Prosthetic heart valve leaflet assemblies, and assembly methods

Abstract

To provide methods of assembling valve leaflet assemblies.SOLUTION: A method includes the steps of: forming leaflet sub-assemblies 110 by a step of placing a skirt 142 on one side of a leaflet 130 such that the skirt 142 extends along a curved cusp edge portion and two commissure tabs 132 of the leaflet 130, a step of folding two end portions of the skirt 142 around corresponding commissure tabs 132, a step of stitching each folded end portion and a corresponding commissure tab 132 together to form a respective half commissure portion, and a step of stitching the skirt 142 and the cusp edge portion together; and forming a leaflet assembly 110 by pairing each half commissure portion of each leaflet sub-assembly 110 with a half commissure portion of another leaflet sub-assembly 110 so as to form a plurality of pairs of adjacent half commissure portions, and for each of the pairs, stitching the adjacent half commissure portions together to form a commissure.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] [CROSS REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Application No. 62 / 928,993, entitled "PROSTHETIC HEART VALVE LEAFLET ASSEMBLIES AND METHODS," filed October 31, 2019, which is incorporated by reference in its entirety.

[0002] The present disclosure relates to prosthetic heart valves, and methods and assemblies for forming leaflet assemblies and mounting the leaflet assemblies to frames of such prosthetic heart valves. [Background technology]

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

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

[0005] Most expandable transcatheter heart valves include a cylindrical metal frame or stent and prosthetic leaflets mounted inside the frame. Typically, the leaflets are secured to a peripheral skirt and attached to the inner surface of the prosthetic frame. Such a conventional skirt can serve as a mounting surface for the leaflets of the valve while establishing a seal with the native tissue when the prosthetic valve is placed at the implantation site. However, the skirt may extend around the entire inner surface of the frame, and mounting multiple leaflets (e.g., three leaflets) to the skirt is time-consuming and requires precise assembly skills to ensure proper mounting. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] US Patent Application Publication No. 2018 / 0153689 [Patent Document 2] US Patent Application Publication No. 2018 / 0344456 [Patent Document 3] U.S. Patent Application Publication No. 2019 / 0060057 [Patent Document 4] US Patent Application Publication No. 2018 / 0325665 [Patent Document 5] U.S. Patent No. 6,730,118 [Patent Document 6] U.S. Patent No. 7,393,360 [Patent Document 7] U.S. Patent No. 7,510,575 [Patent Document 8] U.S. Patent No. 7,993,394 [Patent Document 9] U.S. Patent No. 8,652,202 Summary of the Invention [Problem to be solved by the invention]

[0007] Therefore, there is a need for an improved prosthetic heart valve leaflet assembly and method for assembling the leaflet assembly to a prosthetic heart valve frame. [Means for solving the problem]

[0008] Described herein are methods for assembling a prosthetic heart valve including a leaflet assembly, methods for assembling leaflet subassemblies of a leaflet assembly, and embodiments of a prosthetic heart valve including a leaflet assembly. In some embodiments, a leaflet assembly for a prosthetic heart valve may be comprised of a plurality of leaflet subassemblies that are assembled individually and then connected together at adjacent half-commissure portions to form commissures adapted to be coupled to a commissure support portion of a frame of the prosthetic heart valve. In some embodiments, each leaflet subassembly may include a skirt and a leaflet, and may be formed by: placing the skirt on one side of the leaflet such that the skirt extends along the curved leaflet edge portion of the leaflet and two commissure tabs of the leaflet; folding two end portions of the skirt around the corresponding commissure tabs of the leaflet; sewing each folded end portion to the corresponding one of the two commissure tabs to form a respective half-commissure portion of the leaflet subassembly; and sewing the skirt to the leaflet edge portion.

[0009] In one exemplary embodiment, a method of assembling a prosthetic heart valve including a leaflet assembly includes forming a plurality of leaflet subassemblies, each including a leaflet and a skirt, each leaflet subassembly including a leaflet and a skirt, the steps of: placing a skirt on one side of a leaflet such that the skirt extends along a curved leaflet portion of the leaflet and along two commissure tabs of the leaflet; folding two end portions of the skirt around corresponding commissure tabs of the leaflet; and sewing each folded end portion to a corresponding one of the two commissure tabs to form a respective one of the commissure portions of the leaflet subassembly. and sewing the skirt to the leaflet edge portions of the leaflets; pairing each half commissure portion of each leaflet subassembly with a half commissure portion of another leaflet subassembly of the plurality of leaflet subassemblies to form a plurality of pairs of adjacent half commissure portions, and for each pair, sewing the adjacent half commissure portions together to form a commissure of the leaflet assembly; and securing the leaflet assemblies to a frame of the prosthetic heart valve via fastening each commissure to a commissure support portion of the frame.

[0010] In some embodiments, the method may further include securing the leaflet assemblies to a frame of the prosthetic heart valve via fastening a skirt of each leaflet subassembly to a post of the frame.

[0011] In some embodiments, fastening the skirt of each leaflet subassembly to the struts of the frame includes fastening a central skirt portion of the skirt of each leaflet subassembly to a plurality of interconnected struts of the frame arranged in a grid-like pattern, the central skirt portion being disposed between two tabs of the skirt.

[0012] In some embodiments, each of the two end portions of the skirt includes a tab, and folding the two end portions of the skirt around a corresponding commissure tab of the valve leaflet includes, for each end portion and corresponding commissure tab, folding the tab around the corresponding commissure tab to form a first flap covering a first side of the commissure tab and a second flap covering a second side of the commissure tab.

[0013] In some embodiments, each leaflet subassembly further includes a reinforcing strip, and the method further includes the steps of: positioning the reinforcing strip on a side of the skirt opposite the skirt positioned on the leaflet such that the reinforcing strip extends along the curved portion of the skirt and each of the two end portions of the reinforcing strip rests on a corresponding first flap of the skirt; and sewing each folded end portion of the skirt to a corresponding commissure tab and to a corresponding end portion of the two end portions of the reinforcing strip via a first stitch.

[0014] In some embodiments, folding the two end portions of the skirt around corresponding tabs of the leaflet assembly further includes, for each end portion of the skirt and corresponding commissure tab, folding a free end portion of a first flap back onto itself to cover the corresponding end portion of the reinforcing strip to form two overlapping layers over a first side of the commissure tab, and folding a free end portion of a second flap back onto itself to form two overlapping layers over a second side of the commissure tab.

[0015] In some embodiments, the method can further include sewing the two overlapping layers on the first side of the commissure tab, the commissure tab, and the two overlapping layers on the second side of the commissure tab together via a second stitch.

[0016] In some embodiments, for each pair of adjacent half-commissure portions, sewing the adjacent half-commissure portions together to form the commissures of the leaflet assembly includes sewing the adjacent half-commissure portions together via a third stitch disposed adjacent to the first stitch, the third stitch extending through a corresponding end portion of the reinforcing strip of each leaflet subassembly.

[0017] In some embodiments, sewing adjacent half commissure portions together via a third stitch includes extending a third stitch through two overlapping layers on a first side of the commissure tab, the commissure tab, and two overlapping layers on a second side of the commissure tab for each half commissure portion of the pair of adjacent half commissure portions, hi some embodiments, the third stitch is disposed adjacent to the first stitch on a side of the first stitch facing the second stitch.

[0018] In some embodiments, sewing adjacent half commissure portions together via a third stitch includes extending a third stitch, for each half commissure portion of a pair of adjacent half commissure portions, through the two overlapping layers on a first side of the commissure tab, through the commissure tab, but not through the two overlapping layers on a second side of the commissure tab, In some embodiments, the third stitch is disposed adjacent to the first stitch on a side of the first stitch disposed opposite the first stitch facing the second stitch.

[0019] In some embodiments, sewing the skirt to the leaflet edge portion includes sewing the skirt to the leaflet edge portion via a series of visible and invisible stitches that extend through the leaflet and the skirt, along the leaflet edge portion, from a first of the two commissure tabs of the leaflet to a second of the two commissure tabs of the leaflet.

[0020] In some embodiments, the step of sewing the skirt to the leaflet edge portion via a series of visible and invisible stitches includes extending the series of visible and invisible stitches through and along a first stitch line located in a central skirt portion of the skirt extending between two end portions of the skirt.

[0021] In some embodiments, the first stitch line includes one or more external markings or holes.

[0022] In some embodiments, each leaflet subassembly further includes a reinforcing strip. The method further includes the steps of: placing the reinforcing strip on a side of the skirt opposite the skirt disposed on the leaflet such that the reinforcing strip extends along the curved portion of the skirt and each of the two end portions of the reinforcing strip rests on a corresponding first flap of the skirt; and sewing the reinforcing strip to the skirt via extending a series of visible and invisible stitches through and along a second seam line disposed along the curved central portion of the reinforcing strip. The first seam line and the second seam line are aligned with each other.

[0023] In some embodiments, for each pair of adjacent half-commissure portions, sewing the adjacent half-commissure portions together to form a commissure of the leaflet assembly includes sewing the adjacent half-commissure portions together at the bases of the two commissure portions, the base of each commissure portion being located opposite a corresponding outer edge of the commissure portion and adjacent to the tip of the corresponding leaflet.

[0024] In some embodiments, fastening each commissure to the commissure support portion of the frame includes wrapping an end portion of each commissure around its respective commissure support portion, sewing through the end portion of the commissure via one or more sutures, and tying the one or more sutures on an outer surface of the commissure support portion of the frame.

[0025] In another representative embodiment, the prosthetic heart valve can include an annular frame with a plurality of commissure support portions and a leaflet assembly supported by the frame. The leaflet assembly can include a plurality of leaflet subassemblies, each leaflet subassembly including a leaflet including a leaflet edge portion and two leaflet tabs, each leaflet tab being disposed at an opposite end of the leaflet edge portion, and a skirt including a skirt center portion and two tabs, each tab being disposed at an opposite end of the skirt center portion, each skirt tab wrapped around and secured to a corresponding leaflet tab to form a half commissure portion at either end of the leaflet subassembly. Additionally, each half commissure portion is secured to adjacent half commissure portions of adjacent leaflet subassemblies of the plurality of leaflet subassemblies to form a commissure of the leaflet assembly, each commissure being coupled to a corresponding commissure support portion of the frame.

[0026] In some embodiments, each half commissure portion is secured to an adjacent half commissure portion of an adjacent leaflet subassembly via a suture extending along and through the base of the adjacent half commissure portion, the base being positioned adjacent to the corresponding tip of the leaflet of the leaflet subassembly.

[0027] In some embodiments, the formed commissure includes two outer free ends that are positioned at opposite ends of the commissure, including the ends of adjacent commissure portions that are fixed to one another, and that are wrapped around and bonded to corresponding commissure support portions of the frame.

[0028] In some embodiments, each commissure is coupled to a corresponding commissure support portion of the frame by a series of stitches extending across an outer surface of the commissure support portion.

[0029] In some embodiments, each skirt of each leaflet subassembly is coupled to a strut of the frame.

[0030] In some embodiments, the central skirt portion of the skirt of each leaflet subassembly includes one or more positioning guides disposed along an upper portion of the central skirt portion configured to position the central skirt portion relative to the posts of the frame.

[0031] In some embodiments, the one or more positioning guides are markings on the skirt or holes formed in the skirt.

[0032] In some embodiments, for each leaflet subassembly, the central skirt portion of the skirt is secured to the leaflet edge portion of the leaflet via a series of visible and invisible stitches.

[0033] In some embodiments, for each leaflet subassembly, each of the two tabs of the skirt includes one or more positioning guides configured to position the tab of the skirt relative to a corresponding leaflet tab of the two leaflet tabs of the leaflet.

[0034] In some embodiments, each half commissure portion is formed by multiple overlapping layers of skirt tabs secured to each other and through the leaflet tabs via one or more fasteners on either side of the leaflet tab.

[0035] In some embodiments, each half commissure portion is formed by two overlapping layers of skirt tabs on a first side of the leaflet tab and two overlapping layers of leaflet tabs and skirt tabs on an opposite second side of the leaflet tab, and a fastener extends through each of the two overlapping layers of tabs on the first side of the leaflet tab and the two overlapping layers of tabs on the second side of the leaflet tab.

[0036] In some embodiments, each leaflet subassembly further comprises a reinforcing strip including a central portion and two end portions, each end portion of the two end portions being disposed at opposite ends of the central portion, and each tab of the skirt is wrapped around and secured to a corresponding leaflet tab and corresponding end portion of the reinforcing strip to form one commissure portion on either side of the leaflet subassembly.

[0037] In some embodiments, each tab of the skirt is secured to a corresponding leaflet tab and a corresponding end portion of the reinforcement strip via a first fastener extending through a corresponding end portion of the reinforcement strip, the corresponding leaflet tab, and a flap of the skirt tab located on either side of the corresponding leaflet tab.

[0038] In some embodiments, each tab of the skirt is further secured to a corresponding leaflet tab and a corresponding end portion of the reinforcing strip via a second fastener extending through two overlapping layers of the skirt tab disposed on a first side of the corresponding leaflet tab, the leaflet tab, and two overlapping layers of the skirt tab disposed on an opposite second side of the corresponding leaflet tab.

[0039] In some embodiments, the second fastener is positioned closer to the outer edge of the corresponding leaflet tab than the first fastener.

[0040] In some embodiments, the commissural support portion of the frame includes an actuator of the frame configured to apply expansion and compression forces to the frame to radially expand and compress the prosthetic valve.

[0041] In some embodiments, the commissure support portions of the frame include support struts or posts of the frame.

[0042] In some embodiments, the leaflet assembly comprises three leaflet subassemblies.

[0043] In yet another exemplary embodiment, a method of assembling a leaflet subassembly for a prosthetic valve includes the steps of: placing a skirt of the leaflet subassembly over the leaflets of the subassembly such that a curved central portion of the skirt is aligned with a curved leaflet edge portion of the leaflet and each of two tabs of the skirt overlaps a corresponding one of the two leaflet tabs of the leaflet; wrapping a tab of the skirt around a corresponding leaflet tab of the leaflet at each end of the leaflet subassembly to form a first flap covering a first side of the leaflet tab and a second flap covering a second side of the leaflet tab; and wrapping a contour of a central portion of the reinforcement strip with a contour of the leaflet edge portion of the leaflet and the two end portions of the skirt and the two end portions of the reinforcement strip over the corresponding leaflet tabs of the leaflet. The method may include the steps of placing a reinforcing strip over the skirt such that each end portion of the portion overlaps a corresponding first flap; securing an end portion of the reinforcing strip to a corresponding leaflet tab of the leaflet and a tab of the skirt at each end of the leaflet subassembly; folding a free end portion of the first flap back on itself to cover the end portion of the reinforcing strip and form two overlapping layers over a first side of the leaflet tab and folding a free end portion of the second flap back on itself to form two overlapping layers over a second side of the leaflet tab; and securing the two overlapping layers over the first side of the leaflet tab, the leaflet tab, and the two overlapping layers over the second side of the leaflet tab to one another.

[0044] In some embodiments, the method may further include securing a central portion of the skirt, an edge portion of the leaflet, and a central portion of the reinforcing strip to one another.

[0045] In some embodiments, securing the end portion of the reinforcement strip to the corresponding leaflet tab of the leaflet and the tab of the skirt includes extending a first stitch through each of the end portion of the reinforcement strip, the first flap, the leaflet tab and the second flap.

[0046] In some embodiments, the step of securing the two overlapping layers on the first side of the leaflet tab, the leaflet tab and the two overlapping layers on the second side of the leaflet tab to one another includes extending a second stitch adjacent to the first stitch and outwardly of the first stitch relative to an outer edge of the leaflet tab through each of the two overlapping layers on the first side of the leaflet tab, the leaflet tab and the two overlapping layers on the second side of the leaflet tab.

[0047] In another exemplary embodiment, a leaflet subassembly for a leaflet assembly of a prosthetic heart valve includes a leaflet including a leaflet edge portion and two leaflet tabs, each of the two leaflet tabs being disposed at an opposing end of the leaflet edge portion; a skirt center portion and two tabs, each of the two tabs being disposed at an opposing end of the skirt center portion, the skirt center portion being aligned with the leaflet edge portion of the leaflet, and a skirt being disposed against the leaflet such that each of the two tabs of the skirt overlaps a corresponding one of the two leaflet tabs of the leaflet, each tab of the skirt being aligned with the leaflet edge portion of the leaflet. The valve may include a skirt wrapped around a corresponding leaflet tab of the valve to form a first flap covering a first side of the corresponding leaflet tab and a second flap covering a second side of the corresponding leaflet tab, a central portion, and two end portions, each end portion of the two end portions comprising a reinforcing strip disposed at an opposite end of the central portion, the reinforcing strip being disposed against the skirt such that a contour of the central portion of the reinforcing strip is aligned with a contour of a leaflet edge portion of the leaflet and the central portion of the skirt and each end portion of the two end portions of the reinforcing strip overlap a corresponding first flap. For each leaflet tab, a free end portion of the corresponding first flap is folded back on itself to cover the corresponding end portion of the reinforcing strip and form two overlapping layers over the first side of the corresponding leaflet tab, and a free end portion of the corresponding second flap is folded back on itself to form two overlapping layers over the second side of the corresponding leaflet tab.

[0048] In some embodiments, for each leaflet tab, each of the corresponding end portion of the reinforcement strip, the first flap, the leaflet tab and the second flap are secured together via a first fastener.

[0049] In some embodiments, for each leaflet tab, each of the corresponding leaflet tab, the two overlapping layers on a first side of the leaflet tab, and the two overlapping layers on a second side of the leaflet tab are secured together via a second fastener.

[0050] In some embodiments, the second fastener is positioned adjacent to the first fastener and closer to the outer edge of the corresponding leaflet tab than the first fastener.

[0051] In some embodiments, the central portion of the reinforcing strip, the central skirt portion of the skirt, and the leaflet edge portion of the leaflet are secured together via additional fasteners.

[0052] In some embodiments, the additional fastening is a plurality of visible and hidden stitches.

[0053] In some embodiments, the central portion of the reinforcing strip includes a first seam line located along its center and following the curved shape of the central portion, and the central skirt portion includes a second seam line centered along the length of the central skirt portion, the first seam line and the second seam line overlapping one another.

[0054] In some embodiments, the skirt includes one or more positioning guides located along an upper portion of the central skirt portion configured as markings or holes formed in the skirt.

[0055] In some embodiments, each of the two tabs of the skirt includes one or more rows of positioning guides configured as markings or holes formed in the skirt.

[0056] In some embodiments, each of the two tabs of the skirt extends outward from one end of the skirt central portion in a direction parallel to the centerline of the skirt and perpendicular to the centerline, in a direction away from the centerline.

[0057] The above and other objects, features and advantages of the present invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings. [Brief description of the drawings]

[0058] [Figure 1] 1 is a perspective view of an exemplary embodiment of a prosthetic heart valve. [Figure 2A] FIG. 1 is a plan view of the individual components of a leaflet subassembly, including leaflets, reinforcing strips and a skirt, for a prosthetic heart valve. [Figure 2B] FIG. 1 is a plan view of the individual components of a leaflet subassembly, including leaflets, reinforcing strips and a skirt, for a prosthetic heart valve. [Figure 2C] FIG. 1 is a plan view of the individual components of a leaflet subassembly, including leaflets, reinforcing strips and a skirt, for a prosthetic heart valve. [Diagram 3] FIG. 13 is a schematic diagram of a first stage in assembling the leaflet subassembly, which involves securing the tabs of the skirt to the leaflet tabs of the leaflet. [Figure 4] FIG. 13 is a schematic diagram of a second stage of assembling the leaflet subassembly, which includes securing each of the folded layers of the skirt tab, the leaflet tab of the leaflet, and the reinforcing strip to one another to form one commissure portion of the leaflet subassembly. [Diagram 5] FIG. 13 is a schematic diagram of a third stage of assembling the leaflet subassembly, which includes securing intermediate portions of each of the leaflets, skirt and reinforcing strip relative to one another. [Figure 6A] FIG. 13 is a schematic diagram of an embodiment in which adjacent leaflet subassemblies are attached to one another to form commissures. [Figure 6B] FIG. 13 is a schematic diagram of an embodiment in which adjacent leaflet subassemblies are attached to one another to form commissures. [Figure 7A] 1 is a plan view of a portion of a first leaflet subassembly and a portion of a second leaflet subassembly positioned side-by-side in a relatively flat, two-dimensional plane such that a first half-commissural portion of the first leaflet subassembly can be secured to a second half-commissural portion of the second leaflet subassembly. [Figure 7B] FIG. 2 is a plan view of a portion of a first leaflet subassembly and a portion of a second leaflet subassembly positioned side-by-side in a relatively flat, two-dimensional plane such that a first half-commissural portion of the first leaflet subassembly can be secured to a second half-commissural portion of the second leaflet subassembly. [Figure 8] 1 is a schematic diagram illustrating one embodiment of mounting the commissures of a pair of attached leaflet subassemblies to a commissure support portion of a frame of a prosthetic heart valve. [Figure 9] FIG. 13 is a top view of an exemplary embodiment of the attachment of the commissures of a pair of leaflet subassemblies to a commissure support portion of a frame of a prosthetic heart valve. [Figure 10] FIG. 10 is a perspective view of the exemplary embodiment of FIG. [Figure 11] 10 is a first side view of the exemplary embodiment of FIG. 9, also illustrating one embodiment of attachment of the individual skirts of a pair of leaflet subassemblies to a frame of a prosthetic heart valve. [Figure 12] 10 is a second side view of the exemplary embodiment of FIG. 9, also illustrating one embodiment of attachment of the individual skirts of a pair of leaflet subassemblies to the frame of a prosthetic heart valve. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0059] Described herein are examples of prosthetic heart valves, leaflet assemblies for prosthetic heart valves, leaflet subassemblies of the leaflet assemblies, and methods for assembling the leaflet subassemblies, where the leaflet assemblies include a plurality of leaflet subassemblies, and the prosthetic heart valve includes the leaflet assembly. The prosthetic heart valve may include a frame and a leaflet assembly mounted to the frame. The leaflet assembly may include a plurality of leaflet subassemblies coupled to each other at adjacent half-commissure portions of the leaflet subassemblies. Each leaflet subassembly may include a leaflet (e.g., leaflet of a valve) and a skirt coupled to each other at half-commissure portions formed at either end of the leaflet along a leaflet edge portion. Each half-commissure portion may be formed by folding a tab of the skirt around a corresponding leaflet (e.g., commissure) tab of the leaflet and securing them to each other. The half-commissure portions of the adjacently arranged leaflet subassemblies may then be coupled to each other before being mounted to the frame of the prosthetic heart valve. As a result, the leaflet assembly for the prosthetic heart valve may be more easily assembled to the frame of the prosthetic heart valve, and the time and effort required to secure the leaflet assembly to the frame of the prosthetic heart valve may be reduced.

[0060] FIG. 1 illustrates an exemplary prosthetic heart valve 10 according to one embodiment. The prosthetic heart valve 10 may be radially compressible and expandable between a radially compressed configuration and a radially expanded configuration for delivery into a patient's body. In certain embodiments, the prosthetic heart valve 10 may be implanted within the native aortic valve annulus, although it may also be implanted elsewhere in the heart, including within the native mitral valve, native pulmonary valve, and native tricuspid valve. The prosthetic heart valve 10 may include an annular stent or frame 12 having a first end 14 and a second end 16.

[0061] In the depicted embodiment, the first end 14 is the inflow end and the second end 16 is the outflow end. The outflow end 16 is coupled to a delivery device for delivering and implanting the prosthetic heart valve inside the native aortic valve, which is a transfemoral retrograde delivery approach. Thus, in the delivery configuration of the prosthetic heart valve, the outflow end 16 is the most proximal end of the prosthetic heart valve. In other embodiments, the inflow end 14 may be coupled to a delivery device depending on the particular native valve being replaced and the delivery technique used (e.g., transseptal, transapical, etc.). For example, the inflow end 14 may be coupled to a delivery device (and thus is the most proximal end of the prosthetic heart valve in the delivery configuration) when delivering the prosthetic heart valve to the native mitral valve via a transseptal delivery approach.

[0062] The frame 12 can be made of any of a variety of suitable materials, such as stainless steel, cobalt chromium alloy, or nickel titanium alloy ("NiTi"), e.g., Nitinol. Referring again to FIG. 1, as shown, the frame 12 can include a plurality of interconnected struts 28 arranged in a lattice-like pattern. The struts 28 are shown positioned diagonally or offset at an angle relative to and radially offset from the longitudinal axis of the prosthetic heart valve 10 when the prosthetic heart valve 10 is in an expanded configuration. In other implementations, the struts 28 may be offset by different amounts than depicted in FIG. 1, or some or all of the struts 28 may be positioned parallel to the longitudinal axis of the prosthetic heart valve 10.

[0063] In the illustrated embodiment, the struts 28 are pivotally coupled to one another at one or more pivot joints along the length of each strut. For example, in the illustrated configuration, each of the struts 28 can be formed with holes at opposing ends of the strut and holes spaced along the length of the strut. Respective hinges can be formed where the struts 28 overlap one another via fasteners or pivot members, such as rivets or pins 30, that extend through the holes. The hinges can allow the struts 28 to pivot relative to one another when the frame 12 is radially expanded or compressed, such as during assembly, preparation, or implantation of the prosthetic heart valve 10.

[0064] In some embodiments, the frame 12 can be constructed by forming individual components (e.g., frame posts and fasteners) and then mechanically assembling and connecting the individual components together. In other embodiments, the posts 28 are not coupled to each other at respective hinges, but are otherwise pivotable or bendable relative to each other to allow radial expansion and contraction of the frame 12. For example, the frame 12 can be formed (e.g., via laser cutting, electroforming, or physical vapor deposition) from a single piece of material (e.g., a metal tube). Further details regarding the construction of frames and prosthetic heart valves are described in U.S. Patent Application Publication Nos. 2018 / 0153689, 2018 / 0344456, and 2019 / 0060057, all of which are incorporated herein by reference.

[0065] The prosthetic heart valve 10 may also include a valve structure 18 coupled to the frame 12 and configured to regulate the flow of blood through the prosthetic heart valve 10 from the inflow end 14 to the outflow end 16. The prosthetic heart valve 10 may further include a plurality of actuators 80 disposed on and evenly spaced about the inner surface of the frame 12. The actuators are configured to apply frame expansion and compression forces to radially expand and compress the prosthetic valve.

[0066] In the illustrated embodiment, the actuators 80 are linear actuators, each of which includes an inner member or piston 90 and an outer member or cylinder 92. The inner member 90 is pivotally coupled to a connection of the frame, such as the first end 14, while the outer member 92 is pivotally coupled to another connection of the frame closer to the second end 16. Moving the inner member 90 proximally relative to the outer member 92 and / or moving the outer member 92 distally relative to the inner member 90 is effective to radially expand the prosthetic valve. Conversely, moving the inner member 90 distally relative to the outer member 92 and / or moving the outer member 92 proximally relative to the inner member 90 is effective to radially compress the prosthetic valve. The actuators 80 can include a locking mechanism configured to hold the prosthetic valve in an expanded state within the patient.

[0067] In some embodiments, each of the actuators 80 can be configured to form a releasable connection with one or more respective actuators of a delivery device of the transcatheter delivery system. The actuator of the delivery device can transmit force from the handle of the delivery device to the actuator 80 for expansion or compression of the prosthetic valve. Further details of the actuators, locking mechanisms and delivery devices for actuating the actuators can be found in U.S. Patent Application Publication Nos. 2018 / 0153689, 2019 / 0060057 and 2018 / 0325665, each of which is incorporated herein by reference in its entirety. Any of the actuators and locking mechanisms disclosed in the previously filed applications can be incorporated into any of the prosthetic valves disclosed herein. Additionally, any of the delivery devices disclosed in the previously filed applications can be used to deliver and implant any of the prosthetic valves disclosed herein.

[0068] In some embodiments, each of the actuators 80 can be used to support a respective commissure 24 (described below). Thus, the actuators 80 can include a commissure support portion for supporting the commissures 24 of the valvular structure 18 and attaching the commissures 24 to the frame 12, as described further herein.

[0069] The valve structure 18 may include a leaflet assembly with one or more leaflets 22 (in the illustrated embodiment, three leaflets 22) made of, for example, a flexible material. The leaflets 22 of the leaflet assembly may be made entirely or in part from a biomaterial, a biocompatible synthetic material, or other such material. Suitable biomaterials may include, for example, bovine pericardium (or pericardium from other sources). The leaflets 22 may be arranged to form commissures 24, which may be located, for example, on the commissure support portions of the respective actuators 80. Further details regarding transcatheter prosthetic heart valves, including methods by which valve structures may be coupled to the frame 12 of the prosthetic heart valve 10, can be found, for example, in U.S. Pat. Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,652,202, and U.S. Patent Application Publication No. 2018 / 0325665, all of which are incorporated by reference herein in their entirety.

[0070] 1, the commissures 24 may be attached (e.g., sutured) directly to the commissure support portions of the actuators 80 of the frame 12 via commissure attachments 26. As an example, the commissure attachments 26 may include one or more stitches that secure the commissures 24 to the corresponding actuators 80. In other embodiments, the commissures 24 may be attached to support struts or posts of the frame that are separate from the actuators 80.

[0071] The prosthetic heart valve 10 may also include one or more skirts or sealing members. For example, as shown in FIG. 1, the prosthetic heart valve 10 may include an internal skirt 20 mounted on an inner surface of the frame 12. As shown in FIG. 1, the internal skirt 20 is a peripheral internal skirt that runs around the entire periphery of the inner surface of the frame 12. The internal skirt 20 may function as a sealing member to prevent or reduce perivalvular leakage (e.g., when the valve is positioned at an implantation site) and as a mounting surface for anchoring the leaflets 22 to the frame 12.

[0072] The prosthetic heart valve 10 may also include an outer skirt mounted on the exterior surface of the frame 12 (not shown in FIG. 1). The outer skirt may function as a sealing member for the prosthetic valve by sealing against the tissue of the native valve annulus and helping to reduce paravalvular leakage beyond the prosthetic valve. The inner and outer skirts may be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials (e.g., PET) or natural tissues (e.g., pericardial tissue). The inner and outer skirts may be attached to the frame using sutures, adhesives, welding, and / or other means for attaching the skirts to the frame.

[0073] Because the internal skirt 20 spans the entire inner surface of the frame 12, attachment of multiple leaflets (e.g., three leaflets) 22 to the internal skirt 20 is time consuming and requires precise assembly skills to avoid possible defects throughout the process. Although the skirt 20 is effective in securing the leaflets to the frame, discontinuities 82 may form in the attachment areas of the leaflets 22 and the internal skirt 20 near the corresponding commissure attachments 26 to the frame 12.

[0074] Thus, it may be desirable to separately assemble each leaflet of the leaflet assembly with its individual skirt and leaflet. For example, the leaflet assembly may include a plurality of separately formed leaflet subassemblies, each of which includes a skirt and a leaflet that are secured together at the leaflet edge portion and the commissure (e.g., leaflet) tab. In some embodiments, the skirt and additional reinforcing elements may form a support structure for the leaflet. Each individual leaflet subassembly may then be adjacently positioned and connected to an additional leaflet subassembly at one of the separately formed commissure portions, thereby forming the commissures of the leaflet assembly. The attached leaflet subassemblies, forming the leaflet assembly, may then be connected to the frame of the prosthetic heart valve via the formed commissures. Such an assembly process may allow each leaflet subassembly to be more quickly and easily assembled on a relatively flat, two-dimensional platform before being attached to the three-dimensional frame of the prosthetic heart valve.

[0075] 2A-2C show individual components of a leaflet subassembly for a prosthetic heart valve. The leaflet subassembly components can include leaflets 130 (FIG. 2A), a reinforcing strip 120 (FIG. 2B), and a skirt (e.g., skirt portion) 140 (FIG. 2C). As discussed further below with reference to FIGS. 3-5, the leaflets 130, the reinforcing strip 120, and the skirt 140 can all be secured together to form an individual leaflet subassembly 110.

[0076] In some embodiments, multiple leaflet subassemblies can be attached to one another as shown in Figures 6A-7B. A pair of attached leaflet subassemblies can then be attached to a commissure support portion of a frame of a prosthetic heart valve (e.g., a part of an actuator or a separate support post, etc.) as shown by one example embodiment in Figures 8-11. Additionally, in some embodiments, a skirt portion of each individual leaflet subassembly may be secured to a post of a frame of a prosthetic heart valve as shown in Figures 11-12.

[0077] Figures 2A-6B and 8 show reference axes 104 including an x-axis, a y-axis, and a z-axis. As shown in Figures 2A-2C and 5, the individual components of the leaflet subassembly lie in the xz plane and may be secured to one another in this two-dimensional plane before being coupled to another leaflet subassembly and / or to the frame of a prosthetic heart valve.

[0078] 2A , the leaflet 130 comprises a main leaflet edge portion 134, two leaflet tabs (also referred to herein as commissure tabs) 132 at opposite ends of the leaflet edge portion 134, and an upper edge portion 136. The leaflet edge portion 134, the leaflet tabs 132 and the upper edge portion 136 may be disposed around the circumference of the leaflet 130, with the upper edge portion 136 extending between the two leaflet tabs 132 at the upper edge of the leaflet 130 and the leaflet edge portion 134 extending between the two leaflet tabs 132 at the lower edge of the leaflet 130.

[0079] As used herein, "upper" and "lower" may be relative to a z-axis, which may be aligned parallel to a central longitudinal axis of the prosthetic heart valve when the leaflet assembly is assembled and coupled to the frame of the prosthetic heart valve.

[0080] In some embodiments, the cusp portion 134 has a curved, scallop-like shape (as shown in FIG. 2A ). Thus, the cusp portion 134 may curve between the two leaflet tabs 132.

[0081] 2A-2C show a centerline 102 for each of the individual leaflet components, which may be the centerline of the leaflet subassembly. For example, when assembled, the centerlines 102 for each component of the leaflet subassembly may overlap. Further, as shown in FIG. 2A, the leaflet tabs 132 may be positioned across the centerline 102 from each other at opposite ends of the leaflet edge portion 134. In some embodiments, the leaflet subassembly and / or the components of the leaflet subassembly may have symmetry across the centerline 102 (e.g., reflection symmetry).

[0082] In some embodiments, as shown in FIG. 2B, the reinforcing strip 120 comprises a central portion 124 and two end portions 122 disposed at opposing (e.g., opposite) ends of the central portion 124. The central portion 124 may be elongated compared to the two end portions 122 and has a curved shape. For example, in some embodiments, the central portion 124 can have a curved, scallop-like shape (as shown in FIG. 2B). In some embodiments, the curved, scallop-like shape of the central portion 124 can match (e.g., track) the curved, scallop-like shape of the cusp portion 134 of the leaflet 130.

[0083] In some embodiments, the reinforcing strip 120 may further include a stitch line 126, which may be, for example, a marking (e.g., an ink marking) applied to the strip or a hole formed in the strip. As shown, for example, in FIG. 2B, the stitch line 126 may be located along the center of the central portion 124 and follow the curved shape of the central portion 124.

[0084] In some embodiments, the reinforcement strips 120 can comprise a flexible material. In some embodiments, the reinforcement strips 120 can comprise a fibrous material. In other embodiments, the reinforcement strips 120 can comprise a flexible polymeric material.

[0085] 2C shows a skirt 140. The skirt 140 includes a skirt central portion 144 and two tabs (e.g., skirt tabs) 142 disposed at opposing (e.g., opposite) ends of the skirt central portion 144. In some embodiments, the skirt 140 further includes a stitch line 146 that may be centered along the length of the skirt central portion 144 (e.g., extending between the two tabs 142). The stitch line 146 may follow the same contour as the stitch line 126 of the reinforcement strip 120.

[0086] According to some embodiments, one or more of the stitch lines 126, 146 include external markings, such as ink markings, to visually indicate where a user should suture or sew to assemble the leaflet subassembly 110. In some embodiments, one or more of the stitch lines 126, 146 include a number of holes or openings through which a needle carrying suture (or other thread, twine, stitch, etc.) can be passed.

[0087] The skirt 140 may also include one or more positioning guides 160 disposed along an upper portion of the skirt central portion 144, a first row of positioning guides 161 and a second row of positioning guides 163 on each tab 142. The positioning guides 160, 161 and 163 may be markings (e.g., ink markings) on the skirt 140 or holes formed in the skirt 140. The positioning guides 160 may be used to position the skirt central portion 144 relative to the struts of the frame when the leaflet assembly is connected to the frame of the prosthetic valve. The positioning guides 163, 161 may be used to position the tabs 142 of the skirt 140 relative to the tabs 132 of the corresponding leaflets 130.

[0088] In some embodiments, as shown in FIG. 2C , each tab 142 can extend outward from one end of the skirt central portion 144 in a direction parallel to the centerline 102, and then extend outward from the portion of the tab 142 that extends outward from the one end of the skirt central portion 144 in a direction perpendicular to the centerline 102 and away from the centerline 102.

[0089] The stages of assembly of the leaflets 130, reinforcing strip 120 and skirt 140 into the leaflet subassembly 110 are shown in Figures 3-8. To assemble the leaflet subassembly 110, the skirt 140 can be placed on or against one side of the leaflet 130 (e.g., placed on top of the face of the leaflet 130 shown in Figure 2A, which is the inner face of the leaflet when placed inside the frame). For example, as shown in Figure 5, the skirt 140 can be placed on (e.g., against) the leaflet 130 such that the skirt central portion 144 is aligned with the leaflet edge portion 134 of the leaflet 130 and each tab 142 of the skirt 140 is placed on (e.g., overlaps) a corresponding one of the two leaflet tabs 132 of the leaflet 130. In some embodiments, the skirt 140 may be positioned over the leaflet 130 such that the stitch line 146 extends along the curvature of the leaflet edge portion 134 of the leaflet 130 and / or is positioned adjacent to the curvature of the leaflet edge portion 134 of the leaflet 130.

[0090] Each tab 142 of the skirt 140 may be folded around a corresponding leaflet tab 132 on the leaflet 130 and secured to other components of the leaflet subassembly 110 via one or more fasteners (e.g., sutures or stitches) to form a half-commissure portion for connecting to a half-commissure portion of an adjacent leaflet subassembly, as described further below. Although the formation of such a half-commissure portion may be described with reference to the drawings for one side / end of the leaflet subassembly (e.g., one leaflet tab 132 and one corresponding tab 142 of the skirt 140), it should be noted that the assembly of the half-commissure portions may be performed for both ends of the leaflet subassembly 110 as well (e.g., on either side of the centerline 102).

[0091] Additionally, although the leaflet subassemblies are described herein as including strengthening strips, in alternative embodiments, the leaflet subassemblies may not include strengthening strips.

[0092] 2C and 3, the tab 142 of the skirt 140 can be folded along a first fold line 148a to form two flaps, a first flap 142a and a second flap 142b. For example, as shown in FIG. 3, the tab 142 is wrapped around the outer edge 131 of the leaflet tab 132 such that the first flap 142a covers one side (e.g., a first side) of the leaflet tab 132 and the second flap 142b covers the other side (e.g., an opposite second side) of the leaflet tab 132. In this manner, the tab 142 of the skirt 140 sandwiches the leaflet tab 132.

[0093] The reinforcement strip 120 is then placed atop (e.g., abutting) the skirt 140 such that the contour of its central portion 124 is aligned with the contour of the leaflet edge portion 134 of the leaflet 130 and the central skirt portion 144 of the skirt 140. This may result in, for example, alignment of the stitch line 126 of the reinforcement strip 120 with the stitch line 146 of the skirt 140. Additionally, each end portion 122 of the reinforcement strip may be positioned over (e.g., overlapping or resting on) a corresponding first flap 142a. Thus, the skirt 140 may be positioned between the reinforcement strip 120 and the leaflet 130 such that a first side or surface of the skirt 140 is positioned or disposed against the leaflet 130 and an opposing second side or surface of the skirt 140 is positioned or disposed against the reinforcement strip 120.

[0094] 3 and 5, the end portion 122 of the reinforcement strip 120 is placed on top of the corresponding first flap 142a. The corresponding end portion 122, tab 142 and leaflet tab 132 at the same end or side of the leaflet subassembly 110 can then be secured together via fasteners. In some embodiments, as shown in FIG. 3, the fasteners can be one or more first stitches (e.g., hidden stitches formed with sutures) 162 extending through each of the end portion 122, the first flap 142a, the leaflet tab 132 and the second flap 142b.

[0095] As shown in FIG. 4, an end portion (e.g., a free end portion) of the first flap 142a may then be folded over the end portion 122 of the reinforcement strip 120 along a second fold line 148b (see FIG. 2C) and folded back onto itself to form an outer first flap portion 142c and an inner first flap portion 142d. As a result, as shown in FIG. 4, the first flap 142a is disposed in two overlapping layers over the first side of the leaflet tab 132. As used herein, an "inner" flap portion may be disposed closer to the leaflet tab 132 than an "outer" flap portion, and an "outer" flap portion may have an outer exposed surface.

[0096] Similarly, an end portion (e.g., a free end portion) of the second flap 142b can be folded back upon itself along a third fold line 148c (see FIG. 2C) to form an outer second flap portion 142f and an inner second flap portion 142e. As a result, as shown in FIG. 4, the second flap 142b is disposed in two overlapping layers on the second side of the leaflet tab 132.

[0097] After making the series of folds described above, the end portion 122 of the reinforcing strip 120 is positioned between the outer first flap portion 142c and the inner second flap portion 142d, as shown in Figure 4. Additionally, the end of the first stitch 162 is contained within (e.g., encased by) the folded tab 142 and covered by the outer first flap portion 142c and the outer second flap portion 142f.

[0098] In some embodiments, the outer first flap portion 142c, the inner first flap portion 142d, the outer second flap portion 142f, and the inner second flap portion 142e are all secured together via fasteners. For example, as shown in FIG. 4, the fasteners may be one or more second stitches 164 (e.g., visible and invisible stitches formed with sutures) that extend through each of the outer first flap portion 142c, the inner first flap portion 142d, the leaflet tab 132, the inner second flap portion 142e, and the outer second flap portion 142f.

[0099] 4, the second stitch 164 may be disposed adjacent to the first stitch 162 and outboard of the first stitch 162 relative to the outer edge 131 of the leaflet tab 132. In other embodiments, the second stitch 164 may be disposed further away from the first stitch 162 than shown in FIG. 4, for example further toward the outer edge 131 of the leaflet tab 132.

[0100] The combination of leaflet tabs 132, any flap portions of tabs 142, and end portions 122 of reinforcing strips 120 secured together (as described above with reference to FIGS. 3-4) may be referred to herein as a half-commissure portion 114 (as shown in FIG. 4). Each leaflet subassembly, such as leaflet subassembly 110, includes two formed half-commissure portions 114 (e.g., one on either side of centerline 102). As described further below, the adjacently disposed half-commissure portions of the two leaflet subassemblies may be secured together to form a commissure (e.g., where two adjacent portions of two leaflet subassemblies are connected together) prior to mounting the leaflet subassemblies to a frame of a prosthetic heart valve.

[0101] 5, in some embodiments, the leaflets 130, skirt 140 and reinforcement strip 120 can be further secured to one another with additional fasteners, such as stitches 112 (e.g., of one or more sutures). For example, the imperceptible stitches 112 can extend through the central portion 124 of the reinforcement strip 120, the central skirt portion 144 of the skirt 140 and the cusp portion 134 of the leaflets 130 along at least a portion of the length of the curved outer edge 150 of the leaflet subassembly 110. For example, as shown in FIG. 5, the imperceptible stitches 112 can extend through the central portion 124 of the reinforcement strip 120, the central skirt portion 144 of the skirt 140 and the cusp portion 134 of the leaflets 130 from a first end 152 of the leaflet subassembly 110 (e.g., at one of the two tabs 142) to an opposite second end of the leaflet subassembly 110 (e.g., at the other one of the two tabs 142, not shown in FIG. 5). The stitches 112 may also extend through one commissure portion at each end of the leaflet subassembly as shown.

[0102] In some embodiments, the glimpsed stitches 112 may follow, extend through and along the stitch lines 126 and 146 .

[0103] In some embodiments, the combination of the leaflets 130, skirt 140 and reinforcing strip 120 form a leaflet subassembly. The leaflet subassemblies can be formed separately for each of the leaflets (e.g., each of the three leaflets) of the prosthetic valve as described above. For example, each leaflet subassembly can be formed individually in a relatively flat plane (e.g., the xz plane shown in FIG. 5) before being attached to the frame of the prosthetic heart valve.

[0104] After forming one or more individual leaflet subassemblies, such as leaflet subassembly 110, a pair of leaflet subassemblies that are intended to be positioned adjacent to one another within a prosthetic heart valve may then be attached to one another with additional fasteners before being attached to the frame of the prosthetic heart valve.

[0105] For example, as shown in Figures 6A-6B and 7A-7B, adjacent leaflet subassemblies including a first leaflet subassembly 110' and a second leaflet subassembly 110" (formed in the same manner and including similar components as leaflet subassembly 110) can be positioned such that a first half-commissure portion 114' of the first leaflet subassembly 110' is disposed adjacent to a second half-commissure portion 114" of the second leaflet subassembly 110".

[0106] For example, this positioning can result in the outer second flap portion 142f' (of the first leaflet subassembly 110') and the outer second flap portion 142f" (of the second leaflet subassembly 110") being positioned adjacent to one another. In this configuration, the reinforcing strip 120' of the first leaflet subassembly 110' and the reinforcing strip 120" of the second leaflet subassembly 110" are positioned away from one another on the outer edges of the assemblies such that the reinforcing strips 120' and 120" are not sandwiched between adjacently positioned leaflet tabs.

[0107] The first leaflet subassembly 110' and the second leaflet subassembly 110" may then be attached to one another via fasteners, such as a series of stitches (e.g., sutures) 166. This fastening may be repeated for each pair of adjacently positioned leaflet subassemblies (e.g., for each set of commissures on one side) on either side of the leaflet subassembly.

[0108] As shown in Figures 6A-6B, the series of stitches 166 extend through tab 142' (through at least a portion of flap portions 142'c-f), end portion 122' of reinforcement strip 120' and leaflet tab 132' of the first leaflet subassembly 110', tab 142" (through at least a portion of flap portions 142"c-f), end portion 122" of reinforcement strip 120" and leaflet tab 132" of the adjacent second leaflet subassembly 110".

[0109] In some embodiments, the series of stitches 166 is positioned adjacent to the series of stitches 162' and 162" on the side facing the series of stitches 164' and 164", as depicted in FIG. 6A. In other embodiments, the series of stitches 166 is positioned adjacent to the series of stitches 162' and 162" on the opposite side of the series of stitches 162' and 162" from the series of stitches 164' and 164", as depicted in FIG. 6B.

[0110] In some embodiments, as shown in FIG. 6A , the series of stitches 166 extends through outer first flap portion 142c', reinforcement strip end portion 122', inner first flap portion 142d', leaflet tab 132', inner second flap portion 142e', outer second flap portion 142f', outer second flap portion 142f", inner second flap portion 142e", leaflet tab 132", inner first flap portion 142d", reinforcement strip end portion 122" and outer first flap portion 142c".

[0111] According to another embodiment, as shown in FIG. 6B , the series of stitches 166 extends through outer first flap portion 142c', reinforcing strip end portion 122', inner first flap portion 142d', leaflet tab 132', leaflet tab 132", inner first flap portion 142d", reinforcing strip end portion 122" and outer first flap portion 142c", without extending through any of inner second flap portion 142e', outer second flap portion 142f', outer second flap portion 142f" and inner second flap portion 142e".

[0112] The first and second half commissure portions 114' and 114" secured together (eg, attached) may be referred to herein as the commissures 194 of the two adjacent leaflet subassemblies.

[0113] 7A-7B show views of a portion of a first leaflet subassembly 110' and a portion of a second leaflet subassembly 110" positioned side-by-side in a relatively flat, two-dimensional plane (e.g., the xz plane in which each subassembly was assembled individually in FIGS. 2A-5) such that a first half-commissure portion 114' of the first leaflet subassembly 110' is positioned directly adjacent to a second half-commissure portion 114" of the second leaflet subassembly 110".

[0114] As shown in FIG. 7A , before the two half commissure portions of the first and second leaflet subassemblies are fastened together (e.g., via tightening the series of stitches 166), the outer edges 176' and 176" of the half commissure portions, including the outer edge 131' of leaflet tab 132' and the outer edge 131" of leaflet tab 132", face each other. Thereafter, as shown in FIG. 7B , when the series of stitches 166 is tightened at the bases 174' and 174" of the two half commissure portions 114' and 114", the outer edges 176' and 176" of the half commissure portions face up (e.g., off the page in FIG. 7B ).

[0115] As shown in FIG. 7A, the base 174', 174" of each commissure half 114', 114" is disposed adjacent the tip 178', 178" of the corresponding leaflet, opposite the commissure half's respective outer edge 176', 176".

[0116] As shown in FIG. 7B , the two half commissure portions 114' and 114" are secured together at their bases 174' and 174", forming a gap 190 between an inner surface 192' of the first half commissure portion 114' and an inner surface 192" of the second half commissure portion 114". The gap 190 can be adapted to receive a commissure support portion (e.g., a support post) of a prosthetic heart valve frame, as described further below. The attached half commissure portions 114' and 114" form a commissure 194 of two adjacent leaflet subassemblies.

[0117] For example, as shown in FIG. 8, the attached pair of leaflet subassemblies including first and second leaflet subassemblies 110', 110" can then be attached to a commissure support portion (e.g., a support post) 180 of a frame of the prosthetic heart valve. The commissure support portion 180 can be part of the actuator 80 as shown in FIG. 1 (e.g., an upper portion of the outer member 92), or can be a separate support post or strut of the frame. In some embodiments, as shown in FIG. 8, the commissure 194 formed by the attached first and second commissure half portions 114', 114" can be attached to the commissure support portion 180 using a fastening element, such as a suture 168.

[0118] As shown in FIG. 8 , each commissure half 114′ and 114″ can be wrapped at least partially around the commissure support portion 180. Suture 168 can be sewn through an end portion of each commissure half of each leaflet subassembly 110′ and 110″ using two stitches 170a and 170b. Opposing ends of the two stitches 170a and 170b can be tied together outside (e.g., on the outer surface) of the commissure support portion 180 and frame, such as with a knot 172. In other embodiments, separate sutures can be tied to each commissure half and then tied to each other.

[0119] 9-12, one embodiment of a prosthetic heart valve 200 and a method for mounting a pair of leaflet subassemblies mounted together at a commissure 214 to a frame 202 of the prosthetic heart valve 200 is shown. For example, the first leaflet subassembly 210 and the second leaflet subassembly 212 shown in FIGS. 9-12 may be similar to the leaflet subassemblies 110, 110' and / or 110" described above with reference to FIGS. 2A-8 and thus may include the same or similar components. Furthermore, the first leaflet subassembly 210 and the second leaflet subassembly 212 may be secured to one another in the same or similar manner as described above with reference to FIGS. 2A-7B to form a commissure 214.

[0120] 9-12 show one embodiment of a prosthetic heart valve 200 having a frame 202. Similar to that described above with reference to FIG. 1, the frame 202 can include a plurality of interconnected struts 204 and a plurality of actuators 205, 206, 207 mounted on and evenly spaced about an inner surface of the frame 202. In the illustrated embodiment, the actuators are used to support the commissures, and thus the actuator components are referred to as commissure support portions in the following description, although it should be understood that the frame can include commissure support portions that are separate from the actuators.

[0121] Unlike the prosthetic heart valve 10 of Figure 1, the prosthetic heart valve 200 does not include a single internal skirt that extends around the entire circumference of the frame. Instead, the prosthetic heart valve 200 includes multiple leaflet subassemblies (e.g., three), including a first leaflet subassembly 210 and a second leaflet subassembly 212, each of which includes a leaflet and a separate skirt portion (e.g., leaflet 130 shown in Figure 2A and skirt 140 shown in Figure 2C) that are pre-assembled before being attached to the frame 202, as described above with reference to Figures 2A-7B.

[0122] For example, looking specifically at one leaflet subassembly, a first leaflet subassembly 210 includes individual leaflets 208 and an individual skirt 218. The first leaflet subassembly 210 has a first half commissure portion 220 secured to a first half commissure portion 222 of the second leaflet subassembly 212 to form a commissure 214. Additionally, the first leaflet subassembly 210 includes a second half commissure portion 224 disposed on the opposite side of the first leaflet subassembly 210 from the first half commissure portion 220 (see FIG. 12). The second half commissure portion 224 of the first leaflet subassembly 210 is attached to a first half commissure portion of a third leaflet subassembly to form a second commissure 226 (see FIG. 12). The second half of the commissure portion of the third leaflet subassembly is attached to the second half of the commissure portion of the second leaflet subassembly 212 to form a third commissure (not shown in the views of Figures 9-12) of the prosthetic heart valve 200.

[0123] 11-12, the commissures 214 of the first and second leaflet subassemblies 210 and 212 are attached to the first support post 206 of the frame 202 via fastening elements (e.g., sutures or stitches) 216. The fastening elements 216 may include multiple stitches in some embodiments. The fastening elements 216 may be similar to the stitches 170a and 170b shown in FIG. 8. The support post 206 may be an outer member of the actuator (e.g., similar to the outer member 92 of the actuator 80).

[0124] For example, as shown in Figures 9 and 10, the outer ends of the commissures 214 are wrapped around the first support post 206 toward the front face of the first support post 206. The fastening element 216, which includes a series of stitches, is attached to either end of the commissures 214 and then extends across and around the front (e.g., outer) face of the first support post 206 (see Figures 11 and 12).

[0125] 11 and 12, the skirt of each leaflet subassembly (e.g., skirt 218 of first leaflet subassembly 210) may be secured (e.g., attached) to the posts 204 of the frame 202 via fasteners 230. In some embodiments, the fasteners 230 may include one or more sutures or stitches that extend along the upper and lower edges of a central skirt portion of the skirt 218. The stitches 230 may extend around adjacent posts 204 that extend along the upper and lower edges of the skirt.

[0126] Thus, instead of mounting the individual leaflets to a single internal skirt of the prosthetic heart valve frame (as shown in FIG. 1 ), the skirt of each individual leaflet subassembly may be mounted directly to the posts 204 of the frame 202, and each commissure (e.g., a total of three in the embodiment of FIGS. 9-12 ) may be mounted to a respective support post of the frame 202. Because the leaflets and skirt and each commissure of each leaflet subassembly are already secured together prior to mounting to the frame 202, the overall assembly of the leaflet assembly (including the mounted leaflet subassembly) and mounting of the leaflet assembly to the frame 202 is simplified and may take less time than conventional mounting methods (such as those described above with reference to FIG. 1 ).

[0127] In this way, leaflet subassemblies, each including a skirt and leaflets, can be preassembled before being attached to the frame of the prosthetic heart valve. For example, as described above, instead of attaching the complex leaflets to the three-dimensional structure of a standard skirt arranged along the inner surface of the frame of the prosthetic heart valve, the assembly of each leaflet subassembly can be performed in a simpler manner on a relatively flat surface. Furthermore, by preassembling the leaflet subassemblies individually, any identified defects in one or more leaflet subassemblies can be addressed before forming a complete valve structure (e.g., a leaflet assembly including multiple leaflets attached to a standard skirt of the prosthetic heart valve). Furthermore, the leaflet subassemblies can be attached to the frame of the prosthetic heart valve in a simpler and more rapid manner compared to attaching each leaflet to a three-dimensional skirt already attached to the frame of the prosthetic heart valve.

[0128] [Overall Considerations] For the purpose of this description, certain aspects, advantages and novel features of the disclosed embodiments are described herein. The disclosed methods, devices and systems should not be construed as being limited in any manner. Instead, the disclosure is directed to all novel and unobvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations with each other. The methods, devices and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not claim that any one or more particular advantages are presented or problems are solved. Techniques from any example can be combined with techniques described in any one or more of the other examples. In view of the many possible embodiments to which the principles of the disclosed technology can be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be considered as limiting the scope of the disclosed technology.

[0129] Although some operations of the disclosed embodiments are described in a particular sequential order for convenience of presentation, it should be understood that this manner of description encompasses reordering, unless a particular order is required by specific language described below. For example, operations described in sequence may be reordered or performed simultaneously in some examples. Furthermore, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods may be used in conjunction with other methods. Additionally, the description may use terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and may be readily distinguishable by one of ordinary skill in the art.

[0130] As used herein with reference to prosthetic heart valves and transcatheter delivery systems, "proximal" refers to the location, direction or portion of a component closer to the user and the handle of the delivery system that is external to the patient, and "distal" refers to the location, direction or portion of a component further away from the user and the handle and closer to the implantation site. The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless expressly defined otherwise.

[0131] 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 "comprises" means "comprising." Furthermore, the terms "coupled" and "connected" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or connected and do not exclude the presence of intermediate elements between coupled or associated items, unless specifically stated to the contrary.

[0132] Directions and other relative references (e.g., inside, outside, above, below, etc.) may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, specific terms "inside," "outside," "top," "lower," "inside," "outside," etc. may be used. Such terms are used, where applicable, to provide some clarity of description, especially when addressing relative relationships with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, positions and / or orientations. For example, with respect to an object, an "upper" part may become a "lower" part by simply flipping the object over. It is still the same part and the object is the same. As used herein, "and / or" means "and" or "or" as well as "and" and "or."

[0133] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it is to be recognized that the illustrated embodiments are merely preferred examples of the invention and should not be considered as limiting the scope of the invention, which is rather defined by the following claims, and we therefore claim as our invention all that comes within the spirit and scope of these claims. [Explanation of symbols]

[0134] 10 Artificial Heart Valves 12 Frames 14 First end 16 Second end 18 Valve Structure 20 Inner Skirt 22 Valve leaflet 24 commissure 26 Commissural attachment 28 Posts 30 Rivets or pins 80 Actuator 82 Discontinuities 90 Inner member 92 Outer member 102 Center line 104 Reference axis 110, 110', 110" Leaflet Subassembly 112 Hidden stitches 114, 114', 114" One commissure 120, 120', 120" Reinforcement Strips 122, 122', 122" end section 124 Central part 126 Stitching Line 130 Valve Leaflet 131, 131', 131" outer edge of leaflet 132, 132', 132" Leaflet Tabs 134 Apical part 136 Upper edge part 140 Skirt 142, 142', 142" Tabs 142a First flap 142b Second flap 142c, 142c', 142c" Outer first flap portion 142d, 142d', 142d" Second inner flap 142e, 142e', 142e" Second inner flap 142f, 142f', 142f" Second outer flap 144 Center part of skirt 146 Stitching Line 148a First fold line 148b Second fold line 148c Third fold line 150 Curved outer edge of leaflet subassembly 152 first end of leaflet subassembly 160, 161, 163 Positioning guide 162, 162', 162" 1st stitch 164, 164', 164" Second stitch 166 series of stitches 168 Sutures 170a, 170b stitches 172 Knots 174', 174" base 176', 176" Outer edge of one commissure 178', 178" Tip of valve leaflet 180 Commissure support part 190 Gap 192', 192" Inner surface of one commissure 194 Commissure of Adjacent Leaflet Subassemblies 200 Artificial Heart Valves 202 Frames 204 Post 205, 206, 207 Actuators 206 Support column 208 Valve leaflet 210 First leaflet subassembly 212 Second Leaflet Subassembly 214 commissure 216 Fastening Elements 218 Skirt 220 first half commissure portion of first leaflet subassembly 222 first half commissure of second leaflet subassembly 224 Second half of first leaflet subassembly 226 Second Intersection 230 Fasteners

Claims

1. 1. A method of assembling a prosthetic heart valve including a leaflet assembly, comprising: forming a plurality of leaflet subassemblies, each including a leaflet and a skirt, each leaflet subassembly being formed by: positioning the skirt on one side of the leaflet such that the skirt extends along a curved leaflet edge portion and two commissure tabs of the leaflet; folding two end portions of the skirt around corresponding commissure tabs of the leaflet; sewing each folded end portion to a corresponding one of the two commissure tabs to form a commissure portion of a respective one of the leaflet subassemblies; and sewing the skirt to the leaflet edge portion of the leaflet; forming the leaflet assemblies by pairing each half commissure portion of each leaflet subassembly with a half commissure portion of another leaflet subassembly of the plurality of leaflet subassemblies to form a plurality of pairs of adjacent half commissure portions, and for each pair, sewing the adjacent half commissure portions together to form a commissure of the leaflet assembly; securing the leaflet assembly to a frame of the prosthetic heart valve via fastening each commissure to a commissure support portion of the frame; A method comprising:

2. 10. The method of claim 1, further comprising the step of further securing the leaflet assemblies to a frame of the prosthetic heart valve via fastening a skirt of each leaflet subassembly to a post of the frame.

3. 3. The method of claim 2, wherein fastening the skirt of each leaflet subassembly to the struts of the frame comprises fastening a central skirt portion of each leaflet subassembly skirt to a plurality of interconnected struts of the frame arranged in a grid-type pattern, the central skirt portion being disposed between two tabs of the skirt.

4. 4. The method of claim 1, wherein each of the two end portions of the skirt includes a tab, and wherein folding the two end portions of the skirt around a corresponding commissure tab of a valve leaflet includes, for each end portion and corresponding commissure tab, folding the tab around the corresponding commissure tab to form a first flap covering a first side of the commissure tab and a second flap covering a second side of the commissure tab.

5. 5. The method of claim 4, wherein each leaflet subassembly further includes a reinforcing strip, the method further comprising the steps of: arranging the reinforcing strip on a side of the skirt disposed opposite the skirt disposed on the leaflet such that the reinforcing strip extends along the curved portion of the skirt and each of two end portions of the reinforcing strip rests on a corresponding first flap of the skirt; and sewing each folded end portion of the skirt to the corresponding commissure tab and to the corresponding end portion of the two end portions of the reinforcing strip via a first stitch.

6. 6. The method of claim 5, wherein the step of folding the two end portions of the skirt around corresponding tabs of a leaflet assembly further comprises, for each end portion of the skirt and corresponding commissure tab, folding a free end portion of the first flap back onto itself to cover the corresponding end portion of the reinforcing strip and form two overlapping layers over a first side of the commissure tab, and folding a free end portion of the second flap back onto itself to form two overlapping layers over a second side of the commissure tab.

7. 7. The method of claim 6, further comprising sewing together the two overlapping layers on the first side of the commissure tab, the commissure tab, and the two overlapping layers on the second side of the commissure tab via a second stitch.

8. 8. The method of claim 7, wherein for each pair of adjacent half commissure portions, sewing the adjacent half commissure portions together to form a commissure of the leaflet assembly comprises sewing the adjacent half commissure portions together via a third stitch disposed adjacent to the first stitch, the third stitch extending through a corresponding end portion of a reinforcing strip of each leaflet subassembly.

9. 9. The method of claim 8, wherein sewing the adjacent half commissure portions together via a third stitch includes extending the third stitch through two overlapping layers on a first side of the commissure tab, the commissure tab, and two overlapping layers on a second side of the commissure tab for each half commissure portion of the pair of adjacent half commissure portions.

10. The method of claim 9 , wherein the third stitch is disposed adjacent to the first stitch on a side of the first stitch facing the second stitch.

11. 9. The method of claim 8, wherein the step of sewing the adjacent half commissure portions together via a third stitch includes the step of extending the third stitch, for each half commissure portion of the pair of adjacent half commissure portions, through two overlapping layers on a first side of the commissure tab and through the commissure tab, but not through two overlapping layers on a second side of the commissure tab.

12. The method of claim 11 , wherein the third stitch is disposed adjacent to the first stitch on a side of the first stitch disposed opposite the first stitch facing the second stitch.

13. 13. The method of claim 1, wherein sewing the skirt to the leaflet edge portion comprises sewing the skirt to the leaflet edge portion via a series of visible and invisible stitches that extend through the leaflet and the skirt, along the leaflet edge portion, from a first of the two commissure tabs of the leaflet to a second of the two commissure tabs of the leaflet.

14. 14. The method of claim 13, wherein the step of sewing the skirt to the leaflet edge portion via the series of visible and invisible stitches includes the step of extending the series of visible and invisible stitches through and along a first stitch line located in a central skirt portion of the skirt extending between the two end portions of the skirt.

15. The method of claim 14 , wherein the first stitch line includes one or more external markings or holes.

16. 16. The method of claim 14 or 15, wherein each leaflet subassembly further comprises a reinforcing strip, further comprising the steps of: arranging the reinforcing strip on a side of the skirt disposed opposite the skirt disposed on the leaflet such that the reinforcing strip extends along the curved portion of the skirt and each of two end portions of the reinforcing strip rests on a corresponding first flap of the skirt; and further comprising the steps of sewing the reinforcing strip to the skirt via extending the series of visible and invisible stitches through and along a second stitch line disposed along the curved central portion of the reinforcing strip, wherein the first stitch line and the second stitch line are aligned with each other.

17. 17. The method of claim 1, wherein for each pair of adjacent half commissure portions, sewing the adjacent half commissure portions together to form a commissure of a leaflet assembly comprises sewing the adjacent half commissure portions together at a base of the two commissure portions, the base of each commissure portion being located opposite a corresponding outer edge of the commissure portion and adjacent a tip of a corresponding leaflet.

18. 18. The method of claim 1, wherein fastening each commissure to the commissure support portion of the frame comprises wrapping an end portion of each commissure around a respective commissure support portion, sewing through the end portion of the commissure via one or more sutures, and tying the one or more sutures on an outer surface of the commissure support portion of the frame.

19. 1. A prosthetic heart valve comprising: an annular frame having a plurality of commissure supports; and a leaflet assembly supported by the frame, the leaflet assembly comprising a plurality of leaflet subassemblies, each leaflet subassembly comprising: a leaflet including a leaflet portion and two leaflet tabs, each leaflet tab being disposed at opposite ends of the leaflet portion; a skirt including a central skirt portion and two tabs, each tab located at an opposite end of the central skirt portion; each tab of the skirt is wrapped around and secured to a corresponding leaflet tab of the leaflet to form one commissure portion at either end of the leaflet subassembly; each half commissure portion is secured to an adjacent half commissure portion of an adjacent leaflet subassembly of the plurality of leaflet subassemblies to form a commissure of the leaflet assembly; Each commissure is coupled to a corresponding commissure support portion of the frame.

20. 20. The prosthetic heart valve of claim 19, wherein each half commissure portion is secured to an adjacent half commissure portion of an adjacent leaflet subassembly via a suture extending along and through a base of the adjacent half commissure portion, the base being disposed adjacent a corresponding tip of a leaflet of the leaflet subassembly.

21. 21. The prosthetic heart valve of claim 19 or 20, wherein the formed commissure includes two outer free ends disposed at opposite ends of the commissure with the ends of the adjacent commissure portions fixed to each other and wrapped around and coupled to corresponding commissure support portions of the frame.

22. 22. The prosthetic heart valve of claim 21, wherein each commissure is coupled to the corresponding commissure support portion of the frame by a series of stitches extending across an outer surface of the commissure support portion.

23. 23. The prosthetic heart valve of any one of claims 19 to 22, wherein each skirt of each leaflet subassembly is coupled to a strut of the frame.

24. 24. The prosthetic heart valve of claim 23, wherein the skirt central portion of the skirt of each leaflet subassembly includes one or more positioning guides disposed along an upper portion of the skirt central portion configured to position the skirt central portion relative to the posts of the frame.

25. 25. The prosthetic heart valve of claim 24, wherein the one or more positioning guides are markings on the skirt or holes formed in the skirt.

26. 26. The prosthetic heart valve of any one of claims 19 to 25, wherein for each leaflet subassembly, the central skirt portion of the skirt is secured to the leaflet edge portion of the leaflet via a series of visible and invisible stitches.

27. 27. The prosthetic heart valve of any one of claims 19 to 26, wherein for each leaflet subassembly, each of the two leaflet tabs of the skirt includes one or more positioning guides configured to position the tab of the skirt relative to a corresponding leaflet tab of the two leaflet tabs of the leaflet.

28. 28. The prosthetic heart valve of any one of claims 19 to 27, wherein each half commissure portion is formed by multiple overlapping layers of the skirt tabs secured to each other and through the leaflet tabs via one or more fasteners on either side of the leaflet tabs.

29. 29. The prosthetic heart valve of claim 28, wherein each half commissure portion is formed by two overlapping layers of the tabs of the skirt on a first side of the leaflet tab and two overlapping layers of the leaflet tab and the tabs of the skirt on an opposite second side of the leaflet tab, and the fastener extends through each of the two overlapping layers of the tabs on the first side of the leaflet tab and the two overlapping layers of the tabs on the leaflet tab and the second side of the leaflet tab.

30. 30. The prosthetic heart valve of any one of claims 19 to 29, wherein each leaflet subassembly further comprises a reinforcing strip including a central portion and two end portions, each end portion of the two end portions being disposed at opposite ends of the central portion, and each tab of the skirt is wrapped around and secured to a corresponding leaflet tab and corresponding end portion of the reinforcing strip to form one commissure portion on either side of the leaflet subassembly.

31. 31. The prosthetic heart valve of claim 30, wherein each tab of the skirt is secured to the corresponding leaflet tab and the corresponding end portion of the reinforcement strip via a first fastener extending through the corresponding end portion of the reinforcement strip, the corresponding leaflet tab, and a flap of the tab of the skirt disposed on either side of the corresponding leaflet tab.

32. 32. The prosthetic heart valve of claim 31 , wherein each tab of the skirt is further secured to the corresponding leaflet tab and the corresponding end portion of the reinforcement strip via a second fastener extending through two overlapping layers of the skirt tabs disposed on a first side of the corresponding leaflet tab, the leaflet tab, and the two overlapping layers of the skirt tabs disposed on an opposite second side of the corresponding leaflet tab.

33. 33. The prosthetic heart valve of claim 32, wherein the second fastener is positioned closer to an outer edge of the corresponding leaflet tab than the first fastener.

34. 34. The prosthetic heart valve of any one of claims 19 to 33, wherein the commissure support portion of the frame includes an actuator of the frame configured to apply expansion and compression forces to the frame to radially expand and compress the prosthetic heart valve.

35. 35. The prosthetic heart valve of any one of claims 19 to 34, wherein the commissural support portions of the frame include support struts or posts of the frame.

36. 36. The prosthetic heart valve of any one of claims 19 to 35, wherein the leaflet assembly comprises three leaflet subassemblies.

37. 1. A method of assembling leaflet subassemblies of a prosthetic valve, comprising: placing the skirt of the leaflet sub-assembly over the leaflets of the leaflet sub-assembly such that a curved central portion of the skirt is aligned with a curved leaflet edge portion of the leaflet and each of two tabs of the skirt overlaps a corresponding one of two leaflet tabs of the leaflet; at each end of the leaflet subassembly, wrapping the tab of the skirt around the corresponding leaflet tab of the leaflet to form a first flap covering a first side of the leaflet tab and a second flap covering a second side of the leaflet tab; placing the reinforcing strip over the skirt such that a contour of a central portion of the reinforcing strip is aligned with a contour of the leaflet edge portion of the valve leaflet and such that the central portion of the skirt and each of the two end portions of the reinforcing strip overlap a corresponding first flap; At each end of the leaflet subassembly: securing the end portions of the reinforcement strips to the corresponding leaflet tabs of the leaflets and to the tabs of the skirt; folding a free end portion of the first flap back onto itself to cover the end portion of the reinforcing strip and form two overlapping layers over the first side of the leaflet tab, and folding a free end portion of the second flap back onto itself to form two overlapping layers over the second side of the leaflet tab; and securing the two overlapping layers on the first side of the leaflet tab, and the leaflet tab and the two overlapping layers on the second side of the leaflet tab to one another.

38. 38. The method of claim 37, further comprising securing the central portion of the skirt, the leaflet edge portions of the leaflets, and the central portion of the reinforcing strip to one another.

39. 39. The method of claim 37 or 38, wherein securing an end portion of the reinforcement strip to a corresponding leaflet tab of the leaflet and a tab of the skirt includes extending a first stitch through each of the end portion of the reinforcement strip, the first flap, the leaflet tab and the second flap.

40. 40. The method of claim 39, wherein the step of securing the two overlapping layers on the first side of the leaflet tab, the leaflet tab, and the two overlapping layers on the second side of the leaflet tab to one another includes the step of extending a second stitch adjacent to the first stitch and outwardly of the first stitch relative to an outer edge of the leaflet tab through each of the two overlapping layers on the first side of the leaflet tab, the leaflet tab, and the two overlapping layers on the second side of the leaflet tab.

41. 1. A leaflet subassembly for a leaflet assembly of a prosthetic heart valve, comprising: a leaflet including a leaflet portion and two leaflet tabs, each leaflet tab being disposed at an opposite end of the leaflet portion; a skirt including a skirt central portion and two tabs, the two tabs being disposed at opposite ends of the skirt central portion, the skirt central portion being aligned with the leaflet edge portions of the leaflets, the skirt being disposed against the leaflets such that each of the two tabs of the skirt overlaps a corresponding one of the two leaflet tabs of the leaflets, each of the skirt tabs being wrapped around the corresponding leaflet tab of the leaflets to form a first flap covering a first side of the corresponding leaflet tab and a second flap covering a second side of the corresponding leaflet tab; a reinforcing strip including a central portion and two end portions, each end portion of the two end portions being disposed at an opposite end of the central portion, the reinforcing strip being disposed against the skirt such that a contour of the central portion of the reinforcing strip is aligned with a contour of the cusp portion of the leaflet, and the central portion of the skirt and each end portion of the two end portions of the reinforcing strip overlap a corresponding first flap; and for each leaflet tab, a free end portion of the corresponding first flap is folded back on itself to cover the corresponding end portion of the reinforcing strip and form two overlapping layers on the first side of the corresponding leaflet tab, and a free end portion of the corresponding second flap is folded back on itself to form two overlapping layers on the second side of the corresponding leaflet tab.

42. 42. The leaflet subassembly of claim 41, wherein for each leaflet tab, the corresponding end portion of the reinforcement strip, the first flap, the leaflet tab, and the second flap are each secured together via a first fastener.

43. 43. The leaflet subassembly of claim 42, wherein for each leaflet tab, each of the corresponding leaflet tab, two overlapping layers on a first side of the leaflet tab, and two overlapping layers on the second side of the leaflet tab are secured together via a second fastener.

44. 44. The leaflet subassembly of claim 43, wherein the second fastener is positioned adjacent to the first fastener and closer to an outer edge of the corresponding leaflet tab than the first fastener.

45. 45. The leaflet subassembly of claim 41, wherein the central portion of the reinforcing strip, the central skirt portion of the skirt, and the leaflet edge portion of the leaflet are secured together via additional fasteners.

46. The leaflet subassembly of claim 45, wherein the additional fastener is a plurality of visible and invisible stitches.

47. 47. The valve leaflet subassembly of claim 45 or claim 46, wherein the central portion of the reinforcing strip includes a first stitch line disposed along its center and following the curved shape of the central portion, and the skirt central portion includes a second stitch line centered along the length of the skirt central portion, the first stitch line and the second stitch line overlapping one another.

48. 48. The valve leaflet subassembly of claim 41, wherein the skirt includes one or more positioning guides disposed along an upper portion of the central skirt portion configured as markings or holes formed in the skirt.

49. 49. The valve leaflet subassembly of any one of claims 41 to 48, wherein each of the two tabs of the skirt includes one or more rows of positioning guides configured as markings or holes formed in the skirt.

50. 50. The valve leaflet subassembly of claim 41, wherein each of the two tabs of the skirt extends outward from one end of the skirt central portion in a direction parallel to a centerline of the skirt and perpendicular to the centerline and away from the centerline.

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