Prosthetic heart valve

Abstract

Leaflets for a prosthetic heart valve are disclosed. As one example, a leaflet includes a main body with a free, outflow edge and a cusp edge portion, where the outflow edge is straight or curved towards the cusp edge portion, two lower tabs disposed on opposite sides of the main body, where the cusp edge portion terminates at upper ends thereof at the lower tabs, and the lower tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet, and two upper tabs disposed on opposite sides of and extending laterally outward from the main body. The leaflet further includes two offsetting portions, each extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the outflow edge of the main body.

Description

PROSTHETIC HEART VALVE CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No.63 / 553,275, filed February 14, 2024, incorporated herein by reference in its entirety. FIELD

[0002] The present disclosure relates to prosthetic heart valves, and in particular to leaflets for prosthetic heart valves. BACKGROUND

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

[0004] Most expandable, prosthetic heart valves comprise a cylindrical metal frame or stent and prosthetic leaflets mounted inside the frame. Each leaflet can comprise a main body with a cusp edge portion and one or more sets of commissure tabs extending from the main body on opposite sides of the leaflet. The leaflets can be secured to one another at adjacent commissure tabs to form commissures that are then secured to commissure windows in the frame of the prosthetic heart valve. The cusp edge portion of each leaflet can also be securedto struts of the frame. The leaflets of the prosthetic heart valve are configured to open and close to regulate a flow of blood through the prosthetic heart valve, from an inflow end to an outflow end of the prosthetic heart valve. SUMMARY

[0005] Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves. Also described herein are leaflets configured to be mounted inside a frame of a prosthetic heart valve, and methods for assembling the leaflets together into a leaflet assembly and attaching the leaflets to the frame. The disclosed leaflets, prosthetic heart valves, and methods can, for example, provide more durable leaflets that also open wider during operation of the prosthetic heat valve, thereby decreasing a pressure gradient across the prosthetic valve. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves.

[0006] A leaflet for a prosthetic valve can comprise a main body with a free, outflow edge and a cusp edge portion, two lower tabs disposed on opposite sides of the main body, and two upper tabs disposed on opposite sides of the main body.

[0007] In some examples, a leaflet can comprise a straight outflow edge, wherein the outflow edge is perpendicular to a central longitudinal axis of the leaflet.

[0008] In some examples, a leaflet can comprise a curved outflow edge, wherein the outflow edge curves towards a cusp edge portion of the leaflet.

[0009] In some examples, a leaflet can comprise two sub-commissure tabs, wherein the sub- commissure tabs extend laterally from a main body of the leaflet, wherein the sub- commissure tabs are positioned closer to the cusp edge portion of the leaflet than the two upper tabs and the two lower tabs.

[0010] In some examples, a leaflet can comprise two offsetting portions, each offsetting portion extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the outflow edge of the main body, wherein each upper tab has opposing inner and outer edges that are parallel to one another and disposed parallel to the central longitudinal axis of the leaflet.

[0011] In some examples, a leaflet can comprise two offsetting portions, each offsetting portion extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the free edge of the main body. A first width of each upper tab of the two upper tabs is wider than a second width of each lower tab of the two lower tabs such that an outer edge of each upper tab extends laterally outward farther than an outer edge of a respective lower tab, relative to the central longitudinal axis of the leaflet.

[0012] In some examples, a leaflet can comprise two offsetting portions, each offsetting portion extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the free edge of the main body. Each offsetting portion has an outer edge that extends between an inflow edge of the respective upper tab and an outflow edge of the respective lower tab and an arcuate inner edge that curves between an inner edge of the respective upper tab and the free edge of the main body.

[0013] In some examples, a leaflet for a prosthetic valve comprises a main body with a free, outflow edge and a cusp edge portion, wherein the outflow edge is straight or curved towards the cusp edge portion; two lower tabs disposed on opposite sides of the main body, wherein the cusp edge portion terminates at upper ends thereof at the lower tabs, and the lower tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the main body and extending laterally outward from the main body; and two offsetting portions, each offsetting portion extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the outflow edge of the main body, wherein each upper tab has opposing inner and outer edges that are parallel to one another and disposed parallel to the central longitudinal axis of the leaflet.

[0014] In some examples, a leaflet for a prosthetic valve comprises a main body with a free edge and a cusp edge portion, the free edge disposed at an outflow end of the leaflet, wherein the free edge is straight or curved towards the cusp edge portion; two lower tabs disposed on opposite sides of the main body, wherein the cusp edge portion terminates at upper ends thereof at the lower tabs, and the lower tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the main body and extending laterally outward from the main body; and two offsettingportions, each offsetting portion extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the free edge of the main body, wherein a first width of each upper tab of the two upper tabs is wider than a second width of each lower tab of the two lower tabs such that an outer edge of each upper tab extends laterally outward farther than an outer edge of a respective lower tab, relative to the central longitudinal axis of the leaflet, and wherein the first and second widths extend perpendicular to the central longitudinal axis of the leaflet.

[0015] In some examples, a leaflet for a prosthetic valve comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end, wherein the free edge is straight or curved towards the cusp edge portion; two lower tabs disposed on opposite sides of the main body, wherein the cusp edge portion terminates at upper ends thereof at the lower tabs, and the lower tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the main body and extending laterally outward from the main body; and two offsetting portions, each offsetting portion extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the free edge of the main body, wherein each offsetting portion has an outer edge that extends between an inflow edge of the respective upper tab and an outflow edge of the respective lower tab and an arcuate inner edge that curves between an inner edge of the respective upper tab and the free edge of the main body, wherein the inner edge of each offsetting portion is disposed closer to the central longitudinal axis than the outer edge of the offsetting portion.

[0016] In some examples, a leaflet for a prosthetic valve comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end; two lower tabs disposed on opposite sides of the main body, wherein the lower tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the main body and extending laterally outward from the main body; and two sub-commissure tabs disposed on opposite sides of the main body and extending laterally outward from the main body, wherein the cusp edge portion terminates at upper ends thereof at the sub-commissure tabs.

[0017] In some examples, a leaflet for a prosthetic valve comprises one or more of the components recited in Examples 1-13, 16-23, 26-34, and 37-50 below.

[0018] A prosthetic heart valve can comprise a frame and a valve structure coupled to the frame. In addition to these components, a prosthetic heart valve can further comprise one or more of the components disclosed herein.

[0019] In some examples, a prosthetic heart valve can comprise a sealing member configured to reduce paravalvular leakage.

[0020] In some examples, a prosthetic heart valve comprises a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration, wherein the frame comprises a plurality of interconnected struts including a plurality of rows of angled struts and a plurality of axially extending window strut portions defining a plurality of circumferentially spaced apart commissure windows; and a valvular structure mounted on an inside of the frame and comprising a plurality of leaflets, wherein each leaflet comprises a main body with a free, outflow edge and a cusp edge portion, a pair of lower tabs disposed on opposite sides of the main body, a pair of upper tabs disposed on opposite sides of the main body and folded downwardly against lower tabs, and a pair of sub-commissure tabs disposed on opposite sides of the main body, wherein the pairs of lower and upper tabs of adjacent leaflets are paired to form a commissure that is secured to a respective commissure window of the frame.

[0021] In some examples, a prosthetic heart valve comprises a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; and a plurality of leaflets mounted on an inside of the frame, wherein each leaflet comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end, two lower tabs disposed on opposite sides of the main body, two upper tabs disposed on opposite sides of the main body and folded downwardly against the lower tabs, and two sub-commissure tabs disposed on opposite sides of the main body, wherein lower and upper tabs of adjacent leaflets are paired to form a commissure that is secured to the frame, and wherein sub-commissure tabs of the adjacent leaflets are connected to each other.

[0022] In some examples, a prosthetic heart valve comprises a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; and a plurality of leaflets mounted on an inside of the frame, wherein each leaflet comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining itsinflow end and having two opposing downstream ends, and wherein the cusp edge portion is circular or parabolic in shape, and wherein an angle defined between a laterally extending axis of the leaflet and a line that is tangent to the cusp edge portion at a downstream end thereof is in a range of 50-90 degrees.

[0023] In some examples, a prosthetic heart valve comprises one or more of the components recited in Examples 14, 15, 24, 25, 35, 36, and 51-85 below.

[0024] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG.1 is a perspective view of a prosthetic heart valve.

[0026] FIG.2 is a perspective view of a delivery apparatus for a prosthetic heart valve, according to an example.

[0027] FIG.3A is a plan view of a leaflet for a prosthetic heart valve, according to an example.

[0028] FIG.3B is a plan view of a leaflet for a prosthetic heart valve, according to an example.

[0029] FIG.3C is a plan view of a leaflet for a prosthetic heart valve, according to an example.

[0030] FIG.4 is schematic of a portion of the leaflet of FIG.3A, showing an upper tab of the leaflet folded over a lower tab of the leaflet.

[0031] FIG.5 is a perspective view of a prosthetic valve including a frame and a valvular structure comprising a plurality of the leaflets of FIG.3A mounted on an inside of the frame.

[0032] FIG.6 is a detail view of a portion of the prosthetic valve of FIG.5 showing a commissure of the prosthetic valve.

[0033] FIG.7A is a top view of the prosthetic valve of FIG.5.

[0034] FIG.7B is a top view of the prosthetic valve of FIG.5 when the valve is in a fully open position during operation of the valve.

[0035] FIG.8 is a top perspective view of a portion of the prosthetic valve of FIG.5 showing a commissure of the prosthetic valve attached to a commissure window of the frame.

[0036] FIGS.9-12B show the assembly of commissures of the valvular structure to commissure windows of the frame of the prosthetic valve.

[0037] FIG.13A-13B show the assembly of an inner and outer skirt to the frame of the prosthetic valve.

[0038] FIG.14 is a side view of a prosthetic heart valve, according to an example.

[0039] FIG.15 is a side view of a frame of the prosthetic heart valve of FIG.14.

[0040] FIG.16 is a side view of a portion of the frame of FIG.15, showing the portion of the frame in a straightened (non-annular) state.

[0041] FIG.17 is a side view of a portion of a frame for a prosthetic heart valve, according to one example.

[0042] FIG.18 is a perspective view of the complete frame of FIG.17 in a radially expanded configuration.

[0043] FIG.19 is a plan view of a leaflet for a prosthetic heart valve, according to an example.

[0044] FIG.20 is a partial top view of a portion of a prosthetic heart valve including the leaflets of FIG.19, showing the sub-commissure tabs of the leaflets.

[0045] FIG.21 is a side perspective view of the prosthetic heart valve of FIG.20, showing the sub-commissure tabs of the leaflets from outside of the prosthetic heart valve.

[0046] FIG.22 is a side performance view of the prosthetic heart valve of FIG.20 from inside of the prosthetic heart valve.

[0047] FIG.23 is a side view of the prosthetic heart valve of FIG.20.

[0048] FIGS.24A-24C are side views of an inflow portion of the prosthetic heart valve of FIG.20, showing different configurations for the cusp edge portion of the leaflet. DETAILED DESCRIPTION General Considerations

[0049] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0050] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0051] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0052] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0053] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0054] As introduced above, a leaflet assembly comprising a plurality of leaflets can be mounted on an inside of a frame of a prosthetic heart valve. The leaflet assembly is configured to regulate blood flow through the prosthetic heart valve, from an inflow end to an outflow end of the prosthetic heart valve. Each leaflet can comprise a main body with a cusp edge portion and two sets of commissure tabs extending from the main body on opposite sides of the leaflet. The two sets of commissure tabs can comprise a pair of opposing upper tabs and a pair of opposing lower tabs. The leaflets can be secured to one another at adjacent commissure tabs to form commissures that are then secured to commissure windows in the frame of the prosthetic heart valve. The cusp edge portion of each leaflet can also be secured to struts of the frame. Thus, the main body of each leaflet, between a free (or outflow) edge of the leaflet and the cusp edge portion can be referred to as a “movable” portion of the leaflet that opens and closes during operation of the prosthetic heart valve (during systole and diastole).

[0055] Some leaflet designs with shorter (in width) upper tabs and / or upper tabs with an angled inner edge that connects to the free edge of the leaflet can result in a leaflet assembly that does not open wide enough (e.g., toward the frame) and / or can result in contact between the angled inner edge of the upper tabs and the movable portions of the leaflets, which can result in higher pressure gradients across the valve and reduced long-term durability of the leaflets.

[0056] Disclosed herein is a leaflet that includes upper tabs that are offset from the free edge of the leaflet by a relatively narrow offsetting portion. The free edge of the leaflet can be straight or curved towards the cusp edge portion of the leaflet. The upper tabs can have an inner edge that is relatively straight and parallel to a central longitudinal axis of the leaflet (the central longitudinal axis extending between the outflow end and the inflow end of the leaflet). In some examples, the offsetting portion is curved and offsets a lower, inner corner of the upper tabs both axially and laterally away from the free edge of the leaflet. The upper tabs can also be wider (in a lateral direction that extends in a direction of the free edge of the leaflet) and extend farther outward from the body of the leaflet than the lower tabs.

[0057] Disclosed herein is a leaflet that includes upper tabs and lower tabs that together, with upper and lower tabs of adjacent leaflets, form commissures. The leaflet can also include sub-commissure tabs that extend laterally away from the main body of the leaflet and are disposed closer to the cusp edge portion of the leaflet than the upper and lower tabs. The outer edges of the upper and lower tabs can be angled relative to a central longitudinal axis of the leaflet (e.g., at an angle less than 90 degrees). The outer edges of the sub-commissure tabs can be parallel to the central longitudinal axis.

[0058] Prosthetic valves disclosed herein, such as the prosthetic heart valve shown in FIG.1 and the prosthetic heart valve shown in FIG.14, can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus, such as the delivery apparatus shown in FIG.2. The prosthetic valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later. Examples of the Disclosed Technology

[0059] FIG.1 shows an exemplary prosthetic valve 10, according to one example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valvesalso can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0060] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Patent No.10,363,130, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in US Publication No.2022 / 0079749, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Patent No.11,291,540, which is incorporated herein by reference.

[0061] The prosthetic valve 10 comprises four main components: a stent or frame 12, a valvular structure 14, an inner skirt 16, and a perivalvular outer sealing member or outer skirt 18. The prosthetic valve 10 can have an inflow end portion 15 (also referred to herein as an “inflow end”), an intermediate portion 17, and an outflow end portion 19. The inner skirt 16 can be arranged on and / or coupled to an inner surface of the frame 12, while the outer skirt 18 can be arranged on and / or coupled to an outer surface of the frame 12.

[0062] The valvular structure 14 can comprise three leaflets 40, collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in some instances there can be greater or fewer number of leaflets (e.g., one or more leaflets 40). The leaflets 40 can be secured to one another at their adjacent sides to form commissures 22 of the valvular (e.g., leaflet) structure 14. The lower edge of valvular structure 14 can have an undulating, curved scalloped shape and can be secured to the inner skirt 16 by sutures (not shown). In some examples, the leaflets 40 can be formed of pericardial tissue (e.g., bovinepericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No.6,730,118, which is incorporated by reference herein.

[0063] The frame 12 can be formed with a plurality of circumferentially spaced slots, or commissure windows 20 that are adapted to mount the commissures 22 of the valvular structure 14 to the frame. For example, the commissure windows 20 can be defined by axially extending window strut portions 24 of the frame 12, which can also be referred to herein as “commissure supports”. Each commissure window 20 is adapted to receive a pair of commissure tabs 42 of a pair of adjacent leaflets 40 arranged into a corresponding commissure 22. As shown in FIG.1 and described further below, the pair of commissure tabs 42 extend from inside the frame 12, through the commissure window 20, and exterior to the frame 12. For example, as shown in FIG.1, the commissure tabs 42 can extend over and / or protrude radially outward from an outer surface 44 (radially outward facing surface) of the frame 12, and in particular, outer surfaces of the window strut portions 24.

[0064] The frame 12 can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol). When constructed of a plastically-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0065] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (e.g., the frame 12) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 12 can comprise stainless steel. In some examples, the frame 12 can comprise cobalt- chromium. In some examples, the frame 12 can comprise nickel-cobalt-chromium. In some examples, the frame^12 comprises a nickel-cobalt-chromium-molybdenum alloy, such asMP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0066] FIG.2 shows a delivery apparatus 100, according to an example, that can be used to implant an expandable prosthetic heart valve (e.g., prosthetic valve 10), or another type of expandable prosthetic medical device (such as a stent). In some examples, the delivery apparatus 100 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0067] The delivery apparatus 100 in the illustrated example of FIG.2 is a balloon catheter comprising a handle 102, a steerable, outer shaft 104 extending from the handle 102, an intermediate shaft extending from the handle 102 coaxially through the steerable outer shaft 104, and an inner shaft 106 extending from the handle 102 coaxially through the intermediate shaft and the steerable, outer shaft 104, an inflatable balloon (e.g., balloon) 108 extending from a distal end of the intermediate shaft, and a nosecone 110 arranged at a distal end of the delivery apparatus 100. A distal end portion 112 of the delivery apparatus 100 includes the balloon 108, the nosecone 110, and a balloon shoulder assembly. A prosthetic medical device, such as a prosthetic heart valve may be mounted on a valve retaining portion of the balloon 108. A balloon shoulder assembly is configured to maintain the prosthetic heart valve or other medical device at a fixed position on the balloon 108 during delivery through the patient’s vasculature. In some examples, the balloon shoulder assembly can include a proximal shoulder 120 and / or a distal shoulder 122.

[0068] The balloon 108 can include a central portion (which can be approximately cylindrical when inflated, as shown in FIG.2) and two tapered end portions that connect to the delivery apparatus 100 (e.g., to one or more shafts and / or a nosecone of the delivery apparatus).

[0069] The handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus. In the illustrated example, for example, the handle 102 includes an adjustment member, such as the illustrated rotatable knob 134, which in turn is operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire extends distally from the handle 102 through the outer shaft 104 and has a distal end portion affixed to the outer shaft at or near the distal end of the outer shaft 104.Rotating the knob 134 is effective to increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus.

[0070] The delivery apparatus 100 can be configured to be advanced over a guidewire that can be received within a guidewire lumen defined by an innermost shaft of the delivery apparatus 100.

[0071] In some examples, the delivery apparatus (or another, similar delivery apparatus) can be configured to deploy and implant a prosthetic heart valve (e.g., prosthetic valve 10 of FIG. 1) in the native aortic annulus of a native aortic valve. Further details on such a delivery apparatus can be found in International Application No. PCT / US2021 / 047056, which is incorporated by reference herein.

[0072] As an example, during an implantation procedure for implanting an expandable prosthetic heart valve (e.g., prosthetic valve 10 of FIG.1), the distal end portion of the delivery apparatus 100 (or another similar delivery apparatus or balloon catheter) can be advanced (over a guidewire) to a target implantation site (e.g., a native valve annulus). The balloon 108 can then be inflated to radially expand and implant the prosthetic heart valve within the native valve annulus.

[0073] A leaflet 200 for a prosthetic heart valve, such as the prosthetic heart valve 10 of FIG. 1, the prosthetic heart valve 300 shown in FIG.5, or the prosthetic heart valve 400 shown in FIG.14, is shown in a flattened configuration in FIG.3A. The leaflet 200 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No.6,730,118, which is incorporated by reference herein.

[0074] The leaflet 200 has a main body 202 with a free edge 204 (which can also be referred to as an outflow edge) and a cusp edge portion 206 (also referred to as an inflow edge portion) that is in opposing relation to the free edge 204. As described further below, the cusp edge portion 206 is configured to be attached to an inner skirt, which in turn can be attached to a frame of a prosthetic heart valve, and the free edge 204 is configured to move and contact respective free edges of the other leaflets of a leaflet assembly during closure of the leaflets (e.g., during diastole during operation of the prosthetic heart valve). In someexamples, the cusp edge portion can be directed attached to struts of the frame of the prosthetic heart valve.

[0075] In some examples, as shown in FIG.3A, the free edge 204 comprises a straight or linear edge that is perpendicular to a central longitudinal axis 212 of the leaflet. In some examples, as shown in FIG.3B, the leaflet 200 can comprise a concave free edge 204’ that is curved towards the cusp edge portion 206 of the leaflet 200. In some examples, as shown in FIG.3A, the cusp edge portion 206 comprises a curved or scalloped shape.

[0076] In some examples, the leaflet 200 further comprises two sets of opposing commissure tabs disposed on opposite sides of the leaflet 200. For example, the leaflet 200 includes a pair of upper tabs 208 disposed on opposite sides of the leaflet 200 and a pair of lower tabs 210 disposed on opposite sides of the leaflet 200. The lower tabs 210 are disposed closer to the cusp edge portion 206 than the upper tabs 208.

[0077] For example, the cusp edge portion 206 terminates at its upper ends at the lower tabs 210. The lower tabs 210 extend laterally outward from the body 202 of the leaflet 200, relative to a central longitudinal axis 212 of the leaflet 200. The longitudinal axis 212 may be an axis about which leaflet 200 is symmetrical. As used herein, the axial direction can be a direction parallel to the central longitudinal axis 212 and the lateral direction can be perpendicular to the central longitudinal axis 212 (e.g., from one side of the leaflet to the opposite side of the leaflet, across the central longitudinal axis 212). As shown in FIG.3A, the central longitudinal axis 212 of the leaflet 200 extends from the inflow end to the outflow end of the leaflet 200.

[0078] An upper or outflow edge 214 of each lower tab 210 is positioned at an angle relative to the central longitudinal axis 212. In some examples, as shown in FIG.3A, the angle is 90 degrees. In some examples, as shown in FIG.3A, the outflow edge 214 of each lower tab 210 is axially offset (that is, offset in the axial direction of the leaflet) from the free edge 204 by a distance 215. In some examples, as shown in FIG.3C, the outflow edge 214 of each lower tab 210 is axially aligned and colinear with the free edge 204.

[0079] In some examples, such as when the frame to which the leaflet 200 is to be attached is non-cylindrical (such as tapered, frustoconical, V-shaped, or Y-shaped), the angle measuredbetween the outflow edge 214 of each lower tab 210 and the central longitudinal axis 212 can be less than 90 degrees, such as 80 to 88 degrees.

[0080] In some examples, the angle measured between the outflow edge 214 of each lower tab 210 and the central longitudinal axis 212 can be selected based on a draft angle of the frame to which the leaflet 200 is to be attached, as described in PCT Publication No. WO 2022 / 026351, which is incorporated herein by reference.

[0081] Each lower tab 210 can have a height 216 and width 218. The width 218 can be measured between an outer side edge 220 and an inner side edge 222 (or integral or attached edge) of the corresponding lower tab 210. The inner side edge 222 of the lower tab 210 can be aligned with an inner side edge 228 of the adjacent upper tab 208.

[0082] A slit 226 extends in the leaflet 200 laterally from an inflow edge 224 of the lower tab 210 to a point in the body 202 of the leaflet 200 that aligns with the inner edge 228 of the adjacent upper tab 208. The slit 226 allows for attachment of the corresponding upper tab 208 and the lower tab at a commissure, as described further below.

[0083] In some examples, as shown in FIG.3A, the outer edge 220 and inner edge 222 of each lower tab 210 are parallel to the central longitudinal axis 212. In some examples, as shown in FIG.3A, the inflow edge 224 and an outflow edge 214 of each lower tab are perpendicular to the central longitudinal axis 212.

[0084] Each upper tab 208 can have a substantially rectangular shape with the inner edge 228, an outer side edge 230 disposed opposite the inner edge 228, an outflow edge 232, and an inflow edge 234 disposed opposite the outflow edge 232. In some examples, the inner edge 228 and outer edge 230 can be referred to as side edges and are parallel to one another and the central longitudinal axis 212 (and thus they can be referred to as being vertical edges). In some examples, the outflow edge 232 and the inflow edge 234 are parallel to one another and disposed perpendicular to the inner edge 228 and outer edge 230.

[0085] In some examples, as shown in FIG.3A, the inner edge 228 and the outer edge 230 of each upper tab 208 are parallel to the outer edge 220 of the respective lower tab 210.

[0086] Each upper tab 208 has a height 238 and width 240. In some examples, the width 240 of the upper tabs 208 is larger than the width 218 of the lower tabs 210. Thus, the outer edge 230 of each upper tab 208 extends farther laterally outward, away from the body 202 of theleaflet 200, than the outer edge 220 of the respective lower tab 210. As described further below, this makes assembly of the commissures to the frame easier and more accurate, thereby ensuring the valve can open as large as possible during operation of the prosthetic heart valve.

[0087] Each upper tab 208 is axially and laterally offset from the free edge 204 of the leaflet 200 by an offsetting portion 236 (which can also be referred to as a neck, neck portion, or connecting portion). The offsetting portion 236 extends between the lower tab 210 and the upper tab 208 on each side of the leaflet 200. For example, each offsetting portion 236 can include a relatively straight outer edge 242 that extends between the inflow edge 234 of the corresponding upper tab 208 and the outflow edge 214 of the corresponding lower tab 210.

[0088] Each offsetting portion 236 can also include a curved or arcuate inner edge 244 that curves between the inner edge 228 of the corresponding upper tab 208 and the free edge 204 of the leaflet 200. In some examples, the arcuate inner edge 244 curves 90 degrees between the inner edge 228 of the corresponding upper tab 208 and the free edge 204 of the leaflet 200.

[0089] The offsetting portions 236 have a relatively narrow width 246 which allows a length of the free edge 204 (measured between the two offsetting portions 236) to be as large as possible, thereby allowing the prosthetic valve to open wider and decrease pressure gradients across the prosthetic valve, during operation of the prosthetic valve (as described further below).

[0090] In some examples, the width 246 of the offsetting portions 236 can be less than half the width 218 of the lower tabs 210.

[0091] As described further below, each offsetting portion 236 offsets the inner edge 228 of the respective upper tab 208 laterally (or radially when attached to the frame) outward and away from the body 202 of the leaflet 200 when the upper tab 208 is folded over the lower tab 210, as shown in the schematic of FIG.4. This reduces the likelihood of direct contact of the moving portion of the leaflet 200 (e.g., the body 202) with the inner edge 228 of the upper tabs 208, thereby increasing a durability of the leaflet 200.

[0092] A plurality of the leaflets 200 (e.g., three leaflets 200) can be assembled together into a leaflet assembly or valvular structure 201 and then secured to a frame of a prosthetic heartvalve, such as the frame 302 of the prosthetic valve 300 shown in FIGS.5-8. Though shown secured to frame 302, leaflets 200 can be used with a variety of prosthetic heart valve frames (such as frame 12 of FIG.1, frame 402 of FIG.14, frame 500 of FIG.17).

[0093] As shown in FIG.5, the prosthetic valve 300 has an inflow end 304, an outflow end 306, and a valvular structure 201 comprising a plurality (e.g., three) leaflets 200 coupled to and supported by the frame 302. The prosthetic valve 300 can further comprise an inner and / or outer skirt, however, such components are omitted in FIG.5 for purposes of illustration. An example of such inner and outer skirts secured to the frame 302 are shown in FIGS.13A-13B, as described below.

[0094] The frame 302 can comprise a plurality of interconnected struts 308 that are arranged into a plurality of rows of angled struts 308 disposed between the inflow end 304 and the outflow end 306 of the frame 302. The struts 308 define open cells 310 of the frame 302. The frame 302 has a plurality of circumferentially spaced slots, or commissure windows 312 that are adapted to mount commissures 250 of the valvular structure 201 to the frame 302. For example, the commissure windows 312 can be defined by axially extending window strut portions 314 of the frame 302, which can also be referred to herein as “commissure supports” (see FIG.6 for a more detailed view of the commissure 250 with a portion of the struts of the frame removed to better visualize the folded tabs of the leaflet 200 forming the commissure 250). Each commissure window 312 is adapted to receive a pair of lower tabs 210 of a pair of adjacent leaflets 200 therethrough, as shown in FIGS.5-8.

[0095] For example, referring to FIG.8, adjacent lower tabs 210 of two adjacent leaflets 200 can be coupled together (e.g., via a post, flexible connector, or attachment member, as described further below with reference to FIGS.9-12B), and the upper tabs 208 of the two adjacent leaflets 200 can be folded downward at their offsetting portions 236 such that the lower tabs 210 are disposed between the pair of upper tabs 208. The lower tabs 210 can then be inserted through a commissure window 312 in the frame 302 and folded across the radially outward facing surface 316 of the frame 302. Each lower tab 210 can be coupled to a respective upper tab 208 along a suture line. Further details on forming the commissures 250 using flexible connectors 252 is described below with reference to FIGS.9-12B.

[0096] Further details on the frame 302 and other similar frames that can be used and assembled with the leaflets 200, as described herein, can be found in U.S. Patent No. 9,393,110, which is incorporated by reference herein, and WO 2022 / 026351, as already incorporated by reference above.

[0097] During typical valve operation, the leaflets 200 transition between a closed state in diastole, with their free edges 204 (outflow edges) coapting against each other, and an open state (see e.g., FIG.7B) allowing blood to flow through the prosthetic valve 300. The outflow orifice through which the blood can flow determines the pressure gradient across the valve. Known valves can have valvular structures attached to the frame in such a manner that the outflow edges of each leaflet are spaced radially inward of the frame to prevent leaflet abrasion when the leaflets open under the flow of blood. In such valves, the effective outflow orifice (e.g., as determined by the position of the leaflets), also referred to as the geometric orifice area (GOA), can be narrower than the inflow orifice, producing a relatively high pressure gradient across the prosthetic valve. Accordingly, and particularly when small diameter valves are used, it is preferable to provide a large outflow orifice during systole to prevent elevated pressure gradients.

[0098] As shown in FIGS.7A and 7B (where FIG.7B is the fully open state of the valve), the valvular structure 201 of prosthetic valve 300 advantageously defines a relatively large GOA 350 (e.g., the leaflets 200 are near or touching an inner surface of the frame 302) when compared to the size of the outflow orifice 352 defined by the outflow end 306 of the frame 302. The term “GOA,” as used herein, is defined as the open space through which blood can flow when the valvular structure 201 is in the open configuration. The GOA 350 of the outflow orifice 352 can be sized to provide a selected pressure gradient across the prosthetic valve 300. Such a configuration can be achieved by attaching the leaflets 200 to the frame 302 in such a manner that the radial distance between the outflow, free edges 204 of the leaflets 200 and the frame 302 (or the difference between the outflow orifice 352 and the GOA 350) is minimized.

[0099] The design of the leaflets 200, as described above with reference to FIG.3A-3B, advantageously maximizes the GOA of the prosthetic valve 300, reduces risk of leaflet abrasion, and reduces the pressure gradient across the prosthetic valve 300 compared to other, differently configured leaflets. In particular, the relatively narrower offsetting portions 236,the wider upper tabs 208 with an outer edge 230 that extends farther laterally outward than the outer edge 220 of the lower tabs 210, and the longer free edge 204 of the leaflets allow for the valvular structure 201 to open wider during valve operation (e.g., during systole), thereby decreasing the pressure gradient across the prosthetic valve 300. Further, the straight free edge 204 and the curved free edge 204’ can allow such wider opening during valve operation (e.g., during systole) while reducing the risk of leaflet abrasion against the frame 302.

[0100] Additionally, the configuration of the upper tabs 208 and the offsetting portions 236 of the leaflet 200 can provide for increased durability, which in turn increases a longevity of the prosthetic valve 300. For example, during operation of the prosthetic valve 300, when its leaflets 200 transition into a closed state (for example, in diastole), an inwardly directed force is exerted on the commissures 250 to bend the leaflets 200 relative to the commissures 250 in an inwardly oriented direction. This is shown in the schematic of FIG.4 which depicts an upper tab 208 folded over the respective lower tab 210, at the offsetting portion 236, and the inwardly (toward a central longitudinal axis of the prosthetic valve 300) directed force 261. The smoother, arcuate shape of the offsetting portion 236 can spread the stresses across the bending region between the upper tab 208 and lower tab 210, thereby reducing stress concentrations at the bending region and preserving a structural integrity of the leaflet 200 and commissure 250. Additionally, as mentioned above, the offsetting portions 236 offset the inner edge 228 of the upper tabs 208 away from the body 202 and moving portion of the leaflet 200. As a result, the durability of the leaflet 200 is further increased.

[0101] Turning now to FIGS.9-13B, one example of an assembly method of the commissures 250 to the commissure windows 312 of the frame 302 is shown in more detail. As introduced above, the leaflets 200 can be secured to one another at their adjacent sides to form commissures 250 of the valvular structure 201. A plurality of flexible connectors 252 (one of which is shown in FIGS.9-12B) can be used to interconnect pairs of adjacent sides of the leaflets 200 and to mount the leaflets 200 to the axially extending window strut portions 314 forming the commissure windows 312.

[0102] The flexible connectors 252 can be made from a piece of woven PET fabric, although other synthetic and / or natural materials can be used. Each flexible connector 252 can include a wedge 254 extending from the lower edge to the upper edge at the center of the flexible connector 252. The wedge 254 can comprise a non-metallic material, such as a rope or apiece of Ethibond 2-0 suture material, and optionally can be secured to the flexible connector 252 with a temporary suture. The wedge 254 helps prevent rotational movement of the leaflet tabs once they are secured to the axially extending window strut portions 314. In some examples, the connector 252 can have a series of inner and outer notches formed along its upper and lower edges that help with alignment with the leaflet tabs during assembly of the commissure 250.

[0103] FIGS.9 and 10 show the adjacent sides of two leaflets 200 interconnected by a flexible connector 252 (FIG.9 showing a first side view and FIG.10 showing the opposite, second side view). The opposite end portions of the flexible connector 252 can be placed in an overlapping relationship with the lower tabs 210 with inner notches (which can be V- shaped notches in some examples or markers in some examples) aligned with the outer edges 220 of the lower tabs 210.

[0104] Each lower tab 210 can be secured to a corresponding end portion of the flexible connector 252 by suturing along a line extending from an outer notch or marker on the lower edge to an outer notch or marker on the upper edge of the connector 252, thereby forming stitching lines 256 (FIG.10). Three leaflets 200 can be secured to each other side-to-side using three flexible connectors 252 to form the valvular structure 201.

[0105] FIG.12A is a cross-sectional view and FIG.12B is a top view of a portion of the frame 302 and valvular structure 201 showing the adjacent commissure tabs of two leaflets 200 secured to corresponding axially extending window strut portions 314. FIG.11 depicts an example approach for arranging the commissure tabs of the two adjacent leaflets 200 within the commissure window 312 forming by the axially extending window strut portions 314.

[0106] Prior to inserting the lower tabs 210 through the commissure window 312, the flexible connector 252 securing the two adjacent lower tabs 210 of the two adjacent leaflets 200 is folded widthwise (e.g., into the page in FIG.9) and the upper tabs 208 are folded downwardly against the flexible connector 252 (over the lower tabs 210).

[0107] Each upper tab 208 is creased lengthwise (vertically) to assume an L-shape having an inner portion 258 folded against the inner surface of the leaflet 200 and an outer portion 260 folded against the connector 252 (FIGS.11-12B). The outer portion 260 can then be suturedto the connector 252 along a suture line 262 (FIG.12A). Next, the pair of lower tabs 210 connected by connector 252 is inserted through the commissure window 312 of corresponding axially extending window strut portions 314, as shown in FIG.11.

[0108] The connector 252 and lower tabs 210 extending through the commissure window 312 can then be pressed radially inwardly at a center of the connector 252 (e.g., at the wedge 254) such that one of the lower tabs 210 and a portion of the connector 252 is folded against the frame 302 on one side of the axially extending window strut portions 314 and the other lower tab 210 and a portion of the connector 252 is folded against the frame 302 on other side of the axially extending window strut portions 314 (FIG.12B).

[0109] A pair of suture lines 264 can be formed to retain the lower tabs 210 against the frame 302 in the manner shown in FIG.12A. Each suture line 264 can extend through the connector 252, a lower tab 210, the wedge 254, and another portion of the connector 252. Then, as shown in FIG.12A, each lower tab 210 is secured to a corresponding upper tab 208 with a primary suture line 266 that extends through one layer of the connector 252, the lower tab 210, another layer of the connector 252, another layer of the connector 252, and the upper tab 208.

[0110] As shown in FIGS.11-12B, outer edges 230 of the upper tabs 208 are aligned with edges of the flexible connector 252 (with no gap in the lateral direction therebetween). This alignment is made possible by the larger width 240 of the upper tabs 208 (as described above with reference to FIGS.3 and 4). Being able to align the edge of the flexible connector 252 with the outer edges 230 of the upper tabs 208 makes the assembly process easier and more accurate (e.g., reduces variability and increases consistency from valve to valve). As a result, a likelihood of all leaflets 200 of the valvular structure 201 being evenly arranged within the frame is increased, thereby ensuring the largest possible GOA.

[0111] In some examples, as shown in FIG.12A, the suture material used to form the primary suture line 266 can be used to further form whip stitches 268 at the edges of the lower tabs 210 and upper tabs 208 that extend through two layers of connector 252 sandwiched between the upper and lower tabs 208, 210.

[0112] The leaflets 200 articulate primarily at inner edges 270 of the folded-down inner portions 258 in response to blood flowing through the valve during operation within the body, as opposed to articulating about the axial struts of the commissure windows 312.

[0113] In some examples, an inner skirt and an outer skirt (such as the inner skirt 16 and outer skirt 18 of prosthetic valve 10 of FIG.1) can be secured to the frame 302 and form the prosthetic valve 300. For example, as shown in FIGS.13A and 13B, after all three commissure 250 are secured to respective commissure windows 312, the cusp edge portions 206 of the leaflets 200 can be sutured to an inner skirt 360 (FIG.13A). The inner skirt 360 can be attached to the frame, such as to a fourth row of angled struts 362 of the frame 302, for example with a plurality of whip stitches 364. The inner skirt 360 also can be attached to a first row of angled struts 366 that define the inflow end 304 of the frame 302, for example with a plurality of whip stitches 368.

[0114] As shown in FIG.13B, an outer skirt 370 is positioned around the outer surface of the frame 302 and attached to the frame, such as to a third row of angled struts 372 with a plurality of whip stitches 374. In some examples, the same stitch line comprising stitches 374 can be used to attach both the outer skirt 370 and the inner skirt 360 to the third row of angled struts 372.

[0115] As shown in FIG.13B, in some examples, the outer skirt 370 also can be attached to a second row of angled struts 378 (e.g., with a plurality of whip stitches) and the first row of angled struts 366 (e.g., with a plurality of whip stitches). The second row of angled struts 378 and first row of angled struts 366 are shown in FIG.13A (with the outer skirt 370 removed) and indicated with arrows in FIG.13B to denote their position underneath the outer skirt 370.

[0116] Additional details on the assembly of the leaflets 200 to the frame 302, or a similar prosthetic valve frame, can be found in U.S. Patent No.9,393,110, as already incorporated by reference above.

[0117] FIG.14 shows a prosthetic heart valve 400 (prosthetic valve), according to one example. The prosthetic heart valve 400 can include a stent or frame 402, a valvular structure 404, and a perivalvular outer sealing member or outer skirt 406. The prosthetic heart valve 400 (and the frame 402) can have an inflow end 408 and an outflow end 410. The valvularstructure 404 can be disposed on an interior of the frame 402 while the outer skirt 406 is disposed around an outer surface of the frame 402.

[0118] The valvular structure 404 can comprise a plurality of leaflets 412 (e.g., three leaflets), collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement. In some examples, the leaflets 412 can comprise any of the leaflets described herein (e.g., leaflet 200, leaflet 600). The leaflets 412 can be secured to one another at their adjacent sides (e.g., commissure tabs) to form commissures 414 of the valvular structure 404. For example, each leaflet 412 can comprise opposing commissure tabs disposed on opposite sides of the leaflet 412 and a cusp edge portion extending between the opposing commissure tabs. The cusp edge portion of the leaflets 412 can have an undulating, curved scalloped shape, and can be secured directly to the frame 402 (e.g., by sutures). However, in alternate examples, the cusp edge portion of the leaflets 412 can be secured to an inner skirt which is then secured to the frame 402. In some examples, the leaflets 412 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No.6,730,118, which is incorporated by reference herein.

[0119] In some examples, the outer skirt 406 can be an annular skirt. In some instances, the outer skirt 406 can comprise one or more skirt portions that are connected together and / or individually connected to the frame 402. The outer skirt 406 can comprise a fabric or polymeric material, such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc. In some instances, instead of having a relatively straight upper edge portion, as shown in FIG.1, the outer skirt 406 can have an undulating upper edge portion that extends along and is secured to the angled struts 434. Examples of such outer skirts, as well as various other outer skirts, that can be used with the frame 402 can be found in PCT Publication No. WO 2023 / 244612, which is incorporated by reference herein.

[0120] The frame 402 can be radially compressible and expandable between a radially compressed (or collapsed) configuration and a radially expanded configuration (the expanded configuration is shown in FIG.14). The frame 402 is shown alone in FIG.15 and a portion of the frame 402 in a straightened (non-annular) configuration is shown in FIG.16.

[0121] The frame 402 can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol). When constructed of a plastically-expandable material, the frame^402^(and thus the valve^500) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame^402^(and thus the valve^400) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0122] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (e.g., the frame^402)^include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 402 can comprise stainless steel. In some examples, the frame 402 can comprise cobalt-chromium. In some examples, the frame 402 can comprise nickel-cobalt- chromium. In some examples, the frame 402^comprises a nickel-cobalt-chromium- molybdenum alloy, such as MP35N™ (tradename of SPS technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0123] As shown in FIGS.15 and 16, the frame 402 can comprise a plurality of interconnected struts 416 which form multiple rows of open cells 418 between the outflow end 410 and the inflow end 408 of the frame 402. In some examples, as shown in FIGS.15 and 16, the frame 402 can comprise three rows of cells 418 with a first (upper in the orientation shown in FIGS.15 and 16) row 420 of cells disposed at the outflow end 410. The first row 420 of cells comprises cells 418 that are elongated in an axial direction (relative to a central longitudinal axis 422 of the frame 402), as compared to cells 418 in the remaining rows of cells. For example, the cells 418 of the first row 420 of cells can have a longer axial length 424 (FIG.16) than cells 418 in the remaining rows of cells, which can include a second row 426 of cells and a third row 428 of cells, the third row 428 of cells disposed at the inflow end 408 and the second row 426 of cells disposed between the first row 420 of cells and the third row 428 of cells.

[0124] In some examples, as shown in FIG.15, each row of cells comprises nine cells 418. Thus, in such examples, the frame 402 can be referred to as a nine-cell frame.

[0125] In alternate examples, the frame 402 can comprise more than three rows of cells (e.g., four or five) and / or more or less than nine cells per row. See e.g., frame 500 in FIGS.17 and 18. In some examples, the cells 418 in the first row 420 of cells may not be elongated compared to cells 418 in the remaining rows of cells of the frame 402 (the second row 426 of cells and the third row 428 of cells).

[0126] The interconnected struts 416 can include a plurality of angled struts 430, 432, 434, and 436 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame 402 between the outflow end 410 and the inflow end 408. For example, the frame 402 can comprise a first row of angled struts 430 arranged end-to-end and extending circumferentially at the inflow end 408 of the frame; a second row of circumferentially extending, angled struts 432; a third row of circumferentially extending, angled struts 434; and a fourth row of circumferentially extending, angled struts 436 at the outflow end 410 of the frame 402. The fourth row of angled struts 436 can be connected to the third row of angled struts 434 by a plurality of axially extending window struts 438 (or window strut portions) and a plurality of axial (or axially extending) struts 440. The axially extending window struts 438 (which can also be referred to as axial struts that include a commissure window) define commissure windows (e.g., open windows) 442 that are spaced apart from one another around the frame 402, in a circumferential direction, and which are adapted to receive a pair of commissure tabs of a pair of adjacent leaflets 412 arranged into a commissure (e.g., commissure 414 shown in FIG. 14). In some examples, the commissure windows 442 and / or the axially extending window struts 438 defining the commissure windows 442 can be referred to herein as commissure features or commissure supports, each commissure feature or support configured to receive and / or be secured to a pair of commissure tabs of a pair of adjacent leaflets.

[0127] One or more (for example, two, as shown in FIGS.15 and 16) axial struts 440 can be positioned between, in the circumferential direction, two commissure windows 442 formed by the window struts 438. Since the frame 402 can include fewer cells per row (e.g., nine) and fewer axial struts 440 between each commissure window 442, as compared to some more traditional prosthetic heart valves, each cell 418 can have an increased width (in thecircumferential direction), thereby providing a larger opening for blood flow and / or coronary access.

[0128] Each axial strut 440 and each window strut 438 extends from a location defined by the convergence of the lower ends (e.g., ends arranged inward of and farthest away from the outflow end 410) of two angled struts 436 (which can also be referred to as an upper strut junction or upper elongated strut junction) to another location defined by the convergence of the upper ends (e.g., ends arranged closer to the outflow end 410) of two angled struts 434 (which can also be referred to as a lower strut junction or lower elongate strut junction). Each axial strut 440 and each window strut 438 forms an axial side of two adjacent cells of the first row of cells 420.

[0129] In some examples, as shown in FIG.16, each axial strut 440 can have a width 444 (FIG.16) that is larger than a width of the angled struts 430, 432, 434, and 436. As used herein, a “width” of a strut is measured between opposing locations on opposing surfaces of a strut that extend between the radially facing inner and outer surfaces of the strut (relative to the central longitudinal axis 422 of the frame 402). A “thickness” of a strut is measured between opposing locations on the radially facing inner and outer surfaces of a strut and is perpendicular to the width of the strut. In some examples, the width 444 of the axial struts 440 is 50-200%, 75-150%, or at least 100% larger than (e.g., double) the width of the angled struts of the frame 402.

[0130] By providing the axial struts 440 with the width 444 that is greater than the width of other, angled struts of the frame 402, a larger contact area is provided for when the leaflets 412 contact the wider axial struts 440 during systole, thereby distributing the stress and reducing the extent to which the leaflets 412 may fold over the axial struts 440, radially outward through the cells 418. As a result, a long-term durability of the leaflets 412 can be increased.

[0131] Since the cells 418 of the frame 402 can have a relatively large width compared to alternate prosthetic valves that have more than nine cells per row (as introduced above), the wider axial struts 440 can be more easily incorporated into the frame 402, without sacrificing open space for blood flow and / or coronary access.

[0132] Commissure tabs 415 of adjacent leaflets 412 can be secured together to form commissures 414 (FIG.14). Each commissure 414 of the prosthetic heart valve 400 comprises two commissure tabs 115 paired together, one from each of two adjacent leaflets 412, and extending through a commissure window 442 of the frame 402. Each commissure 414 can be secured to the window struts 438 forming the commissure window 442.

[0133] The cusp edge portion (e.g., scallop edge) of each leaflet 412 can be secured to the frame 402 via one or more fasteners (e.g., sutures). In some examples, the cusp edge portion of each leaflet 412 can be secured directly to the struts of the frame 402 (e.g., angled struts 430, 432, and 434). For example, the cusp edge portions of the leaflets 412 can be sutured to the angled struts 430, 432, and 434 that generally follow the contour of the cusp edge portions of the leaflets 412.

[0134] In some examples, the cusp edge portion of the leaflets 412 can be secured to an inner skirt and the inner skirt can then be secured directly to the frame 402.

[0135] Various methods for securing the leaflets 412 to a frame, such as the frame 402, are disclosed in PCT Publication WO2023 / 086548, which is incorporated by reference herein in its entirety.

[0136] As shown in FIGS.15 and 16, in some examples, one or more of or each of the axial struts 440 can comprise an inflow end portion 446 (e.g., an end portion that is closest to the inflow end 408) and an outflow end portion 448 that are widened relative to a middle portion 450 of the axial strut 440 (which can be defined by the width 444). In some instances, the inflow end portion 446 of the axial strut 440 can comprise an aperture 447. The apertures 447 can be configured to receive fasteners (e.g., sutures) for attaching soft components of the prosthetic heart valve 400 to the frame 402. For example, in some instances, the outer skirt 406 can be positioned around the outer surface of the frame 402 and an upper or outflow edge portion of the outer skirt 406 can be secured to the apertures 447 by fasteners 449 (e.g., sutures), as shown in FIG.14.

[0137] The interconnected struts 416 can also comprise horizontal struts 482 that extend between adjacent cells 418 of a row of cells of the frame 402 (FIGS.15 and 16). The horizontal struts 482 can extend in a circumferential direction and also be referred to as circumferentially extending struts 482. The horizontal struts 482 can connect angled struts oftwo adjacent rows of angled struts of the frame 402 to one another. For example, each horizontal strut 482 can connect to two angled struts of one row of struts (for example, struts 434 shown in FIG.16) and two angled struts in another, adjacent row of struts (for example, struts 432 shown in FIG.16). As a result, an angled strut 484 extending between an axially extending window strut 438 and the horizontal strut 482 and an angled strut 186 extending between the horizontal strut 482 and another horizontal strut 482 disposed adjacent to the inflow end 408 of the frame 402 can be aligned along an angled line that can follow a scallop line of the leaflets (when the leaflets are attached to the frame 402). Thus, the horizontal struts 482 can allow the angled struts to follow a shape that more closely matches a shape of the scallop line of the leaflets when the frame 402 is in the radially expanded configuration (as shown in FIGS.15 and 16). Additionally, the horizontal struts 482 can serve as spacers that can maintain a specified gap between the angled struts when the frame 402 is in the radially compressed configuration, thereby reducing a risk of pinching the leaflets between the struts in the radially compressed configuration.

[0138] The frame 402 can further comprise a plurality of apex regions 452 formed at the inflow end 408 and the outflow end 410, each apex region 452 extending and forming a junction between two angled struts 430 at the inflow end 408 or two angled struts 436 at the outflow end 410. As such, the apex regions 452 are spaced apart from one another, in a circumferential direction at the inflow end 408 and the outflow end 410.

[0139] Each apex region 452 can comprise an apex 454 (the highest or most outward extending, in an axial direction, point) and two thinned (or narrowed) strut portions 456, one thinned strut portion 456 extending from either side of the apex 454 to a corresponding, wider, angled strut 436 (at the outflow end 410) or angled strut 130 (at the inflow end 408) (FIG.16). In this way, each of the apex regions 452 at the outflow end 410 can form a narrowed transition region between and relative to the two angled struts 436 extending from the corresponding apex region 452 and each of the apex regions 452 at the inflow end 408 can form a narrowed transition region between and relative to the two angled struts 430 extending from the corresponding apex region 452.

[0140] The thinned strut portions 456 of the apex regions 452 can have a width 458 that is smaller than a width 460 of the angled struts 430 or 436 (FIG.16). In some examples, the width 458 can be a uniform width (e.g., along an entire length of the strut portion 456). Insome examples, the width 458 of the thinned strut portions 456 can be from about 0.06 – 0.15 mm smaller than the width 460 of the angled struts 430 and / or 436.

[0141] The thinned strut portions 456 of the apex regions 452 can have a first length 462 (FIG.16). In some examples, the first length 462 is in a range of 0.8-1.4 mm, 0.9-1.2 mm, 0.95-1.05 mm, or about 1.0 mm (e.g., ±0.03 mm). In alternate examples, the first length 462 is in a range of 0.3-0.7 mm, 0.4-0.6 mm, 0.45-0.55 mm, or about 0.5 mm (e.g., ±0.03 mm).

[0142] Thus, each outflow apex region 452 can include two thinned strut portions 456 having the first length 462, each extending from the apex 454, outward relative to a central longitudinal axis 464 of the cells 418. Thus, a total length of the apex region 452 can be two times the first length 462.

[0143] Each apex region 452 and two corresponding angled struts 436 at the outflow end 410 can form an outflow strut 466 and each apex region 452 and two corresponding angled struts 430 at the inflow end 408 can form an inflow strut 468.

[0144] Each outflow strut 466 and inflow strut 468 can have a length that includes an apex region 452 and the two angled struts 436 or 430 (or strut portions), respectively, on either side of the apex region 452. One half the total length of each outflow strut 466 and inflow strut 468 is shown in FIG.16 as length 470, which extends from an end of one angled strut 436 or 430 to the central longitudinal axis 464. Thus, the length of each outflow strut 466 and inflow strut 468 is two times length 470. In some examples, the length 470 for half of each inflow strut 468 can be different than the length 470 for half of each outflow strut 466.

[0145] In some instances, the length of each thinned strut portion 456 can be at least 25% of the length 470 of the corresponding half outflow strut 466 or inflow strut 468. Said another way, the length of each apex region 452 (a total length being two times the first length 462) can be at least 25% of the total length (two times length 470) of the outflow strut 466 or inflow strut 468. In some examples, the length of each apex region 452 can be more than 25% of the total length of the corresponding outflow strut 466 or inflow strut 468, such as 25- 35%.

[0146] In some examples, each apex region 452 can comprise a curved, axially facing outer surface 472 and an arcuate or curved, axially facing inner depression 474 which forms the thinned strut portions 456. For example, the curved inner depression 474 can depress towardthe curved outer surface 472 from an inner surface of the angled strut portions 456, thereby forming the smaller width thinned strut portions 456. Thus, the curved inner depressions 474 can be formed on a cell side of the apex region 452 (e.g., as opposed to the outside of the apex region 452).

[0147] In some examples, the curved outer surface 472 of each apex region 452 can form a single, continuous curve from one angled strut portion 456 on a first side of the apex region 452 to another angled strut portion 456 on an opposite, second side of the apex region 452 (for example, the curved outer surface 472 can have a constant convex curvature).

[0148] As used herein, “constant convex curvature” can refer to a continuously curved surface which is convex and which does not have an inflection point (no change in direction of the curvature).

[0149] Each apex region 452 can have a radius of curvature 476, along the curved outer surface 472 (e.g., in some instances, along an entirety or an entire length of the curved outer surface 472) (FIG.16). In some instances, the radius of curvature 476 at the apex 154 and / or along the entire curved outer surface 472 of the apex region 452 can be greater than 1 mm. In some instances, the radius of curvature 476 can be in a range of 1-20 mm, 3-16 mm, or 8-14 mm. In some instances, the radius of curvature 476 can be greater than 10 mm. The radius of curvature 476 can be dependent on (and thus change due to changes in) the width 158 (e.g., the amount of reduction in width from the angled struts 430 or 436) and the first length 462 of the thinned strut portions 456.

[0150] Further, a height (an axial height) 478 of the apex regions 452, which can be defined in the axial direction from an outer surface of the two angled struts 430 or 436 to the curved outer surface 472 of the apex region 452 at the apex 454, can be the width 458 of the thinned strut portions 456 (FIG.16). In this way, the height 478 of the apex regions 452 can be relatively small and not add much to the overall axial height of the radially expanded frame 402. Thus, the leaflets 412 secured to the frame 402 (FIG.14) can be disposed close to the inflow end 408, thereby leaving a larger open space at the outflow end 410 of the frame 402 that is not blocked by the leaflets 412.

[0151] In some examples, each of the apex region 452 can form an angle 180 between the two angled struts 430 or 436 extending from either side of the corresponding apex region 452(FIG.16). In some instances, the angle 180 can be in a range of 120 (not inclusive) to 140 degrees (e.g., such that the angle 180 is greater than 120 degrees and less than or equal to 140 degrees).

[0152] Additional details and examples of frames for prosthetic heart valves that include apex regions can be found in PCT Publication No. WO2022 / 226147, which is incorporated by reference herein in its entirety.

[0153] FIGS.17-18 illustrate another exemplary frame 500 for a prosthetic heart valve. In some examples, the frame 500 can be used in lieu of the frame 402 in the prosthetic heart valve 400 of FIG.14. Frame 500 can comprise a greater number of circumferentially extending rows of cells (e.g., four rows), with a greater number of cells (e.g., twelve cells) in each row than frame 402. A prosthetic valve implementing frame 500 can be implanted using any of the methods, techniques, and / or delivery apparatuses described herein.

[0154] The frame 500 can be radially compressible and expandable between a radially compressed (or collapsed) configuration and a radially expanded configuration (the expanded configuration is shown in FIG.18). FIGS.17 and 18 show the frame alone, FIG.17 shows a portion of the frame (though it should be understood that the frame is an annular structure such as shown in FIG.18).

[0155] The frame 500 can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol). When constructed of a plastically-expandable material, the frame 500 (and thus the prosthetic valve including frame 500) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame^500 (and thus the valve) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size. Suitable plastically-expandable materials used to form the frame are described above with reference to frame 500.

[0156] As shown in FIGS.17 and 18, the frame 500 can comprise a plurality of interconnected struts 502 that form open cells 504 disposed in multiple rows 510 between theoutflow end 506 and the inflow end 508. In some examples, such as shown in FIGS.17 and 18, the frame 500 can comprise four circumferentially extending rows 510 of cells 504 with a first (upper in the orientation shown in FIGS.17 and 18) row 510a of cells disposed at the outflow end 506. The first row 510a of cells comprises cells 504a that are elongated in an axial direction (relative to a central longitudinal axis of the frame), compared to cells 504 in the remaining rows of cells 510. For example, cells 504a in the first row 510a of cells have a longer axial length L1 than cells 504 in the remaining rows 510 of cells, which can include a second row of cells 510b, a third row of cells, 510c, and a fourth row of cells 510d.

[0157] In some examples, such as shown in FIGS.17 and 18, each row 510 of cells comprises twelve cells 504. Thus, the frame 500 can be referred to as a twelve-cell frame. In other examples, the frame 500 can have a greater or fewer number of circumferentially extending rows 510 of cells and / or a greater or fewer number of cells 504 in each row. In some examples, the cells 504a of the first row 510a may not be elongated relative to the other rows and / or the cells of the other rows (e.g., the second, third, or fourth rows 510b, 510c, 510d) may be elongated relative to the remaining rows.

[0158] The interconnected struts 502 can include a plurality of angled struts 512 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame 500 between the outflow end 506 and the inflow end 508. For example, the frame 500 can comprise a first row of angled struts 512a arranged end-to-end and extending circumferentially at the outflow end 506 of the frame (referred to as the “outflow angled struts” 512a); a second row of circumferentially extending, angled struts 512b; a third row of circumferentially extending, angled struts 512c; a fourth row of circumferentially extending, angled struts 512d; and a fifth row of circumferentially extending, angled struts 512e at the inflow end 508 of the frame 500 (referred to as the “inflow angled struts” 512e). The second through fourth rows of angled struts can be referred to as the “intermediate angled struts” 512b-512d).

[0159] The first row of angled struts 512a can be connected to the second row of angled struts 512b by a plurality of axially extending window struts 514 (or window strut portions) and a plurality of axial (or axially extending) struts 516. The axially extending window struts 514 (which can also be referred to as axial struts that include a commissure window) define commissure windows (e.g., open windows) 518 that are spaced apart from one anotheraround the frame 500, in a circumferential direction, and which are adapted to receive a pair of commissure tabs of a pair of adjacent leaflets arranged into a commissure. In some examples, the commissure windows 518 and / or the axially extending window struts 514 defining the commissure windows 518 can be referred to herein as commissure features or commissure supports, each commissure feature or support configured to receive and / or be secured to a pair of commissure tabs of a pair of adjacent leaflets.

[0160] One or more (for example, three, as shown in FIG.18) axial struts 516 can be positioned between, in the circumferential direction, two commissure windows 518 formed by the window struts 514. Each axial strut 516 and each window strut 514 extends from a location defined by the convergence of the lower ends (e.g., ends arranged inward of and farthest away from the outflow end 506) of two angled struts 512 (which can also be referred to as an upper strut junction or upper elongated strut junction) to another location defined by the convergence of the upper ends (e.g., ends arranged closer to the outflow end 506) of two angled struts 512 (which can also be referred to as a lower strut junction or lower elongate strut junction). Each axial strut 516 and each window strut 514 forms an axial side of two adjacent cells of the first row of cells 510a.

[0161] As described previously with reference to FIG.14, the valvular structure can comprise one or more commissures (see e.g., commissures 414). Each commissure can extend through a commissure window 518 of the frame 500. Each commissure can be secured to the window struts 514 forming the commissure window 518. The cusp edge portion of each leaflet of the valvular structure can be secured to the frame 500 via one or more fasteners (e.g., sutures), such as described above with reference to prosthetic valve 400.

[0162] A leaflet 600 for a prosthetic heart valve, such as the prosthetic heart valve 10 of FIG. 1, the prosthetic heart valve 300 shown in FIG.5, or the prosthetic heart valve 400 shown in FIG.14, is shown in a flattened configuration in FIG.19. The leaflet 600 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No.6,730,118, which is incorporated by reference herein.

[0163] The leaflet 600 has a main body 602 with a free edge 604 (which can also be referred to as an outflow edge) and a cusp edge portion 606 (also referred to as an inflow edgeportion) defining a cusp edge 607 (also referred to as an inflow edge) that is in opposing relation to the free edge 604. As described further below, the cusp edge portion 606 is configured to be attached to an inner skirt or to struts of a frame of a prosthetic heart valve and the free edge 604 is configured to move and contact respective free edges of the other leaflets of a leaflet assembly during closure of the leaflets (e.g., during diastole during operation of the prosthetic heart valve).

[0164] In some examples, as shown in FIG.19, the free edge 604 comprises a straight or linear edge. In some examples, the free edge 604 is curved towards the cusp edge portion 606 of the leaflet 600, similar to free edge 204’ of FIG.3B. In some examples, as shown in FIG.19, the cusp edge portion 606 has a constant or substantially constant radius of curvature along its entire length. In some examples, the cusp edge portion 606 comprises a semi- circular shape or a substantially semi-circular shape. In some examples, the cusp edge portion 606 comprises a parabolic shape. In some examples, the cusp edge portion 606 comprises a scalloped shape, a U-shape or a V-shape.

[0165] In some examples, the leaflet 600 further comprises two sets of opposing commissure tabs disposed on opposite sides of the leaflet 600. For example, the leaflet 600 includes a pair of upper tabs 608 disposed on opposite sides of the leaflet 600 and a pair of lower tabs 610 disposed on opposite sides of the leaflet 600. The lower tabs 610 are disposed closer to the cusp edge portion 606 than the upper tabs 608.

[0166] The leaflet 600 further comprises a set of sub-commissure tabs disposed on opposite sides of the leaflet 600. For example, the leaflet 600 includes a pair of sub-commissure tabs 612 disposed on opposite sides of the leaflet 600. The sub-commissure tabs 612 are disposed closer to the cusp edge portion 606 than the lower tabs 610. For example, the cusp edge portion 606 terminates at its upper ends at the sub-commissure tabs 612.

[0167] The lower tabs 610 and the sub-commissure tabs 612 extend laterally outward from the body 602 of the leaflet 200, relative to a central longitudinal axis 614 of the leaflet 600. The longitudinal axis 614 may be an axis about which leaflet 600 is symmetrical. As used herein, the axial direction can be a direction parallel to the central longitudinal axis 614 and the lateral direction can be perpendicular to the central longitudinal axis 614 (e.g., from one side of the leaflet to the opposite side of the leaflet, across the central longitudinal axis 614).As shown in FIG.19, the central longitudinal axis 614 of the leaflet 600 extends from the inflow end to the outflow end of the leaflet 600.

[0168] The leaflet 600 comprises first side edges 616 that extend axially between the upper and lower tabs 608, 610. The first side edges 616 are positioned at an angle relative to the central longitudinal axis 614. In some examples, as shown in FIG.19, the angle is less than 90 degrees. The leaflet 600 comprises second side edges 618 that extend axially between the lower tabs 610 and the sub-commissure tabs 612. In some examples, as shown in FIG.19, the second side edges 618 are disposed parallel to the central longitudinal axis 614. The second side edges 618 are disposed closer in the lateral direction to the central longitudinal axis 614 than the first side edges 616. The second side edges 618 are offset inwardly closer to the axis 614 than the tabs 612 and the tabs 610 to define axially gaps between the tabs 612 and adjacent tabs 610. In some examples, when a leaflet assembly comprising multiple leaflets 600 are assembled onto a frame (such as frame 402 or 500), the side edges 618 can remain unattached to the frame and other components of the prosthetic valve, to minimize stress on the leaflets when the prosthetic valve is radially compressed.

[0169] An upper or outflow edge 620 of each lower tab 610 is positioned at an angle relative to the central longitudinal axis 614. In some examples, as shown in FIG.19, the angle is greater than 90 degrees such that each edge 620 extends downwardly toward the cusp edge portion 606 moving in a direction from side edge 616 to side edge 628. In some examples, the outflow edge 620 of each lower tab 610 is perpendicular to the respective first side edge 616. In some examples, as shown in FIG.19, the outflow edge 620 of each lower tab 610 is axially offset (that is, offset in the axial direction of the leaflet) from the free edge 604 toward the cusp edge portion 606 by a distance 622.

[0170] An upper material portion 624 of the body 602 extends axially between the free edge 604 and the outflow edge 620 of each lower tab 610 and has a height equal to distance 622. The upper material portion 624 provides a material slack adjacent to the free edge 604 that extends the radial reach of the free edge 604 during coaptation. The non-retained upper material portion 624 is able to move radially inward (that is, towards the middle of the valve) in response to tension applied to the leaflet during diastole and thus provides additional material for coaptation.

[0171] The amount of material slack provided by the upper material portion 624 depends on the distance 622 of the upper material portion 624, that is, the amount by which the upper material portion 624 protrudes relative to the lower tabs 610 (or relative to commissures formed at lower tabs 610 when the leaflet is mounted in a frame as part of a valvular structure).

[0172] A lower or inflow edge 626 of the lower tab 610 is positioned at an angle relative to the central longitudinal axis 614. In some examples, the angle is 90 degrees. In some examples, as illustrated in FIG.19, the outflow edge 620 and the inflow edge 626 are disposed at different angles relative to the central longitudinal axis 614. The lower tab 610 also includes an outer side edge 628 that extends axially between the outflow edge 620 and the inflow edge 626. In some examples, the outer edge 628 is disposed at an angle of less than 90 degrees relative to the central longitudinal axis 614 such that the outer edge 628 is angled toward the axis 614 moving in a direction from the outflow edge 620 to the inflow edge 626. In some examples, the outer edge 628 is perpendicular to the outflow edge 620.

[0173] Each sub-commissure tab 612 comprises an upper or outflow edge 630, a lower or inflow edge 632, and an outer side edge 634 extending axially between the outflow edge 630 and the inflow edge 632. The outflow edge 630 and the inflow edge 632 are disposed at an angle relative to the central longitudinal axis 614, for example, at an angle of 90 degrees. As such, in the illustrated example, the outflow edge 630 and the inflow edge 632 are parallel to each other. In some examples, as depicted, the outer edge 634 is parallel to the central longitudinal axis 614.

[0174] Each upper tab 608 can have an inner edge 636, an outer side edge 638 disposed opposite the inner edge 636, an outflow edge 640, and an inflow edge 642 disposed opposite the outflow edge 638. In some examples, the inner edge 636 and outer edge 638 can be angled relative to each other. For example, the inner edge 636 can be angled relative to the central longitudinal axis 614 at a greater angle than that of the outer edge 638. In some examples, the outflow edge 640 and the inflow edge 642 are parallel to one another and disposed perpendicular to the outer edge 638.

[0175] In some examples, as shown in FIG.19, the outer edge 638 of each upper tab 608 is parallel to the outer edge 628 of the respective lower tab 610. The outer edge 638 of eachupper tab 608 extends farther laterally outward, away from the body 602 of the leaflet 600, than the outer edge 628 of the respective lower tab 610. As described above in connection with leaflet 200, this makes assembly of the commissures to the frame easier and more accurate, thereby ensuring the valve can open as large as possible during operation of the prosthetic heart valve.

[0176] Each upper tab 608 is axially and laterally offset from the free edge 604 of the leaflet 600 by an offsetting portion 644 (which can also be referred to as a neck, neck portion, or connecting portion). The offsetting portion 644 extends between the lower tab 610 and the upper tab 608 on each side of the leaflet 600. For example, each offsetting portion 644 is at least partially defined by the side edge 616 and a relatively straight inner edge 646 that extends from the inner edge 636 of the corresponding upper tab 608 to the free edge 604 of the leaflet 600. In some examples, the inner edge 646, the side edge 616, and the outer edge 638 of the corresponding upper tab 608 are all parallel to each other and angled relative to the central longitudinal axis 614.

[0177] A plurality of the leaflets 600 (e.g., three leaflets 600) can be assembled together into a leaflet assembly or valvular structure 601 and then secured to a frame of a prosthetic heart valve, such as the frame 702 of the prosthetic valve 700 shown in FIGS.20-23. Though shown secured to frame 702, leaflets 600 can be used with a variety of prosthetic heart valve frames (such as frame 12 of FIG.1, frame 302 of FIG.5, frame 402 of FIG.14, frame 500 of FIG.17). In some examples, the frame 702 is the same as the frame 500.

[0178] As shown in FIG.20, the prosthetic valve 700 has a frame 702 and an inner skirt 704 coupled to an inner surface 706 of the frame 702. The frame 702 also has an outer surface 708. The valvular structure 601 comprises a plurality (e.g., three) leaflets 600 (two of which are shown in FIG.20) coupled to and supported by the frame 702.

[0179] With additional reference to FIGS.21-23, the frame 702 can comprise a plurality of interconnected struts 710 that are arranged into a plurality of rows of angled struts 710 disposed between an inflow end 712 and an outflow end of the frame 702 (FIG.23). The struts 710 define open cells 716 of the frame 702. The frame 702 has a plurality of circumferentially spaced commissure supports 718 that are adapted to mount commissures 650 of the valvular structure 601 to the frame 702. The commissure supports 718 can definerespective commissure windows (for example, windows 442) for receiving the commissures 650 of the leaflet assembly, as previously described herein. In some examples, the frame 702 can be the same as the frame 500.

[0180] Each commissure window is adapted to receive a pair of lower tabs 610 of a pair of adjacent leaflets 600 therethrough. For example, similar to leaflets 200, adjacent lower tabs 610 of two adjacent leaflets 600 can be coupled together (e.g., via a post, flexible connector, or attachment member, as described above with reference to leaflet 200 and FIGS.9-12B), and the upper tabs 608 of the two adjacent leaflets 600 can be folded downward at their offsetting portions 644 such that the lower tabs 610 are disposed between the pair of upper tabs 608. The lower tabs 610 can then be inserted through a commissure window in the frame 702 and folded across the radially outward facing surface 708 of the frame 702. Each lower tab 610 can be coupled to a respective upper tab 608 along a suture line. Further details on forming the commissures 650 using flexible connectors is described above with reference to leaflet 200 and FIGS.9-12B.

[0181] Further details on the frame 702 and other similar frames that can be used and assembled with the leaflets 600, as described herein, can be found in U.S. Patent No. 9,393,110, which is incorporated by reference herein, and WO 2022 / 026351, as already incorporated by reference above.

[0182] As shown in FIG.20, each sub-commissure tab 612 is paired with an adjacent sub- commissure tab 612 of an adjacent leaflet. The sub-commissure tabs 612 of each pair optionally are folded outwards relative to the main bodies of the leaflets when the valvular structure 601 is coupled to the frame 702. Specifically, the sub-commissure tabs 612 extend radially outwards towards the outer surface 708 of the frame 702. As shown, the sub- commissure tabs 612 optionally can extend radially outwards through an opening or slit 705 in the inner skirt 704 and into a cell 716 of the frame.

[0183] In some examples, as shown, the outer edges 628 of the sub-commissure tabs 612 are positioned radially between the inner surface 706 of the frame 702 and the outer surface 708 of the frame 702 within a cell 716. In some examples, the outer edges 628 of the sub- commissure tabs 612 can extend radially beyond the outer surface 708 of the frame 702.

[0184] FIG.21 illustrates a radially outward facing portion of the prosthetic valve 700 at a location where the sub-commissure tabs 612 extend outwardly at least partially through, a cell 716 of the frame 702 that is directly adjacent to and circumferentially aligned with the commissure support 718. In this way, the commissure 650 formed by a pair of adjacent leaflets 600 and the sub-commissure tabs 612 of the pair of adjacent leaflets 600 both extend radially outwards through the frame 702 at locations that are circumferentially aligned and axially spaced apart. The adjacent commissure tabs 612 can be connected to each other, such as with stitches 734.

[0185] FIG.22 illustrates a radially inward facing portion of the prosthetic valve 700 at a location 652 where the sub-commissure tabs 612 extend outwardly toward the frame 702. Because the sub-commissure tabs 612 are folded such that the outer edges 628 extend through the opening 705 of the inner skirt 704 and into a cell 716 of the frame 702, the leaflets 600 are generally smooth at location 652. For example, there is no radially inward protuberance at location 652 that can restrict opening and closing movements of the leaflets 600.

[0186] The cusp edge portions 606 can be secured to the inner skirt 704 with stitches 730 that extend along the cusp edge portions. The stitches 730 can form what is referred to as a “scallop line” or a scallop-shaped stitch line that tracks the curvature of the cusp edge portions 606. As shown in FIG.22, a reinforcing skirt 732 can be secured to the inner surfaces of the cusp edge portions 606, such as with the stitches 730, such that the cusp edge portions 606 are sandwiched between the inner skirt 704 and the reinforcing skirt 732. The stitches 730 can comprise in-and-out stitches that extend through the inner skirt 704, the cusp edge portion 606 of each leaflet, and the reinforcing skirt 732.

[0187] In some examples, as shown in FIG.23, the inner skirt 704 can be attached to the frame 702, such as along an outflow edge of the inner skirt and a fourth row of angled struts 710 of the frame 702, for example with a plurality of whip stitches 720. The inner skirt 704 can further be attached adjacent an inflow edge of the inner skirt to a first row of angled struts 710 that define the inflow end 712 of the frame 702, for example with a plurality of whip stitches 722. The sub-commissure tabs 612 of adjacent leaflets 600 are folded such that the sub-commissure tabs 612 extend radially outwards through the opening 705 of the inner skirt 704 (FIG.20) and at least partially through a cell 716 of the frame 702 that is defined by athird row of angled struts 710 and the fourth row of angled struts 710. In some examples, as shown, the sub-commissure tabs 612 can extend through a cell 716 that is spaced apart from the inflow end 712 of the prosthetic valve 700.

[0188] As described above, the cusp edge 607 of the leaflet 600 can comprise a circular or substantially circular shape (e.g., parabolic, etc.). In some examples, a higher degree of circularity of the cusp edge 607 can improve washout from the neo-sinus regions of the leaflets and may additionally improve coaptation of the leaflet 600. However, the circularity of the cusp edge 607 of the leaflet 600 may be constrained by certain dimensions of the prosthetic heart valve 700, including dimensions of the leaflet 600 (e.g., height and width of the cusp edge portion, etc.).

[0189] FIGS.24A-24C illustrate partial views of the leaflet 600 as disposed within the frame 702 in a straightened (non-annular) configuration, with different configurations for the cusp edge portion 606 and the cusp edge 607. The curvature of the leaflets can be determined by a trapezoid that is positioned around the cusp edge portion 606 of the leaflet 600, shown in FIGS.24A-24C in dashed lines. For example, the trapezoid surrounds the cusp edge portion 606 of the leaflet 600, that is, the portion of the leaflet 600 that is below the sub-commissure tabs 612 of the leaflet 600 and extends towards the inflow end 712 of the frame 702 in the axial direction. The trapezoid has upper and lower edges 800 and 802, respectively, that are perpendicular to the central longitudinal axis 614 of the leaflet 600 and angled side edges 804 that extend between the upper and lower edges. The upper edge 800 of the trapezoid intersects the downstream most ends 609 of the cusp edge 607, which in some examples, is where the downstream most ends 609 of cusp edge 607 intersect the sub-commissure tabs 612. The upper edge 800 can be referred to as a laterally extending axis which defines a width of the leaflet 600 at the downstream most ends of the cusp edge portion 606. The lower edge 802 of the trapezoid is tangent to the lowermost point 611 along the cusp edge portion 606 (which can be referred to as the “apex” of the cusp edge portion). In the illustrated examples, the cusp edge portion 606 of the leaflet 600 is parabolic in shape and shown with different degrees of circularity.

[0190] An axial height 736 of the cusp edge portion 606 can be defined as the distance between the upper and lower edges 800, 802 of the trapezoid. As shown, the axial height 736is smaller in FIG.24C than in FIGS.24A-24B. In some examples, the height 736 of the cusp edge portion 606 can be in the range of 5-10 mm, 5-8 mm, and 6-8 mm.

[0191] The apex 611 of the cusp edge portion 606 (e.g., the location where the cusp edge portion 606 is closest to the inflow end 712 of the frame 702) can be offset from the inflow end 712 of the frame by an axial offset distance 738. As shown, the offset distance 738 is greater in FIG.24C than in FIGS.24A-24B. In some examples, the offset distance 738 is in a range of 0.5-8 mm, 0.5-5 mm, or 1-3 mm.

[0192] An angle 740 can be defined between the upper edge 800 of the trapezoid and each of the sides 804 of the trapezoid. The sides 804 of the trapezoid are tangent to the cusp edge portion 606 of the leaflet 600 at the downstream most ends of the cusp edge portion (at locations where the cusp edge portion intersects the laterally extending axis 800). As shown, the angle 740 is smaller in FIG.24B than in FIGS.24A and 24C. In some examples, a high degree of circularity of the cusp edge portion 606 can be achieved while staying within the dimensional constraints of the leaflet 600 when the angle 740 is in a range of 50°-90°, 60°- 80°, or 60°-75° and the cusp edge portion 606 desirably (but not necessarily) is circular or parabolic in shape.

[0193] In a specific implementation of FIG.24A, the angle 740 is 72 degrees, the height 736 is 7.77 mm, and the offset distance 738 is 1 mm. In a specific implementation of FIG.24B, the angle 740 is 60 degrees, the height 736 is 7.77 mm, and the offset distance 738 is 1 mm. In a specific implementation of FIG.24C, the angle 740 is 72 degrees, the height 736 is 6 mm, and the offset distance 738 is 2.77 mm.

[0194] In some examples, the dimensions of the leaflet 600 can be selected for a high degree of circularity of the cusp edge portion 606 based on the expanded diameter of the valve 700 (or valve size) in which the leaflet 600 is disposed. In some examples, the axial height 736 of the cusp edge portion 606 can be in the range of 30% to 60%, 35% to 55%, or 40% to 50% of the expanded diameter of the valve 700. Further, a width of the cusp edge portion 606 of the leaflet 600 at the downstream most ends of the cusp edge portion 606 can be defined by the upper edge 800 of the trapezoid. As such, the upper edge 800 can also be referred to as a width 800 of the leaflet 600 at the downstream ends of the cusp edge portion 606. In some examples, the width 800 of the leaflet 600 can be in the range of 85% to 100% or 90% to100% of the expanded diameter of the valve 700. In some examples, the expanded diameter of the valve 700 can be, for example, 20 mm to 32 mm.

[0195] As described above, the higher degree of circularity of the cusp edge portion 606 of the leaflets 600 can improve washout from the neo-sinus regions of the leaflets and may also improve coaptation of the leaflet 600. Delivery Techniques

[0196] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J- sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0197] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) isintroduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0198] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0199] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0200] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

[0201] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electronbeam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Additional Examples of the Disclosed Technology

[0202] In view of the above described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0203] Example 1. A leaflet for a prosthetic valve, comprising: a main body with a free, outflow edge and a cusp edge portion, wherein the outflow edge is straight or curved towards the cusp edge portion; two lower tabs disposed on opposite sides of the main body, wherein the cusp edge portion terminates at upper ends thereof at the lower tabs, and the lower tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the main body and extending laterally outward from the main body; and two offsetting portions, each offsetting portion extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the outflow edge of the main body, wherein each upper tab has opposing inner and outer edges that are parallel to one another and disposed parallel to the central longitudinal axis of the leaflet.

[0204] Example 2. The leaflet of any example herein, particularly example 1, wherein each lower tab has an outer edge that is laterally offset from the main body and disposed parallel to the central longitudinal axis of the leaflet and the outer edge of the respective upper tab.

[0205] Example 3. The leaflet of any example herein, particularly either example 1 or example 2, wherein the outer edge of each upper tab extends laterally outward farther than an outer edge of a respective lower tab, relative to the central longitudinal axis of the leaflet.

[0206] Example 4. The leaflet of any example herein, particularly any one of examples 1-3, wherein a width of each upper tab of the two upper tabs is wider than each lower tab, and wherein the width extends perpendicular to the central longitudinal axis of the leaflet.

[0207] Example 5. The leaflet of any example herein, particularly any one of examples 1-4, wherein each upper tab has an outflow edge and an inflow edge disposed opposite the outflow edge, wherein the inflow edge is disposed closer to a respective lower tab than the outflow edge, and wherein the inflow and outflow edges are perpendicular to the inner and outer edges of the upper tab.

[0208] Example 6. The leaflet of any example herein, particularly any one of examples 1-5, wherein each offsetting portion has an outer edge that extends between an inflow edge of the respective upper tab and an outflow edge of the respective lower tab and an arcuate inner edge that curves between the inner edge of the respective upper tab and the outflow edge of the main body.

[0209] Example 7. The leaflet of any example herein, particularly example 6, wherein the arcuate inner edge curves 90 degrees between the inner edge of the respective upper tab and the outflow edge of the main body.

[0210] Example 8. The leaflet of any example herein, particularly either example 6 or example 7, wherein the outer edge of each offsetting portion extends parallel to the central longitudinal axis of the leaflet.

[0211] Example 9. The leaflet of any example herein, particularly any one of examples 1-8, wherein a width of each offsetting portion is less than half a width of each lower tab, and wherein the outflow edge of the main body extends between the two offsetting portions.

[0212] Example 10. The leaflet of any example herein, particularly any of examples 1-8, wherein the outflow end is straight.

[0213] Example 11. The leaflet of any example herein, particularly example 10, wherein the outflow edge of the main body is co-linear with outflow edges of the lower tabs.

[0214] Example 12. The leaflet of any example herein, particularly example 10, wherein outflow edges of the lower tabs are axially offset from the outflow edge of the main body toward the cusp edge portion.

[0215] Example 13. The leaflet of any example herein, particularly any one of examples 1-8, wherein the outflow edge of the main body is curved towards the cusp edge portion.

[0216] Example 14. A prosthetic heart valve, comprising a plurality of the leaflets of any example herein, particularly any one of examples 1-13, wherein for each leaflet, the upper tabs are folded over the respective lower tabs.

[0217] Example 15. The prosthetic heart valve of any example herein, particularly example 14, wherein the cusp edge portion of each leaflet is couple to struts of a frame of the prosthetic heart valve via an inner skirt of the prosthetic heart valve, and wherein the outflow edge of the main body of each leaflet is free to move during operation of the prosthetic heart valve to regulate a flow of blood through the prosthetic heart valve.

[0218] Example 16. A leaflet for a prosthetic valve, comprising: a main body with a free edge and a cusp edge portion, the free edge disposed at an outflow end of the leaflet, wherein the free edge is straight or curved towards the cusp edge portion; two lower tabs disposed on opposite sides of the main body, wherein the cusp edge portion terminates at upper ends thereof at the lower tabs, and the lower tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the main body and extending laterally outward from the main body; and two offsetting portions, each offsetting portion extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the free edge of the main body, wherein a first width of each upper tab of the two upper tabs is wider than a second width of each lower tab of the two lower tabs such that an outer edge of each upper tab extends laterally outward farther than an outer edge of a respective lower tab, relative to the central longitudinal axis of the leaflet, and wherein the first and second widths extend perpendicular to the central longitudinal axis of the leaflet.

[0219] Example 17. The leaflet of any example herein, particularly example 16, wherein the outer edges of the upper and lower tabs are parallel to the central longitudinal axis of the leaflet.

[0220] Example 18. The leaflet of any example herein, particularly either example 16 or example 17, wherein each upper tab has an inner edge disposed opposite the outer edge, and wherein the inner and outer edges of each upper tab are parallel to the central longitudinal axis of the leaflet.

[0221] Example 19. The leaflet of any example herein, particularly any one of examples 16- 18, wherein each upper tab has opposing inflow and outflow edges that are perpendicular to the central longitudinal axis of the leaflet, and wherein the inflow edge is disposed closer to the free edge of the main body than the outflow edge.

[0222] Example 20. The leaflet of any example herein, particularly any one of examples 16- 19, wherein each offsetting portion has an outer edge that extends between an inflow edge of the respective upper tab and an outflow edge of the respective lower tab and an arcuate inner edge that curves between the inner edge of the respective upper tab and the free edge of the main body.

[0223] Example 21. The leaflet of any example herein, particularly example 20, wherein the arcuate inner edge curves 90 degrees between the inner edge of the respective upper tab and the free edge of the main body.

[0224] Example 22. The leaflet of any example herein, particularly either example 20 or example 21, wherein the outer edge of each offsetting portion extends parallel to the central longitudinal axis of the leaflet.

[0225] Example 23. The leaflet of any example herein, particularly any one of examples 16- 22, wherein a width of each offsetting portion is less than half a width of each lower tab, and wherein the free edge of the main body extends between the two offsetting portions.

[0226] Example 24. A prosthetic heart valve comprising a plurality of the leaflets of any example herein, particularly any one of examples 16-23, wherein for each leaflet, the upper tabs are folded over the respective lower tabs.

[0227] Example 25. The prosthetic heart valve of any example herein, particularly example 24, wherein the cusp edge portion of each leaflet coupled to struts of a frame of the prosthetic heart valve via an inner skirt of the prosthetic heart valve, and wherein the free edge of the main body of each leaflet is free to move during operation of the prosthetic heart valve to regulate a flow of blood through the prosthetic heart valve.

[0228] Example 26. A leaflet for a prosthetic valve, comprising: a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end, wherein the free edge is straight or curved towards the cusp edge portion; two lower tabs disposed on opposite sides of the main body, wherein the cusp edge portion terminates at upper endsthereof at the lower tabs, and the lower tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the main body and extending laterally outward from the main body; and two offsetting portions, each offsetting portion extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the free edge of the main body, wherein each offsetting portion has an outer edge that extends between an inflow edge of the respective upper tab and an outflow edge of the respective lower tab and an arcuate inner edge that curves between an inner edge of the respective upper tab and the free edge of the main body, wherein the inner edge of each offsetting portion is disposed closer to the central longitudinal axis than the outer edge of the offsetting portion.

[0229] Example 27. The leaflet of any example herein, particularly example 26, wherein each offsetting portion has a first width defined between its inner and outer edges that is less than half a second width of the lower tabs.

[0230] Example 28. The leaflet of any example herein, particularly either example 26 or example 27, wherein the arcuate inner edge of each offsetting portion curves 90 degrees between the inner edge of the respective upper tab and the free edge of the main body.

[0231] Example 29. The leaflet of any example herein, particularly any one of examples 26- 28, wherein the outer edge of each offsetting portion extends parallel to the central longitudinal axis of the leaflet.

[0232] Example 30. The leaflet of any example herein, particularly any one of examples 26- 29, wherein each upper tab has an outer edge disposed opposite the inner edge of the upper tab, and wherein the inner and outer edges of each upper tab are parallel to the central longitudinal axis of the leaflet.

[0233] Example 31. The leaflet of any example herein, particularly example 30, wherein each lower tab has an outer edge that is laterally offset from the main body and disposed parallel to the central longitudinal axis of the leaflet and the outer edge of the respective upper tab.

[0234] Example 32. The leaflet of any example herein, particularly example 31, wherein the outer edge of each upper tab extends laterally outward farther than the outer edge of the respective lower tab, relative to the central longitudinal axis of the leaflet.

[0235] Example 33. The leaflet of any example herein, particularly any one of examples 26- 32, wherein a width of each upper tab of the two upper tabs is wider than each lower tab of the two lower tabs, and wherein the width extends perpendicular to the central longitudinal axis of the leaflet.

[0236] Example 34. The leaflet of any example herein, particularly any one of examples 26- 33, wherein each upper tab has an outflow edge disposed opposite to its inflow edge, wherein the inflow edge of the upper tab is disposed closer to a respective lower tab than the outflow edge of the upper tab, and wherein the inflow and outflow edges of the upper tab are perpendicular to the inner edge of the upper tab.

[0237] Example 35. A prosthetic heart valve comprising a plurality of the leaflets of any example herein, particularly any one of examples 26-34, wherein for each leaflet, the upper tabs are folded over the respective lower tabs.

[0238] Example 36. The prosthetic heart valve of any example herein, particularly example 35, wherein the cusp edge portion of each leaflet coupled to struts of a frame of the prosthetic heart valve via an inner skirt of the prosthetic heart valve, and wherein the free edge of the main body of each leaflet is free to move during operation of the prosthetic heart valve to regulate a flow of blood through the prosthetic heart valve.

[0239] Example 37. A leaflet for a prosthetic valve, comprising: a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end; two lower tabs disposed on opposite sides of the main body, wherein the lower tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the main body and extending laterally outward from the main body; and two sub-commissure tabs disposed on opposite sides of the main body and extending laterally outward from the main body, wherein the cusp edge portion terminates at upper ends thereof at the sub-commissure tabs.

[0240] Example 38. The leaflet of any example herein, particularly example 37, wherein the free edge is straight or curved towards the cusp edge portion.

[0241] Example 39. The leaflet of any example herein, particularly either example 37 or example 38, wherein an outer edge of each sub-commissure tab is parallel to the central longitudinal axis.

[0242] Example 40. The leaflet of any example herein, particularly any one of examples 37- 39, wherein the sub-commissure tabs are disposed closer to the cusp edge portion of the leaflet than the lower tabs.

[0243] Example 41. The leaflet of any example herein, particularly any one of examples 37- 40, wherein the main body comprises first side edges extending axially between the upper tabs and the lower tabs, wherein the main body comprises second side edges extending axially between the lower tabs and the sub-commissure tabs, wherein the second side edges are disposed closer in the lateral direction to the central longitudinal axis than the first side edges.

[0244] Example 42. The leaflet of any example herein, particularly example 41, wherein the first side edges are angled relative to the central longitudinal axis.

[0245] Example 43. The leaflet of any example herein, particularly either example 41 or example 42, wherein the second side edges are parallel to the central longitudinal axis.

[0246] Example 44. The leaflet of any example herein, particularly any one of examples 37- 43, wherein outer edges of the upper tabs and outer edges of the lower tabs are angled relative to the central longitudinal axis.

[0247] Example 45. The leaflet of any example herein, particularly example 44, wherein an inner edge of each upper tab is angled relative to the central longitudinal axis, wherein the inner edges are angled at a different angle than the outer edges of the upper tabs.

[0248] Example 46. The leaflet of any example herein, particularly any one of examples 37- 45, wherein the free edge is spaced apart in the axial direction from an outflow edge of each lower tab.

[0249] Example 47. The leaflet of any example herein, particularly any one of examples 37- 46, further comprising two offsetting portions, each offsetting portion extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the free edge of the main body.

[0250] Example 48. The leaflet of any example herein, particularly any one of examples 37- 47, wherein the cusp edge portion is circular or parabolic in shape, and wherein an angledefined between a laterally extending axis of the leaflet and a line that is tangent to the cusp edge portion at an upper end thereof is in a range of 50-90 degrees.

[0251] Example 49. The leaflet of any example herein, particularly example 48, wherein the angle is in a range of 60-80 degrees.

[0252] Example 50. The leaflet of any example herein, particularly either example 48 or example 49, wherein the angle is in a range of 60-75 degrees.

[0253] Example 51. A prosthetic heart valve comprising a plurality of the leaflets of any example herein, particularly any one of examples 37-50, wherein for each leaflet, the upper tabs are folded over the respective lower tabs.

[0254] Example 52. The prosthetic heart valve of any example herein, particularly example 51, wherein the cusp edge portion of each leaflet is coupled to struts of a frame of the prosthetic heart valve via an inner skirt of the prosthetic heart valve, and wherein the free edge of the main body of each leaflet is free to move during operation of the prosthetic heart valve to regulate a flow of blood through the prosthetic heart valve.

[0255] Example 53. The prosthetic heart valve of any example herein, particularly either example 51 or example 52, wherein each sub-commissure is folded and stitched to an adjacent sub-commissure tab of an adjacent leaflet.

[0256] Example 54. A prosthetic heart valve comprising: a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration, wherein the frame comprises a plurality of interconnected struts including a plurality of rows of angled struts and a plurality of axially extending window strut portions defining a plurality of circumferentially spaced apart commissure windows; and a valvular structure mounted on an inside of the frame and comprising a plurality of leaflets, wherein each leaflet comprises a main body with a free, outflow edge and a cusp edge portion, a pair of lower tabs disposed on opposite sides of the main body, a pair of upper tabs disposed on opposite sides of the main body and folded downwardly against lower tabs, and a pair of sub-commissure tabs disposed on opposite sides of the main body, wherein the pairs of lower and upper tabs of adjacent leaflets are paired to form a commissure that is secured to a respective commissure window of the frame.

[0257] Example 55. The prosthetic heart valve of any example herein, particularly example 54, wherein the outflow end is straight.

[0258] Example 56. The prosthetic heart valve of any example herein, particularly example 55, wherein the outflow edge of the main body is co-linear with outflow edges of the lower tabs.

[0259] Example 57. The prosthetic heart valve of any example herein, particularly example 55, wherein outflow edges of the lower tabs are axially offset from the outflow edge of the main body toward the cusp edge portion.

[0260] Example 58. The prosthetic heart valve of any example herein, particularly example 54, wherein the outflow edge of the main body is curved towards the cusp edge portion.

[0261] Example 59. The prosthetic heart valve of any example herein, particularly any one of examples 54-58, wherein outer edges of the upper tabs and outer edges of the lower tabs are angled relative to a central longitudinal axis of the leaflet.

[0262] Example 60. A prosthetic heart valve comprising: a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; and a plurality of leaflets mounted on an inside of the frame, wherein each leaflet comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end, two lower tabs disposed on opposite sides of the main body, two upper tabs disposed on opposite sides of the main body and folded downwardly against the lower tabs, and two sub- commissure tabs disposed on opposite sides of the main body, wherein lower and upper tabs of adjacent leaflets are paired to form a commissure that is secured to the frame, and wherein sub-commissure tabs of the adjacent leaflets are connected to each other.

[0263] Example 61. The prosthetic heart valve of any example herein, particularly example 60, wherein the free edge is straight or curved towards the cusp edge portion.

[0264] Example 62. The prosthetic heart valve of any example herein, particularly either example 60 or example 61, wherein the sub-commissure tabs are disposed closer to the cusp edge portion of the leaflet than the lower tabs.

[0265] Example 63. The prosthetic heart valve of any example herein, particularly any one of examples 60-62, wherein the free edge is spaced apart in the axial direction from an outflow edge of each lower tab.

[0266] Example 64. The prosthetic heart valve of any example herein, particularly any one of examples 60-63, further comprising two offsetting portions, each offsetting portion extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the free edge of the main body.

[0267] Example 65. The prosthetic heart valve of any example herein, particularly any one of examples 60-64, further comprising an inner skirt disposed around an inner surface of the frame and secured to the cusp edge portion of each leaflet.

[0268] Example 66. The prosthetic heart valve of any example herein, particularly any one of examples 60-65, wherein the frame comprises a plurality of interconnected struts including a plurality of rows of angled struts and a plurality of axially extending window strut portions defining a plurality of circumferentially spaced apart commissure windows, and wherein the commissures of the adjacent leaflets are secured to a respective commissure window of the frame.

[0269] Example 67. The prosthetic heart valve of any example herein, particularly any one of examples 60-66, wherein the cusp edge portion is circular or parabolic in shape, and wherein an angle defined between a laterally extending axis of the leaflet and a line that is tangent to the cusp edge portion at an upper end thereof is in a range of 50-90 degrees.

[0270] Example 68. The prosthetic heart valve of any example herein, particularly example 67, wherein the angle is in a range of 60-80 degrees.

[0271] Example 69. The prosthetic heart valve of any example herein, particularly either example 67 or example 68, wherein the angle is in a range of 60-75 degrees.

[0272] Example 70. A prosthetic heart valve comprising: a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; and a plurality of leaflets mounted on an inside of the frame, wherein each leaflet comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end and having two opposing downstream ends, and wherein the cusp edge portion is circular or parabolic in shape, and wherein an angle defined between a laterally extending axis of theleaflet and a line that is tangent to the cusp edge portion at a downstream end thereof is in a range of 50-90 degrees.

[0273] Example 71. The prosthetic heart valve of any example herein, particularly example 70, wherein the angle is in a range of 60-80 degrees.

[0274] Example 72. The prosthetic heart valve of any example herein, particularly either example 70 or example 71, wherein the angle is in a range of 60-75 degrees.

[0275] Example 73. The prosthetic heart valve of any example herein, particularly example 72, wherein the angle is in a range of 70-75 degrees.

[0276] Example 74. The prosthetic heart valve of any example herein, particularly example 73, wherein the angle is 72 degrees.

[0277] Example 75. The prosthetic heart valve of any example herein, particularly any one of examples 70-74, wherein each leaflet further comprises two sub-commissure tabs disposed on opposite sides of the main body, wherein sub-commissure tabs of adjacent leaflets are connected to each other, and wherein the downstream ends of the cusp edge portion are located at the sub-commissure tabs.

[0278] Example 76. The prosthetic heart valve of any example herein, particularly any one of examples 70-75, wherein an axial height of the cusp edge portion of each leaflet is in a range of 5-10 mm, and wherein the axial height extends from an inflow end of the cusp edge portion to the laterally extending axis.

[0279] Example 77. The prosthetic heart valve of any example herein, particularly example 76, wherein the axial height is in a range of 5-8 mm.

[0280] Example 78. The prosthetic heart valve of any example herein, particularly either example 76 or example 77, wherein the axial height is in a range of 6-8 mm.

[0281] Example 79. The prosthetic heart valve of any example herein, particularly any one of examples 70-78, wherein an offset distance between an inflow end of the frame and an inflow end of the cusp edge portion is in a range of 0.5-8 mm.

[0282] Example 80. The prosthetic heart valve of any example herein, particularly example 79, wherein the offset distance is in a range of 0.5-5 mm.

[0283] Example 81. The prosthetic heart valve of any example herein, particularly either example 79 or example 80, wherein the offset distance is in a range of 1-3 mm.

[0284] Example 82. The prosthetic heart valve of any example herein, particularly any one of examples 70-81, wherein an axial height of the cusp edge portion of each leaflet is in a range of 30%-60% of a diameter of the prosthetic heart valve, and wherein the axial height extends from an inflow end of the cusp edge portion to the laterally extending axis.

[0285] Example 83. The prosthetic heart valve of any example herein, particularly any one of examples 70-82, wherein a width of the cusp edge portion at the downstream ends of the cusp edge portion is in a range of 85%-100% of the diameter of the prosthetic heart valve.

[0286] Example 84. The prosthetic heart valve of any example herein, particularly any one of examples 70-83, wherein each leaflet comprises commissure tabs disposed on opposite sides of the leaflets downstream of the cusp edge portion, wherein the commissure tabs are paired with commissure tabs of adjacent leaflets to form commissures that are coupled to the frame.

[0287] Example 85. The prosthetic heart valve of any example herein, particularly example 84, wherein each commissure tab comprises an upper tab and a lower tab, wherein the upper tab is folded against the lower tab.

[0288] Example 86. A method comprising sterilizing the leaflet, prosthetic heart valve, apparatus, and / or assembly of any example.

[0289] Example 87. A leaflet of any one of examples 1-13, 16-23, 26-34, and 37-50, wherein the leaflet is sterilized.

[0290] Example 88. A prosthetic heart valve of any one of examples 14, 15, 24, 25, 35, 36, and 51-85, wherein the prosthetic heart valve is sterilized.

[0291] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one leaflet can be combined with any one or more features of another leaflet. As another example, any one or more features of one prosthetic valve can be combined with any one or more features of another prosthetic valve.

[0292] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

We claim:

1. A leaflet for a prosthetic valve, comprising: a main body with a free, outflow edge and a cusp edge portion; two lower tabs disposed on opposite sides of the main body, wherein the cusp edge portion terminates at upper ends thereof at the lower tabs, and the lower tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the main body and extending laterally outward from the main body; and two offsetting portions, each offsetting portion extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the outflow edge of the main body, wherein each upper tab has opposing inner and outer edges that are parallel to one another and disposed parallel to the central longitudinal axis of the leaflet.

2. The leaflet of claim 1, wherein the outer edge of each upper tab extends laterally outward farther than an outer edge of a respective lower tab, relative to the central longitudinal axis of the leaflet.

3. The leaflet of either claim 1 or claim 2, wherein each upper tab has an outflow edge and an inflow edge disposed opposite the outflow edge, wherein the inflow edge is disposed closer to a respective lower tab than the outflow edge, and wherein the inflow and outflow edges are perpendicular to the inner and outer edges of the upper tab.

4. The leaflet of any one of claims 1-3, wherein each offsetting portion has an outer edge that extends between an inflow edge of the respective upper tab and an outflow edge of the respective lower tab and an arcuate inner edge that curves between the inner edge of the respective upper tab and the outflow edge of the main body.

5. The leaflet of any one of claims 1-4, wherein a width of each offsetting portion is less than half a width of each lower tab, and wherein the outflow edge of the main body extends between the two offsetting portions.

6. The leaflet of any of claims 1-5, wherein the outflow edge is straight.

7. The leaflet of any one of claims 1-5, wherein the outflow edge of the main body is curved towards the cusp edge portion.

8. A leaflet for a prosthetic valve, comprising: a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end; two lower tabs disposed on opposite sides of the main body, wherein the lower tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the main body and extending laterally outward from the main body; and two sub-commissure tabs disposed on opposite sides of the main body and extending laterally outward from the main body, wherein the cusp edge portion terminates at upper ends thereof at the sub-commissure tabs.

9. The leaflet of claim 8, wherein the main body comprises first side edges extending axially between the upper tabs and the lower tabs, wherein the main body comprises second side edges extending axially between the lower tabs and the sub- commissure tabs, wherein the second side edges are disposed closer in the lateral direction to the central longitudinal axis than the first side edges.

10. The leaflet of claim 9, wherein the first side edges are angled relative to the central longitudinal axis.

11. The leaflet of either claim 9 or claim 10, wherein the second side edges are parallel to the central longitudinal axis.

12. The leaflet of any one of claims 8-11, wherein outer edges of the upper tabs and outer edges of the lower tabs are angled relative to the central longitudinal axis.

13. The leaflet of claim 12, wherein an inner edge of each upper tab is angled relative to the central longitudinal axis, wherein the inner edges are angled at a different angle than the outer edges of the upper tabs.

14. The leaflet of any one of claims 8-13, wherein the free edge is spaced apart in the axial direction from an outflow edge of each lower tab.

15. A prosthetic heart valve comprising: a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; and a plurality of leaflets mounted on an inside of the frame, wherein each leaflet comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end and having two opposing downstream ends, and wherein the cusp edge portion is circular or parabolic in shape, and wherein an angle defined between a laterally extending axis of the leaflet and a line that is tangent to the cusp edge portion at a downstream end thereof is in a range of 50-90 degrees.

16. The prosthetic heart valve of claim 15, wherein the angle is in a range of 60-80 degrees.

17. The prosthetic heart valve of either claim 15 or claim 16, wherein an axial height of the cusp edge portion of each leaflet is in a range of 5-10 mm, and wherein the axial height extends from an inflow end of the cusp edge portion to the laterally extending axis.

18. The prosthetic heart valve of any one of claims 15-17, wherein an offset distance between an inflow end of the frame and an inflow end of the cusp edge portion is in a range of 0.5-8 mm.

19. The prosthetic heart valve of any one of claims 15-18, wherein an axial height of the cusp edge portion of each leaflet is in a range of 30%-60% of a diameter of the prosthetic heart valve, and wherein the axial height extends from an inflow end of the cusp edge portion to the laterally extending axis.

20. The prosthetic heart valve of any one of claims 15-19, wherein a width of the cusp edge portion at the downstream ends of the cusp edge portion is in a range of 85%- 100% of the diameter of the prosthetic heart valve.

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