Prosthetic valve docking device

Abstract

A docking device is provided for securing a prosthetic valve to an autologous valve. The docking device may include a coil and a protective member. When in a deployment orientation, the coil includes a plurality of helical turns. The protective member is attached to the coil via at least a portion of the helical turns. The protective member includes a support having a ridge and a plurality of arms extending from the ridge. The plurality of arms are coupled to a cover plate. The protective member is convertible between a radially compressed state in a delivery orientation and a radially expanded state in a deployment orientation.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 592,503, filed October 23, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to examples of protective components and coils for docking devices, the protective components and coils being configured to improve the placement and retention of the docking device and a prosthetic valve inserted into the docking device at an autologous heart valve, and also relates to methods of assembling such devices. Background Technology

[0004] The human heart can suffer from a variety of valvular diseases. These valvular diseases can lead to significant dysfunction of the heart and ultimately require repair of the original valve or replacement with an artificial valve. Many known repair devices (e.g., stents) and artificial valves exist, along with many known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various procedures to deliver prosthetic medical devices to locations within the body that are not easily accessible by surgery or that are desired to be accessible without surgery. In a specific example, a prosthetic heart valve may be mounted in a coiled state on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral and aortic arteries) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by unfolding the prosthetic heart valve from the sheath of the delivery device, allowing the prosthetic heart valve to self-expand to its functional size.

[0005] 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.

[0006] 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.

[0007] 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 autologous tissue at the implantation site may not provide sufficient structure to anchor the THV in place relative to the autologous tissue. Therefore, improvements to the THV and associated transcatheter delivery devices are desired. Summary of the Invention

[0008] 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 heart valve, and a method for assembling and implanting the docking device. The disclosed prosthetic heart valve, delivery device, and method can, for example, improve the stability of the docking device during the immediate phase of implantation and can provide a lower delivery profile. Therefore, the apparatus and methods disclosed herein can, in particular, overcome one or more of the shortcomings of typical prosthetic heart valves and their delivery devices.

[0009] In some examples, a docking device is provided for securing a prosthetic valve to an autologous valve. The docking device includes a coil and a protective member. The coil, when in a deployed orientation, may include a plurality of helical turns. The protective member can be attached to the coil via at least a portion of the helical turns coupled to the coil. The protective member may be configured to include a support having a ridge and a plurality of arms extending from the ridge. The plurality of arms are coupled to a cover plate to form the protective member. The protective member is convertible between a radially compressed state in a delivery orientation and a radially expanded state in a deployed orientation. Therefore, the support may include a shape memory material configured in a deployed orientation, the shape memory material being compressible to a delivery orientation.

[0010] In some examples, a method for manufacturing a docking device according to any of the above examples is provided. The method includes obtaining a support having a ridge and a plurality of arms connected to and extending radially outward from the ridge. The method may include coupling the support to a cover plate to form a protective member. The method may include obtaining a coil and coupling the protective member to the coil.

[0011] In some examples, a method is provided for constructing a docking device for delivery to an autologous valve. The method may include providing a docking device according to any of the examples above, and compressing a protective member by using a compression arm to fold a cover plate into a delivery orientation. The method may include inserting the delivery-oriented protective member into a docking sleeve of a docking delivery system.

[0012] In some examples, a method is provided for implanting a docking device into an autologous valve. The method may include providing a docking device according to any of the examples described above, and delivering the docking device to the autologous valve while it is in a delivery orientation. The method may include deploying a coil of the docking device at the annulus of the autologous valve, and then deploying a protective member at the location of the autologous valve in an unfolding orientation such that the protective member covers or presses against the autologous valve and / or the autologous cardiac chamber associated with the autologous valve.

[0013] In some examples, a method for implanting a prosthetic valve is provided. The method may include providing a docking device according to any of the examples described above and delivering the docking device to an autologous valve. The method may include deploying the docking device at the annulus of the autologous valve such that a protective member expands into an unfolding orientation at the location of the autologous valve, thereby covering or pressing against the autologous valve and / or the autologous heart chamber associated with the autologous valve. The method may include deploying a prosthetic valve within the docking device. During delivery, the coil remains in a substantially straight delivery orientation as the docking device is delivered and transforms into a helical configuration after the docking device is in an unfolding orientation. The protective member remains in a folded delivery orientation as the docking device is delivered and transforms into an open unfolding orientation after the docking device is unfolded.

[0014] In some examples, a coil for fixing a prosthetic valve is provided, the coil comprising: a longitudinal axis extending through a lumen of the coil from an inflow side to an outflow side; a first coil region defining a first lumen diameter and configured to be disposed on the inflow side of an autologous valve annulus and to stabilize the coil relative to the autologous valve annulus; and a second coil region extending from the distal end of the first coil region and including one or more helical turns, each of the one or more helical turns defining a second lumen diameter and configured to be disposed on the outflow side of the autologous valve annulus and to receive the prosthetic valve, wherein a proximal portion of the first coil region is raised relative to a plane defined by the first coil region and perpendicular to the longitudinal axis, and wherein the proximal end of the first coil region is less than 12 mm higher than the plane defined by the first coil region.

[0015] In some examples, the coil further includes a lead coil extending from the distal end of the second coil region and radially outward from the second diameter. In some examples, the proximal portion of the first coil region is raised at an angle relative to a plane defined by the first coil region and perpendicular to the longitudinal axis. In some examples, the angle is in the range of 10 to 50 degrees. In some examples, an attachment portion including one or more eyelets is provided at the proximal portion of the first coil region.

[0016] In some examples, the diameters of the first and second lumens are substantially equal. In some examples, the diameter of the first lumen is 10% to 30% larger than the diameter of the second lumen. In some examples, the diameter of the first lumen is in the range of 25 mm to 30 mm, and the diameter of the second lumen is in the range of 20 mm to 25 mm. In some examples, the first coil region includes a single stabilizing turn.

[0017] In some examples, the docking device includes a protective member at least partially coupled to the outflow side of the stabilizing turn, wherein the protective member is convertible between a radially compressed state and a radially expanded state. In some examples, the protective member includes a support, and the support includes a ridge, a plurality of arms, and one or more end flaps. In some examples, the ridge of the support also includes an outwardly expanding kickout portion configured to enclose the stabilizing turn. In some examples, the protective member includes an outer end flap and an inner end flap, wherein the outwardly expanding kickout portion is located near the inner end flap.

[0018] In some examples, the support also includes one or more retaining elements. In some examples, the retaining element includes a tooth that is attached to the arm at a base portion and tapers to a point at a tip portion.

[0019] In some examples, the coil includes: a longitudinal axis extending from the inflow side to the outflow side through the lumen of the coil; a first coil region configured to be disposed on the inflow side of the autologous valve annulus and to stabilize the coil relative to the autologous valve annulus; and a second coil region extending from the distal end of the first coil region and including one or more helical turns configured to be disposed on the outflow side of the autologous valve annulus and to receive a prosthetic valve, wherein the coil omits an elevation stabilization portion.

[0020] In some examples, the coil includes a lead coil that extends from the distal end of the second coil region and radially outward from the diameter of the second coil region.

[0021] In some examples, the proximal portion of the first coil region is raised at an angle relative to the plane defined by the first coil region and perpendicular to the longitudinal axis. In some examples, the angle is in the range of 10 to 30 degrees. In some examples, the proximal end of the first coil region is less than 12 mm higher than the plane defined by the first coil region.

[0022] In some examples, a first coil region defines a first lumen diameter, and a second coil region defines a second lumen diameter. In some examples, the first lumen diameter and the second lumen diameter are substantially equal. In some examples, the first lumen diameter is 10% to 30% larger than the second lumen diameter. In some examples, the first lumen diameter is in the range of 25 mm to 30 mm, and the second lumen diameter is in the range of 20 mm to 25 mm.

[0023] In some examples, the docking device includes a coil according to any example herein, and further includes a protective member at least partially coupled to the outflow side of the stabilizing coil, wherein the protective member is convertible between a radially compressed state and a radially expanded state. In some examples, the protective member includes a support, and the support includes a ridge, a plurality of arms, and one or more end flaps. In some examples, the protective member is coupled to the outflow side of the stabilizing coil and extends circumferentially between 180 and 330 degrees on the outflow side of the stabilizing turn. In some examples, the ridge of the support also includes an outwardly flared bend configured to enclose the stabilizing turn. In some examples, a portion of the protective member encloses the stabilizing turn and extends circumferentially between 30 and 135 degrees on the inflow side of the stabilizing turn.

[0024] In some examples, the support also includes one or more retaining elements. In some examples, the retaining element includes a tooth that engages with the arm at a base portion and tapers to a point at a tip portion.

[0025] In some examples, a docking device for securing a prosthetic implant to an autologous valve is provided, the docking device comprising: a coil defining a longitudinal axis extending from an inflow side to an outflow side through a lumen of the coil, and including a plurality of helical turns when unfolded at the autologous valve, wherein at least one of the helical turns includes a first coil region configured to be disposed on the inflow side of the autologous valve annulus and to stabilize the coil relative to the autologous valve annulus, wherein a proximal portion of the first coil region is raised relative to a plane defined by the first coil region and perpendicular to the longitudinal axis, and wherein the proximal end of the first coil region is less than 12 mm higher than the plane defined by the first coil region, and at least one of the helical turns includes a second coil region extending from the distal end of the first coil region and configured to be disposed on the outflow side of the autologous valve annulus and to receive the prosthetic valve; and a protective member at least partially coupled to the outflow side of the first coil region, wherein the protective member is convertible between a radially compressed state and a radially expanded state.

[0026] In some examples, a portion of the protective member is connected around the perimeter of the first coil region by at least 225 degrees. In some examples, a portion of the protective member is connected around the perimeter of the first coil region by at least 270 degrees. In some examples, a portion of the protective member is connected to the outflow side of the first coil region by at least 270 degrees around the perimeter of the first coil region, and a portion of the protective member is positioned around the perimeter of the first coil region at at least 15 degrees on the inflow side of the first coil region.

[0027] In some examples, the protective member includes a support, and the support includes a ridge, multiple arms, and one or more end flaps. In some examples, the ridge of the support also includes an outwardly flared portion configured to enclose a stabilizing turn. In some examples, the support also includes one or more retaining elements. In some examples, the retaining element includes a tooth, wherein the tooth engages with the arm at a base portion, and wherein the tooth gradually narrows to a point at a tip portion.

[0028] In some examples, one method includes: delivering the docking device as described in any one of the claims 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 coil remains in a substantially straight configuration during delivery of the docking device and transforms into a helical configuration after the docking device is deployed.

[0029] In some examples, a coil for a docking device for securing a prosthetic valve includes: a core comprising a plurality of helical turns and defining a longitudinal axis extending from an inflow side to an outflow side through a lumen of the plurality of helical turns when deployed at an autologous valve, wherein at least one of the helical turns includes a first region configured to be disposed on the inflow side of the autologous valve annulus and to stabilize the coil relative to the autologous valve annulus, and at least one of the helical turns includes a second region extending from a distal end of the first region and configured to be disposed on the outflow side of the autologous valve annulus and to receive the prosthetic valve; and a cover that surrounds at least a portion of the core and includes a first outer diameter and a second outer diameter greater than the first outer diameter, wherein the second region includes the second outer diameter.

[0030] In some examples, at least a portion of the first region is covered by a cover of a second diameter. In some examples, the cover comprises a first cover having a first outer diameter and a second cover having a second outer diameter, wherein the first and second covers are two separate pieces. In some examples, the coil includes a transition region in which the first cover flares radially outward such that it overlaps with the second cover in the axial direction. In some examples, a connecting member encloses the first cover. In some examples, the connecting member comprises a stitch.

[0031] In some examples, a protective member is provided for a docking device for securing a prosthetic implant to an autologous valve, the protective member comprising: a support having a ridge and a plurality of arms extending from the ridge; and one or more retaining elements coupled to one of the plurality of arms; wherein the protective member is configured to be attached to a coil by at least a portion of a helical turn coupled to the coil, wherein the protective member is switchable between a delivery-oriented radially compressed state and a deployment-oriented radially expanded state.

[0032] In some examples, the protective member includes a cover plate to which the plurality of arms are coupled, and at least a portion of the support is surrounded by the cover plate, and wherein the one or more retaining elements extend through the cover plate. In some examples, the retaining element is a fang configured to engage with cardiac tissue to help ensure device stability. In some examples, the fang includes: a base portion coupled to the arm and having a first width; and a tip portion including a second width, wherein the second width is smaller than the first width. In some examples, the fang includes a tip portion that is a point.

[0033] In some examples, when the protective member is in a radially expanded state in the deployed orientation, the plurality of arms and covers extend radially outward away from the coil and circumferentially along a portion of the coil. In some examples, when the protective member is in the radially expanded state, the retaining element extends from the arm in a clockwise direction. In some examples, the fangs extend out of the plane defined by the bracket. In some examples, an angle in the range of 0 to 90 degrees is formed between the fangs and the plane defined by the bracket. In some examples, an angle in the range of 0 to 45 degrees is formed between the fangs and the plane defined by the bracket. In some examples, an angle in the range of 90 to 180 degrees is formed between the fangs and the plane defined by the bracket.

[0034] The method described in this article can be performed on live animals or on simulated objects, such as corpses, corpse hearts, anthropomorphic ghosts, and simulated objects (e.g., simulated body parts, hearts, tissues, etc.).

[0035] The various innovations disclosed herein can be used in combination or individually. This summary is provided to introduce, in a simplified form, a series of concepts further described in the detailed embodiments below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the detailed embodiments described below with reference to the accompanying drawings. Attached Figure Description

[0036] Figure 1A This is a cross-sectional view of the human heart during diastole.

[0037] Figure 1B This is a cross-sectional view of the human heart during its systolic phase.

[0038] Figure 2A The illustration schematically depicts the first stage of an exemplary mitral valve replacement procedure, in which a guiding catheter and guidewire are inserted into the patient's vascular system and travel through the vascular system and into the patient's heart toward the patient's own mitral valve.

[0039] Figure 2B The second stage of an exemplary mitral valve replacement surgery is illustrated schematically, in which a docking device is deployed at the autologous mitral valve using a docking device delivery device that extends through a guiding catheter.

[0040] Figure 3A The illustration schematically depicts the third stage of an exemplary mitral valve replacement surgery, in which... Figure 2B The docking device was fully implanted in the patient's own mitral valve, and the docking device delivery device had been removed from the patient's body.

[0041] Figure 3B The illustration schematically depicts the fourth stage of an exemplary mitral valve replacement surgery, in which a prosthetic heart valve is deployed within a docking device implanted at the autologous mitral valve using a prosthetic heart valve delivery device that extends through a guide catheter.

[0042] Figure 4A The illustration schematically depicts the fifth stage of an exemplary mitral valve replacement surgery, in which the prosthetic heart valve is fully implanted within the docking device of the autologous mitral valve, and the prosthetic heart valve delivery device has been removed from the patient's body.

[0043] Figure 4B The illustration schematically depicts the sixth stage of an exemplary mitral valve replacement surgery, where the guiding catheter and guidewire have been removed from the patient's body.

[0044] Figure 5A Includes a top view showing an example of a coil of a docking device.

[0045] Figure 5B Includes a top view showing an example of a support for the protective components of the docking device.

[0046] Figure 5C Includes a top view showing an example of a cover plate that is a protective component of the docking device.

[0047] Figure 6A Includes a perspective view showing an example of an assembled docking device with coils and protective components.

[0048] Figure 6B include Figure 6A A top view of the docking device.

[0049] Figure 6C Included Figure 6A The cross-sectional profile marked with an arrow at point 6C.

[0050] Figure 6D Included Figure 6A The cross-sectional profile marked with an arrow at point 6D.

[0051] Figure 7A A top view including a protective member that is radially expanded in its deployment orientation.

[0052] Figure 7B Including a structure that is substantially straight during the transition toward delivery orientation. Figure 7A A top view of the protective components.

[0053] Figure 7C Including radial compression in delivery orientation Figure 7B A top view of the protective components.

[0054] Figure 7D Including delivery orientation in the delivery sleeve of the delivery device Figure 7C A top view of the protective components.

[0055] Figure 8A A top view including an example of a docking device having a protective member with an arm sleeve.

[0056] Figure 8B A top view of an example docking device having a protective member with an arm connected to a cover plate.

[0057] Figure 9A A top view of an example of a support structure including protective components.

[0058] Figure 9B A top view of another example of a support with fewer arms.

[0059] Figure 9C A top view of another example of a bracket that only has arms.

[0060] Figure 9D A top view of another example of a bracket with serpentine arms.

[0061] Figure 9E A top view of another example of a bracket that has arms but the arms do not have heads.

[0062] Figure 9F A top view of another example of a support having arms formed as convex lobes.

[0063] Figure 10A A top view including an example of a bracket with markings.

[0064] Figure 10B A cross-sectional view of an example of the connection between the support and the coil in the docking device.

[0065] Figure 10C A cross-sectional view of an example of the connection between the support and the coil in the docking device.

[0066] Figure 11A A top view of an example of a bracket including protective components, the bracket having a peripheral lip with edge protectors.

[0067] Figure 11B A perspective view including an example of a docking device having a coil and reduced thickness at the protective member.

[0068] Figure 12The diagram shows the docking device implanted into the mitral valve, with the protective member on the left atrial side, wherein the proximal coil region extends into the left atrium, and as shown, the arm extends in an unfolding direction so that the panel can cover the mitral valve anatomy, which can prevent paravalvular leakage (PVL).

[0069] Figure 13 The diagram shows the docking device implanted into the mitral valve, with the protective member on the left atrial side, wherein the proximal coil region extends into the left atrium, which, compared to Figure 12 , Figure 13 The mitral valve in the middle is relatively small in anatomy.

[0070] Figure 14A A top view of an example docking device with protective components is shown, but the valve device is not shown.

[0071] Figure 14B It shows Figure 14A A top view of an example docking device with protective components is shown, as well as a valve device.

[0072] Figure 15 A view of the support is shown, in which each arm gradually narrows from a wider base to a narrower end region adjacent to the head.

[0073] Figure 16 and 16A An example of a support with two terminal lobes is shown. Figure 16 In this context, the support structure is flat and planar. Figure 16A In this case, one of the lobes bends out of the plane to form a spoon-shaped tip (e.g., the tip of a ski).

[0074] Figure 16B It shows Figure 16A Examples of perspective and side views.

[0075] Figures 17A-17B The coil of the docking device is depicted, wherein the attachment portion is located at the proximal end of the stabilizing turn.

[0076] Figure 18 The coil in which the diameter of the stable turns is larger than that of the central region is depicted.

[0077] Figures 19A-19B Depicting including Figures 17A-17B A docking device with a coil and attached protective components.

[0078] Figures 20A-20B Describing the setting Figures 19A-19B The heart valve inside the central cavity of the docking device.

[0079] Figure 21A A support structure with multiple arms, two terminal lobes, and an outwardly flared bend is depicted.

[0080] Figure 21B-21E A support with multiple arms, two end flaps, and retaining elements is depicted.

[0081] Figure 22 A coil of a docking device is depicted, the coil having a cover with a different outer diameter for covering different sections of the coil.

[0082] Figure 23 A coil of a docking device according to another example is depicted, the coil having a cover with a different outer diameter for covering different sections of the coil.

[0083] Figures 24A-24B The segments of the coil are described, such as Figure 22-23 The image depicts coils with covers of different diameters.

[0084] Figure 25 A-25B depicts a configuration including attached protective components. Figure 22 The coil docking device.

[0085] Figure 26 An example depicting a portion of a coil cover is shown, including transition areas for covers of different diameters.

[0086] Figure 27 An example of a transition region for segments of coil covers with different diameters is depicted.

[0087] Figure 28 An example of a transition region for a segment of a coil cover with a different diameter is depicted, according to another example. Detailed Implementation

[0088] General considerations

[0089] The disclosed examples are adaptable to any autologous valve annulus (e.g., pulmonary annulus, mitral annulus, and tricuspid annulus) for delivery and implantation of prosthetic devices into the heart, and can be used with any of a variety of delivery methods (e.g., retrograde, antegrade, transseptal, transventricular, transatricular, etc.).

[0090] 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.

[0091] Although some of the disclosed examples have been described in a specific order for ease of presentation, this description includes rearrangements unless the specific language used 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 "provide" or "implement" 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.

[0092] As used herein, 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, do not exclude the presence of intermediate elements between the linked or associated items. As used herein, the term “and / or” used between the last two elements in the list of elements refers to any one or more of the listed elements. For example, the phrase “A, B, and / or C” means “A,” “B,” “C,” “A and B,” “A and C,” “B and C,” or “A, B, and C.”

[0093] As used herein, the term "proximal" refers to a 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 a 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). The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless otherwise explicitly defined.

[0094] Orientations and other relative references (e.g., inside, outside, top, bottom, etc.) may be used to aid in the explanation of the figures and principles herein, but these orientations and other relative references are not intended to be limiting. For example, certain terms such as “inner,” “outer,” “top,” “down,” “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. In the context of this application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow,” respectively. Thus, for example, unless otherwise explicitly stated, the lower end of a valve or docking station depicted in the figures is typically its inflow end, and the upper end of the valve or docking station is its outflow end.

[0095] Unless otherwise explicitly defined, the terms "longitudinal" and "axial" refer to an axis extending in the upstream and downstream directions or in the proximal and distal directions.

[0096] While alternatives exist for the various components, features, parameters, and operating conditions described herein, this does not imply that these alternatives are necessarily equivalent and / or perform as well. Unless otherwise stated, the alternatives are not listed in a preferred order.

[0097] As used herein, the terms “integral” and “monolithic construction” refer to a construction in which two parts of the construction are attached together without the need for any sutures, fasteners or other fastening devices.

[0098] As used in this article, the term “about” can refer to a number within plus or minus 5% of the indicated value.

[0099] Exemplary transcatheter heart valve replacement surgery

[0100] 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.

[0101] In some examples, the delivery device can be configured to deliver and implant a docking device at the implantation site, such as the autologous valve annulus. The docking device can be configured to more securely hold the expandable prosthetic valve within the docking device at the autologous valve annulus. For example, the docking device can provide or form a more rounded and / or more stable anchoring site, landing area, or implantation area 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 mitral valve annulus locations that do not have an autologous circular cross-section.

[0102] 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, close 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.

[0103] 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.

[0104] Figure 1A and 1B These are cross-sectional views of the human heart (H) during diastole and systole. The right ventricle (RV) and left ventricle (LV) are separated by the tricuspid valve (TV) and mitral valve (MV), respectively; that is, the atrioventricular valves separate the right atrium (RA) and left atrium (LA). Additionally, the aortic valve (AV) separates the left ventricle (LV) from the ascending aorta (AA), and the pulmonary valve (PV) separates the right ventricle from the pulmonary artery (PA). Each of these valves has flexible leaflets that extend inward across a corresponding orifice, which converge or "oppose" in the flow to form a one-way fluid-blocking surface. For illustration, the docking stations of this application are described primarily with respect to the inferior vena cava (IVC), superior vena cava (SVC), mitral valve MV, and aortic / aortic valve. Defective mitral valves may suffer from dysfunction and / or regurgitation.

[0105] Vessels such as the aorta, inferior vena cava (IVC), superior vena cava (SVC), and pulmonary artery (PA) may be healthy, or they may be dilated, tortuous, enlarged, have aneurysms, or otherwise damaged. The anatomy of the right atrium (RA), right ventricle (RV), left atrium (LA), and left ventricle (LV) will be explained in more detail. Whether explicitly described herein or not, the devices described herein can be used in various regions, such as in the inferior vena cava (IVC) and / or superior vena cava (SVC), in the aorta (e.g., an enlarged aorta) for the treatment of defective mitral valves, in other regions of the heart or vascular system, and in grafts, etc.

[0106] The right atrium (RA) receives deoxygenated blood from the venous system via the superior vena cava (SVC) and the inferior vena cava (IVC), the former entering the right atrium from above and the latter from below. The hepatic vein 17 carries blood from the liver to the inferior vena cava (IVC). The coronary sinuses (CS) are a collection of large vessels that join together to form the RA, collecting deoxygenated blood from the heart muscle (myocardium) and delivering it to the right atrium. During diastole or relaxation, as... Figure 1A As shown, with the expansion of the right ventricle (RV), deoxygenated blood collected in the right atrium (RA) from the inferior vena cava (IVC), superior vena cava (SVC), and coronary sinus (CS) passes through the tricuspid valve (TV) and enters the right ventricle (RV), while blood from the left atrium (LA) passes through the mitral valve (MV) and enters the left ventricle (LV). During systole or contraction, as... Figure 1B As shown, the right ventricle (RV) contracts to force the deoxygenated blood collected in the right ventricle (RV) through the pulmonary valve (PV) and the pulmonary artery into the lungs, while the left ventricle (LV) contracts to force the blood in the left ventricle through the mitral valve (MV) into the left atrium (LA).

[0107] The device described herein can be used to supplement the function of a defective mitral valve. During cardiac systole, the leaflets of a properly functioning mitral valve (MV) close to prevent blood from flowing back into the left atrium (LA). When the mitral valve (MV) malfunctions, blood may flow back into the left atrium (LA). This backflow of blood into the left atrium (LA) increases the amount of blood in the atrium and the blood vessels that carry blood to the heart. This can lead to enlargement of the left atrium (LA) and increased blood pressure in the left atrium (LA) and its vessels, potentially causing damage and / or swelling of the liver, kidneys, legs, and other organs. A transcatheter valve (THV) implanted in the mitral valve (MV) can inhibit blood from flowing back into the left atrium (LA) during systole.

[0108] The left atrium (LA) receives oxygenated blood from the left and right pulmonary veins, which then travels through the mitral valve to the left ventricle. During diastole, or during relaxation... Figure 1AAs observed, as the left ventricle (LV) expands, oxygen-rich blood collected in the left atrium (LA) moves through the mitral valve (MV) and into the left ventricle (LV). During systole or contraction, in... Figure 1B As observed, left ventricular (LV) contraction forces oxygen-rich blood through the aortic valve (AV) and aorta into the body via the circulatory system. In some examples, the device described herein can be used to supplement or replace the function of a defective mitral valve (MV).

[0109] exist Figure 2A-4B 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 transcatheter heart valve (e.g., THV) into the docking device.

[0110] As described above, defective autologous 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 the autologous heart valve) and may misplace relative to the autologous tissue, leading to paravalvular leak (PVL), valvular dysfunction, and / or other problems. Therefore, a docking device can be implanted first at the autologous valve annulus, and then the THV can be implanted within the docking device to help anchor the THV to the autologous tissue and provide a seal between the autologous tissue and the THV.

[0111] Figure 2A-4B An exemplary transcatheter heart valve replacement procedure (e.g., mitral valve replacement) is depicted according to an example, utilizing a docking device 52 (e.g., having a protective member, as described herein) and a prosthetic heart valve 62. During the procedure, the user can use a guiding catheter 30 to create a pathway to the patient's own heart valve. Figure 2A The user can use the docking device delivery device 50 to deliver and implant the docking device 52 at the patient's own heart valve. Figure 2B Then, after implanting the docking device 52, the docking device delivery device 50 is removed from the patient 10's body. Figure 3A Then, the user can use the prosthetic valve delivery device 60 to implant the prosthetic heart valve 62 into the implantation docking device 52. Figure 3B Afterwards, the user can remove the prosthetic valve delivery device 60 from the patient's body. Figure 4A ) and guiding catheter 30 ( Figure 4B ).

[0112] Figure 2AThe 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 and travel within the vascular system 12 of the patient 10, into the heart 14 of the patient 10, and toward the autologous mitral valve 16 (e.g., through the cardiac tissue wall between the right atrium RA and the left atrium LA, as shown). Together, the guiding catheter 30 and the 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).

[0113] Initially, the user may first make an incision in the patient's body to access the vascular system 12. For example, as shown in Figure 1, the user may make an incision in the patient's groin to access the femoral vein. Therefore, in such an example, the vascular system 12 may include the femoral vein.

[0114] 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”) may 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 may 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 may extend through the vascular system 12 and into the heart 14, while the stem 32 may be held outside the patient 10 and can be manipulated by the user to control the shaft 34. Figure 2A ).

[0115] 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 26 of the heart 14). Figure 2A ).

[0116] 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 making an incision 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 to 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 advance the guiding catheter 30 through the guidewire 40 into the left atrium 18. Figure 2A ).

[0117] 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 beyond the distal tip of the guide catheter 30 and configured to guide the guide catheter 30 into the left atrium 18 via the guidewire 40. Additionally, in some cases, the guide device may include a proximal end portion extending beyond 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 facilitate its guidance into the left atrium 18, as further described below.

[0118] Figure 2B A second stage of an exemplary mitral valve replacement surgery is depicted, in which a docking device 52 is implanted at the autologous 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”).

[0119] 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 retain 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 retain the docking device 52 within itself in a substantially straight delivery orientation.

[0120] The handle 56 of the docking device delivery device 50 may 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 may be coupled to the proximal end of the delivery shaft 54 ​​and may be configured to remain accessible to the user (e.g., outside the patient's body) during docking device implantation surgery. 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 ​​may 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 may 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.

[0121] 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.

[0122] 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 autologous 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.

[0123] 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.

[0124] 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.

[0125] The pusher assembly 58 can be detachably coupled to the docking device 52, and can therefore be configured to be released, separated, detached, and / or otherwise disconnected from the docking device 52 once it has been deployed at the target implantation site. As an example only, the pusher assembly 58 can 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.

[0126] 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 attached 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.

[0127] Refer again Figure 2BAfter 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 2B 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.

[0128] 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 end 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.

[0129] In some examples, the docking device 52 may be constituted, formed, and / or include 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 may wrap around the leaflet 24 of the mitral valve 16.

[0130] In the ventricular portion that drives the docking device 52 (e.g., Figure 2BAfter 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 with a flanged feature) 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 when 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. The flange feature, described in more detail below, helps to facilitate the retention of the docking device in the autologous mitral valve 16.

[0131] 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.

[0132] Figure 3A The third stage of a mitral valve replacement surgery is depicted, in which the docking device 52 has been fully deployed and implanted at the autologous 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 autologous mitral valve 16, and into the left ventricle 26 (…). Figure 2B 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.

[0133] like Figure 3AAs shown, the docking device 52 may include a plurality of helical turns that enclose the leaflet 24 of the autologous mitral valve 16 (within the left ventricle 26). The implanted docking device 52 may have a more cylindrical shape than the annulus of the autologous mitral valve 16, thereby providing a geometry that more closely matches the shape or contour of the PHV to be implanted. Thus, the docking device 52 with its flanged feature can provide a tighter fit between the prosthetic heart valve and the autologous mitral valve 16, and therefore provide a better seal, as further described below.

[0134] Figure 3B 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.

[0135] like Figure 3B As shown, the prosthetic valve delivery device 60 may include a delivery shaft 64 and a handle 66. The delivery shaft 64 may extend distally from the handle 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 an autologous mitral valve 16. The handle 66 may be configured to be grasped and / or otherwise held by a user to advance the delivery shaft 64 through the patient's vascular system 12.

[0136] 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 to be adjusted 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.

[0137] 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 3B 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 end portion of the delivery shaft 64.

[0138] In other examples, the prosthetic heart valve 62 may be self-expanding and may be configured to expand radially on its own when the sheath or sac of the prosthetic heart valve 62, which is radially compressed over the distal end portion of the delivery shaft 64, is removed. 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.

[0139] As shown in Figure 2D, the prosthetic heart valve 62 can be installed with an expansion mechanism 65 (e.g., an inflatable balloon) around the distal portion of the delivery axis 64 in a radially compressed configuration.

[0140] 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., 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 in Figure 2D. 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, bends, constrictions, and / or other obstacles in the vascular system 12 and the heart 14.

[0141] 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 autologous mitral valve 16. In some examples, as shown in FIG2D, at least a portion of the distal end of the delivery shaft 64 and the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.

[0142] Once the radially compressed prosthetic heart valve 62 is properly positioned within the docking device 52 ( Figure 3B 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.

[0143] Figure 4A The fifth stage of a mitral valve replacement surgery is shown, in which the prosthetic heart valve 62 is in its radially expanded configuration and implanted within the docking device 52 of the autologous mitral valve 16. Figure 4A As shown, the prosthetic heart valve 62 can be received and held within the docking device 52.

[0144] For example Figure 4A As shown, after the prosthetic heart valve 62 has been fully deployed and implanted into the docking device 52 at the autologous 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.

[0145] Figure 4B The sixth stage of a mitral valve replacement procedure is depicted, where the guidewire 40 and guiding catheter 30 have been removed from the patient 10. A docking device 52 with a flanged feature can be configured to provide a seal between the prosthetic heart valve 62 and the leaflet 24 of the autologous mitral valve 16 to reduce paravalvular leakage around the prosthetic heart valve 62. Specifically, the docking device 52 can first contract the leaflet 24 of the autologous mitral valve 16, with the flanged feature located at the top on the left atrial side. Then, as the prosthetic heart valve 62 expands radially within the docking device 52, it 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 autologous 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 autologous mitral valve 16 and the prosthetic heart valve 62 to reduce paravalvular leakage around the prosthetic heart valve 62.

[0146] 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.

[0147] although Figure 2A-4B 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.

[0148] 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.

[0149] Furthermore, despite Figure 2A-4B 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.

[0150] 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.

[0151] Exemplary prosthetic valve

[0152] Details of the prosthetic heart valves and various valve components described herein are described in U.S. Patent No. 11,185,406, which is incorporated herein by reference. Further example prosthetic valves are described in International Patent Application Publication No. WO 2018 / 222799, U.S. Patent No. 9,155,619, and U.S. Patent No. 2018 / 0028310, all of which are incorporated herein by reference in their entirety.

[0153] In some examples, the prosthetic heart valve includes a malleably expandable material, which may be a metal alloy, a polymer, or a combination thereof. Example metal alloys may include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some examples, the prosthetic heart valve may include stainless steel, cobalt-chromium, nickel-cobalt-chromium, or nickel-cobalt-chromium-molybdenum alloys, such as MP35N™ (trade name of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium, and 10 wt% molybdenum.

[0154] In some examples, the prosthetic heart valve may be a self-expanding prosthetic valve with 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, it can be released from the sheath, thus allowing expansion to its functional size. It should be noted that any delivery device disclosed herein may be adapted for use with a self-expanding valve.

[0155] Overview of the docking device

[0156] The docking devices according to examples of this disclosure can provide, for example, a stable anchoring site, landing area, or implantation area 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.

[0157] 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.

[0158] In some examples, the PVL guard can switch between a delivery orientation (or radial compression state) and a deployment orientation (or radial expansion state). When the PVL guard is in the delivery orientation, it can extend along and adjacent to the coil. When the PVL guard is in the deployment orientation, it can rotate about the central longitudinal axis of the coil and extend radially outward from the coil.

[0159] Exemplary docking device

[0160] Figure 5AA top view of an example of a hybrid docking device 70 or a core of a hybrid docking device 70 according to various examples is shown. The docking device 70 can be configured to fit at a mitral valve location, but in other examples it can be shaped and / or adapted in a similar or different manner to better accommodate at other autologous valve locations, such as at a tricuspid valve. Advantageously, the docking device geometry of this disclosure provides engagement with autologous anatomy, which can increase stability and reduce relative movement between the docking device, the prosthetic valve docked therein, and the autologous anatomy. This reduction in relative movement can prevent material degradation of the components of the docking device and / or the prosthetic valve docked therein, and can prevent damage / trauma to autologous tissue and prevent PVL (post-coital vascularization).

[0161] Many examples of docking devices 70 include a central region 80 having a single coil, i.e., a wound portion, or having multiple coils (e.g., 1 coil, 2 coils, 3 coils, 4 coils, 1 to 5 coils or more). The wound portion or coils of the central region 80 may have similar dimensions and shapes, or may have different dimensions and / or shapes. In some embodiments, the central region 80 includes three or approximately three complete coil turns having substantially equal inner diameters. The central region 80 of the docking device 70 acts as a primary landing region or holding region for retaining the expandable prosthetic valve when the docking device 70 and the valve prosthesis are implanted into the patient's body. In some examples, the docking device 70 has a central region 80 with more than three or fewer coil turns, depending on factors such as the patient's anatomy, the required vertical direct contact between the docking device 70 and the valve prosthesis (e.g., a transcatheter heart valve or THV), and / or other factors. One or more winding portions or coils in the central region 80 may also be referred to as “functional coils” or “functional turns” because the characteristics of these coils contribute most to the magnitude of the retaining force generated between the valve prosthesis, docking device 70, and autologous mitral valve leaflets and / or other anatomical structures.

[0162] Various factors can influence the overall holding force between the docking device 70 and the prosthetic valve held therein. For example, the shape of the valve to be implanted in the docking device, such as the valve having an open inlet and outlet, can naturally position the coil in its narrower center. The primary factor is the number of turns included in the functional coil, while other factors include, for example, the inner diameter of the functional coil, frictional forces (e.g., friction between the coil and the prosthetic valve), and the strength of the prosthetic valve and the radial force exerted by the valve on the coil. The docking device can have a variety of numbers of coils and / or turns. The number of functional turns can range from just over half a turn to five turns, or one full turn to five turns, or other ranges. In one example with three full turns, an additional half turn is included in the ventricular portion of the docking device. In another example, the docking device can have a total of three full turns. In one example, in the atrial portion of the docking device, turns of half to three-quarters of a turn or half to three-quarters of a turn can be present. While a range of turns is provided, as the number of turns in a mating assembly decreases, the size and / or material of the coils and / or the wire used to make the coils can also be changed to maintain appropriate holding force. For example, in a mating assembly with fewer coils, the diameter of the wire and / or the diameter of the functional coil turns can be larger. Multiple coils can be present in the atria and ventricles.

[0163] The size of the functional coil or coil in the central region 80 is typically selected based on the desired THV size to be implanted in the patient. Generally, the inner diameter 90 of the functional coil / turn (e.g., in the coil / turn in the central region 80 of the docking device 70) will be smaller than the outer diameter of the expandable heart valve, such that when the prosthetic valve expands in the docking device, additional radial tension or retaining force will act between the docking device and the prosthetic valve to hold the prosthetic valve in place. The retaining force required for adequate implantation of the prosthetic valve varies based on the size of the prosthetic valve and the component's ability to handle approximately 180 mm Hg of mitral valve pressure. For example, based on hemodynamic data using a prosthetic valve with a 29 mm expansion outer diameter, a retaining force of at least 15.8 N may be required between the docking device and the prosthetic valve to securely hold the prosthetic valve in the docking device and resist or prevent valve regurgitation or leakage. However, in this example, to meet this statistically reliable 15.8 N retaining force requirement, the target average retaining force should be significantly greater, for example, approximately 30 N.

[0164] In many examples, when the difference between the outer diameter of the prosthetic valve in its expanded state and the inner diameter of the functional coil is less than about 5 mm, the holding force between the docking device and the valve prosthesis is significantly reduced because the reduced dimensional difference may be too small to generate sufficient holding force between the components. For example, in one example, when a prosthetic valve with a 29 mm expanded outer diameter is expanded in a set of coils with a 24 mm inner diameter, the observed holding force is about 30 N, but when the same prosthetic valve is expanded in a set of coils with a 25 mm (e.g., only 1 mm larger) inner diameter, the observed holding force drops significantly to only 20 N. Therefore, in some examples, the inner diameter of the functional coil should be 24 mm or smaller to generate sufficient holding force between the docking device and the 29 mm prosthetic valve. Typically, the inner diameter of the functional coil (e.g., the central region 80 of the docking device 70) should be selected to be at least about 5 mm smaller than the prosthetic valve selected for implantation. However, if other sizes or size ranges are used, other features and / or properties (e.g., friction-enhancing features, material properties, etc.) can be used to provide better retention, as various factors may affect the retention force.

[0165] However, the diameter of the functional coil should be chosen based on a consideration and balance of several factors to achieve optimal results. For example, the autologous anatomy between the mitral annulus and papillary muscle head at the mitral valve plane forms a roughly trapezoidal shape, and the tissue of the mitral valve leaflets is thicker near the mitral valve plane and thins further below it. A smaller diameter of the central region 80 can cause the docking device 70 to be installed further below the mitral valve plane than desired (a similar effect can be observed at the tricuspid valve). When docking occurs at a location where the mitral valve leaflets are thinner, this can lead to suboptimal anchoring of the prosthetic valve. Therefore, dimensions, diameters, and other characteristics that help hold the prosthetic valve higher on the leaflets can be beneficial. Additionally, the size of the functional coil or the inner diameter of the central region 80 can be chosen to pull the autologous anatomy closer together to at least partially compensate for or counteract valvular regurgitation caused by, for example, left ventricular enlargement, being stretched from the autologous valve annulus.

[0166] It should be noted that the desired retention force discussed above applies to the example of mitral valve replacement. Therefore, other examples of docking devices for replacing other valves may have different dimensional relationships based on the desired retention force for valve replacement at those respective locations. Furthermore, dimensional differences may also vary, for example, based on the materials used for the valve and / or docking device, the presence of any other features preventing functional coil expansion or enhancing friction / locking, and / or based on various other factors.

[0167] In examples where the docking device 70 is used at the mitral valve location, the docking device can first be advanced and delivered to the autologous mitral valve annulus, then positioned at the desired location, followed by implantation of the prosthetic heart valve. In some examples, the docking device 70 is flexible and / or made of shape memory material, allowing the coil of the docking device 70 to also be straightened for delivery via a transcatheter method. In some examples, the coil is made of another biocompatible material, such as stainless steel. The docking device 70 and the prosthetic valve can be delivered using some of the same catheters and other delivery tools without requiring separate preparation steps, thus simplifying the implantation procedure for the end user.

[0168] Because the diameter of the functional coil / turn or coil / turn in the central region 80 of the docking device 70 is kept relatively small (e.g., in one example, the central region 80 may have an inner diameter of approximately 21-24 mm (e.g., ±2 mm) or smaller than another diameter of the prosthetic valve and / or the autologous valve annulus) to increase the holding force with the prosthetic valve, it may be difficult to advance the docking device 70 to the desired position relative to the autologous mitral valve annulus around the existing leaflets and / or chordae tendineae. This is especially true if the entire docking device 70 is made with the same small diameter as the central region 80. Therefore, the docking device 70 may have a distal region or lower region 82 that includes or is composed of the lead coil / turn (sometimes referred to as a surrounding turn or lead ventricular coil / turn) of the docking device 70, which has a smaller diameter but larger than the diameter of the functional coil / turn or the coil / turn in the central region 80.

[0169] Features of the autologous anatomical structure, particularly those in the right and left ventricles, have variable dimensions. For example, an autologous mitral valve anatomical structure can have a maximum width of approximately 25 mm to 65 mm along its long axis. The diameter or width of the circumferential turns or leader coils / turns (e.g., ventricular coils / turns) of the lower region 82 can be selected to be larger to facilitate the travel of the distal or leader tip 84 of the docking device 70 around it and to facilitate the circumferential features of the autologous anatomical structure (e.g., leaflets and / or chordae tendineae).

[0170] Various sizes and shapes are possible; for example, in one example, the diameter can be any size from 25 mm to 75 mm. The term "diameter" as used in this disclosure does not require the coil / turn to be a complete or perfectly circular shape, but is generally used to refer to the maximum width spanning relative points of the coil / turn. For example, the diameter relative to the lead coil / turn can be measured from the distal tip 84 to the opposite side, as the lower region or lead coil / turn 82 forms a complete loop.

[0171] In various examples, the docking device 70 may also include an enlarged proximal or upper region 86, which includes or comprises a stabilizing coil / turn of the docking device 70 (e.g., an atrial coil / turn) and / or is composed of said stabilizing coil / turn. During the instantaneous or intermediate phase of the implantation procedure, i.e., during the time between the deployment and release of the docking device 70 and the final delivery of the prosthetic valve, the coil may deviate and / or move away from its desired location or orientation, for example, through routine cardiac function. This deviation of the docking device 70 may potentially lead to less secure implantation of the prosthetic valve, misalignment of the prosthetic valve, and / or other positioning problems of the prosthetic valve. Stabilizing features or coils can be used to help stabilize the docking device in the desired location. For example, the docking device 70 may include an upper region 86 with an enlarged stabilizing coil / turn (e.g., an enlarged atrial coil / turn with a diameter 92 and / or 94 larger than the functional coil), the stabilizing coil / turn intended to be positioned in the circulatory system (e.g., in the left atrium) to stabilize the docking device. For example, the upper region 86 or the stabilizing coil / turn can be configured to abut or push against the wall of the circulatory system (e.g., against the wall of the left atrium) to improve the ability of the docking device 70 to remain in the desired position before implantation of the prosthetic valve.

[0172] In the illustrated example, the stabilizing coil / turn (e.g., an atrial coil / turn) at the upper region 86 of the docking device 70 may extend to approximately one full turn or one full loop and terminate at a proximal tip 88. In other examples, the stabilizing coil / turn (e.g., an atrial coil) may extend more or less than one turn or one loop, depending on the desired amount of contact between the docking device and the circulatory system (e.g., with the wall of the left atrium) in each particular application. The radial dimension of the stabilizing coil / turn (e.g., an atrial coil) at the upper region 86 may also be significantly larger than the size of the functional coil in the central region 80, such that the stabilizing coil / turn (e.g., an atrial coil or atrial turn) is sufficiently flared or extended to contact the wall of the circulatory system (e.g., the wall of the left atrium). In some examples, the core diameter in the upper region 86 may vary, which may make this segment of the coil stiffer or softer and / or more anatomically conformal than other segments of the coil. Additionally, the stabilizing coil / turn in various examples will be configured to be less abrasive to autologous tissue and / or anatomical structures. For example, the surface texture can be made smoother and / or softer so that the movement of the docking device against the autologous anatomical structure will not damage the autologous tissue.

[0173] Figure 5B The protective member 104 of the coil 102 attached to the docking device 70 is shown (in this document). Figures 6A-6BThe support 120 (described in the figure) includes a ridge 130 and a plurality of arms 122 extending from the ridge. Each arm 122 includes a base portion 122b and a head portion 122h. The support 120 includes a gap 127 between the arms 122, which serves as a panel 140 for the protective member 104. The first set of arms 122 may be linear arms, as shown. The last arm 125 may be a flap, also referred to as a terminal flap 125. In some respects, the arms 122 may have different widths from the base portion 122b to the head portion 122h, wherein the tapered shape formed by the narrowing width from the base portion 122b to the head portion 122h can provide advantageous characteristics when deploying the protective member. That is, the width of the base portion 122b may be greater than the width of the arm 122 near the head portion, wherein the thickness may be constant. However, the width may be constant, while the thickness may gradually narrow from the base portion 122b to the head portion 122h. In some examples, the base portion 122b may have a width ranging from 0.2 mm to 0.3 mm. In some examples, the arm 122 near the head portion 122h may have a width ranging from 0.07 mm to 0.15 mm. In some examples, the width of the arm may vary from 0.25 mm at the base portion 122b to 0.12 mm near the head portion 122h. This tapered arm 122 provides sufficient retaining strength while allowing the arm to better conform to the autologous anatomy of the valve region.

[0174] The protective member 104 can be configured to fit over the mitral valve at a mitral valve location to provide a cover over the mitral valve leaflets and the periphery of the mitral valve region. However, in other examples, the protective member 104 can also be shaped and / or adapted in a similar or different manner to better accommodate other autologous valve locations, such as at the tricuspid valve, that can be constructed together with the docking device 70. Advantageously, the geometry of the protective member 104 of this disclosure is capable of engaging with the autologous anatomy at the mitral valve, which increases stability and reduces relative movement between the docking device 70 and / or the protective member 104 relative to the autologous anatomy. This reduction in relative movement prevents the formation of gaps that could lead to leakage around the protective member 104 and prevents damage / trauma to the autologous tissue. Therefore, the protective member 104 can be configured to provide an adaptive fit with the docking device 70 to suppress movement relative to the mitral valve anatomy and suppress blood leakage, such as PVL. Therefore, the number, length, thickness, and head features of the arms 122 can be adjusted to accommodate different anatomical structures and their various dimensions, ranging from children to adults. Furthermore, the flexibility of the arms 122, resulting in flexibility of the protective member 104, can facilitate shaping and contouring of the protective member 104 to adjacent anatomical structures at the mitral valve. The thickness of the stent or its ridge or arm can vary, being greater at the base of the arm and narrower at the head or tip of the arm.

[0175] The protective member 104 may include a ridge 130 with a shape corresponding to the coil 102 of the docking device 70, such that the ridge 130 and the coil 102 have substantially the same coil or diameter, so that their bodies can be matched and joined together. For example, the ridge 130 may cooperate with an area of ​​the coil 102 from one end to the other, such that they fit together and have the same curvature, such as no gap when the ridge 130 is placed on the coil 102.

[0176] In examples where the docking device 70 is used at the mitral valve location, the docking device 70 with protective member 104 can first be advanced and delivered to the autologous mitral valve annulus, then positioned at the desired location, where the protective member covers the mitral valve leaflets and peripheral anatomy, before the prosthetic heart valve is implanted. In some examples, the protective member 104 is flexible and / or made of shape memory material, such that the ridge 130 coils around the docking device 70 and can also be straightened for delivery via a transcatheter method. In some examples, the stent 120 is made of shape memory material (e.g., nitinol) or another biocompatible material such as stainless steel. The docking device 70 with protective member 104 and the prosthetic valve can be delivered using some of the same catheters and other delivery tools without having to perform separate preparation steps, thus simplifying the implantation procedure for the end user.

[0177] Because the ridge 130 is configured to shape match the coils / turns of the docking device 70, such as the coils / turns at the central region 80, the effective diameter of the ridge 130 can be kept relatively small (e.g., in order to match the central region 80, it may have an inner diameter between approximately 21-24 mm ± 2 mm or smaller than another diameter of the prosthetic valve and / or the autologous valve annulus) to increase the retention force with the prosthetic valve. Furthermore, a protective member 104 can be positioned on the central region 80 at a location where the protective member 104 inhibits further advance of the docking device 70 around the existing leaflets and / or chordae tendineae, and the protective member 104 is shaped to aid in delivery of the docking device 70 to the desired position relative to the autologous mitral valve annulus.

[0178] Ridge 130 may include a front end 132 and a rear end 134, with a concave side 136 between the front end 132 and the rear end 134. The concave side 136 may be shaped to mate with the coil 102 of the mating device 70. Arm 122 extends from the convex shape 138 of ridge 130, thereby extending away from the coil 102 of mating device 70. While ridge 130 may be shaped to mate with coil 102, ridge 130 may or may not be directly coupled to coil 102. In some examples, coil 102 may include a material that can be coupled to the material of ridge 130, such as by stitching, splicing, brazing, welding, adhesives, etc. In some examples, mating device 70 may include a material cover surrounding a base coil, and ridge 130 may also include a material cover (e.g., cover plate 118) capable of being coupled to the cover of the coil. In other words, the covers of the two components can be joined together, such as by sewing, seeding, adhesive, clamping, or otherwise attaching the protective member 104 to the docking device 70, as discussed in more detail herein. For example, the protective member 104 can be sewn to the coil 102 with thread to attach the protective member to the coil.

[0179] The length of the ridge 130 can be adjusted according to the design of the docking device 70. Therefore, the ridge 130 can be configured to cover a certain percentage of the complete coil turns, or even cover the entire 360-degree turns or more. The ridge length can be customized to match the mitral valve anatomy and provide sufficient length for the arm 122 extending from the ridge to engage and overlap the anatomy to provide coverage. The length of the ridge 130 can be relative to the central region 80 of the docking device 70. In some aspects, the length of the ridge 130 from the anterior end 132 to the posterior end 134 can be approximately 20 mm to approximately 150 mm, approximately 30 mm to approximately 100 mm, approximately 40 mm to approximately 90 mm, approximately 45 mm to approximately 80 mm, or approximately 50 mm to approximately 75 mm. In some examples, the length can be approximately 54 mm.

[0180] The thickness of the support 120 can also vary as needed or desired. When referring to thickness, it refers to the Z dimension relative to the XY region of the page. If the support 120 is placed laterally and the arm 122 extends across the horizontal plane, the thickness is the height. The thickness can range from about 0.1 mm to about 0.8 mm, about 0.2 mm to about 0.6 mm, about 0.3 mm to about 0.5 mm, and about 0.4 mm to about 0.45 mm. In some respects, the spine 130 and the arm 122 can have the same thickness. In other respects, the spine 130 can have a greater thickness than the arm 122.

[0181] The widths of ridge 130 and arm 122 can also vary. The width, orthogonal to the thickness, defines the dimensions of the component in the XY plane. The width of ridge 130 lies between the concave side 136 and the convex side 138. The corresponding dimension of arm 122 is also considered as width. The widths of ridge 130 and / or arm 122 can range from about 0.05 mm to about 0.5 mm, about 0.1 mm to about 0.4 mm, about 0.13 mm to about 0.3 mm, about 0.16 mm to about 0.25 mm, or about 0.15 mm to about 0.20 mm, respectively. In a gradually narrowing example, the arm can gradually narrow from about 0.35 mm to about 0.05 mm, or from about 0.25 mm to about 0.1 mm.

[0182] Arm 122 can be distributed along the convex side 138 of ridge 130, such as Figure 5B As shown in the diagram, arm 122 is shown having a base portion 122b attached to ridge 130, with a head portion 122h at the opposite end of arm 122. Arm 122 may include a straight portion 122c extending from base portion 122b to a certain length and then turning into an arc 122a, such that arm 122 bends in a bending region 122d, thereby having a bending region 122d slightly parallel to ridge 130. That is, arc 122a rotates the orientation of arm 122 such that the orientation of bending region 122d is approximately the same as the orientation of ridge 130. Furthermore, it should be noted that the orientation of bending region 122d and head portion 122h is offset from front end 132 and points towards rear end 134.

[0183] Arm 122 may range from about four to about ten arms, from about three to about 20 arms, or from about four to about 15 arms, or from about five to about 10 arms, or from about six to eight arms. The length of arm 122 from the base of the base region 122b (e.g., from the ridge 130) to the tip of the head region 122h may vary from about 10 mm to about 60 mm, from about 20 mm to about 50 mm, from about 25 mm to about 45 mm, from about 30 mm to about 43 mm, or from about 35 mm to about 40 mm. The straight portion 122c may have a length from about 6 mm to about 50 mm, from about 8 mm to about 40 mm, from about 10 mm to about 30 mm, or from about 15 mm to about 20 mm. Arc 122a can have angles of approximately 20 to approximately 90 degrees, approximately 30 to approximately 80 degrees, approximately 40 to approximately 70 degrees, and approximately 50 to approximately 60 degrees. The bending region 122d and the head region 122h can be the size of arm 122 minus the size of the straight portion 122c. However, the arm length can vary depending on the specific example or even between different arms of the same support. In some aspects, the diameter of the support component is larger than the coil of the docking station. When the protective member is attached to the docking station, the protective member has a greater radial coverage due to its own cover plate. Furthermore, the cover plate component of the protective member is cut to be larger than the docking station (e.g., the cover plate has a diameter of 33 mm compared to the 29 mm docking diameter after implantation), so that the textile material of the cover plate is taut during attachment, reducing wrinkles in the textile.

[0184] Arms 122 can be spaced apart from each other by dimensions of approximately 0.3 mm to approximately 15 mm, approximately 0.75 mm to approximately 10 mm, approximately 1 mm to approximately 8 mm, and approximately 1.25 mm to approximately 6 mm.

[0185] The head portion 122h may also be referred to herein as head 122h. Therefore, head 122h may have a circular shape, with or without an orifice. Head 122h may include a ring 122l shape defining an orifice 122k, the size of which may vary. The ring 122l and orifice 122k are shown as having a teardrop shape; however, this shape may be perfectly circular, elliptical, or other variations of roundness. Head 122h may be configured without any sharp ends or tips, which minimizes puncture of the cover plate 118 or mitral valve tissue or related anatomical structures. Head 122h provides a rounded feature that is blunt to prevent any puncture.

[0186] The support 120 may also have a terminal flap 125, which may also be referred to herein or in the incorporated references as a flap. However, two terminal flaps 125 may be placed on the support, one at each end. The terminal flap 125 is shown as having two ends 125a, 125b attached to the ridge 130 to form a ring 125l and an aperture 125k. However, only one end may be attached to the ridge 130, such as at or near the rear end 134. The terminal flap 125 may have various sizes and may be elliptical or slightly teardrop-shaped. The terminal flap 125 may have a length of about 5 mm to about 50 mm, about 10 mm to about 40 mm, or about 20 to about 30 mm, or a length of about 21 mm. The terminal flap 125 may have a width of about 3 mm to about 30 mm, about 5 to about 25 mm, about 10 mm to about 20 mm, or about 11 mm to about 15 mm, or a width of about 10.5 mm.

[0187] In some examples, the stent 120 may include a shape memory material that is shaped and / or pre-constructed to expand the protective member 104 to a radially expanded state when unconstrained (e.g., when deployed at an autologous valve location). For example, the stent 120 may comprise a shape memory alloy with superelastic properties, such as nitinol. In some examples, the stent 120 may comprise a ternary shape memory alloy with superelastic properties, such as NiTiX, where X may be chromium (Cr), cobalt (Co), zirconium (Zr), hafnium (Hf), etc.

[0188] In some examples, the support 120 may comprise a metallic material that does not possess shape memory properties. In such cases, the support 120 may have a biasing mechanism (e.g., using a spring) configured to bias the support 120 (and the protective member 104) to a radially expanded state. Examples of such metallic materials include cobalt-chromium, stainless steel, etc. In one specific example, the support 120 may comprise nickel-free austenitic stainless steel, where nickel may be completely replaced by nitrogen. In another specific example, the support 120 may comprise a cobalt-chromium or cobalt-nickel-chromium-molybdenum alloy with significantly low-density titanium.

[0189] Figure 5CA cover plate 118 of the protective member 104 is shown, as described herein. The cover plate 118 is for mounting on a bracket 120 to form the protective member 104. The cover plate 118 may include at least one cover plate piece 150 having a sleeve 121 formed by sleeve pieces 152 coupled to the cover plate piece 150, the coupling being, for example, using sheet stitch 154, adhesive, or other attachment members. The cover plate 118 is shown as including five panels 140 and one end panel 140a, the end panel 140a being configured to have end lobes in a petal shape (e.g., teardrop shape). Here, the cover plate piece 150 may be one or more pieces and may be configured as at least two pieces joined (e.g., sewn) together to form a cover that slides over an arm through a cavity to cover both sides of the arm such that the arm is located in the cavity between the pieces. Any examples of the one or more cover plate pieces 150 are considered herein. In some respects, sleeve 121 can be a tube, such as a braded tube, which can be fitted onto the arm like a sock. Other sleeve constructions are also possible.

[0190] In some examples, Figure 5C The cover plate 118 is assembled into Figure 5B A protective member 104 is formed on the bracket 120. The protective member is then connected to... Figure 5A The coil 102 is used to form a docking device with a protective member 104.

[0191] The cover plate 118 can be a single cover plate 150 or multiple cover plate pieces 150 attached to the support 120 by any means. This attachment can be achieved by sewing the cover plate 118 to the support 120, for example, via a circular stitch 156. Alternatively, another piece, whether flat or tubular (e.g., a sock), can be configured as a sleeve 121 for receiving the arm 122 and attached to the cover plate piece 150 via a sheet stitch. Therefore, different attachment systems can be used to attach the cover plate piece 150 to the support 120.

[0192] In some examples, at least one arm 122 is attached to a cover plate 118 by means of sheet stitch 154 that connects the cover plate 150 to the sleeve plate 152, the sleeve plate 152 having the arm 122. In some aspects, the cover plate 118 is a flat sheet of material, such as fabric, film, membrane, plastic sheet, foil, etc. In some aspects, the sleeve plate 152 is a flat sheet of material, which may be the same as or different from the cover plate 118. In the combination of the flat cover plate 150 and the flat sleeve plate 152, the arm 122 is fitted between the flat cover plate 150 and the flat sleeve plate 152 using sheet stitch 154, the sheet stitch 154 being used to sew each side of the arm 122 to form a sleeve 121. The arm 122 is able to move freely within the sleeve component of the protective arm, which enhances the ability to compress the protective member into the conduit tube.

[0193] In some examples, at least one arm 122 is attached to the cover plate 118 by sliding a sleeve piece 152, formed as a tube (e.g., two open ends) or a sock (e.g., one open end), over the arm 122 and sewing (e.g., 154) to the cover plate 150. Here, the sleeve piece 152 encloses the arm 122 to provide additional protection, which can be beneficial to the mitral valve tissue. The tubular or sock-shaped sleeve piece 152 may also be made of the same material as the flat cover plate 150, but in certain examples it may or may not be the same material.

[0194] In some examples, at least one arm 122 is attached to the cover plate 118 by stitching a single arm 122 to the cover plate 150 with a loop stitch 156. The loop stitch 156 can pass through the cover plate 150 and around the corresponding arm 122, and return through the cover plate 150 on the other side of the arm 122, thereby forming a loop stitch around the arm 122. Various types of loop stitches 156 can be used, as long as the stitching can form a loop that attaches the arm 122 to the cover plate 150. For example, the end flap 125 is essentially an arm whose ends are attached to the ridge 130. Therefore, the end flap 125 may not be suitable for receiving tubes or sock-shaped sleeve constructions. Furthermore, such an end flap 125 does not have any sharp tips, ends, or edges. Therefore, the arm of the end flap 125 can be stitched to the cover plate 150 with a loop stitch. In some aspects, the protective member may include a base suture around the terminal flap (e.g., annulus), while at the end of the terminal flap, the protective member is sutured only on the inner diameter. Thus, the flap can move within the cover member, allowing the terminal flap to collapse into the catheter.

[0195] In some examples, at least one arm 122 is attached to the cover plate 118 by sewing a single arm 122 between the cover plate 150 and the flat sleeve plate 152 with a loop stitch 156. The loop stitch 156 can pass around the respective arm 122 through the cover plate 150 and the flat sleeve plate 152, and return through the flat sleeve plate 152 and the cover plate 150 on the other side of the arm 122, thereby forming a loop stitch around the arm 122 and the cover plate 150 and the flat sleeve plate 152. Various types of loop stitches 156 can be used, as long as the stitching can form a loop that attaches the arm 122 to the cover plate 150.

[0196] When the arm is the terminal flap 125, the flat sleeve 152 can be constructed as a flat flap 158. The flat flap 158 can be sewn together with the terminal flap 125 between the cover plate 150 and the flat flap 158 according to annular stitches. Figure 5C As shown, the cover plate 150 is circumferentially sutured to the flattened flap 158 via circumferential stitches 156, wherein the terminal flap 125 is located between the cover plate 150 and the flattened flap 158. In some aspects, the flattened flap 158 can be configured as a terminal flap having a flap shape (e.g., a teardrop shape), such as... Figure 5C As shown.

[0197] As described, the protective member 104 is shown comprising five panels 140 formed by a stent 120 and a cover plate 118, and an end panel 140a. Panels 140 may be areas of the cover plate 150 between arms 122. Panels 140 may function as flat umbrella-shaped panels that fold when the stent 120 is folded in a delivery orientation and expand after the stent 120 is released in an unfolding orientation. Panels 140 may have different shapes and sizes for different configurations. Panels 140 extend from the ridge 130 through arms 122 to provide a flanged feature relative to the delivery device 70. Panels 140 may provide a flexible barrier and may contour to the mitral valve anatomy. Panels 140 may inhibit fluid flow through the protective member 104, thereby preventing paravalvular leakage. Depending on the type of material, panels 140 may also allow for inward cell growth, which may promote implantation of beneficial functions and durability.

[0198] like Figures 5B-5CAs shown, arm 122, sleeve 121, end flap 125, and flap sleeve 158 can be oriented clockwise or counterclockwise in deployment orientation. That is, these components can be oriented relative to coil 102 of docking device 70, as shown in clockwise deployment, or in the opposite direction in counterclockwise deployment. Although all arms 121 and end flaps 125 are oriented in the same direction as shown, end flaps 125 can be oriented in the opposite direction (e.g., counterclockwise), while arms 121 remain clockwise. Additionally, one or more arms 121 can be replaced by flaps, which can be internal flaps. Furthermore, end flaps 125 can be replaced by end arms. Therefore, various configurations can be provided, for example... Figures 8A-8B As shown in 9A-9F and described in more detail herein.

[0199] The cover plate 118 can also be connected to the ridge 130 of the support 120. The cover plate 118 can be attached to the ridge 130 in a similar manner to how the cover plate 150 is fixed to the arm 122. The cover plate 118 can be sewn to the ridge 130 with a circumferential stitch, so that the cover plate 118 covers the ridge 130. The sewing can also secure the protective member to the coil member. Alternatively, the cover plate 150 can be wrapped around the ridge itself and then sewn or circumferentially stitched to form an interrupted tubular covering of the cover plate 150 around the portion of the ridge 130 between the arms 122; this interrupted tubular covering may be referred to as the ridge sleeve 153. In some aspects, the ridge sleeve 153 can be formed using another sheet material, which can be done in a manner similar to that of the arms described herein.

[0200] In some examples, cover 118 may be configured to be resilient such that cover 118 can accommodate bracket 120 when protective member 104 changes from delivery orientation to deployment orientation.

[0201] In some examples, the cover plate 118 may be configured to prevent autologous tissue trauma and / or promote inward tissue growth into the cover plate 118. For example, the cover plate 118 may have pores to promote inward tissue growth. In another example, the cover plate 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 plate 118 may be made of any suitable flexible material, including foam, cloth, fabric, and / or polymer, such that the cover plate 118 is compressible and expandable. In one example, the cover plate 118 may comprise a fabric layer made of a thermoplastic polymer material such as polyethylene terephthalate (PET).

[0202] In some examples, the cover plate 118 may be configured to engage with a prosthetic valve deployed within the docking device to form a seal after the protective member 104 expands radially and reduce paravalvular leakage between the prosthetic valve and the docking device. The cover plate 118 may also be configured to engage with autologous tissue (e.g., autologous valve annulus and / or autologous leaflet) to reduce paravalvular leakage between the docking device and / or the prosthetic valve and the autologous tissue.

[0203] Additionally, cover plate 118 may include an edge protector 151 at a peripheral lip, the peripheral lip being the area surrounding arm 122 and / or sleeve 121. Edge protector 151 may be part of cover plate 150 or a separate component coupled to cover plate 150. Further examples of cover plate 118 are described herein.

[0204] Figures 6A-6D A docking device 100 with interconnected coils 102 and protective members 104 is shown according to one example. 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.

[0205] The docking device 100 may include a coil 102 and a protective member 104 (which may also be referred to as a "PVL protector," "sealing member," or "flanged feature") extending along at least a portion of the coil 102. In some examples, the coil 102 may include a shape memory material (e.g., a nickel-titanium alloy or nitinol) such that the docking device 100 (and the coil 102) can be transformed from a substantially straight configuration (also referred to as "delivery orientation") when positioned within a delivery sleeve of a delivery device (e.g., docking device delivery device 50) to a helical configuration (also referred to as "unfolding orientation") after removal from the delivery sleeve. Figure 6A (As shown). In delivery orientation, the arm 122 of the protective member 104 folds upward against the spine 130, causing the panel to fold inward. In deployment orientation, the arm 122 is released and extends away from the spine 130, providing a flanged feature for covering the mitral valve anatomy.

[0206] During delivery of the docking device 100 and after initial deployment of the docking device 100 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 transition to a radially expanded state, such as in... Figures 6A-6B middle.

[0207] In some examples, when the docking device 100 is in the deployed orientation and the protective member 104 is in the radially expanded state, the protective member 104 may extend circumferentially, radially, or laterally relative to the central longitudinal axis 101 of the docking device 100. The protective member 104 may extend 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 around the perimeter of the turns in the coil 102. In other words, the protective member 104 may extend circumferentially from about half a turn (e.g., 180 degrees) around the central longitudinal axis 101 in some examples to more than a full turn (e.g., 400 degrees) around the central longitudinal axis 101 in other examples, including various ranges in between. As used herein, a range (e.g., 180 degrees to 400 degrees, and between 180 degrees and 400 degrees) includes the endpoints of this range (e.g., 180 degrees and 400 degrees), and all ranges described herein include the endpoints. In some aspects, the protective member can achieve at least 360 degrees of coverage over the valvular anatomy in the atrium. This coverage is achieved by opening the protective member. Examples may include a coverage range of approximately 45 degrees to approximately 400 degrees, approximately 90 degrees to approximately 360 degrees, approximately 120 degrees to approximately 300 degrees, or approximately 180 degrees to approximately 225 degrees.

[0208] The coil 102 has a proximal end 102p and a distal end 102g, with a protective member 104 between the proximal and distal ends 102p and 102g, and also defines the proximal and distal ends of the docking device 100, respectively. When positioned within a delivery sheath (e.g., during delivery of the docking device to a patient's vascular system), the body of the coil 102 between the proximal and distal ends 102p, together with the protective member 104, can form a generally straight delivery orientation (i.e., without any coiling or looping portions, but possibly flexing or bending) 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, the coil 102 and the protective member 104 can transition from a delivery orientation to a helical unfolding orientation, wherein the protective member 104 extends laterally from the coil over the mitral valve anatomy, and wherein the coil wraps around the autologous leaflet tissue near the implantation site. For example, when a docking device is implanted at the location of an autologous valve, the coil 102 can be configured to surround the autologous valve leaflet (and the chordae tendineae connecting the autologous valve leaflet to the adjacent papillary muscle, if present), wherein the protective member 104 is on top so as to be located above the location of the leaflet, thereby forming a flange or cover above the mitral valve anatomy in the left atrium.

[0209] 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.

[0210] In some examples, the docking device 100 in a deployment orientation can be configured to fit at the mitral valve location, wherein the protective member 104 laterally covers the mitral valve anatomy from the coil 102 in the left atrium. The protective member 104 can provide a lateral barrier on the periphery of the mitral valve anatomy at the intersection of the left atrium and the mitral valve anatomy. In other examples, the docking device 100 can also be shaped and / or adapted for implantation at other autologous valve locations, such as the tricuspid valve location. As described herein, the geometry of the docking device 100 and its protective member 104 can be configured to engage the autologous anatomy, which can, for example, increase stability and reduce relative movement between the docking device 100, the prosthetic valve docked therein, and / or the autologous anatomy. 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 autologous tissue. Furthermore, the protective member 104 can inhibit leakage of blood in the valvular pathway in the wrong direction from the perivalvular region.

[0211] like Figure 6A As shown, the coil 102 in its unfolded orientation may include a leading turn 106 (or "leading coil"), a central region 108 (e.g., having a protective member 104), and a stabilizing turn 110 (or "stabilizing coil") around a central longitudinal axis 101. The central region 108 may have one or more helical turns having substantially equal inner diameters, one of which is coupled to the protective member 104. 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). However, in other configurations, the diameters may be the same.

[0212] In some examples, the central region 108 may include 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 and / or farthest turn may be partial turns (e.g., rotated less than 360 degrees, such as 180 degrees, 270 degrees, etc.). The protective member 104 may be positioned anywhere along the central region 108 and is shown at the near-side turn of the central region 108.

[0213] In some examples, the topmost or nearest helical turn of the central region 108 may include a protective member 104 connected thereto. This provides the protective member 104 in the region of the coil 102 located in the left atrium, while the distal helical turn surrounds the leaflet and enters the left ventricle.

[0214] The dimensions of the docking device 100 and the protective member 104 are typically selected based on the desired size of the prosthetic valve to be implanted in the patient and the dimensions of the anatomical structures at the intersection of the left atrium and the mitral valve anatomy. In some examples, the central region 108 may be configured to hold the radially expandable prosthetic valve. For example, when the prosthetic valve expands radially, the inner diameter of the helical coil 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 coil in the central region 108 may also be referred to herein as a “functional coil.” The ridge 130 of the protective member 104 may be similarly configured for this intended use.

[0215] 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). In some aspects, the protective member 104 can be opposite the stabilizing turn 110 such that they are laterally extended in opposite directions.

[0216] In one specific example, when the docking device 100 is implanted at the location of the autologous mitral valve, the functional coil in the central region 108 can be substantially disposed in the left ventricle, and the stabilizing coil 110 can be substantially disposed above the protective member 104 in the left atrium. The stabilizing coil 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 opposite the protective member contacting the left atrial wall. In some examples, the contact points between the docking device 100 and the left atrial wall can form a plane generally parallel to the plane of the autologous mitral valve and can be parallel to the plane of the protective member 104. In some aspects, the protective member can be configured to stabilize the docking device into the mitral valve. Therefore, the atrial coil in the coil can be omitted from the device.

[0217] In some examples, the stabilizing turn 110 may have an atrial portion 110c connected to the central region 108 (attached to...). Figure 6A The device comprises a protective member 104, a raised 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 raised stabilizing portion 110a. The ascending portion 110b may be adjacent to the protective member 104. Both the atrial portion 110c and the raised stabilizing portion 110a may be generally parallel to the helical turns in the central region 108, while the ascending portion 110b may be oriented at an angle relative to the atrial portion 110c and the raised stabilizing portion 110a. For example, in some examples, the ascending portion 110b and the raised stabilizing portion 110a may form an angle of about 45 degrees to about 90 degrees (inclusive). When the docking device 100 is implanted at the autologous mitral valve location, the atrial portion 110c may be configured to adjoin the posterior wall of the left atrium, and the raised stabilizing portion 110a may be configured to open outward together with the protective member and press against the anterior wall of the left atrium.

[0218] In some examples, the stabilizing turn of coil 102 may be omitted, and the proximal region of coil 102 may be another part of coil 102. In this example, the protective member 104 provides stability of the docking device relative to the mitral valve anatomy and the left ventricle.

[0219] 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 can help 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 valve, tricuspid valve, etc.). For example, once the guide coil 106 is guided around the desired autologous anatomy, 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 approximately 180 to 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 expand further 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.

[0220] In some examples, at least a portion of the 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 cover is provided below and can be found in International Publication WO 2022 / 087336. This cover may be used to attach a protective member 104 to the coil. Therefore, the material of the protective member 104 may be a material attached to the cover by adhesive, suture, circumferential suture, or other connection.

[0221] like Figures 6C-6D As shown, at least a portion of the core 102a of the coil 102 can be surrounded by an inner cover 112 (which may also be referred to as the "first cover"). Here, the core 102a of the coil 102 is a structural part of the coil 102 and can be referred to as core 102a. The inner cover 112 may have a tubular shape. In some examples, the inner cover 112 may cover the entire length of the core 102a of the coil 102. In some examples, the inner cover 112 covers only a selected portion of the core 102a of the coil 102. It is worth noting that... Figures 6C-6D Core 102a is shown.

[0222] In some examples, the inner cover 112 may be coated and / or bonded to the core 102a of the coil 102. In some examples, the inner cover 112 may be a cushioning pad-like layer protecting the core 102a of 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 securely attached to the core 102a of 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 core 102a of the coil 102 is restricted or prohibited. In some examples, one or more portions of the inner cover 112 (e.g., the distal portion) may be fixedly attached to the core 102a of the coil 102, and one or more other portions of the inner cover (e.g., the intermediate and / or proximal portions) may be movable relative to the core 102a of the coil 102. In some aspects, the inner cover 112 is coupled to the cover plate 150 of the protective member 104.

[0223] In some examples, such as Figure 6C As shown, the docking device 100 may further 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 core 102a of 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. However, the retaining member 114 does not cover the protective member 104. In some aspects, the retaining member 114 may be coupled to the protective member 104, for example, by coupling with the cover plate 150. Thus, 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 is able to frictionally engage the prosthetic heart valve and / or autologous valve leaflet tissue.

[0224] The retaining member 114 may 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 include a fabric material.

[0225] In some examples, the protective member 104 may be fixedly attached to the retaining member 114 and / or the inner cover 112, for example via a protective attachment 148, such as a suture, adhesive and / or any other suitable means for attachment.

[0226] 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.

[0227] In various examples, the protective member 104 can transition between a radially compressed state and a radially expanded state. Specifically, the protective member 104 may include a plurality of arms 122, which may be radially expandable and compressible. Figures 6A-6B In the depicted example, the protective member 104 has four panels 140, including one panel configured as a distal flap 140d and three proximal panels 140p. In other examples, the protective member 104 may have two, three, four, five, six, seven, eight, nine, or more than ten panels 140. The panels 140 may extend circumferentially along a portion of the coil 102 of the docking device 100. The end panel 140p may be in the form of a distal flap 140d, which may or may not include arms, wire frames, or rings. The distal flap 140d may have arms 122 in the sleeve, and it may also include a wire frame 123 between two cover plates as shown, the wire frame 123 being made of the same material as the support 120.

[0228] When the protective member 104 is in a radially compressed state, the panel 140 can be radially compressed against the coil 102, such that the radial profile of the docking device 100 is less than a predetermined threshold, for example, between 2 mm and 3 mm (inclusive). When the protective member 104 transitions from a radially compressed state to a radially expanded state, the panel 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.

[0229] As shown herein, the protective member 104 may include a bracket 120 and a cover plate 118 that substantially surrounds the bracket 120. The shape of the bracket 120 generally defines the shape of the protective member 104. For example, the bracket 120 may include a ridge 130 and a plurality of arms 122 connected to the ridge 130. The ridge 130 defines the inner edge of the protective member 104 and may be attached to the coil 102. Each arm 122 may extend radially outward from the ridge 130 within a corresponding panel 140.

[0230] As described herein, the radial expansion of the protective member 104 can help prevent and / or reduce paravalvular leakage (PVL). 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 may 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 may 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 may be configured to expand to cover and / or fill any opening at that point and suppress leakage along the docking device 100.

[0231] In some examples, the inner cover 112 and / or retaining member 114 may have a slack portion. For example, Figure 6AIt is shown that before radial expansion of the prosthetic valve within docking device 100, the inner cover 112 can be axially compressed to have a relaxation portion 115. The inner cover 112 can be constructed of low-density ePTFE such that the inner cover 112 can be axially compressed and the resulting relaxation portion 115 does not significantly affect the radial profile of docking device 100. When the prosthetic valve is radially expanded within docking device 100, docking device 100 can be further radially expanded, which allows coil 102 to rotate within the autologous loop (also referred to as "clock movement"). During clock movement, relaxation portion 115 allows inner cover 112 to stretch axially and not rotate with coil 102 (i.e., coil 102 can slide axially relative to inner cover 112). Because guard member 104 can be securely attached to retaining member 114, relaxation portion 115 also prevents guard member 104 from rotating and pinning open autologous leaflets during clock movement.

[0232] In various examples, the protective member 104 can help cover the atrial side of the atrioventricular valve to prevent and / or inhibit leakage of blood through the external periphery of the autologous leaflet, commissure, and / or prosthetic valve by preventing the flow of blood in the atrium in the atrium-to-ventricle direction (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 the flow of blood in the ventricle in the ventricle-to-atrium direction (i.e., retrograde flow).

[0233] 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.

[0234] Additional examples and characteristics of protective components are described in the “Exemplary PVL Protective Components” section below.

[0235] 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.

[0236] Exemplary PVL protective components

[0237] Figures 7A-7DAn 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.

[0238] The protective member 204 can switch between a radially compressed state (e.g., delivery orientation) and a radially expanded state (e.g., deployment orientation). For example, Figure 7A The protective member 204 is shown in a radially expanded state. Figure 7B The partially collapsed protective component 204 is shown. Figure 7C The protective member 204 is shown in a radially compressed state. Figure 7D The protective member is shown in a radially compressed state, located in the docking sleeve, with a fully collapsed delivery orientation.

[0239] The protective member 204 can also switch 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-7D The protective member 204 is shown in a substantially upright position.

[0240] The protective component 204 can also be converted between a folded configuration and an open configuration. For example, Figures 7A-7C The protective member 204 is shown in both the open and folded configurations. Figure 7D A protective member 204 in a folded configuration is shown in the docking sleeve 55 of the delivery device 50 for delivery.

[0241] Figure 7D The protective member 204 is depicted in a delivery orientation, for example, when it 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 orientation, the protective member 204 can be folded, radially compressed, and kept substantially straight. Figure 7A A protective member 204 is depicted, for example, in an unfolded orientation after the docking device is deployed at the implantation site and the docking sleeve 55 is removed. In the unfolded orientation, the protective member 204 can open, expand radially, and transition to a bent state.

[0242] exist Figures 7A-7D In the illustrated example, the protective member 204 includes six panels 206, but the number of panels 206 may be greater than or less than six. The panels 206 may extend circumferentially along a portion of the coil 102. When the protective member 204 is in a radially compressed state ( Figures 7C-7D When the protective member 204 is in a radially expanded state, the panel 206 can be radially compressed against the coil 102. When the protective member 204 is in a radially expanded state, the panel 206 can extend radially outward relative to the coil 102.

[0243] Each panel 206 has an arm 222 having a rounded head portion 208 and a curved, elongated base portion 210, and may correspond to a bracket 120 as defined herein. 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 panel 206, the base portion 210 may be attached to the coil 102 (e.g., via stitching), and the head portion 208 may extend radially outward relative to the base portion 210.

[0244] Panel 206 may define the outer edge 212 and inner edge 214 of protective member 204. Protective member 204 may be attached to coil 102 at inner edge 214.

[0245] 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) (inclusive).

[0246] The overall shape, size, and position of panel 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, panel 206 may extend in the same angular direction (e.g., clockwise or counterclockwise when viewed from the top or the stabilizing ring 110 of the docking device) when the protective member 204 is in a radially expanded state. For example, in Figures 7A-7B In the diagram, when viewed from above, all six panels 206 extend in a clockwise direction. In different examples, the panels may be arranged in either a clockwise or counterclockwise direction.

[0247] In some examples, such as Figures 7A-7B As depicted, when the protective member 204 is in a radially expanded state, the panels 206 have substantially the same dimensions. In other examples, when the protective member 204 is in a radially expanded state, at least two of the panels 206 may have different dimensions. In some examples, at least one panel, such as the distal panel, may be configured as a petal shape.

[0248] In some examples, such as Figures 7A-7B As depicted, when the protective member 204 is in a radially expanded state, the panels 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 panels 206 may have different shapes.

[0249] When deployed at an autologous heart valve, panel 206 can be configured to press against the opposite portion of the autologous heart chamber. For example, when deployed at the mitral valve, panel 206 can be configured such that the surface of cover 118 presses against the anterior and posterior leaflets of the mitral valve, with the periphery of the cover pressing against the left atrial wall. The arcuate or circular shape of the peripheral lip of cover 218 can be used for implantation and to prevent PVL (peripheral ventricular lip). In some aspects, the peripheral lip of cover 218 does not include any indentations or fan-shaped shapes, nor any features other than a circular edge.

[0250] The protective member 204 may include a bracket 220 and a cover 218 that substantially surrounds the bracket 220. The shape of the bracket 220 generally defines the shape of the protective member 204. For example, the bracket 220 may include a ridge 230 and a plurality of arms 222 connected to the ridge 230. The arms 222 may extend radially outward from the ridge 230. Each arm 222 may extend along the periphery of a corresponding panel 206. The ridge 230 may extend along the inner edge 214 of the protective member 204. The ridge 230 may be bent to convert the protective member 204 into a bent state, or may be straightened to convert the protective member 204 into a substantially straight state.

[0251] In some examples, ridge 230 and arm 222 are interconnected to form a monolithic part. For example, ridge 230 and arm 222 can be laser-cut from a single sheet of metal or metal alloy. In other examples, arm 222 and ridge 230 can be created as separate parts and then joined together (e.g., by molding, welding, brazing, etc.) to form bracket 220.

[0252] The support 220 may have the same state or configuration as the protective member 204. For example, when the protective member 204 transitions between a radially compressed state and a radially expanded state, the arm 222 may radially compress or expand. When the protective member 204 transitions between a bent state and a substantially straight state, the ridge 230 may bend or straighten. When the protective member 204 transitions between a folded configuration and an open configuration, the ridge 230 may also fold or open.

[0253] Like stent 120, stent 220 may include a shape memory material, such as nitinol. The shape of stent 220 may be configured such that stent 220 is biased towards deployment. For example, when 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, arm 222 may compress radially, and ridge 230 may be substantially straightened and folded. After deployment of the docking device and removal of the docking sleeve from protective member 204, ridge 230 may open and become bent, and arm 222 may expand radially under biasing forces.

[0254] Cover plate 218 may be similar to cover plate 118. For example, cover plate 218 may be configured to be sufficiently resilient such that when the protective member 204 changes from a delivery orientation to a deployment orientation, cover plate 218 can accommodate support 220 (e.g., radial expansion of arm 222 can cause a corresponding radial expansion of cover plate 218). Cover plate 218 may also be configured to prevent autologous tissue trauma and / or promote inward tissue growth into cover plate 218.

[0255] Figure 8A An example of a docking device 800a is shown, which has a coil 802 attached to a protective member 804, wherein the arms 822 are oriented clockwise. The docking device 800 has five arms 822, each having five panels 840 and end flaps 840a (e.g., convex flaps). As shown, a cover plate 818 has sleeves 821 for the arms 822, wherein the sleeves 821 are coupled to cover plate pieces 850. In some examples, the cover plate pieces 850 are folded over the ends of the arms to increase protection of autologous tissue. Furthermore, the end flaps 840a include flap members 841, which are coupled to the cover plate pieces 850 to form a cover plate 118, wherein the convex flap shape of the flap members 841 is formed by stitching (e.g., sutures).

[0256] In this example, the end flap 840a may include an edge facing the coil, which is not connected to the coil and is spaced apart from the coil, for example as... Figure 14A As shown. The terminal flap 840a can extend through the atrial turns of the coil to provide increased coverage. Additionally, see also... Figure 14B The distal flap 840a can be bent inwards such that when the docking member unfolds and the prosthetic valve unfolds therein, the distal flap will contact and / or conform to the outer surface of the valve and improve perivalvular seal, as indicated by arrow A. The distal flap 840a may include suture or stitch patterns, wherein suturing is performed inside the stent member, such as... Figure 14B As shown, this allows arm 822 to elongate when compressed into the catheter delivery lumen, while the exterior is not sutured, allowing for expansion of the exterior.

[0257] Figure 8BAn example of a docking device 800b is shown, which has a coil 802 attached to a protective member 804, wherein the arms 822 are oriented clockwise. The docking device 800 has eight arms 822 with eight panels 840, wherein the end panels resemble other panels (e.g., not lobes). As shown, the cover plate 818 omits the sleeves for the arms 822, wherein the arms 822 are connected to the cover plate piece 850 via stitching (e.g., sutures), specifically by stitching the arms 822 to the cover plate 818 on both sides. Here, the cover plate piece 850 can be one, two, or more pieces, wherein the pieces can be joined together to form a cavity receiving the arms 822.

[0258] Figure 9A An example of a bracket 920 for a protective member is shown. As shown, the bracket 920 includes arms 922 oriented clockwise but also potentially counterclockwise. The bracket 920 is shown as having six arms 922 and one end flap 923. Each arm 922 has a proximal base portion 922b having an elongated proximal region 924 that transforms into an inwardly curved region 925 having a distal head 922h. The distal head 922h is shown with an aperture 926 formed therein. However, the distal head 922h can be solid and the aperture omitted. The aperture 926 can help reduce the material and weight of the bracket 920 while still providing a rounded end to prevent damage to the covering material of the protective member.

[0259] Figure 9B An example of a bracket 920 for a protective member is shown. As shown, the bracket 920 includes arms 922 that are oriented clockwise but can also be oriented counterclockwise. The bracket 920 is shown as having five arms 922 and an end flap 923. Figure 9B The five arms of 922 are wider than Figure 9A The six arms 922 are larger, which provides different mechanical properties for different examples. The wider arms 922 have a proximal base portion 922b, which has an elongated proximal region 924 that transforms into an inwardly curved region 925 with a distal head 922h. The distal head 922h is shown with an aperture 926 formed therein. However, the distal head 922h can be solid and the aperture omitted. The aperture 926 can help reduce the material and weight of the support 820 while still providing a rounded end to prevent damage to the covering material of the protective member. For example, Figure 9B The five arms of the 922 can have a width of 0.30 mm, of which Figure 9AThe six arms 922 may have a width of 0.15 mm. Other examples may include widths from about 0.30 mm to about 0.15 mm or other ranges as described herein. In any example, the thickness of each arm 922 may be from about 0.20 mm to about 0.50 mm, or from about 0.30 mm to about 0.40 mm, or any range between these points.

[0260] Figure 9C An example of a bracket 920 for a protective member is shown. As shown, the bracket 920 includes arms 922 that are oriented counterclockwise but can also be oriented clockwise. The bracket 920 is shown as having five arms 922, each end of which is an end flap. Here, the two ends of the bracket include the arms 922. Therefore, the end flaps are not included.

[0261] Figure 9D An example of a bracket 920 for a protective member is shown. As shown, the bracket 920 includes arms 922 oriented counterclockwise but also clockwise. The bracket 920 is shown as having seven arms 922, each end of one arm being an end. Here, the two ends of the bracket include arms 922. Therefore, end flaps are not included. Furthermore, one of the end arms is a serpentine arm 962, which has a concave curve 964 and a convex curve 966 relative to the end position. Although only one arm is shown as a serpentine arm 962, any arm can be constructed as a serpentine arm 962.

[0262] Figure 9E An example of a bracket 920 for a protective member is shown. As shown, the bracket 920 includes arms 922 that are oriented clockwise but can also be oriented counterclockwise. The bracket 920 is shown as having eight arms 922, each end of which is an end. Here, the two ends of the bracket include the arms 922. Therefore, the end flaps are not included. The arms 922 omit the head and instead extend an inner curved region 925 to the end 927.

[0263] Figure 9F An example of a bracket 920 for a protective member is shown. As shown, the bracket 920 includes arms 922 configured as lobes 929, which are oriented counterclockwise but can also be oriented clockwise. The lobes 929 are formed by the arms 922, each end of which is connected to a ridge 930. The bracket 920 is shown as having eight arms 922 forming four lobes 929, each end of which is an end flap. Here, both ends of the bracket include lobes. Therefore, both ends can be considered to include end flaps, as lobes can also be referred to as flaps. The lobes 929 omit their heads and are actually curved.

[0264] Figure 10AAn example of a stent 120 with a marker 1002 that can be visualized is shown. In some examples, the stent 120 may include at least one radiopaque marker 1002 configured to provide a visual indication of the position of the protective member 104 relative to its surrounding anatomical structures and / or its radial expansion under fluoroscopy. Furthermore, the radiopaque marker 1002 can be used to identify the position of the docking device 100 under fluoroscopy (e.g., when a prosthetic valve is subsequently deployed in the docking device 100). For example, one or more radiopaque markers 1002 (e.g., two are shown) may be placed on the stent 120. In one specific example, the radiopaque markers may be located at the anterior edge 132 and the posterior edge 134 of the ridge 130.

[0265] In some examples, the non-transparent marking 1002 can be replaced by a crimping member, or can be constructed as a crimping member, to indicate an alternative connection between the support 120 and the coil 102 of the docking device 100 (e.g., 70). Thus, the covering member (e.g., 112, 114) can be formed of a wrapping material that can wrap around the ridge 130 of the support 120 and the core 102a of the coil 102, allowing the arm 122 to protrude therefrom. A cover plate can then be mounted on the arm. Thus, an alternative mechanism for attaching the support 120 to the coil 102 can be achieved.

[0266] Figure 10B An example of the cross-sectional profile of a support 120 (e.g., via ridge 130) is shown. The support 120 is coupled to a coil 102 via a coated cover 1004, which wraps around the ridge 130 and the coil 102 to form a cover. The coated cover 1004 can be a variety of biocompatible materials, such as expanded polytetrafluoroethylene (ePTFE). The coated cover 1004 can wrap from the leading edge 132 to the trailing edge, and then a radiopaque mark 1002 configured as a crimp can be crimped around the end of the coated cover 1004 to secure the coated cover 1004 to the device. This allows the crimp to connect the coated cover 1004 to the ridge 130 and the coil 102. This configuration can also be used in… Figure 10A As shown in the image.

[0267] Figure 10C Another example is shown, in which the ridge 130 of the support 120 is outside the coating 1006 (e.g., small OD ePTFE). Here, the coil 102 is in the coating 1006 on which the ridge 130 is located, and the crimp member 1008 is formed around the coil to secure the ridge 130 to the coil 102 so that it is located outside the coating. Any number of crimp members 1008 can be used, and the crimp members can be as follows: Figure 10A It is constructed and applied as shown by the transmissive marking 1002. Furthermore, Figure 10CA coil 102 is shown as a docking core, one side of which is ground flat to receive a ridge 130 with a blocky cross-sectional shape.

[0268] Figure 11A An example of a docking station 1100 is shown, which includes a coil 1102 and a protective member 1104. The protective member 1104 includes a cover plate 1118 having a cover plate 1150 above a support 1120. In this example, the cover plate 1118 includes a cover plate 1150 having a peripheral lip on its periphery, the peripheral lip including an edge protector 1151. Thus, the edge protector 1151 provides protection for the peripheral lip of the cover plate 1118 and can provide further protection for the arm 1112 and its head (not shown here). The edge protector 1151 may be a piece folded around and sewn to the peripheral end of the cover plate 1150. The sewing can be performed laterally from the head of the arm 1112. Thus, the edge protector 1151 can protect the head or arm tip from extending beyond or away from the cover plate 1118, which can prevent the head or arm tip from piercing the tissue adjacent to the cover plate 1118 after unfolding. The edge protector 1151 ensures that the protective member prevents tissue trauma to the left atrium and / or mitral valve anatomy. This enhances the seal to suppress PVL. In some aspects, the edge protector 1151 can be part of the cover plate material, which folds over the head of the arm and sutures back to the cover plate material to form the protector. A cover plate sheet, such as a bottom sheet, can be folded over the tip of the arm to further protect the anatomy from injury. This also optimizes the seal around the folded edge, which is essential for PVL mitigation. Alternatively or separately, a separate fabric tube or straight piece can be sutured as the edge protector 1151. Due to the “3D” nature of the edge and the large piece of fabric, this can prevent PVL, mitigate any tissue damage, and also improve tissue ingrown in this area (e.g., enhance PVL coverage).

[0269] The edge protector 1151 can be made of the same material as any type of cover plate or sleeve described herein. In some examples, the edge protector 1151 can be made of ePTFE, fabric, porous fabric, blurred fabric, or any other biocompatible material that can serve as a protective barrier. In some aspects, the material can be selected to promote rapid inward growth. Thus, the material of the edge protector 1151 may include inward growth hormones, as well as the material used for the rest of the cover plate 1118.

[0270] In some examples, by reducing the diameter of the coil, the docking device with protective members can be configured to have a lower profile when in delivery orientation. That is, the coil core member (e.g., Figures 6C-6D102) can have a reduced diameter to have a lower profile. Alternatively, cover 112 can have a reduced profile by having a reduced diameter. Alternatively, retaining member 114 can have a reduced diameter to provide a reduced profile.

[0271] like Figure 11B As shown, the intermediate region 1130 of coil 1102 may include a larger diameter region 1132, such as where coil 1102 surrounds the leaflets of the mitral valve. A smaller diameter region 1134 is provided adjacently, in which guard member 1104 is attached to coil 1102. Although there may be a gap between the larger diameter region 1132 and guard member 1104, these components may be adjacent to, in contact with, or attached to each other. The region of coil 1102 attached to guard member 1104 has a reduced dimension to aid folding to delivery orientation by folding arm 1122 inward. Therefore, the reduced dimension in the smaller diameter region 1134 provides space for folding arm 1122 and panel 1140. This allows for easier insertion and removal from the delivery device. For example, the larger diameter region 1132 may have a diameter ranging from about 1.4 mm to about 2.5 mm, about 1.5 mm to about 2.2 mm, about 1.6 mm to about 2.1 mm, or about 1.8 mm to about 2.0 mm, or about 1.9 mm. The smaller diameter region 1134 is always smaller than the larger diameter region 1132, and may include a smaller diameter region 1134 having a diameter ranging from about 1.1 mm to about 1.6 mm, about 1.2 mm to about 1.5 mm, or about 1.3 mm to about 1.4 mm. Therefore, this configuration allows for easier installation into a delivery device and the use of less force to deploy the protective member, resulting in better installation outcomes. The smaller diameter region 1134 may be a smaller covering material, such as a smaller ePTFE material.

[0272] in addition, Figure 11B A joint 1137 is shown between a larger diameter region 1132 and a smaller diameter region 1134. This joint 1137 may include a connecting member 1139 or a connecting adhesive for joining the larger diameter region 1132 to the smaller diameter region 1134. The connecting member 1139 may also include suture material for sewing the larger diameter region 1132 and the smaller diameter region 1134 together.

[0273] In some examples, different techniques may be used to fabricate docking devices with protective members. This document explains exemplary methods for manufacturing docking devices with protective members; however, variations may be made to achieve the examples shown and described herein. In the examples, for illustrative purposes, this document (with accompanying drawings) shows docking devices with protective members to illustrate the product of the manufacturing process. However, it should be understood that similar or different methods may be used to manufacture docking devices with different protective members by following the pattern of the docking device and its components.

[0274] In some examples, the support structure of the protective member can be obtained by cutting a substrate to form ridges and arms. Each arm has a head portion and a base portion formed thereon. The base portion connects to the ridge of the support. The head portion is positioned further away from the ridge than the base portion. Each arm can have a tapered shape such that the area of ​​the head portion of the arm is narrower than the base portion. In one specific example, the support structure can be made by laser-cutting nitinol sheet. In other examples, the arms and ridges can be created as separate parts and then joined together (e.g., by molding, welding, brazing, adhesives, etc.) to form the support structure.

[0275] The protective member can be formed by enclosing the support within a cover plate using sleeves in the cover plate for each arm or flap. An exemplary method of manufacturing the cover plate may include a base fabric, and then sleeve fabric may be formed on the cover plate to form each sleeve.

[0276] In some examples, the stent can be attached to the cover plate via multiple sutures stitched thereto. The sutures and stitches can be run in a specific pattern (e.g., circular stitches) to hold the stent in place while also allowing the stent specific mobility within the cover plate.

[0277] For example, at least some sutures, referred to as circumferential or cruciate sutures, may extend across or around the ridge at the base of the convex flap of the wire frame. Such cruciate sutures can hold each arm within its corresponding sleeve, thereby holding the panel within its corresponding sleeve and restricting lateral movement of the support within the cover plate.

[0278] Additionally, at least some sutures, referred to as inner sutures, may extend along one or more suture segments located at the head portion of the arm of the stent and lie inside said one or more suture segments. Therefore, a recess or sleeve may be formed between the inner sutures and the outer edge of the cover plate. The recess or sleeve may restrict sliding movement of the arm within the cover plate. For example, the head portion of the arm may slide within the recess or sleeve, thereby allowing the stent to transition between a radially compressed state and a radially expanded state, and / or between a substantially straight state and a bent state. It is noteworthy that cruciform sutures do not impede sliding movement of the arm within the sleeve of the cover plate.

[0279] In some examples, the protective member can be attached to the coil of the mating device. For example, the cover and / or support of the protective member can be attached to the coil via one or more stitches, loop stitches, wrapping, or other fastening features. The ridge and core can be directly joined together (e.g., adhesive, welding, brazing, etc.) or placed adjacent to each other and wrapped together with a wrapping cover (e.g., Figure 10B ).

[0280] Before the docking device is implanted, the protective members can be held within the docking sleeve (e.g., docking sleeve 55). The protective members held within the docking sleeve can be kept in a radially compressed state. For example, the panels can be radially compressed such that they extend along the coil and substantially parallel to the coil.

[0281] Exemplary docking device

[0282] Figure 14A A top view of an example docking device with protective components is shown, but the valve device is not shown. Figure 14B It shows Figure 14A The top view shows an example of a docking device with protective members, and also shows a valve device. These are described in more detail elsewhere in this application.

[0283] Figure 15 A plan view of a support 1500 with six arms 1504 is shown, wherein each arm gradually narrows / taperes from a wider base 1506 to a narrower end region adjacent to the head 1510 (e.g., neck 1508). For example, the width of the arms 1504 can vary, with a greater width at the base 1506 gradually narrowing to the narrow neck 1508. For example, at least one of the arms, such as two, three, or more of the arms, such as all the arms, can have a gradually narrowing width. For example, at least one of the arms has a wider base width of about 0.2 mm to about 1.0 mm and a narrower neck width of about 0.1 mm to about 0.5 mm. In one example, at least one of the arms, such as all the arms, has a base width of 0.25 mm and a neck width of 0.12 mm.

[0284] Figure 16 and 16A An alternative example of a stent is shown. Figure 16 The illustrated support 1600 includes two terminal lobes 1604 and 1606. The support 1600 is generally flat and / or planar. For example, the ridge 1610, arm 1614, and lobes 1604 and 1606 all define a plane, or lie in a plane, and generally do not extend outside said plane.

[0285] Figure 16AThe bracket 1650 shown also includes two terminal lobes 1654 and 1656. Unlike bracket 1600, bracket 1650 is not completely flat or planar. For example, the bracket includes a ridge 1658 and an arm 1662 defining the plane, with at least one region, such as a portion of the distal lobe 1654, angled away from the plane defined by the ridge and arm. For example, the distal lobe 1654 may include a portion 1668 that bends outward from the plane or is angled to form a shovel-shaped tip (e.g., a "ski tip"). Reference Figure 16B This allows for a better understanding of this feature. Figure 16B The diagram shows a perspective view and a side view of a support 1650, which includes a bent portion 1668 of a flap 1654 that is not in the same plane as the rest of the support. The bent portion 1668 forms a shovel-shaped tip or a "ski tip" structure.

[0286] In some examples not shown, one or both of the terminal lobes 1654 and 1656, such as terminal lobe 1654, can be shaped to fall entirely outside the plane defined by the ridge and arm. For example, as regarding Figure 16-16B As an alternative or supplement to the described "ski-tip" portion, the entire distal flap 1654 may exist outside the plane to define an angle of 5 to 45 degrees. Angle-shaped flaps can achieve or improve conformation with the patient's anatomy throughout implant deployment. In some examples, the two distal flaps are shaped downwards or upwards relative to the coil.

[0287] It should be understood that each of brackets 1500, 1600, and 1650 may be fitted with a cover plate (not shown), as described and shown elsewhere in this document, such cover plate being sized or adapted to fit onto the bracket, thereby forming a protective member having one or more advantages and features described and shown elsewhere in this document.

[0288] Back Figure 14A and 14B At this point, the bracket is positioned within the cover plate to form a docking device with a protective member having two end flaps that are not connected to the coil, allowing the end flaps to move relative to the coil. In other words, it can be modified. Figure 14A and 14B This results in end flaps / plates at both ends that are not connected to the coil. Therefore, when the valve is in Figures 16A-16B In the docking device, the valve expands the coil diameter and pushes against the unattached end flap to compress the valve. Therefore, Figure 14B The compression of the terminal lobe shown can be applied to Figures 16A-16B The two end flaps of the support.

[0289] In some examples, implantation of a prosthetic valve at the autologous valve annulus involves a two-step procedure. As described above, this procedure includes first implanting the docking device and then deploying the prosthetic valve within the docking device. During the immediate phase of the procedure (after docking device implantation and before prosthetic valve implantation), minimizing or eliminating movement of the docking device relative to the autologous anatomy is advantageous. Improving the safety and ease of deployment of the docking device is also beneficial. The docking devices described below enable increased ease of deployment and maintenance of positioning relative to the autologous anatomy. The docking devices described below simplify design and reduce implantation material that is not of long-term usefulness (i.e., material useless outside the initial implantation procedure). The functional turn closest to the atrial side in these designs can have the advantage of an attachment surface with increased flange characteristics, thereby increasing the stability of the docking device within the anatomy.

[0290] As used herein, the turns of the coils referred to herein define the diameter of the cavity and / or are described as being situated in a plane perpendicular to the longitudinal axis 1701. Because the turns of the coil form a helix, they are not necessarily defined by a conventional diameter or plane. The plane referred to herein should be understood as the plane that bisects a reference turn of the coil at the midpoint along the longitudinal axis. In other words, a given turn of the coil is half above and half below the plane in which it is situated. The diameter of a given turn of the coil, as referred to herein, lies in the plane as described above. As mentioned above, the term "diameter" as used in this disclosure does not require the turn to be a complete or perfect circle, but is generally used to refer to the maximum width of the turn at relative points.

[0291] exist Figures 17A-17B The diagram depicts a coil 1702 shown in an unfolded configuration. Coil 1702 may include a stabilizing turn 1710 (also referred to as a "stabilizing coil," a "functional turn closest to the atrium," or a "first coil region"), a central region 1708 (also referred to as a "functional turn" or a "second coil region"), and a lead turn 1706 (or a "lead coil"), each disposed around a longitudinal axis 1701 extending through a central lumen 1720 of coil 1702. The central region 1708 may include one or more helical turns having substantially equal lumen diameters. The lead turn 1706 may extend from the distal end of the central region 1708 and, in some examples, may have a lumen diameter substantially equal to the lumen diameter of the central region 1708. In some examples, the lead turn may include a radially outwardly extending distal portion 1707. In some examples, the stabilizing turn 1710 may extend from the proximal end of the central region 1708 and may have a lumen diameter substantially equal to the lumen diameter of the central region 1708. In some examples, as will be discussed below, the lumen diameter of the stabilizing turn may differ from the lumen diameter of the central region 1708.

[0292] Coil 1702 can be used, for example, as docking device 1700 ( Figure 19A This is part of the docking device. In some examples, when the docking device is implanted at the location of the autologous mitral valve, the functional turn in the central region 1708 can be substantially disposed in the left ventricle, and the stabilizing turn 1710 can be substantially disposed in the left atrium. The stabilizing turn 1710 can be configured to increase stability and improve sealing. In some examples, the contact point between the docking device, including coil 1702, and the left atrial wall can form a plane generally parallel to the plane of the autologous mitral valve. In some examples, a protective member can be used with the stabilizing turn 1710 and configured to provide increased stability to the docking device when it is positioned in the mitral valve.

[0293] In some examples, when coil 1702 is implanted at the location of the autologous mitral valve, the functional turn in central region 1708 can be substantially disposed in the left ventricle, and the stabilizing turn 1710 can be substantially disposed in the left atrium. The stabilizing turn 1710 can be configured to provide one or more contact points or contact areas between coil 1702 and the left atrial wall adjacent to the mitral valve, such as at least three contact points in the left atrium or complete contact on the mitral valve annulus. In some examples, the contact points between coil 1702 and the left atrial wall can form a plane generally parallel to the plane of the autologous mitral valve. In some examples, contact between the stabilizing turn 1710 and the atrial wall can be achieved, for example, through an intermediate member of a protective structure.

[0294] As seen in the illustrated example, coil 1702 is similar to Figures 6A-6B The coil 102 is depicted in the diagram; however, the rising portion 110b and the raised stabilizing portion 110a are omitted from the coil 1702. Omitting these portions reduces the amount of material required, eliminates procedural steps, and / or simplifies deployment. Omitting the rising portion 110b and the raised stabilizing portion 110a also allows for additional attachment surfaces along the stabilizing turn 1710 for the protective member, and can increase the stability of the docking device after it is positioned within the anatomical structure.

[0295] In some examples, the central region 1708 may include multiple helical turns (e.g., coil 1702 may have three helical turns in the central region 1708). Some of the helical turns in the central region 1708 may be full turns (i.e., extending 360 degrees). In some examples, the nearest and / or farthest turn may be partial turns (e.g., extending less than 360 degrees, such as 180 degrees, 270 degrees, etc.). In some examples, coil 1702 may have more than three helical turns or fewer than three helical turns in the central region 1708.

[0296] The lumen 1720 of the central region 1708 can be configured to receive and retain a radially expandable prosthetic valve. The dimensions of the coil 1702, and therefore the lumen diameter 1705 of the lumen 1720, can typically be selected based on the desired size of the prosthetic valve to be implanted in the patient. For example, when the prosthetic valve expands radially, the lumen diameter of the coil in the central region 1708 can be configured to be smaller than the outer diameter of the prosthetic valve, such that additional radial forces can act between the central region 1708 and the prosthetic valve to hold the prosthetic valve in place.

[0297] The stabilizing turn 1710 can be configured to help stabilize the coil 1702 in a desired position. In some examples, the radial dimension of the stabilizing turn 1710 can be substantially the same as the radial dimension of the coil in the central region 1708. In some examples, as described below, the diameter of the stabilizing turn 1710 is ideally larger than the autologous valve annulus, autologous valve plane, and / or autologous chamber for better stabilization. In some examples, the stabilizing turn 1710 can be a full turn (i.e., extending 360 degrees). In some examples, the stabilizing turn 1710 can be a partial turn. In some examples, the partial turn can extend from 90 degrees to 360 degrees. In some examples, the partial turn can extend from 180 degrees to 360 degrees.

[0298] In the depicted example, the attachment portion 1712 is located at the proximal end of the stabilizing turn 1710 and is elevable in the axial direction. This attachment portion terminates at the proximal end 1713. The upward flare of the proximal end portion 1712 may define an angle 1714, which forms with the plane defined by the helical turn in the central region 1708. In some examples, the angle 1714 may include an angle greater than 5 degrees but less than 90 degrees. In some examples, the angle 1714 may include an angle greater than 15 degrees but less than 70 degrees. In some examples, the angle 1714 may include an angle greater than 10 degrees but less than 50 degrees. In some examples, the angle 1714 is 45 degrees. The proximal end 1713 extends no more than 12 mm from the stabilizing turn in the axial proximal direction, i.e., the proximal end portion extends no more than 12 mm in the axial direction from the plane orthogonal to the longitudinal axis 1701 defined by the stabilizing turn 1710.

[0299] The attachment portion 1712 may be configured to releasably attach the coil 1702 to a delivery device (e.g., a docking device delivery device 50). The upward flare of the proximal portion 1712 may facilitate attachment of the coil 1702 to the delivery device, for example, by helping to ensure that the attachment portion 1712 is not obstructed (i.e., blocked by a protective member) and by helping to ensure easier access to the attachment portion 1712. In some examples, as described above, the coil 1702 may be attached to the delivery device via a release suture, which may be configured to be tied to the coil 1702 and cut for removal. In one example, the release suture may be tied to the coil 1702 through one or more eyelets or eyelets 1703 located at the attachment portion 1712 of the coil 1702. In some examples, the release suture may be tied around a circumferential recess located adjacent to the attachment portion 1712 of the coil 1702.

[0300] As described above, in some examples, the lead coil 1706 may have a diameter substantially equal to the diameter of the central region 1708. In some examples, the distal portion 1707 of the lead coil 1706 extends radially outward from the remainder of the lead coil 1706. The lead coil 1706 can help to more easily guide the coil 1702 around and / or through the chordae tendineae and / or sufficiently around all the autologous leaflets of the autologous valve (e.g., autologous mitral valve, tricuspid valve, etc.). For example, once the lead coil 1706 is guided around the desired autologous anatomy, the remaining coils of the coil 1702 (such as functional coils) can also be guided around the same feature. In some examples, the lead coil 1706 may be a full coil (i.e., extending circumferentially 360 degrees). In some examples, the lead coil 1706 may be a partial coil. In some examples, a partial coil may extend from 90 degrees to 360 degrees. In some examples, a partial coil may extend from 180 degrees to 360 degrees. In some examples, the distal portion of the lead turn 1706 is configured not to extend radially outward from the remainder of the lead turn 1706. As the prosthetic valve expands radially within the central region 1708 of the coil, the functional turns in the central region 1708 can further expand radially. Therefore, the lead turn 1706 can be pulled in the proximal direction and become part of the functional turns in the central region 1708.

[0301] Figure 18Coil 1702a, which is substantially similar to coil 1702, is depicted. Several differences between coil 1702a and 1702 are described below. Coil 1702a has a stabilizing turn 1710a with a first lumen diameter 1705a, which may be larger than a second lumen diameter 1705b of the coil in the central region 1708, such that the stabilizing turn 1710a can extend radially outward to abut or press against the walls of the circulatory system, thereby improving the ability of coil 1702a to remain in the desired position before implantation of the prosthetic valve. This feature can enhance docking stability (e.g., in larger anatomical structures). In some examples, the first lumen diameter 1705a is 5% to 50% larger than the second lumen diameter 1705b. In some examples, the first lumen diameter 1705a is 10% to 25% larger than the second lumen diameter 1705b. In some examples, the first lumen diameter 1705a can be between 25 mm and 30 mm, and the second lumen diameter 1705b can be between 20 mm and 25 mm. In some examples, the second lumen diameter 1705b can be 22.7 mm, and the first lumen diameter 1705a can be 25 mm. In some examples, the second lumen diameter 1705b can be 22.7 mm, and the first lumen diameter 1705a can be 28 mm.

[0302] In some examples, the docking device may include a coil, such as coil 1702 used with the protective member. In some examples, the protective member may include a braided sleeve as described in International Publication No. WO2022 / 087336, which is incorporated herein by reference in its entirety. Additional examples of the protective member and other components of the docking device are described in International Application No. WO / 2024 / 37038, which is incorporated herein by reference in its entirety. In some examples, the protective member may include any of the protective members described herein. In some examples, the protective member includes a bracket 1900 (see...). Figure 21A The bracket 1900 has two end flaps depicted in Figure 21. In some examples, the protective member may extend along a portion of the stabilizing turn 1710 of the coil 1702.

[0303] Figures 19A-19BA docking device 1700 is depicted, comprising a coil 1702 and a protective member 1804 coupled to a stabilizing turn 1710 of the coil 1702. The protective member 1804 can transition between a radially compressed state and a radially expanded state. The protective member 1804 may include a plurality of arms defining a panel that can expand and compress radially. The protective member may also include end flaps. In the depicted example, the protective member 1804 has a sleeve 1822 having a panel 1840 and two end flaps, namely an inner end flap 1806 and an outer end flap 1808. As shown, the protective member 1804 includes arms for support (e.g., Figure 21A The sleeve 1822 of the arm 1914 of the scaffold 1900 depicted is connected to a cover plate. In some examples, the cover plate is folded over the end of the arm to increase protection of autologous tissue. Furthermore, the inner terminal flap 1806 and the outer terminal flap 1808 each include a flap member connected to the cover plate, wherein the flap member is formed into a flap shape by suturing (e.g., sutures). As depicted, the inner terminal flap 1806 and the outer terminal flap 1808 may overlap circumferentially.

[0304] In some examples, the protective member 1804 is at least partially connected to the outflow side of the stabilizing coil 1710 (e.g., Figures 19A-19B (The lower side depicted in the image). In some examples, the protective member 1804 is coupled to the outflow side of the stabilizing coil 1710, the coupling extending circumferentially by 180 to 330 degrees. In some examples, the protective member 1804 is coupled to the outflow side of the stabilizing coil 1710, the coupling extending circumferentially by 225 to 315 degrees. In some examples, the protective member 1804 is coupled to the outflow side of the stabilizing coil, the coupling extending approximately 270 degrees circumferentially.

[0305] In some examples, coil 1702 may include... Figures 6C-6D The depicted cross-sectional profile is similar. The protective member 1804 can be securely attached to the retaining member 114 and / or the inner cover 112, for example, via stitches, adhesives, and / or any other suitable means for attachment. In the depicted example, the protective member 1804 is connected to the stabilizing turn 1710 via multiple stitches of stitch 1848. In some examples, the protective member can be connected to the stabilizing turn by other means such as threads, nails, tape, etc.

[0306] Attaching the protective member 1804 to the outflow side of the stabilizing ring 1710 means it can rest on top of the autologous leaflet, rather than on top of the stabilizing ring 1710 in its final implantation position. This improves the function of the protective member and its ability to seal against PVL. It also helps reduce the risk of tissue damage, such as from sutures that come into contact with the autologous leaflet. When the protective member 1804 is attached to the underside of the stabilizing ring, the suture stitches do not come into contact with the autologous leaflet or any of the patient's anatomical structures. Positioning at least a portion of the stabilizing ring on top of the protective member also allows for easier access to the proximal tip 1713 and attachment portion 1712 of the stabilizing ring 1710 of the delivery device.

[0307] In some examples, a portion of the protective member may wrap around the stabilizing turn 1710 and extend proximally to the stabilizing coil. In some examples, the support of the protective member may include one or more features that help the protective member wrap around the stabilizing turn 1710, some of which are depicted in Figure 21. In some examples, said portion of the protective member wraps around the stabilizing turn 1710 and extends circumferentially 30 to 135 degrees proximally. In the depicted example, the protective member 1804 axially passes through the stabilizing turn 1710 near the inner end flap 1806, and the inner flap 1808 extends proximally along the stabilizing turn 1710. In some examples, this helps ensure that the inner end flap 1806 of the protective member remains positioned above the mating core. The inner end flap 1806 of the protective member may wrap around the adjacent portion of the stabilizing turn 1710 from the outflow side to the inflow side and is secured to the top of the stabilizing turn 1710 with sutures. This means that the function of the inner end flap 1806 will not change as a part of the protective member 1804 is attached to the outflow side of the stabilizing turn 1710.

[0308] Figures 20A-20B The coil 1702, protective member 1804, and prosthetic valve frame 1862 (the prosthetic valve can be any prosthetic valve discussed herein, such as prosthetic heart valve 62) are depicted mounted in the docking device. For illustrative purposes, Figures 20A-20B Valve structures (e.g., leaflets) are omitted. The prosthetic valve frame can be configured to initially be inserted into the lumen 1720 of the docking device 1700 in a radially compressed state (e.g., delivery orientation) and then expand to a radially expanded state. The central region 1708 can be configured to receive and retain the radially expanded prosthetic valve. The dimensions of the coil 1702, and therefore the lumen 1720, can typically be selected based on the desired size of the prosthetic valve to be implanted in the patient. Figures 20A-20BAs depicted, when the prosthetic valve expands radially, the lumen diameter of the helical turns in the central region 1708 can be configured to be smaller than the outer diameter of the prosthetic valve frame 1862, and the functional turns in the central region 1708 can expand radially. This allows radial forces to act between the central region 1708 and the prosthetic valve to hold the prosthetic valve frame 1862 in place. Figures 20A-20B As can be seen, when the prosthetic valve frame 1862 expands within the docking device 1700, the coil expands outward, causing the end flaps 1806 and 1808 of the protective member 1804 to no longer overlap circumferentially.

[0309] Figure 21A An example of a stent 1900 is shown, which includes a ridge 1910, a plurality of arms 1914, and two end flaps, namely an inner end flap 1906 and an outer end flap 1908. In the depicted example, the plurality of arms 1914 comprises seven arms 1914. In some examples, the inner end flap 1906 may also include radially extending partial arms 1915. The stent 1900 is depicted as generally flat and / or planar. For example, as depicted, the ridge 1910, arms 1914, and flaps 1906, 1908 all define a plane, or lie in a plane, and generally do not extend outside said plane. In some examples, the stent 1900 may have some or all of the features described above with respect to other stents such as stent 120 described herein. However, the stent 1900 does not need to include all the components described above for any other stent.

[0310] In some examples, the support may not be completely flat or planar. In some examples, the support shape is configured to bring the support to its final form. In some examples, the ridge 1910 and arm 1914 may define a plane, and at least one region, such as a portion of one or more of the terminal lobes 1906, 1908, may extend out of the plane defined by the ridge 1910 and arm 1914. In some examples, the support 1900 may have an outwardly flared bend 1920 adjacent to the inner lobe 1906. The outwardly flared bend 1920 may have the advantage of more easily wrapping around the ridge 1910 from the outflow side (depicted bottom) to the inflow side (depicted top) of the stabilizing turn 1710. In some examples, the outwardly flared bend 1920 may be positioned at location 1820, where the protective member 1804 transitions from the outflow side of the stabilizing turn 1710 to the top inflow side of the stabilizing turn 1710. In some examples, the outwardly flared bend 1920 may be configured in an inclined shape such that the first side 1922 of the outwardly flared bend 1920 is lower so that it can be attached to the bottom of the stabilizing turn 1710, and the second side 1924 is higher so that it can rest on the top of the stabilizing turn 1710.

[0311] The bracket 1900 can be fitted with a cover plate to form a protective component, the cover plate being... Figure 21A Not shown in the diagram, but as described and shown elsewhere in this document. The cover plate can be sized or adjusted for mounting on the bracket. The protective member including bracket 1900 may have one or more of the advantages and features described and shown elsewhere in this document.

[0312] Figure 21B-21E An example of a stent 1900a is depicted, which may be similar to stent 1900 except for the differences described below. For example, stent 1900a may include a ridge 1910, a plurality of arms 1914, and two end flaps, namely an inner end flap 1906 and an outer end flap 1908. In the depicted example, the plurality of arms includes six arms. The inner end flap 1906 may also include radially extending portion arms 1915. In some examples, stent 1900a may have some or all of the features described above with respect to other stents such as stent 1900 described herein. For example, although not shown, stent 1900a may include an flared bend portion similar to the flared bend portion 1920 of stent 1900. However, stent 1900 does not need to include all the components described above with respect to any other stent.

[0313] The stent 1900a may include one or more retaining elements that can engage with cardiac tissue to help ensure device stability before valve deployment and implant anchoring. In the depicted example, the retaining element includes a serration 1916 that can be coupled to the plurality of arms 1914 and / or the medial terminal flap 1906. The serration 1916 may extend from a base portion 1916b coupled to the arm 1914 or the medial terminal flap, wherein the base portion 1916b has a first width 1922. The serration 1916 may terminate at a tip portion 1916t, which is free and has a second width 1924. In some examples, the first width 1922 is greater than the second width 1924, such that each serration 1916 gradually narrows. In some examples, the serration 1916 gradually narrows to a point. In some examples, the retaining element may be sharp or blunt to make a balance that effectively maintains implant stability without causing anatomical trauma. The tooth 1916 can define the length 1926. The retaining feature can vary in length, width (a consistent width or a width that gradually narrows along the length), thickness, and tip shape (e.g., pointed, rounded, flat, etc.). In some examples, the retaining element is constructed of nitinol. In some examples, the retaining element is integrally constructed of the same nitinol sheet as the rest of the support 1900a.

[0314] The stent 1900a is depicted as generally flat and / or planar. For example, as depicted, the ridge 1910, arm 1914, and lobes 1906, 1908 all define a plane, or lie in a plane, and generally do not extend beyond the plane defined by the stent. In some examples, the stent may not be completely flat or planar. In some examples, such as Figure 21D As depicted in -E, the pointed tooth 1916 can extend out of the plane of the support 1900a. Figure 21D In the middle, the pointed tooth 1916 extends at a first angle 1928 relative to the plane defined by the support. In some examples, such as Figure 21D As depicted, the first angle 1928 can include relatively small angles. In some examples, the first angle 1928 can be in the range of 0 to 90 degrees, 0 to 45 degrees, 5 to 45 degrees, and / or 10 to 30 degrees. In some examples, the first angle 1928 is 10 degrees. Figure 21E In this configuration, the canine 1916 extends relative to the plane defined by the support at a second angle 1930. In some examples, the second angle 1930 may include a relatively large angle. In some examples, the second angle 1930 may be in the range of 45 to 180 degrees, 45 to 135 degrees, and / or 60 to 90 degrees. In some examples, the second angle 1930 is 90 degrees. The angle between the canine 1916 and the plane defined by the support can determine how much trauma these features will cause and how effective they are in maintaining stability.

[0315] The bracket 1900a can be fitted with a cover plate, which in Figure 21C Not shown in the figure, but as described and shown elsewhere in this document. The cover plate can be sized or adapted to fit onto the support, thereby forming a protective member having one or more of the advantages and features described and shown elsewhere in this document. In some examples, the fangs 1916 can extend through the cover plate, such that the fangs 1916 directly engage with autologous tissue.

[0316] When the prosthetic implant is deployed within the docking device, including the stent 1900a, portions of the docking device and / or protective member can rotate. In some examples, when the prosthetic implant is deployed within the docking device, the docking device and / or protective member can rotate relative to the patient's own anatomy (e.g., rotate counterclockwise by up to 90 degrees). Therefore, during prosthetic implant deployment, the retaining element can move relative to the patient's anatomy. The retaining element can be oriented to prevent engagement with the patient's own tissue during rotation of the docking device. In some examples, the retaining element can be oriented clockwise to avoid injury during counterclockwise rotation of the docking device. In some examples, the docking device and / or protective member can rotate clockwise during valve deployment within the docking device, and the retaining element can be oriented counterclockwise.

[0317] As mentioned above Figures 7A-7D The protective member described herein can transition between a radially compressed state (e.g., delivery orientation) and a radially expanded state (e.g., deployment orientation). For example, Figure 7A The protective member 204 is shown in a radially expanded state. Figure 7B The partially collapsed protective component 204 is shown. Figure 7C The protective member 204 is shown in a radially compressed state. Figure 7D A protective member in a radially compressed state is shown, located within a docking sleeve, in a fully collapsed delivery orientation. Any protective member described herein, such as a protective member including support 1900 and / or a protective member including support 1900a, can similarly transition between a radially compressed (e.g., delivery orientation) and a radially expanded state (e.g., deployment orientation).

[0318] Go to Figure 22-28 In some examples, at least a portion of the coil used for the docking device may include a cover (such as a cap) that at least partially surrounds the core. Figures 6C-6D (See Cover 112). Covers can, for example, prevent or reduce trauma to autologous tissue and / or prevent or reduce damage to the delivery device, reduce friction with autologous tissue, increase friction with autologous tissue and / or prosthetic heart valves, etc. In some examples, 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 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. In some examples, multiple covers with different outer diameters may be used to cover different portions of the coil. Additional information regarding covers is provided below and can be found in International Publication WO 2022 / 087336.

[0319] In some examples, it is desirable for the coil diameter to vary along the length of the coil. In some examples, there are two different coil diameters, each extending along one or more portions of the coil length. In some examples, by reducing the diameter of a portion of the coil, the docking device with the protective member can be configured to have a lower profile when in a delivery orientation. In some examples, the coil may have a reduced diameter that extends at least in the portion of the coil adjacent to the location where it is attached to the protective member. A reduced diameter can produce a lower profile by providing more space for the protective member when in a delivery orientation of radial compression. In some examples, the cover can reduce the coil profile (e.g., by including a reduced diameter in some portions of the coil).

[0320] Cover diameters that vary along the length of the coil can be provided in several ways. In some examples, multiple individual covers, each with a different diameter, can be attached to the core to create a smaller outer diameter in some sections of the coil while maintaining a larger outer diameter in other sections.

[0321] In some examples, two covers are used such that they partially overlap each other, which helps ensure a smooth transition between the two individual covers. In some examples, at least one cover with a smaller outer diameter can be used with at least one other cover with a larger outer diameter. In some examples, the cover with the smaller outer diameter can be radially flared out at the joint of the two covers, such that the cover with the smaller outer diameter overlaps axially with the cover with the larger diameter. This is discussed in detail below.

[0322] In some examples, a single cover can be attached to provide a larger outer diameter along some segments of the coil and a smaller outer diameter in other segments. In some examples, a single cover can be used on the coil, and the cover can be compressed in certain sections to reduce the outer diameter. In some examples, a single cover is used on the coil, and the cover can be pulled down in certain sections to reduce the outer diameter. In some examples, two or more covers are used such that they overlap each other, with at least one cover having a smaller outer diameter and covering substantially the entire coil, and at least one other cover having a larger outer diameter and being arranged radially outward, and axially overlapping the cover with the smaller outer diameter.

[0323] Figure 22 The diagram depicts a coil 2002 in an unfolded configuration, which may have features similar to those discussed elsewhere herein, including, for example, a leading turn 2006 (or “leading coil”), a central region 2008 (also referred to as the “second coil region”), and a stabilizing turn 2010 (also referred to as the “stabilizing coil” or “first coil region”) surrounding a longitudinal axis 2001 extending through the central lumen of the coil. However, coil 2002 need not include all the components described above for any other coil. In some examples, coil 2002 may omit the rising portion 2010b and the raised stabilizing portion 2010a; in other words, coil 2002 may have features similar to coil 1702.

[0324] As depicted, coil 2002 may include covers of different outer diameters for covering different segments of coil 2002. These different outer diameters are created by variations in cover diameter or transition regions along the length of coil 2002. In the depicted example, coil 2002 includes two transition regions. These are shown as a first transition region 2030 at the proximal tip portion of the coil and a second transition region 2032 between the central region 2008 and the atrial stabilizing turn 2010. In the depicted example, there are three segments: a first segment 2034 including a cover with a first cover diameter, a second segment 2036 including a cover with a second cover diameter, and a third segment 2038 including a cover with a third cover diameter. In some examples, there may be more or fewer transition regions and more or fewer segments with different cover diameters. In some examples, coil 2002 includes a larger diameter cover in the distal ventricular portion of the mating member and a smaller diameter cover for the proximal atrial portion of the mating member.

[0325] Different segments with varying coverage diameters can offer several advantages. In some examples, the first segment 2034 extends along at least a portion of the proximal tip of the coil 2002 and includes a larger diameter. Having a larger outer diameter at the proximal tip of the coil to maintain implant release effectiveness may offer one or more advantages. In some examples, the larger outer diameter at the proximal tip of the coil can be used for the delivery device release mechanism and for interaction with a catheter system, such as a docking device delivery device 50.

[0326] In some examples, the second segment 2036 extends along at least a portion of the stabilizing turn 2010 of the coil 2002 and includes a cover with a smaller diameter. The smaller diameter of the cover on the stabilizing turn 2010, which is coupled to the protective member, provides more space for the protective member when it is in a radially compressed delivery orientation, thus having the advantage of a reduced profile in the delivery orientation. In other words, the reduced size in the second segment 2036 provides space for the arms and panels of the protective member to fold upwards, making it easier to insert and remove from the delivery device. A description of the delivery orientation of the protective member and the transition between a radially compressed state (e.g., delivery orientation) and a radially expanded state (e.g., unfolding orientation) is provided in [reference needed]. Figures 7A-7D And related instructions.

[0327] In some examples, the third segment 2038 extends along the central region 2008 of the coil 2002 and includes a larger diameter cover. This larger diameter cover, which surrounds the functional turns of the coil 2002 around the mitral valve leaflets, helps to support the prosthetic implant anchoring and holding it within the anatomical structure.

[0328] In some examples, the first segment 2034 and the third segment 2038 may have a diameter ranging from 1.4 mm to 2.5 mm, 1.5 mm to 2.2 mm, 1.6 mm to 2.1 mm, or 1.8 mm to 2.0 mm, or 1.9 mm. In some examples, the second segment 2036 may have a diameter ranging from 1.1 mm to 1.6 mm, 1.2 mm to 1.5 mm, or 1.3 mm to 1.4 mm. This configuration allows for integration into delivery devices while requiring less force to deploy the protective member, thus enabling easier installation.

[0329] Figure 22 A first transition region 2030 between the first segment 2034 and the second segment 2036, and a second transition region 2032 between the second segment 2036 and the third segment 2038 are also shown. The first transition region 2030 and / or the second transition region 2032 may include connecting members or connecting adhesives for attaching the cover of the first segment 2034 to the cover of the second segment 2036 and / or attaching the cover of the second segment 2036 to the cover of the third segment 2038. The connecting member may also include a stitching material for sewing the different segments of the cover together. In some examples, the connecting member may include a crimped portion of a metal tube (e.g., a radiopaque marking tape). In some examples, the first transition region 2030 and / or the second transition region 2032 may include any of the other connecting methods described herein.

[0330] Figure 23 The diagram depicts a coil 2102 in an unfolded configuration, which may have features similar to those of coils discussed elsewhere herein. In some examples, coil 2102 shares features with coil 2002. In some examples, coil 2102 described below is identical to coil 2002, except for the differences described below. However, the coil described below need not include all of the aforementioned components. In some examples, coil 2102 includes a leading turn 2106 (or “leading coil”), a central region 2108 (also referred to as the “second coil region”), and a stabilizing turn 2110 (also referred to as the “stabilizing coil” or “first coil region”) around a longitudinal axis 2101 extending through a central lumen of coil 2102. In some examples, the rising portion 2110b and the raised stabilizing portion 2110a may be omitted from coil 2102; in other words, coil 2102 may have features similar to those of coil 1702.

[0331] Coil 2102 may include one or more covers of different diameters, which may extend over one or more segments of coil 2102. In the depicted example, coil 2102 includes a transition region shown as a transition region 2132 located between a coil segment having a first diameter and a coil segment having a second diameter. In the depicted example, there are two segments with covers of different diameters: a first segment 2136 including a cover with a first cover diameter and a second segment 2138 including a cover with a second cover diameter.

[0332] In some examples, the first segment 2136 extends along at least a portion of the stabilizing turn 2110 of the coil 2102 and includes a cover with a smaller diameter. The smaller diameter of the cover on the stabilizing turn 2110, which is coupled to the protective member, provides more space for the protective member when it is in a radially compressed delivery orientation, thus having the advantage of a reduced profile in the delivery orientation. In other words, the reduced size in the first segment 2136 provides space for the arms and panels of the protective member to fold upwards, making it easier to insert and remove from the delivery device. A description of the delivery orientation of the protective member and the transition between a radially compressed state (e.g., delivery orientation) and a radially expanded state (e.g., unfolding orientation) is provided in [reference needed]. Figures 7A-7D And related instructions.

[0333] In some examples, the second segment 2138 extends along at least a portion of the central region 2108 of the coil 2102 and includes a larger diameter cover. This larger diameter cover, which surrounds the functional turns of the central region 2108 where the mitral valve leaflets are located, helps to support valve anchoring and retain the implant within the anatomical structure.

[0334] Figure 23 A transition region 2132 between the first segment 2136 and the second segment 2138 is also shown. This transition region 2132 may include a connecting member or adhesive for joining the first segment 2136 to the second segment 2138. The connecting member may also include a suture material for sewing the first segment 2136 and the second segment 2138 together. In some examples, the connecting member may include a crimped portion of a metal tube (e.g., a radiopaque marking tape). In some examples, the first segment 2136 and the second segment 2138 may be joined by any other method described herein.

[0335] Figures 24A-24BThe diagram depicts segments and cross-sections of coils, such as any of the coils described above. The coil may include a core 2202a, which may be surrounded by a cover 2212 (which may also be referred to as an "inner cover"). Here, the core 2202a of the coil is a structural part of the coil. The cover 2212 may have a tubular shape and may be configured to extend over the core 2202a. In some examples, the cover 2212 may cover the entire length of the core 2202a of the coil. In some examples, the cover 2212 covers only selected portions of the core 2202a of the coil. In some examples, different segments of the cover 2212 may include different diameters. The outer diameter of the coil may be based on the cover 2212 on the core 2202a. In some examples, the cover 2212 may include one or more cover segments 2212a having a first diameter A. In some examples, the cover may include one or more cover segments 2212b having a second diameter B. In some examples, the diameter of core 2202a is constant along the length of the coil, defining the coil diameter C. In some examples, the diameter and / or shape of the coil core may vary along the length of the coil. In some examples, the diameters of both core 2202a and cover 2212 may vary along different sections of the coil.

[0336] Figure 25 A-25B depicts a docking device 2300 including a coil 2302 with a protective member 2304 attached. In some examples, the coil 2302 may have some or all of the features described above with respect to other coils such as coil 2002 or coil 2102 described herein. In some examples, the protective member 2304 may have some or all of the features described above with respect to other protective members described herein; for example, the protective member 2304 may include a bracket 1900 or bracket 1900a.

[0337] The coil 2302 includes different diameters along its length due to variations in the cover diameter or transition regions. In the depicted example, the coil 2302 includes two transition regions. These are shown as a first transition region 2330 at the proximal tip portion of the coil and a second transition region 2332 between the central region 2308 and the atrial stabilizing turn 2310. In the depicted example, there are three segments: a first segment 2334 including a cover with a first cover diameter, a second segment 2336 including a cover with a second cover diameter, and a third segment 2338 including a cover with a third cover diameter. In some examples, there may be more or fewer transition regions and more or fewer segments with different cover diameters. In some examples, the coil 2302 includes a larger diameter cover in the distal ventricular portion of the docking member and a smaller diameter cover for the proximal atrial portion of the docking member.

[0338] As depicted, the first segment 2334 extends along at least a portion of the proximal tip portion of the coil 2302 and includes a larger diameter, which can be used for the implant release mechanism and interaction with the catheter system. As depicted, the second segment 2336 extends along at least a portion of the stabilizing turn 2310 of the coil 2302 and includes a cover with a smaller diameter. The cover on the stabilizing turn 2310, which is coupled to the protective member 2304, has a smaller diameter, which can provide more space for the protective member when the protective member 2304 is in a radially compressed delivery orientation, thus having the advantage of a reduced profile when in the delivery orientation. In other words, the reduced size in the second segment 2036 provides space for the arms 2322 and the panel 2344 of the protective member 2304 to fold upward, thus making it easier to insert and remove from the delivery device. As depicted, the third segment 2338 extends along at least a portion of the central region 2308 of the coil 2302 and includes a cover with a larger diameter, which helps to support valve anchoring and retain the implant within the anatomical structure.

[0339] Figure 26 A portion of a cover assembly 2402 for a coil is depicted, including a transition region 2430 between a first diameter cover 2434 and a second diameter cover 2436. In the depicted example, the first diameter cover 2434 has a larger diameter than the second diameter cover 2436. The transition region 2430 includes the first diameter cover 2434 overlapping the second diameter cover 2436 on top. This can be achieved, for example, by radially flaring the second diameter cover 2436 so that it can axially overlap the first diameter cover 2434, and then fitting the first diameter cover 2434 within the second diameter cover 2436. The two covers are then secured using a connecting member 2440, a connecting adhesive, and / or any other means for joining the smaller diameter region to the larger diameter region. The connecting member may also include suture material for stitching the larger diameter region and the smaller diameter region together. In some examples, the smaller diameter region and the larger diameter region are joined together using a lasso stitch technique. In some examples, the smaller diameter region and the larger diameter region are joined together using a stitch wrap technique. This stitching wrapping technique minimizes penetration of the covering material. This radial wrapping technique can, for example, reduce or eliminate tearing of the covering material at transition areas.

[0340] Figure 27A coil 2502 is depicted, which may include individual covers 2512 with different diameters along different segments of the coil. As depicted, one or more transition regions may exist between the segments of the cover 2512 with different diameters. In some examples, the covers include larger outer diameter covers along some segments of the coil and smaller outer diameter covers in other segments of the coil, wherein shoulders are present at the transition regions between the different diameters. In the depicted example, the coil 2502 includes a first transition region 2530 between a first diameter cover 2534 and a second diameter cover 2536, and a second transition region 2532 between the second diameter cover 2536 and a third diameter cover 2538. In the depicted example, transition regions 2530, 2532 include relatively abrupt diameter changes between the first diameter cover 2534 and the second diameter cover 2536, and between the second diameter cover 2536 and the third diameter cover 2538. In some examples, transition regions 2530, 2532 may include more gradual diameter changes.

[0341] In some examples, the cover 2512 can be compressed at the desired location to provide a smaller diameter. In some examples, the cover is an ePTFE tube, and compression increases the density and stiffness in the compressed region. In some examples, starting with a cover with a lower density (before compression) allows compression to continue. It is important to note that ePTFE density is closely related to the material's durability and tissue inward growth properties (e.g., high density can improve durability, while low density can improve cell adhesion and inward growth).

[0342] Figure 28 A coil 2602 is depicted, which may include individual covers 2612 with different diameters along different segments of the coil 2602. As depicted, one or more transition regions may exist between the segments of the cover 2612 with different diameters. In some examples, the covers include a larger outer diameter cover along a segment of the coil and a smaller outer diameter cover in other segments of the coil, wherein there is a gradual transition region between the different diameters. In the depicted example, the coil 2602 includes a first transition region 2630 between a first diameter cover 2634 and a second diameter cover 2636, and a second transition region 2632 between the second diameter cover 2636 and a third diameter cover 2638. In the depicted example, the transition regions 2630, 2632 are inclined.

[0343] In some examples, the cover 2612 can be pulled down at the desired location to provide a smaller cover diameter. In some examples, the cover is an ePTFE tube, and pulling down the cover may reduce density and stiffness in this region. In some examples, starting with a cover of higher density (before pulling down) allows compression to continue. It is important to note that ePTFE density is closely related to the material's durability and tissue inward growth properties (e.g., high density can improve durability, while low density can improve cell adhesion and inward growth).

[0344] As mentioned above, it may be desirable for the coil diameter to vary along the length of the coil. Coils with different diameters described herein can have the advantage that by reducing the diameter of a portion of the coil while maintaining a larger diameter overlay on the functional turns around the mitral valve leaflets, the profile in delivery orientation can be reduced, thereby aiding in supporting the prosthetic implant anchorage and retention within the anatomical structure. In some examples, the larger outer diameter of the coil at its proximal tip can be used for the delivery device release mechanism and interaction with the catheter system.

[0345] sterilization

[0346] 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.

[0347] Implantation

[0348] Figure 12 The diagram shows the docking device 100 implanted into the mitral valve 16, with the protective member 104 on the left atrial side, wherein the proximal coil region 102p extends into the left atrium 18. As shown, the arm 122 extends in deployment orientation such that the panel 140 covers the mitral valve anatomy, which prevents PVL.

[0349] Figure 13 The diagram shows the docking device 100 implanted in the mitral valve 16, such that the protective member 104 is on the left atrial side, with the proximal coil region 102p extending into the left atrium 18. Figure 12 compared to, Figure 13The mitral valve anatomy is smaller in the figure. As shown, arm 122 extends in the unfolding orientation, causing a proximal fold in panel 140, which has a protrusion 1304 and a gap 1302. However, it is found that panel 140 still provides sufficient protection and blocking, allowing the protective member to prevent PVL. However, Figure 13 It was also shown that reducing the arm length could be useful for constructing a protective member for smaller mitral valve anatomy. This could allow for customized sizes to suit human patients of different age or height groups. In some respects, the arm can still extend fully, but the protective member can extend upwards along the atrial wall instead of extending straight out from the valve. This design allows the protective member to be deployed higher above the valve, allowing the arm to fully expand, and then the docking device to be lowered onto the leaflet, allowing the protective member to move upwards along the atrial wall.

[0350] The treatment techniques, methods, procedures, etc. described or suggested herein or cited in this document may be performed on live animals or on non-living simulants, such as on cadavers, cadaver hearts, anthropomorphic dummy targets, simulants (e.g., those with simulated body parts, tissues, etc.).

[0351] Other examples of the disclosed technology

[0352] 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.

[0353] Example 1. A docking device for securing a prosthetic valve to an autologous valve, the docking device comprising: a coil including a plurality of helical turns in an unfolded orientation; and a protective member attached to the coil by at least a portion of the helical turns coupled to the coil, wherein the protective member includes a support having a ridge and a plurality of arms extending from the ridge, wherein the plurality of arms are coupled to a cover plate, wherein the protective member is convertible between a radially compressed state in a delivery orientation and a radially expanded state in the unfolded orientation.

[0354] Example 2. The docking device according to Example 1, wherein when the protective member is in the radial compression state, the plurality of arms and the cover plate abut against the coil in the delivery orientation under radial compression, such that the cross-sectional profile of the docking device includes a diameter smaller than a predefined threshold diameter.

[0355] Example 3. The docking device according to Example 2, wherein the predefined threshold diameter is in the range of about 2 mm to about 3 mm.

[0356] Example 4. A docking device according to any one of Examples 1 to 3, wherein when the protective member changes from the radially compressed state in the delivery orientation to the radially expanded state in the unfolding orientation, the arm rotates outward and the cover plate extends such that the protective member extends radially outward relative to the coil.

[0357] Example 5. A docking device according to any one of Examples 1 to 4, wherein when the protective member is in the radially expanded state in the deployment orientation, the plurality of arms and cover plates extend radially outward away from the coil and circumferentially along a portion of the coil.

[0358] Example 6. The docking device according to Example 5, wherein the cover plate defines an inner edge connected to the coil, wherein the inner edge of the cover plate has an arc angle greater than 180 degrees.

[0359] Example 7. The docking device according to Example 6, wherein the arc angle is in the range of about 240 degrees to about 360 degrees.

[0360] Example 8. A docking device according to any one of Examples 1 to 7, wherein the number of arms is three to eight.

[0361] Example 9. The docking device according to Example 8, wherein the number of arms is four to six.

[0362] Example 10. A docking device according to any one of Examples 1 to 9, wherein the arms of the plurality of arms have substantially the same length.

[0363] Example 11. A docking device according to any one of Examples 1 to 9, wherein the protective member comprises at least one arm, forming at least one flap by connecting the two ends of the respective at least one arm to the ridge.

[0364] Example 12. The docking device according to Example 11, wherein the at least one lobe includes an end lobe at the end position of the ridge.

[0365] Example 13. The docking device according to Example 12, wherein the end position is the tail position of the ridge, and wherein the curved portions of the plurality of arms are oriented toward the tail position.

[0366] Example 14. A docking device according to any one of Examples 1 to 13, wherein for each arm, when the protective member is in the radially expanded state in the deployment orientation, the base portion of the respective arm is attached to the ridge, and the head portion extends radially outward from the ridge relative to the base portion.

[0367] Example 15. A docking device according to any one of Examples 1 to 14, wherein when the protective member is in the radially expanded state in the deployment orientation, each arm extends relative to the ridge at an angle, wherein the angle is less than or about 80 degrees, less than or about 70 degrees, less than or about 60 degrees, less than or about 50 degrees, less than or about 40 degrees, or less than or about 30 degrees.

[0368] Example 16. The docking device according to Embodiment 15, wherein when the protective member is in the radially expanded state in the deployment orientation, each of the plurality of arms extends relative to the ridge at the angle, wherein the angle of each arm differs from each other by no more than about 10 degrees.

[0369] Example 17. The docking device according to Example 1, wherein when the protective member is in the radially expanded state in the deployment orientation, the cover plate extends from the coil with a radial expansion dimension of about 4 mm to about 30 mm, about 6 mm to about 25 mm, or about 10.5 mm.

[0370] Example 18. A docking device according to any one of Examples 1 to 17, wherein each of the plurality of arms has a length from the ridge to the tip of about 4 mm to about 30 mm, about 8 mm to about 25 mm, or about 10.5 mm.

[0371] Example 19. A docking device according to any one of Examples 1 to 18, wherein when the protective member is in the radially expanded state in the deployment orientation, the one or more arms are spaced apart by substantially equal distances on the ridge, wherein the gap between the arms defines the panel of the cover plate.

[0372] Example 20. A docking device according to any one of Examples 1 to 19, wherein the protective member is connected to the coil via one or more stitches.

[0373] Example 21. A docking device according to any one of Examples 1 to 20, wherein the protective member is sewn to the cover member of the coil via the one or more stitches.

[0374] Example 22. A docking device according to any one of Examples 1 to 21, wherein when the protective member is sewn to the retaining member of the coil, the coil includes a coil core, a tubular covering member above the coil core, and the retaining member serving as a tube above the tubular covering member.

[0375] Example 23. A docking device according to any one of Examples 1 to 22, wherein each arm is within a sleeve, wherein the sleeve is coupled to the cover plate or formed by a sleeve piece sewn to the cover plate to form the sleeve.

[0376] Example 24. A docking device according to any one of Examples 1 to 22, wherein each arm is stitched to the cover plate along a circumferential stitch.

[0377] Example 25. A docking device according to any one of Examples 1 to 23, wherein the cover plate is stitched to the ridge.

[0378] Example 26. A docking device according to any one of Examples 1 to 25, wherein when the protective member is in the deployment orientation at the autologous valve, one or more proximal arms cover or press against a first portion of the autologous heart cavity, and one or more distal arms cover or press against a second portion of the autologous heart cavity substantially opposite the first portion.

[0379] Example 27. The docking device according to Example 26, wherein the autologous valve is a mitral valve, wherein the first portion includes the anterior or posterior leaflet of the mitral valve, and when the first portion includes the anterior leaflet, the second portion includes the posterior leaflet of the mitral valve, and when the first portion includes the posterior leaflet, the second portion includes the anterior leaflet of the mitral valve.

[0380] Example 28. A docking device according to any one of Examples 1 to 27, wherein when the protective member is in the deployment orientation at the mitral valve, the cover plate covers or presses against the posterior leaflet or its left atrial region.

[0381] Example 29. A docking device according to any one of Examples 1 to 27, wherein when the protective member is in the deployment orientation at the mitral valve, the cover plate covers or presses against the anterior leaflet or its left atrial region.

[0382] Example 30. A docking device according to any one of Examples 1 to 27, wherein when the protective member is in the deployment orientation at the mitral valve, the cover plate covers or presses against the anterior and posterior leaflets or their left atrial region.

[0383] Example 31. The docking device according to any one of Examples 1 to 30, wherein the support comprises a shape memory material.

[0384] Example 32. The docking device according to Example 31, wherein the shape memory material comprises a nickel-titanium alloy.

[0385] Example 33. The docking device according to any one of Examples 1 to 32, wherein the cover plate includes at least one layer of biocompatible material coupled to the support.

[0386] Example 34. The docking device according to Example 33, wherein the biomaterial is flexible so as to be able to fold in the delivery orientation and expand in the unfolding orientation.

[0387] Example 35. A docking device according to any one of Examples 33 to 34, wherein the biomaterial is porous and configured for inward cell growth.

[0388] Example 36. A docking device according to any one of Examples 1 to 35, wherein each arm has a head at an end opposite the ridge, wherein each head comprises a circular shape.

[0389] Example 37. The docking device according to Example 36, wherein each head includes a teardrop shape with a rounded distal end.

[0390] Example 38. A docking device according to any one of Examples 1 to 37, wherein each arm includes a bend such that each arm bends clockwise or counterclockwise.

[0391] Example 39. The docking device according to Example 38, wherein the bend causes the distal region of the arm to be substantially parallel to the ridge, wherein the distal region of each arm forms an angle of less than or approximately 10 degrees relative to the ridge.

[0392] Example 40. The docking device according to any one of Examples 36 to 39, wherein each head of each arm is held within a sleeve connected to the cover plate of the protective member.

[0393] Example 41. A docking device according to any one of Examples 1 to 40, wherein the cover is formed from at least one sheet of fabric formed by weaving, knitting, crocheting, or joining fibers together, wherein the fibers are biocompatible. Additional examples include weaving, lamination (e.g., for polymer covers), electrospinning (ePTFE, etc.), and extrusion (ePTFE), as well as other related methods.

[0394] Example 42. The docking device according to any one of Examples 1 to 40, wherein the cover is formed of at least one sheet of polymeric material in the form of a membrane, film, plastic sheet or foil, wherein the sheet material is biocompatible.

[0395] Example 43. The docking device according to Example 42, wherein the sheet material is expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), thermoplastic polyurethane, or silicone.

[0396] Example 44. A docking device according to any one of Examples 1 to 43, wherein the cover plate includes a peripheral lip configured to be coupled to an edge protector of the cover plate, wherein the edge protector covers the distal region of the arm from the top surface to the bottom surface of the cover plate.

[0397] Example 45. The docking device according to Example 44, wherein the edge protector is formed of fabric or polymer sheet.

[0398] Example 46. The docking device according to any one of Examples 1 to 45, wherein the support comprises a uniform thickness in the range of about 0.10 mm to about 0.5 mm.

[0399] Example 47. The docking device according to Example 46, wherein each arm has a width in the range of about 0.10 mm to about 0.30 mm, wherein the width is orthogonal to the thickness.

[0400] Example 48. The docking device according to any one of Examples 46 to 47, wherein each arm has a length in the range of about 10 mm to about 60 mm.

[0401] Example 49. A docking device according to any one of Examples 1 to 48, wherein the cover plate has a size in the range of about 30 mm to about 70 mm, about 40 mm to about 60 mm, or about 45 mm to about 55 mm from the coil.

[0402] Example 50. A docking device according to any one of Examples 1 to 49, wherein the cover plate has a dimension from the coil to the edge boundary in the range of about 4 mm to about 30 mm, about 6 mm to about 20 mm, or about 8 mm to about 10 mm, or about 10.5 mm.

[0403] Example 51. The docking device according to any of the preceding examples, wherein the edge protector on the outer edge of the protective member is made of the same material as the cover plate folded over the head of the arm.

[0404] Example 52. The docking device according to any one of the preceding examples, wherein the base portion of each arm has a width of about 0.1 mm, and the region of each arm adjacent to the head portion has a width of about 0.25 mm.

[0405] Example 53. The docking device according to any one of Examples 1 to 52, wherein the protective member includes a marking strip.

[0406] Example 54. The docking device according to Example 53, wherein the marking strip is pressed onto the protective device.

[0407] Example 55. The docking device according to Example 53, wherein the marking tape is pressed onto the protective device and the coil.

[0408] Example 56. The docking device according to any one of Examples 1 to 55, the docking device further comprising a covering envelope enclosing the coil and the ridge, and a marking tape pressed at each end of the covering envelope.

[0409] Example 57. A docking device according to any one of Examples 1 to 56, wherein the ridge has an arc in a relaxed state, wherein the arc is at least a portion of a perimeter having a diameter, wherein the diameter is in the range of about 0.29 mm to about 40 mm, about 0.31 mm to about 0.38 mm, or about 33 mm to about 35 mm.

[0410] Example 58. A docking device according to any one of Examples 1 to 57, wherein the coil includes a cover having a first covering area outside the protective member, the first covering area being thicker than a second covering area at the protective member.

[0411] Example 59. A docking device according to any one of Examples 1 to 58, wherein the coil includes a cover having: a first covering area outside the protective member having a thickness of about 1.6 mm to 2.2 mm or about 1.9 mm; and a second covering area at the protective member having a thickness of about 1.0 mm to about 1.6 mm or about 1.3 mm.

[0412] Example 60. A docking device according to any one of Examples 1 to 59, wherein the protective member includes a cover that substantially surrounds the support, wherein the cover forms the cover plate.

[0413] Example 61. The docking device according to Example 60, wherein the cover is formed by two cover pieces joined together, the two cover pieces having the support.

[0414] Example 62. A method for manufacturing a docking device according to any one of Examples 1 to 61, the method comprising: obtaining the support including the ridge and a plurality of arms, the plurality of arms being connected to the ridge and extending radially outward from the ridge; coupling the support to the cover plate to form the protective member; obtaining the coil; and coupling the protective member to the coil.

[0415] Example 63. The method according to Example 62, the method further comprising the protective member that surrounds the support within the cover of the cover plate to form the docking device.

[0416] Example 64. The method according to any one of Examples 62 to 63, wherein obtaining the support includes cutting a substrate to form the ridge and the plurality of arms.

[0417] Example 65. The method according to Example 64, wherein the substrate comprises a nickel-titanium alloy (e.g., nitinol) sheet, and wherein the cutting comprises laser cutting the nitinol sheet.

[0418] Example 66. The method according to any one of Examples 62 to 65, the method further comprising stacking two fabric layers together and cutting the two fabric layers using a die placed on the two fabric layers to form the cover, wherein the outer periphery of the die defines the circular shape of the support, and wherein the inner periphery of the die defines the shape of the ridge of the support.

[0419] Example 67. The method according to Example 66, wherein cutting the two fabric layers comprises moving a heating member (e.g., a 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 cover.

[0420] Example 68. The method according to Example 63, wherein surrounding the bracket includes inserting the bracket between the two fabric layers through an opening located radially inward of the inner periphery of the mold, wherein the bracket inserted between the two fabric layers is positioned such that the plurality of arms are aligned with the outer edge of the cover.

[0421] Example 69. The method according to Example 68, wherein surrounding the wireframe further includes moving the heating element (e.g., a soldering iron) along the inner periphery of the mold such that the two fabric layers are thermally cut and sealed together along the inner periphery of the mold to form the inner edge of the cover, wherein the ridge of the support extends along the inner edge of the cover.

[0422] Example 70. The method according to any one of Examples 62 to 69, the method further comprising connecting the bracket to the cover plate via a plurality of sutures.

[0423] Example 71. The method according to Example 70, wherein at least some of the sutures extend across one or more arms or one or more ridge regions of the stent.

[0424] Example 72. The method according to any one of Examples 70 to 71, wherein at least some of the sutures sew the sleeve of each arm to the cover plate.

[0425] Example 73. The method according to any one of Examples 62 to 72, the method further comprising attaching the protective member to the coil of the docking device by sewing the cover plate to the coil covering member.

[0426] Example 74. The method according to any one of Examples 62 to 73, the method comprising sewing the protective member to a retaining member of the coil, wherein the coil includes a coil core, a tubular covering member above the coil core, and the retaining member serving as a tube above the tubular covering member.

[0427] Example 75. The method according to Example 72, the method further comprising forming the sleeve of each arm by cutting a fabric sheet into the shape of the sleeve and sewing the sleeve-shaped fabric sheet in the shape of the sleeve to the cover plate.

[0428] Example 76. The method according to Example 72, the method further comprising forming the sleeve by forming a tube fitted around the respective arm and sewing the tubular sleeve to the cover plate.

[0429] Example 77. The method according to any one of Examples 62 to 76, the method further comprising forming at least one flap on the support, wherein the flap includes flap arms at both ends connected to the ridge.

[0430] Example 78. The method according to any one of Examples 62 to 77, the method further comprising forming a head on each arm of the support.

[0431] Example 79. The method according to Example 78, wherein forming the head includes cutting the head with the corresponding arm from a sheet.

[0432] Example 80. The method according to Example 78, wherein forming the head includes: cutting the arm from the sheet; and bending the distal end of the arm back to itself to form a loop having a rounded end.

[0433] Example 81. The method according to any one of Examples 62 to 80, the method further comprising forming an edge protector on the peripheral lip of the cover plate.

[0434] Example 82. The method according to any one of Examples 62 to 81, the method further comprising forming a marking strip on the protective member.

[0435] Example 83. The method according to any one of Examples 62 to 81, the method further comprising forming a marking strip on the protective member and the coil.

[0436] Example 84. The method according to any one of Examples 62 to 83, the method further comprising: enclosing the core of the coil and the ridge of the support with a covering; and crimping or otherwise attaching each end of the covering to the core and the ridge.

[0437] Example 85. A method of constructing a docking device for delivery to an autologous valve, the method comprising: providing a docking device according to any one of Examples 1 to 61; compressing the protective member by compressing the arm to fold the cover plate into the delivery orientation; and inserting the protective member in the delivery orientation into a docking sleeve of a docking delivery system.

[0438] Example 86. The method according to Example 86 further includes inserting the coil into the mating sleeve.

[0439] Example 87. A method of implanting a docking device into an autologous valve, the method comprising: providing a docking device according to any one of Examples 1 to 61; delivering the docking device to the autologous valve while the docking device is in a delivery orientation; deploying the coil of the docking device at the annulus of the autologous valve; and deploying the protective member at the location of the autologous valve in the deployment orientation such that the protective member covers or presses against the autologous valve and / or the autologous heart chamber associated with the autologous valve.

[0440] Example 88. The method according to Example 87, the method further comprising deploying the protective member such that the plurality of arms rotate and the cover plate expands radially.

[0441] Example 89. The method according to any one of Examples 87 to 88, wherein when the protective member is in the deployment orientation at the autologous valve, one or more proximal arms cover or press against a first portion of the autologous heart chamber, and one or more distal arms cover or press against a second portion of the autologous heart chamber substantially opposite the first portion.

[0442] Example 90. The method according to Example 89, wherein the autologous valve is a mitral valve, wherein the first portion includes the anterior or posterior leaflet of the mitral valve, and when the first portion includes the anterior leaflet, the second portion includes the posterior leaflet of the mitral valve, and when the first portion includes the posterior leaflet, the second portion includes the anterior leaflet of the mitral valve.

[0443] Example 91. The method according to any one of Examples 87 to 90, wherein when the protective member is in the deployment orientation at the mitral valve, the cover plate covers or presses against the posterior leaflet or its left atrial region.

[0444] Example 92. The method according to any one of Examples 87 to 91, wherein when the protective member is in the deployment orientation at the mitral valve, the cover plate covers or presses against the anterior leaflet or its left atrial region.

[0445] Example 93. The method according to any one of Examples 87 to 92, wherein when the protective member is in the deployment orientation at the mitral valve, the cover plate covers or presses against the anterior and posterior leaflets or their left atrial region.

[0446] Example 94. The method according to any one of Examples 87 to 93, wherein the coil remains in a substantially straight configuration in the delivery orientation when the docking device is delivered, and the coil component is transformed into a helical configuration after the docking device is deployed.

[0447] Example 95. The method according to any one of Examples 87 to 94, wherein the protective member remains in the delivery orientation during delivery of the docking device and changes to the deployment orientation after the docking device is deployed.

[0448] Example 96. The method according to any one of Examples 87-95, wherein delivering the docking device includes holding the docking device within a docking sleeve, and deploying the docking device includes removing the docking device from the docking sleeve.

[0449] Example 97. The method according to any one of Examples 87 to 96, wherein deploying the docking device includes removing the delivery sleeve from the coil and protective member while the autologous valve is in place.

[0450] Example 98. A method of implanting a prosthetic valve, the method comprising: providing a docking device according to any one of Examples 1 to 61; delivering the docking device to an autologous valve; deploying the docking device at the annulus of the autologous valve such that a protective member expands at the location of the autologous valve into the unfolding orientation, such that the protective member covers or presses against the autologous valve and / or an autologous heart chamber associated with the autologous valve; and deploying a prosthetic valve within the docking device, wherein the coil remains in a substantially straight delivery orientation during delivery of the docking device and transforms into a helical configuration after the docking device is in the unfolding orientation, wherein the protective member remains in a folded delivery orientation during delivery of the docking device and transforms into an open unfolding orientation after the docking device is deployed.

[0451] Example 99. A coil for a docking device for fixing a prosthetic valve, the coil comprising: a longitudinal axis extending from an inflow side to an outflow side through a lumen of the coil; a first coil region defining a first lumen diameter and configured to be disposed on the inflow side of an autologous valve annulus and to stabilize the coil relative to the autologous valve annulus; and a second coil region extending from a distal end of the first coil region and including one or more helical turns, each of the one or more helical turns defining a second lumen diameter and configured to be disposed on the outflow side of the autologous valve annulus and to receive a prosthetic valve, wherein a proximal portion of the first coil region is raised relative to a plane defined by the first coil region and perpendicular to the longitudinal axis, and wherein the proximal portion of the first coil region is less than 12 mm higher than the plane defined by the first coil region.

[0452] Example 100. The coil according to any example herein, particularly Example 99, further includes a lead coil extending from the distal end of the second coil region and radially outward from the second diameter.

[0453] Example 101. A coil according to any of the examples herein, particularly any one of Examples 99 to 100, wherein the proximal portion of the first coil region is raised at an angle relative to a plane defined by the first coil region and perpendicular to the longitudinal axis.

[0454] Example 102. A coil according to any example in this document, particularly Example 101, wherein the angle is in the range of 10 to 50 degrees.

[0455] Example 103. The coil according to any of the examples herein, particularly any one of Examples 99 to 102, further includes an attachment portion comprising one or more eyelets disposed at the proximal portion of the first coil region.

[0456] Example 104. A coil according to any of the examples herein, particularly any one of Examples 99 to 103, wherein the diameter of the first lumen and the diameter of the second lumen are substantially equal.

[0457] Example 105. A coil according to any of the examples herein, particularly any one of Examples 99 to 103, wherein the diameter of the first lumen is 10% to 30% larger than the diameter of the second lumen.

[0458] Example 106. A coil according to any of the examples herein, particularly any one of Examples 99 to 103, wherein the diameter of the first lumen is in the range of 25 mm to 30 mm, and the diameter of the second lumen is in the range of 20 mm to 25 mm.

[0459] Example 107. A coil according to any of the examples herein, particularly any one of Examples 99 to 106, wherein the first coil region comprises a single stable turn.

[0460] Example 108. A docking device comprising a coil according to any of the examples herein, particularly Examples 99 to 107, and further comprising a protective member at least partially coupled to the outflow side of the stabilizing turn, wherein the protective member is convertible between a radially compressed state and a radially expanded state.

[0461] Example 109. A docking device according to any example herein, particularly Example 108, wherein the protective member includes a support, and the support includes a ridge, a plurality of arms and one or more end flaps.

[0462] Example 110. A docking device according to any of the examples herein, particularly any one of Examples 108 to 109, wherein the ridge of the support further includes an outwardly flared bend configured to enclose the stabilizing turn.

[0463] Example 111. A docking device according to any example herein, particularly Example 110, wherein the protective member includes an outer end flap and an inner end flap, and wherein the outwardly flared bend is located near the inner end flap.

[0464] Example 112. A docking device according to any of the examples herein, particularly any one of Examples 109 to 111, wherein the support further includes one or more retaining elements.

[0465] Example 113. A docking device according to any example herein, particularly Example 112, wherein the retaining element includes a tooth, wherein the tooth is attached to a base portion of the arm, and wherein the tooth tapers to a point at its tip.

[0466] Example 114. A coil for a docking device for fixing a prosthetic valve, the coil comprising: a longitudinal axis extending from an inflow side to an outflow side through a lumen of the coil; a first coil region configured to be disposed on the inflow side of an autologous valve annulus and to stabilize the coil relative to the autologous valve annulus; and a second coil region extending from a distal end of the first coil region and including one or more helical turns, each of the one or more helical turns being configured to be disposed on the outflow side of the autologous valve annulus and to receive the prosthetic valve, wherein the coil omits a raised stabilizing portion.

[0467] Example 115. The coil according to any example herein, particularly Example 114, further includes a lead coil extending from the distal end of the second coil region and radially outward from the diameter of the second coil region.

[0468] Example 116. A coil according to any of the examples herein, particularly any one of Examples 114 to 115, wherein the proximal portion of the first coil region is raised at an angle relative to a plane defined by the first coil region and perpendicular to the longitudinal axis.

[0469] Example 117. A coil according to any example in this document, particularly Example 116, wherein the angle is in the range of 10 to 30 degrees.

[0470] Example 118. A coil according to any of the examples herein, particularly any one of Examples 116 to 117, wherein the proximal end of the first coil region is less than 12 mm higher than the plane defined by the first coil region.

[0471] Example 119. A coil according to any of the examples herein, particularly any one of Examples 114 to 118, wherein the first coil region defines a first lumen diameter and the second coil region defines a second lumen diameter.

[0472] Example 120. A coil according to any example herein, particularly Example 119, wherein the diameter of the first cavity and the diameter of the second cavity are substantially equal.

[0473] Example 121. A coil according to any example in this document, particularly Example 119, wherein the diameter of the first cavity is 10% to 30% larger than the diameter of the second cavity.

[0474] Example 122. A coil according to any example herein, particularly Example 119, wherein the diameter of the first lumen is in the range of 25 mm to 30 mm, and the diameter of the second lumen is in the range of 20 mm to 25 mm.

[0475] Example 123. A docking device comprising a coil according to any of the examples herein, particularly any one of Examples 114 to 122, and further comprising a protective member at least partially coupled to the outflow side of the stabilizing coil, wherein the protective member is convertible between a radially compressed state and a radially expanded state.

[0476] Example 124. A docking device according to any example herein, particularly Example 123, wherein the protective member includes a support, and the support includes a ridge, a plurality of arms and one or more end flaps.

[0477] Example 125. A docking device according to any of the examples herein, particularly any one of Examples 123 to 124, wherein the protective member is coupled to the outflow side of the stabilizing coil and extends circumferentially 180 to 330 degrees on the outflow side of the stabilizing turn.

[0478] Example 126. A docking device according to any of the examples herein, particularly any one of Examples 124 to 125, wherein the ridge of the support further includes an outwardly flared bend configured to enclose the stabilizing turn.

[0479] Example 127. A docking device according to any of the examples herein, particularly any one of Examples 124 to 126, wherein a portion of the protective member wraps around the stabilizing turn and extends circumferentially 30 to 135 degrees on the inflow side of the stabilizing turn.

[0480] Example 128. A docking device according to any of the examples herein, particularly any one of Examples 124 to 127, wherein the support further includes one or more retaining elements.

[0481] Example 129. A docking device according to any example herein, particularly Example 128, wherein the retaining element includes a tooth, wherein the tooth is engaged at the base portion of the arm, and wherein the tooth tapers to a point at its tip.

[0482] Example 130. A docking device for securing a prosthetic implant to an autologous valve, the docking device comprising: a coil defining a longitudinal axis extending from an inflow side to an outflow side through a lumen of the coil, and including a plurality of helical turns when unfolded at the autologous valve, wherein at least one of the helical turns includes a first coil region configured to be disposed on the inflow side of the autologous valve annulus and to stabilize the coil relative to the autologous valve annulus, wherein a proximal portion of the first coil region is raised relative to a plane defined by the first coil region and perpendicular to the longitudinal axis, and wherein the proximal end of the first coil region is less than 12 mm higher than the plane defined by the first coil region, and at least one of the helical turns includes a second coil region extending from a distal end of the first coil region and configured to be disposed on the outflow side of the autologous valve annulus and to receive the prosthetic valve; and a protective member at least partially coupled to the outflow side of the first coil region, wherein the protective member is convertible between a radially compressed state and a radially expanded state.

[0483] Example 131. A docking device according to any example herein, particularly Example 130, wherein a portion of the protective member is connected around the perimeter of the first coil region by at least 225 degrees.

[0484] Example 132. A docking device according to any example herein, particularly Example 130, wherein a portion of the protective member is connected around the perimeter of the first coil region by at least 270 degrees.

[0485] Example 133. A docking device according to any example herein, particularly Example 130, wherein a portion of the protective member is coupled to the outflow side of the first coil region by at least 270 degrees around the perimeter of the first coil region, and a portion of the protective member is disposed on the inflow side of the first coil region by at least 15 degrees around the perimeter of the first coil region.

[0486] Example 134. A docking device according to any of the examples herein, particularly any one of Examples 130 to 133, wherein the protective member comprises a support, and the support comprises a ridge, a plurality of arms and one or more end flaps.

[0487] Example 135. According to any example in this document, particularly Example 134, the docking device wherein the ridge of the support further includes an outwardly flared bend configured to enclose the stabilizing turn.

[0488] Example 136. A docking device according to any of the examples herein, particularly any one of Examples 134 to 135, wherein the support further includes one or more retaining elements.

[0489] Example 137. A docking device according to any example herein, particularly Example 136, wherein the retaining element includes a tooth, wherein the tooth is engaged at the base portion of the arm, and wherein the tooth tapers to a point at its tip.

[0490] Example 138. A method comprising: delivering a docking device according to any of the examples herein, particularly Examples 108 to 113 and / or 130 to 137, 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 coil remains in a substantially straight configuration during delivery of the docking device and transforms into a helical configuration after the docking device is deployed.

[0491] Example 139. A coil for a docking device for securing a prosthetic valve, the coil comprising: a core, which, when unfolded at an autologous valve, includes a plurality of helical turns and defines a longitudinal axis extending from an inflow side to an outflow side through a lumen of the plurality of helical turns, wherein at least one of the helical turns includes a first region configured to be disposed on the inflow side of the autologous valve annulus and to stabilize the coil relative to the autologous valve annulus, and at least one of the helical turns includes a second region extending from a distal end of the first region and configured to be disposed on the outflow side of the autologous valve annulus and to receive the prosthetic valve; and a cover that surrounds at least a portion of the core and includes a first outer diameter and a second outer diameter greater than the first outer diameter, wherein the second region includes the second outer diameter.

[0492] Example 140. A coil according to any example herein, particularly Example 138, wherein at least a portion of the first region is covered by a cover of the second diameter.

[0493] Example 141. A coil according to any of the examples herein, particularly any one of Examples 139 to 140, wherein the cover comprises a first cover having a first outer diameter and a second cover having a second outer diameter, wherein the first cover and the second cover are two separate pieces.

[0494] Example 142. A coil according to any example herein, particularly Example 141, further comprising a transition region in which the first cover flares out radially such that the first cover overlaps with the second cover in the axial direction.

[0495] Example 143. The coil according to any example herein, particularly Example 142, further includes a connecting member that encloses the first cover.

[0496] Example 144. A coil according to any example herein, particularly Example 143, wherein the connecting member includes a stitch.

[0497] Example 145. A protective member for a docking device for securing a prosthetic implant to an autologous valve, the protective member comprising: a support having a ridge and a plurality of arms extending from the ridge; and one or more retaining elements coupled to one of the plurality of arms; wherein the protective member is configured to be attached to the coil by at least a portion of a helical turn coupled to the coil, wherein the protective member is convertible between a delivery-oriented radially compressed state and a deployment-oriented radially expanded state.

[0498] Example 146. According to any example herein, particularly Example 145, the protective member further includes a cover plate, wherein the plurality of arms are coupled to the cover plate, and at least a portion of the support is surrounded by the cover plate, and wherein one or more retaining elements extend through the cover plate.

[0499] Example 147. A protective member according to any of the examples herein, particularly any one of Examples 145 to 146, wherein the retaining element is a tooth configured to engage heart tissue to help ensure device stability.

[0500] Example 148. A protective member according to any example herein, particularly Example 147, wherein the fang includes a base portion coupled to the arm and having a first width, and a tip portion including a second width, wherein the second width is smaller than the first width.

[0501] Example 149. A protective member according to any of the examples herein, particularly any one of Examples 147 to 148, wherein the serration includes a pointed portion as a point.

[0502] Example 150. According to any of the examples herein, particularly any one of Examples 145 to 149, the protective member further includes one or more end flaps.

[0503] Example 151. A protective member according to any example herein, particularly any one of Examples 145 to 150, wherein when the protective member is in the radially expanded state in the deployment orientation, the plurality of arms and cover plates extend radially outward away from the coil and circumferentially along a portion of the coil.

[0504] Example 152. A protective member according to any of the examples herein, particularly any one of Examples 145 to 151, wherein when the protective member is in the radially expanded state, the retaining element extends from the arm in a clockwise direction.

[0505] Example 153. A protective member according to any of the examples herein, particularly any one of Examples 147 to 152, wherein the fangs extend out of the plane defined by the bracket.

[0506] Example 154. A protective member according to any example herein, particularly Example 153, wherein the serrations and the plane defined by the bracket form an angle in the range of 0 to 90 degrees.

[0507] Example 155. A protective member according to any example herein, particularly Example 153, wherein the serrations and the plane defined by the bracket form an angle in the range of 0 to 45 degrees.

[0508] Example 156. A protective member according to any example herein, particularly Example 153, wherein the serrations and the plane defined by the bracket form an angle in the range of 90 to 180 degrees.

[0509] Example 157. A method comprising sterilizing a docking device, coil, or protective component according to any of the examples herein, particularly Examples 1 to 61 or Examples 99 to 156.

[0510] Example 158. 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 61 or Examples 99 to 156.

[0511] 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. As yet another example, any one or more features of a protective member may be combined with any one or more features of another protective member.

[0512] 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 fixing a prosthetic valve to an autologous valve, the docking device comprising: A coil, which, when in an unfolded orientation, comprises a plurality of helical turns; as well as A protective member attached to the coil by at least a portion of a helical turn coupled to the coil, wherein the protective member includes a support having a ridge and a plurality of arms extending from the ridge, wherein the plurality of arms are coupled to a cover plate, wherein the protective member is capable of switching between a radially compressed state in a delivery orientation and a radially expanded state in a deployment orientation.

2. The docking device according to claim 1, wherein when the protective member is in the radial compression state, the plurality of arms and the cover plate abut against the coil in the delivery orientation and are radially compressed, such that the cross-sectional profile of the docking device includes a diameter smaller than a predefined threshold diameter.

3. The docking device according to claim 2, wherein the predefined threshold diameter is in the range of about 2 mm to about 3 mm.

4. The docking device according to any one of claims 1 to 3, wherein when the protective member changes from the radially compressed state in the delivery orientation to the radially expanded state in the unfolding orientation, the arm rotates outward and the cover plate extends such that the protective member extends radially outward relative to the coil.

5. The docking device according to any one of claims 1 to 4, wherein the plurality of arms are three to eight arms.

6. The docking device according to any one of claims 1 to 5, wherein the protective member is sewn to the cover member of the coil via one or more stitches.

7. A method for manufacturing a docking device according to any one of claims 1 to 6, the method comprising: A support is obtained comprising the ridge and a plurality of arms, the plurality of arms being connected to the ridge and extending radially outward from the ridge; The bracket is attached to the cover plate to form the protective member; Obtain the coil; as well as Connect the protective component to the coil.

8. The method of claim 7, further comprising the protective member that surrounds the support within the cover of the cover plate to form the docking device.

9. The method according to any one of claims 7 to 8, the method further comprising connecting the support to the cover plate via a plurality of sutures.

10. A method for implanting a docking device into an autologous valve, the method comprising: Provide a docking device according to any one of claims 1 to 6; When the docking device is in the delivery orientation, the docking device is delivered to the autologous valve; The coil of the docking device is deployed at the valve annulus of the autologous valve; as well as The protective member is deployed in an unfolded orientation at the location of the autologous valve, such that the protective member covers or presses against the autologous valve and / or the autologous heart chamber associated with the autologous valve.

11. A coil for a docking device for fixing a prosthetic valve, the coil comprising: A longitudinal axis extends from the inflow side to the outflow side through the lumen of the coil; A first coil region, the first coil region defining a first lumen diameter, and configured to be disposed on the inflow side of the autologous valve annulus and to stabilize the coil relative to the autologous valve annulus; as well as A second coil region, extending distally from the first coil region and including one or more helical turns, each helical turn defining a second lumen diameter and configured to be disposed on the outflow side of the autologous valve annulus and to receive the prosthetic valve. The proximal portion of the first coil region is raised relative to a plane defined by the first coil region and perpendicular to the longitudinal axis, and wherein the proximal portion of the first coil region is less than 12 mm higher than the plane defined by the first coil region.

12. The coil of claim 11, further comprising a lead coil extending from the distal end of the second coil region and radially outward from the second diameter.

13. The coil according to any one of claims 11 to 12, wherein the proximal portion of the first coil region is raised at an angle relative to a plane defined by the first coil region and perpendicular to the longitudinal axis.

14. The coil of claim 13, wherein the angle is in the range of 10 to 50 degrees.

15. The coil according to any one of claims 11 to 14, the coil further comprising an attachment portion including one or more eyelets disposed at the proximal portion of the first coil region.

16. The coil according to any one of claims 11 to 15, wherein the diameter of the first cavity and the diameter of the second cavity are substantially equal.

17. The coil according to any one of claims 11 to 15, wherein the diameter of the first cavity is 10% to 30% larger than the diameter of the second cavity.

18. The coil according to any one of claims 11 to 15, wherein the diameter of the first cavity is in the range of 25 mm to 30 mm, and the diameter of the second cavity is in the range of 20 mm to 25 mm.

19. The coil according to any one of claims 11 to 18, wherein the first coil region comprises a single stable turn.

20. A docking device comprising a coil according to any one of claims 11 to 19, and further comprising a protective member at least partially coupled to the outflow side of the stabilizing turn, wherein the protective member is capable of transitioning between a radially compressed state and a radially expanded state.

21. A docking device for securing a prosthetic implant to an autologous valve, the docking device comprising: A coil, the coil defining a longitudinal axis extending from the inflow side to the outflow side through the lumen of the coil, and comprising a plurality of helical turns when unfolded at the autologous valve, wherein at least one of the helical turns includes a first coil region configured to be disposed on the inflow side of the autologous valve annulus and to stabilize the coil relative to the autologous valve annulus, wherein a proximal portion of the first coil region is raised relative to a plane defined by the first coil region and perpendicular to the longitudinal axis, and wherein the proximal end of the first coil region is less than 12 mm higher than the plane defined by the first coil region, and at least one of the helical turns includes a second coil region extending from the distal end of the first coil region and configured to be disposed on the outflow side of the autologous valve annulus and to receive a prosthetic valve; as well as A protective member, at least partially connected to the outflow side of the first coil region, wherein the protective member is capable of switching between a radially compressed state and a radially expanded state.

22. The docking device of claim 21, wherein a portion of the protective member is connected around the perimeter of the first coil region by at least 225 degrees.

23. The docking device of claim 21, wherein a portion of the protective member is connected around the perimeter of the first coil region by at least 270 degrees.

24. The docking device of claim 21, wherein a portion of the protective member is connected to the outflow side of the first coil region by at least 270 degrees around the perimeter of the first coil region, and a portion of the protective member is disposed on the inflow side of the first coil region by at least 15 degrees around the perimeter of the first coil region.

25. A method, the method comprising: The docking device according to any one of claims 20 to 24 is delivered to the autologous valve; The docking device is deployed at the annulus of the autologous valve; as well as A prosthetic valve is deployed within the docking device. The coil remains in a substantially straight configuration when the docking device is delivered, and transforms into a helical configuration after the docking device is deployed.

26. A coil for a docking device for fixing a prosthetic valve, the coil comprising: The core, when unfolded at the autologous valve, includes a plurality of helical turns and defines a longitudinal axis extending from an inflow side to an outflow side through the lumen of the plurality of helical turns. At least one of the helical turns includes a first region configured to be disposed on the inflow side of the autologous valve annulus and to stabilize the coil relative to the autologous valve annulus. At least one of the helical turns includes a second region extending from a distal end of the first region and configured to be disposed on the outflow side of the autologous valve annulus and to receive a prosthetic valve. as well as A cover that surrounds at least a portion of the core and includes a first outer diameter and a second outer diameter greater than the first outer diameter, wherein the second region includes the second outer diameter.

27. The coil of claim 26, wherein at least a portion of the first region is covered by a cover of the second diameter.

28. The coil according to any one of claims 26 to 27, wherein the cover comprises a first cover having a first outer diameter and a second cover having a second outer diameter, wherein the first cover and the second cover are two separate pieces.

29. The coil of claim 28, further comprising a transition region in which the first cover opens radially outward, such that the first cover overlaps with the second cover in the axial direction.

30. The coil of claim 29, further comprising a connecting member enclosing the first cover.

31. The coil of claim 30, wherein the connecting member comprises a suture.

32. A protective member for a docking device for securing a prosthetic implant to an autologous valve, the protective member comprising: A support having a ridge and a plurality of arms extending from the ridge; as well as One or more retaining elements, said one or more retaining elements being coupled to one of the plurality of arms; The protective member is configured to be attached to the coil by at least a portion of a helical turn connected to the coil, and the protective member is capable of switching between a delivery-oriented radially compressed state and a deployment-oriented radially expanded state.

33. The protective member of claim 32, further comprising a cover plate, wherein the plurality of arms are coupled to the cover plate, and at least a portion of the support is surrounded by the cover plate, and wherein one or more retaining elements extend through the cover plate.

34. The protective member according to any one of claims 32 to 33, wherein the retaining element is a tooth configured to engage cardiac tissue to help ensure device stability.

35. The protective member of claim 34, wherein the serration includes a base portion connected to the arm and having a first width, and a tip portion having a second width, wherein the second width is smaller than the first width.

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