthetic valve to a native heart valve and methods of assembling such devices. Background Art

[0005] Prosthetic valves can be used to treat valvular heart disease. Natural heart valves (such as the aortic, pulmonary, tricuspid, and mitral valves) function to prevent reverse flow, or regurgitation, while allowing forward flow. Congenital, inflammatory, or infectious conditions can make these valves less effective. These conditions can ultimately lead to severe cardiovascular damage or death. For years, doctors have attempted to treat these disorders by surgically repairing or replacing the valves during open-heart surgery.

[0006] Transcatheter techniques that utilize a catheter to introduce and implant a prosthetic heart valve in a less invasive manner than open heart surgery can reduce the complications associated with open heart surgery. In this technique, a prosthetic valve can be mounted on the end of a catheter in a compressed state and advanced through the patient's blood vessels until the valve reaches the implantation site. The valve at the tip of the catheter can then be expanded to its functional size at 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 as the valve is advanced from a delivery sheath at the distal end of the catheter. Alternatively, the valve can have a frame that is balloon expandable, self-expandable, mechanically expandable, and / or a frame that can be expanded in a variety of ways or in combination.

[0007] In some cases, a transcatheter heart valve (THV) may be appropriately sized to be placed within a particular native valve (e.g., a native aortic valve). Consequently, a THV may not be suitable for implantation at other native valves (e.g., a native mitral valve) and / or in patients with larger native valves. 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. Therefore, improvements to THVs and associated transcatheter delivery devices are desired. Utility Model Content

[0008] The present disclosure relates to methods and devices for treating valvular regurgitation and / or other valvular problems. In particular, the present disclosure relates to docking devices configured to receive a prosthetic valve and methods of assembling and implanting the docking devices.

[0009] A docking device for securing a prosthetic valve at a native valve may include a coil comprising a plurality of helical turns when deployed at the native valve.In addition to these features, the docking device may include one or more components disclosed herein.

[0010] In some examples, the docking device may include a guard member comprising an expandable member and a resilient member.

[0011] In some examples, a first end portion of the expandable member can be fixedly attached to a section of the coil, and a second end portion of the expandable member can be axially movable relative to the coil.

[0012] In some examples, the expandable member can be movable between a radially compressed state and a radially expanded state.

[0013] In some examples, the resilient member can be coupled to the expandable member and extend along an axial length of the expandable member and can be movable between an axially stretched state and a rest state, the resilient member being biased into the rest state.

[0014] In some examples, when the expandable member is in the radially compressed state, the resilient member may be in the axially stretched state and configured to assist in moving the expandable member from the radially compressed state to the radially expanded state.

[0015] In some examples, the elastic member may be in the rest state when the expandable member is in the radially expanded state.

[0016] In some examples, a protective member for a docking device may include an expandable member and a resilient member extending along an axial length of the expandable member.

[0017] In some examples, the expandable member can be movable between a radially compressed state and a radially expanded state.

[0018] In some examples, when the expandable member is in the radially compressed state, the elastic member can be in an axially stretched state.

[0019] In some examples, the resilient member can be configured to return to a resting state in the axially stretched state, thereby moving the expandable member from the radially compressed state to the radially expanded state.

[0020] In some examples, a protective member for a docking device may include an expandable member comprising a woven material.

[0021] In some examples, the expandable member may include multiple expandable portions connected by one or more constricting portions.

[0022] In some examples, the constricted portion may have a higher weave density than the expandable portion.

[0023] In some examples, the expandable portion is movable between a first diameter and a second diameter, the second diameter being larger than the first diameter.

[0024] In some examples, the constricted portion can be configured to maintain a constant, or at least substantially constant, diameter as the expandable portion moves between the first diameter and the second diameter.

[0025] Certain examples of the present disclosure relate to a docking device for securing a prosthetic valve to a natural valve. The docking device may include a coil comprising a plurality of helical turns when deployed at the natural valve, and a protective member comprising an expandable member and an elastic member. A first end portion of the expandable member may be fixedly attached to a section 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 elastic member may be coupled to the expandable member and extend along the axial length of the expandable member and may be movable between an axially stretched state and a resting state, the elastic member being biased to the resting state. When the expandable member is in the radially compressed state, the elastic member may be in the axially stretched state and configured to assist the expandable member in moving from the radially compressed state to the radially expanded state. When the expandable member is in the radially expanded state, the elastic member may be in the resting state.

[0026] Certain examples of the present disclosure also relate to a protective member for a docking device configured to receive a prosthetic valve. The protective member may include an expandable member and an elastic member, wherein the elastic member extends along the axial length of the expandable member. The expandable member can move between a radially compressed state and a radially expanded state. When the expandable member is in the radially compressed state, the elastic member can be in an axially stretched state. The elastic member can be configured to return to a rest state in the axially stretched state, thereby moving the expandable member from the radially compressed state to the radially expanded state.

[0027] According to certain examples, a protective member for a docking device configured to receive a prosthetic valve may include an expandable member comprising a woven material. The expandable member may include a plurality of expandable portions connected by one or more contracting portions. The contracting portions may have a higher weave density than the expandable portions. The expandable portions may be movable between a first diameter and a second diameter, the second diameter being larger than the first diameter. The contracting portions may be configured to maintain a constant, or at least substantially constant, diameter as the expandable portions move between the first diameter and the second diameter.

[0028] Certain aspects of the present disclosure relate to a method for assembling a docking device configured to receive a prosthetic valve. The method may include attaching a protective member to a coil. The coil may be configured to surround native tissue when deployed at a native valve. The protective member may include an expandable member and an elastic member, the elastic member extending along the axial length of the expandable member. The elastic member is movable from a resting state to an axially stretched state, the elastic member being biased to the resting state. When the elastic member moves to the axially stretched state, the expandable member may be in a radially compressed state. When the elastic member returns to the resting state, the expandable member may be in a radially expanded state.

[0029] Certain aspects of the present disclosure also relate to a method for implanting a prosthetic valve. The method may include deploying a docking device at a natural valve and deploying the prosthetic valve within the docking device. The docking device may include a coil and a protective member, the protective member being attached to the coil. The protective member may include an expandable member and an elastic member, the elastic member extending along the axial length of the expandable member. The elastic member is movable from a resting state to an axially stretched state, the elastic member being biased to the resting state. When the elastic member moves to the axially stretched state, the expandable member may be in a radially compressed state. When the elastic member returns to the resting state, the expandable member may be in a radially expanded state.

[0030] The above method(s) may be performed on a living animal or on a simulated body (e.g., a cadaver, a cadaver heart, an anthropomorphic phantom, a simulator (e.g., having a body part, heart, tissue, etc. being simulated), etc.).

[0031] Certain examples of the present disclosure relate to a medical assembly including any of the aforementioned docking devices or a docking device having any of the aforementioned guard members, and a radially expandable and compressible prosthetic valve configured to be received within the docking device.

[0032] Certain aspects of the present disclosure also relate to a medical assembly comprising any of the aforementioned docking devices or a docking device having any of the aforementioned protective members, and a delivery device configured to deliver the docking device to a target implantation site in a patient.

[0033] According to certain examples, a docking device for securing a prosthetic valve to a native valve may include a coil comprising a plurality of helical turns when deployed at the native valve and an expandable member extending radially outward from the coil. The expandable member may be movable between a radially compressed state and a radially expanded state. A first end of the expandable member may be fixedly attached to the coil, and a second end of the expandable member may be axially movable relative to the coil, wherein the second end is opposite the first end.

[0034] According to some examples, the expandable member may include a braided wire frame.

[0035] According to some examples, the expandable member may include a polymer material.

[0036] According to certain examples, the expandable member may include a braided metal wire frame coated with an elastomer.

[0037] According to some examples, the expandable member may include one or more metal wires interwoven with one or more polymer fibers.

[0038] According to certain aspects of the present disclosure, a protective member for a docking device, the docking device being configured to receive a prosthetic valve, the protective member may include an expandable member and an elastic member, the expandable member having a braided wire mesh, the elastic member extending along the axial length of the expandable member. The expandable member can move between a radially compressed state, a first radially expanded state, and a second radially expanded state. The 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. If the elastic member is not coupled to the expandable member, the expandable member can be biased toward the first radially expanded state. If the elastic member is coupled to the expandable member, the expandable member can be biased toward the second radially expanded state.

[0039] According to certain aspects of the present disclosure, a docking device for securing a prosthetic valve to a natural valve may include a coil comprising a plurality of helical turns when deployed at the natural valve and a protective member comprising an expandable member and a coil spring, the coil spring being coupled to the expandable member. The coil may extend through the coil spring. The expandable member may move between a radially compressed state and a radially expanded state. When the expandable member is in the radially compressed state, the coil spring may be axially stretched to a first length, and when the expandable member is in the radially expanded state, the coil spring may return to a second length, the second length being shorter than the first length. The coil spring may be biased toward the second length.

[0040] According to certain aspects of the present disclosure, a docking device for securing a prosthetic valve to a natural valve may include a coil comprising a plurality of helical turns when deployed at the natural valve and a protective member comprising an expandable member and a coil spring, the coil spring being wound around the coil and coupled to the expandable member. The expandable member may be movable between a radially compressed state and a radially expanded state. The coil spring may be movable between an axially stretched state and a resting state, the coil spring being biased to the resting state. When the expandable member is in the radially compressed state, the coil spring may be in the axially stretched state and be configured to assist the expandable member in moving from the radially compressed state to the radially expanded state. When the expandable member is in the radially expanded state, the coil spring may be in the resting state.

[0041] In some examples, the docking apparatus includes one or more components listed in Examples 1-20, 89-108, and 122-128 described in the following section "Additional Examples of the Disclosed Technology."

[0042] In some examples, the protective member includes one or more components listed in Examples 21-70 and 109-121 described in the following section "Additional Examples of the Disclosed Technology."

[0043] The foregoing and other objects, features and advantages of the disclosed technology will become more apparent from the following detailed description with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Figure 1A is a side perspective view of a docking device in a helical configuration according to one example.

[0045] Figure 1B yes Figure 1A A top view of the docking device depicted in FIG.

[0046] Figure 1C Based on an example along Figure 1B A cross-sectional view of the docking device taken along line 1C-1C depicted in FIG.

[0047] Figure 1D Is along with Figure 1C A cross-sectional view of the docking device taken along the same line as in Figure 1D In the embodiment, the docking device is in a substantially straight delivery configuration.

[0048] Figure 1E According to another example Figure 1B A cross-sectional view of the docking device taken along line 1C-1C as described in FIG.

[0049] Figure 1F Is along with Figure 1E A cross-sectional view of the docking device taken along the same line as in Figure 1F In the embodiment, the docking device is in a substantially straight delivery configuration.

[0050] Figure 1G is a schematic diagram depicting a docking device in a substantially straight configuration.

[0051] Figure 2A is a perspective view of a prosthetic valve according to an example.

[0052] Figure 2B According to one example, a Figure 2A A perspective view of a prosthetic valve.

[0053] Figure 3A Is a perspective view of an exemplary prosthetic implant assembly comprising Figure 1A The docking device depicted in FIG. 1 and the device held within the docking device Figure 2B prosthetic valve.

[0054] Figure 3B is a side view of the prosthetic implant assembly of FIG. 3 .

[0055] Figure 4A An expandable member coupled to a resilient member is depicted according to one example.

[0056] Figure 4B An expandable member coupled to a resilient member is depicted according to another example.

[0057] Figure 4C Depicted is an expandable member coupled to another resilient member in the form of a coil spring, wherein the coil spring is in a rest state, according to one example.

[0058] Figure 4D Depicts coupling to Figure 4C An expandable member of a coil spring, wherein the coil spring is in an axially stretched state.

[0059] Figure 5A is a top view of a docking device including a textured woven guard member according to one example.

[0060] Figure 5B yes Figure 5A Side view of the docking device.

[0061] Figure 6A A textured woven protective member in a radially compressed and axially elongated configuration is described.

[0062] Figure 6B Shown in a radially expanded and axially shortened configuration Figure 6A Textured woven protective component.

[0063] Figure 6C Described Figure 6A Part of a textured woven protective component.

[0064] Figure 7A is a schematic top view of a docking device including a textured woven shield member and a prosthetic valve expanded within coils of the docking device according to one example.

[0065] Figure 7B is a view of a textured woven guard member after it has been cut along its longitudinal axis and flattened, according to one example.

[0066] Figure 7C is a cross-sectional view of a portion of a textured woven guard member taken along a longitudinal axis with an inner portion of the expandable portion radially compressed by a prosthetic valve and contacting the coil according to one example.

[0067] Figure 8 is a side view of a delivery assembly according to one example, the delivery assembly including a delivery device and Figure 1A docking device.

[0068] Figure 9A is a side cross-sectional view of a quill according to one example.

[0069] Figure 9B is a side cross-sectional view of a pusher shaft according to one example.

[0070] Figure 10A is a side cross-sectional view of an assembly comprising Figure 9A The sleeve shaft, Figure 9B A pusher shaft, and a delivery sheath, wherein the sleeve shaft covers the docking device.

[0071] Figure 10B yes Figure 10A FIG. 1 is a side cross-sectional view of the same assembly except that the docking device is not covered by the quill.

[0072] Figure 11 is a schematic cross-sectional view of a distal portion of a delivery system illustrating fluid flow through a lumen within the delivery system.

[0073] Figure 12A A perspective view of an example of a sleeve shaft covering a docking device and extending out of a delivery sheath of a delivery system is illustrated.

[0074] Figure 12B The diagram shows Figure 12A The delivery system deploys the docking device and the sleeve shaft around the pusher shaft after removing the sleeve shaft from the docking device.

[0075] Figure 13-26 Depicts the various parts of an exemplary implantation procedure in which a transseptal delivery approach is employed using Figure 8 The delivery equipment will Figure 3A The prosthetic implant component is implanted in the position of the native mitral valve.

[0076] Figure 27 is an atrial side view of another docking device implanted in a mitral valve according to one example.

[0077] Figure 28 According to one example, after receiving the prosthetic valve in the docking device Figure 27 Atrial side view of the docking device. DETAILED DESCRIPTION

[0078] General considerations

[0079] It should be understood that the disclosed examples may be applicable to the delivery and implantation of a prosthetic device in any of the native valve annuli of the heart (e.g., the pulmonary valve annulus, the mitral valve annulus, and the tricuspid valve annulus) and may be used with any of a variety of delivery methods (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0080] For the purpose of this description, some aspects, advantages and novel features of the examples of the present disclosure are described herein. The disclosed methods, devices and systems should not be interpreted as being limited in any way. On the contrary, the present disclosure relates to all novel and non-obvious features and aspects of the various examples disclosed herein (individually and in various combinations and sub-combinations of each other). These methods, devices and systems are not limited to any specific aspect or feature or combination thereof, and the disclosed examples do not require the presence of any one or more specific advantages or the resolution of any one or more specific problems. The technology from any example can be combined with the technology described in any one or more other examples. In view of the fact that the principles of the disclosed technology can be applied to many possible examples, it should be appreciated that the examples shown are only preferred examples and should not be considered as limiting the scope of the disclosed technology.

[0081] Although some of the operations in the disclosed examples are described in a specific, sequential order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language set forth below requires a particular order. For example, the operations described in sequence can be rearranged or performed simultaneously in some cases. In addition, for simplicity, the accompanying drawings may not show the various ways in which the disclosed method can be used in combination with other methods. In addition, the description sometimes uses terms such as "providing" or "implementing" to describe the disclosed method. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms can vary depending on the specific implementation and are easily discernible to those of ordinary skill in the art.

[0082] 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. Additionally, the term "including" means "comprising." Further, the terms "coupled" and "connected" generally mean electrically, electromagnetically, and / or physically coupled or connected, and do not exclude the presence of intervening elements between the coupled or associated items in the absence of specific language to the contrary.

[0083] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, the proximal motion of a device is the motion of the device away from the implantation site and toward the user (e.g., away from the patient's body), while the distal motion of the device is the motion of the device away from the user and toward the implantation site (e.g., into the patient's body). Unless expressly defined otherwise, the terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions.

[0084] As used herein, the terms "substantially" and "about" refer to the listed value and any value within 10% of the listed value. For example, "about 1 mm" refers to any value between about 0.9 mm and about 1.1 mm (inclusive).

[0085] Directional and other relative references (e.g., inside, outside, up, down, etc.) may be used to facilitate the discussion of the figures and principles herein but are not intended to be limiting. For example, certain terms such as "inside," "outside," "top," "down," "inside," "outside," etc. may be used. Where applicable, such terms are used to provide some clarity of description when dealing with relative relationships, particularly with respect to the examples shown. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, the "upper" portion can become the "lower" portion simply by turning the object over. Nevertheless, it is still the same portion, and the object is still the same. As used herein, "and / or" means "and" or "or," as well as "and" and "or."

[0086] Introduction to the disclosed technology

[0087] Disclosed herein are various systems, devices, methods, and the like, including anchoring or docking devices that can be used in conjunction with an expandable prosthetic valve at a native valve annulus (e.g., a native mitral valve annulus and / or tricuspid valve annulus) to more securely implant and maintain the prosthetic valve at the implantation site. Anchoring / docking devices according to examples of the present disclosure can, for example, provide a stable anchoring site, landing zone, or implantation area at an implantation site where a prosthetic valve can be expanded or otherwise implanted. Many disclosed docking devices include a circular or cylindrical portion that can, for example, allow a prosthetic heart valve comprising a circular or cylindrical valve frame to be expanded or otherwise implanted in a native position having a native circular cross-sectional profile and / or implanted in a native position 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 tighten or pull the native valve (e.g., mitral valve, tricuspid valve, etc.) anatomy radially inward. In this way, one of the main causes of valve regurgitation (e.g., functional mitral regurgitation), particularly enlargement of the heart (e.g., enlargement of the left ventricle, etc.) and / or enlargement of the valve annulus, and subsequent stretching of the annulus of a native valve (e.g., mitral valve, etc.), can be at least partially compensated or counteracted. Some examples of anchoring or docking devices also include features that are, for example, shaped and / or modified to better maintain the position or shape of the docking device during and / or after expansion of the prosthetic valve therein. By providing such an anchoring or docking device, a replacement valve can be more securely implanted and retained at various valve annuli, including at the mitral valve annulus that does not have a naturally circular cross-section.

[0088] In some cases, the docking device can include a paravalvular leak (PVL) guard (also referred to herein as a "guard member"). For example, the PVL guard can help reduce regurgitation and / or promote tissue ingrowth between native tissue and the docking device.

[0089] In some examples, the PVL shield can be movable between a delivery configuration and a deployed configuration. When the PVL shield is in the delivery configuration, the outer edge of the PVL shield can extend along and adjacent to the coil. When the PVL shield is in the deployed configuration, the outer edge of the PVL shield can form a spiral shape that rotates about the central longitudinal axis of the coil, and at least a section of the outer edge of the PVL shield can extend radially away from the coil.

[0090] In some examples, a PVL shield can cover or surround a portion of the coil of the docking device. As described more fully below, such a PVL shield can be movable from a radially compressed (and axially elongated) state to a radially expanded (and axially shortened) state, and a proximal portion of the PVL shield can be axially movable relative to the coil.

[0091] Also disclosed herein are exemplary methods of attaching a PVL guard to a docking device and exemplary methods of limiting axial movement of a PVL guard.

[0092] Exemplary Docking Devices

[0093] Figures 1A-1G A docking device 100 according to one example is shown. The docking device 100 can be implanted, for example, within a native valve annulus (see, for example, Figure 15 ).like Figures 3A-3B and Figure 26 As depicted, the docking device can be configured to receive and secure a prosthetic valve within the docking device, thereby securing the prosthetic valve at the native annulus.

[0094] refer to Figures 1A-1G , the docking device 100 can include a coil 102 and a protective member 104 covering at least a portion of the coil 102. In some examples, the coil 102 can include a shape memory material (e.g., nickel titanium alloy or "nitinol") such that the docking device 100 (and coil 102) can move from a substantially straight configuration (also referred to as a "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 a "deployed configuration") after removal from the delivery sheath. Figures 1A-1B shown).

[0095] In some examples, when the guard member 104 is in the deployed configuration, the guard member 104 may extend circumferentially from 180 to 400 degrees, or 210 to 330 degrees, or 250 to 290 degrees, or 260 to 280 degrees relative to the central longitudinal axis 101 of the docking device 100. In one specific example, when the guard member 104 is in the deployed configuration, the guard member 104 may extend circumferentially from 270 degrees relative to the central longitudinal axis 101. In other words, in some examples, the guard member 104 may extend circumferentially from approximately half a rotation around the central longitudinal axis 101 (e.g., 180 degrees) to more than a full rotation around the central longitudinal axis 101 (e.g., 400 degrees) in other examples, including various ranges therebetween. As used herein, ranges (e.g., 180-400 degrees, 180 to 400 degrees, and between 180 and 400 degrees) include the endpoints of the range (e.g., 180 and 400 degrees).

[0096] In some examples, the docking device 100 may further include a retaining element 114 that surrounds at least a portion of the coil 102 and is at least partially covered by the protective member 104. In some cases, the retaining element 114 may include a braided material. In addition, the retaining element 114 may provide a surface area that promotes or facilitates tissue ingrowth and / or adhesion, and / or reduces trauma to native tissue. For example, in some cases, the retaining element 114 may have a textured outer surface configured to promote tissue ingrowth. In some cases, the retaining element 114 may be impregnated with growth factors to stimulate or facilitate tissue ingrowth.

[0097] In one example, if Figures 1A-1B 3A-3B , at least a proximal portion of the retaining element 114 can extend beyond the proximal end of the guard member 104. In another example, the retaining element 114 can be completely covered by the guard member 104.

[0098] 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 inner diameter of the proximal end 105 of the guard member 104 can be substantially the same as the outer diameter of the retaining element 114. Thus, 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 axial movement of the proximal end 105 of the guard member 104 relative to the coil 102 can be hindered by the friction force exerted by the retaining element 114.

[0099] The coil 102 has a proximal end 102p and a distal end 102d (which also define the proximal and distal ends of the docking device 100, respectively). When arranged within a delivery sheath (e.g., during delivery of the docking device to a 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., without any coiled or looped portions, but can flex or bend) so as to maintain a small radial profile while moving through the patient's vasculature. After being removed from the delivery sheath and deployed at the implantation site, the coil 102 can be moved from the delivery configuration to the helical deployment configuration and wrapped around native tissue adjacent to the implantation site. For example, when the docking device is implanted at the site of a native valve, the coil 102 can be configured to surround the native leaflets of the native valve (and the chordae tendineae connecting the native leaflets to the adjacent papillary muscles, if present), as further described below.

[0100] The docking device 100 can be releasably coupled to a delivery device. For example, in some examples, the docking device 100 can be coupled to the delivery device via a release suture (e.g., as further described below), which can be configured to be tied to the docking device 100 and cut for removal. In one example, the release suture can be tied to the docking device 100 via an eyelet or eyelet 103 positioned adjacent the proximal end 102p of the coil. In another example, the release suture can be tied around a circumferential recess positioned adjacent the proximal end 102p of the coil 102.

[0101] In some examples, the docking device 100 in the deployed configuration can be configured to fit at the mitral valve location. In other examples, the docking device can also be shaped and / or adapted for implantation at other native valve locations, such as at the tricuspid valve. As described herein, the geometry of the docking device 100 can be configured to engage native anatomical structures, which can, for example, provide increased stability and reduction in relative motion between the docking device 100, a prosthetic valve docked therein, and / or the native anatomical structures. Reducing such relative motion can, among other things, prevent material degradation of components of the docking device 100 and / or the prosthetic valve docked therein and / or prevent damage or trauma to native tissue.

[0102] like Figures 1A-1B As shown, 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") around 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 have a diameter greater 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 have a diameter greater than the diameter of the central region 108 (in one or more configurations).

[0103] In some examples, the central region 108 may include a plurality of 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. Figure 1AIn the example shown, there is only one intermediate turn 108m between the proximal turn 108p and the distal turn 108d. In other examples, there is more than one intermediate turn 108m between the proximal turn 108p and the distal turn 108d. Some of the spiral turns in the central region 108 may be full turns (i.e., a 360-degree rotation). In some examples, the proximal turn 108p and / or the distal turn 108d may be partial turns (e.g., a rotation less than 360 degrees, such as 180 degrees, 270 degrees, etc.).

[0104] The size of the docking device 100 can generally be selected based on the size of the desired prosthetic valve to be implanted in the patient. In some examples, the central region 108 can be configured to hold a radially expandable prosthetic valve (e.g., Figures 3A-3B (as shown and further described 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 when the prosthetic valve is radially expanded, so that 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."

[0105] Stabilizing turns 110 can be configured to help stabilize docking device 100 in a desired position. For example, the radial dimension of stabilizing turns 110 can be significantly larger than the radial dimension of the coil in central region 108, such that stabilizing turns 110 can flare or extend outward sufficiently to abut or push against the wall of the circulatory system, thereby improving the ability of docking device 100 to remain in its desired position prior to implantation of a prosthetic valve. In some examples, for better stability, the diameter of stabilizing turns 110 is desirably larger than the native annulus, native valve plane, and / or native chamber. In some examples, stabilizing turns 110 can be full turns (i.e., rotated approximately 360 degrees). In some examples, stabilizing turns 110 can be partial turns (e.g., rotated between approximately 180 degrees and approximately 270 degrees).

[0106] In one specific example, when the docking device 100 is implanted at the native mitral valve location, the functional turns in the central region 108 can be positioned substantially in the left ventricle, while the stabilizing turns 110 can be positioned substantially in the left atrium. The stabilizing turns 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 in the left atrium or complete contact with the left atrial wall. In some examples, the contact points between the docking device 100 and the left atrial wall can form a plane that is substantially parallel to the plane of the native mitral valve.

[0107] In some examples, the stabilizing turns 110 can have an atrial portion 110a connected to the proximal turns 108p of the central region 108, a stabilizing portion 110c adjacent the proximal end 102p of the coil 102, and a rising portion 110b 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 spiral turns in the central region 108, while the rising portion 110b can be oriented at an angle relative to the atrial portion 110a and the stabilizing portion 110c. For example, in some examples, the rising portion 110b and the stabilizing portion 110c can form an angle of approximately 45 degrees to approximately 90 degrees (inclusive). In some examples, the stabilizing portion 110c can define a plane that is substantially parallel to the plane defined by the atrial portion 110a. The boundary 107 (defined by Figure 1A 18-19 and 19. The dotted line marking in FIG. 18-19 can be identified as the location where the ascending portion 110b intersects the plane defined by the stabilizing portion 110c. The curvature of the stabilizing turns 110 can be configured such that when the docking device 100 is fully expanded, the atrial portion 110a and the stabilizing portion 110c are arranged on generally opposite sides. When the docking device 100 is implanted in the native mitral valve position, the atrial portion 110a can be configured to abut the posterior wall of the left atrium, while the stabilizing portion 110c can be configured to flare outward and press against the anterior wall of the left atrium (see, e.g., FIG. 18-19 and 19). Figure 26 ).

[0108] As described above, the radial dimensions of the leading turns 106 can be larger than the helical turns in the central region 108. As described herein, the leading turns 106 can help to more easily guide the coil 102 around and / or through the chordae tendineae and / or fully around all of the native leaflets of a native valve (e.g., a native mitral valve, tricuspid valve, etc.). For example, once the leading turns 106 are navigated around the desired native anatomical structure, the remaining coils of the docking device 100 (e.g., the functional turns) can also be guided around the same features. In some examples, the leading turns 106 can be a full turn (i.e., a rotation of approximately 360 degrees). In some examples, the leading turns 106 can be a partial turn (e.g., a rotation between approximately 180 degrees and approximately 270 degrees). As described below with reference to Figure 24 As further described, when the prosthetic valve is radially expanded within the central region 108 of the coil, the functional turns in the central region 108 can be further radially expanded. Thus, the leading turns 106 can be pulled in the proximal direction and become part of the functional turns in the central region 108.

[0109] In some examples, at least a portion of the coil 102 may be surrounded by the first cover 112. Figures 1C-1FAs shown, the first covering 112 can have a tubular shape and, therefore, can also be referred to as a “tubular member.” In some examples, the tubular member 112 can cover the entire length of the coil 102. In some examples, the tubular member 112 only covers a selected portion(s) of the coil 102.

[0110] In some examples, the tubular member 112 can be coated on the coil 102 and / or bonded to the coil 102. In some examples, the tubular member 112 can be a padded-type layer that protects the coil's cushioning. The tubular member 112 can be constructed of various natural and / or synthetic materials. In a specific example, the tubular member 112 can include expanded polytetrafluoroethylene (ePTFE). In some examples, the tubular member 112 is configured to be fixedly attached to the coil 102 (e.g., by textured surface resistance, sutures, glue, thermal bonding, or any other means) so that the relative axial movement between the tubular member 112 and the coil 102 is limited or inhibited.

[0111] In some examples, such as Figures 1C-1D As shown, at least a portion of tubular member 112 can be surrounded by retaining element 114. In some examples, 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.

[0112] In some examples, the distal portion of the retaining element 114 can extend axially beyond the distal end of the guard member 104 (i.e., be positioned distally thereof), while the proximal portion of the retaining element 114 can extend axially beyond the proximal end 105 of the guard member 104 (i.e., be positioned proximal thereof) to facilitate retention and tissue ingrowth of the prosthetic valve. In one example, the distal end of the retaining element 114 can be adjacent to the leading turn 106 (e.g., near the Figure 1A In another example, the distal end of the retaining element 114 can be disposed at or adjacent to the distal end of the coil 102. In one example, the proximal end of the retaining element 114 can be disposed at or adjacent to the rising portion 110b of the coil 102. In one example, as Figures 1E-1F As shown, at least a portion of the tubular member 112 may not be surrounded by the retaining element 114 .

[0113] In some examples, the docking device 100 may have one or more placement markings. For example, Figures 1A-1BA proximal placement marker 121p and a distal placement marker 121d are shown, wherein the proximal placement marker 121p is positioned proximally relative to the distal placement marker 121d. Both the proximal and distal placement markers 121p, 121d can have predefined positions relative to the coil 102. As shown, both the proximal and distal placement markers 121p, 121d can be arranged distally of the rising portion 110b of the coil 102, for example, at the atrial portion 110a. In addition, the proximal end portion of the retaining element 114 can extend to the rising portion 110b and / or be positioned at the rising portion 110b.

[0114] In some examples, the proximal and distal placement markers 121p, 121d can each comprise a radiopaque material, such that these placement markers are visible, for example, under fluoroscopy during the implantation procedure. As further described below, the placement markers 121p, 121d can be used to mark the proximal and distal boundaries of a section 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.

[0115] In some examples, the placement markers 121p, 121d can be arranged on the tubular member 112 and covered by the retaining element 114. In some examples, the placement markers 121p, 121d can be arranged on the atrial portion 110a of the coil 102 and covered by the tubular member 112. In a specific example, the placement markers 121p, 121d can be arranged directly on the retaining element 114. In another optional example, the placement markers 121p, 121d can be arranged on different layers relative to each other. For example, one of the placement markers (e.g., 121p) can be arranged outside the tubular member 112 and covered by the retaining element 114, while the other placement marker (e.g., 121d) can be arranged directly on the coil 102 and covered by the tubular member 112.

[0116] In some examples, the axial length of the segment of coil 102 between the proximal placement marker 121p and the distal placement marker 121d can be between about 2 mm and about 7 mm, or between about 3 mm and about 5 mm. In one specific example, the axial length of the segment of coil between the proximal placement marker 121p and the distal placement marker 121d is about 4 mm.

[0117] In some examples, the axial distance between the proximal placement marker 121p and the distal end of the ascending portion 110b is between about 10 mm and about 30 mm, or between about 15 mm and about 25 mm. In one specific example, the axial distance between the proximal placement marker 121p and the distal end of the ascending portion 110b is about 20 mm.

[0118] although Figures 1A-1BTwo placement marks 121p and 121d are shown in the figure, but it should be understood that the number of placement marks can be more than two or less than two. For example, in one example, the docking device 100 can have only one placement mark (e.g., 121p). In another example, one or more additional placement marks can be placed between the proximal and distal placement marks 121p, 121d. As described above, when the docking device 100 is deployed, the proximal end 105 of the protective member can be positioned between the proximal and distal placement marks 121p, 121d. Therefore, these additional placement marks can act as scales to indicate the precise position of the proximal end 105 of the protective member 104 relative to the coil 102.

[0119] As described herein, the protective member 104 can constitute a portion of a cover assembly 120 for the docking device 100. In some examples, the cover assembly 120 can also include a tubular member 112. In some examples, the cover assembly 120 can also include a retaining element 114.

[0120] In some examples, such as Figures 1A-1B As shown, when the docking device 100 is in the deployed configuration, the protective member 104 can be configured to cover a portion of the stabilizing turns 110 (e.g., the atrial portion 110a) of the coil 102. In some examples, the protective 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 some examples, the protective member 104 can extend over the entire coil 102.

[0121] As described herein, the protective member 104 can be radially expandable to help prevent and / or reduce paravalvular leakage. Specifically, the protective member 104 can be configured to expand radially so that an improved seal is formed at a position closer to and / or against a prosthetic valve deployed within the docking device 100. In some examples, the protective member 104 can be configured to prevent and / or inhibit leakage at a location where the docking device 100 spans between the leaflets of a native valve (e.g., at the commissures of the native leaflets). For example, without the protective member 104, the docking device 100 can push the native leaflets apart at their intersection and allow leakage to occur at that point (e.g., along the docking device or to the side thereof). However, the protective member 104 can be configured to expand to cover and / or fill any opening at that point and inhibit leakage along the docking device 100.

[0122] In another example, when the docking device 100 is deployed at the native atrioventricular valve, the protective member 104 primarily covers a portion of the stabilizing turn 110 and / or a portion of the central region 108. In one example, the protective member 104 may primarily cover the atrial portion 110a of the stabilizing turn 110 that is distal to the ascending portion 110b. Thus, when the docking device 100 is in the deployed configuration, the protective member 104 does not extend to the ascending portion 110b (or at least the protective member 104 may terminate before the anterolateral commissure 419 of the native valve, see, for example, Figures 18-19). In some cases, the protective member 104 may extend over the ascending portion 110b. This may cause the protective member 104 to kink, which (in some cases) may reduce the performance and / or durability of the protective member. Thus, among other things, the retaining member 104 can improve the functionality and / or lifespan of the protective member 114 by preventing the protective member 104 from extending into the ascending portion 110b of the coil 102.

[0123] In another alternative example, the shield member 104 may not only cover the atrial portion 110a but also extend over the ascending portion 110b of the stabilizing turn 110. This may occur, for example, when the docking device is implanted in other anatomical locations and / or when the shield member 104 is reinforced to reduce the risk of wire breakage.

[0124] In various examples, the guard member 104 can help cover the atrial side of the atrioventricular valve, thereby preventing and / or inhibiting blood from leaking around the natural leaflets, commissures, and / or the outside of the prosthetic valve (rather than through the prosthetic valve) by blocking blood in the atria from flowing in the atrial-to-ventricular direction (i.e., antegrade blood flow). Positioning the guard member 104 on the atrial side of the valve can additionally or alternatively help reduce blood in the ventricles from flowing in the ventricle-to-atrial direction (i.e., retrograde blood flow).

[0125] In some examples, the guard member 104 can be positioned on the ventricular side of the atrioventricular valve to prevent and / or inhibit blood leakage through the native leaflets, commissures, and / or around the outside of the prosthetic valve by blocking blood in the ventricles from flowing in a ventricle-to-atrial direction (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 atria from flowing in an atrial-to-ventricular direction (i.e., antegrade blood flow) (rather than through the prosthetic valve).

[0126] The protective member 104 can include an expandable member 116 and a cover member 118 (also referred to as a "secondary cover" or "outer cover") surrounding an outer surface of the expandable member 116. In some examples, the expandable member 116 surrounds at least a portion of the tubular member 112. In some examples, the tubular member 112 can extend (completely or partially) through the expandable member 116.

[0127] The expandable member 116 can extend radially outward from the coil 102 (and the tubular member 112) and can move between a radially compressed (and axially extended) state and a radially expanded (and axially shortened) state. That is, the expandable member 116 can shorten axially when moving from the radially compressed state to the radially extended state, and can lengthen axially when moving from the radially expanded state to the radially compressed state.

[0128] In some examples, the expandable member 116 may include a braided structure, such as a braided wire mesh or grid. In some examples, the expandable member 116 may include a shape memory material that is shaped and / or preconfigured to expand to a specific shape and / or size when unconstrained (e.g., when deployed at a natural valve position). For example, the expandable member 116 may have a braided structure comprising a shape memory alloy (e.g., Nitinol) with superelastic properties. In some examples, the expandable member 116 may have a braided structure comprising 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 some examples, the expandable member 116 may include a metal material that does not have shape memory properties. Examples of such metal materials include cobalt-chromium, stainless steel, etc. In a specific example, the expandable member 116 may include nickel-free austenitic stainless steel, where nickel can be completely replaced by nitrogen. In another specific example, the expandable member 116 may include a cobalt-chromium or cobalt-nickel-chromium-molybdenum alloy with a significantly low titanium density. The quantity of the wire (or fiber, strand etc.) that can select to form braided structure, to realize the desired elasticity and / or strength of expandable member 116.In certain examples, the quantity of the wire for braiding expansion member 116 can be between 16 to 128 (for example, 32 wires, 48 wires, 64 wires, 96 wires etc.).In certain examples, the scope of braiding density is 20 wefts / inch (PPI) to 70PPI, or 25PPI to 65PPI.In a specific example, braiding density is about 36PPI.In another specific example, braiding density is about 40PPI.In certain examples, the diameter range of wire can be about 0.002 inch to about 0.004 inch.In a specific example, the diameter of wire can be about 0.003 inch. In another example, the expandable member 116 may be a combination of a braided wire (which may include a shape memory material or a non-shape memory material) and a polymer material and / or a textile (e.g., polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), thermoplastic polyurethane (TPU), etc.). For example, the expandable member 116 may include a braided wire frame embedded in a polymer material.

[0129] In some examples, expandable member 116 can include a braided metal wire frame coated with an elastomer (e.g., ePTFE, TPU, etc.) that is elastically deformable when the braided wire frame is expanded and / or compressed. In some examples, expandable member 116 can include a braid and / or fabric that includes one or more metal wires and one or more polymer fibers. In other words, the metal wires and polymer fibers can be interwoven to define a braided structure. In some cases, the polymer fibers can have a diameter that is the same or approximately the same as the metal wires. In other cases, the polymer fibers can have a diameter smaller than the metal wires (e.g., microfibers), or vice versa.

[0130] In yet another example, the expandable member 116 can include a polymer material without a braided wire frame, such as a thermoplastic material (eg, PET, polyetheretherketone (PEEK), thermoplastic polyurethane (TPU), etc.).

[0131] In some examples, the expandable member 116 can include a foam structure. For example, the expandable member can include expandable memory foam that can expand to a specific shape or a specific preset shape after the crimping pressure is removed (e.g., the docking device 100 is removed from the delivery sheath) prior to delivery of the docking device.

[0132] As described herein, the covering member 118 can be configured to be resilient so that when the expandable member 116 moves from a radially compressed (and axially extended) state to a radially expanded (and axially shortened) state, the covering member 118 can also radially expand and axially shorten along with the expandable member 116. In other words, the guard member 104 as a whole can move from a radially compressed (and axially extended) state to a radially expanded (and axially shortened) state. As described herein, the radially expanded (and axially shortened) state is also referred to as a "relaxed state," while the radially compressed (and axially extended) state is also referred to as a "collapsed state."

[0133] In some examples, the covering member 118 can be configured to be atraumatic to native tissue and / or to 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-α), transforming growth factor beta (TGF-β), basic fibroblast growth factor (bFGF), vascular epithelial growth factor (VEGF), and combinations thereof. The covering member 118 can be constructed of any suitable material, including foam, cloth, fabric, and / or polymer that is flexible to allow compression and expansion of the covering member 118. In one example, the covering member 118 can include a fabric layer constructed of a thermoplastic polymer material, such as polyethylene terephthalate (PET).

[0134] As described herein, the distal portion 104d of the guard member 104 (including the distal portion of the expandable member 116 and the distal portion of the cover member 118) can be fixedly coupled to the coil 102 (e.g., by suturing, gluing, etc.), and the proximal portion 104p of the guard member 104 (including the proximal portion of the expandable member 116 and the proximal portion of the cover member 118) can be axially movable relative to the coil 102. Furthermore, the proximal portion of the expandable member 116 can be fixedly coupled to the proximal portion of the cover member 118 (e.g., by suturing, gluing, heat compression, laser fusion, etc.).

[0135] Alternatively, the proximal portion 104 p of the guard member 104 may be fixedly coupled to the coil 102 , while the distal portion 104 d of the guard member 104 may be axially movable relative to the coil 102 .

[0136] When the docking device 100 is held in a substantially straight configuration within the delivery sheath, the expandable member 116 can be radially compressed by the delivery sheath and maintained in a radially compressed (and axially extended) state. The radially compressed (and axially extended) expandable member 116 can contact the retaining element 114 (see, e.g., Figure 1C ) or tubular member 112 (see, e.g. Figure 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.

[0137] After the docking device 100 is removed from the delivery sheath and moved from the delivery configuration to the deployed configuration, the protective member 104 may also be moved from the delivery configuration to the deployed configuration. In some examples, the docking piece sleeve (which will be described more fully below) can be configured to cover the docking device 100 and retain it within the delivery sheath while navigating the delivery sheath through the patient's native valve. For example, the docking piece sleeve can also help guide the docking device around the native leaflets and cord. Retraction of the docking piece sleeve relative to the docking device 100 can expose the protective member 104 and move it from the delivery configuration to the deployed configuration. Specifically, without being constrained by the delivery sheath and docking piece sleeve, the expandable member 116 can be radially expanded (and axially shortened) so that a gap can be formed between the retaining element 114 and the expandable member 116 (see, e.g., Figure 1C ) and / or between the tubular member 112 and the expandable member 116 (see, e.g., Figure 1E ) creates a gap or cavity 111. 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 (since there is no gap 111, only the retaining element 114 and / or tubular member 112 separate the coil 102 from the expandable member 116, as shown in FIG. Figure 1D and Figure 1F When the guard member 104 is in the deployed configuration, the outer edge of the guard member 104 may form a spiral shape that rotates about the central longitudinal axis 101 (see, e.g., Figures 1A-1B and 3A-3B), and at least a segment of the outer edge of the guard member may extend radially away from the coil 102 (eg, due to creation of a gap 111 between the expandable member 116 and the retaining element 114 or tubular member 112).

[0138] Because the distal portion 104 d of the guard member 104 is fixedly coupled to the coil 102 and the proximal portion 104 p of the guard member 104 is axially movable relative to the coil 102, when the expandable member 116 moves from the radially compressed state to the radially expanded state, the proximal portion 104 p of the guard member 104 can slide axially over the tubular member 112 and toward the distal end 102 d of the coil 102. Thus, the proximal portion 104 p of the guard member 104 can be disposed closer to the proximal end 102 p of the coil 102 when the expandable member 116 is in the radially compressed state than when the expandable member 116 is in the radially expanded state.

[0139] In some examples, when expandable member 116 is in the radially expanded state, covering member 118 can be configured to engage a prosthetic valve deployed within docking device 100 to form a seal and reduce paravalvular leakage between the prosthetic valve and docking device 100. Covering member 118 can also be configured to engage native tissue (e.g., a native annulus and / or native leaflets) to reduce PVL between the docking device and / or prosthetic valve and the native tissue.

[0140] In some examples, when the expandable member 116 is in the radially expanded state, the proximal portion 104p of the guard member 104 may have a shape similar to the following: Figures 1A-1B The tapered shape shown causes the diameter of the proximal portion 104p to gradually increase from the proximal end 105 of the guard member 104 to the distal main portion of the guard member 104. This can, for example, facilitate loading the docking device into a delivery sheath of a delivery device and / or retracting and / or repositioning the docking device into the delivery device during an implantation procedure. In addition, 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 portion 104p of the guard member 104 relative to the coil 102.

[0141] In some examples, the docking device 100 can include at least one radiopaque marker that is configured to provide a visual indication under fluoroscopy regarding the position of the docking device 100 relative to its surrounding anatomy, and / or the amount of radial expansion of the docking device 100 (e.g., when a prosthetic valve is subsequently deployed in the docking device 100). For example, one or more radiopaque markers can be placed on the coil 102. In one specific example, the radiopaque marker (which can be larger than the placement markers 121p, 121d) can be arranged at the central region 108 of the coil. In another example, one or more radiopaque markers can be placed on the tubular member 112, the expandable member 116, and / or the covering member 118. As described 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. The radiopaque marker(s) used to provide a visual indication of the position and / or amount of radial expansion of the docking device 100 may be in addition to the placement markers (eg, 121 p , 121 d ) described above.

[0142] Figure 1GSome example dimensions of the docking device 100 are schematically depicted when the coil 102 is in a substantially straight configuration (e.g., compared to the spiral configuration depicted in FIG. 1 ). A protective member 104 surrounding the coil 102 is shown in both a collapsed state (shown as a solid outline) and a relaxed state (shown as a dashed outline). In certain examples, the maximum outer diameter (D1) of the protective member 104 in the relaxed state ranges from approximately 4 mm to approximately 8 mm (e.g., approximately 6 mm in one specific example), while the maximum outer diameter (D2) of the protective member 104 in the collapsed state ranges from approximately 1 mm to approximately 3 mm (e.g., approximately 2 mm in one specific example). The expansion of the protective member 104 from the collapsed state to the relaxed state can be characterized by an expansion ratio, defined as D1 / D2. In certain examples, the expansion ratio can range from approximately 1.5 to approximately 8, or from approximately 2 to approximately 6, or from approximately 2.5 to approximately 4. In one specific example, the expansion ratio is approximately 3.

[0143] The distal portion 104d of the guard member 104 can be fixedly attached to the coil 102, for example, by sutures, adhesives, or other means. The portion of the guard member 104 that is fixedly attached to the coil 102 can 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.

[0144] Back again Figure 1G In some examples, when the protective member 104 is in a relaxed state, its movable portion (i.e., the portion extending from the proximal end 105 of the protective member 104 to the proximal end 127 of the distal attachment area 123) can have an axial length (A2) ranging from about 30 mm to about 100 mm. In one specific example, A2 is about 51 mm. In another specific example, A2 is about 81 mm. When the protective member 104 is in a crimped state, its movable portion can have an axial length (A1) ranging from about 50 mm to about 120 mm. In one specific example, A1 is about 72 mm. In another specific example, A1 is between 105 mm and 106.5 mm. The elongation of the protective member 104 from the relaxed state to the crimped state can be characterized by an elongation ratio defined as A1 / A2. In some examples, the elongation 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 example, the elongation ratio is about 1.47. In another specific example, the elongation ratio is about 1.31.

[0145] In certain examples, the axial length (A3) measured from the proximal end 102p of the coil 102 to the distal end 129 of the distal attachment area 123 may range from about 130mm to about 200mm, or from about 140mm to about 190mm. In one specific example, A3 is between 133mm and 135mm (e.g., 134mm). In another specific example, A3 is between 178mm and 180mm (e.g., 179mm). In certain examples, when the protective member 104 is in the collapsed state, the axial length (A4) measured from the proximal end 102p of the coil 102 to the proximal end 105 of the protective member 104 may range from about 40mm to about 90mm, or from about 50mm to about 80mm. In certain examples, A4 is between 60mm and 70mm (e.g., 61mm).

[0146] Further details of various examples of docking devices and variations thereof, including coils, first coverings (or tubular members), second coverings (or covering members), expandable members, and other components of docking devices are described in PCT patent application publication number WO / 2020 / 247907, the entire contents of which are incorporated herein by reference.

[0147] Exemplary prosthetic valves

[0148] Figures 2A-2B A prosthetic valve 10 according to one example is shown. The prosthetic valve 10 may be adapted for implantation in a native valve annulus, such as a native mitral valve annulus, a native aortic valve annulus, a native pulmonary valve annulus, etc., with or without a docking device. The prosthetic valve 10 may include a frame 12, a valve structure 14, and a valve cover 16 (in Figure 2A The valve cover 16 is removed to show the frame structure).

[0149] The valve structure 14 may include three leaflets 40 (however, a greater or lesser number of leaflets may be used) that together form a leaflet structure, which may be arranged to collapse in a tricuspid arrangement. The leaflets 40 are configured to allow blood to flow from the inflow end 22 to the outflow end 24 of the prosthetic valve 10 and to prevent blood from flowing from the outflow end 24 to the inflow end 22 of the prosthetic valve 10. The leaflets 40 may be secured to each other on their adjacent sides to form commissures 26 of the leaflet structure. The lower edge of the valve structure 14 desirably has an undulating, curved, fan-shaped shape. By forming the leaflets 40 with such a fan-shaped geometry, the stresses on the leaflets 40 may be reduced, which in turn may improve the durability of the prosthetic valve 10. In addition, by virtue of the fan-shaped shape at the belly of each leaflet 40 (the central region of each leaflet), folds and corrugations (which may lead to early calcification of these areas) may be eliminated or at least minimized. The scalloped geometry may also reduce the amount of tissue material used to form the leaflet structure, thereby creating a smaller, more uniform crimp profile at the inflow end of the prosthetic valve 10. The leaflets 40 may be formed from pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various 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.

[0150] The frame 12 can be formed with a plurality of circumferentially spaced grooves, or commissure windows 20 (three in the illustrated example), which are suitable for mounting the commissures 26 of the valve structure 14 to the frame. The frame 12 can be made of various suitable plastic expansion materials (e.g., stainless steel, etc.) or self-expanding materials known in the art (e.g., Nitinol). When constructed of plastic expansion materials, the frame 12 (and therefore the prosthetic valve 10) can be curled to a radially compressed state on a delivery device and then expanded in the patient's body by an inflatable balloon or equivalent expansion mechanism. When constructed of self-expanding materials, the frame 12 (and therefore the prosthetic valve 10) can be curled to a radially compressed state and constrained in a compressed state by inserting a valve sheath or equivalent mechanism of the delivery device. Once in the body, the prosthetic valve 10 can be advanced from the delivery sheath, which allows the prosthetic valve 10 to expand to its functional size.

[0151] 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 alloy or nickel-cobalt-chromium alloy), polymers, or combinations thereof. In a specific example, the frame 12 can be made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N. TM (Trade name of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N TM / UNS R30035 contains (by weight) 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum. It has been found that using MP35N to form the frame 12 can provide structural benefits superior to stainless steel. Specifically, when using MP35N as the frame material, less material is required to achieve the same or better performance in terms of radial and compressive resistance, fatigue resistance, and corrosion resistance. In addition, 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 site in the body.

[0152] like Figure 2B As shown, the valve covering 16 can include an outer portion 18 that can cover the entire outer surface of the frame 12. In some examples, such as Figure 3A As shown, the valve covering 16 can also include an inner portion 28. The inner portion 28 can cover the entire inner surface of the frame 12, or alternatively, only a selected portion of the inner surface of the frame 12. In the depicted example, the inner portion 28 is formed by folding the valve cover 16 over the outflow end 24 of the frame 12. In some examples, a protective covering 36 comprising a highly wear-resistant material (e.g., ePTFE, etc.) can be placed over the folded portion of the valve covering 16 at the outflow end 24. In some examples, a similar protective covering 36 can be placed on the inflow end 22 of the frame. The valve covering 16 and the protective covering 36 can be attached to the frame 12 by a variety of means, such as by sutures 30.

[0153] As described herein, the valve covering 16 can be configured to prevent paravalvular leakage between the prosthetic valve 10 and the native valve, protect native anatomy, promote tissue ingrowth, or other purposes. For mitral valve replacement, due to the generally D-shape of the mitral valve and the relatively large annulus compared to the aortic valve, the valve covering 16 can act as a seal around the prosthetic valve 10 (e.g., when the prosthetic valve 10 is sized smaller than the annulus) and allow the native leaflets to smoothly coapt against the prosthetic valve 10.

[0154] In various examples, the valve covering 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 foam, cloth, fabric, one or more synthetic polymers (e.g., polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), etc.), organic tissue (e.g., bovine pericardium, porcine pericardium, equine pericardium, etc.), and / or an encapsulating material (e.g., an encapsulated hydrogel).

[0155] In some examples, the valve covering 16 can be made of a woven fabric or textile having a plurality of floated yarn segments 32 (e.g., protruding or puffed segments, also referred to hereinafter as "floats"). Details of exemplary covered valves having 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 entireties for all purposes). In some examples, the floated yarn segments 32 are separated by one or more horizontal bands 34. In some examples, the horizontal bands 34 can be constructed of a leno weave, which can increase the strength of the woven structure. In some examples of woven fabrics, the vertical fibers (e.g., extending along the longitudinal axis of the prosthetic valve 10) may include yarns or other fibers having a high level of expansion, such as textured weft yarns, while the horizontal fibers in the leno weave (e.g., extending circumferentially around the prosthetic valve 10) may include low-expansion yarns or fibers.

[0156] In some examples, the valve covering 16 can include a woven fabric that resembles a natural fabric when assembled and under tension (e.g., when stretched longitudinally on a compressed valve prior to delivery of the prosthetic valve 10). As the prosthetic valve 10 is deployed and expanded, the tension on the floats 32 is relaxed, allowing the floats 32 to expand. In some examples, the valve covering 16 can be heat set to allow the floats 32 to return to an enlarged, or puffed, space-filling form. In some examples, the number and size of the floats 32 can be optimized to provide a level of expansion to prevent paravalvular leakage across the plane of the mitral valve (e.g., with a higher level of expanded thickness) and / or a lower curl profile (e.g., for delivery of a prosthetic valve). In addition, the horizontal bands 34 can be optimized to allow the valve covering 16 to be attached to the frame 12 based on the specific size or position of the struts or other structural elements on the prosthetic valve 10.

[0157] Further details of the prosthetic valve 10 and its components are described in, for example, U.S. Patent Nos. 9,393,110 and 9,339,384, which are incorporated herein by reference. Other examples of valve coverings are described in PCT Patent Application Publication No. WO / 2020 / 247907.

[0158] As mentioned above and Figures 3A-3B As shown in , the prosthetic valve 10 can be radially expanded and securely anchored within the docking device 100 .

[0159] In some examples, and as follows, Figure 23-24As described, the coil 102 of the docking device 100 in the deployed configuration can move between a first radially expanded configuration before the prosthetic valve 10 is radially expanded within the coil 102 and a second radially expanded configuration after the prosthetic valve 10 is radially expanded within the coil 102. Figures 3A-3B In the example shown, coil 102 is in the second radially expanded configuration, as prosthetic valve 10 is shown in a radially expanded state.

[0160] As described herein, at least a portion of coil 102 (e.g., central region 108) can have a larger diameter in the second radially expanded configuration than in the first radially expanded configuration (i.e., central region 108 can be further radially expanded by radially expanding prosthetic valve 10). As coil 102 moves from the first radially expanded configuration to the second radially expanded configuration, the functional turns and leading turns 106 in central region 108 can rotate circumferentially (e.g., clockwise or counterclockwise when viewed from stabilizing turns 110) as the diameter of central region 108 increases. This circumferential rotation of the functional turns and leading turns 106 in central region 108, also referred to as "clocking," can cause a slight unwinding of the helical coil in central region 108. Typically, this unwinding can be less than one turn, or less than half a turn (i.e., 180 degrees). For example, this unwinding can be approximately 60 degrees, and in some cases can be as high as 90 degrees. Thus, the distance between the proximal end 102 p and the distal end 102 d of the coil 102 , as measured along the central longitudinal axis of the coil 102 , may be shortened.

[0161] exist Figures 3A-3B (and Figure 26 ), proximal end 105 of guard member 104 is shown positioned distal to proximal placement marker 121p. In other examples, after prosthetic valve 10 is radially expanded within coil 102, proximal end 105 of guard member 104 may be positioned proximal to proximal placement marker 121p (i.e., proximal placement marker 121p is covered by guard member 104), but remains distal to ascending portion 110b.

[0162] Exemplary Covering Assembly

[0163] As described above, the docking device 100 can have a cover assembly 120 that includes a tubular member 112 and a guard member 104, and in some cases, a retaining element 114. The guard member 104 can also 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 contract with the expandable member 116.

[0164] In one example, the covering assembly 120 can be assembled by fixedly attaching the distal portion 104d of the guard member 104 to the coil 102 (and the tubular member 112 surrounding the coil 102) while leaving the proximal portion 104p of the guard member 104 unattached to the coil 102 (and the tubular member 112 surrounding the coil 102). As a result, the proximal portion 104p is axially movable relative to the coil 102 and the tubular member 112. Thus, when the coil 102 is moved from the delivery configuration to the deployed configuration (e.g., during initial deployment of the docking device 100), the proximal portion 104p of the guard member 104 can slide distally over the coil 102 to cause the guard member 104 to contract axially (i.e., with a decrease in axial length) while simultaneously expanding radially (i.e., with an increase in diameter).

[0165] On the other hand, the retaining element 114 can limit the extent to which the proximal portion 104p can move distally 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). For example, if the proximal portion 104p of a fully expanded guard member 104 (i.e., expanded to its maximum diameter) can slide distally on the coil 102 to a first position in the absence of the retaining element 114, the presence of the retaining element 114 can cause the proximal portion 104p to slide distally on the coil 102 to a second position proximal to the first position. In other words, the retaining element 114 can prevent the guard member 104 from expanding to its maximum diameter and / or contracting to its shortest axial length.

[0166] Similarly, retaining element 114 can limit the extent of proximal movement of proximal portion 104p relative to coil 102 by applying a frictional force (e.g., frictional interaction between retaining element 114 and proximal end 105 of guard member 104). As described above and further below, when prosthetic valve 10 is radially expanded within coil 102, coil 102 of docking device 100 in the deployed configuration can be further radially expanded (e.g., moved from a first radially expanded configuration to a second radially expanded configuration), and the radial expansion of coil 102 can cause corresponding circumferential rotation of coil 102. The radially expanded prosthetic valve 10 can press against guard member 104, causing guard member 104 to be radially compressed and axially extended. Because distal portion 104d of guard member 104 is fixedly attached to coil 102 and proximal portion 104p of guard member 104 is not tethered to coil 102, proximal portion 104p of guard member 104 may have a tendency to move proximally relative to coil 102 when prosthetic valve 10 is radially expanded within coil 102. However, the presence of retaining element 114 may hinder proximal movement of proximal portion 104p of guard member 104 over coil 102. In a specific example, the presence of retaining element 114 may prevent proximal end 105 of guard member 104 from extending over ascending portion 110b of coil 102. As discussed above, this may, for example, improve the functionality and / or durability of guard member 104.

[0167] The guard member 104 can be coupled to the coil 102 and / or tubular member 112 by various means, such as adhesives, fasteners, welding, and / or other coupling means. For example, in some examples, coupling the cover member 118 to the expandable member 116 or attaching the distal end portion 104d of the guard member to the coil 102 and tubular member 112 can be achieved by using one or more sutures. However, there are several technical challenges associated with the use of sutures. First, when the expandable member 116 has a mesh wire frame made of a metal or metal alloy (e.g., nitinol), sewing sutures with a needle may scratch the surface of the metal or metal alloy and increase the risk of corrosion of the wire frame when exposed to body fluids, especially if the needle is also made of metal. Sewing sutures with non-metallic needles (e.g., plastic needles) has its own disadvantages, as non-metallic needles are generally less strong than metal needles, making it difficult to thread the sutures through the various layers of the cover assembly 120. Furthermore, even non-metallic needles can damage the surface of the metal or metal alloy of the wire frame. Secondly, routing of the sutures can be challenging because the sutures must not only ensure secure attachment between the components of the covering assembly 120, but also ensure that the radial profile of the protective member 104 is not significantly increased so that the docking device 100 can be retained in the delivery sheath of the delivery device for transcatheter implantation.

[0168] An example method of assembling the guard member 104 is described in U.S. Provisional Application No. 63 / 252,524, the entire contents of which are incorporated herein by reference. The method described therein (hereinafter also referred to as the "stitching method") overcomes the aforementioned challenges by forming multiple knots and wraps with suture at both the proximal portion 104p and the distal portion 104d of the guard member 104.

[0169] For example, in the stitching method, two separate processes can be used to prepare the expandable member 116 and the covering 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 the braided wire into a straight configuration. This straight braided wire can be reconfigured to produce a tapered proximal portion (such that the proximal portion 104p of the protective member 104 can have a tapered shape as shown in FIG. Figures 1A-1B ). This 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 reapplying heat to reshape the braided wire to produce a tapered end portion. To prepare the cover member 118, the same steps 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 the braided cover into a straight configuration. The straight braided cover is then transferred to the tapered mandrel, and heat is reapplied to shape the braided cover, thereby producing a tapered end portion that matches the tapered end portion of the expandable member 116. These two separate processes prepare the expandable member 116 and the cover member 118.

[0170] Another example method of assembling the protective member 104 is described in U.S. Provisional Application No. 63 / 253,995, the entire contents of which are incorporated herein by reference. The method described therein (hereinafter also referred to as the "fusion method") includes weaving a first layer on a mandrel, weaving a second layer on the first layer to form a multilayer structure, shaping the multilayer structure so that the multilayer structure conforms to the shape of the mandrel, and laser cutting the multilayer structure to form a proximal end and a distal end. The laser cutting can fuse the second layer to the first layer at the proximal end and the distal end.

[0171] Exemplary PVL guard with elastic member

[0172] In some examples, such as Figures 4A-4B As shown, the guard member 104 can also include a resilient member 122 coupled to the expandable member 116 and extending along the axial length of the expandable member 116. In the depicted example, the cover member 118 is removed from the expandable member 116, exposing the mesh wire frame of the expandable member 116.

[0173] As described herein, elastic member 122 can move between axial tension state and resting state, and elastic member 122 is biased to resting state.When expandable member 116 is in radial compression (and axial extension) state, for example, when docking device 100 is retained in delivery sheath (for example 204) and / or docking piece sleeve (for example, 222), elastic member 122 can be in axial tension state.When docking device is removed from delivery sheath and / or docking piece sleeve, elastic member 122 tends to return to its resting state, therefore can help expandable member 116 to move from radial compression (and axial extension) state to radial expansion (and axial shortening) state.When expandable member 116 is in radial expansion (and axial shortening) state, elastic member 122 can be in resting state.

[0174] In some examples, the elastic member 122 can include a polymer material, such as a thermoplastic material (eg, TPU, etc.).

[0175] In some examples, the elastic member 122 can extend from the proximal portion 116p of the expandable member 116 to the distal portion 116d of the expandable member 116. For example, the proximal end 122p of the elastic member 122 can be attached to the proximal portion 116p of the expandable member 116, and the distal end 122d of the elastic member 122 can be attached to the distal portion 116d of the expandable member 116. In some examples, the elastic member 122 can be an elastic strip that extends parallel to the central longitudinal axis 126 of the expandable member 116.

[0176] Similar to Figures 1A-1B 3A-3B , the distal portion 116 d of the expandable member 116 can be fixedly attached to a section of the coil 102, and the proximal portion 116 p of the expandable member 116 can be axially movable relative to the coil 102. Alternatively, the proximal portion 116 p of the expandable member 116 can be fixedly attached to a section of the coil 102, and the distal portion 116 d of the expandable member 116 can be axially movable relative to the coil 102.

[0177] In some examples, the elastic member 122 can be sewn 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 some examples, the length of the suture 124 can be greater than or equal to the length of the elastic member 122 in its axially stretched state, such that the suture 124 has slack when the elastic member 122 is in its resting state and, therefore, will not hinder the movement of the expandable member 116 to the radially compressed (and axially extended) state.

[0178] In one example, if Figures 4A-4BAs shown, the elastic member 122 can be connected to the expandable member 116 via a suture 124 that runs in a helical path.

[0179] As described herein, it should be understood that the resilient member 122 can be attached to the expandable member 116 in many different ways, and the position of the resilient member 122 relative to the expandable member 116 can also be changed. For example, in some cases, the resilient member 122 can extend along the outer surface of the expandable member 116. In one specific example, the resilient member 122 can form a sheath around the expandable member 116. In some cases, the resilient member 122 can extend through the inner lumen of the expandable member 116. In one specific example, the resilient member 122 can extend along the inner surface of the expandable member 116. In some cases, the resilient member 122 can be woven into and out of the expandable member 116 (e.g., Figure 4B The spiral suture 124 depicted in FIG may be replaced with an elastic member 122. For example, the elastic member 122 may be an elastic strip (e.g., TPU) woven into and out of the expandable member 116 and attached to both the proximal portion 116p and the distal portion 116d without requiring stitching along the length of the elastic band (i.e., no stitching is required between 116p and 116d).

[0180] If the guard member 104 does not have the resilient member 122, the inherent biasing force of the expandable member 116 to move from the radially compressed (and axially elongated) state to the radially expanded (and axially shortened) state may be limited. Therefore, after the docking device 100 is deployed, the guard member 104 (without the resilient member 122) may accidentally extend over the raised portion 110b of the coil 102 (see, e.g., FIG. Figure 18B As described below, in this case, a procedure may be required to reposition the proximal end 105 of the guard member 104 until the proximal end 105 is distal to the rising portion 110b (eg, distal to the proximal placement marker 121p).

[0181] As described herein, by coupling the elastic member 122 to the expandable member 116, the elastic force of the elastic member 122 can help the expandable member 116 move from a radially compressed (and axially extended) state to a radially expanded (and axially shortened) state. Thus, after deployment of the docking device 100, the proximal end 105 of the guard member 104 can be more easily retracted to a position distal to the ascending portion 110b (e.g., under the influence of the greater force generated by both the expandable member 116 and the elastic member 122). Thus, the aforementioned repositioning procedure can be avoided.

[0182] In some examples, such as Figures 4C-4DAs shown, the resilient member can be configured as a coil spring 132 (eg, a compression spring) coupled to the expandable member 116. In some examples, the coil spring 132 can include a shape memory material, such as Nitinol or the like.

[0183] The coil spring 132 can stretch and rebound together with the expandable member 116. For example, when the expandable member 116 is in a radially compressed state (see, e.g., Figure 4D ), the coil spring 132 can be axially stretched to a first length and when the expandable member 116 is in a radially expanded state (see, e.g., Figure 4C ), the coil spring 132 can return to the second length. The second length is shorter than the first length, and the coil spring 132 is biased toward the second length. Therefore, similar to the elastic member 122, the coil spring 132 can help the expandable member 116 move from the radially compressed state to the radially expanded state.

[0184] As shown, the coil 102 of the docking device can extend through the coil spring 132. In some examples, the proximal end 132p of the coil spring 132 can be connected to the proximal portion 116p of the expandable member 116, and the distal end 132d of the coil spring 132 can be connected to the distal portion 116d of the expandable member 116. In some examples, the proximal end 132p of the coil spring 132 can be configured to be less than a full turn (e.g., half a turn, a quarter turn, etc.) to facilitate axial stretching of the coil spring 132. In some examples, the proximal end 132p of the coil spring 132 can be configured to be a full turn or more than one full turn (e.g., 1.5 turns) and have a reduced outer diameter (relative to the main portion of the coil spring 132) to fit within a delivery sheath (e.g., 204) and / or a docking sleeve (e.g., 222) during a delivery procedure. The proximal end 132 p and / or the distal end 132 d of the coil spring 132 may have corresponding hooks connected to the mesh wire at the proximal end portion 116 p and / or the distal end portion 116 d of the expandable member 116 .

[0185] In some examples, such as Figures 4C-4D As shown, the coil spring 132 can be disposed within the lumen of the expandable member 116. In other examples, the coil spring 132 can be disposed on an outer surface of the expandable member 116.

[0186] In certain examples, the pitch of coil spring 132 can be greater than the pitch of the braided wire mesh of expandable member 116. In certain examples, the pitch of coil spring 132 can be between 3mm and 9mm or in the scope of (including end value) between 5mm and 7mm. In a specific example, the pitch of coil spring 132 can be about 6mm. The wire forming coil spring 132 can have a diameter larger than the wire forming the braided wire mesh of expandable member 116. In certain examples, the wire forming coil spring 132 can have a diameter ranging from 0.15mm to 0.22mm (including end value).

[0187] The coil spring 132 can be configured to help radially expand the expandable member 116 to an extent that would not be possible with the expandable member 116 alone (e.g., in the absence of the coil spring 132). For example, without the coil spring 132, the expandable member 116 can 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 can be able to expand to a second, larger radially expanded state (e.g., due to the 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 greater than the diameter of the expandable member 116 in the radially compressed state, and is smaller than the diameter of the expandable member 116 in the second radially expanded state.

[0188] Similar to the resilient member 122, the coil spring 132 can help move the proximal end 105 of the protective member 104 to a more distal position relative to the rising portion 110b after the docking device 100 is initially deployed, thereby, in at least some cases, reducing or eliminating the need to reposition the proximal end of the protective member 104 using the docking member sleeve, as mentioned above and described in more detail below.

[0189] Thus, the elastic members 122 and / or coil springs 132 can pre-bunch the guard member 104 into a more axially compact configuration (i.e., having a larger diameter than a guard member without the elastic members or coil springs) after initial deployment of the docking device. In addition to reducing repositioning procedures, such pre-bunching can also help maintain a relatively large diameter of the guard member 104 during and / or after valve deployment to reduce paravalvular leakage.

[0190] For example, when the prosthetic valve (e.g., 10) is radially expanded within the central region (e.g., 108) of the docking device 100, the coils 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 cause the functional turns of the docking device 100 to slightly unwind. As a result, the distal end of the guard member 104 can move slightly to a more distal position, thereby causing the guard member 104 to stretch axially and decrease in diameter. Furthermore, by radially expanding the prosthetic valve 100, the guard member 102 can be pressed against the native annulus, thereby further causing axial stretching and diameter reduction of the guard member 104. The pre-bunched guard member can compensate for this effect; 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 desired large diameter that effectively reduces paravalvular leakage after the prosthetic valve is deployed within the docking device.

[0191] Exemplary Textured Woven PVL Guard

[0192] Figures 5A-5B A docking device 300 configured to receive a prosthetic valve (e.g., 10) is shown according to another example. The docking device 300 includes a coil 302 that can be moved from a substantially straight configuration or delivery configuration to a spiral or deployment 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. Figures 6A-6C and Figures 7A-7C The textured woven PVL guard (or guard member) 304 is further illustrated in FIG.

[0193] like Figure 6C As shown, the protective member 304 includes an expandable member 306 and an elastic member 308 coupled to the expandable member 306. Figures 1A-1B 3A-3B , the distal portion 306 d of the expandable member 306 can be fixedly attached to a section of the coil 302, and the proximal portion 306 p of the expandable member 306 can be axially movable relative to the coil 302. Alternatively, the proximal portion 306 p of the expandable member 306 can be fixedly attached to a section of the coil 302, and the distal portion 306 d of the expandable member 306 can be axially movable relative to the coil 302.

[0194] Similarly, the guard member 304 (and expandable member 306) can be moved from a radially compressed (and axially extended) state (see, e.g., Figure 6A ) moves to a radially expanded (and axially shortened) state (see e.g. Figure 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 docking sleeve (e.g., 222). After the docking device 300 is removed from the delivery sheath and docking sleeve, 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 resilient member 308, as further described below.

[0195] As shown, the expandable member 306 in the radially expanded state may include a plurality of expanding portions 310 (also referred to as “expandable portions” or “floats”) and one or more contracting portions 312 connecting the plurality of expandable portions 310 .

[0196] In some examples, the expandable member 306 can have a proximal constriction 312p at the proximal end portion 306p and a distal constriction 312d at the distal end portion 306d (see, e.g., Figure 7B ). In other words, 312p is connected to the proximal-most expandable portion and is positioned proximal to the proximal-most expandable portion, while 312d is connected to the distal-most expandable portion and is positioned distal to the distal-most expandable portion.

[0197] As described herein, expandable member 306 can include woven materials, such as polyethylene terephthalate (PET) yarn. Other types of yarn (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 expandable member 306 depicted. As described herein, organized (or textured) yarn refers to a continuous filament yarn whose smooth straight fibers have been displaced from their closely packed parallel positions by forming curling, coiling, loops and / or coils. Compared with flat (i.e., non-textured) yarn, textured yarn has increased volume and / or stretchability.

[0198] In certain examples, contraction portion 312 and expandable portion 310 can be made of identical material (for example, PET).In a specific example, use textured 68 denier 36 filament yarn to weave expandable member 306.In another specific example, can use textured 68 denier 36 filament yarn and flat 40 denier 24 filament yarn to weave expandable member 306.In other examples, also can use yarn with different denier number and / or filament number.The yarn for weaving expandable member 306 can have the density of scope from 10 denier to 100 denier.

[0199] As described herein, contraction 312 can have a first weaving density that is greater than the second weaving density of expandable portion 310. In certain examples, the weaving density of expandable member 306 can be in the scope between 20-100 wefts / inch (PPI) or between 20-80PPI. In certain examples, weft (or weft, filling, insertion) number can be kept constant or substantially constant throughout whole weaving expandable member 306. Contraction 312 and the different weaving densities of expandable portion 310 can be realized by using the different warp count / unit length required for producing corresponding structure. In certain examples, contraction 312 can be woven using plain weave or leno weave.

[0200] The expandable portion 310, which includes textured yarns, can be heat-sealed to create increased volume (compared to the contracted portion 312). In some examples, the expandable portion 310 can be configured to be sufficiently dense so as not to create gaps therein. This can be achieved, for example, by using thicker yarns and increasing the PPI of the yarns as described above, which can prevent yarn separation.

[0201] In some examples, the number of expandable portions 310 in the expandable member 306 can be in a range between 2 and 20, or between 6 and 12, or between 8 and 10, inclusive. In some examples, the number of contraction portions 312 (including 312p and 312d) in the expandable member 306 can be one greater than the number of expandable portions 310. In other examples, the number of contraction portions 312 (e.g., excluding one or both of 312p and 312d) in the expandable member 306 can be the same as or one less than the number of expandable portions 310.

[0202] As described herein, when the expandable member 306 is in a radially expanded state, the contracting portion 312 can be wrapped around the coil 302 and the expandable portion 310 can be radially expanded from the coil 302. Additionally, the contracting portion 312 can be configured to slide axially on the coil 302 (in addition to 312d or 312p (if present) being fixedly attached to the coil 302). Thus, the contracting portion 312 can radially anchor the expandable member 306 so that the expandable member 306 is generally symmetrical about the coil 302 when no prosthetic valve is radially expanded within the coil. At the same time, the slidable contracting portion 312 allows the expandable member 306 to move axially (e.g., lengthen or shorten) on the coil 302.

[0203] As described herein, when the expandable member 306 is in the radially expanded state, the expandable portion 310 has a larger radial profile than the contracted portion 312. In the depicted example, the expandable portions 310 have the same or substantially similar dimensions when the expandable member 306 is in the radially expanded state. In other examples, the expandable portions 310 can have different dimensions when the expandable member 306 is in the radially expanded state.

[0204] As described herein, the constricted portion 312 can maintain a constant or substantially constant radial profile when the expandable member 306 moves from the radially compressed state to the radially expanded state. Figure 6A ) moves to a radially expanded state (see e.g. Figure 6B ), the expandable portion 310 can expand radially and shorten axially, while the contracting portion 312 can remain wound around the coil 302 without significant changes in radial or axial dimensions.

[0205] 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 contracted portion 312 can remain approximately constant at d3 when the expandable member 306 moves from the radially compressed state to the radially expanded state, where d2 > d3. In some examples, d1 and d3 are approximately the same. In some examples, d1 can be greater than d3.

[0206] In some examples, when the expandable member 306 is in the radially expanded state, adjacent expandable portions 310 may contact each other to shield the contracted portion 312. For example, Figure 6C As shown, when the expandable member 306 is in the radially expanded state, at least a portion of two adjacent expanded portions 310 may form direct contact at a position P radially outside the contraction portion 312 , thereby connecting the two adjacent expanded portions 310 .

[0207] like Figure 7AAs shown, when the expandable member 306 is in a radially expanded state and the prosthetic valve 10 is radially expanded within the coil 302, the inner portion 310a of the expandable portion 310 can be radially compressed by the prosthetic valve 10, causing the inner portion 306a to contact the coil 302. At the same time, when deployed at the native valve, 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. The radial distance (T) measured from the outermost edge of the inner portion 310a to the outer portion 310b is (d2+d0) / 2, where d0 represents the diameter of the coil 302. If the thickness of the woven protective member 304 at the contracted portion 312 is negligible, then d0 and d3 are approximately the same. When d2>>d0, T is approximately half of d2, that is, T≈d2 / 2.

[0208] In some examples, d1 may be in a range between 1 mm and 4 mm, or between 2 mm and 3 mm. In one specific example, d1 is between 2.0 mm and 2.6 mm.

[0209] In some examples, d2 is between 4 mm and 10 mm, or between 7 mm and 9 mm. In a specific example, d2 is between 7.5 mm and 8 mm.

[0210] In some examples, d3 is between 0.3 mm and 3 mm, or between 0.5 mm and 2.6 mm. In a specific example, d3 is between 1.5 mm and 2.4 mm.

[0211] The expansion of the expandable member 306 from the radially compressed state to the radially expanded state can be characterized by an expansion ratio defined as d2 / d1. In some examples, the expansion ratio can be in a range between 1.5 and 10, or between 2 and 6. In a specific example, the expansion ratio is between 3 and 4.

[0212] In some examples, when the expandable member 306 is in the radially expanded state, each expandable portion 310 can have an axial length (a1) between 6 mm and 16 mm, or between 8 mm and 14 mm. In one specific example, a1 is between 10 mm and 12 mm. Additionally, when the expandable member 306 is in the radially expanded state, each contraction portion 312 between 312p and 312d can have an axial length (a2) between 0.1 mm and 2 mm, or between 0.3 mm and 1.5 mm. In one specific example, a2 is between 0.5 mm and 1.0 mm. Figure 7B In the example shown, the axial lengths of 312p and 312d are greater than a2. In other examples, the axial lengths of 312p and 312d may be equal to or even less than a2.

[0213] In some examples, when the expandable member 306 is in the radially expanded state, the expandable member 306 can have an axial length (L1) (e.g., measured from the proximal portion 306p to the distal portion 306d) ranging from 60 mm to 120 mm, or from 70 mm to 100 mm. In one specific example, L1 is between 75 mm and 85 mm.

[0214] In some examples, when the expandable member 306 is in the radially compressed state, the expandable member 306 can have an axial length (L2) ranging between 80 mm and 200 mm, or between 100 mm and 160 mm. In a specific example, L2 is between 120 mm and 140 mm.

[0215] The elongation of expandable member 306 from the radially expanded state to the radially compressed state can be characterized by an elongation ratio defined as L2 / L1. In some examples, the elongation ratio can be in the range of between 1.1 and 1.6, or between 1.2 and 1.5. In a specific example, the elongation ratio is between 1.3 and 1.4.

[0216] 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 achieved, for example, by shaping the expandable portion 310 (e.g., by applying heat to the expandable portion 310). Additionally, the resilient member 308 can be configured to assist in moving the expandable member 306 from the radially compressed state to the radially expanded state.

[0217] 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 stretched state and a resting state. When the expandable member 306 is in the radially compressed state, the elastic member 308 can be in the axially stretched state. The elastic member 308 can be biased to the resting state. Thus, the tendency of the elastic member 308 to return to its resting state can apply a biasing force to the expandable member 306, thereby helping to move the expandable member 306 from the radially compressed state to the radially expanded state. When the expandable member 306 is in the radially expanded state, the elastic member 308 can be in the resting state.

[0218] As described herein, after deployment of the docking device 300, the proximal portion 306p of the expandable member 306 can be retracted to a position distal to the ascending portion 110b (eg, under the combined biasing force generated by both the expandable member 306 and the resilient member 308).

[0219] In some examples, the elastic member 308 can extend along the axial length of the expandable member 306. For example, Figure 7BAs shown, the resilient member 308 can include an elastic strip extending parallel to the central longitudinal axis 314 of the expandable member 306. In some examples, the resilient member 308 can form a sheath around a section of the coil 302 covered by the expandable member 306.

[0220] In some examples, such as Figure 7B As shown, the proximal end 308p of the elastic member 308 can be attached to the proximal 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 portion 306d (e.g., 312d) of the expandable member 306.

[0221] In some examples, the elastic member 308 can be attached to the expandable member 306 via a continuous suture 316 extending along the axial length of the expandable member 306. For example, Figure 7B As shown, suture 316 can connect the elastic member 308 to each constriction portion 312, including 312p and 312d at the proximal portion 306p and distal portion 306d, respectively. In this case, the length of suture 316 can be greater than or equal to the length of the elastic member 308 in its axially stretched state, so that the suture 316 has slack when the elastic member 308 is in its resting state.

[0222] In other examples, the elastic member 308 may be attached to the expandable member 306 via sutures 316 only at 312p and 312d, without sutures connecting the constriction portion 312 between 312p and 312d.

[0223] In yet other examples, the elastic member 308 can be attached to the expandable member 306 via sutures 316 at both 312p and 312d and selected constrictions 312 located between 312p and 312d (eg, every other constriction can be connected by sutures 316).

[0224] In some examples, the sutures 316 may not be continuous sutures extending along the axial length of the expandable member 306. For example, discrete sutures 316 may be used to connect the elastic members 308 to the corresponding constriction portions 312.

[0225] Exemplary Delivery Devices

[0226] Figure 8 A delivery device 200 is shown that is configured to implant a docking device (such as docking device 100 described above or other docking devices) into a target implantation site in a patient's body according to one example. Therefore, delivery device 200 may also be referred to as a "dock delivery catheter" or "dock delivery system."

[0227] As shown, the delivery device 200 may 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 may include a handle 206 including one or more knobs, buttons, wheels, and / or other devices for controlling and / or actuating one or more components of the delivery device 200. For example, in some examples, such as Figure 8 As shown, the handle 206 can include knobs 208 and 210 that can be configured to manipulate or control the deflection of the delivery device 200, such as the deflection of the delivery sheath 204 and / or the sleeve shaft 220 as described below.

[0228] In some examples, the delivery device 200 may also include a pusher shaft 212 (see, e.g., Figure 9B ) and a quill 220 (see, e.g., Figure 9A ), both of which can extend through the inner lumen of the delivery sheath 204 and have respective proximal portions extending into the handle assembly 202.

[0229] As described below, the distal end portion (also referred to as the "distal section") of the sleeve shaft 220 can include a lubricated docking sleeve 222 that is configured to cover (e.g., surround) the docking device 100. For example, the docking device 100 (including the protective member 104) can be retained within the docking sleeve 222, which can be further retained by the distal end portion 205 of the delivery sheath 204 while navigating through the patient's vasculature. As described above, the docking device 100 retained within the delivery sheath 204 can be maintained in the delivery configuration. Similarly, the protective member 104 retained within the docking sleeve 222 can also be maintained in the delivery configuration.

[0230] Additionally, the distal portion 205 of the delivery sheath 204 can be configured to be steerable. In one example, by rotating a knob (e.g., 208 or 210) on the handle 206, the curvature of the distal portion 205 can be adjusted so that the distal portion 205 of the delivery sheath 204 can be oriented at a desired angle. For example, Figure 14 As shown and described below, in order to implant the docking device 100 at the native mitral valve location, the distal portion 205 of the delivery sheath 204 can be manipulated in the left atrium so that the docking member sleeve 222 and the docking device 100 retained therein can extend through the native mitral valve annulus at a location adjacent to the posteromedial commissure.

[0231] In some examples, the pusher shaft 212 and the sleeve shaft 220 can be coaxial with each other (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 pressed against the proximal end (e.g., 102d) of the docking device 100 retained within the docking sleeve 222.

[0232] 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 further described below. For example, by pushing the pusher shaft 212 in the distal direction while holding the delivery sheath 204 in place, or retracting the delivery sheath 204 in the proximal direction while holding the pusher shaft 212 in place, or pushing the pusher shaft 212 in the distal direction while retracting the delivery sheath 204 in the proximal direction, the docking device 100 can be pushed out of the distal end 204d of the delivery sheath 204, thereby changing from a delivery configuration to a deployed configuration. In some examples, the pusher shaft 212 and the sleeve shaft 220 can be actuated independently of each other.

[0233] In some examples, the pusher shaft 212 and the sleeve shaft 220 can be configured to move in an axial direction with the docking device 100 as the docking device 100 is deployed 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 along with the pusher shaft 212 and the docking device 100. Thus, during the process of pushing the docking device 100 into position at the target implantation site via the pusher shaft 212, the docking device 100 can remain covered by the docking piece sleeve 222 of the sleeve shaft 220. Thus, when the docking device 100 is initially deployed at the target implantation site, the lubricated docking piece sleeve 222 can facilitate the covered docking device 100 to wrap around native anatomical structures.

[0234] During delivery, the docking device 100 can be connected to the delivery apparatus 200 via a release suture 214 (or other retrieval line, including a thread, yarn, or other material that can be configured to be tied around the docking device 100 and cut for removal) extending through the pusher shaft 212. In one particular example, the release suture 214 can extend through the delivery apparatus 200, e.g., through the inner lumen of the pusher shaft 212, to a suture locking assembly 216 of the delivery apparatus 200.

[0235] The handle assembly 202 can also include a hub assembly 218 to which the suture locking 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 way, operation of the various components of the handle assembly 202 can actuate and control the operation of components disposed within the delivery sheath 204. In some examples, the hub assembly 218 can be coupled to the handle 206 via a connector 226.

[0236] The handle assembly 202 may also include one or more irrigation ports (e.g., Figure 8 Three irrigation ports 232, 236, 238 are shown in the figure to supply irrigation fluid to one or more lumens disposed within the delivery device 200 (eg, an annular lumen disposed between coaxial components of the delivery device 200), as described below.

[0237] Further details regarding delivery devices / catheters / systems configured to deliver a docking device to a target implantation site (including various examples of handle assemblies) can be found in U.S. Patent Publication Nos. 2018 / 0318079 and 2018 / 0263764, all of which are incorporated herein by reference in their entirety.

[0238] Exemplary quills

[0239] Figure 9A A sleeve shaft 220 according to one example is shown. In some examples, the sleeve shaft 220 can have a lubricated distal section 222 (also referred to herein as a "docking sleeve") configured to cover a docking device (e.g., 100) during deployment, a proximal section 228 for manipulating or actuating the position of the distal section 222, and an intermediate section 230 connecting the distal section 222 and the proximal section 228.

[0240] In some examples, the docking sleeve 222 can be configured to be flexible, have a lower hardness than the rest of the sleeve shaft 220, and have a hydrophilic coating that can act as a lubricating surface to improve ease of wrapping around native anatomical structures and reduce the risk of damage to native tissue. In some examples, the docking sleeve 222 can be formed into a tubular structure with an inner diameter sufficient to surround the docking device 100 and an outer diameter small enough to be retained within the delivery sheath 204 and axially movable within the delivery sheath 204. In some examples, the outer diameter of the docking sleeve 222 can be slightly larger than the outer diameter of the intermediate section 230. In some examples, the length of the docking sleeve 222 is sufficient to cover or be longer than the entire length of the docking device 100 when the docking device 100 is retained within the docking sleeve 222.

[0241] The docking sleeve 222 can have a main body portion 221 and a tip portion 223 located at the distal end of the main body portion 221. In some examples, the tip portion 223 can extend distally from the distal end of the main body portion 221 by approximately 1-4 mm (e.g., approximately 2 mm). In some examples, the tip portion 223 can be tapered radially inward such that it has a smaller diameter than the main body portion 221. In some examples, during delivery, the tip portion 223 can extend past the distal end (e.g., 102d) of the docking device, thereby providing the docking sleeve 222 with a more atraumatic tip that can bend, compress, deform, etc. as the docking sleeve 222 navigates around the natural structures of the docking device's implantation site.

[0242] Other examples of docking sleeves, including various features of the main and tip portions of the docking sleeves, are further described in US Provisional Application No. 63 / 138,910, the entire contents of which are incorporated herein by reference.

[0243] In some examples, the intermediate section 230 of the sleeve shaft 220 can be configured to provide sufficient column strength to push the docking sleeve 222 (with the docking device 100) out of the distal end 204d of the delivery sheath 204 and / or to retract the docking sleeve 222 after the docking device 100 is deployed at the target implantation site. The intermediate section 230 can also be configured to have sufficient flexibility to facilitate navigating the patient's anatomy from the insertion point of the delivery device 200 to the heart. In some examples, the docking sleeve 222 and the intermediate section 230 can be formed as a single continuous unit with different properties (e.g., size, polymer, braid, etc.) along the length of the single unit.

[0244] In some examples, a proximal portion of the proximal section 228 can be disposed in the handle assembly 202. The proximal section 228 of the sleeve shaft 220 can be configured to be more rigid and provide column strength to actuate the position of the docking sleeve 222 by pushing the intermediate section 230 and the docking sleeve 222 with the docking device 100 and retracting the docking sleeve 222 after the docking device 100 is deployed at the target implantation site.

[0245] In some examples, the proximal portion of the proximal section 228 can include a cutout portion 229 whose cross-section (in a plane perpendicular to the central longitudinal axis of the sleeve shaft 220) 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 cutout portion 229 and the remainder of the proximal section 228. The end surface 225 can be configured to be 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, as further explained below.

[0246] 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 the 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 from a void space 227 formed in the cutting portion 229 and branch off at an angle relative to the cutting portion 229 into the suture locking assembly 216 of the hub assembly 218 (see, e.g., Figure 8 ). Thus, the pusher shaft 212 and the sleeve shaft 220 can operate parallel to one another, and the overall length of the delivery device 200 into which the sleeve shaft 220 and the pusher shaft 212 are incorporated can be maintained similar to or only minimally longer than a delivery system that does not incorporate the sleeve shaft 220.

[0247] Other examples of quills are further described in PCT patent application publication number WO / 2020 / 247907.

[0248] Exemplary Pusher Shaft

[0249] Figure 9B The pusher shaft 212 is shown according to one example. As shown, the pusher shaft 212 may include a main tube 250, a housing 252 surrounding a proximal portion of the main tube 250, a plug 254 connecting the main tube 250 to the housing 252, and a proximal extension 256 extending from the proximal end of the main tube 250.

[0250] The main tube 250 can be configured to advance and retract a docking device (such as one of the docking devices described herein) and to accommodate a release suture (e.g., 214) that 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 into the handle assembly 202 of the delivery device 200. For example, in some cases, the proximal portion of the pusher shaft 212 (which includes the interface between the main tube 250, the housing 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 a majority of the delivery device 200.

[0251] The main tube 250 can be a relatively rigid tube that provides column strength for the deployment of the actuating docking device. In some examples, the main tube 250 can be a hypotube. In some examples, the main tube 250 can include a biocompatible metal, such as stainless steel. The main tube 250 can have a distal end 250d and a proximal end 250p configured to engage with the docking device, wherein a proximal extension 256 is attached. In some examples, the distal section 258 of the main tube 250 can be relatively more flexible (e.g., by entering one or more incisions in the outer surface of the main tube and / or having a hardness material) than the rest of the main tube 250. Therefore, as the distal section 258 is navigated through the patient's vascular system to arrive at the target implantation site, it can flex and / or bend together with the delivery sheath 204 of the delivery device 200.

[0252] In some examples, the housing 252 can be configured to lock the main tube 250 and provide a hemostatic seal on the pusher shaft 212 without interfering with the movement of the sleeve shaft 220. Figure 9B As shown, the inner diameter of the housing 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 housing 252. Therefore, the proximal section 228 of the sleeve shaft 220 can slide within the annular cavity 260, as further described below. In addition, the flushing fluid provided to the lumen outside the proximal extension 256 in the hub assembly 218 can flow through the annular cavity 260 and exit at the distal end of the housing 252 (as shown by arrow 262) to enter the lumen between the sleeve shaft 220 and the delivery sheath 204 of the delivery device, as described below with reference to Figure 11 Further discussion.

[0253] The plug 254 can be configured to be disposed within the annular cavity 260 at the proximal end 252p of the housing 252. In some examples, the plug 254 can be configured to "plug" or fill the portion of the annular cavity 260 located at the proximal end 252p of the housing 252, while leaving the remainder of the annular cavity 260 open to receive the cutting portion 229 of the quill 220 therein. In some examples, the housing 252 and the plug 254 can be fixedly coupled to the main tube 250 (e.g., by welding) to allow the cutting portion 229 of the quill 220 to slide between the main tube 250 and the housing 252. As described below, the plug 254 can also serve as a stop for the quill 220.

[0254] As described above, the proximal extension 256 can extend from the proximal end 250p of the main tube 250 and the housing 252. The proximal extension 256 can provide some flexibility to the pusher shaft 212 so that it can be routed from the interior of the sleeve shaft 220 (e.g., the cutting portion 229) to the exterior of the sleeve shaft 220, thereby allowing the pusher shaft 212 and the sleeve shaft 220 to be actuated in parallel and reducing the overall length of the delivery device. In some examples, the proximal extension 256 can be made of a flexible polymer.

[0255] Other examples of pusher shafts are further described in PCT Patent Application No. PCT / US20 / 36577.

[0256] Exemplary Quill and Pusher Shaft Assemblies

[0257] Figures 10A-10B The diagram illustrates an example of a pusher shaft 212 and a sleeve shaft 220 arranged within a delivery sheath 204 of a delivery device 200 before and after deployment of a docking apparatus such as 100. As shown, the main tube 250 of the pusher shaft 212 can extend through the lumen of the sleeve shaft 220, and the sleeve shaft 220 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.

[0258] Figure 11 Various lumens are shown that are configured to receive irrigation fluids during the delivery and implantation procedures that may be formed between the docking device 100, the pusher shaft 212, the sleeve shaft 220, and the delivery sheath 204. In addition, Figure 12A A first configuration is shown in which the docking device 100 has been deployed from the delivery sheath 204 while still covered by the docking sleeve 222 of the sleeve shaft 220. The docking sleeve 222 in the first configuration is also referred to as being in a "covered state." When the docking sleeve 222 is in the covered state, the guard member 104 (not shown for clarity) can remain in the delivery configuration (i.e., radially compressed by and retained within the docking sleeve 222). Figure 12B A second configuration is shown in which the docking device 100 is uncovered by the docking sleeve 222 after the sleeve shaft 220 is retracted into the delivery sheath 204. The docking sleeve 222 in the second configuration is also referred to as being in an "uncovered state." When the docking sleeve 222 is in the uncovered state, the guard member 104 (not shown for clarity) can radially expand and move to the deployed configuration.

[0259] Specifically, Figure 10AA first configuration of the pusher shaft 212 and sleeve shaft 220 assembly is illustrated, according to one example, before or during deployment of the docking device 100. As shown, the docking sleeve 222 can be configured to cover the docking device 100, with the end face 225 of the sleeve shaft 220 positioned away from the plug 254. Additionally, the distal end 250d of the pusher shaft 212 can extend into the docking sleeve 222 and contact the proximal end 102p of the docking device 100.

[0260] 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 in an axial direction 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 along with the pusher shaft 212 and the docking device 100. Thus, during the process of pushing the docking device 100 into position at the target implantation site via the pusher shaft 212, the docking device 100 can remain covered by the docking piece sleeve 222 of the sleeve shaft 220, as shown. Figure 12A shown.

[0261] In addition, if Figure 12A As shown, during delivery and implantation of the covered docking device 100 at the target implantation site, the distal portion 223 of the sleeve shaft 220 can extend distal to the distal end 102d of the docking device 100 , thereby providing a more atraumatic tip for the docking sleeve 222 .

[0262] In some examples, one or more radiopaque markers 231 can be placed at the docking sleeve 222 to improve the ability to visualize the docking sleeve 222 during deployment of the docking device (e.g., 100). In some examples, at least one radiopaque marker 231 can be placed at the intersection between the body portion 221 and the tip portion 223. In some 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 positioned near or just distal to the radiopaque marker 231 of the docking sleeve 222.

[0263] In some examples, the radiopaque marker 231 may include a radiopaque material such as a platinum-iridium alloy. In other examples, the radiopaque material included in the radiopaque marker 231 may be barium sulfate (BaSO4), bismuth subcarbonate ((BiO)2CO3), bismuth oxychloride (BiOCl), etc.

[0264] In some examples, the distal portion 223 of the dock sleeve 222 can be made of a polymer material loaded with any of the radiopaque materials described above such that the distal-most edge of the distal portion 223 is visible under fluoroscopy.

[0265] Figure 10B A second configuration of the pusher shaft 212 and sleeve shaft 220 assembly is illustrated after the docking device 100 is deployed at the target implantation site from the delivery sheath 204 and the docking sleeve 222 is removed from the implanted docking device 100, according to one example. As shown, after the docking device 100 is implanted at the target implantation site (in its desired position), the sleeve shaft 220 can be pulled out of the docking device 100 and retracted into the delivery sheath 204 while holding the pusher shaft 212 stable so that its distal end 250d is pressed against the proximal end 102p of the docking device 100. Optionally, the docking device 100 can be exposed by pushing the pusher shaft 212 in a distal direction while holding the sleeve shaft 220 stable. In some examples, such as Figure 10B As shown, after end surface 225 contacts plug 254, sleeve shaft 220 can be prevented from further retraction into the delivery device.

[0266] Figure 12B The sleeve shaft 220 is shown removed from the docking device 100, leaving the docking device 100 uncovered by the docking sleeve 222. As shown, the distal portion 223 of the sleeve shaft 220 can be disposed proximal to the distal end of the pusher shaft 212 (e.g., retracted 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 further explained below, after the docking device 100 is implanted at the target implantation site and the docking sleeve 222 is removed from covering the docking device 100, the docking device 100 can be separated from the delivery device 200 by cutting the release suture 214 (e.g., using the suture locking assembly 216 of the delivery device 200).

[0267] like Figure 11As shown, a first pusher shaft lumen 212i can be formed within the interior of the pusher shaft 212 (e.g., within the main tube 250). The pusher shaft lumen 212i can receive irrigation fluid from a first fluid source, which can be fluidically coupled to a portion of the handle assembly 202. An irrigation fluid stream 264 passing through the pusher shaft lumen 212i can travel along the length of the main tube 250 of the pusher shaft 212 toward the distal end 250d of the main tube 250 of the pusher shaft 212. In some examples, the distal end 250d of the main tube 250 can be spaced apart from the proximal end 102p of the docking device 100. Thus, at least a portion of the irrigation fluid stream 264 can flow into a distal portion of the second quill shaft lumen 220i, which is disposed between an outer surface of the docking device 100 and an inner surface of the docking sleeve 222 of the quill shaft 220, as an irrigation fluid stream 268. Furthermore, in some examples, a portion of the irrigation fluid flow 264 can also flow back into the proximal portion of the sleeve shaft lumen 220i, which is disposed between the outer surface of the pusher shaft 212 and the inner surface of the sleeve shaft 220 proximal to the dock sleeve 222, as irrigation fluid flow 266. Thus, the same first fluid source can provide irrigation fluid to the pusher shaft lumen 212i, the sleeve shaft lumen 220i (including both the distal portion outside the dock sleeve 222 and the proximal portion proximal to the dock sleeve 222) via the pusher shaft lumen 212i.

[0268] Figure 11 Also shown is a third delivery sheath lumen 204i disposed between the inner surface of the delivery sheath 204 and the outer surface of the sleeve shaft 220. The delivery sheath lumen 204i can receive irrigation fluid from one or more second fluid sources that can be fluidly coupled to a portion of the handle assembly 202 and can cause an irrigation fluid flow (as indicated by arrows 262) to flow through the delivery sheath lumen 204i to the distal end 204d of the delivery sheath 204.

[0269] During deployment of the docking device 100 from the delivery device 200 and implantation of the docking device 100 at the target implantation site, flushing the lumen may help prevent or reduce thrombosis on and around the docking device 100 and other concentric components of the delivery device 200. In one example, Figure 8 As shown, the first and / or second fluid sources 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 flushing fluid to the above-mentioned tubular cavity.

[0270] Additional examples of quill and pusher shaft assemblies are further described in PCT Patent Application No. PCT / US20 / 36577.

[0271] Exemplary Implantation Procedure

[0272] Figure 13-26 , 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 FIG. 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 to implant docking devices and prosthetic valves at other target implantation sites.

[0273] Figure 13 The figure illustrates the introduction of a guide catheter 400 into the patient's heart over a previously inserted guidewire 240. Specifically, the guide catheter 400 and guidewire 240 are inserted from the right atrium 402 into the left atrium 404 through the atrial septum 406 (e.g., via a previously punctured hole 403 in the atrial septum 406). To facilitate navigation through the patient's vasculature and transseptal insertion, a nose cone 242 having a tapered distal tip can be positioned at the distal end of the guide catheter 400. After the distal end of the guide catheter 400 enters the left atrium 404, the nose cone 242 and guidewire 240 can be retracted into the guide catheter 400, for example, by operating a handle connected to the proximal end of the guide catheter 400. The guide catheter 400 can be held in place (i.e., extended through the atrial septum 406) such that the distal end of the guide catheter 400 remains within the left atrium 404.

[0274] Figure 14 The illustration shows the introduction of a delivery device (such as the 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 the distal portion 205 of the delivery sheath 204 extends distally away from the distal end of the guide catheter 400 and into the left atrium 404.

[0275] As described above, the delivery device 200 can have a sleeve shaft 220 and a pusher shaft 212, both of which can extend through the lumen of the delivery sheath 204. As shown in Figures 15-17, the distal 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 portion 205 of the delivery sheath 204.

[0276] As described above, the distal portion 205 of the delivery sheath 204 can be manipulated, for example, by operating a knob located on the handle assembly 202. Since the docking sleeve 222 and the docking device 100 are also flexible, flexing of the distal portion 205 of the delivery sheath 204 will also cause flexing of the docking sleeve 222 and the docking device 100 held therein. Figure 14As shown, the distal portion 205 of the delivery sheath 204 (together with the docking piece sleeve 222 that holds the docking device 100) can be flexed in a desired angular direction so that the distal end 204d of the delivery sheath 204 can extend through the natural mitral valve annulus 408 at a position adjacent to the posteromedial commissure 420 and into the left ventricle 414.

[0277] Figure 15 10. The docking device 100 is illustrated as being deployed in the mitral valve position. As shown, the distal portion of the docking device 100, which includes the leading turns 106 and the central region 108 of the coil, can be deployed away from the distal end 204d of the delivery sheath 204 and extended into the left ventricle 414. Note that the deployed distal portion of the docking device 100 is still covered by the docking piece sleeve 222. This can be accomplished, for example, by retracting the delivery sheath 204 in a proximal direction while maintaining the pusher shaft 212 and sleeve shaft 220 in place, thereby causing the distal portion of the docking device 100 to extend distally away from the delivery sheath 204 while it remains covered by the docking piece sleeve 222. Retraction of the delivery sheath 204 can continue until the delivery sheath 204 is moved to the stabilizing turns 110 and proximal to the expandable member 116.

[0278] Without being constrained by the distal portion 205 of the delivery sheath 204, the distal portion of the docking device 100 can be moved from the delivery configuration to the deployed (ie, helical) configuration. Figure 15 As shown, the coils of the docking device 100 (covered by the docking piece sleeve 222) can form a leading turn 106 extending into the left ventricle 414, and a plurality of functional turns in the central region 108 that are wrapped around the native leaflets 410 and chordae tendineae 412 of the native valve.

[0279] Because the docking sleeve 222 has a smooth surface, it prevents or reduces the likelihood that the tubular member 112 (which surrounds the coil 102 of the docking device) will directly contact and catch (or get stuck) the native tissue and helps ensure that the covered docking device 100 surrounds the native anatomy. In addition, the soft distal portion 223 of the docking sleeve 222 (which may have a tapered shape) may also promote atraumatic surrounding of the native tissue. As described above, the irrigation fluid (see, e.g., Figure 11 264) can flow through the docking member sleeve 222 and around the docking device 100 to prevent or reduce thrombosis on and around the docking device 100 and other concentric components of the delivery device 200 during deployment of the docking device 100.

[0280] like Figure 16As shown, after the functional turns of the docking device 100 have successfully wrapped around the native leaflets 410 and chordae tendineae 412, the docking member sleeve 222 can be retracted in a proximal direction relative to the docking device 100. This can be achieved, for example, by pulling the sleeve shaft 220 in a proximal direction while holding the pusher shaft 212 steady so that its distal end can be pressed against the proximal end of the docking device 100, as described above with reference to FIG. Figure 10B As described above, the docking piece sleeve 222 can be retracted into the delivery sheath 204. Figure 17 The docking device 100 (which is not covered by the docking sleeve 222) is shown encircling the native leaflets and chordae tendineae.

[0281] Figure 18A The docking device 100 is illustrated as being stabilized from the atrial side. As shown, the delivery sheath 204 can be retracted into the guide catheter 400 so that the atrial side (i.e., the proximal portion) of the docking device 100 (including the stabilizing turns 110 of the coil) can be exposed. The stabilizing turns 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 in the left atrium or complete contact with the left atrial wall. The stabilizing turns 110 can be flared outward or biased toward both the posterior wall 416 and the anterior wall 418 of the left atrium to prevent the docking device 100 from falling into the left ventricle before the prosthetic valve is deployed in the docking device 100.

[0282] Without being constrained by the delivery sheath 204 and the docking piece sleeve 222, the protective member 104 can be moved to the deployed configuration (due to the radial expansion of the expandable member 116). As shown, the protective member 104 of the docking device 100 can be configured to contact the native valve annulus in the left atrium to create a sealed and atraumatic interface between the docking device 100 and the native tissue. The proximal portion 104p of the protective member can be configured to be positioned adjacent to (but not reaching) the anterolateral commissure 419 of the native valve. In the deployed configuration, the proximal end 105 of the protective member can be configured to be positioned within the atrial portion 110a or the 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., Figure 1A ). For example, after initial deployment of the docking device 100 and before deploying a prosthetic valve (e.g., 10) within the docking device 100, the proximal end 105 of the guard member can be configured to be positioned between the proximal placement marker 121p and the distal placement marker 121d, or in some cases slightly distal to the distal placement marker 121d. In some examples, the distal end portion 104d of the guard member can be positioned in the left ventricle 414 or at least adjacent to the posteromedial commissure 420 of the native valve so that leakage at this location can be prevented or reduced.

[0283] In the depicted example, the proximal end portion of the retaining element 114 extends into the rising portion 110b of the coil. In addition, the proximal end 105 of the guard member 104 is located distal to the proximal placement mark 121p, which is located distal to the rising portion 110b. In some examples, the proximal end 105 of the guard member 104 is located between the proximal placement mark 121p and the distal placement mark 121d (which is covered by the guard member 104 and not in the Figure 18A As described above, this configuration can advantageously improve the sealing and / or durability of the protective member 104.

[0284] In some cases, after initial deployment of the docking device 100, the proximal end 105 of the guard member 104 may be incidentally extended onto the raised portion 110b, such as Figure 18B In this case, the docking sleeve 222 can be used to "reposition" the proximal end 105 of the guard member 104 away from the raised portion 110b. According to one example, the docking sleeve 222 can be pushed out of the delivery sheath 204 until its tapered distal portion 223 contacts the tapered proximal end 105 of the guard member 104 (see, e.g., Figure 18B ). The position of the distal portion 223 of the docking sleeve 222 can be determined, for example, based on visualization of the radiopaque marker 231 on the docking sleeve 222 under fluoroscopy. Thus, by further pushing the docking sleeve 222 in the distal direction, the proximal end 105 of the guard member 104 can be moved distally until it is repositioned distally of the proximal placement marker 121p (see, e.g., Figure 18C ). This positioning can be confirmed, for example, by observing that the radiopaque marker 231 on the docking member sleeve 222 is located distal to the proximal placement marker 121p. The docking member sleeve 222 can then be retracted into the delivery sheath 204. As described above, the retaining element 114 can hinder the axial movement of the proximal portion 104p of the guard member 104 relative to the coil by applying a friction force (e.g., a frictional interaction between the retaining element 114 and the proximal end 105 of the guard member 104). Therefore, the retaining element 114 can maintain the proximal end 105 of the guard member 104 in the repositioned position - distal to the rising portion 110b.

[0285] Figure 19 The docking device 100 is shown fully deployed. The release suture 214, which extends through the pusher shaft 212 and connects the proximal end 102p of the coil to the suture lock assembly 216, can then be cut so that the docking device 100 can be released from the delivery device 200. The delivery device 200 can then be removed from the guide catheter 400 in preparation for implantation of the prosthetic valve.

[0286] Figure 20The guidewire catheter 244 is illustrated as being inserted through the guide catheter 400 , through the docking device 100 , across the native mitral valve annulus, and into the left ventricle 414 .

[0287] Figure 21 The valve guidewire 246 is shown inserted into the left ventricle 414 through the inner lumen of the guidewire catheter 244. The guidewire catheter 244 can then be retracted into the guide catheter 400, and the guide catheter 400 and guidewire catheter 244 can be removed, leaving the valve guidewire 246 in place.

[0288] Figure 22 The diagram illustrates the 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 a valve guidewire 246. During delivery, the prosthetic valve 10 can be crimped onto a deflated balloon 460 positioned between the distal end of an outer shaft 452 of the delivery device 450 and a nose cone 454. In some examples, prior to transseptal delivery of the prosthetic valve 10, the hole 403 in the atrial septum 406 can be further expanded by inserting a balloon catheter through the hole 403 and radially expanding a balloon mounted on the balloon shaft.

[0289] Figure 23 The prosthetic valve 10 is shown placed within the docking device 100. Specifically, the prosthetic valve 10 can be positioned within and substantially coaxial with the functional turns in the central region 108 of the docking device 100. In some examples, the outer shaft 452 can be slightly retracted so that the balloon 460 is located outside of the outer shaft 452.

[0290] Figure 24 The diagram 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 via the delivery device 450, thereby radially expanding the prosthetic valve 10. As the prosthetic valve 10 is radially expanded within the central region 108 of the coil, the functional turns in the central region 108 can be further radially expanded (i.e., the docking device coil 102 can be moved from a first radially expanded configuration to a second radially expanded configuration, as described above). To compensate for the increased diameter of the functional turns, the leading turns 106 can be retracted in a proximal direction and become part of the functional turns in the central region 108.

[0291] Figure 25 The balloon 460 is illustrated as being deflated after the prosthetic valve 10 has been radially expanded within the docking device 100. The balloon 460 may be deflated by withdrawing the inflation fluid from the balloon through the delivery device 450. The delivery device 450 may then be retracted out of the patient's vasculature, and the valve guidewire 246 may also be removed.

[0292] Figure 26The diagram illustrates the final deployment of the docking device 100 at the mitral valve and the prosthetic valve 10 received within the docking device 100. As described above, radial tension between the prosthetic valve 10 and the central region 108 of the docking device can securely hold the prosthetic valve 10 in place. In addition, the protective 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.

[0293] As described above, radially expanding the prosthetic valve 10 within the docking device 100 can cause the guard member 104 to radially compress and axially extend. Consequently, 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 retaining element 114 can frictionally hinder the proximal movement of the proximal end 105 of the guard member 104 over the coil. Furthermore, the proximal placement marker 121p (which defines 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 positioned sufficiently distally 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 100 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 to the ascending portion 110b of the coil 102.

[0294] When the prosthetic heart valve 10 is fully expanded within the docking device 100, the prosthetic heart valve 10 contacts the guard member 104 and urges the guard member 104 against the coil 102, thereby limiting further axial movement of the guard member 104 relative to the native anatomy (e.g., the left atrial wall). In this manner, the retaining member 114 can be used to temporarily maintain 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. Thereafter, the prosthetic heart valve can secure the positioning of the guard member relative to the coil.

[0295] Although in the above-described method, the prosthetic valve 10 is radially expanded using the inflatable balloon 460 , it should be understood that alternative methods may be used to radially expand the prosthetic valve 10 .

[0296] For example, in some cases, the prosthetic valve can be configured to be self-expanding. During delivery, the prosthetic valve can be radially compressed and retained within a valve sheath located at the distal portion of the delivery device. 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 related delivery devices / catheters / systems are described in U.S. Patent Nos. 8,652,202 and 9,155,619 (the entire contents of which are incorporated herein by reference).

[0297] In another example, in some cases, the prosthetic valve can be mechanically expanded. Specifically, the prosthetic valve can have a frame comprising a plurality of interconnected struts such that an axial force applied to the frame (e.g., pressing 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 cause the prosthetic valve to radially expand or compress. Additional details about exemplary mechanically expandable prosthetic valves and related delivery devices / catheters / systems are described in U.S. Patent Application Publication No. 2018 / 0153689 and PCT Patent Application Publication No. WO / 2021 / 188476 (the entire contents of which are incorporated herein by reference).

[0298] The therapeutic techniques, methods, steps, etc. described or suggested herein or in references incorporated herein may be performed on living animals or on non-living simulated bodies (e.g., cadavers, cadaver hearts, anthropomorphic phantoms, simulators (e.g., having body parts, tissues, etc. being simulated), etc.).

[0299] Exemplary Methods of Deploying Textured Woven PVL Protective Elements

[0300] The procedure for delivering the docking device 300 to the implantation site and implanting a prosthetic valve (such as the prosthetic valve 10 described above) within the docking device 300 can be generally similar to that described above with reference to Figure 13-26 The procedures described are as follows, with the differences described below.

[0301] As described above, the functional turns of the docking device successfully encircle the native leaflets and chordae tendineae (see, e.g., Figure 16-17 ), the docking sleeve 222 can be retracted in the proximal direction until it is retracted into the delivery sheath 204. Figure 27 The docking device 300 is shown fully deployed. As shown, the guard member 304 can extend radially outward from the coil 302 without being constrained by the docking sleeve 222, for example, when the expandable member 306 moves from a radially compressed state to a radially expanded state under the biasing force of the expandable member 306 and / or the biasing force of the resilient member 308. As described above, the proximal portion 306p of the expandable member 306 can move 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 device 200.

[0302] like Figure 274. As shown, the distal portion 306d of the expandable member 306 can be configured to extend to a position adjacent the posteromedial commissure 420. In some examples, the distal portion 306d of the expandable member 306 can extend through the native mitral valve annulus 408 and into the left ventricle 414. The proximal portion 306p of the expandable member 306 can be configured to be positioned adjacent the anterolateral commissure 419 of the native valve. As described above, the outer portion 310b of the expandable portion 310 can be pressed against the posterior wall 416 of the left atrium 404. Thus, 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 leak.

[0303] After deploying the docking device 300, follow the instructions above. Figure 20-25 Similar to the steps described, a prosthetic valve (eg, 10) can be delivered into the left atrium 404, placed within the docking device 300, and then radially expanded.

[0304] Figure 28 The diagram illustrates the final deployment of the docking device 300 at the mitral valve and the prosthetic valve 10 received within the docking device 300. As described above, the radial tension between the prosthetic valve 10 and the central region of the docking device 300 can securely hold the prosthetic valve 10 in place. In addition, the protective member 304 can act as a seal between the docking device 300 and the natural wall to prevent or reduce paravalvular leakage around the prosthetic valve 10.

[0305] Sterilization

[0306] Any system, device, equipment etc. herein can be sterilized (for example, utilizing heating / heat, pressure, steam, radiation and / or chemicals etc.) to ensure that they are safe for patient use, and any method herein can comprise the sterilization of associated system, device, equipment etc. as one of steps of the method.The example of heating / thermal sterilization comprises steam sterilization and autoclave.The example of radiation for sterilization includes but is not limited to gamma radiation, ultraviolet radiation and electron beam.The example of chemical for sterilization includes but is not limited to ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde and glutaraldehyde.The sterilization utilizing hydrogen peroxide can use for example hydrogen peroxide plasma to complete.

[0307] Additional Examples of the Disclosed Technology

[0308] In view of the above embodiments of the disclosed subject matter, the present application discloses the following additional examples. It should be noted that a feature or combination of a single example considers more than one feature of an example, and optionally combined with one or more features of one or more other examples also falls within other examples disclosed in the present application.

[0309] Example 1. A docking device for securing a prosthetic valve to a natural valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the natural valve; and a protective member comprising an expandable member and an elastic member; wherein a first end portion of the expandable member is fixedly attached to a section of the coil and a second end portion of the expandable member is axially movable relative to the coil, wherein the second end portion is opposite to the first end portion, wherein the expandable member is movable between a radially compressed state and a radially expanded state, wherein the elastic member is coupled to the expandable member and extends along the axial length of the expandable member and is movable between an axially stretched state and a stationary state, the elastic member being biased to the stationary state, wherein when the expandable member is in the radially compressed state, the elastic member is in the axially stretched state and is configured to assist the expandable member in moving from the radially compressed state to the radially expanded state, and wherein when the expandable member is in the radially expanded state, the elastic member is in the stationary state.

[0310] Example 2. The docking device of any example herein, particularly example 1, wherein the elastic member comprises thermoplastic polyurethane (TPU).

[0311] Example 3. The docking device of any example herein, in particular any of examples 1-2, wherein the elastic member is sewn to the expandable member.

[0312] Example 4. A docking device according to any example herein, in particular any of examples 1-3, wherein the elastic member is connected to the expandable member via a suture running in a helical path.

[0313] Example 5. A docking device according to any example herein, in particular 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.

[0314] Example 6. A docking device according to any example herein, particularly any of Examples 1-5, wherein the expandable member comprises a shape memory material.

[0315] Example 7. A docking device according to any example herein, particularly Example 6, wherein the expandable member comprises nitinol.

[0316] Example 8. A docking device according to any example herein, particularly any of Examples 1-7, wherein the expandable member comprises a woven material.

[0317] Example 9. A docking device according to any example herein, in particular example 8, wherein the expandable member comprises woven polyethylene terephthalate (PET).

[0318] Example 10. A docking device according to any example described herein (in particular any one of Examples 1-9), wherein the expandable member in the radially expanded state includes a plurality of expanded parts and one or more contracted parts connecting the plurality of expanded parts, wherein the expanded part has a larger radial profile than the contracted part.

[0319] Example 11. A docking device according to any example herein, in particular example 10, wherein the constricted portion and the expanded portion are made of the same material.

[0320] Example 12. A docking device according to any example herein, particularly any of Examples 10-11, wherein the contracted portion has a first weave density that is greater than a second weave density of the expanded portion.

[0321] Example 13. A docking device according to any example herein (particularly any one of Examples 10-12), wherein when the expandable member is in the radially expanded state, the contracted portion is wrapped around the coil and the expanded portion radially expands from the coil.

[0322] Example 14. The docking device of any example herein, in particular any of Examples 10-13, wherein the constriction is configured to slide axially on the coil.

[0323] Example 15. A docking device according to any example herein, in particular any of Examples 10-14, wherein the plurality of enlarged portions have approximately the same size.

[0324] Example 16. A docking device according to any example herein, in particular any of Examples 10-14, wherein the plurality of enlarged portions have different sizes.

[0325] Example 17. A docking device according to any example herein (in particular any one of Examples 10-16), wherein when the expandable member is in the radially expanded state, at least portions of two adjacent expanded portions form direct contact at a position radially outside the contraction portion, thereby connecting the two adjacent expanded portions.

[0326] Example 18. A docking device according to any example herein, in particular any of Examples 1-17, wherein the elastic member comprises an elastic strip extending parallel to a central longitudinal axis of the expandable member.

[0327] Example 19. A docking device according to any of the examples described herein (in particular any of Examples 1-18), wherein when the expandable member is in the radially expanded state and the prosthetic valve radially expands within the coil, the inner portion of the expandable member is configured to be radially compressed by the prosthetic valve so that the inner portion of the expandable member contacts the coil.

[0328] Example 20. A docking device according to any of the examples described herein (in particular any of Examples 1-19), wherein when the expandable member is in the radially expanded state, at least a portion of the protective member extends radially outward relative to the coil, so that when deployed at the natural valve, the protective member can reduce paravalvular leakage around the prosthetic valve.

[0329] Example 21. A protective member for a docking device, the docking device being configured to receive a prosthetic valve, the protective member comprising: an expandable member; and an elastic member extending along the axial length of the expandable member; wherein the expandable member is movable between a radially compressed state and a radially expanded state; wherein when the expandable member is in the radially compressed state, the elastic member is in an axially stretched state; wherein the elastic member is configured to return to a stationary state in the axially stretched state, thereby moving the expandable member from the radially compressed state to the radially expanded state.

[0330] Example 22. A protective member according to any example herein, in particular Example 21, wherein the expandable member in the radially expanded state is axially longer than the expandable member in the radially compressed state.

[0331] Example 23. A protective member according to any example herein (particularly any one of Examples 21-22), wherein the proximal end of the elastic member is attached to the proximal portion of the expandable member and the distal end of the elastic member is attached to the distal portion of the expandable member.

[0332] Example 24. A protective member according to any example herein, in particular any 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.

[0333] Example 25. A protective member according to any example herein (particularly Example 24), wherein the length of the suture is greater than or equal to the length of the elastic member in its axially stretched state, so that the suture has slack when the elastic member is in its resting state.

[0334] Example 26. The protective member of any example herein, particularly any of Examples 21-25, wherein the expandable member comprises a mesh wire frame.

[0335] Example 27. A protective member according to any example herein, in particular Example 26, wherein the elastic member extends along an outer surface of the expandable member.

[0336] Example 28. A protective member according to any example herein, in particular example 27, wherein the elastic member forms a sheath around the expansion member.

[0337] Example 29. A protective member according to any example herein, particularly Example 26, wherein the elastic member extends through the inner lumen of the expandable member.

[0338] Example 30. A protective member according to any example herein, in particular Example 29, wherein the elastic member extends along an inner surface of the expandable member.

[0339] Example 31. The protective member of any example herein, particularly Example 26, wherein the elastic member is woven into and out of the expandable member.

[0340] Example 32. The protective member of any example herein, particularly any of Examples 21-25, wherein the expandable member comprises a woven material.

[0341] Example 33. A protective member according to any example herein (particularly Example 32), wherein the expandable member comprises a plurality of expandable portions connected by one or more contraction portions, wherein the contraction portions have a higher weaving density than the expandable portions.

[0342] Example 34. A protective member according to any example herein, in particular example 33, wherein the elastic member is connected to the one or more constriction portions.

[0343] Example 35. A protective member according to any example herein, in particular any of Examples 33-34, wherein the contraction portion maintains a substantially constant diameter when the expandable member moves from the radially compressed state to the radially expanded state.

[0344] Example 36. A protective member according to any example herein (in particular any one of Examples 33-35), wherein when the expandable member is in a radially compressed state, the expandable portion has a first diameter, and when the expandable member is in a radially expanded state, the expandable portion has a second diameter, the second diameter being larger than the first diameter.

[0345] Example 37. A guard member according to any example herein, in particular Example 36, wherein the first diameter of the expandable portion is approximately the same as the diameter of the constricted portion.

[0346] Example 38. A protective member according to any example herein (particularly any one of Examples 33-37), wherein when the expandable member is in the radially expanded state, adjacent expandable portions are configured to contact each other so as to shield the contracted portion.

[0347] Example 39. The guard member of any example herein, in particular any of Examples 36-38, wherein the expandable portion is biased to the second diameter.

[0348] Example 40. A protective member according to any example herein, in particular any of Examples 21-39, wherein the elastic member extends parallel to a central longitudinal axis of the expandable member.

[0349] Example 41. A protective member for a docking device, the docking device being configured to receive a prosthetic valve, the protective member comprising: an expandable member, the expandable member comprising a woven material; wherein the expandable member comprises a plurality of expandable portions connected by one or more contraction portions, wherein the contraction portions have a higher weaving density than the expandable portions; wherein the expandable portions are movable between a first diameter and a second diameter, the second diameter being larger than the first diameter; wherein the contraction portions are configured to maintain a constant or at least substantially constant diameter when the expandable portions move between the first diameter and the second diameter.

[0350] Example 42. A protective member according to any example herein, particularly Example 41, wherein the first diameter of the expandable portion is approximately the same as the diameter of the constricted portion.

[0351] Example 43. A protective member according to any example herein, particularly Example 41, wherein the first diameter of the expandable portion is greater than the diameter of the contracting portion.

[0352] Example 44. A protective member according to any example herein, in particular any of Examples 41-43, wherein the expandable portion is configured to extend axially when moving from the second diameter to the first diameter.

[0353] Example 45. A protective member according to any example herein, in particular any one of Examples 41-44, wherein the expandable member comprises between 2 and 20 expandable portions.

[0354] Example 46. A protective member according to any example herein, in particular Example 45, wherein the expandable member comprises 6 to 12 expandable portions.

[0355] Example 47. A protective member according to any example herein, in particular Example 46, wherein the expandable member comprises 8 to 10 expandable portions.

[0356] Example 48. A protective member according to any example herein, in particular any of Examples 41-47, wherein the first diameter of the expandable portion is between 1 mm and 4 mm.

[0357] Example 49. A protective member according to any example herein, in particular Example 48, wherein the first diameter of the expandable portion is between 2 mm and 3 mm.

[0358] Example 50. A protective member according to any example herein, in particular Example 49, wherein the first diameter of the expandable portion is between 2.0 mm and 2.6 mm.

[0359] Example 51. A protective member according to any example herein, in particular any of Examples 41-50, wherein the second diameter of the expandable portion is between 4 mm and 10 mm.

[0360] Example 52. A protective member according to any example herein, in particular Example 51, wherein the second diameter of the expandable portion is between 7 mm and 9 mm.

[0361] Example 53. A protective member according to any example herein, in particular Example 52, wherein the second diameter of the expandable portion is between 7.5 mm and 8 mm.

[0362] Example 54. A protective member according to any example herein, in particular any of Examples 41-53, wherein the diameter of the constricted portion is between 0.3 mm and 3 mm.

[0363] Example 55. A protective member according to any example herein, in particular Example 54, wherein the diameter of the constricted portion is between 0.5 mm and 2.6 mm.

[0364] Example 56. A protective member according to any example herein, in particular Example 55, wherein the diameter of the constricted portion is between 1.5 mm and 2.4 mm.

[0365] Example 57. A guard member according to any example herein, in particular any of Examples 41-56, wherein each expandable portion at the second diameter has an axial length between 6 mm and 16 mm.

[0366] Example 58. A guard member according to any example herein, in particular example 57, wherein each expandable portion at the second diameter has an axial length between 8 mm and 14 mm.

[0367] Example 59. A guard member according to any example herein, in particular example 58, wherein each expandable portion at the second diameter has an axial length between 10 mm and 12 mm.

[0368] Example 60. A protective member according to any example herein, in particular any of Examples 41-59, wherein the expandable member has an axial length of between 60 mm and 120 mm when the expandable portion is at the second diameter.

[0369] Example 61. A protective member according to any example herein, in particular Example 60, wherein the expandable member has an axial length of between 70 mm and 100 mm when the expandable portion is at the second diameter.

[0370] Example 62. A protective member according to any example herein, in particular Example 60, wherein the expandable member has an axial length of between 75 mm and 85 mm when the expandable portion is at the second diameter.

[0371] Example 63. A protective member according to any example herein, in particular any of Examples 41-62, wherein each constriction has an axial length between 0.1 mm and 2 mm.

[0372] Example 64. A protective member according to any example herein, in particular Example 63, wherein each constriction has an axial length between 0.3 mm and 1.5 mm.

[0373] Example 65. A protective member according to any example herein, in particular example 64, wherein each constriction has an axial length between 0.5 mm and 1.0 mm.

[0374] Example 66. A protective member according to any example herein, in particular any of Examples 41-65, wherein the expandable member has an elongation ratio between 1.1 and 1.6.

[0375] Example 67. A protective member according to any example herein, in particular Example 66, wherein the expandable member has an elongation ratio between 1.2 and 1.5.

[0376] Example 68. The protective member according to any example herein (in particular any one of Examples 41-67) further includes an elastic member extending along the axial length of the expandable member, wherein the elastic member is movable between a resting state and an axially stretched state, the elastic member being biased to the resting state, wherein when the elastic member is in the axially stretched state, the expandable portion has the first diameter, and when the elastic member is in the resting state, the expandable portion has the second diameter.

[0377] Example 69. A protective member according to any of the examples herein (particularly Example 68), wherein the proximal end of the elastic member is attached to the proximal portion of the expandable member, and the distal end of the elastic member is attached to the distal portion of the expandable member, such that axial extension or shortening of the elastic member causes corresponding axial extension or shortening of the expandable member.

[0378] Example 70. A protective member according to any example herein, in particular any of Examples 68-69, wherein the elastic member extends parallel to the central longitudinal axis of the expandable member and connects the one or more contraction portions.

[0379] Example 71. A method for assembling a docking device configured to receive a prosthetic valve, the method comprising: attaching a protective member to a coil, wherein the coil is configured to surround natural tissue when deployed at a natural valve; wherein the protective member comprises an expandable member and an elastic member, wherein the elastic member extends along the axial length of the expandable member; wherein the elastic member is movable from a resting state to an axially stretched state, wherein the elastic member is biased to the resting state; wherein when the elastic member moves to the axially stretched state, the expandable member is in a radially compressed state; wherein when the elastic member returns to the resting state, the expandable member is in a radially expanded state.

[0380] Example 72. The method of any example herein (particularly Example 71 ) further comprises assembling the protective member, wherein assembling the protective member comprises attaching the elastic member to the expandable member.

[0381] Example 73. A method according to any example herein (particularly Example 72), wherein attaching the elastic member to the expandable member includes attaching the proximal end of the elastic member to the proximal portion of the expandable member and attaching the distal end of the elastic member to the distal portion of the expandable member.

[0382] Example 74. A method according to any example described herein (particularly any of Examples 72-73), wherein attaching the elastic member to the expandable member includes suturing the elastic member to the expandable member along the axial length of the expandable member.

[0383] Example 75. A method according to any example herein, in particular any of Examples 72-74, wherein assembling the protective member comprises braiding the expandable member using metal wires to form a mesh wire frame.

[0384] Example 76. A method according to any example herein, in particular Example 75, wherein attaching the elastic member to the expandable member comprises weaving the elastic member onto the mesh wire frame.

[0385] Example 77. A method according to any of the examples described herein (in particular any of Examples 72-74), wherein assembling the protective member includes weaving a fabric to form a plurality of expandable portions connected by one or more contracting portions, wherein the contracting portions have a higher weaving density than the expandable portions.

[0386] Example 78. A method according to any example herein (particularly Example 77), wherein attaching the elastic member to the expandable member includes connecting the elastic member to the one or more contraction portions.

[0387] Example 79. The method of any example herein, in particular any of Examples 77-78, wherein assembling the protective member further comprises shaping the plurality of expandable portions.

[0388] Example 80. A method according to any example herein (in particular any of Examples 71-79), wherein attaching the protective member to the coil includes fixedly attaching the distal end of the protective member to the coil and making the proximal end of the protective member axially movable relative to the coil.

[0389] Example 81. The method according to any example described herein (particularly any one of Examples 71-80) further includes maintaining the protective member within the delivery sheath so that the expandable member is in a radially compressed state and the elastic member is in an axially stretched state.

[0390] Example 82. A method for implanting a prosthetic valve, the method comprising: deploying a docking device at a natural valve; and deploying the prosthetic valve within the docking device; wherein the docking device comprises a coil and a protective member, the protective member being attached to the coil; wherein the protective member comprises an expandable member and an elastic member, the elastic member extending along the axial length of the expandable member; wherein the elastic member is movable from a stationary state to an axially stretched state, the elastic member being biased to the stationary state; wherein when the elastic member moves to the axially stretched state, the expandable member is in a radially compressed state; wherein when the elastic member returns to the stationary state, the expandable member is in a radially expanded state.

[0391] Example 83. The method according to any example herein (particularly Example 82) further includes delivering the docking device to the natural valve, wherein delivering the docking device includes maintaining the docking device in a substantially straight configuration within the delivery sheath.

[0392] Example 84. A method according to any example described herein (particularly Example 83), wherein maintaining the docking device within the delivery sheath includes radially compressing the expandable member to the radially compressed state and axially stretching the elastic member within the delivery sheath to the axially stretched state.

[0393] Example 85. A method according to any of the examples herein (in particular any of Examples 82-84), wherein deploying the docking device includes removing the delivery sheath from the protective member and allowing the elastic member to return to the resting state so as to move the expandable member from the radially compressed state to the radially expanded state.

[0394] Example 86. A method according to any of the examples described herein (particularly any of Examples 82-85), wherein deploying the prosthetic valve includes radially expanding the prosthetic valve so that an inner portion of the expandable member is radially compressed by the prosthetic valve and contacts the coil.

[0395] Example 87. A medical assembly comprising: a docking device according to any one of Examples 1-20 or a docking device including a protective member according to any one of Examples 21-70; and a radially expandable and compressible prosthetic valve configured to be received within the docking device.

[0396] Example 88. A medical assembly comprising: a docking device according to any one of Examples 1-20 or a docking device including a protective member according to any one of Examples 21-70; and a delivery device configured to deliver the docking device to a target implantation site of a patient.

[0397] Example 89. A docking device for securing a prosthetic valve to a natural valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the natural valve; and an expandable member extending radially outward from the coil, wherein the expandable member is movable between a radially compressed state and a radially expanded state, wherein a first end of the expandable member is fixedly attached to the coil and a second end of the expandable member is movable axially relative to the coil, wherein the second end is opposite to the first end, and wherein the expandable member comprises a braided wire frame.

[0398] Example 90. A docking device according to any example herein, in particular Example 89, wherein the braided wire frame comprises a metal alloy having shape memory properties.

[0399] Example 91. A docking device according to any example herein, particularly Example 90, wherein the metal alloy comprises nickel titanium.

[0400] Example 92. A docking device according to any example herein, in particular Example 89, wherein the metal alloy comprises a metallic material.

[0401] Example 93. A docking device according to any example herein, in particular Example 92, wherein the metal material comprises cobalt chromium or stainless steel.

[0402] Example 94. A docking device according to any example herein, in particular any of Examples 89-93, wherein the expandable member comprises a polymer material.

[0403] Example 95. A docking device according to any example herein, in particular Example 94, wherein the braided wire frame is embedded in the polymer material.

[0404] Example 96. A docking device according to any example herein (particularly any of Examples 94-95), wherein the polymer material comprises any one of polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), and thermoplastic polyurethane (TPU).

[0405] Example 97. A docking device according to any example herein, particularly any of Examples 89-96, wherein the braided wire frame comprises 16 to 128 wires, inclusive.

[0406] Example 98. A docking device according to any example herein, particularly Example 97, wherein the braided wire frame comprises 32 to 96 wires, inclusive.

[0407] Example 99. A docking device according to any example herein, particularly Example 98, wherein the braided wire frame comprises 48 to 64 wires, inclusive.

[0408] Example 100. A docking device according to any example herein, in particular any of Examples 89-99, wherein the braided wire frame has a braid density ranging from 20 to 70 picks per inch, inclusive.

[0409] Example 101. A docking device according to any example herein, particularly Example 100, wherein the braided wire frame has a braid density ranging from 25 to 65 picks per inch, inclusive.

[0410] Example 102. A docking device according to any example herein, particularly Example 101, wherein the braided wire frame has a braid density ranging from 36 to 40 picks per inch, inclusive.

[0411] Example 103. A docking device according to any example herein, particularly any of Examples 89-102, wherein the braided wire frame comprises wires having a wire diameter ranging from 0.002 inches to 0.004 inches, inclusive.

[0412] Example 104. A docking device according to any example herein, particularly Example 103, wherein the wire diameter is 0.003 inches.

[0413] Example 105. A docking device for securing a prosthetic valve to a natural valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the natural valve; and an expandable member extending radially outward from the coil, wherein the expandable member is movable between a radially compressed state and a radially expanded state, wherein a first end of the expandable member is fixedly attached to the coil and a second end of the expandable member is movable axially relative to the coil, wherein the second end is opposite to the first end, and wherein the expandable member comprises a polymer material.

[0414] Example 106. A docking device according to any example herein (particularly Example 105), wherein the polymer material comprises PET, PEEK, or TPU.

[0415] Example 107. A docking device for securing a prosthetic valve to a natural valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the natural valve; and an expandable member extending radially outward from the coil, wherein the expandable member is movable between a radially compressed state and a radially expanded state, wherein a first end of the expandable member is fixedly attached to the coil and a second end of the expandable member is movable axially relative to the coil, wherein the second end is opposite to the first end, wherein the expandable member comprises a braided metal wire frame coated with an elastomer.

[0416] Example 108. A docking device for securing a prosthetic valve to a natural valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the natural valve; and an expandable member extending radially outward from the coil, wherein the expandable member is movable between a radially compressed state and a radially expanded state, wherein a first end of the expandable member is fixedly attached to the coil and a second end of the expandable member is movable axially relative to the coil, wherein the second end is opposite to the first end, wherein the expandable member comprises one or more metal wires interwoven with one or more polymer fibers.

[0417] Example 109. A protective member for a docking device, the docking device being configured to receive a prosthetic valve, the protective member comprising: an expandable member comprising a braided wire mesh; and an elastic member extending along the 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 the 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, wherein if the elastic member is not coupled to the expandable member, the expandable member is biased toward the first radially expanded state, and wherein if the elastic member is coupled to the expandable member, the expandable member is biased toward the second radially expanded state.

[0418] Example 110. A protective member according to any example herein, in particular Example 109, wherein the elastic member comprises a coil spring.

[0419] Example 111. The protective member of any example herein, particularly Example 110, wherein the pitch of the coil spring is greater than the pitch of the braided wire mesh.

[0420] Example 112. A guard member according to any example herein, in particular Example 111, wherein the pitch of the coil spring is in a range between 3 mm and 9 mm.

[0421] Example 113. A guard member according to any example herein, in particular Example 112, wherein the pitch of the coil spring is in a range between 5 mm and 7 mm.

[0422] Example 114. A protective member according to any example herein, in particular any of Examples 110-113, wherein the coil spring comprises a first wire and the braided wire mesh comprises a second wire, wherein the first wire has a larger diameter than the second wire.

[0423] Example 115. The protective member of any example herein, in particular Example 114, wherein the diameter of the first wire is in the range from 0.15 mm to 0.22 mm.

[0424] Example 116. A protective member according to any example herein, in particular any of Examples 109-115, wherein the elastic member comprises a shape memory material.

[0425] Example 117. A protective member according to any example herein, in particular any of Examples 109-116, wherein the braided wire mesh comprises a shape memory material.

[0426] Example 118. A protective member according to any example herein (in particular any one of Examples 109-117), wherein when the expandable member is in the radially compressed state, the elastic member is in an axially stretched state, and when the expandable member is in the second radially expanded state, the elastic member is in a stationary state, wherein the elastic member is biased toward the stationary state.

[0427] Example 119. A protective member according to any example herein (particularly any one of Examples 109-118), wherein the first end of the elastic member is connected to the first end of the expandable member, and wherein the second end of the elastic member is connected to the second end of the expandable member.

[0428] Example 120. A protective member according to any example herein, in particular any one of Examples 109-119, wherein the elastic member is disposed within the lumen of the expandable member.

[0429] Example 121. A protective member according to any example herein, in particular any one of Examples 109-119, wherein the elastic member is disposed on an outer surface of the expandable member.

[0430] Example 122. A docking device for securing a prosthetic valve to a natural valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the natural valve; and a protective member comprising an expandable member and a coil spring coupled to the expandable member, wherein the coil extends through the coil spring, wherein the expandable member is movable between a radially compressed state and a radially expanded state, wherein when the expandable member is in the radially compressed state, the coil spring is axially stretched to a first length, and when the expandable member is in the radially expanded state, the coil spring returns to a second length, the second length being shorter than the first length, wherein the coil spring is biased toward the second length.

[0431] Example 123. A docking device according to any example herein (particularly Example 122), wherein a first end portion of the expandable member is fixedly attached to a section of the coil and a second end portion of the expandable member is axially movable relative to the coil.

[0432] Example 124. A docking device according to any example herein, in particular any of Examples 122-123, wherein the expandable member comprises nickel titanium alloy.

[0433] Example 125. A docking device according to any example herein, in particular any of Examples 122-124, wherein the coil spring comprises nickel-titanium alloy.

[0434] Example 126. A docking device according to any example herein, in particular any of Examples 122-125, wherein the expandable member comprises a braided wire mesh.

[0435] Example 127. A docking device according to any example herein (particularly any of Examples 122-126), wherein the first end of the coil spring is connected to the first end of the expandable member and the second end of the coil spring is connected to the second end of the expandable member.

[0436] Example 128. A docking device for securing a prosthetic valve to a natural valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the natural valve; and a protective member comprising an expandable member and a coil spring wound around the coil and coupled to the expandable member, wherein the expandable member is movable between a radially compressed state and a radially expanded state, wherein the coil spring is movable between an axially stretched state and a stationary state, the coil spring being biased to the stationary state, wherein when the expandable member is in the radially compressed state, the coil spring is in the axially stretched state and is configured to assist the expandable member in moving from the radially compressed state to the radially expanded state, and wherein when the expandable member is in the radially expanded state, the coil spring is in the stationary state.

[0437] Example 129. A method comprising sterilizing a docking device according to any of the examples herein (particularly any of Examples 1-20, 89-108, and 122-128), sterilizing a protective member according to any of the examples herein (particularly any of Examples 21-70 and 109-121), or sterilizing a medical component according to any of the examples herein (particularly any of Examples 87-88).

[0438] Example 130. A method of treating a heart in simulation, the method comprising: deploying a docking device at a target location; and deploying a prosthetic valve within the docking device; wherein the docking device comprises a coil and a protective member attached to the coil; wherein the protective member comprises an expandable member and an elastic member, wherein the elastic member extends along the axial length of the expandable member; wherein the elastic member is movable from a resting state to an axially stretched state, and the elastic member is biased to the resting state; wherein when the elastic member moves to the axially stretched state, the expandable member is in a radially compressed state; wherein when the elastic member returns to the resting state, the expandable member is in a radially expanded state.

[0439] Unless otherwise specified, features described herein with respect to any example may be combined with other features described in any one or more other examples. For example, any one or more features of one docking device may be combined with any one or more features of another docking device. As another example, any one or more features of one protective component may be combined with any one or more features of another protective component.

[0440] In view of the many possible examples to which the principles of the disclosed technology can be applied, it should be recognized that the illustrated examples are only preferred examples of the technology and should not be taken as limiting the scope of the disclosure. Rather, the scope of the claimed subject matter is defined by the appended claims and their equivalents.

Claims

1. Docking device, characterized in that The docking device is configured to secure a prosthetic valve to a native valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the native valve; and a protective member comprising an expandable member and an elastic 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, wherein the second end portion is opposite the first end portion, wherein the expandable member is movable between a radially compressed state and a radially expanded state, wherein the elastic member is coupled to the expandable member and extends along an axial length of the expandable member and is movable between an axially stretched state and a rest state, the elastic member being biased to the rest state, wherein when the expandable member is in the radially compressed state, the elastic member is in the axially stretched state and is configured to assist the expandable member in moving from the radially compressed state to the radially expanded state, and wherein when the expandable member is in the radially expanded state, the elastic member is in the rest state, wherein the expandable member in the radially expanded state comprises a plurality of expanded portions and one or more contracted portions connecting the plurality of expanded portions, wherein the expanded portions have a larger radial profile than the contracted portions, The plurality of enlarged portions may have approximately the same or different sizes.

2. The docking device according to claim 1, characterized in that: When the expandable member is in the radially expanded state, at least portions of two adjacent expanded portions are in direct contact at positions radially outside the contracted portion, thereby connecting the two adjacent expanded portions.

3. The docking device according to claim 1, characterized in that: The elastic member includes an elastic strip extending parallel to a central longitudinal axis of the expandable member.

4. The docking device according to claim 1, characterized in that: When the expandable member is in the radially expanded state and the prosthetic valve is radially expanded within the coil, the inner portion of the expandable member is configured to be radially compressed by the prosthetic valve such that the inner portion of the expandable member contacts the coil.

5. The docking device according to claim 1, characterized in that: When the expandable member is in the radially expanded state, at least a portion of the guard member extends radially outward relative to the coil, such that when deployed at the native valve, the guard member can reduce paravalvular leakage around the prosthetic valve.

6. A protective component for a docking device, characterized in that: The docking device is configured to receive a prosthetic valve, the protective member comprising: an expandable member; and an elastic member extending along the axial length of the expandable member; wherein the expandable member is movable between a radially compressed state and a radially expanded state; wherein when the expandable member is in the radially compressed state, the elastic member is in an axially stretched state; wherein the elastic member is configured to return to a rest state in the axially stretched state, thereby moving the expandable member from the radially compressed state to the radially expanded state, The expandable member in the radially expanded state is axially longer than the expandable member in the radially compressed state.

7. The protective component according to claim 6, characterized in that The proximal end of the elastic member is attached to the proximal portion of the expandable member, and the distal end of the elastic member is attached to the distal portion of the expandable member.

8. The protective component according to claim 6, characterized in that The resilient member is attached to the expandable member via a continuous suture extending along an axial length of the expandable member.

9. The protective component according to claim 8, characterized in that: The length of the suture is greater than or equal to the length of the elastic member in its axially stretched state, such that the suture has slack when the elastic member is in its resting state.

10. The protective member according to claim 6, characterized in that The expandable member includes a mesh wire frame.

11. The protective component according to claim 10, characterized in that: The elastic member extends along an outer surface of the expandable member.

12. The protective member according to claim 11, characterized in that The elastic member forms a sheath surrounding the expansion member.

13. The protective member according to claim 10, characterized in that The elastic member extends through the inner lumen of the expandable member.

14. The protective member according to claim 13, characterized in that The elastic member extends along an inner surface of the expandable member.

15. The protective member according to claim 6, characterized in that The expandable member includes a plurality of expandable portions connected by one or more contracting portions, and the contracting portions maintain a substantially constant diameter when the expandable member moves from the radially compressed state to the radially expanded state.

16. The protective member according to claim 15, characterized in that The expandable portion has a first diameter when the expandable member is in a radially compressed state, and has a second diameter when the expandable member is in a radially expanded state, the second diameter being greater than the first diameter.

17. The protective member according to claim 16, characterized in that The first diameter of the expandable portion is approximately the same as the diameter of the constricted portion.

18. The protective member according to claim 16, characterized in that When the expandable member is in the radially expanded state, adjacent expandable portions are configured to contact each other so as to shield the contracted portion.

19. The protective component according to any one of claims 16 to 18, characterized in that: The expandable portion is biased to the second diameter.

20. The protective member according to claim 6, characterized in that The resilient member extends parallel to a central longitudinal axis of the expandable member.

21. A protective member for a docking device configured to receive a prosthetic valve, characterized in that The protective member comprises: an expandable member comprising a woven material; wherein the expandable member comprises a plurality of expandable portions connected by one or more constricted portions, wherein the constricted portions have a higher weave density than the expandable portions; wherein the expandable portions are movable between a first diameter and a second diameter, the second diameter being larger than the first diameter; wherein the constricted portions are configured to maintain a constant or at least constant diameter when the expandable portions move between the first diameter and the second diameter, The first diameter of the expandable portion is greater than or approximately the same as the diameter of the contracted portion.

22. The protective member according to claim 21, characterized in that The expandable portion is configured to axially extend when moving from the second diameter to the first diameter.

23. The protective member according to claim 21, characterized in that The expandable member includes 2 to 20 expandable sections.

24. The protective member according to claim 23, characterized in that The expandable member may include 6 to 12 expandable sections.

25. The protective member according to claim 24, characterized in that The expandable member may include 8 to 10 expandable sections.

26. The protective member according to claim 21, characterized in that The first diameter of the expandable portion is between 1 mm and 4 mm.

27. The protective member according to claim 26, characterized in that The first diameter of the expandable portion is between 2 mm and 3 mm.

28. The protective member according to claim 27, characterized in that The first diameter of the expandable portion is between 2.0 mm and 2.6 mm.

29. The protective member according to claim 21, wherein The second diameter of the expandable portion is between 4 mm and 10 mm.

30. The protective member according to claim 29, characterized in that The second diameter of the expandable portion is between 7 mm and 9 mm.

31. The protective member according to claim 30, characterized in that The second diameter of the expandable portion is between 7.5 mm and 8 mm.

32. The protective member according to claim 21, characterized in that The diameter of the constriction is between 0.3 mm and 3 mm.

33. The protective member according to claim 32, characterized in that The diameter of the constriction is between 0.5 mm and 2.6 mm.

34. The protective member according to claim 33, characterized in that The diameter of the constriction is between 1.5 mm and 2.4 mm.

35. The protective member according to claim 21, characterized in that Each expandable portion at the second diameter has an axial length of between 6 mm and 16 mm.

36. The protective member according to claim 35, characterized in that Each expandable portion at the second diameter has an axial length of between 8 mm and 14 mm.

37. The protective member according to claim 36, characterized in that Each expandable portion at said second diameter has an axial length of between 10 mm and 12 mm.

38. The protective member according to claim 21, characterized in that When the expandable portion is at the second diameter, the expandable member has an axial length of between 60 mm and 120 mm.

39. The protective member according to claim 38, characterized in that When the expandable portion is at the second diameter, the expandable member has an axial length of between 70 mm and 100 mm.

40. The protective member according to claim 38, wherein When the expandable portion is at the second diameter, the expandable member has an axial length of between 75 mm and 85 mm.

41. The protective member according to claim 21, characterized in that Each constriction has an axial length between 0.1 mm and 2 mm.

42. The protective member according to claim 41, characterized in that Each constriction has an axial length of between 0.3 mm and 1.5 mm.

43. The protective member according to claim 42, characterized in that Each constriction has an axial length of between 0.5 mm and 1.0 mm.

44. The protective member according to claim 21, characterized in that The expandable member may have an elongation ratio between 1.1 and 1.

6.

45. The protective member according to claim 44, characterized in that The expandable member may have an elongation ratio between 1.2 and 1.

5.

46. A medical component, characterized in that include: A docking device according to any one of claims 1 to 5 or a docking device comprising a protective member according to any one of claims 6 to 45; and a radially expandable and compressible prosthetic valve configured to be received within the docking device.

47. A medical component, characterized in that include: A docking device according to any one of claims 1 to 5 or a docking device comprising a protective member according to any one of claims 6 to 45; and a delivery device configured to deliver the docking device to a target implantation site in a patient.

48. Docking device, characterized in that The docking device is configured to secure a prosthetic valve to a native valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the native valve; and an expandable member extending radially outward from the coil, wherein the expandable member is movable between a radially compressed state and a radially expanded state, wherein a first end of the expandable member is fixedly attached to the coil and a second end of the expandable member is axially movable relative to the coil, wherein the second end is opposite the first end, wherein the expandable member comprises a braided wire frame, Wherein the braided wire frame comprises a metal alloy having shape memory properties.

49. The docking device according to claim 48, characterized in that The metal alloy includes nickel titanium.

50. The docking device according to claim 48, wherein: The metal alloy includes a metal material.

51. The docking device according to claim 50, characterized in that The metal material includes cobalt chromium or stainless steel.

52. The docking device according to claim 48, wherein: The expandable member includes a polymer material.

53. The docking device according to claim 52, characterized in that The braided wire frame is embedded in the polymer material.

54. The docking device according to any one of claims 52-53, characterized in that The polymer material includes any one of polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), and thermoplastic polyurethane (TPU).

55. The docking device according to claim 48, wherein The braided wire frame includes 16 to 128 wires, inclusive.

56. The docking device according to claim 55, characterized in that The braided wire frame includes 32 to 96 wires, inclusive.

57. The docking device according to claim 56, characterized in that The braided wire frame includes 48 to 64 wires, inclusive.

58. The docking device according to claim 48, wherein: The braided wire frame has a braid density ranging from 20 to 70 picks per inch, inclusive.

59. The docking device according to claim 58, characterized in that The braided wire frame has a braid density ranging from 25 to 65 picks per inch, inclusive.

60. The docking device according to claim 59, wherein: The braided wire frame has a braid density ranging from 36 to 40 picks per inch, inclusive.

61. The docking device according to claim 48, wherein: The braided wire frame includes wires having a wire diameter ranging from 0.002 inches to 0.004 inches, inclusive.

62. The docking device according to claim 61, characterized in that The wire diameter is 0.003 inches.

63. Docking device, characterized in that The docking device is configured to secure a prosthetic valve to a natural valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the natural valve; and an expandable member extending radially outward from the coil, wherein the expandable member is movable between a radially compressed state and a radially expanded state, wherein a first end of the expandable member is fixedly attached to the coil and a second end of the expandable member is axially movable relative to the coil, wherein the second end is opposite to the first end, and wherein the expandable member comprises a polymer material.

64. The docking device according to claim 63, characterized in that The polymer material includes PET, PEEK or TPU.

65. Docking device, characterized in that The docking device is configured to secure a prosthetic valve to a native valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the native valve; and an expandable member extending radially outward from the coil, wherein the expandable member is movable between a radially compressed state and a radially expanded state, wherein a first end of the expandable member is fixedly attached to the coil and a second end of the expandable member is axially movable relative to the coil, wherein the second end is opposite the first end, wherein the expandable member comprises a braided metal wire frame coated with an elastomer.

66. Docking device, characterized in that The docking device is configured to secure a prosthetic valve to a native valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the native valve; and an expandable member extending radially outward from the coil, wherein the expandable member is movable between a radially compressed state and a radially expanded state, wherein a first end of the expandable member is fixedly attached to the coil and a second end of the expandable member is axially movable relative to the coil, wherein the second end is opposite the first end, wherein the expandable member comprises one or more metal wires interwoven with one or more polymer fibers.

67. A protective member for a docking device configured to receive a prosthetic valve, characterized in that The protective member includes: an expandable member, which includes a braided wire mesh; and an elastic member, which extends along the 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 the 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, wherein if the elastic member is not coupled to the expandable member, the expandable member is biased toward the first radially expanded state, and wherein if the elastic member is coupled to the expandable member, the expandable member is biased toward the second radially expanded state.

68. The protective member according to claim 67, characterized in that The elastic member includes a coil spring.

69. The protective member according to claim 68, characterized in that The pitch of the coil spring is greater than the pitch of the braided wire mesh.

70. The protective member according to claim 69, characterized in that The pitch of the coil spring is in the range between 3 mm and 9 mm.

71. The protective member according to claim 70, characterized in that The pitch of the coil spring is in the range between 5 mm and 7 mm.

72. The protective member according to claim 68, characterized in that The coil spring includes a first wire and the braided wire mesh includes a second wire, wherein the first wire has a larger diameter than the second wire.

73. The protective member according to claim 72, characterized in that The diameter of the first wire is in the range from 0.15 mm to 0.22 mm.

74. The protective member according to any one of claims 67 to 73, characterized in that The elastic member includes a shape memory material.

75. The protective member according to any one of claims 67 to 73, characterized in that The braided wire mesh includes a shape memory material.

76. The protective member according to any one of claims 67 to 73, characterized in that The resilient member is in an axially stretched state when the expandable member is in the radially compressed state, and is in a rest state when the expandable member is in the second radially expanded state, wherein the resilient member is biased toward the rest state.

77. The protective member according to any one of claims 67 to 73, characterized in that The first end of the elastic member is connected to the first end of the expandable member, wherein the second end of the elastic member is connected to the second end of the expandable member.

78. The protective member according to any one of claims 67 to 73, characterized in that The elastic member is disposed within the lumen of the expandable member.

79. The protective member according to any one of claims 67 to 73, characterized in that The elastic member is disposed on an outer surface of the expandable member.

80. Docking device, characterized in that The docking device is configured to secure a prosthetic valve to a natural valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the natural valve; and a protective member comprising an expandable member and a coil spring coupled to the expandable member, wherein the coil extends through the coil spring, wherein the expandable member is movable between a radially compressed state and a radially expanded state, wherein when the expandable member is in the radially compressed state, the coil spring is axially stretched to a first length, and when the expandable member is in the radially expanded state, the coil spring returns to a second length, the second length being shorter than the first length, wherein the coil spring is biased toward the second length.

81. The docking device according to claim 80, characterized in that 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.

82. The docking device according to claim 80, wherein: The expandable member comprises nickel titanium alloy.

83. The docking device according to any one of claims 80 to 82, characterized in that: The coil spring comprises nickel titanium alloy.

84. The docking device according to any one of claims 80 to 82, characterized in that The expandable member includes a braided wire mesh.

85. The docking device according to any one of claims 80 to 82, characterized in that A first end of the coil spring is connected to the first end of the expandable member, and a second end of the coil spring is connected to the second end of the expandable member.

86. Docking device, characterized in that The docking device is configured to fix the prosthetic valve to the natural valve, and the docking device includes: a coil, which, when deployed at the natural valve, includes a plurality of helical turns; and a protective member, which includes an expandable member and a coil spring, which is wound around the coil and coupled to the expandable member, wherein the expandable member is movable between a radially compressed state and a radially expanded state, wherein the coil spring is movable between an axially stretched state and a stationary state, and the coil spring is biased to the stationary state, wherein when the expandable member is in the radially compressed state, the coil spring is in the axially stretched state and is configured to assist the expandable member in moving from the radially compressed state to the radially expanded state, and wherein when the expandable member is in the radially expanded state, the coil spring is in the stationary state.

Images