CN117582318A

CN117582318A - prosthetic heart valve

Info

Publication number: CN117582318A
Application number: CN202311044113.7A
Authority: CN
Inventors: N·古威驰; M·布肯; T·阮; B·H·法姆; J·韩
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2022-08-19
Filing date: 2023-08-18
Publication date: 2024-02-23

Abstract

The present invention relates to prosthetic heart valves. Leaflets for use in prosthetic heart valves are disclosed. As one example, a leaflet includes a body having a free outflow edge and a tip edge portion, two lower tabs disposed on opposite sides of the body, wherein the tip edge portion terminates at the lower tab at an upper end thereof and the lower tab extends laterally outward from the body relative to a central longitudinal axis of the leaflet, and two upper tabs disposed on opposite sides of the body and extending laterally outward from the body. The leaflet also includes two offset portions, each extending between a respective lower tab and an upper tab and offset the respective upper tab axially and laterally away from the outflow edge of the body, wherein each upper tab has opposite inner and outer edges that are parallel to each other and to the central longitudinal axis of the leaflet.

Description

Prosthetic heart valve

Cross Reference to Related Applications

The present application claims the benefit of U.S. provisional application No. 63/399,604 filed on day 19 of 8.2022 and U.S. provisional application No. 63/399,626 filed on day 19 of 8.2022, each of which is incorporated herein by reference in its entirety.

Technical Field

The present disclosure relates to prosthetic heart valves, and in particular, to leaflets for prosthetic heart valves.

Background

The human heart may suffer from various valve diseases. These valve diseases can lead to serious dysfunction of the heart and ultimately require repair of the native valve or replacement of the native valve with a prosthetic valve. There are a variety of known prosthetic devices (e.g., stents) and prosthetic valves, and a variety of known methods of implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in a variety of procedures to deliver prosthetic medical devices to locations in the body that are not readily accessible surgically or are desired to be accessed without surgery. In one particular example, the prosthetic heart valve may be mounted on the distal end of the delivery device in a crimped state and advanced through the vasculature of the patient (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon 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 a delivery device so that the prosthetic valve can self-expand to its functional size.

Most expandable prosthetic heart valves include a cylindrical metal frame or stent and prosthetic leaflets mounted inside the frame. Each leaflet can include a body having a tip edge portion and one or more commissure tabs extending from the body on opposite sides of the leaflet. The leaflets may be secured to each other at adjacent commissure tabs to form commissures, which are then secured to commissure windows in the frame of the prosthetic heart valve. The tip edge portion of each leaflet may also be secured to a strut of the frame. The leaflets of the prosthetic heart can be configured to open and close to regulate the flow of blood through the prosthetic heart valve from an inflow end to an outflow end of the prosthetic heart valve.

Disclosure of Invention

Prosthetic heart valves, delivery devices, and methods for implanting prosthetic heart valves are described herein. 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 reducing pressure gradients across the prosthetic valve. This may overcome one or more drawbacks of typical prosthetic heart valves.

A leaflet for a prosthetic valve can include a body having a free outflow edge and a cusp edge portion, two lower tabs disposed on opposite sides of the body, and two upper tabs disposed on opposite sides of the body.

In some examples, a leaflet can include two offset portions, each extending between a respective lower tab and an upper tab and offset the respective upper tab axially and laterally away from the outflow edge of the body, wherein each upper tab has opposing inner and outer edges that are disposed parallel to each other and to the central longitudinal axis of the leaflet.

In some examples, a leaflet may include two offset portions, each extending between a respective lower tab and an upper tab, and offset the respective upper tab axially and laterally away from the free edge of the body. The first width of each of the two upper tabs is wider than the second width of each of the two lower tabs such that an outer edge of each upper tab extends laterally outwardly farther than an outer edge of a corresponding lower tab relative to the central longitudinal axis of the leaflet.

In some examples, a leaflet may include two offset portions, each extending between a respective lower tab and an upper tab, and offset the respective upper tab axially and laterally away from the free edge of the body. Each offset portion has an outer edge extending between an inflow edge of the respective upper tab and an outflow edge of the respective lower tab, and an arcuate inner edge curved between an inner edge of the respective upper tab and the free edge of the body.

In some examples, a leaflet for a prosthetic valve includes a body having a free outflow edge and a cusp edge portion; two lower tabs disposed on opposite sides of the body, wherein the tip edge portion terminates at the lower tabs at an upper end thereof, and the lower tabs extend laterally outward from the body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the body and extending laterally outward from the body; and two offset portions, each extending between and offset a respective lower tab and upper tab axially and laterally away from the outflow edge of the body, wherein each upper tab has opposite inner and outer edges that are disposed parallel to each other and to the central longitudinal axis of the leaflet.

In some examples, a leaflet for a prosthetic valve includes a body having a free edge and a tip edge portion, the free edge disposed at an outflow end of the leaflet; two lower tabs disposed on opposite sides of the body, wherein the tip edge portion terminates at the lower tabs at an upper end thereof, and the lower tabs extend laterally outward from the body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the body and extending laterally outward from the body; and two offset portions, each offset portion extending between a respective lower tab and an upper tab and offset the respective upper tab axially and laterally away from the free edge of the body, wherein a first width of each of the two upper tabs is wider than a second width of each of the two lower tabs such that an outer edge of each upper tab extends further laterally outward relative to the central longitudinal axis of the leaflet than an outer edge of a respective lower tab, and wherein the first width and the second width extend perpendicular to the central longitudinal axis of the leaflet.

In some examples, a leaflet for a prosthetic valve includes a body having a free edge disposed at an outflow end thereof and a tip edge portion defining an inflow end thereof; two lower tabs disposed on opposite sides of the body, wherein the tip edge portion terminates at the lower tabs at an upper end thereof, and the lower tabs extend laterally outward from the body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the body and extending laterally outward from the body; and two offset portions, each offset portion extending between a respective lower tab and an upper tab and offset the respective upper tab axially and laterally away from the free edge of the body, wherein each offset portion has an outer edge extending between an inflow edge of the respective upper tab and an outflow edge of the respective lower tab, and an arcuate inner edge curved between an inner edge of the respective upper tab and the free edge of the body, wherein the inner edge of each offset portion is disposed closer to the central longitudinal axis than the outer edge of the offset portion.

In some examples, a leaflet for a prosthetic valve includes one or more of the components described in examples 1-9, 12-19, and 22-30 below.

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

In some examples, a prosthetic heart valve can include a sealing member configured to reduce paravalvular leakage.

In some examples, a prosthetic heart valve includes a frame radially expandable and collapsible between a radially expanded configuration and a radially collapsed configuration, wherein the frame includes 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 commissure windows. The prosthetic heart valve further includes a valve structure mounted on an inner side of the frame and including a plurality of leaflets, wherein each leaflet includes a main body having a free outflow edge and a cusp edge portion, a pair of lower tabs disposed on opposite sides of the main body, and a pair of upper tabs disposed on opposite sides of the main body, wherein the pair of lower and upper tabs of adjacent leaflets mate to form a commissure that is secured to a respective commissure window of the frame. The prosthetic heart valve further includes an inner skirt disposed about an inner surface of the frame and secured to the cusp edge portion of each leaflet, wherein the inner skirt is attached to a first row of angled struts forming an inflow end of the frame and a second row of angled struts disposed adjacent an outflow end of the frame. The prosthetic heart valve further includes an outer skirt disposed about an outer surface of the frame and attached to the first and third rows of angled struts, wherein the inner skirt and outer skirt are attached together with a single wire trace to a fourth row of angled struts disposed between the second and third rows of angled struts, and wherein a single trailing for the single wire trace is formed around an angled strut of the fourth row of angled struts disposed below one of the commissure windows.

In some examples, a prosthetic heart valve includes one or more of the components described in examples 10, 11, 20, 21, 31, 32-36, and 38 below.

The various innovations of the present 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 present disclosure will become more apparent from the following detailed description, appended claims, and accompanying drawings.

Drawings

Fig. 1 is a perspective view of a prosthetic heart valve.

Fig. 2 is a perspective view of a delivery device for a prosthetic heart valve according to an example.

Fig. 3 is a plan view of a leaflet for a prosthetic heart valve.

Fig. 4 is a schematic view of a portion of the leaflet of fig. 3, showing the upper tab of the leaflet folded over the lower tab of the leaflet.

Fig. 5 is a perspective view of a prosthetic valve including a frame and a valve structure including the plurality of leaflets of fig. 3 mounted on an inner side of the frame.

Fig. 6 is a detailed view of a portion of the prosthetic valve of fig. 5, showing the commissures of the prosthetic valve.

Fig. 7A is a top view of the prosthetic valve of fig. 5.

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.

Fig. 8 is a top perspective view of a portion of the prosthetic valve of fig. 5, showing the commissures of the prosthetic valve attached to the commissure windows of the frame.

Fig. 9-12B illustrate the assembly of the commissures of the valve structure to the commissure windows of the frame of the prosthetic valve.

Figures 13A-15 illustrate the assembly of the inner and outer skirts to the frame of the prosthetic valve.

Fig. 16 is a graph of pressure gradients across two different prosthetic valves having a first size during steady forward flow through the valve, wherein one of the valves includes the plurality of leaflets of fig. 3.

Fig. 17 is a graph of pressure gradients across two different prosthetic valves having a second size during steady forward flow through the valve, wherein one of the valves includes the plurality of leaflets of fig. 3.

Detailed Description

General considerations

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

Although the operations of some of the disclosed examples are described in a particular sequential order for convenience of presentation, it should be understood that this manner of description includes rearrangement, unless a particular order is required by the particular language below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of brevity, the drawings may not illustrate various ways in which the disclosed methods may be used in connection with other methods. In addition, descriptions sometimes use terms such as "provide" or "implement" to describe the disclosed methods. These terms are a high level of abstraction of the actual operations performed. The actual operation of these terms may vary from one embodiment to another and will be readily discernable to one of ordinary skill in the art.

As used in this application and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. In addition, the term "comprising" means "including. Furthermore, the term "coupled" generally means physically, mechanically, chemically, magnetically and/or electrically coupled or connected, and in the absence of a specific contrary language, does not exclude intermediate elements from being present between the coupled or associated items.

As used herein, the term "proximal" refers to a location, direction, or portion of the device that is closer to the user and further from the implantation site. As used herein, the term "distal" refers to a location, direction, or portion of the device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., away from the patient's body), while distal movement of the device is movement 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 axes extending in proximal and distal directions unless explicitly defined otherwise.

As used herein, "e.g. (e.g.)" means "e.g." and "i.e. (i.e.)" means "i.e.".

Summary of the disclosed technology

As described above, a leaflet assembly comprising a plurality of leaflets may be mounted on the inside of the frame of the 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 include a body having a tip edge portion and two sets of commissure tabs extending from the body on opposite sides of the leaflet. The two sets of commissure tabs may include a pair of opposing upper tabs and a pair of opposing lower tabs. The leaflets may be secured to each other at adjacent commissure tabs to form commissures, which are then secured to commissure windows in the frame of the prosthetic heart valve. The tip edge portion of each leaflet may also be secured to a strut of the frame. Thus, the body of each leaflet between the free (or outflow) edge and the tip edge portion of the leaflet may be referred to as the "movable" portion of the leaflet that opens and closes during operation of the prosthetic heart valve (during systole and diastole).

Some leaflet designs having a shorter (in width) upper tab and/or an upper tab with an angled inner edge that connects to the leaflet free edge may result in a leaflet assembly that is not wide enough to open (e.g., toward the frame) and/or may result in contact between the angled inner edge of the upper tab and the movable portion of the leaflet, which may result in a higher pressure gradient across the valve and reduced long-term durability of the leaflet.

Disclosed herein is a leaflet including an upper tab that is offset from a free edge of the leaflet by a relatively narrow offset portion. The upper tab has an inner edge that is relatively straight and parallel to the central longitudinal axis of the leaflet (the central longitudinal axis extending between the outflow and inflow ends of the leaflet). In some examples, the offset portion is curved and offsets the lower interior angle of the upper tab axially and laterally away from the free edge of the leaflet. The upper tab may also be wider (in a lateral direction extending in the direction of the free edge of the leaflet) and extend further outward from the body of the leaflet than the lower tab.

The prosthetic valves disclosed herein (such as the prosthetic heart valve shown in fig. 1) may be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve may be crimped onto or held in a radially compressed state by the implant delivery device as it is being advanced over the delivery device (such as the delivery device shown in fig. 2) through the vasculature of the patient. Once the prosthetic valve reaches the implantation site, the prosthetic valve may be expanded to a radially expanded state. It is to be understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery devices and may be implanted via a variety of delivery procedures, examples of which will be discussed in more detail later.

Examples of the disclosed technology

Fig. 1 illustrates an exemplary prosthetic valve 10 according to one example. Any of the prosthetic valves disclosed herein are configured to be implanted in the native aortic annulus, but in other examples they may be configured to be implanted in other native annuluses of the heart (pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves may also be implanted within vessels in communication with the heart, including the pulmonary artery (for taking over the function of a diseased pulmonary valve), or the superior or inferior vena cava (for taking over the function of a diseased tricuspid valve), or various other veins, arteries, and vessels of the patient. The disclosed prosthetic valve may also be implanted within a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) during an in-valve procedure.

In some examples, the disclosed prosthetic valves may be implanted within a docking or anchoring device that is implanted within a native heart valve or vessel. For example, in one example, the disclosed prosthetic valve may be implanted within a dock implanted within a pulmonary artery to take over the function of a diseased pulmonary valve, as disclosed in U.S. publication No. 2017/023656 (which is incorporated herein by reference). In some examples, the disclosed prosthetic valves may be implanted within a docking device implanted within or at a native mitral valve, as disclosed in PCT publication No. WO2020/247907 (which is incorporated herein by reference). In some examples, the disclosed prosthetic valves may be implanted within a docking device implanted in the superior or inferior vena cava to take over the function of a diseased tricuspid valve as disclosed in U.S. publication No. 2019/0000615 (which is incorporated herein by reference).

The prosthetic valve 10 includes four main components: a stent or frame 12, a valve structure 14, an inner skirt 16, and a paravalvular 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"), a middle portion 17, and an outflow end portion 19. The inner skirt 16 may be disposed on and/or coupled to the inner surface of the frame 12, while the outer skirt 18 may be disposed on and/or coupled to the outer surface of the frame 12.

The valve structure 14 may include three leaflets 40 that together form a leaflet structure that may be arranged to collapse in a tricuspid valve arrangement, but in other examples there may be a greater or lesser number of leaflets (e.g., one or more leaflets 40). The leaflets 40 can be secured to one another at adjacent sides thereof to form commissures 22 of the valve (e.g., leaflet) structure 14. The lower edge of the valve structure 14 may have a contoured scalloped shape that is contoured and may 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., bovine pericardial tissue), biocompatible synthetic material, or various other suitable natural or synthetic materials known in the art and described in U.S. Pat. No. 6,730,118, which is incorporated herein by reference.

The frame 12 may be formed with a plurality of circumferentially spaced slits or commissure windows 20 that are provided to mount commissures 22 of the valve structure 14 to the frame. For example, the commissure windows 20 may be defined by axially extending window strut portions 24 of the frame 12, the window strut portions 24 may 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 disposed in 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 windows 20, and to the outside of the frame 12. For example, as shown in fig. 1, the commissure tabs 42 can extend on and/or protrude radially outward from an outer surface 44 (a radially outward facing surface) of the frame 12, and in particular an outer surface of the window strut portion 24.

The frame 12 may be made of any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol) known in the art. When constructed of a plastically-expandable material, the frame 12 (and thus the prosthetic valve 10) may be crimped onto a delivery catheter to a radially collapsed configuration and then expanded within the patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expanding material, the frame 12 (and thus the prosthetic valve 10) may be crimped to a radially collapsed configuration and constrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery catheter. After in vivo, the prosthetic valve can be pushed out of the delivery sheath, which allows the prosthetic valve to expand to its functional size.

Suitable plastically-expandable materials that may be used to form the frames disclosed herein (e.g., frame 12) include metal alloys, polymers, or combinations thereof. Exemplary metal alloys may include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium or other biocompatible metals. In some examples, frame 12 may comprise stainless steel. In some examples, the frame 12 may include cobalt-chromium. In some examples, the frame 12 may include nickel-cobalt-chromium. In some examples, frame 12 includes a nickel-cobalt-chromium-molybdenum alloy, such as MP35N ^TM (trademark of SPS Technologies), which corresponds to UNS R30035 (encompassed by ASTM F562-02). MP35N by weight ^TM The UNS R30035 contains 35% nickel, 35% cobalt, 20% chromium and 10% molybdenum.

Fig. 2 illustrates a delivery apparatus 100 according to an example, which may be used to implant an expandable prosthetic heart valve (e.g., prosthetic valve 10) or another other type of expandable prosthetic medical device (e.g., stent). In some examples, the delivery device 100 is specifically configured for introducing a prosthetic valve into the heart.

The delivery device 100 in the example of fig. 2 is a balloon catheter that includes 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 105, and a nose cone 110 disposed at a distal end of the delivery device 100. The distal portion 112 of the delivery device 100 includes a balloon 108, a nose cone 110, and a balloon shoulder assembly. A prosthetic medical device, such as a prosthetic heart valve, may be mounted on the valve retaining portion of the balloon 108. The balloon shoulder assembly is configured to maintain a prosthetic heart valve or other medical device in a fixed position on the balloon 108 during delivery through the patient's vasculature. In some examples, the balloon shoulder assembly may include a proximal shoulder 120 and/or a distal shoulder 122.

Balloon 108 may include a central portion (which may be approximately cylindrical when inflated, as shown in fig. 2) and two tapered end portions connected to delivery device 100 (e.g., one or more shafts and/or nose cones connected to the delivery device).

The handle 102 may include a manipulation mechanism configured to adjust the curvature of the distal portion of the delivery device. For example, in the illustrated example, the handle 102 includes an adjustment member, such as the illustrated rotatable knob 134, which in turn is operably coupled to a proximal portion of a pull wire (not shown). A traction wire extends distally from the handle 102 through the outer shaft 104 and has a distal end portion secured to the outer shaft 104 at or near the distal end of the outer shaft. Rotating knob 134 effectively increases or decreases the tension of the pull wire, thereby adjusting the curvature of the distal portion of the delivery device.

The delivery device 100 may be configured to be advanced over a guidewire, which may be received within a guidewire lumen defined by an innermost shaft of the delivery device 100.

In some examples, the delivery device (or another similar delivery device) may be configured to deploy and implant a prosthetic heart valve (e.g., the prosthetic valve 10 of fig. 1) in a native aortic annulus of a native aortic valve. Further details regarding such delivery devices can be found in International application No. PCT/US2021/047056, which is incorporated herein by reference.

As an example, in an implantation procedure for implanting an expandable prosthetic heart valve (e.g., the prosthetic valve 10 of fig. 1), a distal portion of the delivery device 100 (or another similar delivery device or balloon catheter) may be advanced (over a guidewire) to a target implantation site (e.g., a native annulus). Balloon 108 may then be inflated to radially expand and implant the prosthetic heart valve within the native annulus.

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

The leaflet 200 has a body 202, the body 202 having a free edge 204 (which may also be referred to as an outflow edge) and a tip edge portion 206 (also referred to as an inflow edge portion). As described further below, the cusp edge portion 206 is configured to attach to a post of a frame of the prosthetic heart valve, and the free edge 204 is configured to move and contact a corresponding free edge of other leaflets of the leaflet assembly during closure of the leaflets (e.g., during diastole during operation of the prosthetic heart valve).

The leaflet 200 also includes 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 tab 210 is disposed closer to the tip edge portion 206 than the upper tab 208.

For example, the tip edge portion 206 terminates at its upper end at a lower tab 210. The lower tab 210 extends laterally outward from the body 202 of the leaflet 200 relative to a central longitudinal axis 212 of the leaflet 200. As used herein, the axial direction may be a direction parallel to the central longitudinal axis 212, and the lateral direction may be perpendicular to the central longitudinal axis 212 (e.g., from one side of the leaflet to the opposite side of the leaflet through the central longitudinal axis 212). As shown in fig. 3, a central longitudinal axis 212 of the leaflet 200 extends between the inflow and outflow ends of the leaflet 200.

The 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, the angle is 90 degrees, as shown in fig. 3.

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

In some examples, the angle measured between the outflow edge 214 of each lower tab 210 and the central longitudinal axis 212 may be selected based on the draft angle of the frame to which the leaflet 200 is to be attached, as described in PCT publication No. WO2022/026351 (which is incorporated herein by reference).

Each lower tab 210 may have a height 216 and a width 218, and the width 218 may be measured between a laterally outer edge 220 and a laterally inner edge 222 (or integral or attached edges) of the corresponding lower tab 210. The inner edge 222 of the lower tab 210 may be aligned with the lateral inner edge 228 of an adjacent upper tab 208.

The slit 226 extends laterally in the leaflet 200 from the 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 and lower tabs 208, 208 at the commissures, as described further below.

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

Each upper tab 208 may have a substantially rectangular shape with an inner edge 228, a laterally outer 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 the outer edge 230 may be referred to as side edges, and are parallel to each other and to the central longitudinal axis 212 (and thus they may be referred to as vertical edges). In some examples, the outflow edge 232 and the inflow edge 234 are parallel to each other and disposed perpendicular to the inner edge 228 and the outer edge 230.

In some examples, as shown in fig. 3, the inner edge 228 and the outer edge 230 of each upper tab 208 are parallel to the outer edge 220 of the corresponding lower tab 210.

Each upper tab 208 has a height 238 and a width 240. The width 240 of the upper tab 208 is greater than the width 218 of the lower tab 210. Thus, the outer edge 230 of each upper tab 208 extends laterally outwardly farther away from the body 202 of the leaflet 200 than the outer edge 220 of the corresponding lower tab 210. This makes assembly of the commissures to the frame easier and more accurate, as described further below, ensuring that the valve can be opened as much as possible during operation of the prosthetic heart valve.

Each upper tab 208 is axially and laterally offset from the free edge 204 of the leaflet 200 by an offset portion 236 (which may also be referred to as a neck, neck portion, or connecting portion). Offset portions 236 extend between the lower tab 210 and the upper tab 208 on each side of the leaflet 200. For example, each offset portion 236 may 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.

Each offset portion 236 may 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 is bent 90 degrees between the inner edge 228 of the corresponding upper tab 208 and the free edge 204 of the leaflet 200.

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

In some examples, the width 246 of the offset portion 236 may be less than half the width 218 of the lower tab 210.

As further described below, when the upper tab 208 is folded over the lower tab 210, each offset portion 236 offsets the inner edge 228 of the respective upper tab 208 laterally (or radially when connected to the frame) outwardly and away from the body 202 of the leaflet 200, as shown in the schematic diagram of fig. 4. This reduces the likelihood that the moving portion of the leaflet 200 (e.g., the body 202) will be in direct contact with the inner edge 228 of the upper tab 208, thereby increasing the durability of the leaflet 200.

A plurality of leaflets 200 (e.g., three leaflets 200) can be assembled together into a leaflet assembly or valve structure 201 and then secured to a frame of a prosthetic heart valve, such as frame 302 of prosthetic valve 300 shown in fig. 5-8. Although 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.

As shown in fig. 5, the prosthetic valve 300 has an inflow end 304, an outflow end 306, and a valve structure 201, the valve structure 201 including a plurality (e.g., three) of leaflets 200 coupled to the frame 302 and supported by the frame 302. The prosthetic valve 300 may also include an inner skirt and/or an outer skirt, however, these components are omitted from fig. 5 for illustrative purposes. Examples of such inner and outer skirts that are secured to the frame 302 are shown in fig. 13A-15, as described below.

The frame 302 may include a plurality of interconnected struts 308 arranged in 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 adapted to mount the commissures 250 of the valve structure 201 to the frame 302. For example, the commissure windows 312 may be defined by axially extending window strut portions 314 of the frame 302, the window strut portions 314 may also be referred to herein as "commissure supports" (see fig. 6 for a more detailed view of the commissures 250, with a portion of the struts of the frame removed to better visualize the folded tabs of the leaflets 200 forming the commissures 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 fig. 5-8.

For example, referring to fig. 8, adjacent lower tabs 210 of two adjacent leaflets 200 can be coupled together (e.g., via posts, flexible connectors, or attachment members, as described further below with reference to fig. 9-12B), and upper tabs 208 of two adjacent leaflets 200 can be folded down at offset portions 236 thereof such that lower tabs 210 are disposed between a pair of upper tabs 208. The lower tab 210 may then be inserted through the commissure windows 312 in the frame 302 and folded across the radially outward facing surface 316 of the frame 302. Each lower tab 210 may be coupled to a corresponding upper tab 208 along a suture. Further details regarding the formation of the commissures 250 using the flexible connector 252 are described below with reference to fig. 9-12B.

Further details regarding the frame 302 and other similar frames that may be used and assembled with the leaflets 200 as described herein may be found in U.S. patent No. 9,393,110 (which is incorporated herein by reference) and WO2022/026351 (which has been incorporated by reference above).

During operation of a typical valve, the leaflets 200 transition between a closed state at diastole, in which their free edges 204 (outflow edges) coapt against each other, and an open state (see, e.g., fig. 7B) that allows blood to flow through the prosthetic valve 300. The outflow orifice through which blood can flow determines the pressure gradient across the valve. Known valves may have a valve structure attached to the frame in such a way that the outflow edge of each leaflet is spaced radially inward from the frame to prevent the leaflets from wearing out as they open under the flow of blood. In such valves, the effective outflow orifice (e.g., as determined by the position of the leaflets), also known as the Geometric Orifice Area (GOA), may be narrower than the inflow orifice, thereby creating a relatively high pressure gradient across the prosthetic valve. Thus, and especially when using small diameter valves, it is preferable to provide a large outflow orifice during systole to prevent elevated pressure gradients.

As shown in fig. 7A and 7B (where fig. 7B is a fully open state of the valve), the valve structure 201 of the prosthetic valve 300 advantageously defines a relatively large GOA 350 (e.g., the leaflets 200 are near or in contact with the 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. As used herein, the term "GOA" is defined as an open space through which blood may flow when the valve structure 201 is in an open configuration. The GOA 350 exiting the orifice 352 may be sized to provide a selected pressure gradient across the prosthetic valve 300. Such a configuration may be achieved by attaching the leaflet 200 to the frame 302 in such a way that the radial distance between the outflow free edge 204 of the leaflet 200 and the frame 302 (or the difference between the outflow orifice 352 and the GOA 350) is minimized.

The design of the leaflet 200 as described above with reference to fig. 3 advantageously maximizes the GOA of the prosthetic valve 300 and reduces the pressure gradient across the prosthetic valve 300 as compared to other differently configured leaflets. In particular, the relatively narrower offset portion 236, the wider upper tab 208 having an outer edge 230 extending laterally outwardly farther than the outer edge 220 of the lower tab 210, and the longer free edge 204 of the leaflet allow the valve structure 201 to open wider during operation of the valve (e.g., during systole) thereby reducing the pressure gradient across the prosthetic valve 300.

For example, as shown in the example graphs 400 and 420 of fig. 16 and 17, respectively, valve B (e.g., valve 300) comprising a valve structure comprising leaflets 200 has a lower pressure gradient across the valve than a different valve a comprising a valve structure comprising differently configured leaflets (e.g., leaflets that do not have the geometric advantages discussed above for leaflets 200), but are otherwise similarly configured valves. In particular, the leaflets of valve a do not include a wider upper tab as described herein for leaflet 200, a vertically inner edge and a vertically outer edge of the upper tab, or a narrower offset portion that increases the length of the outflow edge of the leaflet.

In particular, graph 400 shows a plot of the pressure gradient across the valve for valve a and valve B having a first size during steady forward flow through the valve (e.g., during operation of the valve), and graph 420 shows a plot of the pressure gradient across the valve for valve a and valve B having a second size during steady forward flow through the valve (e.g., during operation of the valve). In graph 400, valves a and B are 20mm diameter valves, and in graph 420, valves a and B are 23mm diameter valves.

As shown, it can be seen that the prosthetic valve (valve B) including leaflets 200 experiences a substantially lower pressure gradient across the valve during forward flow through the valve as compared to another valve (valve a) that does not include leaflets 200.

Additionally, the configuration of the upper tab 208 and offset portion 236 of the leaflet 200 can provide increased durability, which in turn increases the life of the prosthetic valve 300. For example, during operation of the prosthetic valve 300, when its leaflets 200 transition to a closed state (e.g., in diastole), an inwardly directed force is exerted on the commissures 250 to flex the leaflets 200 in an inwardly-oriented direction relative to the commissures 250. This is shown in the schematic view of fig. 4, fig. 4 depicting the upper tabs 208 folded over the respective lower tabs 210 at the offset portions 236 and the inwardly (toward the central longitudinal axis of the prosthetic valve 300) directed force 261. The smoother arcuate shape of the offset portion 236 can spread the stress across the curved region between the upper and lower tabs 208, 210, thereby reducing stress concentrations at the curved region and maintaining the structural integrity of the leaflet 200 and commissures 250. In addition, as described above, the offset portion 236 offsets the inner edge 228 of the upper tab 208 away from the body 202 and the moving portion of the leaflet 200. Thus, the durability of the leaflet 200 is further increased.

Turning now to fig. 9-13B, the assembly of the commissure 250 to the commissure window 312 of the frame 302 is shown in more detail. As described above, the leaflets 200 can be secured to each other at adjacent sides thereof to form commissures 250 of the valve structure 201. A plurality of flexible connectors 252 (one of which is shown in fig. 9-12B) may be used to interconnect pairs of adjacent sides of the leaflets 200 and mount the leaflets 200 to the axially extending window strut portions 314 forming the commissure windows 312.

The flexible connectors 252 may be made from a piece of woven PET fabric, but other synthetic and/or natural materials may be used, and each flexible connector 252 may include a wedge 254 extending from a lower edge to an upper edge at the center of the flexible connector 252. Wedge 254 may comprise a non-metallic material, such as a rope or a piece of Ethibond 2-0 suture material, secured to flexible connector 252 with a temporary suture. The wedges 254 help prevent rotational movement of the tabs after they are secured to the axially extending window post portion 314. In some examples, the connector 252 may have a series of inner and outer notches formed along its upper and lower edges that facilitate alignment with the leaflet tabs during assembly of the commissures 250.

Fig. 9 and 10 show adjacent sides of two leaflets 200 interconnected by a flexible connector 252 (fig. 9 shows a first side view and fig. 10 shows an opposite second side view). The opposite end portions of the flexible connector 252 may be placed in overlapping relation with the lower tab 210 with the inner notch (which may be a V-shaped notch in some examples, or a mark in some examples) aligned with the outer edge 220 of the lower tab 210.

Each lower tab 210 may be secured to a corresponding end portion of the flexible connector 252 by stitching along lines extending from an external notch or marking on the lower edge to an external notch or marking on the upper edge of the connector 252 to form a stitch line 256 (fig. 10). Three flexible connectors 252 may be used to secure three leaflets 200 to each other side-by-side to form the valve structure 201.

Fig. 12A is a cross-sectional view of a portion of the frame 302 and valve structure 201, while fig. 12B is a top view of a portion of the frame 302 and valve structure 201, showing adjacent commissure tabs of two leaflets 200 secured to corresponding axially extending window strut portions 314. Fig. 11 depicts an exemplary method for disposing commissure tabs of two adjacent leaflets 200 within a commissure window 312 formed by an axially extending window strut portion 314.

Before inserting the lower tabs 210 through the commissure windows 312, the flexible connectors 252 securing the two adjacent lower tabs 210 of two adjacent leaflets 200 are folded laterally (e.g., into the page in fig. 9) and the upper tabs 208 are folded down against the flexible connectors 252 (on the lower tabs 210).

Each upper tab 208 is longitudinally (vertically) crimped to assume an L-shape having an inner portion 258 that folds against the inner surface of the leaflet 200 and an outer portion 260 that folds against the connector 252 (fig. 11-12B). Outer portion 260 may then be sutured to connector 252 along suture 262 (fig. 12A). Next, a pair of lower tabs 210 connected by a connector 252 are inserted through the commissure windows 312 of the corresponding axially extending window strut portions 314, as shown in fig. 11.

The connector 252 and the lower tab 210 extending through the commissure window 312 may then be pressed radially inward at the 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 fold against the frame 302 on one side of the axially extending window strut portion 314 and the other lower tab 210 and a portion of the connector 252 fold against the frame 302 on the other side of the axially extending window strut portion 314 (fig. 12B).

A pair of stitching 264 may be formed to retain the lower tab 210 to the frame 302 in the manner shown in fig. 12A. Each suture 264 may extend through the connector 252, the lower tab 210, the wedge 254, and another portion of the connector 252. Each lower tab 210 is then secured to the corresponding upper tab 208 by a primary suture 266, as shown in fig. 12A, with the primary suture 266 extending through one layer of the connector 252, the lower tab 210, the other layer of the connector 252, and the upper tab 208.

As shown in fig. 11-12B, the outer edge 230 of the upper tab 208 is aligned with the edge of the flexible connector 252 (with no gap in the lateral direction therebetween). This alignment is made possible by the greater width 240 of the upper tab 208 (as described above with reference to fig. 3 and 4). The ability to align the edges 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 valve-to-valve consistency). Thus, the likelihood of all leaflets 200 of the valve structure 201 being uniformly disposed within the frame increases, thereby ensuring the maximum possible GOA.

In some examples, as shown in fig. 12A, the suture material used to form the primary suture 266 may be used to further form a seam over-seam 268 at the edges of the lower and upper tabs 210, 208, the seam over-seam 268 extending through both layers of the connector 252 sandwiched between the upper and lower tabs 208, 210.

The leaflets 200 articulate primarily at the inner edge 270 of the folded down inner portion 258 in response to blood flowing through the valve during operation in the body, rather than articulating about the axial struts of the commissure windows 312.

In some examples, inner and outer skirts (such as inner and outer skirts 16 and 18 of prosthetic valve 10 of fig. 1) may be secured to frame 302 and form prosthetic valve 300. For example, as shown in fig. 13A and 13B, after all three commissures 250 are secured to respective commissure windows 312, the tip edge portions 206 of the leaflets 200 can be sutured to the inner skirt 360 (fig. 13A). The inner skirt 360 may be attached to the fourth row of angled struts 362 of the frame 302, for example, with a plurality of over-wrap stitches 364. The inner skirt 360 is then further attached to the first row of angled struts 366 defining the inflow end 304 of the frame 302, for example, with a plurality of over-lapping stitches 368.

As shown in fig. 13B, the outer skirt 370 is then positioned around the outer surface of the frame 302 and attached to the third row of angled struts 372 with the inner skirt 360 using a plurality of over-lapping stitches 374 (schematically shown with arrows in fig. 14). In this way, the same suture including the trace 374 is used to attach both the outer skirt 370 and the inner skirt 360 to the third row of angled struts 372. In some examples, as shown in fig. 14 and 15, the line of seam lines 374 has a single trailing end 376, the trailing end 376 being formed around an angled strut of the third row of angled struts 372 disposed below the commissure windows 312. By utilizing only a single trailing end 376 and by using the same suture to secure the outer and inner skirts 370, 360 to the third row of angled struts 372, the total number of trailing ends for assembling the valve is minimized, thereby making the assembly process easier and minimizing material interactions with the leaflet 200. For example, the likelihood of a single trailing end being pushed toward the leaflet 200 is reduced, thereby increasing the durability of the leaflet 200.

As shown in fig. 13B, the outer skirt 370 may then be attached to the second row of angled struts 378 (e.g., with a plurality of over-stitching) and then to the first row of angled struts 366 (e.g., with a plurality of over-stitching). The second row of angled struts 378 and the 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 indicate their position under the outer skirt 370.

Additional details regarding the assembly of the leaflet 200 to the frame 302 or similar prosthetic valve frame can be found in U.S. patent No. 9,393,110 (which has been incorporated by reference above).

Delivery techniques

For implantation of the prosthetic valve within the native aortic valve by a transfemoral delivery method, the prosthetic valve is installed in a radially compressed state along a distal portion of the delivery device. The distal portion of the prosthetic valve and delivery device is inserted into the femoral artery and advanced into and through the descending aorta, bypassing 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 a delivery device, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve may be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through the surgical opening of the chest and the apex of the heart, and the prosthetic valve is positioned within the native aortic valve. Optionally, in an trans-aortic procedure, the prosthetic valve (on the distal portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta (e.g., through a partial J-sternotomy or right parasternal mini-thoracotomy), and then advanced through the ascending aorta toward the native aortic valve.

To implant a prosthetic valve within a native mitral valve by transseptal delivery methods, the prosthetic valve is installed along a distal portion of a delivery device in a radially compressed state. The distal portion of the prosthetic valve and delivery device is inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (through the perforations made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve may be implanted within the native mitral valve during a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through the surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

To implant the prosthetic valve within the native tricuspid valve, the prosthetic valve is installed along the distal portion of the delivery apparatus in a radially compressed state. The distal portion of the prosthetic valve and delivery device is inserted into the femoral vein and 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 may be used to implant the prosthetic valve within the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the left ventricle and toward the pulmonary valve/pulmonary artery.

Another delivery method is the transatrial method whereby a prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and an incision made through the atrial wall (of the right or left atrium) to access any native heart valve. Atrial delivery may also be performed intravascularly, such as from the pulmonary veins. Yet another delivery method is a transventricular method whereby a prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision made through the right ventricular wall (typically at or near the base of the heart) to implant the prosthetic valve within the native tricuspid valve, native pulmonary valve, or pulmonary artery.

In all delivery methods, the delivery device may be advanced over a guidewire that was previously inserted into the patient's vasculature. Furthermore, the disclosed delivery methods are not intended to be limiting. Any of the prosthetic valves disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

Any of the systems, devices, apparatuses, etc. herein may be sterilized (e.g., with heat/heat, pressure, steam, radiation, and/or chemicals, etc.) to ensure that they are safe for patient use, and any of the methods herein may include sterilization of the relevant systems, devices, apparatuses, etc. as one of the steps of the method. Examples of heat/heat sterilization include steam sterilization and autoclaving. Examples of radiation for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using, for example, a hydrogen peroxide plasma.

Additional examples of the disclosed technology

In view of the foregoing embodiments of the disclosed subject matter, the present application discloses other examples listed below. It should be noted that a single feature of an example or a combination of more than one feature of an example and optionally one or more features of one or more further examples are further examples that also fall within the disclosure of the present application.

Example 1. A leaflet for a prosthetic valve, comprising: a body having a free outflow edge and a tip edge portion; two lower tabs disposed on opposite sides of the body, wherein the tip edge portion terminates at the lower tabs at an upper end thereof, and the lower tabs extend laterally outward from the body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the body and extending laterally outward from the body; and two offset portions, each extending between and offset a respective lower tab and upper tab axially and laterally away from the outflow edge of the body, wherein each upper tab has opposite inner and outer edges that are disposed parallel to each other and to the central longitudinal axis of the leaflet.

Example 2. A leaflet according to any example herein (particularly example 1), wherein each lower tab has an outer edge that is laterally offset from the body and disposed parallel to the central longitudinal axis of the leaflet and the outer edge of the respective upper tab.

Example 3. A leaflet according to any example herein (particularly example 1 or example 2), wherein the outer edge of each upper tab extends laterally outwardly farther than an outer edge of a corresponding lower tab relative to the central longitudinal axis of the leaflet.

Example 4. The leaflet of any of examples herein (particularly any of examples 1-3), wherein a width of each 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.

Example 5 the leaflet of any one of examples 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 the respective lower tab than the outflow edge, and wherein the inflow edge and the outflow edge are perpendicular to the inner edge and the outer edge of the upper tab.

Example 6 the leaflet of any example herein (particularly any of examples 1-5), wherein each offset portion has an outer edge extending between an inflow edge of the respective upper tab and an outflow edge of the respective lower tab, and an arcuate inner edge curved between the inner edge of the respective upper tab and the outflow edge of the body.

Example 7. The leaflet according to any example herein (particularly example 6), wherein the arcuate inner edge is curved 90 degrees between the inner edge of the respective upper tab and the outflow edge of the body.

Example 8 the leaflet according to any example herein (particularly example 6 or example 7), wherein the outer edge of each offset portion extends parallel to the central longitudinal axis of the leaflet.

Example 9 the leaflet of any example herein (particularly any of examples 1-8), wherein the width of each offset portion is less than half the width of each lower tab, and wherein the outflow edge of the body extends between the two offset portions.

Example 10 a prosthetic heart valve comprising a plurality of leaflets according to any of the examples herein (particularly any of examples 1-9), wherein for each leaflet, the upper tab is folded over the respective lower tab.

Example 11. A prosthetic heart valve according to any one of the examples herein (particularly example 10), wherein the cusp edge portion of each leaflet is attached to a post of a frame of the prosthetic heart valve via an inner skirt of the prosthetic heart valve, and wherein the outflow edge of the body of each leaflet is free to move during operation of the prosthetic heart valve to regulate flow of blood through the prosthetic heart valve.

Example 12. A leaflet for a prosthetic valve, comprising: a body having a free edge and a tip edge portion, the free edge disposed at an outflow end of the leaflet; two lower tabs disposed on opposite sides of the body, wherein the tip edge portion terminates at the lower tabs at an upper end thereof, and the lower tabs extend laterally outward from the body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the body and extending laterally outward from the body; and two offset portions, each offset portion extending between a respective lower tab and an upper tab and offset the respective upper tab axially and laterally away from the free edge of the body, wherein a first width of each of the two upper tabs is wider than a second width of each of the two lower tabs such that an outer edge of each upper tab extends further laterally outward relative to the central longitudinal axis of the leaflet than an outer edge of a respective lower tab, and wherein the first width and the second width extend perpendicular to the central longitudinal axis of the leaflet.

Example 13. A leaflet according to any example herein (particularly example 12), wherein the outer edges of the upper tab and the lower tab are parallel to the central longitudinal axis of the leaflet.

Example 14 the leaflet of any example herein (particularly example 12 or example 13), wherein each upper tab has an inner edge disposed opposite the outer edge, and wherein the inner edge and the outer edge of each upper tab are parallel to the central longitudinal axis of the leaflet.

Example 15 the leaflet of any example herein (particularly any of examples 12-14), wherein each upper tab has opposite inflow and outflow edges perpendicular to the central longitudinal axis of the leaflet, and wherein the inflow edge is disposed closer to the free edge of the body than the outflow edge.

Example 16 the leaflet of any example herein (particularly any of examples 12-15), wherein each offset portion has an outer edge extending 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 body.

Example 17 the leaflet according to any example herein (particularly example 16), wherein the arcuate inner edge is curved 90 degrees between the inner edge of the respective upper tab and the free edge of the body.

Example 18 a leaflet according to any example herein (particularly example 16 or example 17), wherein the outer edge of each offset portion extends parallel to the central longitudinal axis of the leaflet.

Example 19 the leaflet of any one of examples herein (particularly any one of examples 12-18), wherein a width of each offset portion is less than half a width of each lower tab, and wherein the free edge of the body extends between the two offset portions.

Example 20 a prosthetic heart valve comprising a plurality of leaflets according to any of the examples herein (particularly any of examples 12-19), wherein for each leaflet, the upper tab is folded over the respective lower tab.

Example 21. A prosthetic heart valve according to any one of the examples herein (particularly example 20), wherein the cusp edge portion of each leaflet is attached to a post of a frame of the prosthetic heart valve via an inner skirt of the prosthetic heart valve, and wherein the free edge of the body of each leaflet is free to move during operation of the prosthetic heart valve to regulate flow of blood through the prosthetic heart valve.

Example 22 a leaflet for a prosthetic valve, comprising: a body having a free edge disposed at an outflow end thereof and a tip edge portion defining an inflow end thereof; two lower tabs disposed on opposite sides of the body, wherein the tip edge portion terminates at the lower tabs at an upper end thereof, and the lower tabs extend laterally outward from the body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on opposite sides of the body and extending laterally outward from the body; and two offset portions, each offset portion extending between a respective lower tab and an upper tab and offset the respective upper tab axially and laterally away from the free edge of the body, wherein each offset portion has an outer edge extending between an inflow edge of the respective upper tab and an outflow edge of the respective lower tab, and an arcuate inner edge curved between an inner edge of the respective upper tab and the free edge of the body, wherein the inner edge of each offset portion is disposed closer to the central longitudinal axis than the outer edge of the offset portion.

Example 23 the leaflet of any example herein (particularly example 22), wherein each offset portion has a first width defined between its inner and outer edges that is less than half of the second width of the lower tab.

Example 24. The leaflet according to any example herein (particularly example 22 or example 23), wherein the arcuate inner edge of each offset portion is bent 90 degrees between the inner edge of the respective upper tab and the free edge of the body.

Example 25 the leaflet of any of the examples herein (particularly any of examples 22-24), wherein the outer edge of each offset portion extends parallel to the central longitudinal axis of the leaflet.

Example 26 the leaflet of any example herein (particularly any of examples 22-25), wherein each upper tab has an outer edge disposed opposite the inner edge of the upper tab, and wherein the inner edge and the outer edge of each upper tab are parallel to the central longitudinal axis of the leaflet.

Example 27. The leaflet of any example herein (particularly example 26), wherein each lower tab has an outer edge that is laterally offset from the body and disposed parallel to the central longitudinal axis of the leaflet and the outer edge of the respective upper tab.

Example 28. The leaflet according to any example herein (particularly example 27), wherein the outer edge of each upper tab extends laterally outwardly farther than the outer edge of the corresponding lower tab relative to the central longitudinal axis of the leaflet.

Example 29 the leaflet of any example herein (particularly any of examples 22-28), wherein a width of each of the two upper tabs is wider than each of the two lower tabs, and wherein the width extends perpendicular to the central longitudinal axis of the leaflet.

Example 30 the leaflet of any of examples herein (particularly any of examples 22-29), wherein each upper tab has an outflow edge disposed opposite its inflow edge, wherein the inflow edge of the upper tab is closer to a corresponding lower tab than the outflow edge of the upper tab, and wherein the inflow edge and the outflow edge of the upper tab are perpendicular to the inner edge of the upper tab.

Example 31 a prosthetic heart valve comprising a plurality of leaflets according to any of the examples herein (particularly any of examples 22-30), wherein for each leaflet, the upper tab is folded over the respective lower tab.

Example 32. A prosthetic heart valve according to any one of the examples herein (particularly example 31), wherein the cusp edge portion of each leaflet is attached to a post of a frame of the prosthetic heart valve via an inner skirt of the prosthetic heart valve, and wherein the free edge of the body of each leaflet is free to move during operation of the prosthetic heart valve to regulate flow of blood through the prosthetic heart valve.

Example 33 a prosthetic heart valve, comprising: a frame radially expandable and collapsible between a radially expanded configuration and a 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 commissure windows; a valve structure mounted on an inner side of the frame and comprising a plurality of leaflets, wherein each leaflet comprises a body having a free outflow edge and a cusp edge portion, a pair of lower tabs disposed on opposite sides of the body, and a pair of upper tabs disposed on opposite sides of the body, wherein the pair of lower and upper tabs of adjacent leaflets mate to form a commissure that is secured to a respective commissure window of the frame; an inner skirt disposed about an inner surface of the frame and secured to the tip edge portion of each leaflet, wherein the inner skirt is attached to a first row of angled struts forming an inflow end of the frame and a second row of angled struts disposed adjacent an outflow end of the frame; and an outer skirt disposed about an outer surface of the frame and attached to the first and third rows of angled struts, wherein the inner skirt and outer skirt are attached together with a single wire trace to a fourth row of angled struts disposed between the second and third rows of angled struts, and wherein a single trailing for the single wire trace is formed around an angled strut of the fourth row of angled struts disposed below one of the commissure windows.

Example 34 a prosthetic heart valve, comprising: a frame radially expandable and collapsible between a radially expanded configuration and a radially collapsed configuration; a valve structure mounted on an inner side of the frame and comprising a plurality of leaflets according to any of the examples herein (in particular any of examples 1-9, 12-19 and 22-30).

Example 35 the prosthetic heart valve of any example herein (particularly example 33), wherein for each leaflet, the upper tab is folded along a radially extending crease.

Example 36 the prosthetic valve of any example herein (particularly example 34), wherein the valve structure comprises a plurality of commissures, each of the plurality of commissures comprising folded upper and lower tabs of one leaflet and adjacent folded upper and lower tabs of an adjacent leaflet.

Example 37 the prosthetic valve according to any example herein (particularly example 35), wherein the lower tab of each commissure extends through a commissure window of the frame.

Example 38 the prosthetic valve of any of examples herein (particularly any of examples 35-36), wherein the folded upper tab is located inside the frame.

Example 39 the prosthetic valve of any of examples herein (particularly any of examples 35-37), wherein each folded upper tab is further folded along an axially extending crease such that a first portion of the upper tab abuts against a body of a respective leaflet and a second portion of the upper tab extends in a different plane than the first portion.

Example 40 the prosthetic heart valve of any one of examples 1-39, having improved hemodynamic performance.

Example 41 the prosthetic heart valve of any one of examples 1-39, having improved leaflet durability.

Example 42 the prosthetic heart valve of any one of examples 1-39, having improved hemodynamic performance and improved leaflet durability.

Example 43, a method comprising sterilizing a leaflet, prosthetic heart valve, device, and/or assembly according to any of the examples.

Example 44, the prosthetic heart valve of any one of examples 1-39, wherein the prosthetic heart valve is sterilized.

Features described herein with respect to any example may be combined with other features described in any one or more of the other examples, unless otherwise specified. For example, any one or more features of one frame may be combined with any one or more features of another frame. As another example, any one or more features of one prosthetic valve may be combined with any one or more features of another prosthetic valve.

In view of the many possible ways in which the principles of the present disclosure may be applied, it should be recognized that the example configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure and claims. Rather, the scope of the claimed subject matter is defined by the appended claims and equivalents thereof.

Claims

1. A leaflet for a prosthetic valve, comprising:

a body having a free outflow edge and a tip edge portion;

two lower tabs disposed on opposite sides of the body, wherein the tip edge portion terminates at the lower tabs at an upper end thereof, and the lower tabs extend laterally outward from the body relative to a central longitudinal axis of the leaflet;

two upper tabs disposed on opposite sides of the body and extending laterally outward from the body; and

two offset portions, each extending between and offset the respective lower tab and upper tab axially and laterally away from the outflow edge of the body, wherein each upper tab has opposite inner and outer edges that are disposed parallel to each other and to the central longitudinal axis of the leaflet.

2. The leaflet of claim 1, wherein each lower tab has an outer edge that is laterally offset from the body and disposed parallel to the central longitudinal axis of the leaflet and the outer edge of the respective upper tab.

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

4. The leaflet of any one of claims 1-3, 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 the respective lower tab than the outflow edge, and wherein the inflow edge and the outflow edge are perpendicular to the inner edge and the outer edge of the upper tab.

5. The leaflet of any one of claims 1-4, wherein each offset portion has an outer edge extending 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.

6. The leaflet of claim 5, wherein the arcuate inner edge is bent 90 degrees between the inner edge of the respective upper tab and the outflow edge of the body.

7. The leaflet of claim 5 or claim 6, wherein the outer edge of each offset portion extends parallel to the central longitudinal axis of the leaflet.

8. The leaflet of any of claims 1-7, wherein the width of each offset portion is less than half the width of each lower tab, and wherein the outflow edge of the body extends between the two offset portions.

9. A prosthetic heart valve comprising a plurality of leaflets of any one of claims 1-8, wherein for each leaflet, the upper tab is folded over the respective lower tab.

10. The prosthetic heart valve of claim 9, wherein the cusp edge portion of each leaflet is attached 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 body of each leaflet is free to move during operation of the prosthetic heart valve to regulate flow of blood through the prosthetic heart valve.

11. A leaflet for a prosthetic valve, comprising:

a body having a free edge and a tip edge portion, the free edge disposed at an outflow end of the leaflet;

two offset portions, each extending between a respective lower tab and an upper tab and offset the respective upper tab axially and laterally away from the free edge of the body, wherein a first width of each of the two upper tabs is wider than a second width of each of the two lower tabs such that an outer edge of each upper tab extends further laterally outward relative to the central longitudinal axis of the leaflet than an outer edge of a respective lower tab, and wherein the first width and the second width extend perpendicular to the central longitudinal axis of the leaflet.

12. The leaflet of claim 11, wherein the outer edges of the upper tab and the lower tab are parallel to the central longitudinal axis of the leaflet.

13. The leaflet of claim 11 or claim 12, 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.

14. The leaflet of any one of claims 11-13, wherein each upper tab has opposite inflow and outflow edges perpendicular to the central longitudinal axis of the leaflet, and wherein the inflow edge is disposed closer to the free edge of the body than the outflow edge.

15. The leaflet of any one of claims 11-14, wherein each offset portion has an outer edge extending 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 body.

16. The leaflet of any of claims 11-15, wherein the width of each offset portion is less than half the width of each lower tab, and wherein the free edge of the body extends between the two offset portions.

17. A leaflet for a prosthetic valve, comprising:

a body having a free edge disposed at an outflow end thereof and a tip edge portion defining an inflow end thereof;

two offset portions, each offset portion extending between a respective lower tab and an upper tab and offset the respective upper tab axially and laterally away from the free edge of the body, wherein each offset portion has an outer edge extending between an inflow edge of the respective upper tab and an outflow edge of the respective lower tab, and an arcuate inner edge curved between an inner edge of the respective upper tab and the free edge of the body, wherein the inner edge of each offset portion is disposed closer to the central longitudinal axis than the outer edge of the offset portion.

18. The leaflet of claim 17, wherein each offset portion has a first width defined between its inner and outer edges that is less than half of a second width of the lower tab.

19. The leaflet of claim 17 or claim 18, wherein the arcuate inner edge of each offset portion is bent 90 degrees between the inner edge of the respective upper tab and the free edge of the body.

20. The leaflet of any of claims 17-19, wherein the outer edge of each offset portion extends parallel to the central longitudinal axis of the leaflet.