Prosthetic heart valve leaflet coaptation assembly and method

Abstract

This application relates to prosthetic heart valve leaflet coaptation assemblies and methods. Disclosed are prosthetic heart valves and related methods for assembling a prosthetic heart valve including an annular frame and a plurality of leaflets. As one example, the valve includes a plurality of coaptations, each coaptation including an attachment member having a protruding portion, a first coaptation tab of a first leaflet of the plurality of leaflets being disposed adjacent a first side of the protruding portion and directly secured to the attachment member. Each coaptation also includes a second coaptation tab of a second leaflet of the plurality of leaflets being disposed adjacent an opposite second side of the protruding portion and directly secured to the attachment member.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 024,951, filed May 14, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to prosthetic heart valves, and to methods and components for forming commissures with the leaflets of such prosthetic heart valves. Background Technology

[0004] The human heart can suffer from various valvular diseases. These valvular diseases can lead to serious cardiac dysfunction and ultimately require repair of the natural valve or replacement with an artificial valve. Many known repair devices (e.g., stents) and artificial valves exist, along with numerous known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various procedures to deliver prosthetic medical devices to locations within the body that are difficult or impossible to access surgically. In a specific example, a prosthetic heart valve may be mounted in a coiled state on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral and aortic arteries) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then enlarged to its functional size, for example, by inflating a balloon with the prosthetic valve mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by self-expanding the prosthetic valve from the sheath of the delivery device.

[0005] Prosthetic valves that rely on mechanical actuators for expansion can be referred to as "mechanically expandable" prosthetic heart valves. The actuators typically take the form of cables, sutures, threads, and / or shafts configured to transmit expansion forces from the handle of the delivery device to the prosthetic valve.

[0006] Most scalable transcatheter heart valves consist of a cylindrical metal frame or stent and a prosthetic leaflet housed within the frame. The leaflet can be attached to the frame at its suture flaps (also called leaflet flaps). For example, a suture can be formed by connecting the suture flaps of two adjacent leaflets to each other, and in some embodiments, by connecting to a suture support (or attachment) element configured to attach to a suture support portion of the frame. The suture or suture support element can then be attached to the suture support portion of the frame using fasteners such as sutures.

[0007] Typical seams or seam assemblies can be relatively complex and time consuming to form and stitch to the frame, in part because many stitches can be required. In addition, these types of seams and attachment methods to the seam support can be subject to wear along portions of the side and / or outer surface of the seam support that are wrapped by the seam tabs along many stitches. In some examples, installed seams can deteriorate due to displacement of the seam from its initial, fixed position, including rotation about the seam support and sliding up and down the seam support in an axial direction. In addition, in some embodiments, the formation of a vertical fold of the seam (e.g., in an axial direction relative to a central longitudinal axis of the frame) by the seam tabs can result in a less secure attachment to the seam support of the frame.

[0008] The frame of a prosthetic heart valve will typically be shortened, and thus the leaflets undergo changes during crimping and expansion of the valve frame. The leaflets of a prosthetic heart valve can also be subjected to stress from periodic forces during operation of the prosthetic heart valve in the body. For example, repeated opening and closing of the leaflet assembly of the valve can cause degradation of the leaflets, such as degradation of the collagen matrix of the bovine or porcine tissue that makes up the leaflets.

[0009] Accordingly, there is a need for improved prosthetic heart valve leaflet assemblies, as well as seams formed with such leaflet assemblies, and methods of assembling the seams to the frame of a prosthetic heart valve. SUMMARY

[0010] Described herein are embodiments of a prosthetic heart valve and methods for assembling a prosthetic heart valve, the prosthetic heart valve including an annular frame and a leaflet assembly. In some embodiments, a seam can be formed by folding a pair of seam tabs of adjacent leaflets in the leaflet assembly such that the folded portions of the pair of seam tabs are arranged in a radial direction and secure the folded pair of seam tabs to a protruding portion of an attachment member that extends outward from a base portion of the attachment member. The base portion of the attachment member can then be secured to a seam support of the frame in order to secure the seam to the frame.

[0011] In one representative embodiment, a prosthetic heart valve includes an annular frame including a plurality of coaptation supports and a plurality of leaflets positioned within the frame, each leaflet including a body and two opposing coaptation tabs arranged on opposite sides of the body, each coaptation tab paired with an adjacent coaptation tab of an adjacent leaflet to form a coaptation. Each coaptation of the prosthetic heart valve includes an attachment member including a first portion traversing a corresponding coaptation support of the plurality of coaptation supports and directly attached to the corresponding coaptation support of the plurality of coaptation supports or to a coaptation support element configured to couple to the coaptation support, and a second portion projecting radially outward from the first portion and extending radially inward toward a central longitudinal axis of the frame. Each coaptation further includes a first coaptation tab of a first leaflet of the plurality of leaflets folded into two overlapping layers overlapping in a transverse direction arranged perpendicular to an axial direction and a radial direction relative to the central longitudinal axis, the two overlapping layers arranged adjacent to a first side of the second portion of the attachment member and directly secured to the attachment member. Each coaptation further includes a second coaptation tab of a second leaflet of the plurality of leaflets folded into two overlapping layers overlapping in the transverse direction, the two overlapping layers arranged adjacent to an opposite second side of the second portion of the attachment member and directly secured to the attachment member.

[0012] In another representative embodiment, a method of assembling a prosthetic heart valve including a plurality of leaflets includes forming a plurality of coaptations with the plurality of leaflets, each leaflet including two opposing coaptation tabs arranged on opposite sides of a body of the leaflet. Each coaptation is formed by folding each of a first coaptation tab of a first leaflet and a second coaptation tab of an adjacent second leaflet into two overlapping layers overlapping in a transverse direction arranged perpendicular to an axial direction and a radial direction relative to a central longitudinal axis of an annular frame of the prosthetic heart valve; arranging the folded first coaptation tab against a first side of a projecting portion of an attachment member and the folded second coaptation tab against an opposite second side of the projecting portion, the projecting portion extending in the radial direction away from a base portion of the attachment member; securing each of the first coaptation tab and the second coaptation tab to the attachment member; for each coaptation, attaching the attachment member to a respective coaptation support of the annular frame directly or via a coaptation support element configured to couple to the coaptation support, the base portion of the attachment member arranged in the radial direction between the folded first and second coaptation tabs and the coaptation support or the coaptation support element.

[0013] In another representative embodiment, a prosthetic heart valve includes an annular frame including a plurality of coaptation supports, each coaptation support including an inner surface facing a central longitudinal axis of the frame and an oppositely arranged outer surface, and a plurality of leaflets located within the frame, each leaflet including a main body and two opposing coaptation tabs arranged on opposite sides of the main body, each coaptation tab paired with an adjacent coaptation tab of an adjacent leaflet to form a coaptation. Each coaptation of the prosthetic heart valve includes an attachment member directly attached to a corresponding coaptation support of the plurality of coaptation supports, the attachment member including a base extending over the inner surface of the coaptation support and a protruding portion extending radially outward from a central region of the base and radially inward toward the central longitudinal axis. Each coaptation further includes a first coaptation tab of a first leaflet of the plurality of leaflets folded into two overlapping layers overlapping in a transverse direction arranged perpendicular to an axial direction and a radial direction relative to the central longitudinal axis, the two overlapping layers arranged adjacent to a first side of the protruding portion of the attachment member and directly secured to the attachment member. Each coaptation further includes a second coaptation tab of a second leaflet of the plurality of leaflets folded into two overlapping layers overlapping in the transverse direction, the two overlapping layers arranged adjacent to an opposite second side of the protruding portion of the attachment member and directly secured to the attachment member.

[0014] In another representative embodiment, a prosthetic heart valve includes an annular frame including a plurality of coaptation supports, each coaptation support including an inner surface facing a central longitudinal axis of the frame and an oppositely arranged outer surface, and a plurality of leaflets located within the frame, each leaflet including a main body and two opposing coaptation tabs arranged on opposite sides of the main body, each coaptation tab paired with an adjacent coaptation tab of an adjacent leaflet to form a coaptation. Each coaptation of the prosthetic heart valve includes an attachment member directly attached to a corresponding coaptation support of the plurality of coaptation supports, the attachment member including a base extending over the inner surface of the coaptation support and a protruding portion extending radially outward from a central region of the base and radially inward toward the central longitudinal axis. Each coaptation further includes a first coaptation tab of a first leaflet of the plurality of leaflets folded into two overlapping layers overlapping in a transverse direction arranged perpendicular to an axial direction and a radial direction relative to the central longitudinal axis, the two overlapping layers arranged adjacent to a first side of the protruding portion of the attachment member and directly secured to the attachment member. Each coaptation further includes a second coaptation tab of a second leaflet of the plurality of leaflets folded into two overlapping layers overlapping in the transverse direction, the two overlapping layers arranged adjacent to an opposite second side of the protruding portion of the attachment member and directly secured to the attachment member.

[0015] In yet another representative embodiment, a prosthetic heart valve includes an annular frame including a plurality of interconnected and angled struts defining a plurality of rows of cells arranged between an outflow end and an inflow end of the frame, and a plurality of leaflets within the frame, each leaflet including a body and two opposing coaptation tabs arranged on opposite sides of the body, each coaptation tab paired with an adjacent coaptation tab of an adjacent leaflet to form a commissure. Each commissure of the prosthetic heart valve includes an attachment member directly attached to an angled strut defining a cell included in the plurality of rows of cells, the attachment member including a base extending across the cell and a protrusion extending radially outward from a central region of the base and radially inward toward a central longitudinal axis. Each commissure further includes a first coaptation tab of a first leaflet of the plurality of leaflets folded into two overlapping layers overlapping in a transverse direction arranged perpendicular to an axial direction and a radial direction relative to the central longitudinal axis, the two overlapping layers arranged adjacent to a first side of the protrusion of the attachment member and directly secured to the attachment member. Each commissure further includes a second coaptation tab of a second leaflet of the plurality of leaflets folded into two overlapping layers overlapping in the transverse direction, the two overlapping layers arranged adjacent to an opposite second side of the protrusion of the attachment member and directly secured to the attachment member.

[0016] In another representative embodiment, a prosthetic heart valve includes an annular frame including a plurality of interconnected and angled struts defining a plurality of rows of cells arranged between an outflow end and an inflow end of the frame, and a plurality of commissure supports and a plurality of leaflets within the frame, each leaflet including a body and two opposing coaptation tabs arranged on opposite sides of the body, the body including an outflow edge extending through the leaflet between the two opposing coaptation tabs, and a cusped edge portion converging to form an inflow end portion of the leaflet. Each coaptation tab is paired with an adjacent coaptation tab of an adjacent leaflet to form a commissure, wherein each coaptation tab includes one or more pin lines having one or more holes adapted to receive sutures, wherein each pin line extends between an upper edge and a lower edge of the coaptation tab and includes a portion offset from a remainder of the pin line toward the body of the leaflet, the portion including one or more holes arranged inward of a first outer hole of the pin line arranged adjacent to the upper edge, the upper edge connected to the outflow edge of the leaflet. Each commissure is directly secured to a corresponding commissure support of the plurality of commissure supports or to an attachment member configured to couple to a commissure support by one or more sutures extending along the one or more pin lines.

[0017] In another representative embodiment, a prosthetic heart valve includes an annular frame including a plurality of commissure supports and a plurality of leaflets located within the frame, each leaflet including a body and two opposing commissure tabs arranged on opposite sides of the body, each commissure tab paired with an adjacent commissure tab of an adjacent leaflet to form a commissure. Each commissure of the prosthetic heart valve includes an attachment member including a first portion extending transversely across a corresponding one of the plurality of commissure supports and directly attached to the corresponding one of the plurality of commissure supports or to a commissure support element configured to be coupled to the commissure support, and a second portion projecting radially outward from the first portion and extending radially inward toward a central longitudinal axis of the frame. A first commissure tab of a first one of the plurality of leaflets is arranged adjacent to a first side of the second portion of the attachment member and directly secured to the attachment member, and a second commissure tab of a second one of the plurality of leaflets is arranged adjacent to an opposite second side of the second portion of the attachment member and directly secured to the attachment member.

[0018] The foregoing and other objects, features and advantages of the present application will become more readily apparent from the following detailed description, which proceeds with reference to the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0019] FIG. 1 is a perspective view of an exemplary embodiment of a prosthetic heart valve.

[0020] FIG. 2 is a perspective view of a frame for a prosthetic heart valve according to another embodiment, the frame including three expansion locking mechanisms.

[0021] FIG. 3 is a perspective view of a frame for a prosthetic heart valve according to another embodiment, the frame including three expansion locking mechanisms. FIG. 2 is a top view of the frame and expansion locking mechanisms of

[0022] FIG. 4 is a side view of a frame for a prosthetic heart valve having a conical shape according to one embodiment.

[0023] FIG. 5 is a side view of another embodiment of a frame for a prosthetic heart valve, the frame having a conical shape.

[0024] FIG. 6 is a plan view of an exemplary leaflet for a prosthetic heart valve.

[0025] FIG. 7 is a cross-sectional top view of one embodiment of a commissure of a prosthetic heart valve, wherein the commissure is secured to a support post of the prosthetic heart valve.

[0026] FIG. 8 is a front perspective view of an inner side of a support post of FIG. 7 FIG. 7 ​the coaptation of the leaflets is secured to the support post.

[0027] FIG. 9 is FIG. 7 a rear perspective view of the outer side of the support post of FIG. 7 the coaptation of the leaflets is secured to the support post.

[0028] FIG. 10 is a perspective view of a prosthetic heart valve according to an embodiment, the prosthetic heart valve comprising a frame with an open coaptation window.

[0029] FIG. 11 is a perspective view of an exemplary frame of a prosthetic heart valve comprising an open coaptation window.

[0030] FIG. 12 is a perspective view of an embodiment of a coaptation support element and a corresponding actuator assembly of a frame of a prosthetic heart valve, the embodiment being adapted to receive the coaptation support element.

[0031] FIG. 13 is a perspective view of an embodiment of a coaptation support element of FIG. 12 coupled to a corresponding actuator assembly.

[0032] FIG. 14 is FIG. 7 an embodiment of a coaptation of wherein the coaptation is secured to an open coaptation window of a frame of a prosthetic heart valve or is configured to be coupled to a coaptation support element of the frame.

[0033] FIG. 15 is FIG. 7 a detailed perspective view of an embodiment of a coaptation of

[0034] FIG. 16 is a side view of an exemplary prosthetic heart valve comprising FIG. 15 a coaptation of

[0035] FIG. 17 is a flowchart of a method for assembling a prosthetic heart valve comprising a plurality of leaflets.

[0036] FIG. 18 is a detail view of a portion of an exemplary leaflet of a first embodiment having a relatively straight stitch line at a coaptation tab of the leaflet.

[0037] FIG. 19 is a detail view of a portion of an exemplary leaflet of a second embodiment of a stitch line in which a portion of the stitch line is offset from the remainder of the stitch line at a coaptation tab.

[0038] FIG. 20is a detail view of an exemplary leaflet portion of a third embodiment of a stitch line in which a portion of the stitch line at the commissure tab is offset from the remainder of the stitch line.

[0039] FIG. 21 is a side view of an embodiment of a transcatheter delivery device for delivering a prosthetic heart valve to a target implant site, with the prosthetic heart valve held in a radially compressed state within a capsule of the delivery device.

[0040] FIG. 22 is FIG. 21 is a side view of the transcatheter delivery device of DETAILED DESCRIPTION

[0041] For purposes of description, certain aspects, advantages and novel features of the embodiments disclosed herein are described. The described methods, systems, and devices should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with each other. The disclosed methods, systems, and devices are not limited to any particular aspect, feature, or combination of parts, nor do the disclosed methods, systems, and devices require the presence of any recited or unrecited advantage or solution to any problem.

[0042] Features, integers, characteristics, compounds, chemical moieties or groups described in conjunction with a particular aspect, embodiment or example of the present disclosure are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings) and / or all of the steps of any method or process so disclosed can be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. The present disclosure is not restricted to the details of any foregoing embodiments. The present disclosure extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0043] Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement of steps or sub steps, unless a particular ordering is required based on the specific language used. For example, steps or sub steps described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures can not show the various ways in which the disclosed methods, systems, and devices can be used in conjunction with other systems, methods, and devices.

[0044] As used herein, the terms “one,” “a,” and “at least one” encompass one or more of the specified elements. That is, if two of a particular element are present, then “one” or “at least one” of that element is still present even though there are two of that element present. The terms “plurality” and “a plurality” refer to two or more of a particular element.

[0045] As used herein, the term “and / or,” when used between the last two items in a list of elements, means any one or more of the listed elements. For example, the phrase “A, B, and / or C” means “A,” “B,” “C,” “A and B,” “A and C,” “B and C,” or “A, B, and C.”

[0046] As used herein, the term “coupled” generally refers to physically coupled or linked, and does not exclude the presence of intermediate elements between coupled items in the absence of a particular contrary language.

[0047] Directions and other relative references (e.g., inner, outer, upper, lower, etc.) can be used to facilitate the discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms such as “inboard,” “outboard,” “top,” “down,” “interior,” “exterior,” etc. can be used. Such terms, when applicable, are used to provide some clarity of description, especially with respect to the illustrated embodiments. However, these terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, the “upper” portion can simply become the “lower” portion if the object is turned over. However, it is still the same part, and the object is still the same. As used herein, “and / or” means “and” or “or” and “and” and “or.”

[0048] As used herein, with respect to prosthetic heart valves and delivery devices, “proximal” refers to a position, orientation, or portion of a component that is closer to a handle of the delivery device and / or outside of a user and / or patient, while “distal” refers to a position, orientation, or portion of a component that is further away from the user and / or handle of the delivery device and closer to an implantation site. Unless otherwise expressly defined, the terms “longitudinal” and “axial” refer to an axis that extends in a proximal and distal direction. Further, the term “radial” refers to a direction that is arranged perpendicular to the axis and points along a radius from a center of an object (where the axis is located at the center, such as a longitudinal axis of a prosthetic valve).

[0049] Examples of the disclosed technology

[0050] This document describes examples of a prosthetic heart valve, a leaflet assembly, and a suture for assembling a prosthetic heart valve, as well as a method for assembling such a suture. The prosthetic heart valve may include an annular frame and a plurality of leaflets attached to the frame via a suture formed by engaging paired adjacent ends of the leaflets (referred to herein as suture flaps). Forming the suture may include folding each of a first suture flap of a first leaflet and a second suture flap of an adjacent second leaflet into two overlapping layers in a transverse direction perpendicular to both the axial and radial directions relative to the central longitudinal axis of the annular frame. Forming the suture also includes arranging the folded first suture flap against a first side of a protrusion of an attachment member, and arranging the folded second suture flap against the opposite second side of the protrusion, the protrusion extending radially away from the base of the attachment member. In some embodiments, the attachment member may be a flexible fabric or a polymer material. The formation of the seam also includes securing each of the first seam tab and the second seam tab to the attachment member and then attaching the attachment member directly or via a seam support element configured to connect to the seam support to the corresponding seam support of the frame.

[0051] In some embodiments, the base of the attachment member may be arranged radially between the folded first and second suture flaps and the suture support or suture support element. As a result, the suture flaps of the leaflet can be prevented from contacting the frame. This suture configuration can reduce stress on the leaflet during valve operation and during radial expansion and / or contraction of the frame, thereby increasing its lifespan.

[0052] FIG. 1 An exemplary prosthetic heart valve 10 according to one embodiment is shown. The prosthetic heart valve 10 may have a radially compressible configuration for delivery into a patient and a radially expandable configuration (e.g., FIG. 1 The prosthetic heart valve 10 is radially compressible and expandable (as shown). In a particular embodiment, the prosthetic heart valve 10 can be implanted within a natural aortic valve annulus, although it can also be implanted in other locations of the heart, including within a natural mitral valve, a natural pulmonary valve, and a natural tricuspid valve. The prosthetic heart valve 10 may include an annular stent or frame 12 having a first end 14 and a second end 16.

[0053] In the depicted embodiment, the first end 14 is an inflow end, and the second end 16 is an outflow end. The outflow end 16 can be coupled to a delivery device to deliver and implant the prosthetic heart valve within the prosthetic heart valve via a trans-femoral retrograde delivery method. Thus, in a delivery configuration of the prosthetic heart valve, the outflow end 16 is the proximal-most end of the prosthetic valve. In other embodiments, depending on the particular native valve to be replaced and the delivery technique used (e.g., trans-septal, trans-apical, etc.), the inflow end 14 can be coupled to the delivery device. For example, when delivering the prosthetic heart valve to a native mitral valve via a trans-septal delivery method, the inflow end 14 can be coupled to the delivery device (and thus be the proximal-most end of the prosthetic heart valve in the delivery configuration). Exemplary delivery devices that can be used to deliver the prosthetic heart valve are shown in FIG. 21 and FIG. 22 and are described in greater detail below.

[0054] Returning to FIG. 1 , the frame 12 can be made of any of a variety of suitable materials, such as stainless steel, cobalt-chrome alloy, or nickel-titanium alloy ("NiTi"), such as Nitinol. Referring again to FIG. 1 As shown, the frame 12 can include a plurality of interconnected struts 28 arranged in a lattice-type pattern. The illustrated struts 28 are disposed obliquely relative to the longitudinal axis of the prosthetic heart valve 10, or offset at an angle relative to the longitudinal axis of the prosthetic heart valve 10, and radially offset from the longitudinal axis of the prosthetic heart valve 10, when the prosthetic heart valve 10 is in an expanded configuration. In other embodiments, the struts 28 can be offset by different amounts than depicted in FIG. 1 , or some or all of the struts 28 can be positioned parallel to the longitudinal axis of the prosthetic heart valve 10.

[0055] In the illustrated embodiment, the struts 28 are pivotably coupled to one another at one or more pivot joints along the length of each strut. For example, in the illustrated configuration, each strut 28 can be formed with holes at opposite ends of the strut and holes spaced apart along the length of the strut. Individual hinges can be formed at locations where the struts 28 overlap one another by fasteners or pivot members, such as rivets or pins 30 extending through the holes. The hinges can allow the struts 28 to pivot relative to one another when the frame 12 is radially expanded or compressed, such as during assembly, preparation, or implantation of the prosthetic heart valve 10.

[0056] In some embodiments, the frame 12 can be constructed by forming separate components (e.g., struts and fasteners of the frame) and then mechanically assembling and connecting the separate components together. In other embodiments, the struts 28 are not coupled to one another by respective hinges, but are instead pivotable or bendable relative to one another to allow radial expansion and contraction of the frame 12. For example, the frame 12 can be formed from a single piece of material (e.g., a metal tube) (e.g., by being laser cut, electroformed, or physically vapor deposited). Further details regarding the construction of frames and prosthetic heart valves are described in U.S. Patent Application Publication Nos. 2018 / 0153689, 2018 / 0344456, and 2019 / 0060057, which are hereby incorporated by reference in their entireties.

[0057] The prosthetic heart valve 10 can also include a valve structure 18 coupled to the frame 12 and configured to regulate blood flow through the prosthetic heart valve 10 from the inflow end 14 to the outflow end 16. The prosthetic heart valve 10 can also include a plurality of actuators 80 mounted to and equally distributed around an inner surface of the frame 12. The actuators are configured to apply expansion and compression to the frame to radially expand and compress the prosthetic valve.

[0058] In the illustrated embodiment, the actuators 80 are linear actuators each including an inner member or piston 90 and an outer member or cylinder 92. The inner member 90 is pivotably coupled to a joint of the frame, such as at the first end 14, while the outer member 92 is pivotably coupled to another joint of the frame near the second end 16. Moving the inner member 90 proximally relative to the outer member 92 and / or moving the outer member 92 distally relative to the inner member 90 effectively expands the prosthetic valve radially. Conversely, moving the inner member 90 distally relative to the outer member 92 and / or moving the outer member 92 proximally relative to the inner member 90 effectively compresses the prosthetic valve radially. The actuators 80 can include a locking mechanism configured to hold the prosthetic valve in an expanded state within a patient’s body.

[0059] In some embodiments, each actuator 80 can be configured to form a releasable connection with one or more respective actuators of a delivery apparatus of a transcatheter delivery system. The actuators of the delivery apparatus can transmit force from a handle of the delivery apparatus to the actuators 80 to expand or compress the prosthetic valve. More details of actuators, locking mechanisms, and delivery apparatuses for actuating the actuators can be found in U.S. Patent Application Publication Nos. 2018 / 0153689, 2019 / 0060057, and 2018 / 0325665, the entire contents of which are hereby incorporated by reference herein. Any of the actuators and locking mechanisms disclosed in the previously filed applications can be incorporated into any of the prosthetic valves disclosed herein. Further, any of the delivery apparatuses disclosed in the previously filed applications can be used to deliver and implant any of the prosthetic valves disclosed herein.

[0060] In some embodiments, each actuator 80 can be used to support a respective commissure 24 (described below). As such, the actuators 80 can include a commissure support portion for supporting and attaching the commissures 24 of the valve structure 18 to the frame 12, as further described herein.

[0061] The valve structure 18 can include, for example, a leaflet assembly including one or more leaflets 22 (three leaflets 22 in the illustrated embodiment) made of a flexible material. The leaflets 22 of the leaflet assembly can be made, in whole or in part, of a biological material, a biocompatible synthetic material, or other such material. Suitable biological materials can include, for example, bovine pericardium (or pericardium from other sources). Each leaflet 22 includes two opposing commissure tabs arranged on opposite sides of a body of the leaflet. The body of the leaflet can be the portion of the leaflet adapted to bend and move during operation of the prosthetic heart valve 10. The commissure tabs of adjacent leaflets 22 can be arranged to form commissures 24, which can be mounted, for example, on the commissure support portions of the respective actuators 80. More details regarding transcatheter prosthetic heart valves, including the manner in which the valve structure is connected to the frame 12 of the prosthetic heart valve 10, can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,652,202, and U.S. Patent Application Publication No. 2018 / 0325665, the entire contents of which are hereby incorporated by reference herein in their entireties.

[0062] In some embodiments, as FIG. 1As shown, the seam 24 can be directly mounted (e.g., sewn) to the seam support of the actuator 80 of the frame 12 via the seam attachment 26. As an example, the seam attachment 26 may include one or more pins securing the seam 24 to the respective actuator 80. In other embodiments, the seam 24 is mounted to support a strut or post of the frame separate from the actuator 80. In still other embodiments, the seam may be secured to another seam attachment or support member (as further described herein), and then the support member may be secured to the seam support of the actuator 80 or to a support strut or post of the frame.

[0063] The prosthetic heart valve 10 may also include one or more skirts or sealing members. For example, such as FIG. 1 As shown, the prosthetic heart valve 10 may include an inner skirt 20 mounted on the inner surface of the frame 12. (As indicated...) FIG. 1 As shown, the inner skirt 20 is a circumferential inner skirt spanning the entire circumference of the inner surface of the frame 12. The inner skirt 20 can serve as a sealing member to prevent or reduce paravalvular leakage (e.g., when the valve is placed at the implantation site) and as an attachment surface to anchor the leaflet 22 to the frame 12. For example, the inflow (tip) edge of the leaflet 22 can be sutured directly to the inner skirt 20, which in turn can (e.g., with sutures) be directly attached to selected struts 28 of the frame, such as... FIG. 1 As shown.

[0064] The prosthetic heart valve 10 may also include an outer skirt mounted on the outer surface of the frame 12. FIG. 2 (Not shown in the image). The outer skirt, by sealing against the natural valve annulus and helping to reduce paravalvular leakage through the prosthetic valve, can serve as a sealing member of the prosthetic valve. The inner and outer skirts can be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials (e.g., PET) or natural tissues (e.g., pericardial tissue). The inner and outer skirts can be attached to the frame using sutures, adhesives, welding, and / or other methods for attaching the skirts to the frame.

[0065] FIG. 3 and FIG. 2 An exemplary embodiment of a prosthetic valve 100 is shown. According to another embodiment, the prosthetic valve 100 includes a frame 102 and one or more expansion locking mechanisms 150. The frame 102 includes a plurality of pivotally connected struts 104 defining an inflow end 106 (which is the distal end of the frame in the delivery configuration of the illustrated embodiment) and an outflow end 108 (which is the proximal end of the frame in the delivery configuration of the illustrated embodiment). The struts 104 are pivotally connected to each other at a plurality of joints, allowing the struts to pivot relative to each other as described above in connection with the prosthetic valve 10.

[0066] The prosthetic valve 100 can include a valve structure (e.g., valve structure 18) and an inner skirt and / or an outer skirt, as previously described, although these components are omitted from the illustrations for purposes of explanation. FIG. 2 and 3 One or more expansion locking mechanisms 150 can be used in place of or in addition to the actuator 80 described above. The expansion locking mechanisms 150 can be used to radially expand and lock the frame 102 of the prosthetic valve 100 in a radially expanded state. In some embodiments, the commissures of the leaflets can be attached to commissure supports of the expansion locking mechanisms 150. In alternative embodiments, the commissures of the leaflets can be attached to additional commissure posts of the frame 102.

[0067] FIG. 3 Three expansion locking mechanisms 150 are shown mounted to the frame 102, with the frame 102 shown in a radially expanded configuration. Although the illustrated embodiment shows three expansion locking mechanisms 150 spaced apart from one another around the circumference of the frame, it should be noted that the prosthetic valve can include any number of expansion locking mechanisms 150. For example, in some embodiments, the prosthetic valve can include a single expansion locking mechanism, or two expansion locking mechanisms, or four expansion locking mechanisms, etc. The expansion locking mechanisms 150 can be placed at any location around the circumference of the frame 102. For example, in some embodiments, such as the illustrated embodiment, the expansion locking mechanisms 150 are equally spaced apart from one another around the circumference of the frame 102. In other embodiments, it can be advantageous to have two or more expansion locking mechanisms positioned adjacent to one another.

[0068] Each expansion locking mechanism 150 can include an outer member in the form of a sleeve 152 having an internal cavity, lumen, or bore, and an inner member 156 that extends at least partially into the cavity. In the illustrated embodiment, the sleeve 152 includes an inner wall 186, an outer wall 188, and two side walls 190 each extending radially between a longitudinal edge of the inner wall 186 and an opposite longitudinal edge of the outer wall 188. The inner wall 186, the outer wall 188, and the two side walls 190 define a cavity that is sized and shaped to receive the inner member 156.

[0069] In the illustrated embodiment, the sleeve 152 has a rectangular cross-section, while the inner member 156 has a rectangular cross-section corresponding to the shape of the bore. In other embodiments, the sleeve 152 and / or the inner member 156 can have a square cross-sectional profile. As FIG. 1 illustrated, the rectangular and / or square cross-sections can advantageously minimize the distance that the expansion locking member extends into the internal cavity of the frame 102, which can reduce the overall crimp profile of the valve 100. However, in other embodiments, the cross-section of the sleeve and the inner member can have any of a variety of corresponding shapes, such as a circular, oval, triangular, rectangular, square, or combinations thereof.

[0070] As FIG. 3 best shown in FIG. 1, a distal portion 158 of the inner member 156 can be coupled to the frame 102 at a first location by a fastener 160 that is secured to and extends radially from the distal portion 158 of the inner member 156. The fastener 160 can be, for example, a rivet or a pin. As shown, in some embodiments, the fastener 160 can extend through respective holes at the junction of two overlapping struts 104 of the frame 102, and can serve as a pivot pin about which the two struts 104 can pivot relative to each other and the inner member 156. In some embodiments, an end cap or nut 162 (as shown in FIG. 1) can be disposed over the end of the fastener 160. The nut 162 can have a diameter greater than the diameter of the hole to retain the fastener 160 within the hole. In alternative embodiments, the inner member 156 need not include a fastener 160, and can be coupled to the frame 102 via other attachment means (e.g., welding, adhesive, etc.). FIG. 21

[0071] The sleeve 152 can be coupled to the frame 102 at a second location that is axially spaced from the first location. For example, in the illustrated embodiment, the inner member 156 is secured to the frame 102 proximate the distal or inflow end 106 of the frame, and the sleeve 152 is secured to the frame 102 proximate or at the proximal or outflow end 108 of the frame, such as by fasteners 161 (e.g., rivets or pins). The fasteners 161 are secured to and extend radially from the sleeve 152 through respective holes at the junction of two overlapping struts 104, and can serve as a pivot pin about which the two struts 104 can pivot relative to each other and the sleeve 152. A nut 162 can be installed over each fastener 161 to retain the fastener within the respective hole. The expansion locking mechanism 150 can be pivotably coupled to the frame 102 at any two axially spaced, circumferentially aligned locations on the frame.

[0072] The inner member 156 can be axially movable relative to the sleeve 152 in a proximal direction and a distal direction along the central longitudinal axis of the frame 102. As such, because the inner member 156 and the sleeve 152 are secured to the frame at axially spaced locations, axially moving the inner member 156 and the sleeve 152 relative to each other in a telescoping fashion can cause the frame 102 to radially expand or compress. For example, moving the inner member 156 proximally toward the outflow end 108 of the frame while keeping the sleeve 152 in a fixed position and / or moving the sleeve 152 distally toward the inflow end 106 of the frame can axially shorten and radially expand the frame 102. Conversely, moving the inner member 156 distally and / or moving the sleeve 152 proximally causes the frame 102 to axially lengthen and radially compress.​

[0073] The prosthetic valve 100, including one or more expansion locking mechanisms 150, can be expanded in the following exemplary manner. Typically, the prosthetic valve 100 is placed in a radially compressed state and releasably coupled to the distal portion of a delivery device, and then advanced through the patient's vascular system to a selected implantation site (e.g., a natural aortic valve annulus). The expansion locking mechanism 150 can then be used to deploy the prosthetic valve 100 at the implantation site and expand and lock it in the expanded configuration. Further details regarding the prosthetic valve, the expansion locking mechanism, and the delivery device for actuating the expansion locking mechanism can be found in International Application No. PCT / US2020 / 057691, the contents of which are incorporated herein by reference.

[0074] FIG. 1 and 22 The illustration shows a method for inserting a prosthetic heart valve (or prosthetic valve) 1208 (such as, as described above) according to one embodiment. FIG. 2 to FIG. 3 The prosthetic heart valve 10 shown is FIG. 21-22 The delivery device 1200 delivers the prosthetic valve 100 shown to the target implantation site in the patient's body. FIG. 21-22 A prosthetic valve 1208 in a different configuration relative to the delivery device 1200 is shown during the valve implantation procedure. The prosthetic valve 1208 can be releasably coupled to one or more components of the delivery device 1200, as described above and below. It should be understood that the delivery device 1200 can be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0075] The delivery device 1200 in the illustrated embodiment typically includes a handle 1202, an elongated shaft 1204 (including an outer shaft or outermost shaft in the illustrated embodiment) extending distally from the handle 1202, an inner (e.g., innermost) shaft 1210, an intermediate shaft 1224 arranged coaxially with the outer shaft 1204 and the inner shaft 1210 and between them (e.g., perpendicular to the central longitudinal axis 1230 of the delivery device 1200 in the radial direction), and at least one actuator assembly (e.g., member or actuator) 1206 to expand and compress the prosthetic valve 1208, the at least one actuator assembly 1206 extending through the outer shaft 1204 and extending distally outward from the distal portion 1212 of the outer shaft 1204.

[0076] In some embodiments, the outer shaft 1204, inner shaft 1210, intermediate shaft 1224 and / or actuator assembly 1206 may form a delivery conduit of a delivery device 1200 controlled by and attached to the handle 1202.

[0077] Delivery device 1200 may include three actuator assemblies 1206 releasably coupled to prosthetic valve 1208 (inFIG. 21-22 only two of the three actuator assemblies are shown). However, in alternative embodiments, the delivery apparatus 1200 can include more or less than three actuator assemblies 1206 (e.g., one, two, four, etc.). As shown, the plurality of actuator assemblies 1206 are spaced apart from one another in a circumferential direction around a circumference of the delivery apparatus 1200 and can extend axially through the outer shaft 1204 from the handle 1202 to the prosthetic valve 1208. FIG. 1

[0078] In particular embodiments, each actuator assembly 1206 can be releasably coupled to a corresponding actuator of the prosthetic valve (e.g., an actuator 80 as shown in FIG. 2 FIG. 3 and FIG. 21-22 shown) of the expanded locking mechanism 150). Each actuator assembly 1206 can include an inner member having a distal end releasably coupled to an inner member of an actuator of the prosthetic valve and an outer member having a distal end releasably coupled to an outer member of an actuator of the prosthetic valve. In another embodiment, each actuator assembly 1206 can be a threaded sleeve releasably coupled to an actuator assembly of the prosthetic valve 1208.

[0079] In some embodiments, the intermediate shaft 1224 can be adapted to house and organize the actuator assemblies 1206. For example, the actuator assemblies 1206 can be housed within and extend outwardly from a distal end of the intermediate shaft 1224. In some embodiments, each actuator assembly 1206 can be kept separate from other actuator assemblies 1206 within the intermediate shaft 1224. For example, each actuator assembly 1206 can extend through a separate lumen of the intermediate shaft 1224.

[0080] As shown, a distal end of the inner shaft 1210 can include a nose cone 1214, which can be used to guide the delivery apparatus 1200 through a lumen of a patient to a target implantation site for the prosthetic valve 1208. The nose cone 1214 can be disposed proximate a distal end 1226 of the prosthetic valve 1208. FIG. 21 to FIG. 22

[0081] In use, the delivery apparatus 1200 can be releasably coupled to the prosthetic valve 1208 to produce radial expansion and compression of a frame of the prosthetic valve 1208. In some embodiments, the actuator assemblies 1206 of the delivery apparatus 1200 can be configured to transmit a pushing and / or pulling force from the handle 1202 of the delivery apparatus 1200 to the prosthetic valve 1208. For example, in some embodiments, the actuator assemblies 1206 can have a distal end portion that can be releasably connected to the prosthetic valve 1208 by a corresponding release locking unit. ​​​

[0082] In some embodiments, the outer shaft 1204 of the delivery apparatus 1200 can be configured as a steerable guide catheter having an adjustable curvature for steering the delivery apparatus 1200 through the vasculature of a patient. In particular embodiments, the outer shaft 1204 can include a steerable distal portion whose curvature can be adjusted by an operator to aid in guiding the apparatus through the vasculature of a patient.

[0083] The outer shaft 1204 and the actuator assembly 1206 can be moved relative to one another (axially and / or rotationally) to facilitate delivery and positioning of the prosthetic valve 1208 at an implant site within a patient.

[0084] In some embodiments, the distal portion 1212 of the outer shaft 1204 can form and / or function as a sheath tube (or capsule) 1222 that is sized and shaped to receive and house the prosthetic valve 1208 in a radially compressed state for delivery into and through the vasculature of a patient. Once the prosthetic valve 1208 is advanced to or proximate the implant site, the prosthetic valve 1208 can be advanced from the capsule 1222 by causing the outer shaft 1204 to retract and thus the capsule 1222 to axially retract relative to the actuator assembly 1206 and the prosthetic valve 1208 along the central longitudinal axis 1230. In this way, the prosthetic valve 1208 can be exposed as the capsule 1222 moves axially back (e.g., in a proximal direction along the central longitudinal axis 1230) toward the handle 1202. In alternative embodiments, the prosthetic valve 1208 can be advanced from the capsule 1222 by advancing the actuator assembly 1206 relative to the outer shaft 1204, after which the prosthetic valve 1208 can be radially expanded.

[0085] Advancement of the prosthetic valve 1208 from the sheath tube can be actuated by operating the first knob 1216 on the handle 1202 by moving the actuator assembly 1206 axially relative to the outer shaft 1204 or by retracting the outer shaft 1204 relative to the actuator assembly 1206. The first knob 1216 can be operably connected to a proximal portion of the outer shaft 1204 and can be configured to retract the outer shaft 1204 proximally relative to the actuator assembly 1206 to deploy the prosthetic valve 1208 from the distal portion 1212 of the capsule 1222 or can be operably connected to a proximal portion of the actuator assembly 1206 to advance the actuator assembly 1206 distally relative to the outer shaft 1204 to deploy the prosthetic valve 1208 from the distal portion 1212 of the capsule 1222. The first knob 1216 can be a slidable or rotational adjustment element that is operatively connected to the actuator assembly 1206 and / or the outer shaft 1204.

[0086] The handle 1202 can include additional adjustment knobs, such as a second knob 1218 and a third knob 1220, as shown in FIG. 12A. The second knob 1218 can be operatively connected to the actuator assembly 1206 and / or the outer shaft 1204 to adjust the curvature of the distal portion 1212 of the outer shaft 1204. The third knob 1220 can be operatively connected to the actuator assembly 1206 and / or the outer shaft 1204 to adjust the length of the outer shaft 1204 relative to the actuator assembly 1206. FIG. 21The second knob 1218 is shown in a first position. In some embodiments, the second knob 1218 can be operatively coupled to the actuator assembly 1206 and actuate the actuator assembly 1206 to adjust the prosthetic valve 1208 from a non-expanded (or radially compressed) configuration, as shown in FIG. 21 A, to a radially expanded configuration, and vice versa. FIG. 21

[0087] In some embodiments, the third knob 1220 can be operatively coupled to the actuator assembly 1206 and actuate the actuator assembly 1206 to disconnect the prosthetic valve 1208. As a result, the prosthetic valve 1208 can be separated from the delivery apparatus 1200 and implanted (deployed) at a target implantation site.

[0088] FIG. 21 The prosthetic valve 1208 is shown retained within the capsule 1222 of the delivery apparatus 1200 in a radially compressed state. Thus, in FIG. 21 , the prosthetic valve 1208 is in its radially compressed configuration having a minimum diameter D1. The minimum diameter D1 can be approximately the same as the inner diameter of the capsule 1222. The capsule 1222 surrounds the outside of the prosthetic valve 1208, as shown in FIG. 22 , the prosthetic valve can be maintained in the radially compressed configuration. As a result, the prosthetic valve 1208 can be advanced through the vasculature of a patient to, for example, a target implantation site via the delivery apparatus 1200.

[0089] After reaching the target implantation site, the capsule 1222 can be pulled away (or retracted) from the prosthetic valve 1208 in a proximal direction along the central longitudinal axis 1230 of the delivery apparatus 1200 to expose the prosthetic valve 1208. In alternative embodiments, the actuator assembly 1206 can be advanced in a distal direction to move the prosthetic valve 1208 out of the capsule 1222.

[0090] FIG. 22 The prosthetic valve 1208 is shown in an uncovered (sheathed) state in which the prosthetic valve 1208 is disposed outside of the capsule 1222. In this state, the prosthetic valve 1208 is not actively expanded via the actuator assembly 1206. However, since it is no longer surrounded by the capsule 1222 (e.g., no longer retained in the capsule 1222), the prosthetic valve 1208 can have a partially expanded diameter D2 that is greater than the minimum diameter D1 due to the inherent elasticity of the struts of the frame. It should be noted that the extent of expansion of the prosthetic valve 1208 from the compressed minimum diameter D1 FIG. 21 to the partially expanded diameter D2 FIG. 22 may be exaggerated in FIG. 22 for illustrative purposes. After deployment from the capsule 1222, the prosthetic valve 1208 can be expanded to a fully expanded diameter D3, as shown in FIG. 4 ​The illustrated, the prosthetic valve 1208 can then be caused to radially expand and implant by actuation of the actuator assembly 1206.

[0091] Turning now to the embodiments illustrated in FIG. 5 and FIG. 4 In some embodiments, the frame of a prosthetic heart valve can include struts shaped to form a non-cylindrical shape when expanded. For example, such a frame can taper along an axial direction relative to a central longitudinal axis of the frame. In some embodiments, the frame can taper from an outflow end to an inflow end.

[0092] FIG. 1 Another embodiment of a prosthetic valve 200 is illustrated, including a frame 202 shown in its expanded, radially expanded configuration. The prosthetic valve 200 can include a valve structure (e.g., valve structure 18), inner and / or outer skirts, and an actuator (e.g., actuator 80 of FIG. 2 to FIG. 3 or expansion locking mechanism 150 of FIG. 4 As previously described, these components are omitted from FIG. 4 for illustrative purposes. The frame 202 can have an inflow end portion 204 defining an inflow end 224 of the frame 202 and an outflow end portion 206 defining an outflow end 226 of the frame 202. The prosthetic valve 200 can define a longitudinal axis (central longitudinal axis) A extending from the inflow end portion 204 to the outflow end portion 206 and a transverse axis B perpendicular to the longitudinal axis A. While only one side of the frame 202 is illustrated in FIG. 5 , it should be understood that the frame 202 forms an annular structure having an opposite side identical to the illustrated portion.

[0093] The frame 202 includes a plurality of interconnected struts 208 arranged in a lattice-type pattern. Each strut can extend completely from the inflow end 224 of the frame 202 to the outflow end 226 of the frame. Thus, in the illustrated embodiment, the frame 202 can be formed entirely of struts that extend continuously from the inflow end 224 to the outflow end 226. In alternative embodiments, the frame 202 can have struts connected end-to-end along the length of the frame.

[0094] Each strut 208 can include a plurality of holes that can be unequally spaced along the length of each strut 208, defining a plurality of segments 212 of unequal length. In the illustrated embodiment, the length of the segments 212 of each strut 208 can decrease from the inflow end portion 204 to the outflow end portion 206 of the frame 202. In the assembled frame 202, the struts 208 form a plurality of enclosed cells arranged in a plurality of circumferentially extending rows of cells, with the cells progressively decreasing in size from the inflow end 224 to the outflow end 226. In the illustrated embodiment, each strut 208 has five holes defining four segments 112 and three rows of cells, including a first row of cells 228, a second row of cells 230, and a third row of cells 232, with the cells 228 being largest, the cells 230 being smaller than the cells 228, and the cells 232 being smaller than the cells 230.

[0095] In other embodiments, each strut can have a greater or fewer number of holes to define a different number of strut segments and rows of frame cells. For example, FIG. 4 A prosthetic valve 300 is shown (described below) in which each strut includes seven holes.

[0096] As FIG. 4 illustrated, the varying lengths of the strut segments also form angles 244, 246, 248, 250 between the pivotably connected struts, with the angles progressively increasing from the inflow end 224 to the outflow end 226. In alternative embodiments, one or more segments can have unequal lengths and the lengths of one or more segments can be equal.

[0097] As FIG. 1 illustrated, each strut 208 can be helically curved relative to the longitudinal axis A of the frame 202 to define the annular shape of the frame 202. The helical curvature provides each strut 208 with a concave radially inner surface (a surface facing the longitudinal axis A) and an opposing convex radially outer surface (a surface facing away from the longitudinal axis A).

[0098] The holes can be used to connect the struts 208 to one another using fasteners 214, such as those described above with reference to the prosthetic valve 10 FIG. 4 ) described above. In other embodiments, the holes 210 and / or fasteners 214 can be omitted. For example, the struts 208 can be fixedly connected to one another, such as by welding or adhesion, or by laser cutting the individual struts of the frame from a metal tube.

[0099] As shown, segments 212 may be arranged end-to-end relative to each other, with adjacent ends interconnected by intermediate segments 218. Supports 208 may have enlarged end portions 220 (relative to segments 212), forming apexes 222 at the inflow and outflow ends 224, 226 of the frame 202. Each of the intermediate segments 218 and end portions 220 may have a corresponding hole, for example, at its geometric center, for receiving fasteners 214. As shown, each segment 212 may be slightly laterally offset from adjacent segments 212 in a direction perpendicular to the total length of the support 208. In an alternative embodiment, segments 212 may be arranged without any offset relative to each other.

[0100] In the illustrated embodiment, each segment 212 of the support column 208 is curved such that the overall shape of the support column 208 is curved relative to the transverse axis B (or any line parallel to axis B and perpendicular to axis A).

[0101] In a particular embodiment, each support 208 may have a continuous and constant curve from one end of the support to the other. In other embodiments, the projection of each segment 212 in a plane parallel to the longitudinal axis A may be straight (i.e., each segment 112 is straight except for any helical curvature relative to the longitudinal axis A) and the offset of each segment 112 along the length of the support 208 relative to adjacent segments 112 may vary such that the overall shape of the support 208 is curved along its length relative to the transverse axis B (or any line parallel to axis B and perpendicular to axis A); that is, the line extending from one end of the support to the other and intersecting each segment 212 is curved relative to axis B. Alternatively, the individual support segments 212 may be straight and connected end-to-end to each other at a non-zero angle such that the overall shape of the support 208 is curved along its length relative to the transverse axis B (or any line parallel to axis B and perpendicular to axis A). In other embodiments, one or more pillars of the frame may have non-constant or variable curvature along their length (in which case the center of curvature of the pillar may change as it moves along the length of the pillar).

[0102] like FIG. 4 As shown, each support 208 can be bent and arranged such that it is convex relative to the outflow end 226 of the frame 202. Therefore, in the illustrated embodiment, each support 208 has a convex first longitudinal edge 236 facing the outflow end 226 of the frame and a concave second longitudinal edge 238 facing the inflow end 224 of the frame. Due to the unique shape of the supports 208, the frame 202 formed by the supports has a non-Euclidean geometry, particularly an elliptical geometry (also known as a Riemannian geometry).

[0103] like FIG. 5As shown, in the expanded configuration, the curvature of the struts 208 can cause the frame 202 to have a non-cylindrical, conical shape (e.g., a frustoconical shape, a V-shape, or a Y-shape) in which the outflow end 226 has a first diameter D1 that is greater than a second diameter D2 of the inflow end 224. The taper can be referred to as a draft angle of the frame 202, which can be a measure of the angle between the longitudinal axis A and a line C drawn tangent to the outer surface of the frame. The larger outflow relative to the inflow resulting from the conical shape can reduce the pressure gradient across the valve when implanted within a native valve annulus of a patient, thereby helping to improve hemodynamics and reduce the risk of paravalvular leakage.

[0104] In particular embodiments, the draft angle between the lines A and C can be at least 2 degrees, at least 5 degrees, at least 10 degrees, at least 20 degrees, at least 30 degrees, at least 40 degrees, or at least 50 degrees. In particular embodiments, the draft angle can be between 2 degrees and 15 degrees. In particular embodiments, the ratio of the outflow diameter D1 to the inflow diameter D2 is at least greater than 1, at least greater than 1.1, at least greater than 1.2, at least greater than 1.3, at least greater than 1.4, or at least greater than 1.5.

[0105] In some embodiments, there is a 2-3 mm difference between the outflow diameter D1 and the inflow diameter D2. In one particular example, the outflow diameter D1 is about 30 mm and the inflow diameter D2 is about 27 mm. In another example, the outflow diameter D1 is about 31.5 mm and the inflow diameter D2 is about 29 mm. In another example, the outflow diameter D1 is about 24.5 mm and the inflow diameter D2 is about 22 mm.

[0106] In some embodiments, when in the crimped or radially compressed configuration, the frame 202 can maintain the conical shape in which the diameter of the outflow end 226 is greater than the diameter of the inflow end 224, and the draft angle of the frame in the compressed configuration can be greater than the draft angle of the frame when the frame is in the expanded configuration.

[0107] FIG. 1 Another embodiment of a prosthetic valve 300 is shown that includes a frame 302 having a conical shape (shown in its expanded, radially expanded configuration). In particular, the frame 302 has a positive draft angle (e.g., the diameter at the outflow end 326 of the prosthetic valve 300 is greater than the diameter at the inflow end 324), causing the frame 302 to taper from the outflow end 326 to the inflow end 324.

[0108] The prosthetic valve 300 is similar to the prosthetic valve 200, except that the prosthetic valve 300 has a frame 302 in which each strut 308 includes seven holes 310 and thus has more strut segments and frame cells than the struts of the prosthetic valve 200. The frame 302 can be similar to the frame 202, except that the frame 302 has a positive draft angle. FIG. 2 to FIG. 3frame 12 of the prosthetic valve 10 and FIG. 1 frames 102 of the prosthetic valve 100, as each strut of these frames also includes seven holes.

[0109] Similar to the prosthetic valve 10 and / or the prosthetic valve 100, the prosthetic valve 300 can include a valve structure (e.g., the valve structure 18), an inner and / or outer skirt, and an actuator (e.g., the actuator 80 of the prosthetic valve 10) or an expansion locking mechanism (e.g., the expansion locking mechanism 150 of the prosthetic valve 100), as previously described, although these components are omitted for illustrative purposes. The frame 302 can have an inflow end portion 304 defining an inflow end 324 of the frame and an outflow end portion 306 defining an outflow end 326 of the frame. The prosthetic valve can define a longitudinal axis A extending from the inflow end portion 304 to the outflow end portion 306 and a transverse axis B extending perpendicular to the longitudinal axis A. FIG. 2-3 FIG. 5 The frame 302 includes a plurality of interconnected struts 308 extending from the inflow end 324 to the outflow end 326 of the frame 302. Thus, in the illustrated embodiment, the frame 302 can be formed entirely of struts that extend continuously from the inflow end 324 to the outflow end 326. In alternative embodiments, the frame 302 can have struts connected end-to-end along the length of the frame.

[0110] Each strut 308 can include a plurality of holes 310. As shown, the holes 310 can be unequally spaced along the length of the strut 308, defining a plurality of segments 312 having different lengths. In the illustrated embodiment, the strut 308 includes segments 312a, 312b, 312c, 312d, 312e, and 312f, with the segment 312a being the shortest and each subsequent segment 312b, 312c, 312d, 312e, and 312f having progressively increasing lengths. In the assembled frame 302, the struts 308 form a plurality of closed cells arranged in a plurality of circumferentially extending rows of cells, with the cells progressively increasing in size from the inflow end 324 to the outflow end 326. In the illustrated embodiment, each strut 308 has seven holes 310 defining six segments 312 and five rows of cells, including a first row of cells 328, a second row of cells 330, a third row of cells 332, a fourth row of cells 334, and a fifth row of cells 336, with the cells 328 being the smallest and each row of cells progressively increasing in size from the inflow end to the outflow end.

[0111] The varying lengths of the struts also form angles 338, 340, 342, 346, 348 between the pivotably connected struts, with the angles progressively decreasing from the inflow end 324 to the outflow end 326.

[0112] The varying lengths of the struts also form angles 338, 340, 342, 346, 348 between the pivotably connected struts, with the angles progressively decreasing from the inflow end 324 to the outflow end 326.

[0113] ​In alternative embodiments, one or more segments can have unequal lengths, and one or more segments can have equal lengths. For example, segment 312a can be the shortest segment, segments 312b, 312c, 312d, 312e can have equal lengths, and segment 312f can be the longest segment. In other embodiments, holes 310 can be equally spaced along the length of each strut, thereby forming equal length segments.

[0114] As shown in FIG. 3, each strut 308 can be curved helically with respect to a longitudinal axis A of the frame to define a toroidal shape of the frame 302. The helical curvature provides each strut with a concave radially inner surface (a surface facing the longitudinal axis A) and an opposite convex radially outer surface (a surface facing away from the longitudinal axis A). FIG. 6

[0115] Holes 310 can be used to connect struts 308 to one another using fasteners such as fasteners 214 described above.

[0116] Each strut 308 can be curved or arranged such that it is concave with respect to an outflow end 326 of the frame 302.

[0117] In some embodiments, due to the elasticity of struts 308 and the connections between overlapping struts, the degree of curvature of the struts can change during radial compression and expansion of the frame.

[0118] As with the prosthetic valve 200, in the expanded configuration, the curvature of the struts 308 can cause the frame 302 to have a non-cylindrical, conical shape (e.g., a truncated conical shape, a V-shape, or a Y-shape) in which the outflow end 326 has a first diameter D1 that is greater than a second diameter D2 of the inflow end 324. This configuration can reduce the pressure gradient across the prosthetic valve 300 and improve hemodynamics.

[0119] In particular embodiments, the draft angle between lines A and C in the frame 302 can be between 2 and 15 degrees. In particular embodiments, the draft angle can be at least 2 degrees, at least 5 degrees, at least 10 degrees, at least 20 degrees, at least 30 degrees, at least 40 degrees, or at least 50 degrees. In particular embodiments, the ratio of the outflow diameter D1 to the inflow diameter D2 is at least greater than 1, at least greater than 1.1, at least greater than 1.2, at least greater than 1.4, or at least greater than 1.5.

[0120] ​In some embodiments, there is a difference of 2-3 mm between the outflow diameter D1 and the inflow diameter D2. In one particular example, the outflow diameter D1 is about 30 mm and the inflow diameter D2 is about 27 mm. In another example, the outflow diameter D1 is about 31.5 mm and the inflow diameter D2 is about 29 mm. In another example, the outflow diameter D1 is about 24.5 mm and the inflow diameter D2 is about 22 mm.

[0121] Further details regarding prosthetic valves having frames with a conical shape can be found in International Application PCT / US2019 / 056865, filed October 18, 2019, and U.S. Patent Application 16 / 788,090, filed February 11, 2020, each of which is incorporated by reference herein in its entirety.

[0122] Turning now to FIG. 1 , an exemplary leaflet 400 is shown that can be included in a valve structure (e.g., FIG. 6 of the valve structure 18 of the prosthetic heart valve 10. For purposes of illustration, the leaflet 400 is laid flat. The leaflet 400 can include a main portion (or body) 402 having tip (inflow) edge portions 404 and 406. In particular, the tip edge portions 404 and 406 can include a first (left) side tip edge portion 404 and a second (right) side tip edge portion 406 that are joined together at a most inflow end portion 408 of the leaflet 400. The first and second tip edge portions 404 and 406 together form a scallop line of the leaflet 400.

[0123] The leaflet 400 can include commissure tabs 412 and 414 that extend from opposite sides of the main portion 402. The commissure tabs can be configured to engage with corresponding commissure tabs of an adjacent leaflet to form a commissure and for attachment to a frame of a prosthetic heart valve (e.g., by an attachment member of the commissure, as further described herein). An outflow edge portion 410 extends across the leaflet 400 between the commissure tabs 412 and 414.

[0124] Curved edge portions 416, 418 extend between and join a respective one of the commissure tabs 412 and 414 with a respective one of the first and second tip edge portions 404 and 406. Each curved edge portion 416, 418 defines an open area on either side of the leaflet 400, referred to herein as a window 420, 422.

[0125] As FIG. 6As shown, each of the first and second tip edge portions 404 and 406 is angled from the bottom edge of a corresponding one of the curved edge portions 416 and 418 to the inflow end portion 408. The upper edge of each of the first and second tip edge portions 404 and 406 is arranged in a transverse direction perpendicular to the axial direction, inside the outer edge of a corresponding one of the seam tabs 412 and 414, which extends from the outflow edge portion 410 to the inflow end portion 408, parallel to the centerline 424 of the leaflet. As a result, the overall shape of the leaflet is tapered from the outflow edge portion 410 to the inflow end portion 408.

[0126] In some embodiments, the shape of the leaflet 400 may be configured such that the seam tabs 412 and 414 are angled relative to an axial direction parallel to a centerline 424 extending through the center of the leaflet 400 between the outflow edge portion 410 and the inflow end portion 408. For example, as FIG. 6 As shown, the transverse (upper and lower) edges 426 and 428 of each seam tab 412, 414 can form an angle θ with the vertical direction (e.g., centerline 424). FIG. 4 As shown, an angle θ can be defined between the center line 424 and the line 450 extending through the seam tabs 412, 414 perpendicular to the transverse edges 426 and 428.

[0127] In some embodiments, an angle θ can be selected to match or resemble (e.g., within a selected limited range) the draft angle of the prosthetic heart valve frame. For example, as referenced above. FIG. 4 and 5 The frame can be tapered from the outflow end to the inflow end, thereby forming a shape determined by the draft angle (…). FIG. 7-9 and 5 The angle between lines A and C in the diagram defines the tapered shape of the frame. By selecting an angle θ to match or closely match (e.g., within 5-10% or 5% of the frame's draft angle), stress concentrated at the suture tabs of the suture can be reduced, while also allowing sufficient opening of the leaflet during in vivo valve operations (e.g., during the opening and closing of the leaflet).

[0128] In some embodiments, the angle θ can be selected based on the draft angle of the frame and / or based on the geometry of the leaflet to reduce stress experienced at the joint while also allowing full opening of the leaflet in vivo during valve operation. In some embodiments, a tapered frame can facilitate a more cylindrical opening of the leaflet while maintaining a distance between the leaflet and the frame during the opening phase (e.g., to reduce or avoid abrasion).

[0129] In some embodiments, the dimensions of windows 420 and 422 and / or neck regions 430 and 432 of leaflet 400 can be selected to maximize the width of leaflet 400 at each neck region 430, 432 while minimizing the surface area of ​​each window 420, 422. Each neck region 430, 432 is defined between a corresponding one of the suture tabs 412 and 414 of leaflet 400 and the main portion 402. For example, in some embodiments, the width 434 of each neck region 430 and 432 and the window width 436 of each window 420 and 422 can be selected to aid leaflet stress distribution and reduce tissue tension on the leaflet during cyclic loading and unloading (e.g., during closure and opening of the leaflet assembly during valve operation) to increase the lifespan of leaflet 400.

[0130] In some embodiments, the seam tabs 412 and 414 may include multiple rows of holes 438 adapted to receive multiple rows of fasteners (e.g., stitches) during folding and securing the seam tabs to form a seam (see below for reference). FIG. 6 (As further described in 14 and 15). These rows of holes 438 may be referred to herein as stitch 437. FIG. 19 As shown, each seam tab 412 and 414 includes four relatively straight stitches 437. However, in alternative embodiments, each seam tab 412 and 414 may include more or fewer than four stitches 437 (e.g., one, two, three, five, or the like). Furthermore, in some embodiments, instead of relatively straight stitches (e.g., all holes 438 of the same stitches arranged in a relatively straight arrangement), one or more of the stitches 437 may be non-linear, wherein at least a portion (e.g., one or more holes 438) is offset from the remainder of the stitches 437. An example of a leaflet with non-linear stitches having offset holes is shown in... FIG. 6 and 20 As shown below, and further described.

[0131] return FIG. 7-16 In some embodiments, each of the first and second tip edge portions 404 and 406 may include a row of holes 440 adapted to receive a row of fasteners (e.g., sutures) securing the first and second tip edge portions 404 and 406 to a skirt configured to be attached to a frame of a prosthetic heart valve. In some embodiments, the skirt may extend from or just above the row of holes 440 and below the bottom (inflow) edge of the first and second tip edge portions 404 and 406.

[0132] In some embodiments, the skirt can be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials (e.g., PET) or natural tissues (e.g., pericardial tissue). The skirt can be attached to the inner surface of the struts of the prosthetic heart valve frame.

[0133] The coaptation tab of a leaflet, such as one of coaptation tabs 412 and 414 of leaflet 400, can be folded, mated with a folded coaptation tab of an adjacent leaflet of the valve leaflet assembly to form a coaptation, and attached to a coaptation support portion of the frame or to a coaptation support element configured to be coupled to a coaptation support portion (as described further below), thereby forming a coaptation. In some embodiments, the coaptation tab can be folded perpendicularly in an axial direction (e.g., about an axis perpendicular to the central longitudinal axis of the frame). However, this can not provide sufficient surface area for attaching the coaptation to the coaptation support portion of the frame, resulting in a less secure coaptation that can shift during valve operation. Further, in some embodiments, the coaptation tab can be wrapped around the sides and / or back of the coaptation support portion of the frame, then stitched around and to the coaptation support portion. However, the amount of leaflet material added on the sides or back (outward facing surface) of the coaptation support portion of the frame can result in increased stress on the coaptation and / or leaflet.

[0134] Alternatively, as described further below, the coaptations of the prosthetic heart valve can be formed by folding each coaptation tab of each leaflet horizontally (e.g., about an axis parallel to the central longitudinal axis of the frame, such that the folded portion of the folded coaptation tab extends in a circumferential and / or radial direction relative to the central longitudinal axis), and attaching each folded coaptation tab to an attachment member, which can be disposed on a radially inward facing surface (inner surface) of the coaptation support portion or coaptation support element. The attachment member can be directly attached to the coaptation support portion or coaptation support element, with the folded coaptation tab of the coaptation remaining radially inward of the coaptation support portion of the frame. By folding the coaptation tab radially inward in a direction perpendicular to the axial direction (e.g., horizontally rather than perpendicularly), a greater surface area is provided for attaching the coaptation tab to the attachment member, providing increased support in attaching the attachment member to the coaptation support portion or coaptation support element of the frame. As explained further below, by indirectly attaching the coaptation tab of the coaptation to the coaptation support portion of the frame with a fabric attachment member, direct loading of the leaflet and abrasion of the leaflet on a more rigid surface can be reduced. FIG. 7-9

[0135] FIG. 7-9 ​Figs. 14 and 15 illustrate exemplary coaptation tab assemblies folded about an axis parallel to a central longitudinal axis of a frame of a valve and attached to an attachment member, as described above. These figures also illustrate that these coaptation tab assemblies are attached to a coaptation support of a frame of a prosthetic valve, such as a coaptation post or other support structure (e.g., an actuator or expansion locking mechanism) of a frame of a prosthetic valve, or to a coaptation support element configured to associate with a coaptation support of a frame.

[0136] In a first embodiment, as shown in FIG. 1 , the folded coaptation tab assemblies can be secured together to form a coaptation 500, which can then be directly attached (secured) to a coaptation support of a frame of a prosthetic heart valve via the attachment members (or coaptations) of the coaptation tab assemblies. The coaptation support can be a rigid support post 502 of the frame. In some embodiments, the support post 502 can be all or a portion of an actuator (e.g., actuator 80 of FIG. 2-3 ), an expansion locking mechanism (e.g., expansion locking mechanism 150 of FIG. 1 to FIG. 5 ), or another support post of the frame. The frame of the prosthetic heart valve can be one of the frames disclosed above with reference to FIG. 1 to FIG. 5 , and in some embodiments, can combine features of one or more of the frames shown in FIG. 7 .

[0137] FIG. 8 is a cross-sectional top view of the coaptation 500 attached to a support post 502 of a frame 508 of a prosthetic heart valve. FIG. 9 and 9 are perspective views of the inner and outer sides of the support post, respectively. In FIG. 7-9 , the rest of the frame is removed for illustrative purposes. In FIG. 4 , a radial direction 520, a transverse (or circumferential) direction 522, and an axial direction 524 are shown as references, where these directions are relative to a central longitudinal axis of the frame of the prosthetic heart valve. For example, a radially inward (inner) surface of the assembly can face the central longitudinal axis, while a radially outward (e.g., outer) surface of the assembly can face away from the central longitudinal axis. Further, the radially outward surface of the assembly can be positioned radially outward further from the central longitudinal axis of the frame than an opposite radially inward surface of the frame.

[0138] The coaptation 500 includes a first coaptation tab 504a of a first leaflet 506a and a second coaptation tab 504b of a second leaflet 506b. In some embodiments, the first and second leaflets 506a and 506b can be the same as or similar to the leaflets 400 of FIG. 4 . In alternative embodiments, the first and second leaflets 506a and 506b can have features different from the leaflets 400 of FIG. 7-9The first and second leaflets 506a and 506b each have two coaptation tabs arranged on opposite sides of a body of the first or second leaflet.

[0139] To form the coaptation 500, each of the first and second coaptation tabs 504a and 504b is folded over on itself to form two coaptation tab portions, each extending in the radial direction 520. Each of the folded first and second coaptation tabs 504a and 504b is secured to an attachment member 510 (which can also be referred to as a reinforcing member or support member) that is arranged against and secured to the inner surface 512 of the support post 502 (radially inward in the radial direction 520 and relative to the central longitudinal axis of the frame of the valve).

[0140] In some embodiments, the attachment member 510 can be a flexible cloth / fabric that includes one or more layers of cloth / fabric. In some embodiments, the attachment member 510 includes a synthetic material, such as a polyethylene terephthalate (PET) fabric. In alternative embodiments, the attachment member 510 can include a flexible polymeric material.

[0141] As FIG. 7-9 shown, in some embodiments, the attachment member 510 can include a first (base) portion 514 that is positioned against (e.g., in coplanar contact with) the inner surface 512 of the support post 502 and extends in the lateral direction 522 along the inner surface 512 of the support post 502. In some embodiments, as FIG. 7-9 shown, the first portion 514 can only extend along the inner surface 512 and not along additional surfaces of the support post 502. In alternative embodiments, the first portion 514 can additionally extend along at least a portion of the lateral (side) surface 518 of the support post 502 (but not extend to the outer surface of the support post 502).

[0142] The attachment member 510 can further include a second portion 516 that protrudes radially inward toward the central longitudinal axis of the frame and away from the first portion 514. For example, the second portion 516 can extend radially outward from a central region of the first portion 514.

[0143] In some embodiments, as FIG. 7-9As shown, the second portion 516 can include two overlapping layers of the attachment member 510, each extending from a different end of the first portion 514. The two overlapping layers of the second portion 516 of the attachment member 510 can overlap in the lateral direction 522, and each can extend along the radial direction 520. In some embodiments, the second portion 516 can be twice as thick as the first portion 514, as the second portion 516 includes twice as many layers of the first portion 514 (and, in some embodiments, the first portion 514 can include one or more layers of fabric). As such, the second portion 516 can be thicker than the first portion 514.

[0144] It should be noted that the thickness of the attachment members in FIG. 14 (and FIG. 7-9 and 15 ) can be exaggerated relative to the thickness of the leaflets. Thus, in some embodiments, the attachment member 510 can be thinner than shown in the figures, and, as a result, the coaptation tabs of the leaflets can be arranged closer together in the lateral direction 522.

[0145] As described above, each of the first coaptation tab 504a and the second coaptation tab 504b includes two overlapping coaptation tab portions, including a first tab portion 526 and a second tab portion 528. Each of the first tab portion 526 and the second tab portion 528 extends in the radial direction 520, and they overlap each other in the lateral direction 522. As FIG. 7-9 shown, the first tab portion 526 extends radially outward from a main portion of a respective one of the leaflets 506a and 506b toward the first portion 514 of the attachment member 510. Then, from the first tab portion 526, each coaptation tab 504a, 504b is folded over itself to form the second tab portion 528. The second tab portion extends radially inward away from the first portion 514 of the attachment member and toward the central longitudinal axis of the frame 508.

[0146] As FIG. 6 shown, the first tab portion 526 of the first coaptation tab 504a is arranged to abut (e.g., coplanarly contact) a first lateral side of the protruding second portion 516 of the attachment member 510, and the first tab portion 526 of the second coaptation tab 504b is arranged to abut a second lateral side of the protruding second portion 516. For example, in some embodiments, a face of the first lateral side of the second portion 516 and an inner surface of the first tab portion 526 of the first coaptation tab 504a can be coplanarly contacted along a height of the first coaptation tab 504a (e.g., the height can be a distance between an upper edge and a lower edge of the coaptation tab, such as FIG. 7-9Similarly, the face of the second lateral side of the second portion 516 and the inner face of the first tab portion 526 of the second seam tab 504b can be coplanarly contacted along the height of the second seam tab 504b. In this way, the folded seam tabs 504a, 504b have a larger surface area for contact with and support from the second portion 516 of the attachment member 510 (as compared to when the seam tabs are folded vertically about an axis perpendicular to the central longitudinal axis of the valve frame in the axial direction).

[0147] Additionally, as shown, the second tab portion 528 is arranged to abut the first tab portion 526, and a fold 530 between the first tab portion 526 and the second tab portion 528 is positioned to abut (e.g., coplanarly contact) the inner side of the first portion 514 of the attachment member 510. In this way, each folded seam tab 504a, 504b can be wedged on the attachment member 510 in the area of a bend 532 between the first portion 514 and the second portion 516. In some embodiments, the bend 532 can be about 90 degrees. FIG. 7 The protruding second portion 516 of the attachment member 510 can extend a distance 534 in the radial direction (e.g., the distance 534 can be the length of the second portion 516 in the radial direction 520).

[0148] In some embodiments, the distance 534 (or the length of the second portion 516 in the radial direction 520) can be shorter than the length 536 of the second tab portion 528 (e.g., the length of the two overlapping layers of the seam tab). In other embodiments, the distance 536 can be the same as the length 536. FIG. 7-9 The folded first seam tab 504a and the folded second seam tab 504b can each be secured to the attachment member 510 via one or more rows of sutures (sewing threads). For example, first sewing threads 538a and 538b, which include a plurality of in-and-out stitches, can extend (e.g., at the bend 532) through the respective one of the folded seam tabs 504a and 504b and the attachment member 510. In some embodiments, the first sewing threads 538a and 538b can extend through both overlapping layers of the respective one of the folded seam tabs 504a and 504b and the second portion 516 of the attachment member 510 (through at least one layer of the second portion 516). In some embodiments, second sewing threads 540a and 540b, which can include a plurality of in-and-out stitches, can extend through the respective one of the folded seam tabs 504a and 504b (e.g., through both of their overlapping layers) and the second portion 516 of the attachment member 510 (e.g., at a radially inward location of the bend 532, such as between the overlapping layers of the second portion 516 of the attachment member 510). In alternative embodiments, there can be more or fewer rows of sewing threads.

[0149] FIG. 7-9 ​The suture lines shown in FIGS. 1-3 are configured to secure the folded coaptation tabs 504a and 504b to the attachment member 510. The term “sutured lines” can also be referred to as “stitch lines.”

[0150] In this manner, as described above, the attachment member 510 and the first and second coaptation tabs 504a and 504b are secured together to form the coaptation 500.

[0151] As shown in FIG. 4, the attachment member 510 can be secured to the support post 502 by one or more fasteners in order to secure the coaptation 500 to the support post 502. In this way, the folded first and second coaptation tabs 504a and 504b are indirectly attached to the support post 502 via the attachment member 510. In other words, because the attachment member 510 is disposed between the support post 502 and the coaptation tabs 504a and 504b (in the radial direction 520), the attachment member 510 shields the first and second coaptation tabs 504a and 504b (and thus the leaflets 506s and 506b) from contact with the support post 502. FIG. 7-9 In some embodiments, the attachment member 510 is secured to the support post 502 via one or more fasteners. For example, as shown in FIG. 5, the attachment member 510 is secured (coupled) to the support post 502 via sutures 542, which can form a plurality of suture loops 546 that cross over a radially outward (outer) surface 544 of the support post 502, such as disclosed in International Application No. PCT / US2021 / 020206, which is incorporated herein by reference. In some embodiments, during assembly, the plurality of loops 546 can be formed by the sutures 542, each loop surrounding and / or passing through the attachment member 510 and extending radially outward from the attachment member 510. The plurality of loops 546 can then be slid over and tightened around the support post 502. In some embodiments, the tightened loops 546 of the sutures 542 can be cinched by one or more knots 548.

[0152] FIG. 7-9 In this manner, by folding the coaptation tabs of two adjacent leaflets in the lateral and radial directions about an axis disposed parallel to the axial direction 524, such that the overlapping tab portions overlap in the lateral direction and extend in the radial direction, provides a greater surface area for securing the folded coaptation tabs to the projecting portion of the attachment member that extends in the radial direction. As a result, a more secure and robust coaptation is formed. By utilizing the attachment member and securing the attachment member directly to the support post of the frame, the leaflets can be shielded from contact with the support post and the load on the leaflets during radial expansion and compression of the frame can be reduced, thereby reducing degradation of the leaflets.

[0153] In this manner, by folding the coaptation tabs of two adjacent leaflets in the lateral and radial directions about an axis disposed parallel to the axial direction 524, such that the overlapping tab portions overlap in the lateral direction and extend in the radial direction, provides a greater surface area for securing the folded coaptation tabs to the projecting portion of the attachment member that extends in the radial direction. As a result, a more secure and robust coaptation is formed. By utilizing the attachment member and securing the attachment member directly to the support post of the frame, the leaflets can be shielded from contact with the support post and the load on the leaflets during radial expansion and compression of the frame can be reduced, thereby reducing degradation of the leaflets.

[0154] ​In alternative embodiments, instead of a support post coupled to the frame, the coaptation 500 can be attached to a coaptation support of a different frame element (e.g., a different frame configuration of a different prosthetic heart valve) or to a coaptation support element configured to be coupled to a coaptation support of the frame (e.g., an actuator, a support post, etc.). In this way, as described above with reference to FIG. 14 the same coaptation 500 can be used in prosthetic heart valves having different frame designs.

[0155] For example, in a second embodiment, as shown in FIG. 5, the coaptation 500 can be directly attached to a coaptation window 502 of the frame of the prosthetic heart valve or to a coaptation support element of a coaptation support 504 of the frame configured to be coupled to the frame by an attachment member of the coaptation 500. FIG. 10-11 FIG. 12-13 FIG. 10

[0156] FIG. 10 and 11 Exemplary prosthetic heart valve frames having coaptation windows incorporated therein are shown. In particular, FIG. 6 A prosthetic heart valve 600 including a coaptation window incorporated into the frame of the valve according to one embodiment is shown. The prosthetic valve shown is adapted for implantation in a native aortic valve annulus, although in other embodiments it can also be adapted for implantation in other native valve annuli of the heart (e.g., pulmonary, mitral, and tricuspid). The prosthetic valve can also be adapted for implantation in other tubular organs or passageways in the body. The prosthetic valve 600 can have four main components: a stent or frame 612, a valve structure 614, an inner skirt 616, and a paravalvular outer sealing member or outer skirt 618. The prosthetic valve 600 can have an inflow end portion 615, a middle portion 617, and an outflow end portion 619.

[0157] The valve structure 614 can include three leaflets 640 that collectively form a leaflet structure, the three leaflets being capable of being arranged to collapse in a tricuspid arrangement, although in other embodiments there can be a greater or lesser number of leaflets (e.g., one or more leaflets 640). The leaflets 640 can be secured to one another at their adjacent sides to form a coaptation 622 of the valve structure 614. In some embodiments, the leaflets 640 can have the configuration of the leaflets 400, as described above with reference to FIG. 11

[0158] ​​​​The frame 612 may be formed with a plurality of circumferentially spaced slit window frame portions 620 adapted to mount the slit 622 of the valve structure 614 to the frame. For example, each slit window frame portion 620 may define a slit window, opening, or slot 658 defined by slit window struts 660, 662, the slit window, opening, or slot 658 being configured to receive a slit tab of the slit 622 therein, thereby securing the leaflet to the frame.

[0159] As is known in the art, the frame 612 can be made of any of a variety of suitable malleable expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloy (NiTi), such as nitinol). When constructed of a malleable expandable material, the frame 612 (and therefore the prosthetic valve 600) can be rolled into a radially collapsed configuration on the delivery catheter and then expanded in the patient via an expandable balloon or equivalent expansion mechanism. When constructed of a self-expanding material, the frame 612 (and therefore the prosthetic valve 600) can be rolled into a radially collapsed configuration and can be confined in the collapsed configuration by inserting a sheath or equivalent mechanism into the delivery catheter. Once inside the body, the prosthetic valve can be removed from the delivery sheath, thereby expanding the prosthetic valve to its functional size.

[0160] Suitable malleable extension materials that can be used to form frame 612 include, but are not limited to, stainless steel, biocompatible high-strength alloys (e.g., cobalt-chromium alloys or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In a particular embodiment, frame 612 is made of a nickel-cobalt-chromium-molybdenum alloy, such as an equivalent of UNS R30035 alloy (covered by ASTM F562-02). Alloy (SPS Technologies, Jenkintown, Pennsylvania). The UNS R30035 alloy contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. Additional details regarding the prosthetic valve 600 and its various components are described in WIPO patent application publication number WO2018 / 222799, which is incorporated herein by reference.

[0161] FIG. 10 The exposed frame 650 of the prosthetic heart valve is shown; in some embodiments, it may be... FIG. 10 The frame 612 of the prosthetic valve 600 shown is illustrated. The frame 650 has an inlet end 652, an outlet end 654, and a central longitudinal axis 656 extending from the inlet end 652 to the outlet end 654 (in the axial direction). The frame 650 can be constructed from the above references. FIG. 10 Made of any of the materials described. See above reference. FIG. 11The frame 650 can include a plurality of coaptation windows (open windows) 658 spaced apart from each other in the circumferential direction around the circumference of the frame 650. Each coaptation window 658 is adapted to receive a pair of coaptation tabs of a pair of leaflets arranged in a coaptation. As FIG. 12 shown, each coaptation window 658 is formed by two axially extending struts 660 spaced apart from each other in the circumferential direction and two laterally extending struts 662 spaced apart from each other in the axial direction.

[0162] In another embodiment, the coaptation windows configured to receive and secure to the coaptation 500 can be separate coaptation support elements configured to be coupled to the support posts of the frame. FIG. 13 and FIG. 12 An embodiment of a coaptation support element 700 configured as a unitary linear body 702 is shown, including a coupling portion 704 FIG. 12 and a leaflet-receiving window (also referred to as a coaptation-receiving portion) 706 defined by first and second axially extending members 708 and 710. The coaptation support element 700 is shown in FIG. 13 separate from an actuator 722 of the frame of the prosthetic heart valve and in FIG. 1-5 coupled to the actuator 722. In other embodiments, the actuator 722 can instead be an expansion locking mechanism or a coaptation support post, which can be a post separate from the actuator coupled to the frame or an integral part of the frame. In particular embodiments, the actuator 722 and the support element 700 can be incorporated in mechanically expandable prosthetic heart valves such as those shown in FIG. 12 and described above.

[0163] Referring to FIG. 13 , the coupling portion 704 can include a pair of coupling members 712 and 714. The coupling member 712 can be coupled to the first axial member 708 by a curved portion or member 716, and the coupling member 714 can be coupled to the second axial member 710 by a curved portion or member 718.

[0164] The first and second axial members 708 and 710 can be coupled together at their inflow end portions by a member 720. The member 720 can be curved or straight. The members 708, 710, and 720 can at least partially define the leaflet-receiving window 706, which can be open at the top.

[0165] As FIG. 14As shown, the suture support element 700 can be received or coupled to a strut or actuator assembly 722 of an expandable prosthetic heart valve, which can be configured similarly to any of the struts, actuators, or extended locking components described herein. The actuator assembly 722 may include a pair of tubular openings or channels 724 and 726 configured to receive coupling members 712 and 714, respectively. In the illustrated embodiment, channels 724 and 726 may be located on the side of the actuator assembly at the outflow portion 728, although the channels may be located anywhere around the periphery of the actuator assembly and at any position along the length of the actuator assembly. The suture support element 700 can be configured such that, when coupled to the actuator assembly 722, bending members 716 and 718 extend above the upper surface 730 of the actuator assembly 722 (in the outflow direction), although the support element may also be arranged at other positions along the length of the actuator assembly 722 between the inflow and outflow portions of the actuator assembly.

[0166] The seam support element 700 may be formed from a linear body as described above, or it may be laser-cut from a plate or sheet and bent, folded, and / or formed into a specified shape. The seam support element 700 may include metallic materials, polymeric materials, and / or combinations or layers thereof.

[0167] In alternative embodiments, the suture support element may have a different shape and / or configuration than that shown in the figure above, while still having an open leaflet receiving window and a connecting portion configured to engage with an extended locking mechanism of the frame of the support post, actuator, or prosthetic heart valve frame. For example, in some embodiments, the connecting portion of the suture support element may instead be configured as a collar surrounding the top of the support post.

[0168] In an alternative embodiment, instead of having a leaflet receiving window 706, the seam support element 700 may include an alternative seam receiving portion (which is still coupled to the connecting portion 704 and arranged radially inward of and offset from the connecting portion 704). For example, the seam receiving portion may include a relatively flat portion that provides a relatively flat surface for positioning against the attachment member.

[0169] like FIG. 10 As shown, the suture 500 can be attached to the open suture window 802 of the frame of the prosthetic heart valve, such as... FIG. 11 and FIG. 12 The suture window 658 of the prosthetic heart valve frame shown, or the suture window of the suture support element, such as FIG. 14 and 13 The leaf-shaped receiving window 706 of the joint support element 700. Besides securing the attachment member 510 to the joint window 802 (e.g., instead of the support post 502), FIG. 7The illustrated coaptation 500 can be the same as FIG. 14 the coaptation 500 illustrated.

[0170] More specifically, as FIG. 11 illustrated, the coaptation window 802 is formed by two axially extending members 804 and 806 that are spaced apart from each other in the transverse direction 522. In some embodiments, the two axially extending members 804 and 806 can be coaptation windows of a frame of a prosthetic heart valve, such as the two axially extending struts 660 illustrated in FIG. 12 . In other embodiments, the two axially extending members 804 and 806 can be leaflet-receiving windows of coaptation support members configured to couple to coaptation supports of a frame of a prosthetic heart valve, such as the first and second axial members 708 and 718 of the coaptation support member 700 illustrated in FIG. 14 and 13 . In still other embodiments, the axially extending members 804 and 806 can be spaced-apart struts or posts of an actuator of a mechanically expandable heart valve, such as disclosed in International Application Nos. PCT / US2020 / 040318 and PCT / US2021 / 012146, which are incorporated by reference herein.

[0171] The attachment member 510 of the coaptation 500 can extend across and between the inner sides (along the transverse direction 522) of the two axially extending members 804 and 806. In some embodiments, the end portions of the attachment member 510 can curve around and extend at least a portion of the lateral sides (sides arranged perpendicular to the inner sides) of the two axially extending members 804 and 806.

[0172] As FIG. 8 illustrated, the attachment member 510 can be secured to the two axially extending members 804 and 806 via a first suture 808 and a second suture 810, respectively. In some embodiments, a plurality of loops can be formed by the first suture 808 and the second suture 810 and extend around each of the two axially extending members 804 and 806, similar to FIG. 15 to FIG. 16 and 9 illustrated (e.g., for the sutures 542).

[0173] As such, the base portion 516 of the attachment member 510 can be directly coupled to the two axially extending members 804 and 806, while the folded coaptation tab is attached to the protruding portion 516 of the attachment member 510 radially inward of the two axially extending members 804 and 806.

[0174] In a third embodiment, as FIG. 15 illustrated, the coaptation 500 can be directly attached to the cells 902 of the frame 904 of the prosthetic heart valve 900. FIG. 7-9A portion of the inner side of frame 904 is shown, showing the inner side of the coaptation member 910 (which can be the same or similar to the coaptation member 510 of FIG. 16 described above, except that the attachment member 910 extends across the opening of the cell 902 and is secured to the frame strut forming the cell 902. FIG. 15 A prosthetic heart valve 900 is shown, showing the outer side of the attachment member 910.

[0175] Except that the attachment member 910 extends across the opening of the cell 902 and is secured to the frame strut forming the cell 902, FIG. 16 and FIG. 7 the coaptation member 500 shown in FIG. 15 may be the same as the coaptation member 500 shown in

[0176] For example, as shown in FIG. 7-9 the attachment member 910 includes a base first portion 914 (similar to the first portion 514 in FIG. 7-9 ) and a protruding second portion 916 (similar to the second portion 516 shown in FIG. 17 ). The first portion 914 extends across the opening of the cell 902, and the second portion 916 extends from the first portion 914 along the central portion of the cell 902 as a fold outwardly toward the central longitudinal axis of the frame 904. The first portion 914 of the attachment member 910 can be secured to the strut forming the cell 902 via one or more sutures 920 that extend through the first portion 914 and loop around the frame strut, around the perimeter of the cell 902.

[0177] In this way, the base 914 of the attachment member 910 can be directly coupled to the strut of the frame, while the folded coaptation tab is attached to the protruding portion 916 of the attachment member 910, radially inward of the strut of the frame.

[0178] FIG. 1-5 is a flowchart of a method 1000 for assembling a prosthetic heart valve including a plurality of leaflets. In some embodiments, the prosthetic heart valve can be one of the valves described herein with reference to FIG. 6 , 10, 11, and 16. In particular, the method 1000 is a method for forming a plurality of coaptation members having a plurality of leaflets, each leaflet (e.g., the leaflet 400 shown in FIG. 7-9 ) including two opposing coaptation tabs arranged on opposite sides of a body of the leaflet, and attaching the plurality of coaptation members to an annular frame of the prosthetic heart valve.

[0179] The method 1000 begins at 1002 by folding a central portion of an attachment member to form a protruding portion (e.g., the second portion 516 shown in FIG. 7-9 ) extending outwardly from a base (e.g., the first portion 514 shown in FIG. 7-9The attachment member can be formed from a single piece of material (e.g., a single piece of fabric material) that is folded over on itself to form the base portion (e.g., first portion 514 shown in FIG. 13) and the protruding portion (e.g., FIG. 15 The attachment member can be formed from a single piece of material (e.g., a single piece of fabric material) that is folded over on itself to form the base portion (e.g., first portion 514 shown in FIG. 13) and the protruding portion (e.g., FIG. 7-9 The attachment member can be formed from a single piece of material (e.g., a single piece of fabric material) that is folded over on itself to form the base portion (e.g., first portion 514 shown in FIG. 13) and the protruding portion (e.g., 16 The attachment member can be formed from a single piece of material (e.g., a single piece of fabric material) that is folded over on itself to form the base portion (e.g., first portion 514 shown in FIG. 13) and the protruding portion (e.g., FIG. 7-9 As explained above with reference to FIGS. 13-15, the attachment member includes a fabric material.

[0180] At 1004, the method 1000 can include folding each of the first coaptation tab of the first leaflet and the second coaptation tab of the adjacent second leaflet into two overlapping layers that overlap in a transverse direction that is perpendicular to an axial direction and a radial direction relative to a central longitudinal axis of an annular frame of the prosthetic heart valve. For example, each of the first coaptation tab and the second coaptation tab can be folded into two overlapping layers that include a first tab portion (e.g., first tab portion 526 of FIG. 14) and a second tab portion (e.g., second tab portion 528 of FIG. 14). FIG. 7-9 In some embodiments, as explained above with reference to FIGS. 14-15, the first tab portion extends radially outward from a main portion of the respective one of the first and second leaflets toward the base portion (first portion) of the attachment member. Each coaptation tab is then folded over itself from the first tab portion to form the second tab portion. The second tab portion extends radially inward away from the base portion of the attachment member and toward the central longitudinal axis of the frame. FIG. 7-9 In some embodiments, as explained above with reference to FIGS. 14-15, the first tab portion extends radially outward from a main portion of the respective one of the first and second leaflets toward the base portion (first portion) of the attachment member. Each coaptation tab is then folded over itself from the first tab portion to form the second tab portion. The second tab portion extends radially inward away from the base portion of the attachment member and toward the central longitudinal axis of the frame. FIG. 7 In some embodiments, as explained above with reference to FIGS. 14-15, the first tab portion extends radially outward from a main portion of the respective one of the first and second leaflets toward the base portion (first portion) of the attachment member. Each coaptation tab is then folded over itself from the first tab portion to form the second tab portion. The second tab portion extends radially inward away from the base portion of the attachment member and toward the central longitudinal axis of the frame. FIG. 18-20 In some embodiments, as explained above with reference to FIGS. 14-15, the first tab portion extends radially outward from a main portion of the respective one of the first and second leaflets toward the base portion (first portion) of the attachment member. Each coaptation tab is then folded over itself from the first tab portion to form the second tab portion. The second tab portion extends radially inward away from the base portion of the attachment member and toward the central longitudinal axis of the frame.

[0181] At 1006, the method 1000 can include arranging the folded first seam tab against a first side of the protruding portion of the attachment member, and arranging the folded second seam tab against an opposite second side of the protruding portion. In some embodiments, the arranging at 1006 can include arranging a face of the first side of the protruding portion and an inner surface of the first tab portion of the first seam tab in co-planar contact with each other along a height of the first seam tab, which height is arranged in an axial direction, and arranging a face of the second side of the protruding portion and an inner surface of the first tab portion of the second seam tab in co-planar contact with each other along a height of the second seam tab. In some embodiments, the arranging at 1006 can further include, for each of the first seam tab and the second seam tab, arranging a fold against an inner side of the base of the attachment member between the first tab portion and the second tab portion, such that each of the folded first seam tab and the folded second seam tab is wedged against the attachment member in a region of a bend between the base and the protruding portion.

[0182] At 1008, the method 1000 can include securing each of the (folded) first seam tab and the (folded) second seam tab to the attachment member. In some embodiments, the securing can include extending one or more sutures (or stitched lines) through the two overlapping layers of the first seam tab and the protruding portion, and extending one or more sutures (or stitched lines) through the two overlapping layers of the second seam tab and the protruding portion. In some embodiments, the protruding portion can include two overlapping layers, each extending from a different end of the base, and the securing can include extending one or more sutures (or stitched lines) through the two overlapping layers of the first seam tab and a first layer of the protruding portion, and extending one or more sutures (or stitched lines) through the two overlapping layers of the second seam tab and a second layer of the protruding portion.

[0183] At 1010, the method 1000 can include, for each seam, attaching the attachment member to a respective seam support portion of the annular frame directly or via a seam support element configured to couple to the seam support portion, the base of the attachment member being arranged between the folded first and second seam tabs and the seam support portion or the seam support element in a radial direction.

[0184] In some embodiments, attaching the attachment member to the respective seam support portion of the annular frame directly or via the seam support element includes arranging the base of the attachment member against an inner surface of a support column of the annular frame, and securing the attachment member to the support column by sutures extending through the attachment member and around an outer surface of the support column. In some embodiments, the support column is at least part of an actuator or an expansion locking mechanism of the frame.

[0185] In other embodiments, attaching the attachment member directly or via a coaptation support element to a respective coaptation support portion of the annular frame includes arranging a base of the attachment member against an inner surface of an open coaptation window of the annular frame, and securing the attachment member to the open coaptation window by at least a first suture extending through a first end of the base of the attachment member and around a first axially extending strut forming the open coaptation window, and a second suture extending through an opposite second end of the base of the attachment member and around a second axially extending strut forming the open coaptation window.

[0186] In other embodiments, attaching the attachment member directly or via a coaptation support element to a respective coaptation support portion of the annular frame includes arranging a base of the attachment member against an inner surface of a leaflet receiving window of the coaptation support element, securing the attachment member to the leaflet receiving window by at least a first suture extending through a first end of the base of the attachment member and around a first axial member forming the leaflet receiving window, and a second suture extending through an opposite second end of the base of the attachment member and around a second axial member forming the leaflet receiving window, and coupling the coaptation support element to a corresponding coaptation support portion of the frame.

[0187] In some embodiments, attaching the attachment member directly or via a coaptation support element to a respective coaptation support portion of the annular frame includes arranging a base of the attachment member across a cell of the annular frame formed by angled struts of the annular frame, and securing the attachment member to the angled struts forming the cell by one or more sutures extending through the base of the attachment member and around the angled struts around a perimeter of the cell.

[0188] The coaptations and leaflet constructions described herein can together provide a leaflet assembly for a prosthetic heart valve that can experience reduced stress during operation of the valve (due to periodic opening and closing of the leaflets) as well as during radial expansion and / or contraction of the frame of the valve. As a result, the life of the leaflet assembly can be increased.

[0189] By configuring the tacking line(s) of the coaptation tab to reduce stress concentrations along the edge of the leaflet, which can in some cases be more prone to increased stress and in some cases can be more prone to tearing, the integrity and life of the leaflet and coaptation can be further increased. As discussed herein, in some embodiments, the coaptation can be attached directly or via a coaptation support element or attachment member to a support portion of the frame of the prosthetic heart valve (such as a coaptation support post, actuator, expansion locking mechanism, etc.) by one or more sutures extending through one or more tacking lines of the coaptation tab which can include a plurality of holes (suture holes) configured to receive the sutures.

[0190] FIG. 18-20 A detailed view of an exemplary leaflet 1100 portion is shown illustrating different embodiments of a stitch line on a coaptation tab 1102 of the leaflet 1100. For ease of illustration, only one coaptation tab 1102 of the leaflet 1100 is shown in FIG. 6 . However, the leaflet 1100 includes two coaptation tabs arranged on either side of a body 1104 of the leaflet 1100. For example, in some embodiments, the leaflet 1100 can be configured similar to the leaflet 400 shown in FIG. 18-20 , as described above.

[0191] While each of the embodiments shown in FIG. 18-20 illustrate a single stitch line, it should be noted that alternative numbers of stitch lines are possible. For example, each coaptation tab can include FIG. 6 the multiple stitch line embodiments shown in FIG. 18 , such as two, three, or four stitch lines arranged adjacent to each other from an outer edge 1106 of the coaptation tab 1102 toward a neck region 1108 (or body) of the leaflet 1100. For example, the coaptation tabs of the leaflet 400 of

[0192] contain four stitch lines.

[0192] Turning first to FIG. 6 , a first embodiment of a stitch line 1110 formed by a plurality of holes (suture holes) 1112a-1112b arranged in the coaptation tab 1102 is shown. For example, the holes include an outer hole 1112a and an inner hole 1112b. The outer hole 1112a is arranged closer to the upper and lower edges (e.g., upper edge 1114 and lower edge 1116) of the coaptation tab 1102. The upper edge 1114 can be part of (or connected to) an outflow edge 1118 of the leaflet 1100 (e.g., similar to the outflow edge portion 410 shown in FIG. 18 ). The inner hole 1112b is arranged further away from the upper edge 1114 and the lower edge 1116 than the outer hole 1112a. For example, the inner hole 1112b can be arranged closer to an inner or central portion of the coaptation tab 1102. While the stitch line 1110 is shown with four holes 1112 in FIG. 19 (and FIG. 18 ), in alternative embodiments, the stitch line 1110 can include more or less than four holes 1112 (e.g., two, three, five, six, etc.).

[0193] As FIG. 18-20As shown, the pin line 1110 extends along a relatively straight line, in some embodiments, the pin line 1110 can be approximately parallel or slightly angled to a centerline of the leaflet, which can be arranged to be parallel to a central longitudinal axis of the frame (or, in some embodiments, parallel to a support post of the frame). Thus, each of the outer holes 1112a and the inner holes 1112b are aligned with each other along the relatively straight (and, in some embodiments, vertical) pin line 1110.

[0194] As shown in FIG. 11, the pin line 1110 extends along a relatively straight line, in some embodiments, the pin line 1110 can be approximately parallel or slightly angled to a centerline of the leaflet, which can be arranged to be parallel to a central longitudinal axis of the frame (or, in some embodiments, parallel to a support post of the frame). Thus, each of the outer holes 1112a and the inner holes 1112b are aligned with each other along the relatively straight (and, in some embodiments, vertical) pin line 1110. FIG. 6 (And, as shown in FIG. 11, the pin line 1110 extends along a relatively straight line, in some embodiments, the pin line 1110 can be approximately parallel or slightly angled to a centerline of the leaflet, which can be arranged to be parallel to a central longitudinal axis of the frame (or, in some embodiments, parallel to a support post of the frame). Thus, each of the outer holes 1112a and the inner holes 1112b are aligned with each other along the relatively straight (and, in some embodiments, vertical) pin line 1110. FIG. 6 ) the edges of the leaflet 1100 extend inwardly toward the body 1104 and away from the coaptation tab 1102 at an angle relative to the pin line 1110. For example, the outflow edge 1118 of the leaflet 1100 angles and curves downwardly in an axial direction as it travels from the upper edge 1114 of the coaptation tab 1102 to the centerline of the leaflet 1100 (e.g., the centerline 424 shown in FIG. 11). Due to the angled configuration of the leaflet 1100 relative to the pin line 1110, the pin line 1110 can act as a bending line along which the leaflet bends during in vivo operation, during the transition between systole and diastole, resulting in uneven stress distribution. FIG. 18 As shown in FIG. 11, the pin line 1110 extends along a relatively straight line, in some embodiments, the pin line 1110 can be approximately parallel or slightly angled to a centerline of the leaflet, which can be arranged to be parallel to a central longitudinal axis of the frame (or, in some embodiments, parallel to a support post of the frame). Thus, each of the outer holes 1112a and the inner holes 1112b are aligned with each other along the relatively straight (and, in some embodiments, vertical) pin line 1110.

[0195] In some embodiments, the pin line 1110 can be configured to provide a more even stress distribution along the leaflet 1100. For example, the pin line 1110 can be configured to provide a more even stress distribution along the leaflet 1100 by providing a pin line 1110 that is parallel to the centerline of the leaflet 1100 (or, in some embodiments, parallel to a central longitudinal axis of the frame or a support post of the frame). Thus, the pin line 1110 can be configured to provide a more even stress distribution along the leaflet 1100 by providing a pin line 1110 that is parallel to the centerline of the leaflet 1100 (or, in some embodiments, parallel to a central longitudinal axis of the frame or a support post of the frame). FIG. 19 In some embodiments, the pin line 1110 can be configured to provide a more even stress distribution along the leaflet 1100. For example, the pin line 1110 can be configured to provide a more even stress distribution along the leaflet 1100 by providing a pin line 1110 that is parallel to the centerline of the leaflet 1100 (or, in some embodiments, parallel to a central longitudinal axis of the frame or a support post of the frame). Thus, the pin line 1110 can be configured to provide a more even stress distribution along the leaflet 1100 by providing a pin line 1110 that is parallel to the centerline of the leaflet 1100 (or, in some embodiments, parallel to a central longitudinal axis of the frame or a support post of the frame).

[0196] Thus, it can be desirable to provide a pin line configuration at the coaptation tab 1102 that results in higher (e.g., maximum) stress formation along the more interior of the coaptation tab 1102 rather than along the outflow edge 1118. As the coaptation tab 1102 and the more interior portions of the leaflet 1100 can be stronger and less prone to tearing, these areas can be better able to handle increased stress (as compared to the edge portions of the leaflet 1100).

[0197] FIG. 19An embodiment of a stitch line 1130 formed by a plurality of holes 1132a-1132b (e.g., internal holes 1132b and external holes 1132a, which may be the same as or similar to holes 1112a-1112b except for their placement on the seam tab) is shown, which is adapted to concentrate higher stress toward the interior of the seam tab 1102 and the leaflet 1100 and reduce the stress borne along the outflow edge 1118 of the leaflet 1100.

[0198] For example, as shown in the figure FIG. 20 As shown, the stitch line 1130 is not straight, but may have an offset region (relative to the rest of the stitch line 1130) in the more central portion (inner or middle region) of the seam tab 1102. In some embodiments, one or more of the inner holes 1132b may be offset radially inward from the outer hole 1132a (as indicated by arrow 1134, toward the centerline of the body of the leaflet 1100). As a result, a curved stitch line 1130 with an inward peak (a peak arranged away from the outer edge 1106) can be formed. This configuration of the stitch line 1130 can result in higher stress along the middle of the seam tab 1102 and the leaflet 1100, between the upper edge 1114 and the lower edge 1116 and away from the outflow edge 1118 of the leaflet 1100. For example, due to the offset configuration of the stitch line 1130, higher stress may be experienced along stress lines 1120b and 1120c than at stress line 1120a.

[0199] FIG. 20 Another embodiment of a stitch line 1140 formed by a plurality of holes 1142a-1142c (e.g., internal holes 1142b and external holes 1142a and 1142c, which may be the same as or similar to holes 1112a-1112b except for the number of holes and their placement on the seam tab) is shown, which is adapted to concentrate higher stress at a location spaced apart from the outflow edge 1118 of the leaflet 1100 (towards the seam tab 1102 and the inner portion of the leaflet 1100).

[0200] For example, such as FIG. 19As shown, the stitch line 1140 is not straight along all its holes, but may have an offset region (e.g., including holes 1142b and 1142c) that is radially inward (towards the centerline of the body of the leaflet 1100) from the outer hole 1142a arranged near the outlet edge 1118. For example, the upper portion of the stitch line 1140 may be angled radially inward from the outer edge 1106 and the outlet edge 1118, and then the lower portion of the stitch line 1140 may extend in a relatively straight line but radially offset from the outer edge 1106. As a result, higher stress can concentrate along the joint tab 1102 and the middle of the leaflet 1100, starting at the offset lower portion of the stitch line 1140 (e.g., at stress line 1144a), at a location away from the outlet edge 1118. Therefore, lower stress can be experienced near the outlet edge 1118. In some embodiments, the highest stress may be experienced near and / or along the stress line 1144a, while lower stress is experienced outward (in the axial direction) from the stress line 1144a, for example near the outflow edge 1118 and at the stress line 1144b (in the axial direction).

[0201] FIG. 6 and 20 The stitching configuration shown is suitable for use in the seam arrangements described herein. For example, in some embodiments, FIG. 19 The leaflet 400 may include a needle thread 1130 ( FIG. 20 ) and / or 1140 stitches ( FIG. 7-9 The construction involves multiple stitches (arranged adjacent to each other on the seam tab). These offset stitches can then be used to secure the folded seam tab to the attachment member of the seam, as referenced above. ​ As described in 14-17. In this way, the integrity and lifespan of the seam and leaflets can be further increased.

[0202] Other examples of publicly available technology

[0203] In view of the above-described embodiments of the disclosed subject matter, this application discloses the following additional examples. It should be noted that a feature of an example, alone or in combination with more than one feature of that example, and optionally in combination with one or more features of one or more other examples, is also included within the scope of this disclosure.

[0204] Example 1. A prosthetic heart valve comprising: an annular frame comprising a plurality of coaptation supports; and a plurality of leaflets positioned within the frame, each leaflet comprising a body and two opposing coaptation tabs arranged on opposite sides of the body, each coaptation tab paired with an adjacent coaptation tab of an adjacent leaflet to form a coaptation; wherein each coaptation of the prosthetic heart valve comprises: an attachment member comprising a first portion and a second portion, the first portion spanning across and directly attached to a corresponding coaptation support of the plurality of coaptation supports or to a coaptation support element configured to be coupled to a coaptation support, the second portion projecting radially outward from the first portion and extending radially inward toward a central longitudinal axis of the frame; a first coaptation tab of a first leaflet of the plurality of leaflets folded into two overlapping layers that overlap in a transverse direction arranged perpendicular to an axial direction and a radial direction relative to the central longitudinal axis, the two overlapping layers arranged adjacent to a first side of the second portion of the attachment member and directly secured to the attachment member; and a second coaptation tab of a second leaflet of the plurality of leaflets folded into two overlapping layers that overlap in the transverse direction, the two overlapping layers arranged adjacent to an opposite second side of the second portion of the attachment member and directly secured to the attachment member.

[0205] Example 2. The prosthetic heart valve of any example herein, particularly example 1, wherein the first portion of the attachment member is arranged against an inner surface of the coaptation support or a coaptation support element configured to be coupled to the coaptation support, the inner surface facing the central longitudinal axis.

[0206] Example 3. The prosthetic heart valve of any example herein, particularly example 2, wherein the first portion of the attachment member extends across only the inner surface of the coaptation support or coaptation support element.

[0207] Example 4. The prosthetic heart valve of any example herein, particularly example 2, wherein the first portion of the attachment member extends across only the inner surface and a portion of a lateral surface of the coaptation support or coaptation support element, the lateral surface arranged perpendicular to the inner surface.

[0208] Example 5. The prosthetic heart valve of any example herein, particularly any one of examples 1-4, wherein the second portion of the attachment member extends radially outward from a central region of the first portion of the attachment member and comprises two overlapping layers, each overlapping layer extending from a different inner end of the first portion, wherein the two overlapping layers overlap in the transverse direction.

[0209] Example 6. The prosthetic heart valve of any example herein, particularly any one of examples 1-5, wherein the attachment member comprises a fabric material.

[0210] Example 7. The prosthetic heart valve of any example herein, particularly example 6, wherein the attachment member comprises a polyethylene terephthalate (PET) fabric.

[0211] Example 8. The prosthetic heart valve of any example herein, particularly any of examples 1-7, wherein the attachment member comprises a flexible polymeric material.

[0212] Example 9. The prosthetic heart valve of any example herein, particularly any of examples 1-8, wherein the two overlapping layers of each of the first and second coaption tabs comprise a first tab portion arranged against a respective one of the first and second sides of the second portion of the attachment member and a second tab portion arranged against the first tab portion, the first and second sides of the second portion and the first and second tab portions of each of the first and second coaption tabs being arranged parallel to each other.

[0213] Example 10. The prosthetic heart valve of any example herein, particularly example 9, wherein, for each of the first and second coaption tabs, the fold between the first and second tab portions is positioned against an inner side of the first portion of the attachment member, proximate to the respective one of the first and second sides.

[0214] Example 11. The prosthetic heart valve of any example herein, particularly any of examples 1-10, wherein the folded first coaption tab wedges against the attachment member in a region of a first bend between the first portion and the first side of the second portion of the attachment member, and wherein the folded second coaption tab wedges against the attachment member in a region of a second bend between the first portion and the second side of the second portion of the attachment member.

[0215] Example 12. The prosthetic heart valve of any example herein, particularly example 11, wherein each of the first and second bends is 90 degrees.

[0216] Example 13. The prosthetic heart valve of any example herein, particularly any of examples 11 and 12, wherein the two overlapping layers of the first coaption tab are secured to the attachment member by one or more sutured lines extending through the two overlapping layers and the attachment member proximate to the first bend, and wherein the two overlapping layers of the second coaption tab are secured to the attachment member by one or more sutured lines extending through the two overlapping layers and the attachment member proximate to the second bend.

[0217] Example 14. The prosthetic heart valve of any example herein, particularly any of examples 1-13, wherein the second portion of the attachment member extends along an entire height of each of the first and second coaption tabs along an axial direction.

[0218] Example 15. The prosthetic heart valve of any example herein, particularly any of examples 1-14, wherein the attachment member is directly attached to the commissure support, and wherein the commissure support is a support post of the frame.

[0219] Example 16. The prosthetic heart valve of any example herein, particularly example 15, wherein the support post is one of an actuator or an expansion lock mechanism of the frame.

[0220] Example 17. The prosthetic heart valve of any example herein, particularly any of examples 15 and 16, wherein the attachment member is directly attached to the support post via a suture that extends through the attachment member and around an outer surface of the support post.

[0221] Example 18. The prosthetic heart valve of any example herein, particularly any of examples 1-14, wherein the attachment member is directly attached to the commissure support, and wherein the commissure support is a commissure window formed by spaced apart struts of the frame.

[0222] Example 19. The prosthetic heart valve of any example herein, particularly example 18, wherein the attachment member is directly attached to the commissure window via a first suture that extends through a first end of a first portion of the attachment member and around a first axially extending strut forming a first side of the commissure window, and a second suture that extends through a second end of the first portion of the attachment member and around a second axially extending strut forming a second side of the commissure window.

[0223] Example 20. The prosthetic heart valve of any example herein, particularly any of examples 1-14, wherein the attachment member is directly attached to a leaflet receiving window of the commissure support window formed by spaced apart axial members of the commissure support window by a first suture that extends through a first end of a first portion of the attachment member and around a first axial member of the spaced apart axial members, and a second suture that extends through a second end of the first portion of the attachment member and around a second axial member of the spaced apart axial members.

[0224] Example 21. The prosthetic heart valve of any example herein, particularly any of examples 1-14, wherein the attachment member is arranged across and directly attached to a cell of the annular frame formed by one or more sutures that extend through a first portion of the attachment member and around angled struts of the annular frame forming the cell around a perimeter of the cell.

[0225] Example 22. The prosthetic heart valve of any of the examples herein, particularly any of examples 1-21, wherein the annular frame comprises a plurality of interconnected struts, and is collapsible in a radial direction into a collapsed configuration and expandable in a radial direction into an expanded configuration.

[0226] Example 23. The prosthetic heart valve of any of the examples herein, particularly example 22, wherein in the expanded configuration, the annular frame tapers from the outflow end to the inflow end of the frame such that the diameter of the outflow end is greater than the diameter of the inflow end, and wherein the taper from the outflow end to the inflow end is defined as a draft angle of the frame.

[0227] Example 24. The prosthetic heart valve of any of the examples herein, particularly example 22, wherein each coaptation tab of each leaflet is angled at a tab angle defined between a centerline of the leaflet and a line extending through the coaptation tab perpendicular to upper and lower lateral edges of the coaptation tab, and wherein the tab angle is within five percent of the draft angle of the frame.

[0228] Example 25. The prosthetic heart valve of any of the examples herein, particularly example 24, wherein the tab angle matches the draft angle of the frame.

[0229] Example 26. The prosthetic heart valve of any of the examples herein, particularly any of examples 1-25, wherein the body of each leaflet includes first and second tip edge portions disposed on two sides of the body, and wherein a curved edge portion extends between and connects a respective one of the first and second coaptation tabs to a respective one of the first and second tip edge portions, and wherein each curved edge portion defines one open window on either side of the leaflet.

[0230] Example 27. The prosthetic heart valve of any of the examples herein, particularly any of examples 1-26, wherein each of the first and second coaptation tabs includes one or more tacking lines having one or more holes, wherein each tacking line includes a portion offset from a remainder of the tacking line in a direction toward the body of the leaflet, the offset portion disposed away from an outflow edge of the leaflet.

[0231] Example 28. A method of assembling a prosthetic heart valve comprising a plurality of leaflets, comprising: forming a plurality of commissures with the plurality of leaflets, each leaflet comprising two opposing commissure tabs arranged on opposite sides of a body of the leaflet, wherein each commissure is formed by: folding each of a first commissure tab of a first leaflet and a second commissure tab of an adjacent second leaflet into two overlapping layers that overlap in a transverse direction arranged perpendicular to an axial direction and a radial direction relative to a central longitudinal axis of an annular frame of the prosthetic heart valve; arranging the folded first commissure tab against a first side of a protruding portion of an attachment member and the folded second commissure tab against an opposite second side of the protruding portion, the protruding portion extending in the radial direction away from a base of the attachment member; securing each of the first commissure tab and the second commissure tab to the attachment member; for each commissure, attaching the attachment member to a respective commissure support portion of the annular frame directly or via a commissure support element configured to couple to the commissure support portion, the base of the attachment member being arranged in the radial direction between the folded first and second commissure tabs and the commissure support portion or the commissure support element.

[0232] Example 29. The method of any example herein, particularly example 28, further comprising forming the attachment member by folding a central region of the attachment member to form the protruding portion extending outwardly from the base.

[0233] Example 30. The method of any example herein, particularly any of examples 28-29, wherein folding each of the first commissure tab and the second commissure tab comprises folding each of the first commissure tab and the second commissure tab into two overlapping layers comprising a first tab portion and a second tab portion, wherein the first tab portion extends radially outwardly from the body of a respective one of the first and second leaflets toward the base of the attachment member, and the second portion extends radially inwardly from the base of the attachment member and toward the central longitudinal axis of the frame.

[0234] Example 31. The method of any example herein, particularly example 30, wherein folding each of the first commissure tab and the second commissure tab into two overlapping layers comprises: folding each of the first commissure tab and the second commissure tab over itself from the first tab portion to form the second tab portion

[0235] Example 32. The method of any example herein, particularly any of examples 30 and 31, wherein the arranging comprises arranging a face of the first side of the protruding portion and an inner surface of the first tab portion of the first commissure tab in face-to-face contact with each other along a height of the first commissure tab arranged in the axial direction, and arranging a face of the second side of the protruding portion and an inner surface of the first tab portion of the second commissure tab in face-to-face contact with each other along a height of the second commissure tab.

[0236] Example 33. The method of any example herein, particularly example 32, wherein the arranging further comprises, for each of the first coaptation tab and the second coaptation tab, arranging a fold against an inner side of the base of the attachment member between the first tab portion and the second tab portion, such that each of the folded first coaptation tab and the folded second coaptation tab is wedged against the attachment member in a region of the bend between the base and the protruding portion.

[0237] Example 34. The method of any one of examples 30-33 herein, wherein securing each of the first coaptation tab and the second coaptation tab to the attachment member comprises extending one or more sutures through the two overlapping layers and the protruding portion of the first coaptation tab, and extending one or more sutures through the two overlapping layers and the protruding portion of the second coaptation tab.

[0238] Example 35. The method of any example herein, particularly example 34, wherein the securing further comprises extending one or more sutures through the protruding portion and the two overlapping layers of the first coaptation tab along one or more tacking lines of the first coaptation tab that include at least one intermediate portion offset from a remainder of the tacking lines, the intermediate portion being arranged away from an outflow edge of the corresponding leaflet, and toward a centerline of a body of the corresponding leaflet, and wherein the securing further comprises extending one or more sutures through the protruding portion and the two overlapping layers of the second coaptation tab along one or more tacking lines of the second coaptation tab that include at least one intermediate portion offset from a remainder of the tacking lines, the intermediate portion being arranged away from an outflow edge of the corresponding leaflet, and toward a centerline of a body of the corresponding leaflet.

[0239] Example 36. The method of any one of examples 30-33 herein, wherein the protruding portion comprises two overlapping layers, each overlapping layer extending from a different end of the base, and wherein securing each of the first coaptation tab and the second coaptation tab to the attachment member comprises extending one or more sutures through the two overlapping layers and a first layer of the protruding portion of the first coaptation tab, and extending one or more sutures through the two overlapping layers and a second layer of the protruding portion of the second coaptation tab.

[0240] Example 37. The method of any one of examples 28-36 herein, wherein attaching the attachment member to the respective coaptation support of the annular frame, directly or via a coaptation support element, comprises arranging a base of the attachment member against an inner surface of a support post of the annular frame, and securing the attachment member to the support post by a suture extending through the attachment member and around an outer surface of the support post.

[0241] Example 38. The method of any example herein, in particular any one of examples 28-37, wherein attaching the attachment member directly or via the coaptation support element to the respective coaptation support portion of the annular frame comprises including arranging a base portion of the attachment member against an inner surface of an open coaptation window of the annular frame, and securing the attachment member to the open coaptation window by at least a first suture extending through a first end of the base portion of the attachment member and around a first axially extending strut forming the open coaptation window, and a second suture extending through an opposite second end of the base portion of the attachment member and around a second axially extending strut forming the open coaptation window.

[0242] Example 39. The method of any example herein, in particular any one of examples 28-38, wherein attaching the attachment member directly or via the coaptation support element to the respective coaptation support portion of the annular frame comprises arranging a base portion of the attachment member against an inner surface of a leaflet receiving window of the coaptation support element, securing the attachment member to the leaflet receiving window by at least a first suture extending through a first end of the base portion of the attachment member and around a first axial member forming the leaflet receiving window, and a second suture extending through an opposite second end of the base portion of the attachment member and around a second axial member forming the leaflet receiving window, and coupling the coaptation support element to the coaptation support portion of the frame.

[0243] Example 40. The method of any example herein, in particular any one of examples 28-39, wherein attaching the attachment member directly or via the coaptation support element to the respective coaptation support portion of the annular frame comprises arranging a base portion of the attachment member across a cell of the annular frame formed by angled struts of the annular frame, and securing the attachment member to the angled struts forming the cell by one or more sutures extending through the base portion of the attachment member and around the angled struts around a perimeter of the cell.

[0244] Example 41. A prosthetic heart valve comprising: an annular frame comprising a plurality of coaptation supports, each coaptation support comprising an inner surface facing a central longitudinal axis of the frame and an oppositely arranged outer surface; and a plurality of leaflets located within the frame, each leaflet comprising a main body and two opposing coaptation tabs arranged on opposite sides of the main body, each coaptation tab paired with an adjacent coaptation tab of an adjacent leaflet to form a coaptation; wherein each coaptation of the prosthetic heart valve comprises: an attachment member directly attached to a corresponding coaptation support of the plurality of coaptation supports, the attachment member comprising a base extending over the inner surface of the coaptation support and a protruding portion extending radially outward from a central region of the base and radially inward toward the central longitudinal axis; a first coaptation tab of a first leaflet of the plurality of leaflets folded into two overlapping layers overlapping in a transverse direction arranged perpendicular to an axial direction and a radial direction relative to the central longitudinal axis, the two overlapping layers arranged adjacent to a first side of the protruding portion of the attachment member and directly secured to the attachment member, and a second coaptation tab of a second leaflet of the plurality of leaflets folded into two overlapping layers overlapping in the transverse direction, the two overlapping layers arranged adjacent to an opposite second side of the protruding portion of the attachment member and directly secured to the attachment member.

[0245] Example 42. The prosthetic heart valve of any example herein, particularly example 41, wherein a first fold between the two overlapping layers of the first coaptation tab is disposed against the base, adjacent to a first bend between the base and the first side of the protruding portion, and wherein a second fold between the two overlapping layers of the second coaptation tab is disposed against the base, adjacent to a second bend between the base and the second side of the protruding portion.

[0246] Example 43. The prosthetic heart valve of any one of examples 41-42 herein, wherein the first coaptation tab is directly secured to the attachment member by a first suture extending through the two overlapping layers of the first coaptation tab and the first side of the protruding portion on the first side of the protruding portion, and wherein the second coaptation tab is directly secured to the attachment member by a second suture extending through the two overlapping layers of the second coaptation tab and the second side of the protruding portion on the second side of the protruding portion.

[0247] Example 44. The prosthetic heart valve of example 43 herein, wherein each of the first and second coaptation tabs comprises one or more tacking stitches with one or more holes, wherein each tacking stitch comprises a portion offset from a remainder of the tacking stitch in a direction toward the main body of the leaflet, the offset portion arranged away from an outflow edge of the leaflet, wherein the first suture extends through the one or more holes of a first tacking stitch of the one or more tacking stitches of the first coaptation tab, and wherein the second suture extends through the one or more holes of a second tacking stitch of the one or more tacking stitches of the second coaptation tab.

[0248] Example 45. The prosthetic heart valve of any of the examples herein, particularly any of examples 41-44, wherein the first coaptation tab is further secured to the attachment member by a third stitched line extending through both overlapping layers of the first coaptation tab and the protruding portion on the first side of the protruding portion; the third stitched line being disposed at a radially position inboard of the first stitched line relative to the central longitudinal axis, and wherein the second coaptation tab is further secured to the attachment member by a fourth stitched line extending through both overlapping layers of the second coaptation tab and the protruding portion on the second side of the protruding portion, the fourth stitched line being disposed at a radially position inboard of the second stitched line relative to the central longitudinal axis.

[0249] Example 46. The prosthetic heart valve of any of the examples herein, particularly any of examples 41-45, wherein the protruding portion comprises two overlapping layers, each of the overlapping layers extending from a different inner end of the base portion, wherein the two overlapping layers of the protruding portion overlap in the transverse direction.

[0250] Example 47. The prosthetic heart valve of any of the examples herein, particularly any of examples 41-46, wherein the attachment member comprises a fabric material.

[0251] Example 48. The prosthetic heart valve of any of the examples herein, particularly any of examples 41-47, wherein the attachment member comprises a polyethylene terephthalate (PET) fabric.

[0252] Example 49. The prosthetic heart valve of any of the examples herein, particularly any of examples 41-48, wherein the protruding portion of the attachment member extends in the axial direction along an entire height of each of the first coaptation tab and the second coaptation tab.

[0253] Example 50. The prosthetic heart valve of any of the examples herein, particularly any of examples 41-49, wherein the coaptation support portion is at least a portion of a support post of the frame.

[0254] Example 51. The prosthetic heart valve of any of the examples herein, particularly example 50, wherein the support post is one of an actuator, an expansion lock mechanism, and an alternative support post of the frame.

[0255] Example 52. The prosthetic heart valve of any of the examples herein, particularly any of examples 41-51, wherein the coaptation support portion is a coaptation window formed by spaced-apart struts of the frame.

[0256] Example 53. A prosthetic heart valve comprising: an annular frame comprising a plurality of commissure supports; a plurality of leaflets positioned within the frame, each leaflet comprising a body and two opposing commissure tabs arranged on opposite sides of the body, each commissure tab paired with an adjacent commissure tab of an adjacent leaflet to form a commissure; and a plurality of commissure support members, each commissure support member comprising a coupling portion coupled to a respective one of the plurality of commissure supports and a commissure receiving portion; wherein each commissure of the prosthetic heart valve comprises: an attachment member directly attached to the respective commissure support member, the attachment member comprising a base portion extending across an inner surface of the commissure receiving portion of the commissure support member and a protruding portion extending radially outward from a central region of the base portion and radially inward toward a central longitudinal axis of the frame; a first commissure tab of a first leaflet of the plurality of leaflets folded into two overlapping layers that overlap in a transverse direction arranged perpendicular to an axial direction and a radial direction relative to the central longitudinal axis, the two overlapping layers arranged adjacent to a first side of the protruding portion of the attachment member and directly secured to the attachment member; and a second commissure tab of a second leaflet of the plurality of leaflets folded into two overlapping layers that overlap in the transverse direction, the two overlapping layers arranged adjacent to an opposite second side of the protruding portion of the attachment member and directly secured to the attachment member.

[0257] Example 54. The prosthetic heart valve of any example herein, particularly example 53, wherein the commissure receiving portion of the commissure support member is offset from the coupling portion in the radial direction.

[0258] Example 55. The prosthetic heart valve of any example herein, particularly any one of examples 53-54, wherein the commissure receiving portion is an open window formed by two axial members of the commissure support member, the two axial members spaced apart from one another in the transverse direction.

[0259] Example 56. The prosthetic heart valve of any example herein, particularly example 55, wherein the attachment member is directly attached to the open window via a first suture and a second suture, the first suture passing through a first end of the base portion of the attachment member and extending around a first axial member of the two axial members, and the second suture extending through a second end of the base portion of the attachment member and extending around a second axial member of the two axial members.

[0260] Example 57. The prosthetic heart valve of any example herein, particularly any one of examples 53-56, wherein a first fold between the two overlapping layers of the first commissure tab is disposed against the base portion, adjacent to a first bend between the base portion and the first side of the protruding portion, and wherein a second fold between the two overlapping layers of the second commissure tab is disposed against the base portion, adjacent to a second bend between the base portion and the second side of the protruding portion.

[0261] Example 58. The prosthetic heart valve of any example herein, in particular any one of examples 53-57, wherein the first coaptation tab is directly secured to the attachment member by a first suture extending through both overlapping layers of the first coaptation tab and the first side of the protruding portion on the first side of the protruding portion, and wherein the second coaptation tab is directly secured to the attachment member by a second suture extending through both overlapping layers of the protruding portion and the second coaptation tab on the second side of the protruding portion.

[0262] Example 59. The prosthetic heart valve of any example herein, in particular any one of examples 53-58, wherein the first coaptation tab is further secured to the attachment member by a third suture extending through both overlapping layers of the first coaptation tab and the protruding portion on the first side of the protruding portion; the third suture being arranged at a radial position inwards of the first suture with respect to the central longitudinal axis, and wherein the second coaptation tab is further secured to the attachment member by a fourth suture extending through both overlapping layers of the second coaptation tab and the protruding portion on the second side of the protruding portion, the fourth suture being arranged at a radial position inwards of the second suture with respect to the central longitudinal axis.

[0263] Example 60. The prosthetic heart valve of any example herein, in particular any one of examples 53-59, wherein the protruding portion comprises two overlapping layers, each of the overlapping layers extending from a different inner end of the base portion, wherein the two overlapping layers of the protruding portion overlap in the transverse direction.

[0264] Example 61. The prosthetic heart valve of any example herein, in particular any one of examples 53-60, wherein the attachment member comprises a fabric material.

[0265] Example 62. The prosthetic heart valve of any example herein, in particular any one of examples 53-61, wherein the attachment member comprises a polyethylene terephthalate (PET) fabric.

[0266] Example 63. The prosthetic heart valve of any example herein, in particular any one of examples 53-62, wherein the protruding portion of the attachment member extends along the entire height of each of the first coaptation tab and the second coaptation tab along the axial direction.

[0267] Example 64. The prosthetic heart valve of any example herein, in particular any one of examples 53-63, wherein the coaptation support portion is arranged on one of the support posts, the actuator, and the expansion locking mechanism of the frame.

[0268] Example 65. A prosthetic heart valve comprising: an annular frame comprising a plurality of interconnected and angled struts defining a plurality of rows of cells arranged between an outflow end and an inflow end of the frame, and a plurality of leaflets within the frame, each leaflet comprising a body and two opposing coaptation tabs arranged on opposite sides of the body, each coaptation tab paired with an adjacent coaptation tab of an adjacent leaflet to form a commissure; wherein each commissure of the prosthetic heart valve comprises: an attachment member directly attached to an angled strut defining a cell included in the plurality of rows of cells, the attachment member comprising a base extending across the cell and a protrusion extending radially outward from a central region of the base and radially inward toward the central longitudinal axis; a first coaptation tab of a first leaflet of the plurality of leaflets folded into two overlapping layers overlapping in a transverse direction arranged perpendicular to an axial direction and a radial direction relative to the central longitudinal axis, the two overlapping layers arranged adjacent to a first side of the protrusion of the attachment member and directly secured to the attachment member; a second coaptation tab of a second leaflet of the plurality of leaflets folded into two overlapping layers overlapping in the transverse direction, the two overlapping layers arranged adjacent to an opposite second side of the protrusion of the attachment member and directly secured to the attachment member.

[0269] Example 66. The prosthetic heart valve of any of the examples herein, particularly Example 65, wherein the attachment member is directly attached to the angled strut of the cell by one or more sutures extending through the base of the attachment member and extending around the angled strut forming the cell, around a perimeter of the cell.

[0270] Example 67. The prosthetic heart valve of any of Examples 65-66 herein, wherein a first fold between the two overlapping layers of the first coaptation tab is disposed against the base, adjacent to a first bend between the base and the first side of the protrusion, and wherein a second fold between the two overlapping layers of the second coaptation tab is disposed against the base, adjacent to a second bend between the base and the second side of the protrusion.

[0271] Example 68. The prosthetic heart valve of any of the examples herein, particularly any of Examples 65-67, wherein the first coaptation tab is directly secured to the attachment member by a suture extending through the two overlapping layers of the first coaptation tab and the first side of the protrusion on the first side of the protrusion, and wherein the second coaptation tab is directly secured to the attachment member by a suture extending through the two overlapping layers of the second coaptation tab and the second side of the protrusion on the second side of the protrusion.

[0272] Example 69. The prosthetic heart valve of any of the examples herein, particularly any of examples 65-68, wherein the first coaptation tab is further secured to the attachment member by a third stitched line extending across the two overlapping layers of the first coaptation tab and the protruding portion on the first side of the protruding portion; the third stitched line being disposed at a radially position inboard of the first stitched line relative to the central longitudinal axis, and wherein the second coaptation tab is further secured to the attachment member by a fourth stitched line extending across the two overlapping layers of the second coaptation tab and the protruding portion on the second side of the protruding portion, the fourth stitched line being disposed at a radially position inboard of the second stitched line relative to the central longitudinal axis.

[0273] Example 70. The prosthetic heart valve of any of the examples herein, particularly any of examples 65-69, wherein the protruding portion comprises two overlapping layers, each overlapping layer extending from a different inner end of the base, wherein the two overlapping layers of the protruding portion overlap in the transverse direction.

[0274] Example 71. The prosthetic heart valve of any of the examples herein, particularly any of examples 65-70, wherein the attachment member comprises a fabric material.

[0275] Example 72. The prosthetic heart valve of any of the examples herein, particularly any of examples 65-71, wherein the attachment member comprises a polyethylene terephthalate (PET) fabric.

[0276] Example 73. The prosthetic heart valve of any of the examples herein, particularly any of examples 65-72, wherein the protruding portion of the attachment member extends along an entire height of each of the first coaptation tab and the second coaptation tab along the axial direction.

[0277] Example 74. A prosthetic heart valve comprising: an annular frame comprising a plurality of interconnected and angled struts defining a plurality of rows of cells arranged between an outflow end and an inflow end of the frame, and a plurality of coaptation supports; and a plurality of leaflets positioned within the frame, each leaflet comprising a body and two opposing coaptation tabs arranged on opposite sides of the body, the body comprising an outflow edge extending across the leaflet between the two opposing coaptation tabs, and a cusp edge portion merging to form an inflow end portion of the leaflet; each coaptation tab pairing with an adjacent coaptation tab of an adjacent leaflet to form a coaptation, wherein each coaptation tab comprises one or more pin line having one or more holes adapted to receive a suture, wherein each pin line extends between an upper edge and a lower edge of the coaptation tab and comprises a portion offset from a remainder of the pin line toward the body of the leaflet, the portion comprising one or more holes arranged inward of a first outer hole of the pin line arranged adjacent the upper edge, the upper edge connected to the outflow edge of the leaflet, and wherein each coaptation is secured directly to a corresponding coaptation support of the plurality of coaptation supports or to an attachment member configured to couple to a coaptation support by one or more sutures extending along the one or more pin lines.

[0278] Example 75. The prosthetic heart valve of any example herein, particularly example 74, wherein the portion of the pin line offset from the remainder of the pin line is a middle portion of the pin line and comprises one or more inner holes arranged inward of outer holes of the pin line, the outer holes comprising a first outer hole arranged adjacent the upper edge and a second outer hole arranged adjacent the lower edge.

[0279] Example 76. The prosthetic heart valve of any example herein, particularly example 74, wherein the portion of the pin line offset from the remainder of the pin line is a lower portion of the pin line and the lower portion of the pin line comprises one or more inner holes and a second outer hole arranged adjacent the lower edge, the inner holes and the second outer hole arranged at least inward of the first outer hole.

[0280] Example 77. The prosthetic heart valve of any example herein, particularly example 76, wherein the remainder of the pin line comprises one or more outer holes, the one or more outer holes comprising a first outer hole angled from an outer edge of the coaptation tab, the outer edge extending between the upper edge and the lower edge to a midpoint arranged inward of the outer edge, and wherein the offset portion of the pin line extends from the midpoint to the lower edge of the coaptation tab.

[0281] Example 78. The prosthetic heart valve of any of the examples herein, particularly any of examples 74-77, wherein each coaptation tab of the leaflet is connected to the main body by a respective neck region, and wherein the one or more tacking lines comprise at least two tacking lines arranged adjacent to each other between the outer edge of the coaptation tab and the neck region.

[0282] Example 79. The prosthetic heart valve of any of the examples herein, particularly any of examples 74-78, wherein each coaptation is secured to the protruding portion of the attachment member by one or more sutures extending along the one or more tacking lines of the coaptation tab of the coaptation, the attachment member comprising a base coupled to an inner surface of the coaptation support portion, and wherein the protruding portion extends radially outward from the base toward the central longitudinal axis of the frame.

[0283] Example 80. A prosthetic heart valve comprising: an annular frame comprising a plurality of coaptation support portions; and a plurality of leaflets positioned within the frame, each leaflet comprising a main body and two opposing coaptation tabs arranged on opposite sides of the main body, each coaptation tab pairing with an adjacent coaptation tab of an adjacent leaflet to form a coaptation; wherein each coaptation of the prosthetic heart valve comprises: an attachment member comprising a first portion and a second portion, the first portion spanning across and directly attached to a corresponding coaptation support portion of the plurality of coaptation support portions or to a coaptation support element configured to be coupled to a coaptation support portion, the second portion protruding radially outward from the first portion and extending radially inward toward a central longitudinal axis of the frame; a first coaptation tab of a first leaflet of the plurality of leaflets arranged adjacent to a first side of the second portion of the attachment member and directly secured to the attachment member; and a second coaptation tab of a second leaflet of the plurality of leaflets arranged adjacent to an opposite second side of the second portion of the attachment member and directly secured to the attachment member.

[0284] In view of the many possible embodiments to which the principles of the disclosed technology can be applied, it should be recognized that the examples shown are only preferred examples and should not be taken as limiting the scope of the claimed subject matter. Rather, the scope of the claimed subject matter is defined by the claims and their equivalents.

Claims

1. A prosthetic heart valve comprising: an annular frame comprising a plurality of coaptation supports; and a plurality of leaflets located within the frame, each leaflet comprising a main body and two opposing coaptation tabs arranged on opposite sides of the main body, each coaptation tab pairing with an adjacent coaptation tab of an adjacent leaflet to form a coaptation; wherein each coaptation of the prosthetic heart valve comprises: an attachment member comprising a first portion and a second portion, the first portion extending across and directly attached to a corresponding coaptation support of the plurality of coaptation supports or to a coaptation support element configured to be coupled to the coaptation support, the second portion projecting radially outward from the first portion and extending radially inward toward a central longitudinal axis of the frame; a first coaptation tab of a first leaflet of the plurality of leaflets arranged adjacent to a first side of the second portion of the attachment member and directly secured to the attachment member; and a second coaptation tab of a second leaflet of the plurality of leaflets arranged adjacent to an opposite second side of the second portion of the attachment member and directly secured to the attachment member.

2. The prosthetic heart valve of claim 1, wherein, the first portion of the attachment member is arranged against a radially inward surface of the coaptation support or the coaptation support element configured to be coupled to the coaptation support, and wherein the first portion of the attachment member extends across only the radially inward surface of the coaptation support or the coaptation support element or only a portion of the radially inward surface and a lateral surface of the coaptation support or the coaptation support element, the lateral surface arranged perpendicular to the radially inward surface.

3. The prosthetic heart valve of claim 1, wherein, the second portion of the attachment member extends radially outward from a central region of the first portion of the attachment member and comprises two overlapping layers, each overlapping layer extending from a different inner end of the first portion, wherein the two overlapping layers overlap in a lateral direction.

4. The prosthetic heart valve of any of claims 1-3, wherein, the attachment member comprises a fabric material.

5. The prosthetic heart valve of any of claims 1-3, wherein, the first coaptation tab is folded into two overlapping layers overlapping in a lateral direction arranged perpendicular to an axial direction and a radial direction relative to the central longitudinal axis, the two overlapping layers arranged adjacent to the first side of the second portion of the attachment member and directly secured to the attachment member, and wherein the second coaptation tab is folded into two overlapping layers overlapping in a lateral direction, the two overlapping layers arranged adjacent to the second side of the second portion of the attachment member and directly secured to the attachment member.

6. The prosthetic heart valve of claim 5, wherein, the two overlapping layers of each of the first coaptation tab and the second coaptation tab comprise a first tab portion arranged against a respective one of the first side and the second side of the second portion of the attachment member and a second tab portion arranged against the first tab portion, the first side and the second side of the second portion and the first tab portion and the second tab portion of each of the first coaptation tab and the second coaptation tab are all arranged parallel to each other.

7. The prosthetic heart valve of claim 5, wherein, The first folded-in seam tab wedges onto the attachment member in the area of the first bend between the first portion and the first side of the second portion of the attachment member, and wherein the second folded-in seam tab wedges onto the attachment member in the area of the second bend between the first portion and the second side of the second portion of the attachment member.

8. The prosthetic heart valve of claim 7, wherein, The two overlapping layers of the first seam tab are secured to the attachment member by one or more sutured threads extending through the two overlapping layers and the attachment member proximate the first bend, and wherein the two overlapping layers of the second seam tab are secured to the attachment member by one or more sutured threads extending through the two overlapping layers and the attachment member proximate the second bend.

9. The prosthetic heart valve of any of claims 1-3, wherein the second portion of the attachment member extends along an entire height of each of the first seam tab and the second seam tab along an axial direction.

10. The prosthetic heart valve of any of claims 1-3, wherein, The attachment member is directly attached to the coaptation support, wherein the coaptation support is a support post of the frame, and wherein the attachment member is directly attached to the support post via a suture extending through the attachment member and around an outer surface of the support post.

11. The prosthetic heart valve of claim 10, wherein, The support post is one of an actuator or an expansion locking mechanism of the frame.

12. The prosthetic heart valve of any of claims 1-3, wherein, The attachment member is directly attached to the coaptation support, and wherein the coaptation support is a coaptation window formed by spaced apart axially extending struts of the frame.

13. The prosthetic heart valve of any of claims 1-3, wherein, The attachment member is directly attached to a leaflet receiving window of the coaptation support element via a first suture and a second suture, the leaflet receiving window being formed by spaced apart axial members of the coaptation support element, the first suture extending through a first end of the first portion of the attachment member and around a first axial member of the spaced apart axial members, the second suture extending through a second end of the first portion of the attachment member and around a second axial member of the spaced apart axial members.

14. The prosthetic heart valve of any of claims 1-3, wherein, The attachment member is arranged across and directly attached to a cell of the annular frame via one or more sutures, the cell being formed by angled struts of the annular frame, the one or more sutures extending through the first portion of the attachment member and around the angled struts forming the cell around a perimeter of the cell.

15. A method of assembling a prosthetic heart valve comprising a plurality of leaflets, comprising: forming a plurality of coaptations with the plurality of leaflets, each leaflet comprising two opposing coaptation tabs arranged on opposite sides of a body of the leaflet, wherein each coaptation is formed by: folding each of a first coaptation tab of a first leaflet and a second coaptation tab of an adjacent second leaflet into two overlapping layers that overlap in a transverse direction, the transverse direction being arranged perpendicular to an axial direction and a radial direction relative to a central longitudinal axis of an annular frame of the prosthetic heart valve; arranging a folded first coaptation tab against a first side of a protruding portion of an attachment member, and arranging a folded second coaptation tab against an opposite second side of the protruding portion, the protruding portion extending in a radial direction away from a base of the attachment member; securing each of the first and second coaptation tabs to the attachment member; and for each coaptation, attaching the attachment member to a respective coaptation support portion of the annular frame directly or via a coaptation support element configured to couple to the coaptation support portion, the base of the attachment member being arranged in a radial direction between the folded first and second coaptation tabs and the coaptation support portion or the coaptation support element.

16. The method of claim 15, wherein, folding each of the first and second coaptation tabs includes folding each of the first and second coaptation tabs into two overlapping layers including a first tab portion and a second tab portion, wherein the first tab portion extends radially outward from a body of a respective one of the first and second leaflets toward the base of the attachment member, and the second tab portion extends radially inward away from the base of the attachment member and toward the central longitudinal axis of the frame.

17. The method of claim 16, wherein, the arrangement includes arranging a face of the first side of the protruding portion and an inner face of the first tab portion of the first coaptation tab in co-planar contact with each other along a height of the first coaptation tab, and arranging a face of the second side of the protruding portion and an inner face of the first tab portion of the second coaptation tab in co-planar contact with each other along a height of the second coaptation tab, the height of the first coaptation tab being arranged in an axial direction.

18. The method of claim 17, wherein, the arrangement further includes, for each of the first and second coaptation tabs, folding against an inner side of the base of the attachment member between the first tab portion and the second tab portion, such that each of the folded first coaptation tab and the folded second coaptation tab is wedged on the attachment member in a region of a bend between the base and the protruding portion.

19. The method of any of claims 15-18, wherein securing each of the first and second coaptation tabs to the attachment member includes: extending one or more sutures through the protruding portion and the two overlapping layers of the first coaptation tab along one or more tacking lines of the first coaptation tab toward a centerline of a body of a corresponding leaflet, the tacking lines including at least one intermediate portion offset from a remainder of the tacking lines, the intermediate portion being arranged away from an outflow edge of the corresponding leaflet, and extending one or more sutures through the protruding portion and the two overlapping layers of the second coaptation tab along one or more tacking lines of the second coaptation tab toward a centerline of a body of a corresponding leaflet, the tacking lines including at least one intermediate portion offset from a remainder of the tacking lines, the intermediate portion being arranged away from an outflow edge of the corresponding leaflet.

20. The method of any of claims 15-18, wherein, The protruding portion includes two overlapping layers, each overlapping layer extending from a different end of the base, and wherein securing each of the first and second coaptation tabs to the attachment member includes extending one or more sutures through the two overlapping layers of the first coaptation tab and a first layer of the protruding portion, and extending one or more sutures through the two overlapping layers of the second coaptation tab and a second layer of the protruding portion.

21. The method of any of claims 15-18, wherein, Attaching the attachment member to the respective coaptation support portion of the annular frame directly or via a coaptation support element includes arranging the base of the attachment member against an inner surface of a support post of the annular frame, and securing the attachment member to the support post by sutures extending through the attachment member and around an outer surface of the support post.

22. A prosthetic heart valve comprising: an annular frame comprising a plurality of coaptation support portions, each coaptation support portion comprising an inner surface facing a central longitudinal axis of the frame and an oppositely arranged outer surface; and a plurality of leaflets within the frame, each leaflet comprising a main body and two opposing coaptation tabs arranged on opposite sides of the main body, each coaptation tab pairing with an adjacent coaptation tab of an adjacent leaflet to form a coaptation; wherein each coaptation of the prosthetic heart valve comprises: an attachment member directly attached to a corresponding coaptation support portion of the plurality of coaptation support portions, the attachment member comprising a base extending across the inner surface of the coaptation support portion and a protruding portion extending radially outward from a central region of the base and radially inward toward the central longitudinal axis; a first coaptation tab of a first leaflet of the plurality of leaflets folded into two overlapping layers overlapping in a transverse direction arranged perpendicular to an axial direction and a radial direction relative to the central longitudinal axis, the two overlapping layers arranged adjacent to a first side of the protruding portion of the attachment member and directly secured to the attachment member; and a second coaptation tab of a second leaflet of the plurality of leaflets folded into two overlapping layers overlapping in the transverse direction, the two overlapping layers arranged adjacent to an opposite second side of the protruding portion of the attachment member and directly secured to the attachment member.

23. The prosthetic heart valve of claim 22, wherein, a first fold between the two overlapping layers of the first coaptation tab is arranged against the base, adjacent to a first bend between the base and the first side of the protruding portion, and wherein a second fold between the two overlapping layers of the second coaptation tab is arranged against the base, adjacent to a second bend between the base and the second side of the protruding portion.

24. The prosthetic heart valve of claim 22, wherein, The protruding portion includes two overlapping layers, each overlapping layer extending from a different end of the base, wherein the two overlapping layers of the protruding portion overlap in a transverse direction, and wherein the protruding portion of the attachment member extends in the axial direction along an entire height of each of the first and second coaptation tabs.

25. The prosthetic heart valve of any of claims 22-24, wherein, The coaptation support portion is one of: at least a portion of a support column of the frame, wherein the support column is one of an actuator, an expansion lock mechanism, and a replacement support column of the frame; or a mullion window formed by spaced apart axially extending stiles of the frame.

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