Prosthetic implant with outward radial projections

Abstract

A prosthetic heart valve is disclosed herein, where the prosthetic heart valve comprises one or more projections arranged adjacent an outflow end of the prosthetic heart valve. The one or more projections are configured to extend radially outward when the prosthetic heart valve is in a radially expanded configuration to couple the prosthetic heart valve to a surrounding docking device to prevent migration of the prosthetic heart valve in an inflow direction.

Description

THVVA-24620W001 PROSTHETIC IMPLANT WITH OUTWARD RADIAL PROJECTIONS CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 752,571, filed January 31, 2025, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to prosthetic implants, and more particularly to prosthetic heart valves configured for use with a docking device.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 (e.g., 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.

[0004] In a specific example, the prosthetic medical device can be a prosthetic heart valve mounted in a crimped state on a distal end of a delivery apparatus and advanced through the patient’s vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches an implantation site in the heart. The prosthetic 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 valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size.

[0005] An anchoring or docking device can be used in conjunction with an expandable prosthetic implant, for example a prosthetic valve, at an implantation site such as a native heart valve. The anchoring device can be used to securely hold the prosthetic implant inTHVVA-24620W001place at the implantation site when the prosthetic implant is expanded. Docking devices can, for example, provide a stable anchoring site, landing zone, or implantation zone at the implant site in which prosthetic implants can be expanded or otherwise secured. A docking device can be delivered to the implantation site by a delivery apparatus comprising a shaft. The docking device can be releasably coupled to the shaft.SUMMARY

[0006] Described herein are prosthetic implants, delivery apparatuses, and methods for implanting prosthetic implants (such as, for example, prosthetic heart valves). Also described herein are prosthetic heart valves with outflow end portions comprising one or more radial projections that are configured to extend radially outward when the prosthetic heart valve is deployed or implanted. The one or more radial projections are arranged to engage a docking device to prevent movement or migration of the prosthetic heart valve (e.g., in a retrograde blood flow direction). As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic implants and their delivery apparatus.

[0007] A prosthetic heart valve can comprise an annular frame configured to move from a radially compressed configuration to a radially expanded configuration, where the annular frame can comprise an inflow end and an outflow end and a valvular structure coupled to the frame. The valvular structure can comprise a plurality of leaflets disposed within the annular frame and configured to regulate a flow of blood through the frame from the inflow end to the outflow end of the prosthetic heart valve. In addition to these components, a prosthetic heart valve can further comprise one or more of the components disclosed herein.

[0008] In some examples, the prosthetic heart valve can comprise an outer skirt disposed on an outer surface of the frame.

[0009] In some examples, the frame can comprise a plurality of outflow apices defining the outflow end of the prosthetic heart valve.

[0010] In some examples, the prosthetic valve can comprise a binding arranged over an outflow edge of the outer skirt and the outflow end of the annular frame.

[0011] In some examples, the prosthetic valve can comprise one or more projections arranged at or adjacent the outflow end of the prosthetic heart valve.THVVA-24620W001

[0012] In some examples, the one or more projections can be configured to abut a docking device to prevent the prosthetic heart valve from migrating when implanted in a native heart valve.

[0013] In some examples, the binding can comprise the one or more projections extending radially outward.

[0014] In some examples, each of the one or more projections can comprise a retention member coupled to an outlet edge portion of the outer skirt, where the retention member can be captured between the outlet edge portion of the outer skirt and at least a portion of the binding.

[0015] In some examples, one or more retention members can be configured to extend axially outward from the outflow end of the annular frame when the annular frame is in the radially compressed configuration.

[0016] In some examples, the binding can comprise a first edge extending along a first direction and a second edge extending along the first direction and spaced apart from the first edge in a second direction perpendicular to the first direction.

[0017] In some examples, the second edge can be disposed opposite the first edge, where at least the first edge can define one or more extension portions.

[0018] In some examples, at least the first edge can define one or more valley portions and the one or more extension portions offset from the one or more valley portions along the second direction.

[0019] In some examples, the second edge can define one or more extension portions circumferentially aligned with the one or more extension portions defined by the first edge.

[0020] In some examples, the one or more extension portions can correspond to the one or more retention members.

[0021] In some examples, the one or more retention members can be formed as a separate component comprising a continuous and uniform mass.

[0022] In some examples, the one or more retention members can comprise at least one strip of fabric that is folded or rolled and separate from the binding.THVVA-24620W001

[0023] In some examples, the one or more retention members can be stitched, bonded, or glued to the outlet edge portion of the outer skirt.

[0024] In some examples, the one or more retention members can be formed integrally with the binding as a unitary structure.

[0025] In some examples, the one or more retention members can comprise two or more retention members.

[0026] In some examples, the one or more retention members can comprise exactly two retention members.

[0027] In some examples, the one or more retention members can comprise three or more retention members.

[0028] In some examples, the one or more retention members can comprise exactly three retention members.

[0029] In some examples, the one or more extension portions can be each configured to extend around a retention member.

[0030] In some examples, the second edge of the binding can comprise a one or more tabs extending therefrom.

[0031] In some examples, the one or more tabs can be configured to form the one or more projections, where the one or more tabs can be circumferentially aligned with the one or more extension portions.

[0032] In some examples, a prosthetic heart valve comprises an annular frame configured to move from a radially compressed configuration to a radially expanded configuration, wherein the annular frame comprises an inflow end and an outflow end; an outer skirt disposed on an outer surface of the frame; a binding arranged over an outflow edge of the outer skirt and the outflow end of the annular frame; a plurality of leaflets disposed within the annular frame and configured to regulate a flow of blood through the frame from the inflow end to the outflow end of the prosthetic heart valve; and one or more retention members coupled to an outlet edge portion of the outer skirt and configured to extend radially outward from an outer surface of the outer skirt when the annular frame is in the radially expanded configuration and axially outward from the outflow end of the annular frame when the annular frame is inTHVVA-24620W001the radially compressed configuration, wherein the one or more retention members are captured between the outer skirt and at least a portion of the binding.

[0033] In some examples, a prosthetic heart valve comprises a radially expandable and compressible annular frame comprising a plurality of outflow apices defining an outflow end of the prosthetic heart valve; a plurality of leaflets disposed within the annular frame and configured to regulate a flow of blood through the frame; an outer skirt disposed on an outer surface of the frame; and a binding arranged over an outflow edge of the outer skirt and the outflow end of the annular frame, wherein the binding comprises one or more projections extending radially outward and configured to abut a docking device to prevent the prosthetic heart valve from migrating when implanted in a native heart valve.

[0034] In some examples, a prosthetic heart valve comprises one or more of the components recited in Examples 27-38, 40-47, and 56 below.

[0035] An assembly can comprise a docking device configured to encircle native leaflets of a native heart valve and a prosthetic heart valve having an inflow end and an outflow end. In addition to these components, an assembly can further comprise one or more of the components disclosed herein.

[0036] In some examples, the prosthetic valve can comprise an annular frame configured to move from a radially compressed configuration to a radially expanded configuration.

[0037] In some examples, the prosthetic valve can comprise an outer skirt disposed on an outer surface of the frame.

[0038] In some examples, the prosthetic valve can comprise a plurality of leaflets disposed within the annular frame and configured to regulate a flow of blood through the frame from the inflow end to the outflow end of the prosthetic heart valve.

[0039] In some examples, the prosthetic valve can comprise one or more projections arranged adjacent the outflow end of the prosthetic heart valve.

[0040] In some examples, the one or more projections can be configured to extend radially outward from an outer surface of the outer skirt when the annular frame is in the radially expanded configuration.THVVA-24620W001

[0041] In some examples, the one or more projections can be configured to couple the prosthetic heart valve to the docking device to prevent movement of the prosthetic heart valve in a direction of the inflow end.

[0042] In some examples, each of the one or more projections can comprise a retention member coupled to an outlet edge portion of the outer skirt and disposed between the outlet edge portion of the outer skirt and at least a portion of an edge binding.

[0043] In some examples, the retention member can comprise at least one strip that is rolled or folded and separate from the edge binding.

[0044] In some examples, the at least one strip can comprise comprises a first strip and a second strip coupled to the first strip, wherein the first strip can have a first length and the second strip can have a second length that is shorter than the first length.

[0045] In some examples, the first length can be at least twice the second length.

[0046] In some examples, the first and second strips can have the same radial thickness.

[0047] In some examples, the at least one strip can be made of a fabric.

[0048] In some examples, the retention member can be formed from a portion of the edge binding.

[0049] In some examples, the retention member can be formed as a unitary structure comprising a continuous and uniform mass.

[0050] In some examples, the retention member can be stitched, bonded, or glued to the outlet edge portion of the outer skirt.

[0051] In some examples, the one or more projections can be configured to extend axially from the outflow end of the prosthetic heart valve in an outflow direction when the annular frame is in the radially compressed configuration.

[0052] In some examples, the prosthetic valve can comprise one or more wires disposed between the frame and the outer skirt to radially distend a portion of the outer skirt to form the one or more projections.THVVA-24620W001

[0053] In some examples, each of the one or more wires can form a radially outward extending bowed shape comprising a first end and a second end that are both connected to the outer surface of the frame.

[0054] In some examples, the frame can comprise a plurality of outflow apices disposed at an outflow end of the frame and a plurality of commissure support portions spaced circumferentially apart around the frame between adjacent outflow apices.

[0055] In some examples, the first end of each of the one or more wires can be connected to a commissure support portion and the second end of the same wire can be connected to an adjacent outflow apex.

[0056] In some examples, the one or more wires can include one or more pairs of wires, where the first ends of the wires in a pair of wires can be connected to the same commissure support portion and the second ends of the wires in the pair of wires can be connected to respective adjacent outflow apices.

[0057] In some examples, the one or more wires can include a pair of wires for each of the plurality of commissure support portions.

[0058] In some examples, the prosthetic valve can comprise an annular structure fixed to an outer surface of the outer skirt and arranged to extend radially outward from the outer skirt a full 360 degrees around the annular frame to form the one or more projections.

[0059] In some examples, the prosthetic valve can comprise one or more filaments fixed to the outer skirt and arranged to extend from an inflow end portion of the prosthetic heart valve to an outflow end portion of the prosthetic heart valve.

[0060] In some examples, each filament of the one or more filaments can comprise a first portion having a first end and a second end, wherein the first portion can extend straight or at least substantially straight from the first end to the second end, and wherein the first end of the first portion can be arranged adjacent to the inflow end of the prosthetic heart valve.

[0061] In some examples, each filament of the one or more filaments can comprise a second portion connected to the second end of the first portion and disposed adjacent to the outflow end of the prosthetic heart valve, where the second portion can be bowed radially outward from the first portion to define a projection of the one or more projections.THVVA-24620W001

[0062] In some examples, each filament can be embedded within the outer skirt and the second portion of each filament can be configured to radially distend a portion of the outer skirt in a radially outward direction.

[0063] In some examples, each filament can be attached to an outer surface of the outer skirt and the second portion of each filament can be configured to bow radially outwardly therefrom.

[0064] In some examples, the one or more projections can comprise two or more projections.

[0065] In some examples, the one or more projections can comprise exactly two projections.

[0066] In some examples, the one or more projections can comprise three or more projections.

[0067] In some examples, the one or more projections can comprise exactly three projections.

[0068] In some examples, an assembly comprises a docking device configured to encircle native leaflets of a native heart valve; and a prosthetic heart valve having an inflow end and an outflow end, the prosthetic heart valve comprising: an annular frame configured to move from a radially compressed configuration to a radially expanded configuration; an outer skirt disposed on an outer surface of the frame; a plurality of leaflets disposed within the annular frame and configured to regulate a flow of blood through the frame from the inflow end to the outflow end of the prosthetic heart valve; and one or more projections arranged adjacent the outflow end of the prosthetic heart valve and configured to extend radially outward from an outer surface of the outer skirt when the annular frame is in the radially expanded configuration, wherein the one or more projections are configured to couple the prosthetic heart valve to the docking device to prevent movement of the prosthetic heart valve in a direction of the inflow end.

[0069] In some examples, an assembly comprises a docking device configured to encircle native leaflets of a native heart valve; and a prosthetic heart valve having an inflow end and an outflow end, the prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising a plurality of outflow apices disposed at an outflow end of the frame and a plurality of commissure support portions spaced circumferentially apart around the frame between adjacent outflow apices; an outer skirt disposed on an outer surface of the frame; and a plurality of leaflets disposed within the annular frame and formingTHVVA-24620W001a plurality of commissures supported by respective commissure support portions; and one or more wires each comprising a first end and a second end, wherein the first and second ends of each of the one or more wires are attached to the outer surface of the frame, and wherein the one or more wires are disposed between the frame and the outer skirt and are configured to radially distend a portion of the outer skirt into a radially outward projection at the outflow end of the prosthetic heart valve to couple the prosthetic heart valve to the docking device.

[0070] In some examples, an assembly comprises one or more of the components recited in Examples 1-26, 39, and 56 below.

[0071] In some examples, a method of securing a prosthetic heart valve at a native heart valve can comprise deploying a docking device at the native heart valve and delivering a prosthetic heart valve in a delivery configuration to the native heart valve within the docking device, where the docking device can comprise a wire forming one or more turns including at least an outlet turn encircling native leaflets on an outflow side of the native heart valve. In addition to these steps, a method can further comprise one or more of the steps disclosed herein.

[0072] In some examples, the method can further comprise moving the prosthetic heart valve from the delivery configuration to a deployed configuration in which the prosthetic heart valve comprises one or more projections extending radially outward from an outflow end portion of the prosthetic heart valve.

[0073] In some examples, a portion of the one or more projections axially abuts an outer end portion of the outlet turn of the docking device to prevent the prosthetic heart valve from migrating in a retrograde blood flow direction when in the deployed configuration.

[0074] In some examples, a method of securing a prosthetic heart valve at a native heart valve comprises deploying a docking device at the native heart valve, wherein the docking device comprises a wire forming one or more turns including at least an outlet turn encircling native leaflets on an outflow side of the native heart valve; delivering a prosthetic heart valve in a delivery configuration to the native heart valve within the docking device; and moving the prosthetic heart valve from the delivery configuration to a deployed configuration in which the prosthetic heart valve comprises one or more projections extending radially outward from an outflow end portion of the prosthetic heart valve, wherein a portion of theTHVVA-24620W001one or more projections axially abuts an outer end portion of the outlet turn of the docking device to prevent the prosthetic heart valve from migrating in an inflow direction when in the deployed configuration.

[0075] In some examples, a method comprises one or more of the steps recited in Examples 48-55 below.

[0076] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, or simulator (e.g., with body parts, heart, tissue, etc. being simulated).

[0077] 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

[0078] FIG. 1A schematically illustrates a first stage in an exemplary mitral valve replacement procedure where a guide catheter and a guidewire are inserted into a blood vessel of a patient and navigated through the blood vessel and into a heart of the patient, towards a native mitral valve of the heart.

[0079] FIG. 1B schematically illustrates a second stage in the exemplary mitral valve replacement procedure where a docking device delivery apparatus extending through the guide catheter is implanting a docking device for a prosthetic heart valve at the native mitral valve.

[0080] FIG. 1C schematically illustrates a third stage in the exemplary mitral valve replacement procedure where the docking device of FIG. 1B is fully implanted at the native mitral valve of the patient and the docking device delivery apparatus has been removed from the patient.THVVA-24620W001

[0081] FIG. 1D 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 implanting a prosthetic heart valve in the implanted docking device at the native mitral valve.

[0082] FIG. 1E 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.

[0083] FIG. 1F 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.

[0084] FIG. 2 is a perspective view of a prosthetic heart valve shown in an expanded configuration as viewed from above, according to an example, where the prosthetic heart valve comprises a frame, a valvular structure disposed within the frame, an outer skirt, and a plurality of projections extending radially outward along an outflow edge binding.

[0085] FIG. 3 is a perspective view of the prosthetic valve of FIG. 2 as viewed from below with the valvular structure omitted for illustration purposes.

[0086] FIG. 3A is a detail view of one of the plurality of projections of FIG. 3.

[0087] FIG. 4 is a bottom view of a frame and outer skirt of FIG. 3, where a radial thickness of the plurality of projections is shown.

[0088] FIG. 5 is a perspective view of the frame and the outer skirt of FIG. 3 shown in an inverted orientation, where the edge binding is omitted to reveal a retention member coupled to an outflow end portion of the outer skirt.

[0089] FIG. 6 is a detail view of the retention member of FIG. 5, as viewed from below.

[0090] FIG. 7 is a bottom view of the frame and the outer skirt of FIG. 3 with the edge binding omitted to reveal three retention members coupled to the outflow end portion of the outer skirt.

[0091] FIGS. 8A-8E show retention members, according to various examples.THVVA-24620W001

[0092] FIG. 9 is a side view of an edge binding, according to an example, where the edge binding is shown comprising a first edge with a plurality of extension portions.

[0093] FIG. 10 is a side view of the frame and the outer skirt of FIG. 3 deployed within a docking device, according to an example, where the plurality of projections are shown in abutment with an outflow end of the docking device.

[0094] FIG. 11 is a bottom view of the frame, the outer skirt, and the docking device of FIG.10.

[0095] FIG. 12 is a schematic view of a prosthetic heart valve deployed within a docking device in a native heart valve, where a plurality of projections are shown in abutment with an outflow end of the docking device.

[0096] FIG. 13 is a side view of the frame and the outer skirt of FIG. 3 illustrated in a compressed or crimped configuration, where the plurality of projections are shown extending axially from an outflow end of the frame.

[0097] FIG. 14 is a bottom view of the frame and the outer skirt in the compressed configuration of FIG. 13.

[0098] FIG. 15 is a side view of an edge binding, according to another example, comprising a plurality of extension portions configured to form retention members.

[0099] FIG. 16 is a side view of a frame for a prosthetic heart valve, according to an example, showing wires attached to and extending radially outward from an outer surface of the frame adjacent an outflow end at a commissure window.

[0100] FIG. 16A is a detail view showing a commissure window and adjacent outflow apices of the frame of FIG. 16 with wires attached thereto.

[0101] FIG. 17 is a bottom view of the frame of FIG. 16, showing the wires extending radially outward from the outer surface of the frame.

[0102] FIG. 18 is a perspective view of a prosthetic heart valve, according to another example, where the prosthetic heart valve comprises an annular projection arranged adjacent an outflow end of the prosthetic heart valve.THVVA-24620W001

[0103] FIG. 19 is a perspective view of a prosthetic heart valve, according to another example, where the prosthetic heart valve comprises a plurality of filaments, each filament having a portion that extends radially outward adjacent an outflow end of the prosthetic heart valve.

[0104] FIG. 20 is a perspective view of a docking device for a prosthetic heart valve, according to an example.

[0105] FIG. 21 is a perspective view of a docking device for a prosthetic heart valve, according to another example.

[0106] FIG. 22 is a perspective view of a docking device for a prosthetic heart valve, according to another example, where the docking device comprises a brim.DETAILED DESCRIPTIONGeneral Considerations

[0107] 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.

[0108] 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 thatTHVVA-24620W001correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0109] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0110] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., 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 (e.g., into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0111] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0112] As introduced above, docking devices for prosthetic implants (for example, prosthetic heart valves) can be used to securely hold prosthetic implants in place at an implantation site. Prosthetic implants disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. A prosthetic implant can be expanded to a radially expanded state within, for example, a docking device once the prosthetic implant reaches the implantation site. It is desirable, in some instances, to configure a prosthetic implant with features to further secure the prosthetic implant at the implantation site and reduce the likelihood of migration after implantation. For example, a prosthetic implant can be configured with one or more radially extending protrusions (e.g., radial projections) that can engage with a surrounding docking device to prevent or reduce axial movement of the prosthetic implant.THVVA-24620W001

[0113] In some examples, as described in more detail below, the prosthetic implant can be a prosthetic heart valve comprising one or more radial projections at an outflow end portion of the prosthetic heart valve. The one or more radial projections at the outflow end portion of the prosthetic valve can be configured to engage with a surrounding docking device to reduce or eliminate movement of the prosthetic heart valve in a retrograde blood flow direction, which may be advantageous when implanting the prosthetic valve in atrio-ventricular native valve location (e.g., a native mitral valve or a native tricuspid valve).

[0114] The one or more radial projections at the outflow end portion of the prosthetic heart valve can be arranged to protrude outward radially into abutment with at least a portion of a surrounding docking device. In some examples, the prosthetic heart valve can be oriented such that the one or more radial projections are arranged to engage an outflow end of a surrounding docking device when the prosthetic valve is expanded and implanted. The one or more radial projections can serve as a stopper or bumper against at least a portion of the docking device, preventing the prosthetic valve from moving toward an inflow end of the docking device.

[0115] In some examples, the one or more radial projections can be disposed along an outflow edge binding. In such cases, the one or more radial projections can comprise a retention member secured to an outflow edge portion of a skirt. The edge binding can be thereafter arranged over the retention member which can result in a bump-out or radial protrusion or projection.

[0116] In some examples, one or more radial projections can comprise one or more wires arranged between a frame and an outer skirt of a prosthetic heart valve. The one or more wires can be configured to project from an outer surface of the frame to distend the outer skirt and form the one or more radial projections. In some examples, one or more radial projections can comprise an annular structure fixed to an outer surface of the outer skirt. In some examples, one or more radial projections can comprise filaments coupled to an outer skirt of a prosthetic heart valve to bulge or distend the outer skirt.

[0117] In some examples, the one or more radial projections can be arranged on an inflow end (or inflow end portion) of the prosthetic valve and configured to engage an inflow end (or inflow end portion) of a docking device. In this manner, the one or more radial projectionsTHVVA-24620W001can reduce or eliminate migration of the prosthetic valve in an antegrade blood flow direction. This may be advantageous, for example, when implanting a prosthetic valve in a native aortic or a native pulmonary valve.Examples of the Disclosed Technology

[0118] Prosthetic implants disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. The prosthetic implants can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus. As introduced above, the prosthetic implants can be expanded to the radially expanded state once the prosthetic implants reaches the implantation site. Although prosthetic valves are primarily described herein, it is understood that any the delivery apparatuses described herein can be used with any types of prosthetic implant, such as, for example, stents, grafts, or prosthetic valves. It is also understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail below.

[0119] FIGS. 1 A-1B show an exemplary prosthetic implant in the form of a prosthetic valve 100, according to an example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in some examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0120] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such asTHVVA-24620W001disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated by reference herein in its entirety. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907, which is incorporated by reference herein in its entirety. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated by reference herein in its entirety.

[0121] In some examples, the expandable prosthetic implant can be a prosthetic heart valve. FIGS. 1 A-1F depict one example of a transcatheter heart valve replacement procedure (e.g., a mitral valve replacement procedure) which utilizes a docking device 52 and a prosthetic heart valve 62. As described above, the docking device 52 can be used to securely hold the prosthetic heart valve 62 in place at the native mitral valve, where the prosthetic heart valve 62 can be radially expanded inside the docking device 52 within the annulus of the native mitral valve. Although FIG. 1A-1F show the procedure using the docking device 52 and the prosthetic heart valve 62, it is understood that any docking device or prosthetic heart valve described herein can be used.

[0122] During the example procedure depicted in FIGS. 1 A-1F, a user first creates a pathway to a patient’s native heart valve using a guide catheter 30 (FIG. 1A). The user then delivers and implants the docking device 52 at the patient’s native heart valve using a docking device delivery apparatus 50 (FIG. 1B) and then removes the docking device delivery apparatus 50 from the patient 10 after implanting the docking device 52 (FIG. 1C). The user then implants the prosthetic heart valve 62 within the implanted docking device 52 using a prosthetic valve delivery apparatus 60 (FIG. 1D). Thereafter, the user removes the prosthetic valve delivery apparatus 60 from the patient 10 (FIG. 1E), as well as the guide catheter 30 (FIG. 1F).

[0123] FIG. 1A depicts a first stage in a mitral valve replacement procedure, according to an example, where the guide catheter 30 and a guidewire 40 are inserted into a blood vessel 12 of a patient 10 and navigated through the blood vessel 12, into a heart 14 of the patient 10, and toward the native mitral valve 16. Together, the guide catheter 30 and the guidewire 40 can provide a path for the docking device delivery apparatus 50 and the prosthetic valveTHVVA-24620W001delivery apparatus 60 to be navigated through and along, to the implantation site (the native mitral valve 16 or native mitral valve annulus).

[0124] Initially, the user may first make an incision in the patient’s body to access the blood vessel 12. For example, in the example illustrated in FIG. 1A, the user may make an incision in the patient’s groin to access a femoral vein. Thus, in such examples, the blood vessel 12 may be a femoral vein.

[0125] After making the incision at the blood vessel 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 blood vessel 12. The guide catheter 30 (which can also be referred to as an “introducer device,’’ “introducer,” or “guide sheath”) is configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., the docking device delivery apparatus 50 and the prosthetic valve delivery apparatus 60) into and through the blood vessel 12 and may extend through the blood vessel 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 blood vessel 12 and into the heart 14 while the handle 32 remains outside the body of the patient 10 and can be operated by the user in order to manipulate the shaft 34.

[0126] The guidewire 40 is configured to guide the delivery apparatuses (e.g., 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 (e.g., 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 blood vessel 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 of the heart 14) as shown in FIG. 1A.

[0127] In some examples, 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 the blood vessel 12, the user may insert a transseptal puncture device through the incision and into the blood vessel 12. The user may guide the transseptal puncture device through the blood vessel 12 and into the heart 14 (e.g., through the femoral vein and into the right atrium 20). The user can then make a small incision in anTHVVA-24620W001atrial 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 blood vessel 12 and through the incision in the atrial septum 22 into the left atrium 18. Once the guidewire 40 is positioned within the left atrium 18 and / or the left ventricle 26, the transseptal puncture device can be removed from the patient 10. The user can then insert the guide catheter 30 into the blood vessel 12 and advance the guide catheter 30 into the left atrium 18 over the guidewire 40 (FIG. 1A).

[0128] In some examples, an introducer device can be inserted through a lumen of the guide catheter 30 prior to inserting the guide catheter 30 into the blood vessel 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.

[0129] FIG. 1B depicts a second stage in the exemplary mitral valve replacement procedure where the docking device 52 is being implanted at the native mitral valve 16 of the heart 14 of the patient 10 using the docking device delivery apparatus 50 (which may also be referred to as an “implant catheter,’’ a “delivery apparatus,’’ and / or a “docking device delivery device”).

[0130] In general, the docking device delivery apparatus 50 comprises a delivery shaft 54, a handle 56, and a pusher assembly 58. The delivery shaft 54 is configured to be advanced through the patient’s vasculature (blood vessel 12) and to the implantation site (e.g., native mitral valve 16) by the user and may be configured to retain the docking device 52 at a distal end portion 53 of the delivery shaft 54. In some examples, the distal end portion 53 of the delivery shaft 54 retains the docking device 52 therein in a straightened deliveryconfiguration.THVVA-24620W001

[0131] The handle 56 of the docking device delivery apparatus 50 is configured to be gripped and / or otherwise held by the user, outside the body of the patient 10, to advance the delivery shaft 54 through the patient’s vasculature (e.g., blood vessel 12).

[0132] In some examples, the handle 56 can comprise one or more articulation members 57 (or rotatable knobs) that are configured to aid in positioning the delivery shaft 54 within the heart 14. 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 the distal end portion 53 of the delivery shaft 54 to aid in positioning the delivery shaft 54 within the heart 14 for deployment of the docking device 52 at the implantation site (e.g., the native mitral valve 16).

[0133] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at the implantation site (e.g., the native mitral valve 16). For example, the pusher assembly 58 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. An example of a connection mechanism will be described in more detail below in connection with FIGS. 5-10. Further details of the docking device delivery apparatus and its variants are described in PCT Publication No.W02020 / 247907.

[0134] Referring again to FIG. 1B, after the guide catheter 30 is positioned within the left atrium 18, the user may insert the docking device delivery apparatus 50 (e.g., the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 of the docking device delivery apparatus 50 through the guide catheter 30 and over the guidewire 40. In some examples, the guidewire 40 can be at least partially retracted away from the left atrium 18 and into the guide catheter 30. In other examples, the guidewire 40 can be fully removed from the guide catheter 30 prior to insertion of the docking device delivery apparatus 50. The user may then continue to advance the delivery shaft 54 of the docking device delivery apparatus 50 throughTHVVA-24620W001the blood vessel 12 within the guide catheter 30 until the delivery shaft 54 reaches the left atrium 18, as illustrated in FIG. 1B. Specifically, the user may advance the delivery shaft 54 of the docking device delivery apparatus 50 by gripping and exerting a force on (e.g., pushing) the handle 56 of the docking device delivery apparatus 50 toward the patient 10. While advancing the delivery shaft 54 through the blood vessel 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 blood vessel 12 and the heart 14.

[0135] 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 (e.g., the articulation members 57). The user may then push the docking device 52 out of the distal end portion 53 of the delivery shaft 54 with the shaft of the pusher assembly 58 to deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0136] 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. Examples of docking devices will be described in more detail below in connection with FIGS. 20-22.

[0137] After pushing a ventricular portion of the docking device 52 (e.g., the portion of the docking device 52 shown in FIG. 1B that is configured to be positioned within a left ventricle 26 and / or on the ventricular side of the native mitral valve 16), the user may then deploy the remaining portion of the docking device 52 (e.g., an atrial portion of the docking device 52) from the delivery shaft 54 within the left atrium 18 by retracting the delivery shaft 54 away from the posteromedial commissure of the native mitral valve 16.

[0138] 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, the user may retract the docking device delivery apparatus 50 out of the blood vessel 12THVVA-24620W001and 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.

[0139] FIG. 1C 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 guide catheter 30 remains inside the patient 10. In some examples, both the guide catheter 30 and the guidewire 40 remain inside the patient 10. After removing the docking device delivery apparatus 50, the guidewire 40 can be advanced through and / or 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. 1B). 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.

[0140] As illustrated in FIG. 1C, the docking device 52 can comprise a plurality of turns (or coils) that wrap around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has 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 prosthetic heart valve to be implanted. As a result, the docking device 52 can provide a tighter fit, and thus a better seal, between the prosthetic heart valve and the native mitral valve 16.

[0141] FIG. 1D depicts a fourth stage in the mitral valve replacement procedure where the user is delivering and / or implanting a prosthetic heart valve 62 (which can also be referred to herein as a “transcatheter heart valve” or “THV” for short, “replacement heart valve,” and / or “prosthetic mitral valve”) within the docking device 52 using a prosthetic valve delivery apparatus 60.

[0142] As shown in FIG. 1D, the prosthetic valve delivery apparatus 60 can comprise a delivery shaft 64 and a handle 66, the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into the patient’s vasculature 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 is configured to be gripped and / or otherwise held by the user to advance the delivery shaft 64 through the patient’s vasculature.THVVA-24620W001

[0143] 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 blood vessel 12 and the heart 14. Specifically, the articulation member(s) 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 blood vessel 12 and into the left atrium 18 and left ventricle 26 of the heart 14.

[0144] 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. 1D, 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.

[0145] 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 (e.g., the expansion mechanism) configured to radially expand the prosthetic heart valve 62.

[0146] As shown in FIG. 1D, the prosthetic heart valve 62 can be mounted around the expansion mechanism 65 (the inflatable balloon) on the distal end portion of the delivery shaft 64, in a radially compressed configuration.

[0147] 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 (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 (through the blood vessel 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as illustrated in FIG. 1D. More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery apparatus 60 by gripping and exerting a force on (e.g., pushing) the handle 66. While advancing the delivery shaft 64 through the blood vessel 12 and theTHVVA-24620W001heart 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 blood vessel 12 and heart 14.

[0148] 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. 1D, 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.

[0149] Once the radially compressed prosthetic heart valve 62 is appropriately positioned within the docking device 52 (FIG. 1D), 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 (e.g., inflate the inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52.

[0150] FIG. 1E shows a fifth stage in the mitral valve replacement procedure where the prosthetic heart valve 62 is in its radially expanded configuration and implanted within the docking device 52 in the native mitral valve 16. As shown in FIG. 1E, the prosthetic heart valve 62 is received and retained within the docking device 52. Thus, the docking device 52 aids in anchoring the prosthetic heart valve 62 within the native mitral valve 16. In some examples, the docking device 52 can enable better sealing 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.

[0151] As also shown in FIG. 1E, 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.

[0152] FIG. 1F 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.

[0153] Although FIGS. 1 A-1F specifically depict a mitral valve replacement procedure, it should be appreciated that a similar procedure may be utilized to replace other heart valvesTHVVA-24620W001(e.g., tricuspid, pulmonary, and / or aortic valves). Further, the same and / or similar delivery apparatuses (e.g., docking device delivery apparatus 50, prosthetic valve delivery apparatus 60, guide catheter 30, and / or guidewire 40), docking devices (e.g., docking device 52, or any other docking device described herein), replacement heart valves (e.g., prosthetic heart valve 62, or any other prosthetic valve described herein), and / or components thereof may be utilized for replacing these other heart valves. Additional details regarding implantation procedures for docking devices and prosthetic heart valves are described in PCT Publication No. W02023 / 205076, which is incorporated by reference herein in its entirety.

[0154] Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0155] FIG. 2 shows a prosthetic implant in the form of a prosthetic valve 100, according to an example. The prosthetic valve 100 is shown in a radially expanded configuration. The prosthetic valve 100 can be implanted within the docking device 52 in lieu of the prosthetic valve 62, as described above in connection with FIGS. ID- IF.

[0156] In some examples, the disclosed prosthetic valves (for example, prosthetic valves 62 and 100, and / or any other prosthetic valve described herein) can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior orTHVVA-24620W001inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated by reference herein.

[0157] Referring still to FIG. 2, the prosthetic valve 100 can comprise an annular frame 102 having a central, longitudinal axis 103 that defines the longitudinal axis of the prosthetic valve 100. The prosthetic valve 100 can further comprise a valvular structure 104 and a perivalvular outer sealing member or outer skirt 106. The prosthetic valve 100 can have an inflow end portion 108, an outflow end portion 110, and an intermediate portion 112 extending therebetween.

[0158] The valvular structure 104 can comprise a plurality of leaflets 114 collectively forming a leaflet structure. In some examples, the valvular structure 104 can comprise three leaflets 114 arranged in a tricuspid arrangement. However, there can be a greater or fewer number of leaflets. The leaflets 114 can be secured to one another at their adjacent sides to form commissures of the valvular structure 104. The lower edge of the valvular structure 104 can have an undulating, curved scalloped shape. In some examples, the leaflets 114 can be formed of pericardial tissue (such as bovine pericardial tissue), biocompatible synthetic materials, or other various suitable natural or synthetic materials as known in the art and described in U. S. Patent No. 6,730,118, which is incorporated by reference herein.

[0159] The frame 102 can be made of any of various suitable plastically -expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol). When constructed of a plastically -expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable catheter balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size, as introduced above.

[0160] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 102) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following:THVVA-24620W001nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 102 can comprise stainless steel. In some examples, the frame 102 can comprise cobalt-chromium. In some examples, the frame 102 can comprise nickel -cobaltchromium. In some examples, the frame 102 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-2). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0161] The outer skirt 106 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirt 106 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the skirt 106 can comprise a fabric without interlaced yarns or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirt 106 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirt 106 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirt 106 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0162] The prosthetic valve 100 can further comprise an edge binding (also referred to herein as a “binding, ”an “edge cover, ” or an “end cover,’’) 116 that is arranged over and wrapped around an outflow end of the frame 102 and an outflow end portion (also referred to herein as an “outflow selvage” or “selvage”) of the skirt 106. In other words, the binding 116 is configured to extend from an outer surface of the skirt 106, around the outflow end of the frame 102 and the skirt 106, to an inner surface of the frame 102, thus wrapping around the outflow end of the frame 102. The binding 116 can be secured to the frame 102 along a stitchTHVVA-24620W001line 120 using stitches 121, for example. In some examples, the stitches 121 can be in and out stitches, for example, that extend through the binding 116 and the skirt 106 and around portions of the frame 102 to secure the binding 116 to the prosthetic valve 100.

[0163] The binding 116 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the binding 116 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the binding 116 can comprise a fabric without interlaced yarns or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yams or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the binding 116 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, poly etheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the binding 116 can be fabricated in an annular structure. In some examples, the binding 116 can be formed as a linear strip with ends that can be coupled or attached to each other to form an annular shape. In some examples, the binding 116 can have straight or linear edges. In some examples, the shape of a binding can be configured to accommodate variations in profile or contour of an outflow edge portion of the skirt and / or frame, as will be described in more detail below in connection with FIG. 9.

[0164] As introduced above, it can be advantageous, in some instances, to configure a prosthetic heart valve with one or more radial projections 122 at or near an outflow end portion of the prosthetic valve such that the radial projections engage with a surrounding docking device to prevent or reduce the likelihood axial movement of the prosthetic valve in an inflow direction (e.g., in a retrograde blood flow direction). FIGS. 3-4 show the prosthetic valve 100 with the valvular structure 104 and the plurality of leaflets 114 omitted for illustrative purposes. The edge binding 116 can comprise three projections 122 that protrude radially outward beyond an outer surface of the skirt 106 by a radial distance 123, for example, of 0.4mm to 2mm when the prosthetic valve is in the radially expanded configuration shown. Although the illustrated example depicts three projections 122, theTHVVA-24620W001prosthetic valve 100 or any other valve described herein can comprise any number of projections, for example, one projection, two projections, or more than three projections (e.g., 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15).

[0165] In some examples, a projection 122 can comprise a retention member captured between an outflow end portion or a selvage 118 of the outer skirt 106 and the binding 116. In other words, the projections 122 can be formed by attaching retention members to an outer surface of the skirt 106 which is thereafter covered by the binding 116. The retention members can be configured to distend the binding 116 radially outward, forming projections 122 as shown in FIG. 4.

[0166] FIGS. 5-7 show portions of the prosthetic valve 100 including the frame 102 and the outer skirt 106 with the binding 116 and the valvular structure omitted for illustrative purposes. As shown in FIGS. 5-7, a retention member 124 can be secured to an outlet edge portion (e.g., the outflow selvage 118) of the skirt 106. The retention member 124 can be arranged to have an axial dimension 131 (FIG. 5) that extends along a direction of the longitudinal axis 103. The retention member can be arranged to extend a radial thickness 130 (FIG. 7) from an outer surface of the skirt 106. The radial thickness 130 can be, for example, 0.2mm to 1mm. The axial dimension 131 can be, for example, 0.2mm to 2mm. The radial thickness 130 can be selected to result in radial projections 122 that extend radially outward by the radial distance 123 and that cooperate with a docking device as will be described in more detail below in connection with FIGS. 10-12.

[0167] In some examples, as shown in FIG. 8 A, a retention member 124a can comprise a strip 132 of material having a length LI and a thickness Tl, where the length LI corresponds to a distance circumferentially around the prosthetic valve and the thickness Tl corresponds to a radial thickness. In some examples, the length LI can measure 5-15 mm, 8-12 mm, or 10-11 mm. The thickness Tl can measure 0.1-5mm, 0.2-3 mm, or 0.2-1 mm. In some examples, the thickness Tl defines and is the same as the radial thickness 130. A width of the strip 132 can be specified to define the axial dimension 131.

[0168] In some examples, a retention member can comprise two or more strips of material coupled to each other. For example, as shown in FIG. 8B, a retention member 124b can comprise a first strip 134 of material and a second strip 136 of material coupled to the firstTHVVA-24620W001strip 134. The second strip 136 can, for example, be stitched, welded (e.g., laser or heat welded), bonded, or glued to the first strip 134.

[0169] The first strip 134 can have a length L2 and a thickness T2 and the second strip 136 can have a length L3 and a thickness T3, where the lengths L2, L3 correspond to a distance circumferentially around the prosthetic valve and the thicknesses T2, T3 correspond to a radial thickness. In some examples, as shown in FIG. 8B, the length L3 can be smaller than the length L2. In some examples, the length L3 can be the same as the length L2. In some examples, the length L2 can measure 4-15 mm or 5-10 mm. The thickness T2 can measure 0.1-5 mm, 0.2-3 mm, or 0.2-1 mm. In some examples, the length L3 can measure 2-12 mm, 3-8 mm, or 4-5 mm. The thickness T3 can measure 0.1-5 mm, 0.2-3 mm, or 0.2-1 mm.

[0170] In some examples, the thicknesses T2, T3 can be the same as each other. In some examples, the thicknesses T2, T3 can be different than each other. In some examples, the thickness T2, the thickness T3, or the sum of the thicknesses T2, T3 can be the same as Tl. In some examples, the thickness T2, the thickness T3, or the sum of the thicknesses T2, T3 can define the radial thickness 130. In some examples, the length L2 and / or the length L3 can be the same as the length LI. Widths of the first and second strips, 134, 136 can be specified define the axial dimension 131. Although FIG. 8B shows two strips, it should be appreciated that any number of strips can be coupled to each other.

[0171] In some examples, a retention member can comprise one or more strips that are rolled or folded. For example, as shown in FIG. 8C, a retention member 124c can comprise a strip 138 of material that is rolled to create the radial thickness 130. The strip 138 can be configured with a length and a thickness that can be accordingly selected to yield the radial thickness 130. The strip 138 can be configured with a width that can be specified to result in the axial dimension 131.

[0172] In another example, as shown in FIG. 8D, a retention member 124d can comprise a strip 140 of material that is folded to create the radial thickness 130. Although FIG. 8D shows the strip 140 having two folds, it is appreciated that any number of folds is possible. The strip 140 can be configured with a length and a thickness that can be specified to result in the radial thickness 130 when folded. The strip 140 can be configured with a width that can be specified to result in the axial dimension 131.THVVA-24620W001

[0173] The retention members 124a-124d can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the retention members 124a-124d can be made of strips of a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the retention members 124a-124d can be made of strips of a fabric without interlaced yarns or fibers or randomly interlaced yarns or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the retention members 124a-124d can be made of strips comprising a non-textile or non-fabric material, such as a foam, sponge, or a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc.

[0174] In some examples, the retention members 124a-124d can be made of the same material as the outer skirt 106 or the binding 116. In some examples, the retention members 124a-124d can be made of a different material than the outer skirt 106 and / or the binding 116. In some examples, the two or more strips forming a single retention member can be made of the same material or different materials.

[0175] In another example, as shown in FIG. 8E, a retention member 124e can comprise a projection 142 formed as a structure comprising a continuous and uniform mass. In some examples, the projection 142 can be molded, cast, or otherwise formed to have a specific shape or contour using any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the projection 142 can have an angular or squared-off outer envelope. In some cases, as shown in FIG. 8E, the projection 142 can have a rounded outer envelope. A radial thickness, axial dimension, and circumferential length of the projection 142 can be specified to result in the radial thickness 130 and the axial dimension 131 described above.THVVA-24620W001

[0176] The retention member 124 (e.g., the retention members 124a-124e) can be stitched to the outer surface of the skirt 106 or otherwise secured using a bond, weld (e.g., laser or heat welding), and / or glue, for example.

[0177] As introduced above, a retention member (for example, the retention members 124a-124e) can be captured between a binding and the outer surface of a skirt at an outflow end portion or selvage edge of the skirt to form radial projections. To accommodate the increased radial thickness of a retention member, a binding can be configured with extra material or slack in regions that wrap around the retention member.

[0178] To achieve extra slack in regions covering a retention member, a binding can be configured with at least one undulating edge. In some examples, as shown in FIG. 9, the binding 116 can have a first edge 150 and a second edge 152 separated from the first edge 150 by a central portion 154. In some examples, the first edge 150 undulates. In some examples, both the first and second edges 150, 152 can undulate.

[0179] Referring again to FIG. 9, the first edge 150 defines a plurality of alternating extension portions 160 (also referred to herein as “slack portions") and valley portions 162 (also referred to herein as “non-slack portions”), where the valley portions 162 are disposed between adjacent extension portions 160 and the extension portions 160 are generally adjacent axially to retention members.

[0180] In some examples, the first edge 150 can have at least two extension portions 160 and at least two valley portions 162.

[0181] In some examples, the first edge 150 can define exactly three extension portions 160 and exactly three valley portions 160.

[0182] In some examples, only the first edge 150 can define extension and valley portions 160, 162 or only the second edge 152 can define extension and valley portions 160, 162.

[0183] The number of extension portions 160 can generally correspond to the number of retention members coupled to the outer skirt 106.

[0184] In the example shown in FIG. 9, the first edge 150 has three valley portions 162 and three extension portions 160 that correspond to three retention members, as shown in FIG. 7. The binding 116 can have an annular configuration when secured to the prosthetic valve 100THVVA-24620W001such that the alternating extension and valley portions 160, 162 extend circumferentially around the annular frame 102 as shown in FIG. 3. The extension portions 160 are spaced apart from each other by a distance 164 along an x direction, where the distance 164 corresponds to a distance of an adjacent valley 162 and the x direction generally corresponds to a circumference around the prosthetic valve 100 when the binding 116 is attached. The circumferential spacing of the extension portions 160 and the distance 164 is generally determined by the circumferential spacing and the circumferential lengths of retention members. In other words, the circumferential position of the extension portions 160 along the first edge 150 corresponds to the circumferential spacing and sizes of the retention members over which the binding 116 wraps.

[0185] Each extension portion 160 can define an edge portion 165 of the first edge 150 and a length 166. Each valley portion 162 can define an edge portion 167 of the first edge 150.

[0186] The one or more extension portions 160 extend a first distance from the second edge 152 in a y direction and the one or more valley portions 162 extend a second distance that is less than the first distance from the second edge 152, where the y direction is perpendicular to the x direction and corresponds to a longitudinal axis the frame and prosthetic valve, such as for example, the longitudinal axis 103. Stated another way, the edge portions 165 of the one or more extension portions 160 are axially offset from the edge portions 167 of the one or more valley portions 162 by an axial distance 168.

[0187] The binding 116 can be connected to a prosthetic implant via the stitch line 120, in the same manner as previously described for the binding 116. The first and second edges 150, 152 can have preformed apertures 170 to facilitate the formation of stitches 121 along the stitch line 120. The stitches 121 (and therefore the preformed apertures 170) of the stitch line 120 can be disposed adjacent and substantially parallel to the first and second edges 150, 152 shown in FIG. 9, generally alongside and parallel to the edges 165, 167 of the extension and valley portions 160, 162. The edges 165 of the extension portions 160 can be pushed closer to the edges 167 of the valley portions 162 to reduce the distance 168 when the binding 116 is assembled onto a prosthetic valve, such as the prosthetic valve 100, thus forming slack in the binding 116 in regions of the retention members. This slack can billow radially outward, resulting in an increased radial space or volume between the binding 116 and an outer surface of an outer skirt over which the binding 116 wraps.THVVA-24620W001

[0188] Although FIG. 9 only shows the first edge 150 having extension portions 160, it is understood that the second edge 152 can also have extension portions 160 that are circumferentially aligned with the extension portions 160 on the first edge 150. That is, extension portions 160 on the second edge 152 are likewise generally adjacent axially to retention members and can provide additional slack in regions arranged to wrap around the retention members.

[0189] As described above, the length 166 of the one or more extension portions 160 and the distance 168 between the edge portions 165, 167 of the extension and valley portions 160, 162 can be selected to result in sufficient slack to accommodate a retention member. In this way, the binding 116 can be sized to capture, wrap around, and secure a retention member.

[0190] As introduced above, the radial projections 122 can be arranged to extend radially outward by the radial distance 123 and cooperate with a docking device at an implantation site, such as the docking device 200 shown in FIGS. 10-11 according to an example, to prevent the prosthetic valve 100 from moving in an inflow direction once expanded and implanted. Although FIGS. 10-11 show the prosthetic valve 100 deployed within the docking device 200, it should be appreciated that the prosthetic valve 100 or any other prosthetic valve described herein having radial projections can be deployed within any docking device described herein to the same or similar effect.

[0191] In the example shown in FIGS. 10-11, the docking device 200 can comprise two main components: a coil 202 and a guard member 204 covering at least a portion of the coil 202. In certain examples, the coil 202 can include a shape memory material (e.g., Nitinol) such that the docking device 200 (and the coil 202) can move from a substantially straight configuration (also referred to as “delivery configuration”) when disposed within a delivery shaft of a delivery apparatus to a helical configuration (also referred to as “deployed configuration”) after being advanced out of the delivery shaft.

[0192] The coil 202 in the deployed configuration can comprise a plurality of turns (or coils) that, for example, are configured to wrap around leaflets of a native heart valve as schematically shown in FIG. 12, where the docking device 200 and the prosthetic valve 100 are shown in cooperation with each other and implanted within a mitral valve, for example. Referring back to FIGS. 10-11, the coil 202 can comprise a leading turn 214 (or “leadingTHVVA-24620W001coil”), a central region 216 (or “functional turn”), an ascending portion 217, and stabilization turn 218 (also referred to herein as a “stabilization coil” or an “atrial turn”). The plurality of turns of the coil 202 can be arranged to form an inner lumen having a first inner diameter. Further details regarding the docking device 200 will be described in more detail below in connection with FIG. 20.

[0193] The prosthetic valve 100 can be delivered to the implantation site and expanded within the inner lumen of the deployed docking device 200 as shown in FIGS. 10-12. The prosthetic valve 100 can be positioned such that portions of the radial projections 122 toward the inflow end abut an outflow end portion of the docking device 200. In other words, the prosthetic valve 100 can be oriented axially within the lumen of the deployed docking device 200 such that, when expanded, the radial projections 122 of the prosthetic valve 100 are positioned beyond an outlet end of the docking device 200.

[0194] For example, as shown in FIGS. 11-12, the portions of the radial projections 122 toward the inflow end can be deployed beyond or into abutment with an outer end (e.g., shown at the bottom in the orientation of FIG. 10) of the leading turn 214 (also described herein an “outlet turn”) and / or the end of the docking device at the outlet. Because the radial projections 122 extend radially outward from the outer surface of the skirt 106 when the prosthetic valve 100 is expanded, the radial projections 122 increase an outermost diameter of the prosthetic valve 100 at an outflow end portion thereof into a diameter that is greater than the first inner diameter of the inner lumen of the coil 202. This increased diameter at the outflow end portion of the prosthetic valve 100 prevents the prosthetic valve 100 from moving toward the inflow end when deployed and implanted. That is, the radial projections 122 serve as bumpers or stoppers against which the outflow end of the docking device 200 abuts, preventing or reducing the likelihood that the prosthetic valve 100 can migrate in an inflow direction after implantation.

[0195] Positioning the projections 122 at or near the outflow end of the prosthetic valve 100 and / or such that the projections engage the outflow end of the docking device can, for example, help ensure that the prosthetic valve is deployed relatively “high” in the native annulus (i.e., toward the left atrium). This can, among other things, help reduce or eliminate left ventricular outflow tract (LVOT) obstruction.THVVA-24620W001

[0196] As described above, radial projections can be configured to extend radially outward from an outer surface of an outer skirt when a prosthetic valve is in a deployed or expanded configuration. Conversely, it can be advantageous in some cases for the radial projections to have a lower profile when the prosthetic valve is crimped onto a delivery apparatus for advancement through a body to an implantation site. Accordingly, in some examples, radial projections can be configured to move from a lower profile configuration in the delivery configuration to a radially extending configuration in the deployed configuration, for example, as shown in FIG. 3. In some examples, the lower profile configuration can comprise an axially extending configuration. In other words, the radial projections can be configured to move from an axially extending configuration to a radially extending configuration when the prosthetic valve is expanded and deployed at an implantation site.

[0197] For example, FIGS. 13-14 show the prosthetic valve 100 of FIG. 3 in a collapsed or delivery configuration, where the valvular structure is omitted for clarity. As illustrated in FIG. 13, the radial projections 122 are configured to project in an outflow direction along the longitudinal axis 103 away from the outlet end of the prosthetic valve 100 rather than extending radially outward from the outer surface of the skirt 106 as shown in FIGS. 3-4. In other words, the radial projections 122 can be arranged to protrude axially rather than radially when the prosthetic valve is in the compressed or delivery configuration. When the prosthetic valve 100 is expanded or deployed into the configuration shown in FIGS. 3-4 at the implantation site, the projections 122 can move from the axial position shown in FIGS. 13-14 to the radially extending position shown in FIGS. 3-4. In this way, the radial projections 122 can have a lower radial profile configuration for easier movement through a body to an implantation site.

[0198] In some examples, radial projections at an outflow end portion of a prosthetic valve can be formed in other ways. For example, one or more retention members can be incorporated into and formed integrally with an edge binding. That is, one or more retention members can be integrally formed with an edge binding as a single, unitary component with the edge binding. FIG. 15 shows an example of an edge binding 300 that can be used with the prosthetic valve 100 or any other prosthetic valve described herein. For example, the edge binding 300 can be used in lieu of the combination of the binding 116 and retention members 124, 124a-124e.THVVA-24620W001

[0199] The binding 300 can have a central portion 304 bounded by a first edge 310 and a second edge 312 that is radially offset by a thickness from the first edge 310. The first edge 310 can have one or more tabs 314 extending therefrom in a y direction, where the y direction corresponds to a longitudinal axis of a prosthetic valve to which the binding 300 is secured, such as the longitudinal axis 103 of the prosthetic valve 100. The number of tabs 314 can correspond to the number of radial projections desired at an outlet end portion of the prosthetic valve. For example, the binding 300 can be arranged with three tabs 314 as shown in FIG. 15 resulting in three radial projections. In some examples, the binding 300 can have one, two, or more than three tabs 314 (e.g., 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15).

[0200] The binding 300 can have an annular configuration when secured to the prosthetic valve (such as, for example, the prosthetic valves 62, 100, 100, or any other prosthetic valve described herein), such that the tabs 314 extend circumferentially around the prosthetic valve and form radial projections, for example the radial projections 122 as shown in FIG. 3. Each tab 314 can have an axial distance 320, a circumferential length 322 in an x direction, and be spaced apart from each other by a distance 324 along the x direction, where the x direction generally corresponds to a circumference around the prosthetic valve when the binding 300 is attached. The circumferential spacing of the tabs 314 and the distance 324 is generally determined by the desired circumferential spacing between the radial projections and / or the circumferential length of the projections. In other words, the circumferential position of the tabs 314 corresponds to the desired circumferential spacing, position, and size of the resulting radial projections.

[0201] To create a bulging effect (e.g., an increased radial thickness), the one or more tabs 314 can be rolled or folded up in an axial direction (e.g., in the y direction) and tucked underneath the central portion 304 of the binding 300 such that the rolled or folded tabs 314 are disposed and captured between the binding 300 and an outer skirt (such as, the outer skirts 106, 106, or any other outer skirt described herein) when the binding 300 is secured to the prosthetic valve. In other words, a rolled or folded tab 314 produces a bulging effect that distends the central portion 304 of the binding 300 to form a radial projection. The axial distance 320 of each tab 314 can be selected to result in a specified radial thickness. For example, in some instances, a longer axial distance 320 may result in a larger radial thickness and a shorter axial distance 320 may result in a smaller radial thickness.THVVA-24620W001

[0202] To accommodate the increased radial thickness of a tab 314 arranged (e.g., rolled or folded) between the central portion 304 of the binding 300 and an outer skirt over which the binding 300 is wrapped, the binding 300 can be configured with extra material or slack in regions that wrap around the folded or rolled tabs 314. Like the binding 116 described above, to achieve extra slack in regions covering a tab 314, the second edge 312 of the binding 300 can undulate and have one or more extension portions 330 (also referred to herein as “slack portions”) and valley portions 332 (also referred to herein as “non-slack portions”), where the valley portions 332 are disposed between adjacent extension portions 330 and the extension portions 330 are generally circumferentially aligned with the tabs 314.

[0203] The number of extension portions 330 can generally correspond to and be aligned with the tabs 314 disposed along the first edge 310. For example, if the first edge 310 has three tabs 314 extending therefrom, the second edge 312 can likewise have three extension portions 330 extending therefrom that are circumferentially aligned with the three tabs 314, and so on.

[0204] In the example shown in FIG. 15, the second edge 312 has three valley portions 332 and three extension portions 330 that correspond to the three tabs 314. The extension and valley portions 330, 332 can be configured in the same manner along the second edge 312 and have the same effect as the extension and valley portions 160, 162 described above, the description of which applies to the extension and valley portions 330, 332 and is not repeated herein for the sake of brevity.

[0205] Like the binding 116 described above, the first and second edges 310, 312 of the binding 300 can similarly have preformed apertures 340 to facilitate the formation of stitches along a stitch line for attachment to a prosthetic valve frame, akin to the stitches 121, 121 along the stitch lines 120, 120 described above. In the same way, edges of the extension portions 330 can be pushed closer to edges of the valley portions 332 to form slack in the binding 300 in regions of the captured tabs 314.

[0206] As described above, radial projections at an outflow end portion of a prosthetic valve can be formed in other ways, such as for example, by attached retaining members to a frame of a prosthetic valve to bulge or distend an outer skirt coupled thereto. For example, one or more retention members in the form of wires or filaments can be incorporated into andTHVVA-24620W001attached to an outer surface of an annular frame. FIG. 16 shows an example of a frame 400 for a prosthetic valve where the frame 400 comprises one or more wires 402 coupled thereto and extending outward therefrom in a radial direction. As will be described in more detail below, the wires 402 can be configured to distend an outer skirt arranged over an outer surface of the frame 400 to form one or more radial projections into abutment with a surrounding docking device to prevent axial migration.

[0207] In some examples, a prosthetic heart valve (such as, for example, the prosthetic valves 62, 100, 100 or any other prosthetic valve described herein) can include the frame 400, a valvular structure (for example, valvular structure 104), an inner skirt in some cases, and an outer skirt (for example, the outer skirts 106, 106). The frame 400 comprises an inflow end (also referred to herein as an “inlet end”) 408, an outflow end (also referred to herein as an “outlet end”) 410, an outer (i.e., exterior) surface 409, and an inner (i.e., interior) surface 413.

[0208] Like the frames 102, 102 described above, the frame 400 can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol). Suitable plastically-expandable materials that can be used to form the frame 400 include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 400 can comprise stainless steel. In some examples, the frame 400 can comprise cobalt-chromium. In some examples, the frame 400 can comprise nickel-cobalt-chromium. In some examples, the frame 400 comprises 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.

[0209] The frame 400 can comprise a plurality of interconnected struts 417 that form open cells 418 arranged in multiple rows of cells that extend in a circumferential direction and are disposed between the inflow end 408 and the outflow end 410 of the frame 400.

[0210] In the example shown in FIG. 16, the frame 400 can comprise four circumferentially extending rows 419, 421, 423, and 425 of cells with a first row 419 (the lower row in the orientation shown in FIG. 16) disposed at the outflow end 410. The first row 419 comprisesTHVVA-24620W001a plurality of angled struts 417 arranged at the outflow end 410 that meet to form outflow apices 420.

[0211] In some examples, the first row 419 can comprise cells 418a that are elongated in an axial direction (relative to a central longitudinal axis 422 of the frame 400), compared to cells 418b in rows 421 and 423 and cells 418c in row 425. In some examples, the cells 418a of the first row 419 may not be elongated relative to the other rows 421, 423, 425 and / or the cells of the other rows 421, 423, 425 may be elongated relative to the remaining rows. In some examples, the cells 418 can be diamond-shaped or have other shapes and configurations that can facilitate radially expansion and compression. In the example shown in FIG. 16, the frame 400 includes twelve cells per row. In some examples, the frame 400 can include a greater or fewer number of cells in each row.

[0212] The frame 400 can further comprise a plurality of axially extending commissure support portions (also referred to herein as “commissure support portions”) 430 and a plurality of axial struts 432 disposed in the first row 419 of cells at the outflow end 410. As shown in FIG. 16A, each of the axially extending commissure support portions 430 can have an inflow end portion 434 and an outflow end portion 436. The axially extending commissure support portions 430 are shown as commissure windows 440 that are spaced apart from one another around the frame 400 in a circumferential direction as shown in FIG.16.

[0213] Referring to FIG. 16A, each commissure window 440 can have a first axially extending commissure support strut 442 and a second axially extending commissure support strut 444 that is parallel to the first axially extending commissure support strut 442 and circumferentially offset therefrom to define a slot or opening 445 for receiving a valvular commissure. A first circumferential strut 446 extends laterally between and connects inflow end portions of the first and second axially extending commissure support struts 442, 444, and a second circumferential strut 448 extends laterally between and connects outflow end portions of the first and second axially extending commissure support struts 442, 444. In this way, the slot 445 is bounded circumferentially by the first and second axially extending commissure support struts 442, 444 and axially by the first and second circumferential stmts 446, 448. Commissures of a valvular structure (for example, valvular structure 104) can extend through the slots and can be secured to the commissure windows 440 as describedTHVVA-24620W001above in connection with FIG. 2. As such, the circumferential locations of the commissure windows 440 correspond to locations of respective prosthetic leaflet commissures.

[0214] As introduced above, one or more wires 402 can be coupled to the outer surface 409 of the frame 400 adjacent the commissure windows 440 and the outflow end 410 of the frame 400. The one or more radially extending wires 402 can be configured to act as retention members that project radially outward to distend a surrounding outer skirt. The distended outer skirt in regions of the one or more wires 402 forms projections arranged to couple or abut a surrounding docking device (such as, for example, docking devices 52, 200 or any other docking device described herein) to prevent movement of the prosthetic heart in an inflow direction in a similar manner as described above in connection with FIGS. 10-12.

[0215] In some examples, the one or more wires 402 can be welded, bonded, or otherwise secured to the frame 400. In some examples, the one or more wires 402 can be formed integrally with the frame 400 as a unitary, single component. In such cases, the one or more wires 402 can be shape-set into the bowed configuration shown.

[0216] As shown in FIG. 16A, each wire 402 can comprise a first end 450, a second end 452 disposed a length from the first end 450, and thickness 454 which can be a diameter dimension. The thickness 454 can be 1-3 mm. The first end 450 can be coupled to the outflow end portion 436 of a commissure support portion 430 and the second end 452 of the same wire 402 can be coupled to an adjacent outflow apex 420. In some examples, the first end 450 of the frame can be coupled to an end portion or a center portion of a circumferential strut 448 of a commissure support portion 430. In some examples, the first end 450 can be coupled to any region of a commissure support portion 430.

[0217] The wires 402 can be configured to axially elongate with the frame 400 when the frame 400 is in a delivery or crimped configuration and bow out when the frame 400 is radially expanded and foreshortened for implantation. The length of the wire 402 can be specified such that the wire bows out as shown in FIG. 17 when the first and second ends 450, 452 of the wire are coupled to the outer surface 409 of the frame 400 as described (e.g., connected to the outflow apices 420) and the frame 400 is in the radially expanded or deployed configuration shown in FIG. 16. That is, the wires 402 can move from a substantially axially extending state into a bowed out state when the frame 400 foreshortens to the radially expanded and deployed configuration. The length of the wire 402 can beTHVVA-24620W001selected such that the 402 bows out radially from the outer surface 409 of the frame 400 by a specified radial distance 458 as shown in FIG. 17. In some instances, the longer the length of the wire 402, the larger the radial distance 458, and the shorter the length of the wire 402, the smaller the radial distance 458.

[0218] In some examples, one commissure support portion 430 on the frame 400 can have at least one wire 402 extending therefrom to an adjacent outflow apex 420 as described above.

[0219] In some examples, at least one commissure support portion 430 can have two (a pair) of wires 402a, 402b extending therefrom, where a first end 450a of the first wire 402a is coupled to a first portion of the commissure support portion 430 and a first end 450b of the second wire 402b is coupled to the second portion of the same commissure support portion 430. Second ends 452a, 452b of the first and second wires 402a, 402b can be coupled to respective outflow apices 420a, 420b as shown in FIG. 16A.

[0220] In some examples, each commissure support portion 430 has one wire 402 extending therefrom.

[0221] In some examples, each commissure support portion 430 has a first and second (a pair) of wires 402a, 402b extending therefrom that are coupled to adjacent outflow apices 420 as described above and shown in FIG. 17.

[0222] In some examples, one, two, or three commissure support portions 430 have one or more wires 402 extending therefrom.

[0223] In some examples, each wire 402 can have a circular, rectangular or square crosssection that defines the thickness 454. For example, each wire 402 can be made of a monofilament having a diameter that defines the thickness 454. In some examples, each wire 402 can be made of a plurality of filaments that are braided, twisted, or otherwise combined together to form an overall thickness that defines the thickness 454.

[0224] In some examples, the thickness (e.g., diameter) 454 of the one or more wires 402 can be constant or the same from the first end 450 to the second end 452. In some examples, the thickness (e.g., diameter) 454 can vary between the first and second ends 450, 452. For example, the first end 450 can have a larger thickness 454 than the second end 452, or vice-versa. In some examples, a middle portion of the wire 402 between the first and second endsTHVVA-24620W001450, 452 can have a smaller or larger thickness 454 than either or both of the first and second ends 450, 452.

[0225] The one or more wires 402 can made of any biocompatible metallic or polymeric material, such as, for example, stainless steel or Nitinol. The material of the wires 402 can be specified to be compatible with and couplable to the frame 400.

[0226] As introduced above, an outer skirt (such as, for example the outer skirts 106, 106) can be arranged over the outer surface 409 of the frame 400 such that the one or more wires 402 are disposed between the frame 400 and the outer skirt. In other words, the one or more wires 402 are radially inboard of the outer skirt and radially outboard of the frame 400.Extending outward a radial distance 458 from the outer surface 409 of the frame 400, the one or more wires 402 radially distends or pushes portions of the outer skirt arranged over the wires 402 radially outwards to form radial projections. These radial projections, like the radial projections 122 described above in connection with FIGS. 3-4 and 10-12, can be arranged to abut an outflow end of a surrounding docking device (such as, for example, docking devices 52, 200 or any other docking device described herein) to prevent the prosthetic valve and the frame 400 from moving in an axial, inflow direction. Like the radial distance 123, the radial distance 458 can be specified such that the resulting radial projections increase an outermost diameter of the prosthetic valve at an outflow end portion thereof into a diameter that is greater than an inner diameter of an inner lumen of the surrounding docking device. The resulting projections can serve as bumpers or stoppers against which an outflow end of the docking device abuts to prevent or reduce the likelihood that the prosthetic valve can migrate in an inflow direction after implantation.

[0227] In some examples, an outflow end portion of a prosthetic valve can have a radially extending, annular projection configured to abut a docking device when implanted in lieu of separate, individual, or localized projections as described above. FIGS. 18-19 show examples of prosthetic valves each having an annular projection arranged adjacent an outflow end, where each annular projection is configured to extend around an entire circumference of the prosthetic valve. In other words, the annular projections can be configured to extend around an outer surface of the prosthetic valve a full 360 degrees.THVVA-24620W001

[0228] Although FIGS. 18-19 show the annular projections arranged at an outflow portion of the skirt, it should be appreciated that the annular projections can be arranged to extend radially outward along an outflow edge binding as described above in connection with the projections 122. Arrangement along an edge binding may, in some instances, advantageously help with positioning the prosthetic valve axially relative to a surrounding docking device and / or a native anatomy. That is, in some cases, positioning the discrete projections 122 or an annular projection along an edge binding can aid in axially positioning the prosthetic valve relative to a native annulus (for example, closer to an atrium and / or a ventricle as the case may be). Moreover, in some instances, positioning the discrete projections 122 or an annular projection along an edge binding may result in a lower radial profile when the prosthetic valve is in a crimped or delivery configuration by enabling movement of the discrete projections or an annular projection into an axial orientation rather than a radial orientation as described above in connection with FIGS.13-14.

[0229] Referring back to FIGS. 18-19, prosthetic valves 500, 600 are shown with respective annular projections 501, 601, according to examples. The prosthetic valves 500, 600 can have a similar arrangement as the prosthetic valve 100 other than the addition of the annular projections 501, 601 adjacent the outflow end portions 510, 610 in lieu of the projections 122. As such, reference numbers are similarly labeled for the prosthetic valves 500, 600 as for the prosthetic valve 100 and the description for the prosthetic valve 100 applies for the prosthetic valves 500, 600 and may not be repeated again herein for the sake of brevity.

[0230] In some examples, the annular projection 501 shown in FIG. 18 can be a separate structure that extends a full 360 degrees around the longitudinal axis 503 and is stitched, bonded, welded, or otherwise fixed or attached to the prosthetic valve 500. For example, the annular projection 501 can be a separate component that is fixed to an outer surface of the outer skirt 506. In another example, the annular projection 501 can be a separate component that is secured between the frame 502 and the outer skirt 506 so as to distend the outer skirt 506 from inside. In some examples, the annular projection 501 can be made of the same material as the outer skirt 506. In some examples, the annular projection 501 can be made of a different material than the outer skirt 506.

[0231] In some examples, the annular projection 501 can be made in the same manner and using the same materials described above to form the retention members 124a- 124c. That is,THVVA-24620W001instead of extending a finite circumferential length as described above in connection with FIGS. 2-8E, any of the retention members 124a- 124c can be formed instead an annular configuration extending a full 360 degrees around the longitudinal axis 503 and arranged, in some cases, between the outer skirt 506 and the frame 502, or, in other cases, captured between the outer skirt 506 and an outflow edge binding as described above. In other words, one single retention member 124a- 124c can be formed to extend around the entire circumference of the outer skirt 506 to create the annular projection 501.

[0232] In some examples, the annular projection 501 can be an outflow end portion of the skirt 506 that is modified to have more strength, stiffness, and / or loft. This added strength or stiffness can result in additional bulging or radial extension to form the annular projection 501 when prosthetic valve is deployed. In some examples, the annular projection 501 can be a portion of the skirt 506 is that is rolled or folded to create additional bulging or radial extension.

[0233] In some examples, the annular projection 601 shown in FIG. 19 can be formed by the inclusion of one or more stiffened fibers, wires, or filaments 615 attached to, woven as part of, or otherwise fixed to the skirt 606. The filaments 615 can be configured to flare in a region adjacent the outflow end portion 610 of the prosthetic valve 600 when expanded to a deployed shape. For example, the one or more filaments 615 can be fixed to the outer skirt 606 and arranged to extend from the inflow end portion 608 of the prosthetic heart valve 600 to the outflow end portion 610 of the prosthetic heart valve 600.

[0234] Each filament 615 can comprise a first portion 615a and a second portion 615b coupled to each other. The first and second portions 615a, 615b can be integrally formed with each other as a unitary filament or formed separately and secured to each other using welding, gluing, bonding, or any other attachment means.

[0235] The first portion 615a has a first end 617 disposed at or adjacent an inflow end of the prosthetic valve 600 and a second end 619. The first portion 615a extending from the first end 617 to the second end 619 can be straight or at least substantially straight (e.g., linear or disposed parallel or substantially parallel to the longitudinal axis 603). The second portion 615b extends from the second end 619 of the first portion 615a and has an end 621 disposed at or adjacent the outflow end of the prosthetic heart valve 600. Although not illustrated, theTHVVA-24620W001second end 619 can be formed into a round or bend in some instances to reduce the likelihood of localized stresses.

[0236] The second portion 615b can configured to bow radially outward from the first portion 615a when the prosthetic valve 600 is in an expanded, deployed configuration as shown in FIG. 19. For example, the one or more filaments 615 can be shape-set such that, when in the expanded deployed configuration, the second portion 615b assumes a bowed shape. This bowed shape can locally distend portions of the outer skirt 606 attached thereto.

[0237] In some examples, the outer skirt 606 can have 4-8 filaments 615, 5-10 filaments 615, or more than 12 filaments 615 in some examples (e.g., 13, 14, 15, 16, 17, 18, 19, 20-30). The more filaments 615 fixed to the skirt 606, the smoother and more annular the annular projection 601 becomes.

[0238] In some examples, each filament 615 can be embedded within the outer skirt 606. For instance, each filament 615 can be woven into or formed integrally as part of the outer skirt 606.

[0239] In some examples, each filament 615 can be formed separately from the outer skirt 606 and attached thereto using, for example, stitches, bonding, glue, or welding. The filaments 615 can be attached to an outer surface of the skirt 606, an inner surface of the skirt 606, or a combination of the inner and outer surfaces of the skirt 606.

[0240] The one or more filaments 615 can be made of any suitable polymeric or metallic material such as, for example, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the filaments 615 can comprise stainless steel.

[0241] Each filament 615 can have a circular, rectangular or square cross-section that defines a thickness. For example, each filament 615 can be made of a monofilament. In some examples, each filament 615 can be made using a plurality of filaments that are braided, twisted, or otherwise combined together to form an overall thickness.

[0242] In some examples, the thickness of the one or more filaments 615 can be constant or the same from the first end 617 of the first portion 615a to the end 621 of the second portionTHVVA-24620W001615b. In some examples, the thickness can vary between the first end 617 of the first portion 615a to the end 621 of the second portion 615b.

[0243] In some examples, the first and second portions 615a, 615b can be separate pieces that are each fixed to the outer skirt 606 adjacent to each other as shown in FIG. 19 but are otherwise separate and not attached to each other.

[0244] In some examples, the first portion 615a of the filament 615 can be omitted, leaving only the second portion 615b adjacent the outflow end of the prosthetic valve.

[0245] FIG. 20 shows the docking device 200 of FIGS. 10-11 in a deployed, expanded configuration without a prosthetic valve mounted within. The docking device 200 can, for example, be implanted within a native valve annulus and configured to receive and secure a prosthetic valve (such as, for example, the prosthetic valves 62, 100, 100) within the docking device 200, thereby securing the prosthetic valve at the native valve annulus. The docking device 200 can be implanted in lieu of the docking device 52 as described above in connection with FIGS. 1 A-1F. Although described primarily for use herein with a prosthetic valve, any docking device described herein can be used with a variety of prosthetic implants, such as, for example, prosthetic valves, grafts, or stents.

[0246] The coil 202 has a proximal end 210 and a distal end 212. When disposed within the delivery shaft (e.g., during delivery of the docking device into the vasculature of a patient), a body of the coil 202 between the proximal end 210 and distal end 212 can form a generally straight delivery configuration (i.e., without any coiled or looped portions) so as to maintain a small radial profile when moving through a patient's vasculature. After being removed from the delivery shaft and deployed at an implant position, the coil 202 can move from the delivery configuration to the helical deployed configuration and wrap around native tissue adjacent the implant position. For example, when implanting the docking device at the location of a native valve, the coil 202 can be configured to surround native leaflets of the native valve as schematically shown in FIG. 12.

[0247] As described above, the coil 202 in the deployed configuration can include the leading turn 214, the central region 216, the ascending portion 217, and the stabilization turn 218. The central region 216 can have one or more helical turns having substantially equal inner diameters in some examples. The leading turn 214 can extend from a distal end of the centralTHVVA-24620W001region 216 and have a diameter greater than the diameter of the central region 216 (in one or more configurations). The stabilization turn 218 can extend from a proximal end of the central region 216 and have a diameter greater than the diameter of the central region 216 (in one or more configurations). The docking device 200 can comprise additional features as disclosed in PCT Publication No. WO2022 / 087336, which is incorporated by reference herein.

[0248] The docking device 200 can be releasably coupled to a delivery apparatus. For example, the docking device 200 can be coupled to a delivery apparatus via a release suture. In some instances, the release suture can be tied to the docking device 200 through an eyelet, eyehole, or hole 220 located adjacent the proximal end 210 of the coil. In another example, the release suture can be tied around a circumferential recess that is located adjacent the proximal end 210 of the coil 202.

[0249] In some examples, the docking device 200 in the deployed configuration can be configured to fit at the mitral valve position as shown schematically in FIG. 12. In other examples, the docking device can also be shaped and / or adapted for implantation at other native valve positions as well, such as at the tricuspid valve. As described herein, the geometry of the docking device 200 can be configured to engage the native anatomy, which can, for example, provide for increased stability and reduction of relative motion between the docking device 200, the prosthetic valve docked therein, and / or the native anatomy.Reduction of such relative motion can, among other things, prevent material degradation of components of the docking device 200 and / or the prosthetic valve docked therein and / or prevent damage or trauma to the native tissue.

[0250] FIG. 21 shows a docking device 700 in a deployed configuration, according to another example. The docking device 700 comprises a coil 702 having a stabilization turn 704 (also referred to as a “stabilization coil,’’ an “atrial most functional turn,” or a “first coil region”), a central region 706 (also referred to as “functional turns” or a “second coil region”), and a leading turn 708 (also referred to as a “leading coil” or “outlet turn”). The stabilization turn 704, the central region 706 and the leading turn 708 are each disposed around a longitudinal axis 710 which extends through a central lumen 712 of the coil 702. The central region 706 can comprise one or more helical turns having substantially equal diameters, in some instances.THVVA-24620W001

[0251] The leading turn 708 can extend from a distal end of the central region 706 and, in some examples, can have a diameter substantially equal to the diameter of the central region 706. In some examples, the leading turn 708 can comprise a distal end portion 714 that extends radially outward.

[0252] In some examples, the stabilization turn 704 can extend from a proximal end of the central region 706 and can have a diameter substantially equal to the diameter of the central region 706. In some examples, the diameter of the stabilization turn can be different than the diameter of the central region 706.

[0253] In some examples, the coil 702 of docking device 700 can comprise turns having different coil pitches, where the coil pitch can be defined as a distance between two successive turns of the coil. In some examples, the coil 702 of docking device 700 can comprise turns having the same coil pitch from coil to coil.

[0254] An attachment portion 716 can extend from the stabilization turn 704 and can have one or more eyelets, eyeholes, or holes 718 adjacent a proximal end 720 of the coil 702. The attachment portion 716 can be configured to releasably couple the coil 702 to a delivery apparatus. In some examples, the coil 702 can be coupled to the delivery apparatus via a release suture that can be configured to be tied to the coil 702 through the one or more eyelets or holes 718.

[0255] In some examples, a guard member can be used with the stabilization turn 704, where the guard member can be configured to provide increased stability to the docking device as it is deployed. As seen in the depicted example, the coil 702 can be similarly configured as the coil 202 depicted in FIG. 20, with the exception of the ascending portion 217.

[0256] FIG. 22 shows a docking device 800 in a deployed configuration, according to another example. The docking device 800 can comprise a coil 802 that can include a stabilization turn 804 (also referred to as a “stabilization coil,” an “atrial most functional turn,” or a “first coil region”), a central region 906 (also referred to as “functional turns” or a “second coil region”), and a leading turn 908 (also referred to as a “leading coil” or “outlet turn”), each of which are disposed around a longitudinal axis 810 that extends through a central lumen 820. The stabilization turn 804 can have a proximal end 805. The coil 802 can be arranged with the same configuration as the coil 202 and, as such, the description of theTHVVA-24620W001coil 202 applies to the coil 802 and is incorporated herein in connection to coil 802. Some features of the coil 802 may not be repeated here for sake of brevity. In some examples, however, the docking device 800 need not include all of the components described above for the docking device 200.

[0257] In contrast to the docking device 200 shown in FIG. 20, the docking device 800 comprises a guard member (also referred to herein as a “brim”) 830. The brim 830 can move between a radially compressed state and a radially expanded state. The brim 830 can include a plurality of arms defining panels that can be radially expandable and compressible. The brim 830 can also comprise terminal lobes. In the depicted example, the brim 830 can have arms 832 with panels 834 and two terminal lobes 836. In some examples, the brim 830 can comprise a flap sheet. In some examples, the flap sheet is folded over the ends of the arms 832 to provide increased protection to native tissue. Any of the docking devices described herein can comprise a guard member which is substantially similar to the brim 830.Delivery Techniques

[0258] 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. Additionally and / or 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,

[0259] 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 (e.g., by inflating aTHVVA-24620W001balloon, 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). Additionally and / or 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 aorticvalve. Additionally and / or 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 -sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0260] 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 / pul monary artery.

[0261] 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 trans ventricular 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.

[0262] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approachesTHVVA-24620W001are 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.Sterilization

[0263] 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.Simulation

[0264] 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 (e.g., with the body parts, tissue, etc. being simulated), etc.Additional Examples of the Disclosed Technology

[0265] 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.

[0266] Example 1. An assembly comprising: a docking device configured to encircle native leaflets of a native heart valve; and a prosthetic heart valve having an inflow end and an outflow end, the prosthetic heart valve comprising: an annular frame configured to move from a radially compressed configuration to a radially expanded configuration; an outer skirt disposed on an outer surface of the frame; a plurality of leaflets disposed within the annular frame and configured to regulate a flow of blood through the frame from the inflow end to the outflow end of the prosthetic heart valve; and one or more projections arranged adjacentTHVVA-24620W001the outflow end of the prosthetic heart valve and configured to extend radially outward from an outer surface of the outer skirt when the annular frame is in the radially expanded configuration, wherein the one or more projections are configured to couple the prosthetic heart valve to the docking device to prevent movement of the prosthetic heart valve in a direction of the inflow end.

[0267] Example 2. The assembly of any example herein, particularly example 1, wherein each of the one or more projections comprises a retention member coupled to an outlet edge portion of the outer skirt and disposed between the outlet edge portion of the outer skirt and at least a portion of an edge binding.

[0268] Example 3. The assembly of any example herein, particularly example 2, wherein the retention member comprises at least one strip that is rolled or folded and separate from the edge binding.

[0269] Example 4. The assembly of any example herein, particularly example 3, wherein the at least one strip comprises a first strip and a second strip coupled to the first strip, wherein the first strip has a first length and the second strip has a second length that is shorter than the first length.

[0270] Example 5. The assembly of any example herein, particularly example 4, wherein the first length is at least twice the second length.

[0271] Example 6. The assembly of any example herein, particularly of any one of examples 4-5, wherein the first length is 10 mm and the second length is 4 mm.

[0272] Example 7. The assembly of any example herein, particularly of any one of examples 4-6, wherein the first and second strips have the same radial thickness.

[0273] Example 8. The assembly of any example herein, particularly of any one of examples 3-7, wherein the at least one strip is made of a fabric.

[0274] Example 9. The assembly of any example herein, particularly example 2, wherein the retention member is formed from a portion of the edge binding.

[0275] Example 10. The assembly of any example herein, particularly example 2, wherein the retention member is formed as a unitary structure comprising a continuous and uniform mass.THVVA-24620W001

[0276] Example 11. The assembly of any example herein, particularly of any one of examples 2-10, wherein the retention member has a radial thickness of 2-6 mm.

[0277] Example 12. The assembly of any example herein, particularly of any one of examples 3-11, wherein the retention member has a radial thickness of 3-4 mm.

[0278] Example 13. The assembly of any example herein, particularly of any one of examples 2-12, wherein the retention member is stitched, bonded, or glued to the outlet edge portion of the outer skirt.

[0279] Example 14. The assembly of any example herein, particularly of any one of examples 1-13, wherein the one or more projections are configured to extend axially from the outflow end of the prosthetic heart valve in an outflow direction when the annular frame is in the radially compressed configuration.

[0280] Example 15. The assembly of any example herein, particularly example 1, further comprising one or more wires disposed between the frame and the outer skirt to radially distend a portion of the outer skirt to form the one or more projections, wherein each of the one or more wires forms a radially outward extending bowed shape comprising a first end and a second end that are both connected to the outer surface of the frame.

[0281] Example 16. The assembly of any example herein, particularly example 15, wherein the frame comprises a plurality of outflow apices disposed at an outflow end of the frame and a plurality of commissure support portions spaced circumferentially apart around the frame between adjacent outflow apices, and wherein the first end of each of the one or more wires is connected to a commissure support portion and the second end of the same wire is connected to an adjacent outflow apex.

[0282] Example 17. The assembly of any example herein, particularly example 16, wherein the one or more wires includes one or more pairs of wires, and wherein the first ends of the wires in a pair of wires are connected to the same commissure support portion and the second ends of the wires in the pair of wires are connected to respective adjacent outflow apices.

[0283] Example 18. The assembly of any example herein, particularly example 17, wherein the one or more wires includes a pair of wires for each of the plurality of commissure support portions.THVVA-24620W001

[0284] Example 19. The assembly of any example herein, particularly example 1, further comprising an annular structure fixed to an outer surface of the outer skirt and arranged to extend radially outward from the outer skirt a full 360 degrees around the annular frame to form the one or more projections.

[0285] Example 20. The assembly of any example herein, particularly example 1, further comprising one or more filaments fixed to the outer skirt and arranged to extend from an inflow end portion of the prosthetic heart valve to an outflow end portion of the prosthetic heart valve, wherein each filament of the one or more filaments comprises: a first portion having a first end and a second end, wherein the first portion extends straight or at least substantially straight from the first end to the second end, and wherein the first end of the first portion is arranged adjacent to the inflow end of the prosthetic heart valve; and a second portion connected to the second end of the first portion and disposed adjacent to the outflow end of the prosthetic heart valve, wherein the second portion is bowed radially outward from the first portion to define a projection of the one or more projections.

[0286] Example 21. The assembly of any example herein, particularly example 20, wherein each filament is embedded within the outer skirt and the second portion of each filament is configured to radially distend a portion of the outer skirt in a radially outward direction.

[0287] Example 22. The assembly of any example herein, particularly example 20, wherein each filament is attached to an outer surface of the outer skirt and the second portion of each filament is configured to bow radially outwardly therefrom.

[0288] Example 23. The assembly of any example herein, particularly of any one of examples 1-22, wherein the one or more projections comprises two or more projections.

[0289] Example 24. The assembly of any example herein, particularly example 23, wherein the one or more projections comprises exactly two projections.

[0290] Example 25. The assembly of any example herein, particularly of any one of examples 1-23, wherein the one or more projections comprises three or more projections.

[0291] Example 26. The assembly of any example herein, particularly example 25, wherein the one or more projections comprises exactly three projections.THVVA-24620W001

[0292] Example 27. A prosthetic heart valve comprising: an annular frame configured to move from a radially compressed configuration to a radially expanded configuration, wherein the annular frame comprises an inflow end and an outflow end; an outer skirt disposed on an outer surface of the frame; a binding arranged over an outflow edge of the outer skirt and the outflow end of the annular frame; a plurality of leaflets disposed within the annular frame and configured to regulate a flow of blood through the frame from the inflow end to the outflow end of the prosthetic heart valve; and one or more retention members coupled to an outlet edge portion of the outer skirt and configured to extend radially outward from an outer surface of the outer skirt when the annular frame is in the radially expanded configuration and axially outward from the outflow end of the annular frame when the annular frame is in the radially compressed configuration, wherein the one or more retention members are captured between the outer skirt and at least a portion of the binding.

[0293] Example 28. The prosthetic heart valve of any example herein, particularly example 27, wherein the binding comprises a first edge extending along a first direction and a second edge extending along the first direction and spaced apart from the first edge in a second direction perpendicular to the first direction, wherein at least the first edge defines one or more valley portions and one or more extension portions offset from the one or more valley portions along the second direction.

[0294] Example 29. The prosthetic heart valve of any example herein, particularly example 28, wherein the second edge defines one or more extension portions circumferentially aligned with the one or more extension portions defined by the first edge.

[0295] Example 30. The prosthetic heart valve of any example herein, particularly of any one of examples 28-29, wherein the one or more extension portions correspond to the one or more retention members.

[0296] Example 31. The prosthetic heart valve of any example herein, particularly example 27, wherein the one or more retention members are formed as a separate component comprising a continuous and uniform mass.

[0297] Example 32. The prosthetic heart valve of any example herein, particularly example 27, wherein the one or more retention members comprise at least one strip of fabric that is folded or rolled and separate from the binding.THVVA-24620W001

[0298] Example 33. The prosthetic heart valve of any example herein, particularly of any one of examples 27-32, wherein the one or more retention members are stitched, bonded, or glued to the outlet edge portion of the outer skirt.

[0299] Example 34. The prosthetic heart valve of any example herein, particularly example 27, wherein the one or more retention members are formed integrally with the binding as a unitary structure.

[0300] Example 35. The prosthetic heart valve of any example herein, particularly of any one of examples 27-34, wherein the one or more retention members comprise two or more retention members.

[0301] Example 36. The prosthetic heart valve of any example herein, particularly example 35, wherein the one or more retention members comprise exactly two retention members.

[0302] Example 37. The prosthetic heart valve of any example herein, particularly of any one of examples 27-35, wherein the one or more retention members comprise three or more retention members.

[0303] Example 38. The prosthetic heart valve of any example herein, particularly example 37, wherein the one or more retention members comprise exactly three retention members.

[0304] Example 39. An assembly comprising a docking device configured to encircle native leaflets of a native heart valve and the prosthetic heart valve of any example herein, particularly of any one of examples 27-38, wherein the one or more retention members each form a projection extending radially outward from the prosthetic heart valve that is configured to couple the prosthetic heart valve to the docking device to prevent movement of the prosthetic heart valve in a direction of the inflow end of the prosthetic heart valve.

[0305] Example 40. A prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising a plurality of outflow apices defining an outflow end of the prosthetic heart valve; a plurality of leaflets disposed within the annular frame and configured to regulate a flow of blood through the frame; an outer skirt disposed on an outer surface of the frame; and a binding arranged over an outflow edge of the outer skirt and the outflow end of the annular frame, wherein the binding comprises one or more projections extending radially outward and configured to abut a docking device to prevent the prosthetic heart valve from migrating when implanted in a native heart valve.THVVA-24620W001

[0306] Example 41. The prosthetic heart valve of any example herein, particularly example 40, wherein the binding comprises a first edge and a second edge disposed opposite the first edge, wherein at least the first edge defines one or more extension portions.

[0307] Example 42. The prosthetic heart valve of any example herein, particularly example 41, wherein each of the one or more projections comprises a retention member coupled to an outlet edge portion of the outer skirt, and wherein the retention member is captured between the outlet edge portion of the outer skirt and at least a portion of the binding.

[0308] Example 43. The prosthetic heart valve of any example herein, particularly example 42, wherein the one or more extension portions are each configured to extend around a retention member.

[0309] Example 44. The prosthetic heart valve of any example herein, particularly example 41, wherein the second edge of the binding comprises a one or more tabs extending therefrom that are configured to form the one or more projections, wherein the one or more tabs are circumferentially aligned with the one or more extension portions.

[0310] Example 45. An assembly comprising: a docking device configured to encircle native leaflets of a native heart valve; and a prosthetic heart valve having an inflow end and an outflow end, the prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising a plurality of outflow apices disposed at an outflow end of the frame and a plurality of commissure support portions spaced circumferentially apart around the frame between adjacent outflow apices; an outer skirt disposed on an outer surface of the frame; and a plurality of leaflets disposed within the annular frame and forming a plurality of commissures supported by respective commissure support portions; and one or more wires each comprising a first end and a second end, wherein the first and second ends of each of the one or more wires are attached to the outer surface of the frame, and wherein the one or more wires are disposed between the frame and the outer skirt and are configured to radially distend a portion of the outer skirt into a radially outward projection at the outflow end of the prosthetic heart valve to couple the prosthetic heart valve to the docking device.

[0311] Example 46. The assembly of any example herein, particularly example 45, wherein the first end of each of the one or more wires is attached to the outer surface of the frame atTHVVA-24620W001or adjacent to a commissure support portion and the second end of the same wire is attached to an adjacent outflow apex.

[0312] Example 47. The assembly of any example herein, particularly example 46, wherein each commissure support portion has at least one of the one or more wires attached thereto.

[0313] Example 48. A method of securing a prosthetic heart valve at a native heart valve, the method comprising: deploying a docking device at the native heart valve, wherein the docking device comprises a wire forming one or more turns including at least an outlet turn encircling native leaflets on an outflow side of the native heart valve; delivering a prosthetic heart valve in a delivery configuration to the native heart valve within the docking device; and moving the prosthetic heart valve from the delivery configuration to a deployed configuration in which the prosthetic heart valve comprises one or more projections extending radially outward from an outflow end portion of the prosthetic heart valve, wherein a portion of the one or more projections axially abuts an outer end portion of the outlet turn of the docking device to prevent the prosthetic heart valve from migrating in a retrograde blood flow direction when in the deployed configuration.

[0314] Example 49. The method of any example herein, particularly example 48, wherein the prosthetic heart valve further comprises: an annular frame configured to move from a radially compressed configuration to a radially expanded configuration, wherein the annular frame comprises an inflow end and an outflow end; an outer skirt disposed on an outer surface of the frame; a binding arranged over an outflow edge of the outer skirt and the outflow end of the annular frame; and one or more retention members captured between the outer skirt and at least a portion of the binding to form the one or more projections.

[0315] Example 50. The method of any example herein, particularly of any one of examples 48-49, wherein the one or more projections extend axially from an outflow end of the prosthetic heart valve when the prosthetic heart valve is in the delivery configuration.

[0316] Example 51. The method of any example herein, particularly example 48, wherein the prosthetic heart valve further comprises: an annular frame configured to be radially compressed when the prosthetic heart valve is in the delivery configuration and radially expanded when the prosthetic heart valve is in the deployed configuration; and an outer skirt disposed on an outer surface of the frame; and one or more wires arranged between the frameTHVVA-24620W001and the outer skirt and configured to distend the outer skirt in a radially outward direction to form the one or more projections, wherein each wire of the one or more wires has a first end and a second end that are both connected to the outer surface of the frame at the outflow end portion of the prosthetic heart valve.

[0317] Example 52. The method of any example herein, particularly of any one of examples 48-51, wherein the prosthetic heart valve comprises two or more projections extending radially outward from an outflow end portion of the prosthetic heart valve.

[0318] Example 53. The method of any example herein, particularly of any one of examples 48-52, wherein the prosthetic heart valve comprises three or more projections extending radially outward from an outflow end portion of the prosthetic heart valve.

[0319] Example 54. The method of any example herein, particularly of any one of examples 48-53, wherein the prosthetic heart valve comprises exactly three projections extending radially outward from an outflow end portion of the prosthetic heart valve.

[0320] Example 55. A method comprising sterilizing the prosthetic heart valve, apparatus, and / or assembly of any example.

[0321] Example 56. A prosthetic heart valve or assembly of any one of examples 1-47, wherein the prosthetic heart valve is sterilized.

[0322] 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 assembly can be combined with any one or more features of another assembly. As another example, any one or more features of prosthetic implant can be combined with any one or more features of another prosthetic implant.

[0323] 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

THVVA-24620W001CLAIMS:

1. An assembly comprising:a docking device configured to encircle native leaflets of a native heart valve: and a prosthetic heart valve having an inflow end and an outflow end, the prosthetic heart valve comprising:an annular frame configured to move from a radially compressed configuration to a radially expanded configuration;an outer skirt disposed on an outer surface of the frame;a plurality of leaflets disposed within the annular frame and configured to regulate a flow of blood through the frame from the inflow end to the outflow end of the prosthetic heart valve; andone or more projections arranged adjacent the outflow end of the prosthetic heart valve and configured to extend radially outward from an outer surface of the outer skirt when the annular frame is in the radially expanded configuration, wherein the one or more projections are configured to couple the prosthetic heart valve to the docking device to prevent movement of the prosthetic heart valve in a direction of the inflow end.

2. The assembly of claim 1, wherein each of the one or more projections comprises a retention member coupled to an outlet edge portion of the outer skirt and disposed between the outlet edge portion of the outer skirt and at least a portion of an edge binding.

3. The assembly of claim 2, wherein the retention member comprises at least one strip that is rolled or folded and separate from the edge binding.

4. The assembly of claim 2, wherein the retention member is formed from a portion of the edge binding.THVVA-24620W0015. The assembly of claim 2, wherein the retention member is formed as a unitary structure comprising a continuous and uniform mass.

6. The assembly of any one of claims 2-5, wherein the retention member is stitched, bonded, or glued to the outlet edge portion of the outer skirt.

7. The assembly of any one of claims 1-6, wherein the one or more projections are configured to extend axially from the outflow end of the prosthetic heart valve in an outflow direction when the annular frame is in the radially compressed configuration.

8. The assembly of claim 1, further comprising one or more wires disposed between the frame and the outer skirt to radially distend a portion of the outer skirt to form the one or more projections, wherein each of the one or more wires forms a radially outward extending bowed shape comprising a first end and a second end that are both connected to the outer surface of the frame.

9. The assembly of claim 8, wherein the frame comprises a plurality of outflow apices disposed at an outflow end of the frame and a plurality of commissure support portions spaced circumferentially apart around the frame between adjacent outflow apices, and wherein the first end of each of the one or more wires is connected to a commissure support portion and the second end of the same wire is connected to an adjacent outflow apex.

10. The assembly of claim 9, wherein the one or more wires includes one or more pairs of wires, and wherein the first ends of the wires in a pair of wires are connected to the same commissure support portion and the second ends of the wires in the pair of wires are connected to respective adjacent outflow apices.

11. The assembly of claim 1, further comprising an annular structure fixed to an outer surface of the outer skirt and arranged to extend radially outward from the outer skirt a full 360 degrees around the annular frame to form the one or more projections.THVVA-24620W00112. The assembly of claim 1, further comprising one or more filaments fixed to the outer skirt and arranged to extend from an inflow end portion of the prosthetic heart valve to an outflow end portion of the prosthetic heart valve, wherein each filament of the one or more filaments comprises:a first portion having a first end and a second end, wherein the first portion extends straight or at least substantially straight from the first end to the second end, and wherein the first end of the first portion is arranged adjacent to the inflow end of the prosthetic heart valve; anda second portion connected to the second end of the first portion and disposed adjacent to the outflow end of the prosthetic heart valve, wherein the second portion is bowed radially outward from the first portion to define a projection of the one or more projections.

13. A prosthetic heart valve comprising:an annular frame configured to move from a radially compressed configuration to a radially expanded configuration, wherein the annular frame comprises an inflow end and an outflow end;an outer skirt disposed on an outer surface of the frame;a binding arranged over an outflow edge of the outer skirt and the outflow end of the annular frame;a plurality of leaflets disposed within the annular frame and configured to regulate a flow of blood through the frame from the inflow end to the outflow end of the prosthetic heart valve; andone or more retention members coupled to an outlet edge portion of the outer skirt and configured to extend radially outward from an outer surface of the outer skirt when the annular frame is in the radially expanded configuration and axially outward from the outflow end of the annular frame when the annular frame is in the radially compressed configuration, wherein the one or more retention members are captured between the outer skirt and at least a portion of the binding.

14. The prosthetic heart valve of claim 1, wherein the binding comprises a first edge extending along a first direction and a second edge extending along the first direction and spaced apart from the first edge in a second direction perpendicular to the first direction,THVVA-24620W001wherein at least the first edge defines one or more valley portions and one or more extension portions offset from the one or more valley portions along the second direction.

15. The prosthetic heart valve of claim 14, wherein the second edge defines one or more extension portions circumferentially aligned with the one or more extension portions defined by the first edge.

16. The prosthetic heart valve of any one of claims 14-15, wherein the one or more extension portions correspond to the one or more retention members.

17. The prosthetic heart valve of claim 13, wherein the one or more retention members comprise at least one strip of fabric that is folded or rolled and separate from the binding.

18. The prosthetic heart valve of claim 13, wherein the one or more retention members are formed integrally with the binding as a unitary structure.

19. The prosthetic heart valve of any one of claims 13-18, wherein the one or more retention members comprise three or more retention members.

20. A method of securing a prosthetic heart valve at a native heart valve, the method comprising:deploying a docking device at the native heart valve, wherein the docking device comprises a wire forming one or more turns including at least an outlet turn encircling native leaflets on an outflow side of the native heart valve;delivering a prosthetic heart valve in a delivery configuration to the native heart valve within the docking device; andmoving the prosthetic heart valve from the delivery configuration to a deployed configuration in which the prosthetic heart valve comprises one or more projections extending radially outward from an outflow end portion of the prosthetic heart valve, wherein a portion of the one or more projections axially abuts an outer end portion of the outlet turn ofTHVVA-24620W001the docking device to prevent the prosthetic heart valve from migrating in a retrograde blood flow direction when in the deployed configuration.

21. The method of claims 20, wherein the one or more projections extend axially from an outflow end of the prosthetic heart valve when the prosthetic heart valve is in the delivery configuration.

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