PROSTHETIC VALVE DOCKING DEVICE

Abstract

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

Description

FIELD

The present disclosure concerns examples of a docking device configured to secure a prosthetic valve at a native heart valve, as well as methods of assembling such devices.

BACKGROUND

Prosthetic valves can be used to treat cardiac valvular disorders. Native heart valves (e.g., the aortic, pulmonary, tricuspid and mitral valves) function to prevent backward flow or regurgitation, while allowing forward flow. These heart valves can be rendered less effective by congenital, inflammatory, infectious conditions, etc. Such conditions can eventually lead to serious cardiovascular compromise or death. For many years, the doctors attempted to treat such disorders with surgical repair or replacement of the valve during open heart surgery.

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

In some instances, a transcatheter heart valve (THV) may be appropriately sized to be placed inside a particular native valve (e.g., a native aortic valve). As such, the THV may not be suitable for implantation at another native valve (e.g., a native mitral valve) and/or in a patient with a larger native valve. Additionally or alternatively, the native tissue at the implantation site may not provide sufficient structure for the THV to be secured in place relative to the native tissue. Accordingly, improvements to THVs and the associated transcatheter delivery apparatus are desirable.

SUMMARY

The present disclosure relates to methods and devices for treating valvular regurgitation and/or other valve issues. Specifically, the present disclosure is directed to a docking device configured to receive a prosthetic valve and the methods of assembling the docking device and implanting the docking device.

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

In certain examples, a docking device can comprise a guard member including an expandable member and an elastic member.

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

In certain examples, the expandable member can be movable between a radially compressed state and a radially expanded state.

In certain examples, the elastic member can be coupled to and extend along an axial length of the expandable member and can be movable between an axially stretched state and a resting state, the elastic member being biased to the resting state.

In certain examples, when the expandable member is in the radially compressed state, the elastic member can be in the axially stretched state and configured to assist the expandable member to move from the radially compressed state to the radially expanded state.

In certain examples, when the expandable member is in the radially expanded state, the elastic member can be in the resting state.

In certain examples, a guard member for a docking device can comprise an expandable member and an elastic member extending along an axial length of the expandable member.

In certain examples, the expandable member can be movable between a radially compressed state and a radially expanded state.

In certain examples, when the expandable member is in the radially compressed state, the elastic member can be in an axially stretched state.

In certain examples, the elastic member in the axially stretched state can be configured to return to a resting state, thereby moving the expandable member from the radially compressed state to the radially expanded state.

In certain examples, a guard member for a docking device can comprise an expandable member having a woven material.

In certain examples, the expandable member can include a plurality of enlargeable portions connected by one or more constricted portions.

In certain examples, the constricted portions can have a higher weave density than the enlargeable portions.

In certain examples, the enlargeable portions can be movable between a first diameter and a second diameter, the second diameter being larger than the first diameter.

In certain examples, the constricted portions can be configured to remain at a constant or at least substantially constant diameter when the enlargeable portions move between the first diameter and the second diameter.

Certain examples of the disclosure concern a docking device for securing a prosthetic valve at a native valve. The docking device can include a coil having a plurality of helical turns when deployed at the native valve, and a guard member including an expandable member and an elastic member. A first end portion of the expandable member can be fixedly attached to a segment of the coil, and a second end portion of the expandable member can be axially movable relative to the coil. The second end portion is opposite to the first end portion. The expandable member can be movable between a radially compressed state and a radially expanded state. The elastic member can be coupled to and extend along an axial length of the expandable member and can 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 can be in the axially stretched state and configured to assist the expandable member to move from the radially compressed state to the radially expanded state. When the expandable member is in the radially expanded state, the elastic member can be in the resting state.

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

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

Certain aspects of the disclosure concern a method for assembling a docking device configured to receive a prosthetic valve. The method can include attaching a guard member to a coil. The coil can be configured to surround native tissue when deployed at a native valve. The guard member can include an expandable member and an elastic member extending along an axial length of the expandable member. The elastic member can be moved from a resting state to an axially stretched state, the elastic member being biased to the resting state. The expandable member can be in a radially compressed state when the elastic member is moved to the axially stretched state. The expandable member can be in a radially expanded state when the elastic member returns to the resting state.

Certain aspects of the disclosure also concern a method for implanting a prosthetic valve. The method can include deploying a docking device at a native valve, and deploying the prosthetic valve within the docking device. The docking device can include a coil and a guard member attached to the coil. The guard member can include an expandable member and an elastic member extending along an axial length of the expandable member. The elastic member can be moved from a resting state to an axially stretched state, the elastic member being biased to the resting state. The expandable member can be in a radially compressed state when the elastic member is moved to the axially stretched state. The expandable member can be in a radially expanded state when the elastic member returns to the resting state.

The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with body parts, heart, tissue, etc. being simulated).

Certain examples of the disclosure concern a medical assembly including any of the docking devices describe above or a docking device having any of the guard members described above, and a radially expandable and compressible prosthetic valve configured to be received within the docking device.

Certain aspects of the disclosure also concern a medical assembly including any of the docking devices describe above or a docking device having any of the guard members described above, and a delivery apparatus configured to deliver the docking device to a target implantation site of a patient.

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

According to certain examples, the expandable member can include a braided wire frame.

According to certain examples, the expandable member can include a polymeric material.

According to certain examples, the expandable member can include a braided metallic wireframe coated with an elastomer.

According to certain examples, the expandable member can include one or more metallic wires interwoven with one or more polymeric fibers.

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

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

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

In some examples, a docking device comprises one or more of the components recited in Examples 1-20, 89-108, and 122-128 described in the section “Additional Examples of the Disclosed Technology” below.

In some examples, a guard member comprises one or more of the components recited in Examples 21-70 and 109-121 described in the section “Additional Examples of the Disclosed Technology” below.

The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side perspective view of a docking device in a helical configuration, according to one example.

FIG. 1B is a top view of the docking device depicted in FIG. 1A.

FIG. 1C is a cross-sectional view of the docking device taken along line 1C-1C depicted in FIG. 1B, according to one example.

FIG. 1D is a cross-sectional view of the docking device taken along the same line as in

FIG. 1C, except in FIG. 1D, the docking device is in a substantially straight delivery configuration.

FIG. 1E is a cross-sectional view of the docking device taken along line 1C-1C depicted in FIG. 1B, according to another example.

FIG. 1F is a cross-sectional view of the docking device taken along the same line as in

FIG. 1E, except in FIG. 1F, the docking device is in a substantially straight delivery configuration.

FIG. 1G is a schematic diagram depicting the docking device in a substantially straight configuration.

FIG. 2A is a perspective view a prosthetic valve, according to one example.

FIG. 2B is a perspective view of the prosthetic valve of FIG. 2A with an outer cover, according to one example.

FIG. 3A is a perspective view of an exemplary prosthetic implant assembly comprising the docking device depicted in FIG. 1A and the prosthetic valve of FIG. 2B retained within the docking device.

FIG. 3B is a side elevation view of the prosthetic implant assembly of FIG. 3.

FIG. 4A depicts an expandable member coupled to an elastic member, according to one example.

FIG. 4B depicts an expandable member coupled to an elastic member, according to another example.

FIG. 4C depicts an expandable member coupled to another elastic member in the form of a coil spring, according to one example, wherein the coil spring is in a resting state.

FIG. 4D depicts the expandable member coupled to the coil spring of FIG. 4C, wherein the coil spring is in an axially stretched state.

FIG. 5A is a top view of a docking device comprising a texturized woven guard member, according to one example.

FIG. 5B is a side elevation view of the docking device of FIG. 5A.

FIG. 6A depicts a texturized woven guard member in a radially compressed and axially elongated configuration.

FIG. 6B depicts the texturized woven guard member of FIG. 6A in a radially expanded and axially foreshortened configuration.

FIG. 6C depicts a portion of the texturized woven guard member of FIG. 6A.

FIG. 7A is a schematic top view of a docking device comprising a texturized woven guard member and a prosthetic valve expanded within a coil of the docking device, according to one example.

FIG. 7B is a view of a texturized woven guard member after it is cut along a longitudinal axis and flattened, according to one example.

FIG. 7C is a cross-sectional view of a portion of the texturized woven guard member taken along the longitudinal axis and an inner portion of enlargeable portions is radially compressed by the prosthetic valve and contacts the coil, according to one example.

FIG. 8 is a side view of a delivery assembly comprising a delivery apparatus and the docking device of FIG. 1A, according to one example.

FIG. 9A is a side cross-sectional view of a sleeve shaft, according to one example.

FIG. 9B is a side cross-sectional view of a pusher shaft, according to one example.

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

FIG. 10B is a side cross-sectional view of the same assembly of FIG. 10A, except the docking device is uncovered by the sleeve shaft.

FIG. 11 is a schematic cross-sectional view of a distal end portion of a delivery system, showing fluid flow through lumens within the delivery system.

FIG. 12A illustrates a perspective view of an example of a sleeve shaft covering a docking device and extending outside of a delivery sheath of a delivery system.

FIG. 12B illustrates the sleeve shaft surrounding a pusher shaft after deploying the docking device from the delivery system of FIG. 12A and removing the sleeve shaft from the docking device.

FIGS. 13-26 depict various portions of an exemplary implantation procedure in which the delivery apparatus of FIG. 8 is being used to implant the prosthetic implant assembly of FIG. 3A at a native mitral valve location using a transseptal delivery approach.

FIG. 27 is an atrial side view of another docking device implanted in the mitral valve, according to one example.

FIG. 28 is an atrial side view of the docking device of FIG. 27 after a prosthetic valve is received within the docking device, according to one example.

DETAILED DESCRIPTION

General Considerations

It should be understood that the disclosed examples can be adapted to deliver and implant prosthetic devices in any of the native annuluses of the heart (e.g., the pulmonary, mitral, and tricuspid annuluses), and can be used with any of various delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the terms “coupled” and “connected” generally mean electrically, electromagnetically, and/or physically (e.g., mechanically or chemically) coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

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

As used herein, the term “approximately” and “about” means the listed value and any value that is within 10% of the listed value. For example, “about 1 mm” means any value between about 0.9 mm and about 1.1 mm, inclusive.

Directions and other relative references (e.g., inner, outer, upper, lower, etc.) may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as “inside,” “outside,”, “top,” “down,” “interior,” “exterior,” and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and/or orientations. For example, with respect to an object, an “upper” part can become a “lower” part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same. As used herein, “and/or” means “and” or “or,” as well as “and” and “or.”

Introduction to the Disclosed Technology

Disclosed herein are various systems, apparatuses, methods, etc., including anchoring or docking devices, which can be used in conjunction with expandable prosthetic valves at a native valve annulus (e.g., a native mitral and/or tricuspid valve annulus), in order to more securely implant and hold the prosthetic valve at the implant site. Anchoring/docking devices according to examples of the disclosure can, for example, provide a stable anchoring site, landing zone, or implantation zone at the implant site in which prosthetic valves can be expanded or otherwise implanted. Many of the disclosed docking devices comprise a circular or cylindrically-shaped portion, which can (for example) allow a prosthetic heart valve comprising a circular or cylindrically-shaped valve frame to be expanded or otherwise implanted into native locations with naturally circular cross-sectional profiles and/or in native locations with naturally with non-circular cross sections. In addition to providing an anchoring site for the prosthetic valve, the anchoring/docking devices can be sized and shaped to cinch or draw the native valve (e.g., mitral, tricuspid, etc.) anatomy radially inwards. In this manner, one of the main causes of valve regurgitation (e.g., functional mitral regurgitation), specifically enlargement of the heart (e.g., enlargement of the left ventricle, etc.) and/or valve annulus, and consequent stretching out of the native valve (e.g., mitral, etc.) annulus, can be at least partially offset or counteracted. Some examples of the anchoring or docking devices further include features which, for example, are shaped and/or modified to better hold a position or shape of the docking device during and/or after expansion of a prosthetic valve therein. By providing such anchoring or docking devices, replacement valves can be more securely implanted and held at various valve annuluses, including at the mitral valve annulus which does not have a naturally circular cross-section.

In some instances, a docking device can comprise a paravalvular leakage (PVL) guard (also referred to herein as “a guard member”). The PVL guard can, for example, help reduce regurgitation and/or promote tissue ingrowth between the native tissue and the docking device.

The PVL guard can, in some examples, be movable between a delivery configuration and a deployed configuration. When the PVL guard is in the delivery configuration, an outer edge of the PVL guard can extend along and adjacent the coil. When the PVL guard is in the deployed configuration, the outer edge of the PVL guard can form a helical shape rotating about a central longitudinal axis of the coil and at least a segment of the outer edge of PVL guard can extend radially away from the coil.

In certain examples, the PVL guard can cover or surround a portion of a coil of the docking device. As described more fully below, such PVL guard can move from a radially compressed (and axially elongated) state to a radially expanded (and axially foreshortened) state, and a proximal end portion of the PVL guard can be axially movable relative to the coil.

Exemplary methods of attaching the PVL guard to the docking device and example methods of limiting axial movement of the PVL guard are also disclosed herein.

Exemplary Docking Devices

FIGS. 1A-1G show a docking device 100, according to one example. The docking device 100 can, for example, be implanted within a native valve annulus (see, e.g., FIG. 15). As depicted in FIGS. 3A-3B and FIG. 26, 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 valve annulus.

Referring to FIGS. 1A-1G, the docking device 100 can comprise a coil 102 and a guard member 104 covering at least a portion of the coil 102. In certain examples, the coil 102 can include a shape memory material (e.g., nickel titanium alloy or “Nitinol”) such that the docking device 100 (and the coil 102) can move from a substantially straight configuration (also referred to as “delivery configuration”) when disposed within a delivery sheath of a delivery apparatus (as described more fully below) to a helical configuration (also referred to as “deployed configuration,” as shown in FIGS. 1A-1B) after being removed from the delivery sheath.

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

In some examples, the docking device 100 can also include a retention element 114 surrounding at least a portion of the coil 102 and at least being partially covered by the guard member 104. In some instances, the retention element 114 can comprise a braided material. In addition, the retention element 114 can provide a surface area that encourages or promotes tissue ingrowth and/or adherence, and/or reduce trauma to native tissue. For example, in certain instances, the retention element 114 can have a textured outer surface configured to promote tissue ingrowth. In certain instances, the retention element 114 can be impregnated with growth factors to stimulate or promote tissue ingrowth.

In one example, as illustrated in FIGS. 1A-1B and 3A-3B, at least a proximal end portion of the retention element 114 can extend out of a proximal end of the guard member 104. In another example, the retention element 114 can be completely covered by the guard member 104.

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

The coil 102 has a proximal end 102p and a distal end 102d (which also respectively define the proximal and distal ends of the docking device 100). When being disposed within the delivery sheath (e.g., during delivery of the docking device into the vasculature of a patient), a body of the coil 102 between the proximal end 102p and distal end 102d can form a generally straight delivery configuration (i.e., without any coiled or looped portions, but can be flexed or bent) so as to maintain a small radial profile when moving through a patient's vasculature. After being removed from the delivery sheath and deployed at an implant position, the coil 102 can move from the delivery configuration to the helical deployed configuration and wrap around native tissue adjacent the implant position. For example, when implanting the docking device at the location of a native valve, the coil 102 can be configured to surround native leaflets of the native valve (and the chordae tendineae that connects native leaflets to adjacent papillary muscles, if present), as described further below.

The docking device 100 can be releasably coupled to a delivery apparatus. For example, in certain examples, the docking device 100 can be coupled to a delivery apparatus (as described further below) via a release suture that 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 through an eyelet or eyehole 103 located adjacent the proximal end 102p of the coil. In another example, the release suture can be tied around a circumferential recess that is located adjacent the proximal end 102p of the coil 102.

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

As shown in FIGS. 1A-1B, the coil 102 in the deployed configuration can include a leading turn 106 (or “leading coil”), a central region 108, and a stabilization turn 110 (or “stabilization coil”) around the central longitudinal axis 101. The central region 108 can possess one or more helical turns having substantially equal inner diameters. The leading turn 106 can extend from a distal end of the central region 108 and has a diameter greater than the diameter of the central region 108 (in one or more configurations). The stabilization turn 110 can extend from a proximal end of the central region 108 and has a diameter greater than the diameter of the central region 108 (in one or more configurations).

In certain examples, the central region 108 can include a plurality of helical turns, such as a proximal turn 108p in connection with the stabilization turn 110, a distal turn 108d in connection with the leading turn 106, and one or more intermediate turns 108m disposed between the proximal turn 108p and the distal turn 108d. In the example shown in FIG. 1A, there is only one intermediate turn 108m between the proximal turn 108p and the distal turn 108d. In other examples, there are more than one intermediate turns 108m between the proximal turn 108p and the distal turn 108d. Some of the helical turns in the central region 108 can be full turns (i.e., rotating 360 degrees). In some examples, the proximal turn 108p and/or the distal turn 108d can be partial turns (e.g., rotating less than 360 degrees, such as 180 degrees, 270 degrees, etc.).

A size of the docking device 100 can be generally selected based on the size of the desired prosthetic valve to be implanted into the patient. In certain examples, the central region 108 can be configured to retain a radially expandable prosthetic valve (as shown in FIGS. 3A-3B and described further below). For example, the inner diameter of the helical turns in the central region 108 can be configured to be smaller than an outer diameter of the prosthetic valve when the prosthetic valve is radially expanded so that additional radial force 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.”

The stabilization turn 110 can be configured to help stabilize the docking device 100 in the desired position. For example, the radial dimension of the stabilization turn 110 can be significantly larger than the radial dimension of the coil in the central region 108, so that the stabilization turn 110 can flare or extend sufficiently outwardly so as to abut or push against the walls of the circulatory system, thereby improving the ability of the docking device 100 to stay in its desired position prior to the implantation of the prosthetic valve. In some examples, the diameter of stabilization turn 110 is desirably larger than the native annulus, native valve plane, and/or native chamber for better stabilization. In some examples, the stabilization turn 110 can be a full turn (i.e., rotating about 360 degrees). In some examples, the stabilization turn 110 can be a partial turn (e.g., rotating between about 180 degrees and about 270 degrees).

In one particular example, when implanting the docking device 100 at the native mitral valve location, the functional turns in the central region 108 can be disposed substantially in the left ventricle and the stabilization turn 110 can be disposed substantially in the left atrium. The stabilization turn 110 can be configured to provide one or more points or regions of contact between the docking device 100 and the left atrial wall, such as at least three points of contact in the left atrium or complete contact on the left atrial wall. In certain examples, the points of contact between the docking device 100 and the left atrial wall can form a plane that is approximately parallel to a plane of the native mitral valve.

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

As noted above, the leading turn 106 can have a larger radial dimension than the helical turns in the central region 108. As described herein, the leading turn 106 can help more easily guide the coil 102 around and/or through the chordae tendineae and/or adequately around all native leaflets of the native valve (e.g., the native mitral valve, tricuspid valve, etc.). For example, once the leading turn 106 is navigated around the desired native anatomy, the remaining coil (such as the functional turns) of the docking device 100 can also be guided around the same features. In some examples, the leading turn 106 can be a full turn (i.e., rotating about 360 degrees). In some examples, the leading turn 106 can be a partial turn (e.g., rotating between about 180 degrees and about 270 degrees). As described further below in reference to FIG. 24, when a 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. As a result, the leading turn 106 can be pulled in the proximal direction and become a part of the functional turn in the central region 108.

In certain examples, at least a portion of the coil 102 can be surrounded by a first cover 112. As shown in FIGS. 1C-1F, the first cover 112 can have a tubular shape and thus can also be referred to as a “tubular member.” In certain examples, the tubular member 112 can cover an entire length of the coil 102. In certain examples, the tubular member 112 covers only selected portion(s) of the coil 102.

In certain examples, the tubular member 112 can be coated on and/or bonded on the coil 102. In certain examples, the tubular member 112 can be a cushioned, padded-type layer protecting the coil. The tubular member 112 can be constructed of various native and/or synthetic materials. In one particular example, the tubular member 112 can include expanded polytetrafluoroethylene (ePTFE). In certain examples, the tubular member 112 is configured to be fixedly attached to the coil 102 (e.g., by means of textured surface resistance, suture, glue, thermal bonding, or any other means) so that relative axial movement between the tubular member 112 and the coil 102 is restricted or prohibited.

In some examples, as illustrated in FIGS. 1C-1D, at least a portion of the tubular member 112 can be surrounded by the retention element 114. In some examples, the tubular member 112 can extend through an entire length of the retention element 114. Exemplary methods of attaching the retention element 114 to the tubular member 112 are described further below.

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

In certain examples, the docking device 100 can have one or more seating markers. For example, FIGS. 1A-1B show a proximal seating marker 121p and a distal seating marker 121d, wherein the proximal seating marker 121p is positioned proximal relative to the distal seating marker 121d. Both the proximal and distal seating markers 121p, 121d can have predefined locations relative to the coil 102. As shown, both the proximal and distal seating markers 121p, 121d can be disposed distal to the ascending portion 110b, e.g., at the atrial portion 110a, of the coil 102. In addition, a proximal end portion of the retention element 114 can extend to, and/or positioned at, the ascending portion 110b.

In certain examples, both the proximal and distal seating markers 121p, 121d can include a radiopaque material so that these seating markers can be visible under fluoroscopy such as during an implantation procedure. As described further below, the seating markers 121p, 121d can be used to mark the proximal and distal boundaries of a segment of the coil 102 where the proximal end 105 of the guard member 104 can be positioned when deploying the docking device 100.

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

In certain examples, a segment of the coil 102 located between the proximal seating marker 121p and the distal seating marker 121d can have an axial length 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 coil segment between the proximal seating marker 121p and the distal seating marker 121d is about 4 mm.

In certain examples, an axial distance between the proximal seating marker 121p and a 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 seating marker 121p and the distal end of the ascending portion 110b is about 20 mm.

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

As described herein, the guard member 104 can constitute a part of a cover assembly 120 for the docking device 100. In some examples, the cover assembly 120 can also include the tubular member 112. In some examples, the cover assembly 120 can further include the retention element 114.

In some examples, as shown in FIGS. 1A-1B, when the docking device 100 is in the deployed configuration, the guard member 104 can be configured to cover a portion (e.g., the atrial portion 110a) of the stabilization turn 110 of the coil 102. In certain examples, the guard member 104 can be configured to cover at least a portion of the central region 108 of the coil 102, such as a portion of the proximal turn 108p. In certain examples, the guard member 104 can extend over the entirety of the coil 102.

As described herein, the guard member 104 can radially expand so as to help preventing and/or reducing paravalvular leakage. Specifically, the guard member 104 can be configured to radially expand such that an improved seal is formed closer to and/or against a prosthetic valve deployed within the docking device 100. In some examples, the guard member 104 can be configured to prevent and/or inhibit leakage at the location where the docking device 100 crosses between leaflets of the native valve (e.g., at the commissures of the native leaflets). For example, without the guard member 104, the docking device 100 may push the native leaflets apart at the point of crossing the native leaflets and allow for leakage at that point (e.g., along the docking device or to its sides). However, the guard 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.

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

Yet in alternative examples, the guard member 104 can cover not only the atrial portion 110a, but can also extend over the ascending portion 110b of the stabilization turn 110. This can occur, e.g., in circumstances when the docking device is implanted in other anatomical locations and/or the guard member 104 is reinforced to reduce the risk of wire break.

In various examples, the guard member 104 can help covering an atrial side of an atrioventricular valve to prevent and/or inhibit blood from leaking through the native leaflets, commissures, and/or around an outside of the prosthetic valve by blocking blood in the atrium from flowing in an atrial to ventricular direction (i.e., antegrade blood flow)—other than through the prosthetic valve. Positioning the guard member 104 on the atrial side of the valve can additionally or alternatively help reduce blood in the ventricle from flowing in a ventricular to atrial direction (i.e., retrograde blood flow).

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

The guard member 104 can include an expandable member 116 and a cover member 118 (also referred to as a “second cover” or an “outer cover”) surrounding an outer surface of the expandable member 116. In certain examples, the expandable member 116 surrounds at least a portion of the tubular member 112. In certain examples, the tubular member 112 can extend (completely or partially) through the expandable member 116.

The expandable member 116 can extend radially outwardly from the coil 102 (and the tubular member 112) and is movable between a radially compressed (and axially elongated) state and a radially expanded (and axially foreshortened) state. That is, the expandable member 116 can axially foreshorten when it moves from the radially compressed state to the radially expanded state and can axially elongate when it moves from the radially expanded state to the radially compressed state.

In certain examples, the expandable member 116 can include a braided structure, such as a braided wire mesh or lattice. In certain examples, the expandable member 116 can include a shape memory material that is shape set and/or pre-configured to expand to a particular shape and/or size when unconstrained (e.g., when deployed at a native valve location). For example, the expandable member 116 can have a braided structure containing a shape memory alloy with Superelastic properties, such as Nitinol. In certain examples, the expandable member 116 can have a braided structure containing a ternary shape memory alloy with Superelastic properties, such as NiTiX where X can be chromium (Cr), cobalt (Co), zirconium (Zr), hafnium (Hf), etc. In certain examples, the expandable member 116 can comprise a metallic material that does not have the shape memory properties. Examples of such metallic material include cobalt-chromium, stainless steel, etc. In one specific example, the expandable member 116 can comprise nick-free austenitic stainless steel in which nickel can be completely replaced by nitrogen. In another specific example, the expandable member 116 can comprise cobalt-chromium or cobalt-nickel-chromium-molybdenum alloy with significantly low density of titanium. The number of wires (or fibers, strands, or the like) forming the braided structure can be selected to achieve a desired elasticity and/or strength of the expandable member 116. In certain examples, the number of wires used to braid the expanding member 116 can range from 16 to 128 (e.g., 32 wires, 48 wires, 64 wires, 96 wires, etc.). In certain examples, the braid density can range from 20 picks per inch (PPI) to 70 PPI, or from 25 PPI to 65 PPI. In one specific example, the braid density is about 36 PPI. In another specific example, the braid density is about 40 PPI. In certain examples, the diameter of the wires can range from about 0.002 inch to about 0.004 inch. In one particularly example, the diameter of the wires can be about 0.003 inch. In another example, the expandable member 116 can be a combination of braided wire (which can include a shape memory material or non-shape memory material) and a polymeric material and/or textile (e.g., polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyether ether ketone (PEEK), thermoplastic polyurethane (TPU), etc.). For example, the expandable member 116 can include a braided wireframe embedded in a polymeric material.

In some examples, the expandable member 116 can include a braided metallic wireframe coated with an elastomer (e.g., ePTFE, TPU, or the like), which can elastically deform as the braided wireframe expands and/or compresses. In some examples, the expandable member 116 can comprise a braid and/or weave that includes one or more metallic wires and one or more polymeric fibers. In other words, the metallic wires and the polymeric fibers can be interwoven together to define a braided structure. In some instances, the polymeric fibers can have the same or about the same diameter as the metallic wires. In other instances, the polymeric fibers can have a smaller diameter (e.g., microfibers) than the metallic wires, or vice versa.

In yet another example, the expandable member 116 can include a polymeric material, such as a thermoplastic material (e.g., PET, polyether ether ketone (PEEK), thermoplastic polyurethane (TPU), etc.), without a braided wireframe.

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

As described herein, the cover member 118 can be configured to be so elastic that when the expandable member 116 moves from the radially compressed (and axially elongated) state to the radially expanded (and axially foreshortened) state, the cover member 118 can also radially expand and axially foreshorten together with the expandable member 116. In other words, the guard member 104, as a whole, can move from a radially compressed (and axially elongated) state to a radially expanded (and axially foreshortened) state. As described herein, the radially expanded (and axially foreshortened) state is also referred to as the “relaxed state,” and the radially compressed (and axially elongated) state is also referred to as the “collapsed state.”

In certain examples, the cover member 118 can be configured to be atraumatic to native tissue and/or promote tissue ingrowth into the cover member 118. For example, the cover member 118 can have pores to encourage tissue ingrowth. In another example, the cover member 118 can be impregnated with growth factors to stimulate or promote tissue ingrowth, such as transforming growth factor alpha (TGF-alpha), transforming growth factor beta (TGF-beta), basic fibroblast growth factor (bFGF), vascular epithelial growth factor (VEGF), and combinations thereof. The cover member 118 can be constructed of any suitable material, including foam, cloth, fabric, and/or polymer, which is flexible to allow for compression and expansion of the cover member 118. In one example, the cover member 118 can include a fabric layer constructed from a thermoplastic polymer material, such as polyethylene terephthalate (PET).

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

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

When the docking device 100 is retained within the delivery sheath in the substantially straight configuration, the expandable member 116 can be radially compressed by the delivery sheath and remains in the radially compressed (and axially elongated) state. The radially compressed (and axially elongated) expandable member 116 can contact the retention element 114 (see, e.g., FIG. 1C) or the tubular member 112 (see, e.g., FIG. 1E) so that no gap or cavity exists between the retention element 114 and the expandable member 116 or between the tubular member 112 (and/or the coil 102) and the expandable member 116.

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

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

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

In certain examples, when the expandable member 116 is in the radially expanded state, the proximal end portion 104p of the guard member 104 can have a tapered shape as shown in FIGS. 1A-1B, such that the diameter of the proximal end portion 104p gradually increases from a proximal end 105 of the guard member 104 to a distally located body portion of the guard member 104. This can, for example, help to facilitate loading the docking device into a delivery sheath of the delivery apparatus and/or retrieval and/or re-positioning of the docking device into the delivery apparatus during an implantation procedure. In addition, due to its small diameter, the proximal end 105 of the guard member 104 can frictionally engage with the retention element 114 so that the retention element 114 can reduce or prevent axial movement of the proximal end portion 104p of the guard member 104 relative to the coil 102.

In certain examples, the docking device 100 can include at least one radiopaque marker configured to provide visual indication about the location 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) under fluoroscopy. For example, one or more radiopaque markers can be placed on the coil 102. In one particular example, a radiopaque marker (which can be larger than the seating markers 121p, 121d) can be disposed 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 cover member 118. As noted above, the docking device 100 can also have one or more radiopaque markers (e.g., 121p and/or 121d) located distal to the ascending portion 110b of the coil 102. The radiopaque marker(s) used to provide visual indication about the location and/or the amount of radial expansion of the docking device 100 can be in addition to the seating markers (e.g., 121p, 121d) described above.

FIG. 1G schematically depicts some example dimensions of the docking device 100 when the coil 102 is in a substantially straight configuration (e.g., compared to the helical configuration depicted in FIG. 1A). The guard member 104 surrounding the coil 102 is shown in both the collapsed state (shown in solid contour) and the relaxed state (shown in dashed contour). In certain examples, the guard member 104 in the relaxed state can have a maximum outer diameter (D1) ranging from about 4 mm to about 8 mm (e.g., about 6 mm in one particular example), and the guard member 104 in the collapsed state can have a maximum outer diameter (D2) ranging from about 1 mm to about 3 mm (e.g., about 2 mm in one particular example). The expansion of the guard 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 about 1.5 to about 8, or from about 2 to about 6, or from about 2.5 to about 4. In one specific example, the expansion ratio is about 3.

The distal end portion 104d of the guard member 104 can be fixedly attached to the coil 102, e.g., via sutures, gluing, 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, which has a proximal end 127 and a distal end 129. Thus, only the portion of the guard member 104 that is proximal to the distal attachment region 123 is movable relative to the coil 102.

Returning again to FIG. 1G, in certain examples, when the guard member 104 is in the relaxed state, its movable portion (i.e., the portion extending from the proximal end 105 of the guard member 104 to the proximal end 127 of the distal attachment region 123) can have an axial length (A2) 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 guard member 104 is in the collapsed 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 guard member 104 from the relaxed state to the collapsed state can be characterized by an elongation ratio defined as A1/A2. In certain 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.

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

Further details of the docking device and its variants, including various examples of the coil, the first cover (or tubular member), the second cover (or cover member), the expandable member, and other components of the docking device, are described in PCT Patent Application Publication No. WO/2020/247907, the entirety of which is incorporated by reference herein.

Exemplary Prosthetic Valves

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

The valvular structure 14 can include three leaflets 40, collectively forming a leaflet structure (although a greater or fewer number of leaflets can be used), which can be arranged to collapse in a tricuspid arrangement. The leaflets 40 are configured to permit the flow of blood from an inflow end 22 to an outflow end 24 of the prosthetic valve 10 and block the flow of blood from the outflow end 24 to the inflow end 22 of the prosthetic valve 10. The leaflets 40 can be secured to one another at their adjacent sides to form commissures 26 of the leaflet structure. The lower edge of valvular structure 14 desirably has an undulating, curved scalloped shape. By forming the leaflets 40 with this scalloped geometry, stresses on the leaflets 40 can be reduced, which in turn can improve durability of the prosthetic valve 10. Moreover, by virtue of the scalloped shape, folds and ripples at the belly of each leaflet 40 (the central region of each leaflet), which can cause early calcification in those areas, can be eliminated or at least minimized. The scalloped geometry can also reduce the amount of tissue material used to form leaflet structure, thereby allowing a smaller, more even crimped profile at the inflow end of the prosthetic valve 10. The leaflets 40 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Pat. No. 6,730,118, which is incorporated by reference herein.

The frame 12 can be formed with a plurality of circumferentially spaced slots, or commissure windows 20 (three in the illustrated example) that are adapted to mount the commissures 26 of the valvular structure 14 to the frame. The frame 12 can be made of any of various suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol) as known in the art. When constructed of a plastically expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially compressed state on a delivery apparatus and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a valve sheath or equivalent mechanism of a delivery apparatus. Once inside 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.

Suitable plastically expandable materials that can be used to form the frame 12 include, without limitation, stainless steel, a nickel-based alloy (e.g., a cobalt-chromium or a nickel-cobalt-chromium alloy), polymers, or combinations thereof. In particular examples, frame 12 can be made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™/UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight. It has been found that the use of MP35N to form the frame 12 can provide superior structural results over stainless steel. In particular, when MP35N is used as the frame material, less material is needed to achieve the same or better performance in radial and crush force resistance, fatigue resistances, and corrosion resistance. Moreover, since less material is required, the crimped profile of the frame can be reduced, thereby providing a lower profile valve assembly for percutaneous delivery to the treatment location in the body.

As shown in FIG. 2B, the valve cover 16 can include an outer portion 18 which can cover an entire outer surface of the frame 12. In certain examples, as shown in FIG. 3A, the valve cover 16 can also include an inner portion 28. The inner portion 28 can cover an entire inner surface of the frame 12, or alternatively, cover only selected portions 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 certain examples, a protective cover 36 comprising a high abrasion resistant material (e.g., ePTFE, etc.) can be placed over the fold of the valve cover 16 at the outflow end 24. In certain examples, similar protective cover 36 can be placed over the inflow end 22 of the frame. The valve cover 16 and the protective cover 36 can be affixed to the frame 12 by a variety of means, such as via sutures 30.

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

In various examples, the valve cover 16 can include a material that can be crimped for transcatheter delivery of the prosthetic valve 10 and 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 tissues (e.g., bovine pericardium, porcine pericardium, equine pericardium, etc.), and/or an encapsulated material (e.g., an encapsulated hydrogel).

In certain examples, the valve cover 16 can be made of a woven cloth or fabric possessing a plurality of floated yarn sections 32 (e.g., protruding or puffing sections, also referred to as “floats” hereinafter). Details of exemplary covered valves with a plurality of floats 32 are further described in U.S. Patent Publication Nos. US2019/0374337, US2019/0192296, and US2019/0046314, the disclosures of which are incorporated herein in their entireties for all purposes. In certain examples, the float yarn sections 32 are separated by one or more horizontal bands 34. In some examples, the horizontal bands 34 can be constructed via a leno weave, which can improve the strength of the woven structure. In some examples of the woven cloth, vertical fibers (e.g., running along the longitudinal axis of the prosthetic valve 10) can include a yarn or other fiber possessing a high level of expansion, such as a texturized weft yarn, while horizontal fibers (e.g., running circumferentially around the prosthetic valve 10) in a leno weave can include a low expansion yarn or fiber.

In some examples, the valve cover 16 can include a woven cloth resembling a greige fabric when assembled and under tension (e.g., when stretched longitudinally on a compressed valve prior to delivery of a prosthetic valve 10). When the prosthetic valve 10 is deployed and expanded, tension on floats 32 is relaxed allowing expansion of the floats 32. In some examples, the valve cover 16 can be heat set to allow floats 32 to return to an enlarged, or puffed, space-filling form. In some examples, the number and sizes of floats 32 can be optimized to provide a level of expansion to prevent paravalvular leakage across the mitral plane (e.g., to have a higher level of expansion thickness) and/or a lower crimp profile (e.g., for delivery of the prosthetic valve). Additionally, the horizontal bands 34 can be optimized to allow for attachment of the valve cover 16 to the frame 12 based on the specific size or position of struts or other structural elements on the prosthetic valve 10.

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

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

In certain examples, and as described further below in reference to FIGS. 23-24, the coil 102 of the docking device 100 in the deployed configuration can be movable 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. In the example depicted in FIGS. 3A-3B, the coil 102 is in the second radially expanded configuration since the prosthetic valve 10 is shown in the radially expanded state.

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

In the example depicted in FIGS. 3A-3B (and FIG. 26), the proximal end 105 of the guard member 104 is shown to be positioned distal to the proximal seating marker 121p. In other examples, after the prosthetic valve 10 is radially expanded within the coil 102, the proximal end 105 of the guard member 104 can be positioned proximal to the proximal seating marker 121p (i.e., the proximal seating marker 121p is covered by the guard member 104) but remains distal to the ascending portion 110b.

Exemplary Cover Assembly

As described above, the docking device 100 can have a cover assembly 120 including the tubular member 112 and the guard member 104, and in some instances the retention element 114. The guard member 104 can further include the expandable member 116 and the cover member 118. As described herein, the cover member 118 can be fixedly coupled to the expandable member 116 so that the cover member 118 can radially expand and axially foreshorten together with the expandable member 116.

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

On the other hand, the retention element 114, by applying a friction force (e.g., the frictional interaction between the retention element 114 and the proximal end 105 of the guard member 104), can limit the extent of distal movement of the proximal end portion 104p relative to the coil 102. For example, if the proximal end portion 104p of a fully expanded guard member 104 (i.e., expanding to its largest diameter) can slide distally over the coil 102 to a first location in the absence of retention element 114, then the presence of the retention element 114 can cause the proximal end portion 104p to slide distally over the coil 102 to a second location that is proximal to the first location. In other words, the retention element 114 can prevent the guard member 104 to expand to its largest diameter and/or contract to its shortest axial length.

Similarly, the retention element 114, by exerting a friction force (e.g., the frictional interaction between the retention element 114 and the proximal end 105 of the guard member 104), can limit the extent of proximal movement of the proximal end portion 104p relative to the coil 102. As noted above and described further below, the coil 102 of the docking device 100 in the deployed configuration can be further radially expanded (e.g., moving from the first radially expanded configuration to the second radially expanded configuration) when the prosthetic valve 10 is radially expanded within the coil 102, and radial expansion of the coil 102 can cause corresponding circumferential rotation of the coil 102. The radially expanded prosthetic valve 10 can press against the guard member 104, causing the guard member 104 to be radially compressed and axially extended. Because the distal end portion 104d of the guard member 104 is fixedly attached to the coil 102 and the proximal end portion 104p of the guard member 104 is untethered to the coil 102, the proximal end portion 104p of the guard member 104 can have a tendency to move proximally relative to the coil 102 when the prosthetic valve 10 is radially expanded within the coil 102. However, the presence of the retention element 114 can impede the proximal end portion 104p of the guard member 104 to move proximally over the coil 102. In specific examples, the presence of the retention element 114 can prevent the proximal end 105 of the guard member 104 from extending onto the ascending portion 110b of the coil 102. This can, for example, improve the functionality and/or durability of the guard member 104, as discussed above.

The guard member 104 can be coupled to the coil 102 and/or tubular member 112 in various ways such as adhesive, fasteners, welding, and/or other means for coupling. For example, in some examples, attaching 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 the tubular member 112 can be achieved by using one or more sutures. However, there are several technical challenges when using the sutures. First, when the expandable member 116 has a meshed wire frame made of certain metal or metal alloy (e.g., Nitinol), sewing the sutures with a needle may scratch the surface of the metal or metal alloy and increase the risk of corrosion for the wire frame when exposed to the bodily fluid, especially if the needle is also made of metal. Sewing the sutures with a non-metal needle (e.g., a plastic needle) has its own disadvantages because the non-metal needle typically has less strength compared to a metal needle, thus making it difficult to thread through various layers of the cover assembly 120. Further, even a non-metal needle can damage the surface of the metal or metal alloy of the wire frame. Second, the routing of sutures can be challenging because the sutures not only must ensure secure attachment between components of the cover assembly 120, but also not significantly increase the radial profile of the guard member 104 so that the docking device 100 can be retained in a delivery sheath of a delivery apparatus for transcatheter implantation.

An example method of assembling the guard member 104 is described in Provisional U.S. Application No. 63/252,524, the entirety of which is incorporated by reference herein. The method described therein (also referred to as the “stitching method” hereinafter) overcomes the challenges described above by forming a plurality of knots and wraps with sutures at both the proximal end portion 104p and distal end portion 104d of the guard member 104.

For example, in the stitching method, two separate processes can be used to prepare the expandable member 116 and the cover member 118. Specifically, to prepare the expandable member 116, a wire (e.g., Nitinol) is first braided onto a straight mandrel and then heat is applied to shape-set the braided wire to a straight configuration. Such straight-shaped braided wire can be reconfigured to generate a tapered proximal end portion (so that the proximal end portion 104p of the guard member 104 can have a tapered shape as shown in FIGS. 1A-1B). Such reconfiguration can be achieved by transferring the braided wire to a tapered mandrel (i.e., one end of the mandrel has a tapered shape), and then reapplying heat to shape-set the braided wire to create the 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, then a heat is applied to shape-set the braided cover to a straight configuration. Then, the straight-shaped braided cover is transferred to a tapered mandrel, and heat is reapplied to shape-set the braided cover to create a tapered end portion matching that of the expandable member 116. These two separate processes prepare the expandable member 116 and the cover member 118.

Another example method of assembling the guard member 104 is described in Provisional U.S. Application No. 63/253,995, the entirety of which is incorporated by reference herein. The method described therein (also referred to as the “fusing method” hereinafter) includes braiding a first layer over a mandrel, braiding a second layer over the first layer to form a multi-layer structure, shape-setting the multi-layer structure so that the multi-layer structure conforms to a shape of the mandrel, and laser cutting the multi-layer 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.

Exemplary PVL Guard with an Elastic Member

In certain examples, as depicted in FIGS. 4A-4B, the guard member 104 can further include an elastic member 122, which is coupled to and extends along an axial length of the expandable member 116. In the depicted examples, the cover member 118 is removed from the expandable member 116, thus exposing the meshed wire frame of the expandable member 116.

As described herein, the elastic member 122 can be movable between an axially stretched state and a resting state, and the elastic member 122 is biased to the resting state. When the expandable member 116 is in the radially compressed (and axially elongated) state, e.g., when the docking device 100 is retained within a delivery sheath (e.g., 204) and/or a dock sleeve (e.g., 222), the elastic member 122 can be in the axially stretched state. After the docking device is removed from the delivery sheath and the dock sleeve, the elastic member 122 tends to return to its resting state, thus can assist the expandable member 116 to move from the radially compressed (and axially elongated) state to the radially expanded (and axially foreshortened) state. When the expandable member 116 is in the radially expanded (and axially foreshortened) state, the elastic member 122 can be in the resting state.

In certain examples, the elastic member 122 can comprise a polymeric material, such as a thermoplastic material (e.g., TPU, etc.).

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

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

In certain examples, the elastic member 122 can be stitched to the expandable member 116. For example, the elastic member 122 can be attached to the expandable member 116 via a continuous suture 124 extending along the axial length of the expandable member 116. In certain examples, a length of the suture 124 can be greater than or equal to a length of the elastic member 122 in its axially stretched state such that the suture 124 has slacks when the elastic member 122 is in its resting state, thus will not hinder the expandable member 116 from moving to the radially compressed (and axially elongated) state.

In one example, as depicted in FIGS. 4A-4B, the elastic member 122 can be connected to the expandable member 116 via the suture 124 routed in a spiral path.

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

If the guard member 104 has no elastic member 122, the intrinsic biasing force of the expandable member 116 to move from the radially compressed (and axially elongated) state to the radially expanded state (and axially foreshortened) may be limited. Thus, after deploying the docking device 100, the guard member 104 (without the elastic member 122) may incidentally extend onto the ascending portion 110b of the coil 102 (see, e.g., FIG. 18B). As described below, in such circumstances, a procedure may be needed to reposition the proximal end 105 of guard member 104 until the proximal end 105 is located distal to the ascending portion 110b (e.g., distal to the proximal seating marker 121p).

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

In certain examples, as depicted in FIGS. 4C-4D, the elastic member can be configured as a coil spring 132 (e.g., a compression spring) coupled to the expandable member 116. In certain examples, the coil spring 132 can comprise a shape memory material, such as Nitinol, etc.

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

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

In certain examples, as depicted in FIGS. 4C-4D, 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 over the outer surface of the expandable member 116.

A pitch of the coil spring 132 can be larger than a pitch of the braided wire mesh of the expandable member 116. In certain examples, the pitch of the coil spring 132 can range between 3 mm and 9 mm, or between 5 mm and 7 mm, inclusive. In one particular example, the pitch of the coil spring 132 can be about 6 mm. The wire forming the coil spring 132 can have a larger diameter than the wire forming the braided wire mesh of the expandable member 116. In certain examples, the wire forming the coil spring 132 can have a diameter ranging from 0.15 mm and 0.22 mm, inclusive.

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

Similar to the elastic member 122, the coil spring 132 can assist moving the proximal end 105 of the guard member 104 to a more distal position relative to the ascending portion 110b after initially deploying the docking device 100, thus, in at least some instance, reducing or eliminating the need to reposition the proximal end of the guard member 104 with the dock sleeve, as mentioned above and described in more detail below.

Accordingly, the elastic member 122 and/or the coil spring 132 can pre-bunch the guard member 104 to a more axially compact configuration (i.e., having a larger diameter than a guard member without the elastic member or coil spring) after initial deployment of the docking device. Besides reducing the repositioning procedure, such pre-bunching may also help maintaining a relatively large diameter of the guard member 104 during and/or after valve deployment so as to reduce paravalvular leakage.

For example, when a prosthetic valve (e.g., 10) is radially expanded within the central region (e.g., 108) of the docking device 100, the coil 102 of the docking device can move from the first radially expanded configuration to the second radially expanded configuration, as described above. Such further radial expansion can cause the function turns of the docking device 100 to slightly unravel. As a result, the distal end of the guard member 104 can move slightly to a more distal position, thus causing the guard member 104 to axially stretch and decrease in diameter. In addition, by radially expanding the prosthetic valve 100, the guard member 102 can be pressed against the native annulus, thus further causing axial stretch and diameter reduction of the guard member 104. Pre-bunching the guard member can compensate for such effects, e.g., if radial expansion of the prosthetic valve causes axial stretching of the guard member 104, the guard member 104 can still achieve a desirably large diameter that is effective to reduce paravalvular leakage after the prosthetic valve is deployed within the docking device.

Exemplary Texturized Woven PVL Guard

FIGS. 5A-5B show a docking device 300 configured to receive a prosthetic valve (e.g., 10), according to another example. The docking device 300 includes a coil 302 which can move from a substantially straight or delivery configuration to a helical or deployed configuration similar to the coil 102. The docking device 300 also includes a texturized woven PVL guard (or guard member) 304 attached to the coil 302, which is further illustrated in FIGS. 6A-6C and FIGS. 7A-7C.

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

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

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

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

As described herein, the expandable member 306 can include a woven material, such as polyethylene terephthalate (PET) yarns. Other types of yarns, such as polyimide, Ultra-High Molecular Weight Polyethylene (UHMWPE), low density polyethylene (LDPE), high density polyethylene (HDPE), nylon, etc., can also be texturized and be woven into the form or shape of the depicted expandable member 306. As described herein, textured (or texturized) yarns refer to continuous filament yarns whose smooth straight fibers have been displaced from their closely packed, parallel position by the formation of crimps, curls, loops, and/or coils. Compared to flat (i.e., non-texturized) yarns, texturized yarns have increased volume and/or stretchability.

In certain examples, the constricted portions 312 and the enlargeable portions 310 can be made of the same material (e.g., PET). In one specific example, texturized 68-denier, 36-filament yarns are used to weave the expandable member 306. In another specific example, the expandable member 306 can be woven using both texturized 68-denier, 36-filament yarns and flat 40-denier, 24-filament yarns. In other examples, yarns with different denier count and/or filament count can also be used. For example, the yarns used to weave the expandable member 306 can have a density ranging from 10 denier to 100 denier.

As described herein, the constricted portions 312 can have a first weave density that is greater than a second weave density of the enlargeable portions 310. In certain examples, the weave density of the expandable member 306 can range between 20-100 picks per inch (PPI), or between 20-80 PPI. In certain examples, the number of picks (or weft, filling, insertions) can remain constant or substantially constant throughout the entirety of the woven expandable member 306. The different weave densities of the constricted portions 312 and the enlargeable portions 310 can be achieved by using different number of ends per unit length that is necessary to create the corresponding structure. In certain examples, the constricted portions 312 can be woven using plain weave or leno weave.

The enlargeable portions 310, which comprise textured yarns, can be heat seat to create increased volume (compared to the constricted portions 312). In certain examples, the enlargeable portions 310 can be configured to be sufficiently dense so as to not create gaps therein. This can be achieved, for example, by using thicker yarns and increasing PPI of the yarns as noted above, which can prevent the yarns from separating.

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

As described herein, when the expandable member 306 is in the radially expanded state, the constricted portions 312 can wrap around the coil 302 and the enlargeable portions 310 can radially expand from the coil 302. In addition, the constricted portions 312 can be configured to slide axially over the coil 302 (except 312d or 312p, if exists, is fixedly attached to the coil 302). Thus, the constricted portions 312 can radially anchor the expandable member 306 so that the expandable member 306 is generally symmetric about the coil 302 when no prosthetic valve is radially expanded within the coil. Meanwhile, the slidable constricted portions 312 allow axial movement (e.g., elongation or foreshortening) of the expandable member 306 over the coil 302.

As described herein, when the expandable member 306 is in the radially expanded state, the enlargeable portions 310 have a larger radial profile than the constricted portions 312. In the depicted examples, when the expandable member 306 is in the radially expanded state, the enlargeable portions 310 have the same or substantially similar size. In other examples, when the expandable member 306 is in the radially expanded state, the enlargeable portions 310 can have different sizes.

As described herein, the constricted portions 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. Thus, when the expandable member 306 moves from the radially compressed state (see, e.g., FIG. 6A) to the radially expanded state (see, e.g., FIG. 6B), the enlargeable portions 310 can radially expand and axially foreshorten whereas the constricted portions 312 can remain wrapping around the coil 302 without a noticeable change in either radial or axial dimension.

As an example, the radial diameter of the enlargeable portions 310 can increase from d1 to d2 (i.e., d2>d1) whereas the radial diameter of the constricted portions 312 can remain about constant at d3 when the expandable member 306 moves from the radially compressed state to the radially expanded state, where d2>d3. In certain examples, d1 is about the same as d3. In certain examples, d1 can be larger than d3.

In certain examples, when the expandable member 306 is in the radially expanded state, adjacent enlargeable portions 310 can contact each other so as to shield the constricted portions 312. For example, as illustrated in FIG. 6C, when the expandable member 306 is in the radially expanded state, at least portions of two adjacent enlarged portions 310 can form a direct contact at a location P that is radially outwardly of the constricted portion 312 connecting the two adjacent enlarged portions 310.

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

In certain examples, d1 can 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.

In certain examples, d2 is between 4 mm and 10 mm, or between 7 mm and 9 mm. In one specific example, d2 is between 7.5 mm and 8 mm.

In certain examples, d3 is between 0.3 mm and 3 mm, or between 0.5 mm and 2.6 mm. In one specific example, d3 is between 1.5 mm and 2.4 mm.

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 certain examples, the expansion ratio can range between 1.5 and 10, or between 2 and 6. In one specific example, the expansion ratio is between 3 and 4.

In certain examples, when the expandable member 306 is in the radially expanded state, each enlargeable 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 constricted portion 312 located 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. In the example depicted in FIG. 7B, the axial length of 312p and 312d is larger than a2. In other examples, the axial length of 312p and 312d can be the same as, or even smaller than a2.

In certain 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 end portion 306p to the distal end portion 306d) ranging between 60 mm and 120 mm, or between 70 mm and 100 mm. In one specific example, L1 is between 75 mm and 85 mm.

In certain 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 one specific example, L2 is between 120 mm and 140 mm.

The elongation of the 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 certain examples, the elongation ratio can range between 1.1 and 1.6, or between 1.2 and 1.5. In one specific example, the elongation ratio is between 1.3 and 1.4.

As described herein, the expandable member 306 can be biased to the radially expanded state (i.e., the enlargeable portions 310 are biased to the larger diameter d2). This can be achieved, for example, by shape setting (e.g., by applying a heat to) the enlargeable portions 310. In addition, the elastic member 308 can be configured to assist moving the expandable member 306 from the radially compressed state to the radially expanded state.

The elastic member 308 can be similar to the elastic member 122. For example, the elastic member 308 can comprise a thermoplastic material (e.g., TPU) and can move between an axially stretched state and a resting state. The elastic member 308 can be in the axially stretched state when the expandable member 306 is in the radially compressed 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 applying a biasing force to the expandable member 306, assisting the expandable member 306 to move 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.

As described herein, after deploying the docking device 300, the proximal end portion 306p of the expandable member 306 can be retracted (e.g., under a combined biasing force generated by both the expandable member 306 and the elastic member 308) to a position that is distal to the ascending portion 110b.

In certain examples, the elastic member 308 can extend along an axial length of the expandable member 306. For example, as shown in FIG. 7B, the elastic member 308 can include a strip of elastic band extending parallel to a central longitudinal axis 314 of the expandable member 306. In certain examples, the elastic member 308 can form a sheath surrounding a segment of the coil 302 covered by the expandable member 306.

In certain examples, as depicted in FIG. 7B, a proximal end 308p of the elastic member 308 can be attached to the proximal end portion 306p (e.g., 312p) of the expandable member 306, and a distal end 308d of the elastic member 308 can be attached to the distal end portion 306d (e.g., 312d) of the expandable member 306.

In certain 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, as depicted in FIG. 7B, the suture 316 can connect the elastic member 308 to each constricted portion 312, including 312p and 312d located at the proximal end portion 306p and the distal end portion 306d, respectively. In such circumstances, the length of the suture 316 can be greater than or equal to the length of the elastic member 308 in its axially stretched state such that the suture 316 has slacks when the elastic member 308 is in its resting state.

In other examples, the elastic member 308 can be attached to the expandable member 306 via sutures 316 only at 312p and 312d, while no suture connection is made to the constricted portions 312 located between 312p and 312d.

In still other examples, the elastic member 308 can be attached to the expandable member 306 via sutures 316 at both 312p and 312d, as well as selected constricted portions 312 located between 312p and 312d (e.g., every other constricted portion can be connected by the suture 316).

In certain examples, the suture 316 may not be a continuous one extending along the axial length of the expandable member 306. For example, discrete sutures 316 can be used to connect the elastic member 308 to respective constricted portions 312.

Exemplary Delivery Apparatus

FIG. 8 shows a delivery apparatus 200 configured to implant a docking device, such as the docking device 100 described above or other docking devices, to a target implantation site in a patient, according to one example. Thus, the delivery apparatus 200 can also be referred to as a “dock delivery catheter” or “dock delivery system.”

As shown, the delivery apparatus 200 can include a handle assembly 202 and a delivery sheath 204 (also referred to as the “delivery shaft” or “outer shaft” or “outer sheath”) extending distally from the handle assembly 202. The handle assembly 202 can include a handle 206 including one or more knobs, buttons, wheels, and/or other means for controlling and/or actuating one or more components of the delivery apparatus 200. For example, in some examples, as shown in FIG. 8, the handle 206 can include knobs 208 and 210 which can be configured to steer or control flexing of the delivery apparatus 200 such as the delivery sheath 204 and/or the sleeve shaft 220 described below.

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

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

Additionally, the distal end 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, a curvature of the distal end portion 205 can be adjusted so that the distal end portion 205 of the delivery sheath 204 can be oriented in a desired angle. For example, as shown in FIG. 14 and described below, to implant the docking device 100 at the native mitral valve location, the distal end portion 205 of the delivery sheath 204 can be steered in the left atrium so that the dock sleeve 222 and the docking device 100 retained therein can extend through the native mitral valve annulus at a location adjacent the posteromedial commissure.

In certain examples, the pusher shaft 212 and the sleeve shaft 220 can be coaxial with one another, at least within the delivery sheath 204. In addition, 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, a distal end of the pusher shaft 212 can be inserted into a lumen of the sleeve shaft 220 and press against the proximal end (e.g., 102d) of the docking device 100 retained inside the dock sleeve 222.

After reaching a target implantation site, the docking device 100 can be deployed from the delivery sheath 204 by manipulating the pusher shaft 212 and sleeve shaft 220 using a hub assembly 218, as described further 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 simultaneously retracting the delivery sheath 204 in the proximal direction, the docking device 100 can be pushed out of a distal end 204d of the delivery sheath 204, thus changing from the delivery configuration to the deployed configuration. In certain examples, the pusher shaft 212 and the sleeve shaft 220 can be actuated independently of each other.

In certain examples, when deploying the docking device 100 from the delivery sheath 204, the pusher shaft 212 and the sleeve shaft 220 can be configured to move together, in the 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. As such, the docking device 100 can remain being covered by the dock sleeve 222 of the sleeve shaft 220 during the procedure of pushing the docking device 100 into position at the target implantation site via the pusher shaft 212. Thus, when the docking device 100 is initially deployed at the target implantation site, the lubricous dock sleeve 222 can facilitate the covered docking device 100 to encircle the native anatomy.

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

The handle assembly 202 can further include a hub assembly 218 to which the suture lock assembly 216 and a 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 an 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 operation of the components arranged within the delivery sheath 204. In some examples, the hub assembly 218 can be coupled to the handle 206 via a connector 226.

The handle assembly 202 can further include one or more flushing ports (e.g., three flushing ports 232, 236, 238 are shown in FIG. 8) to supply flush fluid to one or more lumens arranged within the delivery apparatus 200 (e.g., annular lumens arranged between coaxial components of the delivery apparatus 200), as described below.

Further details on delivery apparatus/catheters/systems (including various examples of the handle assembly) that are configured to deliver a docking device to a target implantation site can be found in U.S. Patent Publication Nos. 2018/0318079 and 2018/0263764, which are all incorporated by reference herein in their entireties.

Exemplary Sleeve Shaft

FIG. 9A shows a sleeve shaft 220, according to one example. In some examples, the sleeve shaft 220 can have a lubricous distal section 222 (also referred to as the “dock sleeve” herein) configured to cover a docking device (e.g., 100) during deployment, a proximal section 228 used to manipulate or actuate position of the distal section 222, and a middle section 230 connecting the distal section 222 and the proximal section 228.

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

The dock sleeve 222 can have a body portion 221 and a tip portion 223 located at a distal end of the body portion 221. In some examples, the tip portion 223 can extend about 1-4 mm (e.g., about 2 mm) distally from the distal end of the body portion 221. In some examples, the tip portion 223 can taper radially inwardly such that it has a smaller diameter than the 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 dock sleeve 222 with a more atraumatic tip that can bend, squeeze, deform, or the like, as it is navigated around the native architecture of the implantation site for the docking device.

Additional examples of the dock sleeve, including various features of the body portion and tip portion of the dock sleeve, are described further in Provisional U.S. Application No. 63/138,910, the entirety of which is incorporated by reference herein.

In some examples, the middle section 230 of the sleeve shaft 220 can be configured to provide a sufficient column strength so as to push the dock sleeve 222 (with the docking device 100) out of a distal end 204d of the delivery sheath 204, and/or retract the dock sleeve 222 after the docking device 100 is deployed at the target implantation site. The middle section 230 can also be configured to have an enough flexibility so as to facilitate navigating the anatomy of a patient from the point of insertion of the delivery apparatus 200 to the heart. In certain examples, the dock sleeve 222 and the middle section 230 can be formed as a single, continuous unit with varying properties (e.g., dimensions, polymers, braids, etc.) along the length of the singular unit.

In some examples, a proximal portion of the proximal section 228 can be arranged 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 dock sleeve 222 by pushing the middle section 230 and dock sleeve 222 with the docking device 100 and retracting the dock sleeve 222 after the docking device 100 is deployed at the target implantation site.

In some examples, the proximal portion of the proximal section 228 can include a cut portion 229 which has a cross-section (in a plane normal to a central longitudinal axis of the sleeve shaft 220) that is not a complete circle (e.g., is open and does not form a closed tube). An end surface 225 can be formed between the cut portion 229 and the remainder of the proximal section 228. The end surface 225 can be configured normal to a central longitudinal axis of the sleeve shaft 220 and can be configured to come into contact with a stop element (e.g., plug 254) of the pusher shaft 212, as explained further below.

The cut portion 229 can extend into the hub assembly 218 of the handle assembly 202. As described below, a proximal extension 256 of the pusher shaft 212 can extend along an inner surface of the cut portion 229. The cut (e.g., open) profile of the cut portion 229 can allow the proximal extension 256 of the pusher shaft 212 to extend out of a void space 227 formed in the cut portion 229 and branch off, at an angle relative to the cut portion 229, into the suture lock assembly 216 of the hub assembly 218 (see e.g., FIG. 8). As such, the pusher shaft 212 and sleeve shaft 220 can be operated in parallel with one another and an overall length of the delivery apparatus 200 in which the sleeve shaft 220 and 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.

Additional examples of the sleeve shaft are described further in PCT Patent Application Publication No. WO/2020/247907.

Exemplary Pusher Shaft

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

The main tube 250 can be configured for advancing and retracting a docking device (such as one of the docking devices described herein) and housing the 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 apparatus 200. For example, in certain cases, a proximal end portion of the pusher shaft 212, which includes an interface between the main tube 250, the shell 252, the plug 254, and the proximal extension 256, can be arranged within or proximate to the hub assembly 218 of the handle assembly 202. Thus, the main tube 250 can be an elongate tube that extends along a majority of the delivery apparatus 200.

The main tube 250 can be a relatively rigid tube that provides column strength for actuating deployment of a docking device. In some examples, the main tube 250 can be a hypo tube. In some examples, the main tube 250 can comprise a biocompatible metal, such as stainless steel. The main tube 250 can have a distal end 250d configured to interface with a docking device and a proximal end 250p, where the proximal extension 256 is attached. In some examples, a distal section 258 of the main tube 250 can be relatively more flexible (e.g., via one or more cuts into an outer surface of the main tube and/or having a durometer material) than the remaining part of the main tube 250. Thus, the distal section 258 can flex and/or bend along with the delivery sheath 204 of the delivery apparatus 200, as it is navigated through a vasculature of a patient, to the target implantation site.

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

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

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

Additional examples of the pusher shaft are described further in PCT Patent Application No. PCT/US20/36577.

Exemplary Sleeve Shaft and Pusher Shaft Assembly

FIGS. 10A-10B illustrate example arrangements of the pusher shaft 212 and sleeve shaft 220 in the delivery sheath 204 of the delivery apparatus 200, before and after deployment of a docking device such as 100. As shown, the main tube 250 of the pusher shaft 212 can extend through a lumen of the sleeve shaft 220, which can extend through a 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.

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

Specifically, FIG. 10A illustrates a first configuration of the pusher shaft 212 and sleeve shaft 220 assembly, pre-deployment or during deployment of the docking device 100, according to one example. As shown, the dock sleeve 222 can be configured to cover the docking device 100 while the end surface 225 of the sleeve shaft 220 is positioned away from the plug 254. In addition, the distal end 250d of the pusher shaft 212 can extend into the dock sleeve 222 and come into contact with the proximal end 102p of the docking device 100.

During deploying the docking device 100 from the delivery sheath 204, the pusher shaft 212 and the sleeve shaft 220 can be configured to move together, in the 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. As such, the docking device 100 can remain being covered by the dock sleeve 222 of the sleeve shaft 220 during the procedure of pushing the docking device 100 into position at the target implantation site via the pusher shaft 212, as illustrated in FIG. 12A.

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

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

In some examples, the radiopaque markers 231 can include a radiopaque material such as platinum-iridium. In other examples, the radiopaque material included in the radiopaque markers 231 can be Barium Sulphate (BaSO4), Bismuth Subcarbonate ((BiO)₂CO₃), Bismuth Oxychloride (BiOCl), or the like.

In some examples, the tip portion 223 of the dock sleeve 222 can be made from a polymeric material loaded with any one of the radiopaque material described above so as to enable the most distal edge of the tip portion 223 to be visible under fluoroscopy.

FIG. 10B illustrates a second configuration of the pusher shaft 212 and sleeve shaft 220 assembly, after deploying the docking device 100 from the delivery sheath 204 at the target implantation site and removing the dock sleeve 222 from the implanted docking device 100, according to one example. As shown, after implanting the docking device 100 at the target implantation site, in its desired position, the sleeve shaft 220 can be pulled off the docking device 100 and retracted back into delivery sheath 204 while holding the pusher shaft 212 steady so that its distal end 250d presses against the proximal end 102p of the docking device 100. Alternatively, the docking device 100 can be exposed by pushing the pusher shaft 212 in the distal direction while holding the sleeve shaft 220 steady. In some examples, as shown in FIG. 10B, the sleeve shaft 220 can be stopped from further retraction into the delivery apparatus upon the end surface 225 coming into contact with the plug 254.

FIG. 12B shows the sleeve shaft 220 removed from the docking device 100, leaving the docking device 100 uncovered by the dock sleeve 222. As shown, the tip portion 223 of the sleeve shaft 220 can be arranged proximal to (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 explained further below, after implanting the docking device 100 at the target implantation site and removing the dock sleeve 222 from covering the docking device 100, the docking device 100 can be disconnected from the delivery apparatus by cutting the release suture 214, e.g., by using the suture lock assembly 216 of the delivery apparatus 200.

As shown in FIG. 11, a first, pusher shaft lumen 212i can be formed within an interior of the pusher shaft 212 (e.g., within an interior of the main tube 250). The pusher shaft lumen 212i can receive a flush fluid from a first fluid source, which may be fluidly coupled to a portion of the handle assembly 202. The flush fluid flow 264 through the pusher shaft lumen 212i can travel along a length of the main tube 250 of the pusher shaft 212, to 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 away from the proximal end 102p of the docking device 100. Thus, at least a portion of the flush fluid flow 264 can flow into a distal portion of a second, sleeve shaft lumen 220i, which is arranged between an outer surface of the docking device 100 and an inner surface of the dock sleeve 222 of the sleeve shaft 220, as flush fluid flow 268. Further, in some examples, a portion of the flush fluid flow 264 can also flow back into a proximal portion of the sleeve shaft lumen 220i, which is arranged between an outer surface of the pusher shaft 212 and an inner surface of the sleeve shaft 220 that is proximal to the dock sleeve 222, as flush fluid flow 266. Thus, the same, first fluid source may provide flush 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 that is proximal to the dock sleeve 222), via the pusher shaft lumen 212i.

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

Flushing the above-described lumens can help prevent or reduce thrombosis on and around the docking device 100 and other concentric parts of the delivery apparatus 200 during deployment of the docking device 100 from the delivery apparatus 200 and implantation of the docking device 100 at a target implantation site. In an example, as shown in FIG. 8, the first and/or the second fluid sources can be connected to one or more flushing ports (e.g., 232, 236, 238) arranged on and/or coupled to the handle assembly 202 of the delivery apparatus 200 to provide the flush fluid to the lumens described above.

Additional examples of the sleeve shaft and pusher shaft assembly are described further in PCT Patent Application No. PCT/US20/36577.

Exemplary Implantation Procedure

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

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

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

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

As described above, the distal end portion 205 of the delivery sheath 204 can be steerable, for example, by operating a knob located on the handle assembly 202. Because the dock sleeve 222 and the docking device 100 are also flexible, flexing of the distal end portion 205 of the delivery sheath 204 can also cause flexing of the dock sleeve 222 and the docking device 100 retained therein. As shown in FIG. 14, the distal end portion 205 of the delivery sheath 204 (along with the dock sleeve 222 retaining the docking device 100) can be flexed in desired angular directions so that the distal end 204d of the delivery sheath 204 can extend through the native mitral valve annulus 408 at a location adjacent the posteromedial commissure 420 and into the left ventricle 414.

FIG. 15 illustrates deployment of the docking device 100 at the mitral valve location. As shown, a distal portion of the docking device 100, which includes the leading turn 106 and the central region 108 of the coil, can be deployed out of the distal end 204d of the delivery sheath 204 and extend into the left ventricle 414. Note that the deployed distal portion of the docking device 100 is still covered by the dock sleeve 222. This can be achieved, for example, by retracting the delivery sheath 204 in the proximal direction while holding both the pusher shaft 212 and the sleeve shaft 220 in place, thus causing the distal portion of the docking device 100 to extend distally out of the delivery sheath 204 while it remains to be covered by the dock sleeve 222. Retraction of the delivery sheath 204 can continue until the delivery sheath 204 is moved to the stabilization turn 110 and proximal to the expandable member 116.

Not being restrained by the distal end portion 205 of the delivery sheath 204, the distal portion of the docking device 100 can move from the delivery configuration to the deployed (i.e., helical) configuration. Specifically, as shown in FIG. 15, the coil of the docking device 100 (covered by the dock sleeve 222) can form the leading turn 106 extending into the left ventricle 414, as well as a plurality of functional turns in the central region 108 that wrap around the native leaflets 410 of the native valve and the chordae tendineae 412.

Because the dock sleeve 222 has a lubricious surface, it can prevent or reduce the likelihood of the tubular member 112 (which surrounds the coil 102 of the docking device) from directly contacting and catching (or getting stuck with) the native tissue and help ensure that the covered docking device 100 encircles the native anatomy. In addition, the soft tip portion 223 (which can have a tapered shape) of the dock sleeve 222 can also facilitate atraumatic encircling around the native tissue. As noted above, a flush fluid (see e.g., 264 in FIG. 11) can flow through the dock sleeve 222 and around the docking device 100 to prevent or reduce thrombosis on and around the docking device 100 and other concentric parts of the delivery apparatus 200 during deployment of the docking device 100.

As shown in FIG. 16, after the functional turns of the docking device 100 successfully wraps round the native leaflets 410 and the chordae tendineae 412, the dock 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 the proximal direction while holding the pusher shaft 212 steady so that its distal end can press against the proximal end of the docking device 100, as described above with reference to FIG. 10B. As noted above, the dock sleeve 222 can be retracted back into the delivery sheath 204. FIG. 17 shows the docking device 100, which is uncovered by the dock sleeve 222, encircling the native leaflets and chordae tendineae.

FIG. 18A illustrates stabilizing the docking device 100 from the atrial side. As shown, the delivery sheath 204 can be retracted into the guiding catheter 400 so that the atrial side (i.e., the proximal portion) of the docking device 100, including the stabilization turn 110 of the coil can be exposed. The stabilization turn 110 can be configured to provide one or more points or regions of contact between the docking device 100 and the left atrial wall, such as at least three points of contact in the left atrium or complete contact on the left atrial wall. The stabilization turn 110 can be flared out or biased toward both the posterior wall 416 and the anterior wall 418 of the left atrium so as to prevent the docking device 100 from falling into the left ventricle prior to deployment of a prosthetic valve therein.

Without the constraint of the delivery sheath 204 and the dock sleeve 222, the guard member 104 can move to the deployed configuration (due to radial expansion of the expandable member 116). As shown, the guard member 104 of the docking device 100 can be configured to contact the native annulus in the left atrium to create a sealed and atraumatic interface between the docking device 100 and the native tissue. The proximal end portion 104p of the guard member can be configured to be positioned adjacent (but does not reach) the anterolateral commissure 419 of the native valve. In the deployed configuration, the proximal end 105 of the guard member can be configured to be positioned within the atrial portion 110a or the ascending portion 110b of the stabilization turn, but distal to the boundary 107 between the ascending portion 110b and the stabilization portion 110c (see, e.g., FIG. 1A). For example, after the initial deployment of the docking device 100 and before deploying the 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 seating marker 121p and the distal seating marker 121d, or slightly distal to the distal seating marker 121d in certain circumstances. In certain examples, the distal end portion 104d of the guard member can be disposed in the left ventricle 414 or at least adjacent a posteromedial commissure 420 of the native valve so that leakage at that location can be prevented or reduced.

In the depicted example, a proximal end portion of the retention element 114 extends into the ascending portion 110b of the coil. In addition, the proximal end 105 of the guard member 104 is located distal to the proximal seating marker 121p, which is located distal to the ascending portion 110b. In certain examples, the proximal end 105 of the guard member 104 is located between the proximal seating marker 121p and the distal seating marker 121d (which is covered by the guard member 104 and not shown in FIG. 18A). As described above, such configuration can advantageously improve the sealing and/or durability of the guard member 104.

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

FIG. 19 illustrates the fully deployed docking device 100. 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 apparatus 200. The delivery apparatus 200 can then be removed from the guiding catheter 400 to prepare for implantation of a prosthetic valve.

FIG. 20 illustrates inserting a guidewire catheter 244 through the guiding catheter 400, across the native mitral valve annulus through the docking device 100, and into the left ventricle 414.

FIG. 21 illustrates inserting a valve guidewire 246 into the left ventricle 414 through an inner lumen of the guidewire catheter 244. The guidewire catheter 244 can then be retracted back into the guiding catheter 400, and the guiding catheter 400 and the guidewire catheter 244 can be removed, leaving the valve guidewire 246 in place.

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

FIG. 23 illustrates placing the prosthetic valve 10 within the docking device 100. Specifically, the prosthetic valve 10 can be positioned within and substantially coaxial with the functional 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 the outer shaft 452.

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

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

FIG. 26 illustrates the final disposition of the docking device 100 at the mitral valve and the prosthetic valve 10 received within the docking device 100. As described above, the 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 guard member 104 can act as a seal between the docking device 100 and the prosthetic valve 10 disposed therein to prevent or reduce paravalvular leakage around the prosthetic valve 10.

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

As 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 restricting further axial movement of the guard member 104 relative to the native anatomy (e.g., the left atrial wall). In this manner, the retention member 114 can serve to temporarily retain the proximal end of the guard member in the desired position from the time the docking device is deployed until the prosthetic heart valve is expanded therein. After that, the prosthetic heart valve can secure the positioning of the guard member relative to the coil.

Although in the method described above, the prosthetic valve 10 is radially expanded using the inflatable balloon 460, it is to be understood that alternative methods can be used to radially expand the prosthetic valve 10.

For example, in some instances, the prosthetic valve can be configured to be self-expandable. During delivery, the prosthetic valve can be radially compressed and retained within a valve sheath located at a distal end portion of a delivery apparatus. When the valve sheath is disposed within the central region 108 of the docking device, the valve sheath can be retracted to expose the prosthetic valve, which can then self-expand and securely engage with the central region 108 of the docking device. Additional details regarding exemplary self-expandable prosthetic valves and the related delivery apparatus/catheters/systems are described in U.S. Pat. Nos. 8,652,202 and 9,155,619, the entirety of which is incorporated by reference herein.

In another example, in certain instances, the prosthetic valve can be mechanically expanded. Specifically, the prosthetic valve can have a frame comprising a plurality of struts that are connected to each other such that an axial force applied to the frame (e.g., pressing an inflow and an outflow end of the frame in toward each other or pulling the inflow end and the outflow end of the frame away from each other) can cause the prosthetic valve to radially expand or compress. Additional details regarding exemplary mechanically-expandable prosthetic valves and the related delivery apparatus/catheters/systems are described in U.S. Patent Application Publication No. 2018/0153689 and PCT Patent Application Publication No. WO/2021/188476, the entirety of which are incorporated by reference herein.

The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc.

Exemplary Method of Deploying Texturized Woven PVL Guard

The procedure for delivering the docking device 300 to an 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 the procedure described above in reference to FIGS. 13-26, with the exceptions described below.

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

As shown in FIG. 27, the distal end portion 306d of the expandable member 306 can be configured to extend to a location adjacent to the posteromedial commissure 420. In certain examples, the distal end portion 306d of the expandable member 306 can extend through the native mitral valve annulus 408 and into the left ventricle 414. The proximal end portion 306p of the expandable member 306 can be configured to be positioned adjacent to the anterolateral commissure 419 of the native valve. As described above, the outer portion 310b of the enlargeable portions 310 can press against the posterior wall 416 of the left atrium 404. In addition, adjacent enlargeable portions 310 can contact each other so as to for a shield covering the constricted portions 312. 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 leakage.

After deploying the docking device 300, a prosthetic valve (e.g., 10) can be delivered into the left atrium 404, placed within the docking device 300, and then radially expanded, following similar steps described above in reference to FIGS. 20-25.

FIG. 28 illustrates the final disposition 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 guard member 304 can act as a seal between the docking device 300 and the native wall to prevent or reduce paravalvular leakage around the prosthetic valve 10.

Sterilization

Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat/thermal, pressure, steam, radiation, and/or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat/thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.

Additional Examples of the Disclosed Technology

In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

Example 1. A docking device for securing a prosthetic valve at a native valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the native valve; and a guard 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 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 and extends along an axial length of the expandable member and is movable between an axially stretched state and a resting state, the elastic member being biased to the resting state, wherein when the expandable member is in the radially compressed state, the elastic member is in the axially stretched state and configured to assist the expandable member to move 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 resting state.

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

Example 3. The docking device of any example herein, particularly any one of examples 1-2, wherein the elastic member is stitched to the expandable member.

Example 4. The docking device of any example herein, particularly any one of examples 1-3, wherein the elastic member is connected to the expandable member via a suture routed in a spiral path.

Example 5. The docking device of any example herein, particularly 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.

Example 6. The docking device of any example herein, particularly any one of examples 1-5, wherein the expandable member comprises a shape memory material.

Example 7. The docking device of any example herein, particularly example 6, wherein the expandable member comprises Nitinol.

Example 8. The docking device of any example herein, particularly any one of examples 1-7, wherein the expandable member comprises a woven material.

Example 9. The docking device of any example herein, particularly example 8, wherein the expandable member comprises woven polyethylene terephthalate (PET).

Example 10. The docking device of any example herein, particularly any one of examples 1-9, wherein the expandable member in the radially expanded state comprises a plurality of enlarged portions and one or more constricted portions connecting the plurality of enlarged portions, wherein the enlarged portions have a larger radial profile than the constricted portions.

Example 11. The docking device of any example herein, particularly example 10, where the constricted portions and the enlarged portions are made of the same material.

Example 12. The docking device of any example herein, particularly any one of examples 10-11, wherein the constricted portions have a first weave density that is greater than a second weave density of the enlarged portions.

Example 13. The docking device of any example herein, particularly any one of examples 10-12, wherein when the expandable member is in the radially expanded state, the constricted portions wraps around the coil and the enlarged portions radially expand from the coil.

Example 14. The docking device of any example herein, particularly any one of examples 10-13, wherein the constricted portions are configured to slide axially over the coil.

Example 15. The docking device of any example herein, particularly any one of examples 10-14, wherein the plurality of enlarged portions have about the same size.

Example 16. The docking device of any example herein, particularly any one of examples 10-14, wherein the plurality of enlarged portions have varying sizes.

Example 17. The docking device of any example herein, particularly any one of examples 10-16, wherein when the expandable member is in the radially expanded state, at least portions of two adjacent enlarged portions form a direct contact at a location that is radially outwardly of a constricted portion connecting the two adjacent enlarged portions.

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

Example 19. The docking device of any example herein, particularly any one of examples 1-18, wherein when the expandable member is in the radially expanded state and the prosthetic valve is radially expanded within the coil, an 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.

Example 20. The docking device of any example herein, particularly any one of examples 1-19, wherein when the expandable member is in the radially expanded state, at least a portion of the guard member extends radially outwardly relative to the coil such that the guard member can reduce paravalvular leakage around the prosthetic valve when deployed at the native valve.

Example 21. A guard member for a docking device configured to receive a prosthetic valve, the guard member comprising: an expandable member; and an elastic member extending along an 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 in the axially stretched state is configured to return to a resting state, thereby moving the expandable member from the radially compressed state to the radially expanded state.

Example 22. The guard member of any example herein, particularly example 21, wherein the expandable member in the radially expanded state is axially longer than the expandable member in the radially compressed state.

Example 23. The guard member of any example herein, particularly any one of examples 21-22, wherein a proximal end of the elastic member is attached to a proximal end portion of the expandable member, and a distal end of the elastic member is attached to a distal end portion of the expandable member.

Example 24. The guard member of any example herein, particularly any one of examples 21-23, wherein the elastic member is attached to the expandable member via a continuous suture extending along the axial length of the expandable member.

Example 25. The guard member of any example herein, particularly example 24, wherein a length of the suture is greater than or equal to a length of the elastic member in its axially stretched state such that the suture has slacks when the elastic member is in its resting state.

Example 26. The guard member of any example herein, particularly any one of examples 21-25, wherein the expandable member comprises a meshed wire frame.

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

Example 28. The guard member of any example herein, particularly example 27, wherein the elastic member forms a sheath surrounding the expanding member.

Example 29. The guard member of any example herein, particularly example 26, wherein the elastic member extends through an inner lumen of the expandable member.

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

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

Example 32. The guard member of any example herein, particularly any one of examples 21-25, wherein the expandable member comprises a woven material.

Example 33. The guard member of any example herein, particularly example 32, wherein the expandable member comprises a plurality of enlargeable portions connected by one or more constricted portions, wherein the constricted portions have a higher weave density than the enlargeable portions.

Example 34. The guard member of any example herein, particularly example 33, wherein the elastic member is connected to the one or more constricted portions.

Example 35. The guard member of any example herein, particularly any one of examples 33-34, wherein the constricted portions maintain a generally constant diameter when the expandable member moves from the radially compressed state to the radially expanded state.

Example 36. The guard member of any example herein, particularly any one of examples 33-35, wherein the enlargeable portions have a first diameter when the expandable member is in the radially compressed state and a second diameter when the expandable member is in the radially expanded state, the second diameter being larger than the first diameter.

Example 37. The guard member of any example herein, particularly example 36, wherein the first diameter of the enlargeable portions is about the same as the diameter of the constricted portions.

Example 38. The guard member of any example herein, particularly any one of examples 33-37, wherein when the expandable member is in the radially expanded state, adjacent enlargeable portions are configured to contact each other so as to shield the constricted portions.

Example 39. The guard member of any example herein, particularly any one of examples 36-38, wherein the enlargeable portions are biased to the second diameter.

Example 40. The guard member of any example herein, particularly any one of examples 21-39, wherein the elastic member extends parallel to a central longitudinal axis of the expandable member.

Example 41. A guard member for a docking device configured to receive a prosthetic valve, the guard member comprising: an expandable member comprising a woven material; wherein the expandable member comprises a plurality of enlargeable portions connected by one or more constricted portions, wherein the constricted portions have a higher weave density than the enlargeable portions; wherein the enlargeable 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 remain at a constant or at least substantially constant diameter when the enlargeable portions move between the first diameter and the second diameter.

Example 42. The guard member of any example herein, particularly example 41, wherein the first diameter of the enlargeable portions is about the same as the diameter of the constricted portions.

Example 43. The guard member of any example herein, particularly example 41, wherein the first diameter of the enlargeable portions is larger than the diameter of the constricted portions.

Example 44. The guard member of any example herein, particularly any one of examples 41-43, wherein the enlargeable portions are configured to axially elongate when moving from the second diameter to the first diameter.

Example 45. The guard member of any example herein, particularly any one of examples 41-44, wherein the expandable member comprises between 2 and 20 enlargeable portions.

Example 46. The guard member of any example herein, particularly example 45, wherein the expandable member comprises between 6 and 12 enlargeable portions.

Example 47. The guard member of any example herein, particularly example 46, wherein the expandable member comprises between 8 and 10 enlargeable portions.

Example 48. The guard member of any example herein, particularly any one of examples 41-47, wherein the first diameter of the enlargeable portions is between 1 mm and 4 mm.

Example 49. The guard member of any example herein, particularly example 48, wherein the first diameter of the enlargeable portions is between 2 mm and 3 mm.

Example 50. The guard member of any example herein, particularly example 49, wherein the first diameter of the enlargeable portions is between 2.0 mm and 2.6 mm.

Example 51. The guard member of any example herein, particularly any one of examples 41-50, wherein the second diameter of the enlargeable portions is between 4 mm and 10 mm.

Example 52. The guard member of any example herein, particularly example 51, wherein the second diameter of the enlargeable portions is between 7 mm and 9 mm.

Example 53. The guard member of any example herein, particularly example 52, wherein the second diameter of the enlargeable portions is between 7.5 mm and 8 mm.

Example 54. The guard member of any example herein, particularly any one of examples 41-53, wherein the diameter of the constricted portion is between 0.3 mm and 3 mm.

Example 55. The guard member of any example herein, particularly example 54, wherein the diameter of the constricted portions is between 0.5 mm and 2.6 mm.

Example 56. The guard member of any example herein, particularly example 55, wherein the diameter of the constricted portions is between 1.5 mm and 2.4 mm.

Example 57. The guard member of any example herein, particularly any one of examples 41-56, wherein each enlargeable portion at the second diameter has an axial length between 6 mm and 16 mm.

Example 58. The guard member of any example herein, particularly example 57, wherein each enlargeable portion at the second diameter has an axial length between 8 mm and 14 mm.

Example 59. The guard member of any example herein, particularly example 58, wherein each enlargeable portion at the second diameter has an axial length between 10 mm and 12 mm.

Example 60. The guard member of any example herein, particularly any one of examples 41-59, wherein when the enlargeable portions are at the second diameter, the expandable member has an axial length between 60 mm and 120 mm.

Example 61. The guard member of any example herein, particularly example 60, wherein when the enlargeable portions are at the second diameter, the expandable member has an axial length between 70 mm and 100 mm.

Example 62. The guard member of any example herein, particularly example 60, wherein when the enlargeable portions are at the second diameter, the expandable member has an axial length between 75 mm and 85 mm.

Example 63. The guard member of any example herein, particularly any one of examples 41-62, wherein each constricted portion has an axial length between 0.1 mm and 2 mm.

Example 64. The guard member of any example herein, particularly example 63, wherein each constricted portion has an axial length between 0.3 mm and 1.5 mm.

Example 65. The guard member of any example herein, particularly example 64, wherein each constricted portion has an axial length between 0.5 mm and 1.0 mm.

Example 66. The guard member of any example herein, particularly any one of examples 41-65, wherein the expandable member has an elongation ration between 1.1 and 1.6.

Example 67. The guard member of any example herein, particularly example 66, wherein the expandable member has an elongation ration between 1.2 and 1.5.

Example 68. The guard member of any example herein, particularly any one of examples 41-67, further comprising an elastic member extending along an 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 the enlargeable portions have the first diameter when the elastic member is in the axially stretched state and have the second diameter when the elastic member is in the resting state.

Example 69. The guard member of any example herein, particularly example 68, wherein a proximal end of the elastic member is attached to a proximal end portion of the expandable member and a distal end of the elastic member is attached to a distal end portion of the expandable member such that axial elongation or shortening of the elastic member causes corresponding axial elongation or shortening of the expandable member.

Example 70. The guard member of any example herein, particularly any one of examples 68-69, wherein the elastic member extends parallel to a central longitudinal axis of the expandable member and is connected the one or more constricted portions.

Example 71. A method for assembling a docking device configured to receive a prosthetic valve, the method comprising: attaching a guard member to a coil, wherein the coil is configured to surround native tissue when deployed at a native valve; wherein the guard member comprises an expandable member and an elastic member extending along an axial length of the expandable member; wherein the elastic member can be moved from a resting state to an axially stretched state, the elastic member being biased to the resting state; wherein the expandable member is in a radially compressed state when the elastic member is moved to the axially stretched state; wherein the expandable member is in a radially expanded state when the elastic member returns to the resting state.

Example 72. The method of any example herein, particularly example 71, further comprising assembling the guard member, wherein assembly the guard member comprises attaching the elastic member to the expandable member.

Example 73. The method of any example herein, particularly example 72, wherein attaching the elastic member to the expandable member comprises attaching a proximal end of the elastic member to a proximal end portion of the expandable member and attaching a distal end of the elastic member to a distal end portion of the expandable member.

Example 74. The method of any example herein, particularly any one of examples 72-73, wherein attaching the elastic member to the expandable member comprises suturing the elastic member to the expandable member along the axial length of the expandable member.

Example 75. The method of any example herein, particularly any one of examples 72-74, wherein assembling the guard member comprises braiding the expandable member using metal wires to form a meshed wire frame.

Example 76. The method of any example herein, particularly example 75, wherein attaching the elastic member to the expandable member comprises weaving the elastic member onto the meshed wire frame.

Example 77. The method of any example herein, particularly any one of examples 72-74, wherein assembling the guard member comprises weaving a fabric to form a plurality of enlargeable portions connected by one or more constricted portions, wherein the constricted portions have a higher weave density than the enlargeable portions.

Example 78. The method of any example herein, particularly example 77, wherein attaching the elastic member to the expandable member comprises connecting the elastic member to the one or more constricted portions.

Example 79. The method of any example herein, particularly any one of examples 77-78, wherein assembling the guard member further comprises shape setting the plurality of enlargeable portions.

Example 80. The method of any example herein, particularly any one of examples 71-79, wherein attaching the guard member to the coil comprises fixedly attaching a distal end of the guard member to the coil and making a proximal end of the guard member axially movable relative to the coil.

Example 81. The method of any example herein, particularly any one of examples 71-80, further comprising retaining the guard member within a delivery sheath such that the expandable member is in the radially compressed state and the elastic member is in the axially stretched state.

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

Example 83. The method of any example herein, particularly example 82, further comprising delivering the docking device to the native valve, wherein delivering the docking device comprises retaining the docking device within a delivery sheath in a substantially straight configuration.

Example 84. The method of any example herein, particularly example 83, wherein retaining the docking device within the delivery sheath comprises radially compressing the expandable member to the radially compressed state and axially stretching the elastic member to the axially stretched state within the delivery sheath.

Example 85. The method of any example herein, particularly any one of examples 82-84, wherein deploying the docking device comprises removing the delivery sheath from the guard 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.

Example 86. The method of any example herein, particularly any one of examples 82-85, wherein deploying the prosthetic valve comprises 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.

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

Example 88. A medical assembly comprising: a docking device according to any one of the examples 1-20 or a docking device comprising a guard member according to any one of the examples 21-70; and a delivery apparatus configured to deliver the docking device to a target implantation site of a patient.

Example 89. A docking device for securing a prosthetic valve at 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 outwardly 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, wherein the expandable member comprises a braided wire frame.

Example 90. The docking device of any example herein, particular example 89, wherein the braided wire frame comprises a metal alloy with shape memory properties.

Example 91. The docking device of any example herein, particular example 90, wherein the metal alloy comprises nickel titanium.

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

Example 93. The docking device of any example herein, particular example 92, wherein the metallic material comprises cobalt chromium or stainless steel.

Example 94. The docking device of any example herein, particularly any one of examples 89-93, wherein the expandable member comprises a polymeric material.

Example 95. The docking device of any example herein, particular example 94, wherein the braided wireframe is embedded in the polymeric material.

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

Example 97. The docking device of any example herein, particularly any one of examples 89-96, wherein the braided wireframe comprises between 16 and 128 wires, inclusive.

Example 98. The docking device of any example herein, particular example 97, wherein the braided wireframe comprises between 32 and 96 wires, inclusive.

Example 99. The docking device of any example herein, particular example 98, wherein the braided wireframe comprises between 48 and 64 wires, inclusive.

Example 100. The docking device of any example herein, particularly any one of examples 89-99, wherein the braided wireframe has a braid density ranging from 20 to 70 picks per inch, inclusive.

Example 101. The docking device of any example herein, particular example 100, wherein the braided wireframe has a braid density ranging from 25 to 65 picks per inch, inclusive.

Example 102. The docking device of any example herein, particular example 101, wherein the braided wireframe has a braid density ranging from 36 to 40 picks per inch, inclusive.

Example 103. The docking device of any example herein, particularly any one of examples 89-102, wherein the braided wireframe comprises wires having a wire diameter ranging from 0.002 inch to 0.004 inch, inclusive.

Example 104. The docking device of any example herein, particular example 103, wherein the wire diameter is 0.003 inch.

Example 105. A docking device for securing a prosthetic valve at 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 outwardly 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, wherein the expandable member comprises a polymeric material.

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

Example 107. A docking device for securing a prosthetic valve at 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 outwardly 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, wherein the expandable member comprises a braided metallic wireframe coated with an elastomer.

Example 108. A docking device for securing a prosthetic valve at 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 outwardly 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, wherein the expandable member comprises one or more metallic wires interwoven with one or more polymeric fibers.

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

Example 110. The guard member of any example herein, particular example 109, wherein the elastic member comprises a coil spring.

Example 111. The guard member of any example herein, particular example 110, wherein a pitch of the coil spring is larger than a pitch of the braided wire mesh.

Example 112. The guard member of any example herein, particular example 111, wherein the pitch of the coil spring ranges between 3 mm and 9 mm.

Example 113. The guard member of any example herein, particular example 112, wherein the pitch of the coil spring ranges between 5 mm and 7 mm.

Example 114. The guard member of any example herein, particularly any one of examples 110-113, wherein 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.

Example 115. The guard member of any example herein, particular example 114, wherein the diameter of the first wire ranges from 0.15 mm and 0.22 mm.

Example 116. The guard member of any example herein, particularly any one of examples 109-115, wherein the elastic member comprises a shape-memory material.

Example 117. The guard member of any example herein, particularly any one of examples 109-116, wherein the braided wire mesh comprises a shape-memory material.

Example 118. The guard member of any example herein, particularly any one of examples 109-117, wherein the elastic member is in an axially stretched state when the expandable member is in the radially compressed state and in a resting state when the expandable member is in the second radially expanded state, wherein the elastic member is biased toward the resting state.

Example 119. The guard member of any example herein, particularly any one of examples 109-118, wherein a first end of the elastic member is connected to a first end of the expandable member, wherein a second end of the elastic member is connected to a second end of the expandable member.

Example 120. The guard member of any example herein, particularly any one of examples 109-119, wherein the elastic member is disposed within a lumen of the expandable member.

Example 121. The guard member of any example herein, particularly any one of examples 109-119, wherein the elastic member is disposed over an outer surface of the expandable member.

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

Example 123. The docking device of any example herein, particular example 122, 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.

Example 124. The docking device of any example herein, particularly any one of examples 122-123, wherein the expandable member comprises nickel titanium alloy.

Example 125. The docking device of any example herein, particularly any one of examples 122-124, wherein the coil spring comprises nickel titanium alloy.

Example 126. The docking device of any example herein, particularly any one of examples 122-125, wherein the expandable member comprises a braided wire mesh.

Example 127. The docking device of any example herein, particularly any one of examples 122-126, wherein a first end of the coil spring is connected to a first end of the expandable member, and a second end of the coil spring is connected to a second end of the expandable member.

Example 128. A docking device for securing a prosthetic valve at a native valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the native valve; and a guard member comprising an expandable member and a coil spring coiling 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 resting state, the coil spring being biased to the resting state, wherein when the expandable member is in the radially compressed state, the coil spring is in the axially stretched state and configured to assist the expandable member to move 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 resting state.

Example 129. A method comprising sterilizing the docking device of any example herein, particularly any one of examples 1-20, 89-108 and 122-128, sterilizing the guard member of any example herein, particularly any one of examples 21-70 and 109-121, or sterilizing the medical assembly of any example herein, particularly any one of examples 87-88.

Example 130. A method of treating a heart on a 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 guard member attached to the coil; wherein the guard member comprises an expandable member and an elastic member extending along an axial length of the expandable member; wherein the elastic member can be moved from a resting state to an axially stretched state, the elastic member being biased to the resting state; wherein the expandable member is in a radially compressed state when the elastic member is moved to the axially stretched state; wherein the expandable member is in a radially expanded state when the elastic member returns to the resting state.

The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one docking device can be combined with any one or more features of another docking device. As another example, any one or more features of one guard member can be combined with any one or more features of another guard member.

In view of the many possible examples to which the principles of the disclosed technology may 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 following claims and their equivalents.

Claims

1. A docking device for securing a prosthetic valve at a native valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the native valve; anda guard 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 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 and extends along an axial length of the expandable member and is movable between an axially stretched state and a resting state, the elastic member being biased to the resting state,wherein when the expandable member is in the radially compressed state, the elastic member is in the axially stretched state and configured to assist the expandable member to move from the radially compressed state to the radially expanded state, andwherein when the expandable member is in the radially expanded state, the elastic member is in the resting state.

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

3. The docking device of claim 1, wherein the elastic member is stitched to the expandable member.

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

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

6. The docking device of claim 1, wherein the expandable member comprises a shape memory material.

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

8. The docking device of claim 1, wherein the expandable member comprises a woven material.

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

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

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

12. The docking device of claim 10, wherein the constricted portions have a first weave density that is greater than a second weave density of the enlarged portions.

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

14. The docking device of claim 10, wherein the constricted portions are configured to slide axially over the coil.

15. A guard member for a docking device configured to receive a prosthetic valve, the guard member comprising: an expandable member; andan elastic member extending along an 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 in the axially stretched state is configured to return to a resting state, thereby moving the expandable member from the radially compressed state to the radially expanded state.

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

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

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

19. A guard member for a docking device configured to receive a prosthetic valve, the guard member comprising: an expandable member comprising a woven material;wherein the expandable member comprises a plurality of enlargeable portions connected by one or more constricted portions, wherein the constricted portions have a higher weave density than the enlargeable portions;wherein the enlargeable 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 remain at a constant or at least substantially constant diameter when the enlargeable portions move between the first diameter and the second diameter.

20. The guard member of claim 19, further comprising an elastic member extending along an 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 the enlargeable portions have the first diameter when the elastic member is in the axially stretched state and have the second diameter when the elastic member is in the resting state.

21. A docking device for securing a prosthetic valve at a native valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the native valve; andan expandable member extending radially outwardly 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,wherein the expandable member comprises a braided wire frame.