Docking devices for prosthetic implants

Abstract

Docking devices for securing a prosthetic valve at a native valve are provided. The docking device can include a coil and a guard member. The coil includes a plurality of helical turns when in a deployed orientation. The guard member may be attached to the coil by being coupled to at least a portion of a helical turn thereof. The docking devices include a atrial functional turn configured to enhance the transient stage stability of the docking device in the left atrium of the heart.

Description

Attorney Docket No: THVVA-24206W001DOCKING DEVICES FOR PROSTHETIC IMPLANTSCROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 705,734, filed October 10, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to docking devices for prosthetic implants.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.SUMMARY

[0004] Described herein are docking devices, prosthetic implants (e.g, prosthetic heart valves), delivery apparatus, and methods for implanting the docking devices and / or prosthetic implants. The disclosed docking devices can, for example, provide improved placement, stabilization, and retention of the docking device. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatus.Attorney Docket No: THVVA-24206W001

[0005] In some examples, a coil for a docking device for securing a prosthetic valve comprises a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the coil relative to the native annulus, wherein the first coil region defines a first axis extending through a lumen of the first coil region from the inflow side to an outflow side; and a second coil region extending from an outflow end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein the second coil region defines a second axis extending through a lumen of the second coil region from the inflow side to the outflow side, wherein the first axis and the second axis are offset relative to one another by an angle. In some examples, the angle is in in a range of 10 degrees to 45 degrees. In some examples, the angle is in a range of 20 degrees to 30 degrees. In some examples, the first axis and second axis are offset such that a posterior side portion of the first coil region is raised relative to an anterior side portion of the first coil region.

[0006] In some examples, a coil for a docking device for securing a prosthetic valve comprises: a first coil region comprising a helical turn configured to be disposed on an inflow side of a native annulus and to stabilize the coil relative to the native annulus, wherein the first coil region defines a first coil pitch; and a second coil region extending from a distal end of the first coil region and comprising a plurality of helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein the second coil region defines a second coil pitch, wherein the first coil pitch is larger than the second coil pitch. In some examples, the first coil region comprises a first coil pitch in a range of 2 to 5 mm. In some examples, the first coil pitch is within a range of 3 to 4 mm.

[0007] In some examples, a coil for a docking device for securing a prosthetic valve comprises: a helical core, wherein the core defines: a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the coil relative to the native annulus, wherein at least a portion of the first coil region defines a first core cross section; a second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein at least a portion of the second coil region comprises a second core cross section; and wherein an area of the second core cross section is greater than an area of the first core cross section. In some examples, the first core cross section and the second core cross section each comprise a circular cross section with the first core cross section defining a first diameter and the second core cross section defining a second diameter,Attorney Docket No: THVVA-24206W001 wherein the second diameter is larger than the first diameter. In some examples, the first core cross section defines a portion of a circle and the second core cross section defines a circular cross section. In some examples, the portion of the first coil region which defines the first core cross section extends circumferentially in a range of 90 to 270 degrees around a circumference of the first coil region.

[0008] In some examples, a coil for a docking device for securing a prosthetic valve comprises: a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the coil relative to the native annulus; and a second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein in a relaxed configuration, the first coil region extends radially outward of the second coil region and extends towards the outflow side such that a portion of the first coil region overlaps axially with the second coil region, and wherein in an implanted configuration, the coil is configured to apply a compressive force between the first coil region and the second coil region to the native annulus.

[0009] In some examples, a docking device for securing a prosthetic implant at a native valve comprises: a coil according to any example herein and a guard member coupled at least partially to the first coil region wherein the guard member is movable between a radially compressed state and a radially expanded state. In some examples, the guard member is coupled around a circumference of the first coil region in a range of 180 to 315 degrees.

[0010] In some examples, a method comprises: delivering a docking device comprising a coil of any example herein to a native valve; and deploying the docking device at an annulus of the native valve; wherein the coil remains in a substantially straight configuration when delivering the docking device and moves to a helical configuration after the docking device is deployed, wherein the one or more turns of the first coil region are configured to be deployed on the inflow side of the native valve and one or more turns of the second coil region are configured to be deployed on the outflow side of the native valve. In some examples, the method further comprising deploying a prosthetic heart valve within the docking device.

[0011] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated).Attorney Docket No: THVVA-24206W001

[0012] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. 1 A is a cutaway view of the human heart in a diastolic phase.

[0014] FIG. IB is a cutaway view of the human heart in a systolic phase.

[0015] FIG. 2A schematically illustrates a first stage in an exemplary 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.

[0016] FIG. 2B schematically illustrates a second stage in the exemplary 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.

[0017] FIG. 3A schematically illustrates a third stage in the exemplary 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.

[0018] FIG. 3B schematically illustrates a fourth stage in the exemplary 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.

[0019] FIG. 4A schematically illustrates a fifth stage in the exemplary 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.Attorney Docket No: THVVA-24206W001

[0020] FIG. 4B schematically illustrates a sixth stage in the exemplary mitral valve replacement procedure where the guide catheter and the guidewire have been removed from the patient.

[0021] FIGS. 5A-5B depicts a coil of a docking device according to one example.

[0022] FIGS. 6A-6B depicts a coil of a docking device according to another example.

[0023] FIGS. 7A-7B includes exemplary cross-sectional profiles of a coil for a docking device.

[0024] FIG. 8 depicts a docking device including a coil and a guard member with an atrial portion with the posterior side lifted higher than the rest of the docking device.

[0025] FIGS. 9A-9D depict a coil for a docking device, according to another example, with an atrial functional turn that is higher than the rest of the docking device.

[0026] FIGS. 10A-10D depict exemplary cross-sectional profiles of a coil for a docking device, according to another example.

[0027] FIG. 10E depicts a docking device according to another example where a portion of the coil can include the cross-sectional profiles of FIGS. 10A-10E.

[0028] FIG. 11A-11B depict a coil for a docking device according to another example, with the atrial functional turn shaped to extend below the subsequent turns.DETAILED DESCRIPTIONGeneral Considerations

[0029] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0030] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, this manner of description encompasses rearrangement, unless a particular ordering is required by specific language setAttorney Docket No: THVVA-24206W001 forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0031] 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 term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0032] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (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). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0033] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”

[0034] As used herein, any ranges disclosed include the endpoints of the range.Exemplary Transcatheter Heart Valve Replacement Procedure

[0035] Described herein are various systems, apparatuses, methods, or the like, that can be used in or with delivery apparatuses to deliver a prosthetic implant (for example, a prosthetic valve, a docking device, etc.) into a patient body.

[0036] In certain examples, a delivery apparatus can be configured to deliver and implant a docking device at an implantation site, such as a native valve annulus. The docking device can be configured to more securely hold an expandable prosthetic valve implanted within theAttorney Docket No: THVVA-24206W001 docking device, at the native valve annulus. For example, a docking device can 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 can be expanded or otherwise implanted. By providing such anchoring or docking devices, replacement prosthetic valves can be more securely implanted and held at various valve annuluses, including at the mitral annulus which does not have a naturally circular cross-section.

[0037] In some examples, the docking device can be arranged within an outer shaft of the delivery apparatus. A sleeve shaft can cover or surround the docking device within the delivery apparatus and during delivery to a target implantation site. A pusher shaft can 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 can 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 can be removed from the docking device and retracted back into the outer shaft of the delivery apparatus.

[0038] Fluid (for example, a flush fluid, such as heparinized saline or the like) can 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 can be reduced or avoided, thereby reducing a risk of thrombus formation.

[0039] 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 flowstream 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 (I VC), superior vena cava (SVC), mitral valve MV, and aorta / aortic valve. A defective mitral valve can suffer from insufficiency and / or regurgitation.Attorney Docket No: THVVA-24206W001

[0040] 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 can 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.

[0041] 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. 1A, 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 mitral valve MV into the left atrium LA.

[0042] The devices described herein can 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 can 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 can cause the left atrium LA to enlarge and cause blood pressure to increase in the left atrium LA and blood vessels, which can cause damage to and / or swelling of the liver, kidneys, legs, other organs, etc. A transcatheter valve (THV) implanted in the mitral valve MV can inhibit blood from backflowing into the left atrium LA during the systolic phase.

[0043] 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, orAttorney Docket No: THVVA-24206W001 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 examples, the devices described herein can be used to supplement or replace the function of a defective mitral valve MV.

[0044] An exemplary 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 (for example, THV) inside the docking device is depicted in the schematic illustrations of FIGS. 2A-4B.

[0045] 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, and / or other issues. Thus, a docking device may be implanted first at the native valve annulus and then the THV can 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.

[0046] FIGS. 2A-4B depict an exemplary transcatheter heart valve replacement procedure (for example, a mitral valve replacement procedure) which utilizes a docking device 52 (e.g., with guard member as described herein) and a prosthetic heart valve 62, according to one example. During the procedure, a user can create a pathway to a patient’s native heart valve using a guide catheter 30 (FIG. 2A). The user can 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 can 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 can remove the prosthetic valve delivery apparatus 60 from the patient 10 (FIG. 4A), as well as the guide catheter 30 (FIG. 4B).

[0047] 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 can be inserted into a vasculature 12 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 RAAttorney Docket No: THVVA-24206W001 to left atrium LA as shown). Together, the guide catheter 30 and the guidewire 40 can 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 (for example, the native mitral valve 16 or native mitral valve annulus).

[0048] Initially, the user may first make an incision in the patient’s body to access the vasculature 12. For example, as illustrated in FIG. 1, 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.

[0049] After making the incision to access the vasculature 12, the user may insert the guide catheter 30, the guidewire 40, and / or additional devices (such as an introducer device or transseptal puncture device) through the incision and into the vasculature 12. The guide catheter 30 (which can also be referred to as an “introducer device,” “introducer,” or “guide sheath”) can be configured to facilitate the percutaneous introduction of various implant delivery devices (for example, 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 can comprise a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 can extend through the vasculature 12 and into the heart 14 while the handle 32 can remain outside the body of the patient 10 and can be operated by the user to manipulate the shaft 34 (FIG. 2A).

[0050] The guidewire 40 can be configured to guide the delivery apparatuses (for example, the guide catheter 30, the docking device delivery apparatus 50, the prosthetic valve delivery apparatus 60, additional catheters, or the like) and their associated devices (for example, docking device, prosthetic heart valve, and the like) to the implantation site within the heart 14, and thus may extend all the way through the vasculature 12 and into a left atrium 18 of the heart 14 (and in some examples, through the native mitral valve 16 and into a left ventricle 26 of the heart 14) (FIG. 2A).

[0051] In some instances, a transseptal puncture device or catheter can 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 (for example,Attorney Docket No: THVVA-24206W001 through the femoral vein and into the right atrium 20). The user can 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 can 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 guide wire 40 is positioned within the left atrium 18 and / or the left ventricle 26, the transseptal puncture device can be removed from the patient 10. The user can 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 (FTG. 2A).

[0052] In some instances, an introducer device can 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 can 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 can 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 can remove the introducer device from inside the guide catheter 30 and the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain 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.

[0053] FIG. 2B depicts a second stage in the exemplary mitral valve replacement procedure where a docking device 52 can be implanted at the native mitral valve 16 of the heart 14 of the patient 10 using a docking device delivery apparatus 50 (which may also be referred to as an “implant catheter,” or a “docking device delivery device,” or simply “delivery apparatus”).

[0054] In general, the docking device delivery apparatus 50 can include a delivery shaft 54 (which may also be referred to as an “outer shaft”), a handle 56, and a pusher assembly 58 (which may also be referred to as a “pusher shaft”). The delivery shaft 54 can be configured to be advanced through the patient’s vasculature 12 and to the implantation site (for example, 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 can retain the docking device 52 therein in a substantially straight delivery orientation.

[0055] The handle 56 of the docking device delivery apparatus 50 can be configured to be gripped and / or otherwise held by the user to advance the delivery shaft 54 through the patient’sAttorney Docket No: THVVA-24206W001 vasculature 12. Specifically, the handle 56 can be coupled to a proximal end of the delivery shaft 54 and can be configured to remain accessible to the user (for example, outside the body of the patient 10) during the docking device implantation procedure. In this way, the user can advance the delivery shaft 54 through the patient’s vasculature 12 by exerting a force on (for example, pushing) the handle 56. In some examples, the delivery shaft 54 can 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 can 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.

[0056] In some examples, the handle 56 can 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 can 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.

[0057] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at the implantation site (for example, the native mitral valve 16). For example, the pusher assembly 58 can 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 can extend through the delivery shaft 54 and can be disposed adjacent to the docking device 52 within the delivery shaft 54. In some examples, the docking device 52 can 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 can 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 can advance in lockstep with the pusher assembly 58 through and / or out of the delivery shaft 54.

[0058] In addition to the pusher shaft, in certain instances, the pusher assembly 58 can also include a sleeve shaft. The pusher shaft can 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, can 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 theAttorney Docket No: THVVA-24206W001 delivery shaft 54 and positioning the docking device 52 at the implantation site. In some examples, the pusher shaft can be covered, at least in part, by the sleeve shaft.

[0059] In some examples, the pusher assembly 58 can 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 (for example, to push the pusher shaft into and / or out of the distal end portion 53 of the delivery shaft 54). The dock sleeve can 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 can include a sleeve handle that is coupled to the sleeve shaft and is configured to be pulled by a user to retract (for example, axially move) the sleeve shaft relative to the pusher shaft, thereby retracting the dock sleeve.

[0060] The pusher assembly 58 can be removably coupled to the docking device 52, and as such can 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.

[0061] In some examples, the pusher assembly 58 can include a suture lock assembly (also referred to as a “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 can extend from the docking device 52, through the pusher assembly 58, to the suture lock assembly. The suture lock assembly can 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 can comprise a cutting mechanism that is configured to be adjusted by the user to cut the suture.

[0062] 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 (for example, 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 and over the guidewire 40. In some examples, the guidewire 40 can 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 untilAttorney Docket No: THVVA-24206W001 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 (for example, 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, corners, constrictions, and / or other obstacles in the vasculature 12 and the heart 14.

[0063] Once the delivery shaft 54 reaches the left atrium 18 and extends out of a distal end of the guide catheter 30, the user can 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 (for example, 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.

[0064] 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.

[0065] After pushing a ventricular portion of the docking device 52 (for example, 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 (for example, an atrial portion of the docking device 52 having the 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 can maintain the position of the pusher assembly 58 (for example, 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 can 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 can also remove the dock sleeve from the docking device 52, for example, by retracting the sleeve shaft.Attorney Docket No: THVVA-24206W001The brim feature that is described in more detail below can help facilitate retention of the docking device in the native mitral valve 16.

[0066] 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 (for example, 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 the user can deliver and implant a prosthetic heart valve 62 within the implanted docking device 52 at the native mitral valve 16.

[0067] 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, the guidewire 40 can 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 can 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.

[0068] As illustrated in FIG. 3A, the docking device 52 can comprise a plurality of helical turns that wrap around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 can 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 PHV to be implanted. As a result, the docking device 52 with the brim feature can provide a tighter fit, and thus a better seal, between the prosthetic heart valve and the native mitral valve 16, as described further below.

[0069] 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.

[0070] As shown in FIG. 3B, the prosthetic valve delivery apparatus 60 can comprise a delivery shaft 64 and a handle 66. The delivery shaft 64 can extend distally from the handle 66. The delivery shaft 64 can 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 dockingAttorney Docket No: THVVA-24206W001 device 52 at the native mitral valve 16. The handle 66 can be configured to be gripped and / or otherwise held by the user to advance the delivery shaft 64 through the patient’ s vasculature 12.

[0071] In some examples, the handle 66 can 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 can 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 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.

[0072] In some examples, the prosthetic valve delivery apparatus 60 can 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 can 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 can be coupled to the distal end portion of the delivery shaft 64.

[0073] In other examples, the prosthetic heart valve 62 can be self-expanding and can 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 can be mechanically expandable and the prosthetic valve delivery apparatus 60 can include one or more mechanical actuators (for example, the expansion mechanism) configured to radially expand the prosthetic heart valve 62.

[0074] As shown in FIG. 2D, the prosthetic heart valve 62 can be mounted around the expansion mechanism 65 (for example, the inflatable balloon) on the distal end portion of the delivery shaft 64, in a radially compressed configuration.

[0075] To navigate the distal end portion of the delivery shaft 64 to the implantation site, the user can insert the prosthetic valve delivery apparatus 60 (for example, the delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guidewire 40. The user can continue to advance the prosthetic valve delivery apparatus 60 along the guidewire 40 (for example, through the vasculature 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as illustrated in FIG. 2D. More specifically, the user can advanceAttorney Docket No: THVVA-24206W001 the delivery shaft 64 of the prosthetic valve delivery apparatus 60 by gripping and exerting a force on (for example, pushing) the handle 66. While advancing the delivery shaft 64 through the vasculature 12 and the heart 14, the user can 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.

[0076] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted around the distal end portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some examples, as shown in FIG. 2D, a distal end of the delivery shaft 64 and a least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.

[0077] Once the radially compressed prosthetic heart valve 62 is appropriately positioned within the docking device 52 (FIG. 3B), the user can manipulate one or more actuation mechanisms of the handle 66 of the prosthetic valve delivery apparatus 60 to actuate the expansion mechanism 65 (for example, inflate the inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52. In some examples, the user can lock the prosthetic heart valve 62 in its fully expanded position (for example, with a locking mechanism) to prevent the prosthetic heart valve 62 from collapsing.

[0078] 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 can be received and retained within the docking device 52.

[0079] 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 (including the delivery shaft 64) can be removed from the patient 10 such that only the guidewire 40 and the guide catheter 30 remain inside the patient 10.

[0080] 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 the brim feature can be configured to provide a seal between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16 to reduce paraval vul ar leakage around the prosthetic heart valve 62. Specifically, the docking device 52 can initially constrict the leaflets 24 of the native mitral valve 16, where the brim feature sits on top on the left atrial side. The prosthetic heart valve 62 can then push the leaflets 24 against the docking device 52Attorney Docket No: THVVA-24206W001 as it radially expands within the docking device 52. Thus, the docking device 52 and the prosthetic heart valve 62 can 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 can 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.

[0081] 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 can comprise one or more fluid ports that are configured to supply flushing fluid to the lumens thereof to prevent and / or reduce the likelihood of blood clot (for example, thrombus) formation. Example fluid ports that can be used to inject flushing fluid into a docking device delivery apparatus are described further below.

[0082] Although FIGS. 2A-4B specifically depict a mitral valve replacement procedure, however, the same and / or similar procedure may be utilized to replace other heart valves (for example, tricuspid, pulmonary, and / or aortic valves). Further, the same and / or similar delivery apparatuses (for example, docking device delivery apparatus 50, prosthetic valve delivery apparatus 60, guide catheter 30, and / or guidewire 40), docking devices (for example, docking device 52), replacement heart valves (for example, prosthetic heart valve 62), and / or components thereof may be utilized for replacing these other heart valves.

[0083] 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 dockingAttorney Docket No: THVVA-24206W001 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.

[0084] 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. 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 left ventricle 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.

[0085] 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. US2018 / 0318079, US2018 / 0263764, and US2018 / 0177594, which are all incorporated by reference herein in their entireties.Exemplary Prosthetic Valves

[0086] 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 No. 11,096,781, all of which are incorporated herein by reference in their entireties.

[0087] In some examples, the prosthetic heart valves comprise a plastically expandable material, which can be metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the prosthetic heart valve can 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.

[0088] In some examples, the prosthetic heart valve can 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 canAttorney Docket No: THVVA-24206W001 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 can be released from the sheath, and therefore allowed to expand to its functional size. Any of the delivery apparatuses disclosed herein can be adapted for use with a self-expanding valve.Overview of Docking Devices

[0089] The disclosed docking devices can, for example, provide a stable anchoring site, landing zone, or implantation zone at the implant site in which prosthetic valves can be expanded or otherwise implanted. Many of the disclosed docking devices comprise a circular or cylindrically-shaped portion, which can (for example) allow a prosthetic heart valve comprising a circular or cylindrically-shaped valve frame to be expanded or otherwise implanted into native locations with naturally circular cross-sectional profiles and / or in native locations with naturally with non-circular cross sections. In addition to providing an anchoring site for the prosthetic valve, the docking devices can be sized and shaped to cinch or draw the native valve (for example, mitral, tricuspid, etc.) anatomy radially inwards. In this manner, one of the main causes of valve regurgitation (for example, functional mitral regurgitation), specifically enlargement of the heart (for example, enlargement of the left ventricle, etc.) and / or valve annulus, and consequent stretching out of the native valve (for example, mitral, etc.) annulus, can 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 can be more securely implanted and held at various valve annuluses, including at the mitral valve annulus which does not have a naturally circular cross-section.

[0090] In some instances, a docking device can comprise a paravalvular leakage (PVL) guard (also referred to herein as “a guard member”). The PVL guard can, for example, help reduce regurgitation and / or promote tissue ingrowth between the native tissue and the docking device.

[0091] The PVL guard can, in some examples, be movable between a delivery orientation (or radially compressed state) and a deployed orientation (or radially expanded state). When the PVL guard is in the delivery orientation, the PVL guard can extend along and adjacent the coil. When the PVL guard is in the deployed orientation, the PVL guard can rotate about a central longitudinal axis of the coil and extend radially outwardly from the coil.Attorney Docket No: THVVA-24206W001

[0092] In some examples, implanting a prosthetic valve at a native annulus involves a two-step implementation procedure including first implanting a docking device, followed by deployment of the prosthetic valve within the docking device. In the transient stage of the procedure (following docking device implant and before the prosthetic valve has been implanted) the docking device must remain stable within the intended implant location before deployment of the prosthetic valve permanently anchors the implants. It is desirable to improve safety and ease of deployment of the docking device.Exemplary Docking Devices

[0093] FIGS. 5A-6B depict coils of docking devices according to some examples. In some examples, any of the docking devices herein can comprise a coil in use with a guard member. In some examples, the guard member can comprise a braided sleeve as described in International Publication No. WO2022 / 087336 which is incorporated by reference herein in its entirety. Additional examples of guard members and other components of docking devices are described in International Application No. WO / 2024 / 37038 and in Applicant Docket No. THVMC-23455US02, the entireties of which are incorporated by reference herein. In some examples, the guard member can comprise any of the guard members described herein. An example of a docking device 500 comprising a guard member 504 attached to a coil 502 can be seen in FIG. 9A, similar guard members can be used with any of the coils disclosed herein.

[0094] FIGS. 5A-5B depict a docking device 100 which comprises a coil 102 with an inflow side 160 and an outflow side 170. In some examples, the docking device 100 can further comprise a guard member as shown elsewhere herein. The docking device 100 can be configured to fit at the mitral position but can be shaped and / or adapted similarly or differently in other examples for better accommodation at other native valve positions as well, such as at the tricuspid valve. Docking device geometries disclosed herein may provide for engagement with the native anatomy that can provide for increased stability and reduction of relative motion between the docking device, the prosthetic valve docked therein, and the native anatomy (which is moving during and after the implantation procedure). Reduction of such relative motion can, for example, prevent material degradation of components of the docking device and / or the prosthetic valve docked therein and can prevent damage / trauma to the native tissues as well as preventing PVL.

[0095] The coil 102 can include a central region 108 with a turn, coiled portion, or multiple turns (e.g., 2 turns, 3 turns, 4 turns, between 2-5 turns, or more). The turns of the centralAttorney Docket No: THVVA-24206W001 region 108 can be similarly sized and shaped or vary in size and / or shape. In some examples, the central region 108 comprises three or approximately three full coil turns having substantially equal inner diameters. The central region 108 of the coil 102 serves as the main landing region or holding region for holding the expandable prosthetic valve when the coil 102 and the valve prosthesis are implanted into a patient’s body. In some examples, the coil 102 has a central region 108 with more or less than three coil turns, depending for example, on the patient’s anatomy, the amount of vertical contact desired between the coil 102 and the valve prosthesis (e.g., transcatheter heart valve or THV), and / or other factors. The coiled portion or tum(s) of the central region 108 can also be referred to as the “functional coils” or “functional turns” since the properties of these turns contribute the most to the amount of retention force generated between the valve prosthesis, the coil 102, and the native mitral leaflets and / or other anatomical structures.

[0096] In examples where the docking device 100 is used at the mitral position, the docking device can 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 examples, the coil 102 is flexible and / or made of a shape memory material, so that the coils can be straightened for delivery via a transcatheter approach as well. In some examples, the coil 102 can be made of another biocompatible material, such as stainless steel. Some of the same catheters and other delivery tools can be used for both delivery of the docking device 100 and the prosthetic valve, without having to perform separate preparatory steps, simplifying the implantation procedure for the end user.

[0097] Since the functional coils / turns or coils / tums of the central region 108 of the coil 102 are kept relatively small in diameter (e.g., the central region 108 in one examples can 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) in order to increase retention force with the prosthetic valve, it might be difficult to advance the docking device 100 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 100 is made to have the same small diameter as the central region 108. Therefore, the coil 102 can have a distal or lower region that comprises and / or consists of a leading turn 106 (sometimes referred to as an encircling turn or a leading ventricular coil / turn) of the coil 102, which has a lower diameter that is greater than the diameter of the functional coils / turns or of the coils / tums of central region 108.Attorney Docket No: THVVA-24206W001

[0098] Features of the native anatomy, especially in the right and left ventricles, have variable dimensions. For example, native mitral anatomy can have an approximately 25 mm to 65 mm greatest width on a long axis. The diameter or width of the encircling turn or leading turn 106 (e.g., ventricular coil / turn) can be selected to be larger to more easily navigate a distal or leading tip portion 107 of the docking device 100 around and encircle the features of the native anatomy (e.g., leaflets and / or chordae tendineae).

[0099] As used herein, the turns of the coil are referred to as defining a lumen diameter and / or as being disposed in a plane that is normal to the longitudinal axis 101. Because the turns of the coil form a spiral, they do not necessarily define a traditional diameter or plane. The plane referred to herein should be understood to be a plane that bisects the referenced turn of the coil in at a midpoint along the longitudinal axis. In other words, a given turn of the coil will be half above and half below the plane that it is said to be disposed in.

[0100] A diameter of a given turn of the coil as referred to herein lies in a plane as described above. As mentioned above, the term “diameter’" as used in this disclosure does not require that a 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 can be measured from the distal tip portion 107 to the opposite side, as if the lower region or leading turn 106 formed a complete rotation. Various sizes and shapes are possible, for example, the diameter could be any size from 25 mm to 75 mm.

[0101] In some examples, the docking device 100 can also include an enlarged proximal or upper region that comprises and / or consists of a stabilization turn 110 (e.g., which can be an atrial coil / turn) of the docking device 100. During a transient or intermediate stage of the implantation procedure, the docking device is released from the delivery apparatus but not yet fully secured relative to the native anatomy by the prosthetic heart valve. The docking devices disclosed herein can, for example, improve stability and / or reduce movement of the docking device during the transient stage. In some examples, a stabilization feature or coil can be used to help stabilize the docking device in the desired position. In some examples, the stabilization turn 110 can be configured to abut or push against the walls of the circulatory system (e.g., against the walls of the left atrium), in order to improve the ability of the docking device 100 to stay in its desired position prior to the implantation of the prosthetic valve.Attorney Docket No: THVVA-24206W001

[0102] In some examples, the stabilization turn 110 can have an atrial portion 110c in connection with the central region 108, a stabilization portion 110a adjacent to the proximal end portion 112 of the coil 102, and an ascending portion 110b located between the atrial portion 1 10c and the stabilization portion 110a. Both the atrial portion 110c and the stabilization portion 110a can be generally parallel to the helical turns in the central region 108, whereas the ascending portion 110b can be oriented to be angular relative to the atrial portion 110c and the stabilization portion 110a. For example, in certain examples, the ascending portion 110b and the stabilization portion 110a can form an angle from 45 degrees to about 90 degrees (inclusive). When implanting the docking device 100 at the native mitral valve location, the atrial portion 110c can be configured to abut against a posterior wall of the left atrium and the stabilization portion 110a can be configured to flare out and press against an anterior wall of the left atrium, along with the guard member.

[0103] The stabilization turn 110 (e.g., atrial coil / turn) of the docking device 100 in the example shown can extend up to about one full turn or rotation, and terminates at a proximal end portion 112. In some examples, the stabilization coil / turn (e.g., atrial coil) can 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 turn 1 10 can also be significantly larger than the size of the functional coils in the central region 108, so that the stabilization coil / turn (e.g., atrial coil or atrial turn) flares or extends sufficiently outwardly in order to contact the walls of the circulatory system (e.g., the walls of the left atrium). Additionally, the stabilization coil / turn of various examples will be configured to be less abrasive to the native tissue and / or anatomy. For example, the surface texture can be made smoother and / or softer, such that movement of the docking device against the native anatomy will not damage the native tissue.

[0104] Depicted in FIGS. 6A-6B is a docking device 200 comprising a coil 202. In some examples, the docking device 200 is the same as the docking device 100 except for the differences described below. For example, the docking device 200 can comprise an inflow side 260 and an outflow side 270 and include can include a stabilization turn 210 (also referred to as a “stabilization coil” or a “first coil region”), a central region 208 (also referred to as “functional turns” or a “second coil region”), and a leading turn 206 (or “leading coil”), each of which are disposed around a longitudinal axis 201 which extends through a central lumen 220, etc. some components may not be repeated here for sake of brevity. However, theAttorney Docket No: THVVA-24206W001 docking device 200 need not include all of the components described above for the docking device 100. For example, the docking device 200 may omit the ascending portion 110b and the raised stabilization portion 110a. Omitting these portions may reduce required materials, eliminate procedural steps, and in some examples, can make deployment easier. Omitting the ascending portion 110b and the raised stabilization portion 110a also allows for additional attachment surface for a guard member along the stabilization turn 210 and can lead to increased stability of the docking device once it is disposed in the anatomy.

[0105] In some examples, when implanting the docking device at the native mitral valve location, functional turns in a central region 208 can be disposed substantially in the left ventricle and the stabilization turn 210 can be disposed substantially in the left atrium. The stabilization turn 210 can be configured to provide increased stability and improved sealing. In some examples, the points of contact between a docking device comprising the coil 202 and the left atrial wall can form a plane that is approximately parallel to a plane of the native mitral valve. In some examples, a guard member can be used with the stabilization turn 210 and configured to provide increased stability to the docking device as it is positioned in the mitral valve.

[0106] In the depicted example, an attachment portion 212 (also referred to as a “proximal end portion”) of the stabilization turn 210 can be lifted the axial direction. This attachment portion terminates in a proximal end 213. The upward flare of the attachment portion 212 can be define an angle 214 which is formed with a plane defined by the helical turns in the central region 208. In some examples, the angle 214 can comprise and angle greater than 5-degrees but less than 90 degrees. In some examples, the angle 214 can comprise and angle greater than 15-degrees but less than 45-degrees. In some examples, the angle 214 can comprise and angle greater than 20 degrees but less than 40-degrees. In some examples, the angle 214 is 30 degrees. The proximal end 213 does not extend more than 12 mm in the axially proximal direction from the stabilization turn, that is the proximal end portion does not extend more than 12 mm in an axial direction from a plane defined by the stabilization turn 210 that is orthogonal to the longitudinal axis and 201.

[0107] The attachment portion 212 can be configured to releasably couple the coil 202 to a delivery apparatus (for example, docking device delivery apparatus 50). The upward flare of the attachment portion 212 can be advantageous in coupling the coil 202 to the delivery apparatus, for example by helping to ensure that the attachment portion 212 is not obstructed (i.e. by the guard member) and helps to ensure easier access to the attachment portion 212. InAttorney Docket No: THVVA-24206W001 some examples, as discussed above, the coil 202 can be coupled to the delivery apparatus via a release suture that can be configured to be tied to the coil 202 and cut for removal. In one example, the release suture can be tied to the coil 202 through one or more eyelets or eyeholes 216 located at the attachment portion 212 of the coil 202. In some examples, the release suture can be tied around a circumferential recess that is located adjacent the attachment portion 212 of the coil 202.

[0108] The central region 208 can comprise one or more helical turns having substantially equal lumen diameters. The leading turn 206 can extend from a distal end of the central region 208 and, in some examples, can have a lumen diameter substantially equal to the lumen diameter of the central region 208. In some examples, the leading turn can comprise a distal end portion 207 that extends radially outward. In some examples, the stabilization turn 210 can extend from a proximal end of the central region 208 and can have a lumen diameter substantially equal to the lumen diameter of the central region 208. In some examples, the lumen diameter of the stabilization turn can be different than the lumen diameter of the central region 208.

[0109] In some examples, when implanting the docking device 200 at the native mitral valve location, the functional turns in the central region 208 can be disposed substantially in the left ventricle and the stabilization turn 110 can be disposed substantially in the left atrium. The stabilization turn 210 can be configured to provide one or more points or regions of contact between the docking device 200 and the left atrial wall adjacent to the mitral valve, such as at least three points of contact in the left atrium or complete contact on mitral anulus. In some examples, the points of contact between the docking device 200 and the left atrial wall can form a plane that is approximately parallel to a plane of the native mitral valve. In some examples, the contact between the stabilization turn 210 and the atrial wall can be through an intermediary, such as a guard member.

[0110] Shown in FIGS. 7A-7B is a cross section 350 of a coil, the coil can be a coil for any of the docking devices described herein, in some examples the cross section of the coil can be a cross section of the coils of either docking device 100 and / or docking device 200 described above. In some examples the cross section 350 of the coil can represent a cross section of any of the coils described below. As shown, at least a portion of the core 302a of the coil can be surrounded by a first cover 304 (which may also be referred to as “an inner cover”). Here, the core 302a of the coil is the structural part of the coil. The first cover 304 can have a tubular shape. In some examples, the first cover 304 can cover an entire length of the core 302a of theAttorney Docket No: THVVA-24206W001 coil. In some examples, the first cover 304 covers only selected portion(s) of the core 302a of the coil.

[0111] In some examples, the first cover 304 can be coated on and / or bonded on the core 302a of the coil. In some examples, the first cover 304 can be a cushioned, padded-type layer protecting the core 302a of the coil. The first cover 304 can he constructed of various natural and / or synthetic materials. In one particularly example, the first cover can include a foam material (e.g., expanded polytetrafluoroethylene (ePTFEJ). In some examples, the first cover is configured to be fixedly attached to the core 302a of the coil (for example, by means of textured surface resistance, suture, glue, thermal bonding, or any other means) so that relative axial movement between the first cover 304 and the core 302a of the coil is restricted or prohibited. In some examples, one or more portions of the first cover 304 (e.g., a distal end portion) can be fixedly attached to the core 302a of the coil and one or more other portions of the inner cover (e.g., an intermediate portion and / or a proximal end portion) can be movable relative to the core 302a of the coil. In some aspects, the first cover 304 is coupled with the flap sheet of a guard member (shown elsewhere herein).

[0112] In some examples, as shown in FIG. 7A, the coil can also include a retention member 306 (which may also be referred to as “a second cover” or “an outer cover”) surrounding at least a portion of the first cover 304 (and the core 302a). In some examples, retention member 306 can extend over the entire length of the first cover 304. In the illustrated example, the retention member 306 extends over only a portion of the first cover 304 so that one or more portions of the first cover 304 (e.g., the proximal and / or distal end portions) are exposed. In particular examples, a proximal end of the retention member 306 can be positioned proximal to a proximal end of a guard member. For example, when used with the docking device 100 the proximal end of the retention member 306 can be disposed at or adjacent the ascending portion 110b of the coil 102. In some examples, a distal end of the retention member 306 can be positioned distal to a distal end of the guard member. For example, the distal end of the retention member 306 can be positioned adjacent a leading turn. In some examples, the retention member 306 can cover functional turns of the coil in a central region. However, the retention member 306 does not cover the guard member. In some aspects, the retention member 306 can be coupled to the guard member. When the docking device is deployed at the native valve and the prosthetic valve is radially expanded within the docking device, the retention member 306 at a central region can frictionally engage the prosthetic heart valve and / or the native leaflet tissue.Attorney Docket No: THVVA-24206W001

[0113] The retention member 306 can be formed of various materials configured to engage the native tissue and / or prosthetic heart valve to increase friction therebetween and / or promote tissue ingrown. For example, the retention member can comprise a biocompatible fabric material (e.g., polyethylene terephthalate (PET)). In some examples, the retention member 306 can comprise a braided material. In some examples, the retention member 306 can include a woven material.

[0114] The docking devices described herein may undergo a two-step implementation procedure including implantation of a docking device followed by prosthetic heart valve deployment. In the transient stage of the procedure (following docking device implantation and before the valve has been implanted) the docking device should maintain stability within the anatomy before the valve deployment permanently anchors the implant. The atrial functional turn of the docking de vice is the proximal-most turn of the coils of the docking device. In some examples, the atrial functional turn can be the atrial portion 110c of the stabilization turn 1 10 of the docking device 100. In some examples, the atrial functional turn can be the stabilization turn 210 of docking device 200. In some examples, the atrial functional turn can comprise all or a portion of the stabilization turn of any of the other docking device coil described herein. The atrial functional turn is positioned in the atrium, as opposed to the other functional turns, which form the central region, of the docking device and are positioned in the ventricle wrapped around the chordae of the mitral apparatus.

[0115] The atrial functional turn may maintain transient docking device stability before valve deployment and can help with mitigation of PVL. The mitral leaflets may be compressed between the atrial functional turn and the ventricular functional turns. The docking devices described below each include a modified atrial functional turn to enhance the transient stage stability of the docking device in the left atrium of the heart. In some examples, the first coil region is configured to minimize a pinch force exerted on the native annulus between the first coil region and the second coil region. In some examples, the first coil region is configured to increase a pinch force exerted on the native annulus between the first coil region and the second coil region.

[0116] FIG. 8 depicts a docking device 400 with an inflow side 460 and an outflow side 470 . The docking device 400 may be the same as the docking device 100 and / or the docking device 200 except for the differences described below. For example, the docking device 400 can comprise a coil 402 which can include a stabilization turn 410 (also referred to as a “stabilization coil” or a “first coil region”), a central region 408 (also referred to asAttorney Docket No: THVVA-24206W001“functional turns” or a “second coil region”), and a leading turn 406 (or “leading coil”), each of which are disposed around a longitudinal axis 401 which extends through a central lumen, etc. some components may not be repeated here for sake of brevity. However, the docking device 400 need not include all of the components described above for the docking device 100 and / or the docking device 200.

[0117] In the depicted example, the docking device 400 comprises a stabilization turn 410 which can have an atrial portion 410c that is shaped to reduce help minimize the compressive force on the native mitral annulus when implanted. In some examples, a first side and / or a first portion of the functional turn may be lifted or raised higher than a second side and / or a second portion of the functional turn. In some examples, the functional turn is shape set in a way where the posterior side 421 of the stabilization turn 410 is lifted higher than the rest of the docking device, including the anterior side 422 of the stabilization turn 410. In some examples, the inflow most turn of the turns of the central region 408 defines a first plane 426 and the longitudinal axis 401 is perpendicular to the first plane 426. In some examples, the coil of the atrial portion 410c defines a second plane 428 and a second axis 403 which is perpendicular to the second plane 428. The second axis 403 can be offset from the longitudinal axis 401 by an angle 405. In some examples, the angle 405 can be within a range of 0 degrees to 90 degrees, within a range of 10 degrees to 45 degrees, within a range of 20 degrees to 30 degrees. In one example, the angle is 30 degrees. In some examples, the angle is defined as an angle 430 between the first plane 426 and the second plane 428.

[0118] Lifting the posterior side of the atrial portion 410c can have the advantage of better centering the second axis 403 (in other words, the axis of the atrial portion 410c of the docking device) near the native mitral annulus, this can minimize the forces acting on the docking device throughout the cardiac cycle. This can have the advantage of reducing the effects of the forces of the cardiac cycle on the stability of the docking device.

[0119] FIGS. 9A and 9C depict a docking device 500 with an inflow side 560 and an outflow side 570. In some examples, the docking device 500 is the same as the docking device 100 and / or the docking device 200 except for the differences described below. For example, the docking device 500 can comprise a coil 502 and include can include a stabilization turn 510 (also referred to as a “stabilization coil” or a “first coil region”), a central region 508 (also referred to as “functional turns” or a “second coil region”), and a leading turn 506 (or “leading coil”), each of which are disposed around a longitudinal axis 501 which extends through a central lumen 520, etc. some components may not be repeatedAttorney Docket No: THVVA-24206W001 here for sake of brevity. However, the docking device 500 need not include all of the components described above for the docking device 100 and / or the docking device 200.

[0120] Coil 502 of docking device 500 can comprise different coil pitches along the turns of the coil as one moves along the longitudinal axis 501. The coil pitch can be defined as the distance between two successive turns of the coil. For example, as depicted in FIG. 9C, there can be a first coil pitch 532 at the stabilization turn 510 and a second coil pitch 530 in the central region 508.

[0121] For purposes of contrast, FIG. 9B depicts an example of a docking device 500a in which the coil 502a has a constant pitch along the longitudinal axis 501a. In other words, all of the turns of the docking device 500a are spaced the same and are either touching the adjacent most turns or are nearly in contact with the adjacent most turns. In some examples, each turn of coil 502a has a second coil pitch 530 that is constant along the longitudinal axis 501a.

[0122] FIG. 9A and 9C depict the docking device 500 with a coil pitch that varies along the longitudinal axis 501. The change in pitch between the central region 508 and the stabilization turn 510 has the result that the stabilization turn 510 is raised over the rest of the docking device (i.e. there is more space between the stabilization turn 510 and the uppermost turn of the central region 508). The docking device 500 can be positioned such that the change in pitch between the central region 508 and the stabilization turn 510 is positioned where the coil 502 crosses the annulus (e.g., at the medial commissure), therefore reducing the compressive force between the coils of the docking device and the anatomy. In other words, a portion of the coil 502 where the first coil region and the second coil region meet is positioned where the coil crosses the annulus. This can have the advantage of allowing the docking device to sit freely within the native valve without external forces acting upon it and increase docking device stability.

[0123] As depicted in FIG. 9C, the central region 508 of the coil 502 can have the second coil pitch 530 and the stabilization turn 510 can have the first coil pitch 532. In some examples, the first coil pitch 532 can have a nominal measurement in a range of 1-10 mm. In some examples, the first coil pitch 532 can have a nominal measurement in a range of 2-5 mm. In some examples, the first coil pitch 532 can have a nominal measurement in a range of 3-4 mm. In some examples, the first coil pitch 532 can have a nominal measurement of 3.5 mm. In some examples, the first coil pitch 532 can have a nominal measurement of 4.9 mm.Attorney Docket No: THVVA-24206W001The increased coil pitch along portions of the coil 502 can have the advantage of reducing the pinch force applied by the docking device on the anatomy which may allow the docking device to sit more freely and increase docking device stability.

[0124] As depicted in FIG. 9D, in some examples, the stabilization turn 510 of the coil 502 can have a first lumen diameter DI which can be larger than a second lumen diameter D2 of the coils in the central region 508, so that the stabilization turn 510 can extend radially outwardly so as to abut or push against the walls of the circulatory system, thereby improving the ability of the coil 502 to stay in its desired position prior to the implantation of the prosthetic valve. This feature may enhance dock stability (e.g., in larger anatomies). In some examples, the first lumen diameter DI is within a range of 5 percent to 50 percent greater than the second lumen diameter D2. In some examples, the first lumen diameter DI is within a range of 10 percent to 25 percent, greater than the second lumen diameter D2. In some examples, the first lumen diameter DI is within a range of 20 percent to 23 percent, greater than the second lumen diameter D2. In some examples, the first lumen diameter DI can have a nominal measurement within a range of 25 mm to 30 mm and the second lumen diameter D2 can have a nominal measurement within a range of 20 mm to 25 mm. In some examples, the second lumen diameter D2 can have a nominal measurement of 22 mm and the first lumen diameter DI can have a nominal measurement of 28 mm.

[0125] As mentioned above, in some examples, the docking devices described herein can comprise a guard member. As depicted in FIG. 9A the docking device 500 comprises a guard member 504. The guard member 504 can move between a radially compressed state and a radially expanded state. The guard member 504 can include a plurality of arms defining panels which can be radially expandable and compressible. The guard member can also comprise terminal lobes. In the depicted example, the guard member 504 has arms 522 with panels 540 and two terminal lobes. In some examples, the guard member can comprise a flap sheet. In some examples, the flap sheet is folded over the ends of the arms to provide increased protection to native tissue. Any of the other docking devices described herein can comprise a guard member which is substantially similar to the guard member 504.

[0126] Depicted in FIGS. 10A-10E are aspects of a docking device 600 with an inflow side 660 and an outflow side 670, according to another example. In some examples, the docking device 600 is the same as the docking device 100 and / or the docking device 200 except for the differences described below. For example, the docking device 600 can comprise a coil 602 and include can include a stabilization turn 610 (also referred to as a “stabilization coil”Attorney Docket No: THVVA-24206W001 or a “first coil region”), a central region 608 (also referred to as “functional turns” or a “second coil region”), and in some examples a leading turn (or “leading coil”), each of which are disposed around a longitudinal axis 601 which extends through a central lumen 620, etc. some components may not be repeated here for sake of brevity. However, the docking device 600 need not include all of the components described above for the docking device 100 and / or the docking device 200.

[0127] FIGS. 10A -10C depict cross sections of a core 602a of a coil 602 which can be similar to the core 302a described with respect to FIGS. 7A-7B above. In some examples, the core 602a may be surrounded by a first cover and / or a retention member which can be similar to the first cover 304 and retention member 306 depicted in FIGS. 7A-7B above. FIG. 10A depicts a core cross section 650a of the core 602a that can be the same shape and diameter as the core 302a cross section depicted in FIGS. 7A-7B and is included here for reference purposes. In some examples, as depicted in FIG. 10B a core cross section 650b of the core 602a may be circular in shape but have a reduced diameter. In some examples, as depicted in FIG. 10C, a core cross section 650c of the core 602a may comprise a portion which is omitted or removed in order that the core cross section 650c of the core 602a defines a partial circular shape. In the example depicted in FIG. 10C the removed portion of the core 602a comprises a half circle. In some examples (as depicted in FIG. 10D) a core cross section 650d of the core 602a may comprise a circle with multiple sections omitted or removed. In FIG. 10D, two sections of the core 602a are removed to form two flat portions.

[0128] FIG. 10E depicts an exemplary coil 602 delineating a portion 652 of the stabilization turn 610 which may comprise a first core cross section the remaining portions of the coil 602 may comprise a second core cross section. In some examples, the first cross section comprises one of the reduced cross-sectional profiles described above.

[0129] In some examples, the first cross section extends along a portion of the stabilization turn 610 extending circumferentially between 0 degrees and 360 degrees. In some examples, the reduced cross-sectional profile extends along a portion of the atrial functional turn extending circumferentially between 45 and 270 degrees. In some examples, the reduced cross-sectional profile extends along a portion of the atrial functional turn extending circumferentially between 90 and 225 degrees. In the depicted example, the reduced cross- sectional profile extends along a portion of the atrial functional turn extending 130-200 degrees. Altering the cross sections of the core in the manner described above may decrease the spring force when the coils are separated when crossing the annulus (e.g., at the medialAttorney Docket No: THVVA-24206W001 commissure), therefore reducing the compressive force between the coils of the docking device and the anatomy. This can have the advantage of allowing the docking device to sit freely within the native valve without external forces acting upon it and increase docking device stability.

[0130] FIGS. 11 A-l IB depict a docking device 700 with an inflow side 760 and an outflow side 770, according to another example. In some examples, the docking device 700 is the same as the docking device 100 and / or the docking device 200 except for the differences described below. For example, the docking device 700 can comprise a coil 702 and include can include a stabilization turn 710 (also referred to as a “stabilization coil’' or a “first coil region”), a central region 708 (also referred to as “functional turns” or a “second coil region”), and in some examples a leading turn 706 (or “leading coil”), each of which are disposed around a longitudinal axis 701 which extends through a central lumen 720, etc. some components may not be repeated here for sake of brevity. However, the docking device 700 need not include all of the components described above for the docking device 100 and / or the docking device 200.

[0131] In some examples, the coil 702 of the docking device 700 may have a stabilization turn 710 which can extend radially outward and further in the outflow direction than the subsequent turns (such as for example, the turns of the central region 708) when the docking device 700 is in a radially expanded state. Described in other words, the turns of the central region 708 may have a positive pitch and the stabilization turn 710 may have a negative pitch in its shape set / relaxed configuration (e.g., FIG. 11 A).

[0132] In some examples, the first coil region be shape set to extend radially outward from the second coil region and further in the outflow direction than the second coil region. In a relaxed configuration, the first coil region extends radially outward of the second coil region and extends towards the outflow side such that a portion of the first coil region overlaps axially with the second coil region. In an implanted configuration, the first coil region is configured to be disposed on the inflow side of the native valve and the second coil region is configured to be disposed on the outflow side of the native valve. The coil is therefore configured to apply a compressive force on the native valve between the first coil region and the second coil region.

[0133] Depicted in FIG. 1 IB, the docking device 700 as installed on an element 790 which can mimic the native anatomy, for example a patient’s mitral annulus. As depicted, whenAttorney Docket No: THVVA-24206W001 installed the stabilization turn 710 is positioned above the element 790 and the central region 708 positioned below. In this configuration there are pinch forces F applied between the stabilization turn 710 and the turns of the central region 708 which cause the docking device 700 to apply a compressive force to the element 790. The features described above may have the advantage of increasing the compressive force on the anatomy and securing the docking device in place which can enhance the transient stage stability of the docking device.

[0134] The docking devices described herein may enhance the transient stage stability of the docking device in the left atrium of the heart during the transient stage of the procedure (following docking device implantation and before the valve has been implanted).

[0135] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.Delivery Techniques

[0136] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand).Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve.Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of theAttorney Docket No: THVVA-24206W001 delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0137] For implanting a prosthetic implant (e.g., a docking device and / or prosthetic heart valve) within the native mitral valve via a transseptal delivery approach, the prosthetic implant is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic implant and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0138] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0139] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.Attorney Docket No: THVVA-24206W001

[0140] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

[0141] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with the body parts, tissue, etc. being simulated), etc.Additional Examples of the Disclosed Technology

[0142] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. 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.

[0143] Example 1. A coil for a docking device for securing a prosthetic valve, the coil comprising: a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the coil relative to the native annulus, wherein the first coil region defines a first axis extending through a lumen of the first coil region from the inflow side to an outflow side; and a second coil region extending from an outflow end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein the second coil region defines a second axis extending through a lumen of the second coil region from the inflow side to the outflow side, wherein the first axis and the second axis are offset relative to one another by an angle.

[0144] Example 2. The coil of any example herein, particularly example 1, wherein the angle is in in a range of 10 degrees to 45 degrees.

[0145] Example 3. The coil of any example herein, particularly example 1, wherein the angle is in a range of 20 degrees to 30 degrees.

[0146] Example 4. The coil of any example herein, particularly any one of examples 1-3, wherein the first axis and second axis are offset such that a posterior side portion of the first coil region is raised relative to an anterior side portion of the first coil region.Attorney Docket No: THVVA-24206W001

[0147] Example 5. A coil for a docking device for securing a prosthetic valve, the coil comprising: a first coil region comprising a helical turn configured to be disposed on an inflow side of a native annulus and to stabilize the coil relative to the native annulus, wherein the first coil region defines a first coil pitch; and a second coil region extending from a distal end of the first coil region and comprising a plurality of helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein the second coil region defines a second coil pitch, wherein the first coil pitch is larger than the second coil pitch.

[0148] Example 6. The coil of any example herein, particularly example 5, wherein the first coil region comprises a first coil pitch in a range of 2 to 5 mm.

[0149] Example 7. The coil of any example herein, particularly example 5, wherein the first coil pitch is within a range of 3 to 4 mm.

[0150] Example 8. A coil for a docking device for securing a prosthetic valve, the coil comprising: a helical core, wherein the core defines: a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the coil relative to the native annulus, wherein at least a portion of the first coil region defines a first core cross section; a second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein at least a portion of the second coil region comprises a second core cross section; and wherein an area of the second core cross section is greater than an area of the first core cross section.

[0151] Example 9. The coil of example 8, wherein the first core cross section and the second core cross section each comprise a circular cross section with the first core cross section defining a first diameter and the second core cross section defining a second diameter, wherein the second diameter is larger than the first diameter.

[0152] Example 10. The coil of example 8, wherein the first core cross section defines a portion of a circle and the second core cross section defines a circular cross section.

[0153] Example 11. The coil of any example herein, particularly any one of examples 8-10, wherein the portion of the first coil region which defines the first core cross section extends circumferentially in a range of 90 to 270 degrees around a circumference of the first coil region.Attorney Docket No: THVVA-24206W001

[0154] Example 12. A coil for a docking device for securing a prosthetic valve, the coil comprising: a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the coil relative to the native annulus; and a second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein in a relaxed configuration, the first coil region extends radially outward of the second coil region and extends towards the outflow side such that a portion of the first coil region overlaps axially with the second coil region, and wherein in an implanted configuration, the coil is configured to apply a compressive force between the first coil region and the second coil region to the native annulus.

[0155] Example 13. A docking device for securing a prosthetic implant at a native valve, the docking device comprising: a coil according to any example herein, particularly any one of examples 1-12; and a guard member coupled at least partially to the first coil region wherein the guard member is movable between a radially compressed state and a radially expanded state.

[0156] Example 14. The docking device of any example herein, particularly example 13, wherein the guard member is coupled around a circumference of the first coil region in a range of 180 to 315 degrees.

[0157] Example 15. A method comprising: delivering a docking device comprising a coil of any example herein, particularly any one of examples 1-12 to a native valve; and deploying the docking device at an annulus of the native valve; wherein the coil remains in a substantially straight configuration when delivering the docking device and moves to a helical configuration after the docking device is deployed, wherein the one or more turns of the first coil region are configured to be deployed on the inflow side of the native valve and one or more turns of the second coil region are configured to be deployed on the outflow side of the native valve.

[0158] Example 16. The method of any example herein, particularly example 15, further comprising deploying a prosthetic heart valve within the docking device.

[0159] Example 17. The coil of any example herein, particularly example 5, wherein the first coil region defines a first lumen diameter and the second coil region defines a second lumen diameter and wherein the first lumen diameter is larger than the second lumen diameter.Attorney Docket No: THVVA-24206W001

[0160] Example 18. The coil of any example herein, particularly example 17, wherein the first lumen diameter is within a range of 10 percent to 25 percent greater than the second lumen diameter.

[0161] Example 19. The method of any example herein, particularly any one of examples 15- 16, further comprising positioning the docking device such that a portion where the first coil region and the second coil region meet is positioned where the coil crosses the annulus.

[0162]

[0163] Example 20. The method of any example herein, particularly example 19, wherein the coil crosses the annulus at a medial commissure.

[0164] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one docking device can be combined with any one or more features of another docking device. As another example, any one or more features of one delivery apparatus can be combined with any one or more features of another delivery apparatus.

[0165] In view of the many possible ways in which the principles of the disclosure may be applied, the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

Attorney Docket No: THVVA-24206W001Claims:

1. A coil for a docking device for securing a prosthetic valve, the coil comprising: a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the coil relative to the native annulus, wherein the first coil region defines a first axis extending through a lumen of the first coil region from the inflow side to an outflow side; and a second coil region extending from an outflow end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein the second coil region defines a second axis extending through a lumen of the second coil region from the inflow side to the outflow side, wherein the first axis and the second axis are offset relative to one another by an angle.

2. The coil of claim 1 , wherein the angle is in in a range of 10 degrees to 45 degrees.

3. The coil of claim 1 , wherein the angle is in a range of 20 degrees to 30 degrees.

4. The coil of any one of claims 1-3, wherein the first axis and second axis are offset such that a posterior side portion of the first coil region is raised relative to an anterior side portion of the first coil region.

5. A coil for a docking device for securing a prosthetic valve, the coil comprising: a first coil region comprising a helical turn configured to be disposed on an inflow side of a native annulus and to stabilize the coil relative to the native annulus, wherein the first coil region defines a first coil pitch; and a second coil region extending from a distal end of the first coil region and comprising a plurality of helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein the second coil region defines a second coil pitch,Attorney Docket No: THVVA-24206W001 wherein the first coil pitch is larger than the second coil pitch.

6. The coil of claim 5, wherein the first coil region defines a first lumen diameter and the second coil region defines a second lumen diameter and wherein the first lumen diameter is larger than the second lumen diameter.

7. The coil of claim 6, wherein the first lumen diameter is within a range of 10 percent to 25 percent greater than the second lumen diameter.

8. The coil of any one of claims 5-7, wherein the first coil region comprises a first coil pitch in a range of 2 to 5 mm.

9. The coil of any one of claims 5-7, wherein the first coil pitch is within a range of 3 to 4 mm.

10. A coil for a docking device for securing a prosthetic valve, the coil comprising: a helical core, wherein the core defines: a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the coil relative to the native annulus, wherein at least a portion of the first coil region defines a first core cross section; a second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein at least a portion of the second coil region comprises a second core cross section; and wherein an area of the second core cross section is greater than an area of the first core cross section.

11. The coil of claim 10, wherein the first core cross section and the second core cross section each comprise a circular cross section with the first core cross section defining a first diameter and the second core cross section defining a second diameter, wherein the second diameter is larger than the first diameter.Attorney Docket No: THVVA-24206W00112. The coil of claim 10, wherein the first core cross section defines a portion of a circle and the second core cross section defines a circular cross section.

13. The coil of any one of claims 10-12, wherein the portion of the first coil region which defines the first core cross section extends circumferentially in a range of 90 to 270 degrees around a circumference of the first coil region.

14. A coil for a docking device for securing a prosthetic valve, the coil comprising: a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the coil relative to the native annulus; and a second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein in a relaxed configuration, the first coil region extends radially outward of the second coil region and extends towards the outflow side such that a portion of the first coil region overlaps axially with the second coil region, and wherein in an implanted configuration, the coil is configured to apply a compressive force between the first coil region and the second coil region to the native annulus.

15. A docking device for securing a prosthetic implant at a native valve, the docking device comprising: a coil according to any one of claims 1-14; and a guard member coupled at least partially to the first coil region wherein the guard member is movable between a radially compressed state and a radially expanded state.

16. The docking device of claim 15, wherein the guard member is coupled around a circumference of the first coil region in a range of 180 to 315 degrees.

17. A method comprising : delivering a docking device comprising a coil of any one of claims 1-16 to a native valve; and deploying the docking device at an annulus of the native valve;Attorney Docket No: THVVA-24206W001 wherein the coil remains in a substantially straight configuration when delivering the docking device and moves to a helical configuration after the docking device is deployed, wherein the one or more turns of the first coil region are configured to be deployed on the inflow side of the native valve and one or more turns of the second coil region are configured to be deployed on the outflow side of the native valve.

18. The method of claim 17, further comprising positioning the docking device such that a portion where the first coil region and the second coil region meet is positioned where the coil crosses the annulus.

19. The method of claim 18, wherein the coil crosses the annulus at a medial commissure.

20. The method of any one of claims 17-19, further comprising deploying a prosthetic heart valve within the docking device.

Images