Docking device release mechanism

Abstract

Systems, assemblies, and methods for treating valve regurgitation and other valve problems are described. Docking devices can be used to repair or reshape native heart valves and to secure prosthetic heart valves at a specific location and position relative to a native heart valve. Delivery apparatus can be used to deploy a docking device into the heart, including a lubricous sleeve in the delivery apparatus. Docking devices and delivery apparatus can include a connection mechanism with a coupling member disposed at a proximal end portion of the docking device and a socket element disposed at a distal end portion of the pusher shaft. The connection mechanism can releasably couple the docking device to the delivery apparatus.

Description

THVMC-24044W001DOCKING DEVICE RELEASE MECHANISMCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 736,418, filed December 19, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to docking devices for prosthetic implants and delivery devices for docking devices.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 prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves. The disclosed docking devices, delivery apparatus, and methods can, for example, provide improved release of a docking device from a delivery apparatus. As such, the devices and methods disclosed herein can, among other things,THVMC-24044W001 overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatus.

[0005] A docking device can comprise a coil and a capture member. A delivery apparatus can comprise a handle and one or more shafts coupled to the handle. In addition to these components, a prosthetic heart valve can further comprise one or more of the components disclosed herein.

[0006] In some examples, a delivery apparatus for delivering a docking device to a native valve, the delivery apparatus comprises: a sleeve defining a lumen configured to receive a docking device; and a pusher shaft extending through the lumen of the sleeve and comprising a socket element disposed at a distal portion of the pusher shaft and configured to releasably secure the docking device to the delivery apparatus. Tn some examples, the socket element comprises a braided basket. In some examples, at least a portion of the pusher shaft comprises a braided material. In some examples, the portion of the pusher shaft and the braided basket comprise the same braided material.

[0007] In some examples, the socket element comprises a plurality of claws. In some examples, the claws are curved so as to at least partially form a spherical cavity. In some examples, the plurality of claws comprises three claws.

[0008] In some examples, the socket element comprises a plurality of bumper elements which are disposed at a distal end portion of the socket element. In some examples, each claw of the plurality of claws comprises a bumper member coupled to a distal end portion of each claw.

[0009] In some examples, the socket element is radially compressed by the sleeve while the sleeve axially overlaps the socket element. In some examples, each claw of the plurality of claws is shape set to extend radially outward from the sleeve when not axially overlapped by the sleeve. In some examples, the socket is configured to releasably couple with a capture member disposed on a proximal end portion of the docking device and to release when the sleeve is moved proximally relative to the pusher shaft.

[0010] In some examples, the pusher shaft comprises a first section adjacent to the socket; and a second section proximal to the first section, wherein the first section is more flexible than the second section. In some examples, the first section comprises a plurality of cuts in the pusher shaft. In some examples, the first section comprises a first diameter and the secondTHVMC-24044W001 section comprises a second diameter, the first diameter being smaller than the second diameter. In some examples, the first section comprises a braided material.

[0011] In some examples, a docking device for securing a prosthetic valve comprises: a coil comprising a proximal end portion and a distal end portion; and a spheroid coupling member coupled to the proximal end portion of the coil. In some examples, the spheroid coupling member comprises a sphere. In some examples, the spheroid coupling member comprises an elongate spheroid.

[0012] In some examples, the proximal end portion of the coil defines an axis extending through the coupling member. In some examples, the coupling member comprises one or more grooves which extend in an axial direction along an outer surface of the coupling member.

[0013] In some examples an assembly comprises a delivery apparatus and a docking device. In some examples, the assembly comprises a delivery apparatus which comprises claws and the capture member of the docking device comprises grooves, and the claws are configured to fit within the grooves. In some examples, there are more grooves than claws.

[0014] In some examples a method of implanting a docking device into a native valve comprises: delivering a docking device to a native valve while the docking device is in a delivery orientation within a sleeve shaft of a delivery apparatus; deploying the docking device from the sleeve shaft at the native valve by moving the sleeve shaft proximally relative to the docking device to a first position; and releasing the docking device from the delivery apparatus by moving the sleeve shaft further proximally relative to the docking device from the first position to a second position. In some examples, retracting the sleeve to the first position comprises retracting the sleeve until it reaches a detent. In some examples, at the first position the sleeve shaft axially overlaps with a socket element coupled to a distal end of a pusher shaft disposed within the sleeve shaft. In some examples, when the sleeve shaft axially overlaps with the socket element, the socket element captures a coupling member disposed at a proximal end of the docking device. In some examples, at the first position the docking device is maintained in position axially relative to the delivery apparatus. In some examples, at the first position the sleeve shaft is locked relative to the docking device.

[0015] In some examples, the method further comprises unlocking the sleeve shaft relative to the docking device before moving to the second position. In some examples, the act ofTHVMC-24044W001 unlocking the sleeve shaft relative to the docking device comprises pushing a button. In some examples, at the second position the delivery apparatus disengages from the docking device. In some examples, at the second position the sleeve shaft does not axially overlap the socket element. In some examples, the act of unlocking the sleeve shaft relative to the docking device comprises pulling a pin. In some examples, the act of retracting the sleeve shaft to the first position results in a majority of the docking device being deployed. In some examples, the act of retracting the sleeve shaft to the first position results in only a portion of an atrial turn of the docking device remaining within the sleeve.

[0016] 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).

[0017] 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

[0018] FIG. 1 A is a cutaway view of the human heart in a diastolic phase.

[0019] FIG. IB is a cutaway view of the human heart in a systolic phase.

[0020] 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.

[0021] 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.

[0022] 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 nativeTHVMC-24044W001 mitral valve of the patient and the docking device delivery apparatus has been removed from the patient.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] FIGS 5A-5B illustrate a delivery apparatus for a docking device.

[0027] FIG. 6 depicts a docking device, including a capture member, to be used with the delivery apparatus of FIGS. 5A-5B.

[0028] FIGS. 7A-7C depict partial cross-sections of a distal end portion of the delivery apparatus of FIGS. 5A-5B and a proximal end portion of the docking device of FIG. 6.

[0029] FIGS. 8A-8C depict proximal end portions of the docking device of FIG. 6 with examples of different capture members.

[0030] FIGS. 9A-9D depict distal end portion of a pusher shaft according to various examples.

[0031] FIG. 10 depicts a distal end portion of a pusher shaft including bumper members.

[0032] FIG. 11 A depicts a distal end portion of a pusher shaft with a braided socket element.

[0033] FIG. 1 IB depicts a distal end portion of a braided pusher shaft with a braided socket element being formed on a mandrel.DETAILED DESCRIPTIONGeneral ConsiderationsTHVMC-24044W001

[0034] 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.

[0035] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0036] 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 tern “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.

[0037] 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 tern “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).THVMC-24044W001The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0038] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”

[0039] Directions and other relative references (for example, inner, outer, upper, lower, etc.) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting. For example, certain terms may be used such as “inside,” “outside,”, “top,” “down,” “interior,” “exterior,” and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an “upper” part can become a “lower” part simply by turning the object over. Nevertheless, it is still the same part, and the object remains the same. In the context of the present application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow”, respectively. Thus, for example, typically the lower end of a valve or docking station as depicted in the figures is its inflow end and the upper end of the valve or docking station is its outflow end unless explicitly described otherwise.

[0040] The terms “longitudinal” and “axial” refer to an axis extending in the upstream and downstream directions, or in the proximal and distal directions, unless otherwise expressly defined.

[0041] Although there are alternatives for various components, features, parameters, operating conditions, etc., set forth herein, that does not mean that those alternatives are necessarily equivalent and / or perform equally well. Nor does it mean that the alternatives are listed in a preferred order unless stated otherwise.

[0042] As used herein, the terms “integrally formed” and “unitary construction” refer to a construction that does not require any sutures, fasteners, or other securing means to attach two portions of the construction together.Exemplary Transcatheter Heart Valve Replacement Procedure

[0043] 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.THVMC-24044W001

[0044] 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 the 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.

[0045] 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.

[0046] 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.

[0047] 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 (IV C), superior venaTHVMC-24044W001 cava (SVC), mitral valve MV, and aorta / aortic valve. A defective mitral valve can suffer from insufficiency and / or regurgitation.

[0048] 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 R A, 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.

[0049] The right atrium RA receives deoxygenated blood from the venous system through the superior vena cava SVC and the inferior vena cava IVC, the former entering the right atrium from above, and the latter from below. The hepatic veins 17 carry blood from the liver to the inferior vena cava IVC. The coronary sinus (CS) is a collection of veins joined together to form a large vessel that collects deoxygenated blood from the heart muscle (myocardium), and delivers it to the right atrium RA. During the diastolic phase, or diastole, seen in FIG. 1 A, the deoxygenated blood from the inferior vena cava IVC, superior vena cava SVC, and coronary sinus CS that has collected in the right atrium RA passes through the tricuspid valve TV and into the right ventricle RV as the right ventricle RV expands, while blood from the left atrium LA passes through the mitral valve MV into the left ventricle LV. In the systolic phase, or systole, seen in FIG. IB, the right ventricle RV contracts to force the deoxygenated blood collected in the right ventricle RV through the pulmonary valve PV and pulmonary artery into the lungs, while the left ventricle LV contracts to force blood in the left ventricle through the mitral valve MV into the left atrium LA.

[0050] 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.THVMC-24044W001

[0051] The left atrium LA receives oxygenated blood from the left and right pulmonary veins, which then travels through the mitral valve to the left ventricle. During the diastolic phase, or diastole, seen in FIG. 1A, the oxygen rich blood that collects in the left atrium LA passes through the mitral valve MV and into the left ventricle LV as the left ventricle LV expands. In the systolic phase, or systole, seen in FIG. IB, the left ventricle LV contracts to force the oxygen rich blood through the aortic valve AV and aorta into the body through the circulatory system. In certain examples, the devices described herein can be used to supplement or replace the function of a defective mitral valve MV.

[0052] 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.

[0053] 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.

[0054] 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).

[0055] 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 vasculatureTHVMC-24044W00112 of a patient 10 and navigated through the vasculature 12, into a heart 14 of the patient 10, and toward the native mitral valve 16 (e.g., through heart tissue wall between right atrium RA to left atrium LA as shown). 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).

[0056] 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.

[0057] 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).

[0058] 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).

[0059] 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 transseptalTHVMC-24044W001 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, 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 (FIG. 2A).

[0060] 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.

[0061] 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”).

[0062] 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.THVMC-24044W001

[0063] 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’s 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.

[0064] 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.

[0065] 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.

[0066] 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 dockingTHVMC-24044W001 device 52 within the delivery shaft 54 and while pushing the docking device 52 out of the delivery shaft 54 and positioning the docking device 52 at the implantation site. In some examples, the pusher shaft can be covered, at least in part, by the sleeve shaft.

[0067] 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.

[0068] 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. In some examples, 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.

[0069] 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. In some examples, the pusher assembly 58 can be configured to release, detach, decouple, and / or otherwise disconnect from the docking device 52 in other ways which will be described herein.

[0070] 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 someTHVMC-24044W001 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 until the delivery shaft 54 reaches the left atrium 18, as illustrated in FIG. 2B. Specifically, the user may advance the delivery shaft 54 of the docking device delivery apparatus 50 by gripping and exerting a force on (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.

[0071] 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.

[0072] 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.

[0073] 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, therebyTHVMC-24044W001 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. The brim feature that is described in more detail below can help facilitate retention of the docking device in the native mitral valve 16.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] 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.THVMC-24044W001The 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 docking 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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 (forTHVMC-24044W001 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 advance 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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 paravalvular leakage around the prosthetic heart valve 62. Specifically, the docking device 52 can initially constrict theTHVMC-24044W001 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 52 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.

[0089] 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.

[0090] Although FIGS. 2A-4B specifically depict a mitral valve replacement procedure, it should be appreciated that the same and / or similar procedure may be utilized to replace other heart valves (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.

[0091] 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 guide wire 40 until theTHVMC-24044W001 prosthetic heart valve 62 is positioned or disposed within the docking device 52 and the tricuspid valve. The user may then expand the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery apparatus 60 from the patient 10. In another example, the user may perform the same and / or similar process to replace the aortic valve but may access the aortic valve from the outflow side of the aortic valve via a femoral artery.

[0092] Further, although FIGS. 2A-4B depict a mitral valve replacement procedure that accesses the native mitral valve 16 from the left atrium 18 via the right atrium 20 and femoral vein, it should be appreciated that the native mitral valve 16 may alternatively be accessed from the left ventricle 26. For example, the user may access the native mitral valve 16 from the 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.

[0093] In some examples, a docking device delivery apparatus can be used to deliver docking devices to a heart and / or native valve of an animal, human, cadaver, cadaver heart, anthropomorphic ghost, and / or simulation / simulator. Such devices include transcatheter devices that can be used to guide the delivery of a docking device through vasculature. 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 in U.S. Patent Publication Nos. US2018 / 0318079, US2018 / 0263764, and US2018 / 0177594, which are all incorporated by reference herein in their entireties.

[0094] FIGS. 5A-5B depict an exemplary delivery apparatus 100 configured to deliver a docking device, such as docking device 200, to a target implantation site. The delivery apparatus can include a handle assembly 120 and an outer shaft 160 (e.g., delivery catheter) extending distally from the handle assembly 120. The handle assembly 120 can include a handle 122 including one or more knobs, buttons, wheels, or the like. In some examples, the handle 122 can include knobs 124 and 126 which can be configured to control flexing of the delivery apparatus (e.g., the outer shaft 160).

[0095] In some examples, the delivery apparatus 100 can include a pusher shaft 138 and a sleeve shaft 140 which are coaxially located within the outer shaft 160 and each have portions that extend into the handle assembly 120. The pusher shaft 138 can be configured to deploy the docking device 200 from inside a distal end portion of the outer shaft 160, upon reaching the target implantation site. The pusher shaft 138 can extend through the outer shaft 160 and aTHVMC-24044W001 distal end portion of the pusher shaft 138 can be disposed adjacent to the docking device 200 within the outer shaft 160. In some examples, the docking device 200 can be releasably coupled to the pusher shaft 138 via a connection mechanism such that the docking device 200 can be released after being deployed at the native mitral valve. Because the docking device 200 is retained by, held, and / or otherwise coupled to the pusher shaft 138, the docking device 200 can advance in lockstep with the pusher shaft 138 through and / or out of the outer shaft 160. In some examples, the pusher shaft can comprise hypodermic tube (also referred to as “hypo tube”).

[0096] In addition to the pusher shaft, in some examples, the delivery apparatus 100 can also include a sleeve shaft 140. The pusher shaft can be configured to advance the docking device 200 through the outer shaft 160 and out of a distal end portion of the outer shaft 160, while the sleeve shaft 140, when included, can have a distal dock sleeve configured to cover the docking device 200 within the outer shaft 160 and while pushing the docking device 200 out of the outer shaft 160 and positioning the docking device 200 at the implantation site. In some examples, the pusher shaft can be covered, at least in part, by the sleeve shaft 140. The delivery apparatus 100 can be configured to adjust an axial position of the sleeve shaft to remove a sleeve portion (e.g., distal section) of the sleeve shaft 140 from the docking device 200 during implantation at the target implantation site, as explained further below.

[0097] The handle assembly 120 can further include a hub assembly 130 with a sleeve handle 134 and pusher handle 136 attached thereto which can be configured to control the sleeve shaft 140 and the pusher shaft 138 respectively. The pusher handle 136 can be configured to control a position of the pusher shaft 138, sleeve shaft 140, and docking device 200 relative to the outer shaft 160. The sleeve handle 134 can control a position of the sleeve shaft 140 relative to the pusher shaft 138 and the outer shaft 160. In this way, operation of the various components of the handle assembly 120 can actuate and control operation of the components arranged within the outer shaft 160. In some examples, the hub assembly 130 can be coupled to the handle 122 via a connector 132.

[0098] In some examples, the hub assembly 130 can comprise a detent which allows the user to retract the sleeve shaft to a first position relative to the docking device and pusher shaft, then requires the user to take some action before retracting the sleeve shaft to a second position relative to the docking device and pusher shaft. In some examples, the detent can comprise release mechanism which engages when the when the sleeve handle 134 is moved axially proximally to the first position LI relative to the hub assembly 130. When the release mechanism is engaged (also referred to as “locked”) the sleeve shaft 140 is locked andTHVMC-24044W001 prevented from moving axially proximally relative to the outer shaft 160 and the pusher shaft 138. Then, when desired by the user, the release mechanism can be released (also referred to as “unlocked”) such that the sleeve shaft can be moved axially proximally relative to the outer shaft 160 and pusher shaft 138. In some examples, the release mechanism can comprise a push button, a pull pin, a pull knob, one or more teeth, and / or any other mechanism that provides a mechanical detent. As will be discussed in greater detail below, this detent can help ensure that the sleeve shaft 140 is not prematurely moved too far proximally which could potentially result in release of the docking device 200 from the pusher shaft 138.

[0099] As depicted in FIGS. 5A-5B, in some examples, the release mechanism comprises a push button 135, the which can be coupled to a proximal portion of the sleeve shaft 140 (e.g., initially located within the hub assembly 130). When the sleeve handle 134 is moved axially proximally to the first position LI, the sleeve shaft 140 is moves axially proximally such that the push button 135 snaps into an aperture 137 which can, for example, be located within the hub assembly 130 as depicted. With the push button 135 in the aperture 137, the sleeve handle 134 and the sleeve shaft 140 are no longer free to move axially in the proximal direction. When the user is ready to move the sleeve handle 134 (and the sleeve shaft 140) more in the axially proximal direction relative to the docking device 200 and pusher shaft 138 the user can disengage the release mechanism. In the depicted example, disengaging the release mechanism can comprise pressing on the push button 135 such that it slides under the edge of the aperture 137.

[0100] The handle assembly 120 can include one or more flushing ports to supply flush fluid to one or more lumens arranged within the delivery apparatus 100 (e.g., annular lumens arranged between coaxial components of the delivery apparatus 100) in order to reduce potential thrombus formation. In some examples, the delivery apparatus 100 includes three flushing ports (e.g., flushing ports 110, 116, and 118) as shown in FIGS. 5A-5B.

[0101] In some examples, a connection mechanism which comprises elements disposed at a proximal end portion of the docking device and at a distal end portion of the pusher shaft releasably couples the docking device to the delivery apparatus. In some examples, the connection mechanism can releasably couple the docking device 200 to the pusher shaft 138. As shown in FIG. 5B, the delivery apparatus 100 can include a socket element 150 disposed at a distal end portion of the pusher shaft 138 and a coupling member 250 disposed at a proximal end portion the docking device 200.

[0102] As depicted in FIGS. 7A-7C, in some examples, the socket element 150 can comprise a plurality of claws 152 which are coupled to the distal end portion of the pusher shaft 138. InTHVMC-24044W001 some examples, the claws 152 are shape set to extend radially outward as well as axially distal from the pusher shaft 138. In some examples, the claws 152 are curved so as to at least partially form a spherical cavity. In some examples, the claws and the pusher shaft are integrally formed with the pusher shaft. In some examples, where the pusher shaft comprises hypo tube, the claws are laser cut and then shaped or to have claw-like features, such as a radially outward flair and a curve along the length of the claw. In some examples, the claws are coupled to the pusher shaft by a permanent or semi -permanent connection, such as by adhesive, weld, and / or by other similar means. In some examples, the claws can comprise a polymer and can be coupled to the end portion of the pusher shaft. In some examples, the claws can comprise a metal which is coated with a polymer, this can have the advantage of improving the grip of the claws on the coupling member. Further details regarding operation of the pusher shaft, sleeve shaft, and capture element are discussed below.

[0103] Docking devices can provide a stable anchoring site, landing zone, or implantation zone at the desired native implant site in which prosthetic valves can be expanded or otherwise implanted. In some examples, 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.

[0104] In examples where the docking device 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, a coilTHVMC-24044W001 of the docking device is flexible and / or made of a shape memory material, so that the coils can be straightened for delivery via a transcatheter approach. In some examples, the coil can be made of a 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 and the prosthetic valve, without having to perform separate preparatory steps, simplifying the implantation procedure for the end user.

[0105] In some instances, a docking device can comprise a paravalvular leakage (PVL) guard (also referred to herein as “a guard member”). The PVL guard can, for example, help reduce regurgitation and / or promote tissue ingrowth between the native tissue and the docking device. The PVL guard can, in some examples, be movable between a delivery 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. Additional examples of docking devices including coils, guard members, and other components are described in International Application No. WO / 2024 / 37038 and in Applicant Docket No. THVMC-23455US02 and THVMC-24206US01, the entireties of which are incorporated by reference herein.

[0106] FIG. 6 depicts a docking device 200 with a capture element coupled to a proximal end portion. In some examples, the docking device 200 can include a coil 202, a guard member 204, a stabilization turn 210, and a capture member 250. The docking device 200 can define an inflow side 260 and an outflow side 270. The docking device 200 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.

[0107] The coil 202 can include a central region 208 with a turn, coiled portion, or multiple turns (e.g., 2-5 turns, or more). The central region 208 of the coil 202 serves as the main landing region or holding region for holding the expandable prosthetic valve when the coil 202 and the valve prosthesis are implanted into a patient’s body. The coiled portion or tum(s) of the central region 208 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 202, and the native mitral leaflets and / or other anatomical structures.THVMC-24044W001

[0108] In some examples, the coil 202 of the docking device 200 can also include an enlarged proximal or upper region that comprises and / or consists of a raised stabilization turn 210 (e.g., which can be an atrial coil / turn) of the docking device 200. 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 expansion of the prosthetic heart valve. 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 raised stabilization turn 210 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 200 to stay in its desired position prior to the implantation of the prosthetic valve. In some examples, the raised stabilization turn can be omitted as described in detail in in Applicant Docket No. THVMC-23455US02. The capture member 250, described herein, can be used with a coil in which the raised stabilization turn has been omitted.

[0109] The stabilization turn 210 of the docking device 200 in the example shown can extend up to about one full turn or rotation, and can terminate at a proximal end portion 212. In some examples, the stabilization turn 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 210 can also be significantly larger than the size of the functional coils in the central region 208, so that the stabilization turn 210 flares or extends sufficiently outwardly in order to contact the walls of the circulatory system (e.g., the walls of the left atrium). In some examples, the stabilization coil / turn can 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.

[0110] As mentioned above, the connection mechanism can comprise one or more elements disposed on the docking device and / or the pusher shaft. The connection mechanism can releasably couple the docking device to the delivery apparatus. In some examples, a capture member can be coupled to a proximal end portion of a docking device to releasably couple the docking device to a delivery apparatus, for example to couple the docking device 200 to the delivery apparatus 100. In the depicted example, the docking device 200 includes a capture member 250 coupled to the proximal end portion 212 of the stabilization turn 210. In some examples, the capture member can comprise a spheroid. As used herein, a spheroid canTHVMC-24044W001 include any approximately spherical body which can have, for example, bumps, irregularities, or other deviations and can include any biaxial or triaxial ellipsoidal shape. The spheroid capture member may provide the advantages of allowing some degrees of freedom of motion within the connection mechanism, for example, allowing the capture member 250 to twist and / or rotate within the socket element 150.

[0111] The capture member, such as capture member 250, may be coupled to the docking device 200 such that it cannot move axially or radially relative to the docking device. In some examples, the capture member is integrally formed with the docking device, such that the docking device and capture member comprise one continuous piece. In some examples the capture member can comprise nitinol, polyether ether ketone (PEEK), or another biocompatible material. In some examples the capture member is coupled with the docking device by a permanent or semi-permanent connection, such as by suture, adhesive, bolts, screws, pins or by other similar means. In some examples, the proximal end portion of the proximal end portion 212 of the stabilization turn 210 comprises one or more eyelets or eyeholes and the capture member 250 can be sutured to the one or more eyelets. In some examples, the capture member can be attached by suture to a circumferential recess that is located at the proximal end portion 212.

[0112] FIGS. 7A-7C depict enlarged views of a partial cross-section of the distal end portion of the delivery apparatus 100 of FIGS. 5A-5B and a proximal end portion 212 of the docking device 200, including the capture member 250. In some examples, the pusher shaft 138 comprises a first section 170 adjacent to the socket element 150 and a second section 172 extending in a proximal direction from the first section. In some examples, as will be discussed below, the first section 170 comprises one or more features which make it more flexible than the second section 172. FIG. 7A corresponds to FIG. 5A, FIG. 7B depicts an intermediate configuration, and FIG. 7C corresponds to FIG. 5B. Prior to the configuration depicted in FIG. 5A and FIG. 7A, the pusher handle 136 coupled to the pusher shaft 138, as described above, is pushed by the user to translate the pusher shaft 138 axially relative to the outer shaft 160 (for example, to deploy the docking device 200 at the native valve). Prior to FIG. 5A and FIG. 7A, the sleeve shaft 140 can be positioned such that it extends over at least a portion of the docking device 200. In some examples, the sleeve shaft 140 can be positioned such that it extends over all of the docking device 200.

[0113] FIG. 5A and FIG. 7A, depict a configuration in which the user has retracted the sleeve shaft 140 to a first position by moving the sleeve handle 134 axially in a proximalTHVMC-24044W001 direction relative to the hub assembly 130 to a first position LI. The axial motion of the sleeve handle 134 results in the sleeve shaft 140 being pulled axially proximally relative to pusher shaft 138 and the docking device 200, such that a portion of the docking device 200 is no longer axially overlapped by the sleeve shaft 140. In some examples, when the sleeve handle 134 is retracted to the first position LI the sleeve shaft only axially overlaps with a portion of stabilization turn 210 and the capture member 250 of the docking device 200.

[0114] In some examples, when the sleeve handle 134 is at the first position LI, the release mechanism, such as push button 135, can engage with a corresponding feature on the hub assembly 130, such as the aperture 137. At position LI, the push button 135is positioned in the aperture 137 and the user is restrained from pulling the sleeve handle 134 more in the proximal direction and, therefore, the sleeve shaft 140 is no longer free to move in the proximal direction. In other words, when the handle 134 is in the first position LI, engagement of the release mechanism can restrict further axial motion of the sleeve shaft 140 relative to the docking device 200 and pusher shaft 1 8.

[0115] As can be seen in FIG. 7A, while at the first position the sleeve shaft 140 axially overlaps the socket element 150 and the distal end portion of the pusher shaft 138. The axially overlapping sleeve shaft 140 presses the socket element 150 radially inward. The sleeve shaft 140 applies a radially inward force on the claws 152 pressing them inward to capture the capture member 250. As can be seen in FIG. 7A, the claws 152 can have a curved shape, such that each of the distal end portions 152d can extend around and radially inward from the capture member 250, preventing the capture member 250 from moving in an axially distal direction relative to the socket element 150. In some examples, when the sleeve handle is retracted to the first position LI, the sleeve shaft 140 may axially overlap a portion of the stabilization turn 210 in addition to the socket element 150 and capture member 250. The axial overlap of the socket element 150 by the sleeve shaft 140 at the first position LI can have the advantage of not allowing the socket element 150 to release from capture member 250 prematurely.

[0116] In some examples, to transition from the configuration depicted in FIG. 7A to the configuration depicted in FIG. 7B, the user takes an action to disengage the release mechanism before retracting the sleeve shaft 140 relative to the pusher shaft 138 and docking device 200. When the user is ready to move the sleeve handle 134 (and the sleeve shaft 140) more in the axially proximal direction relative to the docking device 200 and pusher shaft 138 the user can disengage the release mechanism. In some examples, the release mechanismTHVMC-24044W001 comprises a push button 135 and an aperture 137, and the user pushes the push button 135 inward until it slides proximally under an edge of the aperture 137. In some examples, the release mechanism can comprise removing a pull pin, pulling on a pull knob, and / or releasing one or more teeth.

[0117] Once the release mechanism has been disengaged, the user is able to move the sleeve handle 134 and the sleeve shaft 140 axially proximally relative to the pusher shaft 138 and the docking device 200. Pulling the sleeve handle 134 in a proximal direction to the second position L2 results in the sleeve shaft 140 no longer axially overlapping with the socket element 150. As depicted in FIG. 7B, once the sleeve shaft 140 no longer axially overlaps with the socket element 150, the claws 152 are free to return to their rest state, that is to expand radially outward, with the result that the claws 152 do not extends around and radially inward from the capture member 250. Thus, the claws 152 do not prevent the capture member 250 from moving in an axially distal direction relative to the socket element 150.

[0118] FIG. 7C depicts a configuration in which the delivery apparatus 100 has been retracted in the proximal direction. Since the claws 152 are expanded radially outward, the retraction of the delivery apparatus can be accomplished without affecting the position of the docking device 200. In some examples, prior to withdrawing the delivery apparatus 100 from the patient’s vasculature, the sleeve shaft 140 may be re-advanced axially such that it axially overlaps with the socket element 150 (with the socket element 150 removed from the capture member 250). Positioning the sleeve shaft back over the socket element 150 may have the advantage of reducing friction with the patient’s vasculature as the delivery apparatus is withdrawn.

[0119] FIGS. 8A-8C depict proximal end portions of docking device 200 shown in FIG. 6 with examples of different capture members. FIG. 8A depicts a capture member that comprises a sphere, i.e. a capture member that has a first distance DI in all directions. FIGS. 8B-8C depict a capture member 250’ which has a second distance D2 along its axial direction and a third distance D3 along its radial direction. In other words, the spheroid coupling member 250’ can comprise an elongate spheroid

[0120] FIG. 8C depicts a capture member which has one or more grooves in an outer surface of the capture member. In the depicted example, the proximal end portion of the coil 202 defines an axis 201 extending through the coupling member 250’ and the one or more grooves 252 can extend along the outer surface of the coupling member 250’ in a directionTHVMC-24044W001 that parallels the axis 201. In some examples, the grooves 252 may provide a flush path for a flush fluid providing a consistent flow of fluid through these lumens of the delivery apparatus which can have the advantage of reducing stagnation of blood within the delivery apparatus, thereby reducing a risk of thrombus formation. In some examples, the capture member can comprise grooves and the capture element, such as a socket element 150, comprises claws which can be configured to fit within the grooves. In some examples, the capture member comprises more grooves than the number of claws on the capture element. In some examples, the socket element 150 can comprise 2 to 4 claws and the 3-6 the coupling member 250’ can comprise 3 to 6 grooves. In some examples, the socket element 150 can comprise 3 claws and the capture member 250’ can comprise six grooves.

[0121] FIGS. 9A-9D depict examples of the pusher shaft 138 of delivery apparatus 100. In some examples, the pusher shaft 138 comprises a first section 170a, 170b, 170c, 170d adjacent to the socket element 150; and a second section 172a, 172b, 172c, 170d extending in a proximal direction from the first section. In some examples, the first section comprises one or more features which make it more flexible than the second section. The more flexible first section can have the advantage of making the delivery apparatus more maneuverable and / or allowing the distal end portion of the pusher shaft to flex with the docking device during implantation.

[0122] In some examples, as depicted in FIG. 9A the first section 170a comprises a plurality of cuts 139. In some examples the cuts 139 can be perpendicular to an axis of the pusher shaft. The cuts 139 extend through a portion of the pusher shaft 138. In some examples, the cuts extend into the pusher shaft 138 in a range of 10 percent to 60 percent of a diameter of the pusher shaft. In some examples, the cuts extend into the pusher shaft in a range of 20 percent to 50 percent of the diameter of the pusher shaft. In some examples, the cuts extend into the pusher shaft in a range of 30 percent to 40 percent of the diameter of the pusher shaft. In some examples, as depicted, the cuts 139 are on alternating sides of the pusher shaft, such that a cut portion on one side of the pusher shaft 138 corresponds to an uncut potion on the other side of the pusher shaft. In some examples, the cuts 139 can be sized and positioned to achieve a particular flexibility and / or maneuverability goal.

[0123] In some examples, as depicted in in FIG. 9B, the first section 170b comprises a braided material. In some examples, the braided material may have different pick counts depending on performance requirements. The pick count can be expressed in picks per inch of length (PPI), which represents the number of times the wire crosses for every inch of shaftTHVMC-24044W001 length. The higher the PPI, the more wire coverage is achieved. For example, a braided material with a higher PPI can achieve a greater torque but may reduce the flexibility of the shaft, and vice versa. In some examples, the diameter of the braid material may be selected to provide more or less stiffness and torque but may also affect the flexibility of the braided section. In some examples, the first section 170b may be braided in certain pattern to allow flexibility (e.g., less PPI). In some examples, the second section 172b may comprise a nonbraided material such as hypotube. In some examples, the second section 172b comprise a braided material which is braided in a pattern to allow less flexibility (e.g., higher PPI).

[0124] In some examples, as depicted in FIG. 9C, the first section 170c comprises a first width and / or diameter W1 and the second section 172c comprises a second width and / or diameter W2, where the first diameter W1 is smaller than the second diameter W2.

[0125] In some examples, as depicted in FIG. 9D the first section 170d comprises a plurality of cuts 176 which can comprise material removed in interrupted spirals. The cuts 176 may be interrupted by elements 178 of the pusher shaft material which remain uncut. In some examples, changing the pitch of the interrupted spirals can make the pusher more flexible or less flexible as desired. In the depicted example, there are different portions of the first section 170d comprising a first portion 180, a second portion 182, a third portion 184, a fourth portion 186, and a fifth portion 188. As depicted, the portions 180, 182, 184, 186, 188 comprise spiral cuts with different pitches, this results in variable flexibility along the first section 170c. As depicted, the first portion 180 may have a lower pitch and thus be the most flexible relative to the other portions and the fifth portion 188 may have a lower pitch and thus be the least flexible relative to the other portions.

[0126] In some examples, the connection mechanism may comprise one or more features which help to increase the security of the connection between the elements disposed on the docking device and the pusher. FIG. 10 depicts a socket element comprising a plurality of bumper elements 174 which are disposed at a distal end portion of the socket element. In some examples, the socket element comprises a plurality of claws 152 and each claw of the plurality of claws comprises a bumper element 174 disposed at a distal end portion on the radially outward side of each claw 152. The bumper elements 174 push the distal end portions of the claws 152 radially inward and help close the socket element onto the capture member of the docking device to ensure attachment. If there is a force applied in the distal direction to the docking device relative to the delivery apparatus, this will be the mechanical lock that prevents premature release. In some examples, the bumper elements have aTHVMC-24044W001 thickness in a range of 0 mm to 1 mm, in a range of 0.1 mm to 0.5 mm, and / or in a range of 0.2 mm to 0.4 mm. In some examples, the bumpers have a thickness of 0.33 mm. In some examples, the bumpers may be positioned on the radial inward side of each claw.

[0127] FIG. 11 A depicts an example of a braided pusher shaft 338, which can be the same as the pusher shaft 138 except for the differences described below. For example, the braided pusher shaft 338 can be used with the delivery apparatus 100 in a similar fashion to the pusher shaft 138. However, the braided pusher shaft 338 need not include all of the components described above for the pusher shaft 138.

[0128] In some examples, the braided pusher shaft 338 can comprise a braided material. In some examples, the braided material can be braided in a pattern which has the advantage of allowing more or less flexibility, as desired, along the length of the pusher shaft. For example, a higher PPI can achieve a greater torque but may reduce the flexibility of the shaft, and vice versa. In some examples, the diameter of the braid material may be selected to provide more or less stiffness and torque but may also affect the flexibility of the braided section. In some examples, the first section 370 may be braided in certain pattern to allow flexibility (e.g., less PPI). In some examples, the second section 372 comprise a braided material which is braided in a pattern to allow less flexibility (e.g., higher PPI).

[0129] In some examples, as depicted in FIG. 11 A, the socket element can comprise a braided socket element 350 (also referred to as a “braided basket”), which can be disposed at a distal end portion of the braided pusher shaft 338. In some examples, the braided pusher shaft 338 and the braided socket element 350 can be formed of the same braided material which has a variable braid pattern. The braided socket element may comprise axially aligned elements 352 as well as circumferentially aligned elements 354. In some examples, the braided pattern can be a different pattern such as a pattern comprising diagonally aligned elements. In some examples, the braided socket element 350 can be used to couple a delivery apparatus, such as delivery apparatus 100 to a coupling member 250 disposed at a proximal end portion the docking device 200.

[0130] In some examples, as depicted in FIG. 1 IB, a braided socket element, such as braided sock element 350’, can be formed on a mandrel 400. In some examples, the braided socket element 350’ can share features with any of the socket elements described above, for example the braided socket element 350. In some examples, the braided socket element 350’ is the same as the braided socket element 350, except for the differences described below.THVMC-24044W001However, the braided socket element 350' described below need not include all the components described above. In some examples, the braided socket element 350 may be formed on a mandrel similar to the mandrel 400 described below.

[0131] In some examples, the socket element can comprise a braided socket element 350’ (also referred to as a “braided basket”), which can be disposed at a distal end portion of the braided pusher shaft 338’. In some examples, the braided pusher shaft 338’ and the braided socket element 350’ can be formed of the same braided material which has a variable braid pattern. In some examples the open end of the braided socket element 350’ can comprise closed loop 356.

[0132] In some examples, the braided basket can be braided using a manufacturing mandrel 400 with a negative of the basket 404 on the distal end that transitions to a negative of the tubular shape 402 of the braided pusher shaft 338’. In some examples, the ends of the braid can be welded and / or bonded to a hypotube to connect the braided basket 350’ to the pusher shaft. In some examples, the braid can be directly braided onto the manufacturing mandrel 400 and then removed from the mandrel 400. In some examples, the braid can be pre-formed and transferred to the mandrel 400 to give its shape. In some examples, a shape memory material is used, and the basket shape can be formed by shape setting while on the mandrel 400.

[0133] The connection mechanisms disclosed herein can releasably couple a docking device to a pusher shaft and can have several advantages. For example, the connection mechanisms may be less expensive than traditional methods, can reduce manufacturing touch time, and simplify operating procedures. The low force required to release the docking device may have the advantage of increasing docking device implant location accuracy.Exemplary Prosthetic Valves

[0134] Details regarding the prosthetic heart valves described herein and various valve components are described U.S. Patent No. 11,185,406, which is incoiporated herein by reference. Additional example prosthetic valves are described in International Patent Application Publication No. WO 2018 / 222799, U.S. Patent No. 9,155,619, and U.S. Patent Publication No. 2018 / 0028310, all of which are incorporated herein by reference in their entireties.

[0135] In some examples, the prosthetic heart valve comprises a plastically expandable material, which can be metal alloys, polymers, or combinations thereof. Example metal alloysTHVMC-24044W001 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 R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0136] 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 can 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. It should be noted that any of the delivery apparatuses disclosed herein can be adapted for use with a self-expanding valve.Delivery Techniques

[0137] 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 the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-stemotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.THVMC-24044W001

[0138] For implanting a prosthetic valve within the native mitral valve via a transseptal 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 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.

[0139] 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.

[0140] 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.

[0141] 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.THVMC-24044W001

[0142] 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.

[0143] 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

[0144] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0145] Example 1. A delivery apparatus for delivering a docking device to a native valve, the delivery apparatus comprising: a sleeve defining a lumen configured to receive a docking device: and a pusher shaft extending through the lumen of the sleeve and comprising a socket element disposed at a distal portion of the pusher shaft and configured to releasably secure the docking device to the delivery apparatus.

[0146] Example 2. The delivery apparatus of any example herein, particularly example 1, wherein the socket element comprises a braided basket.

[0147] Example 3. The delivery apparatus of any example herein, particularly example 2, wherein at least a portion of the pusher shaft comprises a braided material.

[0148] Example 4. The delivery apparatus of any example herein, particularly example 3, wherein the portion of the pusher shaft and the braided basket comprise the same braided material.THVMC-24044W001

[0149] Example 5. The delivery apparatus of any example herein, particularly example 1, wherein the socket element comprises a plurality of claws.

[0150] Example 6. The delivery apparatus of any example herein, particularly example 5, wherein the claws are curved so as to at least partially form a spherical cavity.

[0151] Example 7. The delivery apparatus of any example herein, particularly any one of examples 3-5, wherein the plurality of claws comprises three claws.

[0152] Example 8. The delivery apparatus of any example herein, particularly any one of examples 1-7, wherein the socket element further comprises a plurality of bumper elements which are disposed at a distal end portion of the socket element.

[0153] Example 9. The delivery apparatus of any example herein, particularly any one of examples 5-8, wherein each claw of the plurality of claws comprises a bumper member coupled to a distal end portion of each claw.

[0154] Example 10. The delivery apparatus of any example herein, particularly any one of examples 1-9, wherein the socket element is radially compressed by the sleeve while the sleeve axially overlaps the socket element.

[0155] Example 11. The delivery apparatus of any example herein, particularly any one of examples 5-9, wherein each claw of the plurality of claws is shape set to extend radially outward from the sleeve when not axially overlapped by the sleeve.

[0156] Example 12. The delivery apparatus of any example herein, particularly any one of examples 1-11, wherein the socket is configured to releasably couple with a capture member disposed on a proximal end portion of the docking device and to release when the sleeve is moved proximally relative to the pusher shaft.

[0157] Example 13. The delivery apparatus of any example herein, particularly any one of examples 1-12, wherein the pusher shaft comprises a first section adjacent to the socket; and a second section proximal to the first section, wherein the first section is more flexible than the second section.

[0158] Example 14. The delivery apparatus of any example herein, particularly example 13, wherein the first section comprises a plurality of cuts in the pusher shaft.

[0159] Example 15. The delivery apparatus of any example herein, particularly example 13, wherein the first section comprises a first diameter and the second section comprises a second diameter, the first diameter being smaller than the second diameter.THVMC-24044W001

[0160] Example 16. The delivery apparatus of any example herein, particularly example 13, wherein the first section comprises a braided material.

[0161] Example 17. A docking device for securing a prosthetic valve, the docking device comprising: a coil comprising a proximal end portion and a distal end portion; and a spheroid coupling member coupled to the proximal end portion of the coil.

[0162] Example 18. The docking device of any example herein, particularly example 17, wherein the spheroid coupling member comprises a sphere.

[0163] Example 19. The docking device of any example herein, particularly example 17, wherein the spheroid coupling member comprises an elongate spheroid.

[0164] Example 20. The docking device of any example herein, particularly example 17, wherein the proximal end portion of the coil defines an axis extending through the coupling member.

[0165] Example 21. The coil of any example herein, particularly example 20, wherein the coupling member comprises one or more grooves which extend in an axial direction along an outer surface of the coupling member.

[0166] Example 22. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 1-14 and the docking device of any example herein, particularly any one of examples 15-19.

[0167] Example 23. The assembly of any example herein, particularly example 22, wherein the delivery apparatus comprises claws and the capture member of the docking device comprises grooves, and wherein the claws are configured to fit within the grooves.

[0168] Example 24. The assembly of any example herein, particularly example 23, wherein there are more grooves than claws.

[0169] Example 25. A method of implanting a docking device into a native valve, the method comprising: delivering a docking device to a native valve while the docking device is in a delivery orientation within a sleeve shaft of a delivery apparatus; deploying the docking device from the sleeve shaft at the native valve by moving the sleeve shaft proximally relative to the docking device to a first position; and releasing the docking device from the delivery apparatus by moving the sleeve shaft further proximally relative to the docking device from the first position to a second position.THVMC-24044W001

[0170] Example 26. The method of any example herein, particularly example 25, wherein retracting the sleeve to the first position comprises retracting the sleeve until it reaches a detent.

[0171] Example 27. The method of any example herein, particularly any one of examples 25-26, wherein at the first position the sleeve shaft axially overlaps with a socket element coupled to a distal end of a pusher shaft disposed within the sleeve shaft.

[0172] Example 28. The method of any example herein, particularly example 27, wherein when the sleeve shaft axially overlaps with the socket element, the socket element captures a coupling member disposed at a proximal end of the docking device.

[0173] Example 29. The method of any example herein, particularly any one of examples 25-28, wherein at the first position the docking device is maintained in position axially relative to the delivery apparatus.

[0174] Example 30. The method of any example herein, particularly any one of examples 25-29, wherein at the first position the sleeve shaft is locked relative to the docking device.

[0175] Example 31. The method of any example herein, particularly example 30, wherein the method further comprises unlocking the sleeve shaft relative to the docking device before moving to the second position.

[0176] Example 32. The method of any example herein, particularly example 31, wherein the act of unlocking the sleeve shaft relative to the docking device comprises pushing a button.

[0177] Example 33. The method of any example herein, particularly any one of examples 25-32, wherein at the second position the delivery apparatus disengages from the docking device.

[0178] Example 34. The method of any example herein, particularly any one of examples 27-33, wherein at the second position the sleeve shaft does not axially overlap the socket element.

[0179] Example 35. The method of any example herein, particularly example 31, wherein the act of unlocking the sleeve shaft relative to the docking device comprises pulling a pin

[0180] Example 36. The method of any example herein, particularly any one of examples 25-35, wherein the act of retracting the sleeve shaft to the first position results in a majority of the docking device being deployed.THVMC-24044W001

[0181] Example 37. The method of any example herein, particularly any one of examples 25-35, wherein the act of retracting the sleeve shaft to the first position results in only a portion of an atrial turn of the docking device remaining within the sleeve.

[0182] 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 delivery apparatus can be combined with any one or more features of another delivery apparatus. As another example, any one or more features of one docking device can be combined with any one or more features of another docking device.

[0183] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that 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

THVMC-24044W001Claims:

1. A delivery apparatus for delivering a docking device to a native valve, the delivery apparatus comprising: a sleeve defining a lumen configured to receive a docking device; and a pusher shaft extending through the lumen of the sleeve and comprising a socket element disposed at a distal portion of the pusher shaft and configured to releasably secure the docking device to the delivery apparatus.

2. The delivery apparatus of claim 1, wherein the socket element comprises a braided basket.

3. The delivery apparatus of claim 2, wherein at least a portion of the pusher shaft comprises a braided material.

4. The delivery apparatus of claim 3, wherein the portion of the pusher shaft and the braided basket comprise the same braided material.

5. The delivery apparatus of claim 1, wherein the socket element comprises a plurality of claws.

6. The delivery apparatus of claim 5, wherein the claws are curved so as to at least partially form a spherical cavity.

7. The delivery apparatus of any one of claims 5-6, wherein each claw of the plurality of claws comprises a bumper member coupled to a distal end portion of each claw.

8. The delivery apparatus of any one of claims 1-7, wherein the socket element is radially compressed by the sleeve while the sleeve axially overlaps the socket element.

9. The delivery apparatus of any one of claims 5-7, wherein each claw of the plurality of claws is shape set to extend radially outward from the sleeve when not axially overlapped by the sleeve.THVMC-24044W00110. The delivery apparatus of any one of claims 1-9, wherein the socket is configured to releasably couple with a capture member disposed on a proximal end portion of the docking device and to release when the sleeve is moved proximally relative to the pusher shaft.

11. The delivery apparatus of any one of claims 1-10, wherein the pusher shaft comprises: a first section adjacent to the socket; and a second section proximal to the first section, wherein the first section is more flexible than the second section.

12. A docking device for securing a prosthetic valve, the docking device comprising: a coil comprising a proximal end portion and a distal end portion; and a spheroid coupling member coupled to the proximal end portion of the coil.

13. The docking device of claim 12, wherein the proximal end portion of the coil defines an axis extending through the coupling member.

14. The coil of claim 13, wherein the coupling member comprises one or more grooves which extend in an axial direction along an outer surface of the coupling member.

15. A method of implanting a docking device into a native valve, the method comprising: delivering a docking device to a native valve while the docking device is in a delivery orientation within a sleeve shaft of a delivery apparatus; deploying the docking device from the sleeve shaft at the native valve by moving the sleeve shaft proximally relative to the docking device to a first position; and releasing the docking device from the delivery apparatus by moving the sleeve shaft further proximally relative to the docking device from the first position to a second position.

16. The method of claim 15, wherein retracting the sleeve to the first position comprises retracting the sleeve until it reaches a detent.THVMC-24044W00117. The method of any one of claims 15-16, wherein at the first position the sleeve shaft axially overlaps with a socket element coupled to a distal end of a pusher shaft disposed within the sleeve shaft.

18. The method of claim 17, wherein when the sleeve shaft axially overlaps with the socket element, the socket element captures a coupling member disposed at a proximal end of the docking device.

19. The method of any one of claims 15-18, wherein at the first position the sleeve shaft is locked relative to the docking device.

20. The method of claim 19, wherein the method further comprises unlocking the sleeve shaft relative to the docking device before moving to the second position.

21. The method of any one of claims 15-20, wherein at the second position the delivery apparatus disengages from the docking device.

22. The method of any one of claims 17-21, wherein at the second position the sleeve shaft does not axially overlap the socket element.

Images