Prosthetic heart valve

Abstract

Prosthetic heart valves are disclosed. In some examples, a prosthetic heart valve comprises a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration, a plurality of leaflets mounted on an inside of the frame, wherein commissure tabs of adjacent leaflets are paired to form a commissure that is secured to the frame, and a main skirt disposed within the frame and coupled to the leaflets, the main skirt comprising a plurality of windows, wherein a portion of each pair of adjacent leaflets extend radially outwards through a respective window of the plurality of windows.

Description

PROSTHETIC HEART VALVECROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U. S. Provisional Patent Application No.63 / 712,918, filed October 28, 2024, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to prosthetic heart valves, and in particular to skirts and leaflet configurations for prosthetic heart valves.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart 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 heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.SUMMARY

[0004] Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves. The disclosed prosthetic heart valves, delivery apparatus, and methods can, for example, provide skirt configurations that allow the leaflets to be disposed closer to the frame to improve flow through the valve. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatus.

[0005] A prosthetic heart valve can comprise a frame and a valvular structure coupled to the frame. In addition to these components, a prosthetic heart valve can further comprise one or more of the components disclosed herein.

[0006] In some examples, a prosthetic heart valve can comprise a sealing member configured to reduce paravalvular leakage.

[0007] In some examples, a prosthetic heart valve can comprise an inner skirt with openings that enable portions of leaflets to extend radially outwards and at least partially through a cell of the frame.

[0008] In some examples, a prosthetic heart valve can comprise an inner skirt comprising a plurality of panels coupled together, wherein windows are defined between adjacent panels to enable portions of leaflets to extends radially outwards through the windows.

[0009] In some examples, a prosthetic heart valve comprises a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; a plurality of leaflets mounted on an inside of the frame, wherein commissure tabs of adjacent leaflets are paired to form a commissure that is secured to the frame; and a main skirt disposed within the frame and coupled to the leaflets, the main skirt comprising a plurality of windows, wherein a portion of each pair of adjacent leaflets extend radially outwards through a respective window of the plurality of windows.

[0010] In some examples, a prosthetic heart valve comprises a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; a plurality of leaflets mounted on an inside of the frame, wherein commissure tabs of adjacent leaflets are paired to form a commissure that is secured to the frame; and a main skirt disposed within the frame and coupled to the leaflets, the main skirt comprising three panels defining three windows, each panel having an inflow end and an outflow end, wherein two adjacent panels are coupled together with stitches extending from the inflow end to an intermediate point of the panels, wherein a window is defined between the intermediate point and the outflow end of the two adjacent panels, wherein a portion of each pair of adjacent leaflets extend radially outwards through a respective window.

[0011] In some examples, a prosthetic heart valve comprises a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; a plurality of leaflets mounted on an inside of the frame, wherein each leaflet comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end, two lower tabs disposed on opposite sides of the main body, two upper tabs disposed on opposite sides of the main body and folded downwardly against the lower tabs,and two wings disposed on opposite sides of the main body, wherein lower and upper tabs of adjacent leaflets are paired to form a commissure that is secured to the frame, and wherein wings of the adjacent leaflets are folded radially outwards and extend through the frame; and a main skirt coupled to the inside of the frame, the main skirt comprising a plurality of panels that are coupled together, the main skirt defining a window between each pair of adjacent panels, wherein the wings of the adjacent leaflets extend radially outwards through a respective window.

[0012] In some examples, a prosthetic heart valve comprises one or more of the components recited in Examples 1-21 below.

[0013] In some examples, a method for assembling a prosthetic heart valve comprises coupling a skirt to a frame of a prosthetic heart valve; and coupling leaflets to the frame of the prosthetic heart valve.

[0014] In some examples, a method for assembling a prosthetic heart valve comprises coupling a skirt panel to an adjacent skirt panel with stitches along a portion of an overall height of the skirt panels such that the skirt panels are coupled together at a first end and free at a second end; extending wings of an adjacent pair of leaflets between the skirt panels adjacent to the second end; and coupling the second ends of the skirt panels to the frame of the prosthetic heart valve.

[0015] In some examples, a method comprises one or more of the steps recited in Example 22 below.

[0016] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated).

[0017] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1 is a perspective view of a prosthetic heart valve, according to an example.

[0019] FIG. 2 is a plan view of a portion of the frame of the prosthetic heart valve of FIG. 1 in a laid flat configuration.

[0020] FIG. 3 is a plan view of a leaflet of the prosthetic heart valve of FIG. 1.

[0021] FIG. 4 is a plan view of a reinforcing strip of the prosthetic heart valve of FIG. 1.

[0022] FIG. 5 is a plan view of a post of the prosthetic heart valve of FIG. 1.

[0023] FIG. 6 is a plan view of a panel of an inner skirt of the prosthetic heart valve of FIG.1.

[0024] FIG. 7 is a side view of the prosthetic heart valve of FIG. 1, with an outer skirt removed.

[0025] FIG. 8 is a side view of a portion of the prosthetic heart valve of FIG. 7.

[0026] FIG. 9 is a perspective view of the prosthetic heart valve of FIG. 7, illustrating an interior of the prosthetic heart valve.

[0027] FIG. 10A-10E are perspective views illustrating stitching together two of the panels of FIG. 6 to form the inner skirt.

[0028] FIG. 11 is a perspective view of the inner skirt of the prosthetic heart valve of FIG. 7.DETAILED DESCRIPTIONGeneral Considerations

[0029] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0030] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity,the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0031] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0032] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0033] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Examples of the Disclosed Technology

[0034] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0035] FIG. 1 shows an exemplary prosthetic valve 100, according to one example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0036] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U. S. Publication No. 2017 / 0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U. S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0037] FIG. 1 illustrates the prosthetic valve 100 in a radially expanded position. As shown in FIG. 1, the prosthetic valve 100 can include a frame 102 and a valvular structure 104 comprising a plurality of leaflets 200 situated at least partially within the frame 102. The prosthetic valve 100 can also include an outer covering 106 (which is also referred to herein as an “outer skirt”) situated about the frame 102. As described in more detail below, the prosthetic valve 100 can also include an inner skirt 116 (FIG. 7) disposed within the frame 102. As shown in FIG. 1, the prosthetic valve 100 includes an inflow end 108 and an outflow end 110. The terms “inflow” and “outflow” are related to the normal direction of blood flow (for example, antegrade blood flow) through the prosthetic valve 100. For example, the leaflets 200 can allow blood flow through the valve 100 in a direction from the inflow end 108 to the outflow end 110 and prevent the reverse flow (for example, prevent flow in a direction from the outflow end 110 to the inflow end 108).

[0038] The frame 102 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol) as known in the art. When constructed of a plastically-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve 100 can be advanced from the delivery sheath, which allows the valve 100 to expand to its functional size.

[0039] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 102) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 102 can comprise stainless steel. In some examples, the frame 102 can comprise cobalt-chromium. In some examples, the frame 102 can comprise nickel -cobaltchromium. In some examples, the frame 102 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-2). MP35N™ / UNS R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0040] The outer skirt 106 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the outer skirt 106 can comprise a fabric having interlaced yams or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the outer skirt 106 can comprise a fabric without interlaced yams or fibers or randomly interlaced yarns or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for fomiing such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the outer skirt 106 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide,polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)). etc. In some examples, the outer skirt 106 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the outer skirt 106 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0041] Further details of the prosthetic heart valve and its variants are described in U. S. Patent No. 11,185,406, which is incorporated by reference herein in its entirety.

[0042] FIG. 2 illustrates a portion of the frame 102 in a laid-flat configuration for purposes of illustration. The frame 102 includes a plurality of strut members 112 that can be arranged end-to-end to form a plurality of rows or rungs of strut members that extend circumferentially around the frame 102. For example, with reference to FIG. 2, the frame 102 can comprise a first or lower row I of angled strut members 112 forming the inflow end 108 of the frame; a second row II of strut members 112 above the first row; a third row III of strut members 112 above the second row; a fourth row IV of strut members 112 above the third row, and a fifth row V of strut members 112 above the fourth row and forming the outflow end 110 of the frame. At the outflow end 110 of the frame, the strut members 112 of the fifth row V can be arranged at alternating angles in a zig-zag pattern. The strut members 112 of the fifth row V are spaced apart from the strut members 112 of the fourth row IV by axial struts 136 and commissure windows 138. The strut members 112 of the fifth row V can be joined together at their distal ends (relative to the direction of implantation in the mitral valve) to form the apices 114 and joined together at their proximal ends at junctions 134, which may form part of the commissure windows 138 and the axial struts 136. Additional structure and characteristics of the rows I-V of strut members 112 are described in greater detail in U. S. Patent No. 9,393,110, which is incorporated by reference herein in its entirety.

[0043] The leaflet 200 of the prosthetic heart valve 100 of FIG. 1 is shown in a flattened configuration in FIG. 3. The leaflet 200 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U. S. Patent No. 6,730,118, which is incorporated by reference herein.

[0044] The leaflet 200 has a main body 202 with a free edge 204 (which can also be referred to as an outflow edge) and a cusp edge portion 206 (also referred to as an inflow edge portion) that is in opposing relation to the free edge 204. The free edge 204 is configured to move and contact respective free edges of the other leaflets of a leaflet assembly duringclosure of the leaflets (e.g., during diastole during operation of the prosthetic heart valve). As described further below, the cusp edge portion 206 is configured to be attached to an inner skirt, which in turn can be attached to a frame of a prosthetic heart valve. For example, the cusp edge portion 206 can include apertures 207 extending along the length of the cusp edge portion 206 and following the curvature of the cusp edge portion 206. The apertures 207 can facilitate attachment of the cusp edge portion 206 to the inner skirt and frame of the prosthetic heart valve. In some examples, the cusp edge portion 206 can be directed attached to struts of the frame of the prosthetic heart valve.

[0045] In some examples, as shown in FIG. 3, the free edge 204 comprises a straight or linear edge that is perpendicular to a central longitudinal axis 212 of the leaflet. In some examples, as shown in FIG. 3, the cusp edge portion 206 comprises a curved or scalloped shape. In some examples, the radius of curvature of the cusp edge portion 206 is constant.

[0046] In some examples, the leaflet 200 further comprises two sets of opposing commissure tabs disposed on opposite sides of the leaflet 200. For example, the leaflet 200 includes a pair of upper tabs 208 disposed on opposite sides of the leaflet 200 and a pair of lower tabs 210 disposed on opposite sides of the leaflet 200. The lower tabs 210 are disposed closer to the cusp edge portion 206 than the upper tabs 208.

[0047] The lower tabs 210 extend laterally outward from the body 202 of the leaflet 200, relative to the central longitudinal axis 212 of the leaflet 200. The longitudinal axis 212 may be an axis about which leaflet 200 is symmetrical. As used herein, the axial direction can be a direction parallel to the central longitudinal axis 212 and the lateral direction can be perpendicular to the central longitudinal axis 212 (e.g., from one side of the leaflet to the opposite side of the leaflet, across the central longitudinal axis 212). As shown in FIG. 3, the central longitudinal axis 212 of the leaflet 200 extends from the inflow end to the outflow end of the leaflet 200.

[0048] An upper or outflow edge 214 of each lower tab 210 is positioned at an angle relative to the central longitudinal axis 212. In some examples, as shown in FIG. 3, the angle is 90 degrees. A lower or inflow edge 224 of each lower tab 210 is positioned at an angle relative to the central longitudinal axis 212. In some examples, as shown in FIG. 3, the angle is 90 degrees. In some examples, as shown in FIG. 3, the outflow edge 214 of each lower tab 210 is axially aligned and colinear with the free edge 204.

[0049] Each lower tab 210 can have an outer side edge 220. In some examples, as shown in FIG. 3, the outer edge 220 of each lower tab 210 is parallel to the central longitudinal axis212. In some examples, as shown in FIG. 3, the inflow edge 224 and an outflow edge 214 of each lower tab are perpendicular to the central longitudinal axis 212.

[0050] Each upper tab 208 can have a substantially rectangular shape with an inner edge 228, an outer side edge 230 disposed opposite the inner edge 228, an outflow edge 232, and an inflow edge 234 disposed opposite the outflow edge 232. In some examples, the inner edge 228 and outer edge 230 can be referred to as side edges and are parallel to one another and the central longitudinal axis 212 (and thus they can be referred to as being vertical edges). In some examples, the outflow edge 232 and the inflow edge 234 are parallel to one another and disposed perpendicular to the inner edge 228 and outer edge 230.

[0051] In some examples, as shown in FIG. 3, the inner edge 228 and the outer edge 230 of each upper tab 208 are parallel to the outer edge 220 of the respective lower tab 210.

[0052] In some examples, the outer edge 230 of each upper tab 208 extends farther laterally outward, away from the body 202 of the leaflet 200, than the outer edge 220 of the respective lower tab 210. In some examples, this makes assembly of the commissures to the frame easier and more accurate, thereby ensuring the valve can open as large as possible during operation of the prosthetic heart valve.

[0053] Each upper tab 208 is axially and laterally offset from the free edge 204 of the leaflet 200 by an offsetting portion 236 (which can also be referred to as a neck, neck portion, or connecting portion). The offsetting portion 236 extends between the lower tab 210 and the upper tab 208 on each side of the leaflet 200. For example, each offsetting portion 236 can include a relatively straight outer edge 242 that extends between the inflow edge 234 of the corresponding upper tab 208 and the outflow edge 214 of the corresponding lower tab 210.

[0054] Each offsetting portion 236 can also include an inner edge having a relatively straight portion 240 and an angled portion 244 that is angled between the straight portion 240 and the inner edge 228 of the corresponding upper tab 208. In some examples, the angled portion 244 of the inner edge is angled at approximately 45 degrees between the straight portion 240 and the inner edge 228 of the corresponding upper tab 208. In some examples, the angled portion 244 is angled between 30 degrees and 60 degrees.

[0055] The offsetting portions 236 have a relatively narrow width 246 which allows a length of the free edge 204 (measured between the two offsetting portions 236) to be as large as possible, thereby allowing the prosthetic valve to open wider and decrease pressure gradients across the prosthetic valve, during operation of the prosthetic valve (as described further below).

[0056] The cusp edge portion 206 includes a wing 248 on either side of the main body 202. For example, the cusp edge portion 206 terminates at its upper ends at the wings 248. Each wing 248 is defined by an upper or outflow edge 250 and the cusp edge portion 206. The upper edge 250 of the wing 248 is perpendicular to the central longitudinal axis 212 of the leaflet 200. The wing 248 is spaced apart from the lower tab 210 in the axial direction by a side edge 252 of the main body 202. The curved cusp edge portion 206 and the straight outflow edge 250 form a tip of the wing 248 at their junction. In some examples, the lower tab 210 extends laterally outwards farther than the tip of the wing 248.

[0057] In some examples, the outer edge 242 of the offsetting portion 236 is positioned laterally outwards of the side edge 252 of the main body 202. In some examples, the outer edge 242 of the offsetting portion 236 and the side edge 252 of the main body 202 are colinear and aligned in the lateral direction.

[0058] A plurality of the leaflets 200 (e.g., three leaflets 200) can be assembled together into a leaflet assembly or valvular structure 104 and then secured to the frame 102 of the prosthetic valve 100 shown in FIGS. 1-2. Though shown secured to frame 102, leaflets 200 can be used with a variety of prosthetic heart valve frames.

[0059] As noted above, the leaflet structure 104 in the illustrated embodiment includes three leaflets 200 (although a greater or fewer number of leaflets can be used). Each leaflet 200 can have a reinforcing strip 216 secured (e.g., sewn) to the inner surface of the cusp edge portion 206, as shown in FIG. 4. For example, the reinforcing strip 216 can include a plurality of apertures 218 through which a suture can pass. The reinforcing strip 216 is curved to correspond to the shape of the cusp edge portion 206 of the leaflet 200. In some examples, the reinforcing strip 216 can include tabs 238 at either end of the reinforcing strip 216. In some examples, as shown in FIG. 4, the reinforcing strip 216 can include a slit 254, for example, to enable greater flexibility in the reinforcing strip 216.

[0060] The leaflets 200 can be secured to one another at their adjacent sides toform commissures 256 (FIG. 7) of the leaflet structure 104. A plurality of flexible connectors or posts 258 (one of which is shown in FIG. 5) can be used to interconnect pairs of adjacent sides of the leaflets 200 and to mount the leaflets 200 to thecommissure windows 138. For example, the posts 258 can include a plurality of apertures 260 and a plurality of slits 262 to pair the adjacent sides of the leaflets 200.

[0061] Each commissure window 138 is adapted to receive a pair of lower tabs 210 of a pair of adjacent leaflets 200 therethrough. For example, adjacent lower tabs 210 of two adjacent leaflets 200 can be coupled together (e.g., via a post 258), and the upper tabs 208 of the twoadjacent leaflets 200 can be folded downward at their offsetting portions 236 such that the lower tabs 210 are disposed between the pair of upper tabs 208. The lower tabs 210 can then be inserted through a commissure window 138 in the frame 102 and folded across the radially outward facing surface of the frame 102. Each lower tab 210 can be coupled to a respective upper tab 208 along a suture line.

[0062] Additional details on the assembly of the leaflets 200 to the frame 102, or a similar prosthetic valve frame, can be found in U. S. Patent No. 9,393,110, as already incorporated by reference above.

[0063] As introduced above, the prosthetic heart valve 100 can include an inner skirt 116 secured to an inside of the frame 102. The inner skirt 116 can comprise a plurality of panels 118 (e.g., three panels 118) coupled together to form the inner skirt 116. One panel 118 of the inner skirt 116 is shown alone in FIG. 6 in a laid-flat configuration. The inner skirt 116 can assist in securing the leaflets 200 to the frame 102 and assist in forming a good seal between the valve and the native annulus by blocking the flow of blood through the open cells of the frame 102 below the cusp edge portion 206 of the leaflets 200.

[0064] Each panel 118 includes side edges 120 extending between an inflow edge 122 and an outflow edge 124 of the panel 118. The inflow edge 122 can comprise a straight edge and the side edges 120 can be perpendicular to the inflow edge 122. The outflow edge 124 of the panel 118 can be formed with a plurality of projections 126 that define an undulated shape that generally follows the shape of the fourth row of strut members 112 immediately adjacent the lower ends of the axial struts 136 and the commissure windows 138. In this manner, as shown in FIG. 7, the outflow edge 124 of skirt 116 can be tightly secured to strut members 112 with a plurality of whip stitches 128. The skirt 116 can also be formed with slits 130 to facilitate attachment of the skirt 116 to the frame 102. As shown, the slits 130 are positioned between the projections 126.

[0065] The panel 118 includes a plurality of first apertures 132 positioned along the side edges 120. In some examples, as shown in FIG. 6, two columns of apertures 132 are positioned adjacent to each side edge 120 such that the side edge 120 can be folded over to aligned the two columns of apertures 132 with each other. The panel 118 also includes a plurality of second apertures 140 that follow a curved path across the panel 118 that generally follows the shape of the cusp edge portion 206 of the leaflet 200.

[0066] The panels 118 can be secured together to form the inner skirt 116. For example, as described in more detail below in connection with FIGS. 10A-11, the side edges 120 ofadjacent panels 118 can be coupled together with a shoelace stitch 142 that passes through the first apertures 132 of two adjacent panels 118. In some examples, the side edges 120 are folded over to align the pair of first apertures 132 prior to coupling the panels 118 together, such that the folded edges are adjacent when the panels 118 are coupled together.

[0067] FIGS. 7-9 illustrate the prosthetic valve 100 with the outer skirt 106 removed for purposes of illustration. FIGS. 7 and 8 illustrate a view from outside of the frame 102, and FIG. 9 illustrates a view of the interior of the frame 102. As shown in FIGS. 7-8, each wing 248 is paired with an adjacent wing 248 of an adjacent leaflet 200. The wings 248 of each pair are folded outwards relative to the main bodies of the leaflets 200 when the valvular structure 104 is coupled to the frame 102. Specifically, the wings 248 extend radially outwards towards an outer surface of the frame 102. As shown, the wings 248 can extend radially outwards through a window 144 defined between two panels 118 of the inner skirt 116 and into a cell 150 of the frame 102. An inflow end of the window 144 is defined by the shoelace stitch 142 coupling the two panels 118 of the skirt 116.

[0068] In some examples, the inner skirt 116 can comprise one piece, rather than three panels 118, and the wings 248 can extend radially outwards through a slit or opening through the inner skirt 116.

[0069] The wings 248 extend outwardly at least partially through a cell 150 of the frame 102 that is directly adjacent to and circumferentially aligned with the commissure window 138. In this way, the commissure 256 formed by a pair of adjacent leaflets 200 and the wings 248 of the pair of adjacent leaflets 200 both extend radially outwards through the frame 102 at locations that are circumferentially aligned and axially spaced apart.

[0070] FIG. 9 illustrates a radially inward facing portion of the prosthetic valve 100 at a location where the wings 248 and a commissure 256 extend outwardly through the frame 102. Because the wings 248 are folded such that the wings 248 extend through the window 144 of the inner skirt 116 and into a cell 150 of the frame 102, the leaflets 200 are generally smooth at this location. For example, there is no radially inward protuberance that can restrict opening and closing movements of the leaflets 200.

[0071] The cusp edge portions 206 can be secured to the inner skirt 116 with stitches 146 that extend along the cusp edge portions. The stitches 146 can form what is referred to as a “scallop line” or a scallop-shaped stitch line that tracks the curvature of the cusp edge portions 206. As shown in FIG. 9, a reinforcing strip 216 can be secured to the inner surfaces of the cusp edge portions 206, such as with the stitches 146, such that the cusp edge portions206 are sandwiched between the inner skirt 116 and the reinforcing strip 216. The stitches 146 can comprise in-and-out stitches that extend through the inner skirt 116, the cusp edge portion 206 of each leaflet, and the reinforcing strip 216. Stitches 146, which secure the reinforcing strip 216 and the leaflet structure 104 to skirt 116, can be any suitable suture, such as an Ethibond® suture. Stitches 146 can extend through apertures 218 of the reinforcing strip 216 and second apertures 140 of the inner skirt 116.

[0072] In some examples, as shown in FIG. 7, the inner skirt 116 can be attached to the frame 102, such as along an outflow edge of the inner skirt 116 and a fourth row of angled strut members 112 of the frame 102, for example with a plurality of whip stitches 128. The inner skirt 116 can further be attached adjacent to the inflow edge 122 of the inner skirt 116 to a first row of angled strut members 112 that define the inflow end 108 of the frame 102, for example with a plurality of whip stitches 152. The wings 248 of adjacent leaflets 200 are folded such that the wings 248 extend radially outwards through the window 144 of the inner skirt 116 (FIG. 8) and at least partially through a cell 150 of the frame 102 that is defined by a third row of angled strut members 112 and the fourth row of angled strut members 112. In some examples, as shown, the wings 248 can extend through a cell 150 that is spaced apart from the inflow end 108 of the prosthetic valve 100.

[0073] The outflow end of the window 144 can be defined by the stitches 146 and / or the whip stitches 128. For example, the stitches 146 can extend through one or more of the first apertures 132 above the wings 248 (e.g„ between the wings 248 and the outflow end 110), such that stitches 146 define the outflow end of the window 144 and the shoelace stitch 142 defines the inflow end of the window 144. In some examples, the whip stitches 128 can extend through one or more of the first apertures 132 to define the outflow end of the window 144 and / or to couple the panels 118 at the outflow edge 124 to the frame 102.

[0074] FIGS. 10A-10E illustrate an example process for coupling a first panel 118a of the inner skirt 116 to a second panel 118b of the inner skirt 116. Initially, the side edges 120 of the first panel 118a and the second panel 118b are folded inwardly to align the two columns of apertures 132 and form folded edges 119. The folded edges 119 are positioned adjacent to each other, such that the apertures 132 of the first panel 118a are aligned with the apertures 132 of the second panel 118b. Then, to couple the first panel 118a to the second panel 118b, a needle 154 carrying a suture 156 is passed through the apertures 132 at the inflow edge 122 of the panels 118a, 118b (FIG. 10A) and a knot is formed (FIG. 10B), for example, by looping the suture 156 through the apertures 132 adjacent the inflow edge 122. Next, the needle 154 carrying the suture 156 is passed through an adjacent aperture 132 of the first panel 118a(FIG. IOC) from an inner side of the panel 118a to an outer side of the panel 118a. Next, the needle 154 carrying the suture 156 is passed through an adjacent aperture 132 of the second panel 118b (FIG. 10D) from an inner side of the panel 118b to an outer side of the panel 118b. The needle 154 carrying the suture 156 is repeatedly passed through apertures 132 of the panel 118a and the panel 118b in an alternating pattern from the inner to the outer side of the panels 118a, 118b, forming a shoelace stitch 142 (FIG. 10E). After the shoelace stitch 142 is formed, a knot can be formed at the outflow end of the shoelace stitch 142 and any tails of the suture 156 can be woven into the shoelace stitch 142.

[0075] As shown in FIG. 11, the shoelace stitch 142 extends from the inflow edge 122 of the panels 118a, 118b to an intermediate point of the panels 118a, 118b between the inflow edge 122 and the outflow edge 124. In some examples, the intermediate point is positioned closer to the outflow edge 124 than the inflow edge 122. In some examples, the intermediate point is a location where the first apertures 132 are adjacent to the second apertures 140. In some examples, the shoelace stitch 142 extends along 50% to 75% of the length of the side edge 120 of the inner skirt 116 (e.g., extends through 50% to 75% of the apertures 132). The shoelace stitch 142 does not extend to the outflow edge 124, leaving a portion of the panels 118a, 118b uncoupled in order to form the window 144 for the wings 248 to pass through. In this manner, the shoelace stitch 142 (e.g., the outflow end of the shoelace stitch 142) can define the inflow end of the window 144 between the first panel 118a and the second panel 118b. As described above, the outflow end of the window 144 can be defined by stitches 146 and / or the whip stitches 128.

[0076] In some examples, as shown in FIG. 11, the side edges 120 of the panels 118a, 118b are folded radially outwards along folded edges 119, such that the side edges 120 are radially outwards of the remainder of the panels 118a, 118b. In some examples, the side edges 120 are folded radially inwards along folded edges 119.Delivery Techniques

[0077] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating aballoon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini -thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0078] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0079] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0080] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a trans ventricular approach whereby aprosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0081] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

[0082] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.

[0083] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with the body parts, tissue, etc. being simulated), etc.Additional Examples of the Disclosed Technology

[0084] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0085] Example 1. A prosthetic heart valve comprising: a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; a plurality of leaflets mounted on an inside of the frame, wherein commissure tabs of adjacent leaflets are paired to form a commissure that is secured to the frame; and a main skirt disposed within the frame and coupled to the leaflets, the main skirt comprising a plurality of windows,wherein a portion of each pair of adjacent leaflets extend radially outwards through a respective window of the plurality of windows.

[0086] Example 2. The prosthetic heart valve of any example herein, particularly example 1, wherein the main skirt comprises three panels, wherein each window is defined between adjacent panels.

[0087] Example 3. The prosthetic heart valve of any example herein, particularly example 2, wherein the panels are coupled together with a shoelace stitch.

[0088] Example 4. The prosthetic heart valve of any example herein, particularly example 3, wherein the shoelace stitch extends from an inflow end of the main skirt to a respective window.

[0089] Example 5. The prosthetic heart valve of any example herein, particularly either example 3 or example 4, wherein the shoelace stitch extends 50% to 75% of a total height of the panel.

[0090] Example 6. The prosthetic heart valve of any example herein, particularly any one of examples 2-5, wherein a side edge of each panel is folded along a folded edge, wherein folded edges of adjacent leaflets at least partially define a respective window.

[0091] Example 7. The prosthetic heart valve of any example herein, particularly any one of examples 1-6, wherein the plurality of windows is positioned adjacent to an outflow end of the main skirt.

[0092] Example 8. A prosthetic heart valve comprising: a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; a plurality of leaflets mounted on an inside of the frame, wherein commissure tabs of adjacent leaflets are paired to form a commissure that is secured to the frame; and a main skirt disposed within the frame and coupled to the leaflets, the main skirt comprising three panels defining three windows, each panel having an inflow end and an outflow end, wherein two adjacent panels are coupled together with stitches extending from the inflow end to an intermediate point of the panels, wherein a window is defined between the intermediate point and the outflow end of the two adjacent panels, wherein a portion of each pair of adjacent leaflets extend radially outwards through a respective window.

[0093] Example 9. The prosthetic heart valve of any example herein, particularly example 8, wherein each panel comprises an inflow edge, an outflow edge positioned opposite of the inflow edge, and side edges extending between the inflow edge and the outflow edge, wherein the side edges are perpendicular to the inflow edge.

[0094] Example 10. The prosthetic heart valve of any example herein, particularly example 9, wherein the outflow edge comprises projections and slits positioned between the projections.

[0095] Example 11. The prosthetic heart valve of any example herein, particularly either example 9 or example 10, wherein the side edges are folded radially outwards about folded edges.

[0096] Example 12. The prosthetic heart valve of any example herein, particularly any one of examples 8-11, wherein each panel includes a first column of apertures positioned adjacent to a first side edge and a second column of apertures positioned adjacent to the first column of apertures, wherein the first column of apertures and the second column of apertures are aligned when the first side edge is folded about a first folded edge.

[0097] Example 13. The prosthetic heart valve of any example herein, particularly example 12, wherein the stitches extend through an aperture of the first column of apertures and an aperture the second column of apertures.

[0098] Example 14. The prosthetic heart valve of any example herein, particularly either example 12 or example 13, wherein the first column of apertures and the second column of apertures extend from an inflow end of the main skirt to an outflow end of the main skirt.

[0099] Example 15. The prosthetic heart valve of any example herein, particularly any one of examples 8-14, wherein the intermediate point is positioned closer to an outflow end of the main skirt than an inflow end of the main skirt.

[0100] Example 16. The prosthetic heart valve of any example herein, particularly any one of examples 8-15, wherein the stitches comprise a shoelace stitch.

[0101] Example 17. A prosthetic heart valve comprising: a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration; a plurality of leaflets mounted on an inside of the frame, wherein each leaflet comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end, two lower tabs disposed on opposite sides of the main body, two upper tabs disposed on opposite sides of the main body and folded downwardly against the lower tabs, and two wings disposed on opposite sides of the main body, wherein lower and upper tabs of adjacent leaflets are paired to form a commissure that is secured to the frame, and wherein wings of the adjacent leaflets are folded radially outwards and extend through the frame; and a main skirt coupled to the inside of the frame, the main skirt comprising a plurality of panels that are coupled together, the main skirt defining a window between each pair of adjacent panels,wherein the wings of the adjacent leaflets extend radially outwards through a respective window.

[0102] Example 18. The prosthetic heart valve of any example herein, particularly example 17, wherein the frame includes a plurality of cells and a plurality of commissure posts, wherein the commissure is secured to a commissure post, and wherein the wings extend through a cell that is circumferentially aligned with the commissure post.

[0103] Example 19. The prosthetic heart valve of any example herein, particularly either example 17 or example 18, wherein adjacent panels are coupled together with stitches, and wherein the stitches extend from an inflow end of the main skirt to a respective window.

[0104] Example 20. The prosthetic heart valve of any example herein, particularly any one of examples 17-19, wherein the wings are partially defined by the cusp edge portion of the leaflet.

[0105] Example 21. The prosthetic heart valve of any example herein, particularly any one of examples 17-20, wherein a side edge of each panel is folded along a folded edge, wherein folded edges of adjacent leaflets at least partially define a respective window.

[0106] Example 22. A method comprising: coupling a skirt panel to an adjacent skirt panel with stitches along a portion of an overall height of the skirt panels such that the skirt panels are coupled together at a first end and free at a second end; extending wings of an adjacent pair of leaflets between the skirt panels adjacent to the second end; and coupling the second ends of the skirt panels to the frame of the prosthetic heart valve.

[0107] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one inner skirt can be combined with any one or more features of another inner skirt. As another example, any one or more features of one prosthetic heart valve can be combined with any one or more features of another prosthetic heart valve.

[0108] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

Claims:

1. A prosthetic heart valve comprising:a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration;a plurality of leaflets mounted on an inside of the frame, wherein commissure tabs of adjacent leaflets are paired to form a commissure that is secured to the frame; anda main skirt disposed within the frame and coupled to the leaflets, the main skirt comprising a plurality of windows, wherein a portion of each pair of adjacent leaflets extend radially outwards through a respective window of the plurality of windows.

2. The prosthetic heart valve of claim 1, wherein the main skirt comprises three panels, wherein each window is defined between adjacent panels.

3. The prosthetic heart valve of claim 2, wherein the panels are coupled together with a shoelace stitch.

4. The prosthetic heart valve of claim 3, wherein the shoelace stitch extends from an inflow end of the main skirt to a respective window.

5. The prosthetic heart valve of either claim 3 or claim 4, wherein the shoelace stitch extends 50% to 75% of a total height of the panel.

6. The prosthetic heart valve of any one of claims 2-5, wherein a side edge of each panel is folded along a folded edge, wherein folded edges of adjacent leaflets at least partially define a respective window.

7. The prosthetic heart valve of any one of claims 1-6, wherein the plurality of windows is positioned adjacent to an outflow end of the main skirt.

8. A prosthetic heart valve comprising;a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration;a plurality of leaflets mounted on an inside of the frame, wherein commissure tabs of adjacent leaflets are paired to form a commissure that is secured to the frame; anda main skirt disposed within the frame and coupled to the leaflets, the main skirt comprising three panels defining three windows, each panel having an inflow end and an outflow end, wherein two adjacent panels are coupled together with stitches extending from the inflow end to an intermediate point of the panels, wherein a window is defined between the intermediate point and the outflow end of the two adjacent panels, wherein a portion of each pair of adjacent leaflets extend radially outwards through a respective window.

9. The prosthetic heart valve of claim 8, wherein each panel comprises an inflow edge, an outflow edge positioned opposite of the inflow edge, and side edges extending between the inflow edge and the outflow edge, wherein the side edges are perpendicular to the inflow edge.

10. The prosthetic heart valve of claim 9, wherein the outflow edge comprises projections and slits positioned between the projections.

11. The prosthetic heart valve of either claim 9 or claim 10, wherein the side edges are folded radially outwards about folded edges.

12. The prosthetic heart valve of any one of claims 8-11, wherein each panel includes a first column of apertures positioned adjacent to a first side edge and a second column of apertures positioned adjacent to the first column of apertures, wherein the first column of apertures and the second column of apertures are aligned when the first side edge is folded about a first folded edge.

13. The prosthetic heart valve of claim 12, wherein the stitches extend through an aperture of the first column of apertures and an aperture the second column of apertures.

14. The prosthetic heart valve of either claim 12 or claim 13, wherein the first column of apertures and the second column of apertures extend from an inflow end of the main skirt to an outflow end of the main skirt.

15. The prosthetic heart valve of any one of claims 8-14, wherein the intermediate point is positioned closer to an outflow end of the main skirt than an inflow end of the main skirt.

16. The prosthetic heart valve of any one of claims 8-15, wherein the stitches comprise a shoelace stitch.

17. A prosthetic heart valve comprising:a frame that is radially expandable and collapsible between a radially expanded and radially collapsed configuration;a plurality of leaflets mounted on an inside of the frame, wherein each leaflet comprises a main body with a free edge disposed at its outflow end and a cusp edge portion defining its inflow end, two lower tabs disposed on opposite sides of the main body, two upper tabs disposed on opposite sides of the main body and folded downwardly against the lower tabs, and two wings disposed on opposite sides of the main body, wherein lower and upper tabs of adjacent leaflets are paired to form a commissure that is secured to the frame, and wherein wings of the adjacent leaflets are folded radially outwards and extend through the frame; anda main skirt coupled to the inside of the frame, the main skirt comprising a plurality of panels that are coupled together, the main skirt defining a window between each pair of adjacent panels, wherein the wings of the adjacent leaflets extend radially outwards through a respective window.

18. The prosthetic heart valve of claim 17, wherein the frame includes a plurality of cells and a plurality of commissure posts, wherein the commissure is secured to a commissure post, and wherein the wings extend through a cell that is circumferentially aligned with the commissure post.

19. The prosthetic heart valve of either claim 17 or claim 18, wherein adjacent panels are coupled together with stitches, and wherein the stitches extend from an inflow end of the main skirt to a respective window.

20. The prosthetic heart valve of any one of claims 17-19, wherein the wings are partially defined by the cusp edge portion of the leaflet.

21. The prosthetic heart valve of any one of claims 17-20, wherein a side edge of each panel is folded along a folded edge, wherein folded edges of adjacent leaflets at least partially define a respective window.

22. A method comprising:coupling a skirt panel to an adjacent skirt panel with stitches along a portion of an overall height of the skirt panels such that the skirt panels are coupled together at a first end and free at a second end;extending wings of an adjacent pair of leaflets between the skirt panels adjacent to the second end; andcoupling the second ends of the skirt panels to a frame of a prosthetic heart valve.

Images