Prosthetic heart valve leaflet assembly and assembly method

Abstract

Leaflet assemblies for prosthetic heart valves are disclosed. As an example, a method includes forming a plurality of leaflet assemblies, each leaflet assembly including a leaflet and a skirt, and forming the leaflet assemblies by: arranging the skirt on one side of the leaflet so that the skirt extends along a curved cusp edge portion and two commissure tabs of the leaflet, folding two ends of the skirt around corresponding commissure tabs, sewing each folded end to a corresponding commissure tab to form a corresponding half-commissure portion, and sewing the skirt to the cusp edge portion, and forming the leaflet assemblies by pairing each half-commissure portion of each leaflet assembly with a half-commissure portion of another leaflet assembly to form a plurality of pairs of adjacent half-commissure portions, and sewing the adjacent half-commissure portions to each other for each pair to form a commissure.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application Serial No. 62 / 928,993, filed October 31, 2019, entitled “PROSTHETIC HEART VALVE LEAFLET ASSEMBLIES AND METHODS,” which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to prosthetic heart valves and to methods and assemblies for forming and attaching leaflet assemblies to the frame of such prosthetic heart valves. Background Art

[0004] The human heart may suffer from various valvular diseases. These valvular diseases can lead to serious dysfunction of the heart and ultimately require repairing the natural valve or replacing the natural valve with an artificial valve. There are a variety of known repair devices (e.g., stents) and artificial valves, as well as a variety of known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various procedures to deliver prosthetic medical devices to locations in the body that are difficult to reach or expected to be reached without surgery. In one embodiment, a prosthetic heart valve can be mounted on the distal end of a delivery device in a crimped state and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of a delivery device so that the prosthetic valve can self-expand to its functional size.

[0005] Prosthetic valves that rely on mechanical actuators for expansion may be referred to as "mechanically expandable" prosthetic heart valves. The actuators typically take the form of pull cables, sutures, wires, and / or shafts that are configured to transmit an expansion force from the handle of a delivery device to the prosthetic valve.

[0006] Most expandable transcatheter heart valves include a cylindrical metal frame or stent and prosthetic leaflets mounted within the frame. Typically, the leaflets are secured to a circumferential skirt that is attached to the inner surface of the frame of the prosthetic valve. This conventional skirt can serve as an attachment surface for the valve leaflets while also establishing a seal with the native tissue when the prosthetic valve is arranged at the implant site. However, because the skirt can span the entire circumference of the inner surface of the frame, attaching multiple leaflets (e.g., three leaflets) to the skirt can be time-consuming and requires sophisticated assembly skills to ensure accurate attachment.

[0007] Therefore, a need exists for improved prosthetic heart valve leaflet assemblies and methods for assembling leaflet assemblies to prosthetic heart valve frames. Summary of the Invention

[0008] Methods for assembling a prosthetic heart valve including a leaflet assembly, methods for assembling a leaflet assembly, and embodiments of a prosthetic heart valve including a leaflet assembly are described herein. In some embodiments, a leaflet assembly for a prosthetic heart valve can include a plurality of leaflet assemblies that are individually assembled and then connected together at adjacent semi-commissure portions to form commissures configured to couple to commissure support portions of a frame of a prosthetic heart valve. In some embodiments, each leaflet assembly can include a skirt and a leaflet, and can be formed by arranging the skirt on one side of the leaflet such that the skirt extends along a curved cusp edge portion of the leaflet and two commissure tabs of the leaflet, folding two ends of the skirt around corresponding commissure tabs of the leaflet, sewing each folded end to a corresponding commissure tab of the two commissure tabs to form a corresponding semi-commissure portion of the leaflet assembly, and sewing the skirt to the cusp edge portion of the leaflet.

[0009] In one representative embodiment, a method of assembling a prosthetic heart valve including a leaflet assembly may include: forming a plurality of leaflet assemblies, each leaflet assembly including a leaflet and a skirt, wherein each leaflet assembly is formed by: arranging the skirt on one side of the leaflet so that the skirt extends along a curved cusp edge portion of the leaflet and two commissure tabs of the leaflet, folding two ends of the skirt around corresponding commissure tabs of the leaflet, sewing each folded end to a corresponding commissure tab of the two commissure tabs to form a corresponding half-commissure portion of the leaflet assembly, and sewing the skirt to the cusp edge portion of the leaflet; forming the leaflet assembly by pairing each half-commissure portion of each leaflet assembly with a half-commissure portion of another leaflet assembly in the plurality of leaflet assemblies to form multiple pairs of adjacent half-commissure portions, and for each pair, sewing the adjacent half-commissure portions to each other to form a commissure of the leaflet assembly; and securing the leaflet assembly to a frame of the prosthetic heart valve by fastening each commissure to a commissure support portion of the frame.

[0010] In some embodiments, the method can further include securing the leaflet assembly to the frame of the prosthetic heart valve by fastening the skirt of each leaflet assembly to a strut of the frame.

[0011] In some embodiments, securing the skirt of each leaflet assembly to the struts of the frame includes securing a skirt mid-portion of the skirt of each leaflet assembly to a plurality of interconnected struts of the frame arranged in a lattice-type pattern, wherein the skirt mid-portion is disposed between two lugs of the skirt.

[0012] In some embodiments, each of the two ends of the skirt includes a lug, and folding the two ends of the skirt around the corresponding commissure lugs of the leaflet includes: for each end and the corresponding commissure lug, folding the lug around the corresponding commissure lug to form a first flap covering a first side of the commissure lug and a second flap covering a second side of the commissure lug.

[0013] In some embodiments, each leaflet assembly further includes a reinforcement band, and the method may further include arranging the reinforcement band on a side of the skirt that is opposite to the side of the skirt arranged on the leaflet, so that the reinforcement band extends along the curved portion of the skirt and each of its two ends covers the corresponding first flap of the skirt; and sewing each folded end of the skirt to the corresponding joint lug and the corresponding end of the two ends of the reinforcement band via a first stitching line.

[0014] In some embodiments, folding the two ends of the skirt around the corresponding lugs of the leaflet assembly further includes: for each end of the skirt and the corresponding commissure lug, folding the free end of the first flap back on itself to cover the corresponding end of the reinforcement band and form two overlapping layers on the first side of the commissure lug, and folding the free end of the second flap back on itself to form two overlapping layers on the second side of the commissure lug.

[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 to each other via a second seam line.

[0016] In some embodiments, for each pair of adjacent semi-commissure portions, sewing the adjacent semi-commissure portions to each other to form a commissure of the leaflet assembly includes sewing the adjacent semi-commissure portions to each other via a third seam line arranged adjacent to the first seam line, wherein the third seam line extends through the respective ends of the reinforcement band of each leaflet assembly.

[0017] In some embodiments, sewing adjacent semi-commissure portions to one another via a third seam line includes, for each semi-commissure portion in a pair of adjacent semi-commissure portions, extending the third seam line 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. In some embodiments, the third seam line is disposed adjacent to the first seam line on a side of the first seam line that faces the second seam line.

[0018] In some embodiments, sewing adjacent commissure portions to each other via a third seam line includes, for each of the pair of adjacent commissure portions, extending the third seam line through the two overlapping layers and the commissure tab on a first side of the commissure tab, but not through the two overlapping layers on a second side of the commissure tab. In some embodiments, the third seam line is disposed adjacent to the first seam line, on a side of the first seam line that is disposed opposite a side of the first seam line that faces the second seam line.

[0019] In some embodiments, sewing the skirt to the cusp edge portion of the leaflet includes sewing the skirt to the cusp edge portion along the cusp edge portion from a first of the two commissure lugs of the leaflet to a second of the two commissure lugs of the leaflet via a series of entry and exit sutures extending through the leaflet and the skirt.

[0020] In some embodiments, sewing the skirt to the cusp edge portion of the leaflet via a series of entry and exit sutures includes passing the series of entry and exit sutures through a first suture line disposed on a mid-portion of the skirt extending between the two ends of the skirt and extending along the first suture line.

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

[0022] In some embodiments, each leaflet assembly further includes a reinforcement band. The method further includes positioning the reinforcement band on a side of the skirt opposite the side of the skirt positioned over the leaflet, such that the reinforcement band extends along a curvilinear portion of the skirt and each of its two ends overlaps a corresponding first flap of the skirt, and sewing the reinforcement band to the skirt by passing a series of in-and-out stitches through a second stitch line positioned along a curvilinear middle portion of the reinforcement band and extending along the second stitch line. The first stitch line and the second stitch line are aligned with each other.

[0023] In some embodiments, for each pair of adjacent semi-commissure portions, sewing the adjacent semi-commissure portions to each other to form a commissure of the leaflet assembly includes sewing the adjacent semi-commissure portions to each other at the base of the two commissure portions, wherein the base of each commissure portion is arranged opposite to the corresponding outer edge of the commissure portion, near the cusp of the corresponding leaflet.

[0024] In some embodiments, securing each joint to the joint support portion of the frame includes wrapping the end of each joint around the corresponding joint support portion, and sewing one or more sutures through the ends of the joints and tying the one or more sutures together on the outer surface of the joint support portion of the frame.

[0025] In another exemplary embodiment, a prosthetic heart valve may include an annular frame including a plurality of commissure support portions, and a leaflet assembly supported by the frame. The leaflet assembly may include a plurality of leaflet assemblies, each leaflet assembly including a leaflet including a cusp edge portion and two leaflet lugs, each of the two leaflet lugs being disposed at opposite ends of the cusp edge portion; and a skirt including a skirt mid-portion and two lugs, each of the two lugs being disposed at opposite ends of the skirt mid-portion, wherein each lug of the skirt is wrapped around and secured to a corresponding leaflet lug to form a semi-commissure portion at either end of the leaflet assembly. Furthermore, each semi-commissure portion is secured to an adjacent semi-commissure portion of an adjacent leaflet assembly of the plurality of leaflet assemblies to form a commissure of the leaflet assembly, and each commissure is coupled to a corresponding commissure support portion of the frame.

[0026] In some embodiments, each hemicommissure portion is secured to an adjacent hemicommissure portion of an adjacent leaflet assembly via sutures extending along and through the base of the adjacent hemicommissure portion, which base is disposed adjacent a corresponding cusp of a leaflet of the leaflet assembly.

[0027] In some embodiments, the formed joint includes two outer free ends that are arranged opposite to the joint ends of the adjacent half-joint portions that are fixed to each other, and the two outer free ends are wrapped around and connected to the corresponding joint 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 stitching lines extending across an outer surface of the commissure support portion.

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

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

[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 assembly, a skirt intermediate portion of the skirt is secured to the cusp edge portion of the leaflet via a series of in and out sutures.

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

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

[0035] In some embodiments, each semi-commissure portion is formed by two overlapping layers of skirt lugs on a first side of the lobe lug, the lobe lug, and two overlapping layers of skirt lugs on an opposite second side of the lobe lug, and wherein the fastener extends through each of the two overlapping layers of lugs on the first side of the lobe lug, the lobe lug, and the two overlapping layers of lugs on the second side of the lobe lug.

[0036] In some embodiments, each leaflet assembly further includes a reinforcement band including a middle portion and two end portions, each of the two end portions being disposed at an opposite end of the middle portion, wherein each lug of the skirt is wrapped around and secured to a corresponding leaflet lug and a corresponding end portion of the reinforcement band to form a semi-commissure portion at either end of the leaflet assembly.

[0037] In some embodiments, each lug of the skirt is secured to a corresponding leaflet lug and a corresponding end of the reinforcement band via a first fastener extending through the corresponding end of the reinforcement band, the corresponding leaflet lug, and the flaps of the skirt lug arranged on either side of the corresponding leaflet lug.

[0038] In some embodiments, each lug of the skirt is further secured to the corresponding leaflet lug and the corresponding end of the reinforcement band via a second fastener, which extends through two overlapping layers of skirt lugs arranged on a first side of the corresponding leaflet lug, the leaflet lug, and two overlapping layers of skirt lugs arranged on an opposite second side of the corresponding leaflet lug.

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

[0040] In some embodiments, 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 valve.

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

[0042] In some embodiments, the leaflet assembly includes three leaflet assemblies.

[0043] In another representative embodiment, a method of assembling a leaflet assembly of a prosthetic valve may include: arranging a skirt of the leaflet assembly on the leaflet of the subassembly so that a curved middle portion of the skirt is aligned with a curved cusp edge portion of the leaflet and each of the two lugs of the skirt overlaps with a corresponding one of the two leaflet lugs of the leaflet, and at each end of the leaflet assembly, wrapping the lugs of the skirt around the corresponding leaflet lugs of the leaflet to form a first flap covering a first side of the leaflet lug and a second flap covering a second side of the leaflet lug; arranging a reinforcement band on the skirt so that a contour of a middle portion of the reinforcement band aligns with the cusp edge portion of the leaflet The contours of the edge portion and the middle portion of the skirt are aligned, and each of the two end portions of the reinforcement band overlaps with the corresponding first flap; and at each end of the leaflet assembly: fixing the end portion of the reinforcement band to the corresponding leaflet lug of the leaflet and the corresponding lug of the skirt; folding the free end portion of the first flap back on itself to cover the end portion of the reinforcement band and form two overlapping layers on the first side of the leaflet lug, and folding the free end portion of the second flap back on itself to form two overlapping layers on the second side of the leaflet lug; and fixing the two overlapping layers on the first side of the leaflet lug, the leaflet lug, and the two overlapping layers on the second side of the leaflet lug to each other.

[0044] In some embodiments, the method can further include securing the intermediate portion of the skirt, the cusp edge portions of the leaflets, and the intermediate portion of the reinforcement band to one another.

[0045] In some embodiments, securing the ends of the reinforcement band to the corresponding leaflet tabs of the leaflets and the corresponding tabs of the skirt comprises extending a first suture line through each of the ends of the reinforcement band, the first flap, the leaflet tabs, and the second flap.

[0046] In some embodiments, securing the two overlapping layers on the first side of the leaflet lug, the leaflet lug, and the two overlapping layers on the second side of the leaflet lug to each other includes extending a second stitch line through each of the two overlapping layers on the first side of the leaflet lug, the leaflet lug, and the two overlapping layers on the second side of the leaflet lug, adjacent to the first trace and outside the first stitch line relative to the outer edge of the leaflet lug.

[0047] In another representative embodiment, a leaflet assembly for a prosthetic heart valve may include: a leaflet, the leaflet including a cusp edge portion and two leaflet lugs, each of the two leaflet lugs being arranged at opposite ends of the cusp edge portion; a skirt, the skirt including a skirt middle portion and two lugs, each of the two lugs being arranged at opposite ends of the skirt middle portion, the skirt being arranged against the leaflet so that the middle portion of the skirt is aligned with the cusp edge portion of the leaflet and each of the two lugs of the skirt is aligned with the two leaflet lugs of the leaflet The invention also provides a plurality of embodiments of the present invention, wherein the respective leaflet tabs in the ear overlap, wherein each tab of the skirt wraps around the respective leaflet tab of the leaflet to form a first flap covering a first side of the respective leaflet tab and a second flap covering a second side of the respective leaflet tab; and a reinforcement band comprising a middle portion and two end portions, each of the two end portions being arranged at opposite ends of the middle portion, the reinforcement band being arranged against the skirt such that a contour of the middle portion of the reinforcement band is aligned with a contour of a cusp edge portion of the leaflet and a middle portion of the skirt, and each of the two end portions of the reinforcement band overlaps the respective first flap. For each leaflet tab, the free end portion of the respective first flap is folded back on itself to overlap the respective end portion of the reinforcement band and form two overlapping layers on the first side of the respective leaflet tab, and the free end portion of the respective second flap is folded back on itself to form two overlapping layers on the second side of the respective leaflet tab.

[0048] In some embodiments, for each leaflet tab, each of the respective ends of the reinforcement band, 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 respective leaflet tab, the two overlapping layers on the first side of the leaflet tab, and the two overlapping layers on the second side of the leaflet tab are secured together via a second fastener.

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

[0051] In some embodiments, the middle portion of the reinforcement band, the skirt middle portion of the skirt, and the cusp edge portions of the leaflets are secured together via additional fasteners.

[0052] In some embodiments, the additional fastener is a plurality of entry and exit seams.

[0053] In some embodiments, the middle portion of the reinforcing tape includes a first seam line arranged along its center, following the curvilinear shape of the middle portion, and the skirt middle portion includes a second seam line centered along the length of the skirt middle portion, the first seam line and the second seam line overlapping each other.

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

[0055] In some embodiments, each of the two lugs 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 lugs of the skirt extends outward from one end of the middle portion of the skirt in a direction parallel to the centerline of the skirt and in a direction perpendicular to and away from the centerline.

[0057] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description made with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0058] Figure 1 is a perspective view of an exemplary embodiment of a prosthetic heart valve.

[0059] Figures 2A-2C are plan views of the individual components of a leaflet assembly for a prosthetic heart valve, including the leaflets, reinforcement bands, and skirt.

[0060] Figure 3 is a schematic diagram of the first stage of assembling the leaflet assembly, including securing the tabs of the skirt to the leaflet tabs of the leaflet.

[0061] Figure 4 is a schematic diagram of a second stage of assembling the leaflet assembly, including securing the skirt tabs, the leaflet tabs of the leaflet, and each of the folded layers of the reinforcing tape to one another to form a hemi-commissure portion of the leaflet assembly.

[0062] Figure 5is a schematic diagram of the third stage of assembling the leaflet assembly, including securing the intermediate portions of each of the leaflet, skirt, and reinforcement strap to one another.

[0063] Figures 6A-6B is a schematic diagram of an embodiment of attaching adjacent leaflet assemblies to each other to form a commissure.

[0064] Figures 7A-7B is a plan view of a portion of a first leaflet assembly and a portion of a second leaflet assembly, wherein the portion of the first leaflet assembly and the second leaflet assembly are positioned side by side in a relatively flat two-dimensional plane so that a first half-commissure portion of the first leaflet assembly can be secured to a second half-commissure portion of the second leaflet assembly.

[0065] Figure 8 is a schematic diagram showing an embodiment of attaching commissures of a pair of attached leaflet assemblies to a commissure support portion of a frame of a prosthetic heart valve.

[0066] Figure 9 is a top view of an exemplary embodiment of attaching commissures of a pair of leaflet assemblies to commissure support portions of a frame of a prosthetic heart valve.

[0067] Figure 10 yes Figure 9 A perspective view of an exemplary embodiment of FIG.

[0068] Figure 11 yes Figure 9 A first side view of an exemplary embodiment of a prosthetic heart valve further illustrating an embodiment of attaching individual skirts of the pair of leaflet assemblies to a frame of a prosthetic heart valve.

[0069] Figure 12 yes Figure 9 A second side view of an exemplary embodiment of a further embodiment of attaching the individual skirts of the pair of leaflet assemblies to the frame of a prosthetic heart valve. DETAILED DESCRIPTION

[0070] Described herein are examples of prosthetic heart valves, leaflet assemblies for prosthetic heart valves, leaflet assemblies of leaflet assemblies and methods for assembling leaflet assemblies, leaflet assemblies comprising a plurality of leaflet assemblies, and prosthetic heart valves comprising leaflet assemblies. The prosthetic heart valve may include a frame and a leaflet assembly attached to the frame. The leaflet assembly may include a plurality of leaflet assemblies that are coupled to each other at adjacent semi-commissure portions of the leaflet assembly. Each leaflet assembly may include a leaflet (e.g., a leaflet) and a skirt that is coupled to each other at semi-commissure portions formed along a cusp edge portion of the leaflet and at either end of the cusp edge portion. Each semi-commissure portion may be formed by folding the tabs of the skirt around corresponding leaflet (e.g., commissure) tabs of the leaflet and securing them to each other. The semi-commissure portions of the adjacently arranged leaflet assemblies may then be coupled to each other before being attached to the frame of the prosthetic heart valve. Thereby, a leaflet assembly for a prosthetic heart valve can be assembled more easily from the frame of the prosthetic heart valve, and the time and effort of securing the leaflet assembly to the frame of the prosthetic heart valve can be reduced.

[0071] Figure 1 An exemplary prosthetic heart valve 10 is shown according to one embodiment. The prosthetic heart valve 10 can be radially compressible and expandable between a radially compressed configuration (for delivery to a patient) and a radially expanded configuration. In a particular embodiment, the prosthetic heart valve 10 can be implanted within the native aortic valve annulus, although it can also be implanted at other locations in the heart, including within the native mitral valve, native pulmonary valve, and native tricuspid valve. The prosthetic heart valve 10 can include an annular stent or frame 12 having a first end 14 and a second end 16.

[0072] 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 can be coupled to a delivery device to deliver and implant the prosthetic heart valve within the native aortic valve via a retrograde femoral delivery approach. Thus, in the delivery configuration of the prosthetic heart valve, the outflow end 16 is the proximal-most end of the prosthetic valve. In other embodiments, the inflow end 14 can be coupled to a delivery device, depending on the specific native valve being replaced and the delivery technique used (e.g., trans-septal, trans-apical, etc.). For example, when the prosthetic heart valve is delivered to the native mitral valve via a trans-septal delivery approach, the inflow end 14 can be coupled to a delivery device (and therefore is the proximal-most end of the prosthetic heart valve in the delivery configuration).

[0073] The frame 12 may be made of any of a variety of suitable materials, such as stainless steel, cobalt-chromium alloys, or nickel-titanium alloys ("NiTi"), such as Nitinol. Figure 1As shown, the frame 12 can include a plurality of interconnected struts 28 arranged in a grid-type pattern. When the prosthetic heart valve 10 is in the expanded configuration, the struts 28 are shown as being diagonally positioned, or offset at an angle relative to the longitudinal axis of the prosthetic heart valve 10, and radially offset relative to the longitudinal axis of the prosthetic heart valve 10. In other embodiments, the struts 28 can be arranged in a pattern other than Figure 1 , or some or all of struts 28 may be positioned parallel to the longitudinal axis of prosthetic heart valve 10 .

[0074] In an exemplary embodiment, the struts 28 are pivotally coupled to each other at one or more pivot joints along the length of each strut. For example, in an exemplary configuration, each strut 28 can be formed with a hole at an opposite end of the strut, and the holes can be spaced apart along the length of the strut. Corresponding hinges can be formed at locations where the struts 28 overlap each other via fasteners or pivot members, such as rivets or pins 30 extending through the holes. The hinges can allow the struts 28 to pivot relative to each other when the frame 12 is radially expanded or compressed, such as during assembly, preparation, or implantation of the prosthetic heart valve 10.

[0075] In some embodiments, the frame 12 can be constructed by forming individual components (e.g., the struts and fasteners of the frame) and then mechanically assembling and connecting the individual components together. In other embodiments, the struts 28 are not coupled to each other by corresponding hinges, but are pivotable or bendable relative to each other in other ways 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 the frame and prosthetic heart valve are described in U.S. Patent Application Publication Nos. 2018 / 0153689, 2018 / 0344456, and 2019 / 0060057, all of which are incorporated herein by reference.

[0076] The prosthetic heart valve 10 may also include a valve structure 18 coupled to the frame 12 and configured to regulate blood flow 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 mounted to and equally spaced about the inner surface of the frame 12. The actuators are configured to apply expansion and compression forces to the frame to radially expand and compress the prosthetic valve.

[0077] In an exemplary 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 junction of the frame, such as at the first end 14, while the outer member 92 is pivotally coupled to another junction 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 effectively radially expands 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 effectively radially compresses the prosthetic valve. The actuator 80 may include a locking mechanism configured to maintain the prosthetic valve in an expanded state within the patient.

[0078] In some embodiments, each actuator 80 can be configured to form a releasable connection with one or more corresponding actuators of a delivery device of a transcatheter delivery system. The actuator of the delivery device can transfer force from the handle of the delivery device to the actuator 80 for expanding or compressing the prosthetic valve. Further details of the actuator, locking mechanism, and delivery device for actuating the actuator 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 actuator and locking mechanism disclosed in the previously submitted application can be incorporated into any prosthetic valve disclosed herein. Further, any delivery device disclosed in the previously submitted application can be used for delivery and implantation in any prosthetic valve disclosed herein.

[0079] In some embodiments, each actuator 80 can be used to support a corresponding commissure 24 (described below). Thus, the actuator 80 can include a commissure support portion for supporting the commissures 24 of the valve structure 18 and attaching it to the frame 12, as further described herein.

[0080] The valve structure 18 can include, for example, a leaflet assembly comprising one or more leaflets 22 (in the illustrated embodiment, three leaflets 22) made of a flexible material. The leaflets 22 of the leaflet assembly can be made in whole or in part of a biomaterial, a biocompatible synthetic material, or other such material. Suitable biomaterials can include, for example, bovine pericardium (or pericardium from other sources). The leaflets 22 can be arranged to form commissures 24, which can, for example, be mounted to the commissure support portions of corresponding actuators 80. Further details about transcatheter prosthetic heart valves, including the manner in which the valve structure can be coupled to the frame 12 of the prosthetic heart valve 10, can be found, for example, in U.S. Patent 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 herein by reference in their entirety).

[0081] In some embodiments, as Figure 1 As shown, the commissures 24 can be mounted (e.g., sewn) directly to the commissure support portions of the actuators 80 of the frame 12 via the commissure attachments 26. As an example, the commissure attachments 26 can include one or more stitches that secure the commissures 24 to the respective actuators 80. In other embodiments, the commissures 24 can be mounted to support struts or columns of the frame that are separate from the actuators 80.

[0082] The prosthetic heart valve 10 may also include one or more skirts or sealing members. Figure 1 As shown, the prosthetic heart valve 10 may include an inner skirt 20 mounted on the inner surface of the frame 12. Figure 1 As shown, the inner skirt 20 is a circumferential inner skirt that spans the entire circumference of the inner surface of the frame 12. The inner skirt 20 can act as a sealing member to prevent or reduce paravalvular leakage (e.g., when the valve is deployed at the implantation site) as well as an attachment surface to anchor the leaflets 22 to the frame 12.

[0083] The prosthetic heart valve 10 may further include an outer skirt portion ( Figure 1 (not shown). The outer skirt can act as a sealing member for the prosthetic valve by sealing against tissue of the native annulus and helping to reduce paravalvular leakage through the prosthetic valve. The inner and outer skirts can be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials (e.g., PET) or natural tissue (e.g., pericardial tissue). The inner and outer skirts can be mounted to the frame using sutures, adhesives, welding, and / or other means for attaching the skirts to the frame.

[0084] Because the inner skirt 20 spans the entire circumference of the inner surface of the frame 12, the attachment of multiple leaflets (e.g., three leaflets) 22 to the inner skirt 20 is time consuming and requires sophisticated assembly skills to avoid potential defects during the process. The skirt 20 effectively secures the leaflets relative to the frame, although discontinuities 82 may be formed at the attachment areas of the leaflets 22 to the inner skirt 20, near the corresponding commissure attachments 26 of the frame 12.

[0085] Thus, it may be desirable to assemble the leaflets of a leaflet assembly separately from the individual skirts and leaflets. For example, a leaflet assembly may include a plurality of separately formed leaflet assemblies, each leaflet assembly including a skirt and a leaflet secured to one another at the cusp edge portions of the leaflets and at the commissure (e.g., leaflet) lugs. In some embodiments, the skirt and additional reinforcing elements may form a support structure for the leaflets. Each individual leaflet assembly may then be connected to another leaflet assembly at adjacently arranged and separately formed semi-commissure portions to form the commissures of the leaflet assembly. The attached leaflet assemblies - forming the leaflet assembly - may then be connected to the frame of the prosthetic heart valve via the formed commissures. This assembly process may allow each leaflet assembly 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.

[0086] Figures 2A-2C Individual components of a leaflet assembly for a prosthetic heart valve are shown. The components of the leaflet assembly may include leaflet 130 ( Figure 2A ), reinforcement belt 120 ( Figure 2B ) and a skirt (eg, skirt portion) 140 ( Figure 2C ). For reference, see the following Figure 3-5 As further discussed, the leaflets 130 , reinforcement band 120 , and skirt 140 may all be secured to one another to form the individual leaflet assemblies 110 .

[0087] In some embodiments, as Figures 6A-7B As shown, multiple leaflet assemblies can be attached to each other. Pairs of attached leaflet assemblies can then be attached to commissure support portions of a frame of a prosthetic heart valve (e.g., such as a portion of an actuator or separate support struts), such as Figure 8-11 Additionally, in some embodiments, the skirt portion of each individual leaflet assembly can be secured to a strut of a prosthetic heart valve frame, such as Figure 11-12 shown.

[0088] Figures 2A-6B and Figure 8 Reference axes 104 are shown, including an x-axis, a y-axis, and a z-axis. Figures 2A-2C and Figure 5As shown, the individual components of the leaflet assembly lie in the xz plane and can be secured to one another in this two-dimensional plane before being coupled to another leaflet assembly and / or a prosthetic heart valve frame.

[0089] like Figure 2A As shown, the leaflet 130 includes a main cusp edge portion 134, two leaflet lugs (also referred to herein as commissure lugs) 132 at opposite ends of the cusp edge portion 134, and an upper edge portion 136. The cusp edge portion 134, the leaflet lugs 132, and the upper edge portion 136 can be arranged around the circumference of the leaflet 130, with the upper edge portion 136 extending between the two leaflet lugs 132 at the upper edge of the leaflet 130 and the cusp edge portion 134 extending between the two leaflet lugs 132 at the lower edge of the leaflet 130.

[0090] As used herein, "superior" and "inferior" can be relative to the z-axis, which can be disposed 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.

[0091] In some embodiments, the cusp edge portion 134 has a curved scalloped shape (e.g., Figure 2A Thus, the cusp edge portion 134 can be curved between the two leaflet ears 132.

[0092] Figures 2A-2C The centerline 102 of each individual leaflet component is shown, which may also be the centerline of the leaflet assembly. For example, when assembled, the centerlines 102 of the components of the leaflet assembly may overlap. Further, as Figure 2A As shown, leaflet lugs 132 can be arranged at opposite ends of cusp edge portions 134, across centerline 102 from one another. In some embodiments, a leaflet assembly and / or components of a leaflet assembly can have symmetry (e.g., reflection symmetry) across centerline 102.

[0093] In some embodiments, as Figure 2B As shown, the reinforcing band 120 includes a middle portion 124 and two end portions 122 disposed at opposite (e.g., opposite) ends of the middle portion 124. The middle portion 124 can be elongated and have a curved shape compared to the two end portions 122. For example, in some embodiments, the middle portion 124 can have a curved scalloped shape (e.g., Figure 2B In some embodiments, the curved, scalloped shape of the intermediate portion 124 can match (eg, track) the curved, scalloped shape of the cusp edge portion 134 of the leaflet 130 .

[0094] In some embodiments, the reinforcement tape 120 may further include seam lines 126, which may be, for example, markings applied to the tape (e.g., ink markings) or holes formed in the tape. Figure 2B As shown, the seam line 126 may be disposed along the center thereof, following the curved shape of the mid-portion 124 .

[0095] In some embodiments, the reinforcement strip 120 can comprise a flexible material. In some embodiments, the reinforcement strip 120 can comprise a fabric material. In other embodiments, the reinforcement strip 120 can comprise a flexible polymer material.

[0096] Figure 2C A skirt 140 is shown. The skirt 140 includes a skirt midsection 144 and two lugs (e.g., skirt lugs) 142 disposed at opposing (e.g., opposite) ends of the skirt midsection 144. In some embodiments, the skirt 140 further includes a seam line 146 that can be centered along the length of the skirt midsection 144 (e.g., extending between the two lugs 142). The seam line 146 can follow the same profile as the seam line 126 of the reinforcement tape 120.

[0097] According to some embodiments, one or more of the stitching lines 126, 146 include external markings, such as ink markings, to visually indicate stitching or suturing locations to a user assembling the leaflet assembly 110. In some embodiments, one or more of the stitching lines 126, 146 include a plurality of holes or openings through which needle sutures (or other yarn, thread, sewing thread, etc.) can be passed.

[0098] The skirt 140 may also include one or more positioning guides 160 arranged along an upper portion of the skirt midsection 144, and a first column of positioning guides 161 and a second column of positioning guides 163 in each lug 142. Positioning guides 160, 161, and 163 may be markings (e.g., ink markings) on the skirt 140 or holes formed in the skirt 140. Positioning guides 160 may be used to position the skirt midsection 144 relative to the struts of the frame when the leaflet assembly is connected to the frame of the prosthetic valve. Positioning guides 163, 161 may be used to position the lugs 142 of the skirt 140 relative to the lugs 132 of the corresponding leaflets 130.

[0099] In some embodiments, as Figure 2C As shown, each lug 142 may extend outwardly from one end of the skirt middle portion 144 in a direction parallel to the centerline 102 , and then extend outwardly from the portion of the lug 142 extending outwardly from the one end of the skirt middle portion 144 in a direction perpendicular to and away from the centerline 102 .

[0100] Figure 3-8 The diagram shows a stage in which the leaflet 130, the reinforcing band 120, and the skirt 140 are assembled into the leaflet assembly 110. To assemble the leaflet assembly 110, the skirt 140 may be placed on or against a side of the leaflet 130 (e.g., placed on the side of the leaflet 130). Figure 2A (above the side shown, i.e. the inner surface of the leaflet after being arranged in the frame). For example, Figure 5 As shown, the skirt 140 can be positioned over (e.g., against) the leaflet 130 such that the skirt intermediate portion 144 is aligned with the cusp edge portion 134 of the leaflet 130, and each lug 142 of the skirt 140 is positioned over (e.g., overlaps) a corresponding one of the two leaflet lugs 132 of the leaflet 130. In some embodiments, the skirt 140 can be positioned over the leaflet 130 such that the suture line 146 extends along and / or is positioned adjacent to the curve of the cusp edge portion 134 of the leaflet 130.

[0101] Each lug 142 of the skirt 140 can then be folded around a corresponding leaflet lug 132 on the leaflet 130 and secured to the other components of the leaflet assembly 110 via one or more fasteners (e.g., sutures or stitches) to form a semi-commissure portion for connection with the semi-commissure portion of an adjacent leaflet assembly, as further described below. It should be noted that although the formation of these semi-commissure portions may be described below with reference to the figures with respect to one side / end of a leaflet assembly (e.g., with respect to a leaflet lug 132 and a corresponding lug 142 of the skirt 140), the semi-commissure portions can be similarly assembled at both ends of the leaflet assembly 110 (e.g., on either side of the centerline 102).

[0102] Further, while the leaflet assembly is described herein as including a reinforcement strap, in alternative embodiments, the leaflet assembly may not include a reinforcement strap.

[0103] like Figure 2C and Figure 3 As shown, the lug 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. Figure 3 As shown, the tabs 142 wrap around the outer edge 131 of the leaflet tab 132 such that a first flap 142a covers one side (e.g., a first side) of the leaflet tab 132 and a second flap 142b covers the other side (e.g., an opposite second side) of the leaflet tab 132. In this manner, the tabs 142 of the skirt 140 sandwich the leaflet tab 132.

[0104] The reinforcing band 120 can then be positioned over (e.g., against) the skirt 140 such that the contour of its middle portion 124 is aligned with the contour of the cusp edge portion 134 of the leaflet 130 and the skirt middle portion 144 of the skirt 140. This can result in, for example, the seam lines 126 of the reinforcing band 120 being aligned with the seam lines 146 of the skirt 140. Further, each end 122 of the reinforcing band can be positioned (e.g., overlapped or overlaid) on a corresponding first flap 142a. Thus, the skirt 140 can be positioned between the reinforcing band 120 and the leaflet 130 such that a first face or surface of the skirt 140 is positioned or disposed against the leaflet 130, and an opposing second face or surface of the skirt 140 is positioned or disposed against the reinforcing band 120.

[0105] For example, Figure 3 and Figure 5 As shown, the end 122 of the reinforcing band 120 is placed over the corresponding first flap 142a. The corresponding end 122, lug 142 and leaflet lug 132 on the same end or side of the leaflet assembly 110 can then be secured to each other via fasteners. In some embodiments, such as Figure 3 As shown, the fastener may be one or more first suture lines (eg, in-and-out suture lines formed by sutures) 162 extending through each of the end 122, the first flap 142a, the leaflet lugs 132, and the second flap 142b.

[0106] like Figure 4 As shown, the end (eg, the free end) of the first flap 142a can then be folded along the second fold line 148b (see Figure 2C ) is folded over the end portion 122 of the reinforcing strip 120 to be folded back on itself to form the outer first flap portion 142c and the inner first flap portion 142d. Figure 4 As shown, the first flap 142a is arranged in two overlapping layers on a first side of the leaflet lug 132. As used herein, the "inboard" flap portion is arranged closer to the leaflet lug 132 than the "outboard" flap portion, and the "outboard" flap portion can have an outboard exposed surface.

[0107] Similarly, the end portion (eg, the free end portion) of the second flap 142b may be folded along a third fold line 148c (see Figure 2C ) is folded back on itself to form the outer second flap portion 142f and the inner second flap portion 142e. Figure 4 As shown, the second flap 142b is arranged on the second side of the leaflet lug 132 in two overlapping layers.

[0108] After the above series of folding, 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. Figure 4 Additionally, the ends of the first seam line 162 are contained (eg, enclosed) within the folded lug 142 and covered by the outer first flap portion 142c and the outer second flap portion 142f.

[0109] 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 to each other via fasteners. Figure 4 As shown, the fastener can be one or more second suture lines 164 (e.g., entry and exit suture lines formed by sutures) that extend through each of the outer first flap portion 142c, the inner first flap portion 142d, the leaflet lug 132, the inner second flap portion 142e, and the outer second flap portion 142f.

[0110] In some embodiments, as Figure 4 As shown, the second suture line 164 can be arranged adjacent to the first suture line 162 and outboard of the first suture line 162 relative to the outer edge 131 of the leaflet lug 132. In other embodiments, the second suture line 164 can be closer than Figure 4 Shown further away from the first suture line 162 , such as closer to the outer edge 131 of the leaflet lug 132 .

[0111] The leaflet lugs 132, all flap portions of the lugs 142, and the end portions 122 of the reinforcing band 120 are secured together (as described above with reference to FIG. Figure 3-4 The combination of the above) may be referred to herein as a semi-commissure portion 114 (e.g. Figure 4 ). Each leaflet assembly, such as leaflet assembly 110, includes two formed semi-commissure portions 114 (e.g., one on either side of centerline 102). As described further below, prior to attaching the leaflet assembly to the frame of a prosthetic heart valve, the semi-commissure portions of two adjacently arranged leaflet assemblies can be secured to one another to form a commissure (e.g., wherein two adjacent portions of the two leaflet assemblies are connected together).

[0112] like Figure 5As shown, in some embodiments, the leaflet 130, skirt 140, and reinforcement band 120 can be further secured to one another by additional fasteners, such as a suture line (e.g., a suture line of one or more sutures) 112. For example, the inlet and outlet suture line 112 can extend along at least a portion of the length of the curved outer edge 150 of the leaflet assembly 110 through the middle portion 124 of the reinforcement band 120, the skirt middle portion 144 of the skirt 140, and the cusp edge portion 134 of the leaflet 130. For example, Figure 5 As shown, the access seam line 112 may extend from a first end 152 of the leaflet assembly 110 (e.g., at one of the two lugs 142) to an opposite second end of the leaflet assembly 110 (e.g., at the other of the two lugs 142). Figure 5 14 (not shown) extends through the middle portion 124 of the reinforcing band 120, the skirt middle portion 144 of the skirt 140, and the cusp edge portion 134 of the leaflet 130. The suture line 112 may also extend through the hemicommissure portions at the opposite ends of the leaflet assembly, as shown.

[0113] In some embodiments, the entry and exit seam lines 112 may follow, extend through, and along the seam lines 126 and 146 .

[0114] In some embodiments, the combination of leaflets 130, skirt 140, and reinforcement band 120 forms a leaflet assembly. A leaflet assembly can be formed separately as described above for each leaflet of a prosthetic valve (e.g., each of the three leaflets). For example, each leaflet assembly can be individually formed on a relatively flat surface (e.g., a flat surface) before being attached to the frame of the prosthetic heart valve. Figure 5 is formed in the xz plane shown in ).

[0115] After forming one or more individual leaflet assemblies such as leaflet assembly 110, pairs of leaflet assemblies (intended to be arranged adjacent to each other within a prosthetic heart valve frame) can then be attached to each other by additional fasteners - before being attached to the frame of the prosthetic heart valve.

[0116] For example, Figures 6A-6B and Figures 7A-7B As shown, adjacent leaflet assemblies (formed in the same manner and including similar components as leaflet assembly 110) including a first leaflet assembly 110' and a second leaflet assembly 110" can be positioned such that the first half-joint portion 114' of the first leaflet assembly 110' is arranged adjacent to the second half-joint portion 114" of the second leaflet assembly 110".

[0117] For example, such positioning can result in the outer second flap portion 142f' (of the first leaflet assembly 110') and the outer second flap portion 142f" (of the second leaflet assembly 110") being arranged adjacent to each other. In this configuration, the reinforcement band 122' of the first leaflet assembly 110' and the reinforcement band 122" of the second leaflet assembly 110" are arranged away from each other on the outer edges of the assemblies so that the reinforcement bands 122' and 122" are not sandwiched between adjacently arranged leaflet lugs.

[0118] The first leaflet assembly 110 ′ and the second leaflet assembly 110 ″ may then be attached to one another via a fastener, such as a stitch (e.g., suture) 166 . This fastening may be repeated for each pair of adjacently arranged leaflet assemblies, on either side of the leaflet assemblies (e.g., for each set of hemi-commissure portions).

[0119] like Figures 6A-6B As shown, the stitch line 166 extends through the tab 142' (through at least some of the flap portion 142'cf), the end 122' of the reinforcement band 120' and the leaflet tab 132' of the first leaflet assembly 110' and the tab 142" (through at least some of the flap portion 142"cf), the end 122" of the reinforcement band 120", and the leaflet tab 132" of the adjacent second leaflet assembly 110".

[0120] In some embodiments, seam line 166 is positioned adjacent to seam lines 162' and 162" on a side facing seam lines 164' and 164", as shown in FIG. Figure 6A In other embodiments, as Figure 6B As depicted, seam line 166 is positioned adjacent to seam lines 162 ′ and 162 ″ on an opposite side of seam lines 162 ′ and 162 ″ from seam lines 164 ′ and 164 ″.

[0121] In some embodiments, as Figure 6A As shown, the suture line 166 extends through the outer first flap portion 142c', the reinforcement band end 122', the inner first flap portion 142d', the leaflet lug 132', the inner second flap portion 142e', the outer second flap portion 142f', the outer second flap portion 142f", the inner second flap portion 142e", the leaflet lug 132", the inner first flap portion 142d", the reinforcement band end 122" and the outer first flap portion 142c".

[0122] According to other embodiments, Figure 6BAs shown, the stitching line 166 extends through the outer first flap portion 142c', the reinforcement band end 122', the inner first flap portion 142d', the leaflet lug 132', the leaflet lug 132", the inner first flap portion 142d", the reinforcement band end 122" and the outer first flap portion 142c", and does not extend through any of the inner second flap portion 142e', the outer second flap portion 142f', the outer second flap portion 142f" and the inner second flap portion 142e".

[0123] The first and second commissure portions 114 ′, 114 ″ that are secured together (eg, attached) may be referred to herein as commissures 194 of two adjacent leaflet assemblies.

[0124] Figures 7A-7B A portion of the first leaflet assembly 110' and a portion of the second leaflet assembly 110" are shown on a relatively flat two-dimensional plane (eg, Figure 2A-5 1. A view of the subassemblies 110 and 111 being positioned side by side with each other in the xz plane (in which the subassemblies are individually assembled) such that the first commissure half portion 114' of the first leaflet assembly 110' is arranged directly adjacent to the second commissure half portion 114" of the second leaflet assembly 110".

[0125] like Figure 7A As shown, before the two half-commissure portions of the first and second leaflet assemblies are fastened to each other (e.g., by tightening the seam line 166), the outer edges 176' and 176" of the half-commissure portions, including the outer edge 131' of the leaflet lug 132' and the outer edge 131" of the leaflet lug 132", are facing each other. Figure 7B As shown, after tightening the seam line 166, 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 upward (e.g., at Figure 7B to leave the page).

[0126] like Figure 7A As shown, the base 174', 174" of each semi-commissure portion 114', 114" is disposed opposite a corresponding outer edge 176', 176" of the semi-commissure portion, proximate to the cusp 178', 178" of the corresponding leaflet.

[0127] like Figure 7BAs shown, securing the two half-commissure portions 114' and 114" together at their bases 174' and 174" creates 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 configured to receive a commissure support portion (e.g., a support strut) of a frame of a prosthetic heart valve, as further described below. The attached half-commissure portions 114' and 114" form the commissure 194 of two adjacent leaflet assemblies.

[0128] For example, Figure 8 As shown, the pair of attached leaflet assemblies including the first leaflet assembly 110 ′ and the second leaflet assembly 110 ″ can then be attached to the commissure support portion (e.g., support struts) 180 of the frame of the prosthetic heart valve. The commissure support portion 180 can be a portion of the actuator 80 (e.g., an upper portion of the outer member 92), as shown. Figure 1 In some embodiments, as shown, a single support column or support pillar of the frame. Figure 8 As shown, the commissures 194 formed by the attached first and second commissure portions halves 114 ′, 114 ″ may be attached to the commissure support portion 180 using fastening elements such as sutures 168 .

[0129] like Figure 8 As shown, each semi-commissure portion 114', 114" can be at least partially wrapped around the commissure support portion 180. Suture 168 can be sewn through the end of each semi-commissure portion of each leaflet assembly 110' and 110" using two suture lines 170a and 170b. The opposing ends of the two suture lines 170a and 170b can be tied together on the outside (e.g., the outer surface) of the commissure support portion 180 and the frame, such as at a tie 172. In other embodiments, separate sutures can be tied to each semi-commissure portion and then tied to each other.

[0130] Now turn Figure 9-12 , shows an embodiment of a prosthetic heart valve 200 and a method for attaching a pair of leaflet assemblies attached together at commissures 214 to a frame 202 of the prosthetic heart valve 200. For example, Figure 9-12 The first leaflet assembly 210 and the second leaflet assembly 212 shown may be similar to those described above with reference to Figure 2A-8 The leaflet assemblies 110, 110' and / or 110" described above may therefore include the same or similar components. Further, the first leaflet assembly 210 and the second leaflet assembly 212 may be the same as those described above. Figures 2A-7B The same or similar means are fixed to each other to form a joint portion 214.

[0131] Figure 9-12 An embodiment of a prosthetic heart valve 200 is shown having a frame 202. Similar to the above reference Figure 1 As shown, the frame 202 may include a plurality of interconnected struts 204 and a plurality of actuators 205, 206, 207 mounted to and equally spaced about the inner surface of the frame 202. In the illustrated embodiment, the actuators are used to support the commissures, and thus, components of the actuators are referred to as commissure support portions in the following description, although it should be understood that the frame may include commissure support portions separate from the actuators.

[0132] and Figure 1 Unlike the prosthetic heart valve 10 of the present invention, the prosthetic heart valve 200 does not include a single inner skirt extending around the entire circumference of the frame. Instead, the prosthetic heart valve 200 includes a plurality of leaflet assemblies (e.g., three), including a first leaflet assembly 210 and a second leaflet assembly 212, each of which includes a leaflet and a discrete skirt portion (e.g., Figure 2A The leaflet 130 and Figure 2C The skirt 140 shown, the leaflets and discrete skirt portions are preassembled before being attached to the frame 202, as described above with reference to Figures 2A-7B As stated.

[0133] For example, referring specifically to one leaflet assembly, a first leaflet assembly 210 includes individual leaflets 208 and individual skirts 218. The first leaflet assembly 210 has a first commissure half portion 220 that is secured to a first commissure half portion 222 of a second leaflet assembly 212 to form commissures 214. Further, the first leaflet assembly 210 includes a second commissure half portion 224 that is disposed on a side of the first leaflet assembly 210 opposite the first commissure half portion 220 (see FIG. Figure 12 The second commissure portion 224 of the first leaflet assembly 210 is attached to the first commissure portion of the third leaflet assembly to form a second commissure 226 (see Figure 12 The second commissure half portion of the third leaflet assembly can be attached to the second commissure half portion of the second leaflet assembly 212 to form the third commissure of the prosthetic heart valve 200 (at Figure 9-12 is not visible in the view).

[0134] like Figure 11-12 As shown, the commissures 214 of the first leaflet assembly 210 and the second leaflet assembly 212 are attached to the first support strut 206 of the frame 202 by fastening elements (e.g., sutures or stitches) 216. In some embodiments, the fastening elements 216 may include a plurality of stitches. The fastening elements 216 may be similar to Figure 8Support struts 206 may be an outer member of the actuator (eg, similar to outer member 92 of actuator 80).

[0135] For example, Figure 9 and 10 As shown, the outer ends of the commissures 214 wrap around the first support strut 206 toward the anterior surface of the first support strut 206. Fastening elements 216, comprising a series of sutures, are attached to either end of the commissures 214 and then extend across and around the anterior (e.g., outer) surface of the first support strut 206 (see FIG. Figure 11 and 12 ).

[0136] In some embodiments, as Figure 11 and 12 As shown, the skirt of each leaflet assembly (e.g., skirt 218 of first leaflet assembly 210) can be secured (e.g., attached) to struts 204 of frame 202 via fasteners 230. In some embodiments, fasteners 230 can include one or more sutures or stitches extending along the upper and lower edges of the skirt mid-portion of skirt 218. Stitches 230 can extend around adjacent struts 204 extending along the upper and lower edges of the skirt.

[0137] Thus, instead of a single inner skirt (e.g., a portion of a heart valve) attaching the individual leaflets to the frame of the prosthetic heart valve, Figure 1 ), the skirt of each individual leaflet assembly can be attached directly to the struts 204 of the frame 202, and each commissure (e.g., at Figure 9-12 In the embodiment, there are three leaflets (three in total) can be attached to corresponding support struts of the frame 202. Because the leaflet and skirt of each leaflet assembly and each commissure are secured together before being attached to the frame 202, the overall assembly of the leaflet assembly (including the attached leaflet assembly) and the attachment of the leaflet assembly to the frame 202 can be simplified and more convenient than conventional attachment methods (such as those described above with reference to FIG. Figure 1 The time taken is less).

[0138] In this way, leaflet assemblies (each comprising a skirt and leaflets) can be pre-assembled prior to attachment to the frame of a prosthetic heart valve. For example, as described above, assembly of each leaflet assembly can be performed in a simpler manner on a relatively flat surface, instead of the complex attachment of the leaflets to the three-dimensional structure of a standard skirt provided along the inner surface of the frame of the prosthetic heart valve. Further, by pre-assembling the leaflet assemblies individually, any identified defects in one or more leaflet assemblies can be addressed prior to forming a complete valve structure (e.g., a leaflet assembly comprising multiple leaflets attached to a standard skirt of a prosthetic heart valve). Still further, the leaflet assemblies can be attached to the frame of the prosthetic heart valve in a simpler and faster manner than attaching each leaflet to a three-dimensional skirt that is already attached to the frame of the prosthetic heart valve.

[0139] Overall considerations

[0140] For the purposes of this description, certain aspects, advantages and novel features of embodiments of the present disclosure are described herein. The disclosed methods, apparatus and systems should not be construed as limiting in any way. Instead, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments - individually and in various combinations and sub-combinations with each other. The methods, apparatus and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages exist or that a problem be solved. Techniques from any example may be combined with techniques described in any one or more other examples. Given that the principles of the disclosed technology are applicable to many possible embodiments, it should be recognized that the illustrated embodiments are merely preferred examples and should not be considered to limit the scope of the disclosed technology.

[0141] Although the operations of some disclosed embodiments are described in a specific sequential order for the convenience of presentation, it should be understood that this description includes rearrangement unless a specific order is required by the following specific language. For example, the operations described in sequence may be rearranged or performed simultaneously in some cases. In addition, for simplicity, the accompanying drawings may not show the various ways in which the disclosed method can be used in combination with other methods. In addition, the description sometimes uses terms such as "providing" or "implementing" to describe the disclosed method. These terms are highly abstract versions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific embodiment and are easily discernible to those of ordinary skill in the art.

[0142] As used herein, with respect to prosthetic heart valves and transcatheter delivery systems, "proximal" refers to a location, direction, or portion of a component that is closer to a user and a handle of the delivery system outside the patient's body, and "distal" refers to a location, direction, or portion of a component that is farther from the user and the handle and closer to the implantation site. Unless expressly defined otherwise, the terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions.

[0143] 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 "including" means "comprising." Further, the terms "coupled" and "connected" generally mean electrical, electromagnetic, and / or physical (e.g., mechanical or chemical) couplings or connections, and do not exclude the presence of intervening elements between the coupled or associated items in the absence of specific relative language.

[0144] Directional and other relative references (e.g., inside, outside, up, down, etc.) may be used to facilitate discussion of the figures and principles herein but are not intended to be limiting. For example, certain terms such as "inside," "outside," "up," "down," "inside," "outside," etc. may be used. Such terms are used, where applicable, to provide a certain clarity of description when dealing with relative relationships, particularly with respect to example embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, the "upper" portion may become the "lower" portion by turning the object over. Nevertheless, it is still the same part and the object remains unchanged. As used herein, "and / or" means "and" or "or" as well as "and" and "or."

[0145] While the principles of the disclosed invention are applicable to a variety of possible embodiments, it should 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. Rather, the scope of the invention is defined by the appended claims. We therefore claim that all inventions that fall within the scope and spirit of these claims are our invention.

Claims

1. A method of assembling a prosthetic heart valve including a leaflet assembly, comprising: forming a plurality of leaflet assemblies, each leaflet assembly comprising a leaflet and a skirt, wherein each leaflet assembly is formed by: arranging the skirt on one side of the leaflet so that the skirt extends along a curved cusp edge portion of the leaflet and two commissure tabs of the leaflet, folding two ends of the skirt around corresponding commissure tabs of the leaflet, sewing each folded end to a corresponding one of the two commissure tabs to form a corresponding half-commissure portion of the leaflet assembly, and sewing the skirt to the cusp edge portion of the leaflet; forming the leaflet assembly by pairing each hemicommissure portion of each leaflet assembly with a hemicommissure portion of another leaflet assembly of the plurality of leaflet assemblies to form a plurality of pairs of adjacent hemicommissure portions, and for each pair, sewing the adjacent hemicommissure portions to one another to form a commissure of the leaflet assembly; as well as The leaflet assembly is secured to the frame of the prosthetic heart valve by fastening each commissure to a commissure support portion of the frame.

2. The method of claim 1 , further comprising further securing the leaflet assembly to the frame of the prosthetic heart valve by fastening the skirt of each leaflet assembly to a strut of the frame.

3. The method of claim 2 , wherein securing the skirt of each leaflet assembly to a post of the frame comprises securing a skirt mid-portion of the skirt of each leaflet assembly to a plurality of interconnected posts of the frame arranged in a grid-type pattern, wherein the skirt mid-portion is disposed between two lugs of the skirt.

4. The method of any one of claims 1-3, wherein each of the two ends of the skirt comprises a tab, and wherein folding the two ends of the skirt around corresponding commissure tabs of the leaflets comprises: For each end and corresponding commissure tab, the tab is folded about 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. The method of claim 4 , wherein each leaflet assembly further comprises a reinforcement band, and the method further comprises arranging the reinforcement band on a side of the skirt opposite to the side of the skirt disposed on the leaflet, such that the reinforcement band extends along a curved portion of the skirt, and each of the two ends of the reinforcement band covers a corresponding first flap of the skirt, and sewing each folded end of the skirt to a corresponding commissure tab and a corresponding end of the two ends of the reinforcement band via a first stitching line.

6. The method of claim 5, wherein folding the two ends of the skirt around corresponding lugs of the leaflet assembly further comprises: For each end of the skirt and the corresponding joint lug, the free end of the first flap is folded back on itself to cover the corresponding end of the reinforcement band and form two overlapping layers on the first side of the joint lug, and the free end of the second flap is folded back on itself to form two overlapping layers on the second side of the joint lug.

7. The method of claim 6, further comprising 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 to one another via a second seam line.

8. A method according to claim 7, wherein, for each pair of adjacent semi-commissure portions, sewing the adjacent semi-commissure portions to each other to form the commissure of the leaflet assembly includes sewing the adjacent semi-commissure portions to each other via a third stitching line, the third stitching line being arranged adjacent to the first stitching line, and the third stitching line extending through the corresponding end of the reinforcement band of each leaflet assembly.

9. The method of claim 8 , wherein sewing the adjacent semi-joint portions to each other via the third seam line comprises, for each semi-joint portion of the pair of adjacent semi-joint portions, extending the third seam line through the two overlapping layers on the first side of the joint tab, the joint tab, and the two overlapping layers on the second side of the joint tab. 10 . The method according to claim 9 , wherein the third seam line is arranged adjacent to the first seam line on a side of the first seam line facing the second seam line.

11. The method of claim 8 , wherein sewing the adjacent semi-joint portions to each other via the third seam line comprises, for each semi-joint portion of the pair of adjacent semi-joint portions, extending the third seam line through the two overlapping layers and the joint tab on the first side of the joint tab, but not through the two overlapping layers on the second side of the joint tab. 12 . The method according to claim 11 , wherein the third seam line is arranged adjacent to the first seam line on a side of the first seam line that is arranged opposite to a side of the first seam line that faces the second seam line.

13. A method according to any one of claims 1-3 and 5-12, wherein sewing the skirt to the cusp edge portion of the leaflet includes sewing the skirt to the cusp edge portion along the cusp edge portion from the first of the two commissure lugs of the leaflet to the second of the two commissure lugs of the leaflet via a series of entry and exit sutures extending through the leaflet and the skirt.

14. A method according to claim 13, wherein sewing the skirt to the cusp edge portion of the leaflet via the series of entry and exit sutures includes passing the series of entry and exit sutures through and extending along a first suture line, and the first suture line is arranged on the skirt middle portion of the skirt extending between the two ends of the skirt.

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

16. A method according to claim 14 or claim 15, wherein each leaflet assembly further includes a reinforcement band, the method further including arranging the reinforcement band on a side of the skirt opposite to the side of the skirt that is arranged on the leaflet, so that the reinforcement band extends along the curved portion of the skirt and each of the two ends of the reinforcement band covers the corresponding first petal of the skirt; and further including sewing the reinforcement band to the skirt by passing the series of entry and exit seams through and extending along a second seam line, the second seam line being arranged along the curved middle portion of the reinforcement band, and wherein the first seam line and the second seam line are aligned with each other.

17. A method according to any one of claims 1-3, 5-12 and 14-15, wherein for each pair of adjacent semi-commissure portions, sewing the adjacent semi-commissure portions to each other to form the commissure of the leaflet assembly includes sewing the adjacent semi-commissure portions to each other at the base of the two commissure portions, wherein the base of each commissure portion is arranged opposite to the corresponding outer edge of the commissure portion, close to the cusp of the corresponding leaflet.

18. A method according to any one of claims 1-3, 5-12 and 14-15, wherein securing each joint to the joint support portion of the frame includes wrapping the end of each joint around the corresponding joint support portion, and sewing one or more sutures through the ends of the joints and tying the one or more sutures together on the outer surface of the joint support portion of the frame.

19. Prosthetic heart valves, including: an annular frame comprising a plurality of commissure support portions; and A leaflet assembly supported by the frame, the leaflet assembly comprising a plurality of leaflet assemblies, each leaflet assembly comprising: a leaflet comprising a cusp edge portion and two leaflet lugs, each of the two leaflet lugs being disposed at opposite ends of the cusp edge portion; a skirt comprising a skirt middle portion and two lugs, each of the two lugs being disposed at opposite ends of the skirt middle portion; and wherein each lug of the skirt is wrapped around and secured to a corresponding leaflet lug of the leaflet to form a hemi-commissure portion at either end of the leaflet assembly; and wherein each semi-commissure portion is secured to an adjacent semi-commissure portion of an adjacent leaflet assembly of the plurality of leaflet assemblies to form a commissure of the leaflet assembly; and Each commissure is coupled to a corresponding commissure support portion of the frame.

20. A prosthetic heart valve according to claim 19, wherein each semi-commissure portion is secured to an adjacent semi-commissure portion of an adjacent leaflet assembly via sutures extending along and through the base of the adjacent semi-commissure portion, the base being arranged adjacent to the corresponding cusp of the leaflet of the leaflet assembly.

21. A prosthetic heart valve according to claim 19 or claim 20, wherein the formed commissure includes two outer free ends, which are arranged opposite to the ends of the commissure including the ends of the adjacent half-commissure parts fixed to each other, and the outer free ends are wrapped around the corresponding commissure support parts of the frame and connected to the corresponding commissure support parts of the frame.

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

23. The prosthetic heart valve of any one of claims 19-20 and 22, wherein each skirt of each leaflet assembly is coupled to a strut of the frame.

24. A prosthetic heart valve according to claim 23, wherein the skirt middle portion of the skirt of each leaflet assembly includes one or more positioning guides, which are arranged along the upper portion of the skirt middle portion, and the positioning guides are configured to position the skirt middle portion relative to the support of the frame.

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. The prosthetic heart valve according to any one of claims 19-20, 22 and 24-25, wherein For each leaflet assembly, the skirt intermediate portion of the skirt is secured to the cusp edge portion of the leaflet via a series of in and out sutures.

27. A prosthetic heart valve according to any one of claims 19-20, 22 and 24-25, wherein for each leaflet assembly, each of the two lugs of the skirt includes one or more positioning guides, which are configured to position the lug of the skirt relative to the corresponding leaflet lug of the two leaflet lugs of the leaflet.

28. A prosthetic heart valve according to any one of claims 19-20, 22 and 24-25, wherein each semi-commissure portion is formed by multiple overlapping layers of the lugs of the skirt on either side of the leaflet lug, and the multiple overlapping layers are secured to each other and through the leaflet lugs via one or more fasteners.

29. A prosthetic heart valve according to claim 28, wherein each semi-commissure portion is formed by two overlapping layers of the lugs of the skirt on a first side of the leaflet lug, the leaflet lug, and two overlapping layers of the lugs of the skirt on an opposite second side of the leaflet lug, and wherein a fastener extends through each of the two overlapping layers of the lugs on the first side of the leaflet lug, the leaflet lug, and the two overlapping layers of the lugs on the second side of the leaflet lug.

30. A prosthetic heart valve according to any one of claims 19-20, 22, 24-25 and 29, wherein each leaflet assembly further includes a reinforcement band, the reinforcement band including a middle portion and two end portions, each of the two end portions being arranged at opposite ends of the middle portion, wherein each lug of the skirt is wrapped around and fixed to the corresponding leaflet lug and the corresponding end portion of the reinforcement band to form the semi-commissure portion at either end of the leaflet assembly.

31. A prosthetic heart valve according to claim 30, wherein each lug of the skirt is secured to a corresponding leaflet lug and a corresponding end of the reinforcement band via a first fastener, the first fastener extending through the corresponding end of the reinforcement band, the corresponding leaflet lug and the flaps of the lug of the skirt arranged on either side of the corresponding leaflet lug.

32. A prosthetic heart valve according to claim 31, wherein each lug of the skirt is further secured to the corresponding leaflet lug and the corresponding end of the reinforcement band via a second fastener, the second fastener extending through two adjacent overlapping layers of the lugs of the skirt arranged on a first side of the corresponding leaflet lug, the leaflet lug, and two overlapping layers of the lugs of the skirt arranged on an opposite second side of the corresponding leaflet lug.

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

34. A prosthetic heart valve according to any one of claims 19-20, 22, 24-25, 29 and 31-33, wherein the commissure support portion of the frame includes an actuator of the frame, and the actuator is configured to apply expansion and compression forces to the frame to radially expand and compress the prosthetic valve.

35. The prosthetic heart valve of any one of claims 19-20, 22, 24-25, 29, and 31-33, wherein the commissure support portions of the frame comprise support struts or support posts of the frame.

36. The prosthetic heart valve of any one of claims 19-20, 22, 24-25, 29, and 31-33, wherein the leaflet assembly comprises three leaflet assemblies.

37. A method of assembling a leaflet assembly of a prosthetic valve, comprising: placing a skirt of the leaflet assembly over a leaflet of the subassembly such that a curvilinear mid-portion of the skirt is aligned with a curvilinear cusp edge portion of the leaflet and each of the two lugs of the skirt overlaps a respective one of the two leaflet lugs of the leaflet; wrapping the tabs of the skirt at each end of the leaflet assembly around corresponding leaflet tabs 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 a reinforcing band on the skirt such that a contour of a middle portion of the reinforcing band is aligned with a cusp edge portion of the leaflet and a contour of the middle portion of the skirt, and each of two end portions of the reinforcing band overlaps with a corresponding first flap; as well as At each end of the leaflet assembly: securing the ends of the reinforcement band to corresponding leaflet lugs of the leaflet and corresponding lugs of the skirt; folding the free end of the first flap back upon itself to cover the end of the reinforcement band and form two overlapping layers on the first side of the leaflet lug, and folding the free end of the second flap back upon itself to form two overlapping layers on the second side of the leaflet lug; and 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 are secured to one another.

38. The method of claim 37, further comprising securing the middle portion of the skirt, the cusp edge portion of the leaflet, and the middle portion of the reinforcement band to one another.

39. A method according to claim 37 or claim 38, wherein securing the end of the reinforcement band to the corresponding leaflet lug of the leaflet and the corresponding lug of the skirt includes extending a first suture line through each of the end of the reinforcement band, the first flap, the leaflet lug and the second flap.

40. The method of claim 39, wherein 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 comprises: A second suture line is extended through the two overlapping layers on the first side of the leaflet lug, the leaflet lug, and each of the two overlapping layers on the second side of the leaflet lug, the second suture line being adjacent to the first suture line and being outside of the first suture line relative to the outer edge of the leaflet lug.

41. A leaflet assembly for a prosthetic heart valve, comprising: a leaflet comprising a cusp edge portion and two leaflet lugs, each of the two leaflet lugs being disposed at opposite ends of the cusp edge portion; a skirt comprising a skirt middle portion and two lugs, each of the two lugs being disposed at opposite ends of the skirt middle portion, the skirt being disposed against the leaflet such that the skirt middle portion is aligned with the cusp edge portion of the leaflet and each of the two lugs of the skirt overlaps a corresponding one of the two leaflet lugs of the leaflet, wherein each lug of the skirt wraps around a corresponding leaflet lug of the leaflet to form a first flap covering a first side of the corresponding leaflet lug and a second flap covering a second side of the corresponding leaflet lug; and a reinforcing band comprising a middle portion and two end portions, each of the two end portions being disposed at an opposite end of the middle portion, the reinforcing band being disposed against the skirt such that a contour of the middle portion of the reinforcing band is aligned with a contour of the cusp edge portion of the leaflet and the middle portion of the skirt, and each of the two end portions of the reinforcing band overlaps a corresponding first flap; as well as wherein, for each leaflet lug, the free end of the corresponding first flap is folded back on itself to cover the corresponding end of the reinforcement band and form two overlapping layers on the first side of the corresponding leaflet lug, and the free end of the corresponding second flap is folded back on itself to form two overlapping layers on the second side of the corresponding leaflet lug.

42. The leaflet assembly of claim 41, wherein: For each leaflet tab, each of the respective ends of the reinforcement band, the first flap, the leaflet tab, and the second flap are secured together via a first fastener.

43. The leaflet assembly of claim 42, wherein: For each leaflet tab, the respective leaflet tab, each of the two overlapping layers on the first side of the leaflet tab, and the two overlapping layers on the second side of the leaflet tab are secured together via a second fastener.

44. The leaflet assembly of claim 43, wherein the second fastener is disposed adjacent to the first fastener and closer to the outer edge of the corresponding leaflet lug than the first fastener.

45. The leaflet assembly of any one of claims 41-44, wherein the middle portion of the reinforcement band, the skirt middle portion of the skirt, and the cusp edge portion of the leaflet are secured together via additional fasteners.

46. The leaflet assembly of claim 45, wherein the additional fastener is a plurality of entry and exit stitches.

47. A leaflet assembly according to claim 45, wherein the middle portion of the reinforcement band includes a first seam line arranged along the center thereof, following the curved shape of the middle portion, and wherein the skirt middle portion includes a second seam line centered along the length of the skirt middle portion, the first seam line and the second seam line overlapping each other.

48. The leaflet assembly of any one of claims 41-44 and 46-47, wherein the skirt includes one or more positioning guides disposed along an upper portion of the skirt mid-section configured as markings or holes formed in the skirt.

49. The leaflet assembly of any one of claims 41-44 and 46-47, wherein each of the two lugs of the skirt includes one or more rows of positioning guides configured as markings or holes formed in the skirt.

50. The leaflet assembly of any one of claims 41-44 and 46-47, wherein each of the two lugs of the skirt extends outwardly from one end of the skirt middle portion in a direction parallel to a centerline of the skirt and in a direction perpendicular to and away from the centerline.

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