Leaflet for prosthetic valve and prosthetic heart valve

Abstract

The utility model relates to a leaflet for a prosthetic valve and a prosthetic heart valve. A leaflet for a prosthetic heart valve is 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, and two upper tabs disposed on opposite sides of the body, where the tip edge portion terminates at the lower tabs at an upper end thereof, the lower tab extends laterally outward from the body with respect to a central longitudinal axis of the leaflet, and the two upper tabs are disposed on opposite sides of the body and extend laterally outward from the body. The leaflet further includes two offset 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 body, where each upper tab has opposing inner and outer edges, and each upper tab has an offset portion extending between the respective lower tab and upper tab and offset the respective upper tab axially and laterally away from the outflow edge of the body. The inner and outer edges are parallel to each other and parallel to the central longitudinal axis of the leaflets.

Description

Technical Field

[0001] The present disclosure relates to prosthetic heart valves, and in particular to leaflets for prosthetic heart valves. Background Art

[0002] The human heart may suffer from various valvular diseases. These valvular diseases can lead to serious dysfunction of the heart, and ultimately require repairing the native valve or replacing the native valve with an artificial valve. There are a variety of known repair devices (e.g., stents) and artificial valves, as well as a variety of known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used for various procedures to deliver prosthetic medical devices to a position in the body that is not easily accessible by surgery or is expected to be accessible without surgery. In a specific example, a prosthetic heart valve can be mounted on the distal end of a delivery device in a curled state and is advanced through the patient's vascular system (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by expanding the 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 the sheath of the delivery device so that the prosthetic valve can be self-expanded to its functional size.

[0003] Most expandable prosthetic heart valves include a cylindrical metal frame or stent and prosthetic leaflets mounted inside the frame. Each leaflet may include a body having a tip edge portion and one or more sets of 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 the struts of the frame. The leaflets of the prosthetic heart may be configured to open and close to regulate the flow of blood through the prosthetic heart valve from the inflow end to the outflow end of the prosthetic heart valve. Utility Model Content

[0004] Prosthetic heart valves, delivery devices, and methods for implanting prosthetic heart valves are described herein. 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 are also described herein. The disclosed leaflets, prosthetic heart valves, and methods can, for example, provide more durable leaflets that also open wider during operation of the prosthetic thermal valve, thereby reducing pressure gradients across the prosthetic valve. This can overcome one or more deficiencies of typical prosthetic heart valves.

[0005] A leaflet for a prosthetic valve may include a body having a free flow edge and a tip edge portion, two lower tabs disposed on opposite sides of the body, and two upper tabs disposed on opposite sides of the body.

[0006] In some examples, a leaflet can include two offset portions, each extending between a corresponding lower tab and an upper tab and offsetting the corresponding upper tab axially and laterally away from the outflow edge of the body, wherein each upper tab has relative inner and outer edges, the inner and outer edges being parallel to each other and arranged parallel to the central longitudinal axis of the leaflet.

[0007] In some examples, a leaflet may include two offset portions, each offset portion extending between a respective lower tab and an upper tab and offsetting the respective upper tab axially and laterally away from the free edge of the body. 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 laterally outwardly farther relative to the central longitudinal axis of the leaflet than an outer edge of the respective lower tab.

[0008] In some examples, a leaflet can include two offset portions, each offset portion extending between a respective lower tab and an upper tab and offsetting 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.

[0009] In some examples, a leaflet for a prosthetic valve includes a body having a free outflow edge and a tip edge portion; two lower tabs, the two lower tabs being disposed on opposite sides of the body, wherein the tip edge portion terminates at the lower tabs at their upper ends and the lower tabs extend laterally outward from the body relative to a central longitudinal axis of the leaflet; two upper tabs, the two upper tabs being disposed on opposite sides of the body and extending laterally outward from the body; and two offset portions, each offset portion extending between a corresponding lower tab and an upper tab and offsetting the corresponding upper tab axially and laterally away from the outflow edge of the body, wherein each upper tab has relative inner and outer edges, the inner and outer edges being parallel to each other and disposed parallel to the central longitudinal axis of the leaflet.

[0010] In some examples, a leaflet for a prosthetic valve includes a body having a free edge and a tip edge portion, the free edge being disposed at an outflow end of the leaflet; two lower tabs disposed on opposite sides of the body, wherein the tip edge portions terminate at the lower tabs at their upper ends 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 a respective lower tab and an upper tab and offsetting 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 laterally outward farther relative to the central longitudinal axis of the leaflet than an outer edge of the respective lower tab, and wherein the first width and the second width extend perpendicular to the central longitudinal axis of the leaflet.

[0011] In some examples, a leaflet for a prosthetic valve includes a body having a free edge disposed at its outflow end and a tip edge portion defining its inflow end; two lower tabs disposed on opposite sides of the body, wherein the tip edge portions terminate at the lower tabs at their upper ends 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 a respective lower tab and an upper tab and offsetting 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.

[0012] 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.

[0013] A prosthetic heart valve may include a frame and a valve structure coupled to the frame.In addition to these components, a prosthetic heart valve may also include one or more of the components disclosed herein.

[0014] In some examples, a prosthetic heart valve can include a sealing member configured to reduce paravalvular leakage.

[0015] In some examples, a prosthetic heart valve includes a frame that is radially expandable and collapsible between a radially expanded configuration and a radially collapsed configuration, wherein the frame includes a plurality of interconnected struts, the plurality of interconnected struts including a plurality of rows of angled struts and a plurality of axially extending window strut portions, the plurality of axially extending window strut portions defining a plurality of circumferentially spaced commissure windows. The prosthetic heart valve also includes a valve structure mounted on an inner side of the frame and including a plurality of leaflets, wherein each leaflet includes a body, a pair of lower tabs and a pair of upper tabs, the body having a free outflow edge and a tip edge portion, the pair of lower tabs being disposed on opposite sides of the body, the pair of upper tabs being disposed on opposite sides of the body, wherein the pairs of lower tabs and upper tabs of adjacent leaflets mate to form commissures that are secured to corresponding commissure windows of the frame. The prosthetic heart valve also includes an inner skirt disposed around the inner surface of the frame and fixed to the tip edge portion of each leaflet, wherein the inner skirt is attached to a first row of angled struts forming the inflow end of the frame and a second row of angled struts disposed adjacent the outflow end of the frame. The prosthetic heart valve also includes an outer skirt disposed around the outer surface of the frame and attached to the first row of angled struts and a third row of angled struts, wherein the inner skirt and the outer skirt are attached together with a single stitch line to a fourth row of angled struts disposed between the second row of angled struts and the third row of angled struts, and wherein a single end for the single stitch line is formed around an angled strut in the fourth row of angled struts disposed below one of the angled struts in the commissure window.

[0016] 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.

[0017] The various innovations of the present disclosure may be used in combination or individually. This summary is provided to introduce some ideas in a simplified form, which are further described in the detailed description below. This summary is not intended to identify the key features or essential features of the claimed subject matter, nor is it intended 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 through the following detailed description, the appended claims and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 is a perspective view of a prosthetic heart valve.

[0019] Figure 2 is a perspective view of a delivery device for a prosthetic heart valve according to an example.

[0020] Figure 3 is a plan view of a leaflet for a prosthetic heart valve.

[0021] Figure 4 yes Figure 3 Schematic diagram of a portion of a leaflet showing the upper tab of the leaflet folded over the lower tab of the leaflet.

[0022] Figure 5 is a perspective view of a prosthetic valve including a frame and a valve structure including a valve mounted on the inner side of the frame Figure 3 Multiple leaflets.

[0023] Figure 6 yes Figure 5 Detailed view of a portion of a prosthetic valve showing the commissures of the prosthetic valve.

[0024] Fig. 7A yes Figure 5 Top view of a prosthetic valve.

[0025] Figure 7B is when the valve is in the fully open position during operation of the valve Figure 5 Top view of a prosthetic valve.

[0026] Figure 8 yes Figure 5 A top perspective view of a portion of a prosthetic valve showing the commissures of the prosthetic valve attached to the commissure windows of a frame.

[0027] Figure 9-12B The assembly of the commissures of the valve structure to the commissure windows of the frame of the prosthetic valve is shown.

[0028] Figure 13A-15 The assembly of the inner and outer skirts to the frame of a prosthetic valve is shown.

[0029] Fig.16 is a graph of a pressure gradient across two different prosthetic valves having a first size during steady forward flow through the valve, wherein one of the valves includes Figure 3 Multiple leaflets.

[0030] Fig.17 is a graph of a pressure gradient across two different prosthetic valves of a second size during steady forward flow through the valve, wherein one of the valves includes Figure 3 Multiple leaflets. DETAILED DESCRIPTION

[0031] General considerations

[0032] For the purposes of this description, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, devices, and systems should not be interpreted as limiting in any way. Alternatively, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually or in various combinations and sub-combinations with each other. The methods, devices, 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 exist or problems be solved.

[0033] Although the operations of some disclosed examples are described in a specific sequential order for convenience of presentation, it should be understood that this description includes reordering unless a specific order is required by the specific language described below. For example, the operations described in sequence may be reordered or performed simultaneously in some cases. In addition, for the sake of brevity, the accompanying drawings may not show the various ways in which the disclosed method can be used in combination with other methods. In addition, the description sometimes uses terms such as "providing" or "implementing" to describe the disclosed method. These terms are highly abstract of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation method and are easily discernible by a person of ordinary skill in the art.

[0034] As used in this application and the appended claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "comprising" means "including". Furthermore, the term "coupled" generally means a physical, mechanical, chemical, magnetic, and / or electrical coupling or connection, and does not exclude the presence of intermediate elements between the coupled or associated items in the absence of specific language to the contrary.

[0035] As used herein, the term "proximal" refers to a position, direction or part of a device that is closer to a user and further away from an implantation site. As used herein, the term "distal" refers to a position, direction or part of a device that is further away from a user and closer to an implantation site. Thus, for example, the proximal motion of a device is the motion of a device away from an implantation site and toward a user (e.g., leaving the patient's body), while the distal motion of a device is the motion of a device away from a user and toward an implantation site (e.g., entering the patient's body). The terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions, unless otherwise clearly defined.

[0036] As used herein, "eg" means "for example," and "ie" means "ie."

[0037] Overview of the Disclosed Technology

[0038] As described above, a leaflet assembly including a plurality of leaflets can be mounted on the inner side of a frame of a prosthetic heart valve. The leaflet assembly is configured to regulate blood flow from the inflow end to the outflow end of the prosthetic heart valve through the prosthetic heart valve. Each leaflet may include a main body having a tip 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 may include a pair of opposing upper tabs and a pair of opposing lower tabs. The leaflets may be fixed to each other at adjacent commissure tabs to form commissures, which are then fixed to commissure windows in the frame of the prosthetic heart valve. The tip edge portion of each leaflet may also be fixed to the pillars of the frame. Therefore, the main 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, which opens and closes during operation of the prosthetic heart valve (during cardiac contraction and cardiac diastole).

[0039] Some leaflet designs having an upper tab that is shorter (in width) and / or having an upper tab that is angled inner edge connected 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 tab and the movable portion of the leaflet, which can result in higher pressure gradients across the valve and reduced long-term durability of the leaflet.

[0040] Disclosed herein is a leaflet comprising an upper tab 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 a central longitudinal axis of the leaflet (the central longitudinal axis extends between an outflow end and an inflow end of the leaflet). In some examples, the offset portion is curved and offsets a lower inner corner of the upper tab axially and laterally away from the free edge of the leaflet. The upper tab may also be wider (in a transverse 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.

[0041] The prosthetic valves disclosed herein (such as Figure 1 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, when a device (such as a Figure 2 When the prosthetic valve is advanced through the patient's vasculature on an implant delivery device (shown in Figure 1), the prosthetic valve can be crimped on the implant delivery device or maintained in a radially compressed state by the implant delivery device. Once the prosthetic valve reaches the implantation site, the prosthetic valve can be expanded to a radially expanded state. It should be understood that the prosthetic valve disclosed herein can be used in conjunction with a variety of implant delivery devices and can be implanted via a variety of delivery procedures, examples of which will be discussed in more detail later.

[0042] Examples of the Disclosed Technology

[0043] Figure 1 An exemplary prosthetic valve 10 according to one example is shown. Any of the prosthetic valves disclosed herein are configured to be implanted in the native aortic valve annulus, but in other examples, they can be configured to be implanted in other native valve annuli of the heart (pulmonary, mitral and tricuspid valves). The disclosed prosthetic valves can also be implanted in vessels connected to the heart, including the pulmonary artery (to take over the function of a diseased pulmonary valve), or the superior vena cava or inferior vena cava (to take over the function of a diseased tricuspid valve) or various other veins, arteries and vessels of the patient. The disclosed prosthetic valves can also be implanted in a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0044] In some examples, the disclosed prosthetic valve can be implanted in a docking or anchoring device that is implanted in a native heart valve or vessel. For example, in one example, the disclosed prosthetic valve can be implanted in a docking device implanted in the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in U.S. Publication No. 2017 / 0231756 (which is incorporated herein by reference). In some examples, the disclosed prosthetic valve can be implanted in a docking device implanted in 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 valve can be implanted in a docking device implanted in the superior vena cava or the inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in U.S. Publication No. 2019 / 0000615 (which is incorporated herein by reference).

[0045] The prosthetic valve 10 includes four main components: a stent or frame 12, a valve 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"), a middle portion 17, and an outflow end portion 19. The inner skirt 16 can be disposed on and / or coupled to an inner surface of the frame 12, while the outer skirt 18 can be disposed on and / or coupled to an outer surface of the frame 12.

[0046] The valve structure 14 can include three leaflets 40 that together form a leaflet structure that can be arranged to collapse in a tricuspid valve arrangement, but in other examples there can be a greater or lesser number of leaflets (e.g., one or more leaflets 40). The leaflets 40 can be secured to each other at their adjacent sides to form the commissures 22 of the valve (e.g., leaflet) structure 14. The lower edge of the valve 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., bovine pericardial tissue), a 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).

[0047] The frame 12 can be formed with a plurality of circumferentially spaced slits or commissure windows 20 that are configured to mount the commissures 22 of the valve 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 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. Figure 1 As shown and described further below, the pair of commissure tabs 42 extend from the interior of the frame 12 through the commissure windows 20 and extend to the exterior of the frame 12. For example, Figure 1 As shown, the commissure tabs 42 may extend on and / or protrude radially outward from an outer surface 44 (a radially outwardly facing surface) of the frame 12 and, in particular, an outer surface of the window post portion 24 .

[0048] The frame 12 can be made of any of various suitable plastic expansion materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol) known in the art. When composed of plastic expansion materials, the frame 12 (and therefore the prosthetic valve 10) can be curled to a radially collapsed configuration on a delivery catheter and then expanded in the patient's body by an inflatable balloon or equivalent expansion mechanism. When composed of self-expanding materials, the frame 12 (and therefore the prosthetic valve 10) can be curled to a radially collapsed configuration and restricted in a collapsed configuration by being inserted into a sheath or equivalent mechanism of a delivery catheter. Once in the body, the prosthetic valve can be pushed out of the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0049] Suitable plastic expansion materials that can 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 include stainless steel. In some examples, frame 12 may include cobalt-chromium. In some examples, 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 is equivalent to UNS R30035 (covered by ASTM F562-02). By weight, MP35N TM / UNS R30035 contains 35% nickel, 35% cobalt, 20% chromium and 10% molybdenum.

[0050] Figure 2 A delivery apparatus 100 according to an example is shown that can be used to implant an expandable prosthetic heart valve (eg, prosthetic valve 10) or another other type of expandable prosthetic medical device (eg, a stent). In some examples, the delivery apparatus 100 is specifically configured for introducing a prosthetic valve into a heart.

[0051] Figure 2 The delivery device 100 of the present invention is a balloon catheter, which 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 expandable balloon (e.g., a balloon) 108 extending from the distal end of the intermediate shaft 105, and a nose cone 110 disposed at the distal end of the delivery device 100. The distal portion 112 of the delivery device 100 includes the balloon 108, the nose cone 110, and a balloon shoulder assembly. A prosthetic medical device, such as a prosthetic heart valve, can be mounted on the valve holding portion of the balloon 108. The balloon shoulder assembly is configured to hold the prosthetic heart valve or other medical device in a fixed position on the balloon 108 during delivery through the patient's vascular system. In some examples, the balloon shoulder assembly may include a proximal shoulder 120 and / or a distal shoulder 122 .

[0052] The balloon 108 may include a central portion (which may be approximately cylindrical when inflated, such as Figure 2 ) and two tapered end portions connected to the delivery device 100 (eg, to one or more shafts and / or a nose cone of the delivery device).

[0053] 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 an illustrated rotatable knob 134, which in turn is operably coupled to the proximal portion of a traction wire (not shown). The traction wire extends distally from the handle 102 through the outer shaft 104 and has a distal portion fixed to the outer shaft at or near the distal end of the outer shaft 104. Rotating the knob 134 effectively increases or decreases the tension of the traction wire, thereby adjusting the curvature of the distal portion of the delivery device.

[0054] The delivery device 100 can be configured to be advanced over a guidewire, which can be received within a guidewire lumen defined by the innermost shaft of the delivery device 100 .

[0055] In some examples, the delivery device (or another similar delivery device) can be configured to deliver a prosthetic heart valve (e.g., Figure 1 The prosthetic valve 10) is deployed and implanted in the native aortic valve ring of the native aortic valve. Further details about this delivery device can be found in Publication No. PCT / US2021 / 047056, which is incorporated herein by reference.

[0056] As an example, in a device for implanting an expandable prosthetic heart valve (e.g., Figure 1 In an implantation procedure of a prosthetic heart valve 10), the distal portion of the delivery device 100 (or another similar delivery device or balloon catheter) can be advanced (over a guidewire) to a target implantation site (e.g., native valve annulus). The balloon 108 can then be inflated to radially expand the prosthetic heart valve and implant it within the native valve annulus.

[0057] For prosthetic heart valves such as Figure 1 Prosthetic heart valves 10 or Figure 5 The leaflets 200 of the prosthetic heart valve 300 shown are Figure 3 The leaflet 200 may be formed from pericardial tissue (eg, bovine pericardial tissue), a biocompatible synthetic material, or various other suitable natural or synthetic materials known in the art and described in US Pat. No. 6,730,118, which is incorporated herein by reference.

[0058] Leaflet 200 has a body 202 with 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 further described below, tip edge portion 206 is configured to attach to a strut of a frame of a prosthetic heart valve, and free edge 204 is configured to move and contact corresponding free edges of other leaflets of the leaflet assembly during closure of the leaflet (e.g., during diastole during operation of the prosthetic heart valve).

[0059] 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 tabs 210 are disposed closer to the tip edge portion 206 than the upper tabs 208.

[0060] 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 the central longitudinal axis 212 of the leaflet 200. As used herein, an axial direction can be a direction parallel to the central longitudinal axis 212, and a lateral direction can be perpendicular to the central longitudinal axis 212 (e.g., passing through the central longitudinal axis 212 from one side of the leaflet to the opposite side of the leaflet). Figure 3 As shown, a central longitudinal axis 212 of the leaflet 200 extends between the inflow end and the outflow end of the leaflet 200 .

[0061] The upper edge or outflow edge 214 of each lower tab 210 is positioned at an angle relative to the central longitudinal axis 212. In some examples, such as Figure 3 As shown, the angle is 90 degrees.

[0062] In some examples, such as when the frame to which the leaflet 200 is to be attached is non-cylindrical (such as conical, truncated conical, V-shaped, or Y-shaped), the angle measured between 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.

[0063] 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 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).

[0064] Each lower tab 210 can have a height 216 and a width 218, which can be measured between a transverse outer edge 220 and a transverse inner edge 222 (or integral or attached edge) of the corresponding lower tab 210. The inner edge 222 of the lower tab 210 can be aligned with the transverse inner edge 228 of the adjacent upper tab 208.

[0065] The slits 226 extend 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 aligned with the inner edge 228 of the adjacent upper tab 208. The slits 226 allow for attachment of the corresponding upper and lower tabs 208 at the commissures, as further described below.

[0066] In some examples, such as Figure 3 As shown, 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, such as Figure 3 As shown, the inflow edge 224 and the outflow edge 214 of each lower tab are perpendicular to the central longitudinal axis 212 .

[0067] Each upper tab 208 can have a substantially rectangular shape having an inner edge 228, a lateral 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 can be referred to as side edges and are parallel to each other and to the central longitudinal axis 212 (and thus they can 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.

[0068] In some examples, such as Figure 3 As shown, 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 .

[0069] 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. As described further below, this makes assembly of the commissures to the frame easier and more accurate, thereby ensuring that the valve can open as far as possible during operation of the prosthetic heart valve.

[0070] Each upper tab 208 is axially and laterally offset from the free edge 204 of the leaflet 200 by an offset portion 236 (also referred to as a neck, neck portion, or connecting portion). The offset portion 236 extends 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.

[0071] 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 curves 90 degrees between the inner edge 228 of the corresponding upper tab 208 and the free edge 204 of the leaflet 200.

[0072] The offset portions 236 have a relatively narrow width 246 which 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 and reducing pressure gradients across the prosthetic valve during operation of the prosthetic valve (as further described below).

[0073] In some examples, the width 246 of the offset portion 236 may be less than half the width 218 of the lower tab 210 .

[0074] 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 corresponding upper tab 208 laterally (or radially when connected to the frame) outward and away from the body 202 of the leaflet 200, as shown in FIG. Figure 4 This reduces the possibility of direct contact between the moving portion of the leaflet 200 (eg, the body 202) and the inner edge 228 of the upper tab 208, thereby increasing the durability of the leaflet 200.

[0075] A plurality of leaflets 200 (eg, three leaflets 200) may be assembled together into a leaflet assembly or valve structure 201 and then secured to a frame of a prosthetic heart valve, such as Figure 5-8 Frame 302 of prosthetic valve 300 is shown. Although shown as being fixed to frame 302, leaflet 200 can be attached to various prosthetic heart valve frames (such as Figure 1 The framework 12) is used together.

[0076] like Figure 5 As shown, 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 of (e.g., three) leaflets 200 coupled to and supported by a frame 302. The prosthetic valve 300 may also include an inner skirt and / or an outer skirt, however, for the purpose of illustration, the inner skirt is not shown in FIG. Figure 5 These components are omitted. Figure 13A-15 An example of such inner and outer skirts secured to frame 302 is shown in FIG. 3 , as described below.

[0077] The frame 302 can include a plurality of interconnected struts 308 arranged as a plurality of rows of angled struts 308 disposed between an inflow end 304 and an 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 apart 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 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 for a more detailed view of the commissures 250). Figure 6 , wherein a portion of the struts of the frame are removed to better visualize the folded tabs of the leaflets 200 that form 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, such as Figure 5-8 shown.

[0078] For example, refer to Figure 8 , the adjacent lower tabs 210 of two adjacent leaflets 200 may be coupled together (eg, via a rod, a flexible connector, or an attachment member, as described below with reference to Figure 9-12B 302 ), and the upper tabs 208 of two adjacent leaflets 200 can be folded downward at their offset portions 236 so that the lower tab 210 is disposed between a pair of upper tabs 208. The lower tabs 210 can 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 can be coupled to a corresponding upper tab 208 along a suture line. Figure 9-12B Further details regarding the use of flexible connectors 252 to form commissures 250 are described.

[0079] Further details regarding the frame 302 and other similar frames that may be used and assembled with the leaflet 200 as described herein may be found in Publication Nos. US2012123529A1 (which is incorporated herein by reference) and WO2022 / 026351 (as already incorporated by reference above).

[0080] During typical valve operation, the leaflets 200 are in a closed state during diastole, wherein their free edges 204 (outflow edges) are in engagement with one another, and in an open state allowing blood to flow through the prosthetic valve 300 (see, e.g., Figure 7B) between an inflow orifice and an outflow orifice through which blood can flow determines the pressure gradient across the valve. Known valves can 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 wear of the leaflets as 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 known as the geometric orifice area (GOA)) can be narrower than the inflow orifice, thereby creating a relatively high pressure gradient across the prosthetic valve. Therefore, and particularly when using small diameter valves, it is preferred to provide a large outflow orifice during systole to prevent elevated pressure gradients.

[0081] like Fig. 7A and 7B As shown (where Figure 7B 350) 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 can flow when the valve structure 201 is in an 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 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.

[0082] Compared with other leaflets with different configurations, such as the above reference Figure 3 The described design of the leaflet 200 advantageously maximizes the GOA of the prosthetic valve 300 and reduces the pressure gradient across the prosthetic valve 300. In particular, the relatively narrower offset portion 236, the wider upper tab 208 having an outer edge 230 that extends laterally outward 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.

[0083] Fig.16 Individual value curves involving pressure gradients, 95% CI for the mean; and Fig.17 The individual value curves of the pressure gradients of valve A and valve B at 25 L / min. For example, Fig.16 and 17As shown, valve B (e.g., valve 300) including a valve structure including leaflets 200 has a lower pressure gradient across the valve than a different valve A including a valve structure including leaflets in a different configuration (e.g., leaflets without the geometric advantages discussed above for leaflets 200) but a valve of similar construction in other respects. In particular, the leaflets of valve A do not include a wider upper tab, a vertical inner edge and a vertical outer edge of the upper tab, or a narrower offset portion that increases the length of the outflow edge of the leaflet as described herein for leaflet 200.

[0084] In particular, Fig.16 shows a graph of a pressure gradient across the valve for valve A and valve B having a first size during steady forward flow through the valve (eg, during operation of the valve), and Fig.17 Graphs 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) are shown. Fig.16 In the figure, valves A and B are 20 mm diameter valves and Fig.17 In the present invention, valves A and B are 23 mm diameter valves.

[0085] As shown, it can be seen that the prosthetic valve including leaflets 200 (Valve B) experiences a substantially lower pressure gradient across the valve during forward flow through the valve as compared to another valve not including leaflets 200 (Valve A).

[0086] Additionally, the configuration of the upper tabs 208 and offset portions 236 of the leaflets 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), inwardly directed forces are exerted on the commissures 250 to cause the leaflets 200 to bend in an inwardly oriented direction relative to the commissures 250. This Figure 4 As shown in the schematic diagram, Figure 4 The upper tab 208 is depicted folded over the corresponding lower tab 210 at the offset portion 236 and the force 261 is directed inward (toward the central longitudinal axis of the prosthetic valve 300). The smoother arcuate shape of the offset portion 236 can distribute stress over the bend region between the upper tab 208 and the lower tab 210, thereby reducing stress concentrations at the bend region and maintaining the structural integrity of the leaflet 200 and the commissure 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.

[0087] Now go to Figure 9-13B, showing in more detail the assembly of the commissure 250 to the commissure window 312 of the frame 302. As described above, the leaflets 200 can be fixed to each other at their adjacent sides to form the commissure 250 of the valve structure 201. A plurality of flexible connectors 252 (one of which is Figure 9-12B ) can be used to interconnect pairs of adjacent sides of the leaflet 200 and mount the leaflet 200 to the axially extending window strut portion 314 that forms the commissure window 312.

[0088] The flexible connectors 252 can be made of a piece of woven PET fabric, although other synthetic and / or natural materials can also be used, and each flexible connector 252 can include a wedge 254 extending from a lower edge to an upper edge at the center of the flexible connector 252. The wedge 254 can include a non-metallic material secured to the flexible connector 252 with a temporary suture, such as a rope or a piece of Ethibond 2-0 suture material. The wedge 254 helps prevent rotational movement of the leaflet tabs after they are secured to the axially extending window strut portion 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 align the leaflet tabs during assembly of the commissure 250.

[0089] Fig. 9 and 10 Adjacent sides of two leaflets 200 are shown interconnected by a flexible connector 252 ( Fig. 9 A first side view is shown, and Fig.10 2 shows an opposite second side view). The opposite end portion of the flexible connector 252 can be placed in an overlapping relationship with the lower tab 210 with the inner notch (which in some examples can be a V-shaped notch, or in some examples can be a marking) aligned with the outer edge 220 of the lower tab 210.

[0090] Suture line 256 ( may be formed by sewing along a line extending from an external notch or mark on the lower edge to an external notch or mark on the upper edge of connector 252) Fig.10 ) to fix each lower tab 210 to the corresponding end portion of the flexible connector 252. Three flexible connectors 252 can be used to fix three leaflets 200 to each other side by side to form a valve structure 201.

[0091] Fig. 12A is a cross-sectional view of a portion of the frame 302 and the valve structure 201, and 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 post portions 314 . Fig.11An exemplary method for arranging the commissure tabs of two adjacent leaflets 200 within the commissure windows 312 formed by the axially extending window strut portions 314 is depicted.

[0092] Before inserting the lower tabs 210 through the commissure windows 312, the flexible connectors 252 securing the two adjacent lower tabs 210 of the two adjacent leaflets 200 are folded laterally (e.g., into the Fig. 9 ), and fold the upper tab 208 downward against the flexible connector 252 (on the lower tab 210).

[0093] Each upper tab 208 is longitudinally (vertically) creased to present 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 ( Figure 11-12B The outer portion 260 may then be sutured to the connector 252 along the suture line 262 ( Fig. 12A Next, a pair of lower tabs 210 connected by the connector 252 are inserted through the commissure windows 312 of the corresponding axially extending window support portions 314, as shown in FIG. Fig.11 shown.

[0094] The connector 252 and the lower tab 210 extending through the commissure window 312 can then be squeezed radially inward at the center of the connector 252 (e.g., at the wedge 254) so ​​that one of the lower tabs 210 and a portion of the connector 252 are folded against the frame 302 on one side of the axially extending window post portion 314, and the other lower tab 210 and a portion of the connector 252 are folded against the frame 302 on the other side of the axially extending window post portion 314 ( Fig. 12B ).

[0095] A pair of sutures 264 may be formed so as to Fig. 12A The lower tab 210 is held on the frame 302 in the manner shown. Each suture 264 can extend through the connector 252, the lower tab 210, the wedge 254 and another portion of the connector 252. Then, as shown in FIG. Fig. 12A As shown, each lower tab 210 is secured to the corresponding upper tab 208 by a main suture 266 extending 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.

[0096] like Figure 11-12B As shown, 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). Figure 3 and 4The ability to align the edge of the flexible connector 252 with the outer edge 230 of the upper tab 208 makes the assembly process easier and more accurate (e.g., reducing variability and increasing consistency between valves). As a result, the likelihood that all leaflets 200 of the valve structure 201 are evenly arranged within the frame increases, thereby ensuring the maximum possible GOA.

[0097] In some examples, such as Fig. 12A As shown, the suture material used to form the main suture line 266 can be used to further form a suture stitch 268 at the edges of the lower tab 210 and the upper tab 208, and the suture stitch 268 extends through the two layers of the connector 252 sandwiched between the upper tab 208 and the lower tab 210.

[0098] The leaflet 200 articulates primarily at the inner edge 270 of the downwardly folded inner portion 258 in response to blood flowing through the valve during operation in vivo, rather than about the axial struts of the commissure windows 312 .

[0099] In some examples, the inner skirt and the outer skirt (such as Figure 1 The inner skirt 16 and the outer skirt 18 of the prosthetic valve 10 can be fixed to the frame 302 and form the prosthetic valve 300. For example, Fig.13A and 13B As shown, after all three commissures 250 are secured to the corresponding commissure windows 312, the tip edge portion 206 of the leaflet 200 can be sutured to the inner skirt 360 ( Fig.13A ). The inner skirt 360 can be attached to the fourth row of angled struts 362 of the frame 302, for example, using a plurality of overlock 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, using a plurality of overlock stitches 368.

[0100] like Fig. 13B As shown, the outer skirt 370 is then positioned around the outer surface of the frame 302 and secured to the frame 302 using a plurality of overlock stitches 374 (in Fig.14 372) is attached to the third row of angled struts 372 together with the inner skirt 360. In this way, the same stitching line including stitch 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, such as Fig.14 and 15As shown, the line of overlock stitch 374 has a single tail 376 formed around the angled struts of the third row of angled struts 372 that are disposed below the commissure window 312. By utilizing only a single tail 376 and by using the same suture line to secure the outer skirt 370 and the inner skirt 360 to the third row of angled struts 372, the total number of tails used to assemble the valve is minimized, thereby making the assembly process easier and minimizing material interaction with the leaflet 200. For example, the likelihood of the single tail being pushed against the leaflet 200 is reduced, thereby increasing the durability of the leaflet 200.

[0101] like Fig. 13B As shown, the outer skirt 370 can then be attached to the second row of angled struts 378 (e.g., using a plurality of overlock stitches), and then attached to the first row of angled struts 366 (e.g., using a plurality of overlock stitches). The second row of angled struts 378 and the first row of angled struts 366 are Fig.13A (with the outer skirt 370 removed), and in Fig. 13B Indicated by an arrow in the figure to indicate its position below the outer skirt 370.

[0102] Additional details regarding the assembly of leaflets 200 to frame 302 or a similar prosthetic valve frame may be found in Publication No. US2012123529A1 (as incorporated by reference above).

[0103] Delivery Technology

[0104] In order to implant the prosthetic valve in the natural aortic valve by the transfemoral delivery method, the prosthetic valve is installed along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral artery and are advanced into and through the descending aorta, bypassing the aortic arch and passing through the ascending aorta. The prosthetic valve is positioned in the natural aortic valve and is radially expanded (e.g., by inflating the balloon, actuating one or more actuators of the delivery device, or deploying the prosthetic valve from the sheath to allow the prosthetic valve to self-expand). Optionally, the prosthetic valve can be implanted in the natural 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 in the natural aortic valve. Optionally, in a transaortic 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 (such as through a partial J-shaped sternotomy or a right parasternal mini-thoracotomy) and then advanced through the ascending aorta toward the native aortic valve.

[0105] To implant a prosthetic valve within the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted in a radially compressed state along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (through a perforation made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0106] To implant the prosthetic valve within the native tricuspid valve, the prosthetic valve is installed in a radially compressed state along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are 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 method can 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.

[0107] Another delivery method is a transatrial approach, whereby the 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 can also be performed intravascularly, such as from the pulmonary veins. Yet another delivery method is a transventricular approach, whereby the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and an incision made through the right ventricular wall (generally at or near the base of the heart) to implant the prosthetic valve in the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0108] In all delivery methods, the delivery device can be advanced over a guidewire that has been previously inserted into the patient's vasculature. In addition, the disclosed delivery methods are not intended to be limited. Any prosthetic valve disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0109] Any system, device, equipment, etc. herein can be sterilized (e.g., with heat / heat, pressure, steam, radiation and / or chemicals, etc.) to ensure that it is safe for use by patients, and any method herein can include sterilization of related systems, devices, equipment, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclave sterilization. Examples of radiation used for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization using hydrogen peroxide can be accomplished using, for example, hydrogen peroxide plasma.

[0110] Additional Examples of the Disclosed Technology

[0111] In view of the above 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 a combination of one or more features of one or more further examples are further examples that also fall within the disclosure of the present application.

[0112] Example 1. A leaflet for a prosthetic valve, comprising: a main body having a free outflow edge and a tip edge portion; two lower tabs, the two lower tabs being arranged on opposite sides of the main body, wherein the tip edge portion terminates at the lower tabs at its upper end, and the lower tabs extend laterally outward from the main body relative to the central longitudinal axis of the leaflet; two upper tabs, the two upper tabs being arranged on opposite sides of the main body and extending laterally outward from the main body; and two offset portions, each offset portion extending between a corresponding lower tab and an upper tab, and offsetting the corresponding upper tab axially and laterally away from the outflow edge of the main body, wherein each upper tab has relative inner and outer edges, the inner and outer edges being parallel to each other and arranged parallel to the central longitudinal axis of the leaflet.

[0113] Example 2. A leaflet according to any of the examples herein (particularly Example 1), wherein each lower tab has an outer edge that is laterally offset from the body and is arranged parallel to the central longitudinal axis of the leaflet and the outer edge of the corresponding upper tab.

[0114] Example 3. A leaflet according to any of the examples herein (particularly Example 1 or Example 2), wherein the outer edge of each upper tab extends laterally outward further relative to the central longitudinal axis of the leaflet than the outer edge of the corresponding lower tab.

[0115] Example 4. A leaflet according to any of the examples herein (particularly any of Examples 1-3), wherein the 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.

[0116] Example 5. A leaflet according to any of the examples herein (particularly any of Examples 1-4), wherein each upper tab has an outflow edge and an inflow edge arranged opposite to the outflow edge, wherein the inflow edge is arranged closer to the corresponding 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.

[0117] Example 6. A leaflet according to any of the examples herein (particularly any of Examples 1-5), wherein each offset portion has an outer edge extending between the inflow edge of the corresponding upper tab and the outflow edge of the corresponding lower tab, and an arcuate inner edge bent between the inner edge of the corresponding upper tab and the outflow edge of the body.

[0118] Example 7. A leaflet according to any example herein, in particular Example 6, wherein the arcuate inner edge bends 90 degrees between the inner edge of the corresponding upper tab and the outflow edge of the body.

[0119] Example 8. A 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.

[0120] Example 9. A leaflet according to any of the examples 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.

[0121] Example 10. A prosthetic heart valve comprising a plurality of leaflets according to any of the examples herein, in particular any of Examples 1-9, wherein for each leaflet, the upper tab is folded over the corresponding lower tab.

[0122] Example 11. A prosthetic heart valve according to any of the examples herein (particularly Example 10), wherein the tip edge portion of each leaflet is attached to a support 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 moves freely during operation of the prosthetic heart valve to regulate the flow of blood through the prosthetic heart valve.

[0123] Example 12. A leaflet for a prosthetic valve, comprising: a body having a free edge and a tip edge portion, the free edge being disposed at an outflow end of the leaflet; two lower tabs, the two lower tabs being disposed on opposite sides of the body, wherein the tip edge portions terminate at the lower tabs at their upper ends, and the lower tabs extend laterally outward from the body relative to a central longitudinal axis of the leaflet; two upper tabs, the two upper tabs being disposed on opposite sides of the body and extending laterally outward from the body; and two offset portions, each extending between a corresponding lower tab and an upper tab and offsetting the corresponding 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 laterally outward farther relative to the central longitudinal axis of the leaflet than an outer edge of a corresponding lower tab, and wherein the first width and the second width extend perpendicular to the central longitudinal axis of the leaflet.

[0124] Example 13. The leaflet according to any example herein, in particular Example 12, wherein the outer edges of the upper tab and the lower tab are parallel to the central longitudinal axis of the leaflet.

[0125] Example 14. A leaflet according to any of the examples herein (particularly Example 12 or Example 13), wherein each upper tab has an inner edge arranged opposite to 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.

[0126] Example 15. A leaflet according to any of the examples herein (in particular any of Examples 12-14), wherein each upper tab has relative inflow edges and outflow edges perpendicular to the central longitudinal axis of the leaflet, and wherein the inflow edge is arranged closer to the free edge of the body than the outflow edge.

[0127] Example 16. A leaflet according to any of the examples herein (particularly any of Examples 12-15), wherein each offset portion has an outer edge extending between the inflow edge of the corresponding upper tab and the outflow edge of the corresponding lower tab, and an arcuate inner edge bent between the inner edge of the corresponding upper tab and the free edge of the body.

[0128] Example 17. A leaflet according to any example herein, in particular Example 16, wherein the arcuate inner edge is bent 90 degrees between the inner edge of the corresponding upper tab and the free edge of the body.

[0129] Example 18. A leaflet according to any example herein, in particular example 16 or example 17, wherein the outer edge of each offset portion extends parallel to the central longitudinal axis of the leaflet.

[0130] Example 19. A leaflet according to any of the examples herein (particularly any of Examples 12-18), 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.

[0131] Example 20. A prosthetic heart valve comprising a plurality of leaflets according to any of the examples herein, in particular any of Examples 12-19, wherein for each leaflet, the upper tab is folded over the corresponding lower tab.

[0132] Example 21. A prosthetic heart valve according to any of the examples herein (particularly Example 20), wherein the tip edge portion of each leaflet is attached to a support 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 moves freely during operation of the prosthetic heart valve to regulate the flow of blood through the prosthetic heart valve.

[0133] Example 22. A leaflet for a prosthetic valve, comprising: a body having a free edge disposed at its outflow end and a tip edge portion defining its inflow end; two lower tabs disposed on opposite sides of the body, wherein the tip edge portions terminate at the lower tabs at their upper ends, 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 a corresponding lower tab and an upper tab and offsetting the corresponding upper tab axially and laterally away from the free edge of the body, wherein each offset portion has an outer edge extending between the inflow edge of the corresponding upper tab and the outflow edge of the corresponding lower tab, and an arcuate inner edge curved between the inner edge of the corresponding 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.

[0134] Example 23. A leaflet according to any of the examples herein, in particular Example 22, wherein each offset portion has a first width defined between its inner edge and outer edge, the first width being less than half of the second width of the lower tab.

[0135] Example 24. A leaflet according to any of the examples 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 corresponding upper tab and the free edge of the body.

[0136] Example 25. The leaflet of any example herein, in particular any of Examples 22-24, wherein the outer edge of each offset portion extends parallel to the central longitudinal axis of the leaflet.

[0137] Example 26. A leaflet according to any of the examples herein (in particular any of Examples 22-25), wherein each upper tab has an outer edge arranged opposite to 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.

[0138] Example 27. A leaflet according to any of the examples herein (particularly Example 26), wherein each lower tab has an outer edge that is laterally offset from the body and is arranged parallel to the central longitudinal axis of the leaflet and the outer edge of the corresponding upper tab.

[0139] Example 28. A leaflet according to any of the examples herein (particularly Example 27), wherein the outer edge of each upper tab extends laterally outward further relative to the central longitudinal axis of the leaflet than the outer edge of the corresponding lower tab.

[0140] Example 29. A leaflet according to any of the examples herein (particularly any of Examples 22-28), wherein the 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.

[0141] Example 30. A leaflet according to any of the examples herein (in particular any of Examples 22-29), wherein each upper tab has an outflow edge arranged opposite to its inflow edge, wherein the inflow edge of the upper tab is closer to the 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.

[0142] Example 31. A prosthetic heart valve comprising a plurality of leaflets according to any of the examples herein, in particular any of Examples 22-30, wherein for each leaflet, the upper tab is folded over the corresponding lower tab.

[0143] Example 32. A prosthetic heart valve according to any of the examples herein (particularly Example 31), wherein the tip edge portion of each leaflet is attached to a support 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 moves freely during operation of the prosthetic heart valve to regulate the flow of blood through the prosthetic heart valve.

[0144] Example 33. A prosthetic heart valve, comprising: a frame, which is radially expandable and collapsible between a radially expanded configuration and a radially collapsed configuration, wherein the frame includes a plurality of interconnected struts, the plurality of interconnected struts including a plurality of rows of angled struts and a plurality of axially extending window strut portions, the plurality of axially extending window strut portions defining a plurality of circumferentially spaced commissure windows; a valve structure, the valve structure being mounted on the inner side of the frame and comprising a plurality of leaflets, wherein each leaflet includes a main body, a pair of lower tabs and a pair of upper tabs, the main body having a free outflow edge and a tip edge portion, the pair of lower tabs being disposed on opposite sides of the main body, the pair of upper tabs being disposed on opposite sides of the main body, wherein the pair of lower tabs and upper tabs of adjacent leaflets are paired to form a commissure, the commissure being fixed to the a corresponding commissure window of the frame; an inner skirt, which is arranged around the inner surface of the frame and fixed to the tip edge portion of each leaflet, wherein the inner skirt is attached to a first row of angled struts forming the inflow end of the frame and a second row of angled struts arranged adjacent to the outflow end of the frame; and an outer skirt, which is arranged around the outer surface of the frame and attached to the first row of angled struts and the third row of angled struts, wherein the inner skirt and the outer skirt are attached together with a single stitch line to a fourth row of angled struts, the fourth row of angled struts being arranged between the second row of angled struts and the third row of angled struts, and wherein a single end for the single stitch line is formed around an angled strut in the fourth row of angled struts that is arranged below one of the angled struts in the commissure window.

[0145] Example 34. A prosthetic heart valve comprising: a frame that is radially expandable and collapsible between a radially expanded configuration and a radially collapsed configuration; a valve structure that is mounted on the inner side of the frame and comprises a plurality of leaflets according to any of the examples described herein (in particular any of Examples 1-9, 12-19 and 22-30).

[0146] Example 35. A prosthetic heart valve according to any of the examples herein, in particular Example 33, wherein for each leaflet, the upper tab is folded along a radially extending fold.

[0147] Example 36. A prosthetic valve according to any of the examples herein (particularly Example 34), wherein the valve structure includes a plurality of commissures, each of the plurality of commissures including a folded upper tab and a lower tab of a leaflet and adjacent folded upper tabs and a lower tab of an adjacent leaflet.

[0148] Example 37. A prosthetic valve according to any of the examples herein, in particular Example 35, wherein the lower tab of each commissure extends through a commissure window of the frame.

[0149] Example 38. A prosthetic valve according to any of the examples herein, in particular any of Examples 35-36, wherein the folded upper tab is located inside the frame.

[0150] Example 39. A prosthetic valve according to any of the examples herein (particularly any of Examples 35-37), wherein each folded upper tab is further folded along an axially extending crease so that a first portion of the upper tab abuts the body of the corresponding leaflet and a second portion of the upper tab extends in a plane different from the first portion.

[0151] Example 40. A prosthetic heart valve according to any one of Examples 1 to 39, having improved hemodynamic performance.

[0152] Example 41. A prosthetic heart valve according to any of Examples 1 to 39, having improved leaflet durability.

[0153] Example 42. A prosthetic heart valve according to any of Examples 1 to 39, having improved hemodynamic performance and improved leaflet durability.

[0154] Example 43. A method comprising sterilizing a leaflet, prosthetic heart valve, device and / or assembly according to any of the examples.

[0155] Example 44. A prosthetic heart valve according to any of Examples 1-39, wherein the prosthetic heart valve is sterilized.

[0156] Unless otherwise stated, features described herein with respect to any example may be combined with other features described in any one or more of the other examples. 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.

[0157] In view of the fact that the principles of the present disclosure can be applied in many possible ways, it should be appreciated that the exemplary configurations depict examples of the disclosed technology and should not be considered to limit the scope of the present disclosure and the claims. Rather, the scope of the claimed subject matter is defined by the appended claims and their equivalents.

Claims

1. A leaflet for a prosthetic valve, It is characterized in that The leaflets include: a body having a free flow 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 a respective lower tab and an upper tab and offsetting 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, the inner and outer edges being arranged parallel to each other and to the central longitudinal axis of the leaflet.

2. The leaflet according to claim 1, It is characterized in that 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 corresponding upper tab.

3. The leaflet according to claim 1 or claim 2, It is characterized in that The outer edge of each upper tab extends laterally outwardly further relative to the central longitudinal axis of the leaflet than the outer edge of the corresponding lower tab.

4. The leaflet according to claim 1 or claim 2, It is characterized in that Each upper tab has an outflow edge and an inflow edge arranged opposite the outflow edge, wherein the inflow edge is arranged closer to the corresponding 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 according to claim 1 or claim 2, It is characterized in that Each offset portion has an outer edge extending between an inflow edge of the corresponding upper tab and an outflow edge of the corresponding lower tab, and an arcuate inner edge curved between the inner edge of the corresponding upper tab and the outflow edge of the body.

6. The leaflet according to claim 5, It is characterized in that The arcuate inner edge bends 90 degrees between the inner edge of the corresponding upper tab and the outflow edge of the body.

7. The leaflet according to claim 5, It is characterized in that The outer edge of each offset portion extends parallel to the central longitudinal axis of the leaflet.

8. The leaflet according to any one of claims 1-2 and 6-7, It is characterized in that 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, It is characterized in that The prosthetic heart valve comprises a plurality of leaflets for a prosthetic valve according to any one of claims 1-8, wherein for each leaflet, the upper tab is folded over the corresponding lower tab.

10. The prosthetic heart valve according to claim 9, It is characterized in that The tip edge portion of each leaflet is attached to a strut 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 the flow of blood through the prosthetic heart valve.

11. A leaflet for a prosthetic valve, It is characterized in that The leaflets include: a body having a free edge and a tip edge portion, the free edge being 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 extending between a corresponding lower tab and an upper tab and offsetting the corresponding 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, so that an outer edge of each upper tab extends laterally outward farther relative to the central longitudinal axis of the leaflet than an outer edge of the corresponding lower tab, and wherein the first width and the second width extend perpendicular to the central longitudinal axis of the leaflet.

12. The leaflet according to claim 11, It is characterized in that The outer edges of the upper and lower tabs are parallel to the central longitudinal axis of the leaflet.

13. A leaflet according to claim 11 or claim 12, It is characterized in that 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.

14. The leaflet according to claim 11 or claim 12, It is characterized in that Each upper tab has opposing 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 according to claim 13, It is characterized in that 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 free edge of the body.

16. The leaflet according to any one of claims 11-12 and 15, It is characterized in that 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, It is characterized in that The leaflets include: 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 extending between a respective lower tab and an upper tab and offsetting 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 according to claim 17, It is characterized in that Each offset portion has a first width defined between an inner edge and an outer edge thereof, the first width being less than half of a second width of the lower tab.

19. A leaflet according to claim 17 or claim 18, It is characterized in that The arcuate inner edge of each offset portion bends 90 degrees between the inner edge of the corresponding upper tab and the free edge of the body.

20. A leaflet according to claim 17 or claim 18, It is characterized in that The outer edge of each offset portion extends parallel to the central longitudinal axis of the leaflet.

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