Prosthetic valve docking device having a compressible plug for perivalvular leakage mitigation at medial commissure

Abstract

A docking device to secure a prosthetic heart valve at a native heart valve includes a coil and a compressible plug. The coil includes multiple helical turns when in a deployed orientation. The compressible plug includes a scaffold formed from a shape-memory material. The compressible plug is configured to provide a liquid plugging function. The compressible plug is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation. The compressible plug is coupled to a helical turn of the coil by a tether. In the deployed orientation, the tether is configured to accommodate relative movement between the compressible plug and the helical turn of the coil within a predefined range that depends at least on the tether.

Description

Attorney Docket No.: THVMC-23670W001PROSTHETIC VALVE DOCKING DEVICE HAVING A COMPRESSIBLE PLUG FOR PERIVALVULAR LEAKAGE MITIGATION AT MEDIAL COMMISSURECROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 719,235, filed November 12, 2024, which is incorporated herein by reference in its entirety.FIELD

[0002] The present disclosure concerns examples of a compressible plug for a docking device that is configured to reduce perivalvular leakage at the medial commissure. The compressible plug may plug perivalvular leaks at the medial commissure that may result from implantation of the docking device and the prosthetic valve that fits into the docking device at a native heart valve.BACKGROUND

[0003] Prosthetic valves may be used to treat cardiac valvular disorders. Native heart valves (for example, the aortic, pulmonary, tricuspid and mitral valves) function to prevent backward flow or regurgitation, while allowing forward flow. These heart valves may be rendered less effective by congenital, inflammatory, infectious conditions, etc. Such conditions may eventually lead to serious cardiovascular compromise or death. For many years, doctors attempted to treat such disorders with surgical repair or replacement of the valve during open heart surgery.

[0004] A transcatheter technique for introducing and implanting a prosthetic heart valve using a catheter in a manner that is less invasive than open heart surgery may reduce complications associated with open heart surgery. In this technique, a prosthetic valve may be mounted in a compressed state on the end portion of a catheter and advanced through a blood vessel of the patient until the valve reaches the implantation site. The valve at the catheter tip may then be expanded to its functional size at the site of the defective native valve, such as by inflating a balloon on which the valve is mounted or, for example, the valve may have a resilient, selfexpanding frame that expands the valve to its functional size when it is advanced from a delivery sheath at the distal end of the catheter. Optionally, the valve may have a balloonexpandable, self-expanding, mechanically-expandable frame, and / or a frame expandable in multiple or a combination of ways.Attorney Docket No.: THVMC-23670W001

[0005] In some instances, a transcatheter heart valve (THV) may be appropriately sized to be placed inside a particular native valve (for example, a native aortic valve). As such, the THV may not be suitable for implantation at another native valve (for example, a native mitral valve) and / or in a patient with a larger native valve. Additionally, or alternatively, the native tissue at the implantation site may not provide sufficient structure for the THV to be secured in place relative to the native tissue. Accordingly, improvements to THVs and the associated transcatheter delivery apparatus are desirable.SUMMARY

[0006] The present disclosure relates to methods and devices for treating valvular regurgitation and / or other valve issues. Specifically, the present disclosure is directed to a docking device having a compressible plug that is configured to receive a prosthetic valve, as well as the methods of assembling the docking device and implanting the docking device.

[0007] In some embodiments, a docking device to secure a prosthetic valve at a native valve includes a coil and a plug. The coil includes multiple helical turns when in a deployed orientation. The plug includes a scaffold formed from a shape-memory material. The plug is configured to provide a liquid plugging function. The plug is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation. The plug is coupled to a helical turn of the coil by a tether. In the deployed orientation, the tether is configured to accommodate relative movement between the plug and the helical turn of the coil within a predefined range that depends at least on the tether.

[0008] In some embodiments, a docking device to secure a prosthetic valve at a native valve includes a coil, a guard member, and a plug. The coil includes multiple helical turns when in a deployed orientation. The guard member is attached to the coil by being coupled to at least a portion of a helical turn thereof, the guard member including a scaffold with a spine, multiple arms extending from the spine, and a flap coupled to the arms. The plug includes a scaffold formed from a shape-memory material. The guard member is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation. The plug is configured to provide a liquid plugging function. The plug is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation. The plug is coupled to a helical turn of the coil by a tether. In the deployed orientation, the tether is configured to accommodate relative movement between the plug and the helical turn of the coil within a predefined range that depends at least on the tether.Attorney Docket No.: THVMC-23670W001

[0009] In some embodiments, a method for making the docking device of one of the embodiments may be provided. The method may include forming multiple wires of a shapememory material into the scaffold. The method may include attaching a cover to the scaffold to form the plug. The method may include coupling the plug to the coil with a tether to accommodate relative movement between the plug and the helical turn of the coil within a predefined range that depends at least on the tether.

[0010] In some embodiments, a method of configuring the docking device of one of the embodiments for delivery to a native valve may be provided. The method may include compressing the plug by compressing the scaffold of the plug into the delivery orientation. The method may include inserting the plug in the delivery orientation into a dock sleeve of a dock delivery system.

[0011] In some embodiments, a method of implanting the docking device of one of the embodiments into a native valve may be provided. The method may include delivering the docking device to a native valve while the docking device is in a delivery orientation. The method may include deploying the coil of the docking device at an annulus of the native valve. The method may include deploying the plug into the deployed orientation at a position at the native heart valve so that the plug has a first portion to one side of a commissure of the native heart valve, a second portion to an opposite side of the commissure, and an intermediate portion within the commissure that couples the first portion to the second portion.

[0012] In some embodiments, a method of implanting a prosthetic heart valve into the docking device of one of the embodiments may be provided. The method may include delivering the docking device to a native heart valve. The method may include deploying the docking device at an annulus of the native heart valve so that the plug expands into the deployed orientation at a position at the native heart valve so that the plug has a first portion to one side of a commissure of the native heart valve, a second portion to an opposite side of the commissure, and an intermediate portion within the commissure that couples the first portion to the second portion. The method may include deploying a prosthetic heart valve within the docking device. The coil may remain in a substantially straight delivery orientation when delivering the docking device and may move to a helical configuration after the docking device is in the deployed orientation. The plug may remain in a radially compressed state in a delivery orientation when delivering the docking device and may move to a radially expanded state in a deployed orientation after the docking device is deployed.Attorney Docket No.: THVMC-23670W001

[0013] The methods described herein may be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated).

[0014] The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 A is a cutaway view of the human heart in a diastolic phase.

[0016] FIG. IB is a cutaway view of the human heart in a systolic phase.

[0017] FIG. 2A schematically illustrates a first stage in an example mitral valve replacement procedure where a guide catheter and a guidewire are inserted into a vasculature of a patient and navigated through the vasculature and into a heart of the patient, towards a native mitral valve of the heart.

[0018] FIG. 2B schematically illustrates a second stage in the example mitral valve replacement procedure where a docking device delivery apparatus extending through the guide catheter is used to deploy a docking device at the native mitral valve.

[0019] FIG. 3A schematically illustrates a third stage in the example mitral valve replacement procedure where the docking device of FIG. 2B is fully implanted at the native mitral valve of the patient and the docking device delivery apparatus has been removed from the patient.

[0020] FIG. 3B schematically illustrates a fourth stage in the example mitral valve replacement procedure where a prosthetic heart valve delivery apparatus extending through the guide catheter is used to deploy a prosthetic heart valve within the implanted docking device at the native mitral valve.

[0021] FIG. 4A schematically illustrates a fifth stage in the example mitral valve replacement procedure where the prosthetic heart valve is fully implanted within the docking device at the native mitral valve and the prosthetic heart valve delivery apparatus has been removed from the patient.

[0022] FIG. 4B schematically illustrates a sixth stage in the example mitral valve replacement procedure where the guide catheter and the guidewire have been removed from the patient.

[0023] FIG. 5 is an atrial view of an example mitral valve in which some embodiments herein may be implemented.Attorney Docket No.: THVMC-23670W001

[0024] FIGS. 6A-6C show example plug scaffolds for use as a medial commissure compressible plug.

[0025] FIG. 7A depicts various scaffold shapes or outlines that compressible plugs herein may have.

[0026] FIG. 7B illustrates various 2-lobe compressible plug embodiments in which an intermediate waist of the compressible plug has various sizes or diameters relative to its lobes.

[0027] FIG. 7C illustrates various 2-lobe compressible plug embodiments in which the intermediate waist is offset (downward in the orientation of FIG. 7C) different amounts relative to the lobes.

[0028] FIG. 8A illustrates a top view of an example embodiment of a docking device or a coil of a docking device.

[0029] FIG. 8B includes a cross-sectional profile of the coil in FIG. 8 A.

[0030] FIG. 8C includes another cross-sectional profile of the coil in FIG. 8A.

[0031] FIG. 8D includes a top view that illustrates an embodiment of a coil and compressible plug of a docking device.

[0032] FIG. 8E includes a side view that illustrates an embodiment of a coil and compressible plug of a docking device of FIG. 8D.

[0033] FIGS. 9A-9C illustrate various example tethers that may couple a compressible plug to a coil of a docking device.

[0034] FIGS. 10 A- 10C depict an example unsleeving process for the docking device and compressible plug of FIG. 9C.

[0035] FIGS. 11 A-l IB depict the docking device and compressible plug of FIG. 9C implanted at a native mitral valve.

[0036] FIGS. 12A-12B depict the clocking of the docking device of FIGS. 11 A-l IB that occurs when a prosthetic heart valve is implanted.

[0037] FIGS. 13A-13B depict the clocking of a docking device coupled to a compressible plug by a short tether that occurs when a prosthetic heart valve is implanted.

[0038] FIG. 14A includes a top view that illustrates an embodiment of a scaffold of a guard member of a docking device.

[0039] FIG. 14B includes a top view that illustrates an embodiment of a flap of a guard member of a docking device.

[0040] FIG. 14C includes a perspective view that illustrates an embodiment of an assembled docking device having the coil and guard member.Attorney Docket No.: THVMC-23670W001

[0041] FIG. 14D includes a top view of the docking device of FIG. 14C.

[0042] FIG. 14E includes a top view of the docking device having the compressible plug and an optional guard member.

[0043] FIG. 14F includes a perspective view of the docking device with compressible plug and optional guard member of FIG. 14E.

[0044] FIGS. 15A-15B include a perspective view and side view of a compressible plug with two lobes of unequal size.

[0045] FIGS. 16A-16B include a perspective view and side view of a compressible plug with two lobes of equal size and a relatively larger intermediate waist.

[0046] FIGS. 17A-17B include a perspective view and side view of a compressible plug with two lobes of equal size and a midsize intermediate waist.

[0047] FIG. 18 illustrates an example compressible plug with an example coverthat is braided.

[0048] FIG. 19 illustrates an example compressible plug with an example cover that is woven.

[0049] FIGS. 20 and 21 illustrate example compressible plugs.

[0050] FIG. 22 illustrates an example compressible plug with an example cover that is fuzzy for tissue ingrowth and flow impediment.

[0051] FIG. 23 illustrates an example compressible plug with an example cover that is fuzzy for tissue ingrowth and flow impediment.

[0052] FIG. 24 illustrates a compressible plug having a scaffold filled with pluggable members, which may be absorbent or hydrophobic.DETAILED DESCRIPTIONGeneral Considerations

[0053] It should be understood that the disclosed examples may be adapted to deliver and implant prosthetic devices in any of the native annuluses of the heart (for example, the pulmonary, mitral, and tricuspid annuluses), and may be used with any of various delivery approaches (for example, retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0054] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combinationAttomey Docket No.: THVMC-23670W001thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved. The technologies from any example may be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

[0055] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods may be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide" or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0056] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the terms “coupled” and “connected” generally mean electrically, electromagnetically, fluidly, anatomically, and / or physically (for example, mechanically or chemically) coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, the term “and / or” used between the last two of a list of elements means 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.”

[0057] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user (e.g., clinician) and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). TheAttorney Docket No.: THVMC-23670W001terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0058] Directions and other relative references (for example, inner, outer, upper, lower, etc.) may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as “inside,” “outside,”, “top,” “down,” “interior," “exterior,” and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an “upper” part may become a “lower” part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same. In the context of the present application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow”, respectively. Thus, for example, typically the lower end of a valve or docking station as depicted in the figures is its inflow end and the upper end of the valve or docking station is its outflow end unless explicitly described otherwise.

[0059] The terms “longitudinal” and “axial” refer to an axis extending in the upstream and downstream directions, or in the proximal and distal directions, unless otherwise expressly defined.

[0060] Although there are alternatives for various components, features, parameters, operating conditions, etc., set forth herein, that does not mean that those alternatives are necessarily equivalent and / or perform equally well. Nor does it mean that the alternatives are listed in a preferred order unless stated otherwise.

[0061] As used herein, the terms “integrally formed” and “unitary construction” refer to a construction that does not require any sutures, fasteners, or other securing means to attach two portions of the construction together.Example Transcatheter Heart Valve Replacement Procedure

[0062] Described herein are various systems, apparatuses, methods, or the like, that may be used in or with delivery apparatuses to deliver a prosthetic implant (e.g., a prosthetic valve, a docking device, etc.) into a patient body.

[0063] In certain examples, a delivery apparatus may be configured to deliver and implant a docking device at an implantation site, such as a native valve annulus. The docking device may be configured to more securely hold an expandable prosthetic valve implanted within theAttorney Docket No.: THVMC-23670W001docking device, at the native valve annulus. For example, a docking device may provide or form a more circular and / or stable anchoring site, landing zone, or implantation zone at the implant site, in which a prosthetic valve may be expanded or otherwise implanted. By providing such anchoring or docking devices, replacement prosthetic valves may be more securely implanted and held at various valve annuluses, including at the mitral annulus which does not have a naturally circular cross-section.

[0064] In some examples, the docking device may be arranged within an outer shaft of the delivery apparatus. A sleeve shaft may cover or surround the docking device within the delivery apparatus and during delivery to a target implantation site. A pusher shaft may be disposed within the outer shaft, proximal 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 apparatus. After positioning the docking device at the target implantation site, the sleeve shaft may be removed from the docking device and retracted back into the outer shaft of the delivery apparatus.

[0065] Fluid (e.g., a flush fluid, such as heparinized saline or the like) may be provided to a pusher shaft lumen defined within an interior of the pusher shaft, a delivery shaft lumen defined between the sleeve shaft and the outer shaft of the delivery apparatus, and a sleeve shaft lumen defined between the pusher shaft and the sleeve shaft. By providing a consistent flow of fluid through these lumens of the delivery apparatus, stagnation of blood within the delivery apparatus may be reduced or avoided, thereby reducing a risk of thrombus formation.

[0066] FIGS. 1A and IB are cutaway views of the human heart H in diastolic and systolic phases, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and the mitral valve MV; i.e., the atrioventricular valves. 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 extending inward across the respective orifices that come together or "coapt" in the flow stream to form one-way, fluid-occluding surfaces. The docking stations of the present application are described, for illustration, primarily with respect to the inferior vena cava IVC, superior vena cava SVC, mitral valve MV, and aorta / aortic valve. A defective mitral valve may suffer from insufficiency and / or regurgitation.Attorney Docket No.: THVMC-23670W001

[0067] The blood vessels, such as the aorta, inferior vena cava IVC, superior vena cava SVC, pulmonary artery PA, may be healthy or may be dilated, distorted, enlarged, have an aneurysm, or be otherwise impaired. Anatomical structures of the right atrium RA, right ventricle RV, left atrium LA, and left ventricle LV will be explained in greater detail. The devices described herein may be used in various areas whether explicitly described herein or not, e.g., in the inferior vena cava IVC and / or superior vena cava SVC, in the aorta (e.g., an enlarged aorta) as treatment for a defective mitral valve, in other areas of the heart or vasculature, in grafts, etc.

[0068] The right atrium RA receives deoxygenated blood from the venous system through 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 veins 17 carry blood from the liver to the inferior vena cava IVC. The coronary sinus CS is a collection of veins joined together to form a large vessel that collects deoxygenated blood from the heart muscle (myocardium), and delivers it to the right atrium RA. During the diastolic phase, or diastole, seen in FIG. 1 A, the deoxygenated blood from the inferior vena cava IVC, superior vena cava SVC, and coronary sinus CS that has collected in the right atrium RA passes through the tricuspid valve TV and into the right ventricle RV as the right ventricle RV expands, while blood from the left atrium LA passes through the mitral valve MV into the left ventricle LV. In the systolic phase, or systole, seen in FIG. IB, the right ventricle RV contracts to force the deoxygenated blood collected in the right ventricle RV through the pulmonary valve PV and pulmonary artery into the lungs, while the left ventricle LV contracts to force blood in the left ventricle through the Aortic Valve AV into the Ascending Aorta AA.

[0069] The devices described herein may be used to supplement the function of a defective mitral valve. During systole, the leaflets of a normally functioning mitral valve MV close to prevent the blood from regurgitating back into the left atrium LA. When the mitral valve MV does not operate normally, blood may backflow or regurgitate into the left atrium LA. Blood regurgitating backward into the left atrium LA increases the volume of blood in the atrium and the blood vessels that direct blood to the heart. This may cause the left atrium LA to enlarge and cause blood pressure to increase in the left atrium LA and blood vessels, which may cause damage to and / or swelling of the liver, kidneys, legs, other organs, etc. A transcatheter heart valve (THV) implanted in the mitral valve MV may inhibit blood from backflowing into the left atrium LA during the systolic phase.Attorney Docket No.: THVMC-23670W001

[0070] 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 the diastolic phase, or diastole, seen in FIG. 1A, the oxygen rich blood that collects in the left atrium LA passes through the mitral valve MV and into the left ventricle LV as the left ventricle LV expands. In the systolic phase, or systole, seen in FIG. IB, the left ventricle LV contracts to force the oxygen rich blood through the aortic valve AV and aorta into the body through the circulatory system. In certain embodiments, the devices described herein may be used to supplement or replace the function of a defective mitral valve MV.

[0071] An example transcatheter heart valve replacement procedure which utilizes a first delivery apparatus to deliver a docking device to a native valve annulus and then a second delivery apparatus to deliver a prosthetic transcatheter heart valve (THV) inside the docking device is depicted in the schematic illustrations of FIGS. 2A-4B.

[0072] As introduced above, defective native heart valves may be replaced with THVs. However, in certain instances, such THVs may not be able to sufficiently secure themselves to the native tissue (for example, to the leaflets and / or annulus of the native heart valve) and may undesirably shift around relative to the native tissue, leading to paravalvular leakage (PVL), valve malfunction, THV embolism, and / or other issues. Thus, a docking device may be implanted first at the native valve annulus and then the THV may be implanted within the docking device to help anchor the THV to the native tissue and provide a seal between the native tissue and the THV.

[0073] FIGS. 2A-4B depict an example THV replacement procedure (e.g., a mitral valve replacement procedure) which utilizes a docking device 52 (e.g., with compressible plug as described herein) and a prosthetic heart valve 62, according to one example. During the procedure, a user may create a pathway to a patient’s native heart valve using a guide catheter 30 (FIG. 2A). The user may deliver and implant the docking device 52 at the patient’s native heart valve using a docking device delivery apparatus 50 (FIG. 2B) and then removes the docking device delivery apparatus 50 from the patient 10 after implanting the docking device 52 (FIG. 3A). The user may then implant the prosthetic heart valve 62 within the implanted docking device 52 using a prosthetic valve delivery apparatus 60 (FIG. 3B). Thereafter, the user may remove the prosthetic valve delivery apparatus 60 from the patient 10 (FIG. 4A), as well as the guide catheter 30 (FIG. 4B).

[0074] FIG. 2A depicts a first stage in a mitral valve replacement procedure, according to one example. As shown, the guide catheter 30 and a guidewire 40 may be inserted into a vasculatureAttorney Docket No.: THVMC-23670W00112 of a patient 10 and navigated through the vasculature 12, into a heart 14 of the patient 10, and toward the native mitral valve 16 (e.g., through heart tissue wall between right atrium RA to left atrium LA as shown). The guide catheter 30 may provide a path for the docking device delivery apparatus 50 and the prosthetic valve delivery apparatus 60 to be navigated through and along, to the implantation site (e.g., the native mitral valve 16 or native mitral valve annulus). The guidewire 40 is removed before inserting a dock delivery system.

[0075] Initially, the user may first make an incision in the patient’s body to access the vasculature 12. For example, the user may make an incision in the patient’s groin to access a femoral vein. Thus, in such examples, the vasculature 12 may include a femoral vein.

[0076] After making the incision to access the vasculature 12, the user may insert the guide catheter 30, the guidewire 40, and / or additional devices (e.g., an introducer device or transseptal puncture device) through the incision and into the vasculature 12. The guide catheter 30 (i.e., “introducer device,” “introducer,” or “guide sheath”) may be configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., the docking device delivery apparatus 50 and the prosthetic valve delivery apparatus 60) into and through the vasculature 12 and may extend through the vasculature 12 and into the heart 14 but may stop short of the native mitral valve 16. The guide catheter 30 may comprise a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 may extend through the vasculature 12 and into the heart 14 while the handle 32 may remain outside the body of the patient 10 and may be operated by the user to manipulate the shaft 34 (FIG. 2A).

[0077] In some instances, a transseptal puncture device or catheter may be used to initially access the left atrium 18, prior to inserting the guidewire 40 and the guide catheter 30. For example, after making the incision to access the vasculature 12, the user may insert a transseptal puncture device through the incision and into the vasculature 12. The user may guide the transseptal puncture device through the vasculature 12 and into the heart 14 (e.g., through the femoral vein and into the right atrium 20). The user may then make a small incision in an atrial septum 22 of the heart 14 to allow access to the left atrium 18 from the right atrium 20. The user may then insert and advance the guidewire 40 through the transseptal puncture device within the vasculature 12 and through the incision in the atrial septum 22 into the left atrium 18. Once the guidewire 40 is positioned within the left atrium 18 and / or the left ventricle 26, the transseptal puncture device may be removed from the patient 10. The user may then insert the guide catheter 30 into the vasculature 12 and advance the guide catheter 30 into the left atrium 18 over the guidewire 40 (FIG. 2A).Attorney Docket No.: THVMC-23670W001

[0078] In some instances, an introducer device may be inserted through a lumen of the guide catheter 30 prior to inserting the guide catheter 30 into the vasculature 12. In some instances, the introducer device may include a tapered end that extends out a distal tip of the guide catheter 30 and that is configured to guide the guide catheter 30 into the left atrium 18 over the guidewire 40. Additionally, in some instances the introducer device may include a proximal end portion that extends out a proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user may remove the introducer device from inside the guide catheter 30 and the patient 10. The guidewire 40 is also removed. Thus, only the guide catheter 30 remains inside the patient 10. The guide catheter 30 is then in position to receive an implant delivery apparatus and help guide it to the left atrium 18, as described further below.

[0079] FIG. 2B depicts a second stage in the example mitral valve replacement procedure where a docking device 52 may be implanted at the native mitral valve 16 of the heart 14 of the patient 10 using a docking device delivery apparatus 50 (i.e., “implant catheter,” or a “docking device delivery device,” or simply “delivery apparatus”).

[0080] In general, the docking device delivery apparatus 50 may include a delivery shaft 54 (i.e., as an “outer shaft”), a handle 56, and a pusher assembly 58 (i.e., “pusher shaft”). The delivery shaft 54 may be configured to be advanced through the patient’s vasculature 12 and to the implantation site (e.g., native mitral valve 16) by the user, and may be configured to retain the docking device 52 in a distal end portion 53 of the delivery shaft 54. In some examples, the distal end portion 53 of the delivery shaft 54 may retain the docking device 52 therein in a substantially straight delivery orientation.

[0081] The handle 56 of the docking device delivery apparatus 50 may be configured to be gripped and / or otherwise held by the user to advance the delivery shaft 54 through the patient's vasculature 12. Specifically, the handle 56 may be coupled to a proximal end of the delivery shaft 54 and may be configured to remain accessible to the user (e.g., outside the body of the patient 10) during the docking device implantation procedure. In this way, the user may advance the delivery shaft 54 through the patient’s vasculature 12 by exerting a force on (e.g., pushing) the handle 56. In some examples, the delivery shaft 54 may be configured to carry the pusher assembly 58 and / or the docking device 52 with it as it advances through the patient’s vasculature 12. In this way, the docking device 52 and / or the pusher assembly 58 may advance through the patient’s vasculature 12 in lockstep with the delivery shaft 54 as the user grips the handle 56 and pushes the delivery shaft 54 deeper into the patient’s vasculature 12.Attorney Docket No.: THVMC-23670W001

[0082] In some examples, the handle 56 may comprise one or more articulation members 57 that are configured to aid in navigating the delivery shaft 54 through the vasculature 12. For example, the one or more articulation members 57 may comprise one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and / or otherwise articulate a distal end portion 53 of the delivery shaft 54 to aid in navigating the delivery shaft 54 through the vasculature 12 and / or within the heart 14.

[0083] The pusher assembly 58 may be configured to deploy and / or implant the docking device 52 at the implantation site (e.g., the native mitral valve 16). For example, the pusher assembly 58 may be configured to be adjusted by the user to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54. A pusher shaft of the pusher assembly 58 may extend through the delivery shaft 54 and may be disposed 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 apparatus 50 such that the docking device 52 may be released after being deployed at the native mitral valve 16. Because the docking device 52 is retained by, held, and / or otherwise coupled to the pusher assembly 58, the docking device 52 may advance in lockstep with the pusher assembly 58 through and / or out of the delivery shaft 54.

[0084] In addition to the pusher shaft, in certain instances, 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 the sleeve shaft, when included, may have a distal dock sleeve configured to cover the docking device 52 within the delivery shaft 54 and while pushing the docking device 52 out of the delivery shaft 54 and positioning the docking device 52 at the implantation site. In some examples, the pusher shaft may be covered, at least in part, by the sleeve shaft.

[0085] In some examples, the pusher assembly 58 may comprise a pusher handle that is coupled to the pusher shaft and that is configured to be gripped and pushed by the user to translate the pusher shaft axially relative to the delivery shaft 54 (e.g., to push the pusher shaft into and / or out of the distal end portion 53 of the delivery shaft 54). The dock sleeve may be configured to be retracted and / or withdrawn from the docking device 52, after positioning the docking device 52 at the target implantation site. For example, the pusher assembly 58 may include a sleeve handle that is coupled to the sleeve shaft and is configured to be pulled by aAttorney Docket No.: THVMC-23670W001user to retract (e.g., axially move) the sleeve shaft relative to the pusher shaft, thereby retracting the dock sleeve.

[0086] The pusher assembly 58 may be removably coupled to the docking device 52, and as such may be configured to release, detach, decouple, and / or otherwise disconnect from the docking device 52 once the docking device 52 has been deployed at the target implantation site. As just one example, the pusher assembly 58 may be removably coupled to the docking device 52 via a thread, string, yarn, suture, or other suitable material that is tied or sutured to the docking device 52. In an example, a suture is threaded through an eyelet of the docking device 52 and tied off at a suture lock.

[0087] In some examples, the pusher assembly 58 may include a suture lock assembly (i.e., “suture lock”) that is configured to receive and / or hold the thread or other suitable material that is coupled to the docking device 52 via a suture. The thread or other suitable material that forms 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, detach, decouple, and / or otherwise disconnect the docking device 52 from the pusher assembly 58. For example, the suture lock assembly may comprise a cutting mechanism that is configured to be adjusted by the user to cut the suture. Alternatively, the suture lock assembly may be configured to be detached from the delivery system to give access to the sutures so the user may manually cut and remove the suture to release the docking device 52.

[0088] Referring again to FIG. 2B, after the guide catheter 30 is positioned within the left atrium 18, the user may insert the docking device delivery apparatus 50 (e.g., the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 of the docking device delivery apparatus 50 through the guide catheter 30. In some examples, the guidewire 40 may be at least partially retracted away from the left atrium 18 and into the guide catheter 30. The user may then continue to advance the delivery shaft 54 of the docking device delivery apparatus 50 through the vasculature 12 along the guidewire 40 until the delivery shaft 54 reaches the left atrium 18, as illustrated in FIG. 2B. Specifically, the user may advance the delivery shaft 54 of the docking device delivery apparatus 50 by gripping and exerting a force on (e.g., pushing) the handle 56 of the docking device delivery apparatus 50 toward the patient 10. While advancing the delivery shaft 54 through the vasculature 12 and the heart 14, the user may adjust the one or more articulation members 57 of the handle 56 to navigate the various turns, comers, constrictions, and / or other obstacles in the vasculature 12 and the heart 14.Attorney Docket No.: THVMC-23670W001

[0089] Once the delivery shaft 54 reaches the left atrium 18 and extends out of a distal end of the guide catheter 30, the user may position the distal end portion 53 of the delivery shaft 54 at and / or near the posteromedial commissure of the native mitral valve 16 using the handle 56 (e.g., the articulation members 57). The user may then push the docking device 52 out of the distal end portion 53 of the delivery shaft 54 with the shaft of the pusher assembly 58 to deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0090] In some examples, the docking device 52 may be constructed from, formed of, and / or comprise a shape memory material, and as such, may return to its original, pre-formed shape when it exits the delivery shaft 54 and is no longer constrained by the delivery shaft 54. As one example, the docking device 52 may originally be formed as a coil, and thus may wrap around leaflets 24 of the native mitral valve 16 as it exits the delivery shaft 54 and returns to its original coiled configuration.

[0091] After pushing a ventricular portion of the docking device 52 (e.g., the portion of the docking device 52 shown in FIG. 2B that is configured to be positioned within a left ventricle 26 and / or on the ventricular side of the native mitral valve 16), the user may then deploy the remaining portion of the docking device 52 (e.g., an atrial portion of the docking device 52, optionally having a brim feature) from the delivery shaft 54 within the left atrium 18 by retracting the delivery shaft 54 away from the medial commissure of the native mitral valve 16. For example, the user may maintain the position of the pusher assembly 58 (e.g., by exerting a holding and / or pushing force on the pusher shaft) while retracting the delivery shaft 54 proximally so that the delivery shaft 54 withdraws and / or otherwise retracts relative to the docking device 52 and the pusher assembly 58. In this way, the pusher assembly 58 may hold the docking device 52 in place while the user retracts the delivery shaft 54, thereby releasing the docking device 52 from the delivery shaft 54. In some examples, the user may also remove the dock sleeve from the docking device 52, for example, by retracting the sleeve shaft. The compressible plug feature that is described in more detail below may help facilitate retention of the docking device in the native mitral valve 16 and avoid PVL.

[0092] After deploying and implanting the docking device 52 at the native mitral valve 16, the user may disconnect the docking device delivery apparatus 50 from the docking device 52. Once the docking device 52 is disconnected from the docking device delivery apparatus 50 (e.g., by cutting the suture tied to the docking device 52), the user may retract the docking device delivery apparatus 50 out of the vasculature 12 and away from the patient 10 so that theAttorney Docket No.: THVMC-23670W001user may deliver and implant a prosthetic heart valve 62 within the implanted docking device 52 at the native mitral valve 16.

[0093] FIG. 3A depicts a third stage in the mitral valve replacement procedure, where the docking device 52 has been fully deployed and implanted at the native mitral valve 16 and the docking device delivery apparatus 50 (including the delivery shaft 54) has been removed from the patient 10 such that only the guidewire 40 and the guide catheter 30 remain inside the patient 10. In some examples, after removing the docking device delivery apparatus 50, the guidewire 40 may be advanced out of the guide catheter 30, through the implanted docking device 52 at the native mitral valve 16, and into the left ventricle 26 (FIG. 2B). As such, the guidewire 40 may help to guide the prosthetic valve delivery apparatus 60 through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.

[0094] As illustrated in FIG. 3A, the docking device 52 may comprise a plurality of helical turns that wrap around the leaflets 24 of the native mitral valve 16 (e.g., within the left ventricle 26). The implanted docking device 52 may have a more cylindrical shape than the annulus of the native mitral valve 16, thereby providing a geometry that more closely matches the shape or profile of the THV to be implanted. As a result, the docking device 52 with the compressible plug may provide a tighter fit, and thus a better seal, between the prosthetic heart valve and the native mitral valve 16 to inhibit PVL at the medial commissure, as described further below.

[0095] FIG. 3B depicts a fourth stage in the mitral valve replacement procedure where the user is delivering and / or implanting a prosthetic heart valve 62 within the docking device 52 using a prosthetic valve delivery apparatus 60.

[0096] As shown in FIG. 3B, the prosthetic valve delivery apparatus 60 may comprise 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 vasculature 12 to deliver, implant, expand, and / or otherwise deploy the prosthetic heart valve 62 within the docking device 52 at the native mitral valve 16. The handle 66 may be configured to be gripped and / or otherwise held by the user to advance the delivery shaft 64 through the patient's vasculature 12.

[0097] In some examples, the handle 66 may comprise one or more articulation members 68 that are configured to aid in navigating the delivery shaft 64 through the vasculature 12 and the heart 14. Specifically, the articulation members 68 may comprise one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and / or otherwise articulate aAttorney Docket No.: THVMC-23670W001distal end portion of the delivery shaft 64 to aid in navigating the delivery shaft 64 through the vasculature 12 and into the left atrium 18 and left ventricle 26 of the heart 14.

[0098] In some examples, the prosthetic valve delivery apparatus 60 may include an expansion mechanism 65 that is configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. In some instances, as shown in FIG. 3B, the expansion mechanism 65 may comprise an inflatable balloon that is configured to be inflated 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.

[0099] In other examples, the prosthetic heart valve 62 may be self-expanding and may be configured to radially expand on its own upon removable of a sheath or capsule covering the radially compressed prosthetic heart valve 62 on the distal end portion of the delivery shaft 64. In still other examples, the prosthetic heart valve 62 may be mechanically expandable and the prosthetic valve delivery apparatus 60 may include one or more mechanical actuators (e.g., the expansion mechanism) configured to radially expand the prosthetic heart valve 62.

[0100] As shown in FIG. 3B, the prosthetic heart valve 62 may be mounted around the expansion mechanism 65 (e.g., the inflatable balloon) on the distal end portion of the delivery shaft 64, in a radially compressed configuration.

[0101] To navigate the distal end portion of the delivery shaft 64 to the implantation site, the user may insert the prosthetic valve delivery apparatus 60 (e.g., the delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guidewire 40. The user may continue to advance the prosthetic valve delivery apparatus 60 along the guidewire 40 (e.g., through the vasculature 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as illustrated in FIG. 3B. More specifically, the user may advance the delivery shaft 64 of the prosthetic valve delivery apparatus 60 by gripping and exerting a force on (e.g., pushing) the handle 66. While advancing the delivery shaft 64 through the vasculature 12 and the heart 14, the user may adjust the one or more articulation members 68 of the handle 66 to navigate the various turns, comers, constrictions, and / or other obstacles in the vasculature 12 and heart 14.

[0102] The user may 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 native mitral valve 16. In some examples, as shown in FIG. 3B, a distal end of the delivery shaft 64 and a least a portion of the radially compressed prosthetic heart valve 62 may be positioned within the left ventricle 26.Attorney Docket No.: THVMC-23670W001

[0103] Once the radially compressed prosthetic heart valve 62 is appropriately positioned within the docking device 52 (FIG. 3B), the user may manipulate one or more actuation mechanisms of the handle 66 of the prosthetic valve delivery apparatus 60 to actuate the expansion mechanism 65 (e.g., inflate the inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52. In some examples, the user may lock the prosthetic heart valve 62 in its fully expanded position (e.g., with a locking mechanism) to prevent the prosthetic heart valve 62 from collapsing.

[0104] FIG. 4A shows a fifth stage in the mitral valve replacement procedure where the prosthetic heart valve 62 in its radially expanded configuration and implanted within the docking device 52 in the native mitral valve 16. As shown in FIG. 4A. the prosthetic heart valve 62 may be received and retained within the docking device 52.

[0105] As also shown in FIG. 4A, after the prosthetic heart valve 62 has been fully deployed and implanted within the docking device 52 at the native mitral valve 16, the prosthetic valve delivery apparatus 60 (e.g., including the delivery shaft 64) may be removed from the patient 10 such that only the guidewire 40 and the guide catheter 30 remain inside the patient 10.

[0106] FIG. 4B depicts a sixth stage in the mitral valve replacement procedure, where the guidewire 40 and the guide catheter 30 have been removed from the patient 10. The docking device 52 with a compressible plug and optionally a brim feature (e.g., guard member) may be configured to provide a seal between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16 to reduce paravalvular leakage around the prosthetic heart valve 62. The compressible plug may be configured for plugging the medial commissure to inhibit any leakage from the area. Specifically, the docking device 52 may initially constrict the leaflets 24 of the native mitral valve 16, where the brim feature sits on top on the left atrial side and the compressible plug fits on or into the medial commissure. The prosthetic heart valve 62 may then push the leaflets 24 against the docking device 52 as it radially expands within the docking device 52. Thus, the docking device 52 and the prosthetic heart valve 62 may be configured to sandwich the leaflets 24 of the native mitral valve 16 when the prosthetic heart valve 62 is expanded within the docking device 52. In this way, the docking device 52 may provide a seal between the leaflets 24 of the native mitral valve 16 and the prosthetic heart valve 62 to reduce paravalvular leakage around the prosthetic heart valve 62, especially with the medial commissure being plugged by the compressible plug.

[0107] In some examples, one or more of the docking device delivery apparatus 50, the prosthetic valve delivery apparatus 60, and / or the guide catheter 30 may comprise one or moreAttorney Docket No.: THVMC-23670W001fluid ports that are configured to supply flushing fluid to the lumens thereof 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 a docking device delivery apparatus are described further below.

[0108] Although FIGS. 2A-4B specifically depict a mitral valve replacement procedure, it should be appreciated that the same and / or similar procedure may be utilized to replace other heart valves (e.g., tricuspid, pulmonary, and / or aortic valves). Further, the same and / or similar delivery apparatuses (e.g., docking device delivery apparatus 50, prosthetic valve delivery apparatus 60, guide 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 may be utilized for replacing these other heart valves.

[0109] For example, when replacing a native tricuspid valve, the user may also access the right atrium 20 via a femoral vein but may not need to cross the atrial septum 22 into the left atrium 18. Instead, the user may leave the guidewire 40 in the right atrium 20 and perform the same and / or similar docking device implantation process at the tricuspid valve. Specifically, the user may push the docking device 52 out of the delivery shaft 54 around the ventricular side of the tricuspid valve leaflets, release the remaining portion 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 apparatus 50 from the patient 10. The user may then advance the guidewire 40 through the tricuspid valve into the right ventricle and perform the same and / or similar prosthetic heart valve implantation process at the tricuspid valve, within the docking device 52. Specifically, the user may advance the delivery shaft 64 of the prosthetic valve delivery apparatus 60 through the patient’s vasculature along the guidewire 40 until the prosthetic heart valve 62 is positioned or disposed within the docking device 52 and the tricuspid valve. The user may then expand the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery apparatus 60 from the patient 10. In another example, the user may perform the same and / or similar process to replace the aortic valve but may access the aortic valve from the outflow side of the aortic valve via a femoral artery.

[0110] Further, although FIGS. 2A-4B depict a mitral valve replacement procedure that accesses the native mitral valve 16 from the left atrium 18 via the right atrium 20 and femoral vein, it should be appreciated that the native mitral valve 16 may alternatively be accessed from the left ventricle 26. For example, the user may access the native mitral valve 16 from the leftAttorney Docket No.: THVMC-23670W001ventricle 26 via the aortic valve by advancing one or more delivery apparatuses through an artery to the aortic valve, and then through the aortic valve into the left ventricle 26.

[0111] Additional examples of the docking device delivery apparatus, including its variants, and methods of implanting a docking device and implanting a prosthetic valve within the docking device are described in International Publication Nos. WO 2020 / 247907 and WO 2022 / 087336, and U.S. Patent Publication Nos. US 2018 / 0318079, US2018 / 0263764, and US2018 / 0177594, which are all incorporated by reference herein in their entireties.Example Prosthetic Valves

[0112] Details regarding the prosthetic heart valves described herein and various valve components are described U.S. Patent No. 11,185,406, which is incorporated herein by reference. Additional 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 Publication No. 2018 / 0028310, all of which are incorporated herein by reference in their entireties.

[0113] In some examples, the prosthetic heart valves comprise a plastically expandable material, which may be metal alloys, polymers, or combinations thereof. Example metal alloys may comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the prosthetic heart valve may comprise stainless steel, cobalt-chromium, nickel-cobalt-chromium, a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0114] In some examples, the prosthetic heart valve may be a self-expandable prosthetic valve with a frame made from a self-expanding material, such as nickel-titanium alloy or Nitinol. When the prosthetic valve is a self-expanding valve, the balloon of the delivery apparatus may be replaced with a sheath or similar restraining device that retains the prosthetic valve in a radially compressed state for delivery through the body. When the prosthetic valve is at the implantation location, the prosthetic valve may be released from the sheath, and therefore allowed to expand to its functional size. It should be noted that any of the delivery apparatuses disclosed herein may be adapted for use with a self-expanding valve.Overview of Docking Devices

[0115] Docking devices according to examples of the disclosure can, for example, provide a stable anchoring site, landing zone, or implantation zone at the implant site in which prostheticAttorney Docket No.: THVMC-23670W001valves may be expanded or otherwise implanted. Many of the disclosed docking devices comprise a circular or cylindrically-shaped portion, which may (for example) allow a prosthetic heart valve comprising a circular or cylindrically-shaped valve frame to be expanded or otherwise implanted into native locations with naturally circular cross-sectional profiles and / or in native locations with naturally non-circular cross sections. In addition to providing an anchoring site for the prosthetic valve, the docking devices may be sized and shaped to cinch or draw the native valve (e.g., mitral, tricuspid, etc.) anatomy radially inwards. In this manner, one of the main causes of valve regurgitation (e.g., functional mitral regurgitation), specifically enlargement of the heart (e.g., enlargement of the left ventricle, etc.) and / or valve annulus, and consequent stretching out of the native valve (e.g., mitral, etc.) annulus, may be at least partially offset or counteracted. Some examples of the docking devices further include features which, for example, are shaped and / or modified to better hold a position or shape of the docking device during and / or after expansion of a prosthetic valve therein. By providing such docking devices, replacement valves may be more securely implanted and held at various valve annuluses, including at the mitral valve annulus which does not have a naturally circular cross-section.

[0116] FIG. 5 is an atrial view of an example mitral valve 500 in which some embodiments herein may be implemented. As illustrated, the mitral valve 500 includes an anterior leaflet, a posterior leaflet, a medial commissure, and a lateral commissure. The two commissures are located where the anterior and posterior leaflets come together. In some embodiments, docking devices for use in a mitral valve and / or other native heart valves may include a helical coil that defines the circular or cylindrical-shaped valve frame to receive and support the prosthetic valve. In these and other embodiments, the helical coil may pass through one of the two commissures, with a first portion of the helical coil of the docking device located to an atrial side of the native valve and a second portion of the helical coil located to a ventricular side of the native valve, the helical coil extending from the atrial side to the ventricular side (or vice versa) through the corresponding commissure. The docking device and native tissue may be prone to PVL at or through the commissure through which the helical coil extends from the atrial to the ventricular side of the native valve.

[0117] Use of the compressible plug herein may reduce or at least inhibit such PVL, e.g., by placing the compressible plug within the commissure, e.g., with a first portion on an atrial side of the native valve, a second portion on a ventricular side of the native valve, and a third portion (e.g., that connects the first portion to the second portion) position within the commissure through which the helical coil passes. For simplicity in the discussion that follows, it is assumedAttorney Docket No.: THVMC-23670W001that the helical coil of the docking device passes from the atrial to the ventricular side of the native mitral valve at the medial commissure such that the compressible plug may be positioned within the medial commissure and may optionally be referred to as a medial commissure compressible plug. In other embodiments, the compressible plugs described herein may be implemented in or at other native valves (e.g., the tricuspid valve) and / or other valve commissures (e.g., the lateral commissure of the native mitral valve).Example Medial Commissure Plug

[0118] FIGS. 6A-6C show example plug scaffolds 200 for use as a medial commissure compressible plug 210, arranged in accordance with at least one embodiment herein. The compressible plug 210 includes the scaffold and a plugging component 208. In the illustrated embodiments, the plugging component 208 includes a cover on one or more surfaces of the compressible plug 210. More generally, the plugging component may include a cover, inner bladder, absorbable members, compressible hydrophobic members, or the like or any combination thereof that inhibit fluid from passing the compressible plug 210 from the medial commissure.

[0119] FIG. 6A includes a perspective view that shows an embodiment of a compressible plug scaffold 200 that is shaped as an atrial lobe 202 and a ventricular lobe 204 connected by an intermediate waist 206. In the illustrated example, each of the lobes 202, 204 and the intermediate waist 206 is generally circular, cylindrical, and / or disk-shaped. The compressible plug 210 includes or defines an axis 212 that may be orthogonal to an axis of a helical coil of a docking device to or in which the compressible plug 210 is coupled or included. In some embodiments, in use, the atrial lobe 202 may be located on an atrial side of the native valve / medial commissure with the ventricular lobe 204 located on a ventricular side of the native valve / medial commissure, with the intermediate waist 206 passing through the medial commissure. In these and other embodiments, the axis 212 of the compressible plug 210 may be arranged generally orthogonal to the native valve plane and / or parallel to (or aligned with and / or within) the medial commissure gap.

[0120] The compressible plug scaffold 200 in FIG. 6A is a three-dimensional body having the atrial lobe 202 and the ventricular lobe 204 coupled by the intermediate waist 206. The three-dimensional body is shaped as a mesh scaffold that is formed of one or more wires that are formed of a shape -memory material to define apertures. This allows for the compressible plug scaffold 200 to be formed into a desired compressible shape for shape-memory return. The compressible shape may have an internal space with volume, that when compressed closes theAttorney Docket No.: THVMC-23670W001shape to be substantially tubular and / or elongated without any internal space or internal volume (or with significantly reduced internal space and / or internal volume). The wires of the mesh scaffold are formed so that they may be formed into the shape-memory compressible shape and then compressed to conform with whatever shape is being defined by the compression. For example, a catheter delivery device may have a tubular lumen for receiving an implantable medical device, such as a docking station. The wires are formed so that the compressible plug scaffold 200 may be deformed into a tubular, cylindrical, shorted or elongated in some direction to overall compress the scaffold 200 into a tubular lumen, and often to be a layer around a coil in a tubular lumen. The wires of the mesh scaffold 200 thereby provide significant flexibility to conform the compressible plug into a lumen of a delivery device tube and often deforming into a layer around a coil functioning as a core, which is configured as a compressible plug shell around the coil core.

[0121] FIG. 6B illustrates an embodiment of the compressible plug 210 having the compressible plug scaffold 200 formed by the mesh scaffold with the shape-memory wires to define apertures between the wires, the compressible plug scaffold 200 having the shape of a single cylindrical body 214 when not compressed. In use, the cylindrical body 214 may be positioned to pass through the medial commissure with a first portion of the cylindrical body 214 being positioned on an atrial side of the commissure, a second portion of the cylindrical body 214 being positioned on a ventricular side of the commissure, and a third portion of the cylindrical body 214 passing through the commissure. The nature of the mesh scaffold may permit the third portion within the commissure to be at least somewhat compressed to conform to available space through the commissure while the first and second portions located to the atrial and ventricular sides may be in their expanded shape to better cover and / or plug the commissure. As in FIG. 6A, the axis 212 of the compressible plug 210 of FIG. 6B may be arranged generally orthogonal to the native valve plane and / or parallel to (or aligned with and / or within) the medial commissure gap in use.

[0122] FIG. 6C illustrates another embodiment of a compressible plug 210 having the compressible plug scaffold 200 formed by the mesh scaffold with the shape-memory wires to define apertures between the wires. Here, the mesh scaffold is again formed into the atrial lobe 202 and the ventricular lobe 204 coupled by the intermediate waist 206, but the lobes 202, 204 are of generally equal size in FIG. 6C, whereas in FIG. 6 A, the atrial lobe 202 is much longer axially (e.g., along the axis 212) than the ventricular lobe 204.Attorney Docket No.: THVMC-23670W001

[0123] In the examples of FIGS. 6A-6C, the scaffold 200 has a generally circular shape in a plane orthogonal to the axis 212. More generally, the scaffold 200 may have virtually any desired shape or outline in the plane orthogonal to the axis 212. FIG. 7 A depicts various scaffold shapes or outlines that compressible plugs herein may have, e.g., in the plane orthogonal to the axis 212, in accordance with at least one embodiment herein. For example, as illustrated in FIG. 7A, compressible plugs herein may have a shape in a plane orthogonal to the axis 212 that is a generally circular shape 702, a generally oval shape 704, a generally kidney or crescent shape 706, a generally rectangular shape 708, or other desired shape.

[0124] In the examples of FIGS. 6A and 6C, the compressible plug 210 has two lobes 202, 204 coupled by the intermediate waist 206 in which the intermediate waist 206 has a diameter that is much smaller than diameters of the lobes 202, 204. More generally, in embodiments with two lobes 202, 204, the intermediate waist 206 may have any desired diameter or size relative to the diameters of the lobes 202, 204. For example, FIG. 7B illustrates various compressible plug 2-lobe embodiments 702, 704, 706 in which the intermediate waist 206 has various sizes or diameters relative to the lobes 202, 204, in accordance with at least one embodiment herein. While the two lobes 202, 204 are depicted as equal in size in the embodiments 702, 704, 706 of FIG. 7B, in other embodiments they may have different sizes, e.g., as in FIG. 6A.

[0125] Although not depicted in FIGS. 6A-6C, in some embodiments the compressible plug 210 may include one or more marker bands or radio opaque markers at one or more locations on the compressible plug 210, such as at one or both ends, the atrial lobe 202, the ventricular lobe 204, the intermediate waist 206, or more generally at any desired location. The marker bands may include platinum iridium, tantalum, gold, tungsten, or other desired marker. The marker bands may enable better visualization of positioning of the compressible plug 210 during deployment.

[0126] FIG. 7B further illustrates the intermediate waist 206 centered (vertically in the orientation of FIG. 7B) relative to the lobes 202, 204. In other embodiments, the intermediate waist 206 may be offset to one side or the other (i.e., up, down, into the page, out of the page, or a combination thereof in the orientation of FIG. 7B). For example, FIG. 7C illustrates various compressible plug 2-lobe embodiments 708, 710, 712 in which the intermediate waist 206 is offset (downward in the orientation of FIG. 7C) different amounts relative to the lobes 202, 204, in accordance with at least one embodiment herein. While the two lobes 202, 204 are depicted as equal in size in FIG. 7C, in other embodiments they may have different sizes, e.g., as in FIG. 6A.Attorney Docket No.: THVMC-23670W001

[0127] FIG. 8A illustrates a top view of an example embodiment of a docking device 70 or a coil of a docking device 70 in accordance with at least one embodiment herein. The docking device 70 may be configured to fit at the mitral position but may be shaped and / or adapted similarly or differently in other embodiments for better accommodation at other native valve positions as well, such as at the tricuspid valve. The docking device 70 may include, be included in, or correspond to other docking devices herein, such as the docking device 52 of FIGS. 2B-4B. Advantageously, the docking device geometries of the present disclosure provide for engagement with the native anatomy that may provide for increased stability and reduction of relative motion between the docking device 70, the prosthetic valve docked therein, and the native anatomy. Reduction of such relative motion may prevent material degradation of components of the docking device and / or the prosthetic valve docked therein and may prevent damage / trauma to the native tissues as well as preventing PVL, such as through the medial commissure.

[0128] The docking device 70 of many embodiments includes a central region 80 with a coil, coiled portion, or multiple coils (e.g., 2 coils, 3 coils, 4 coils, between 2-5 coils, or more). The coiled portion or coils of the central region 80 may be similarly sized and shaped or vary in size and / or shape. In some implementations, the central region 80 comprises three or approximately three full coil turns having substantially equal inner diameters. The central region 80 of the docking device 70 serves as the main landing region or holding region for holding the expandable prosthetic valve when the docking device 70 and the valve prosthesis are implanted into a patient’s body. In some embodiments, the docking device 70 has a central region 80 with more or less than three coil turns, depending for example, on the patient’s anatomy, the amount of vertical contact desired between the docking device 70 and the valve prosthesis (e.g., transcatheter heart valve or THV), and / or other factors. The coiled portion or coil(s) of the central region 80 may also be referred to as the “functional coils” or “functional turns” since the properties of these coils contribute the most to the amount of retention force generated between the valve prosthesis, the docking device 70, and the native mitral leaflets and / or other anatomical structures.

[0129] Various factors may contribute to the total retention force between the docking device 70 and the prosthetic valve held therein. A main factor is the number of turns included in the functional coils, while other factors include, for example, an inner diameter of the functional coils, friction force (e.g., between the coils and the prosthetic valve), and the strength of the prosthetic valve and the radial force the valve applies on the coil. A docking device may haveAttorney Docket No.: THVMC-23670W001a variety of numbers of coils and / or coil turns. The number of functional turns may be in ranges from just over a half turn to 5 turns, or one full turn to 5 turns, or more. In one embodiment with three full turns, an additional one-half turn is included in the ventricular portion of the docking device. In another embodiment, there may be three full turns total in the docking device. In one embodiment, in the atrial portion of the docking device, there may be one-half to three-fourths turn or one -half to three-fourths of a circle. While a range of turns is provided, as the number of turns in a docking device is decreased, the dimensions and / or materials of the coil and / or the wire that the coil is made from may also change to maintain a proper retention force. For example, the diameter of the wire may be larger and / or the diameter of the functional coil turn(s) in a docking device with fewer coils. There may be a plurality of coils in the atrium and in the ventricle.

[0130] A size of the functional coils or coils of the central region 80 is generally selected based on the size of the desired THV to be implanted into the patient. Generally, the inner diameter 90 of the functional coils / tums (e.g., of the coils / tums of the central region 80 of the docking device 70) will be smaller than the outer diameter of the expandable heart valve, so that when the prosthetic valve is expanded in the docking device, additional radial tension or retention force will act between the docking device 70 and the prosthetic valve to hold the prosthetic valve in place. The retention force needed for adequate implantation of a prosthetic valve varies based on the size of the prosthetic valve and on the ability of the assembly to handle mitral pressures of approximately 180 mm Hg. For example, based on hemodynamic data using a prosthetic valve with a 29 mm expanded outer diameter, a retention force of at least 15.8 Newtons (N) may be needed between the docking device and the prosthetic valve to securely hold the prosthetic valve in the docking device and to resist or prevent valve regurgitation or leakage. However, under this example, to meet this 15.8 N retention force requirement with statistical reliability, a target average retention force should be substantially greater, for example, approximately 30 N.

[0131] In many embodiments, the retention force between the docking device 70 and the valve prosthesis reduces dramatically when a difference between the outer diameter of the prosthetic valve in its expanded state and the inner diameter of the functional coils is less than about 5 mm, since the reduced size differential may be too small to create sufficient retention force between the components. For example, when, in one embodiment, a prosthetic valve with a 29 mm expanded outer diameter was expanded in a set of coils with a 24 mm inner diameter, the retention force observed was about 30 N, but when the same prosthetic valve was expanded inAttorney Docket No.: THVMC-23670W001a set of coils with a 25 mm inner diameter (e.g., only 1 mm larger), the retention force observed dropped significantly to only 20 N. Therefore, in some embodiments, to create a sufficient retention force between the docking device and a 29 mm prosthetic valve, the inner diameter of the functional coils (e.g., the coils of the central region of docking device 70) should be 24 mm or less. Often, the inner diameter of the functional coils (e.g., central region 80 of the docking device 70) should be selected to be at least about 5 mm less than the prosthetic valve that is selected for implantation, though other features and / or characteristics (e.g., friction enhancing features, material characteristics, etc.) may be used to provide better retention if other sizes or size ranges are used, as various factors may affect retention force.

[0132] However, diameter of the functional coils should be selected based on consideration and balancing of several factors to obtain optimal results. For example, the native anatomy between the mitral annulus at the mitral plane and the papillary muscle heads forms a generally trapezoidal shape, and the tissue of the mitral leaflets is thicker near the mitral plane and thins the further below the mitral plane. Smaller diameters of the central region 80 may encourage the docking device 70 to install further below the mitral plane than desirable (a similar effect may be observed at the tricuspid valve as well). When docking occurs at a location where the mitral leaflets are thinner, this may result in a suboptimal anchoring position for the prosthetic valve. Accordingly, size, diameters, and other features that help hold the prosthetic valve higher on the leaflets may be beneficial. In addition, a size of the inner diameter of the functional coils or central region 80 may also be selected to draw the native anatomy closer together, to at least partially offset or counteract valve regurgitation that is caused by stretching out of the native valve annulus as a result of, for example, left ventricular enlargement.

[0133] It is noted that the desired retention forces discussed above are applicable to embodiments for mitral valve replacements. Therefore, other embodiments of the docking device that are used for replacement of other valves may have different size relationships based on the desired retention forces for valve replacement at those respective positions. In addition, the size differentials may also vary, for example, based on the materials used for the valve and / or the docking device, whether there are any other features to prevent expansion of the functional coils or to enhance friction / locking, and / or based on various other factors.

[0134] In embodiments where the docking device 70 is used at the mitral position, the docking device may first be advanced and delivered to the native mitral valve annulus, and then set at a desired position, prior to implantation of the prosthetic heart valve. In some embodiments, the docking device 70 is flexible and / or made of a shape memory material, so that the coils ofAttorney Docket No.: THVMC-23670W001the docking device 70 may be straightened for delivery via a transcatheter approach as well. In some embodiments, the coil is made of another biocompatible material, such as stainless steel. Some of the same catheters and other delivery tools may be used for both delivery of the docking device 70 and the prosthetic valve, without having to perform separate preparatory steps, simplifying the implantation procedure for the end user.

[0135] Since the functional coils / tums or coils / tums of the central region 80 of the docking device 70 are kept relatively small in diameter (e.g., the central region 80 in one embodiment may have an inner diameter of between approximately 21-24 mm (e.g., ± 2 mm) or another diameter smaller than the prosthetic valve and / or the native annulus) to increase retention force with the prosthetic valve, it might be difficult to advance the docking device 70 around the existing leaflets and / or chordae tendineae to a desired position relative to the native mitral annulus. This is especially true, if the entire docking device 70 is made to have the same small diameter as the central region 80. Therefore, the docking device 70 may have a distal or lower region 82 that comprises and / or consists of a leading coil / tum (sometimes referred to as an encircling turn or a leading ventricular coil / turn) of the docking device 70, which has a lower diameter that is greater than the diameter of the functional coils / tums or of the coils / tums of central region 80.

[0136] Features of the native anatomy, especially in the right and left ventricles, have variable dimensions. For example, native mitral anatomy may have an approximately 35 mm to 45 mm greatest width on a long axis. The diameter or width of the encircling turn or leading coil / turn (e.g., ventricular coil / turn) of the lower region 82 may be selected to be larger to more easily navigate a distal or leading tip 84 of the docking device 70 around and encircle the features of the native anatomy (e.g., leaflets and / or chordae tendineae).

[0137] Various sizes and shapes are possible, for example, in one embodiment, the diameter could be any size from 25 mm to 75 mm. The term “diameter” as used in this disclosure does not require that a coil / turn be a complete or perfectly-shaped circle but is generally used to refer to a greatest width across opposing points of the coil / tum. For example, with respect to the leading coil / turn, diameter may be measured from the distal tip 84 to the opposite side, as if the lower region 82 or leading coil / turn formed a complete rotation.

[0138] In various embodiments, the docking device 70 may also include an enlarged proximal or upper region 86 that comprises and / or consists of a stabilizing coil / tum (e.g., which may be an atrial coil / tum) of the docking device 70. During a transient or intermediate stage of the implantation procedure, that is, during the time between the deployment and release of theAttorney Docket No.: THVMC-23670W001docking device 70 and final delivery of the prosthetic valve, there is a possibility that the coil could be shifted and / or dislodged from its desired position or orientation, for example, by regular heart function. Shifting of the docking device 70 could potentially lead to a less secure implantation, misalignment, and / or other positioning issues for the prosthetic valve. A stabilization feature or coil may be used to help stabilize the docking device 70 in the desired position. For example, the docking device 70 may include the upper region 86 with an enlarged stabilization coil / tum (e.g., an enlarged atrial coil / turn having a greater diameter 92 and / or 94 than the functional coils) intended to be positioned in the circulatory system (e.g. in the left atrium) such that it may stabilize the docking device. For example, the upper region 86 or stabilization coil / tum may be configured to abut or push against the walls of the circulatory system (e.g., against the walls of the left atrium), to improve the ability of the docking device 70 to stay in its desired position prior to the implantation of the prosthetic valve.

[0139] The stabilization coil / turn (e.g., atrial coil / tum) at the upper region 86 of the docking device 70 in the embodiments shown may extend up to about one full turn or rotation, and temiinates at a proximal tip 88. In other embodiments, the stabilization coil / tum (e.g., atrial coil) may extend for more or less than one turn or rotation, depending for example on the amount of contact desired between the docking device and the circulatory system (e.g., with the walls of the left atrium) in each particular application. The radial size of the stabilization coil / turn (e.g., atrial coil) at the upper region 86 may also be significantly larger than the size of the functional coils in the central region 80, so that the stabilization coil / tum (e.g., atrial coil or atrial turn) flares or extends sufficiently outwardly to contact the walls of the circulatory system (e.g., the walls of the left atrium). Additionally, the stabilization coil / turn of various embodiments will be configured to be less abrasive to the native tissue and / or anatomy. For example, the surface texture may be made smoother and / or softer, such that movement of the docking device 70 against the native anatomy will not damage the native tissue.

[0140] In some examples, at least a portion of the coil 102 may be at least partially surrounded by a cover. The cover can, for example, prevent or reduce trauma to native tissue and / or prevent or reduce damage to the delivery device, reduce friction with the native tissue, increase friction with the native tissue and / or prosthetic heart valve, etc. In some instances, the coil 102 may comprise a plurality of covers and / or a plurality of sections of one or more covers, each configured for a particular purpose. For example, a first cover may be provided over all or at least substantially all of the coil 102, for example, to prevent or reduce trauma to the native tissue. A second cover may extend over a portion of the first cover and can, for example, beAttorney Docket No.: THVMC-23670W001configured to increase friction between the cover and native leaflet tissue. Additional information about the covers is provided below and may be found in International Publication No. WO 2022 / 087336. This cover may be used to couple a guard member 104 (FIGS. 14A-14F) to the coil. As such, material of the guard member 104 may be coupled to material of the cover, such as by adhesive, stitching, loop stitching, or other coupling. The cover may be external or internal. When internal, the cover may function similar to a bladder, which covers the scaffold from the inside.

[0141] As shown in FIGS. 8B-8C, at least a portion of a core 102a of the coil 102 may be surrounded by an inner cover 112 (which may also be referred to as “a first cover”). Here, the core 102a of the coil 102 is the structural part of the coil 102, which may be referred to as the core 102a. The inner cover 112 may have a tubular shape. In some examples, the inner cover 112 may cover an entire length of the core 102a of the coil 102. In some examples, the inner cover 112 covers only selected portion(s) of the core 102a of the coil 102. Notably, FIGS. 8B-8C show the core 102a.

[0142] In some examples, the inner cover 112 may be coated on and / or bonded on the core 102a of the coil 102. In some examples, the inner cover 112 may be a cushioned, padded-type layer protecting the core 102a of the coil 102. The inner cover 112 may be constructed of various natural and / or synthetic materials. In one particular example, the inner cover 112 may include a foam material (e.g., expanded polytetrafluoroethylene (ePTFE)). In some examples, the inner cover 112 is configured to be fixedly attached to the core 102a of the coil 102 (for example, by means of textured surface resistance, suture, glue, thermal bonding, or any other means) so 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., a distal end 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., an intermediate portion and / or a proximal end portion) may be movable relative to the core 102a of the coil 102. In some aspects, the inner cover 112 is coupled with a flap sheet 150 (FIG. 14B) of the guard member 104.

[0143] In some examples, as shown in FIG. 8B, the docking device 70 may also include a retention member 114 (which may also be referred to as “a second cover” or “an outer cover”) surrounding at least a portion of the inner cover 112 (and the core 102a of the coil 102). In some examples, the retention member 114 may extend over the entire length of the inner cover 112. In the illustrated example, the retention member 114 extends over only a portion of the inner cover 112 so that one or more portions of the inner cover 112 (e.g., the proximal and / orAttorney Docket No.: THVMC-23670W001distal end portions) are exposed. In particular examples, a proximal end of the retention member 114 may be positioned proximal to a proximal end of the guard member 104. For example, the proximal end of the retention member 114 may be disposed at or adjacent an ascending portion 110b (FIG. 8E) of the coil 102. In some examples, a distal end of the retention member 114 may be positioned distal to a distal end of the guard member 104. For example, the distal end of the retention member 114 may be positioned adjacent the leading turn 106. In some examples, the retention member 114 may cover the functional turns of the coil 102 in a central region 108. However, the retention member 114 does not cover the guard member 104. In some aspects, the retention member 114 may be coupled to the guard member 104, such as by being coupled with the flap sheet 150. Thus, when the docking device 70 is deployed at the native valve and the prosthetic valve is radially expanded within the docking device 70, the retention member 114 at the central region 108 may frictionally engage the prosthetic heart valve and / or the native leaflet tissue.

[0144] The retention member 114 may be formed of various materials configured to engage the native tissue and / or prosthetic heart valve to increase friction therebetween and / or promote tissue ingrowth. For example, the retention member 114 may comprise a biocompatible fabric material (e.g., polyethylene terephthalate (PET)). In some examples, the retention member 114 may comprise a braided material. In some examples, the retention member 114 may include a woven material.

[0145] In some examples, the guard member 104 may be fixedly attached to the retention member 114 and / or the inner cover 112, for example, via a guard attachment such as sutures, adhesive, and / or any other suitable means for attaching.

[0146] FIGS. 8D-8E illustrate a compressible plug 210 (described herein, FIGS. 6A-6C) that attaches to the coil 102 of the docking device 70 of FIG. 8 A.

[0147] FIG. 8D includes a top view that shows the docking station 70 having the coil 102 attached to the compressible plug 210. The compressible plug 210 may include a cover as the plugging component (not illustrated in FIGS. 8D-8E). The cover may be porous or fluid tight depending on different embodiments, such as woven, braided, knitted, or other cloth or expanded materials (ePTFE). The porous cover may allow for cellular ingrowth, where the pores may be small enough to inhibit blood from flowing therethrough. The blood may also coagulate at the pores to provide more leak inhibition. The compressible plug 210 is tethered to the coil 102 by a tether (not shown) configured to accommodate relative movement between the plug 210 and the coil 102 within a predefined range. The tether may be coupled at one endAttorney Docket No.: THVMC-23670W001to a lobe (at any location) or to its intermediate waist (if any) and at its other end to the coil 102. The tether may be sutured to a cover of the coil 102, such as either or both of the covers 112, 114 (FIGS. 8B-8C).

[0148] The end of the tether coupled to the compressible plug 210 may be coupled to a cover of the compressible plug 210 (e.g., plugging component 208 of FIGS. 6A-6C), the underlying scaffold 200, or any other portion of the compressible plug 210. In embodiments in which the tether is coupled to a cover of the compressible plug 210, the cover may include a reinforcement patch at the tether attachment location to prevent or at least inhibit tears in the cover.

[0149] FIG. 8E includes a perspective view that shows the docking station 70 with the coil 102 in the coiled shape and with the compressible plug 210 tethered to the coil 102 at its intermediate waist. The end of the tether coupled to the coil 102 may be fixed relative to the coil 102 or movable relative to the coil. In an example in which the end is fixed relative to the coil 102, the tether may be relatively longer than in the example in which the end is movable relative to the coil 102. In the first example (i.e., in which the end is fixed relative to the coil 102), the predefined range of movement of the plug 210 relative to the coil 102 (and specifically relative to the location on the coil 102 at which the end of the tether is attached) may be twice a length of the tether. For example, the compressible plug 210 may be moved in one direction relative to the coil 102 by the full length of the tether, and then in the other direction relative to the coil 102 also by the full length of the tether, or anywhere between these two extremes. In the second example (i.e., in which the end is movable relative to the coil 102) the end of the tether attached to the coil 102 may be a loop or otherwise configured to permit the tether to slip along coil 102 while remaining coupled to the coil 102. The coil 102 may include two stops (such as sutures or other stops) formed thereon at opposing ends of the predefined range, with the end of the tether coupled to the coil 102 free to move between the two stops. If the tether is relatively short (i.e., not permitting significant relative movement between the compressible plug 210 and the end of the tether coupled to the coil 102), the tether confines movement within the predefined range by slipping / sliding along the coil 102 between the stops and then stopping when it reaches either stop.

[0150] The compressible plug 210 may be configured to fit at the medial commissure with respect to the mitral valve so as to provide a cover over the mitral leaflets and perimeter of the mitral valve region at the medial commissure. The compressible plug 210 may be pressed at least partially through the medial commissure to inhibit PVL through this region. However, it should be recognized that the compressible plug 210 may be shaped and / or adapted similarlyAttorney Docket No.: THVMC-23670W001or differently in other embodiments for better accommodation at other native valve positions as well, such as at the tricuspid valve, which may be configured along with the docking device 70. Advantageously, the predefined range of movement between the compressible plug 210 and the coil 102 facilitated by the tether may permit the compressible plug 210 to remain in place within and / or relative to the medial commissure when the docking station 70 clocks during prosthetic valve placement in the docking station 70. In particular, when the prosthetic valve is deployed within the docking station 70, the prosthetic valve may expand, which in turn may cause the docking device 70 to expand (i.e., the diameter 90 (FIG. 8A) to increase). This expansion of the docking device 70 causes portions of the coil 102 to rotate, with the most extreme rotation being experienced at the distal tip 84 and / or the proximal tip 88 of the coil 102 as the diameter 90 grows to accommodate the deployed prosthetic valve. Intermediate portions of the coil 102 also experience some rotation, or clocking, including the portion at which the end of the tether is coupled. By permitting the compressible plug 210 to move relative to the coil 102 (or, correspondingly, the coil 102 to move relative to the plug 210) within the predefined range, the coil 102 can expand to accommodate the prosthetic valve without pulling the compressible plug 210 out of the medial commissure. Accordingly, the compressible plug 210 may be configured to remain within the medial commissure while permitting clocking of the coil 102 during prosthetic valve deployment to thereafter inhibit leaks at the medial commissure of the mitral valve anatomy and inhibit leakage of blood, such as inhibit PVL. Accordingly, the shape of the compressible plug, the number of expanded body regions (e.g., lobes) of the compressible plug, the presence or absence of an intermediate waist, as well as the length, thickness, and bulbous features of the compressible plug may be modulated for different sized anatomies, such as from children through adults, and the various sizes thereof. Also, the flexibility of the compressible plug 210 due to the flexibility of the mesh scaffold formed of the shape-memory material may contribute with shaping and contouring of the compressible plug 210 with the adjacent anatomy at the mitral valve. The thickness of the compressible plug scaffold may be varied in dimension to be bigger at a bulbous end and / o lobe compared to the narrower intermediate waist.

[0151] In embodiments where the docking device 70 is used at the mitral position, the docking device 70 with the compressible plug 210 may first be advanced and delivered to the native mitral valve annulus, and then set at a desired position with the compressible plug 210 inserted at least partially through the medial commissure so that an atrial portion or lobe covers the mitral leaflets and perimeter anatomy at the medial commissure on the atrial side, a ventricularAttorney Docket No.: THVMC-23670W001portion or lobe covers the mitral leaflets and perimeter anatomy at the medial commissure on the ventricular side, and an intermediate portion waist passes through the medial commissure, prior to implantation of the prosthetic heart valve. In some embodiments, the compressible plug 210 is flexible and / or made of a shape memory material, so that the wires conform with the shape of the coil of the docking device 70 and may be straightened (or crimped or otherwise compressed) for delivery via a transcatheter approach as well. In some embodiments, the compressible plug scaffold is made of shape memory material (e.g., nitinol) or another biocompatible material, such as stainless steel. Some of the same catheters and other delivery tools may be used for both delivery of the docking device 70 with the compressible plug 210 and the prosthetic valve, without having to perform separate preparatory steps, simplifying the implantation procedure for the end user.

[0152] In some embodiments, the coil 102 may include a material that may be coupled with the tether, such as be sewing, stitching, suturing, brazing, welding, adhesive, clipping, clamping, crimping, riveting, any mechanical securement or the like. In some embodiments, the docking device 70 may include a material cover around the base coil, and the compressible plug 210 may also include a material cover.

[0153] In some embodiments, the compressible plug 210 may be formed of a tightly woven or braided material that forms a body resistant to fluids. That is, the materials described herein may be prepared into proper filaments to be woven or braided with tightness as desired. The woven or braided material may have tightness that does not have any gaps or interstitial spaces between the weaves or braids. The tightness of the weave and braid may range from loose with gaps to tight so as to form fluid tightness with essentially no gap or interstitial spaces. Accordingly, the compressible scaffold itself may be a woven or braided pattern that is fluid tight. Such a configuration of the compressible scaffold may be indirectly coupled to the coil 102 via the tether, where the coupling may include the tether being fixedly or slidably coupled to the core 102a or a cover 112, 114 of the coil 102. The coupling to the core 102a or cover 112, 114 of the coil 102 may be by be sewing, stitching, suturing, brazing, welding, adhesive, riveting, any mechanical securement or the like.

[0154] The dimensions of the compressible plug 210, the tether, the stop-to-stop distance, and / or the predefined range may be modulated depending on the design of the docking device 70. For example, the tether length and / or the stop-to-stop distance may be tailored so that the compressible plug 210 may remain in place in the medial commissure while the docking device clocks during prosthetic valve deployment. As another example, the axial length of theAttorney Docket No.: THVMC-23670W001intermediate waist (if any) may be selected to correspond to a distance through the medial commissure that permits the atrial and ventricular lobes of the compressible plug 210 to be close enough to cover and plug the medial commissure from the atrial and ventricular sides. In some aspects, the axial length of the compressible plug 210 from one end to the other may be in a range from about 5 millimeters (mm) to about 40 mm, or from about 5 mm to about 20 mm, or from about 5 mm to about 10 mm, or from about 10 mm to about 15 mm, or from about 15 mm to about 20 mm, or the like, while a diameter of the compressible plug may be in a range from about 5 mm to about 40 mm, or from about 5 mm to about 20 mm, or from about 5 mm to about 10 mm, or from about 10 mm to about 15 mm, or from about 15 mm to about 20 mm, or the like.

[0155] In some examples, the plug scaffold 200 may include a shape memory material that is shape set and / or pre-configured to expand the compressible plug 210 to the radially expanded state when unconstrained (for example, when deployed at a native valve location). For example, the plug scaffold 200 may contain a shape memory alloy with super-elastic properties, such as Nitinol. In some examples, the plug scaffold 200 may contain a ternary shape memory alloy with super-elastic properties, such as NiTiX where X may be chromium (Cr), cobalt (Co), zirconium (Zr), hafnium (Hf), etc.

[0156] In some examples, the plug scaffold 200 may comprise a metallic material that does not have the shape memory properties. In such circumstances, the plug scaffold 200 may have a biasing mechanism (e.g., using springs, etc.) configured to bias the scaffold to the radially expanded state. Examples of such metallic material include cobalt-chromium, stainless steel, etc. In one specific example, the scaffold may comprise nickel-free austenitic stainless steel in which nickel may be completely replaced by nitrogen. In another specific example, the plug scaffold 200 may comprise cobalt-chromium or cobalt-nickel-chromium-molybdenum alloy with significantly low density of titanium.

[0157] In some examples, the cover of the plug scaffold 200 may be configured to be so elastic that when the compressible plug 210 moves from the delivery orientation to the deployed orientation, the cover may accommodate the plug scaffold 200. The shape of the compressible plug scaffold 200 and cover may be cooperatively configured such that the compressible plug 210 has an adaptable shape that may be adjusted during deployment to accommodate various anatomy shapes and sizes. The plug scaffold 200 and cover (e.g., external cover or internal cover) are prepared to inhibit fluids from passing through or around the compressible plug 210. The shape and adjustability of the compressible plug 210 may be used to inhibit any fluid flowAttorney Docket No.: THVMC-23670W001or leaking through the medial commissure. For example, the compressible plug 210 may be compressed within the medial commissure, or may have an intermediate waist within the medial commissure, while non-compressed ends or lobes may cover the medial commissure from the atrial and ventricular sides to prevent or at least reduce PVL.

[0158] In some examples, the plug cover may be configured to be atraumatic to native tissue and / or promote tissue ingrowth into the material of the plug cover. For example, the plug cover may have pores to encourage tissue ingrowth. In another example, the plug cover may be impregnated with growth factors to stimulate or promote tissue ingrowth, such as transforming growth factor alpha (TGF-alpha), transforming growth factor beta (TGF-beta), basic fibroblast growth factor (bFGF), vascular epithelial growth factor (VEGF), and combinations thereof. The plug cover may be constructed of any suitable material, including foam, cloth, fabric, metal, shape memory alloys, and / or polymer, which is flexible to allow for compression and expansion of the plug cover. In one example, the plug cover may include a fabric layer constructed from a thermoplastic polymer material, such as polyethylene terephthalate (PET), which may be knitted, woven, or braided to form a cover. In some aspects, the plug cover may be formed of a shape-memory alloy or other metal that may be woven or braided into a fluid tight sheet. For example, nitinol may be formed into filaments that are woven or braided into a body that is substantially fluid tight or at least fluid mitigating to inhibit fluids from passing through the material.

[0159] The plug cover as an external cover and / or an internal filler used instead of or in addition to the plug cover prevent or at least inhibit blood from flowing through the compressible plug 210 after it is implanted. The external cover could have the added benefit of acting as a protective layer to mitigate tissue erosion caused by the scaffold. In an embodiment, the external cover includes a braided yarn structure outside of the scaffold. This yam could be a PET material that has a dense braid and similar elongation characteristics to the scaffold. This braided cover could be a shape-set component or a straight cylindrical component that is collapsed onto the shape of the scaffold. The distal end of the braided cover could be folded inward on itself before it is attached to the scaffold to provide a double layer of this braided cover over the scaffold. The braided cover could be porous to allow blood to enter the inside of the scaffold, where it would eventually coagulate and provide sealing. Alternatively, the cover could be sealed with a thin layer of non-porous coating, such as silicone, to prevent any absorption of blood into the feature. An alternative external cover may include elastomeric coatings only without a braided cover. Such elastomeric coatings may include implantableAttorney Docket No.: THVMC-23670W001urethanes, silicone copolymers, etc. Furthermore, thin films or sleeves of elastomer or PTFE could be placed on the outside of the braid and bonded on certain regions. The material, surface features, and structure of the external covers could be modified to increase or minimize tissue ingrowth and minimize thrombus formation. Furthermore, internal fillers could be added inside of the scaffold to reduce / prevent flow acutely, and / or encourage a thrombogenic or endothelial response to minimize flow chronically. These internal fillers may include a low-density fabric, such as PET or PTFE, a fine, dense nitinol braid, etc.

[0160] In some embodiments, the cover may also include an elastomer, such as a rubber, styrene butadiene rubber, polybutadiene rubber, polyisoprene rubber, neoprene, nitrile rubber, silicone. The material of the cover may be applied via dip coating, spray coating, brush on, and other application protocols. The application may provide the cover to have a certain thickness and durometer to achieve collapsibility and maintain a minimal profile when the plug 210 is collapsed into the sleeve. The cover material may also enable the plug 210 to achieve its fully-expanded shape, while still covering all of the cells of the scaffold. This principle may be applied to an external or internal cover relative to the plug scaffold 200.

[0161] In some embodiments, a separate braided mesh of one of the materials may be added to the interior open space of the plug 210, which braided mesh may be an internal cover. This additional mesh may be made of a thinner wire and have a smaller pore size than an outer structural mesh. The internal cover may then act as a flow inhibitor due to the smaller pores.

[0162] In some examples, the plug cover may be configured to engage with the prosthetic valve deployed within the docking device so as to form a seal and reduce paravalvular leakage between the prosthetic valve and the docking device after the compressible plug 210 is radially expanded. Particularly, the plug cover may help inhibit PVL at the medial commissure. The plug cover may also be configured to engage with the native tissue (for example, the native annulus and / or native leaflets) to reduce PVL between the docking device and / or the prosthetic valve and the native tissue.

[0163] Referring to FIGS. 8D-8E, the coil 102 has a proximal end 102p and a distal end 102d, with the compressible plug 210 therebetween, which also respectively define the proximal and distal ends of the docking device 70. When being disposed within the delivery sheath (e.g., during delivery of the docking device into the vasculature of a patient), a body of the coil 102 between the proximal end 102p and the distal end 102d along with the compressible plug 210 may form the generally straight delivery orientation (that is, without any coiled or looped portions, but may be flexed or bent) so as to maintain a small radial profile when movingAttorney Docket No.: THVMC-23670W001through a patient’ s vasculature. After being removed from the delivery sheath and deployed at an implant position, the coil 102 and compressible plug 210 may move from the delivery orientation to the helical deployed orientation with the compressible plug 210 coupled to the coil 102 and movable relative thereto within the predefined range and the compressible plug 210 inserted partially through the medial commissure, and with the coil 102 wrapping around native leaflet tissue adjacent the implant position. For example, when implanting the docking device at the location of a native valve, the coil 102 may be configured to surround native leaflets of the native valve (and the chordae tendineae that connects native leaflets to adjacent papillary muscles, if present) with the compressible plug 210 extending at least partially through the medial commissure so as to be over where the leaflets would be, thereby the compressible plug 210 forming a plug over the medial commissure and over the mitral valve anatomy in the left atrium and the left ventricle.

[0164] The docking device 70 may be releasably coupled to a delivery apparatus (e.g., docking device delivery apparatus 50). For example, in certain examples, the docking device 70 may be coupled to the delivery apparatus via a release suture that may be configured to be tied to the docking device 70 and cut for removal. In one example, the release suture may be tied to the docking device 70 through an eyelet or eyehole located adjacent the proximal end 102p of the coil. In another example, the release suture may be tied around a circumferential recess that is located adjacent the proximal end 102p of the coil 102.

[0165] As shown in FIG. 8E, the coil 102 in the deployed orientation may include a leading turn 106 (or “leading coil”), a central region 108 (e.g. having the compressible plug 210), and a stabilization turn 110 (or “stabilization coil”) around the central longitudinal axis. However, the leading turn 106 may be omitted in some design embodiments. The central region 108 may possess one or more helical turns having substantially equal inner diameters with one of these turns being coupled with the compressible plug 210 via the tether. The leading turn 106 may extend from a distal end of the central region 108 and has a diameter greater than the diameter of the central region 108 (in one or more configurations). The stabilization turn 110 may extend from a proximal end of the central region 108 and has a diameter greater than the diameter of the central region 108 (in one or more configurations). However, the diameters may be the same in other configurations.

[0166] In some examples, the central region 108 may include a plurality of helical turns (e.g., the docking device 70 may have three helical turns in the central region 108). Some of the helical turns in the central region 108 may be full turns (that is, rotating 360 degrees). In someAttorney Docket No.: THVMC-23670W001examples, the most proximal turn and / or the most distal turn may be partial turns (for example, rotating less than 360 degrees, such as 180 degrees, 270 degrees, etc.). The compressible plug 210 may be positioned anywhere along the central region 108, and is shown at the proximal turn thereof in FIG. 8E.

[0167] The size of the docking device 70 and compressible plug 210 may be generally selected based on the size of the desired prosthetic valve to be implanted into the patient and the size of the anatomy at the left atrium intersection with the mitral valve anatomy. In some examples, the central region 108 may be configured to retain a radially expandable prosthetic valve. For example, the inner diameter of the helical turns in the central region 108 may be configured to be smaller than an outer diameter of the prosthetic valve when the prosthetic valve is radially expanded so that additional radial force may act between the central region 108 and the prosthetic valve to hold the prosthetic valve in place. The helical turns in the central region 108 may also be referred to herein as “functional turns.”

[0168] The stabilization turn 110 may be configured to help stabilize the docking device 70 in the desired position. For example, the radial dimension of the stabilization turn 110 may be significantly larger than the radial dimension of the coil in the central region 108, so that the stabilization turn 110 may flare or extend sufficiently outwardly so as to abut or push against the walls of the circulatory system, thereby improving the ability of the docking device 70 to stay in its desired position prior to the implantation of the prosthetic valve. In some examples, the diameter of stabilization turn 110 is desirably larger than the native annulus, native valve plane, and / or native chamber for better stabilization. In some examples, the stabilization turn 110 may be a full turn (that is, rotating about 360 degrees). In some examples, the stabilization turn 110 may be a partial turn (for example, rotating between about 180 degrees and about 270 degrees).

[0169] In one particular example, when implanting the docking device 70 at the native mitral valve location, the functional turns in the central region 108 may be disposed substantially in the left ventricle and the stabilization turn 110 may be disposed substantially in the left atrium above the guard member 104 (if any). The stabilization turn 110 may be configured to provide one or more points or regions of contact between the docking device 70 and the left atrial wall, such as at least three points of contact in the left atrium or complete contact on the left atrial wall opposite of the guard member contacting the left atrial wall. In some examples, the points of contact between the docking device 70 and the left atrial wall may form a plane that is approximately parallel to a plane of the native mitral valve, and may be parallel to a plane ofAttorney Docket No.: THVMC-23670W001the guard member 104. In some aspects, the guard member may be configured to stabilize the docking device 70 into the mitral valve. As such, the docking device 70 may omit an atrial turn in the coil 102.

[0170] In some examples, the stabilization turn 110 may have an atrial portion 110c in connection with the central region 108, a stabilization 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 stabilization portion 110a. Both the atrial portion 110c and the stabilization portion 110a may be generally parallel to the helical turns in the central region 108, whereas the ascending portion 110b may be oriented to be angular relative to the atrial portion 110c and the stabilization portion 110a. For example, in certain examples, the ascending portion 110b and the stabilization portion 110a may form an angle from about 45 degrees to about 90 degrees (inclusive). When implanting the docking device 70 at the native mitral valve location, the atrial portion 110c may be configured to abut against a posterior wall of the left atrium and the stabilization portion 110a may be configured to flare out and press against an anterior wall of the left atrium, along with the guard member (if any).

[0171] In some embodiments, the coil 102 may omit the stabilization turn, and the proximal region of the coil 102 may be another portion coil 102. In this embodiment, the guard member 104 may provide the stabilization of the docking device 70 with respect to the mitral valve anatomy and the left ventricle.

[0172] As noted above, the leading turn 106 may have a larger radial dimension than the helical turns in the central region 108. The leading turn 106 may help more easily guide the coil 102 around and / or through the chordae tendineae and / or adequately around all native leaflets of the native valve (for example, the native mitral valve, tricuspid valve, etc.). For example, once the leading turn 106 is navigated around the desired native anatomy, the remaining coil (such as the functional turns) of the docking device 70 may also be guided around the same features. In some examples, the leading turn 106 may be a full turn (that is, rotating about 360 degrees). In some examples, the leading turn 106 may be a partial turn (for example, rotating between about 180 degrees and about 270 degrees). When a prosthetic valve is radially expanded within the central region 108 of the coil, the functional turns in the central region 108 may be further radially expanded. As a result, the leading turn 106 may be pulled in the proximal direction and become a part of the functional turn in the central region 108.

[0173] In some examples, the compressible plug 210 may be coupled by the tether to a portion (e.g., the atrial portion) of the stabilization turn 110 of the coil 102. In some examples, theAttorney Docket No.: THVMC-23670W001compressible plug 210 may be coupled by the tether to a portion of the central region 108 of the coil 102 (e.g., a portion of the most proximal turn). If the tether is not fixed at a given location to the coil 102, the coil 102 may include stops that define ends of the predefined range of movement between the compressible plug 210 and the coil 102. One or both stops may be somewhere on the stabilization turn 110, e.g., the atrial portion 110c, somewhere on the central region, e.g., a portion of the most proximal turn, or other suitable locations of the coil 102.

[0174] In various examples, the compressible plug 210 may move between a compressed state and a radially expanded state. Specifically, the guard member 104 may include a wire plug scaffold that may be radially expandable and compressible. When the compressible plug 210 is in the radially compressed state, the scaffold may be radially compressed against the coil 102 so that the radial profile of the docking device 70 is smaller than a predefined threshold, for example, between 0.5 mm and 3 mm, inclusive. When the compressible plug 210 moves from the compressed state to the radially expanded state, the scaffold may extend radially outwardly relative to the coil 102. The compressible plug 210 may be biased toward the radially expanded state due to the shape-memory material of the wires of the mesh scaffold. Thus, the compressible plug 210 may be retained in the radially compressed state by a dock sleeve of a delivery apparatus, and automatically return to the radially expanded state after the dock sleeve is removed. As shown herein, the compressible plug 210 may include a plug scaffold 200 and a cover substantially enclosing the scaffold. The shape of the plug scaffold 200 may generally define the shape of the compressible plug 210. Alternatively, the cover or sealing mechanism may be inside the plug scaffold 200 to provide the functions described herein. In some aspects, an internal cover or sealing mechanism may be used with or without an external cover. As such, the cover or sealing mechanism does not have to be on the outside of the plug scaffold 200.

[0175] As described herein, the permitted range of motion between the coil 102 and the compressible plug 210 and / or the configuration of the compressible plug 210 may help prevent, reduce, and / or inhibit paravalvular leakage (PVL) at the medial commissure. Specifically, the placement of the smaller intermediate waist and / or a compressible intermediate portion of the compressible plug 210 within the medial commissure combined with the larger lobes or uncompressed ends may form an improved seal around a prosthetic valve deployed within the docking device 70, while the permitted movement facilitates the compressible plug 210 remaining in place relative to the medial commissure during prosthetic valve deployment (and corresponding clocking of the docking device 70). In some examples, the compressible plugAttorney Docket No.: THVMC-23670W001210 may be configured to prevent and / or inhibit leakage at the location where the docking device 70 crosses between leaflets of the native valve (e.g., at the commissures of the native leaflets). For example, without the compressible plug 210, the docking device 70 may push the native leaflets apart at the point of crossing the native leaflets, e.g., at the medial commissure, and allow for leakage at the medial commissure (e.g., along the docking device or to its sides). However, the compressible plug 210 may be configured to expand to cover and / or fill the medial commissure and inhibit leakage along the docking device 70 from the medial commissure. This allows the plug to cover both the medial commissure and the surrounding leaflets, such as the P2 and P3 leaflets.

[0176] In various examples, a portion of the compressible plug 210 (e.g., an atrial lobe) may cover an atrial side of the medial commissure at an atrioventricular valve to prevent and / or inhibit blood from leaking through the native leaflets, commissures, and / or around an outside of the prosthetic valve by blocking blood in the atrium from flowing in an atrial to ventricular direction (that is, antegrade blood flow) — other than through the prosthetic valve. The portion of the compressible plug 210 on the atrial side of the valve may additionally or alternatively help reduce blood in the ventricle from flowing in a ventricular to atrial direction (that is, retrograde blood flow) at the medial commissure. In addition, another portion of the compressible plug 210 (e.g., a ventricular lobe) may be positioned on a ventricular side of an atrioventricular valve to prevent and / or inhibit blood from leaking through the native leaflets, medial commissure, and / or around an outside of the prosthetic valve by blocking blood in the ventricle from flowing in a ventricular to atrial direction (that is, retrograde blood flow). The portion of the compressible plug 210 on the ventricular side of the valve may additionally or alternatively help reduce blood in the atrium from flowing in the atrial to ventricular direction (that is, antegrade blood flow) — other than through the prosthetic valve.Example Tethers

[0177] FIGS. 9A-9C illustrate various example tethers, arranged in accordance with at least one embodiment described herein. In FIG. 9A, the compressible plug 210 includes an atrial lobe 202 and a ventricular lobe 204 connected by an intermediate waist 206 with a tether 902 that couples the compressible plug 210 to the coil 102 of the docking device 70. One end of the tether 902 is coupled to the ventricular lobe 204 of the compressible plug 210 while the other end of the tether 902 loops around the coil 102 such that the tether 902 can slide along the coil 102. The tether 902 in FIG. 9A is short, being made up primarily of the loop around the coil 102. The coil 102 includes coupled thereto a proximal stop 904 and a distal stop 906Attorney Docket No.: THVMC-23670W001that define ends of the predefined range of motion between the coil 102 and the compressible plug 210. In some embodiments, the stops 904, 906 increase a size of the coil 102 at their respective locations to larger than a size of the loop of the tether 902, the loop of the tether 902 being larger than the size of the coil 102 between the two stops 904 such that the loop of the tether 902 can slide along the coil 102 between the two stops 904 but cannot pass beyond or over either stop 904, 906.

[0178] In FIG. 9B, the compressible plug 210 includes a single cylindrical body 214 with a tether 902 that couples the compressible plug 210 to the coil 102 of the docking device 70. One end of the tether 902 is coupled to the cylindrical body 214 of the compressible plug 210 while the other end of the tether 902 loops around the coil 102 such that the tether 902 can slide along the coil 102. The tether 902 in FIG. 9B is short, being made up primarily of the loop around the coil 102. The coil 102 includes stops in the form of an ascending portion 110b as well as a distal stop 906 that define ends of the predefined range of motion between the coil 102 and the compressible plug 210. In some embodiments, the change in direction of the coil 102 may prevent or inhibit sliding motion of the compressible plug 210 proximally upward along the ascending portion 110b while the distal stop 906 may prevent or inhibit sliding motion of the compressible plug 210 beyond the distal stop 906.

[0179] The stops 904, 906 in FIGS. 9A-9B and / or other embodiments herein may be coupled to and / or formed in or on the coil 102 in any suitable manner. For example, the stops 904, 906 may be coupled to the coil 102 by sewing, stitching, suturing, brazing, welding, adhesive, clipping, clamping, crimping, riveting, any mechanical securement or the like. Other structure in or on the coil 102 may act as a stop, such as the ascending portion 110b, an end of a guard member also coupled to or formed on the coil 102, or the like or any combination thereof.

[0180] In FIG. 9C, the compressible plug 210 includes an atrial lobe 202 and a ventricular lobe 204 connected by an intermediate waist 206 (not visible in FIG. 9C) with a tether 902 that couples the compressible plug 210 to the coil 102 of the docking device 70. One end of the tether 902 is coupled to the intermediate waist 206 of the compressible plug 210 while the other end of the tether 902 is coupled to the coil 102 at a fixed location. The length of the tether 902 defines the size of the predefined range, the predefined range specifically being twice a length of the tether in this example. For example, the compressible plug 210 may be as far in one direction as the length of the tether 902 permits relative to the coil 102, or as far in an opposite direction as the length of the coil permits relative to the coil 102, or anywhere in between the two foregoing extremes. As in other embodiments herein, the predefined range is configuredAttorney Docket No.: THVMC-23670W001to accommodate relative movement between the coil 102 and the compressible plug 210, e.g., as the coil 102 is clocked during expansion of the prosthetic valve within the docking device 70 so that the compressible plug 210 remains in place in the commissure during clocking of the coil 102.

[0181] The tether 902 is shown as coupled to the compressible plug 210 at three specific locations in FIGS. 9A-9C. More generally, the tether 902 may be coupled to the compressible plug 210 at any desired location, such as a top, bottom, side, etc. of a single body 214 of the compressible plug 210; a top, bottom, side, etc. of a ventricular lobe 204 of the compressible plug 210; a top, bottom, side, etc. of an atrial lobe 202 of the compressible plug 210; a side, etc. of an intermediate waist 206 of the compressible plug 210; or other desired location.

[0182] FIGS. 9A-9B show examples in which the tether 902 is short and essentially allows only sliding movement of the compressible plug 210 relative to the coil 102 within the predefined range having endpoints defined by stops 904, 906, the ascending portion 110b, and / or other components or structure. FIG. 9C shows an example in which the tether 902 is long with both ends fixed (one to the compressible plug 210, the other to the coil 102), the predefined range dependent on the length of the tether 902. In other embodiments, the tether 902 may be both long and slidable along the coil 102 (at least in a region between two stops) such that the predefined range may depend on both the length of the tether 902 and the distance between the two stops.

[0183] The tether 902 in FIGS. 9A-9C and / or other embodiments herein may be coupled to the coil 102 or the compressible plug 210 in any suitable manner. For example, a given end of the tether 902 may be coupled to the coil 102 or the compressible plug 210 by forming a loop, sewing, stitching, suturing, brazing, welding, adhesive, clipping, clamping, crimping, riveting, any mechanical securement or the like.

[0184] FIGS. 10A-10C depict an example unsleeving process for the docking device 70 and compressible plug 210 of FIG. 9C. As depicted in FIG. 10A, the compressible plug 210 and the docking device 70 may be compressed and loaded into a dock sleeve 1002 of a dock delivery system with the ventricular lobe 204 arranged distally, the atrial lobe 202 arranged proximally, and the compressible plug 210 located distally relative to an attachment 1004 of the tether 902 to the coil 102. The attachment 1004 may be fixed relative to the coil 102 and may include one or more of sewing, stitching, suturing, brazing, welding, adhesive, or the like. The coil 102 includes a stop 1006 formed thereon distally disposed relative to the attachment 1004, the compressible plug 210 distally disposed relative to the stop 1006.Attorney Docket No.: THVMC-23670W001

[0185] During unsleeving, the dock sleeve 1002 moves proximally relative to the docking device 70 and the compressible plug 210 and / or the docking device 70 and the compressible plug 210 move distally relative to the dock sleeve 1002. FIG. 10B depicts the docking device 70 and the compressible plug 210 partially unsleeved from the dock sleeve 1002 with the ventricular lobe 204 of the compressible plug 210 unsleeved and the remainder of the compressible plug 210 still sleeved within the dock sleeve 1002. FIG. 10C depicts the docking device 70 and the compressible plug 210 completely unsleeved.

[0186] During unsleeving (e.g., FIG. 10A), friction between the dock sleeve 1002 and the compressible plug 210 may tend to pull the compressible plug 210 proximally relative to the docking device 70, which may result in an undesirable repositioning of the compressible plug 210 relative to the docking device 70. In the example of FIGS. 10A-10C, however, if the compressible plug 210 is pulled proximally relative to the docking device 70 by the dock sleeve 1002 during unsleeving, the stop 1006 may engage the compressible plug 210 to prevent, or at least inhibit, any further proximal movement of the compressible plug 210 relative to the docking device 70 during unsleeving.

[0187] In some embodiments, it may be useful to at least partially re-sleeve the compressible plug 210 and the docking device 70 after a partial unsleeving. During re-sleeving the dock sleeve 1002 moves distally relative to the docking device 70 and the compressible plug 210 and / or the docking device 70 and the compressible plug 210 move proximally relative to the dock sleeve 1002. During re-sleeving, friction between the dock sleeve 1002 and the compressible plug 210 may tend to pull the compressible plug 210 distally relative to the docking device 70, which may result in an undesirable repositioning of the compressible plug 210 relative to the docking device 70. In the example of FIGS. 10A-10C, however, if the compressible plug 210 is pulled distally relative to the docking device 70 by the dock sleeve 1002 during re-sleeving, the tether 902, by virtue of being fixedly coupled to both the coil 102 and the compressible plug 210 in this example, may prevent, or at least inhibit, any distal movement of the compressible plug 210 relative to the docking device 70 during re-sleeving after the compressible plug 210 reaches the end of tether 902.Example Implantation

[0188] FIGS. 11A-1 IB depict the docking device 70 and compressible plug 210 of FIG. 9C implanted at a native mitral valve 500, arranged in accordance with at least one embodiment described herein. FIG. 11 A is from the atrial side and FIG. 1 IB is from the ventricular side. As illustrated in FIG. HA, the stabilization turn 110 and other portions of the docking device 70,Attorney Docket No.: THVMC-23670W001including part of the coil 102, are disposed in the left atrium. As illustrated in FIG. 11B, the leading turn 106 and other portions of the docking device 70, including part of the coil 102, are disposed within the left ventricle, e.g., around chordae tendinae 1102 (only some of which are labeled for simplicity) that connect the native mitral valve 500 leaflets to papillary muscles.

[0189] FIGS. 11 A-l IB further depict deployment of the compressible plug 210 in the medial commissure. In particular, the intermediate waist 206 (not visible in FIGS. 11A-11B) of the compressible plug 210 is disposed within the medial commissure, while the atrial lobe 202 of the compressible plug 210 covers and plugs the medial commissure from the atrial side (FIG.11 A) of the medial commissure and the ventricular lobe 204 of the compressible plug 210 covers and plugs the medial commissure from the ventricular side (FIG. 11B) of the medial commissure.

[0190] In some embodiments, the docking device 70 and / or other docking devices herein may be implanted as known, with the added features of the compressible plug 210 (or other compressible plug herein) being located at the medial commissure. In some aspects, a single body compressible plug may be used with a first portion positioned above (to an atrial side of) the medial commissure and a second portion position below (to a ventricular side of) the medial commissure and an intermediate portion being compressed within and / or conforming to a shape of the medial commissure. In some aspects, a two-lobe compressible plug may be used with an atrial lobe positioned above (to an atrial side of) the medial commissure and a ventricular lobe positioned below (to a ventricular side of) the medial commissure and an intermediate waist positioned within the medial commissure. In these and other embodiments, the compressible plug 210 may cover both sides of the medial commissure (i.e., by the first / second portions and / or the atrial / ventricular lobes) while also plugging the medial commissure with the intermediate portion and / or intermediate waist to inhibit PVL.

[0191] FIGS. 12A-12B depict the clocking of the docking device 70 of FIGS. 11 A-l IB that occurs when a prosthetic heart valve is implanted, arranged in accordance with at least one embodiment described herein. In FIG. 12A, a prosthetic heart valve 1202 has been maneuvered into position within the mitral valve 500 and the docking device 70, e.g., using a prosthetic heart valve delivery device. The prosthetic heart valve 1202 is connected to an expansion mechanism 65 in FIG. 12A, which in this example is an inflatable balloon. The expansion mechanism 65 may be operated to expand the prosthetic heart valve 1202 to its deployed configuration within the docking device 70. In particular, the expansion mechanism 65 may beAttorney Docket No.: THVMC-23670W001inflated to thereby expand the prosthetic heart valve 1202 to its deployed configuration or state illustrated in FIG. 12B.

[0192] Prior to deploying the prosthetic heart valve 1202, the docking device 70 has a first diameter as illustrated in FIG. 12A. However, the docking device 70 may expand when the prosthetic heart valve 1202 is deployed (i.e., expanded), causing the coil 102, or at least the atrial end of the coil 102 depicted in FIG. 12 A, to clock in a direction 1204. This can be seen by the change in position of the atrial end of the coil 102 in FIG. 12B relative to FIG. 12A.

[0193] FIGS. 12A-12B also depict the tether 902 that couples the compressible plug 210 to the coil 102. The tether 902 is coupled to the coil 102 by an attachment 1206 which couples the tether 902 to the coil 102 at a fixed location relative to the coil 102, similar to the attachment 1004 of FIGS. 10A-10C. Portions of the tether 902 and attachment 1206 are occluded by the prosthetic heart valve 1202 and not visible in FIG. 12B. Much of the coil 102 itself is also occluded by the prosthetic heart valve 1202 and not visible in FIG. 12B. It can be seen from FIGS. 12A and 12B that the clocking of the atrial end of the coil 102 rotates the attachment 1206 closer to the compressible plug 210 without affecting the positioning of the compressible plug 210 within the medial commissure as this relative movement is within the predefined range based, at least in part, on the tether 902. In an extreme scenario, the attachment 1206 could rotate up to a full length of the tether 902 past the compressible plug 210 before the tether 902 would begin pulling on the compressible plug 210. Thus, the predefined range of relative movement permitted by the tether 902 allows the compressible plug 210 to remain in place within the medial commissure while the docking device 70 (and particularly, the atrial end of the coil 102) clocks during deployment of the prosthetic heart valve 1202.

[0194] FIGS. 13A-13B depict the clocking of a docking device 70 coupled to a compressible plug 210 by a short tether (not visible) that occurs when a prosthetic heart valve is implanted, arranged in accordance with at least one embodiment described herein. In FIG. 13 A, a prosthetic heart valve 1302 has been maneuvered into position within the mitral valve 500 and the docking device 70, e.g., using a prosthetic heart valve delivery device. The prosthetic heart valve 1302 is connected to an expansion mechanism 65 in FIG. 13A, which in this example is an inflatable balloon. The expansion mechanism 65 may be operated to expand the prosthetic heart valve 1302 to its deployed configuration within the docking device 70. In particular, the expansion mechanism 65 may be inflated to thereby expand the prosthetic heart valve 1302 to its deployed configuration or state illustrated in FIG. 13B.Attorney Docket No.: THVMC-23670W001

[0195] Prior to deploying the prosthetic heart valve 1302, the docking device 70 has a first diameter as illustrated in FIG. 13 A. However, the docking device 70 may expand when the prosthetic heart valve 1302 is deployed (i.e., expanded), causing the coil 102, or at least the atrial end of the coil 102 depicted in FIG. 13 A, to clock in a direction 1304. This can be seen by the change in position of the atrial end of the coil 102 in FIG. 13B relative to FIG. 13 A.

[0196] In FIGS. 13A-13B, the tether (not visible) that couples the compressible plug 210 to the coil 102 may be a short tether, such as the tether 902 of FIGS. 9 A and 9B that is generally a loop around the coil 102 that may be free to slide along the coil 102 within a predefined range. It can be seen from FIGS. 13A and 13B that the clocking of the atrial end of the coil 102 rotates the stabilization turn 110 closer to the compressible plug 210 without affecting the positioning of the compressible plug 210 within the medial commissure as this relative movement is within the predefined range based, at least in part, on the tether and corresponding stops (e.g., stop(s) 902, 904 not shown in FIGS. 13A-13B, and / or atrial portion 110c) on the coil 102. The predefined range of relative movement permitted by the tether and the stops allows the compressible plug 210 to remain in place within the medial commissure while the docking device 70 (and particularly, the atrial end of the coil 102) clocks during deployment of the prosthetic heart valve 1302.Example Brimmed Docking Devices

[0197] FIG. 14A illustrates a scaffold 120 of the guard member 104 (described herein, FIG.14B) that attaches to the coil 102 of a docking device 100 of FIGS. 14C and 14D. The docking device 100 may include, be included in, or correspond to other docking devices herein, such as the docking device 100 and / or the docking device 52. The scaffold 120 includes a spine 130 with multiple arms 122 extending therefrom. The arms 122 include a base portion 122b and a head portion 122h. The scaffold 120 includes gaps 127 between the arms 122, where the gaps 127 become panels 140 of the guard member 104 when the scaffold 120 is covered by a material (e.g., flap sheet 150 in FIG. 14B). A first set of arms of the arms 122 may be linear arms as shown. A last arm 125 of the anus 122 may be a lobe, also referred to as terminal lobe 125. In some aspects, the arms 122 may have varying widths from the base portion 122b to the head portion 122h, where a narrowing taper of the width from the base portion 122b to the head portion 122h may provide for favorable characteristics when deploying the guard member. That is, the base portion 122b may be wider than the arm 122 near the head portion, where the thickness may be constant. However, the width could be constant and the thickness could narrow from the base portion 122b to the head portion 122h. This tapered arm 122 allows forAttorney Docket No.: THVMC-23670W001the arms to better conform to the native anatomy of the valve region. The width and / or thickness of the arms may be varied to obtain different properties, as desired.

[0198] The guard member 104 may include the spine 130 in a shape that corresponds with the coil 102 of the docking device 70, such that both the spine 130 and coil 102 have substantially the same coil or diameter so that the bodies thereof match and may be coupled together. For example, the spine 130 from one end to the other may be cooperative with a region of the coil 102 such that they fit together and have the same curvature, such as without gaps when the spine 130 is placed on the coil 102 and the coil 102 is in a deployed orientation.

[0199] In some embodiments, the spine 130 could have a larger diameter, such as a diameter that matches the diameter of a 29 mm valve implant. Accordingly, the arms may be in a relaxed state once the coil diameter increases with the valve. The guard member 104 or brim may be sewn or otherwise attached to the coil 102 such that the spine diameter is pulled in to match the coil diameter, resulting in the brim being in tension until the valve is deployed.

[0200] In embodiments where the docking device 100 is used at the mitral position, the docking device 100 with the guard member 104 may first be advanced and delivered to the native mitral valve annulus, and then set at a desired position with the guard member covering the mitral leaflets and perimeter anatomy, prior to implantation of the prosthetic heart valve. In some embodiments, the guard member 104 is flexible and / or made of a shape memory material, so that the spine 130 coils with the docking device 100 and may be straightened for delivery via a transcatheter approach as well. In some embodiments, the scaffold 120 is made of shape memory material (e.g., nitinol) or another biocompatible material, such as stainless steel, or any of the other materials described herein with respect to, e.g., the plug scaffold 200. Some of the same catheters and other delivery tools may be used for both delivery of the docking device 100 with the guard member 104 and the prosthetic valve, without having to perform separate preparatory steps, simplifying the implantation procedure for the end user.

[0201] In some embodiments, the spine 130 is configured to be shaped to match the coils / tums of the docking device 100, such as at the central region 80, the effective diameter of the spine 130 may be kept relatively small in diameter (e.g., to match the central region 80 in one embodiment may have an inner diameter of between approximately 21 -24 mm ± 2 mm or another diameter smaller than the prosthetic valve and / or the native annulus) to increase retention force with the prosthetic valve. Also, the guard member 104 may be placed at a location on the central region 80 where the guard member 104 inhibits further advancing of the docking device 100 around the existing leaflets and / or chordae tendineae, and guard memberAttorney Docket No.: THVMC-23670W001104 is shaped to help deliver the docking device 100 to a desired position relative to the native mitral annulus. However, the spine 130 could be of the larger embodiments as described above.

[0202] The spine 130 may include a leading end 132 and a trailing end 134 with a concave side 136 therebetween. The concave side 136 may be shaped to match the coil 102 of the docking device 100. The arms 122 extend from a convex side 138 of the spine 130, and thereby away from the coil 102 of the docking device 100. While the spine 130 may be shaped to match the coil 102, the spine 130 may or may not be directly coupled with the coil 102. In some embodiments, the coil 102 may include a material that may be coupled with the material of the spine 130, such as by sewing, stitching, suturing, brazing, welding, adhesive, or the like. In some embodiments, the docking device 100 may include a material cover around the base coil 102, and the spine 130 may also include a material cover (e.g., flap 118) that may be coupled with the cover of the coil 102. That is, the covers of the two components may be coupled together, such as by suturing, sewing, adhesive, clipping, or otherwise affixing the guard member 104 to the docking device 100, which is discussed in more detail herein. For example, the guard member 104 may be stitched to the coil 102 with sutures to couple the guard member 104 to the coil 102.

[0203] The length of the spine 130 may be modulated depending on the design of the docking device 100. Accordingly, the spine 130 may be configured to cover a certain percentage of a full coil turn or even a full 360 degree turn or more. The spine length may be tailored so that is matches with the mitral valve anatomy and provides a sufficient length for arms 122 extending therefrom to engage and overlap the anatomy to provide a cover. The length of the spine 130 may be relative to the central region 80 of the docking device 100. In some aspects, the length of the spine 130 from the leading end 132 to the trailing end 134 may be from about 20 mm to about 110 mm, from about 30 mm to about 100 mm, from about 40 mm to about 90 mm, from about 45 mm to about 80 mm, or about 50 mm to about 75 mm. In some embodiments, the length may be about 54 mm.

[0204] The thickness of the scaffold 120 may also be varied as needed or desired. In some embodiments, the thickness may be referring to the Z dimension relative to the X-Y area of the page. The thickness is the height of the scaffold 120 while the scaffold 120 is laid on its side with the arms 122 extending across the horizontal plane. The thickness may range from about 0.1 mm to about 0.8 mm, from about 0.2 mm to about 0.6 mm, from about 0.3 mm to about 0.5 mm, from about 0.4 to about 0.45 mm. In some aspects, the spine 130 and the arms 122 mayAttorney Docket No.: THVMC-23670W001have the same thickness. In other aspects, the spine 130 may have a larger thickness compared with the amis 122.

[0205] The width of the spine 130 and arms 122 may also vary. The width, which is orthogonal with the thickness, defines dimension in the X-Y plane of the component. The width of the spine 130 is between the concave side 136 and the convex side 138. The corresponding dimension of the arms 122 is also considered the width. The width of the spine 130 and / or the arms 122 may independently range from about 0.05 mm to about 0.5 mm, from about 0.1 mm to about 0.4 mm, from about 0.13 mm to about 0.3 mm, from about 0.16 to about 0.25 mm, or from about 0.15 mm to about 0.20 mm. In a tapered example, the arm may taper from about 0.35 mm to about 0.05 mm, or from about 0.25 mm to about 0.1 mm.

[0206] The arms 122 may be distributed along the convex side 138 of the spine 130 as shown in FIG. 14A. The arms 122 are shown to have the base portion 122b attached to the spine 130 with the head portion 122h on the opposite end of the arms 122. The arm 122 may include a straight portion 122c extending from the base portion 122b for a certain length, which then turn into an arc 122a that bends the arm 122 in a bend region 122d around so that the arm 122 has the bend region 122d that is somewhat parallel with the spine 130. That is, the arc 122a turns the direction of the arm 122 so that the bend region 122d is oriented in about the same direction as the spine 130. Also, it is noted that the bend region 122d and head portion 122h are oriented away from the leading end 132 and pointed toward the trailing end 134; however, the head of the arms could be pointed toward the leading end and oriented away from the trailing end.

[0207] The arms 122 may range from about 4 arms to about 10 arms, from about 3 arms to about 20 arms, or about 4 anus to about 15 arms, or about 5 arms to about 10 arms, or about 6 amis to about 8 anus. The arms 122 may vary in length from the base of the base region 122b (e.g., from spine 130) to the tip of the head region 122h 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 about 35 mm to about 40 mm. The straight portion 122c may have a length of 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. The arc 122a may have an angle from about 20 degrees to about 90 degrees, from about 30 degrees to about 80 degrees, from about 40 degrees to about 70 degrees, or from about 50 degrees to about 60 degrees. The bend region 122d and the head region 122h may be the dimension of the arm 122 minus the dimension straight region 122c. However, the lengths of the am may vary across different embodiments or across the different arms of the same scaffold. In some aspects, the size of the scaffold component isAttorney Docket No.: THVMC-23670W001larger in diameter than the coil 102 of the docking station. When the guard member is attached to the docking station, the guard member has more radial coverage with the flap of the guard member. Also, the flap member of the guard member is cut larger than the docking station (e.g., 33 mm diameter of flap as compared to the dock diameter of 29 mm after implant) so the textile materials of the flap are stretched tight during attachment, mitigating wrinkles in the textiles.

[0208] The arms 122 may be separated from each other by a dimension of about 0.3 mm to about 15 mm, from about 0.75 mm to about 10 mm, from about 1 mm to about 8 mm, from about 1.25 mm to about 6 mm.

[0209] The head portion 122h may also be referred to as the head 122h herein. As such, the head 122h may have a rounded shape with or without an aperture. The head 122h may include a loop 1221 shape that defines an aperture 122k, which dimensions may vary. The loop 1221 and aperture 122k is shown to have a teardrop shape; however, the shape may be completely circular, oval, or other variation of roundedness. The head 122h may be configured so that it does not have any sharp ends or points, which may minimize puncturing of the flap 118 or the mitral valve tissue or related anatomy. The head 122h provides for a rounded feature that is blunted to inhibit any puncturing.

[0210] The scaffold 120 may also have a terminal lobe 125, which may also be referred to as a petal herein or in the incorporated references. However, two terminal lobes 125 may be placed on the scaffold, with one at each end. The terminal lobe 125 is shown to have two ends attached to the spine 130 to form the loop 1251 and aperture 125k. However, only a single end may be attached to the spine 130, such as at or near the trailing end 134. The terminal lobe 125 may have various dimension and may be oblong or somewhat teardrop shaped. The terminal lobe 125 may have a length of about 5 mm to about 50 mm, from about 10 mm to about 40 mm, or from about 20 to about 30, or about 21 mm. The terminal lobe 125 may have a width from about 3 mm to about 30 mm, from about 5 to about 25 mm, from about 10 mm to about 20 mm, or from about 11 mm to about 15 mm, or about 10.5 mm.

[0211] In some examples, the scaffold 120 may include a shape memory material that is shape set and / or pre -configured to expand the guard member 104 to the radially expanded state when unconstrained (for example, when deployed at a native valve location). For example, the scaffold 120 may contain a shape memory alloy with super-elastic properties, such as Nitinol. In some examples, the scaffold 120 may contain a ternary shape memory alloy with superAttorney Docket No.: THVMC-23670W001elastic properties, such as NiTiX where X may be chromium (Cr), cobalt (Co), zirconium (Zr), hafnium (Hf), etc.

[0212] In some examples, the scaffold 120 may comprise a metallic material that does not have the shape memory properties. In such circumstances, the scaffold 120 may have a biasing mechanism (e.g., using springs, etc.) configured to bias the scaffold 120 (and the guard member 104) to the radially expanded state. Examples of such metallic material include cobaltchromium, stainless steel, etc. In one specific example, the scaffold 120 may comprise nickel-free austenitic stainless steel in which nickel may be completely replaced by nitrogen. In another specific example, the scaffold 120 may comprise cobalt-chromium or cobalt-nickel-chromium-molybdenum alloy with significantly low density of titanium.

[0213] FIG. 14B illustrates a flap 118 of the guard member 104, as described herein. The flap 118 is adapted to fit over the scaffold 120 to form the guard member 104. The flap 118 may include a at least one flap sheet 150 that has sleeves 121 formed of sleeve sheet 152 coupled with the flap sheet 150, such as with sheet stiches 154, adhesive, or other attachment means. Multiple sheets may be used, and the sleeves may be stitched out of the multiple sheets, whether over or under the scaffold 120. The flap 118 is shown to include five panels 140 and one terminal panel 140a configured as a terminal petal, with a petal shape (e.g., teardrop-like shape). Here, the flap sheet 150 may be one or more sheets, and may be configured as at least two sheets coupled (e.g., stitched) together to form a cover that with a cavity slips over the arms to cover both sides so that the arms are in the cavity between the sheets. Any embodiment of the one or more flap sheets 150 is considered herein. In some aspects, the sleeves 121 may be tubes, such as braded tubes, which may fit over the arms like a sock with a closed end. This closed end may be formed through the braiding process, or sealed closed via heat sealing (e.g., using a laser or soldering iron to melt the opening closed), sutures, or other methods of closing a braided tube. Other sleeve configurations may also be used.

[0214] In some embodiments, the flap 118 of FIG. 14B is fit onto the scaffold 120 of FIG. 14A to form the guard member 104. The guard member is then coupled to the coil 102 of FIG. 8 A to form the docking device 100 having the guard member 104 of FIGS. 14C-14D.

[0215] The flap 118 may be a single flap sheet 150 or a plurality of flap sheets 150 affixed to the scaffold 120 by any means. The affixing may be via the flap 118 being sutured to the scaffold 120, such as by loop stitches 156. Alternatively, another sheet, whether flat or tubular (e.g., sock), may be configured as a sleeve 121 that receives the arms 122 and is coupled withAttorney Docket No.: THVMC-23670W001the flap sheet 150 via sheet stiches. Accordingly, different coupling systems may be used to couple the flap sheet 150 to the scaffold 120.

[0216] In some embodiments, at least one arm 122 is coupled to the flap 118 by having the flap sheet 150 coupled with a sleeve sheet 152 with the arm 122 therein with sheet stiches 154 coupling the flap sheet 150 to the sleeve sheet 152. In some aspects, the flap 118 is a flat sheet of material, such as a fabric, film, membrane, plastic sheet, foil, or the like. In some aspects, the sleeve sheet 152 is a flat sheet of material, which may be the same or different material from the flap 1 18. In a combination of the flat flap sheet 150 and the flat sleeve sheet 152, the arm 122 is fit between the flat flap sheet 150 and flat sleeve sheet 152 with sheet stitches 154 stitching each side of the am 122 to form the sleeve 121. The arm 122 is able to freely move inside of the sleeve component that protects the arms, which enhances the ability to compress the guard member into the catheter tube.

[0217] In some embodiments, at least one am 122 is coupled to the flap 118 by having the sleeve sheet 152 formed as a tube (e.g., two open ends) or sock (e.g., one open end) slipped over the arm 122 and stitched (e.g., 154) to the flap sheet 150. Here, the sleeve sheet 152 encapsulates the arm 122 to provide additional protection, which may be beneficial to the mitral valve tissue. The tubular or sock sleeve sheet 152 may also be made from the same materials as the flat flap sheet 150, but may or may not be the same material in a particular embodiment.

[0218] In some embodiments, at least one am 122 is coupled to the flap 118 by having loop stiches 156 stitching a single am 122 to a flap sheet 150. The loop stiches 156 may go through the flap sheet 150 and around the respective am 122 and back through the flap sheet 150 on the other side of the arm 122 to form a looping stitch around the am 122. Various types of loop stiches 156 may be used so long as the stitching forms a loop coupling the arm 122 to the flap sheet 150. For example, the terminal lobe 125 is basically an arm with both ends coupled to the spine 130. As such, the teminal lobe 125 may not be adapted to receive the tube or sock sleeve configuration. Also, such a terminal lobe 125 does not have any sharp points, ends or edges. Accordingly, the am of the terminal lobe 125 may be loop stitched to the flap sheet 150. In some aspects, the guard member may include stitching around the base of the terminal lobe (e.g., loop), whereas at the end of the teminal lobe it is only stitched on the inner diameter. Therefore, the lobe may move within the flap member to allow the terminal lobe to collapse into the catheter.

[0219] In some embodiments, at least one am 122 is coupled to the flap 118 by having loop stiches 156 stitching a single arm 122 between a flap sheet 150 and flat sleeve sheet 152, whereAttorney Docket No.: THVMC-23670W001loop stiches 156 are used. The loop stiches 156 may go through the flap sheet 150 and the flat sleeve sheet 152 around the respective arm 122 and back through the flat sleeve sheet 152 and flap sheet 150 on the other side of the arm 122 to form a looping stitch around the arm 122 and the flap sheet 150 and flat sleeve sheet 152. Various types of loop stiches 156 may be used so long as the stitching forms a loop coupling the arm 122 to the flap sheet 150. Additionally, various methods may be used for the attachment, such as whip stiches, running a stitch that follows the perimeter of the arm, heat coupling, or other attachment methods.

[0220] When the arm is the terminal lobe 125, the flat sleeve sheet 152 may be configured as a flat lobe sheet 158. The flat lobe sheet 158 may be loop stitched with the terminal lobe 125 between the flap sheet 150 and flat lobe sheet 158. As shown in FIG. 14B, the flap sheet 150 is loop stitched via the loop stiches 156 to the flat lobe sheet 158 with the terminal lobe 125 therebetween. In some aspects, the flat lobe sheet 158 may be configured as a terminal petal, with a petal shape (e.g., teardrop-like shape), as shown in FIG. 14B. Additionally, other methods of attachment, such as described herein or generally known, may be used for forming the attachment.

[0221] As described, the guard member 104 is shown to include five panels 140 and one terminal panel 140a formed from the scaffold 120 and the flap 118. The panels 140 may be regions of the flap sheet 150 between the arms 122. The panels 140 may function as flat umbrella panels that may fold up when the scaffold 120 is folded into a delivery orientation and then expand once the scaffold 120 is released into a deployed orientation. The panels 140 may be various shapes and sizes for different configurations. The panels 140 extend from the spine 130 out past the amis 122 to provide a brim feature with respect to the docking device 70. The panels 140 may provide a barrier that is flexible and may contour with the mitral valve anatomy. The panels 140 may inhibit fluid flow from passing the guard member 104, and thereby may function to guard against paravalvular leakage. The panels 140 may also allow for cellular ingrowth depending on the type of material, which may facilitate implantation and longevity of beneficial function.

[0222] As shown in FIGS. 14A-14B, the arms 122, sleeves 121, terminal lobe 125 and flat lobe sheet 158 may be oriented clockwise or counter-clockwise in the deployed orientation. That is, these components may be oriented with respect to the coil 102 of the docking device 70 as illustrated in clockwise deployment or in the opposite direction in counter-clockwise deployment. While all of the arms 122 and terminal lobe 125 are oriented in the same direction as illustrated, the terminal lobe 125 may be oriented in the opposite direction (e.g.,Attorney Docket No.: THVMC-23670W001counterclockwise) while the arms 122 are still in clockwise orientation. Additionally, one or more arms 122 may be substituted with lobes, which may be internal lobes. Also, the terminal lobe 125 may be substituted with a terminal arm.

[0223] The flap 118 may also be coupled with the spine 130 of the scaffold 120. The flap 118 may be affixed with the spine 130 in a similar manner as the flap sheet 150 is fixed to an arm 122. The flap 118 may be loop stitched with the spine 130 so that the flap 118 covers the spine 130. The stitching may also secure the guard member 104 to the coil member. In another aspect, the flap sheet 150 may be looped around the spine itself and then stitched or loop stitched, which forms an interrupted tubular covering of the flap sheet 150 around the portions of the spine 130 between the arms 122, which interrupted tubular cover may be referred to as a spine sleeve 153. In some aspects, another sheet material may be used for forming the spine sleeve 153, which may be performed similar to the arm as described herein.

[0224] In some examples, the flap 118 may be configured to be so elastic that when the guard member 104 moves from the delivery orientation to the deployed orientation, the flap 118 may accommodate the scaffold 120.

[0225] In some examples, the flap 118 may be configured to be atraumatic to native tissue and / or promote tissue ingrowth into the flap 118. For example, the flap 118 may have pores to encourage tissue ingrowth. In another example, the flap 118 may be impregnated with growth factors to stimulate or promote tissue ingrowth, such as transforming growth factor alpha (TGF-alpha), transforming growth factor beta (TGF-beta), basic fibroblast growth factor (bFGF), vascular epithelial growth factor (VEGF), and combinations thereof. The flap 118 may be constructed of any suitable material, including foam, cloth, fabric, and / or polymer, which is flexible to allow for compression and expansion of the flap 118. In one example, the flap 118 may include a fabric layer constructed from a thermoplastic polymer material, such as polyethylene terephthalate (PET).

[0226] In some examples, the flap 118 may be configured to engage with the prosthetic valve deployed within the docking device so as to form a seal and reduce paravalvular leakage between the prosthetic valve and the docking device after the guard member 104 is radially expanded. The flap 118 may also be configured to engage with the native tissue (for example, the native annulus and / or native leaflets) to reduce PVL between the docking device and / or the prosthetic valve and the native tissue.Attorney Docket No.: THVMC-23670W001

[0227] Additionally, the flap 118 may include an edge protector 151 at a peripheral lip that is the region peripheral to the arms 122 and / or sleeves 121. The edge protector 151 may be a part of the flap sheet 150 or a separate member coupled with the flap sheet 150.

[0228] FIGS. 14C-14D show a docking device 100 with a coil 102 coupled to a guard member 104, according to one or more embodiments of the present disclosure. The docking device 100 may, for example, be implanted within a native valve annulus. The docking device 100 may be configured to receive and secure a prosthetic valve (e.g., prosthetic heart valve 62), thereby securing the prosthetic valve at the native valve annulus.

[0229] The docking device 100 may comprise a coil 102 and a guard member 104 (i.e., “a PVL guard” or “a sealing member” or a “brim feature”) extending along at least a portion of the coil 102. In certain examples, the coil 102 may include a shape memory material (e.g., nickel titanium alloy or Nitinol) such that the docking device 100 (and the coil 102) may move from a substantially straight or elongated configuration (i.e., “delivery orientation”) when disposed within a delivery sheath of a delivery apparatus (e.g., docking device delivery apparatus 50) to a helical configuration (i.e., “deployed orientation,” as shown in FIG. 14C) after being removed from the delivery sheath. In the delivery orientation, the arms 122 of the guard member 104 are folded up against the spine 130 so that the panels are folded inward. In the deployed orientation, the arms 122 are released and extend out away from the spine 130, which provides a brim feature for covering the mitral valve anatomy.

[0230] During delivery of the docking device 100 and after initial deployment of the docking device 100 at the implantation site, the guard member 104 may be retained in a radially compressed state by a dock sleeve of the delivery apparatus. After the docking device 100 is deployed at the implantation site, the dock sleeve may be removed so as to expose the guard member 104, thereby allowing the guard member 104 to move to a radially expanded state, such as in FIGS. 14C-14D.

[0231] In some examples, when the docking device 100 is in the deployed orientation and the guard member 104 is in the radially expanded state, the guard member 104 may extend circumferentially, radially, or laterally relative to a central longitudinal axis 101 of the docking device 100. The guard member 104 may extend around the circumference of a turn in the coil 102 from 90 degrees to 400 degrees, or from 140 degrees to 330 degrees, or from 180 degrees to 290 degrees, or from 220 degrees to 280 degrees (e.g., 270 degrees) relative to the central longitudinal axis 101. In other words, the guard member 104 may extend circumferentially from about one half of a revolution (e.g., 180 degrees) around the central longitudinal axis 101Attorney Docket No.: THVMC-23670W001in some examples to more than a full revolution (e.g., 400 degrees) around the central longitudinal axis 101 in other examples, including various ranges in between. As used herein, a range (e.g., from 180 degrees to 400 degrees, and between 180 degrees and 400 degrees) includes the endpoints of the range (e.g., 180 degrees and 400 degrees), as will all ranges recited herein being inclusive of the endpoints. In some aspects, the guard member 104 may achieve at least 360 degrees of coverage of the valve anatomy in the atrium. The unfolding of the guard member 104 allows for such coverage. Examples may include about 45 degrees of coverage to about 400 degrees ofcoverage, about 90 degrees ofcoverage to about 360 degrees ofcoverage, about 120 degrees of coverage to about 300 degrees of coverage, or about 180 degrees of coverage to about 225 degrees of coverage.

[0232] The coil 102 has a proximal end 102p and a distal end, with the guard member 104 therebetween, which also respectively define the proximal and distal ends of the docking device 100. The docking device 100 may be releasably coupled to a delivery apparatus (e.g., docking device delivery apparatus 50). For example, in certain examples, the docking device 100 may be coupled to the delivery apparatus via a release suture that may be configured to be tied to the docking device 100 and cut for removal. In one example, the release suture may be tied to the docking device 100 through an eyelet or eyehole 103 located adjacent the proximal end 102p of the coil. In another example, the release suture may be tied around a circumferential recess that is located adjacent the proximal end 102p of the coil 102.

[0233] In some examples, the docking device 100 in the deployed orientation may be configured to fit at the mitral valve position with the guard member 104 covering the mitral anatomy laterally from the coil 102 in the left atrium. The guard member 104 may provide a lateral barrier on a peripheral of the mitral valve anatomy in the left atrium intersection with the mitral valve anatomy. In other examples, the docking device 100 may also be shaped and / or adapted for implantation at other native valve positions as well, such as at the tricuspid valve. As described herein, the geometry of the docking device 100 and the guard member 104 thereof may be configured to engage the native anatomy, which can, for example, provide for increased stability and reduction of relative motion between the docking device 100, the prosthetic valve docked therein, and / or the native anatomy. Reduction of such relative motion can, among other things, prevent material degradation of components of the docking device 100 and / or the prosthetic valve docked therein and / or prevent damage or trauma to the native tissue. Also, the guard member 104 may inhibit paravalvular leaking of blood in the wrong direction in the valvular pathway.Attorney Docket No.: THVMC-23670W001

[0234] In some examples, the guard member 104 may extend along a portion (for example, the atrial portion) of the stabilization turn 110 of the coil 102. In some examples, the guard member 104 may extend along at least a portion of the central region 108 of the coil 102 (for example, a portion of the most proximal turn). In some examples, the guard member 104 may extend along a majority (or even an entirety) of the functional turns in the central region 108. In one example, when the docking device 100 is deployed at a native atrioventricular valve, the guard member 104 does not extend into the ascending portion 110b.

[0235] In various examples, the guard member 104 may move between a radially compressed state and a radially expanded state. Specifically, the guard member 104 may include a plurality of anus 122 which may be radially expandable and compressible. In the example depicted in FIGS. 14C-14D, the guard member 104 has four panels 140, including one panel configured as a distal lobe 140d and three proximal panels 140p. In other examples, the guard 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 terminal panel may be in the form of a distal petal 140d, which may or may not include an arm, a wire frame, or a loop. The distal petal 140d may have an arm 122 in a sleeve, or it may include a wire frame 123 as shown between two flap sheets, which wire frame 123 may be the same material as the scaffold 120.

[0236] When the guard member 104 is in the radially compressed state, the panels 140 may be radially compressed against the coil 102 so that the radial profile of the docking device 100 is smaller than a predefined threshold, for example, between 2 mm and 3 mm, inclusive. When the guard member 104 moves from the radially compressed state to the radially expanded state, the panels 140 may extend radially outwardly relative to the coil 102. The guard member 104 may be biased toward the radially expanded state. Thus, the guard member 104 may be retained in the radially compressed state by a dock sleeve of a delivery apparatus, and automatically return to the radially expanded state after the dock sleeve is removed.

[0237] As shown herein, the guard member 104 may include a scaffold 120 and a flap 118 substantially enclosing the scaffold 120. The shape of the scaffold 120 may generally define the shape of the guard member 104. For example, the scaffold 120 may include a spine 130 and a plurality of arms 122 connected to the spine 130. The spine 130 defines an inner edge of the guard member 104 and may be attached to the coil 102. Each arm 122 may extend radially outwardly from the spine 130 within a corresponding panel 140.Attorney Docket No.: THVMC-23670W001

[0238] As described herein, radial expansion of the guard member 104 may help prevent, reduce, and / or inhibit paravalvular leakage (PVL). Specifically, radial expansion of the guard member 104 may form an improved seal around a prosthetic valve deployed within the docking device 100. In some examples, the guard member 104 may be configured to prevent and / or inhibit leakage at the location where the docking device 100 crosses between leaflets of the native valve (for example, at the commissures of the native leaflets). For example, without the guard member 104, the docking device 100 may push the native leaflets apart at the point of crossing the native leaflets and allow for leakage at that point (for example, along the docking device or to its sides). However, the guard member 104 may be configured to expand to cover and / or fill any opening at that point and inhibit leakage along the docking device 100.

[0239] In some examples, the inner cover 112 and / or the retention member 114 may have slack. For example, FIG. 14C shows that the inner cover 112 may be axially compressed to have slack 115 before radially expanding a prosthetic valve within the docking device 100. The inner cover 112 may be constructed with a low density ePTFE so that the inner cover 112 may be axially compressed and the resulting slack 115 does not significantly impact the radial profile of the docking device 100. When radially expanding a prosthetic valve within the docking device 100, the docking device 100 may be further radially expanded, which may cause the coil 102 to rotate within the native annulus (also referred to as “clocking”). During the clocking, the slack 115 allows the inner cover 112 to be axially stretched and not rotate together with the coil 102 (that is, the coil 102 may slide axially relative to the inner cover 112). Because the guard member 104 may be fixedly attached to the retention member 114, the slack 115 may also prevent the guard member 104 from rotating and pinning open the native leaflets during the clocking.

[0240] In various examples, the guard member 104 may help cover an atrial side of an atrioventricular valve to prevent and / or inhibit blood from leaking through the native leaflets, commissures, and / or around an outside of the prosthetic valve by blocking blood in the atrium from flowing in an atrial to ventricular direction (that is, antegrade blood flow) — other than through the prosthetic valve. Positioning the guard member 104 on the atrial side of the valve may additionally or alternatively help reduce blood in the ventricle from flowing in a ventricular to atrial direction (that is, retrograde blood flow).

[0241] In some examples, the guard member 104 may be positioned on a ventricular side of an atrioventricular valve to prevent and / or inhibit blood from leaking through the native leaflets, commissures, and / or around an outside of the prosthetic valve by blocking blood in theAttorney Docket No.: THVMC-23670W001ventricle from flowing in a ventricular to atrial direction (that is, retrograde blood flow). Positioning the guard member 104 on the ventricular side of the valve may additionally or alternatively help reduce blood in the atrium from flowing in the atrial direction to ventricular direction (that is, antegrade blood flow) — other than through the prosthetic valve.

[0242] Additional examples of the docking device and its variants, including various examples of the coil, guard member, inner cover, and other components of the docking device, are described in International Publication No. WO / 2020 / 247907, the entirety of which is incorporated by reference herein.

[0243] FIG. 14E shows an embodiment of a docking device that includes a coil 102 having a guard member 104 and a compressible plug 210, arranged in accordance with at least one embodiment herein. FIG. 14F shows a side view of the docking device of FIG. 14E, arranged in accordance with at least one embodiment herein. The compressible plug 210 is shown to be distal compared to the guard member 104 on the coil 102. The compressible plug 210 is attached to the coil 102 by a short tether (not visible in FIGS. 14E-14F) having one end forming a loop around the coil 102 and another end coupled to the atrial lobe 202 of the compressible plug 210. The tether may be similar to, e.g., the tether 902 of FIGS. 9A-9B. The coil 102 includes stops 902, 906 between which the compressible plug 210 can slide via the tether within the predefined range of movement. In other embodiments, the tether may be coupled to some other part of the compressible plug 210 and / or the tether maybe longer and may be coupled to the coil 102 at a fixed location.

[0244] Additionally, it should be recognized that the compressible plug 210 forms a plug with the guard member 104, so that both the compressible plug 210 and guard member 104 cooperate to block fluid leakage. As such, the compressible plug 210 may form a plug along with the guard member 104 to inhibit PVL. The compressible plug 210 and guard member 104 may be so close that there is no gap, such as both being in contact or overlapping. The compressible plug 210 and the guard member 104 may cover any gaps that may otherwise (i.e., in the absence of the plug 210 and / or guard member 104) leak fluid between the coil 102, the guard member 104, and the plug 210.Example Medial Commissure Plug

[0245] FIGS. 15A-15B illustrate an embodiment of a compressible plug 1500 having a plug cover 1502 over the compressible plug scaffold of one of the examples provided herein. As shown, the compressible plug 1500 includes lobes 1504, 1506 (e.g., an atrial lobe and a ventricular lobe) coupled by an intermediate waist 1508. The compressible plug 1500 may beAttorney Docket No.: THVMC-23670W001attached, e.g., via any tether herein, to the coil 102 at the lobe 1504 (top, bottom, or side), the lobe 1506 (top, bottom, or side), the intermediate waist 1508, or any other location of the compressible plug 1500. The tether may be attached at one end to the coil 102 and at the other end to the compressible plug 1500 by any attachment means. This embodiment includes a three-dimensional expanded shape of the compressible scaffold where each of the lobes 1504, 1506 includes a generally crescent or kidney shape, with the lobe 1504 being larger (e.g., extending further in the axial direction) than the lobe 1506.

[0246] FIGS. 16A-16B illustrate another embodiment of a compressible plug 1600 having a plug cover 1602 over the compressible plug scaffold of one of the examples provided herein. As shown, the compressible plug 1600 includes lobes 1604, 1606 (e.g., an atrial lobe and a ventricular lobe) coupled by an intermediate waist 1608. The compressible plug 1600 may be attached, e.g., via any tether herein, to the coil 102 at the lobe 1604 (top, bottom, or side), the lobe 1606 (top, bottom, or side), the intermediate waist 1608, or any other location of the compressible plug 1600. The tether may be attached at one end to the coil 102 and at the other end to the compressible plug 1600 by any attachment means. This embodiment includes a three-dimensional expanded shape of the compressible scaffold where each of the lobes 1604, 1606 includes a generally crescent or kidney shape, with the lobe 1604 being equal or approximately equal in size to the lobe 1606. The intermediate waist 1608 of FIGS. 16A-16B is larger relative to the lobes 1604, 1606 than the intermediate waist 1508 of FIGS. 15A-15B relative to the lobes 1504, 1506.

[0247] FIGS. 17A-17B illustrate another embodiment of a compressible plug 1700 having a plug cover 1702 over the compressible plug scaffold of one of the examples provided herein. As shown, the compressible plug 1700 includes lobes 1704, 1706 (e.g., an atrial lobe and a ventricular lobe) coupled by an intermediate waist 1708. The compressible plug 1700 may be attached, e.g., via any tether herein, to the coil 102 at the lobe 1704 (top, bottom, or side), the lobe 1706 (top, bottom, or side), the intermediate waist 1708, or any other location of the compressible plug 1700. The tether may be attached at one end to the coil 102 and at the other end to the compressible plug 1700 by any attachment means. This embodiment includes a three-dimensional expanded shape of the compressible scaffold where each of the lobes 1704, 1706 includes a generally crescent or kidney shape, with the lobe 1704 being equal or approximately equal in size to the lobe 1706. The intermediate waist 1708 of FIGS. 17A-17B is larger relative to the lobes 1704, 1706 than the intermediate waist 1508 of FIGS. 15A-15B relative to the lobes 1504, 1506. The intermediate waist 1708 of FIGS. 17A-17B is smallerAttorney Docket No.: THVMC-23670W001relative to the lobes 1704, 1706 than the intermediate waist 1608 of FIGS. 16A-16B relative to the lobes 1504, 1506. In addition, in the orientation of FIG. 17B, the intermediate waist 1708 is vertically centered relative to the lobes 1704, 1706, whereas in the orientations of FIGS. 15B and 16B, the intermediate waist 1508, 1608 is vertically offset towards the bottom relative to the lobes 1504, 1506, 1604, 1606.

[0248] FIGS. 18-24 illustrate various example compressible plugs with various example covers (internal or external), arranged in accordance with at least one embodiment herein. Each cover may be porous or fluid tight depending on different embodiments, such as woven, braided, knitted, or other cloth or expanded materials (ePTFE). The cover may allow for cellular ingrowth, where the pores may be small enough to inhibit blood from flowing therethrough. The blood may also coagulate at the pores to provide more leak inhibition. While specific covers are illustrated with specific compressible plugs in FIGS. 18-24, more generally any of the covers herein may be used with any of the compressible plugs herein.

[0249] In more detail, FIG. 18 illustrates an example compressible plug 1800 with an example cover 1802 that is braided, arranged in accordance with at least one embodiment herein. The compressible plug 1800 includes two lobes coupled by an intermediate waist. In the orientation of FIG. 18, the upper lobe may be an atrial lobe and in some embodiments may be cylinder shaped, while the lower lobe may be a ventricular lobe and in some embodiments may be disk shaped.

[0250] FIG. 19 illustrates an example compressible plug 1900 with an example cover 1902 that is woven, arranged in accordance with at least one embodiment herein. The compressible plug 1900 includes a single body. FIG. 19 further illustrates an example coil 102 to which the compressible plug 1900 is coupled via a tether 902.

[0251] FIGS. 20 and 21 illustrate example compressible plugs 2000, 2100, arranged in accordance with at least one embodiment herein. Each of the compressible plugs includes two lobes coupled by an intermediate waist. The two lobes in FIG. 20 may generally be diskshaped. The two lobes in FIG. 21 may generally be cylinder shaped. The compressible plugs 2000, 2100 may lack any cover at all. Alternatively, the compressible plugs 2000, 2100 may have a scaffold woven or joined together tightly enough to inhibit blood flow, may have an internal cover not visible in FIGS. 20-21, or the like or any combination thereof.

[0252] FIG. 22 illustrates an example compressible plug 2200 with an example cover 2202 that is fuzzy for tissue ingrowth and flow impediment, arranged in accordance with at least oneAttorney Docket No.: THVMC-23670W001embodiment herein. The compressible plug 2200 includes a single body. FIG. 22 further illustrates an example coil 102 to which the compressible plug 2200 is coupled via a tether 902.

[0253] FIG. 23 illustrates an example compressible plug 2300 with an example cover 2302 that is fuzzy for tissue ingrowth and flow impediment, arranged in accordance with at least one embodiment herein. The compressible plug 2300 includes two lobes coupled by an intermediate waist. In the example of FIG. 23, the cover 2302 is provided on one, but not both, of the intermediate lobes.

[0254] FIG. 24 illustrates a compressible plug 2400 having a scaffold 2402 filled with pluggable members 2404, which may be absorbent or hydrophobic, arranged in accordance with at least one embodiment herein. The pluggable members 2404 are compressible. The pluggable members 2404 may be any shape and may vary in size. The spherical pluggable members may be used, which could also be rods, cylinders, discs, cubes, rectangles, flat members, fluffed members, random shapes, or irregular shapes. For example, a flat or fluffy cloth material may be used as a pluggable member.

[0255] FIGS. 6A-6C illustrate an example compressible plug 210 with a partial cover, e.g., plugging component 208, on only some of the compressible plug 210. Such a partial cover may advantageously minimize a collapsed / compressed profile of the compressible plug 210 for, e.g., insertion into and passage through a delivery device.

[0256] In some embodiments, different techniques may be used to prepare the docking device having the guard member. An example method of making the docking device having the guard member is explained herein; however, variations may be made to achieve the embodiments illustrated and described herein. In the example, the docking device having the guard member is shown herein (figures) for illustration purposes to show the product of the manufacturing procedure. Although it should be understood that similar or different methods may be used to make docking devices having different guard members by following the patterns and components thereof.

[0257] The coil may be provided in any one of the embodiments. The compressible scaffold may be prepared from one or more shape-memory wires formed into a three-dimensional shape. The scaffold may be combined with a plugging component to provide a plugging function. The plugging component may be selected from a cover (e.g., external or internal) for the scaffold, absorbent members located within the compressible scaffold, or one or more compressible members (e.g., hydrophobic) in an internal space within the scaffold. The plugging component may be combined with the scaffold before or after the scaffold is coupledAttorney Docket No.: THVMC-23670W001with the coil. The combination of the plugging component and the compressible scaffold provides the compressible plug, which may be used for the plugging of fluid at the medial commissure. The compressible plug may be coupled to the coil by a tether that may be coupled to the coil and the compressible plug by any one or more of stitching with sutures (e.g., as described herein for any stitching), or a clip, or a wrapping tape, or a loop of the tether, or other fastening means to couple the tether to the plug and the coil.

[0258] In some embodiments, the compressible plug may be attached via the tether to the coil of the docking device. For example, the cover and / or the scaffold of the compressible plug may be attached through the tether to the coil via one or more sutures, loop stiches, wraps, or other fastening feature. The compressible plug may be directly bonded together (e.g., adhesive, welding, brazing, etc.), or placed adjacent and wrapped together with a wrapping cover.

[0259] Before implanting the docking device, the compressible plug may be retained within a dock sleeve (for example, the dock sleeve 1002). The compressible plug retained within the dock sleeve may remain in a radially compressed state. For example, the compressible plug may be radially compressed so that the body shapes to extend along the coil and body molded to the coil to be parallel to the coil.Sterilization

[0260] Any of the systems, devices, apparatuses, etc. herein may be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein may include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Additional Examples of the Disclosed Technology

[0261] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.Attorney Docket No.: THVMC-23670W001

[0262] Example 1. A docking device to secure a prosthetic heart valve at a native heart valve, the docking device comprising:a coil comprising a plurality of helical turns when in a deployed orientation; and a compressible plug including a scaffold formed from a shape-memory material, wherein:the compressible plug is configured to provide a liquid plugging function; the compressible plug is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation;the compressible plug is coupled to a helical turn of the coil by a tether; and in the deployed orientation, the tether is configured to accommodate relative movement between the compressible plug and the helical turn of the coil within a predefined range that depends at least on the tether.

[0263] Example 2. A docking device to secure a prosthetic heart valve at a native heart valve, the docking device comprising:a coil comprising a plurality of helical turns when in a deployed orientation;a guard member attached to the coil by being coupled to at least a portion of a helical turn thereof, the guard member including a scaffold with a spine, a plurality of arms extending from the spine, and a flap coupled to the plurality of arms; anda compressible plug including a scaffold formed from a shape-memory material, wherein:the guard member is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation;the compressible plug is configured to provide a liquid plugging function; the compressible plug is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation;the compressible plug is coupled to a helical turn of the coil by a tether; and in the deployed orientation, the tether is configured to accommodate relative movement between the compressible plug and the helical turn of the coil within a predefined range that depends at least on the tether.

[0264] Example 3. The docking device of any example herein, particularly of any one of examples 1-2, wherein the scaffold of the compressible plug includes a body formed by one or more wires of the shape-memory material that is shaped into a three-dimensional expanded shape.Attorney Docket No.: THVMC-23670W001

[0265] Example 4. The docking device of any example herein, particularly of example 3, wherein the one or more wires are woven, braided, wound, a mesh, or associated together to form the body having the three-dimensional expanded shape.

[0266] Example 5. The docking device of any example herein, particularly of any one of examples 3-4, wherein the three-dimensional expanded shape of the scaffold has one or more of:an atrial lobe, a ventricular lobe, and an intermediate waist that couples the atrial lobe and the ventricular lobe together;a hollow external shell;a lobe that is disk-shaped;a lobe that is cylinder-shaped;a lobe that is kidney-shaped;a lobe that is crescent-shaped;a lobe that is rectangle-shaped;a lobe that is oval-shaped;a single cylindrical body;a single kidney-like body;a single crescent-like body;a single rectangular body;a single oval body; ora hollow internal core.

[0267] Example 6. The docking device of any example herein, particularly of any one of examples 3-5, wherein the three-dimensional expanded shape of the scaffold includes a diskshaped ventricular lobe, a cylinder-shaped atrial lobe, and an intermediate waist coupling the disk-shaped ventricular lobe and the cylinder-shaped atrial lobe together.

[0268] Example 7. The docking device of any example herein, particularly of any one of examples 3-5, wherein the three-dimensional expanded shape of the scaffold includes a diskshaped ventricular lobe, a disk-shaped atrial lobe, and an intermediate waist coupling the diskshaped ventricular lobe and the disk-shaped atrial lobe together.

[0269] Example 8. The docking device of any example herein, particularly of any one of examples 3-5, wherein the three-dimensional expanded shape of the scaffold includes a kidneyshaped ventricular lobe, a kidney-shaped atrial lobe, and an intermediate waist coupling the kidney-shaped ventricular lobe and the kidney-shaped atrial lobe together.Attorney Docket No.: THVMC-23670W001

[0270] Example 9. The docking device of any example herein, particularly of any one of examples 1-8, wherein the shape-memory material includes a nickel titanium alloy.

[0271] Example 10. The docking device of any example herein, particularly of any one of examples 1-9, wherein the tether is coupled to the helical turn at a fixed location of the helical turn, the predefined range being centered at the fixed location and twice a length of the tether along the helical coil.

[0272] Example 11. The docking device of any example herein, particularly of example 10, further comprising a stop along the helical turn distal to the fixed location.

[0273] Example 12. The docking device of any example herein, particularly of example 11, wherein the stop is configured to inhibit proximal movement of the compressible plug relative to the helical turn when the compressible plug is unsleeved during implantation of the docking device at the native heart valve.

[0274] Example 13. The docking device of any example herein, particularly of any one of examples 11-12, wherein the stop comprises a suture wrapped around the helical turn, a crimp crimped onto the helical turn, or an expanded polytetrafluoroethylene (ePTFE) section having a larger outer diameter than the helical turn.

[0275] Example 14. The docking device of any example herein, particularly of any one of examples 1-9, wherein the tether is slidable along the helical turn within the predefined range.

[0276] Example 15. The docking device of any example herein, particularly of example 14, further comprising a first stop coupled to the helical turn at a proximal end of the predefined range and a second stop coupled to the helical turn at a distal end of the predefined range, the tether slidable along the helical turn between the first stop and the second stop.

[0277] Example 16. The docking device of any example herein, particularly of example 15, wherein each of the first stop and the second stop comprises a suture wrapped around the helical turn, a crimp crimped onto the helical turn, or an expanded polytetrafluoroethylene (ePTFE) section having a larger outer diameter than the helical turn.

[0278] Example 17. The docking device of any example herein, particularly of example 15, wherein the first stop comprises a distal end of the guard member.

[0279] Example 18. The docking device of any example herein, particularly of any one of examples 1-17, the compressible plug further comprising a plugging component associated with the scaffold, wherein the plugging component includes a cover on or around or within the scaffold.Attorney Docket No.: THVMC-23670W001

[0280] Example 19. The docking device of any example herein, particularly of example 18, wherein the cover is an external cover or internal cover that forms a fluid tight covering surface on or around or within the scaffold.

[0281] Example 20. The docking device of any example herein, particularly of any one of examples 18-19, wherein the cover is waterproof.

[0282] Example 21. The docking device of any example herein, particularly of any one of examples 18-20, wherein the cover is at least one of:coupled to an inner surface or an outer surface of the scaffold so as to conform with the three-dimensional expanded shape;formed into a sack retaining the scaffold therein;formed into a sheet within the scaffold;formed into a bladder within the scaffold; orformed into an internal surface covering within the scaffold.

[0283] Example 22. The docking device of any example herein, particularly of any one of examples 18-21, wherein the cover is over an outer surface of the scaffold.

[0284] Example 23. The docking device of any example herein, particularly of any one of examples 18-21, wherein the cover is under an internal surface of an internal space of the scaffold.

[0285] Example 24. The docking device of any example herein, particularly of any one of examples 18-23, wherein the cover is formed of a material expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), thermoplastic polyurethane, metal, or silicone.

[0286] Example 25. The docking device of any example herein, particularly of any one of examples 1-24, the compressible plug further comprising a plugging component that includes one or more fluid absorbent members or one or more fluid impermeable members located within the internal space of the scaffold.

[0287] Example 26. The docking device of any example herein, particularly of any one of examples 1-25, the compressible plug further comprising a plugging component that includes one or more compressible members in the internal space of the scaffold.

[0288] Example 27. The docking device of any example herein, particularly of any one of examples 1-26, wherein the compressible plug is configured for fitting, at least partially within, or extending through a commissure of a native heart valve, and / or covering the commissure and at least part of adjacent leaflets.Attorney Docket No.: THVMC-23670W001

[0289] Example 28. The docking device of any example herein, particularly of example 27, wherein the commissure of the native heart valve comprises the medial commissure of a native mitral valve.

[0290] Example 29. The docking device of any example herein, particularly of example 28, wherein the compressible plug includes an atrial lobe configured to be retained in a left atrium, and a ventricular lobe configured to be retained in a left ventricle, the atrial and ventricular lobes coupled through the medial commissure.

[0291] Example 30. The docking device of any example herein, particularly of any one of examples 1-29, wherein the compressible plug is free to move along the helical turn within the predefined range.

[0292] Example 31. The docking device of any example herein, particularly of any one of examples 1-30, further comprising at least one marker band coupled with the compressible plug.

[0293] Example 32. The docking device of any example herein, particularly of any one of examples 1-31, wherein when the compressible plug is in the radially compressed state, the scaffold is radially compressed against the coil in the delivery orientation so that a cross-sectional profile of the docking device includes a diameter that is smaller than a predefined threshold diameter.

[0294] Example 33. The docking device of any example herein, particularly of example 32, wherein the predefined threshold diameter ranges from about 2 millimeters (mm) to about 3 mm.

[0295] Example 34. The docking device of any example herein, particularly of any one of examples 1-33, wherein the tether comprises one or more sutures, sowings, adhesives, clips, clamps, mechanical coupler, or any combination thereof.

[0296] Example 35. The docking device of any example herein, particularly of any one of examples 18-24, wherein the cover of the compressible plug includes at least one layer of a biocompatible material coupled to the scaffold.

[0297] Example 36. The docking device of any example herein, particularly of example 35, wherein the biocompatible material is flexible so as to be capable of being folded in the delivery orientation and expanded in the deployed orientation.

[0298] Example 37. The docking device of any example herein, particularly of any one of examples 35-36, wherein the biocompatible material is porous and configured for cellular ingrowth.Attorney Docket No.: THVMC-23670W001

[0299] Example 38. The docking device of any example herein, particularly of any one of examples 18-24 or 35-37, wherein the cover is formed of at least one sheet of fabric formed by weaving, knitting, crocheting, braiding, laminating, electrospinning, extrusion, or bonding fibers together, wherein the fibers are biocompatible.

[0300] Example 39. The docking device of any one of examples 18-24 or 35-38, wherein the cover is formed of at least one sheet of material that is polymeric in a form of a membrane, film, plastic sheet, or foil, wherein the sheet material is biocompatible, wherein the sheet material is expanded polytetrafluoroethylene (ePTEE), polytetrafluoroethylene (PTFE), thermoplastic polyurethane, or silicone.

[0301] Example 40. The docking device of any example herein, particularly of any one of examples 18-24 or 35-39, wherein the cover is formed of a metal that is woven or braided.

[0302] Example 41. The docking device of any example herein, particularly of any one of examples 3-8, wherein the three-dimensional expanded shape has a maximum diameter that ranges from about 5 millimeters (mm) to about 25 mm, from about 10 mm to about 20 mm, or about 14 mm to about 16 mm.

[0303] Example 42. The docking device of any example herein, particularly of any one of examples 3-8 or 41, wherein the three-dimensional expanded shape of the compressible plug has a length that ranges from about 3 millimeters (mm) to about 50 mm, from about 8 mm to about 40 mm, or about 15 mm to about 30 mm, or about 20 mm.

[0304] Example 43. A method for making the docking device of any example herein, particularly of any one of examples 1-42, the method comprising:forming a plurality of wires of a shape-memory material into the scaffold; attaching a cover to the scaffold to form the compressible plug; andcoupling the compressible plug to the coil with a tether to accommodate relative movement between the compressible plug and the helical turn of the coil within a predefined range that depends at least on the tether.

[0305] Example 44. The method of any example herein, particularly of example 43, further comprisingforming a body with one or more wires of the shape-memory material; and shaping the body into a three-dimensional expanded shape.

[0306] Example 45. The method of any example herein, particularly of any one of examples 43-44, further comprising forming the body by weaving, braiding, winding, forming a mesh,Attorney Docket No.: THVMC-23670W001or associating the one or more wires together to form the body having the three-dimensional expanded shape.

[0307] Example 46. The method of any example herein, particularly of any one of examples 44-45, further comprising forming the three-dimensional expanded shape of the scaffold to have one or more of:an atrial lobe, a ventricular lobe, and an intermediate waist that couples the atrial lobe and the ventricular lobe together;a hollow external shell;a lobe that is disk-shaped;a lobe that is cylinder-shaped;a lobe that is kidney-shaped;a lobe that is crescent-shaped;a lobe that is rectangle-shaped;a lobe that is oval-shaped;a single cylindrical body:a single kidney-like body;a single crescent-like body;a single rectangular body;a single oval body; ora hollow internal core.

[0308] Example 47. The method of any example herein, particularly of any one of examples 43-46, further comprising enclosing a scaffold of a guard member within a cover to form the guard member of the docking device.

[0309] Example 48 The method of any example herein, particularly of any one of examples 43-47, further comprising inserting absorbent members into an interior space of the scaffold of the compressible plug.

[0310] Example 49. The method of any example herein, particularly of any one of examples 43-48, further comprising inserting compressible members into an interior space of the scaffold of the compressible plug.

[0311] Example 50. The method of any example herein, particularly of example 49, wherein the compressible members are hydrophobic, and when compressed form a hydrophobic barrier.Attorney Docket No.: THVMC-23670W001

[0312] Example 51. The method of any one of examples 43-50, wherein coupling the compressible plug to the coil with the tether comprises stitching the tether to a coil cover member.

[0313] Example 52. The method of any example herein, particularly of any one of examples 43-50, wherein coupling the compressible plug to the coil with the tether comprises stitching the tether to a retention member of the coil, wherein the coil includes a coil core, a tubular cover member over the coil core, and the retention member as a tube over the tubular cover member.

[0314] Example 53. The method of any example herein, particularly of any one of examples 43-52, further comprising forming a marker band onto one or more of the compressible plug or the coil.

[0315] Example 54. A method of configuring a docking device for delivery to a native heart valve, the method comprising:providing the docking device of any example herein, particularly of any one of examples 1-42;compressing the compressible plug by compressing the scaffold of the compressible plug into the delivery orientation; andinserting the compressible plug in the delivery orientation into a dock sleeve of a dock delivery system.

[0316] Example 55. The method of any example herein, particularly of example 54, further comprising inserting the coil into the dock sleeve.

[0317] Example 56. A method of implanting a docking device into a native heart valve, the method comprising;providing the docking device of any example herein, particularly of any one of examples 1-42;delivering the docking device to a native heart valve while the docking device is in a delivery orientation;deploying the coil of the docking device at an annulus of the native heart valve; and deploying the compressible plug into the deployed orientation at a position at the native heart valve so that the compressible plug has a first portion to one side of a commissure of the native heart valve, a second portion to an opposite side of the commissure, and an intermediate portion within the commissure that couples the first portion to the second portion.Attorney Docket No.: THVMC-23670W001

[0318] Example 57. The method of any example herein, particularly of example 56, wherein when the compressible plug is in the deployed orientation at the native heart valve, the intermediate portion is at least partially compressed within the commissure.

[0319] Example 58. The method of any example herein, particularly of any one of examples 56-57, wherein when the compressible plug is in the deployed orientation at the native heart valve, the compressible plug overlays or presses against at least one of a leaflet, an atrial region, or a ventricular region.

[0320] Example 59. The method of any example herein, particularly of any one of examples 56-58, wherein the coil remains in a substantially straight configuration in the delivery orientation when delivering the docking device and the coil moves to a helical configuration after the docking device is deployed.

[0321] Example 60. The method of any example herein, particularly of any one of examples 56-59, wherein the compressible plug remains in the delivery orientation when delivering the docking device and moves to the deployed orientation after the docking device is deployed.

[0322] Example 61. The method of any example herein, particularly of any one of examples 56-60, wherein delivering the docking device comprises retaining the docking device within a dock sleeve and wherein deploying the docking device comprises moving the docking device out of the dock sleeve.

[0323] Example 62. The method of any example herein, particularly of any one of examples 56-61, wherein deploying the coil of the docking device comprises removing a delivery sleeve from the coil and compressible plug while at the native heart valve.

[0324] Example 63. The method of any example herein, particularly of any one of examples 56-62, further comprising installing a prosthetic heart valve in the docking device and clocking the coil clockwise and / or counterclockwise during installation of the prosthetic heart valve.

[0325] Example 64. The method of any example herein, particularly of example 63, wherein the compressible plug is movable relative to the coil within a predefined range and wherein as the coil is clocked clockwise and / or counterclockwise during installation of the prosthetic heart valve, a portion of the coil rotates past the compressible plug as the compressible plug remains at the position at the native heart valve.

[0326] Example 65. A method of implanting a prosthetic heart valve, the method comprising:providing the docking device of any example herein, particularly of any one of examples 1-42;delivering the docking device to a native heart valve;Attorney Docket No.: THVMC-23670W001deploying the docking device at an annulus of the native heart valve so that the compressible plug expands into the deployed orientation at a position at the native heart valve so that the compressible plug has a first portion to one side of a commissure of the native heart valve, a second portion to an opposite side of the commissure, and an intermediate portion within the commissure that couples the first portion to the second portion; and deploying a prosthetic heart valve within the docking device,wherein the coil remains in a substantially straight delivery orientation when delivering the docking device and moves to a helical configuration after the docking device is in the deployed orientation,wherein the compressible plug remains in a radially compressed state in a delivery orientation when delivering the docking device and moves to a radially expanded state in a deployed orientation after the docking device is deployed.

[0327] The features described herein with regard to any example may be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one docking device may be combined with any one or more features of another docking device.

[0328] In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples of the technology and should not be taken as limiting the scope of the disclosure. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

Attorney Docket No.: THVMC-23670W001What is claimed is:

1. A docking device to secure a prosthetic heart valve at a native heart valve, the docking device comprising:a coil comprising a plurality of helical turns when in a deployed orientation; and a compressible plug including a scaffold formed from a shape-memory material, wherein:the compressible plug is configured to provide a liquid plugging function; the compressible plug is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation;the compressible plug is coupled to a helical turn of the coil by a tether; and in the deployed orientation, the tether is configured to accommodate relative movement between the compressible plug and the helical turn of the coil within a predefined range that depends at least on the tether.

2. A docking device to secure a prosthetic heart valve at a native heart valve, the docking device comprising:a coil comprising a plurality of helical turns when in a deployed orientation;a guard member attached to the coil by being coupled to at least a portion of a helical turn thereof, the guard member including a scaffold with a spine, a plurality of arms extending from the spine, and a flap coupled to the plurality of arms; anda compressible plug including a scaffold formed from a shape-memory material, wherein:the guard member is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation;the compressible plug is configured to provide a liquid plugging function; the compressible plug is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation;the compressible plug is coupled to a helical turn of the coil by a tether; and in the deployed orientation, the tether is configured to accommodate relative movement between the compressible plug and the helical turn of the coil within a predefined range that depends at least on the tether.Attorney Docket No.: THVMC-23670W0013. The docking device of any one of claims 1-2, wherein the scaffold of the compressible plug includes a body formed by one or more wires of the shape-memory material that is shaped into a three-dimensional expanded shape.

4. The docking device of claim 3, wherein the one or more wires are woven, braided, wound, a mesh, or associated together to form the body having the three-dimensional expanded shape.

5. The docking device of any one of claims 3-4, wherein the three-dimensional expanded shape of the scaffold has one or more of:an atrial lobe, a ventricular lobe, and an intermediate waist that couples the atrial lobe and the ventricular lobe together;a hollow external shell;a lobe that is disk-shaped;a lobe that is cylinder-shaped;a lobe that is kidney-shaped;a lobe that is crescent-shaped;a lobe that is rectangle-shaped;a lobe that is oval-shaped;a single cylindrical body:a single kidney-like body;a single crescent-like body;a single rectangular body;a single oval body; ora hollow internal core.

6. The docking device of any one of claims 3-5, wherein the three-dimensional expanded shape of the scaffold includes a disk-shaped ventricular lobe, a cylinder-shaped atrial lobe, and an intermediate waist coupling the disk-shaped ventricular lobe and the cylinder-shaped atrial lobe together.

7. The docking device of any one of claims 3-5, wherein the three-dimensional expanded shape of the scaffold includes a disk-shaped ventricular lobe, a disk-shaped atrial lobe, and anAttorney Docket No.: THVMC-23670W001intermediate waist coupling the disk-shaped ventricular lobe and the disk-shaped atrial lobe together.

8. The docking device of any one of claims 3-5, wherein the three-dimensional expanded shape of the scaffold includes a kidney-shaped ventricular lobe, a kidney-shaped atrial lobe, and an intermediate waist coupling the kidney-shaped ventricular lobe and the kidney-shaped atrial lobe together.

9. A method for making the docking device of any one of claims 1-8, the method comprising:forming a plurality of wires of a shape-memory material into the scaffold; attaching a cover to the scaffold to form the compressible plug; andcoupling the compressible plug to the coil with a tether to accommodate relative movement between the compressible plug and the helical turn of the coil within a predefined range that depends at least on the tether.

10. A method of configuring a docking device for delivery to a native heart valve, the method comprising:providing the docking device of any one of the claims 1-8;compressing the compressible plug by compressing the scaffold of the compressible plug into the delivery orientation; andinserting the compressible plug in the delivery orientation into a dock sleeve of a dock delivery system.

11. The method of claim 10, further comprising inserting the coil into the dock sleeve.

12. A method of implanting a docking device into a native heart valve, the method comprising:providing the docking device of any one of claims 1-8;delivering the docking device to a native heart valve while the docking device is in a delivery orientation;Attorney Docket No.: THVMC-23670W001deploying the coil of the docking device at an annulus of the native heart valve; and deploying the compressible plug into the deployed orientation at a position at the native heart valve so that the compressible plug has a first portion to one side of a commissure of the native heart valve, a second portion to an opposite side of the commissure, and an intermediate portion within the commissure that couples the first portion to the second portion.

13. The method of claim 12, wherein when the compressible plug is in the deployed orientation at the native heart valve, the intermediate portion is at least partially compressed within the commissure.

14. The method of any one of claims 12-13, wherein when the compressible plug is in the deployed orientation at the native heart valve, the compressible plug overlays or presses against at least one of a leaflet, an atrial region, or a ventricular region.

15. The method of any one of claims 12-14, wherein the coil remains in a substantially straight configuration in the delivery orientation when delivering the docking device and the coil moves to a helical configuration after the docking device is deployed.

16. The method of any one of claims 12-15, wherein the compressible plug remains in the delivery orientation when delivering the docking device and moves to the deployed orientation after the docking device is deployed.

17. The method of any one of claims 12-16, wherein delivering the docking device comprises retaining the docking device within a dock sleeve and wherein deploying the docking device comprises moving the docking device out of the dock sleeve.

18. The method of any one of claims 12-17, wherein deploying the coil of the docking device comprises removing a delivery sleeve from the coil and compressible plug while at the native heart valve.

19. The method of any one of claims 12-18, further comprising installing a prosthetic heart valve in the docking device and clocking the coil clockwise and / or counterclockwise during installation of the prosthetic heart valve.Attorney Docket No.: THVMC-23670W00120. The method of claim 19, wherein the compressible plug is movable relative to the coil within a predefined range and wherein as the coil is clocked clockwise and / or counterclockwise during installation of the prosthetic heart valve, a portion of the coil rotates past the compressible plug as the compressible plug remains at the position at the native heart valve.

21. A method of implanting a prosthetic heart valve, the method comprising:providing the docking device of any one of claims 1-8;delivering the docking device to a native heart valve;deploying the docking device at an annulus of the native heart valve so that the compressible plug expands into the deployed orientation at a position at the native heart valve so that the compressible plug has a first portion to one side of a commissure of the native heart valve, a second portion to an opposite side of the commissure, and an intermediate portion within the commissure that couples the first portion to the second portion; and deploying a prosthetic heart valve within the docking device,wherein the coil remains in a substantially straight delivery orientation when delivering the docking device and moves to a helical configuration after the docking device is in the deployed orientation,wherein the compressible plug remains in a radially compressed state in a delivery orientation when delivering the docking device and moves to a radially expanded state in a deployed orientation after the docking device is deployed.

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