Prosthetic heart valve coating material

Abstract

A covering and / or skirt for a prosthetic heart valve is disclosed, in one example, the prosthetic heart valve comprising a frame including three axially extending commissural support portions, a plurality of rows of angled struts, including a first row of angled struts defining an inflow end of the frame, a second row of angled struts downstream from the first row of angled struts, and a third row of angled struts downstream from the second row of angled struts and defining an outflow end of the frame, wherein the downstream ends of the struts in the second row of angled struts are connected to one another at a plurality of junctions, and the commissural support portions extend from each junction of the plurality of junctions in the second row of angled struts to the third row of struts. The valve further includes leaflets forming three commissures secured to respective commissure support portions, and an outer skirt including an outflow edge that aligns with the commissure support portions and forms three circumferentially spaced projections that cover respective coaptations, the outflow edge including a straight section extending between adjacent projections upstream of the coaptations.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 384,273, filed November 18, 2022, and U.S. Provisional Patent Application No. 63 / 582,383, filed September 13, 2023, which are incorporated by reference in their entireties.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to prosthetic heart valves, and in particular to coverings and / or skirts for prosthetic heart valves. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can lead to serious cardiac dysfunction and ultimately require repair of the native valve or replacement of the native valve with a prosthetic valve. There are several known repair devices (e.g., stents) and prosthetic valves, as well as several known methods for implanting these devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations within the body that are not easily accessible by surgery or where non-surgical access is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state onto the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site within 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, activating a mechanical actuator that applies an expansive force to the prosthetic valve, or deploying the prosthetic valve from a sheath in the delivery device and allowing the prosthetic valve to self-expand to its functional size.

[0004] Most expandable prosthetic heart valves include a cylindrical metal frame or stent with prosthetic valve leaflets mounted inside the frame. These valves may also include an outer covering or skirt disposed around the exterior surface of the frame. The outer skirt may be configured to establish a seal with the native tissue and reduce peripheral leakage when the prosthetic heart valve is placed at the implantation site (and thus may be referred to as a sealing member). In some embodiments, these valves may additionally or alternatively include an inner skirt disposed around the interior surface of the frame. Summary of the Invention

[0005] Prosthetic heart valves, delivery devices, and methods for implanting the prosthetic heart valves are described herein. In particular, the present disclosure describes examples of outer and / or inner skirts for the prosthetic heart valves and methods for attaching such inner and / or outer skirts to a frame of the prosthetic heart valve. The prosthetic heart valve may include a frame and a leaflet assembly disposed inside the frame. The prosthetic heart valve may include an outer skirt disposed on an outer surface of the frame around the periphery of the frame. The outer skirt may include an outflow edge portion disposed upstream of a commissural support portion of the frame where adjacent sides of adjacent leaflets are attached to the frame (forming a commissure). In some embodiments, the outflow edge portion may form three circumferentially spaced protrusions aligned with the commissural support portion, configured to cover a gap between the straight section of the outflow edge portion and the commissural support portion. In some embodiments, the prosthetic heart valve may include an inner skirt disposed around the periphery of the frame and on the inner surface of the frame, the inner skirt including an outflow edge portion with circumferentially spaced protrusions aligned with the commissural support portions of the frame (and, as described above, the cover gaps in the frame). In some embodiments, each commissure may include an attachment member, the attachment member including an extension extending axially upstream of the respective commissural support portion to cover the gap between the outflow edge portion of the outer skirt and the commissural support portion. Such outer and / or inner coverings (outer skirt protrusions, inner skirt protrusions, or attachment member extensions) may cover gaps in the frame not covered by the inner and / or outer skirt, thereby reducing peripheral leakage through the frame when the prosthetic heart valve is implanted in native tissue. In some embodiments, the inner skirt may include configurations such as overlapping edge portions configured to be secured to the cusp edges of the prosthetic valve leaflets, and / or in some embodiments, may include folded portions along the outflow edge portions that may overlap with the outflow edge of the outer skirt of the prosthetic valve.Thus, the devices and methods disclosed in this disclosure may, among other things, overcome one or more deficiencies of typical prosthetic heart valves.

[0006] The prosthetic heart valve may include a frame and a valve structure coupled to the frame. In addition to these components, the prosthetic heart valve may further include one or more of the components disclosed in this disclosure.

[0007] In some embodiments, the prosthetic heart valve may be configured with a sealing member, such as an outer skirt, configured to reduce paravalvular leakage.

[0008] In some embodiments, the prosthetic heart valve may comprise an outer skirt including an inflow edge and an outflow edge, the outflow edge aligning with a commissural support portion of the frame and forming three circumferentially spaced lobes covering a gap in the frame disposed between the commissural support portion and a straight section of the outflow edge, the straight section extending between adjacent lobes and located upstream of the commissural support portion.

[0009] In some embodiments, the prosthetic heart valve may include attachment members that commissure with adjacent edges of the valve leaflets and are attached to the commissure support portions of the frame, each attachment member including an extension that extends axially upstream of its respective commissure support portion and covers a gap between the outflow edge of the outer skirt and the commissure support portion.

[0010] In some embodiments, the prosthetic heart valve includes a radially expandable and compressible frame including three axially extending commissure support portions and a plurality of rows of angled struts, including a first row of angled struts defining an inflow end of the frame, a second row of angled struts downstream of the first row of angled struts, and a third row of angled struts downstream of the second row of angled struts defining an outflow end of the frame. The downstream ends of the angled struts of the second row of angled struts are connected to one another at a plurality of junctions. A commissure support portion extends from each junction of the plurality of junctions of the second row of angled struts to the third row of angled struts. The prosthetic heart valve further includes a plurality of leaflets forming three commissures secured to respective commissure support portions of the frame, and an outer skirt disposed around an outer surface of the frame and including an inflow edge and an outflow edge. The outflow edge forms three circumferentially spaced projections that align with the commissure support portions and cover the junctions of each of the second rows of angled struts, and the outflow edge further includes circumferentially extending sections that extend between adjacent projections, the circumferentially extending sections being located upstream of the junctions of the second rows of angled struts.

[0011] In some embodiments, the prosthetic heart valve includes a radially expandable and compressible frame, the frame including three commissure support portions and a plurality of rows of angled struts, the plurality of rows including a first row of angled struts defining an inflow end of the frame, a second row of angled struts downstream of the first row of angled struts, and a third row of angled struts downstream of the second row of angled struts defining an outflow end of the frame. The downstream ends of the angled struts of the second row of angled struts are connected to one another at a plurality of junctions. The prosthetic heart valve further includes a plurality of leaflets forming three commissures secured to respective commissure support portions of the frame, wherein upstream ends of the commissures are located adjacent to respective junctions of the second row of struts. The prosthetic heart valve further comprises an outer skirt disposed around an outer surface of the frame and including an inflow edge and an outflow edge, the outflow edge aligning with the commissural support portions and forming three circumferentially spaced lobes overlying each junction of the second row of angled struts, the outflow edge further comprising straight sections extending between adjacent lobes, the straight sections located upstream of the junction of the second row of angled struts.

[0012] In some embodiments, the prosthetic heart valve includes a radially expandable and compressible frame, the frame including three commissural support portions and a plurality of rows of angled struts, including a first row of angled struts defining an inflow end of the frame, a second row of angled struts downstream of the first row of angled struts, and a third row of angled struts downstream of the second row of angled struts defining an outflow end of the frame. The downstream ends of the angled struts of the second row of angled struts are connected to one another at a plurality of junctions. The prosthetic heart valve further includes a plurality of leaflets forming three commissures secured to respective commissural support portions of the frame, wherein upstream ends of the commissures are located adjacent to respective junctions of the second row of angled struts. The prosthetic heart valve further includes an outer skirt disposed around an outer surface of the frame and including an inflow edge and an outflow edge, the outflow edge being located upstream of the junction of the second row of angled struts. The prosthetic heart valve further includes a plurality of commissural extension members located at respective commissural support portions on the outer surface of the frame, each commissural extension member including an extension extending axially upstream of a commissure to cover a gap in the frame formed between a corresponding commissure and the outflow edge of the outer skirt.

[0013] In some embodiments, the prosthetic heart valve includes a frame including a plurality of interconnected struts and an inner skirt disposed around an inner surface of the frame. The inner skirt includes an inflow edge portion and an outflow edge portion, and opposing first and second edge portions, each extending between the inflow and outflow edge portions and non-perpendicular to the inflow edge portions, the first and second edge portions overlapping each other to form an annular configuration of the inner skirt within the frame. The prosthetic heart valve further includes a plurality of leaflets disposed within the frame, a leaflet edge of a first leaflet of the plurality of leaflets disposed along the overlapping first and second edge portions, and a plurality of stitches securing the overlapping first and second edge portions and the leaflet edge of the first leaflet to each other. In some embodiments, the plurality of stitches are suture stitches.

[0014] In some embodiments, the prosthetic heart valve comprises a frame including a plurality of interconnected struts forming a plurality of rows of open cells between an outflow end and an inflow end of the frame, an outer skirt disposed around an outer surface of the frame and including an inflow edge and an outflow edge, and an inner skirt disposed around an inner surface of the frame, the inner skirt including an inflow edge portion and an outflow edge portion, the outflow edge portion extending to the exterior of the frame through the plurality of rows of open cells of the frame and folded over the outflow edge of the outer skirt.

[0015] In some embodiments, a prosthetic heart valve includes a radially expandable and compressible frame including a plurality of interconnected struts and having an inflow end and an outflow end, a plurality of leaflets disposed inside the frame, and an inner skirt disposed about an inner surface of the frame, the inner skirt including an inflow edge portion and an outflow edge portion, the outflow edge portion folded upon itself to form a folded edge, and a free edge of the outflow edge portion disposed against a surface of the inner skirt facing away from the leaflets.

[0016] In some embodiments, the prosthetic heart valve includes one or more components described in Examples 1-61 and Examples 69-92 below.

[0017] A method for assembling a prosthetic heart valve may include: arranging an inner skirt for the prosthetic heart valve in an annular configuration such that opposing first and second edge portions of the inner skirt overlap one another; arranging a leaflet edge of a first leaflet of a plurality of leaflets of the prosthetic heart valve along the overlapping first and second edge portions; and securing the overlapping first and second edge portions and the leaflet edge of the first leaflet to one another.

[0018] In some embodiments, the first and second edge portions extend at an angle of less than 90 degrees between the inflow edge portion and the outflow edge portion of the inner skirt.

[0019] In some embodiments, the overlapping first and second edge portions and the leaflet edge of the first leaflet are secured together with a plurality of suture stitches.

[0020] In some examples, a plurality of suture stitches extend through the aligned openings and through the first and second edge portions and the leaflet edge of the first leaflet.

[0021] In some embodiments, a method for assembling a prosthetic heart valve includes: arranging an inner skirt for the prosthetic heart valve in an annular configuration such that opposing first and second edge portions of the inner skirt overlap one another and the first and second edge portions extend at an angle of less than 90 degrees between an inflow edge portion and an outflow edge portion of the inner skirt; arranging a leaflet edge of a first leaflet of a plurality of leaflets of the prosthetic heart valve along the overlapping first and second edge portions; and securing the overlapping first and second edge portions and the leaflet edge of the first leaflet to one another with a plurality of suture stitches.

[0022] In some embodiments, the method includes one or more of the components described in Examples 62-68 below.

[0023] The various innovations in this disclosure can be used in combination or separately. This Summary is provided to introduce in a simplified form a selection of various concepts that are further described in the Detailed Description below. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. These and other objects, features, and advantages of the present disclosure will become more apparent from the following Detailed Description, from the claims, and from the accompanying drawings. [Brief explanation of the drawings]

[0024] [Figure 1] FIG. 1 is a side view of a prosthetic heart valve, according to one embodiment. [Figure 2] 2 is a side view of the frame of the prosthetic heart valve of FIG. 1. FIG. [Figure 3] FIG. 3 is a side view of a portion of the frame of FIG. 2, showing the portion of the frame in a straight (non-annular) state. [Figure 4] FIG. 4 is a side view of an exemplary delivery device configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site. [Figure 5] FIG. 5 is a perspective view of a prosthetic heart valve according to one embodiment. [Figure 6] FIG. 6 is a side view of a portion of a frame of a prosthetic heart valve having an outer skirt disposed around the outer surface of the frame, the outer skirt including an outflow edge that forms circumferentially spaced projections that extend from a straight section of the outflow edge toward the commissural support portion of the frame. [Figure 7] FIG. 7 is a side view of a portion of a frame of a prosthetic heart valve having an outer skirt disposed around the outer surface of the frame, the outer skirt having an outflow edge forming circumferentially spaced projections extending from a straight section of the outflow edge toward a commissure support portion of the frame, each projection being formed by extending the outflow edge and securing the projection to a respective commissure support portion. [Figure 8] FIG. 8 is a plan view of an exemplary commissure attachment member including a body and an extension extending away from the body, the body forming a commissure and configured to be secured to a commissure support portion of a frame of a prosthetic heart valve. [Figure 9] 9 is a side view of the mounting member of FIG. 8 in a folded position around an axially extending window strut of a frame of a prosthetic heart valve. [Figure 10] 10 is a side view of a portion of the frame of a prosthetic heart valve in which the mounting member of FIG. 8 is folded and connected to the axially extending window struts of the frame, and the extension of the mounting member is secured to the outflow edge of the outer skirt of the prosthetic heart valve. [Figure 11]FIG. 11 is a side view of an exemplary commissure attachment member in a folded configuration around an axially extending window strut of a frame of a prosthetic heart valve, the attachment member splitting into two pieces configured to couple to different leaflets of two adjacent leaflets of the prosthetic heart valve. [Figure 12] FIG. 12 is a side view of a portion of a frame of a prosthetic heart valve in which an inner skirt is disposed around the inner surface of the frame, showing a configuration in which the inner skirt includes an outflow edge portion that forms circumferentially spaced projections that extend from a straight section of the outflow edge portion toward the commissural support portion of the frame. [Figure 13] FIG. 13 is a side view of an inner skirt for a prosthetic heart valve, according to one embodiment, showing the inner skirt in a flat configuration. [Figure 14] FIG. 14 is a side view of a portion of the inner skirt of FIG. 13 , showing the opposing angled edge portions of the inner skirt overlapping each other and the cusp edges of the leaflets for the prosthetic valve, and showing the stitching securing the overlapping edge portions of the inner skirt and the cusp edges of the leaflets together. [Figure 15] Figure 15 is a cross-sectional view of the inner skirt of Figure 13, showing the configuration in which the inner skirt is disposed against the inner surface of the frame of the prosthetic heart valve and suture stitches extending through the two overlapping edge portions of the inner skirt and the cusp edges of the valve leaflets. [Figure 16] FIG. 16 is a side view of a prosthetic valve including a frame, showing the inner skirt of FIG. 13 positioned around the inner surface of the frame, and the outer skirt positioned around the outer surface of the frame, the inner skirt including a protrusion extending from a straight section of the outflow edge portion of the inner skirt toward the commissure support portion of the frame. [Figure 17] FIG. 17 is a side view of a portion of the inner skirt of FIG. 13 showing one of its straight sections folded over to form a folded portion at the outflow edge of the inner skirt. [Figure 18]FIG. 18 is a side view of another portion of the inner skirt of FIG. 13, showing the straight sections of the outflow edge portion folded over the inner skirt and the leaflets secured to the inner skirt along their leaflet edges. [Figure 19] FIG. 19 is a side view of a portion of a frame of a prosthetic valve showing an outer skirt disposed around the outer surface of the frame and an inner skirt disposed around the inner surface with inflow and outflow edge portions folded over corresponding inflow and outflow edges of the outer skirt. [Figure 20] FIG. 20 is a side view of an inner skirt for a prosthetic heart valve, showing the inner skirt in a flattened configuration with slits along a straight section of the outflow edge portion, according to one embodiment. [Figure 21] FIG. 21 is a cross-sectional view of a frame for a prosthetic valve, an outer skirt positioned against the outer surface of the frame, and an inner skirt positioned against the inner surface of the frame, showing an arrangement in which the inflow and outflow edge portions of the inner skirt each extend around the entire circumference of the frame and each of the outer skirts overlaps with the corresponding inflow and outflow edges. DETAILED DESCRIPTION OF THE INVENTION

[0025] Basic premise For purposes of description, certain aspects, advantages, and novel configurations of examples of the disclosure are described in this disclosure. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Instead, the disclosure covers all novel and non-obvious configurations and aspects of the various disclosed examples, alone, in various combinations with each other, and in various subcombinations with each other. The methods, apparatus, and systems are not limited to any particular aspect, configuration, or combination thereof, nor do the disclosed embodiments require that any one or more particular advantages be present or problems be solved.

[0026] Although some operations in the disclosed embodiments are described in a particular sequential order for convenience of presentation, it should be understood that aspects of the description encompass reordering unless a specific order is required by specific language set forth below. For example, operations described sequentially may, in some cases, be reordered or performed simultaneously. Also, for simplicity, the accompanying drawings may not show various aspects in which the disclosed methods can be used in combination with other methods. Also, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual actions that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0027] 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." Furthermore, the term "coupled" generally means to physically, mechanically, chemically, magnetically, and / or electrically couple or connect, and does not exclude the presence of intermediate elements between coupled or associated members, unless specific language to the contrary exists.

[0028] As used in this disclosure, the term "proximal" refers to a position, orientation, or portion of a device that is closer to the user and farther away from the implantation site. As used in this disclosure, the term "distal" refers to a position, orientation, or portion of a device that is located away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of a device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial," unless expressly defined otherwise, refer to axes extending in a proximal-distal direction.

[0029] As used herein, "eg" means "for example" and "ie" means "that is."

[0030] As used in this disclosure, "upstream" and "downstream" refer to a location, direction, or portion of a prosthetic valve relative to the outflow and inflow ends of the prosthetic valve and / or the frame of the prosthetic valve, and the direction of blood flow through the prosthetic valve (from the inflow end to the outflow end). For example, the outflow end of the prosthetic valve and / or frame is the downstream end of the prosthetic valve and / or frame, and the inflow end of the prosthetic valve and / or frame is the upstream end of the prosthetic valve and / or frame.

[0031] Overview of the disclosed technology As described above, a prosthetic heart valve may include a frame including interconnected struts, leaflets mounted inside the frame, and an outer skirt disposed around the outer surface of the frame. In some embodiments, the prosthetic heart valve may include an inner skirt disposed around the inner surface of the frame. The frame may include multiple rows of angled struts and multiple commissural support portions. The leaflets form commissures secured to respective commissural support portions of the frame. Each commissural support portion may extend between an angled strut of a first row of angled struts defining the outflow end of the frame and an angled strut of a second row of angled struts disposed upstream of the first row of angled struts, or may be at least partially formed by an angled strut of the first row of angled struts.

[0032] In some embodiments, the outflow edge of the outer skirt and the outflow edge of the inner skirt (if included) are formed between the angled struts of the second row of angled struts and are located upstream of the junctions connecting to the commissural support portions of the frame. As a result, gaps are formed between the outflow edges of the outer skirt (and / or inner skirt) and the commissural support portions of the frame, through which blood may flow after implantation of the prosthetic heart valve (referred to as "circumferential leakage," or "PVL"). While this configuration may reduce the crimp profile of the prosthetic heart valve (when in a radially compressed configuration mounted on a delivery device), peripheral leakage may occur through the gaps, thereby reducing the efficiency of the prosthetic heart valve.

[0033] The present disclosure describes an outer skirt having an outflow edge forming three circumferentially spaced lobes, each lobe positioned between adjacent linear sections of the outer skirt. The lobes align with the commissural support portions and cover the joints between the second row of angled struts that connect to the commissural support portions. As a result, the lobes can cover gaps formed between the linear portions of the outflow edge of the outer skirt and the commissural support portions, thereby reducing peripheral leakage.

[0034] The present disclosure also describes a plurality of attachment members that form commissures with adjacent edges of the leaflets and are attached to the commissure support portions of the frame, the attachment members having extensions that extend axially upstream of each commissure support portion to cover the gap between the outflow edge of the outer skirt and the commissure support portion, thereby reducing peripheral leakage.

[0035] The present disclosure also describes an inner skirt having an outflow edge forming three circumferentially spaced lobes, each lobe being disposed between adjacent linear sections of the outer skirt. The lobes align with the commissural support portions and extend to the junctions between the second rows of angled struts connecting to the commissural support portions. As a result, gaps formed between the linear portions of the outflow edge of the inner skirt and the commissural support portions are covered by the lobes, thereby reducing peripheral leakage.

[0036] In some embodiments, the inner skirt may include additional features, such as angled edges, that overlap one another at a circumferential location on the inner skirt. During assembly of the prosthetic heart valve, the overlapping angled edges may also overlap the leaflet edges of the valve leaflets, and the resulting three overlapping layers may be secured together with the same suture (or sutures).

[0037] In some embodiments, the inflow and / or outflow edge portions may be configured to fold over the corresponding edges of the outer skirt on the outside of the frame, thereby preventing outwardly protruding fibers of the outer skirt from extending inward toward the valve leaflets.

[0038] The prosthetic valves disclosed in the present disclosure may be configured to be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be advanced through a patient's vasculature by a delivery device while crimped on or held by an implant delivery device in a radially compressed state. After the prosthetic valve reaches the implantation site, the prosthetic valve can be expanded to a radially expanded state. It will be appreciated that the prosthetic valves disclosed in the present disclosure can be used with a variety of implant delivery devices and implanted via a variety of delivery procedures, examples of which are discussed in more detail below.

[0039] FIG. 1 illustrates an exemplary prosthetic heart valve including a frame, leaflets secured to the interior of the frame, and an outer skirt disposed around the exterior of the frame. In some embodiments, the frame may include a plurality of interconnected angled struts, including struts forming commissural windows (commissural support portions of the frame) configured to receive the commissures of the valve leaflets, as shown in FIGS. 1-3. In some embodiments, the frame of the prosthetic heart valve may include a plurality of commissural support portions configured to receive the commissures of the valve leaflets, each commissural support portion formed by angled struts that form open cells of the frame, as shown in FIG. 5. The prosthetic heart valve can be advanced through a patient's vasculature to, for example, a native heart valve, using a delivery device, such as the exemplary delivery device shown in FIG. 4.

[0040] In some embodiments, an outer skirt for a prosthetic valve may have an outflow edge that forms three circumferentially spaced protrusions, each disposed between adjacent circumferentially extending sections of the outer skirt, as shown in Figures 6 and 7. In some embodiments, these protrusions are pre-formed in the outer skirt (Figure 6). In some embodiments, these protrusions are formed by extending the outflow edge and securing the extensions to the commissural support sections to form the protrusions. In both cases, the protrusions can cover gaps between the commissural support sections and the circumferentially extending sections of the outflow edge of the outer skirt, which are disposed on the frame. In this manner, paravalvular leakage can be reduced.

[0041] In some embodiments, the commissure attachment member may include a body portion and an extension portion extending from the body portion, as shown in FIG. 8. The body portion may include axially extending window struts and laterally extending flaps configured to fold around and attach to the leaflets of the prosthetic valve (FIGS. 9 and 10). In some embodiments, the attachment member may be formed as two separate pieces configured to separately mate with adjacent edges of two adjacent leaflets (FIG. 11). An extension of the attachment member may be attached to the outflow edge of the outer skirt of the prosthetic valve, thereby covering the gap in the frame and reducing peripheral leakage (FIG. 10).

[0042] In some embodiments, an inner skirt for a prosthetic valve may have an outflow edge that forms three circumferentially spaced protrusions, each disposed between adjacent circumferentially extending sections of the outer skirt, as shown in Figures 12-16. The protrusions may cover gaps disposed in the frame between the commissural support portions and the circumferentially extending sections of the outflow edge of the inner skirt, as shown in Figures 12 and 16. In this manner, paravalvular leakage may be reduced.

[0043] In some embodiments, the inner skirt may have angled edge portions configured to overlap when the inner skirt is disposed in an annular configuration within the frame of the prosthetic valve. For example, as shown in Figures 14 and 15, the overlapping edge portions of the inner skirt may be configured to secure to the leaflet edges of the prosthetic heart valve leaflets, thereby simplifying the valve assembly process.

[0044] In some embodiments, the outflow edge portion of the inner skirt may be configured to be folded such that the free edge of the outflow edge portion is positioned toward the outer surface (the surface facing the frame) of the inner skirt, as shown in FIGS. 17 and 18. In some embodiments, as shown in FIGS. 19 and 21, one or more folded portions of the outer skirt may be folded over and cover the outflow edge of the outer skirt that is positioned around the outer surface of the frame of the prosthetic valve. In some embodiments, as shown in FIG. 20, the outflow edge portion of the inner skirt may be configured with slits that allow the multiple folded portions to be formed and extend through open cells in the frame to the exterior of the frame. In some embodiments, the inflow edge portion of the inner skirt may be configured to be folded around the frame and over the inflow edge of the outer skirt, as shown in FIGS. 19 and 21.

[0045] Examples of the disclosed technology FIG. 1 illustrates a prosthetic heart valve 100 (artificial valve) according to one embodiment. While all of the prosthetic valves disclosed herein are configured for implantation in the native aortic valve annulus, in other embodiments, they may be adapted for implantation in other native heart valve annulus locations (such as the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves may also be implanted in blood vessels commissural to the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), the superior vena cava, or the inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, or blood vessels of a patient. The disclosed prosthetic valves may also be implanted within a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0046] In some embodiments, the disclosed prosthetic valves can be implanted within a docking device or anchoring device that is implanted within a native heart valve or blood vessel. For example, in one embodiment, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another embodiment, the disclosed prosthetic valves can be implanted within a docking device implanted within or into a native mitral valve, such as disclosed in International Publication No. WO 2020 / 247907, which is incorporated herein by reference. In another embodiment, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior vena cava or inferior vena cava to replace the function of a diseased tricuspid valve, such as disclosed in U.S. Patent Application Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0047] The prosthetic heart valve 100 may include a stent or frame 102, a valvular structure 104, and a circumferential outer sealing member or outer skirt 106. The prosthetic heart valve 100 (and frame 102) may have an inflow end 108 and an outflow end 110. The valvular structure 104 may be disposed within the frame 102, with the outer skirt 106 disposed around the outer surface of the frame 102.

[0048] The valvular structure 104 may have a plurality of leaflets 112 (e.g., three leaflets as shown in FIG. 1 ) collectively forming a leaflet structure that may be configured to be in a contracted state in a tricuspid configuration. The leaflets 112 may be secured to one another at adjacent sides (e.g., commissure tabs) to form commissures 114 of the valvular structure 104. For example, each leaflet 112 may include opposing buccal tabs located on opposite sides of each leaflet 112 and leaflet edges extending between the opposing commissure tabs. The leaflet edges of the leaflets 112 may have an undulating, curved, scalloped shape and may be secured directly to the frame 102 (e.g., with sutures). However, in alternative embodiments, the leaflet edges of the leaflets 112 may be secured to an inner skirt, which in turn may be secured to the frame 102. In some embodiments, the leaflets 112 may be formed from pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or a variety of other suitable natural or synthetic materials known in the art and described in U.S. Pat. No. 6,730,118, which is incorporated herein by reference.

[0049] In some embodiments, the outer skirt 106 may be an annular skirt. In some examples, the outer skirt 106 may have one or more skirt sections connected together and / or individually to the frame 102. The outer skirt 106 may be comprised of a woven or polymeric material, such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, or the like. In some examples, instead of having a relatively straight upper edge as shown in FIG. 1 , the outer skirt 106 may have a contoured upper edge that extends along and is secured to the angled struts 134. Examples of various outer skirts that may be used with such outer skirts and other frames 102 are described, for example, in U.S. Provisional Patent Application No. 63 / 366,599, filed June 17, 2022, which is incorporated herein by reference.

[0050] Frame 102 may be configured to be radially compressible and expandable between a radially compressed (or collapsed) configuration and a radially expanded configuration (the expanded configuration is shown in FIG. 1). Frame 102 is shown alone in FIG. 2, and a portion of frame 102 in a linear (non-annular) configuration is shown in FIG. 3.

[0051] Frame 102 can be made of any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol). If frame 102 (and thus valve 100) is constructed from a plastically expandable material, it can be crimped into a radially compressed state on a delivery catheter and then expanded within the patient's body by an inflatable balloon or equivalent expansion mechanism. If frame 102 (and thus valve 100) is constructed from a self-expandable material, it can be constrained in a compressed state by insertion into a sheath or equivalent mechanism on a delivery catheter that is crimped into a radially compressed state. Once introduced into the body, the valve can be advanced from the delivery sheath, allowing the valve to expand to its functional size.

[0052] Suitable plastically expandable materials that can be used to form the frame 102 include, but are not limited to, metal alloys, polymers, or combinations thereof. Exemplary metal alloys can include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some embodiments, the frame 102 can be comprised of stainless steel. In some embodiments, the frame 102 can be comprised of cobalt-chromium. In some embodiments, the frame 102 can be comprised of nickel-cobalt-chromium. In some embodiments, the frame 102 can be comprised of a nickel-cobalt-chromium alloy, such as MP35N™ (a trade name of SPS Technologies), which is equivalent to UNS R30035 (certified per ASTM F562-02). MP35N™ / UNS R30035 contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight.

[0053] As shown in Figures 2 and 3, the frame 102 may be configured with a plurality of interconnected struts 116 that form multiple rows of open cells 118 between the outflow end 110 and the inflow end 108 of the frame 102. In some embodiments, as shown in Figures 2 and 3, the frame 102 is configured with three rows of cells 118, with a first row (the upper row in the orientation shown in Figures 2 and 3) of cells 120 located at the outflow end 110. The cells 120 in the first row include cells 118 that are axially elongated (relative to a central longitudinal axis 122 of the frame 102) compared to the cells 118 in the remaining rows. For example, the cells 118 of the first row of cells 120 may have a longer axial length 124 (FIG. 3) than the cells 118 of the remaining rows, which include the cells 126 of the second row and the cells 128 of the third row, with the cells 128 of the third row being disposed at the inflow end 108 and the cells 126 of the second row being disposed between the cells 120 of the first row and the cells 128 of the third row.

[0054] 2, each column of cells includes nine cells 118. Thus, in such an embodiment, frame 102 may be referred to as a nine-cell frame.

[0055] In alternative embodiments, frame 102 may include more than three rows of cells (e.g., four or five rows) and / or may include more than ten cells or fewer than eight cells per row. In some embodiments, cells 118 in first row of cells 120 may be less elongated than cells 118 in the remaining rows of cells of frame 102 (e.g., second row of cells 126 and third row of cells 128).

[0056] The interconnected struts 116 may include a plurality of angled struts 130, 132, 134, and 136 arranged in multiple rows of circumferentially extending rows of angled struts, which rows may be arranged along the length of the frame 102 between the outflow end 110 and the inflow end 108. For example, the frame 102 may include a first row of circumferentially extending angled struts 130, a second row of circumferentially extending angled struts 132, a third row of circumferentially extending angled struts 134, and a fourth row of circumferentially extending angled struts 136 at the outflow end 110 of the frame 102, disposed end-to-end. The fourth row of angled struts 136 may be connected to the third row of angled struts 134 by a plurality of axially extending window struts 138 (or window strut portions) and a plurality of axial (e.g., axially extending) struts 140. The axially extending window struts 138 (also referred to as axial struts including commissural windows) are spaced circumferentially around the frame 102 and define commissural windows (e.g., open windows) 142 adapted to receive a pair of commissure tabs of a pair of adjacent leaflets 112 disposed at a commissure (e.g., commissure 114 shown in FIG. 1 ). In some embodiments, the commissural windows 142 and / or the axially extending window struts 138 defining the commissural windows 142 may be referred to in the present disclosure as commissural structures or commissural supports, with each commissural structure or support configured to receive and / or be secured to a pair of commissural tabs of a pair of adjacent leaflets.

[0057] One or more axial struts 140 (e.g., two as shown in FIGS. 2 and 3 ) may be configured circumferentially between two commissural fenestrae 142 formed by the fenestrations 138. Because the frame 102 may be configured with fewer cells per row (e.g., nine) and fewer axial struts 140 between each commissural fene 142 than some more conventional prosthetic heart valves, each cell 118 may be increased in width (circumferentially), thereby providing a larger opening for blood flow and / or coronary access.

[0058] Each axial strut 140 and each window strut 138 extends from a location defined by the convergence of the lower ends (e.g., the ends disposed inwardly and furthest from the outflow end 110) of two angled struts 136 (which may also be referred to as upper strut junctions or upper elongated strut junctions) to another location defined by the convergence of the upper ends (e.g., the ends disposed closer to the outflow end 110) of two angled struts 134 (which may also be referred to as lower strut junctions or lower elongated strut junctions). Each axial strut 140 and each window strut 138 forms the axial sides of two adjacent ones of the first row of cells 120.

[0059] In some embodiments, as shown in FIG. 3, each axial strut 140 may have a width 144 (FIG. 3) that is greater than the widths of the angled struts 130, 132, 134, and 136. As used in this disclosure, the "width" of a strut is measured between opposite locations on opposite faces of the strut extending between the radially-facing inner and outer faces of the strut (relative to the central longitudinal axis 122 of the frame 102). The "thickness" of a strut is measured between opposite locations on the radially-facing inner and outer faces of the strut and is perpendicular to the strut's width. In some embodiments, the width 144 of the axial strut 140 is 50% to 200%, 75% to 150%, or at least 100% greater (e.g., twice as large) than the widths of the angled struts of the frame 102.

[0060] By providing axial struts 140 with widths 144 that are greater than the widths of the other angled struts of frame 102, a larger contact area is provided when leaflets 112 contact the wider axial struts 140 during systole, thereby distributing stress and reducing the extent to which leaflets 112 may collapse radially outward through cells 118 onto axial struts 140, which may increase the long-term durability of leaflets 112.

[0061] Because the cells 118 of the frame 102 may have a relatively large width compared to alternative prosthetic valves having more than nine cells per row (as introduced above), wider axial struts 140 may be more easily incorporated into the frame 102 without sacrificing open space for blood flow and / or coronary access.

[0062] The commissure tabs 115 of adjacent leaflets 112 may be secured together to form a commissure portion 114 (FIG. 1). Each commissure 114 of the prosthetic heart valve 100 includes two paired commissure tabs 115, one from each of two adjacent leaflets 112, that extend through commissure windows 142 in the frame 102. Each commissure 114 may be secured to a window strut 138 that forms the commissure window 142.

[0063] The leaflet edge (e.g., scallop edge) of each leaflet 112 may be secured to the frame 102 via one or more fasteners (e.g., sutures). In some embodiments, the leaflet edge of each leaflet 112 may be secured directly to struts (e.g., angled struts 130, 132, and 134) of the frame 102. For example, the leaflet edge of the leaflet 112 may be sutured to the angled struts 130, 132, and 134 that generally follow the contour of the leaflet edge of the leaflet 112.

[0064] In some embodiments, the leaflets 112 may have their edges secured to an inner skirt, which may be secured directly to the frame 102 .

[0065] Various methods for securing the valve leaflets 112 to a frame, such as the frame 102, are disclosed in U.S. Provisional Patent Application No. 63 / 278,922, filed November 12, 2021, and U.S. Provisional Patent Application No. 63 / 300,302, filed January 18, 2022, both of which are incorporated herein by reference.

[0066] As shown in FIGS. 2 and 3 , in some embodiments, one or more or each of the axial struts 140 may include an inflow end portion 146 (e.g., the end portion closest to the inflow end 108) and an outflow end portion 148 that are wider relative to an intermediate portion 150 (which may be defined by a width 144) of the axial strut 140. In some examples, the inflow end portion 146 of the axial strut 140 may include an opening 147. The opening 147 may be configured to receive a fastener (e.g., suture) for attaching the soft components of the prosthetic heart valve 100 to the frame 102. For example, in some examples, the outer skirt 106 may be disposed around the outer surface of the frame 102, and an upper or outflow edge portion of the outer skirt 106 may be secured to the opening 147 by a fastener 149 (e.g., suture), as shown in FIG. 1 .

[0067] The interconnected columns 116 may also include horizontal columns 182 extending between adjacent cells 118 in one row of cells of the frame 102 (FIGS. 2 and 3). The horizontal columns 182 may extend circumferentially and may also be referred to as circumferentially extending columns 182. The horizontal columns 182 may connect angled columns of two adjacent rows of the frame 102. For example, each horizontal column 182 may connect to two angled columns of one row of columns (e.g., column 134 shown in FIG. 3) and to two angled columns of another adjacent row of columns (e.g., column 132 shown in FIG. 3). As a result, the angled struts 184 extending between the axially extending window struts 138 and the horizontal struts 182, and the angled struts 186 extending between the horizontal struts 182 and another horizontal strut 182 disposed adjacent the inflow end 108 of the frame 102, can be aligned along angled lines that can follow the scalloped lines of the valve leaflets (when the leaflets are attached to the frame 102). Thus, the horizontal struts 182 allow the angled struts to follow a shape that more closely matches the shape of the scalloped lines of the valve leaflets when the frame 102 is in the radially expanded configuration (as shown in FIGS. 2 and 3). The horizontal struts 182 can also function as spacers that can maintain a specified gap between the angled struts when the frame 102 is in the radially compressed configuration, thereby reducing the risk of the leaflets becoming pinched between the struts in the radially compressed configuration.

[0068] The frame 102 may further include a plurality of apex regions 152 formed at the inlet flow end 108 and the outlet flow end 110, with each apex region 152 extending between and forming a junction between two of the angled struts 130 at the inlet flow end 108 or two of the angled struts 136 at the outlet flow end 110. Thus, the apex regions 152 are circumferentially spaced apart from one another at the inlet flow end 108 and the outlet flow end 110.

[0069] Each apex region 152 may have an apex 154 (its highest or outermost axially extending point) and two thinned (or narrowed) strut portions 156, one extending from each side of the apex 154 to a corresponding wider angled strut 136 (at the outflow end 110) or angled strut 130 (at the inflow end 108) (FIG. 3). In this manner, each apex region 152 at the outflow end 110 may form a narrowed transition region between and to the two angled struts 136 extending from the corresponding apex region 152, and each apex region 152 at the inflow end 108 may form a narrowed transition region between and to the two angled struts 130 extending from the corresponding apex region 152.

[0070] The thinned strut portions 156 of the apex region 152 may have a width 158 that is smaller than the width 160 of the angled struts 130 or 136 (FIG. 3). In some embodiments, the width 158 may be constant (e.g., along the entire length of the strut portions 156). In some embodiments, the width 158 of the thinned strut portions 156 may be smaller than the width 160 of the angled struts 130 and / or 136 by approximately 0.06 to 0.15 mm.

[0071] The thin-walled strut portions 156 of the apex region 152 may be configured to have a first length 162 (FIG. 3). In some embodiments, the first length 162 is in the range of 0.8-1.4 mm, 0.9-1.2 mm, 0.95-1.05 mm, or about 1.0 mm (e.g., ±0.03 mm). In alternative embodiments, the first length 162 is in the range of 0.3-0.7 mm, 0.4-0.6 mm, 0.45-0.55 mm, or about 0.5 mm (e.g., ±0.03 mm).

[0072] Thus, each outflow apex region 152 may include two thin-walled strut sections 156 having a first length 162, each strut section extending outward from the apex 154 relative to a central longitudinal axis 164 of the cell 118. Thus, the total length of the apex region 152 may be twice the first length 162.

[0073] The two corresponding angled struts 136 in each apex region 152 and outflow end 110 may be configured to form outflow side struts 166, and the two corresponding angled struts 130 in each apex region 152 and inflow end 108 may be configured to form inflow side struts 168.

[0074] Each outflow strut 166 and inflow strut 168 may have a length that includes the apex region 152 and the two angled struts 136 or 130 (or strut portions) on either side of the apex region 152. In FIG. 3 , half of the total length of each outflow strut 166 and inflow strut 168 is shown as length 170, which extends from the end of one angled strut 136 or 130 to the central longitudinal axis 164. Thus, the length of each outflow strut 166 and inflow strut 168 is twice the length 170. In some embodiments, the length 170 for one half of each inflow strut 168 may be different from the length 170 for the other half of each outflow strut 166.

[0075] In some cases, the length of each thinned strut portion 156 may be at least 25% of the length 170 of the corresponding half outflow strut 166 or inflow strut 168. In other words, the length of each apex region 152 (whose total length is twice the first length 162) may be at least 25% of the total length (twice the length 170) of the outflow strut 166 or inflow strut 168. In some embodiments, the length of each apex region 152 may be more than 25%, for example, 25-35%, of the total length of the corresponding outflow strut 166 or inflow strut 168.

[0076] In some embodiments, each apex region 152 may have a curved, axially-facing outer surface 172 and an arcuate or curved, axially-facing inner recess 174 that forms the thin-walled post portion 156. For example, the curved inner recess 174 may be recessed from the inner surface of the angled post portion 156 toward the curved outer surface 172, thereby forming a thinner post portion 156 with a smaller width. Thus, the curved inner recess 174 may be formed on a cell side of the apex region 152 (e.g., opposite the exterior of the apex region 152).

[0077] In some embodiments, the curved outer surface 172 of each apex region 152 may be configured to form a single continuous curve from one angled strut portion 156 on a first side of the apex region 152 to another angled strut portion 156 on an opposite second side of the apex region 152 (e.g., the curved outer surface 172 may be configured to have a constant convex curvature).

[0078] Each apex region 152 may have a radius of curvature 176 along its curved outer surface 172 (e.g., in some cases, along the entire or full length of the curved outer surface 172) (FIG. 3). In some examples, the radius of curvature 176 at the apex 154 and / or along the entire curved outer surface 172 of the apex region 152 may be greater than 1 mm. In some examples, the radius of curvature 176 may be in a range of 1 to 20 mm, 3 to 16 mm, or 8 to 14 mm. In some examples, the radius of curvature 176 may be greater than 10 mm. The radius of curvature 176 may be dependent on (and thus vary due to) the width 158 (e.g., the reduction in width from the angled strut portion 130 or 136) and the first length 162 of the thin-walled strut portion 156.

[0079] Furthermore, the height (axial height) 178 of the apex region 152, which may be defined axially from the outer surfaces of the two angled struts 130 or 136 to the curved outer surface 172 of the apex region 152 at the apex 154, may be the width 158 of the thin-walled strut portion 156 ( FIG. 3 ). In this manner, the height 178 of the apex region 152 may be relatively small and may not add much height to the overall axial height of the radially expanded frame 102. Thus, the leaflets 112 ( FIG. 1 ) secured to the frame 102 may be positioned closer to the inflow end 108, thereby leaving more open space at the outflow end 110 of the frame 102 that is not blocked by the leaflets 112.

[0080] In some embodiments, each vertex region 152 may be configured to form a 180-degree angle between the two angled struts 130 or 136 extending from either side of the corresponding vertex region 152 (FIG. 3). In some cases, angle 180 may range from (but not limited to) 120 degrees to 140 degrees (e.g., angle 180 is greater than 120 degrees and less than or equal to 140 degrees).

[0081] Further details and examples of prosthetic heart valve frames, including apex regions, are described in PCT Application No. PCT / US2022 / 025687, which is incorporated herein by reference.

[0082] Figure 5 shows another exemplary prosthetic heart valve 350. Similar to the prosthetic heart valve 100 of Figure 1, the prosthetic valve 350 may have three main components: a stent or frame 352, a valve structure 354, and a sealing member 356.

[0083] The valvular structure 354 may include three leaflets 360 that collectively form the leaflet structure, and these three leaflets may be configured to fold in a tricuspid valve arrangement, although in other examples, there may be more or fewer leaflets (e.g., one or more leaflets 360). In some embodiments, the leaflets 360 may be formed from the same or similar pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or various other suitable natural or synthetic materials as the leaflets 112 described above with reference to FIG.

[0084] Each leaflet 360 may be coupled to the frame 352 along its inflow edge and at a commissure 364 of the valvular structure 354 where adjacent portions of the two leaflets (e.g., commissure tabs) are connected to one another. In some embodiments, the commissure 364 may comprise an attachment member 365 (e.g., comprising a fabric, a flexible polymer, or the like) disposed across a cell 374 (e.g., a commissure cell) of the frame 352, the cell 374 being formed by struts 372 (e.g., angled struts) of the frame 352. The attachment member 365 may be secured to the frame struts 372 that form the cell 374, and adjacent portions of the two leaflets may be connected to the attachment member 365 to form the commissure 364.

[0085] In some embodiments, a reinforcing element or connecting skirt, such as a fabric strip, may be connected directly to the leaflet edge of the leaflet and to the struts of the frame to couple the leaflet edge to the frame.

[0086] Frame 352 may be made from any of a variety of suitable plastically expandable or self-expanding materials, such as any of the materials described in this disclosure above with respect to frame 102. If constructed of a plastically expandable material, frame 352 (and thus prosthetic valve 350) may be configured to be crimped into a radially collapsed configuration on a delivery device (e.g., delivery device 200, described below) and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. Various crimping devices can be used to crimp prosthetic valve 350 and other prosthetic valves described in this disclosure around a delivery device, such as the crimping device described in U.S. Patent No. 7,530,253, which is incorporated herein by reference.

[0087] In some examples, the prosthetic valve 350 can be crimped directly onto an inflatable balloon of a delivery device such that the prosthetic valve 350 is axially aligned with and disposed radially outward of the balloon during advancement of the prosthetic valve on the delivery device to the implantation site, as described, for example, in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference. In an alternative example, the prosthetic valve 350 can be crimped onto the delivery device axially offset from the balloon and then moved over the balloon at the implantation site prior to inflation of the balloon and radial expansion of the prosthetic valve, as described in U.S. Patent Application No. 9,339,384, which is incorporated herein by reference.

[0088] If constructed of a self-expandable material, the frame 352 (and thus the prosthetic valve 350) can be radially crimped into a collapsed configuration and restrained in the collapsed configuration by insertion into a delivery device sheath or equivalent mechanism. Within the body, the prosthetic valve can be advanced from the delivery sheath, allowing it to expand to its functional size.

[0089] The frame 352 in the illustrated embodiment comprises a plurality of circumferentially extending rows of angled struts 372 that define rows of open cells 374 (or openings) in the frame. The frame 352 may be configured to have a cylindrical or substantially cylindrical shape with a constant diameter from the inlet end to the outlet end of the frame 352, as shown, or the frame 352 may be configured with a varying diameter along the height of the frame, as disclosed in U.S. Patent Publication No. 2012 / 0239142, which is incorporated herein by reference.

[0090] The frame 352 may be configured with a plurality of vertices 380 spaced apart around the circumference of the frame 352 at each of the inlet and outlet ends.

[0091] The sealing member 356 in the illustrated embodiment is attached to the outside of the frame 352 and functions to create a seal against surrounding tissue (e.g., the native valve leaflets and / or the native valve annulus) to prevent or at least minimize paravalvular leakage.

[0092] In some embodiments, the sealing member 356 may include an inner layer 376 (which may contact the outer surface of the frame 352) and an outer layer 378. The sealing member 356 may be connected to the frame 352 using any suitable technique or mechanism. For example, the sealing member 356 may be sutured to the frame 352 via sutures threaded around the struts 372 and through the inner layer 376. In alternative embodiments, the inner layer 376 may be attached to the inner surface of the frame 352, while the outer layer 378 is on the outside of the frame 352. The outer layer 378 may be configured or shaped to extend radially outward from the inner layer 376 and the frame 352 when the prosthetic valve 350 is deployed. When the prosthetic valve is fully expanded outside the patient's body, the outer layer 378 may expand away from the inner layer 376, creating a space between the two layers. Thus, when implanted inside the body, this allows the outer layer 378 to expand into contact with the surrounding tissue.

[0093] Further details regarding the prosthetic valve 350 and its various components are described in U.S. Patent Publication No. 2018 / 0028310, which is incorporated herein by reference.

[0094] In some embodiments, instead of sealing member 356, for example, as described in PCT Application No. PCT / US2021 / 025045, which is incorporated herein by reference, prosthetic heart valve 350, or any of the other prosthetic heart valves described herein (such as prosthetic heart valve 100 of FIG. 1 ), may include an outer skirt or sealing member secured around the outer surface of the frame and having one or more layers positioned near the outer surface of the frame (e.g., frame 352 or frame 102). For example, such an outer skirt may include a braided outer layer and an inner layer (which may, in some embodiments, be woven).

[0095] 4 illustrates an example delivery device 200 that may be used to implant an expandable prosthetic heart valve (e.g., prosthetic heart valve 100 of FIG. 1, prosthetic heart valve 350 of FIG. 5, and / or any other prosthetic heart valve described in this disclosure). In some examples, delivery device 200 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0096] 4 is a balloon catheter including a handle 202 and a steerable outer shaft 204 extending distally from the handle 202. The delivery device 200 may further include an intermediate shaft 206 (which may also be referred to as a balloon shaft) extending proximally and distally from the handle 202, the portion extending distally from the handle 202 extending coaxially through the outer shaft 204. In addition, the delivery device 200 may further include an inner shaft 208 extending coaxially through the intermediate shaft 206 and outer shaft 204 distally from the handle 202 and coaxially through the intermediate shaft 206 proximally from the handle 202.

[0097] The outer shaft 204 and the intermediate shaft 206 may be configured to translate (e.g., move) longitudinally relative to one another along a central longitudinal axis 220 of the delivery device 200 to facilitate delivery and positioning of the prosthetic valve at an implantation site within a patient's body.

[0098] The midshaft 206 may include a proximal end portion 210 that extends proximally from the proximal end of the handle 202 to an adapter 212. A rotatable knob 214 may be mounted on the proximal end portion 210 and may be configured to rotate the midshaft 206 relative to the outer shaft 204 about a central longitudinal axis 220.

[0099] The adapter 212 may include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 240 may be fluidly coupled to the inner lumen of the midshaft 206.

[0100] The mid-shaft 206 may further have a distal end portion that extends distally beyond the distal end of the outer shaft 204 when the distal end of the outer shaft 204 is positioned away from the inflatable balloon 218 of the delivery device 200. The distal end portion of the inner shaft 208 may extend distally beyond the distal end portion of the mid-shaft 206.

[0101] The balloon 218 can be coupled to the distal end portion of the midshaft 206 .

[0102] In some embodiments, the distal end of the balloon 218 can be coupled to the distal end of the delivery device 200, such as a nosecone 222 (as shown in FIG. 4 ), or to an alternative component at the distal end (e.g., a distal shoulder) of the delivery device 200. The intermediate portion of the balloon 218 can be configured to cover a valve mounting portion 224 at the distal end portion of the delivery device 200, and the distal end portion of the balloon 218 can be configured to cover a distal shoulder 226 of the delivery device 200. The valve mounting portion 224 and the intermediate portion of the balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 4 , a prosthetic heart valve 250 (which can be one of the prosthetic valves described herein) can be mounted around the balloon 218 at the valve mounting portion 224 of the delivery device 200.

[0103] The balloon shoulder assembly, including the distal shoulder 226, is configured to maintain the prosthetic heart valve 250 (or other medical device) in a fixed position on the balloon 218 during delivery through the patient's vasculature.

[0104] The outer shaft 204 may have a distal tip portion 228 mounted on its distal end. The outer shaft 204 and the intermediate shaft 206 may be axially translated relative to one another to position the distal tip portion 228 adjacent the proximal end of the valve mounting portion 224 when the prosthetic valve 250 is mounted in radial compression on the valve mounting portion 224 (as shown in FIG. 4 ) and during delivery of the prosthetic valve to the target implantation site. Thus, the distal tip portion 228 may be configured to resist axial, proximal movement of the prosthetic valve 250 relative to the balloon 218 when the distal tip portion 228 is positioned proximally adjacent the valve mounting portion 224.

[0105] An annular space may be defined between the outer surface of the inner shaft 208 and the inner surface of the midshaft 206 and may be configured to receive fluid from a fluid source via the second port 240 of the adapter 212. The annular space may be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 208 and the inner surface of the balloon 218. Thus, fluid from the fluid source may flow from the annular space into the fluid passageway, inflating the balloon 218 and radially expanding and deploying the prosthetic valve 250.

[0106] The inner lumen of the inner shaft may be configured to receive a guidewire therethrough for navigating the distal end portion of the delivery device 200 to a target implantation site.

[0107] The handle 202 may be configured with a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 200. In the illustrated embodiment, for example, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, that is operably coupled to a proximal end portion of a pull wire. The pull wire may extend distally from the handle 202 through the outer shaft 204 and have a distal end portion secured to the outer shaft 204 at or near its distal end. By rotating the knob 260, the tension in the pull wire may be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 200. Further details regarding steering or bending mechanisms for delivery devices are described in U.S. Pat. No. 9,339,384, which is incorporated herein by reference.

[0108] The handle 202 may further include an adjustment mechanism 261 that includes an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism that includes another adjustment member configured as a rotatable knob 278. The adjustment mechanism 261 is configured to adjust the axial position of the intermediate shaft 206 relative to the outer shaft 204 (e.g., for fine positioning at the implantation site). Further details regarding the delivery device 200 are described in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference.

[0109] As described above, in some embodiments, the outflow edge of the outer skirt and / or inner skirt for a prosthetic heart valve may extend around the frame of the prosthetic heart valve at a location upstream of the frame's commissure support portion (which connects to the commissures of the prosthetic valve leaflet assembly). For example, as shown in FIG. 3 , the outer skirt's outflow edge 190, indicated by the dashed line, extends around the frame 102 at a location upstream (toward the inflow end 108) of the axially extending window struts 138 (commissural support portion) that form the commissure window 142. As a result, a gap 192 (indicated by distance 194 in FIG. 3 ) is formed between the commissure window 142 and the outer skirt's outflow edge 190. Blood can escape the prosthetic valve through the gap 192, thereby causing peripheral leakage and reduced efficiency of the prosthetic valve.

[0110] In some embodiments, a gap 192 through which blood can pass through the frame 102 may be defined between the inflow end of the junction 196 and the outflow edge 190 of the outer skirt (e.g., the open space within the cell). The downstream ends of the third row of angled struts 134 connect to one another at the junction 196. A portion of the junction 196 connects to and / or forms the upstream (lower) ends of the axially extending window struts 138.

[0111] When the commissures 114 are secured to the window struts 138 , the upstream edges of the commissures 114 are located at or adjacent to the junctions 196 of each of the angled struts 134 .

[0112] Another example of such a gap 382 is illustrated in FIG. 5, where the gap 382 is defined between the outflow edge 358 of the sealing member 356 and a strut joint 375 formed between the upper (or downstream) ends of a row of angled struts that are coupled to the commissure support portion of the frame 352 (the angled struts 372 that form the cells 374 through which the mounting members 365 extend).

[0113] Positioning the outflow edge of the outer skirt upstream of the commissural support portions (toward the inflow end of the frame) can reduce the crimp profile of the prosthetic valve, but such an arrangement also creates gaps between adjacent leaflets adjacent to the commissural support portions of the frame that are prone to peripheral leakage (because the frame is not covered by the outer skirt or leaflets in these gap regions).

[0114] To address peripheral leakage through such gaps, while still maintaining a relatively small crimp profile of the prosthetic heart valve, the outer skirt of the prosthetic heart valve may be configured with an outflow edge that forms circumferentially spaced protrusions that align with the commissural support portions of the frame. The protrusions may extend from a straight section (also referred to as a circumferentially extending section) of the outflow edge of the outer skirt toward and / or to the commissural support portions of the frame, thereby covering the gap or gap region (as defined above) in the frame. The straight section may be configured to be located upstream of the commissural support portions of the frame.

[0115] For example, Figure 6 shows an example of an outer skirt 400 comprising an outflow edge 402 and an inflow edge 404 disposed around the outer surface of a prosthetic heart valve frame 102. Although the outer skirt 400 is shown disposed around the frame 102 in Figure 6, the outer skirt 400 may be configured to be positioned around a variety of frames, such as frame 352, or alternative frames for a prosthetic device.

[0116] In some embodiments, the outer skirt 400 is an annular skirt. In some cases, the outer skirt 400 may comprise one or more skirt sections that are connected together and / or individually to the frame 102. The outer skirt 400 may comprise a fabric or polymeric material, such as any of the materials described above with reference to the outer skirt 106 and / or the sealing member 356.

[0117] The outflow edge 402 forms a plurality (e.g., three) of circumferentially spaced apart protrusions 406 that align with the commissural support portions (e.g., axially extending window struts 138 and commissural windows 142) of the frame 102 when the outer skirt 400 is positioned about the frame 102. Because FIG. 6 shows only a portion of the frame 102 that includes one commissural window 142, only one protrusion 406 is shown in FIG. 6 . However, it should be noted that the outer skirt 400 can include three circumferentially spaced apart protrusions 406 along the outflow edge 402. In embodiments in which the frame includes more or fewer than three commissural support portions (e.g., commissural windows or frame cells), the outer skirt 400 can be configured with a corresponding number of protrusions (e.g., two, four, etc.).

[0118] The outflow edge 402 further comprises straight sections 408 (which may also be referred to as circumferentially extending sections) that extend between adjacent protrusions 406. For example, as shown in FIG. 6 , a visible protrusion 406 is disposed between two straight sections 408. In some embodiments, the straight sections 408 may be completely straight, extending in a line from one protrusion 406 to the next. In some embodiments, the straight sections 408 may extend in a relatively straight path between adjacent protrusions 406, but may have some wave or curvature at the edges of the straight sections 408 (while still extending in a relatively straight path between adjacent protrusions 406).

[0119] As shown in FIG. 6, straight section 408 is located upstream of junction 196 of the second row of angled struts 134 (and therefore upstream of the commissural support portion, or window strut 138, that forms conical window 142).

[0120] The protrusion 406 extends outward and away from the straight section 408 toward (e.g., in a downstream direction) the outflow end 110 of the frame. In some embodiments, the protrusion 406 may also be referred to as an extension of the outer skirt 400.

[0121] Each protrusion 406 is configured to cover a respective junction 196 of the second row of angled struts 134. In some embodiments, as shown in FIG. 6, a free end 410 (or downstream end or apex) of each protrusion 406 may be configured to extend toward the commissure window 142.

[0122] In some examples, the free end 410 of each protrusion 406 may be configured to extend to or above the commissure support portion of the frame, such as to the inflow end of the commissure window 142 of frame 102 (above the lower or inflow or upstream end portion of the axially extending window strut 138 and adjacent the upstream end of the commissure secured to the commissure window 142), or to or above a portion of a cell of the frame configured to receive an attachment member of the commissure (e.g., cell 374 of frame 352 in FIG. 5).

[0123] Each protrusion 406 may be configured to cover the downstream ends and respective junctions 196 of a respective pair of angled struts in the third row of angled struts 134. In some embodiments, the shape of the protrusions 406 may be A-shaped or trapezoidal (an acute angled trapezoid widening towards the straight section 408), as shown in FIG.

[0124] In some embodiments, the edge of each protrusion 406 extending between free end 410 and straight section 408 may be more or less angled than shown in FIG.

[0125] In some embodiments, the edges of each protrusion 406 may be curved to follow the contours of the angled struts 134 and extend over the respective joints 196. As a result, the protrusions can cover the gaps 192 (shown in FIG. 3 ) while maintaining a reduced crimp profile of the radially compressed prosthetic valve.

[0126] Each protrusion 406 may be a pre-formed feature in the outer skirt 400, such as being woven or knitted with the remainder of the outer skirt 400. In some examples, each protrusion may be a pre-formed feature in the outer skirt 400 by weaving and / or knitting a relatively rectangular outer skirt and then cutting a section from the outflow end of the outer skirt 400 to form the protrusion 406 (e.g., before attaching the outer skirt 400 to the frame of the prosthetic valve).

[0127] The outflow edge 402 may be secured to the angled struts 134 and the joint 196 with sutures, such as stitches 512 and / or 514 shown in FIG. 7 (as further described below).

[0128] 6, the inlet edge 404 of the outer skirt 400 may be configured with a notch 412 (space or recessed area) along the outer skirt 400 at the same circumferential location as the protrusion 406. For example, FIG. 6 shows one notch 412 axially aligned with the protrusion 406.

[0129] Each cutout 412 may be configured to match or conform to the shape of the angled struts 130 that define the inflow end 108 (e.g., inflow struts 168) of the frame 102. For example, as shown in FIG. 6 , the cutout 412 may be configured such that, in the region of the cutout 412, the inflow edge 404 extends from adjacent straight portions 414 (or sections) of the inflow edge 404 located on either side of the cutout 412 toward the outflow edge 402. Furthermore, the cutout 412 may be configured such that the inflow edge 404 extends along two adjacent, connected angled struts 130 that form two adjacent inflow struts 168. The cutout 412 may have an apex or peak 416 at the junction between the two angled struts 130 and two angled struts 132 of adjacent rows of angled struts 132 (e.g., horizontal struts 182).

[0130] The cutout 412 allows the overall height (measured axially) of the outer skirt 400 to remain substantially the same along the entire circumference of the outer skirt 400. For example, as shown in FIG. 6 , a first height 418 defined between a peak 416 of the cutout 412 and the free end 410 of the protrusion 406 may be the same or substantially the same as a second height 420 defined between the straight section 408 of the outflow edge 402 and the straight portion 414 of the inflow edge 404.

[0131] Maintaining a substantially uniform height along the outer skirt 400 can be advantageous in maintaining a reduced (or minimized) crimp profile of a radially compressed prosthetic valve.

[0132] Figure 7 shows another embodiment of an outer skirt 500 comprising an outflow edge 502 and an inflow edge 504 disposed around the outer surface of a prosthetic heart valve frame 102. Although the outer skirt 500 is shown disposed around the frame 102 in Figure 7, the outer skirt 500 may be configured to be positioned around a variety of frames, such as frame 352, or alternative frames for the prosthetic device.

[0133] In some embodiments, the outer skirt 500 is an annular skirt. In some cases, the outer skirt 500 may include one or more skirt sections that are connected together and / or individually to the frame 102.

[0134] The outer skirt 500 may be constructed of a fabric or polymeric material, such as any of the materials described above with reference to the outer skirt 106 and / or the sealing member 356 .

[0135] In some embodiments, the outer skirt 500 comprises a stretchable fabric or polymeric material, such as thermoplastic polyurethane (TPU).

[0136] In some embodiments, the outer skirt 500 may be comprised of one or more woven or polymeric materials knitted together (or some other nonwoven structure) to form the outer skirt 500. In some examples, such materials may be at least recoverable with minimal strain. Such knitted or nonwoven outer skirts may be elastic (configured to stretch) because the filaments of the material flex.

[0137] Thus, as shown in FIG. 7 , when the outer skirt 500 is positioned around the outer surface of the frame 102, the portion of the outflow edge 502 aligned with the commissural support portions of the frame 102 (e.g., the axially extending window struts 138 and the commissural windows 142) may be stretched across the joint 196 toward the lower (or inflow) end of the commissural window 142 and secured to the frame 102 (e.g., with one or more stitches 514, as described further below). As a result, multiple (e.g., three) circumferentially spaced apart projections 506 are formed on the outflow edge 502, with straight sections 508 formed between adjacent projections 506. The projections 506 cover the gap between the joint 196 and the straight sections 508 of the outer skirt 500 that existed prior to the stretching of the outflow edge 502 portions. The straight sections 508 may be the same as or similar to the straight sections 408, as described above.

[0138] In some embodiments, the outer skirt 500 (and outer skirt 400) may be attached to the frame 102 along angled struts to which the leaflet edges (scallops) of the valve leaflets are attached. For example, as shown in FIG. 7 , the outer skirt 500 is attached by stitches 512 (one or more sutures) to the angled struts 134, 132, and 130 that follow the leaflet scallops (when the leaflets are secured inside the frame 102). In some embodiments, an additional stitch 514 (or one or more additional stitches) may attach each projection 506 to its respective commissure support portion and / or coaptation 196. In some embodiments, the stitches 514 may extend around the coaptation 196, through the commissure window 142, and through the material of the outer skirt 500 (at the projections 506).

[0139] Protrusions 506 (shown in FIG. 7 ) may be similar to protrusions 406, as described above, in that they cover the respective joints 196 of the second row of angled struts 134 when secured to frame 102. In some embodiments, as shown in FIG. 7 , the free end 510 (or downstream end) of each protrusion 506 may extend toward and / or to a commissure support portion of the frame, such as to the inflow end of a commissure window 142 (on the lower or inflow or upstream end portion of an axially extending window strut 138) of frame 102, or to a portion of a cell of the frame configured to receive an attachment member of the commissure (e.g., cell 374 of frame 352 in FIG. 5 ).

[0140] 7, straight section 508 is located upstream of junction 196 of the second row of angled struts 134 (and thus upstream of the commissural support portion, or window strut 138, that forms commissural window 142). Protrusion 506 extends outward from and away from straight section 508 toward (e.g., in a downstream direction) the outflow end 110 of the frame. In some embodiments, protrusion 506 may also be referred to as an extension of outer skirt 500.

[0141] 7, when secured to the frame 102, each protrusion 506 can cover the downstream ends and respective junctions 196 of a respective pair of angled struts in the third row of angled struts 134. In some embodiments, the shape of the resulting protrusions 506 can be A-shaped or trapezoidal (an acute angled trapezoid widening towards a straight section 508).

[0142] In some embodiments, the inflow edge 504 of the outer skirt 500 may be relatively straight, as shown in Figure 7. In some instances, the straight section 508 of the outflow edge 502 may be configured to extend parallel to the inflow edge 504.

[0143] In some embodiments, the inflow edge 504 of the outer skirt 500 may be wavy and / or shaped to follow the shape of the inflow struts 168 .

[0144] The outer skirt 500 has a first height 516 defined between the straight section 508 of the outflow edge 502 and the inflow edge 504. By extending the outflow edge 502 of the outer skirt 500 to form the protrusion 506, the outer skirt 500, when secured to the frame 102, has a second height 518 in the region of the protrusion 506 and the commissure support portion of the frame 102, as shown in FIG. 7 , which is greater than the first height 516. The second height 518 can be measured between the free end 510 of the protrusion 506 and the inflow edge 504 of the outer skirt 500.

[0145] In some embodiments, the attachment members for the commissures of the prosthetic valve (instead of the outer skirt with protrusions described above and shown in FIGS. 3 and 5) may have extensions configured to cover gaps or gap regions in the frame. For example, FIGS. 8-11 show attachment members 600 ( FIGS. 8-10 ) or 650 ( FIG. 11 ) configured to form commissures with adjacent edges or ends (e.g., commissure tabs) of the leaflets of the prosthetic valve and to attach to commissure support portions of the frame of the prosthetic valve. The attachment members may be configured to include flexible fabric, flexible polymer, or the like.

[0146] 8-10 show a single attachment member 600 and commissure 640 formed by the attachment member 600, it should be noted that a prosthetic valve can have multiple such attachment members 600 and commissures 640 (e.g., three if the prosthetic valve has three leaflets). Furthermore, although attachment member 600 is described below and shown in FIG. 10 as being configured to attach to a tolerance window in frame 102 and cover a gap in frame 102, attachment member 600 and / or similar attachment members may be adapted for use with a variety of prosthetic valve frames, such as frames having differently shaped commissure windows and / or frames in which the commissure support portions are formed by struts that form the cells of the frame (e.g., frame 352 of FIG. 5).

[0147] 8 , attachment member 600 (also referred to herein in some embodiments as a commissural extension member or patch) comprises a body 602 (or upper portion) and an extension 604 extending outward and away from a lower lateral edge 606 (or inflow edge) of body 602. As described further below, body 602 of attachment member 600 may be configured to attach to a commissural support portion of a frame of a prosthetic valve, and extension 604 may be configured to extend axially upstream of the commissural support portion to cover a gap between the outflow edge of the outer skirt of the prosthetic valve and the commissural support portion.

[0148] In some embodiments, attachment member 600 need not perform an attachment function to attach the commissures to the frame of the prosthetic valve. Instead, in some instances, attachment member 600 may simply function to cover a gap in the frame via extension 604. In such embodiments, attachment member 600 may extend between the commissures and the outer skirt (without attaching the commissures to the frame).

[0149] 8-10, the body 602 may be configured with two laterally extending flaps 608, and the extension 604 may extend outward from a central portion of the body 602 where the two flaps 608 connect together. The shape and size of the body 602 may be configured to mate with the commissure support portion of the frame.

[0150] For example, in some instances, the height 610 of the body 602 and flaps 608 may be designed to fit through the commissural windows 142 of the frame 102 ( FIG. 10 ). Specifically, in some instances, the height 610 may be similar to or slightly smaller than the height of the commissural windows 142 (as defined in the axial direction of the prosthetic valve).

[0151] In some examples, the length 612 of each of the flaps 608 may be configured such that each flap 608 aligns with the commissure tabs of the prosthetic valve leaflets and may be folded at the commissure tabs and around the axially extending window struts 138 of the frame, as described further below. As shown in FIG. 8 , the length 612 of each flap 608 may be configured to be defined between a free edge 614 of the flap 608 and a central axis 616 of the attachment member 600.

[0152] In some embodiments, the free edges 614 of the flaps 608 are parallel to one another (FIG. 8).

[0153] In some embodiments, the free edge 614 of the flap 608 is perpendicular to the lower lateral edge 606 and the upper lateral edge 618 of the body 602 .

[0154] 10 and as described above, the outflow edge 190 of the outer skirt 106 of the prosthetic valve may be configured to be offset from and extend around the frame 102 at a location upstream of the junction 196, thereby forming an outer skirt having a height 642. Accordingly, the extension 604 of the attachment member 600 may be shaped to cover a gap in the frame 102 located between the outflow edge 190 of the outer skirt 106 (or an alternative outer skirt disposed around the frame) and the respective junction 196.

[0155] In some embodiments, the extension 604 may be an axially extending extension that tapers from a free end 620 (or upstream end) of the extension 604 to a downstream end 622 of the extension 604 where it connects to the main body 602. For example, the extension 604 may be configured with two angled edges 624 that angle inwardly toward each other from the free end 620 to each of the flaps 608.

[0156] In some embodiments, extension 604 has a trapezoidal shape that widens toward free end 620 (FIG. 6).

[0157] In some embodiments, the extensions 604 may have a V-shape, with the V being wide enough or the point of the V connecting low enough on the outer skirt so that the gap between the respective joints 196 and the outflow edges 190 is covered when the prosthetic valve is in its radially expanded state.

[0158] To couple the mounting member 600 to the frame 102 (e.g., to the axially extending window struts 138 that form the commissural windows 142), in some embodiments, each flap 608 may be configured to fold onto itself (toward the opposite flap 608) on the radially outward facing surface of the axially extending window struts 138 ( FIG. 9 ). The flap 608 then folds radially inward to extend through the commissural windows 142 and across the laterally inward facing surface of the axially extending window struts 138 ( FIG. 9 ). The flap 608 then folds away from the opposite flap 608 onto the radially inward facing surface of the axially extending window struts 138 ( FIG. 9 ).

[0159] As used in this disclosure, the radially inward and radially outward surfaces of an axially extending window strut (or another component of the prosthetic valve) are based on the central longitudinal axis of the prosthetic valve (e.g., central longitudinal axis 122 in FIG. 1).

[0160] In some embodiments, adjacent ends of two adjacent leaflets, such as adjacent commissure tabs, may be positioned against respective flaps 608 of the attachment member 600 and folded together with the flaps 608 around the axially extending window struts 138, as described above. For example, in some instances, when the leaflets are positioned within the interior of the frame 102, adjacent commissure tabs may be pushed to the exterior of the frame through respective commissure windows 142, as described above, and then mated with and folded together with the respective flaps 608.

[0161] After the flap 608 is folded around the axially extending window strut 138, the folds of the flap 608 may then be sewn together around the axially extending window strut 138.

[0162] In some instances, the flap 608 can be further sutured to the commissure tabs of two adjacent leaflets, thereby forming the commissure 640 ( FIG. 10 ). Note that in FIGS. 9-11 , the leaflets are omitted for illustrative purposes only, and the final commissure 640 includes the adjacent ends (e.g., commissure tabs) of the two adjacent leaflets secured to the folded flap 608 of the attachment member 600.

[0163] The extension 604 of the attachment member can then be positioned over the gap region (between the junction 196 and the outflow edge 190 of the outer skirt 106) and secured to the frame 102 and / or the outflow edge 190 of the outer skirt 106, thereby sealing the gap or gap region with the extension 604. As a result, peripheral leakage through the frame 102 is reduced when the prosthetic valve is implanted into the native anatomy at the implantation site.

[0164] 10 , the free end 620 of the extension 604 can be attached to the outflow edge 190 of the outer skirt 106 with one or more stitches 626. In some examples, the extension 604 can be secured to a frame, such as the portion of the angled strut 134 extending between the outer skirt 106 and the joint 196.

[0165] In some examples, the free end 620 of the extension 604 overlaps the outflow edge 190 (such that the outflow edge 190 is positioned between the free end 620 and the frame 102) and is positioned on the outer surface of the outer skirt 106.

[0166] In some examples, the free end 620 of the extension 604 overlaps the outflow edge 190 (such that the free end 620 is positioned between the outflow edge 190 and the frame 102) and is positioned on the inner surface of the outer skirt 106.

[0167] In some embodiments, instead of having a laterally extending flap 608 that folds and extends through the commissural window 142 of the frame 102, the body of the attachment member may be configured to span a cell of the frame of the prosthetic valve, such as cell 374 of frame 352 shown in FIG. 5. Thus, the extension of the attachment member may extend upstream toward the outflow edge of the outer skirt to cover a gap in the frame between the strut junction 375 and the outflow edge (e.g., gap 382).

[0168] In some embodiments, a commissure attachment member may include two separate attachment member portions (one for each commissure tab of two adjacent leaflets). For example, as shown in FIG. 11 , attachment member 650 may include first attachment member portion 652a and second attachment member portion 652b, each including a body 654a, 654b and an extension 658a, 658b, with bodies 654a, 654b including laterally extending flaps 656a, 656b. The components of attachment member portions 652a, 652b may be configured identically or similarly to the corresponding components (e.g., flaps, extensions, etc.) of attachment member 600, except that bodies 654a, 654b and extensions 658a, 658b are half (or asymmetrically divided portions, such as one-third, two-thirds, etc.) of body 603 and extension 604 of attachment member 600.

[0169] In some embodiments, the first attachment member portion 652a and the second attachment member portion 652b are equal halves of the entire attachment member 650 (as indicated by the dividing line 660 in FIG. 11).

[0170] In some embodiments, the first and second mounting member portions 652a, 652b are not equal to half of the entire mounting member 650, such as one of the first and second mounting member portions 652a, 652b being larger than the other of the first and second mounting member portions 652a, 652b.

[0171] Each of the first and second attachment member portions 652 a, 652 b may be configured to be mated and attached to a corresponding upper portion (e.g., commissure tab) of a leaflet (of two adjacent leaflets) prior to assembly within the valve frame. Then, when the leaflets are placed within the frame (e.g., frame 102), each of the first and second attachment member portions 652 a, 652 b may be configured to be pushed radially outward through a commissure window (e.g., window 142) and then folded and attached to a respective axially extending window strut, similar to that described above with reference to FIGS. 9 and 10. Following this attachment to the frame, the first and second attachment member portions 652 a, 652 b may then be secured (e.g., sutured) together along the parting line 660.

[0172] By using two separate attachment members (or attachment member portions) for each leaflet of the commissure, the attachment members or attachment member portions can be more easily attached to the outer leaflets of the frame (e.g., in a flat configuration) before attachment to the frame, thereby simplifying the prosthetic valve assembly process.

[0173] In some embodiments, instead of or in addition to an outer skirt with protrusions, the prosthetic valve may have an inner skirt with circumferentially spaced protrusions aligned with the commissural support portions of the frame, and the protrusions may be configured to cover gaps or gap regions in the frame (similar to those described above and shown in FIGS. 3 and 5). For example, FIGS. 12 and 13 show an example of an inner skirt 700 comprising an outflow edge portion 702 and an inflow edge portion 704. FIG. 13 shows the inner skirt 700 in a linear (non-annular) configuration, while FIG. 12 shows the inner skirt 700 disposed around the inner surface of the frame 102 of the prosthetic heart valve (FIG. 16 shows a full side view of the inner skirt 700 disposed around the frame 102 in an annular configuration). While the inner skirt 700 is shown disposed around the frame 102 in FIGS. 12 and 16, the inner skirt 700 may be configured to be positioned around a variety of frames, such as the frame 352 or alternative frames for the prosthetic device.

[0174] In some embodiments, the inner skirt 700 is an annular skirt (as shown in Figures 12 and 13).

[0175] In some cases, the inner skirt 700 may include one or more skirt portions that are connected together and / or individually to the frame 102 .

[0176] The inner skirt 700 may be constructed of a fabric or polymeric material, such as any of the skirt materials described in this disclosure.

[0177] The outflow edge portion 702 forms a plurality (e.g., three) circumferentially spaced apart protrusions 706 (as shown in FIG. 13 ) that align with the commissural support portions (e.g., axially extending window struts 138 and commissural windows 142) of the frame 102 when the inner skirt 700 is positioned around the frame 102 (as shown in FIG. 12 ). Because FIG. 12 shows only a portion of the frame 102 that includes one commissural window 142, only one protrusion 706 is shown in FIG. 12 . However, as shown in FIG. 13 , the inner skirt 700 may be configured with three circumferentially spaced apart protrusions 706 along the outflow edge portion 702. In embodiments in which the frame includes more or fewer than three commissural support portions (e.g., commissural windows or frame cells), the inner skirt 700 may be configured with a corresponding number of protrusions (e.g., two, four, etc.).

[0178] The outflow edge portion 702 further comprises straight sections 708 (which may also be referred to as circumferentially extending sections) extending between adjacent protrusions 706. For example, as shown in Figure 12, a visible protrusion 706 is disposed between two straight sections 708.

[0179] In some embodiments, as shown in FIG. 13 , the straight section 708 may be configured to be positioned above (and axially offset from) the protrusions 706 when the inner skirt 700 is not coupled to the frame. In such a configuration, in some embodiments, the straight section 708 may be configured to be directly connected to the protrusions 706 by an angled portion 709 (or edge). During or prior to placing the inner skirt 700 around the inner surface of the frame 102, the straight section 708 may be configured to be folded to form a folded edge 711 of the straight section 708 (as shown in FIG. 12 and also as illustrated in FIG. 17 , which is described in more detail below). The angled portion 709 allows the folded edge 711 to connect adjacent protrusions 706 and form an outflow edge of the inner skirt 700 that is positioned upstream of the protrusions 706 ( FIG. 12 ). Therefore, the folded edge 711 of the straight section 708 can also be referred to as the straight section of the outflow edge of the inner skirt 700 when the inner skirt 700 is disposed about the frame 102 .

[0180] In some embodiments, the inner skirt 700 may be configured not to include a straight section 708 configured to fold over the inner skirt 700, and instead the inner skirt 700 may be configured to include an outflow edge portion 702 having a straight section that is positioned below (or upstream of) the protrusion 706 both before and after placing the inner skirt 700 around the frame 102.

[0181] As shown in FIG. 12, the folded edge 711 of the straight section 708 is located upstream of the junction 196 of the second row of angled struts 134 (i.e., upstream of the commissural support portion or upstream of the window strut 138 that forms the commissural window 142).

[0182] The protrusion 706 extends outward and away from the (folded) straight section 708 toward (e.g., in a downstream direction) the outflow end 110 of the frame 102. In some embodiments, the protrusion 706 may also be referred to as an extension of the inner skirt 700.

[0183] Each protrusion 706 is configured to cover a gap in the frame formed between a respective junction 196 of the straight section 708 of the inner skirt 700 and the folded edge 711. In some embodiments, as shown in FIG. 12 , a free end or apex 710 of each protrusion 706 may be configured to extend toward the commissure window 142.

[0184] While FIG. 12 shows the apex 710 of the protrusion 706 extending to the upstream end of the joint 196, in some embodiments, the apex 710 of the protrusion 706 may be configured to extend inside the frame (behind the frame from the perspective of FIG. 12 ) across the surface of the joint 196 and / or the upstream end portion of the axially extending window support 138.

[0185] In some embodiments, each protrusion 706 may be configured to be shaped to cover or be flush with the downstream end edge and respective junction 196 of each pair of angled struts in the third row of angled struts 134. In some embodiments, as shown in FIGS. 12 and 13 , the shape of the protrusions 706 may be A-shaped or trapezoidal (an acute trapezoid that widens toward the folded edge 711 of the straight section 708).

[0186] In some embodiments, the edge of each protrusion 706 extending between the apex 710 and the folded edge 711 of the straight section 708 may be angled more or less than shown in FIGS.

[0187] As shown in FIG. 13, each protrusion 706 may be a pre-formed feature within the inner skirt 700, such as being woven or knitted with the remainder of the inner skirt 700.

[0188] FIG. 16 shows a prosthetic valve including an inner skirt 700 (on the inner surface of the frame 102) secured to the frame 102, leaflets 112 positioned within the frame and forming commissures 114 secured to the commissure windows 142, and an exemplary outer skirt 750 positioned around the outer surface of the frame 102.

[0189] The outflow edge portion 702 of the inner skirt 700 may be secured to the angled struts 134 and the joints 196 using sutures, such as stitches 712 shown in FIG.

[0190] In some embodiments, the stitches 712 extend through pre-formed openings 714 in the inner skirt 700 (as shown in FIG. 13 ). In some embodiments, the openings 714 and stitches 712 may be configured to follow the edge of the leaflet. For example, the openings 714 may be arranged in an undulating pattern from a first edge portion 716 to a second edge portion 718, as shown in FIG. 13 , thereby following the shape of the leaflet edge.

[0191] In some embodiments, the stitches 712 may also secure the leaflet edges of the leaflets to the inner skirt 700 , thereby securing the leaflets to the frame 102 .

[0192] In some embodiments, a separate stitch (such as stitch 724 shown in FIG. 18 ) can secure the leaflets to the inner skirt, and stitch 712 can secure the inner skirt 700 to the frame (e.g., by looping through stitch 724 and around the frame post, or by extending stitch 712 through the skirt material and then around the frame post).

[0193] As shown in FIG. 16 , in some embodiments, the outflow edge 752 of the outer skirt 750 may be offset from and located upstream of the corresponding outflow edge portion 702 (or outflow edge) of the inner skirt 700, and the inflow edge 754 of the outer skirt 750 may be offset from and located downstream of the corresponding inflow edge portion 704 (or inflow edge) of the inner skirt 700.

[0194] In some embodiments, the outflow edge 752 and the inflow edge 754 of the outer skirt 750 may be secured to the inner skirt 700 and / or the frame 102 with stitching 756, as shown in FIG.

[0195] In this manner, by utilizing an outer skirt and / or inner skirt having protrusions formed along their outflow edges and aligned with the frame's commissural support portions (as described above with reference to FIGS. 6 and 7, and 12, 13, and 16), or by utilizing commissural attachment members having extensions extending in an upstream direction, gaps or openings in the valve frame located between the commissural support portions and the outflow edges of the one or more skirts (e.g., the relatively straight portions of the outflow edges) can be covered, thereby providing enhanced peripheral leak (PVL) sealing. At the same time, by allowing a majority or relatively straight portion of the outflow edges of the one or more skirts to be positioned upstream of the commissural support portions, a reduced crimp profile of a radially compressed prosthetic heart valve can be maintained. In this manner, the configuration of one or more skirts and / or attachment members described herein provides both a reduced crimp profile of the prosthetic heart valve and an increased PVL seal.

[0196] In some embodiments, the inner skirt may have angled edge portions configured to overlap when the inner skirt is arranged in an annular configuration and secured inside the frame of the prosthetic valve. The leaflet edge of one leaflet of the prosthetic heart valve may be arranged along the overlapping edge portion of the inner skirt, and all three overlapping layers (two skirt layers and one leaflet layer) may be secured together (e.g., with stitches). This can simplify assembly of the prosthetic valve by shortening assembly time and reducing the amount of material used in the assembly process.

[0197] For example, the inner skirt 700 shown in FIG. 13 has a first edge portion 716 and a second edge portion 718, each extending between the inflow edge portion 704 and the outflow edge portion 702. The first and second edge portions 716, 718 may be non-perpendicular to the inflow edge portion 704. For example, the first and second edge portions 716, 718 may extend at a non-zero angle, such as approximately 45 degrees (or within a range of 40-50 degrees), relative to the inflow edge portion 704 (and / or the straight section 708 of the outflow edge portion 702). The first edge portion 716 and the second edge portion 718 may be referred to as angled edges of the inner skirt 700.

[0198] The first and second edge portions 716, 718 may each have a row of spaced-apart openings 720 (or perforations) extending through the material of the inner skirt 700. When the outer skirt 700 is converted into its annular configuration (e.g., when fitted around a prosthesis, as shown in FIGS. 12 and 16 ), the first and second edge portions 716, 718 may overlap one another, with their respective openings 720 also overlapping (as shown in FIGS. 14 and 15 ). The leaflet edges 113 of the leaflets 112 may be positioned relative to the overlapping first and second edge portions 716, 718 (e.g., as shown in FIG. 14 , the leaflets are positioned behind the inner skirt 700 in the view of FIG. 14 ). In some embodiments, the leaflet edges 113 of the leaflets 112 may also have openings that align with the openings 720. Sutures can then be used to form multiple stitches in an in-and-out pattern through the overlapping openings 720 (e.g., stitch 722 shown in FIG. 14 ) and the leaflet edge 113 (or openings formed in the leaflet edge) of the leaflet 112, thereby securing the first and second edge portions 716, 718 and the leaflet 112 together and forming the annular configuration of the inner skirt 700.

[0199] In some examples, as shown in Figure 13, each of the first and second edge portions 716, 718 includes only a single line of apertures 720, which can be used to secure the overlapping first and second edge portions 716, 718 and the leaflet edges of the leaflets 112 together with a single line of suture stitches 722, as shown in Figure 14. This can simplify the assembly process by reducing assembly time and materials.

[0200] 15, the suture stitches 722 can extend through the overlapping openings 720 and the leaflet edges of the leaflets 112. Also, in some embodiments, the suture stitches 722 can extend through openings in the leaflet edges that overlap the openings 720 in the first and second edge portions 716, 718, as shown in FIG.

[0201] During assembly of the prosthetic valve, the remaining portions of the leaflets 112 shown in Figure 14 may be secured to additional openings 714 in the inner skirt 700 by stitches 724, shown in Figure 18. For example, Figure 18 illustrates the inner skirt 700 and other portions of the leaflets 112 positioned below (or behind, in Figure 18) the inner skirt 700, with their leaflets aligned along the row of openings 714 and with stitches 724 extending therethrough, thereby securing the leaflets 112 to the inner skirt 700. All of the leaflets 112 of the prosthetic valve may be secured to the inner skirt 700 in a similar manner, thereby forming a leaflet assembly secured to the inner skirt 700.

[0202] The inner skirt 700 can be secured to the frame 102 by stitching. In some embodiments, stitches 712, shown in FIG. 16, can extend through stitches 724 or through the material of the inner skirt 700 to secure the inner skirt 700 to the frame 102.

[0203] In some embodiments, instead of separate stitches, the same stitch (such as stitch 724) can be used to secure the leaflets to the inner skirt and the inner skirt to the frame.

[0204] In some embodiments, the outflow edge portion 702 of the inner skirt 700, the inflow edge portion 704 of the inner skirt 700, or both the outflow edge portion 702 and the inflow edge portion 704 may be configured to fold on itself or on itself such that the free edges of the outflow edge portion 702 and / or the inflow edge portion 704 face outward, away from the leaflets of the prosthetic valve.

[0205] 17 shows a portion of an inner skirt 700 with the outflow edge portion 702 folded over itself on the outer surface 726 of the inner skirt 700 such that the free edge of the outflow edge portion 702 is disposed against the outer surface 726. The outer surface 726 may be the surface of the inner skirt 700 that faces and is disposed against the inner surface of the frame when the inner skirt 700 is disposed about the frame. In this manner, the outer surface 726 may be referred to as the surface that faces radially outward relative to the central longitudinal axis of the prosthetic valve.

[0206] In some embodiments, as described above, each straight section 708 of inner skirt 700 (as shown in FIGS. 17 and 18 ) can be folded to form multiple folded portions 728, each having a folded edge 711 spaced apart (e.g., by protrusions 706) around inner skirt 700. Folded portions 728 of outflow edge portion 702 can be secured to the body of the inner skirt by sutures, such as stitches 730, as shown in FIGS. 17 and 18 .

[0207] Folding over the outflow edge portion 702 in this manner can reduce unwanted wear of the leaflets against the free edge of the outflow edge portion 702, thereby increasing the long-term durability of the leaflets.

[0208] In some embodiments, the folded portion 728 of the outflow edge portion 702 of the inner skirt 700 may be configured to be positioned inside the frame (e.g., against the inner surface of the frame 102, as shown in FIG. 16).

[0209] In some embodiments, the folded portion 728 (before being secured to the body of the inner skirt 700) may be configured to extend through the frame (e.g., through the cells of the frame) and fold over a corresponding outflow edge of the outer skirt on the exterior of the frame.

[0210] In some embodiments, the inflow edge portion 704 may also extend through the frame and be configured to fold over a corresponding inflow edge of the outer skirt.

[0211] For example, Figure 19 shows the outflow edge portion 702 of the inner skirt 700 extending through the cells 118 of the frame 102 and forming multiple folded portions 728 that are folded over (and over) the outflow edge 752 of the outer skirt 750. Figure 19 also shows the inflow edge portion 704 of the inner skirt 700 extending around the inflow end 108 of the frame 102 and folded over (and over) the inflow edge 754 of the outer skirt 750, thereby forming folded portions 732 of the inflow edge portion 704.

[0212] In some embodiments, the outer skirt 750 may include a plurality of outwardly extending fibers or filaments, which may be configured to promote tissue ingrowth (for improved sealing against the native anatomy). By folding the inner skirt 700 over the inflow and outflow edges (or edge portions) of the outer skirt 750, the outwardly protruding fibers of the outer skirt 750 (or other relatively rough material of the outer skirt) may be prevented from extending inward into the frame and contacting the valve leaflets, and / or may prevent undesired tissue overgrowth along the outflow and inflow edges of the outer skirt 750.

[0213] In some embodiments, to facilitate the outflow edge portion 702 of the inner skirt 700 extending through the frame cells 118 and around the axial struts 140 and / or axially-extending window struts 138 (as shown in FIG. 19 ), the outflow edge portion 702 may include slits 734 (or cuts) extending through the inner skirt 700, as shown in FIG. 20 . For example, the outflow edge portion 702 may include two pairs of angled slits 734 in each straight section 708, thereby forming three folded portions 728 in each straight section 708. Each folded portion 728 is configured to extend through a respective cell 118 of the frame, with adjacent folded portions 728 extending on either side of the axial struts 140 or axially-extending window struts 138 (as shown in FIG. 19 ).

[0214] In some embodiments, instead of being angled, the slits 734 may be configured to be perpendicular to the free edge of the straight section 708, as shown in FIG.

[0215] In some embodiments, the inner skirt 700 may be configured to include more or fewer slits 734 than shown in Figure 20. For example, a single slit 734 may be used between each folded portion 728, or more or fewer pairs of slits 734 may be formed depending on the number of cells in each row of cells in the frame.

[0216] In some embodiments, as shown in FIG. 20 , the outflow edge portion 702 may have a plurality of spaced-apart apertures 738 disposed therethrough. A portion of the inner skirt 700 disposed away from the outflow edge portion 702, toward the inflow edge portion 704, may have a plurality of spaced-apart apertures 740 disposed therethrough. As described above, when the straight section 708 is folded, the apertures 738 and 740 overlap one another, and then sutures may be used to secure the folded portion 728 to the main body of the inner skirt 700, such as with a plurality of suture stitches 742 (as shown in FIG. 21 ).

[0217] In some embodiments, the stitching 742 may extend through the outer skirt 750, as shown in the cross-sectional view of FIG.

[0218] 20 is exemplary, and other numbers and arrangements of apertures are possible for securing the folded portion 728 about the frame to the inner skirt 700. In some embodiments, the inner skirt 700 may be configured without pre-formed apertures 738 and 740, and instead, the apertures are formed in the folded portion 728 and the body of the inner skirt 700 as the needle penetrates the fabric of the inner skirt 700 and forms the sewing stitch.

[0219] 20 (and FIG. 13), the inflow edge portion 704 may be configured with a plurality of apertures 736. When the inflow edge portion 704 is folded over itself to form the folded portion 732, a sewing stitch 744 may be formed through the apertures 736, thereby securing the folded portion 732 to the main body of the inner skirt 700 (and / or the outer skirt 750). For example, FIG. 21 shows an exemplary stitch 744 extending through the folded portion 732 of the inflow edge portion 704 on the inside of the frame, the outer skirt 750, and the main body of the inner skirt 700.

[0220] As shown in FIG. 21 , in some embodiments, the straight sections 708 of the outflow edge portion 702 of the inner skirt 700 may be configured to be folded such that a portion of each folds onto itself inside the frame 102 (forming the inner folded portion 746) and then another portion extends through the frame 102 onto the outer surface of the outer skirt 750 (forming the folded portion 728).

[0221] 13 , in some embodiments, the inner skirt 700 can include a plurality of first filaments 748 and a plurality of second filaments 749 that extend at a 45-degree angle from the inflow edge portion 704 to the outflow edge portion 702. For example, the plurality of first filaments 748 and the plurality of second filaments 749 can each be disposed at a 45-degree angle relative to the inflow edge portion 704. In some embodiments, the first filaments 748 can be disposed at a 90-degree angle relative to the second filaments 749. As shown in FIG. 13 , this arrangement of the first filaments 748 and the second filaments 749 can allow the inner skirt 700 to extend beyond its initial or pre-cut length and diameter when disposed in an annular configuration around the inner surface of the frame of a prosthetic valve.

[0222] For example, to deploy a prosthetic valve, such as the prosthetic valve shown in FIG. 16 including an inner skirt 700, the frame (e.g., frame 102) is radially expanded to a larger diameter (which may be referred to as the deployed diameter). The deployed diameter may be within a working range of diameters defined between a minimum deployed diameter and a maximum deployed diameter. In one non-limiting example, the minimum deployed diameter is about 26 mm and the maximum deployed diameter is about 29 mm.

[0223] In some embodiments, the inner skirt 700 may be configured to stretch slightly in the circumferential direction when the frame 102 is expanded radially (e.g., as shown in FIG. 16 ). In some embodiments, the inner skirt 700 may be configured to have a size such that the inner skirt 700 can stretch to fit closely or snugly against the inner surface of the frame 102 (so that no slack forms in the inner skirt 700 around the circumference of the frame 102) when the frame 102 is expanded to a diameter within its operating range.

[0224] For example, during assembly of the prosthetic valve, the inner skirt 700 can be sutured to the frame 102 when expanded to its minimum deployed diameter. The inner skirt 700 can be sized and configured to fit snugly against the inner surface of the frame 102 without radial looseness when the frame 102 is expanded to its minimum deployed diameter.

[0225] As the frame 102 is radially expanded to larger diameters within its operating range of deployed diameters, the inner skirt 700 may be configured to tighten further onto the frame 102. Thus, in some embodiments, it can be ensured that the inner skirt 700 does not have any radial slack when the frame 102 is expanded to any diameter within its operating range. In some embodiments, to ensure that the inner skirt 700 fits tightly around the frame 102 at its minimum deployed diameter, the inner skirt 700 may be cut to a smaller size, and the inner skirt 700 may be mounted onto the frame 102 (at its minimum deployed diameter), with some circumferential stretch.

[0226] In some embodiments, the inner skirt 700 may be sized and configured to fit snugly around the frame 102 when the frame is expanded to its smallest deployed diameter without stretching the skirt in any direction and without any radial slack. When the frame is radially expanded to a larger diameter within its operating range, the inner skirt 700 may stretch slightly and tighten around the frame.

[0227] delivery technology To implant a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve may be implanted within the native aortic valve via a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and apex of the heart, and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a right parasternal minithoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0228] To implant a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve may be implanted within the native mitral valve via a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0229] To implant a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used to implant a prosthetic valve within the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0230] Another delivery approach is the transatrial approach, whereby the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (of the right or left atrium) to access either of the native heart valves. Atrial delivery can also be performed intravascularly, such as from a pulmonary vein. Yet another delivery approach is the transventricular approach, where the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve within the native tricuspid valve, within the native pulmonary valve, or within the pulmonary artery.

[0231] In all delivery approaches, the delivery device may be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed in this disclosure can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0232] Any system, device, apparatus, etc. described herein can be sterilized (e.g., using heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use on patients, and any method described herein can include sterilizing the associated system, device, apparatus, etc. as one of the steps in the method. Examples of heat sterilization include steam sterilization and autoclave sterilization. Examples of radiation for use in sterilization include, but are not limited to, gamma rays, ultraviolet light, and electron beams. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Hydrogen peroxide sterilization can be achieved, for example, using hydrogen peroxide plasma.

[0233] Additional Examples of the Disclosed Techniques In view of the implementations described above with respect to the disclosed subject matter, the present application discloses the following additional embodiments, which should be noted that any individual feature of an embodiment, a combination of features of two or more additional embodiments, and optionally a combination of features of two or more additional embodiments with one or more features of one or more additional embodiments are also additional embodiments that are included within the disclosure of the present application.

[0234] Example 1. A prosthetic heart valve comprising a radially expandable and compressible frame, the prosthetic heart valve comprising: three axially extending commissural support portions; a plurality of rows of angled struts, the plurality of rows including a first row of angled struts defining an inflow end of the frame; a second row of angled struts downstream of the first row of angled struts; and a third row of angled struts downstream of the second row of angled struts defining an outflow end of the frame, the downstream ends of the angled struts of the second row of angled struts being connected to one another at a plurality of junctions, the commissural support portions extending from each junction of the plurality of junctions of the second row of angled struts to the respective junctions of the angled struts. a frame extending to the third row of struts; a plurality of leaflets forming three commissures secured to respective commissure support portions of the frame; and an outer skirt disposed around an outer surface of the frame, the outer skirt having an inflow edge and an outflow edge, the outflow edge forming three circumferentially spaced projections that align with the commissure support portions and cover each junction of the second row of angled struts, the outflow edge further comprising circumferentially extending sections extending between adjacent projections, the circumferentially extending sections being located upstream of the junction of the second row of angled struts.

[0235] Example 2. The prosthetic heart valve of any of the examples described herein, particularly Example 1, wherein each protrusion is shaped to cover the downstream ends and respective junctions of a respective pair of angled struts in said second row of angled struts.

[0236] Example 3. The prosthetic heart valve of any of the examples described herein, particularly Example 2, wherein each protrusion has a shape that is an acute trapezoid extending from the downstream end of said protrusion to said circumferentially extending section.

[0237] Example 4. The prosthetic heart valve of any of the embodiments described herein, particularly Example 2 or Example 3, wherein each protrusion is secured to the downstream ends of each pair of angled struts in the second row of angled struts and to each of the junctions with one or more stitches.

[0238] Example 5. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 1-4, wherein the outer skirt is attached to the frame along a portion of the angled struts of the first row of angled struts, the second row of angled struts, and a fourth row of angled struts disposed with sutures between the first and second rows of angled struts, and wherein a portion of the angled struts extends from one commissure support portion to the inflow end of the frame and from the inflow end to an adjacent commissure support portion.

[0239] Example 6. The prosthetic heart valve of any of the embodiments described herein, particularly Example 5, wherein leaflet edges of the plurality of leaflets are attached to a portion of the angled struts.

[0240] Example 7. The prosthetic heart valve of any example described herein, particularly Example 5 or Example 6, wherein each protrusion is attached to a respective commissural support portion by one or more stitches.

[0241] Example 8. The prosthetic heart valve of any of the examples described herein, particularly any one of Examples 1-7, wherein the three protrusions are pre-formed on the outer skirt.

[0242] Example 9. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 8, wherein the inflow edge of the outer skirt includes three circumferentially spaced notches that are aligned with the protrusions and have a shape that follows the shape of the angled struts of the first row of angled struts, each notch having a shape such that the inflow edge extends from a straight portion of the inflow edge located on either side of the notch toward the outflow edge.

[0243] Example 10. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 9, wherein each cutout has a peak at a junction between two angled struts of a first row of angled struts and two angled struts of a fourth row of angled struts located downstream of the first row of angled struts, and wherein the outer skirt has a first height defined between the peak of the cutout and the downstream end of each protrusion.

[0244] Example 11. A prosthetic heart valve according to any of the examples described herein, particularly Example 10, wherein the outer skirt has a second height defined between the circumferentially extending section of the outflow edge and the straight portion of the inflow edge, and the first height and the second height are the same.

[0245] Example 12. The prosthetic heart valve of any example described herein, particularly any one of Examples 1-7, wherein the outer skirt comprises a stretchable fabric or polymeric material.

[0246] Example 13. A prosthetic heart valve according to any of the examples described herein, particularly Example 12, wherein the three protrusions are formed by extending the outflow edge of the outer skirt over the respective junctions in areas adjacent to the commissure support portions and attaching the extended protrusions to the respective commissure support portions with one or more stitches.

[0247] Example 14. The prosthetic heart valve of any of the embodiments described herein, particularly example 13, wherein each protrusion is further attached to a downstream end portion of a respective pair of angled struts in said second row of angled struts.

[0248] Example 15. A prosthetic heart valve described in any of the examples described herein, particularly any one of Examples 12 to 14, wherein the inflow edge of the outer skirt extends circumferentially along the inflow end of the frame and is parallel to the circumferentially extending section of the outflow edge, and the height of the outer skirt between the inflow edge and the outflow edge is greater at the protrusion than between the circumferentially extending section of the outflow edge and the inflow edge.

[0249] Example 16. A prosthetic heart valve according to any of the examples described herein, particularly any one of Examples 1 to 15, wherein each circumferentially extending section extends linearly between two adjacent protrusions.

[0250] Example 17. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 1 to 16, wherein the commissural support portion forms a commissural window, and the leaflets of the plurality of leaflets connect to each other at adjacent ends, and each pair of adjacent ends connects to each other and is configured in a corresponding commissural window to form a commissure.

[0251] Example 18. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 17, wherein each protrusion tapers from two adjacent circumferentially extending sections to an apex located adjacent the upstream edge of the respective cone.

[0252] Example 19. A prosthetic heart valve comprising: a radially expandable and compressible frame, the frame including three commissure support portions; a plurality of rows of angled struts, the plurality of rows including a first row of angled struts defining an inflow end of the frame; a second row of angled struts downstream of the first row of angled struts; and a third row of angled struts downstream of the second row of angled struts defining an outflow end of the frame, wherein the downstream ends of the angled struts of the second row of angled struts are connected to one another at a plurality of joints; and three commissure-forming struts secured to respective commissure support portions of the frame. and an outer skirt disposed around an outer surface of the frame and including an inflow edge and an outflow edge, the outflow edge forming three circumferentially spaced lobes that align with the commissure support portions and cover the junctions of the second row of angled struts, the outflow edge further including straight sections extending between adjacent lobes, the straight sections being located upstream of the junctions of the second row of angled struts.

[0253] Example 20. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 19, wherein each protrusion is shaped to cover the downstream ends and respective joints of each pair of angled struts in the second row of angled struts.

[0254] Example 21. A prosthetic heart valve according to any of the examples described herein, particularly example 20, wherein each protrusion is A-shaped and extends from a downstream end of the protrusion relative to the straight section, and the downstream end of the protrusion is positioned adjacent to a respective commissure support portion.

[0255] Example 22. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 20 or Example 21, wherein each protrusion is secured to the downstream ends of each pair of angled struts in the second row of angled struts and to each of the junctions with one or more stitches.

[0256] Example 23. A prosthetic heart valve described in any of the embodiments described herein, particularly any one of Examples 19 to 22, wherein the outer skirt is attached to the frame along a portion of the angled struts of the first row of angled struts, the second row of angled struts, and a fourth row of angled struts disposed with sutures between the first and second rows of angled struts, and wherein a portion of the angled struts extends from one commissure support portion of the frame to the inflow end and from the inflow end to an adjacent commissure support portion.

[0257] Example 24. The prosthetic heart valve of any of the examples described herein, particularly example 23, wherein leaflet edges of the plurality of leaflets are attached to a portion of the angled struts.

[0258] Example 25. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 19-24, wherein each protrusion is attached to its respective commissure support portion by one or more stitches.

[0259] Example 26. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 19-25, wherein the three protrusions are pre-formed in the outer skirt prior to attaching the outer skirt to the frame.

[0260] Example 27. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 26, wherein the inflow edge of the outer skirt includes three circumferentially spaced cutouts aligned with the protrusions and shaped to follow the shape of the angled struts of the first row of angled struts, each cutout shaped such that the inflow edge extends from straight sections of the inflow edge located on either side of the notch towards the outflow edge, the straight sections extending along the inflow end of the frame and parallel to the straight sections of the outflow edge.

[0261] Example 28. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 27, wherein each cutout has a peak at the junction between two angled struts of a first row of angled struts and two angled struts of a fourth row of angled struts located downstream of the first row of angled struts, and the outer skirt has a first height defined between the peak of the cutout and the downstream end of each protrusion.

[0262] Example 29. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 28, wherein the outer skirt has a second height defined between the straight section of the outflow edge and the straight portion of the inflow edge, and the first and second heights are the same.

[0263] Example 30. A prosthetic heart valve described in any of the examples described herein, particularly any one of Examples 19 to 25, wherein the outer skirt comprises a stretchable fabric or polymeric material, and the three protrusions are formed by extending the outflow edge of the outer skirt over the respective junctions in areas adjacent to the commissure support portions and attaching the extended protrusions to the respective commissure support portions with one or more stitches.

[0264] Example 31. The prosthetic heart valve of any of the embodiments described herein, particularly example 30, wherein each protrusion is further attached to a downstream end portion of a respective pair of angled struts in the second row of angled struts.

[0265] Example 32. A prosthetic heart valve as described in any of the examples described herein, particularly Example 30 or Example 31, wherein the inflow edge of the outer skirt extends circumferentially along the inflow end of the frame and is parallel to the straight section of the outflow edge, and the height of the outer skirt between the inflow edge and the outflow edge is greater at the protrusion than between the straight section of the outflow edge and the inflow edge.

[0266] Example 33. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 19 to 32, wherein the commissural support portion extends axially from each junction of the plurality of junctions of the second row of angled struts to the third row of angled struts to form a commissural window, and the leaflets of the plurality of leaflets connect with each other at adjacent ends, and each pair of adjacent ends connect with each other and are configured in a corresponding commissural window to form a commissure.

[0267] Example 34. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 19-32, wherein the commissural support portion is a frame cell defined by the angled struts of the third row of angled struts and a fourth row of angled struts disposed between the second and third rows of angled struts.

[0268] Example 35. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 34, wherein each commissure is secured to an attachment member disposed across a respective cell, said attachment members being secured to the angled struts of the angled struts of the third and fourth rows of angled struts defining the cell.

[0269] Example 36. A prosthetic heart valve comprising a radially expandable and compressible frame, the frame comprising three commissure support portions, a plurality of rows of angled struts, the plurality of rows of angled struts including a first row of angled struts defining an inflow end of the frame, a second row of angled struts downstream of the first row of angled struts, and a third row of angled struts downstream of the second row of angled struts and defining an outflow end of the frame, wherein the downstream ends of the angled struts of the second row of angled struts are connected to each other at a plurality of joints, and a plurality of valve members forming three commissures secured to respective commissure support portions of the frame. 1. A prosthetic heart valve comprising: a plurality of leaflets, the leaflets having upstream edges of the commissures located adjacent to the junctions of the respective second row of angled struts; an outer skirt disposed around an outer surface of the frame and including an inflow edge and an outflow edge, the outflow edge located upstream of the junctions of the second row of angled struts; and a plurality of commissure extension members disposed at respective commissure support portions on the outer surface of the frame, the commissure extension members including extensions that extend axially upstream of the junctions and cover gaps in the frame formed between a respective junction and the outflow edge of the outer skirt.

[0270] Example 37. The prosthetic heart valve of any of the embodiments described herein, particularly example 36, wherein the upstream end of the extension is secured to the outflow edge of the outer skirt.

[0271] Example 38. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 36 or Example 37, wherein the extensions are secured to the angled struts of the second row of angled struts connected together by their respective joints.

[0272] Example 39. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 36-38, wherein the extension overlaps the outflow edge of the outer skirt.

[0273] Example 40. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 36 to 39, wherein each commissure extension member forms a respective commissure and includes a body secured to a respective commissure support portion, and the extension extends outward in an upstream direction from the lower lateral edge of the body and the upstream edge of the respective commissure.

[0274] Example 41. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 40, wherein the body has two laterally extending flaps, and the extension extends outward from a central portion of the body where the two flaps connect.

[0275] Example 42. A prosthetic heart valve according to any of the examples described herein, particularly example 41, wherein the commissural support portion is an axially extending fenestrated portion extending axially from each junction of the plurality of junctions of the second row of angled struts to the third row of angled struts and forming a commissural fenestration therein, and wherein the height of the body is sized to fit through each commissural fenestration.

[0276] Example 43. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 42, wherein the two laterally extending flaps are folded and secured around their respective axially extending window strut portions.

[0277] Example 44. A prosthetic heart valve according to any of the examples described herein, particularly any one of Examples 41 to 43, wherein each commissure is formed by two adjacent ends of two adjacent leaflets of the plurality of leaflets, and each laterally extending flap is coupled to the respective adjacent ends of the corresponding leaflet.

[0278] Example 45. The prosthetic heart valve of any of the embodiments described herein, particularly example 44, wherein the commissural extension members are formed as a single piece.

[0279] Example 46. A prosthetic heart valve according to any of the examples described herein, particularly Example 44, wherein the commissural extension member is formed as a two-piece body having two portions, each portion having one of the two flaps, and each portion of the commissural extension member is individually coupled to a respective adjacent end of each valve leaflet.

[0280] Example 47. A prosthetic heart valve described in any of the embodiments described herein, particularly any one of Examples 40 to 46, wherein the extension tapers from its upstream end at the outflow edge of the outer skirt to its downstream end where it connects to the main body.

[0281] Example 48. A prosthetic heart valve according to any of the examples described herein, particularly any one of Examples 36 to 47, wherein the extension has a trapezoidal shape that widens toward the upstream end of the extension that connects to the outflow edge of the outer skirt.

[0282] Example 49. A prosthetic heart valve described in any of the embodiments described herein, particularly any one of Examples 36 to 48, wherein the outer skirt is attached to the frame along a portion of the angled struts of the first row of angled struts, a fourth row of angled struts arranged with sutures between the first and second rows of angled struts, and a portion of the angled struts extending from one commissure support portion of the frame to the inflow end and from the inflow end to an adjacent commissure support portion.

[0283] Example 50. A prosthetic heart valve according to any of the embodiments described herein, particularly example 49, wherein the leaflet edges of the plurality of leaflets are attached to a portion of the angled struts.

[0284] Example 51. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 36 to 50, wherein the outflow edge and the inflow edge of the outer skirt are parallel to each other.

[0285] Example 52. A prosthetic heart valve comprising: a frame including a plurality of interconnected struts; an inner skirt disposed around the inner surface of the frame, the inner skirt having an outflow edge portion and an inflow edge portion, and opposing first and second edge portions extending between the inflow and outflow edge portions, respectively, and non-perpendicular to the inflow edge portion, the first and second edge portions overlapping each other to form an annular configuration of the inner skirt within the frame; a plurality of leaflets disposed within the frame, wherein a leaflet edge of a first leaflet of the plurality of leaflets is disposed along the overlapping first and second edge portions; and a plurality of suture stitches securing the overlapping first and second edge portions and the leaflet edge of the first leaflet to each other.

[0286] Example 53. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 52, wherein the plurality of interconnected struts of the frame form a plurality of rows of angled struts, and the inner skirt is fixed to a portion of the angled struts of the plurality of rows of angled struts.

[0287] Example 54. A prosthetic heart valve as described in any of the examples described herein, particularly either Example 52 or Example 53, wherein the first and second edge portions each have a row of spaced apart openings penetrating the material of the inner skirt, the first and second edge portions overlap each other so that their respective openings overlap each other, and the plurality of suture stitches extend through the overlapping openings in the first and second edge portions and through the cusp edge of the first valve leaflet.

[0288] Example 55. A prosthetic heart valve described in any of the embodiments described herein, particularly any one of Examples 52 to 54, wherein the inner skirt has a plurality of spaced openings arranged in a wavy pattern along the inner skirt from the first edge portion to the second edge portion, and the leaflet edges of the second and third leaflets of the plurality of leaflets are fixed to the inner skirt by suture stitches extending through the leaflet edges of the second and third leaflets and the plurality of spaced openings.

[0289] Example 56. A prosthetic heart valve described in any of the examples described herein, particularly any one of Examples 52 to 55, wherein the outflow edge portion of the inner skirt forms three circumferentially spaced protrusions and a plurality of circumferentially extending sections extending between adjacent protrusions.

[0290] Example 57. A prosthetic heart valve according to any of the examples described herein, particularly example 56, wherein the plurality of circumferentially extending sections are a plurality of circumferentially extending folded portions extending between adjacent protrusions, each folded portion forming a folded edge and a free edge positioned against the surface of the inner skirt facing in a direction opposite the plurality of valve leaflets.

[0291] Example 58. A prosthetic heart valve described in any of the examples described herein, particularly example 56 or example 57, wherein the frame has three axially extending commissure support portions, each protrusion extending in alignment with a respective one of the three commissure support portions, and the plurality of circumferentially extending sections are located upstream of the three commissure support portions.

[0292] Example 59. A prosthetic heart valve described in any of the embodiments described herein, particularly any one of Examples 52 to 58, wherein the inner skirt comprises a plurality of first filaments and a plurality of second filaments extending at a 45-degree angle between the inflow edge portion and the outflow edge portion.

[0293] Example 60 The prosthetic heart valve of any embodiment described herein, particularly example 59, wherein the plurality of first filaments are positioned at a 90 degree angle relative to the plurality of second filaments.

[0294] Example 61. A prosthetic heart valve described in any of the embodiments described herein, particularly any one of Examples 52 to 60, comprising an outer skirt disposed around the outer surface of the frame, the outer skirt having an inflow edge and an outflow edge, a plurality of interconnected struts of the frame forming a plurality of rows of open cells between the outflow end and the inflow end of the frame, and an outflow edge portion of the inner skirt extending through the plurality of rows of open cells of the frame and folded over the outflow edge of the outer skirt.

[0295] Example 62. A method for assembling a prosthetic heart valve, the method comprising: arranging an inner skirt for the prosthetic heart valve in an annular configuration so that opposing first and second edge portions of the inner skirt overlap each other and extend at an angle of less than 90 degrees between an inflow edge portion and an outflow edge portion of the inner skirt; arranging a leaflet edge of a first leaflet of a plurality of leaflets of the prosthetic heart valve along the overlapping first and second edge portions; and securing the overlapping first and second edge portions and the leaflet edge of the first leaflet to each other using a plurality of suture stitches.

[0296] Example 63. A method according to any of the examples described herein, particularly Example 62, wherein positioning the cusp edge of the first valve leaflet along the overlapping first and second edge portions comprises positioning the cusp edge and the first and second edge portions in an overlapping manner so that openings extending through the cusp edge and the first and second edge portions and spaced apart along each of the first and second edge portions are aligned with one another, and wherein fixing the overlapping first and second edge portions and the cusp edge of the first valve leaflet to one another comprises extending the plurality of suture stitches through the aligned openings.

[0297] Example 64. A method as described in any of the examples described herein, particularly Example 62 or Example 63, further comprising fixing leaflet edges of the remaining leaflets of the plurality of leaflets to the inner skirt along a plurality of spaced apart openings disposed within the inner skirt, the plurality of spaced apart openings being arranged in an undulating manner along the inner skirt from the first edge portion to the second edge portion.

[0298] Example 65. The method of any of the embodiments described herein, particularly any of Examples 62-64, further comprising securing the inner skirt to an inner surface of an annular frame of the prosthetic heart valve.

[0299] Example 66. A method according to any of the examples described herein, particularly example 65, further comprising folding the inner skirt over the outflow edge portion and fixing the free edge of the outflow edge portion to the outer surface of the inner skirt so that the free edge faces the inner surface of the annular frame.

[0300] Example 67. A method according to any of the embodiments described herein, particularly Example 65, further comprising: folding over a plurality of straight sections of the outflow edge portion of the inner skirt to form a plurality of folded portions; extending each folded portion through open cells of the annular frame formed by a plurality of struts of the annular frame; and folding each folded portion over an outflow edge of an outer skirt disposed around the outer surface of the frame.

[0301] Example 68. A method according to any of the examples described herein, particularly Example 67, wherein the outflow edge portion of the inner skirt forms three circumferentially spaced protrusions, each protrusion being positioned between two adjacent folded portions of the plurality of folded portions, and the method further includes aligning each protrusion with a respective commissural support portion of the three commissural support portions of the annular frame, and fixing each protrusion to an angled strut connecting to the respective commissural support portion.

[0302] Example 69. A prosthetic heart valve comprising: a frame including a plurality of interconnected struts forming a plurality of rows of open cells between the outflow end and the inflow end of the frame; an outer skirt disposed around the outer surface of the frame and having an inflow edge and an outflow edge; and an inner skirt disposed around the inner surface of the frame, wherein the inner skirt has an inflow edge portion and an outflow edge portion, and the outflow edge portion extends to the outside of the frame through the cells of the plurality of rows of open cells of the frame and is folded over the outflow edge of the outer skirt.

[0303] Example 70. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 69, wherein the outflow edge portion comprises a plurality of folded portions, each folded portion extending through a respective cell of a first row of the plurality of rows of open cells of the frame.

[0304] Example 71. A prosthetic heart valve according to any of the embodiments described herein, particularly example 70, wherein the first row of cells is at least partially defined by struts of the plurality of interconnected struts that define the outflow end of the frame.

[0305] Example 72. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 70 or Example 71, wherein the plurality of interconnected struts includes a first row of angled struts defining the outflow end of the frame and a second row of angled struts disposed upstream of the first row of angled struts, the first and second rows of angled struts at least partially defining the first row of cells, and each folded portion being folded around two angled struts of the second row of angled struts.

[0306] Example 73. A prosthetic heart valve according to any of the examples described herein, particularly example 72, wherein the plurality of interconnected struts comprises a plurality of axially extending struts spaced circumferentially around the frame, the plurality of axially extending struts extending between the first row of angled struts and the second row of angled struts and forming axial sides of the first row of cells.

[0307] Example 74. A prosthetic heart valve described in any of the embodiments described herein, particularly any one of Examples 70 to 73, wherein each folded portion includes an inner folded portion folded onto itself inside the frame, and an outer folded portion extending from the inner folded portion, through the respective cell, and over the outflow edge of the outer skirt.

[0308] Example 75. A prosthetic heart valve described in any of the embodiments described herein, particularly any one of Examples 69 to 74, wherein the inflow edge portion of the inner skirt is folded around the inflow end of the frame and over the inflow edge of the outer skirt.

[0309] Example 76. A prosthetic heart valve described in any of the embodiments described herein, particularly any one of Examples 69 to 75, wherein the outflow edge portion of the inner skirt forms three circumferentially spaced protrusions and a plurality of circumferentially extending folded portions extending between adjacent protrusions.

[0310] Example 77. A prosthetic heart valve according to any of the embodiments described herein, particularly example 76, wherein each folded portion forms a folded edge and a free edge disposed over the outflow edge of the outer skirt.

[0311] Example 78. A prosthetic heart valve described in any of the examples described herein, particularly example 76 or example 77, wherein the frame has three axially extending commissure support portions, each protrusion extending in alignment with a respective one of the three commissure support portions, and the plurality of circumferentially extending folded portions are located upstream of the three commissure support portions.

[0312] Example 79. A prosthetic heart valve according to any of the examples described herein, particularly example 78, further comprising a plurality of leaflets disposed inside the frame, secured together at adjacent ends, and secured to each of the three commissural support portions.

[0313] Example 80. A prosthetic heart valve according to any of the embodiments described herein, particularly example 79, wherein the leaflet edges of the plurality of leaflets are fixed to the inner surface of the inner skirt.

[0314] Example 81. A prosthetic heart valve described in any of the embodiments described herein, Examples 69 to 80, wherein the inner skirt comprises a plurality of first filaments and a plurality of second filaments extending at a 45-degree angle between the inflow edge and outflow edge portions.

[0315] Example 82. The prosthetic heart valve of any of the embodiments described herein, particularly example 81, wherein the plurality of first filaments are arranged at a 90 degree angle relative to the plurality of second filaments.

[0316] Example 83. A prosthetic heart valve comprising: a radially expandable and compressible frame including a plurality of interconnected struts, the frame having an inflow end and an outflow end; a plurality of valve leaflets disposed within the frame; and an inner skirt disposed around the inner surface of the frame and having an inflow edge portion and an outflow edge portion, the outflow edge portion being folded upon itself to form a folded edge, and a free edge of the outflow edge portion being disposed against a surface of the inner skirt facing away from the valve leaflets.

[0317] Example 84. A prosthetic heart valve according to any of the examples described herein, particularly example 83, wherein the folded outflow edge portion includes a plurality of circumferentially extending folded portions, each of which forms a folded edge and a free edge that are positioned against the surface of the inner skirt facing away from the valve leaflets.

[0318] Example 85. A prosthetic heart valve according to any of the embodiments described herein, particularly example 84, wherein the free edge of each folded portion is fixed to the surface of the inner skirt by a plurality of stitches.

[0319] Example 86. A prosthetic heart valve according to any of the embodiments described herein, particularly example 84 or example 85, wherein the frame comprises three axially extending commissure support portions and a plurality of rows of angled struts, including a first row of angled struts defining an inflow end of the frame, a second row of angled struts downstream of the first row of angled struts, and a third row of angled struts downstream of the second row of angled struts and defining an outflow end of the frame, wherein the second row of angled struts the downstream ends of the angled struts are connected to one another at a plurality of junctions, the commissural support portions extend from each junction of the plurality of junctions of the second row of angled struts to the third row of angled struts, the plurality of leaflets form three commissures secured to respective commissural support portions of the frame, and the outflow edge portions form three circumferentially spaced protrusions aligned with the commissural support portions and extending to each junction of the second row of angled struts.

[0320] Example 87. A prosthetic heart valve as described in any of the embodiments described herein, particularly Example 86, wherein the plurality of circumferentially extending folded portions extend between adjacent protrusions of three circumferentially spaced apart protrusions, and each protrusion is positioned between two respective adjacent folded portions of the plurality of circumferentially extending folded portions.

[0321] Example 88. A prosthetic heart valve according to any of the embodiments described herein, particularly Example 86 or Example 87, wherein the folded edge of each folded portion is located upstream of the junction of the second row of angled struts.

[0322] Example 89. A prosthetic heart valve described in any of the embodiments described herein, particularly any one of Examples 83 to 88, wherein the inflow edge portion of the inner skirt is wrapped around the inflow end of the frame and over the inflow edge of an outer skirt disposed around the outer surface of the frame.

[0323] Example 90. A prosthetic heart valve described in any of the examples described herein, particularly any one of Examples 83 to 89, wherein the surface of the inner skirt onto which the free edge of the outflow edge portion is folded is positioned facing the inner surface of the frame.

[0324] Example 91. A prosthetic heart valve described in any of the embodiments described herein, particularly any one of Examples 83 to 90, wherein the inner skirt comprises a plurality of first filaments and a plurality of second filaments extending at a 45 degree angle between the inflow edge portion and the outflow edge portion, and the plurality of first filaments are arranged at a 90 degree angle relative to the plurality of second filaments.

[0325] Example 92. A prosthetic heart valve comprising: a frame including a plurality of interconnected struts; an inner skirt disposed around an inner surface of the frame, the inner skirt having an outflow edge portion and an inflow edge portion, and opposing first and second edge portions extending between the inflow and outflow edge portions, respectively, and non-perpendicular to the inflow edge portions, the first and second edge portions overlapping each other to form an annular configuration of the inner skirt within the frame; a plurality of leaflets disposed within the frame, wherein a leaflet edge of a first leaflet of the plurality of leaflets is disposed along the overlapping first and second edge portions; and a plurality of stitches securing the overlapping first and second edge portions and the leaflet edge of the first leaflet to each other.

[0326] Example 93. A prosthetic heart valve according to any one of Examples 1 to 91, which is sterilized.

[0327] Any feature described in this disclosure with respect to any embodiment may be combined with any other feature described in one or more of the other embodiments, unless otherwise specified. For example, any one or more features of one frame may be combined with any one or more features of another frame. As another example, any one or more features of one outer skirt or attachment member may be combined with any one or more features of another outer skirt or attachment member, respectively.

[0328] In view of the many possible manners to which the principles of the present disclosure may be applied, it will be understood that the illustrated configurations illustrate some examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure and the claims that follow. Rather, the scope of claimed subject matter is defined by the following claims and their equivalents.

Claims

1. 1. A prosthetic heart valve, comprising: a radially expandable and compressible frame, comprising three axially extending commissure support portions and a plurality of rows of angled struts, including a first row of angled struts defining an inflow end of the frame, a second row of angled struts downstream of the first row of angled struts, and a third row of angled struts downstream of the second row of angled struts and defining an outflow end of the frame; the downstream ends of the angled struts in the second row of angled struts are connected to one another at a plurality of joints; a frame, the commissure support portions extending from each of the plurality of junctions of the second row of angled struts to the third row of angled struts; a plurality of leaflets forming three commissures secured to respective commissure support portions of the frame; an outer skirt disposed around an outer surface of the frame, the outer skirt having an inflow edge and an outflow edge, the outflow edge forming three circumferentially spaced projections that align with the commissural support portions and cover each junction of the second row of angled struts, the outflow edge further comprising circumferentially extending sections extending between adjacent projections, the circumferentially extending sections being located upstream of the junction of the second row of angled struts.

2. 10. The prosthetic heart valve of claim 1, wherein each protrusion is shaped to cover the downstream ends and respective joints of a respective pair of angled struts in the second row of angled struts.

3. 3. The prosthetic heart valve of claim 2, wherein each protrusion has a shape that is an acute trapezoid that extends from the downstream end of the protrusion to the circumferentially extending section.

4. 4. The prosthetic heart valve of claim 2, wherein each protrusion is secured to the downstream ends of a respective pair of the angled struts in the second row of angled struts and to the respective junctions with one or more stitches.

5. 5. The prosthetic heart valve of claim 1, wherein the outer skirt is attached to the frame along a portion of the angled struts of the first row of angled struts, the second row of angled struts, and a fourth row of angled struts disposed with sutures between the first and second rows of angled struts, and wherein a portion of the angled struts extends from one commissural support portion to the inflow end of the frame and from the inflow end to an adjacent commissural support portion.

6. The prosthetic heart valve of claim 5 , wherein each protrusion is attached to a respective commissural support portion by one or more stitches.

7. 7. The prosthetic heart valve of claim 1, wherein the inflow edge of the outer skirt includes three circumferentially spaced cutouts that are aligned with the protrusions and are shaped to follow the shapes of the angled struts of the first row of angled struts, each cutout being shaped such that the inflow edge extends from a straight portion of the inflow edge located on either side of the cutout toward the outflow edge.

8. The prosthetic heart valve of any one of claims 1 to 7, wherein the outer skirt comprises a stretchable fabric or polymeric material.

9. 9. The prosthetic heart valve of claim 8, wherein the three lobes are formed by extending the outflow edge of the outer skirt over the respective commissural support portions in areas adjacent the commissural support portions and attaching the extended lobes to the respective commissural support portions with one or more stitches.

10. 1. A prosthetic heart valve, comprising: a radially expandable and compressible frame comprising three commissural support portions and a plurality of rows of angled struts including a first row of angled struts defining an inflow end of the frame, a second row of angled struts downstream of the first row of angled struts, and a third row of angled struts downstream of the second row of angled struts defining an outflow end of the frame; a frame, wherein downstream ends of the angled struts in the second row of angled struts are connected to one another at a plurality of joints; a plurality of leaflets forming three commissures secured to respective commissure support portions of the frame, the upstream edges of the commissures being located adjacent respective joints of the second row of struts; an outer skirt disposed around an outer surface of the frame and including an inflow edge and an outflow edge, the outflow edge forming three circumferentially spaced lobes that align with the commissural support portions and cover each junction of the second row of angled struts, the outflow edge further including straight sections extending between adjacent lobes, the straight sections located upstream of the junction of the second row of angled struts.

11. 11. The prosthetic heart valve of claim 10, wherein each protrusion is shaped to cover the downstream ends and respective joints of a respective pair of angled struts in the second row of angled struts.

12. 12. The prosthetic heart valve of claim 11, wherein each projection is A-shaped and flares out from a downstream end of the projection toward the straight section, the downstream end of the projection being positioned adjacent a respective commissural support portion.

13. 13. The prosthetic heart valve of claim 10, wherein the outer skirt is attached to the frame along a portion of the angled struts of the first row of angled struts, the second row of angled struts, and a fourth row of angled struts disposed with sutures between the first and second rows of angled struts, the portion of the angled struts extending from a first commissural support portion of the frame to the inflow end and from the inflow end to an adjacent second commissural support portion.

14. The prosthetic heart valve of any one of claims 10 to 13, wherein each protrusion is attached to a respective commissural support portion by one or more stitches.

15. 1. A prosthetic heart valve, comprising: a frame including a plurality of interconnected columns; an inner skirt disposed about an inner surface of the frame, an outflow edge portion and an inflow edge portion; an inner skirt having opposing first and second edge portions extending between the inlet and outlet edge portions, respectively, and non-perpendicular to the inlet edge portions, the first and second edge portions overlapping one another to form an annular configuration of the inner skirt within the frame; a plurality of leaflets disposed within the frame, wherein a leaflet edge of a first leaflet of the plurality of leaflets is disposed along the overlapping first and second edge portions; a plurality of stitches securing the overlapping first and second edge portions and the leaflet edge of the first leaflet to one another.

16. 16. The prosthetic heart valve of claim 15, wherein the plurality of interconnected struts of the frame form a plurality of rows of angled struts, and the inner skirt is secured to a portion of the angled struts of the plurality of rows.

17. 17. The prosthetic heart valve of claim 15, wherein the first and second edge portions each have a single row of spaced apart openings extending through the material of the inner skirt, the first and second edge portions overlap one another such that their respective openings overlap one another, and the plurality of stitches are suture stitches extending through the overlapping openings in the first and second edge portions and through a leaflet edge of a first valve leaflet.

18. 18. The prosthetic heart valve of claim 15, wherein the inner skirt comprises a plurality of spaced apart openings arranged in an undulating manner along the inner skirt from the first edge portion to the second edge portion, and leaflet edges of second and third leaflets of the plurality of leaflets are secured to the inner skirt by suture stitches extending through the leaflet edges of the second and third leaflets and through the plurality of spaced apart openings.

19. 19. The prosthetic heart valve of claim 15, wherein the outflow edge portion of the inner skirt defines three circumferentially spaced apart projections and a plurality of circumferentially extending sections extending between adjacent projections.

20. 20. The prosthetic heart valve of claim 19, wherein the plurality of circumferentially extending sections are a plurality of circumferentially extending folded portions extending between adjacent lobes, each folded portion forming a folded edge and a free edge that are positioned against a surface of the inner skirt facing away from the plurality of leaflets.

21. 21. The prosthetic heart valve of claim 19, wherein the frame comprises three axially extending commissural support portions, each projection extending in alignment with a respective one of the three commissural support portions, and the plurality of circumferentially extending sections are located upstream of the three commissural support portions.

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