artificial heart valves

Abstract

Leaflets for a prosthetic heart valve are disclosed. By way of example, the leaflets include a body having a free outflow edge and a cusp portion, two lower tabs disposed on either side of the body, the cusp portions terminating at their upper ends at the lower tabs and extending laterally outward from the body relative to a central longitudinal axis of the leaflet, and two upper tabs disposed on either side of the body and extending laterally outward from the body. The leaflets further include two offset portions, each extending between a respective lower and upper tab and offsetting the respective upper tab axially and laterally away from the outflow edge of the body, each upper tab having opposing inner and outer edges that are parallel to each other and to the central longitudinal axis of the leaflet.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 399,604, filed August 19, 2022, and U.S. Provisional Patent Application No. 63 / 399,626, filed August 19, 2022, the entire contents of each of which are incorporated herein by reference.

[0002] TECHNICAL FIELD The present disclosure relates to prosthetic heart valves, and in particular to valve leaflets for prosthetic heart valves. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can cause serious cardiac dysfunction, ultimately necessitating repair of the native valve or replacement of the native valve with a prosthetic valve. Numerous repair devices (e.g., stents) and prosthetic valves are known, as are numerous methods for implanting such devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations within the body that are not easily accessible by surgery or where non-surgical access is desirable. In one embodiment, a prosthetic heart valve can be compressed onto the end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) to reach the implantation site within the heart. The prosthetic valve is then radially expanded to its functional size, for example, by inflating a balloon to which the prosthetic valve is attached, or by activating a mechanical actuator that applies an expansive force to the prosthetic valve, or by deploying the prosthetic valve from a sheath on a delivery device, allowing the prosthetic valve to self-expand to its functional size.

[0004] Most expandable prosthetic heart valves include a cylindrical metal frame or stent and prosthetic leaflets mounted within the frame. Each leaflet may include a body with a leaflet edge portion and one or more sets of commissure tabs extending from the body on either side of the leaflet. The leaflets are secured to each other at adjacent commissure tabs to form commissures, which may then be secured to commissure windows in the prosthetic heart valve frame. The leaflet edge portions of each leaflet may also be secured to struts of the frame. The prosthetic heart valve leaflets are configured to open and close to regulate blood flow through the prosthetic heart valve from the inflow end to the outflow end of the prosthetic heart valve. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] US Patent Application Publication No. 2017 / 0231756 [Patent Document 2] International Publication No. 2020 / 247907 [Patent Document 3] U.S. Patent Application Publication No. 2019 / 0000615 [Patent Document 4] U.S. Patent No. 6,730,118 [Patent Document 5] International Application No. PCT / US2021 / 047056 [Patent Document 6] International Publication No. 2022 / 026351 [Patent Document 7] U.S. Patent No. 9,393,110 Summary of the Invention

[0006] Described herein are prosthetic heart valves, delivery devices, and methods for implanting the prosthetic heart valves. Also described herein are valve leaflets configured to be mounted inside the frame of the 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 provide, for example, more durable leaflets that can also open more widely during operation of the prosthetic heart valve, thereby reducing pressure gradients across the prosthetic valve. Thus, the devices and methods disclosed herein can overcome, among other things, one or more deficiencies of typical prosthetic heart valves.

[0007] A leaflet for a prosthetic valve can include a body having a free outflow edge and a leaflet portion, two lower tabs disposed on either side of the body, and two upper tabs disposed on either side of the body.

[0008] In some examples, the leaflet can include two offset portions, each extending between a respective lower and upper tab and offsetting the respective upper tab axially and laterally away from the outflow edge of the body, each upper tab having opposing inner and outer edges that are parallel to each other and aligned parallel to the central longitudinal axis of the leaflet.

[0009] In some examples, the leaflet can include two offset portions, each extending between a respective lower and 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 greater than a second width of each of the two lower tabs, such that an outer edge of each upper tab extends laterally outward farther than an outer edge of the respective lower tab relative to the central longitudinal axis of the leaflet.

[0010] In some examples, the leaflets can include two offset portions, each extending between a respective lower and upper tab and offsetting the respective upper tab axially and laterally away from the free edge of the body, each offset portion having an outer edge extending between the inflow edge of the respective upper tab and the outflow edge of the respective lower tab, and an arcuate inner edge curving between the inner edge of the respective upper tab and the free edge of the body.

[0011] In some examples, a leaflet for a prosthetic valve comprises: a body having a free outflow edge and a leaflet portion; two lower tabs disposed on either side of the body, where the leaflet portion terminates at its upper end at the lower tab and the lower tab extends laterally outward from the body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on either side of the body and extending laterally outward from the body; and two offset portions, each extending between a respective lower and upper tab and offsetting a respective upper tab axially and laterally away from the outflow edge of the body, each upper tab having opposing inner and outer edges that are parallel to each other and disposed parallel to the central longitudinal axis of the leaflet.

[0012] In some examples, a leaflet for a prosthetic valve includes a body having a free edge and a leaflet portion, the free edge being disposed at the outflow end of the leaflet; two lower tabs disposed on either side of the body, the leaflet portion terminating at its upper end at the lower tab, the lower tabs extending laterally outward from the body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on either side of the body, extending laterally outward from the body; and two offset portions, each offset portion extending laterally outward from its and two offset portions extending between each of the lower and upper tabs, offsetting each 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 greater than a second width of each of the two lower tabs, such that an outer edge of each upper tab extends laterally outward farther from the central longitudinal axis of the valve 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 valve leaflet.

[0013] In some examples, a leaflet for a prosthetic valve comprises: a body having a free edge disposed at an outflow end and a leaflet portion defining an inflow end; two lower tabs disposed on opposite sides of the body, where the leaflet portion terminates at its upper end at the lower tab and the lower tab extends 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 and upper tab and offsetting each upper tab axially and laterally away from the free edge of the body, each offset portion having an outer edge extending between the inflow edge of the respective upper tab and the 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, where the inner edge of each offset portion is disposed closer to the central longitudinal axis than the outer edge of the offset portion.

[0014] In some examples, the leaflets for the prosthetic valve comprise one or more of the components listed in Examples 1-9, 12-19, and 22-30 below.

[0015] The prosthetic heart valve can include a frame and a valve structure coupled to the frame. In addition to these components, the prosthetic heart valve can further include one or more of the components disclosed herein.

[0016] In some examples, the prosthetic heart valve may include a sealing member configured to reduce paravalvular leakage.

[0017] In some examples, the prosthetic heart valve comprises a frame radially expandable and collapsible between a radially expanded configuration and a radially collapsed configuration, the frame comprising 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 comprises a valvular structure mounted on the interior of the frame and comprising a plurality of leaflets, each leaflet comprising a body having a free outflow edge and a leaflet 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, the pairs of lower and upper tabs of adjacent leaflets being paired to form commissures that are secured to respective commissure windows of the frame. The prosthetic heart valve further comprises an inner skirt disposed around the inner surface of the frame and secured to the leaflet portion of each leaflet, the inner skirt 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 further comprises an outer skirt disposed about the outer surface of the frame and attached to the first row of angled struts and the third row of angled struts, the inner skirt and the outer skirt being attached together with a single stitch line to a fourth row of angled struts located between the second row of angled struts and the third row of angled struts, and a single knot tail for the single stitch line being formed around the angled struts of the fourth row of angled struts located under one of the commissure windows.

[0018] In some examples, the prosthetic heart valve comprises one or more of the components listed in Examples 10, 11, 20, 21, 31, 32-36, and 38 below.

[0019] The various innovations in this disclosure can be used in combination or separately. This Summary is provided to introduce in a simplified form a selection of various concepts 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. These and other objects, features, and advantages of the present disclosure will become more apparent from the following Detailed Description, from the claims, and from the accompanying drawings. [Brief explanation of the drawings]

[0020] [Figure 1] FIG. 1 is a perspective view of a prosthetic heart valve. [Figure 2] 1 is a perspective view of a delivery device for a prosthetic heart valve, according to one example. [Figure 3] FIG. 1 is a plan view of a valve leaflet for a prosthetic heart valve. [Figure 4] 4 is a schematic diagram of a portion of the leaflet of FIG. 3, showing the upper tab of the leaflet folded over the lower tab of the leaflet. [Figure 5] 4 is a perspective view of a prosthetic valve including a frame and a valve structure with multiple leaflets of FIG. 3 mounted on the inside of the frame. [Figure 6] FIG. 6 is a detailed view of a portion of the prosthetic valve of FIG. 5, showing the commissures of the prosthetic valve. [Figure 7A] FIG. 6 is a top view of the artificial valve of FIG. 5. [Figure 7B] FIG. 6 is a top view of the prosthetic valve of FIG. 5 when the valve is in a fully open position during valve operation. [Figure 8] 6 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. [Figure 9] 1 shows the assembly of the commissures of the valve structures into the commissure windows of the prosthetic valve frame. [Figure 10] 1 shows the assembly of the commissures of the valve structures into the commissure windows of the prosthetic valve frame. [Figure 11] 1 shows the assembly of the commissures of the valve structures into the commissure windows of the prosthetic valve frame. [Figure 12A] 1 shows the assembly of the commissures of the valve structures into the commissure windows of the prosthetic valve frame. [Figure 12B] 1 shows the assembly of the commissures of the valve structures into the commissure windows of the prosthetic valve frame. [Figure 13A] 1 shows the assembly of the inner and outer skirts onto the frame of the prosthetic valve. [Figure 13B] 1 shows the assembly of the inner and outer skirts onto the frame of the prosthetic valve. [Figure 14] 1 shows the assembly of the inner and outer skirts onto the frame of the prosthetic valve. [Figure 15] 1 shows the assembly of the inner and outer skirts onto the frame of the prosthetic valve. [Figure 16] 4 is a graph of the pressure gradient across two different prosthetic valves having a first size, one of the valves comprising the multiple leaflets of FIG. 3, during steady forward flow through the valve. [Figure 17] 4 is a graph of the pressure gradient across two different prosthetic valves having a second size, one of the valves comprising the multiple leaflets of FIG. 3, during steady forward flow through the valve. DETAILED DESCRIPTION OF THE INVENTION

[0021] General Considerations For purposes of this specification, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, devices, 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, in various combinations with each other, and in various subcombinations with each other. The methods, devices, and systems are not limited to any particular aspect, feature, or combination thereof, nor do the methods, devices, and systems require the presence of any one or more particular advantages or problems to be solved.

[0022] Although operations in some disclosed examples are described in a particular sequential order for convenience of presentation, it will be understood that aspects of the description encompass reordering unless a particular order is required by specific language set forth below. For example, operations described sequentially may, in some cases, be reordered or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0023] As used in this application and the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Furthermore, the term "coupled" generally means to physically, mechanically, chemically, magnetically, and / or electrically join or connect, and does not exclude the presence of intervening elements between coupled or associated members unless specific language to the contrary exists.

[0024] As used herein, the term "proximal" refers to a position, orientation, or portion of a device that is closer to the user and farther away from the implantation site. As used herein, the term "distal" refers to a position, orientation, or portion of a device that is located away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site and toward the user (e.g., outside the patient's body), while distal movement of a 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," unless expressly defined otherwise, refer to axes extending in a proximal-distal direction.

[0025] As used herein, "eg" means "for example" and "ie" means "that is."

[0026] Overview of the technology to be disclosed As introduced above, a leaflet assembly including multiple leaflets can be mounted inside the frame of a prosthetic heart valve. The leaflet assembly is configured to regulate blood flow through the prosthetic heart valve from the inflow end to the outflow end of the prosthetic heart valve. Each leaflet can include a body having a leaflet edge portion and two sets of commissure tabs extending from the body on either side of the leaflet. The two sets of commissure tabs can include a pair of opposing upper tabs and a pair of opposing lower tabs. The leaflets are secured to each other at adjacent commissure tabs to form commissures, which can then be secured to commissure windows in the frame of the prosthetic heart valve. The leaflet edge portion of each leaflet can also be secured to the struts of the frame. Thus, the body of each leaflet between the leaflet's free (or outflow) edge and the leaflet edge portion can be referred to as the "moving" portion of the leaflet, which opens and closes during operation of the prosthetic heart valve (during systole and diastole).

[0027] Some leaflet designs with shorter (wider) upper tabs and / or upper tabs with angled inner edges connected to the free edges of the leaflets may result in a leaflet assembly that does not open wide enough (e.g., toward the frame) and / or may result in contact between the angled inner edges of the upper tabs and the moving portions of the leaflets, which may result in higher pressure gradients across the valve and reduced long-term leaflet durability.

[0028] Disclosed herein are valve leaflets that include an upper tab offset from the 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, offsetting the lower inner corner of the upper tab both axially and laterally away from the free edge of the leaflet. The upper tab can also be wider (in the transverse direction extending toward the free edge of the leaflet) and extend farther outward from the body of the leaflet than the lower tab.

[0029] The prosthetic valves disclosed herein, such as the prosthetic heart valve shown in FIG. 1 , can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be compressed or held by an implant delivery device in a radially compressed state while being advanced through a patient's vasculature on a delivery device, such as the delivery device shown in FIG. 2 . After the prosthetic valve reaches the implantation site, the prosthetic valve can be expanded to a radially expanded state. It will be understood that the prosthetic valves disclosed herein can be used with a variety of implant delivery devices and can be implanted via a variety of delivery procedures, examples of which are described in more detail below.

[0030] Examples of the disclosed technology FIG. 1 illustrates an exemplary prosthetic valve 10, according to one example. While any of the prosthetic valves disclosed herein are configured to be implanted within the native aortic valve annulus, in other examples, the prosthetic valves can be configured to be implanted within other native valve annulus of the heart (such as the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves can also be implanted within blood vessels communicating with the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), the superior vena cava, or the inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of a patient. The disclosed prosthetic valves can also be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0031] In some instances, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or blood vessel. For example, in one instance, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in U.S. Patent No. 6,275,999, which is incorporated herein by reference. In some instances, the disclosed prosthetic valves can be implanted within a docking device implanted within the native mitral valve or at the mitral valve, as disclosed in U.S. Patent No. 6,275,999, which is incorporated herein by reference. In some instances, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in U.S. Patent No. 6,275,999, which is incorporated herein by reference.

[0032] The prosthetic valve 10 includes four major components: a stent or frame 12, a valvular structure 14, an inner skirt 16, and a perivalvular outer sealing member or outer skirt 18. The prosthetic valve 10 can have an inflow end portion 15 (also referred to herein as the "inflow end"), an intermediate portion 17, and an outflow end portion 19. The inner skirt 16 can be disposed on and / or bonded to the inner surface of the frame 12, while the outer skirt 18 can be disposed on and / or bonded to the outer surface of the frame 12.

[0033] The valvular structure 14 may include three leaflets 40 that collectively form the valve structure, which may be configured to collapse in a tricuspid arrangement, although in some cases there may be more or fewer leaflets (e.g., one or more leaflets 40). The leaflets 40 may be secured to one another at adjacent sides to form commissures 22 of the valve (e.g., leaflet) structure 14. The lower edge of the valvular structure 14 may have a curved, scalloped, such as undulating, shape and may be secured to the inner skirt 16 by sutures (not shown). In some examples, the leaflets 40 may be formed from pericardial tissue (e.g., bovine pericardial tissue), from a biocompatible synthetic material, or from a variety of other suitable natural or synthetic materials as known in the art and as described in U.S. Patent Application Publication No. 2009 / 0129994, incorporated herein by reference.

[0034] The frame 12 can be formed with a plurality of circumferentially spaced slots or commissural windows 20 configured to attach commissures 22 of the valvular structure 14 to the frame. For example, the commissural windows 20 can be defined by axially extending window strut portions 24 of the frame 12, which may also be referred to herein as “commissural supports.” Each commissural window 20 is adapted to receive a commissure tab 42 of a pair of adjacent valve leaflets 40 disposed within the corresponding commissure 22. As shown in FIG. 1 and described further below, the pair of commissure tabs 42 extend from the interior of the frame 12, through the commissure windows 20, and to the exterior of the frame 12. For example, as shown in FIG. 1, the commissure tabs 42 can extend over and / or protrude radially outward from an outer surface 44 (radially outward surface) of the frame 12, specifically the outer surface of the window strut portions 24.

[0035] Frame 12 can be formed from any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol). When constructed from a plastically expandable material, frame 12 (and thus prosthetic valve 10) can be crimped into a radially collapsed configuration on a delivery catheter and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. When constructed from a self-expandable material, frame 12 (and thus prosthetic valve 10) can be crimped into a radially collapsed configuration and restrained in the collapsed configuration by insertion within a sheath of a delivery catheter or equivalent mechanism. Inside the body, the prosthetic valve can be advanced from a delivery sheath, allowing it to expand to its functional size.

[0036] Suitable plastically expandable materials that can be used to form the frames (e.g., frame 12) disclosed herein include metal alloys, polymers, or combinations thereof. Exemplary metal alloys can include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some examples, frame 12 can include stainless steel. In some examples, frame 12 can include cobalt chromium. In some examples, frame 12 can include nickel-cobalt-chromium. In some examples, frame 12 can include a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (a trademark of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight.

[0037] 2 illustrates an example delivery apparatus 100 that can be used to implant an expandable prosthetic heart valve (e.g., prosthetic valve 10) or another type of expandable prosthetic medical device (e.g., a stent). In some examples, delivery apparatus 100 is specifically configured for use in introducing a prosthetic valve into the heart.

[0038] 2 is a balloon catheter that includes a handle 102, a steerable outer shaft 104 extending from the handle 102, a midshaft extending from the handle 102 and coaxially through the steerable outer shaft 104, an inner shaft 106 extending from the handle 102 and coaxially through the midshaft and through the steerable outer shaft 104, an inflatable balloon (e.g., balloon) 108 extending from a distal end of the midshaft, and a nosecone 110 disposed at the distal end of the delivery device 100. The distal end portion 112 of the delivery device 100 includes the balloon 108, the nosecone 110, and a balloon shoulder assembly. A prosthetic medical device, such as a prosthetic heart valve, may be mounted on a valve-retaining portion of the balloon 108. The balloon shoulder assembly is configured to maintain the prosthetic heart valve or other medical device in a fixed position on the balloon 108 during delivery through a patient's vasculature. In some examples, the balloon shoulder assembly can include a proximal shoulder 120 and / or a distal shoulder 122 .

[0039] The balloon 108 can include a central portion (which can be generally cylindrical when inflated, as shown in FIG. 2) and two tapered end portions connected to the delivery device 100 (e.g., connected to one or more shafts and / or to the nosecone of the delivery device).

[0040] The handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device. In the illustrated example, for example, the handle 102 includes an adjustment member, such as the illustrated rotatable knob 134, that is operably coupled to a proximal end portion of a puller wire (not shown). The puller wire extends distally from the handle 102 through the outer shaft 104 and has a distal end portion that is fixed relative to the outer shaft at or near the distal end of the outer shaft 104. Rotating the knob 134 is effective to increase or decrease the tension in the puller wire, thereby adjusting the curvature of the distal end portion of the delivery device.

[0041] 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 delivery device 100.

[0042] In some examples, the delivery device (or another similar delivery device) can be configured to deploy and implant a prosthetic heart valve (e.g., prosthetic valve 10 of FIG. 1) within the native aortic annulus of a native aortic valve. Further details regarding such delivery devices can be found in U.S. Patent Application Publication No. 2007 / 0129994, which is incorporated herein by reference.

[0043] As an example, during an implantation procedure for implanting an expandable prosthetic heart valve (e.g., prosthetic valve 10 of FIG. 1 ), the distal end portion of delivery device 100 (or another similar delivery device or balloon catheter) can be advanced (over a guidewire) to the target implantation site (e.g., the native valve annulus). Balloon 108 can then be inflated to radially expand the prosthetic heart valve and implant it within the native valve annulus.

[0044] Leaflets 200 for a prosthetic heart valve, such as the prosthetic heart valve 10 of Figure 1 or the prosthetic heart valve 300 shown in Figure 5, are shown in a flattened configuration in Figure 3. Leaflets 200 may be formed from pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or a variety of other suitable natural or synthetic materials known in the art and described in U.S. Patent Application Publication No. 2006 / 0129994, which is incorporated herein by reference.

[0045] Leaflet 200 has a body 202 having a free edge 204 (which may also be referred to as an outflow edge) and a leaflet edge portion 206 (also referred to as an inflow edge portion). As described further below, leaflet edge portion 206 is configured to be attached to struts of a frame of a prosthetic heart valve, and free edge 204 is configured to move and contact the free edges of each of the other leaflets of the leaflet assembly during leaflet closure (e.g., during diastole during operation of the prosthetic heart valve).

[0046] Leaflet 200 further comprises two sets of opposing commissure tabs located on either side of leaflet 200. For example, leaflet 200 includes a pair of upper tabs 208 located on either side of leaflet 200 and a pair of lower tabs 210 located on either side of leaflet 200. Lower tabs 210 are located closer to leaflet edge portion 206 than upper tabs 208.

[0047] For example, the leaflet edge portion 206 terminates at its upper end in 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, an axial direction may be a direction parallel to the central longitudinal axis 212, and a 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 across the central longitudinal axis 212). As shown in FIG. 3 , the central longitudinal axis 212 of the leaflet 200 extends between the inflow end and the outflow end of the leaflet 200.

[0048] 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.

[0049] In some instances, such as when the frame to which the leaflets 200 are attached is non-cylindrical (e.g., tapered, frusto-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 may be less than 90 degrees, such as between 80 and 88 degrees.

[0050] 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 attached, as described in U.S. Patent Application Publication No. 2006 / 0122999, which is incorporated herein by reference.

[0051] Each lower tab 210 may have a height 216 and a width 218. The width 218 may be measured between an outer lateral edge 220 and an inner lateral edge 222 (or integral or attached edge) of the corresponding lower tab 210. The inner edge 222 of a lower tab 210 may be aligned with an inner lateral edge 228 of the adjacent upper tab 208.

[0052] A slit 226 extends laterally into the leaflet 200 from the inflow edge 224 of the lower tab 210 to a point within the body 202 of the leaflet 200 that aligns with an inner edge 228 of the adjacent upper tab 208. The slit 226 allows for attachment of corresponding upper and lower tabs 208 at their commissures, as described further below.

[0053] In some examples, as shown in Figure 3, the outer edge 220 and inner edge 222 of each lower tab 210 are parallel to the central longitudinal axis 212. In some examples, as shown in Figure 3, the inflow edge 224 and outflow edge 214 of each lower tab are perpendicular to the central longitudinal axis 212.

[0054] 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 may be referred to as side edges and are parallel to each other and to the central longitudinal axis 212 (and therefore 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.

[0055] In some examples, as shown in FIG. 3, the inner edge 228 and outer edge 230 of each upper tab 208 are parallel to the outer edge 220 of the respective lower tab 210.

[0056] Each upper tab 208 has a height 238 and a width 240. The width 240 of the upper tabs 208 is greater than the width 218 of the lower tabs 210. Thus, the outer edge 230 of each upper tab 208 extends laterally outward, away from the body 202 of the valve leaflet 200, further than the outer edge 220 of the respective lower tab 210. As described further below, this allows for easier and more accurate assembly of the commissures to the frame, thereby ensuring that the valve can open as wide as possible during operation of the prosthetic heart valve.

[0057] 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). 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 can include a relatively straight outer edge 242 that extends between the inflow edge 234 of the corresponding upper tab 208 and the outflow edge 214 of the corresponding lower tab 210.

[0058] Each offset portion 236 also includes 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 valve 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 valve leaflet 200.

[0059] The offset portion 236 has 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 during operation and reducing the pressure gradient across the prosthetic valve (as described further below).

[0060] In some examples, the width 246 of the offset portion 236 may be less than half the width 218 of the lower tab 210 .

[0061] As described further below, each offset portion 236 offsets the inner edge 228 of the respective upper tab 208 laterally (or radially when attached to a frame) outward and away from the body 202 of the valve leaflet 200 when the upper tab 208 is folded over the lower tab 210, as shown in the schematic diagram of Figure 4. This reduces the likelihood that a moving portion of the valve leaflet 200 (e.g., the body 202) will come into direct contact with the inner edge 228 of the upper tab 208, thereby increasing the durability of the valve leaflet 200.

[0062] Multiple leaflets 200 (e.g., three leaflets 200) can be assembled together into a leaflet assembly or valvular structure 201 and then secured to a prosthetic heart valve frame, such as frame 302 of prosthetic valve 300 shown in Figures 5-8. Although shown secured to frame 302, leaflets 200 can be used with a variety of prosthetic heart valve frames (e.g., frame 12 of Figure 1).

[0063] As shown in Figure 5, the prosthetic valve 300 has a valve structure 201 including an inflow end 304, an outflow end 306, and a plurality of (e.g., three) valve leaflets 200 coupled to and supported by a frame 302. The prosthetic valve 300 may further include an inner skirt and / or an outer skirt, although such components are omitted from Figure 5 for illustrative purposes. An example of such an inner skirt and outer skirt secured to the frame 302 is shown in Figures 13A-15, described below.

[0064] The frame 302 can include a plurality of interconnected struts 308 arranged in multiple rows 308 of angled struts 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 commissural windows 312, adapted to mount the commissures 250 of the valvular structure 201 to the frame 302. For example, the commissure windows 312 can be defined by axially extending window strut portions 314 of the frame 302, which may also be referred to herein as "commissural supports" (see FIG. 6 for a more detailed view of the commissures 250, in which portions of the frame struts have been removed to better visualize the folded tabs of the leaflets 200 that form the commissures 250). As shown in FIGS. 5-8, each commissure window 312 is adapted to receive a pair of lower tabs 210 of a pair of adjacent leaflets 200 therethrough.

[0065] For example, with reference to FIG. 8 , adjacent lower tabs 210 of two adjacent leaflets 200 may be coupled together (e.g., via posts, flexible connectors, or attachment members, as further described below with reference to FIGS. 9-12B ), and the upper tabs 208 of the two adjacent leaflets 200 may be folded downward at their offset portions 236 such that the lower tabs 210 are disposed between a pair of upper tabs 208. The lower tabs 210 may then be inserted into the frame 302 through the commissure windows 312 and folded across the radially outward-facing surface 316 of the frame 302. Each lower tab 210 may be coupled to a respective upper tab 208 along a suture line. Further details regarding forming commissures 250 using flexible connectors 252 are described below with reference to FIGS. 9-12B .

[0066] Further details regarding frame 302 and other similar frames that may be used and assembled with leaflet 200 as described herein may be found in U.S. Patent No. 6,229,999, which is incorporated herein by reference, and U.S. Patent No. 6,229,999, which was previously incorporated by reference above.

[0067] During typical valve operation, the leaflets 200 transition between a closed state during diastole, in which their free edges 204 (outflow edges) coapt against one another, and an open state (see, e.g., FIG. 7B ), allowing 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 can have valve structures attached to a frame in such a way that the outflow edges of each leaflet are spaced radially inward of the frame to prevent abrasion of the leaflets as they open under blood flow. In such valves, the effective outflow orifice (e.g., determined by the position of the leaflets), also referred to as the geometric orifice area (GOA), can be narrower than the inflow orifice, generating a relatively high pressure gradient across the prosthetic valve. Therefore, and particularly when small-diameter valves are used, it is preferable to provide a large outflow orifice during systole to prevent elevated pressure gradients.

[0068] As shown in FIGS. 7A and 7B (FIG. 7B shows the valve in a fully open state), the leaflet 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) compared to the size of the outflow orifice 352 defined by the outflow edge 306 of the frame 302. As used herein, the term "GOA" is defined as the open space through which blood can flow when the leaflet structure 201 is in an open configuration. The GOA 350 of the outflow 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 leaflets 200 to the frame 302 in a manner such 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.

[0069] 3, the design of the valve leaflets 200 advantageously maximizes the GOA of the prosthetic valve 300 and reduces pressure gradients across the prosthetic valve 300 compared to other, differently configured leaflets. Specifically, the relatively narrower offset portion 236, the wider upper tabs 208 having outer edges 230 that extend laterally outward farther than the outer edges 220 of the lower tabs 210, and the longer free edges 204 of the leaflets allow the valvular structure 201 to open wider during valve operation (e.g., during systole), thereby reducing pressure gradients across the prosthetic valve 300.

[0070] 16 and 17, respectively, valve B, which includes a valvular structure (e.g., valve 300) that includes leaflet 200, has a lower pressure gradient across the valve than a different valve A, which includes a valvular structure with a differently configured leaflet (e.g., a leaflet without the geometric advantages described above for leaflet 200), but is an otherwise similarly constructed valve. Specifically, the leaflets of valve A do not include wider upper tabs, vertical inner and outer edges of the upper tabs, or narrower offset portions that increase the length of the outflow edges of the leaflets, as described herein for leaflet 200.

[0071] Specifically, graph 400 shows a plot of the pressure gradient across the valve for valves A and B having a first size, and graph 420 shows a plot of the pressure gradient across the valve for valves A and B having a second size during steady forward flow through the valve (e.g., during valve operation). In graph 400, valves A and B are 20 mm diameter valves, and in graph 420, valves A and B are 23 mm diameter valves.

[0072] As shown in the graph, it can be seen that a prosthetic valve including leaflet 200 (Valve B) experiences a substantially lower pressure gradient across the valve during forward flow through the valve than another valve not including leaflet 200 (Valve A).

[0073] Additionally, the configuration of the upper tabs 208 and offset portion 236 of the valve leaflets 200 can provide increased durability, which can extend the lifespan of the prosthetic valve 300. For example, during operation of the prosthetic valve 300, as the leaflets 200 transition to a closed state (e.g., during diastole), an inwardly directed force is applied to the commissures 250, bending the leaflets 200 in a direction oriented inward relative to the commissures 250. This is shown in the schematic diagram of FIG. 4, which illustrates the upper tabs 208 folded over their respective lower tabs 210 at the offset portion 236, and an inwardly directed force 261 (toward the central longitudinal axis of the prosthetic valve 300). The smoother, arcuate shape of the offset portion 236 spreads stress across the bending region between the upper and lower tabs 208, 210, thereby reducing stress concentrations in the bending region and maintaining the structural integrity of the valve leaflets 200 and commissures 250. Additionally, as described above, the offset portion 236 offsets the inner edge 228 of the upper tab 208 away from the moving portion of the body 202 and leaflet 200. As a result, the durability of the leaflet 200 is further increased.

[0074] 9-13B, the assembly of the commissures 250 to the commissure windows 312 of the frame 302 is shown in more detail. As introduced above, the leaflets 200 can be secured to one another at their adjacent sides to form the commissures 250 of the valvular structure 201. Multiple flexible connectors 252 (one of which is shown in FIGS. 9-12B) can be used to interconnect pairs of adjacent sides of the leaflets 200 and to attach the leaflets 200 to the axially extending window strut portions 314 to form the commissure windows 312.

[0075] The flexible connectors 252 may be made from a piece of woven PET fabric, although other synthetic and / or natural materials may be used. Each flexible connector 252 may include a wedge 254 extending from the lower edge to the upper edge at the center of the flexible connector 252. The wedge 254 may include a piece of non-metallic material, such as a single piece of Ethibond 2-0 suture material, secured to the flexible connector 252 with temporary sutures. The wedge 254, when secured to the axially extending window strut portions 314, helps prevent rotational movement of the leaflet tabs. In some examples, the connectors 252 may have a series of medial and lateral notches formed along their upper and lower edges to aid in alignment with the leaflet tabs during assembly of the commissures 250.

[0076] 9 and 10 show adjacent sides of two leaflets 200 interconnected by flexible connector 252 (FIG. 9 shows a first side view and FIG. 10 shows an opposite second side view). Opposing end portions of flexible connector 252 can be positioned in overlapping relationship with lower tab 210, with an inner notch (which in some instances can be a V-shaped notch, or in some instances a marker) aligned with outer edge 220 of lower tab 210.

[0077] Each lower tab 210 can be secured to a corresponding end portion of the flexible connector 252 by suturing along a line extending from an outer notch or marker on the lower edge of the connector 252 to an outer notch or marker on the upper edge, thereby forming a suture line 256 (FIG. 10). Three leaflets 200 can be secured next to each other using three flexible connectors 252 to form the valvular structure 201.

[0078] Figure 12A is a cross-sectional view and Figure 12B is a top view of a portion of the frame 302 and valvular structure 201 showing adjacent commissure tabs of two leaflets 200 secured to corresponding axially extending window strut portions 314. Figure 11 shows an exemplary approach for positioning the commissure tabs of two adjacent leaflets 200 within the commissure windows 312 formed by the axially extending window strut portions 314.

[0079] Prior to 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 widthwise (e.g., into the page in FIG. 9 ) and the upper tabs 208 are folded downward (over the lower tabs 210) relative to the flexible connectors 252.

[0080] Each upper tab 208 is folded lengthwise (vertically) to assume an L-shape with an inner portion 258 folded against the inner surface of the leaflet 200 and an outer portion 260 folded against the connector 252 (FIGS. 11-12B). The outer portion 260 may then be sutured to the connector 252 along 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 corresponding axially extending window strut portions 314, as shown in FIG.

[0081] The connectors 252 and lower tabs 210 extending through the commissure windows 312 can then be pushed radially inward at the center of the connectors 252 (e.g., with a wedge 254), so that one of the lower tabs 210 and a portion of the connector 252 is folded against the frame 302 on one side of the axially extending window strut portion 314, and the other lower tab 210 and a portion of the connector 252 is folded against the frame 302 on the other side of the axially extending window strut portion 314 (Figure 12B).

[0082] A pair of sutures 264 may be formed to hold 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 with a primary suture 266 that extends through one layer of the connector 252, the lower tab 210, another layer of the connector 252, another layer of the connector 252, and the upper tab 208, as shown in FIG. 12A.

[0083] As shown in FIGS. 11-12B , the outer edge 230 of the upper tab 208 aligns with the edge of the flexible connector 252 (with no lateral gap between them). This alignment is made possible by the larger width 240 of the upper tab 208 (as described above with reference to FIGS. 3 and 4 ). Being able to align the edge of the flexible connector 252 with the outer edge 230 of the upper tab 208 makes the assembly process easier and more accurate (e.g., reducing valve-to-valve variability and increasing consistency). As a result, all of the leaflets 200 of the valvular structure 201 are more likely to be evenly positioned within the frame, thereby ensuring the greatest possible GOA.

[0084] In some instances, as shown in FIG. 12A, the suture material used to form the primary suture 266 may also be used to form whip stitches 268 at the edges of the lower tab 210 and upper tab 208 that extend through the two layers of connector 252 sandwiched between the upper tab 208 and lower tab 210.

[0085] Rather than articulating around the axial struts of the commissure windows 312, the leaflets 200 articulate primarily at the inner edges 270 of the folded inner portions 258 in response to blood flowing through the valve during operation in the body.

[0086] In some examples, an inner skirt and an outer skirt (such as the inner skirt 16 and outer skirt 18 of the prosthetic valve 10 of FIG. 1) can be secured to a frame 302 to form the prosthetic valve 300. For example, as shown in FIGS. 13A and 13B, after all three commissures 250 are secured to their respective commissure windows 312, the leaflet edge portions 206 of the leaflets 200 can be sutured to the inner skirt 360 ( FIG. 13A ). The inner skirt 360 can be attached to the fourth row 362 of angled struts of the frame 302, for example, with a plurality of whip stitches 364. The inner skirt 360 is then further attached to the first row 366 of angled struts that define the inflow end 304 of the frame 302, for example, with a plurality of whip stitches 368.

[0087] As shown in FIG. 13B, the outer skirt 370 is then positioned around the outer surface of the frame 302 and attached, along with the inner skirt 360, to the third row 372 of angled struts with a plurality of whip stitches 374 (schematically indicated by arrows in FIG. 14). In this manner, the same stitch line containing the stitches 374 is used to attach both the outer skirt 370 and the inner skirt 360 to the third row 372 of angled struts. In some instances, as shown in FIGS. 14 and 15, the line of whip stitches 374 has a single knot tail 376 formed around one of the angled struts of the third row 372 of angled struts that is positioned below the commissure window 312. By utilizing only a single knot tail 376 and by using the same stitch line to secure the outer skirt 370 and inner skirt 360 to the third row of angled struts 372, the total number of knot tails used to assemble the valve is minimized, thereby making the assembly process easier and minimizing material interaction with the valve leaflets 200. For example, the likelihood of a single knot tail being pushed towards the valve leaflets 200 is reduced, thereby increasing the durability of the valve leaflets 200.

[0088] As shown in Figure 13B, the outer skirt 370 may then be attached to the second row of angled struts 378 (e.g., with multiple whip stitches) and then to the first row of angled struts 366 (e.g., with multiple whip stitches). The second row of angled struts 378 and the first row of angled struts 366 are shown in Figure 13A (with the outer skirt 370 removed) and are indicated by arrows in Figure 13B to indicate their position under the outer skirt 370.

[0089] Further details regarding the assembly of leaflets 200 onto frame 302, or similar prosthetic valve frames, can be found in US Pat. No. 6,223,999, previously incorporated by reference above.

[0090] delivery technology To implant a prosthetic valve into the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath and allowing it to self-expand). Alternatively, the prosthetic valve can be implanted within the native aortic valve via a transapical procedure, in which the prosthetic valve (on the distal end 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 aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a right parasternal minithoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0091] To implant a prosthetic valve into the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into the inferior vena cava and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted into the native mitral valve via a transapical procedure, in which the prosthetic valve (on the distal end 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 inside the native mitral valve.

[0092] To implant the prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used to implant a prosthetic valve within the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0093] Another delivery approach is the transatrial approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (of the right or left atrium) to access either of the native heart valves. Atrial delivery can also be performed intravascularly, such as through a pulmonary vein. Yet another delivery approach is the transventricular approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve within the native tricuspid valve, within the native pulmonary valve, or within the pulmonary artery.

[0094] In all delivery approaches, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches 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 any of a variety of delivery devices known in the art.

[0095] Any system, device, apparatus, etc. herein can be sterilized (e.g., using heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use on patients, and any method herein can include sterilizing the associated system, device, apparatus, etc. as one of the steps in the method. Examples of heat sterilization include steam sterilization and autoclave sterilization. Examples of radiation for use in sterilization include, but are not limited to, gamma rays, ultraviolet light, and electron beams. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Hydrogen peroxide sterilization can be achieved, for example, using hydrogen peroxide plasma.

[0096] Additional Examples of the Disclosed Techniques In view of the above-described implementations of the disclosed subject matter, the present application discloses the following additional embodiments: It should be noted that one feature individually in an embodiment, or two or more features in combination in that embodiment, and optionally in combination with one or more features in one or more additional embodiments, are also additional embodiments within the disclosure of the present application.

[0097] Example 1. A leaflet for a prosthetic valve comprising: a body having a free outflow edge and a leaflet portion; two lower tabs disposed on either side of the body, where the leaflet portion terminates at its upper end at the lower tab and the lower tabs extend laterally outward from the body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on either side of the body and extending laterally outward from the body; and two offset portions, each extending between a respective lower and upper tab and offsetting a respective upper tab axially and laterally away from the outflow edge of the body, each upper tab having opposing inner and outer edges that are parallel to each other and disposed parallel to the central longitudinal axis of the leaflet. Example 2. A valve leaflet as described in any example herein, particularly Example 1, wherein each lower tab has an outer edge that is laterally offset from the body and aligned parallel to the central longitudinal axis of the leaflet and the outer edge of the respective upper tab. Example 3. A valve leaflet as described in any example herein, particularly Example 1 or Example 2, wherein the outer edge of each upper tab extends laterally outward farther relative to the central longitudinal axis of the valve leaflet than the outer edge of the respective lower tab. Example 4. The valve leaflet of any example herein, particularly any one of Examples 1-3, wherein each of the two upper tabs has a width greater than each of the lower tabs, the width extending perpendicular to the central longitudinal axis of the valve leaflet. Example 5. The valve leaflet of any example herein, particularly any one of Examples 1-4, wherein each upper tab has an outflow edge and an inflow edge located opposite the outflow edge, the inflow edges being located closer to the respective lower tab than the outflow edges, and the inflow and outflow edges are perpendicular to the inner and outer edges of the upper tabs. Example 6. The valve leaflet of any example herein, particularly any one of Examples 1-5, wherein each offset portion has an outer edge extending between the inflow edge of the respective upper tab and the outflow edge of the respective lower tab, and an arcuate inner edge curving between the inner edge of the respective upper tab and the outflow edge of the body. Example 7. The leaflet of any example herein, particularly example 6, wherein the arcuate inner edge curves 90 degrees between the inner edge of each upper tab and the outflow edge of the body. Example 8. The leaflet of 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 valve leaflet of any example herein, particularly any one of Examples 1-8, wherein the width of each offset portion is less than half the width of each lower tab, and the outflow edge of the body extends between the two offset portions. Example 10. A prosthetic heart valve comprising a plurality of leaflets as described in any example herein, particularly any one of Examples 1-9, wherein for each leaflet, an upper tab is folded over a respective lower tab. Example 11. A prosthetic heart valve as described in any example herein, particularly example 10, wherein a leaflet edge portion of each leaflet is attached to the struts of the frame of the prosthetic heart valve via the 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. Example 12. A leaflet for a prosthetic valve, comprising: a body having a free edge and a leaflet portion, the free edge being disposed at the outflow end of the leaflet; two lower tabs disposed on either side of the body, the leaflet portion terminating at its upper end at the lower tab, the lower tabs extending laterally outward from the body relative to a central longitudinal axis of the leaflet; two upper tabs disposed on either side of the body and extending laterally outward from the body; and two offset portions, each offset portion extending laterally outward from a respective and two offset portions extending between the lower and upper tabs, offsetting each 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 greater than a second width of each of the two lower tabs, such that an outer edge of each upper tab extends laterally outward farther from a central longitudinal axis of the valve 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 valve leaflet. Example 13. The leaflet of any example herein, especially Example 12, wherein the outer edges of the upper and lower tabs are parallel to the central longitudinal axis of the leaflet. Example 14. A valve leaflet as described in any of the examples herein, particularly Example 12 or Example 13, wherein each upper tab has an inner edge disposed opposite the outer edge, and the inner and outer edges of each upper tab are parallel to the central longitudinal axis of the valve leaflet. Example 15. A valve leaflet as described in any example herein, particularly any one of Examples 12-14, wherein each upper tab has opposing inflow and outflow edges that are perpendicular to the central longitudinal axis of the valve leaflet, and the inflow edges are positioned closer to the free edge of the body than the outflow edges. Example 16. The valve leaflet of any example herein, particularly any one of Examples 12-15, wherein each offset portion has an outer edge extending between the inflow edge of the respective upper tab and the outflow edge of the respective lower tab, and an arcuate inner edge curving between the inner edge of the respective upper tab and the free edge of the body. Example 17 The leaflet of any example herein, particularly example 16, wherein the arcuate inner edge curves 90 degrees between the inner edge of each upper tab and the free edge of the body. Example 18. The leaflet of 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 valve leaflet of any example herein, particularly any one of Examples 12-18, wherein the width of each offset portion is less than half the width of each lower tab, and the free edge of the body extends between the two offset portions. Example 20. A prosthetic heart valve comprising a plurality of leaflets as described in any example herein, particularly any one of Examples 12-19, wherein for each leaflet, an upper tab is folded over a respective lower tab. Example 21. A prosthetic heart valve as described in any example herein, particularly example 20, wherein a leaflet 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 a free 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. Example 22. A valve leaflet for an artificial valve, comprising: a body having a free edge disposed at the outflow end and a leaflet portion defining an inflow end; two lower tabs disposed on either side of the body, wherein the leaflet portion terminates at its upper end at the lower tab, and the lower tab extends laterally outward from the body relative to a central longitudinal axis of the valve leaflet; two upper tabs disposed on either side of the body and extending laterally outward from the body; and two offset portions, each extending between the respective lower and upper tabs and offsetting the respective upper tabs axially and laterally away from the free edge of the body, each offset portion having an outer edge extending between the inflow edge of the respective upper tab and the 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, 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 valve 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 the second width of the lower tab. Example 24. A valve leaflet as described in any of the examples herein, particularly example 22 or example 23, wherein the arcuate inner edge of each offset portion curves 90 degrees between the inner edge of the respective upper tab and the free edge of the body. Example 25. The valve leaflet of any example herein, particularly any one of Examples 22-24, wherein the outer edge of each offset portion extends parallel to the central longitudinal axis of the valve leaflet. Example 26. A valve leaflet described in any example herein, particularly any one of Examples 22-25, wherein each upper tab has an outer edge disposed opposite the inner edge of the upper tab, and the inner and outer edges of each upper tab are parallel to the central longitudinal axis of the valve leaflet. Example 27. A valve leaflet as described in any example herein, particularly example 26, wherein each lower tab has an outer edge that is laterally offset from the body and aligned parallel to the central longitudinal axis of the leaflet and the outer edge of the respective upper tab. Example 28. The valve leaflet of any example herein, particularly example 27, wherein the outer edge of each upper tab extends laterally outward farther relative to the central longitudinal axis of the valve leaflet than the outer edge of the respective lower tab. Example 29. The valve leaflet of any example herein, particularly any one of Examples 22-28, wherein each of the two upper tabs has a width greater than each of the two lower tabs, the width extending perpendicular to the central longitudinal axis of the valve leaflet. Example 30. A valve leaflet as described in any example herein, particularly any one of Examples 22-29, wherein each upper tab has an outflow edge disposed opposite its inflow edge, the inflow edges of the upper tabs are disposed closer to their respective lower tabs than the outflow edges of the upper tabs, and the inflow and outflow edges of the upper tabs are perpendicular to the inner edges of the upper tabs. Example 31. A prosthetic heart valve comprising a plurality of leaflets as described in any example herein, particularly any one of Examples 22-30, wherein for each leaflet, an upper tab is folded over a respective lower tab. Example 32. A prosthetic heart valve as described in any example herein, particularly example 31, wherein a leaflet 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 a free 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. Example 33. A prosthetic heart valve comprising: a frame radially expandable and collapsible between a radially expanded configuration and a radially collapsed configuration, the frame comprising 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 valvular structure mounted on the inside of the frame and comprising a plurality of leaflets, each leaflet comprising a body having a free outflow edge and a leaflet edge portion, a pair of lower tabs disposed on either side of the body, and a pair of upper tabs disposed on either side of the body, the pairs of lower and upper tabs of adjacent leaflets being paired to form commissures secured to respective commissure windows of the frame; and a valvular structure mounted on the periphery of the inner surface of the frame and comprising a plurality of leaflets. and an outer skirt disposed around an 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 is attached to a first row of angled struts forming the inflow end of the frame and a second row of angled struts located adjacent the outflow end of the frame, the inner skirt being attached to a first row of angled struts forming the inflow end of the frame and a second row of angled struts located adjacent the outflow end of the frame; and an outer skirt disposed around an outer surface of the frame and attached to the first row of angled struts and the third row of angled struts, the inner skirt and the outer skirt being attached together with a single stitch line to a fourth row of angled struts located between the second row of angled struts and the third row of angled struts, and a single knot tail for the single stitch line is formed around the angled struts of the fourth row of angled struts located under one of the commissure windows. 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, and a valve structure mounted inside the frame and including a plurality of leaflets as described in any of the examples herein, particularly any one 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 tabs are folded along radially extending folds. Example 36. A prosthetic valve as described in any example herein, particularly example 34, wherein the valve structure comprises a plurality of commissures, each of which includes folded upper and lower tabs of one leaflet and folded upper and lower tabs of an adjacent leaflet. Example 37 The prosthetic valve of any example herein, particularly example 35, wherein the lower tab of each commissure extends through a commissure window in the frame. Example 38 The prosthetic valve of any example herein, particularly example 35 or 36, wherein the folded upper tab is positioned inside the frame. Example 39. A prosthetic valve described in any example herein, particularly any one of Examples 35-37, wherein each folded upper tab is further folded along an axially extending fold such that a first portion of the upper tab is positioned relative to the body of the respective valve leaflet and a second portion of the upper tab extends in a different plane than the first portion. Example 40. A prosthetic heart valve according to any one of Examples 1 to 39, having improved hemodynamic performance. Example 41. A prosthetic heart valve according to any one of Examples 1 to 39, having improved leaflet durability. Example 42. A prosthetic heart valve according to any one of Examples 1 to 39, having improved hemodynamic performance and improved leaflet durability. Example 43. A method comprising sterilizing the valve leaflet, prosthetic heart valve, device, and / or assembly of any example. Example 44. The prosthetic heart valve of any one of Examples 1 to 39, wherein the prosthetic heart valve is sterilized.

[0098] Each feature described herein with respect to any embodiment may be combined with other features described in any one or more other embodiments, unless otherwise stated. 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.

[0099] In view of the many possible manners to which the principles of the present disclosure may be applied, it will be recognized that the illustrated configurations are illustrative examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure and the claims. Rather, the scope of claimed subject matter is defined by the following claims, and their equivalents.

Claims

1. A valve leaflet for an artificial valve, comprising: a body having a free outflow edge and a pointed portion; two lower tabs disposed on opposite sides of the body, the cusp portions terminating at their upper ends at the lower tabs and extending 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 upper tab and offsetting the respective upper tab axially and laterally away from the outflow edge of the body, each upper tab having opposing inner and outer edges that are parallel to one another and disposed parallel to the central longitudinal axis of the valve leaflet.

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

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

4. 4. The valve leaflet of claim 1, wherein each upper tab has an outflow edge and an inflow edge located opposite the outflow edge, the inflow edge being located closer to the respective lower tab than the outflow edge, and the inflow and outflow edges are perpendicular to the inner and outer edges of the upper tab.

5. 5. The valve leaflet of claim 1, 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 curving between the inner edge of the respective upper tab and the outflow edge of the body.

6. The valve leaflet of claim 5 , wherein the arcuate inner edge forms a 90 degree curve between the inner edge of the respective upper tab and the outflow edge of the body.

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

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

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

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

11. A valve leaflet for an artificial valve, comprising: a body having a free edge and a leaflet portion, the free edge being disposed at the outflow end of the leaflet; two lower tabs disposed on opposite sides of the body, the cusp portions terminating at their upper ends at the lower tabs and extending 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 and 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 greater than a second width of each of the two lower tabs, such that an outer edge of each upper tab extends laterally outward farther than an outer edge of a respective lower tab, relative to the central longitudinal axis of the valve leaflet, and wherein the first width and the second width extend perpendicular to the central longitudinal axis of the valve leaflet.

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

13. 13. The valve leaflet of claim 11 or 12, wherein each upper tab has an inner edge disposed opposite the outer edge, the inner edge and the outer edge of each upper tab being parallel to the central longitudinal axis of the leaflet.

14. 14. The valve leaflet of claim 11, wherein each upper tab has opposing inflow and outflow edges that are perpendicular to the central longitudinal axis of the leaflet, the inflow edges being located closer to the free edge of the body than the outflow edges.

15. 15. The valve leaflet of claim 11, 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 curving between the inner edge of the respective upper tab and the free edge of the body.

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

17. A valve leaflet for an artificial valve, comprising: a body having a free edge disposed at an outflow end and a pointed portion defining an inflow end; two lower tabs disposed on opposite sides of the body, the cusp portions terminating at their upper ends at the lower tabs and extending 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 upper tab and offsetting the respective upper tab axially and laterally away from the free edge of the body, each offset portion having 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 curving between an inner edge of the respective upper tab and the free edge of the body, the inner edge of each offset portion being disposed closer to the central longitudinal axis than the outer edge of the offset portion.

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

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

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

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