Prosthetic valve docking device

Abstract

A docking device for securing a prosthetic valve at a native valve includes a coil having a plurality of helical turns when deployed at the native valve and a guard member attached to the coil. The guard member is movable between a radially compressed state and a radially expanded state. The guard member includes a plurality of flaps. Each flap includes a rounded head portion and a tapered base portion. The head portion is wider than the base portion when the guard member is in the radially expanded state.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 514,554, filed July 19, 2023, which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to examples of docking devices configured to secure a prosthetic valve to an autologous heart valve, and methods for assembling such devices. Background Technology

[0004] Prosthetic heart valves can be used to treat valvular heart disease. Autologous heart valves (such as the aortic valve, pulmonary valve, tricuspid valve, and mitral valve) prevent regurgitation or backflow while allowing forward flow. These heart valves can become less effective due to congenital, inflammatory, or infectious conditions. Such conditions can ultimately lead to serious cardiovascular damage or death. For many years, doctors have attempted to treat these conditions by surgically repairing or replacing the valves during open-heart surgery.

[0005] Transcatheter techniques for introducing and implanting prosthetic heart valves using catheters, which are less invasive than open-heart surgery, can reduce complications associated with open-heart surgery. In this technique, the prosthetic valve can be mounted in a compressed state on the distal portion of a catheter and advanced through the patient's blood vessels until the valve reaches the implantation site. The valve at the catheter tip can then be expanded to its functional size at the site of a defective autologous valve, for example, by inflating a balloon on which the valve is mounted, or, for example, the valve can have a resilient, self-expanding frame that expands the valve to its functional size as a delivery sheath is advanced from the distal end of the catheter. Optionally, the valve can have a balloon-expanding, self-expanding, mechanically expandable frame, and / or a frame that is expandable in a variety of ways or combinations thereof.

[0006] In some cases, a transcatheter heart valve (THV) can be appropriately sized to fit within a specific autologous valve (e.g., an autologous aortic valve). Therefore, a THV may not be suitable for implantation in another autologous valve (e.g., an autologous mitral valve) and / or in patients with a larger autologous valve. Additionally or alternatively, the native tissue at the implantation site may not provide sufficient structure to anchor the THV in place relative to the native tissue. Therefore, improvements to the THV and associated transcatheter delivery devices are desired. Summary of the Invention

[0007] This disclosure relates to methods and apparatus for treating valvular regurgitation and / or other valvular problems. Specifically, this disclosure relates to a docking device configured to receive a prosthetic valve, and a method for assembling and implanting the docking device.

[0008] A docking device for securing a prosthetic valve to an autologous valve may include a coil comprising a plurality of helical turns when deployed at the autologous valve. In addition to these features, the docking device may also include one or more components disclosed herein.

[0009] In some examples, the docking device may include a protective member attached to the coil and movable between a radially compressed state and a radially expanded state.

[0010] In some examples, the protective component may contain multiple lobes.

[0011] In some examples, each flap may have a circular head portion and a conical base portion, and the head portion is wider than the base portion when the protective member is in a radially expanded state.

[0012] In some examples, the protective member may include a wireframe comprising a ridge and a plurality of lobes connected to the ridge, the lobes extending radially outward from the ridge.

[0013] Some aspects of this disclosure relate to a protective member for a docking device configured to secure a prosthetic valve to an autologous valve. The protective member may comprise a wireframe and a cover that substantially encloses the wireframe. The wireframe may include a ridge and a plurality of flaps connected to the ridge. The flaps may extend radially outward from the ridge. The plurality of flaps may be radially expandable and compressible.

[0014] Some aspects of this disclosure relate to a method for fabricating a docking device configured to secure a prosthetic valve to an autologous valve. The method may include obtaining a wireframe including a ridge and a plurality of lobes connected to and extending radially outward from the ridge, and a protective member for closing the wireframe with a cap to form the docking device.

[0015] Certain aspects of this disclosure relate to a method for implanting a prosthetic valve. The method includes delivering a docking device to an autologous valve, deploying the docking device at the annulus of the autologous valve, and deploying a prosthetic valve within the docking device. The docking device includes a coil and a protective member attached to the coil. The coil may be held in a substantially straight configuration during delivery of the docking device and moved to a helical configuration after the docking device has been deployed. The protective member may be held in a folded configuration during delivery of the docking device and moved to an unfolded configuration after the docking device has been deployed.

[0016] The above methods can be performed on live animals or on simulated objects, such as corpses, corpse hearts, anthropomorphic ghosts, and simulators (e.g., with simulated body parts, hearts, tissues, etc.).

[0017] In some examples, the docking device or protective member includes one or more components described in Examples 1 to 60 of the following “Additional Examples of the Disclosed Technology” section.

[0018] The foregoing and other objects, features and advantages of the disclosed technology will become more apparent from the following detailed embodiments with reference to the accompanying drawings. Attached Figure Description

[0019] Figure 1 The illustration schematically depicts the first stage of an exemplary mitral valve replacement surgery, in which a guiding catheter and guidewire are inserted into the patient's vascular system and guided through the vascular system and into the patient's heart, toward the heart's natural mitral valve.

[0020] Figure 2A The second stage of an exemplary mitral valve replacement surgery is illustrated schematically, wherein a docking device delivery device extending through a guide catheter is used to deploy the docking device at the natural mitral valve.

[0021] Figure 2B The illustration schematically depicts the third stage of an exemplary mitral valve replacement surgery, in which... Figure 2A The docking device was fully implanted in the patient's natural mitral valve, and the docking device delivery device has been removed from the patient.

[0022] Figure 3A The illustration schematically depicts the fourth stage of an exemplary mitral valve replacement surgery, in which a prosthetic heart valve is deployed into an implanted docking device located at the natural mitral valve via a prosthetic heart valve delivery device extending through a guide catheter.

[0023] Figure 3B The illustration schematically depicts the fifth stage of an exemplary mitral valve replacement surgery, in which the prosthetic heart valve is fully implanted into the docking device located at the natural mitral valve, and the prosthetic heart valve delivery device has been removed from the patient.

[0024] Figure 4 The illustration schematically depicts the sixth stage of an exemplary mitral valve replacement procedure, where the guiding catheter and guidewire have been removed from the patient.

[0025] Figure 5 This is a perspective view of an example prosthetic heart valve.

[0026] Figure 6AThis is a side perspective view of a docking device in a deployment configuration, based on an example, which includes a helical coil and a protective member.

[0027] Figure 6B yes Figure 6A A top view of the docking device.

[0028] Figure 6C It was taken along line 6C-6C. Figure 6A A transverse cross-sectional view of the docking device.

[0029] Figure 6D It is a 6D-6D section along the line. Figure 6A Another transverse cross-sectional view of the docking device.

[0030] Figure 7A A protective member in a radially expanded state is depicted according to an example.

[0031] Figure 7B Depicting Figure 7A The protective components are in a basically vertical configuration.

[0032] Figure 7C Depicting Figure 7B The protective components are radially compressed.

[0033] Figure 7D Depicting Figure 7C The protective components are in a folded configuration.

[0034] Figure 8A A docking device deployed at an autologous valve according to an example is schematically depicted, the docking device including another protective member.

[0035] Figure 8B The illustration depicts a deployment based on an example. Figure 8A The prosthetic valve inside the docking device.

[0036] Figure 9A Depicting an example of an expanded configuration Figure 8A The wireframe of the protective components.

[0037] Figure 9B Depicting a folded configuration Figure 9A The wireframe.

[0038] Figure 10A A method is described, according to an example, for cutting two layers of fabric using a die to produce a cover for a protective component of a docking device.

[0039] Figure 10B The protective components are described, which include, according to Figure 10A The resulting cap and the wireframe enclosed within the cap.

[0040] Figure 10C Depicts attaching a wireframe to an example Figure 10B The cover of the protective component.

[0041] Figure 10D Depicting based on an example Figure 10C The protective components are attached to the coil of the docking device. Detailed Implementation

[0042] General considerations

[0043] It should be understood that the disclosed examples are adaptable to delivering and implanting prosthetic devices into any autologous ring of the heart (e.g., pulmonary ring, mitral annulus, and tricuspid annulus) and can be used with any of a variety of delivery methods (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0044] For the 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 limiting in any way. Rather, this disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and sub-combinations with each other. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed examples do not require the presence of any one or more particular advantages or problems solved. Techniques from any example can be combined with techniques described in any one or more other examples. Given the many possible examples to which the principles of the disclosed techniques can be applied, it should be recognized that the examples shown are merely preferred examples and should not be considered as limiting the scope of the disclosed techniques.

[0045] Although the operations of some disclosed examples are described in a specific order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language described below requires a particular order. For example, in some cases, the operations described in sequence may be rearranged or performed simultaneously. Furthermore, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods can be combined with other methods. Additionally, this specification sometimes uses terms such as "provides" or "implements" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are readily discernible to those skilled in the art.

[0046] As used in this application and claims, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” include the plural forms. Additionally, the term “comprising” means “including.” Furthermore, the terms “link” and “connection” generally mean an electrical, electromagnetic, and / or physical (e.g., mechanical or chemical) connection or link, and in the absence of specific contrasting language, the presence of intermediate elements between the linked or associated items is not excluded.

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

[0048] Orientation and other relative references (e.g., inside, outside, top, bottom, etc.) may be used to facilitate the discussion of the figures and principles herein, but are not intended to be limiting. For example, certain terms such as “inside,” “outside,” “top,” “bottom,” “internal,” “external,” etc., may be used. When dealing with relative relationships, particularly with respect to the examples shown, such terms are used where applicable to provide some clarity of description. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, for an object, the “upper” portion can simply become the “lower” portion by flipping the object. Nevertheless, it remains the same portion and the object remains unchanged. As used herein, “and / or” means “and” or “or,” as well as “and” and “or.”

[0049] Exemplary transcatheter heart valve replacement surgery

[0050] This article describes various systems, devices, methods, etc., that can be used in or in conjunction with delivery devices to deliver prosthetic implants (e.g., prosthetic valves, docking devices, etc.) into a patient.

[0051] In some examples, the delivery device can be configured to deliver and implant a docking device at the implantation site, such as the natural valve annulus. The docking device can be configured to more securely hold the expandable prosthetic valve within the docking device at the natural valve annulus. For example, the docking device can provide or form a more rounded and / or more stable anchoring site, landing zone, or implantation zone at the implantation site, where the prosthetic valve can expand or otherwise implant. By providing such anchoring or docking devices, the replacement prosthetic valve can be more securely implanted and held at individual valve annulus locations, including at the mitral valve annulus, which does not have a natural circular cross-section.

[0052] In some examples, the docking device may be disposed within the outer shaft of the delivery device. A sleeve shaft may cover or surround the docking device within the delivery device during delivery to the target implantation site. A pusher shaft may be disposed within the outer shaft, adjacent to the docking device, and configured to push the docking device out of the outer shaft to position the docking device at the target implantation site. The sleeve shaft may also surround the pusher shaft within the outer shaft of the delivery device. After the docking device has been positioned at the target implantation site, the sleeve shaft can be removed from the docking device and retracted into the outer shaft of the delivery device.

[0053] Fluids (e.g., flushing fluids, such as heparinized saline) can be supplied to the actuator shaft lumen defined within the actuator shaft, the delivery shaft lumen defined between the sleeve shaft and the outer shaft of the delivery device, and the sleeve shaft lumen defined between the actuator shaft and the sleeve shaft. By providing consistent fluid flow through these lumens of the delivery device, blood stagnation within the delivery device can be reduced or avoided, thereby lowering the risk of thrombosis.

[0054] exist Figures 1 to 4 The schematic diagram depicts an exemplary transcatheter heart valve replacement procedure, which utilizes a first delivery device to deliver a docking device to an autologous valve ring, and then utilizes a second delivery device to deliver a prosthetic heart valve (e.g., THV) into the docking device.

[0055] As described above, defective natural heart valves can be replaced with THVs. However, in some cases, such THVs may not adequately anchor themselves to the autologous tissue (e.g., to the leaflets and / or annulus of an autologous heart valve) and may displace undesirably relative to the autologous tissue, leading to paravalvular leaks, valvular dysfunction, and / or other problems. Therefore, a docking device can be implanted first at the natural valve annulus, and then the THV can be implanted within the docking device to help anchor the THV to the natural tissue and provide a seal between the natural tissue and the THV.

[0056] Figures 1 to 4An exemplary transcatheter heart valve replacement procedure (e.g., mitral valve replacement) is depicted according to an example, utilizing a docking device 52 and a prosthetic heart valve 62. During the procedure, the user uses a guiding catheter 30 ( Figure 1 This creates a pathway to the patient's natural heart valve. The user can use the docking device to deliver the device 50 ( Figure 2A The docking device 52 is delivered and implanted at the patient's natural heart valve, and then the docking device delivery device 50 is removed from the patient 10 after the docking device 52 has been implanted. Figure 2B The user can then use the prosthetic valve delivery device 60 ( Figure 3A The prosthetic heart valve 62 is implanted into the implantation docking device 52. Afterwards, the user can remove the prosthetic valve delivery device 60 from the patient 10. Figure 3B ) and guiding catheter 30 ( Figure 4 ).

[0057] Figure 1 The first stage of an example mitral valve replacement surgery is depicted. As shown, a guiding catheter 30 and a guidewire 40 can be inserted into the vascular system 12 of the patient 10 and guided through the vascular system 12 into the heart 14 of the patient 10, toward the natural mitral valve 16. Together, the guiding catheter 30 and guidewire 40 provide a path for the docking device delivery device 50 and the prosthetic valve delivery device 60 to pass through and be guided along this path to the implantation site (e.g., the autologous mitral valve 16 or the autologous mitral valve annulus).

[0058] Initially, the user can first make an incision in the patient's body to access the vascular system 12. For example, as Figure 1 As shown, the user can make an incision in the patient's groin to access the femoral vein. Therefore, in such examples, the vascular system 12 may include the femoral vein.

[0059] After an incision is made to access the vascular system 12, the user can insert a guiding catheter 30, a guidewire 40, and / or additional devices (such as a guide device or a transseptal puncture device) into the vascular system 12 through the incision. The guiding catheter 30 (which may also be referred to as a “guide device,” “guide,” or “guide sheath”) can be configured to facilitate the percutaneous introduction and passage of various implant delivery devices (e.g., docking device delivery device 50 and prosthetic valve delivery device 60) through the vascular system 12, and can extend through the vascular system 12 and into the heart 14, but may stop before the autologous mitral valve 16. The guiding catheter 30 may include a stem 32 and a shaft 34 extending distally from the stem 32. The shaft 34 can extend through the vascular system 12 and into the heart 14, while the stem 32 can be held outside the patient 10 and can be manipulated by the user to control the shaft 34. Figure 1 ).

[0060] The guidewire 40 can be configured to guide delivery devices (e.g., guiding catheter 30, docking device delivery device 50, prosthetic valve delivery device 60, additional catheters, etc.) and their associated devices (e.g., docking device, prosthetic heart valve, etc.) to the implantation site within the heart 14, and thus can extend all the way through the vascular system 12 and into the left atrium 18 of the heart 14 (and in some examples, through the autologous mitral valve 16 and into the left ventricle of the heart 14). Figure 1 ).

[0061] In some cases, a transseptal puncture device or catheter can be used for initial access to the left atrium 18 before the insertion of guidewire 40 and guiding catheter 30. For example, after an incision is made to access the vascular system 12, the user can insert the transseptal puncture device through the incision into the vascular system 12. The user can guide the transseptal puncture device through the vascular system 12 and into the heart 14 (e.g., through the femoral vein and into the right atrium 20). The user can then make a small incision in the atrioventricular septum 22 of the heart 14 to allow access from the right atrium 20 into the left atrium 18. The user can then insert and advance the guidewire 40 through the transseptal puncture device within the vascular system 12 and through the incision in the atrioventricular septum 22 into the left atrium 18. Once the guidewire 40 is positioned within the left atrium 18 and / or left ventricle 26, the transseptal puncture device can be removed from the patient 10. The user can then insert the guiding catheter 30 into the vascular system 12 and through the guidewire 40 ( Figure 1 The guiding catheter 30 is advanced into the left atrium 18.

[0062] In some cases, a guide device may be inserted through the lumen of the guide catheter 30 before the guide catheter 30 is inserted into the vascular system 12. In some cases, the guide device may include a tapered end extending from the distal end of the guide catheter 30 and configured to guide the guide catheter 30 into the left atrium 18 via a guidewire 40. Additionally, in some cases, the guide device may include a proximal portion extending from the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user can remove the guide device from the guide catheter 30 and the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain in the patient 10. The guide catheter 30 is then positioned to receive the implant delivery device and assist in guiding it into the left atrium 18, as further described below.

[0063] Figure 2A A second stage of an exemplary mitral valve replacement surgery is depicted, wherein a docking device 52 is implanted at the natural mitral valve 16 of the heart 14 of the patient 10 using a docking device delivery device 50 (which may also be referred to as an “implant catheter” and / or a “docking device delivery device” or simply a “delivery device”).

[0064] Typically, the docking device delivery device 50 may include a delivery shaft 54 ​​(which may also be referred to as an "outer shaft"), a handle 56, and a pusher assembly 58 (which may also be referred to as a "pusher shaft"). The delivery shaft 54 ​​may be configured to be advanced by a user through the patient's vascular system 12 and to the implantation site (e.g., autologous mitral valve 16), and may be configured to hold the docking device 52 in the distal portion 53 of the delivery shaft 54. In some examples, the distal portion 53 of the delivery shaft 54 ​​may hold the docking device 52 therein in a substantially straight delivery configuration.

[0065] The handle 56 of the docking device delivery device 50 can be configured to be grasped and / or otherwise held by a user to advance the delivery shaft 54 ​​through the patient's vascular system 12. Specifically, the handle 56 can be coupled to the proximal end of the delivery shaft 54 ​​and can be configured to remain accessible to the user during docking device implantation surgery (e.g., outside the patient's body). In this way, the user can advance the delivery shaft 54 ​​through the patient's vascular system 12 by applying force to the handle 56 (e.g., pushing the handle). In some examples, the delivery shaft 54 ​​can be configured to carry a pusher assembly 58 and / or a docking device 52 as it is advanced through the patient's vascular system 12. In this way, the docking device 52 and / or the pusher assembly 58 can advance in lockstep with the delivery shaft 54 ​​through the patient's vascular system 12 as the user grasps the handle 56 and pushes the delivery shaft 54 ​​deeper into the patient's vascular system 12.

[0066] In some examples, the handle 56 may include one or more hinge members 57 configured to facilitate guiding the delivery shaft 54 ​​through the vascular system 12. For example, the one or more hinge members 57 may include one or more of a knob, button, wheel, and / or other type of physically adjustable control member configured to be adjusted by a user to flex, bend, twist, rotate, and / or otherwise hinge the distal end portion 53 of the delivery shaft 54 ​​to facilitate guiding the delivery shaft 54 ​​through the vascular system 12 and / or within the heart 14.

[0067] The pusher assembly 58 may be configured to deploy and / or implant the docking device 52 at an implantation site (e.g., autologous mitral valve 16). For example, the pusher assembly 58 may be configured to be adjusted by a user to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54. The pusher shaft of the pusher assembly 58 may extend through the delivery shaft 54 ​​and may be positioned adjacent to the docking device 52 within the delivery shaft 54. In some examples, the docking device 52 may be releasably coupled to the pusher shaft of the pusher assembly 58 via a connection mechanism of the docking device delivery device 50, such that the docking device 52 may be released after deployment at the natural mitral valve 16. Because the docking device 52 is held, secured, and / or otherwise coupled to the pusher assembly 58, the docking device 52 may advance through and / or exit the delivery shaft 54 ​​in a lockstep manner with the pusher assembly 58.

[0068] In addition to the pusher shaft, in some cases, the pusher assembly 58 may also include a sleeve shaft. The pusher shaft may be configured to advance the docking device 52 through the delivery shaft 54 ​​and out of the distal end portion 53 of the delivery shaft 54, while when the sleeve shaft is included, it may have a distal docking sleeve configured to cover the docking device 52 within the delivery shaft 54 ​​and simultaneously push the docking device 52 out of the delivery shaft 54 ​​and position the docking device 52 at the implantation site. In some examples, the pusher shaft may be at least partially covered by the sleeve shaft.

[0069] In some examples, the pusher assembly 58 may include a pusher handle coupled to the pusher shaft and configured to be gripped and pushed by a user to axially translate the pusher shaft relative to the delivery shaft 54 ​​(e.g., push the pusher shaft into and / or push out the distal portion 53 of the delivery shaft 54). The docking sleeve may be configured to retract and / or withdraw from the docking device 52 after the docking device 52 has been positioned at the target implantation site. For example, the pusher assembly 58 may include a sleeve handle coupled to the sleeve shaft and configured to be pulled by a user to retract (e.g., axially move) the sleeve shaft relative to the pusher shaft, thereby retracting the docking sleeve.

[0070] The pusher assembly 58 may be detachably coupled to the docking device 52 and can therefore be configured to release, separate, detach, and / or otherwise disconnect from the docking device 52 once it has been deployed at the target implantation site. As an example only, the pusher assembly 58 may be detachably coupled to the docking device 52 via thread, rope, yarn, suture, or other suitable material tied to or sewn to the docking device 52.

[0071] In some examples, the pusher assembly 58 may include a suture lock assembly (also referred to as a "suture lock") configured to receive and / or hold thread or other suitable material coupled to the docking device 52 via suture. The thread or other suitable material forming the suture may extend from the docking device 52 through the pusher assembly 58 to the suture lock assembly. The suture lock assembly may also be configured to cut the suture to release, separate, disengage, and / or otherwise disconnect the docking device 52 from the pusher assembly 58. For example, the suture lock assembly may include a cutting mechanism configured to be adjusted by a user to cut the suture.

[0072] Refer again Figure 2A After the guiding catheter 30 is positioned within the left atrium 18, the user can insert the docking device delivery device 50 (e.g., delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 ​​of the docking device delivery device 50 through the guiding catheter 30 and over the guidewire 40. In some examples, the guidewire 40 may be retracted at least partially away from the left atrium 18 and into the guiding catheter 30. The user can then continue advancing the delivery shaft 54 ​​of the docking device delivery device 50 along the guidewire 40 through the vascular system 12 until the delivery shaft 54 ​​reaches the left atrium 18, as... Figure 2A As shown. Specifically, the user can advance the delivery shaft 54 ​​of the docking device delivery device 50 toward the patient 10 by grasping the handle 56 of the docking device delivery device 50 and applying force to the handle (e.g., pushing the handle). As the delivery shaft 54 ​​is advanced through the vascular system 12 and the heart 14, the user can adjust one or more hinge members 57 of the handle 56 to guide various turns, corners, constrictions and / or other obstacles in the vascular system 12 and the heart 14.

[0073] Once the delivery shaft 54 ​​reaches the left atrium 18 and extends distally from the guide catheter 30, the user can use the handle 56 (e.g., hinge member 57) to position the distal portion 53 of the delivery shaft 54 ​​at and / or near the posteromedial commissure of the autologous mitral valve 16. The user can then use the shaft of the pusher assembly 58 to push the docking device 52 out of the distal portion 53 of the delivery shaft 54 ​​to deploy and / or implant the docking device 52 within the annulus of the autologous mitral valve 16.

[0074] In some examples, the docking device 52 may be constituted, formed, and / or contain shape memory material, and thus, when the docking device leaves the delivery shaft 54 ​​and is no longer constrained by the delivery shaft 54, it can return to its initial pre-formed shape. As an example, the docking device 52 may be initially formed as a coil, and thus, when it leaves the delivery shaft 54 ​​and returns to its initial coiled configuration, it can wind around the leaflet 24 of the mitral valve 16.

[0075] In the ventricular portion that drives the docking device 52 (e.g., Figure 2A After the docking device 52 is configured to be positioned within the left ventricle 26 and / or on the ventricular side of the autologous mitral valve 16, the user can then deploy the remaining portion of the docking device 52 (e.g., the atrial portion of the docking device 52) from the delivery shaft 54 ​​into the left atrium 18 by retracting the delivery shaft 54 ​​away from the medial commissure of the autologous mitral valve 16. For example, the user can maintain the position of the pusher assembly 58 (e.g., by applying a holding force and / or thrust on the pusher shaft) while retracting the delivery shaft 54 ​​proximally, such that the delivery shaft 54 ​​is withdrawn and / or otherwise retracted relative to the docking device 52 and the pusher assembly 58. In this way, the pusher assembly 58 can hold the docking device 52 in place as the user retracts the delivery shaft 54, thereby releasing the docking device 52 from the delivery shaft 54. In some examples, the user can also remove the docking sleeve from the docking device 52, for example, by retracting the sleeve shaft.

[0076] After deploying and implanting the docking device 52 at the autologous mitral valve 16, the user can disconnect the docking device delivery device 50 from the docking device 52. Once the docking device 52 is disconnected from the docking device delivery device 50 (e.g., by cutting the sutures attached to the docking device 52), the user can retract the docking device delivery device 50 from the vascular system 12 and away from the patient 10, allowing the user to deliver and implant the prosthetic heart valve 62 within the implanted docking device 52 at the autologous mitral valve 16.

[0077] Figure 2B This illustrates the third stage of a mitral valve replacement surgery, where the docking device 52 has been fully deployed and implanted at the natural mitral valve 16, and the docking device delivery device 50 (including the delivery shaft 54) has been removed from the patient 10, leaving only the guidewire 40 and the guiding catheter 30 in the patient 10. In some examples, after removal of the docking device delivery device, the guidewire 40 can be advanced beyond the guiding catheter 30, through the docking device 52 implanted at the natural mitral valve 16, and into the left ventricle 26 (…). Figure 2A Therefore, the guidewire 40 can help guide the prosthetic valve delivery device 60 through the annulus of the autologous mitral valve 16 and at least partially into the left ventricle 26.

[0078] like Figure 2BAs shown, the docking device 52 may include multiple helical bends surrounding the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 may have a more cylindrical shape than the annulus of the native mitral valve 16, thereby providing a closer geometric fit to the shape or contour of the prosthetic heart valve to be implanted. Therefore, the docking device 52 can provide a tighter fit between the prosthetic heart valve and the native mitral valve 16, and thus provide a better seal, as further described below.

[0079] Figure 3A The fourth stage of a mitral valve replacement surgery is depicted, in which the user uses a prosthetic valve delivery device 60 to deliver and / or implant a prosthetic heart valve 62 into a docking device 52.

[0080] like Figure 3A As shown, the prosthetic valve delivery device 60 may include a delivery shaft 64 and a stem 66. The delivery shaft 64 extends distally from the stem 66. The delivery shaft 64 may be configured to extend into the patient's vascular system 12 to deliver, implant, dilate a prosthetic heart valve, and / or otherwise deploy a prosthetic heart valve 62 within a docking device 52 at the natural mitral valve 16. The stem 66 may be configured to be grasped by a user and / or otherwise held to advance the delivery shaft 64 through the patient's vascular system 12.

[0081] In some examples, the handle 66 may include one or more hinge members 68 configured to facilitate guiding the delivery shaft 64 through the vascular system 12 and the heart 14. Specifically, the hinge member 68 may include one or more of a knob, button, wheel, and / or other type of physically adjustable control member configured by a user to flex, bend, twist, rotate, and / or otherwise hinge the distal portion of the delivery shaft 64 to facilitate guiding the delivery shaft 64 through the vascular system 12 and into the left atrium 18 and left ventricle 26 of the heart 14.

[0082] In some examples, the prosthetic valve delivery device 60 may include an expansion mechanism 65 configured to radially expand and unfold the prosthetic heart valve 62 at the implantation site. In some cases, such as Figure 3A As shown, the expansion mechanism 65 may include an inflatable balloon configured to inflate to radially expand the prosthetic heart valve 62 within the docking device 52. The inflatable balloon may be coupled to the distal portion of the delivery shaft 64.

[0083] In other examples, the prosthetic heart valve 62 may be self-expanding and configured to expand radially on its own when removed from a sheath or sac of the prosthetic heart valve 62 that is radially compressed over a distal portion covering the delivery shaft 64. In other examples, the prosthetic heart valve 62 may be mechanically expandable, and the prosthetic valve delivery device 60 may include one or more mechanical actuators (e.g., expansion mechanisms) configured to radially expand the prosthetic heart valve 62.

[0084] like Figure 3A As shown, the prosthetic heart valve 62 can be installed in a radially compressed configuration around an expansion mechanism 65 (e.g., an inflatable balloon) on the distal portion of the delivery axis 64.

[0085] To guide the distal portion of the delivery shaft 64 to the implantation site, the user inserts the prosthetic valve delivery device 60 (e.g., the delivery shaft 64) into the patient 10 via the guide catheter 30 and guidewire 40. The user can continue advancing the prosthetic valve delivery device 60 along the guidewire 40 (e.g., through the vascular system 12) until the distal portion of the delivery shaft 64 reaches the autologous mitral valve 16, as shown. Figure 3A As shown. More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery device 60 by grasping the handle 66 and applying force to the handle (e.g., pushing the handle). As the delivery shaft 64 is advanced through the vascular system 12 and the heart 14, the user can adjust one or more hinge members 68 of the handle 66 to guide various turns, corners, constrictions and / or other obstacles in the vascular system 12 and the heart 14.

[0086] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62, mounted around the distal end portion of the delivery shaft 64, is positioned within the docking device 52 and the natural mitral valve 16. In some examples, such as Figure 3A As shown, the distal end of the delivery shaft 64 and at least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.

[0087] Once the radially compressed prosthetic heart valve 62 is properly positioned within the docking device 52 ( Figure 3A The user can manipulate one or more actuating mechanisms of the stem 66 of the prosthetic valve delivery device 60 to actuate the expansion mechanism 65 (e.g., to inflate the inflatable balloon), thereby causing the prosthetic heart valve 62 to expand radially within the docking device 52. In some examples, the user can lock the prosthetic heart valve 62 in its fully expanded position (e.g., using a locking mechanism) to prevent the prosthetic heart valve 62 from collapsing.

[0088] Figure 3BThe fifth stage of a mitral valve replacement surgery is shown, in which the prosthetic heart valve 62 is in its radially expanded configuration and is implanted within the docking device 52 in the natural mitral valve 16. Figure 3B As shown, the prosthetic heart valve 62 is received and held within the docking device 52.

[0089] For example Figure 3B As shown, after the prosthetic heart valve 62 has been fully deployed and implanted into the docking device 52 at the natural mitral valve 16, the prosthetic valve delivery device 60 (including the delivery shaft 64) can be removed from the patient 10, leaving only the guidewire 40 and the guiding catheter 30 in the patient 10.

[0090] Figure 4 The sixth stage of a mitral valve replacement surgery is depicted, where the guidewire 40 and guiding catheter 30 have been removed from the patient 10. The docking device 52 can be configured to provide a seal between the prosthetic heart valve 62 and the leaflet 24 of the natural mitral valve 16 to reduce paravalvular leakage around the prosthetic heart valve 62. Specifically, the docking device 52 can initially contract the leaflet 24 of the natural mitral valve 16. Then, as the prosthetic heart valve 62 expands radially within the docking device 52, the prosthetic heart valve can push the leaflet 24 against the docking device 52. Thus, the docking device 52 and the prosthetic heart valve 62 can be configured to sandwich the leaflet 24 of the natural mitral valve 16 between them when the prosthetic heart valve 62 expands within the docking device 52. In this way, the docking device 52 can provide a seal between the leaflet 24 of the natural mitral valve 16 and the prosthetic heart valve 62 to reduce paravalvular leakage around the prosthetic heart valve 62.

[0091] In some examples, one or more of the docking device delivery device 50, prosthetic valve delivery device 60, and / or guiding catheter 30 may include one or more fluid ports configured to supply flushing fluid into their lumen to prevent and / or reduce the likelihood of blood clot (e.g., thrombus) formation. Example fluid ports that may be used to inject flushing fluid into the docking device delivery device will be further described below.

[0092] although Figures 1 to 4 The mitral valve replacement procedure is specifically described, but it should be understood that the same and / or similar procedures can be used to replace other heart valves (e.g., tricuspid, pulmonary, and / or aortic valves). Furthermore, these other heart valves can be replaced using the same and / or similar delivery devices (e.g., docking device delivery device 50, prosthetic valve delivery device 60, guiding catheter 30, and / or guidewire 40), docking devices (e.g., docking device 52), replacement heart valves (e.g., prosthetic heart valve 62), and / or components thereof.

[0093] For example, when replacing an autologous tricuspid valve, the user may access the right atrium 20 via the femoral vein, but may not need to cross the interatrial septum 22 to access the left atrium 18. Instead, the user can leave the guidewire 40 in the right atrium 20 and perform the same and / or similar docking device implantation procedure at the tricuspid valve. Specifically, the user can push the docking device 52 out of the delivery shaft 54 ​​around the ventricular side of the tricuspid valve leaflet, release the remainder of the docking device 52 from the delivery shaft 54 ​​within the right atrium 20, and then remove the delivery shaft 54 ​​of the docking device delivery device 50 from the patient 10. The user can then advance the guidewire 40 through the tricuspid valve into the right ventricle and perform the same and / or similar prosthetic heart valve implantation procedure at the tricuspid valve within the docking device 52. Specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery device 60 along the guidewire 40 through the patient's vascular system until the prosthetic heart valve 62 is positioned or placed within the docking device 52 and the tricuspid valve. The user can then expand the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery device 60 from the patient 10. In another example, the user can perform the same and / or similar procedure to replace the aortic valve, but can access the aortic valve from the outflow side via the femoral artery.

[0094] Furthermore, despite Figure 1-4 A mitral valve replacement procedure is described, with the patient accessing the autologous mitral valve 16 from the left atrium 18 via the right atrium 20 and the femoral vein. However, it should be understood that the autologous mitral valve 16 can alternatively be accessed from the left ventricle 26. For example, the patient may access the autologous mitral valve 16 from the left ventricle 26 via the aortic valve by advancing one or more delivery devices through an artery to the aortic valve and then through the aortic valve to the left ventricle 26.

[0095] Additional examples of docking device delivery devices (including variations thereof) and methods of implanting docking devices and implanting prosthetic valves within docking devices are described in International Publications Nos. WO 2020 / 247907 and WO 2022 / 087336 and U.S. Patent Publications Nos. US2018 / 0318079, US2018 / 0263764 and US2018 / 0177594, all of which are incorporated herein by reference in their entirety.

[0096] Exemplary prosthetic valve

[0097] Figure 5 This is a perspective view of an example prosthetic heart valve 62. As shown, the heart valve 62 includes a frame or support 72 and leaflet structures 74 supported by the frame. In some examples, the prosthetic heart valve 62 is adapted for implantation in an autologous aortic valve and can be implanted using, for example, the prosthetic valve delivery device 60 described above.

[0098] In some examples, frame 72 comprises a malleably expandable material, which may be a metal alloy, a polymer, or a combination thereof. Example metal alloys may contain one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some examples, frame 72 may comprise stainless steel. In some examples, frame 72 may comprise cobalt-chromium. In some examples, frame 72 may comprise nickel-cobalt-chromium. In some examples, frame 72 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (a trademark of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 contains 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium, and 10 wt% molybdenum.

[0099] In some examples, the prosthetic valve 62 may be a self-expanding prosthetic valve having a frame made of a self-expanding material such as nitinol or nitinol. When the prosthetic valve is a self-expanding valve, the balloon of the delivery device may be replaced by a sheath or similar restraint device that holds the prosthetic valve in a radially compressed state for delivery through the body. When the prosthetic valve is in the implantation position, the prosthetic valve can be released from the sheath and thus allowed to expand to its functional size. It should be noted that any delivery device disclosed herein may be adapted for use with a self-expanding valve.

[0100] Additional details regarding the prosthetic valves and various valve components described herein are described in U.S. Patent No. 11,185,406, which is incorporated herein by reference. Further exemplary prosthetic valves are described in International Patent Application Publication No. WO 2018 / 222799, U.S. Patent No. 9,155,619, and U.S. Patent Publication No. 2018 / 0028310, all of which are incorporated herein by reference in their entirety.

[0101] Overview of the docking device

[0102] The docking devices according to examples of this disclosure can provide, for example, a stable anchoring site, landing zone, or implantation zone at the implantation site, wherein the prosthetic valve can be expanded or otherwise implanted. Many disclosed docking devices include circular or cylindrical portions that can, for example, allow a prosthetic heart valve comprising a circular or cylindrical valve frame to expand or otherwise implant into an autologous location having a natural circular cross-sectional profile and / or an autologous location having a natural non-circular cross-section. In addition to providing an anchoring site for the prosthetic valve, the size and shape of the docking device can be designed to radially inward clamp or pull on the anatomy of the autologous valve (e.g., mitral, tricuspid, etc.). In this way, one of the main causes of valvular regurgitation (e.g., functional mitral regurgitation), particularly the enlargement of the heart (e.g., left ventricular enlargement, etc.) and / or the enlargement of the valve annulus, and subsequently the extension from the annulus of the autologous valve (e.g., mitral, etc.), can be at least partially counteracted or resisted. Some examples of docking devices also include features, for example, shaped and / or modified to better maintain the position or shape of the docking device during and / or after the expansion of the prosthetic valve therein. By providing such docking devices, the replacement valve can be more securely implanted and held at various valve annulus locations, including at the mitral valve annulus which does not have a natural circular cross-section.

[0103] In some cases, the docking device may include a paravalvular leakage (PVL) guard (also referred to herein as a “guarding member”). PVL guards can, for example, help reduce backflow and / or promote inward tissue growth between autologous tissue and the docking device.

[0104] In some examples, the PVL protector can move between a delivery configuration (or radial compression state) and a deployment configuration (or radial expansion state). When in the delivery configuration, the PVL protector can extend along and adjacent to the coil. When in the deployment configuration, the PVL protector can rotate about the central longitudinal axis of the coil and extend radially outward from the coil.

[0105] Exemplary docking device

[0106] Figures 6A to 6D A docking device 100 according to an example is shown. The docking device 100 can be implanted, for example, within an autologous valve annulus. The docking device 100 can be configured to receive and secure a prosthetic valve (e.g., a prosthetic heart valve 62), thereby securing the prosthetic valve to the autologous valve annulus.

[0107] The docking device 100 may include a coil 102 and a protective member 104 (which may also be referred to as a "PVL protector" or "sealing member") extending along at least a portion of the coil 102. In some examples, the coil 102 may comprise a shape memory material (e.g., a nickel-titanium alloy or nitinol) such that the docking device 100 (and the coil 102) can be moved from a substantially straight configuration (also referred to as a "delivery configuration") when placed within a delivery sleeve of a delivery device (e.g., docking device delivery device 50) to a spiral configuration (also referred to as a "deployment configuration") after removal from the delivery sleeve. Figure 6A (As shown).

[0108] During delivery of the docking device and after initial deployment of the docking device at the implantation site, the protective member 104 can be held in a radially compressed state by the docking sleeve of the delivery device. After the docking device 100 is deployed at the implantation site, the docking sleeve can be removed to expose the protective member 104, thereby allowing the protective member 104 to move to a radially expanded state.

[0109] In some examples, when the docking device 100 is in a deployment configuration and the protective member 104 is in a radially expanded state, the protective member 104 may extend circumferentially relative to the central longitudinal axis 101 of the docking device 100 by 180 to 400 degrees, or 210 to 330 degrees, or 250 to 290 degrees, or 260 to 280 degrees (e.g., 270 degrees) relative to the central longitudinal axis 101. In other words, the protective member 104 may extend circumferentially from about half a circle (e.g., 180 degrees) around the central longitudinal axis 101 in some examples to more than a full circle (e.g., 400 degrees) around the central longitudinal axis 101 in other examples, encompassing various ranges in between. As used herein, the range (e.g., 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).

[0110] Coil 102 has a proximal end 102p and a distal end, which also define the proximal and distal ends of docking device 100, respectively. When placed within a delivery sheath (e.g., during delivery of the docking device to a patient's vascular system), the body of coil 102 between the proximal end 102p and the distal end can be configured in a generally straight delivery configuration (i.e., without any coiling or looping portions, but which may be flexed or bent) to maintain a small radial profile as it moves through the patient's vascular system. After removal from the delivery sheath and deployment at the implantation site, coil 102 can be moved from a delivery configuration to a helical deployment configuration and wound around the natural tissue adjacent to the implantation site. For example, when the docking device is implanted at the location of a natural valve, coil 102 can be configured to surround the natural leaflet of the natural valve (and the chordae tendineae connecting the natural leaflet to the adjacent papillary muscle, if present).

[0111] The docking device 100 can be releasably coupled to a delivery device (e.g., docking device delivery device 50). For example, in some examples, the docking device 100 can be coupled to the delivery device via a release suture, which can be configured to be attached to the docking device 100 and cut for removal. In one example, the release suture can be attached to the docking device 100 through an eyelet or eyelet 103 located adjacent to the proximal end 102p of the coil. In another example, the release suture can be tied around a circumferential recess located adjacent to the proximal end 102p of the coil 102.

[0112] In some examples, the docking device 100 in a deployment configuration can be configured to fit at the mitral valve location. In other examples, the docking device 100 can also be shaped and / or adapted for implantation at other natural valve locations, such as the tricuspid valve location. As described herein, the geometry of the docking device 100 can be configured to engage autologous anatomical structures, which can, for example, provide increased stability and reduced relative movement between the docking device 100, the prosthetic valve docked therein, and / or the autologous anatomical structure. This reduction in relative movement can, in particular, prevent material degradation of the components of the docking device 100 and / or the prosthetic valve docked therein and / or prevent damage or trauma to natural tissues.

[0113] like Figure 6A As shown, a coil 102 in a deployment configuration may include a leading turn 106 (or "leading coil"), a central region 108, and a stabilizing turn 110 (or "stabilizing coil") surrounding a central longitudinal axis 101. The central region 108 may have one or more helical turns having substantially equal inner diameters. The leading turn 106 may extend from the distal end of the central region 108 and has a diameter larger than the diameter of the central region 108 (in one or more configurations). The stabilizing turn 110 may extend from the proximal end of the central region 108 and has a diameter larger than the diameter of the central region 108 (in one or more configurations).

[0114] In some examples, the central region 108 may contain multiple helical turns (e.g., the docking device 100 may have three helical turns in the central region 108). Some of the helical turns in the central region 108 may be full turns (i.e., rotated 360 degrees). In some examples, the nearest side turn and / or the farthest side turn may be partial turns (e.g., rotated less than 360 degrees, such as 180 degrees, 270 degrees, etc.).

[0115] The dimensions of the docking device 100 are typically selected based on the required size of the prosthetic valve to be implanted in the patient. In some examples, the central region 108 may be configured to hold a radially expandable prosthetic valve. For example, when the prosthetic valve expands radially, the inner diameter of the helical turns in the central region 108 may be configured to be smaller than the outer diameter of the prosthetic valve, such that additional radial forces can act between the central region 108 and the prosthetic valve to hold the prosthetic valve in place. The helical turns in the central region 108 may also be referred to herein as “functional turns”.

[0116] The stabilizing turn 110 can be configured to help stabilize the docking device 100 in a desired position. For example, the radial dimension of the stabilizing turn 110 can be significantly larger than the radial dimension of the coil in the central region 108, allowing the stabilizing turn 110 to flare outward or extend sufficiently to abut or push against the wall of the circulatory system, thereby improving the ability of the docking device 100 to remain in its desired position prior to implantation of the prosthetic valve. In some examples, the diameter of the stabilizing turn 110 is desired to be larger than the autologous valve annulus, autologous valve plane, and / or autologous chamber for better stability. In some examples, the stabilizing turn 110 can be a full turn (i.e., rotated approximately 360 degrees). In some examples, the stabilizing turn 110 can be a partial turn (e.g., rotated between approximately 180 degrees and approximately 270 degrees).

[0117] In one specific example, when the docking device 100 is implanted at the location of the autologous mitral valve, the functional turn in the central region 108 can be substantially positioned in the left ventricle, and the stabilizing turn 110 can be substantially positioned in the left atrium. The stabilizing turn 110 can be configured to provide one or more contact points or contact areas between the docking device 100 and the left atrial wall, such as at least three contact points in the left atrium or complete contact on the left atrial wall. In some examples, the contact points between the docking device 100 and the left atrial wall can form a plane that is generally parallel to the plane of the autologous mitral valve.

[0118] In some examples, the stabilizing turn 110 may have an atrial portion 110c connected to the central region 108 (attached to...). Figure 6AThe device comprises a protective member 104, a stabilizing portion 110a adjacent to the proximal end 102p of the coil 102, and an ascending portion 110b located between the atrial portion 110c and the stabilizing portion 110a. Both the atrial portion 110c and the stabilizing portion 110a can be generally parallel to the helical turns in the central region 108, while the ascending portion 110b can be oriented at an angle relative to the atrial portion 110c and the stabilizing portion 110a. For example, in some examples, the ascending portion 110b and the stabilizing portion 110a can form an angle of approximately 45 degrees to approximately 90 degrees (inclusive). When the docking device 100 is implanted at the autologous mitral valve location, the atrial portion 110c can be configured to dock with the posterior wall of the left atrium, and the stabilizing portion 110a can be configured to open and press against the anterior wall of the left atrium.

[0119] As described above, the guide coil 106 may have a larger radial dimension than the helical coil in the central region 108. The guide coil 106 helps to more easily guide the coil 102 around and / or through the chordae tendineae and / or sufficiently around all the autologous leaflets of the autologous valve (e.g., autologous mitral, tricuspid, etc.). For example, once the guide coil 106 is guided around the desired natural anatomical structure, the remaining coils of the docking device 100 (e.g., functional coils) may also be guided around the same feature. In some examples, the guide coil 106 may be a full coil (i.e., rotated approximately 360 degrees). In some examples, the guide coil 106 may be a partial coil (e.g., rotated between approximately 180 degrees and approximately 270 degrees). As the prosthetic valve expands radially within the central region 108 of the coil, the functional coil in the central region 108 may further expand radially. Thus, the guide coil 106 may be pulled in the proximal direction and become part of the functional coil in the central region 108.

[0120] In some examples, at least a portion of coil 102 may be at least partially surrounded by a cover. The cover may, for example, prevent or reduce trauma to the autologous tissue and / or prevent or reduce damage to the delivery device, reduce friction with the autologous tissue, increase friction with the autologous tissue and / or prosthetic heart valve, etc. In some cases, the coil may include multiple covers and / or multiple segments of one or more covers, each cover and / or segment configured for a specific purpose. For example, a first cover may be disposed over all or at least substantially all of the coil, for example, to prevent or reduce trauma to the autologous tissue. A second cover may extend over a portion of the first cover and may, for example, be configured to increase friction between the cover and the autologous valve leaflet tissue. Additional information regarding the covers is provided below and can be found in International Publication WO 2022 / 087336.

[0121] like Figures 6C to 6DAs shown, at least a portion of the coil 102 may be surrounded by an inner cover 112 (which may also be referred to as a "first cover"). The inner cover 112 may have a tubular shape. In some examples, the inner cover 112 may cover the entire length of the coil 102. In some examples, the inner cover 112 may cover only a selected portion of the coil 102.

[0122] In some examples, the inner cover 112 may be coated on and / or bonded to the coil 102. In some examples, the inner cover 112 may be a cushion-like layer protecting the coil 102. The inner cover 112 may be made of a variety of natural and / or synthetic materials. In one specific example, the inner cover 112 may include a foam material (e.g., expanded polytetrafluoroethylene (ePTFE)). In some examples, the inner cover 112 is configured to be fixedly attached to the coil 102 (e.g., by texturing surface resistance, stitching, adhesive, thermal bonding, or any other means) such that relative axial movement between the inner cover 112 and the coil 102 is restricted or prohibited. In some examples, one or more portions of the inner cover (e.g., the distal portion) may be fixedly attached to the coil, and one or more other portions of the inner cover (e.g., the intermediate and / or proximal portions) may be movable relative to the coil.

[0123] In some examples, such as Figure 6C As shown, the docking device 100 may also include a retaining member 114 (which may also be referred to as a "second cover" or "outer cover") surrounding at least a portion of the inner cover 112 (and the coil 102). In some examples, the retaining member 114 may extend over the entire length of the inner cover 112. In the illustrated example, the retaining member 114 extends only over a portion of the inner cover 112, exposing one or more portions of the inner cover 112 (e.g., proximal and / or distal portions). In a particular example, the proximal end of the retaining member 114 may be positioned proximal to the proximal end of the protective member 104. For example, the proximal end of the retaining member 114 may be located at or near the rising portion 110b of the coil 102. In some examples, the distal end of the retaining member 114 may be positioned distal to the distal end of the protective member 104. For example, the distal end of the retaining member 114 may be positioned adjacent to the lead turn 106. In some examples, the retaining member 114 may cover the functional turns of the coil 102 in the central region 108. Therefore, when the docking device 100 is deployed at the autologous valve and the prosthetic valve expands radially within the docking device 100, the retaining member 114 at the central region 108 can frictionally engage the prosthetic heart valve and / or the autologous leaflet tissue.

[0124] The retaining member 114 can be formed of various materials configured to engage autologous tissue and / or a prosthetic heart valve to increase friction between them and / or promote inward tissue growth. For example, the retaining member may include a biocompatible fabric material (e.g., polyethylene terephthalate (PET)). In some examples, the retaining member 114 may include a woven material. In some examples, the retaining member 114 may contain a fabric material.

[0125] In some examples, the protective member 104 may be securely attached to the retaining member 114 and / or the inner cover 112, for example, via stitch 148, adhesive and / or any other suitable means for attachment.

[0126] In some examples, the protective member 104 may extend along a portion of the stabilizing turn 110 of the coil 102 (e.g., the atrial portion). In some examples, the protective member 104 may extend along at least a portion of the central region 108 of the coil 102 (e.g., a portion of the nearest lateral turn). In some examples, the protective member 104 may extend along most (or even all) of the functional turns in the central region 108. In one example, when the docking device 100 is deployed at the autologous atrioventricular valve, the protective member 104 does not extend into the rising portion 110b.

[0127] In various examples, the protective member 104 can move between a radially compressed state and a radially expanded state. Specifically, the protective member 104 may include a plurality of lobes 140, which may be radially expandable and compressible. Figures 6A to 6B In the example depicted, the protective member 104 has four lobes 140, including one distal lobe 140d and three proximal lobes 140p. In other examples, the protective member 104 may have two, three, or more than four lobes 140. The lobes 140 may extend circumferentially along a portion of the coil 102 of the docking device 100.

[0128] When the protective member 104 is in a radially compressed state, the flap 140 can be radially compressed against the coil 102, such that the radial profile of the docking device 100 is smaller than a predefined threshold, for example, between 2 mm and 3 mm (inclusive). When the protective member 104 moves from a radially compressed state to a radially expanded state, the flap 140 can extend radially outward relative to the coil 102. The protective member 104 can be biased toward the radially expanded state. Therefore, the protective member 104 can be held in a radially compressed state by the docking sleeve of the delivery device and automatically return to the radially expanded state after the docking sleeve is removed.

[0129] In some examples, the protective member 104 may fold at a hinge portion 116 that separates the distal flap 140d from the proximal flap 140p. For example, when the protective member 104 is in a radially compressed state (e.g., held within a mating sleeve), the protective member 104 may remain folded such that at least one of the distal flap 140d and the proximal flap 140p overlaps, as described more fully below. When the protective member 104 is in a radially expanded state (e.g., after the mating sleeve has been removed), the protective member 104 may unfold itself such that the flap 140 can surround the self-ring. To allow the protective member 104 to fold and unfold at the hinge portion 116, the proximal flap 140p may be securely attached to the coil 102 (e.g., using sutures), while the distal flap 140d may be detached from the coil 102.

[0130] The protective member 104 may include a wire frame 120 and a cover 118 that substantially encloses the wire frame 120. The shape of the wire frame 120 may generally define the shape of the protective member 104. For example, the wire frame 120 may include a ridge 130 and a plurality of lobes 122 connected to the ridge 130. The ridge 130 defines an inner edge of the protective member 104 and may be attached to a coil 102. Each lobe 122 may extend radially outward from the ridge 130 within a corresponding lobe 140.

[0131] In some examples, wireframe 120 may contain a shape memory material that is shape-set and / or pre-configured to expand the protective member 104 to a radially expanded state when unconstrained (e.g., when deployed at an autologous valve location). For example, wireframe 120 may contain a shape memory alloy with hyperelastic properties, such as nitinol. In some examples, wireframe 120 may contain a ternary shape memory alloy with hyperelastic properties, such as NiTiX, where X may be chromium (Cr), cobalt (Co), zirconium (Zr), hafnium (Hf), etc.

[0132] In some examples, wireframe 120 may comprise a metallic material that does not possess shape memory properties. In this case, wireframe 120 may have a biasing mechanism (e.g., using a spring) configured to bias wireframe 120 (and guard member 104) to a radially expanded state. Examples of such metallic materials include cobalt-chromium, stainless steel, etc. In one specific example, wireframe 120 may comprise nickel-free austenitic stainless steel, where nickel may be completely replaced by nitrogen. In another specific example, wireframe 120 may comprise a cobalt-chromium or cobalt-nickel-chromium-molybdenum alloy with significantly low-density titanium.

[0133] In some examples, cover 118 may be configured to be resilient, such that cover 118 can accommodate wireframe 120 when protective member 104 is moved from delivery configuration to deployment configuration.

[0134] In some examples, the cover 118 may be configured to be non-invasive to autologous tissue and / or promote inward tissue growth into the cover 118. For example, the cover 118 may have pores to promote inward tissue growth. In another example, the cover 118 may be impregnated with growth factors to stimulate or promote inward tissue growth, such as transforming growth factor α (TGF-α), transforming growth factor β (TGF-β), basic fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF), and combinations thereof. The cover 118 may be made of any suitable material, including foam, cloth, fabric, and / or polymer, which is flexible to allow for compression and expansion of the cover 118. In one example, the cover 118 may comprise a fabric layer made of a thermoplastic polymer material such as polyethylene terephthalate (PET).

[0135] In some examples, the cap 118 may be configured to engage with a prosthetic valve deployed within the docking device to form a seal between the prosthetic valve and the docking device and reduce paravalvular leakage after the protective member 104 expands radially. The cap 118 may also be configured to engage with autologous tissue (e.g., autologous rings and / or natural leaflets) to reduce paravalvular leakage between the docking device and / or the prosthetic valve and the autologous tissue.

[0136] As described herein, the radial expansion of the protective member 104 can help prevent and / or reduce paravalvular leakage. Specifically, the radial expansion of the protective member 104 can create an improved seal around the prosthetic valve deployed within the docking device 100. In some examples, the protective member 104 can be configured to prevent and / or suppress leakage at locations where the docking device 100 passes between the leaflets of the autologous valve (e.g., at the commissure of the autologous leaflets). For example, without the protective member 104, the docking device 100 could push the autologous leaflet apart at the point where it passes through the autologous leaflet, allowing leakage at that point (e.g., along the docking device or to its side). However, the protective member 104 can be configured to expand to cover and / or fill any opening at that point and suppress leakage along the docking device 100.

[0137] In some examples, the inner cover 112 and / or the retaining member 114 may have a slack portion. For example, Figure 6AIt is shown that before radial expansion of the prosthetic valve within the docking device 100, the inner cap 112 can be axially compressed to have a relaxation portion 115. The inner cap 112 can be constructed of low-density ePTFE such that the inner cap 112 can be axially compressed and the resulting relaxation portion 115 does not significantly affect the radial profile of the docking device 100. When the prosthetic valve is radially expanded within the docking device 100, the docking device 100 can be further radially expanded, which allows the coil 102 to rotate within the autologous loop (also referred to as "clock movement"). During clock movement, the relaxation portion 115 allows the inner cap 112 to stretch axially and not rotate with the coil 102 (i.e., the coil 102 can slide axially relative to the inner cap 112). Because the protective member 104 can be securely attached to the retaining member 114, the relaxation portion 115 also prevents the protective member 104 from rotating and pinning open autologous leaflets during clock movement.

[0138] In some examples, the portion of the inner cover 112 located below the radially compressed flap 140 (e.g., the portion between 6C-6C and 6D-6D) to Figure 6A The portion marked 110C may have a smaller outer diameter than the remainder of the inner cap 112 and / or retaining member 114, so that the protective member 104 (with radially compressed flaps 140) can be fitted into the docking sleeve of the delivery device during delivery of the docking device 100 and after initial deployment of the docking device 100 at the implantation site. In some examples, the portion of the inner cap 112 located below the radially compressed flaps 140 may have an outer diameter between 1.10 mm and 1.40 mm (e.g., about 1.20 mm), while the remainder of the inner cap 112 and / or retaining member 114 may have an outer diameter between 1.8 mm and 2.3 mm (e.g., about 1.9 mm).

[0139] In various examples, the protective member 104 can help cover the atrial side of the atrioventricular valve to prevent and / or inhibit blood leakage through the native leaflets, commissure, and / or around the prosthetic valve by preventing blood in the atria from flowing in the atrium to the ventricle (i.e., antegrade flow) rather than through the prosthetic valve. Positioning the protective member 104 on the atrial side of the valve can additionally or alternatively help reduce blood flow in the ventricle in the ventricle to the atrium (i.e., retrograde flow).

[0140] In some examples, the protective member 104 may be positioned on the ventricular side of the atrioventricular valve to prevent and / or inhibit blood leakage through the native leaflets, commissure, and / or around the prosthetic valve by preventing blood in the ventricle from flowing in the ventricular-to-atrial direction (i.e., retrograde flow). Positioning the protective member 104 on the ventricular side of the valve may additionally or alternatively help reduce blood flow in the atrium in the atrial-to-ventricular direction (i.e., antegrade flow) rather than through the prosthetic valve.

[0141] In some examples, the docking device 100 may include at least one radiopaque marker configured to provide, under fluoroscopy, a visual indication of the position of the docking device 100 relative to its surrounding anatomical structures and / or the amount of radial expansion of the docking device 100 (e.g., when a prosthetic valve is subsequently deployed in the docking device 100). For example, one or more radiopaque markers may be placed on the coil 102. In a particular example, the radiopaque marker may be located at the central region 108 of the coil. In some examples, one or more radiopaque markers may be placed on the inner cover 112, the protective member 104, and / or other components of the docking device 100.

[0142] Additional examples and characteristics of protective components are described in the “Exemplary PVL Protective Components” section below.

[0143] Additional examples of docking devices and variations thereof are described in International Publication WO / 2020 / 247907, including various examples of coils, protective members, inner covers and other components of the docking device, the entire contents of which are incorporated herein by reference.

[0144] Exemplary PVL protective components

[0145] Figures 7A to 7D An example protective member 204 is depicted. For docking devices, any protective member described herein can be interchangeable. For example, protective member 204 can replace protective member 104 of the docking device 100 described above.

[0146] The protective member 204 can move between a radially compressed state and a radially expanded state. For example, Figures 7A to 7B The protective member 204 is shown in a radially expanded state, and Figures 7C to 7D The protective member 204 is shown in a radially compressed state.

[0147] The protective member 204 can also move between a bent state and a substantially straight state. For example, Figure 7A The protective member 204 is shown in a bent state, and Figures 7B to 7D The protective member 204 is shown in a substantially upright position.

[0148] The protective component 204 can also move between a folded configuration and an unfolded configuration. For example, Figures 7A to 7C The protective member 204 is shown in its deployed configuration, and Figure 7D The protective member 204 is shown in a folded configuration.

[0149] Figure 7D A protective member 204 is depicted in a delivery configuration, for example, when the protective member 204 is held within the docking sleeve 55 of the delivery device (e.g., during delivery of the docking device and after initial deployment of the docking device at the implantation site). In the delivery configuration, the protective member 204 can be folded, radially compressed, and kept substantially straight. Figure 7A The protective member 204 is depicted in a deployment configuration, for example, after the docking device has been deployed at the implantation site and the docking sleeve 55 has been removed. In the deployment configuration, the protective member 204 can unfold, expand radially, and move into a bent state.

[0150] exist Figures 7A to 7D In the example shown, the protective member 204 comprises six lobes 206, but the number of lobes 206 may be greater than or less than six. The lobes 206 may extend circumferentially along a portion of the coil 102. When the protective member 204 is in a radially compressed state ( Figures 7C to 7D The flap 206 can be radially compressed against the coil 102. When the protective member 204 is in a radially expanded state, the flap 206 can extend radially outward relative to the coil 102.

[0151] Each flap 206 has a circular head portion 208 and a conical base portion 210. When the protective member 204 is in a radially expanded state, the head portion 208 may be wider than the base portion 210. For each flap 206, the base portion 210 may be attached to the coil 102 (e.g., via a suture), and the head portion 208 may extend radially outward relative to the base portion 210.

[0152] The flap 206 can define the outer edge 212 and the inner edge 214 of the protective member 204. The protective member 204 can be attached to the coil 102 at the inner edge 214.

[0153] When the protective member 204 is in a bent state, the inner edge 214 may be bent at an arc angle A. In some examples, the arc angle A is greater than 180 degrees. In some examples, the arc angle A may be between 240 degrees and 360 degrees (e.g., about 270 degrees) (including end values).

[0154] In some examples, when the protective member 204 is in a radially expanded state, each petal 206 may extend at an angle relative to the coil 102, such that the outer edge 212 may have a wavy or fan-shaped shape similar to a rolling wave.

[0155] In some examples, the wavy outer edge 212 may have one or more flap joints 215. Each flap joint 215 is located between two adjacent flaps 206. In some examples, when the protective member 204 is in a radially expanded state, the one or more flap joints 215 may be radially spaced from the coil 102 by approximately equal distances.

[0156] The overall shape, size, and position of the flap 206 are configured to conform to the autologous anatomy of the implantation site (e.g., autologous mitral valve annulus) and not to puncture or erode adjacent autologous tissue. In some examples, the flap 206 may extend in the same angular direction (e.g., clockwise or counterclockwise when viewed from the top of the docking device or the stabilizing ring 110) when the protective member 204 is in a radially expanded state. For example, in Figures 7A to 7B In the figure, when viewed from above, all six lobes 206 extend in a clockwise direction. In other examples, when the protective member 204 is in a radially expanded state, at least two of the lobes may extend in opposite angular directions (e.g., one lobe extends clockwise and the other extends counterclockwise). For example, in Figures 6A to 6B In the middle, when viewed from the top of the docking device 100, the distal lobe 140d extends in a clockwise direction, while the three proximal lobe 140p extend in a counterclockwise direction.

[0157] In some examples, the number of lobes in the protective member can be between three and eight, or between four and six, all including end values. For example, Figures 7A to 7D The protective member 204 is shown to have six lobes 206, while Figures 6A to 6B The protective member 104 is shown to have four lobes 140.

[0158] In some examples, such as Figures 7A to 7B As depicted, when the protective member 204 is in a radially expanded state, the flaps 206 have substantially the same size. In other examples, when the protective member 204 is in a radially expanded state, at least two of the flaps 206 may have different sizes.

[0159] In some examples, such as Figures 7A to 7B As depicted, when the protective member 204 is in a radially expanded state, the flaps 206 have substantially the same shape. In other examples, when the protective member 204 is in a radially expanded state, at least two of the flaps 206 may have different shapes.

[0160] As described above, the protective member 204 can move between a folded configuration and an unfolded configuration. For example, the protective member 204 can be folded at a hinge portion 216 that divides a plurality of lobes 206 into one or more distal lobes 206d (i.e., lobes located distal to the hinge portion 216) and one or more proximal lobes 206p (i.e., lobes located proximal to the hinge portion 216).

[0161] In some examples, the number of distal leaflets may be less than the number of proximal leaflets. For example, Figures 7B to 7C The protective member 204 depicted has two distal lobes 206d and four proximal lobes 206p. In some examples, the number of distal lobes may be the same as the number of proximal lobes. In other examples, the number of distal lobes may be greater than the number of proximal lobes.

[0162] When the protective member 204 is in a radially compressed state, the distal flap can fold over and overlap with at least some of the proximal flaps. For example, Figure 7D The diagram shows two distal lobes 206d folded and overlapping with two of the proximal lobes 206p. When the protective member 204 moves from a radially compressed state to a radially expanded state, the distal lobes 206d can unfold and flip to the opposite side of the proximal lobes 206p.

[0163] When deployed at an autologous heart valve, the distal leaflet 206d and the proximal leaflet 206p can be configured to press against opposing portions of the autologous heart chamber. For example, when deployed at the mitral valve, the distal leaflet 206d can be configured to press against the anterior leaflet of the mitral valve, and the proximal leaflet 206p can be configured to press against the posterior leaflet of the mitral valve. The hinge portion 216 can be positioned adjacent to the medial commissure of the mitral valve.

[0164] The protective member 204 may include a wireframe 220 and a cover 218 that substantially encloses the wireframe 220. The shape of the wireframe 220 generally defines the shape of the protective member 204. For example, the wireframe 220 may include a ridge 230 and a plurality of lobes 222 connected to the ridge 230. The lobes 222 may extend radially outward from the ridge 230. Each lobe 222 may extend along the periphery of a corresponding lobe 206. The ridge 230 may extend along the inner edge 214 of the protective member 204. The ridge 230 may be bent to move the protective member 204 to a bent state, or may be straightened to move the protective member 204 to a substantially straight state.

[0165] In some examples, ridge 230 and lobes 222 are interconnected to form a monolithic part. For example, ridge 230 and lobes 222 may be laser-cut from a single sheet of metal or metal alloy. In other examples, lobes 222 and ridge 230 may be created as separate parts and then joined together (e.g., via molding, welding, brazing, etc.) to form wireframe 220.

[0166] The wireframe 220 may have the same state or configuration as the protective member 204. For example, when the protective member 204 moves between a radially compressed state and a radially expanded state, the lobes 222 may be radially compressed or expanded. When the protective member 204 moves between a bent state and a substantially straight state, the ridge 230 may be bent or straightened. When the protective member 204 moves between a folded configuration and an unfolded configuration, the ridge 230 may also be folded or unfolded.

[0167] Similar to wireframe 120, wireframe 220 may include a shape memory material, such as nitinol. Wireframe 220 may be shaped such that it is biased toward a deployment configuration. For example, when the protective member 204 is held within the docking sleeve (e.g., docking sleeve 55) of the delivery device during delivery of the docking device and after initial deployment of the docking device at the implantation site, the flap 222 may be radially compressed, and the ridge 230 may substantially straighten and fold. After deployment of the docking device and removal of the docking sleeve from the protective member 204, the ridge 230 may unfold and become curved, and the flap 222 may expand radially under biasing forces.

[0168] The cover 218 may be similar to the cover 118. For example, the cover 218 may be configured to be sufficiently resilient such that when the protective member 204 is moved from a delivery configuration to a deployment configuration, the cover 218 can accommodate the wireframe 220 (e.g., radial expansion of the flap 222 may cause a corresponding radial expansion of the cover 218). The cover 218 may also be configured to be non-invasive to autologous tissue and / or to promote tissue inward growth into the cover 218.

[0169] Figure 8A A docking device 300 deployed at an autologous valve is depicted according to an example. Figure 8B A prosthetic valve 62 deployed within a docking device 300 is depicted. The docking device 300 includes a coil 102 and a protective member 304 attached to the coil 102. In this example, the implantation site is the mitral valve 16 that separates the left atrium 18 from the left ventricle (this view is taken from the left atrial side, and the left ventricle is posterior to the mitral valve annular plane).

[0170] In the depicted example, the protective member 304 includes five lobes 306, comprising two distal lobes 306d and three proximal lobes 306p located on opposite sides of the hinge portion 316 of the protective member 304. In other examples, the protective member 304 may have different numbers of proximal and / or distal lobes, and the total number of lobes may be greater than or less than five.

[0171] Similarly, the protective member 304 may be held within a docking sleeve (e.g., docking sleeve 55) and retained in the delivery configuration during delivery of the docking device 300 and after initial deployment of the docking device 300 at the autologous valve. In the delivery configuration, the protective member 304 may be substantially straight. The flap 306 may be radially compressed. Additionally, the distal flap 306d may fold around the hinge portion 316 and overlap with some of the proximal flap 306p. In some examples, the hinge portion 316 may include a ring 328, as described more fully below. The proximal flap 306p may be attached to the coil 102 (e.g., via a suture), and the distal flap 306d may detach from the coil 102 to allow the protective member 304 to fold at the hinge portion 316.

[0172] After the docking device 300 is deployed at the autologous valve and the docking sleeve is removed, the protective member 304 can automatically move to the deployment configuration, such as... Figures 8A to 8B As shown. In the deployment configuration, the protective member 304 can unfold, expand radially, and move into a bent state, as described above. As a result, the distal leaflet 306d can press against the anterior leaflet 19a of the mitral valve, and the proximal leaflet 306p can press against the posterior leaflet 19b of the mitral valve. Notably, in the deployment configuration, all the leaflets 306 of the protective member 304 reside in the left atrium 18, while the coil 102 can extend into the left ventricle, for example, through the medial commissure 28 of the mitral valve. The leaflets 306 can serve as flanges extending around the autologous mitral valve annulus, thereby preventing the docking device 300 from falling into the left ventricle. In addition, by retaining the protective member 304 in the left atrium 18, the risk of left ventricular outflow tract obstruction can be reduced (e.g., compared to extending the protective member into the left ventricle in other ways).

[0173] In some examples, the hinge portion 316 of the protective member 304 may be configured to align with the inner mitral junction 28 when the protective member 304 is in a deployment configuration. A distal flap 306d and a proximal flap 306p adjacent to the hinge portion 316 may be configured to cover the area surrounding the inner mitral junction 28, thereby preventing or reducing perivalvular leakage at said location.

[0174] Furthermore, by pressing against the opposing portion of the mitral valve annulus, the protective member 304 can more securely anchor the docking device 300 to the mitral valve. For example, when the prosthetic valve 62 is radially expanded within the docking device 300, the docking device 300 can expand further radially, which can cause clockwork or rotation of the coil 102 within the mitral valve annulus. Rotation of the coil 102 can tend to move the docking device 300 toward the left ventricle. However, the hinge portion 316 prevents the docking device 300 from falling into the left ventricle due to clockwork. As described above, the distal flap 306 remains in the left atrium 18, while the coil 102 can extend into the left ventricle. Thus, a wedge can be formed at the hinge portion 316, which can capture the medial commissure 28 and prevent clockwork of the docking device 300 into the left ventricle.

[0175] Similar to protective members 104 and 204, protective member 304 includes a frame 320 and a cover 318 that substantially encloses the frame 320. Cover 318 may be similar to covers 118 and 218 described above.

[0176] Figures 9A to 9B A wireframe 320 of the protective member 304 is shown. Similar to wireframe 220, wireframe 320 includes a ridge 330 and a plurality of lobes 322 connected to the ridge (five lobes are shown in this example). The ridge 330 may extend along the inner edge of the protective member 304, and each lobe 322 may extend along the periphery of a corresponding lobe 306 of the protective member 304.

[0177] The convex lobe 322 can be radially expandable and compressible. For example... Figure 9A As shown, each flap 322 includes a head portion 324 and a base portion 326. For each flap 322, the base portion 326 is narrower than the head portion 324 when the flap 322 expands radially. The head portion and base portion of each flap 322 generally define the corresponding head portion and base portion of the flap 306 of the protective member 304.

[0178] In some examples, the base portion 326 of each lobe 322 may be connected to the ridge 330 at two connection points 334. In some examples, the base portions 326 of two adjacent lobes 322 may be separated by a gap 332 along the ridge 330.

[0179] Ridge 330 (and wireframe 320) can be in a bent state (e.g. Figure 9A (as shown) and a basically straight state (similar to) Figures 7B to 7C The ridge 330 (as depicted in the figure) moves between itself. In some examples, when the ridge 330 is in a curved state, the ridge 330 may define an arc angle greater than 180 degrees.

[0180] Ridge 330 (and wireframe 320) can be configured in a folding configuration (such as...) Figure 9B (as shown) and expanded configuration (as shown) Figure 9A The ridge 330 can move between (as shown). For example, the ridge 330 may have a proximal portion 330p, a distal portion 330d, and a ring 328 connecting the proximal portion 330p and the distal portion 330d. The ring 328 corresponds to the hinge portion 316 of the protective member 304, meaning that the ridge 330 can be folded at the ring 328. In some examples, the ring 328 may be configured as a helical spring that biases the ridge 330 toward the unfolded configuration. To move the ridge 330 to the folded configuration, an external force may be applied to overcome the biasing force of the ring 328.

[0181] The lobes 322 may include one or more distal lobes 322d connected to the distal portion 330d of the ridge and one or more proximal lobes 322p connected to the proximal portion 330p of the ridge. Figures 9A to 9B The diagram shows two distal lobes and three proximal lobes. Therefore, when the ridge 330 is in a folded configuration, the distal lobes 322d can be folded relative to the proximal lobes 322p.

[0182] In the depicted example, when unfolded, the distal lobe 322d and the proximal lobe 322p extend in opposite angular directions. Therefore, when folded, the distal lobe 322d can extend in the same angular direction as the proximal lobe 322p, and in some cases, can substantially overlap with some of the proximal lobes 322p. For example, Figure 9B The diagram shows two distal lobes 322d that substantially overlap with two proximal lobes 322p. In other examples, when unfolded, the distal and proximal lobes can extend in the same angular direction (e.g., Figure 7D The convex lobe 222 depicted in the image.

[0183] Because the ring 328 corresponds to the hinge portion 316 of the protective member 304, the ring 328 can be aligned with the inner commissure portion 28 of the mitral valve when the protective member 304 is in a deployment configuration. In some examples, the cap 318 of the protective member 304 may have an opening or hole through which the ring 328 extends. In some examples, the hole may be positioned such that, when deployed at an autologous valve, the ring 328 extends radially inward toward the central axis of the helical coil formed by the coil 102 (or the center of the autologous ring). This configuration can reduce the risk of tissue abrasion caused by the ring 328 exposed outside the cap 318. In some examples, the ring 328 extending from the cap 318 may be enclosed within the protective member to further reduce the likelihood of abrasion to surrounding tissues.

[0184] Figures 10A to 10DAn example method for manufacturing a docking device is shown. In the illustrated example, a docking device 100 with a protective member 104 is shown for illustrative purposes; however, it should be understood that similar methods can be used to manufacture docking devices with different protective members (e.g., protective members 204, 304, etc.).

[0185] In some examples, the wireframe 120 of the protective member 104 can be obtained by cutting a substrate to form ridges 130 and lobes 122. Each lobe 122 has a head portion 122h and a base portion 122b. The base portion 122b is connected to the ridge 130 of the wireframe 120. The head portion 122h is positioned further away from the ridge 130 than the base portion 122b. Each lobe 122 may have a tapered shape such that the head portion 122h is wider than the base portion. In one specific example, the wireframe 120 can be fabricated by laser cutting nitinol sheet. In other examples, the lobes 122 and ridges 130 can be created as separate components and then joined together (e.g., via molding, welding, brazing, etc.) to form the wireframe 120.

[0186] The protective member 104 can be produced by enclosing the wireframe 120 within the cover 118. An example method for manufacturing the cover 118 is described in... Figures 10A to 10B As shown in the illustration. In the depicted example, the two fabric layers 124a and 124b can be stacked together.

[0187] The cover 118 can be produced by cutting the two fabric layers 124a, 124b using a die 142 placed on the two fabric layers 124a, 124b. The die 142 matches the desired shape of the protective member 104 in the deployment configuration. For example, the outer periphery 144 of the die 142 can define the shape of the lobes 122 of the wireframe 120. The inner periphery 146 of the die 142 can define the shape of the ridges 130 of the wireframe 120.

[0188] In some examples, two fabric layers 124a, 124b can be cut in a specific order. First, a heated soldering iron 126 can be moved along the outer periphery 144 of the mold 142, such that the two fabric layers 124a, 124b are thermally cut and sealed together along the outer periphery 144 of the mold to form the outer edge 152 of the cover 118. The outer edge 152 of the cover 118 defines a wavy or fan-shaped shape of the flap 140. Next, a wireframe 120 can be inserted between the two fabric layers 124a, 124b, for example, through an opening (marked by dashed line 125), which can be created at a radially inward position on the inner periphery 146 of the mold 142. The wireframe 120 inserted between the two fabric layers 124a, 124b can be positioned such that the flap 122 is aligned with the outer edge 152 of the cover 118. In this way, each flap 122 is held within the corresponding flap 140. Then, the heated soldering iron 126 can be moved along the inner periphery 146 of the mold 142, such that the two fabric layers 124a, 124b are thermally cut and sealed together along the inner periphery 146 of the mold 142 to form the inner edge 154 of the cover 118. Thus, the ridge 130 of the wire frame 120 extends along the inner edge 154 of the cover 118.

[0189] In other examples, the cover 118 can be produced by different methods. For example, instead of using a heated soldering iron 126, the two fabric layers 124a, 124b can be cut using scissors, a laser beam, or other cutting methods. After cutting, the inner edge 154 and / or outer edge 152 of the cover 118 can be sealed by heat, stitching, adhesive, or other sealing methods.

[0190] In some examples, the wireframe 120 can be connected to the cover 118 via multiple stitches 132. For example... Figure 10C As shown, the stitching 132 can pass through a specific pattern to hold the wireframe 120 in place while also allowing some mobility of the wireframe 120 within the cover 118.

[0191] For example, at least some of the sutures 132, referred to as cross sutures 132a, may extend through one or more line segments 134 located at the base portion 122b of the flap of the wire frame. Such cross sutures 132a may retain each flap 122 within its corresponding leaflet 140 and limit lateral movement of the wire frame 120 within the cover 118.

[0192] Additionally, at least some of the sutures 132 (referred to as inner sutures 132b) may extend and be positioned inwardly along one or more segments 136 located at the head portion 122h of the flap 122 within the wire frame. Thus, a recess 138 may be formed between the line of the inner suture 132b and the outer edge 152 of the cover 118. The recess 138 allows limited sliding movement of the flap 122 within the cover 118. For example, the head portion 122h of the flap may slide within the recess 138, thereby allowing the wire frame 120 to move between a radially compressed state and a radially expanded state, and / or between a substantially straight state and a curved state. Notably, the cross sutures 132a do not impede the sliding movement of the flap 122 within the cover 118.

[0193] like Figure 10D As shown, the protective member 104 can be attached to the coil 102 of the docking device 100. For example, the cover 118 and / or wire frame 120 of the protective member 104 can be attached to the coil 102 via one or more stitches 148.

[0194] Before the docking device 100 is implanted, the protective member 104 may be held within the docking sleeve (e.g., docking sleeve 55). The protective member 104 held within the docking sleeve may be held in a radially compressed state. For example, the flaps 140 may be radially compressed such that they extend along the coil 102 and are substantially parallel to the coil 102.

[0195] The protective member 104, which is held within the mating sleeve, can also be held in a folded configuration. For example, the distal flap 140d can be folded relative to the proximal flap 140p at the hinge portion 116 therebetween. In some examples, the hinge portion 116 may include a ring 128 (similar to ring 328) formed at the ridge 130 of the wire frame.

[0196] like Figure 10B As shown, a hole 117 may be formed in the cover 118, through which a ring 128 may be exposed and extend out of the cover 118. In some examples, the ring 128 extending out of the cover 118 may be covered with a protective layer to reduce the possibility of abrasion to surrounding tissue. In some examples, the protective layer may comprise a fabric layer, a polymer layer, or one or more suture loops.

[0197] sterilization

[0198] Any of the systems, devices, equipment, etc., described herein may be sterilized (e.g., by heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure their safety for patient use, and any method described herein may include sterilization of the associated systems, devices, equipment, etc., as a step in the process. Examples of heating / heat sterilization include steam sterilization and autoclaving. Examples of radiation used for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. For example, sterilization with hydrogen peroxide may be performed using hydrogen peroxide plasma.

[0199] Other examples of the disclosed technology

[0200] In view of the embodiments described above for the disclosed subject matter, this application discloses further examples listed below. It should be noted that a feature or combination of features of a single example, or more than one feature of an example, and optionally combined with one or more features of one or more other examples, are also further examples falling within the scope of this application's disclosure.

[0201] Example 1. A docking device for securing a prosthetic valve to an autologous valve, the docking device comprising: a coil comprising a plurality of helical turns when deployed at the autologous valve; and a protective member attached to the coil and movable between a radially compressed state and a radially expanded state, wherein the protective member comprises a plurality of flaps, each flap comprising a circular head portion and a conical base portion, wherein when the protective member is in the radially expanded state, the head portion is wider than the base portion.

[0202] Example 2. A docking device according to any example in this document, particularly the docking device of Example 1, wherein when the protective member is in a radially compressed state, the plurality of lobes are radially compressed against the coil, such that the radial profile of the docking device is smaller than a predefined threshold.

[0203] Example 3. A docking device according to any of the examples in this document, particularly the docking device according to Example 2, wherein a predefined threshold is between 2 mm and 3 mm, including the end value.

[0204] Example 4. A docking device according to any of the examples herein, particularly a docking device according to any one of Examples 1 to 3, wherein the plurality of lobes extend radially outward relative to the coil when the protective member moves from the radially compressed state to the radially expanded state.

[0205] Example 5. A docking device according to any of the examples herein, particularly the docking device of any one of Examples 1 to 4, wherein when the protective member is in a radially expanded state, the plurality of lobes extend circumferentially along a portion of the coil.

[0206] Example 6. A docking device according to any example in this document, particularly the docking device of Example 5, wherein the plurality of lobes define an inner edge having an arc angle greater than 180 degrees.

[0207] Example 7. A docking device according to any example in this document, particularly the docking device according to Example 6, wherein the arc angle is between 240 degrees and 360 degrees, including the end value.

[0208] Example 8. A docking device according to any of the examples herein, particularly a docking device according to any one of Examples 1 to 7, wherein the number of lobes is between three and eight, including end values.

[0209] Example 9. A docking device according to any of the examples herein, particularly the docking device of Example 8, wherein the number of lobes is between four and six, including end values.

[0210] Example 10. A docking device according to any of the examples herein, particularly a docking device according to any one of Examples 1 to 9, wherein the plurality of lobes have substantially the same size when the protective member is in a radially expanded state.

[0211] Example 11. A docking device according to any example herein, particularly a docking device according to any one of Examples 1 to 9, wherein at least two of the plurality of lobes have different sizes when the protective member is in a radially expanded state.

[0212] Example 12. A docking device according to any of the examples herein, particularly any one of Examples 1 to 11, wherein the plurality of lobes have substantially the same shape when the protective member is in a radially expanded state.

[0213] Example 13. A docking device according to any of the examples herein, particularly any one of Examples 1 to 11, wherein at least two of the plurality of lobes have different shapes when the protective member is in a radially expanded state.

[0214] Example 14. A docking device according to any of the examples herein, particularly any one of Examples 1 to 13, wherein for each flap, when the protective member is in a radially expanded state, the base portion is attached to the coil, and the head portion extends radially outward relative to the base portion.

[0215] Example 15. A docking device according to any of the examples herein, particularly any one of Examples 1 to 14, wherein each flap extends at an angle relative to the coil when the protective member is in a radially expanded state.

[0216] Example 16. A docking device according to any example herein, particularly the docking device of Example 15, wherein the plurality of lobes extend in the same angular direction when the protective member is in a radially expanded state.

[0217] Example 17. A docking device according to any example herein, particularly the docking device of Example 15, wherein when the protective member is in a radially expanded state, at least two of the plurality of lobes extend in opposite angular directions.

[0218] Example 18. A docking device according to any of the examples herein, particularly a docking device according to any one of Examples 1 to 17, wherein the plurality of lobes define a wavy outer edge including one or more lobe joints, wherein each lobe joint is located between two adjacent lobes.

[0219] Example 19. A docking device according to any example herein, particularly the docking device of Example 18, wherein when the protective member is in the radially expanded state, the one or more flap joints are radially spaced from the coil by approximately equal distances.

[0220] Example 20. A docking device according to any of the examples herein, particularly the docking device of any one of Examples 1 to 19, wherein the plurality of lobes are connected to the coil via one or more sutures.

[0221] Example 21. A docking device according to any example herein, particularly a docking device according to any one of Examples 1 to 20, wherein the plurality of flaps comprises one or more distal flaps and one or more proximal flaps, wherein the one or more proximal flaps are connected to the one or more proximal flaps at a hinge portion of the protective member.

[0222] Example 22. A docking device according to any of the examples herein, particularly the docking device of Example 21, wherein when the protective member is in a radially compressed state, the one or more distal lobes fold over and overlap at least some proximal lobes.

[0223] Example 23. A docking device according to any example herein, particularly the docking device of Example 22, wherein when the protective member moves from a radially compressed state to a radially expanded state, the one or more distal lobes unfold and flip to the opposite side of the one or more proximal lobes.

[0224] Example 24. A docking device according to any of the examples herein, particularly any one of Examples 21 to 23, wherein the number of distal lobes is the same as the number of proximal lobes.

[0225] Example 25. A docking device according to any of the examples herein, particularly any one of Examples 21 to 23, wherein the number of distal lobes is less than the number of proximal lobes.

[0226] Example 26. A docking device according to any of the examples herein, particularly any one of Examples 21 to 25, wherein when the coil is deployed at the autologous valve, the one or more distal flaps press against a first portion of the autologous heart chamber, and the one or more proximal flaps press against a second portion of the autologous heart chamber opposite the first portion.

[0227] Example 27. A docking device according to any example herein, particularly the docking device of Example 26, wherein the autologous valve is a mitral valve, wherein a first portion includes the anterior leaflet of the mitral valve and a second portion includes the posterior leaflet of the mitral valve, wherein the hinge portion of the protective member is positioned adjacent to the inner commissure of the mitral valve.

[0228] Example 28. A docking device according to any of the examples herein, particularly the docking device of any one of Examples 21 to 27, wherein one or more proximal lobes are fixedly attached to a coil, and wherein one or more distal lobes are detached from the coil.

[0229] Example 29. A docking device according to any of the examples herein, particularly any one of Examples 21 to 28, wherein the protective member comprises a frame and a cover that substantially encloses the frame.

[0230] Example 30. A docking device according to any of the examples herein, particularly the docking device of Example 29, wherein the wireframe includes a ring at the hinge portion.

[0231] Example 31. A docking device according to any of the examples herein, particularly a docking device according to any one of Examples 29 to 30, wherein the wireframe comprises a shape memory material.

[0232] Example 32. A docking device according to any of the examples herein, particularly the docking device of Example 31, wherein the shape memory material comprises a nickel-titanium alloy.

[0233] Example 33. A docking device according to any of the examples herein, particularly a docking device according to any one of Examples 29 to 32, wherein the wireframe includes a ridge and a plurality of lobes connected to the ridge, wherein the lobes extend radially outward from the ridge.

[0234] Example 34. A docking device according to any of the examples herein, particularly the docking device of Example 33, wherein the ridge and the plurality of lobes are interconnected to form an integral part.

[0235] Example 35. A docking device according to any of the examples herein, particularly the docking device of any one of Examples 33 to 34, wherein each lob extends along the periphery of the corresponding lobe.

[0236] Example 36. A docking device according to any of the examples herein, particularly any one of Examples 33 to 35, wherein each lobe is connected to a ridge at two connection points axially spaced apart from each other.

[0237] Example 37. A docking device according to any of the examples herein, particularly any one of Examples 33 to 36, wherein two adjacent lobes are axially separated along the ridge by a gap.

[0238] Example 38. A docking device according to any of the examples herein, particularly any one of Examples 30 to 37, wherein the ring extends out of the cover through a hole in the cover.

[0239] Example 39. A docking device according to any example herein, particularly the docking device of Example 38, wherein the hole is positioned such that when deployed at the autologous valve, the ring extends radially inward toward the central axis of the helical turn formed by the coil.

[0240] Example 40. A docking device according to any of the examples herein, particularly any one of Examples 30 to 39, wherein the ring is enclosed within a protective member.

[0241] Example 41. A docking device for securing a prosthetic valve to an autologous valve, the docking device comprising: a coil including a plurality of helical turns when deployed at the autologous valve; and a protective member attached to the coil and movable between a radially compressed state and a radially expanded state, wherein the protective member includes a wire frame having a ridge and a plurality of lobes connected to the ridge, wherein the lobes extend radially outward from the ridge.

[0242] Example 42. A docking device according to any of the examples herein, particularly the docking device according to Example 41, wherein the protective member further includes a cover that substantially encloses the wire frame.

[0243] Example 43. A docking device according to any example herein, particularly a docking device according to any one of Examples 41 to 42, wherein each lob includes a circular head portion and a conical base portion, wherein the head portion is wider than the base portion when the protective member is in a radially expanded state.

[0244] Example 44. A docking device according to any of the examples herein, particularly the docking device of Example 43, wherein the plurality of lobes are radially expandable and compressible.

[0245] Example 45. A docking device according to any of the examples herein, particularly a docking device according to any one of Examples 41 to 44, wherein the plurality of lobes includes one or more proximal lobes and one or more distal lobes, wherein the one or more distal lobes are configured to be foldable relative to the one or more proximal lobes.

[0246] Example 46. A docking device according to any example herein, particularly the docking device of Example 45, wherein when the protective member is in a radially compressed state, the one or more distal lobes fold over the one or more proximal lobes, wherein when the protective member is in a radially expanded state, the one or more distal lobes unfold from the one or more proximal lobes.

[0247] Example 47. A docking device according to any of the examples herein, particularly a docking device according to any one of Examples 45 to 46, wherein the wireframe includes a ring located between the one or more proximal lobes and the one or more distal lobes.

[0248] Example 48. A docking device according to any of the examples herein, particularly any one of Examples 45 to 47, wherein, when deployed, the one or more distal lobes and the one or more proximal lobes extend in the same angular direction.

[0249] Example 49. A docking device according to any of the examples herein, particularly any one of Examples 45 to 47, wherein, when deployed, the one or more distal lobes and the one or more proximal lobes extend in opposite angular directions.

[0250] Example 50. A docking device according to any of the examples herein, particularly a docking device according to any one of Examples 41 to 49, wherein the ridge defines an arc angle greater than 180 degrees when the protective member is in a radially expanded state.

[0251] Example 51. A protective member for a docking device configured to secure a prosthetic valve to an autologous valve, the protective member comprising: a wire frame; and a cover substantially enclosing the wire frame, wherein the wire frame includes a ridge and a plurality of lobes connected to the ridge, wherein the lobes extend radially outward from the ridge, and wherein the plurality of lobes are radially expandable and compressible.

[0252] Example 52. A protective member according to any example herein, particularly the protective member according to Example 51, wherein each flap includes a head portion and a base portion, wherein the base portion is narrower than the head portion when the flap expands radially.

[0253] Example 53. A protective member according to any example herein, particularly the protective member according to Example 52, wherein the base portion of each lob is connected to the ridge at two connection points.

[0254] Example 54. A protective member according to any example herein, particularly any one of Examples 52 to 53, wherein the base portions of two adjacent lobes are separated by a gap along a ridge.

[0255] Example 55. A protective member according to any of the examples herein, particularly any one of Examples 51 to 54, wherein the ridge is movable between a folded configuration and an unfolded configuration.

[0256] Example 56. A protective member according to any of the examples herein, particularly any one of Examples 51 to 55, wherein the ridge is movable between a bent state and a substantially straight state.

[0257] Example 57. A protective member according to any of the examples herein, particularly a protective member according to any one of Examples 55 to 56, wherein the plurality of lobes includes one or more proximal lobes and one or more distal lobes, wherein when the ridge is in a folded configuration, the one or more distal lobes are folded over the one or more proximal lobes, and wherein when the ridge is in an unfolded configuration, the one or more distal lobes unfold from the one or more proximal lobes.

[0258] Example 58. A protective member according to any example herein, particularly the protective member of Example 57, wherein the ridge includes a hinge portion, wherein the one or more distal lobes are foldable relative to the one or more proximal lobes.

[0259] Example 59. A protective member according to any example herein, particularly the protective member according to Example 58, wherein the ridge includes a proximal portion and a distal portion connected by a ring at the hinge portion.

[0260] Example 60. A protective member according to any of the examples herein, particularly the protective member according to Example 59, wherein the ring is configured to offset the ridge to move from a folded configuration to an unfolded configuration.

[0261] Example 61. A method for fabricating a docking device configured to secure a prosthetic valve to an autologous valve, the method comprising: obtaining a wireframe including a ridge and a plurality of lobes connected to and extending radially outward from the ridge; and closing the wireframe with a cap to form a protective member of the docking device.

[0262] Example 62. The method according to any of the examples herein, particularly the method of Example 61, wherein obtaining the wireframe includes cutting a substrate to form ridges and the plurality of lobes.

[0263] Example 63. The method according to any example herein, particularly the method of Example 62, wherein the substrate comprises a nitinol sheet, and wherein the cutting comprises laser cutting the nitinol sheet.

[0264] Example 64. The method according to any of the examples herein, particularly the method of any one of Examples 62 to 63, further includes stacking two fabric layers together and cutting the two fabric layers using a die placed on the two fabric layers to form a cover, wherein the outer periphery of the die defines the shape of the plurality of lobes of the wire frame, and wherein the inner periphery of the die defines the shape of the ridge of the wire frame.

[0265] Example 65. The method according to any of the examples herein, particularly the method of Example 64, wherein cutting the two fabric layers comprises moving a heated soldering iron along the outer periphery of the mold such that the two fabric layers are thermally cut along the outer periphery of the mold and sealed together to form the outer edge of the cap.

[0266] Example 66. The method according to any of the examples herein, particularly the method of Example 65, wherein closing the wireframe includes inserting the wireframe between two fabric layers through an opening located radially inward on the inner periphery of the mold, wherein the wireframe inserted between the two fabric layers is positioned such that the plurality of flaps are aligned with the outer edge of the cover.

[0267] Example 67. The method according to any of the examples herein, particularly the method of Example 66, wherein the closed wireframe further includes moving a heated soldering iron along the inner periphery of the mold such that two fabric layers are thermally cut and sealed together along the inner periphery of the mold to form the inner edge of the cap, wherein the ridge of the wireframe extends along the inner edge of the cap.

[0268] Example 68. The method according to any of the examples herein, particularly the method of any one of Examples 61 to 66, further includes connecting the wire frame to the cover via a plurality of sutures.

[0269] Example 69. The method according to any example herein, particularly the method of Example 68, wherein at least some of the sutures extend through one or more line segments located at the base portion of the plurality of lobes of the wireframe, wherein the base portion is connected to the ridge of the wireframe.

[0270] Example 70. The method according to any of the examples herein, particularly the method of any one of Examples 68 to 69, wherein at least some of the sutures extend and are positioned inward along one or more line segments located at the head portion of the plurality of convex flaps in the wireframe, wherein the head portion is positioned further away from the ridge than the base portion.

[0271] Example 71. The method according to any of the examples herein, particularly the method of any one of Examples 61 to 70, further includes attaching the protective member to the coil of the docking device.

[0272] Example 72. The method according to any of the examples herein, particularly the method of Example 71, wherein the attachment includes stitching the cover or the wire frame to the coil of the docking device.

[0273] Example 73. The method according to any of the examples herein, particularly the method of any one of Examples 61 to 72, further includes folding the protective member at the hinge portion of the ridge, wherein the folding causes one or more lobes located at the distal portion of the ridge to fold over one or more lobes located at the proximal portion of the ridge.

[0274] Example 74. The method according to any of the examples herein, particularly the method of Example 73, further includes a radial compression guard member such that the guard member can be held within the mating sleeve.

[0275] Example 75. The method according to any of the examples herein, particularly the method of any one of Examples 73 to 74, further includes forming a hole in the cover and exposing the hinge portion of the ridge through the hole.

[0276] Example 76. The method according to any of the examples in this document, particularly the method according to Example 75, further includes covering the hinge portion with a protective layer.

[0277] Example 77. The method according to any of the examples herein, particularly the method of Example 76, wherein the protective layer comprises a fabric layer, a polymer layer, or one or more suture loops.

[0278] Example 78. A method comprising: delivering a docking device to an autologous valve; deploying the docking device at the annulus of the autologous valve; and deploying a prosthetic valve within the docking device, wherein the docking device includes a coil and a protective member attached to the coil, wherein the coil is held in a substantially straight configuration during delivery of the docking device and moves to a helical configuration after deployment of the docking device, and wherein the protective member is held in a folded configuration during delivery of the docking device and moves to an unfolded configuration after deployment of the docking device.

[0279] Example 79. The method according to any example herein, particularly the method of Example 78, wherein delivering the docking device includes holding the docking device within the docking sleeve, and wherein deploying the docking device includes removing the docking device from the docking sleeve.

[0280] Example 80. The method according to any of the examples herein, particularly the method of any one of Examples 78 to 79, wherein deploying the docking device includes aligning the hinge portion of the protective member with the inner commissure of the autologous valve, wherein the protective member is folded or unfolded around the hinge portion.

[0281] Example 81. A method comprising sterilizing a docking device or protective member according to any of the examples herein, particularly any one of Examples 1 to 60.

[0282] Example 82. A method of treating the heart on a simulator, the method comprising: deploying a docking device at a target location; and deploying a prosthetic valve within the docking device; wherein the docking device is the docking device according to any one of Examples 1 to 50.

[0283] Unless otherwise stated, any feature described in any example herein may be combined with other features described in any one or more of the other examples. For example, any one or more features of a docking device may be combined with any one or more features of another docking device.

[0284] Given the many possible examples to which the principles of the disclosed technology can be applied, it should be recognized that the examples shown are merely preferred examples of the technology and should not be considered as limiting the scope of this 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; and a guard member attached to the coil and movable between a radially compressed state and a radially expanded state, wherein the guard member comprises a plurality of petals, wherein each petal comprises a circular head portion and a tapered base portion, wherein the head portion is wider than the base portion when the guard member is in the radially expanded state.

2. The docking device of claim 1, wherein the plurality of petals are radially compressed against the coil when the guard member is in the radially compressed state such that a radial profile of the docking device is less than a predefined threshold.

3. The docking device of any one of claims 1-2, wherein the plurality of petals extend radially outward relative to the coil when the guard member moves from the radially compressed state to the radially expanded state.

4. The docking device of any one of claims 1-3, wherein the plurality of petals extend circumferentially along a portion of the coil when the guard member is in the radially expanded state.

5. The docking device of claim 4, wherein the plurality of petals define an inner edge having an arc angle greater than 180 degrees.

6. The docking device of any one of claims 1-5, wherein for each petal, the base portion is attached to the coil and the head portion extends radially outward relative to the base portion when the guard member is in the radially expanded state.

7. The docking device of any one of claims 1-6, wherein each petal extends at an angle relative to the coil when the guard member is in the radially expanded state.

8. The docking device of claim 7, wherein the plurality of petals extend in the same angular direction when the guard member is in the radially expanded state.

9. The docking device of claim 7, wherein at least two of the plurality of petals extend in opposite angular directions when the guard member is in the radially expanded state.

10. The docking device of any one of claims 1-9, wherein the plurality of petals define a contoured outer edge comprising one or more petal junctions, wherein each petal junction is located between two adjacent petals.

11. The docking device of any one of claims 1-10, wherein the plurality of petals are connected to the coil via one or more sutures.

12. The docking device of any one of claims 1-11, wherein the plurality of petals comprise one or more distal petals and one or more proximal petals, wherein the one or more proximal petals are connected to the one or more distal petals at a hinge portion of the guard member.

13. 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 attached to the coil and movable between a radially compressed state and a radially expanded state, wherein the guard member comprises a wire frame including a spine and a plurality of lobes connected to the spine, wherein the lobes extend radially outward from the spine.

14. The docking device of claim 13, wherein the guard member further comprises a cap substantially enclosing the wire frame.

15. The docking device of any one of claims 13-14, wherein each lobe comprises a circular head portion and a tapered base portion, wherein the head portion is wider than the base portion when the guard member is in the radially expanded state.

16. The docking device of claim 15, wherein the plurality of lobes are radially expandable and compressible.

17. The docking device of any one of claims 13-16, wherein the plurality of lobes comprise one or more proximal lobes and one or more distal lobes, wherein the one or more distal lobes are configured to be foldable relative to the one or more proximal lobes.

18. The docking device of claim 17, wherein the one or more distal lobes are folded over the one or more proximal lobes when the guard member is in the radially compressed state, wherein the one or more distal lobes are unfolded from the one or more proximal lobes when the guard member is in the radially expanded state.

19. The docking device of any one of claims 17-18, wherein the wire frame comprises a ring between the one or more proximal lobes and the one or more distal lobes.

20. A method comprising: delivering a docking device to a native valve; deploying the docking device at an annulus of the native valve; and deploying a prosthetic valve inside the docking device, wherein the docking device comprises a coil and a guard member attached to the coil, wherein the coil remains in a substantially straight configuration when the docking device is delivered and moves to a helical configuration after the docking device is deployed, wherein the guard member remains in a folded configuration when the docking device is delivered and moves to an unfolded configuration after the docking device is deployed.

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