Prosthetic heart valve leaflet commissure assembly and method

Abstract

A prosthetic heart valve including an annular frame and multiple leaflets and an associated method for assembling the prosthetic heart valve are disclosed. In one example, the valve includes multiple commissures, each of which includes an attachment member having a protruding portion and a first commissure tab of a first leaflet of the multiple leaflets disposed adjacent a first side of the protruding portion and secured directly to the attachment member. Each commissure further includes a second commissure tab of a second leaflet of the multiple leaflets disposed adjacent a second, opposite side of the protruding portion and secured directly to the attachment member.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 024,951, filed May 14, 2020, which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to prosthetic heart valves and methods and assemblies for forming the leaflets and commissures of such prosthetic heart valves. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can cause significant cardiac dysfunction, ultimately necessitating repair of the native valve or replacement of the native valve with a prosthetic valve. There are many known repair devices (e.g., stents) and prosthetic valves, as well as many known methods for implanting these devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver prosthetic (artificial) medical devices to locations within the body that are not easily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve may be attached in a crimped state to the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon to which the prosthetic valve is attached, by activating a mechanical actuator that applies an expansive force to the prosthetic valve, or by deploying the prosthetic valve from a sheath. The delivery device is adjusted to allow the prosthetic valve to self-expand to its functional size.

[0004] Prosthetic valves that rely on mechanical actuators for expansion may be referred to as "mechanically expandable" prosthetic heart valves. The actuators typically take the form of pull cables, sutures, wires, and / or shafts configured to transmit an expansion force from the handle of the delivery device to the prosthetic valve.

[0005] Most expandable transcatheter heart valves include a cylindrical metal frame or stent and prosthetic valve leaflets attached to the inside of the frame. The leaflets may be attached to the frame by their commissure tabs (also called leaflet tabs). For example, a commissure may be formed by connecting the commissure tabs of two adjacent leaflets to each other, and in some embodiments, by connecting them to a commissure support (or attachment) element configured to couple to the commissure support portion of the frame. The commissure or commissure support element may then be attached to the commissure support portion of the frame via fasteners such as sutures.

[0006] Typical commissures or commissure assemblies are relatively complex due to the numerous stitches that may be required, and forming and suturing the commissure support portion of the frame can be time-consuming. Furthermore, these types of attachment methods to the commissures and commissure support portions can be subject to wear along the numerous stitches and along the portions of the commissure tabs that wrap around the sides and / or outward-facing surfaces of the commissure support portion. In some instances, an attached commissure can deteriorate due to displacement of the commissure from its initial, fixed position, including rotation around the commissure support portion and sliding axially up and down along the commissure support portion. Furthermore, in some embodiments, bending the commissure tabs perpendicularly (e.g., axially relative to the central longitudinal axis of the frame) to form the commissure can result in weaker attachment of the frame to the commissure support portion.

[0007] The frame of a prosthetic heart valve typically undergoes shortening, resulting in leaflet changes during crimping and expansion of the valve frame. The leaflets of a prosthetic heart valve may also experience stress from cyclic forces experienced during operation of the prosthetic heart valve in vivo. For example, repeated opening and closing of the valve leaflet assembly can cause degradation of the leaflets, such as degradation of the tissue collagen matrix of bovine or porcine tissue that makes up the leaflets.

[0008] Therefore, a need exists for improved prosthetic heart valve leaflet assemblies and commissures formed with such leaflet assemblies, as well as methods for assembling the commissures to the prosthetic heart valve frame. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] U.S. Patent Application Publication No. 2018 / 0153689 [Patent Document 2] U.S. Patent Application Publication No. 2018 / 0344456 [Patent Document 3] U.S. Patent Application Publication No. 2019 / 0060057 [Patent Document 4] U.S. Patent Application Publication No. 2018 / 0325665 [Patent Document 5] U.S. Patent No. 6,730,118 [Patent Document 6] U.S. Patent No. 7,393,360 [Patent Document 7] U.S. Patent No. 7,510,575 [Patent Document 8] U.S. Patent No. 7,993,394 [Patent Document 9] U.S. Patent No. 8,652,202 [Patent Document 10] International Application No. PCT / US2020 / 057691 [Patent Document 11] International Application No. PCT / US2019 / 056865 [Patent Document 12] U.S. Patent Application No. 16 / 788,090 [Patent Document 13] International Application No. PCT / US2021 / 020206 [Patent Document 14] International Publication No. WO2018 / 222799 [Patent Document 15] International Application No. PCT / US2020 / 040318 [Patent Document 16] International Application No. PCT / US2021 / 012146 Summary of the Invention

[0010] Described herein are embodiments of prosthetic heart valves and methods for assembling prosthetic heart valves including annular frames and leaflet assemblies. In some embodiments, commissures may be formed by folding a pair of commissure tabs of adjacent leaflets within a leaflet assembly such that the folded portions of the pair of commissure tabs are radially disposed and secure the pair of folded commissure tabs to protruding portions of the attachment members that extend outward from the base portions of the attachment members. The base portions of the attachment members may then be secured to the commissure support portions of the frame to secure the commissures to the frame.

[0011] In one exemplary embodiment, a prosthetic heart valve includes an annular frame including a plurality of commissure support portions and a plurality of leaflets positioned within the frame, each leaflet including a body and two opposing commissure tabs disposed on opposite sides of the valve, each commissure tab pairing 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 across and directly attached to a commissure support element configured to couple to a corresponding commissure support portion or portions of the plurality of commissure support portions, and a second portion projecting radially outward from the first portion and extending radially inward toward a central longitudinal axis of the frame. Each commissure further includes a first commissure tab of a first leaflet of the plurality of leaflets folded into two laterally overlapping layers, the laterally oriented axially and radially perpendicular to the central longitudinal axis, the two overlapping layers positioned adjacent to a first side of the second portion of the attachment member and directly secured to the attachment member. Each commissure further includes a second commissure tab of a second leaflet of the plurality of leaflets folded into two laterally overlapping overlapping layers, the two overlapping layers positioned adjacent to a second, opposite side of the second portion of the attachment member and directly secured to the attachment member.

[0012] In another exemplary embodiment, a method of assembling a prosthetic heart valve with multiple leaflets includes forming a plurality of leaflets and a plurality of commissures, each leaflet including two opposing commissure tabs disposed on either side of a body of the leaflet. Each commissure is formed by: folding each first commissure tab of a first leaflet and each second commissure tab of an adjacent second leaflet into two laterally overlapping layers, the laterally oriented perpendicular to the axial direction and the laterally oriented radially relative to a central longitudinal axis of the annular frame of the prosthetic heart valve; positioning the folded first commissure tab against a first side of a protruding portion of the attachment member and the folded second commissure tab against an opposite second side of the protruding portion; securing each of the first and second commissure tabs of the attachment member to the attachment member, the protruding portion extending radially away from the base; and attaching, for each commissure, the attachment member to a respective commissure support portion of the annular frame, either directly or via a commissure support element configured to be coupled to the commissure support portion, wherein the base portion of the attachment member is radially formed by the folded first and second commissure tabs and the commissure support portion or commissure support element.

[0013] In another exemplary embodiment, a prosthetic heart valve includes an annular frame including a plurality of commissural support portions, each including an inner surface facing a central longitudinal axis of the frame and an outer surface disposed on an opposite side, and each leaflet includes a body and two opposing commissural tabs disposed on either side of the body, each commissural tab pairing with an adjacent commissural tab of an adjacent leaflet to form a commissure. Each commissure of the prosthetic heart valve includes an attachment member directly attached to a corresponding one of the plurality of commissural support portions, the attachment member including a base portion extending across the inner surface of the commissural support portion and an extending protruding portion, extending radially outward from a central region of the base portion and extending radially inward toward the central longitudinal axis. Each commissure further includes a first commissure tab of a first leaflet of the plurality of leaflets folded into two laterally overlapping layers, the laterally oriented perpendicular to the axial and radial directions relative to the central longitudinal axis, the two overlapping layers positioned adjacent a first side of the protruding portion of the attachment member and directly secured to the attachment member. Each commissure further includes a second commissure tab of a second leaflet of the plurality of leaflets folded into two laterally overlapping layers, the two overlapping layers positioned adjacent a second, opposite side of the protruding portion of the attachment member and directly secured to the attachment member.

[0014] In another exemplary embodiment, a prosthetic heart valve includes an annular frame including a plurality of commissural support portions, a plurality of leaflets disposed within the frame, each leaflet including a body and two opposing commissural tabs disposed on either side of the body, each commissural tab mating with an adjacent commissural tab of an adjacent leaflet to form a commissure, and a plurality of commissural support elements, each including a connecting portion coupled to a corresponding one of the plurality of commissural support portions and a commissural receiving portion, each commissural support element including a base portion extending across an inner surface of the commissural receiving portion of the commissural support element and a radially extending protruding portion, the frame extending outward from a central region of the base portion and extending radially inward toward a central longitudinal axis of the frame. Each commissure further includes a first commissure tab of a first leaflet of the plurality of leaflets folded into two laterally overlapping layers, the laterally oriented perpendicular to the axial and radial directions relative to the central longitudinal axis, the two overlapping layers positioned adjacent a first side of the protruding portion of the attachment member and directly secured to the attachment member. Each commissure further includes a second commissure tab of a second leaflet of the plurality of leaflets folded into two laterally overlapping layers, the two overlapping layers positioned adjacent a second, opposite side of the protruding portion of the attachment member and directly secured to the attachment member.

[0015] In yet another exemplary embodiment, a prosthetic heart valve includes an annular frame including a plurality of interconnected canted struts defining a plurality of rows of cells disposed between the inflow and outflow ends of the frame, and a plurality of leaflets positioned within the frame, each leaflet including a body and two opposing commissure tabs disposed on either side of the body, each commissure tab pairing with an adjacent commissure tab of an adjacent leaflet to form a commissure. Each commissure of the prosthetic heart valve includes an attachment member attached directly to the canted strut defining one of the rows of cells, the attachment member including a base portion extending across the cells and a protruding portion extending radially outward from a center of the base portion, the protruding portion extending radially inward toward the central longitudinal axis. Each commissure further includes a first commissure tab of a first leaflet of the plurality of leaflets folded into two laterally overlapping layers, the laterally oriented perpendicular to the axial and radial directions relative to the central longitudinal axis, the two overlapping layers positioned adjacent a first side of the protruding portion of the attachment member and directly secured to the attachment member, and each commissure further includes a second commissure tab of a second leaflet of the plurality of leaflets folded into two laterally overlapping layers, the two overlapping layers positioned adjacent a second, opposite side of the protruding portion of the attachment member and directly secured to the attachment member.

[0016] In another exemplary embodiment, a prosthetic heart valve includes an annular frame including a plurality of interconnected angled struts defining a plurality of rows of cells disposed between the outflow and inflow ends of the frame, a plurality of commissure support portions, and a plurality of leaflets positioned within the frame, each leaflet including a body and two opposing commissure tabs disposed on either side of the body, the body including an outflow edge extending across the leaflet between the two opposing commissure tabs and a cusp edge portion that meets to form the inflow end of the leaflet. Each commissure tab mates with an adjacent commissure tab of an adjacent leaflet to form a commissure, and each commissure tab includes one or more suture lines including one or more apertures configured to receive sutures, each suture line extending between the upper and lower edges of the commissure tab and including a portion offset from the remainder of the suture line toward the body of the leaflet, the portion including one or more apertures disposed inside a first outer aperture of the suture line disposed adjacent the upper edge connected to the outflow edge of the leaflet. Each commissure is secured directly to a corresponding one of the plurality of commissure support portions or via one or more sutures extending along the one or more suture lines to an attachment member configured to be coupled to the commissure support portion.

[0017] In another exemplary embodiment, a prosthetic heart valve includes an annular frame including a plurality of commissure support portions and a plurality of leaflets positioned within the frame, each leaflet including a body and two opposing commissure tabs disposed on either side of the body. Each commissure tab pairs 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 across and directly attached to a commissure support element configured to couple to a corresponding commissure support portion or commissure support portions of the plurality of commissure support portions, 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 leaflet of the plurality of leaflets disposed adjacent 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 leaflet of the plurality of leaflets disposed adjacent 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 invention will become more apparent from the following detailed description which proceeds with reference to the accompanying drawings. [Brief explanation of the drawings]

[0019] [Figure 1] 1 shows a perspective view of an exemplary embodiment of a prosthetic heart valve. [Figure 2] 10 shows a perspective view of a frame for a prosthetic heart valve with three expansion and locking mechanisms according to another embodiment. [Figure 3] 3 shows a top view of the frame and extension and locking mechanism of FIG. 2. [Figure 4] 1 shows a side view of a frame for a prosthetic heart valve having a tapered shape, according to one embodiment. [Figure 5] FIG. 10 is a side view of another embodiment of a frame of a prosthetic heart valve, the frame having a tapered shape. [Figure 6] 1 shows a plan view of an exemplary leaflet of a prosthetic heart valve. [Figure 7]1A shows a cross-sectional top view of an embodiment of a commissure of a prosthetic heart valve, where the commissure is secured to the struts of the prosthetic heart valve. [Figure 8] 8 shows a front perspective view of the inside of the strut of FIG. 7 with the commissure of FIG. 7 fixed to the strut. [Figure 9] 8 shows a rear perspective view of the outside of the strut of FIG. 7 with the commissure of FIG. 7 fixed to the strut. [Figure 10] 1 shows a perspective view of a prosthetic heart valve including a frame with open commissural windows, according to one embodiment. [Figure 11] 1 shows a perspective view of an exemplary frame of a prosthetic heart valve including open commissural windows. [Figure 12] 1A-1C show perspective views of embodiments of commissural support elements and corresponding actuator components of a frame of a prosthetic heart valve adapted to receive the commissural support elements. [Figure 13] 13 shows a perspective view of the embodiment of the commissural support element of FIG. 12 coupled to a corresponding actuator component. [Figure 14] 8 shows a cross-sectional, top view of the embodiment of the commissure of FIG. 7, in which the commissure is secured to an open commissure window in the frame of a prosthetic heart valve or to a commissure support element configured to be coupled to the frame. [Figure 15] 8 shows a detailed perspective view of the commissure embodiment of FIG. 7, in which the commissure is fixed to a cell of the frame of the prosthetic heart valve. [Figure 16] 16 shows a side view of an exemplary prosthetic heart valve including the commissures of FIG. 15. [Figure 17] 1 shows a flowchart of a method for assembling a prosthetic heart valve including multiple leaflets. [Figure 18] 1 shows a detailed view of a portion of an exemplary leaflet having a first embodiment of relatively straight suture lines at the commissure tabs of the leaflet. [Figure 19] 10 shows a detailed view of a portion of an exemplary leaflet having a second embodiment of sutures at the commissure tabs, with portions of the sutures offset from the remainder of the sutures. [Figure 20] 10 shows a detailed view of a portion of an exemplary leaflet having a third embodiment of sutures at the commissure tabs, with portions of the sutures offset from the remainder of the sutures. [Figure 21] FIG. 1 shows a side view of an embodiment of a transcatheter delivery device for delivering a prosthetic heart valve to a target implantation site, with the prosthetic heart valve held in a radially compressed state within a capsule of the delivery device. [Figure 22] FIG. 22 is a side view of the transcatheter delivery device of FIG. 21 , showing the capsule retracted to expose the prosthetic heart valve. DETAILED DESCRIPTION OF THE INVENTION

[0020] For purposes of this description, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The described methods, systems, and apparatuses 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, both alone and in various combinations and subcombinations with each other. The disclosed methods, systems, and apparatuses are not limited to any particular aspect, feature, or combination thereof, and the disclosed methods, systems, and apparatuses do not require that any one or more particular advantages be present or problems be solved.

[0021] It should be understood that any feature, element, property, compound, chemical moiety, or group described in connection with a particular aspect, embodiment, or example of the present disclosure is applicable to any other aspect, embodiment, or example described herein, unless inconsistent therewith. All features disclosed herein (including the accompanying claims, abstract, and drawings), and / or all steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. The present disclosure is not limited to the details of the foregoing embodiments. The present disclosure extends to any novel one or any novel combination of features disclosed herein (including the accompanying claims, abstract, and drawings), or any novel one or any novel combination of steps of any method or process so disclosed.

[0022] Although some operations of the disclosed methods are described in a particular sequential order for convenience, it should be understood that the description of this method encompasses rearrangements unless a particular order is required by specific language set forth below. For example, operations described in sequence may in some cases be reordered or performed simultaneously. Moreover, for the sake of brevity, the accompanying figures may not show the various ways in which the disclosed methods, systems, and apparatus can be used in combination with other systems, methods, and apparatus.

[0023] As used herein, the terms "a," "an," and "at least one" include one or more of the specified elements. That is, if there are two of a particular element, then one of those elements is also present, and therefore there is "one" element. The terms "plurality" and "plurality" mean two or more of the specified elements.

[0024] As used herein, the term "and / or" used between the last two of listed 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."

[0025] As used herein, the term "coupled" generally means physically connected or linked and does not exclude the existence of intermediate elements between connected items absent a specific opposite.

[0026] Directions and other relative references (e.g., inside, outside, top, bottom, etc.) may be used to facilitate discussion of the figures and principles herein, but are not intended to be limiting. For example, specific terms such as "inside," "outside," "top," "bottom," "inside," "outside," etc. may be used. Such terms are used to provide a degree of clarity of description, where applicable, particularly when dealing with relative relationships with respect to the illustrated embodiments. However, such terms do not imply absolute relationships, positions, and / or orientations. For example, an object can be simply turned over and an "upper" part becomes a "lower" part. Nevertheless, it is the same part and the subject remains the same. As used herein, "and / or" means "and" or "or," as well as "and" and "or."

[0027] As used herein, with respect to prosthetic heart valves and delivery devices, "proximal" refers to a position, direction, or portion of a component closer to the user and / or the handle of the delivery device, while "distal" refers to a position, direction, or portion of a component further from the user and / or the handle of the delivery device, closer to the implantation site. The terms "longitudinal" and "axial," unless expressly defined otherwise, refer to axes extending proximally and distally. Additionally, the term "radial" refers to a direction disposed perpendicular to an axis and pointing along a radius from the center of the object (where the axis is located at the center, such as the longitudinal axis of a prosthetic valve).

[0028] [Example of the disclosed technology] Described herein are examples of prosthetic heart valves, leaflet assemblies, and commissures for prosthetic heart valves, as well as methods for assembling prosthetic heart valve commissures. The prosthetic heart valve may include an annular frame and multiple leaflets attached to the frame via commissures formed by joining pairs of adjacent leaflet ends (referred to herein as commissure tabs). Forming the commissures includes folding a first commissure tab of a first leaflet and a second commissure tab of an adjacent second leaflet into two overlapping layers that are laterally overlapping, the laterality being axially and radially perpendicular to the central longitudinal axis of the annular frame. Forming the commissures further includes positioning the folded first commissure tab against a first side of a protruding portion of an attachment member and the folded second commissure tab against a second, opposite side of the protruding portion, the protruding portion being radially spaced from a base portion of the attachment member. In some embodiments, the attachment member may be a flexible fabric or polymeric material. Forming the commissures may further include securing each of the first and second commissure tabs to an attachment member, and then attaching the attachment members to respective commissure support portions of the frame, either directly or via commissure support elements configured to be coupled to the commissure support portions.

[0029] In some embodiments, the base portion of the attachment member may be radially positioned between the folded first and second commissure tabs and the commissure support portion or element, thereby blocking the commissure tabs of the valve leaflets from contacting the frame. This commissure configuration may reduce stress on the valve leaflets during valve actuation and radial expansion and / or contraction of the frame, thereby extending their lifespan.

[0030] FIG. 1 illustrates an exemplary prosthetic heart valve 10, according to one embodiment. The prosthetic heart valve 10 may be radially compressible and expandable between a radially compressed configuration (as shown in FIG. 1) and a radially expanded configuration for delivery to a patient. In certain embodiments, the prosthetic heart valve 10 may be implanted within the native aortic valve annulus, but may also be implanted in other locations in the heart, including within the native mitral valve, native pulmonary valve, and native 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.

[0031] In the illustrated embodiment, the first end 14 is the inflow end, and the second end 16 is the outflow end. The outflow end 16 may be coupled to a delivery device for delivering and implanting a prosthetic heart valve into a native aortic valve via a transfemoral retrograde delivery approach. Thus, in the delivery configuration of the prosthetic heart valve, the outflow end 16 is the most proximal end of the prosthetic valve. In other embodiments, the inflow end 14 may be coupled to a delivery device depending on the particular native valve being replaced and the delivery technique (e.g., transseptal, transapical, etc.) being used. For example, the inflow end 14 may be coupled to a delivery device (and thus is the most proximal end of the prosthetic heart valve in the delivery configuration) for an approach to deliver a prosthetic heart valve into a native mitral valve via a transseptal delivery approach. Exemplary delivery devices that can be used to deliver a prosthetic heart valve are shown in FIGS. 21 and 22 and are described in more detail below.

[0032] Returning to FIG. 1 , the frame 12 may be made of any of a variety of suitable materials, such as stainless steel, cobalt-chromium alloy, or nickel-titanium alloy (“NiTi”), e.g., nitinol. Referring again to FIG. 1 , as shown, the frame 12 may include a plurality of interconnected struts 28 arranged in a lattice-type pattern. The struts 28 are shown as being arranged diagonally, angularly offset, or radially offset relative to 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 may be offset by a different amount than shown in FIG. 1 , or some or all of the struts 28 may be arranged parallel to the longitudinal axis of the prosthetic heart valve 10.

[0033] In the illustrated embodiment, the struts 28 are pivotally coupled to one another at one or more pivot joints (connections) along the length of each strut. For example, in the illustrated configuration, each of the struts 28 defines an aperture at opposing ends thereof, and apertures may be formed at intervals along the length of the strut. Respective hinges may be formed where the struts 28 overlap one another via fasteners or pivot members, such as rivets or pins 30, that extend through the apertures. The hinges may 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.

[0034] In some embodiments, frame 12 may be constructed by forming individual components (e.g., frame struts and fasteners) and then mechanically assembling and connecting the individual components. In other embodiments, struts 28 are not joined to one another at respective hinges, but are otherwise pivotable or bendable relative to one another to allow radial expansion and contraction of frame 12. For example, frame 12 may be formed (e.g., by laser cutting, electroforming, or physical vapor deposition) from a single piece of material (e.g., a metal tube). Further details regarding the structure of frames and prosthetic heart valves are described in U.S. Patent Application Publication Nos. 2018 / 0153689, 2018 / 0344456, and 2019 / 0060057, all of which are incorporated herein by reference.

[0035] The prosthetic heart valve 10 may 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 may further include a plurality of actuators 80 attached to an inner surface of the frame 12 and evenly spaced therearound. The actuators are configured to apply expansion and compression to the frame to radially expand and compress the prosthetic valve.

[0036] In the illustrated embodiment, the actuators 80 are linear actuators, each comprising an inner member or piston 90 and an outer member or cylinder 92. The inner member 90 is pivotally coupled to a joint of the frame, such as the first end 14, and the outer member 92 is pivotally coupled to another joint of the frame closer to 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 is effective to radially expand the prosthetic valve. 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 is effective to radially compress the prosthetic valve. The actuators 80 may include a locking mechanism configured to retain the prosthetic valve in an expanded state within the patient.

[0037] In some embodiments, each of the actuators 80 can be configured to form a releasable connection with one or more respective actuators of a delivery device of the transcatheter delivery system. The delivery device actuator can transmit force from the delivery device handle to the actuator 80 to expand or compress the prosthetic valve. Further details of the actuators, locking mechanisms, and delivery devices for actuating the actuators can be found in U.S. Patent Application Publication Nos. 2018 / 0153689 (Patent Document 1), 2019 / 0060057 (Patent Document 3), and 2018 / 0325665 (Patent Document 4), each of which is incorporated herein by reference in its entirety. Any of the actuators and locking mechanisms disclosed in the previously filed applications can be incorporated into any of the prosthetic valves disclosed herein. Additionally, any of the delivery devices disclosed in the previously filed applications can be used to deliver and implant any of the prosthetic valves disclosed herein.

[0038] In some embodiments, each of the actuators 80 may be used to support a respective commissure 24 (as described below). Accordingly, the actuators 80 may include commissure support portions for supporting and attaching the commissures 24 of the valvular structure 18 to the frame 12, as further described herein.

[0039] The valve structure 18 may include, for example, a leaflet assembly with one or more leaflets 22 (three leaflets 22 in the illustrated embodiment) made of a flexible material. The leaflets 22 of the leaflet assembly may be made, in whole or in part, from a biological material, a biocompatible synthetic material, or other such material. Suitable biological materials may include, for example, bovine pericardium (or pericardium from other sources). Each leaflet 22 includes two opposing commissure tabs located on either side of the leaflet body. The leaflet body may be the portion of the leaflet configured to flex and move during operation of the prosthetic heart valve 10. The commissure tabs of adjacent leaflets 22 may be arranged to form a commissure 24, which may be attached, for example, to a commissure support portion of a respective actuator 80. Further details regarding transcatheter prosthetic heart valves, including methods by which valve structures may be coupled to the frame 12 of the prosthetic heart valve 10, are described, for example, in U.S. Pat. No. 6,730,118 (Patent Document 5), U.S. Pat. No. 7,393,360 (Patent Document 6), U.S. Pat. No. 7,510,575 (Patent Document 7), U.S. Pat. No. 7,993,394 (Patent Document 8), U.S. Pat. No. 8,652,202 (Patent Document 9), and U.S. Patent Application Publication No. 2018 / 0325665 (Patent Document 4), all of which are incorporated herein by reference in their entireties.

[0040] 1, the commissures 24 may be attached (e.g., sutured) directly to the commissure support portions of the actuators 80 of the frame 12 via commissure attachments 26. As an example, the commissure attachments 26 may include one or more stitches that secure the commissures 24 to the corresponding actuators 80. In other embodiments, the commissures 24 may be attached to a support strut or post of the frame that is separate from the actuators 80. In still other embodiments, the commissures may be secured to additional commissure attachments or support members (as described further herein), which are in turn secured to the commissure support portions of the actuators 80 or to support struts or posts of the frame.

[0041] The prosthetic heart valve 10 may also include one or more skirts or sealing members. For example, as shown in FIG. 1 , the prosthetic heart valve 10 may include an inner skirt 20 attached to the inner surface of the frame 12. As shown in FIG. 1 , the inner skirt 20 is a circumferential inner skirt that spans the entire circumference of the inner surface of the frame 12. The inner skirt 20 may function as a sealing member to prevent or reduce perivalvular leakage (e.g., when the valve is placed at an implantation site) and as a mounting surface for securing the leaflets 22 to the frame 12. For example, the inflow (cusp) edges of the leaflets 22 may be sutured directly to the inner skirt 20, which in turn may be directly connected, such as by sutures, to selected struts 28 of the frame, as shown in FIG. 1 .

[0042] The prosthetic heart valve 10 may also include an outer skirt (not shown in FIG. 1 ) attached to the exterior surface of the frame 12. The outer skirt may function as a sealing member of the prosthetic valve by sealing against the tissue of the native annulus and helping to reduce paravalvular leakage through the prosthetic valve. The inner and outer skirts may be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials (e.g., PET) or native tissue (e.g., pericardial tissue). The inner and outer skirts may be attached to the frame using sutures, adhesives, welding, and / or other means for attaching the skirts to the frame.

[0043] 2 and 3 illustrate an exemplary embodiment of a prosthetic valve 100, which, according to another embodiment, comprises a frame 102 and one or more expansion and locking mechanisms 150. The frame 102 comprises a plurality of pivotally connected struts 104 that define an inflow end 106 (the distal end of the frame in the delivery configuration of the illustrated embodiment) and an outflow end 108 (the proximal end of the frame in the delivery configuration of the illustrated embodiment). The struts 104 are pivotally connected to one another at a plurality of joints that allow the struts to pivot relative to one another when the frame 102 is radially compressed and expanded, as described above in connection with the prosthetic valve 10.

[0044] The prosthetic valve 100 may 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 FIGS. 2 and 3 for purposes of illustration. One or more expansion and locking mechanisms 150 may be used in place of or in addition to the actuator 80 described above. The expansion and locking mechanisms 150 may be used to radially expand and lock the frame 102 of the prosthetic valve 100 in the radially expanded state. In some embodiments, the commissures of the valve leaflets may be attached to the commissure support portions of the expansion and locking mechanisms 150. In alternative embodiments, the commissures of the valve leaflets may be attached to additional commissure struts of the frame 102.

[0045] FIG. 2 shows three expansion and locking mechanisms 150 attached to the frame 102, with the frame 102 shown in a radially expanded configuration. While the illustrated embodiment shows three expansion and locking mechanisms 150 spaced apart from one another around the circumference of the frame, it should be noted that the prosthetic valve may include any number of expansion and locking mechanisms 150. For example, in some embodiments, the prosthetic valve may include a single expansion and locking mechanism, or two expansion and locking mechanisms, or four expansion and locking mechanisms, etc. The expansion and locking mechanisms 150 may be positioned anywhere around the circumference of the frame 102. For example, in some embodiments, such as the illustrated embodiment, the expansion and locking mechanisms 150 are equally spaced apart from one another around the circumference of the frame 102. In other embodiments, it may be advantageous to have two or more expansion and locking mechanisms positioned adjacent to one another.

[0046] Each expansion and locking mechanism 150 may include an outer member in the form of a sleeve 152 having a lumen, cavity, or bore, and an inner member 156 extending at least partially within the cavity. The sleeve 152 in the illustrated embodiment includes an inner wall 186, an outer wall 188, and two side walls 190, each of which extends radially between a longitudinal edge of the inner wall 186 and an opposing longitudinal edge of the outer wall 188. The inner wall 186, the outer wall 188, and the two side walls 190 define a cavity sized and shaped to receive the inner member 156.

[0047] In the illustrated embodiment, sleeve 152 has a rectangular cross-section, and inner member 156 has a rectangular cross-section corresponding to the shape of the bore. In other embodiments, sleeve 152 and / or inner member 156 may have a square cross-sectional profile. As shown in FIG. 3 , a rectangular and / or square cross-section may advantageously minimize the distance the expansion and locking members extend into the lumen of frame 102, thereby reducing the overall crimp profile of valve 100. However, in other embodiments, sleeve and inner member may have any of a variety of corresponding cross-sectional shapes, such as, for example, circular, oval, triangular, rectangular, square, or combinations thereof.

[0048] As best shown in FIG. 1 , the distal end portion 158 of the inner member 156 may be coupled to the frame 102 at a first location via a fastener 160 attached to and extending radially therefrom. The fastener 160 may be, for example, a rivet or a pin. As shown, in some embodiments, the fastener 160 may extend through corresponding apertures at the junction of two overlapping struts 104 of the frame 102 and function as a pivot pin along which the two struts 104 may pivot relative to each other and relative to the inner member 156. In some embodiments, an end cap or nut 162 (as shown in FIG. 3 ) may be disposed over the end of the fastener 160 within the aperture. In alternative embodiments, the inner member 156 need not include the fastener 160 and may be coupled to the frame 102 via other attachment means, such as welding, adhesives, etc.

[0049] The sleeve 152 may be coupled to the frame 102 at a second location axially spaced from the first location. For example, in the illustrated embodiment, the inner member 156 is secured to the frame 102 near the distal or inflow end 106 of the frame, and the sleeve 152 is secured to the frame 102 near the proximal or outflow end 108 of the frame 102, or may be secured to the frame via fasteners 161 (e.g., rivets or pints), etc. The fasteners 161 are attached to the sleeve 152 and extend radially from the sleeve 152 through corresponding apertures at the junction of the two overlapping struts 104, and may function as pivot pins along which the two struts 104 may pivot relative to each other and relative to the sleeve 152. A nut 162 may be attached to each fastener 161 to retain the fastener within the corresponding aperture. The expansion and locking mechanism 150 may be pivotally coupled to the frame 102 at any two axially spaced, circumferentially aligned locations on the frame.

[0050] The inner member 156 may be axially movable proximally and distally relative to the sleeve 152 along the central longitudinal axis of the frame 102. Axially telescoping the inner member 156 and the sleeve 152 relative to one another may cause radial expansion or compression of the frame 102. For example, holding the sleeve 152 in a fixed position while moving the inner member 156 proximally toward the outflow end 108 of the frame and / or moving the sleeve 152 distally toward the inflow end 106 of the frame causes the frame 102 to shorten axially and expand radially. Conversely, moving the inner member 156 distally and / or moving the sleeve 152 proximally causes the frame 102 to expand axially and compress radially.

[0051] A prosthetic valve 100, including one or more expansion and locking mechanisms 150, may be expanded in the following exemplary manner. Generally, the prosthetic valve 100 is positioned in a radially compressed state, releasably coupled to a distal end portion of a delivery device, and then advanced through the patient's vasculature to a selected implantation site (e.g., the native aortic valve annulus). The prosthetic valve 100 may then be deployed at the implantation site and expanded and locked into an expanded configuration using the expansion and locking mechanisms 150. Further details regarding the prosthetic valve, the expansion and locking mechanisms, and a delivery device for actuating the expansion and locking mechanisms can be found in International Application No. PCT / US2020 / 057691, the contents of which are incorporated herein by reference.

[0052] 21 and 22 illustrate a delivery device 1200 configured to deliver a prosthetic heart valve (or artificial valve) 1208, such as the prosthetic heart valve 10 shown in FIG. 1 and / or the prosthetic valve 100, inserted into a target implantation site in a patient, as shown in FIGS. 2-3 described above, according to one embodiment. FIGS. 21-22 illustrate the prosthetic valve 1208 in different configurations relative to the delivery device 1200 during a valve implantation procedure. The prosthetic valve 1208 may be releasably coupled to one or more components of the delivery device 1200, as described above and further below. It should be understood that the delivery device 1200 may be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0053] The delivery device 1200 in the illustrated embodiment generally includes a handle 1202, an elongated shaft 1204 (including an outer, or outermost, shaft in the illustrated embodiment) extending distally from the handle 1202, an inner (e.g., innermost) shaft, an intermediate shaft 1224 coaxially disposed between and (radially perpendicular to a central longitudinal axis 1230 of the delivery device 1200) the outer shaft 1204 and the inner shaft 1210, and at least one actuator assembly 1206 (e.g., a member or actuator) for expanding and compressing the prosthetic valve 1208, the at least one actuator assembly 1206 extending distally outward from a distal end portion 1212 of the outer shaft 1204 through the outer shaft 1204.

[0054] In some embodiments, the outer shaft 1204 , inner shaft 1210 , middle shaft 1224 , and / or actuator assembly 1206 comprise a delivery device catheter of the delivery device 1200 and may be controlled by and attached to the handle 1202 .

[0055] The delivery device 1200 may include three actuator assemblies 1206 (only two of the three are shown in FIGS. 21-22 ) releasably coupled to the prosthetic valve 1208. However, in alternative embodiments, the delivery device 1200 may include more or fewer than three actuator assemblies 1206 (e.g., one, two, four, etc.). As shown in FIGS. 21-22 , the multiple actuator assemblies 1206 may be circumferentially spaced apart from one another around the circumference of the delivery device 1200 and extend axially through the outer shaft 1204 from the handle 1202 to the prosthetic valve 1208.

[0056] In certain embodiments, each actuator assembly 1206 may be releasably coupled to a corresponding actuator of the prosthetic valve (e.g., actuator 80 as shown in FIG. 1 or part of the expansion and locking mechanism 150 as shown in FIGS. 2 and 3). Each actuator assembly 1206 may include an inner member having a distal end releasably coupled to the inner member of the actuator of the prosthetic valve and an outer member having a distal end releasably coupled to the outer member of the actuator of the prosthetic valve. In another embodiment, each actuator assembly 1206 may be an actuator assembly releasably coupled to the prosthetic valve 1208 via a threaded sleeve.

[0057] In some embodiments, the midshaft 1224 can be configured to house and organize the actuator assemblies 1206. For example, the actuator assemblies 1206 can be housed within and extend outwardly from the distal end of the midshaft 1224. In some embodiments, each actuator assembly 1206 can be maintained separate from the other actuator assemblies 1206 within the midshaft 1224. For example, each actuator assembly 1206 can extend through a separate lumen in the midshaft 1224.

[0058] 21 and 22 , the distal end of the inner shaft 1210 may include a nosecone 1214 that may be used to guide the delivery device 1200 through a patient's lumen to a target implantation site of the prosthetic valve 1208. The nosecone 1214 may be positioned proximate a distal end 1226 of the prosthetic valve 1208.

[0059] In use, the delivery device 1200 can be releasably coupled to the prosthetic valve 1208 to generate radial expansion and compression of the frame of the prosthetic valve 1208. In some embodiments, the actuator assembly 1206 of the delivery device 1200 transfers pushing and / or pulling forces from the handle 1202 of the delivery device 1200 to the prosthetic valve 1208. For example, in some embodiments, the actuator assembly 1206 can have a distal end portion that can be releasably connected to the prosthetic valve 1208 via respective release and fixation units.

[0060] In some embodiments, the outer shaft 1204 of the delivery device 1200 can be configured as a steerable guide catheter having an adjustable curvature for use in steering the delivery device 1200 through a patient's vasculature. In certain embodiments, the outer shaft 1204 can include a steerable distal portion, the curvature of which can be adjusted by the operator to aid in guiding the device through the patient's vasculature.

[0061] The outer shaft 1204 and the actuator assembly 1206 may be moved (axially and / or rotationally) relative to one another to facilitate delivery and positioning of the prosthetic valve 1208 at an implantation site within a patient's body.

[0062] In some embodiments, the distal end portion 1212 of the outer shaft 1204 may form and / or function as a sheath (or capsule) 1222 that is sized and shaped to receive the prosthetic valve 1208 and house it in a radially compressed state for delivery through the patient's vasculature. As the prosthetic valve 1208 is advanced to or adjacent to the implantation site, the prosthetic valve 1208, and thus the capsule 1222, move axially along the central longitudinal axis 1230 relative to the actuator assembly 1206 and prosthetic valve 1208. Thus, the prosthetic valve 1208 may be uncovered while the capsule 1222 moves axially back toward the handle 1202 (e.g., proximally along the central longitudinal axis 1230). In an alternative embodiment, 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.

[0063] Advancement of the prosthetic valve 1208 from the sheath by axially moving the actuator assembly 1206 relative to the outer shaft 1204 or by retracting the outer shaft 1204 relative to the actuator assembly 1206 can be actuated by manipulating a first knob 1216 on the handle 1202. The first knob 1216 can be operably connected to a proximal end portion of the outer shaft 1204 and configured to retract the outer shaft 1204 proximally relative to the actuator assembly 1206 to deploy the prosthetic valve 1208 from the distal end portion 1212 of the capsule 1222, or can be operably connected to a proximal end 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 end portion 1212 of the capsule 1222. The first knob 1216 can be a slidable or rotatable adjustment element operably connected to the actuator assembly 1206 and / or the outer shaft 1204.

[0064] The handle 1202 may include additional adjustment knobs, such as a second knob 1218 and a third knob 1220, as shown in Figures 21-22. In some embodiments, the second knob 1218 is operably coupled to the actuator assembly 1206 and can actuate the actuator assembly 1206 to radially adjust the prosthetic valve 1208 (as shown in Figure 21) from an unexpanded (or radially compressed) configuration to an expanded configuration, or vice versa.

[0065] In some embodiments, the third knob 1220 is operably coupled to the actuator assembly 1206 and can actuate the actuator assembly 1206 to decouple from the prosthetic valve 1208. As a result, the prosthetic valve 1208 can be removed from the delivery device 1200 and implanted (deployed) at the target implantation site.

[0066] FIG. 21 shows the prosthetic valve 1208 held in a radially compressed state within the capsule 1222 of the delivery device 1200. Thus, in FIG. 21 , the prosthetic valve 1208 is in its radially compressed configuration having a minimum diameter D1. The minimum diameter D1 may be approximately the same as the inner diameter of the capsule 1222. As shown in FIG. 21 , the capsule 1222 surrounding the outside of the prosthetic valve 1208 may maintain the prosthetic valve in the radially compressed configuration. As a result, the prosthetic valve 1208 may be advanced through the patient's vasculature, for example, via the delivery device 1200, to a target implantation site.

[0067] After reaching the target implantation site, the capsule 1222 may be pulled (or retracted) proximally away from the nosecone 1214 and prosthetic valve 1208 along the central longitudinal axis 1230 of the delivery device 1200, exposing the prosthetic valve 1208. In an alternative embodiment, the actuator assembly 1206 may be advanced distally to move the prosthetic valve 1208 out of the capsule 1222.

[0068] FIG. 22 illustrates an unsheathed state in which the prosthetic valve 1208 is disposed outside the capsule 1222. In this state, the prosthetic valve 1208 is not actively expanded via the actuator assembly 1206. However, because the prosthetic valve 1208 is no longer constrained by (e.g., held within) the capsule 1222, the prosthetic valve 1208 may assume a partially expanded diameter D2, which is greater than the minimum diameter D1, due to the inherent resiliency of the struts of the frame. Note that the degree 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. As shown in FIG. 22 , after being deployed from the capsule 1222, the prosthetic valve 1208 may be radially expanded and implanted by actuation of the actuator assembly 1206.

[0069] 4 and 5, in some embodiments, the frame of the prosthetic heart valve may include struts shaped to form a non-cylindrical shape when expanded. For example, such a frame may be tapered axially relative to a central longitudinal axis of the frame. In some embodiments, the frame may be tapered from the outflow end to the inflow end.

[0070] FIG. 4 illustrates another embodiment of a prosthetic valve 200 with a frame 202 shown in a deployed, radially expanded configuration. The prosthetic valve 200 may include a valve structure (e.g., valve structure 18), an inner and / or outer skirt, and an actuator (e.g., actuator 80 of FIG. 1 ) or the expansion and locking mechanism 150 of FIGS. 2-3 , as previously described. However, these components are omitted from FIG. 4 for illustrative purposes. The frame 202 may have an inflow end 204 defining an inflow end 224 of the frame 202 and an outflow end 206 defining an outflow end 226 of the frame 202. The prosthetic valve 200 may define a longitudinal axis A (central longitudinal axis) extending from the inflow end 204 to the outflow end 206, and a transverse axis B extending perpendicular to the longitudinal axis A. While only one side of the frame 202 is shown in FIG. 4 , it should be understood that the frame 202 forms an annular structure with the opposite side identical to the illustrated portion.

[0071] The frame 202 comprises a plurality of interconnected struts 208 arranged in a lattice pattern. Each strut may 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 may be formed entirely of struts that extend continuously from the inflow end 224 to the outflow end 226. In another embodiment, the frame 202 may have struts connected end to end along the length of the frame.

[0072] Each strut 208 may include a plurality of apertures unequally spaced along the length of the respective strut 208, defining a plurality of segments 212 having unequal lengths. In the illustrated embodiment, the segments 212 of each strut 208 may decrease in length from the inflow end 204 to the outflow end 206 of the frame 202. In the assembled frame 202, the struts 208 form a plurality of closed cells arranged in circumferentially extending rows of cells, with the cells becoming progressively smaller from the inflow end 224 to the outflow end 226. In the illustrated embodiment, each strut 208 has five apertures defining four segments 112 and three rows of cells, including a first row 228, a second row 230, and a third row 232 of cells, with cell 228 being the largest, cell 230 being smaller than cell 228, and cell 232 being smaller than cell 230.

[0073] In other embodiments, each strut may have a greater or lesser number of apertures to define a different number of strut segments and rows of frame cells. For example, Figure 5 shows a prosthetic valve 300 (described below) in which each strut includes seven apertures.

[0074] 4, the varying lengths of the strut segments also form angles 244, 246, 248, 250 between the pivotally connected struts, which angles gradually increase from the inflow end 224 to the outflow end 226. One or more segments may be of unequal length, or one or more segments may be of the same length.

[0075] 4, each strut 208 may be helically curved relative to the longitudinal axis A of the frame 202 to define the annular shape of the frame 202. The helical curve forms in each strut 208 a concave radially inner surface (the surface facing the longitudinal axis A) and an opposing convex radially outer surface (the surface facing away from the longitudinal axis A).

[0076] The apertures may 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. 1). In other embodiments, the apertures 210 and / or fasteners 214 may be omitted. For example, the struts 208 may be fixedly connected to one another, such as by welding or gluing, or by laser cutting the individual struts of the frame from a metal tube.

[0077] As shown, the segments 212 may be disposed end-to-end relative to one another, with adjacent ends interconnected to one another by intermediate segments 218. The struts 208 may have enlarged ends 220 (relative to the segments 212) that form apexes 222 at the inflow end 224 and outflow end 226 of the frame 202. Each of the intermediate segment 218 and end 220 may have a respective aperture, such as at its geometric center, for receiving the fastener 214. Each segment 212 may be slightly laterally offset from an adjacent segment 212 in a direction perpendicular to the length of the strut 208, as shown. In an alternative embodiment, the segments 212 may be disposed without offset relative to one another.

[0078] In the illustrated embodiment, each segment 212 of strut 208 is curved such that the overall shape of strut 208 is curved relative to transverse axis B (or any line parallel to axis B and perpendicular to axis A).

[0079] In certain embodiments, each strut 208 may have a continuous, constant curve from one end of the strut to the other. In other embodiments, the projection of each segment 212 in a plane parallel to the longitudinal axis A is straight (i.e., each segment 112 is straight except for any helical curvature with respect to the longitudinal axis A), and the offset of each segment 112 relative to adjacent segments 112 along the length of the strut 208 may vary such that the overall shape of the strut 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, a line extending from one end of the strut to the other and intersecting each segment 212 is curved relative to axis B. Alternatively, the individual strut segments 212 may be straight and connected end-to-end at a non-zero angle such that the overall shape of the strut 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 of the struts of the frame may have a non-constant or variable curvature along its length (in which case the center of curvature of the strut may change as you move along the length of the strut).

[0080] 4, each strut 208 may be curved and positioned so as to be convex relative to the outflow end 226 of the frame 202. Thus, in the illustrated embodiment, each strut 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 struts 208, the frame 202 formed by the struts has a non-Euclidean geometry, specifically an elliptical geometry (also known as a Riemannian geometry).

[0081] As shown in FIG. 4 , in the expanded configuration, the curvature of the struts 208 can give the frame 202 a non-cylindrical, tapered shape (e.g., frusto-conical, V-shaped, or Y-shaped), where the outflow end 226 has a first diameter D1 that is larger than the second diameter D2 of the inflow end 224. The degree of taper is referred to as the 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. When implanted within the native annulus, the increased outflow relative to inflow created by the tapered shape reduces the pressure gradient across the prosthetic valve, improving hemodynamics and reducing the risk of paravalvular leak.

[0082] In certain embodiments, the draft angle between line A and line C may 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 certain embodiments, the draft angle may be between 2 degrees and 15 degrees. In certain embodiments, the ratio of the outlet diameter D1 to the inlet 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.

[0083] In some embodiments, there is a difference of 2-3 mm between the outlet diameter D1 and the inlet diameter D2. In one particular example, the outlet diameter D1 is about 30 mm and the inlet diameter D2 is about 27 mm. In another example, the outlet diameter D1 is about 31.5 mm and the inlet diameter D2 is about 29 mm. In another example, the outlet diameter D1 is about 24.5 mm and the inlet diameter D2 is about 22 mm.

[0084] In some embodiments, while in the crimped or radially compressed configuration, the frame 202 retains a tapered shape in which the outflow end 226 has a diameter 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 in the expanded configuration.

[0085] 5 illustrates another embodiment of a prosthetic valve 300 shown in a deployed, radially expanded configuration, with a frame 302 having a tapered shape. 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 larger than the diameter at the inflow end 324), thereby causing the frame 302 to taper from the outflow end 326 to the inflow end 324.

[0086] Prosthetic valve 300 is similar to prosthetic valve 200, except that prosthetic valve 300 has a frame 302 in which each strut 308 includes seven apertures 310, and therefore has more strut segments and frame cells than the struts of prosthetic valve 200. Because each strut of these frames also includes seven apertures, frame 302 can be similar to frame 12 of FIG. 1 and frame 102 of FIGS. 2-3.

[0087] Similar to prosthetic valve 10 and / or prosthetic valve 100, prosthetic valve 300 may include a valve structure (e.g., valve structure 18), an inner and / or outer skirt, and an actuator (e.g., actuator 80 of FIG. 1 ) or the expansion and locking mechanism previously described (e.g., expansion and locking mechanism 150 of FIGS. 2-3 ), although these components have been omitted for purposes of illustration. Frame 302 may have an inflow end 304 defining an inflow end 324 of the frame and an outflow end 306 defining an outflow end 326 of the frame. The prosthetic valve may define a longitudinal axis A extending from inflow end 304 to outflow end 306, and a transverse axis B extending perpendicular to longitudinal axis A.

[0088] The frame 302 comprises a plurality of interconnected struts 308 that extend from the inflow end 324 to the outflow end 326 of the frame 302. Thus, in the illustrated embodiment, the frame 302 may be formed entirely of struts that extend continuously from the inflow end 324 to the outflow end 326. In alternative embodiments, the frame 302 may have struts connected end-to-end along the length of the frame.

[0089] Each strut 308 may include a plurality of apertures 310. As shown, the apertures 310 may be unequally spaced along the length of the strut 308, defining a plurality of segments 312 having unequal lengths. In the illustrated embodiment, the strut 308 includes segments 312a, 312b, 312c, 312d, 312e, and 312f, with segment 312a being the shortest and each subsequent segment 312b, 312c, 312d, 312e, and 312f having a progressively longer length. In the assembled frame 302, the struts 308 form a plurality of closed cells arranged in circumferentially extending rows of cells, with the cells progressively larger from the inflow end 324 to the outflow end 326. In the illustrated embodiment, each strut 308 has seven apertures 310 defining six segments 312 and five cell rows, including a first cell row 328, a second cell row 330, a third cell row 332, a fourth cell row 334, and a fifth cell row 336, with cells 328 being the smallest and each cell row becoming progressively larger from the inflow end to the outflow end.

[0090] The varying lengths of the struts also create angles 338 , 340 , 342 , 346 , 348 between the pivotally connected struts, which angles gradually decrease from the inflow end 324 to the outflow end 326 .

[0091] In alternative embodiments, one or more segments may have unequal lengths, and one or more segments may have equal lengths. For example, segment 312a is the shortest segment, segments 312b, 312c, 312d, and 312e have equal lengths, and segment 312f is the longest segment. In yet other embodiments, apertures 310 may be evenly spaced along the length of each strut, forming segments of equal length.

[0092] 5, each strut 308 may be helically curved relative to the longitudinal axis A of the frame to define the annular shape of the frame 302. The helical curve gives each strut a concave radially inner surface (the surface facing the longitudinal axis A) and an opposing convex radially outer surface (the surface opposite the longitudinal axis A).

[0093] Apertures 310 may be used to connect struts 308 to one another using fasteners such as fasteners 214 described above.

[0094] Each strut 308 may be curved or positioned so as to be concave relative to the outflow end 326 of the frame 302 .

[0095] In some embodiments, the elasticity of the struts 308 and the connections between overlapping struts allows the degree of curvature of the struts to change during radial compression and expansion of the frame.

[0096] Similar to prosthetic valve 200, in the expanded configuration, the curvature of struts 308 can give frame 302 a non-cylindrical tapered shape (e.g., a frusto-conical, V-shaped, or Y-shaped), with outflow end 326 having a first diameter D1 that is larger than second diameter D2 of inflow end 324. This configuration can reduce pressure gradients across prosthetic valve 300 and improve hemodynamics.

[0097] In certain embodiments, the draft angle between line A and line C in frame 302 can be between 2 and 15 degrees. In certain 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 certain embodiments, the ratio of outlet diameter D1 to inlet 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.

[0098] In some embodiments, there is a difference of 2-3 mm between the outlet diameter D1 and the inlet diameter D2. In one particular example, the outlet diameter D1 is about 30 mm and the inlet diameter D2 is about 27 mm. In another example, the outlet diameter D1 is about 31.5 mm and the inlet diameter D2 is about 29 mm. In another example, the outlet diameter D1 is about 24.5 mm and the inlet diameter D2 is about 22 mm.

[0099] Further details regarding prosthetic valves having frames with tapered shapes can be found in International Application No. PCT / US2019 / 056865 (Patent Document 11), filed October 18, 2019, and U.S. Patent Application No. 16 / 788,090 (Patent Document 12), filed February 11, 2020, each of which is incorporated herein by reference in its entirety.

[0100] Referring now to FIG. 6 , an exemplary leaflet 400 that may be included in a valve structure of a prosthetic heart valve (e.g., the valve structure 18 of the prosthetic heart valve 10 of FIG. 1 ) is shown. The leaflet 400 is laid flat for illustrative purposes. The leaflet 400 may include a main body (or main body) 402 having leaflet (inflow) edge portions 404, 406. In particular, the leaflet edge portions 404, 406 may include a first (left) side leaflet edge portion 404 and a second (right) side leaflet edge portion 406 that connect to each other at an inflow-most end 408 of the leaflet 400. Together, the first leaflet edge portion 404 and the second leaflet edge portion 406 form a scallop line of the leaflet 400.

[0101] The leaflet 400 may include commissure tabs 412, 414 extending from opposite sides of the body 402. The commissure tabs may be configured to engage with corresponding commissure tabs on adjacent leaflets to form commissures and to attach to a frame of a prosthetic heart valve (e.g., via commissure attachment members, as described further herein). An outflow edge 410 extends across the leaflet 400 between the commissure tabs 412, 414.

[0102] Curved edges 416, 418 extend between and connect a corresponding one of the commissure tabs 412, 414 to a corresponding one of the first and second leaflet portions 404, 406. Each curved edge 416, 418 defines an open area on either side of the leaflet 400, referred to herein as a window 420, 422.

[0103] 6 , each of the first and second cusp portions 404, 406 slopes from the bottom edge of a corresponding one of the curved edges 416, 418 to the inflow end 408. The top edge of each of the first and second cusp portions 404, 406 is laterally disposed inward of the outer edge of a corresponding one of the commissure tabs 412, 414, perpendicular to the axial direction, and extends axially parallel to the leaflet centerline 424 from the outflow edge 410 to the inflow end 408. As a result, the overall shape of the leaflet tapers from the outflow edge 410 to the inflow end 408.

[0104] In some embodiments, the shape of the leaflet 400 can be configured so that the commissure tabs 412, 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 410 and the inflow end 408. For example, as shown in FIG. 6, the (superior and inferior) side edges 426, 428 of each commissure tab 412, 414 can be angled at an angle θ from vertical (e.g., the centerline 424). As shown in FIG. 6, the angle θ can be defined between the centerline 424 and a line 450 extending through the commissure tabs 412, 414 and perpendicular to the side edges 426, 428.

[0105] In some embodiments, angle θ can be selected to match or resemble (e.g., within a selected finite range) the draft angle of the frame of the prosthetic heart valve. For example, as described above with reference to FIGS. 4 and 5, the frame can taper from the outflow end to the inflow end of the frame, creating a tapered shape for the frame defined by the draft angle (the angle between lines A and C in FIGS. 4 and 5). Selecting angle θ that matches or closely matches (e.g., within 5-10% or 5%) the draft angle of the frame can reduce stress concentration on the commissure tabs of the commissures while allowing the leaflets to open sufficiently during valve operation in vivo (e.g., during opening and closing of the leaflets).

[0106] In some embodiments, angle θ may be selected based on the draft angle of the frame and / or based on the shape of the valve leaflets while allowing the leaflets to open sufficiently during in vivo valve manipulation. In some embodiments, a tapered frame may facilitate a more cylindrical opening of the leaflets while maintaining distance between the leaflets and the frame during the opening phase (e.g., to reduce or avoid wear).

[0107] In some embodiments, the dimensions of the fenestrations 420, 422 and / or neck regions 430, 432 of the leaflet 400 may be selected to maximize the width of the leaflet 400 at the respective neck regions 430, 432, while minimizing the surface area of ​​the respective fenestrations 420, 422. Each neck region 430, 432 is defined between a corresponding one of the commissure tabs 412, 414 and the body 402 of the leaflet 400. For example, in some embodiments, the width 434 of each neck region 430, 432 and the window width 436 of each fenestrations 420, 422 may be selected to aid in leaflet stress distribution during cyclic loading and unloading (e.g., during opening and closing of the leaflet assembly during valve manipulation) and reduce strain on the leaflet tissue to extend the life of the leaflet 400.

[0108] In some embodiments, the commissure tabs 412, 414 may include a plurality of rows of apertures 438 adapted to receive a plurality of rows of fasteners (e.g., sutures) during folding and securing of the commissure tabs to form the commissures (as further described below with reference to FIGS. 7-9, 14, and 15). These rows of apertures 438 may be referred to herein as suture lines 437. As shown in FIG. 6, each commissure tab 412, 414 includes four relatively straight suture lines 437. However, in other embodiments, each commissure tab 412, 414 may include more or fewer than four suture lines 437 (e.g., one, two, three, five, etc.). Additionally, in some embodiments, instead of relatively straight sutures (e.g., all apertures 438 of the same suture are arranged in a relatively straight line), one or more of the sutures 437 may be non-straight, with at least a portion (e.g., one or more apertures 438) that is offset from the remainder of the suture 437. As described further below, examples of leaflets having non-straight sutures with offset apertures are shown in FIGS. 19 and 20.

[0109] 6 , in some embodiments, each of the first and second cusp portions 404, 406 may include a row of apertures 440 configured to receive a row of fasteners (e.g., sutures) that secure the first and second cusp portions 404, 406 to a skirt configured to attach the first and second cusp portions 404, 406 to a frame of a prosthetic heart valve. In some embodiments, the skirt may extend below (through) the bottom (inflow) edges of the first and second cusp portions 404, 406 from or just above the row of apertures 440.

[0110] In some embodiments, the skirt may be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials (e.g., PET) or native tissue (e.g., pericardial tissue). The skirt may be attached to the inner surface of the struts of the frame of the prosthetic heart valve.

[0111] A commissure tab of a leaflet, such as one of the commissure tabs 412, 414 of the valve leaflet 400, is folded and paired with a folded commissure tab of an adjacent leaflet of the valve leaflet assembly to form a commissure, and is attached to the leaflet assembly and to a commissure support portion of a frame or a commissure support element configured to be coupled to the commissure support portion (as described further below), thereby forming the commissure. In some embodiments, the commissure tab may be folded vertically axially (e.g., about an axis perpendicular to the central longitudinal axis of the frame). However, this may not provide sufficient surface area for attaching the commissure to the commissure support portion of the frame, resulting in a non-rigid commissure that may move during valve manipulation. Furthermore, in some embodiments, the commissure tab may be wrapped around the sides and / or back of the commissure support portion of the frame and then sutured around and to the commissure support portion. However, increasing the amount of leaflet material on the sides or back (outward facing) of the commissure-supporting portion of the frame can increase stress on the commissures and / or leaflets.

[0112] Alternatively, as further described below with reference to Figures 7-16, the commissures of the prosthetic heart valve can be formed by horizontally folding each commissure tab of each leaflet (e.g., about an axis parallel to the central longitudinal axis of the frame, such that the folded portions of the folded commissure tabs extend circumferentially and / or radially relative to the central longitudinal axis), with each folded commissure tab attached to an attachment member that can be disposed on the radially inward-facing surface (inner surface) of the commissure support portion or element. The attachment member can be directly attached to the commissure support portion or element, while the folded commissure tab of the commissure remains disposed radially inward of the commissure support portion of the frame. Folding the commissure tabs radially inward and perpendicular to the axial direction (e.g., horizontally rather than vertically) provides a larger surface area for attaching the commissure tabs to the attachment member, thereby enhancing support when the attachment member is attached to the commissure support portion or element of the frame. As described further below, direct leaflet loading and leaflet wear against rigid surfaces can be reduced by indirectly attaching the commissure tabs of the commissures to the commissure support portions of the frame using fabric attachment members.

[0113] As introduced above, Figures 7-9, 14, and 15 show exemplary commissure tab assemblies aligned parallel to the central longitudinal axis of the valve frame and folded about an axis attached to a mounting member. These figures further illustrate the attachment of these commissure tab assemblies to commissure support portions of the frame of the prosthetic valve, such as commissure posts or other support structures of the frame of the prosthetic valve (e.g., actuator or expansion and locking mechanism), or to commissure support elements configured to couple to the commissure support portions of the frame.

[0114] In a first embodiment, as shown in Figures 7-9, the folded commissure tab assemblies can be secured together to form a commissure 500, which can be directly attached (secured) to the commissure support portion of the frame of the prosthetic heart valve via the attachment members of the commissure tab assembly (or commissure). The commissure support portion can be a rigid strut 502 of the frame. In some embodiments, the strut 502 can be all or part of the frame's actuator (e.g., actuator 80 of Figure 1), the frame's expansion and locking mechanism (e.g., expansion and locking mechanism 150 of Figures 2-3), or one of the frame's other struts. The prosthetic heart valve frame can be one of the frames disclosed above with reference to Figures 1-5, and in some embodiments, can combine one or more features of the frames shown in Figures 1-5.

[0115] FIG. 7 is a cross-sectional top view of a commissure 500 attached to a strut 502 of a frame 508 of a prosthetic heart valve. FIGS. 8 and 9 are inner and outer perspective views of the strut, respectively. In FIG. 9, the remainder of the frame has been removed for illustrative purposes. In FIGS. 7-9, radial 520, lateral (or circumferential) 522, and axial 524 directions are shown for reference, and 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 a component may face the central longitudinal axis, and a radially outward (e.g., outer) surface of the component may face away from the central longitudinal axis. Furthermore, a radially outward surface of a component may be positioned further radially outward from the central longitudinal axis of the frame than the opposite radially inward surface of the component.

[0116] The commissure 500 includes a first commissure tab 504a on the first leaflet 506a and a second commissure tab 504b on the second leaflet 506b. In some embodiments, the first leaflet 506a and the second leaflet 506b can be the same as or similar to the leaflet 400 of FIG. 4. In alternative embodiments, the first leaflet 506a and the second leaflet 506b can have a different configuration than that shown in FIG. 4. However, each of the first leaflet 506a and the second leaflet 506b has two commissure tabs located on opposite sides of the body of the first leaflet or the second leaflet.

[0117] To form the commissure 500, each of the first commissure tab 504a and the second commissure tab 504b is folded upon itself to form two commissure tab portions, each extending in a radial direction 520. Each of the folded first commissure tab 504a and the folded second commissure tab 504b is secured to an attachment member 510 (also called a reinforcing member or support member) that is positioned against an inner surface 512 of the strut 502 (radially inward, in the radial direction 520, relative to the central longitudinal axis of the valve frame) and secured to the strut 502.

[0118] In some embodiments, the attachment member 510 may be a flexible fabric / cloth including one or more layers of fabric / cloth. In some embodiments, the attachment member 510 comprises a synthetic material such as a polyethylene terephthalate (PET) fabric. In other embodiments, the attachment member 510 may comprise a flexible polymeric material.

[0119] As shown in Figures 7-9, in some embodiments, the mounting member 510 may include a first (base) portion 514 that is positioned against (e.g., in flush contact with) and extends along an inner surface 512 of the strut 502. In some embodiments, as shown in Figures 7-9, the first portion 514 may extend only along the inner surface 512 and may not extend along additional surfaces of the strut 502. In alternative embodiments, the first portion 514 may further extend along at least a portion of a lateral (side) surface 518 of the strut 502 (but not to the outer surface of the strut 502).

[0120] The mounting member 510 may further include a second portion 516 that projects (extends) radially inward toward the central longitudinal axis of the frame and projects away from the first portion 514. For example, the second portion 516 may extend radially outward from a central region of the first portion 514.

[0121] 7-9, second portion 516 may include two overlapping layers of attachment member 510, each extending from a different end of first portion 514. The two overlapping layers of second portion 516 of attachment member 510 may overlap in lateral direction 522 and each extend in radial direction 520. In some embodiments, second portion 516 may include twice the number of layers as first portion 514 and therefore be twice as thick as first portion 514 (in some embodiments, first portion 514 may include one or more layers of fabric). In this manner, second portion 516 may be thicker than first portion 514.

[0122] Note that the thickness of the attachment member relative to the thickness of the valve leaflets in Figures 7-9 (and Figures 14 and 15) may be exaggerated for illustrative purposes. Thus, in some embodiments, the attachment member 510 may be thinner than shown, and thus the commissure tabs of the valve leaflets may be positioned closer together in the lateral direction 522.

[0123] As introduced above, each of the first and second commissure tabs 504a, 504b includes two overlapping commissure tab portions, including a first tab portion 526 and a second tab portion 528. The first and second tab portions 526, 528 extend radially 520, and overlap each other laterally 522. As shown in FIGS. 7-9 , the first tab portion 526 extends radially outward from the body of the corresponding one of the leaflets 506a, 506b toward the first portion 514 of the attachment member 510. Each commissure tab 504a, 504b then folds from the first tab portion 526 onto itself to form a second tab portion 528. The second tab portion extends radially inward, away from the first portion 514 of the attachment member, toward the central longitudinal axis of the frame 508.

[0124] As shown in FIGS. 7-9, the first tab portion 526 of the first commissure tab 504a is disposed against (e.g., in coplanar contact with) the first side of the protruding portion, and the second portion 516 of the attachment member 510 and the first tab portion 526 of the second commissure tab 504b are disposed against a second side of the protruding second portion 516. For example, in some embodiments, the first outer surface of the second portion 516 and the inner surface of the first tab portion 526 of the first commissure tab 504a can have coplanar contact along the height of the first commissure tab 504a (e.g., the height can be the distance between the upper and lower edges of the commissure tab, such as upper edge 426 and lower edge 428 shown in FIG. 6). Similarly, the second side surface of the second portion 516 and the inner surface of the first tab portion 526 of the second commissure tab 504b can have coplanar contact along the height of the second commissure tab 504b. In this manner, the folded commissure tabs 504a, 504b have a larger surface area for contacting and supporting the second portion 516 of the attachment member 510 (compared to when the commissure tabs are folded vertically, axially, about an axis perpendicular to the central longitudinal axis of the valve frame).

[0125] 7-9, the second tab portion 528 is positioned relative to the first tab portion 526, and the fold 530 between the first tab portion 526 and the second tab portion 528 is positioned relative to (e.g., in flush contact with) the inside of the first portion 514 of the attachment member 510. In this manner, each of the folded commissure tabs 504a, 504b can be wedged relative to the attachment member 510 in the area of ​​the bend 532 between the first portion 514 and the second portion 516. In some embodiments, the bend 532 can be approximately 90 degrees.

[0126] The protruding second portion 516 of the attachment member 510 may extend radially a distance 534 ( FIG. 7 ). In some embodiments, the distance 534 (or the length of the second portion 516 in the radial direction 520) may be less than the length 536 of the second tab portion 528 (e.g., the length of the two overlapping layers of the commissure tabs). In other embodiments, the distance 534 may be the same as the length 536.

[0127] The first folded commissure tab 504a and the second folded commissure tab 504b may each be secured to the attachment member 510 via one or more rows of sutures. For example, the first sutures 538a, 538b may include multiple inner and outer sutures and extend, for example, through the corresponding one of the folded commissure tabs 504a, 504b and the attachment member 510 (e.g., at the bend 532). In some embodiments, the first sutures 538a, 538b may extend through two overlapping layers of the corresponding one of the folded commissure tabs 504a, 504b and the second portion 516 of the attachment member 510 (through at least one layer of the second portion 516). In some embodiments, for example, second suture lines 540a, 540b including multiple inner and outer sutures may extend through a corresponding one of the folded commissure tabs 504a, 504b (e.g., through their two overlapping layers) and through the second portion 516 of the attachment member 510 (e.g., at a location radially inward of the bend 532, such as between the overlapping layers of the second portion 516 of the attachment member 510). In alternative embodiments, there may be more or fewer suture lines than those shown in FIGS. 7-9 configured to secure the folded commissure tabs 504a, 504b to the attachment member 510. As used herein, the term "suture line" may also be referred to as "sewing line."

[0128] In this manner, the attachment member 510 and the first and second commissure tabs 504a, 504b are secured together as described above to form the commissure 500.

[0129] 7-9, to secure the commissures 500 to the struts 502, attachment members 510 may be secured to the struts 502 via one or more fasteners. In this manner, the folded first and second commissure tabs 504a, 504b are indirectly attached to the struts 502 (via the attachment members 510). In other words, because the attachment members 510 are positioned (in the radial direction 520) between the struts 502 and the commissure tabs 504a, 504b, the attachment members 510 shield the first and second commissure tabs 504a, 504b (and thus the leaflets 506s, 506b) from contacting the struts 502.

[0130] In some embodiments, the attachment member 510 is secured to the strut 502 via one or more fasteners. For example, as shown in FIGS. 7-9 , the attachment member 510 is secured (coupled) to the strut 502 via a suture 542 that may form multiple suture loops 546 that cross on a radially outward (outer) surface 544 of the strut 502, as disclosed, for example, in International Application No. PCT / US2021 / 020206 (Patent Document 13), which is incorporated herein by reference. In some embodiments, during assembly, multiple loops 546 may be formed by the suture 542, each loop extending radially outward from the attachment member 510, around and / or through the attachment member 510. The multiple loops 546 may then be slid over the strut 502 and tightened around the strut 502. In some embodiments, the tightened loops 546 of the suture 542 may be tied with one or more knots 548.

[0131] Thus, by forming commissure 500 by laterally and radially folding the commissure tabs of two adjacent leaflets about an axis aligned parallel to axial direction 524, the overlapping tab portions overlap laterally and extend radially, providing a larger surface area for securing the folded commissure tabs to the protruding portions of the radially extending attachment members, resulting in a more secure and robust commissure. By utilizing attachment members and securing the attachment members directly to the struts of the frame, contact between the leaflets and the struts can be prevented, reducing the load on the leaflets during radial expansion and compression of the frame, thereby reducing leaflet degradation.

[0132] In alternative embodiments, instead of being coupled to the struts of a frame, the commissures 500 may be attached to a commissure support portion of a different frame element (e.g., a frame of a different configuration for a different prosthetic heart valve), or to a commissure support element configured to couple to a commissure support portion of a frame (e.g., an actuator, strut, etc.). In this way, the same commissures 500 described above with reference to Figures 7-9 may be utilized for prosthetic heart valves having different frame designs.

[0133] For example, in a second embodiment, as shown in FIG. 14, the commissure 500 may be attached via an attachment member of the commissure 500 directly to the (open) commissure window of a frame of a prosthetic heart valve (FIGS. 10-11) or to the commissure support portion of a strut of the frame (FIGS. 12-13).

[0134] 10 and 11 illustrate an exemplary prosthetic heart valve frame incorporating commissural windows. Specifically, FIG. 10 illustrates a prosthetic heart valve 600 including commissural windows incorporated into the valve frame, according to one embodiment. While the illustrated prosthetic valve is adapted for implantation in the native aortic valve annulus, in other embodiments, it may be adapted for implantation in other native valve annulus of the heart (e.g., the pulmonary, mitral, and tricuspid valves). The prosthetic valve may also be adapted for implantation in other tubular organs or passageways within the body. The prosthetic valve 600 may have four main components: a stent or frame 612, a valve structure 614, an inner skirt 616, and a perivalvular outer sealing member or outer skirt 618. The prosthetic valve 600 may have an inflow end 615, an intermediate portion 617, and an outflow end 619.

[0135] The valve structure 614 can include three leaflets 640, collectively forming a valve structure, which can be arranged to collapse in a tricuspid configuration, although in other embodiments there can be more or fewer leaflets (e.g., one or more leaflets 640). The leaflets 640 can be secured to one another at their adjacent sides to form commissures 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. 6.

[0136] The frame 612 may be formed with a plurality of circumferentially spaced commissure window frame portions 620 adapted to attach the commissures 622 of the valvular structure 614 to the frame. For example, each commissure window frame portion 620 may define a commissure window, aperture, or slot 658 defined by the struts 660, 662 of the commissure window and configured to receive the commissure tabs of the commissure 622 therein, thereby securing the valve leaflets to the frame.

[0137] The frame 612 can be made of any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloys (NiTi) such as Nitinol) as known in the art. If constructed of a plastically expandable material, the frame 612 (and thus the prosthetic valve 600) can be crimped into a radially collapsed configuration onto a delivery catheter and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. If constructed of a self-expandable material, the frame 612 (and thus the prosthetic valve 600) can be crimped into a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism on the delivery catheter. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, allowing it to expand to a functional size.

[0138] Suitable plastically expandable materials that can be used to form the frame 612 include, but are not limited to, stainless steel, biocompatible high-strength alloys (e.g., cobalt-chromium or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In certain embodiments, the frame 612 is made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (coated per ASTM F562-02). MP35N alloy / UNS R30035 alloy is composed of 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. Further details regarding the prosthetic valve 600 and its various components are described in International Publication No. WO 2018 / 222799, which is incorporated herein by reference.

[0139] FIG. 11 shows a bare frame 650 of a prosthetic heart valve, which in some embodiments may be the frame 612 of the prosthetic valve 600 shown in FIG. 10. The frame 650 has an inflow end 652, an outflow end 654, and a central longitudinal axis 656 extending (axially) from the inflow end 652 to the outflow end 654. The frame 650 may be made of any of the materials described above with reference to FIG. 10. As described above with reference to FIG. 10, the frame 650 may include a plurality of commissural windows (open windows) 658 spaced circumferentially around the periphery of the frame 650. Each commissural window 658 receives a pair of commissural tabs of a pair of valve leaflets disposed at the commissure. As shown in FIG. 11, each commissural window 658 is formed by two axially extending struts 660 spaced circumferentially (also referred to as laterally) and two laterally extending struts 662 that are also axially spaced apart.

[0140] In another embodiment, the commissural window configured to receive and secure the commissure 500 can be a separate commissural support element configured to be coupled to a strut of a frame. Figures 12 and 13 show an embodiment of a commissural support element 700 configured as a single wire-like body 702 including a connecting portion 704 (Figure 12) and a leaflet-receiving window (also referred to as a commissural receiving portion) 706 defined by axially extending first and second members 708 and 710. The commissural support element 700 is shown separate from an actuator 722 of the frame of the prosthetic heart valve in Figure 12 and coupled to the actuator 722 in Figure 13. In other embodiments, the actuator 722 can instead be a separate strut from the actuator coupled to the frame, or an expansion and locking mechanism or commissural support strut that is an integral part of the frame. In certain embodiments, the actuator 722 and support element 700 can be incorporated into a mechanically expandable prosthetic heart valve, such as those shown in Figures 1-5 and described above.

[0141] 12, the coupling portion 704 may include a pair of coupling members 712, 714. The coupling member 712 may be coupled to the first axial member 708 by a curved portion or member 716, and the coupling member 714 may be coupled to the second axial member 710 by a curved portion or member 718.

[0142] The first and second axial members 708, 710 may be joined together at their inflow ends by a member 720. The member 720 may be curved or straight. The members 708, 710, 720 may at least partially define a leaflet-receiving window 706 that may open at an apex.

[0143] As shown in FIG. 13 , the commissural support element 700 can be received by or coupled to a post or actuator component 722 of an expandable prosthetic heart valve, which can be configured similarly to any of the posts, actuators, or expansion and locking components described herein. The actuator component 722 can include a pair of tubular openings or channels 724, 726 configured to receive the coupling members 712, 714, respectively. In the illustrated embodiment, the channels 724, 726 can be positioned on the sides of the actuator component at an outflow end 728 thereof, although the channels can be positioned anywhere around the circumference and along the length of the actuator component. The commissural support element 700 can be configured such that, when coupled to the actuator component 722, the curved members 716, 718 extend (in the outflow direction) above a top surface 730 of the actuator component 722, although support elements can also be positioned elsewhere along the length of the actuator component 722 between the inflow and outflow ends of the actuator component.

[0144] The commissural support element 700 may be formed from a wire-form body, as introduced above, or may be laser cut from a plate or sheet and bent, folded, and / or formed into a particular shape. The commissural support element 700 may comprise metallic materials, polymeric materials, and / or combinations or layers thereof.

[0145] In alternative embodiments, the commissural support elements may have different shapes and / or configurations than those shown above, but still have open leaflet-receiving windows and connecting portions configured to connect with struts, actuators, or expansion and locking mechanisms of the frame of the prosthetic heart valve. For example, in some embodiments, the connecting portions of the commissural support elements may instead be collars configured to surround the tops of the struts.

[0146] In an alternative embodiment, instead of having leaflet-receiving windows 706, commissural support element 700 may include an alternative commissural receiving portion (still attached to attachment portion 704, but disposed radially inward of and offset from attachment portion 704). For example, the commissural receiving portion may include a relatively flat portion that provides a relatively flat surface against which an attachment member rests.

[0147] As shown in Figure 14, the commissure 500 can be attached to an open commissure window 802 of a frame of a prosthetic heart valve, such as the commissure window 658 of the prosthetic heart valve frame shown in Figures 10 and 11, or to a commissure support element, such as the leaflet-receiving window 706 of the commissure support element 700 of Figures 12 and 13. The commissure 500 shown in Figure 14 can be the same as the commissure 500 shown in Figure 7, except that the attachment member 510 is secured to the commissure window 802 (e.g., instead of the struts 502).

[0148] More specifically, as shown in FIG. 14 , the commissural window 802 is formed by two axially extending members 804, 806 spaced apart from one another in the lateral direction 522. In some embodiments, the two axially extending members 804, 806 can be axially extending struts of a commissural window of a frame of a prosthetic heart valve, such as the two axially extending struts 660 shown in FIG. 11 . In other embodiments, the two axially extending members 804, 806 can be axially extending members of a leaflet-receiving window of a commissural support element configured to be coupled to a commissural support portion of a frame of a prosthetic valve, for example, the first axial member 708 and the second axial member 718 of the commissural support element 700 shown in FIGS. 12 and 13 . In other embodiments, the axially extending members 804, 806 may be spaced apart from struts or posts of an actuator of a mechanically expandable heart valve, as disclosed, for example, in International Application No. PCT / US2020 / 040318 (Patent Document 15) and International Application No. PCT / US2021 / 012146 (Patent Document 16), which are incorporated herein by reference.

[0149] The attachment members 510 of the commissure 500 may extend across and between (in the lateral direction 522) the interior of the two axially extending members 804, 806. In some embodiments, the ends of the attachment members 510 may curve around and extend along at least a portion of the side surfaces (the sides disposed perpendicular to the interior) of the two axially extending members 804, 806.

[0150] 14, attachment member 510 may be secured to two axially extending members 804, 806 via first and second sutures 808, 810, respectively. In some embodiments, multiple loops may be formed by first and second sutures 808, 810 and extend around each of the two axially extending members 804, 806, similar to those shown in FIGS. 8 and 9 (e.g., for suture 542).

[0151] In this manner, the base portion 516 of the mounting member 510 may be directly coupled to the two axially extending members 804, 806, while the folded commissure tabs may be attached to the protruding portion 516 of the mounting member 510 radially inward of the two axially extending members 804, 806.

[0152] In a third embodiment, as shown in Figures 15 and 16, the commissures 500 may be attached directly to the cells 902 of the frame 904 of the prosthetic heart valve 900. Figure 15 shows a portion of the inside of the frame 904, showing the inside of the commissures 500 and attachment members 910 (which may be the same as or similar to the attachment members 510 of Figures 7-9, except that they are positioned across the cells 902 of the frame 904 rather than across the struts of the frame). Figure 16 shows the prosthetic heart valve 900, showing the outside of the attachment members 910.

[0153] The commissure 500 shown in Figures 15 and 16 may be the same as the commissure 500 shown in Figure 7, except that the attachment member 910 extends across the opening of the cell 902 and is secured to the frame struts that form the cell 902.

[0154] For example, as shown in FIG. 15, attachment member 910 includes a base first portion 914 (similar to first portion 514 in FIGS. 7-9) and a protruding second portion 916 (similar to second portion 516 in FIGS. 7-9). First portion 914 extends across the opening of cell 902, and second portion 916 extends outward from first portion 914 as a fold along a central portion of cell 902 toward the central longitudinal axis of frame 904. First portion 914 of attachment member 901 may be secured to the struts forming cell 902 via one or more sutures 920 that extend through first portion 914 and loop around the frame struts around the perimeter of cell 902.

[0155] In this manner, the base portion 914 of the attachment member 910 may be directly coupled to the strut of the frame, while the folded commissure tabs are attached to the protruding portion 916 of the attachment member 910 radially inward of the strut of the frame.

[0156] Figure 17 is a flowchart of a method 1000 for assembling a prosthetic heart valve including multiple leaflets. In some embodiments, the prosthetic heart valve can be one of the valves described herein with reference to Figures 1-5, 10, 11, and 16. In particular, method 1000 is a method of forming multiple commissures in multiple leaflets, each leaflet (e.g., leaflet 400 shown in Figure 6) including two opposing commissure tabs located on either side of the body of the leaflet, connecting the multiple commissures to an annular frame of the prosthetic heart valve.

[0157] Method 1000 begins at 1002 by forming an attachment member (e.g., attachment member 510 shown in FIGS. 7-9 and 14 , or attachment member 910 shown in FIGS. 15 and 16 ) by folding a central portion of the attachment member to form a protruding portion (e.g., first portion 514 shown in FIGS. 7-9 ) extending outward from a base portion (e.g., second portion 516 shown in FIGS. 7-9 ). In some embodiments, when the base portion of the attachment member is coupled (directly or via a commissural support element) to an inner surface of a commissural support portion of a prosthetic heart valve frame, the protruding portion extends radially away from the base portion toward a central longitudinal axis of the valve frame. In some embodiments, the attachment member comprises a fabric material, as described above with reference to FIGS. 7-9 , 14 , and 15 .

[0158] At 1004, method 1000 includes folding each of a first commissure tab of a first leaflet and a second commissure tab of an adjacent second leaflet into two laterally overlapping layers, where the second leaflet may be divided into two laterally overlapping layers disposed axially and radially perpendicular to the central longitudinal axis of the annular frame of the prosthetic heart valve. For example, each of the first and second commissure tabs may be folded into two overlapping layers including a first tab portion (e.g., first tab portion 526 in FIGS. 7-9 ) and a second tab portion (e.g., second tab portion 528 in FIGS. 7-9 ). In some embodiments, as described above with reference to FIGS. 7-9 , the first tab portion extends radially outward from the body of the corresponding one of the first and second leaflets toward the base (first) portion of the attachment member. Each commissure tab is then folded from the first tab portion onto itself to form a second tab portion. The second tab portion extends radially inward, away from the base of the attachment member, toward the central longitudinal axis of the frame. In some embodiments, the majority of each of the first and second tab portions of each of the first and second commissure tabs can extend radially parallel to one another, as shown, for example, in FIG. 7 .

[0159] At 1006, the method 1000 may include positioning a folded first commissure tab against a first side of a protruding portion of the attachment member and positioning a folded second commissure tab against an opposite second side of the protruding portion. In some embodiments, the positioning at 1006 may include positioning a surface of the first side of the protruding portion and an inner surface of a first tab portion of the first commissure tab in flush contact with each other along an axially disposed height of the first commissure tab, and positioning a surface of the second side of the protruding portion and an inner surface of the first tab portion of the second commissure tab in flush contact with each other along a height of the second commissure tab. In some embodiments, the positioning at 1006 may further include positioning a fold between the first tab portion and the second tab portion for each of the first and second commissure tabs against an inside of the base portion of the attachment member such that each of the folded first and second commissure tabs is wedged against the attachment member in a region of bend between the base portion and the protruding portion.

[0160] At 1008, method 1000 may include securing each of the (folded) first commissure tab and the (folded) second commissure tab to the attachment member. In some embodiments, the securing may include extending one or more sutures (or suture lines) through the first commissure tab and the two overlapping layers of the protruding portion, and extending one or more sutures (or suture lines) through the second commissure tab and the two overlapping layers of the protruding portion. In some embodiments, the protruding portion includes two overlapping layers, each extending from a different end of the base portion, and the securing may include extending one or more sutures (or suture lines) through the two overlapping layers of the first commissure tab and the first layer of the protruding portion, and extending one or more sutures (or suture lines) through the two overlapping layers of the second commissure tab and the second layer of the protruding portion.

[0161] At 1010, method 1000 includes, for each commissure, attaching an attachment member for the commissure to the respective commissure support portion of the annular frame directly or via a commissure support element configured to couple to the commissure support portion and a base portion of the attachment member disposed between the radially folded first and second commissure tabs and the commissure support portion or commissure support element.

[0162] In some embodiments, attaching the attachment members directly or via commissural support elements to the respective commissural support portions of the annular frame includes positioning a base portion of the attachment member against an inner surface of a strut of the annular frame and securing the attachment member to the strut via a suture that extends through the attachment member and around the outer surface of the strut, hi some embodiments, the strut is at least part of an actuator or expansion and locking mechanism of the frame.

[0163] In other embodiments, attaching the attachment members directly or via commissural support elements to the respective commissural support portions of the annular frame includes positioning the base of the attachment member against the inner surface of the open commissural window of the annular frame, and securing the attachment member to the open commissural window via at least a first suture extending through a first end of the base portion of the attachment member and extending around a first axially extending strut that forms the open commissural window, and a second suture extending through an opposite second end of the base portion of the attachment member and extending around a second axially extending strut that forms the open commissural window.

[0164] In yet another embodiment, attaching the attachment members directly to the respective commissural support portions of the annular frame or via the commissural support elements includes positioning a base portion of the attachment member against an inner surface of the leaflet receiving window of the commissural support element, securing the attachment member to the leaflet receiving window via 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 commissural support element to the corresponding commissural support portion of the frame.

[0165] In some embodiments, attaching the attachment members directly or via commissural support elements to the respective commissural support portions of the annular frame includes positioning a base portion of the attachment member across a cell of the annular frame, the cell being formed by angled struts of the annular frame, and securing the attachment member to the angled struts forming the cell via one or more sutures extending through the base portion of the attachment member and around the angled struts along the periphery of the cell.

[0166] Accordingly, the commissure and leaflet configurations described herein can provide a leaflet assembly for a prosthetic heart valve that can reduce stress during valve operation (due to the cyclic opening and closing of the leaflets) and radial expansion and / or contraction of the valve frame, thereby increasing the longevity of the leaflet assembly.

[0167] The integrity and longevity of the leaflets and commissures may be further increased by configuring the sutures of the commissure tabs to reduce stress concentrations along the edges of the leaflets, which are prone to increased stress and, in some cases, tearing. As discussed herein, in some embodiments, the commissures may be attached to attachment members, either directly or via commissure support elements, to support portions of the frame of the prosthetic heart valve (such as commissure struts, actuators, expansion and locking mechanisms, etc.), or via one or more sutures extending through the commissure tabs along one or more suture lines of the commissure tabs, which may include multiple apertures (suture apertures) configured to receive the sutures.

[0168] 18-20 show detailed views of a portion of an exemplary valve leaflet 1100 having different embodiments of sutures on the commissure tabs 1102 of the valve leaflet 1100. Only one commissure tab 1102 of the valve leaflet 1100 is shown in FIGS. 18-20 for ease of illustration. However, the valve leaflet 1100 includes two commissure tabs located on opposite sides of the body 1104 of the valve leaflet 1100. For example, in some embodiments, the valve leaflet 1100 can be configured similarly to the valve leaflet 400 shown in FIG. 6 (discussed above).

[0169] 18-20 show a single suture line, it should be noted that other numbers of suture lines are possible. For example, each commissure tab may include the multiple suture line embodiments shown in FIGS. 18-20, such as two, three, or four suture lines, all positioned adjacent to one another from the outer edge 1106 of the commissure tab 1102 toward the neck region 1108 (or body) of the leaflet 1100. For example, each of the commissure tabs of the leaflet 400 of FIG. 6 includes four suture lines.

[0170] Referring initially to FIG. 18 , a first embodiment of a suture line 1110 formed by multiple apertures (suturing apertures) 1112a-b disposed on the commissure tab 1102 is shown. For example, the apertures include an outer aperture 1112a and an inner aperture 1112b. The outer aperture 1112a is disposed closer to the upper and lower edges (e.g., the upper edge 1114 and the lower edge 1116) of the commissure tab 1102. The upper edge 1114 may be part of (or connected to) the outflow edge 1118 of the valve leaflet 1100 (e.g., similar to the outflow edge 410 shown in FIG. 6 ). The inner aperture 1112b is disposed farther from the upper edge 1114 and the lower edge 1116 than the outer aperture 1112a. For example, the inner aperture 1112b may be disposed closer to the interior or central portion of the commissure tab 1102. Although the suture line 1110 is shown in FIG. 18 (and FIG. 19) with four apertures 1112, in other embodiments, the suture line 1110 may include more or less than four apertures 1112 (e.g., two, three, five, six, etc.).

[0171] 18, the suture line 1110 extends along a relatively straight line and, in some embodiments, may be approximately parallel to or slightly angled to the centerline of the leaflets and aligned parallel to the central longitudinal axis of the frame (or, in some embodiments, the struts of the frame). Thus, each of the outer aperture 1112a and inner aperture 1112b is aligned with one another along the relatively straight (and, in some embodiments, perpendicular) suture line 1110.

[0172] As shown in FIGS. 18-20 (and FIG. 6 ), the edges of the leaflet 1100 that extend inward toward the body 1104 and away from the commissure tabs 1102 are angled relative to the suture line 1110. For example, the outflow edge 1118 of the leaflet 1100 curves axially downward at an angle as one moves from the upper edge 1114 of the commissure tab 1102 to the centerline of the leaflet 1100 (e.g., centerline 424 shown in FIG. 6 ). The angled configuration of the leaflet 1100 relative to the suture line 1110 allows the suture line 1110 to function 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.

[0173] 18 , this uneven stress distribution is illustrated by stress lines 1120a-1120c. Specifically, stresses occurring along a first stress line 1120a, located along the outflow edge 1118 of the valve leaflet 1100, may be higher than stresses occurring along more medial portions of the commissure tabs 1102 and body 1104 of the valve leaflet 1100. For example, stresses experienced along stress lines 1120a-1120c may increase from the third stress line 1120c to the first stress line 1120a, with the greatest amount of stress experienced proximate or at the outflow edge 1118. Thus, because the edges of the valve leaflet, such as the outflow edge 1118, are susceptible to tearing under certain conditions, portions of the outflow edge 1118 may deteriorate under stress and / or tear over time.

[0174] Therefore, it may be desirable to provide a suture configuration on the commissure tabs 1102 that results in higher (e.g., greatest) stress formation along the more inner portions of the commissure tabs 1102 rather than along the outflow edge 1118. Because the commissure tabs 1102 and the more inner portions of the leaflets 1100 are stronger and less prone to tearing, these regions are better able to handle increased stress (compared to the edges of the leaflets 1100).

[0175] FIG. 19 shows one embodiment of a suture line 1130 formed by multiple apertures 1132a-1132b (e.g., the inner aperture 1132b and the outer aperture 1132a can be the same as or similar to the apertures 1112a-1112b except for their placement on the commissure tabs) configured to concentrate higher stresses toward the commissure tabs 1102 and the inner portion of the leaflet 1100 and reduce stress experienced along the outflow edge 1118 of the leaflet 1100.

[0176] 19, the sutures 1130 may not be straight, but instead have an offset region (relative to the remainder of the sutures 1130) in a more central portion (interior or middle region) of the commissure tabs 1102. In some embodiments, one or more of the inner apertures 1132b may be offset radially inward (toward the centerline of the body of the leaflet 1100, as shown by arrows 1134) from the outer apertures 1132a. As a result, a curved suture 1130 may be formed with an inner peak (a peak positioned away from the outer edge 1106). This configuration of the sutures 1130 may result in higher stresses occurring along the commissure tabs 1102 and the middle portion of the leaflet 1100, between the upper edge 1114 and the lower edge 1116, away from the outflow edge 1118 of the leaflet 1100. For example, the offset configuration of suture line 1130 may result in higher stress along stress lines 1120b, 1120c than along stress line 1120a.

[0177] FIG. 20 shows another embodiment of a suture line 1140 formed by multiple apertures 1142a-1142c (e.g., the inner aperture 1142b and outer apertures 1142a, 1142c can be the same or similar to the apertures 1112a-1112b except for the number of apertures and their placement on the commissure tabs) configured to concentrate higher stresses away from the outflow edge 1118 of the leaflet 1100 (toward the commissure tabs 1102 and the inner portion of the leaflet 1100).

[0178] 20 , the suture line 1140 may not be straight along all of its apertures, but instead may have offset regions (e.g., including apertures 1142b, 1142c) that are offset radially inward (toward the centerline of the body of the leaflet 1100) from an outer aperture 1142a disposed proximate the outflow edge 1118. For example, the upper portion of the suture line 1140 may be angled radially inward from the outer edge 1106 and the outflow edge 1118, while the lower portion of the suture line 1140 may extend in a relatively straight line but may be radially offset from the outer edge 1106. This may result in higher stress concentrations along the commissure tabs 1102 and the middle portion of the leaflet 1100, beginning at the offset lower portion of the suture line 1140 (e.g., stress line 1144a) at a location disposed away from the outflow edge 1118. Thus, lower stresses may be experienced proximal to outflow edge 1118. In some embodiments, the highest stresses may be experienced near and / or along stress line 1144a, while lower stresses are experienced outward (axially) from stress line 1144a, near outflow edge 1118 and at stress line 1144b.

[0179] The suture configurations shown in Figures 19 and 20 can be used in the commissure arrangements described herein. For example, in some embodiments, the leaflet 400 of Figure 6 can include multiple sutures (positioned adjacent to each other on the commissure tabs) having the configuration of suture 1130 (Figure 19) and / or suture 1140 (Figure 20). These offset sutures can then be used to secure the folded commissure tabs to the commissure attachment members, as described above with reference to Figures 7-9 and 14-17. In this manner, the integrity and longevity of the commissures and leaflets can be further increased.

[0180] [Additional examples of disclosed technologies] In view of the above implementations of the disclosed subject matter, the present application discloses the following additional examples: It should be noted that one feature of an example in isolation, or two or more features of an example in combination, and optionally combined with one or more features of one or more additional examples, are additional examples included in the disclosure herein.

[0181] Example 1. A prosthetic heart valve comprising: an annular frame including a plurality of commissural support portions; and a plurality of leaflets positioned within the frame, each leaflet including a body and two opposing commissural tabs disposed on opposite sides of the body, each said commissural tab pairing with an adjacent commissural tab of an adjacent leaflet to form a commissure, wherein each commissure of the prosthetic heart valve extends across and includes a first portion directly attached to a commissural support element configured to be coupled to a corresponding one of the plurality of commissural support portions or a commissural support element configured to be coupled to a corresponding one of the plurality of commissural support portions; and a second portion extending 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 laterally overlapping layers disposed perpendicular to an axial direction and a radial direction relative to the central longitudinal axis, the two overlapping layers being positioned adjacent 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 leaflet of the plurality of leaflets folded into two laterally overlapping layers, the two overlapping layers being positioned adjacent a second, opposite side of the second portion of the attachment member and directly secured to the attachment member.

[0182] Example 2. The prosthetic heart valve of any example herein, particularly Example 1, wherein the first portion of the attachment member is positioned against an inner surface of the commissural support portion or a commissural support element configured to be coupled to the commissural support portion, the inner surface facing the central longitudinal axis.

[0183] 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 commissural support portion or element.

[0184] Example 4. The prosthetic heart valve of any example herein, particularly example 2, wherein the first portion of the attachment member extends across only a portion of the inner surface and lateral surface of the commissural support portion or element, and the lateral surface is disposed perpendicular to the inner surface.

[0185] 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 includes two overlapping layers, each extending from a different inner end of the first portion, and the two overlapping layers overlap laterally.

[0186] Example 6 The prosthetic heart valve of any example herein, particularly any one of Examples 1-5, wherein the attachment members comprise a textile material.

[0187] Example 7 The prosthetic heart valve of any example herein, particularly example 6, wherein the attachment members comprise a polyethylene terephthalate (PET) fabric.

[0188] Example 8 The prosthetic heart valve of any example herein, particularly any one of Examples 1-7, wherein the attachment members comprise a flexible polymeric material.

[0189] Example 9. The prosthetic heart valve of any of the Examples herein, particularly any one of Examples 1-8, wherein the two overlapping layers of each of the first and second commissure tabs include a first tab portion disposed against a respective one of a first side and a second side of the second portion of the attachment member, and a second tab portion disposed against the first tab portion, and wherein the first and second sides of the second portion and the first and second tab portions of each of the first and second commissure tabs are all disposed parallel to one another.

[0190] Example 10. Any of the examples herein, particularly the prosthetic heart valve of Example 9, wherein for each of the first commissure tab and the second commissure tab, the fold between the first tab portion and the second tab portion is disposed adjacent a corresponding one of the first side and the second side relative to the inside of the first portion of the attachment member.

[0191] Example 11. The prosthetic heart valve of any of the examples herein, particularly any one of Examples 1-10, wherein the folded first commissure tab is wedged against the attachment member in a region of a first bend between the first portion of the attachment member and the first side of the second portion, and the folded second commissure tab is wedged against the attachment member in a region of a second bend between the first portion of the attachment member and the second side of the second portion.

[0192] Example 12 The prosthetic heart valve of any example herein, particularly example 11, wherein the first bend and the second bend are each 90 degrees.

[0193] Example 13. The prosthetic heart valve of any one of the examples herein, particularly any one of Examples 11 and 12, wherein the two overlapping layers of the first commissure tab are secured to the attachment member by one or more suture lines extending through the two overlapping layers and the attachment member proximate to the first bend, and the two overlapping layers of the second commissure tab are secured to the attachment member by one or more suture lines extending through the two overlapping layers and the attachment member proximate to the second bend.

[0194] Example 14. The prosthetic heart valve of any example herein, particularly any one of Examples 1-13, wherein the second portion of the attachment member extends axially along the entire height of each of the first and second commissure tabs.

[0195] Example 15. The prosthetic heart valve of any example herein, particularly any one of Examples 1-14, wherein the attachment members are attached directly to the commissural support portions, and the commissural support portions are struts of the frame.

[0196] Example 16 The prosthetic heart valve of any of the embodiments herein, especially example 15, wherein the strut is one of the actuators of the frame or the expansion and locking mechanism.

[0197] Example 17 The prosthetic heart valve of any of the embodiments herein, particularly any one of Examples 15 and 16, wherein the attachment members are attached directly to the struts via sutures that extend through the attachment members and around the outer surface of the struts.

[0198] Example 18. The prosthetic heart valve of any of the embodiments herein, particularly any one of Examples 1-14, wherein the attachment members are attached directly to the commissural support portions, and the commissural support portions are commissural fenestrae formed by spaced struts of the frame.

[0199] Example 19. The prosthetic heart valve of any of the embodiments herein, particularly example 18, wherein the attachment member is directly attached to the commissural fenestra via a first suture extending 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 commissural fenestra, and a second suture extending 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 commissural fenestra.

[0200] Example 20. The prosthetic heart valve of any example herein, particularly any one of Examples 1-14, wherein the attachment member is directly attached to the leaflet-receiving windows of the commissural support elements formed by the spaced-apart axial members of the commissural support elements via a first suture extending around a first axial member of the spaced-apart axial members through a first end of the first portion of the attachment member and a second suture extending around a second axial member of the spaced-apart axial members through a second end of the first portion of the attachment member.

[0201] Example 21. The prosthetic heart valve of any of the examples herein, particularly any one of Examples 1-14, wherein the attachment members are positioned across and directly attached to the cells of the annular frame, the cells being formed by the angled struts of the annular frame via one or more sutures extending through a first portion of the attachment members and around the angled struts forming the cells around the cells.

[0202] Example 22. The prosthetic heart valve of any of the embodiments herein, particularly any one of Examples 1-21, wherein the annular frame includes a plurality of interconnected struts and is radially contractible to a contracted configuration and radially expandable to an expanded configuration.

[0203] Example 23. The prosthetic heart valve of any of the embodiments herein, particularly Example 22, wherein in the expanded configuration, the annular frame is tapered 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 the degree of taper from the outflow end to the inflow end defines the draft angle of the frame.

[0204] Example 24. The prosthetic heart valve of any example herein, particularly example 22, wherein each commissure tab of each leaflet is angled by a tab angle defined between a centerline of the leaflet and a line extending through the commissure tab and perpendicular to the upper and lower lateral edges of the commissure tab, and wherein the tab angle is within 5% of the draft angle of the frame.

[0205] Example 25 The prosthetic heart valve of any example herein, especially example 24, wherein the tab angle matches the frame draft angle.

[0206] Example 26. The prosthetic heart valve of any of the Examples herein, particularly any one of Examples 1-25, wherein the body of each leaflet includes a first leaflet portion and a second leaflet portion disposed on opposite sides of the body, and a curved edge extends between and connects a corresponding one of the first and second commissure tabs to a corresponding one of the first and second leaflet portions, each curved edge defining a window open on either side of the leaflet.

[0207] Example 27. The prosthetic heart valve of any of the examples herein, particularly any one of Examples 1-26, wherein each of the first commissure tab and the second commissure tab includes one or more suture lines including one or more apertures, each suture line including a portion offset from the remainder of the suture line in a direction toward the body of the valve leaflet, the offset portion being positioned away from the outflow edge of the valve leaflet.

[0208] Example 28. A method of assembling a prosthetic heart valve including a plurality of leaflets, the method comprising the steps of forming a plurality of commissures with the plurality of leaflets, each leaflet including two opposing commissure tabs disposed on opposite sides of a body of the leaflet, each said commissure comprising: folding a first commissure tab of a first leaflet and a second commissure tab of an adjacent second leaflet into two laterally overlapping overlapping layers disposed perpendicular to an axial direction and a radial direction relative to a central longitudinal axis of an annular frame of the prosthetic heart valve; and positioning the folded first commissure tab against a first side of a protruding portion of an attachment member and attaching the folded second commissure tab to the protruding portion. and positioning the first and second commissure tabs against an opposite second side of the annular frame, the protruding portion extending radially away from the base of the attachment member; securing each of the first and second commissure tabs to the attachment member; and, for each commissure, attaching the attachment member to a corresponding commissure support portion of the annular frame either directly or via a commissure support portion, a base portion of the attachment member positioned radially between the folded first and second commissure tabs, and a commissure support element configured to be coupled to the commissure support portion or the commissure support element.

[0209] Example 29 The method of any example herein, especially example 28, further comprising folding a central region of the attachment member to form the attachment member and form a protrusion extending outwardly from the base.

[0210] Example 30. The method of any example herein, particularly the method of any one of Examples 28-29, wherein folding each of the first and second commissure tabs comprises folding each of the first and second commissure tabs into two overlapping layers comprising a first tab portion and a second tab portion, the first tab portion extending radially outward from the body of the corresponding one of the first and second leaflets toward a base portion of the attachment member, and the second portion extending radially inward, away from the base portion of the attachment member, toward the central longitudinal axis of the frame.

[0211] Example 31. The method of any example herein, particularly example 30, wherein folding each of the first and second commissure tabs into two overlapping layers includes folding each of the first and second commissure tabs from a first tab portion onto itself to form a second tab portion.

[0212] Example 32. The method of any example herein, particularly the method of any one of Examples 30 and 31, wherein the placing step includes the steps of: placing a first side surface of the protruding portion and an inner surface of the first tab portion of the first commissure tab in axially arranged, surface-sharing contact with each other along a height of the first commissure tab; and placing a second side surface of the protruding portion and an inner surface of the first tab portion of the second commissure tab in surface-sharing contact with each other along a height of the second commissure tab.

[0213] Example 33. The method of any example herein, particularly example 32, wherein the positioning step further includes, for each of the first and second commissure tabs, positioning a fold between the first and second tab portions against an interior side of the base portion of the attachment member such that each of the folded first and second commissure tabs is wedged against the attachment member in a region of bend between the base portion and the protruding portion.

[0214] Example 34. The method of any example herein, particularly the method of any one of Examples 30-33, wherein the step of securing each of the first commissure tab and the second commissure tab to the attachment member includes extending one or more sutures through the two overlapping layers of the first commissure tab and the protruding portion, and extending one or more sutures through the two overlapping layers of the second commissure tab and the protruding portion.

[0215] Example 35. The method of any example herein, particularly example 34, wherein the step of securing each of the first and second commissure tabs to the attachment member comprises: extending one or more sutures along one or more suture lines of the first commissure tab, through the protruding portion and the two overlapping layers of the first commissure tab, toward a centerline of the body of the corresponding leaflet, the one or more suture lines including at least a middle portion offset from the remainder of the suture line, the middle portion being positioned away from the outflow edge of the corresponding leaflet; and the securing comprises: extending one or more sutures along one or more suture lines of the second commissure tab, through the protruding portion and the two overlapping layers of the second commissure tab, toward a centerline of the body of the corresponding leaflet, the one or more suture lines including at least a middle portion offset from the remainder of the suture line, the middle portion being positioned away from the outflow edge of the corresponding leaflet.

[0216] Example 36. The method of any example herein, particularly the method of any one of Examples 30-33, wherein the protruding portion includes two overlapping layers, each extending from a different end of the base portion, and wherein securing each of the first commissure tab and the second commissure tab to the attachment member includes extending one or more sutures through the two overlapping layers of the first commissure tab and the first layer of the protruding portion, and extending one or more sutures through the two overlapping layers of the second commissure tab and the second layer of the protruding portion.

[0217] Example 37. The method of any example herein, particularly the method of any one of Examples 28-36, wherein the step of attaching the attachment members directly to the respective commissural support portions of the annular frame or attaching them via commissural support elements includes the steps of positioning a base of the attachment member against an inner surface of a strut of the annular frame, and securing the attachment member to the strut via a suture extending through the attachment member and around an outer surface of the strut.

[0218] Example 38. The method of any example herein, particularly the method of any one of Examples 28-37, wherein the step of attaching the attachment members directly to the respective commissural support portions of the annular frame or attaching them via commissural support elements includes positioning a base of the attachment member against an inner surface of the open commissural window of the annular frame, and securing the attachment member to the open commissural window via 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 that forms the open commissural 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 that forms the open commissural window.

[0219] Example 39. The method of any example herein, particularly the method of any one of Examples 28-38, wherein the step of attaching the attachment members directly to the respective commissural support portions of the annular frame or attaching them via the commissural support elements includes the steps of positioning a base portion of the attachment member against an inner surface of the leaflet receiving window of the commissural support element, securing the attachment member to the leaflet receiving window via 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 commissural support elements to the commissural support portions of the frame.

[0220] Example 40. The method of any example herein, particularly the method of any one of Examples 28-39, wherein the step of attaching the attachment members directly or via commissural support elements to respective commissural support portions of the annular frame includes the steps of positioning a base portion of the attachment member across a cell of the annular frame, the cell being formed by oblique struts of the annular frame, and securing the attachment member to the oblique struts forming the cell via one or more sutures that pass through the base portion of the attachment member and extend around the oblique struts around the cell.

[0221] Example 41. A prosthetic heart valve comprising: an annular frame including a plurality of commissural support portions, each of the commissural support portions including an inner surface facing a central longitudinal axis of the frame and an outer surface disposed on the opposite side; and a plurality of valve leaflets positioned within the frame, each of the valve leaflets including a body and two opposing commissural tabs disposed on opposite sides of the body, each commissural tab pairing with an adjacent commissural tab of an adjacent leaflet to form a commissure; wherein each commissure of the prosthetic heart valve is directly attached to a corresponding one of the plurality of commissural support portions, the attachment member including a base portion extending across the inner surface of the commissural support portion and a center portion of the base portion. a first commissure tab of a first leaflet of the plurality of leaflets folded into two laterally overlapping layers arranged axially and radially perpendicular to the central longitudinal axis, the two overlapping layers being positioned adjacent a first side of the attachment member's protruding portion and secured directly to the attachment member; and a second commissure tab of a second leaflet of the plurality of leaflets folded into two laterally overlapping layers, the two overlapping layers being positioned adjacent a second, opposite side of the attachment member's protruding portion and secured directly to the attachment member.

[0222] 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 commissure tab is positioned adjacent to a first bend between the base portion and a first side of the protruding portion relative to the base portion, and a second fold between the two overlapping layers of the second commissure tab is positioned adjacent to a second bend between the base portion and a second side of the protruding portion relative to the base portion.

[0223] Example 43. The prosthetic heart valve of any of the examples herein, particularly any one of Examples 41-42, wherein the first commissure tab is secured directly to the attachment member on a first side of the protruding portion via a first suture line extending through the first commissure tab and the two overlapping layers of the protruding portion, and the second commissure tab is secured directly to the attachment member on a second side of the protruding portion via a second suture line extending through the second commissure tab and the two overlapping layers of the protruding portion.

[0224] Example 44. The prosthetic heart valve of any example herein, particularly example 43, wherein each of the first and second commissure tabs includes one or more suture lines including one or more apertures, each suture line including a portion offset from the remainder of the suture line in a direction toward the body of the valve leaflet, the offset being positioned away from the outflow edge of the valve leaflet, and wherein the first suture line extends through the one or more apertures in a first suture line of the one or more suture lines of the first commissure tab, and the second suture line extends through the one or more apertures in a second suture line of the one or more suture lines of the second commissure tab.

[0225] Example 45. The prosthetic heart valve of any of the examples herein, particularly any one of Examples 41-44, wherein the first commissure tab is further secured to the attachment member on a first side of the protruding portion via a third suture line extending through the first commissure tab and the two overlapping layers of the protruding portion, the third suture line being disposed inward of the first suture line relative to the central longitudinal axis at a radial position; and the second commissure tab is further secured to the attachment member on a second side of the protruding portion via a fourth suture line extending through the second commissure tab and the two overlapping layers of the protruding portion, the fourth suture line being disposed inward of the second suture line relative to the central longitudinal axis at a radial position.

[0226] Example 46. The prosthetic heart valve of any example herein, particularly any one of Examples 41-45, wherein the protruding portion includes two overlapping layers, each extending from a different inner end of the base portion, and the two overlapping layers of the protruding portion overlap laterally.

[0227] Example 47 The prosthetic heart valve of any example herein, particularly any one of Examples 41-46, wherein the attachment members comprise a textile material.

[0228] Example 48 The prosthetic heart valve of any example herein, particularly any one of Examples 41-47, wherein the attachment members comprise a polyethylene terephthalate (PET) fabric.

[0229] Example 49. The prosthetic heart valve of any of the embodiments herein, particularly any one of Examples 41-48, wherein the protruding portion of the attachment member extends axially along the entire height of each of the first and second commissure tabs.

[0230] Example 50 The prosthetic heart valve of any example herein, particularly any one of Examples 41-49, wherein the commissural support portions are at least part of the struts of the frame.

[0231] Example 51 The prosthetic heart valve of any of the embodiments herein, particularly example 50, wherein the strut is one of the actuator, the expansion and locking mechanism, and the frame alternate strut.

[0232] Example 52 The prosthetic heart valve of any example herein, particularly any one of Examples 41-51, wherein the commissural support portion is a commissural fenestra formed by spaced struts of the frame.

[0233] Example 53. A prosthetic heart valve comprising: an annular frame including a plurality of commissural support portions; a plurality of leaflets positioned within the frame, each leaflet including a body and two opposing commissural tabs disposed on opposite sides of the body, each commissural tab pairing with an adjacent commissural tab of an adjacent leaflet to form a commissure; and a plurality of commissural support elements, each commissural support element including a connecting portion connected to a corresponding one of the plurality of commissural support portions and a commissural receiving portion, wherein each commissure of the prosthetic heart valve comprises an attachment member directly attached to a corresponding commissural support element, the attachment member comprising: a base portion extending across an inner surface of the commissural receiving portion of the commissural support element; a first commissure tab of a first leaflet of the plurality of leaflets folded into two laterally overlapping layers arranged axially and radially perpendicular to the central longitudinal axis, the two overlapping layers being positioned adjacent a first side of the attachment member's protruding portion and secured directly to the attachment member; and a second commissure tab of a second leaflet of the plurality of leaflets folded into two laterally overlapping layers, the two overlapping layers being positioned adjacent a second, opposite side of the attachment member's protruding portion and secured directly to the attachment member.

[0234] Example 54 The prosthetic heart valve of any example herein, particularly example 53, wherein the commissure-receiving portion of the commissure-supporting member is radially offset from the attachment portion.

[0235] Example 55. The prosthetic heart valve of any of the embodiments 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 portion material spaced laterally from one another.

[0236] Example 56. The prosthetic heart valve of any example herein, particularly example 55, wherein the attachment member is attached directly to the open fenestration via a first suture extending through a first end of the base portion of the attachment member and around a first of the two axial members, and a second suture extending through a second end of the base of the attachment member and around a second of the two axial members.

[0237] Example 57. The prosthetic heart valve of any of the examples herein, particularly any one of Examples 53-56, wherein a first fold between the two overlapping layers of the first commissure tab is positioned adjacent to a first bend between the base portion and a first side of the protruding portion relative to the base portion, and a second fold between the two overlapping layers of the second commissure tab is positioned adjacent to a second bend between the base portion and a second side of the protruding portion relative to the base portion.

[0238] Example 58. The prosthetic heart valve of any of the examples herein, particularly any one of Examples 53-57, wherein the first commissure tab is secured directly to the attachment member on a first side of the protruding portion via a first suture line extending through the two overlapping layers of the first commissure tab and the protruding portion, and the second commissure tab is secured directly to the attachment member on a second side of the protruding portion via a second suture line extending through the two overlapping layers of the second commissure tab and the protruding portion.

[0239] Example 59. The prosthetic heart valve of any of the examples herein, particularly any one of Examples 53-58, wherein the first commissure tab is further secured to the attachment member via a third suture line extending through the two overlapping layers of the first commissure tab and the protruding portion on a first side of the protruding portion, the third suture line being positioned inward of the first suture line relative to the central longitudinal axis at a radial position; and the second commissure tab is further secured to the attachment member via a fourth suture line extending through the two overlapping layers of the second commissure tab and the protruding portion on a second side of the protruding portion, the fourth suture line being positioned inward of the second suture line relative to the central longitudinal axis at a radial position.

[0240] Example 60. The prosthetic heart valve of any example herein, particularly any one of Examples 53-59, wherein the protruding portion includes two overlapping layers, each extending from a different inner end of the base portion, and the two overlapping layers of the protruding portion overlap laterally.

[0241] Example 61 The prosthetic heart valve of any example herein, particularly any one of Examples 53-60, wherein the attachment members comprise a textile material.

[0242] Example 62 The prosthetic heart valve of any example herein, particularly any one of Examples 53-61, wherein the attachment members comprise a polyethylene terephthalate (PET) fabric.

[0243] Example 63. The prosthetic heart valve of any of the embodiments herein, particularly any one of Examples 53-62, wherein the protruding portion of the attachment member extends axially along the entire height of each of the first commissure tab and the second commissure tab.

[0244] Example 64. The prosthetic heart valve of any of the embodiments herein, particularly any one of Examples 53-63, wherein the commissural support portions are disposed on one of the struts of the frame, the actuator, and the expansion and locking mechanism.

[0245] Example 65. A prosthetic heart valve comprising: an annular frame including a plurality of interconnected oblique struts defining a plurality of rows of cells disposed between the outflow end and the inflow end of the frame; and a plurality of leaflets positioned within the frame, each leaflet comprising a body and two opposing commissure tabs disposed on opposite sides of the body, each commissure tab pairing with an adjacent commissure 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 oblique strut defining one of the cells in the plurality of rows of cells, the attachment member having a base portion extending across the cells and a central region of the base portion extending radially outward from the central region of the base portion. a first commissure tab of a first leaflet of the plurality of leaflets folded into two laterally overlapping layers arranged axially and radially perpendicular to the central longitudinal axis, the first commissure tab being positioned adjacent a first side of the attachment member's protruding portion and secured directly to the attachment member; and a second commissure tab of a second leaflet of the plurality of leaflets folded into two laterally overlapping layers, the second commissure tab being positioned adjacent a second, opposite side of the attachment member's protruding portion and secured directly to the attachment member.

[0246] Example 66. The prosthetic heart valve of any of the embodiments herein, particularly example 65, wherein the attachment member is attached directly to the angled struts of the cell via one or more sutures that pass through a base portion of the attachment member and extend around the periphery of the cell, around the angled struts that form the cell.

[0247] Example 67. The prosthetic heart valve of any of the examples herein, particularly any one of Examples 65-66, wherein a first fold between the two overlapping layers of the first commissure tab is positioned adjacent to a first bend between the base portion and a first side of the protruding portion relative to the base portion, and a second fold between the two overlapping layers of the second commissure tab is positioned adjacent to a second bend between the base portion and a second side of the protruding portion relative to the base portion.

[0248] Example 68. The prosthetic heart valve of any example herein, particularly any one of Examples 65-67, wherein the first commissure tab is secured directly to the attachment member on a first side of the protruding portion via a first suture line extending through the two overlapping layers of the first commissure tab and the protruding portion, and the second commissure tab is secured directly to the attachment member on a second side of the protruding portion via a second suture line extending through the two overlapping layers of the second commissure tab and the protruding portion.

[0249] Example 69. The prosthetic heart valve of any of the examples herein, particularly any one of Examples 65-68, wherein the first commissure tab is further secured to the attachment member via a third suture line extending through the two overlapping layers of the first commissure tab and the protruding portion on a first side of the protruding portion, the third suture line being positioned inward of the first suture line relative to the central longitudinal axis at a radial position; and the second commissure tab is further secured to the attachment member via a fourth suture line extending through the two overlapping layers of the second commissure tab and the protruding portion on a second side of the protruding portion, the fourth suture line being positioned inward of the second suture line relative to the central longitudinal axis at a radial position.

[0250] Example 70. The prosthetic heart valve of any example herein, particularly any one of Examples 65-69, wherein the protruding portion includes two overlapping layers, each extending from a different inner end of the base portion, and the two overlapping layers of the protruding portion overlap laterally.

[0251] Example 71 The prosthetic heart valve of any example herein, particularly any one of Examples 65-70, wherein the attachment members comprise a textile material.

[0252] Example 72 The prosthetic heart valve of any example herein, particularly any one of Examples 65-71, wherein the attachment members comprise a polyethylene terephthalate (PET) fabric.

[0253] Example 73. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 65-72, wherein the protruding portion of the attachment member extends axially along the entire height of each of the first commissure tab and the second commissure tab.

[0254] Example 74. An annular frame including a plurality of interconnected angled struts defining a plurality of rows of cells disposed between the outflow end and the inflow end of the frame, and a plurality of commissure support portions; and a plurality of leaflets positioned within the frame, each leaflet including a body including an outflow edge extending across the leaflet between two opposing commissure tabs, two opposing commissure tabs each disposed on opposite sides of the body, and cusp edges that meet to form the inflow end of the leaflet. 1. A prosthetic heart valve comprising: a plurality of leaflets, each having a commissure tab and a suture line including one or more suture lines with one or more apertures adapted to receive a suture, each suture line extending between an upper edge and a lower edge of the commissure tab and including a portion offset from the remainder of the suture line toward the body of the valve leaflet, the portion including one or more apertures disposed inside a first outer aperture of the suture line disposed adjacent the upper edge, the upper edge being connected to the outflow edge of the leaflet; and each commissure is secured to a corresponding one of the plurality of commissure support portions directly or via one or more sutures extending along the one or more suture lines to an attachment member configured to be coupled to the commissure support portion.

[0255] Example 75. The prosthetic heart valve of any example herein, particularly example 74, wherein the portion of the suture line that is offset from the remainder of the suture line is an intermediate portion of the suture line and includes one or more inner apertures disposed inside the outer apertures of the suture line, the outer apertures including a first outer aperture disposed adjacent the upper edge and a second outer aperture disposed adjacent the lower edge.

[0256] Example 76. The prosthetic heart valve of any example herein, particularly example 74, wherein the portion of the suture line that is offset from the remainder of the suture line is a lower portion of the suture line, the lower portion of the suture line including one or more inner apertures and a second outer aperture disposed adjacent a lower edge, the inner apertures and the second outer aperture being disposed inside at least the first outer aperture.

[0257] Example 77. The prosthetic heart valve of any example herein, particularly example 76, wherein the remainder of the suture line is angled from the outer edge of the commissure tab and includes one or more outer apertures including the first outer aperture, the outer edge extending between the upper and lower edges to a midpoint disposed inward of the outer edge, and the offset portion of the suture line extends from the midpoint to the lower end of the commissure tab.

[0258] Example 78. The prosthetic heart valve of any of the examples herein, particularly any one of Examples 74-77, wherein the commissure tabs of each of the valve leaflets are connected to the body via a corresponding neck region, and the one or more sutures include at least two sutures positioned adjacent to each other between the outer edge of the commissure tab and the neck region.

[0259] Example 79. The prosthetic heart valve of any example herein, particularly any one of Examples 74-78, wherein each commissure is secured to a protruding portion of an attachment member via one or more sutures extending along one or more suture lines of a commissure tab of the commissure, the attachment member including a base portion coupled to an inner surface of the commissure support portion, and the protruding portion extending radially outward from the base portion toward the central longitudinal axis of the frame.

[0260] Example 80. A prosthetic heart valve comprising: an annular frame including a plurality of commissure support portions; and a plurality of valve leaflets positioned within the frame, each leaflet comprising a body and two opposing commissure tabs, each positioned on opposite sides of the body, each commissure tab pairing with an adjacent commissure tab of an adjacent leaflet to form a commissure; wherein each commissure of the prosthetic heart valve comprises an attachment member including: a first portion extending across and directly attached to a commissure support element configured to be coupled to a corresponding commissure support portion or commissure support portion of the plurality of commissure support portions; 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 leaflet of the plurality of leaflets positioned 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 leaflet of the plurality of leaflets positioned adjacent to a second side opposite the second portion of the attachment member and directly secured to the attachment member.

[0261] In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are merely preferred examples of the disclosed technology and should not be construed as limiting the scope of the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents. [Explanation of symbols]

[0262] 10, 100, 200, 300 artificial heart valves 12 Circular stent or frame 14 First end, inlet end 16 Second end, outflow end 18 Valve Structure 20 Inner Skirt 22 Valve leaflets 24 commissure 26 Commissural attachment 28 Strut 30 Rivets or pins 80 Actuator 90 Piston, inner member 92 Cylinder, outer member 102, 202, 302 frames 104, 208, 308 struts 106, 224, 324 inflow end, distal end 108, 226, 326 Outflow end, proximal end 112, 212, 312 segments 150 Extension and Locking Mechanism 152 sleeve 156 Inner member 158 Distal end section 160, 214 Fasteners 162 End cap or nut 186 Inner wall 188 Exterior Wall 190 Side wall 204, 304 Inflow end 206, 306 Outflow end 218 Middle Segment 220 End 228, 230, 232, 328, 330, 332, 334, 336 cells 244, 246, 248, 250, 338, 340, 342, 346, 348 angle 310 Aperture 400 leaflets 402 Main Unit 404, 406 Apical part 408 End, inflow end 410 Outflow edge 412, 414 commissure tabs 416, 418 curved edge 420, 422 window 424 Center line 426 Upper edge part 428 Lower edge part 430, 432 Neck area 434 Width (neck area) 436 Window width 437 Suture 438 Aperture Row 440 aperture 500 commissures 502 Post 504a First commissure tab 510 Mounting member 504b Second commissure tab 506a First leaflet 506b Second leaflet 508 frames 512 Interior 514 First (base) part 516 Second Part 518 Lateral (side) surface 520 Radial 522 Lateral (or Circumferential) Direction 524 axial direction 526 First tab part 528 Second tab part 530 creases 532 bending 534 distance 536 length 538a, 538b First suture 540a, 540b Second suture line 542 Sutures 546 Loops 600 Artificial Valves 612 Stent or frame 614 Valve Structure 615 Inflow end 616 Inner Skirt 617 Middle part 618 Perivalvular outer seal or outer skirt 619 Outflow end 620 Commissural window frame part 622 commissure 640 Valve Leaflet 650 frames 652 Inflow end 654 Outlet end 656 Central Longitudinal Axis 658 Aperture or slot, commissural window 660, 662 struts 700 Commisural support elements 702 Main Unit 704 Joining part 706 Leaflet receiving window, commissure receiving portion 708 First shaft member 710 Second shaft member 712, 714 Connecting member 716, 718 Curved parts, curved members 722 Actuators and actuator components 724, 726 Tubular aperture or channel 728 Outflow end 730 Top 802 Commissural window 804, 806 Parts 809 First Suture 810 Second suture 900 Artificial Heart Valves 902 cells 904 frames 910 Mounting material 914 First Part 916 Second Part 920 Sutures 1100 Leaflet 1102 Commissure tab 1104 Main unit 1106 outer edge 1108 Neck area 1110, 1130, 1140 sutures 1112, 1132a~1132b, 1142a~1142c Aperture 1112a outer aperture 1112b Inner Aperture 1114 Upper edge 1116 Lower edge 1118 Outflow edge 1120a~1120c, 1144a, 1144b Stress lines 1200 Delivery Device 1202 Handle 1204 Shaft, outer shaft 1206 Actuator Assembly 1208 Artificial heart valves, artificial valves 1210 Inner shaft 1212 distal end 1214 Nosecone 1218 Second Knob 1220 Third Knob 1222 Sheath, capsule 1224 Intermediate shaft 1226 Distal end 1230 central longitudinal axis

Claims

1. an annular frame including a plurality of commissure support portions; a plurality of valve leaflets positioned within the frame, each leaflet including a body and two opposing commissure tabs disposed on opposite sides of the body, each commissure tab paired with an adjacent commissure tab of an adjacent leaflet to form a commissure; 1. A prosthetic heart valve comprising: Each commissure of the prosthetic heart valve comprises: an attachment member including a first portion extending across and directly attached to a commissural support element configured to be coupled to a corresponding one of a plurality of commissural support portions or a commissural support portion, and a second portion projecting radially from the first portion and extending radially inward toward a central longitudinal axis of the frame; a first commissure tab of a first leaflet of the plurality of leaflets disposed adjacent a first side of the second portion of the attachment member and secured directly to the attachment member; a second commissure tab of a second leaflet of the plurality of leaflets disposed adjacent a second, opposite side of the attachment member second portion and secured directly to the attachment member; A prosthetic heart valve comprising:

2. 2. The prosthetic heart valve of claim 1, wherein the first portion of the attachment member is positioned against a radially inwardly facing surface of the commissural support portion or commissural support element configured to be coupled to the commissural support portion, and the first portion of the attachment member extends across only the radially inwardly facing surface of the commissural support portion or commissural support element, or across only the radially inwardly facing surface and a portion of a side surface of the commissural support portion or commissural support element, the side surface being disposed perpendicular to the radially inwardly facing surface.

3. 3. The prosthetic heart valve of claim 1, wherein the second portion of the attachment member extends radially from a central region of the first portion of the attachment member and includes two overlapping layers, each extending from a different inner end of the first portion, the two overlapping layers overlapping laterally.

4. The prosthetic heart valve of any one of claims 1 to 3, wherein the attachment members comprise a textile material.

5. 5. The prosthetic heart valve of claim 1, wherein the first commissure tabs are folded into two laterally overlapping overlapping layers disposed perpendicular to an axial direction and a radial direction relative to the central longitudinal axis, the two overlapping layers being positioned adjacent to a first side of the second portion of the attachment member and secured directly to the attachment member, and the second commissure tabs are folded into two laterally overlapping overlapping layers being positioned adjacent to a second side of the second portion of the attachment member and secured directly to the attachment member.

6. 6. The prosthetic heart valve of claim 5, wherein the two overlapping layers of each of the first and second commissure tabs include a first tab portion disposed against a respective one of a first side and a second side of the second portion of the attachment member and a second tab portion disposed against the first tab portion, and the first and second sides of the second portion and the first and second tab portions of each of the first and second commissure tabs are all disposed parallel to one another.

7. 7. The prosthetic heart valve of claim 5, wherein the folded first commissure tab is wedged against the attachment member at a region of a first bend between the first portion of the attachment member and a first side of the second portion, and the folded second commissure tab is wedged against the attachment member at a region of a second bend between the first portion of the attachment member and a second side of the second portion.

8. 8. The prosthetic heart valve of claim 7, wherein the two overlapping layers of the first commissure tabs are secured to the attachment member by one or more sutures that extend through the two overlapping layers and the attachment member proximate the first bend, and the two overlapping layers of the second commissure tabs are secured to the attachment member by one or more sutures that extend through the two overlapping layers and the attachment member proximate the second bend.

9. 9. The prosthetic heart valve of claim 1, wherein the second portion of the attachment member extends axially along the entire height of each of the first and second commissure tabs.

10. 10. The prosthetic heart valve of claim 1, wherein the attachment members are attached directly to the commissural support portions, which are struts of the frame, and the attachment members are attached directly to the struts via sutures that extend through the attachment members and around the outer surfaces of the struts.

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

12. 10. The prosthetic heart valve of claim 1, wherein the attachment members are directly attached to the commissural support portions, the commissural support portions being commissural fenestrae formed by spaced, axially extending struts of the frame.

13. 10. The prosthetic heart valve of claim 1, wherein the attachment member is attached directly to leaflet-receiving windows of the commissural support elements formed by the spaced-apart axial members via a first suture extending through a first end of the first portion of the attachment member and around a first one of the spaced-apart axial members, and a second suture extending through a second end of the first portion of the attachment member and around a second one of the spaced-apart axial members.

14. 10. The prosthetic heart valve of claim 1, wherein the attachment members are positioned across and directly attached to cells of the annular frame, the cells being formed by angled struts of the annular frame via one or more sutures that pass through a first portion of the attachment member and around the angled struts that form the cells around the cells.

15. 1. A method of assembling a prosthetic heart valve including multiple leaflets, comprising: forming a plurality of commissures with a plurality of leaflets, each leaflet including two opposing commissure tabs located on either side of a body of the leaflet; Each of said commissures is Folding each of a first commissure tab of a first leaflet and a second commissure tab of an adjacent second leaflet into two laterally overlapping overlapping layers disposed perpendicular to an axial and radial direction relative to a central longitudinal axis of an annular frame of the prosthetic heart valve; placing 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 portion of the attachment member; securing each of the first and second commissure tabs to the attachment member; for each commissure, attaching the attachment member directly to a corresponding commissure support portion of the annular frame or via the commissure support portion, a base portion of the attachment member positioned radially between the folded first and second commissure tabs, and a commissure support element configured to be coupled to the commissure support portion or commissure support element; 1. A method for assembling a prosthetic heart valve, comprising:

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

17. 17. The method of claim 16, wherein the arranging step includes: arranging a first side surface of the protruding portion and an inner surface of a first tab portion of the first commissure tab in flush contact with each other along a height of the axially disposed first commissure tab; and arranging a second side surface of the protruding portion and an inner surface of a first tab portion of the second commissure tab in flush contact with each other along a height of the second commissure tab.

18. 18. The method of claim 17, wherein the positioning step further comprises, for each of the first and second commissure tabs, positioning a fold between the first and second tab portions against an interior side of a base portion of the attachment member such that each of the folded first and second commissure tabs is wedged against the attachment member in a region of bend between the base portion and the protruding portion.

19. The step of securing each of the first commissure tabs and the second commissure tabs to the attachment member includes: extending one or more sutures along one or more suture lines of the first commissure tab, including at least a middle portion offset from the remainder of the suture line, through the protruding portion and two overlapping layers of the first commissure tab, toward a centerline of a body of a corresponding leaflet, the middle portion being positioned away from an outflow edge of the corresponding leaflet; extending one or more sutures along one or more suture lines of the second commissure tab, including at least a middle portion offset from the remainder of the suture line, through the protruding portion and two overlapping layers of the second commissure tab, toward a centerline of a body of a corresponding leaflet, the middle portion being positioned away from an outflow edge of the corresponding leaflet; The method according to any one of claims 15 to 18, comprising:

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

21. 21. The method of claim 15, wherein the step of attaching the attachment members to the respective commissural support portions of the annular frame directly or via the commissural support elements comprises the steps of positioning a base portion of the attachment member against an inner surface of a strut of the annular frame, and securing the attachment member to the strut via a suture extending through the attachment member and around an outer surface of the strut.

22. an annular frame including a plurality of commissural support portions, each commissural support portion including an inner surface facing a central longitudinal axis of the frame and an oppositely disposed outer surface; a plurality of valve leaflets positioned within the frame, each leaflet including a body and two opposing commissure tabs disposed on opposite sides of the body, each commissure tab pairing with an adjacent commissure tab of an adjacent leaflet to form a commissure; 1. A prosthetic heart valve comprising: Each commissure of the prosthetic heart valve comprises: an attachment member directly attached to a corresponding one of the plurality of commissural support portions, the attachment member including a base portion extending across an inner surface of the commissural support portion and a protruding portion extending radially outward from a central region of the base portion and extending radially inward toward the central longitudinal axis; a first commissure tab of a first leaflet of the plurality of leaflets folded into two laterally overlapping overlapping layers disposed axially and radially perpendicular to the central longitudinal axis, the two overlapping layers disposed adjacent a first side of a protruding portion of the attachment member and directly secured to the attachment member; a second commissure tab of a second leaflet of the plurality of leaflets folded into two laterally overlapping layers, the second commissure tab being positioned adjacent a second side of the attachment member opposite the protruding portion and directly secured to the attachment member; and A prosthetic heart valve comprising:

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

24. 24. The prosthetic heart valve of claim 22 or claim 23, wherein the protruding portion includes two overlapping layers each extending from a different inner end of the base portion, the two overlapping layers of the protruding portion overlapping laterally, and the protruding portion of the attachment member extends axially along the entire height of each of the first and second commissure tabs.

25. The commissure support portion At least a portion of a strut of the frame, the strut being one of an actuator, an expansion and fixation mechanism, and an alternative strut of the frame; or 25. The prosthetic heart valve of any one of claims 22 to 24, wherein commissural fenestrae are formed by spaced apart, axially extending struts of the frame.

Images