Prosthetic heart valve

Abstract

Leaflets and frames for prosthetic valves are disclosed. A prosthetic valve can comprise a frame comprising a plurality of interconnected struts forming plurality of circumferentially extending rows of struts including a first row of first struts defining the inflow end of the frame and a second row of second struts disposed downstream of the first row of struts, where a pair of first struts and a pair of second struts are interconnected at each of a plurality of circumferentially spaced strut junctions, and where the frame comprises a plurality of inflow apices, each connected to inflow ends of two first struts. The prosthetic valve can comprise a plurality of leaflets mounted inside the frame, each leaflet comprising an outflow edge portion and a cusp edge portion, where an inflow end of the cusp edge portion is coupled to selected strut junctions downstream of the plurality of inflow apices.

Description

THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]PROSTHETIC HEART VALVECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U. S. Provisional Patent Application Nos.63 / 736,695, filed December 20, 2024 and 63 / 895,597, filed October 8, 2025, the entire contents of each of which are incorporated by reference herein.FIELD

[0002] The present disclosure relates to prosthetic heart valves, including frame and leaflet designs for prosthetic heart valves.BACKGROUND

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

[0004] Most expandable prosthetic heart valves comprise a radially expandable and compressible cylindrical metal frame or stent and prosthetic leaflets mounted inside the frame. Each leaflet can comprise a main body with a cusp edge portion and a set of commissure tabs extending from the main body on opposite sides of the leaflet. The leaflets can be secured to one another at adjacent commissure tabs to form commissures that are then secured to the frame of the prosthetic heart valve. The cusp edge portion of each leaflet canTHVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]also be coupled to struts of the frame. The leaflets of the prosthetic heart valve are configured to open and close to regulate a flow of blood through the prosthetic heart valve, from an inflow end to an outflow end of the prosthetic heart valve.SUMMARY

[0005] Described herein are prosthetic heart valves, delivery apparatuses, and methods for implanting prosthetic heart valves. Also described herein are frames for prosthetic heart valves, leaflets configured to be mounted inside a frame of a prosthetic heart valve, and methods for assembling and attaching the leaflets to the frames. In some examples, the leaflets can be secured to the frame via one or more connecting skirts which also cover inflow apices of the frame. The disclosed leaflets, frames, and resulting prosthetic heart valves can, for example, provide leaflets with improved mobility with cusp edges that can be attached to struts of the frame. In some examples, the leaflets can have a curved cusp edge. In some examples, the leaflets can have a trapezoidal-shaped cusp edge with an inflow end that is attached downstream of inflow apices of the frame. As such, the devices, assemblies, and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves.

[0006] A prosthetic valve, such as a prosthetic heart valve, can comprise a frame and a valvular structure coupled to the frame. In addition to these components, a prosthetic heart valve can further comprise one or more of the components disclosed herein.

[0007] In some examples, the prosthetic valve can comprise a sealing member configured to reduce paravalvular leakage.

[0008] In some examples, the valvular structure can include a plurality of leaflets mounted on an inside of the frame.

[0009] In some examples, the frame can comprise a plurality of interconnected struts forming plurality of circumferentially extending rows of angled struts arrayed along a length of the frame between an inflow end and an outflow end of the frame.

[0010] In some examples, the plurality of circumferentially extending rows of stmts includes a first row of first struts defining the inflow end of the frame, a second row of second struts downstream of the first row of first stmts, and a third row of third stmts downstream of the second row of second stmts.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0011] In some examples, each leaflet can comprise an outflow edge portion and a cusp edge portion that is attached to a portion of struts in each of the first row, second row, and third row.

[0012] In some examples, the cusp edge portion is curved.

[0013] In some examples, the cusp edge portion is rounded.

[0014] In some examples, a first angle between first struts of the first row of first struts, a second angle between second struts of the second row of second struts, and a third angle between third struts of the third row of struts can be defined such that sets of one first strut, one second strut, and one third strut that are connected end-to-end follow a curvature of the cusp edge portion of the leaflet.

[0015] In some examples, the first angle is larger than the second angle and the second angle is larger than the third angle.

[0016] In some examples, each second strut is shorter than each third strut and each first strut is shorter than each second strut.

[0017] In some examples, a second axial height of the second row of second struts is larger than a first axial height of the first row of first strut and smaller than a third axial height of the third row of third struts.

[0018] In some examples, the frame can comprise a plurality of inflow apices spaced circumferentially apart around the inflow end of the frame, each inflow apex connected to inflow ends of two first struts of the first row of first struts.

[0019] In some examples, an inflow end of the cusp edge portion of each leaflet intersects a portion of first struts of the first row of first struts downstream of the plurality of inflow apices.

[0020] In some examples, the inflow end of the cusp edge portion of each leaflet is coupled to a portion of strut junctions that interconnect first struts of a first row of first struts defining an inflow end of the frame and second struts of a second row of second struts that is disposed downstream of the first row.

[0021] In some examples, the cusp edge portion of each leaflet has a trapezoidal shape.

[0022] In some examples, an axial length of each leaflet is shorter than an axial length of the frame, as defined between the inflow end and the outflow end of the frame.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0023] In some examples, the cusp edge portion of each leaflet is attached to a central portion and side base portions of a connecting skirt and the central portion and side base portions are attached to struts of the frame, thereby connecting the leaflet to the frame.

[0024] In some examples, the connecting skirt comprises two tabs extending outward from the central portion and each tab covers and wraps around a respective inflow apex of the frame.

[0025] In some examples, the connecting skirt comprises to extension portions and each extension portion extends across and covers struts of the frame arranged between cusp edge portions of adjacent leaflets and covers an inflow apex of the frame.

[0026] In some examples, a prosthetic valve comprises a frame comprising a plurality of interconnected struts forming plurality of circumferentially extending rows of angled struts arrayed along a length of the frame between an inflow end and an outflow end of the frame, wherein the plurality of circumferentially extending rows of struts includes a first row of first struts defining the inflow end of the frame, a second row of second struts downstream of the first row of first struts, and a third row of third struts downstream of the second row of second struts. The prosthetic valve can further comprise a plurality of leaflets mounted on an inside the frame. Each leaflet can comprise a curved cusp edge portion that is attached to a portion of struts in each of the first row, second row, and third row. A first angle between first struts of the first row of first struts, a second angle between second struts of the second row of second struts, and a third angle between third struts of the third row of struts can be defined such that sets of one first strut, one second strut, and one third strut that are connected end-to-end follow a curvature of the cusp edge portion of the leaflet.

[0027] In some examples, a prosthetic valve comprises a frame comprising a plurality of interconnected struts forming plurality of circumferentially extending rows of angled struts arrayed along a length of the frame between an inflow end and an outflow end of the frame, wherein the plurality of circumferentially extending rows of angled struts includes a first row of first struts defining the inflow end of the frame, a second row of second struts disposed downstream of the first row of struts, and a third row of third struts disposed downstream of the second row of struts. Each second strut is shorter than each third strut and each first strut is shorter than each second strut. The prosthetic valve further comprises a plurality of leaflets mounted on an inside the frame, wherein each leaflet comprises an outflow edge portion andTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]a cusp edge portion. Each side of the cusp edge portion extends along one first strut, one second strut, and one third strut.

[0028] In some examples, a prosthetic valve comprises a frame comprising a plurality of interconnected struts forming plurality of circumferentially extending rows of angled struts arrayed along a length of the frame between an inflow end and an outflow end of the frame, wherein the plurality of circumferentially extending rows of angled struts includes a first row of first struts defining the inflow end of the frame, a second row of second struts disposed downstream of the first row of struts, and a third row of third struts disposed downstream of the second row of stmts. A second axial height of the second row of second stmts is larger than a first axial height of the first row of first stmt and smaller than a third axial height of the third row of third stmts. The prosthetic valve further comprises a plurality of leaflets mounted on an inside the frame, wherein each leaflet comprises an outflow edge portion and a curved cusp edge portion. The curved cusp edge portion is attached to a portion of stmts in each of the first row, second row, and third row.

[0029] In some examples, a prosthetic valve comprises a frame comprising a plurality of interconnected struts forming plurality of circumferentially extending rows of struts arrayed along a length of the frame between an inflow end and an outflow end of the frame, wherein a first row of first struts of the plurality of circumferentially extending rows of struts defines the inflow end of the frame. The frame comprises a plurality of inflow apices spaced circumferentially apart around the inflow end of the frame, each inflow apex connected to inflow ends of two first struts of the first row of first struts. The prosthetic valve further comprises a plurality of leaflets mounted on an inside the frame, wherein each leaflet comprises an outflow edge portion and a cusp edge portion. An inflow end of the cusp edge portion intersects a portion of first struts of the first row of first struts downstream of the plurality of inflow apices.

[0030] In some examples, a prosthetic valve comprises a frame that is radially expandable from a radially collapsed configuration to a radially expanded configuration, wherein the frame has an inflow end and an outflow end. The prosthetic valve further comprises a plurality of leaflets mounted on an inside the frame, wherein each leaflet comprises a main body with a cusp edge portion and an outflow edge portion. The cusp edge portion is formed by two angled side edges and an inflow edge extending between the two angled side edges. The inflow edge defines an inflow end of the cusp edge portion which extends in aTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]circumferential direction relative to the frame. A central portion of the outflow edge portion depresses inward toward the inflow edge relative to opposing ends of the outflow edge portion. The inflow edge of each leaflet is coupled to the frame downstream of the inflow end of the frame.

[0031] In some examples, a prosthetic heart valve comprises an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame comprises a plurality of struts, and wherein the plurality of struts form a plurality of inflow apices at the inflow end of the frame. The prosthetic heart valve further comprises a valvular structure mounted within the frame and comprising a plurality of leaflets, wherein each leaflet comprises opposing tabs on opposite sides of the leaflet and a cusp edge portion between the tabs. The cusp edge portion of each leaflet is connected to the frame by a connecting skirt. Each connecting skirt comprises a central portion and opposing side base portions on opposite sides of the central portion that are connected to each of and disposed between the frame and the cusp edge portion of the leaflet, side extension portions that extend from the cusp edge portion of the leaflet and across struts of the frame that are disposed between cusp edge portions of adjacent leaflets, and two adjacent tabs that extend from the central portion of the connecting skirt, wherein each tab wraps around a respective inflow apex of the plurality of inflow apices.

[0032] In some examples, a prosthetic heart valve comprises an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame comprises a plurality of struts, and wherein the plurality of stmts form a plurality of inflow apices at the inflow end of the frame. The prosthetic heart valve further comprises a valvular structure mounted within the frame and comprising a plurality of leaflets, wherein each leaflet comprises opposing tabs on opposite sides of the leaflet and a cusp edge portion between the tabs, wherein each tab is paired with an adjacent tab of an adjacent leaflet to form a plurality of commissures that are connected to the frame. The prosthetic heart valve further comprises a plurality of connecting skirts, each connecting skirt connecting a cusp edge portion of a respective leaflet of the plurality of leaflets to the frame. Each connecting skirt comprises two side base portions and a central portion connected to each of the cusp edge portion of the respective leaflet and a portion of struts of the plurality of struts, two sideTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]extension portions that extend away from the cusp edge portion, wherein each side extension portion of each connecting skirt extends across struts of the plurality of struts that are disposed between cusp edge portions of adjacent leaflets, and two tabs that each extend from the central portion, wherein each tab wraps around a respective inflow apex of the plurality of inflow apices.

[0033] In some examples, a prosthetic (heart) valve comprises one or more of the components recited in Examples 1-76 and 90.

[0034] A method can comprise forming a plurality of leaflet assemblies, where each leaflet assembly is formed by securing a central portion and side base portions of a connecting skirt to a cusp edge portion of a leaflet.

[0035] In some examples, each connecting skirt comprises two side portions, one arranged on either side of the central portion, where each side portion comprises a respective side base portion of the side base portions and a side extension portion extending away from the corresponding side base portion.

[0036] In some examples, each connecting skirt comprises two tabs extending from the central portion.

[0037] In some examples, the method includes arranging the plurality of leaflet assemblies on an inside of a frame of the prosthetic heart valve and securing the connecting skirt of each leaflet assembly to the frame such that the cusp edge portion of each leaflet is spaced away from an inflow end of the frame, in a downstream direction.

[0038] In some examples, the securing includes, for each leaflet assembly, securing the central portion and side base portions of the connecting skirt to a first set of struts of the frame, and extending each side extension portion of the connecting skirt across a second set of struts of the frame that are disposed between cusp edge portions of adjacent leaflets.

[0039] In some examples, the securing includes, for each leaflet assembly, wrapping each tab of the two tabs around a respective inflow apex of two adjacent inflow apices of the plurality of inflow apices and securing the tab thereto such that the inflow apex is covered by the tab.

[0040] In some examples, a method of assembling a prosthetic heart valve comprising a plurality of leaflets comprises forming a plurality of leaflet assemblies with the plurality of leaflets. Each leaflet assembly is formed by securing a central portion and side base portions of a connecting skirt to a cusp edge portion of a leaflet, wherein each connecting skirt comprises two side portions, one arranged on either side of the central portion, wherein eachTHVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]side portion comprises a respective side base portion of the side base portions and a side extension portion extending away from the corresponding side base portion, and wherein the connecting skirt comprises two tabs extending from the central portion. The method further comprises arranging the plurality of leaflet assemblies on an inside of a frame of the prosthetic heart valve and securing the connecting skirt of each leaflet assembly to the frame such that the cusp edge portion of each leaflet is spaced away from an inflow end of the frame, in a downstream direction, the frame comprising a plurality of interconnected and angled struts and a plurality of inflow apices at the inflow end of the frame. The securing includes, for each leaflet assembly, securing the central portion and side base portions of the connecting skirt to a first set of struts of the plurality of interconnected and angled struts, extending each side extension portion of the connecting skirt across a second set of struts of the plurality of interconnected and angled struts that are disposed between cusp edge portions of adjacent leaflets, and wrapping each tab of the two tabs around a respective inflow apex of two adjacent inflow apices of the plurality of inflow apices and securing the tab thereto such that the inflow apex is covered by the tab.

[0041] In some examples, a method comprises one or more of the features recited in Examples 77-89.

[0042] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0043] FIG. 1A is a perspective view of a prosthetic heart valve, according to an example.

[0044] FIG. 1B is a perspective view of the prosthetic valve of FIG. 1A with the components on the outside of the frame shown in transparent lines for purpose of illustration.

[0045] FIG. 2A is a side view of an exemplary delivery apparatus configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site.

[0046] FIG. 2B is a cross-sectional side view of a distal end portion of the delivery apparatus of FIG. 2A.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0047] FIG. 3A shows a leaflet with a shortened, trapezoidal shaped cusp edge portion superimposed over a more traditional leaflet; the leaflets depicted in a flattened configuration.

[0048] FIG. 3B shows a leaflet with a shortened cusp edge portion and a concave outflow edge portion superimposed over a more traditional leaflet; the leaflets depicted in a flattened configuration.

[0049] FIG. 4 is a side view of a portion of a frame and the leaflet of FIG. 3 A arranged inside the frame, the frame and leaflet shown in a flattened (non-annular) configuration.

[0050] FIG. 5 is a side view of a portion of a frame for a prosthetic heart valve that has multiple circumferentially extending rows of angled struts that are angled to create a more curved or rounded shape for attaching a rounded cusp edge portion of a leaflet thereto, the frame shown in a flattened (non-annular) configuration.

[0051] FIG. 6 shows a leaflet with a rounded cusp edge portion arranged inside the frame of FIG. 5, with the rounded cusp edge portion following the angling of the angled struts.

[0052] FIG. 7A is a plan view of a connecting skirt for connecting a cusp edge portion of a leaflet to a frame of a prosthetic heart valve, where the connecting skirt is an unfolded configuration.

[0053] FIG. 7B is a plan view of the connecting skirt of FIG. 7A in a partially folded configuration.

[0054] FIG. 8 is a plan view of a leaflet assembly including the connecting skirt of FIG. 7A attached to a cusp edge portion of a leaflet.

[0055] FIG. 9 is partial view of an inflow end of a frame where the two tabs of the connecting skirt of FIG. 7A are arranged across and cover inner surfaces of first struts and inflow apices of the frame that define the inflow end of the frame.

[0056] FIG. 10 is a side view of the leaflet assembly of FIG. 9 arranged within a frame for a prosthetic heart valve.

[0057] FIG. 11 is a side view of the leaflet assembly secured to struts of the frame of FIG. 11 via a stitch line of the connecting skirt.

[0058] FIG. 12 is a cross-sectional view of a prosthetic heart valve depicting an exemplary attachment of a cusp edge portion of a leaflet to the frame via the connecting skirt of FIG. 7A.

[0059] FIG. 13 is another side view of the leaflet assembly secured to the struts of the frame of FIG. 11, which depicts extension portions of two adjacent connecting skirts covering innerTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]surfaces of struts of the frame that extend between cusp edge portions of adjacent leaflets, including two inflow apices.

[0060] FIG. 14 is an interior, partial view of an inflow end portion of the prosthetic heart valve of FIGS. 12 and 14 depicting extension portions of adjacent connecting skirts wrapped around two adjacent inflow apices and an outskirt disposed around an outside of the frame.

[0061] FIG. 15 is an interior, partial view of the inflow end portion of the prosthetic heart valve of FIGS. 12 and 14 depicting adjacent tabs of a connecting skirt wrapped around two adjacent inflow apices and an outskirt disposed around an outside of the frame.

[0062] FIG. 16 is a schematic depicting eight whip stitches used to secure the tabs of a connecting skirt to struts defining the inflow end of the frame and an additional whip stitch at each inflow apex used to secure a respective tab to the inflow apex.DETAILED DESCRIPTIONGeneral Considerations

[0063] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0064] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0065] As used in this application and in the claims, the singular forms “a," “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0066] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0067] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0068] As introduced above, a leaflet assembly comprising a plurality of leaflets can be mounted on an inside of a frame of a prosthetic heart valve. The leaflet assembly is configured to regulate blood flow through the prosthetic heart valve, from an inflow end to an outflow end of the prosthetic heart valve. Each leaflet can comprise a main body with a cusp edge portion and a free or outflow edge (or edge portion). In some examples, each leaflet can also comprise a set of commissure tabs extending from the main body on opposite sides of the leaflet. The leaflets can be secured to one another at adjacent commissure tabs to form commissures that are then secured to the frame of the prosthetic heart valve. The cusp edge portion of each leaflet can also be coupled to struts of the frame (either directly or indirectly by an inner skirt, which may be referred to herein as a connecting skirt), and in some examples the inflow end or end portion of the cusp edge portion can be secured to the inflow end of the frame. The main body of each leaflet, between the free (or outflow) edge of the leaflet and the cusp edge portion can be movable and opens and closes (or coapts) during operation of the prosthetic heart valve (during systole and diastole).THVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]

[0069] In some examples, the cusp edge portions of the leaflets can be sutured directly to the struts of the frame, or indirectly by an inner skirt (or connecting skirt). However, such attachment methods can restrict the leaflet geometry to the shape of the frame (for example, the contour of the cusp edge portion of the leaflets follows the shape of the angled struts of the frame). In some examples, this can result in the cusp edge portion of the leaflet having a long V-shape, or trapezoidal shape, which can result in higher flow gradients and reduced leaflet mobility.

[0070] In some examples, with such implanted prosthetic valves, blood stagnation in the neosinus may occur, which can result in reduced longevity of the prosthetic valve.

[0071] Disclosed herein are leaflets, leaflet assemblies, and frames that result in improved mobility of the leaflet when a cusp edge portion of the leaflet is attached to the frame (either directly or indirectly through an inner sealing member or connecting skirt), reduced flow gradients through the prosthetic valve, and improved blood washout from the neosinus. For example, as described further below, by changing the shape of the leaflet, the curvature of the leaflet cusp edge, the location of attachment of the leaflet to the frame, and / or the shapes and / or angles of the commissure tabs of the leaflets, blood flow patterns in the prosthetic valve can be changed to reduce blood stagnation and increase washout in the neosinus, thereby increasing a longevity of the prosthetic valve and improving overall performance of the prosthetic valve.

[0072] In some examples, the cusp edge portion of the leaflets can be shortened and widened slightly (relative to a more traditional leaflet) such that the inflow end (or edge) of the cusp edge portion is attached to the frame downstream of inflow apices of the frame. This can give the leaflet an overall U-shape, and thus a rounder shape along its inflow end portion, thereby reducing flow gradients and increasing leaflet mobility (particularly at the inflow end portion of the leaflet).

[0073] In some examples, the cusp edge portion of the leaflets can be curved, thereby giving the main body of the leaflet a rounder shape overall. This rounded leaflet shape can result in reduced flow gradients and increased leaflet mobility. For the curved or rounded cusp edge portion of the leaflets to be attached to the struts of the frame, the angled struts of the frame can have specified angles that result in the struts following a curvature of the cusp edge portion of the leaflets, for example from a commissure of the frame to the inflow end of the frame and back to an adjacent commissure. For example, a first angle defined between theTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]angled struts of a first row of angled struts defining the inflow end of the frame can be larger than angles defined between the angled struts of downstream rows of angled struts.

[0074] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus. The prosthetic valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0075] FIGS. 1A and 1B show an exemplary prosthetic heart valve in a radially expanded configuration that can be mounted onto a delivery apparatus (e.g., the delivery apparatus of FIGS. 2A and 2B) in a radially compressed configuration.

[0076] FIGS. 3A-4 present example of leaflets for a prosthetic heart valve that have a U-like shape, with an inflow edge of the cusp edge portion of the leaflets being attached to a frame of the prosthetic valve downstream of inflow apices of the frame.

[0077] FIGS. 5 and 6 present a frame for a prosthetic valve that comprises a plurality of circumferentially extending rows of angled struts that are sized and angled such that the angled struts create a curved shape from each commissure to the inflow end of the frame and back toward or to an adjacent commissure. As such, a leaflet with a curved or rounded cusp edge portion can be attached to the struts of the frame (as shown in FIG. 6).

[0078] In some examples, a leaflet configured to be attached to the frame downstream of the inflow end, such as the leaflets of FIGS. 3A and 3B, can be secured to the frame via a connecting skirt. An exemplary connecting skirt is depicted in FIGS. 7A and 7B. As shown in FIG. 8, a central portion and opposing side base portion of the connecting skirt are arranged along and secured to the cusp edge portion of the leaflet. Once the connecting skirt is secured to the cusp edge portion of the leaflet, the resulting leaflet assembly is arranged within the frame (as shown in FIG. 10) and can be secured to struts of the frame with a plurality of stitches, as shown in FIGS. 11 and 12. The inflow end of the cusp edge portion of the leaflet is secured to strut junctions of the frame that are downstream of the inflowTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]apices. In this way, the inflow ends of the leaflets are axially offset from the inflow end of the frame (as shown in FIG. 13).

[0079] Tabs of the connecting skirt that extend outward from the central portion are configured to cover and be secured around inflow apices of the frame, as shown in FIGS. 9, 15, and 16.

[0080] Extension portions of the connecting skirt extend outward from the cusp edge portion of the leaflet and across struts disposed between cusp edge portions of adjacent leaflets. Each extension portion can also cover struts and inflow apices defining the inflow end of the frame, as shown in FIG. 13. The extension portions of two adjacent connecting skirts can be connected to one another and wrapped around the corresponding inflow apices, as depicted in FIG. 14.Examples of the Disclosed Technology

[0081] FIGS. 1 A and IB show an exemplary prosthetic valve 50, according to an example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0082] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U. S. Publication No. 2017 / 0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implantedTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U. S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0083] The prosthetic valve 50 can have three main components: a stent or frame, 52, a valvular structure 54, and a sealing member 56 (FIG. 1A). FIG. 1B is a perspective view of the prosthetic valve 50 with the components on the outside of the frame 52 (including the sealing member 56) shown in transparent lines for purposes of illustration. The prosthetic valve 50 can have an inflow end 66 and an outflow end 68.

[0084] The valvular structure 54 can comprise three leaflets 60, collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in other examples there can be greater or fewer number of leaflets (e.g., one or more leaflets 60). In some examples, the leaflets 60 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U. S. Patent No. 6,730,118, which is incorporated by reference herein.

[0085] Each leaflet 60 can be coupled to the frame 52 along its inflow edge 62 (the lower edge in the figures; also referred to as “cusp edges”) and at commissures 64 of the valvular structure 54 where adjacent portions (e.g., commissure tabs) of two leaflets are connected to each other. In some examples, the commissures 64 can comprise an attachment member 93 (e.g., comprising fabric, flexible polymer, or the like) arranged across a cell (e.g., commissure cell) of the frame 52, the cell formed by struts of the frame. The attachment member 93 can be secured to the struts of the frame forming the cell and the adjacent portions of the two leaflets can be connected to the attachment member to form the commissure 64. As shown in FIG. 3A, each leaflet 60 can have two upper tabs 90 and two lower tabs 92 on opposite sides of the leaflet. One way to form a commissure 64 involves folding each upper tab 90 downwardly against the respective lower tab 92 and folding the lower tab 92 along a vertical fold line, as depicted in FIG. 1 A. An upper and lower tab of one leaflet can be paired with an upper and lower tab of an adjacent leaflet and stitched to each other and / or to struts of the frame to form a commissure 64. In some examples, the folded tabs of a pair of leaflets can be stitched to an attachment member 93, which in turn can be stitched to struts of the frame. In some examples, the attachment member 93 can be stitched to four struts forming a cell at the outflow end of the frame. In some examples, any of theTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]leaflets disclosed herein can be without upper tabs, in which case the lower tabs (e.g., tabs 92) are the only tabs of the leaflet and a commissure can be formed in a similar manner but without the need to fold the upper tabs.

[0086] In some examples, a reinforcing element or connecting skirt, such as a fabric strip, can be connected directly to the cusp edges of the leaflets and to the struts of the frame to couple the cusp edges of the leaflets to the frame.

[0087] The frame 52 can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol). When constructed of a plastically-expandable material, the frame 52 (and thus the prosthetic valve 50) can be crimped to a radially collapsed configuration on a delivery apparatus (e.g., catheter) and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism.Various crimping devices can be used to crimp the prosthetic valve 50 and the other prosthetic valves described herein around the delivery apparatus, such as the crimping devices described in U. S. Patent No. 7,530,253, which is incorporated herein by reference.

[0088] In some instances, the prosthetic valve 50 can be crimped directly onto the inflatable balloon of the delivery apparatus, such that the prosthetic valve 50 is axially aligned with and disposed radially outward of the balloon during advancing the prosthetic valve on the delivery apparatus to the implantation site, for example as described in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference. In alternate instances, the prosthetic valve 50 can be crimped onto the delivery apparatus 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, such as described in U. S. Patent Application 9,339,384, which is incorporated herein by reference.

[0089] When constructed of a self-expandable material, the frame 52 (and thus the prosthetic valve 50) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery apparatus. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0090] Suitable plastically-expandable materials that can be used to form the frame 52 include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 52 can comprise stainless steel. In someTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]examples, the frame 52 can comprise cobalt-chromium. In some examples, the frame 52 can comprise nickel-cobalt-chromium. In some examples, the frame 52 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0091] The frame 52 in the illustrated example comprises a plurality of circumferentially extending rows of angled struts 72 defining rows of open cells 74 (or openings) of the frame. The frame 52 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 66 to the outflow end 68 of the frame 52 as shown, or the frame 52 can vary in diameter along the height of the frame, as disclosed in U. S. Patent Publication No. 2012 / 0239142, which is incorporated herein by reference.

[0092] The frame 52, at each of the inflow end 66 and the outflow end 68, may comprise a plurality of apices 80 spaced apart from one another around a circumference of the frame 52.

[0093] The sealing member 56 in the illustrated example is mounted on the outside of the frame 52 and functions to create a seal against the surrounding tissue (e.g., the native leaflets and / or native annulus) to prevent or at least minimize paravalvular leakage. The sealing member 56 can comprise an inner layer 76 (which can be in contact with the outer surface of the frame 52) and an outer layer 78. The sealing member 56 can be connected to the frame 52 using suitable techniques or mechanisms. For example, the sealing member 56 can be sutured to the frame 52 via sutures that can extend around the struts 72 and through the inner layer 76. In alternative examples, the inner layer 76 can be mounted on the inner surface of the frame 52, while the outer layer 78 is on the outside of the frame 52.

[0094] The outer layer 78 can be configured or shaped to extend radially outward from the inner layer 76 and the frame 52 when the prosthetic valve 50 is deployed. When the prosthetic valve is fully expanded outside of a patient’s body, the outer layer 78 can expand away from the inner layer 76 to create a space between the two layers. Thus, when implanted inside the body, this allows the outer layer 78 to expand into contact with the surrounding tissue.

[0095] Additional details regarding the prosthetic valve 50 and its various components are described in U. S. Patent Publication No. 2018 / 0028310, which is incorporated herein by reference.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0096] FIG. 2 A shows an example delivery apparatus 100, which can be used to implant an expandable prosthetic heart valve (for example, the prosthetic valve 50 of FIG. 1 A), or another type of expandable prosthetic medical device (such as a stent). A distal end portion 109 of the delivery apparatus 100 is shown in FIG. 2B. In some examples, the delivery apparatus 100 is specifically adapted for use in introducing a prosthetic valve into a heart. As described further below, the delivery apparatus 100 can be configured to rotate the prosthetic valve, mounted on the delivery apparatus in a radially compressed state, at the target implantation site (for example, at a native valve of the heart) to achieve commissure alignment between the native valve and prosthetic valve after deploying the prosthetic valve.

[0097] In the depicted example, the delivery apparatus 100 is a balloon catheter comprising a handle 102 and a steerable, outer shaft 104 extending distally from the handle 102. The delivery apparatus 100 can further comprise an intermediate shaft 106 (which also may be referred to as a balloon shaft) that extends both proximally and distally from the handle 102. The portion of the intermediate shaft 106 extending distally from the handle 102 also extends coaxially through the outer shaft 104. Additionally, the delivery apparatus 100 can further comprise an inner shaft 108 extending distally from the handle 102 and coaxially through the intermediate shaft 106 and the outer shaft 104. The inner shaft 108 also extends proximally from the handle 102 and coaxially through the intermediate shaft 106.

[0098] The outer shaft 104 and the intermediate shaft 106 are configured to translate longitudinally, along a central longitudinal axis 120 of the delivery apparatus 100, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient’ s body.

[0099] The intermediate shaft 106 can include a proximal end portion 110 that extends proximally from a proximal end of the handle 102, to an adaptor 112. A rotatable knob 114 can be mounted on the proximal end portion 110. The knob 114 can be configured to rotate the intermediate shaft 106 around the central longitudinal axis 120 of the delivery apparatus 100 and relative to the outer shaft 104.

[0100] The adaptor 112 can include a first port 138 configured to receive a guidewire therethrough and a second port 140 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 140 can be fluidly coupled to an inner lumen of the intermediate shaft 106.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0101] The intermediate shaft 106 can further include a distal end portion 116 that extends distally beyond a distal end of the outer shaft 104 when the distal end of the outer shaft 104 is positioned away from an inflatable balloon 118 of the delivery apparatus. A distal end portion of the inner shaft 108 can extend distally beyond the distal end portion 116 of the intermediate shaft 106.

[0102] The balloon 118 can be coupled to the distal end portion 116 of the intermediate shaft 106. For example, a proximal end portion of the balloon 118 can be coupled to and / or around a distal end 148 of the intermediate shaft 106.

[0103] The balloon 118 can comprise a distal end portion (or section) 132, a proximal end portion (or section) 133, and an intermediate portion (or section) 135, the intermediate portion 135 disposed between the distal end portion 132 and the proximal end portion 133.

[0104] In some examples, a distal end of the distal end portion 132 of the balloon 118 can be coupled to a distal end of the delivery apparatus 100, such as to a nose cone 122, or to an alternate component at the distal end of the delivery apparatus 100 (for example, a distal shoulder). In some examples, the intermediate portion 135 of the balloon 118 can overlay a valve mounting portion 124 of a distal end portion 109 of the delivery apparatus 100, the distal end portion 132 can overly a distal shoulder 126 of the delivery apparatus 100, and the proximal end portion 133 can surround a portion of the inner shaft 108 (FIG. 2B). The valve mounting portion 124 and the intermediate portion 135 of the balloon 118 can be configured to receive a prosthetic valve in a radially compressed state.

[0105] As described herein, rotation of the intermediate shaft 106 can cause rotation of the balloon 118 and the prosthetic valve mounted thereon for rotational positioning of the prosthetic valve relative to the native anatomy at the target implantation site.

[0106] The delivery apparatus 100 can include a balloon shoulder assembly 180 configured to maintain the prosthetic heart valve or other medical device at a fixed position on the balloon 118 during delivery through the patient’s vasculature. The balloon shoulder assembly 180 can include a distal shoulder 126 arranged within a distal end portion of the balloon 118 and coupled to the distal end portion of the inner shaft 108. The distal shoulder 126 can be configured to resist movement of the prosthetic valve or other medical device mounted on the valve mounting portion 124 distally, in an axial direction (for example, along the central longitudinal axis 120), relative to the balloon 118.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0107] For example, the distal shoulder 126 can include a flared portion 131 arranged adjacent to the valve mounting portion 124. In some examples, the flared portion 131 can include a plurality of wings 130 that flare radially outward from a base portion 125 (for example, shaft) of the distal shoulder 126, toward the valve mounting portion 124.

[0108] The outer shaft 104 can include a distal tip portion 128 mounted on its distal end. In some examples, the distal tip portion 128 can be configured as a flex adaptor including a plurality of inner and outer helical grooves. The outer shaft 104 and the intermediate shaft 106 can be translated axially relative to one another to position the distal tip portion 128 adjacent to a proximal end of the valve mounting portion 124, when a prosthetic valve is mounted in the radially compressed state on the valve mounting portion 124 and during delivery of the prosthetic valve to the target implantation site. As such, the distal tip portion 128 can be configured to resist movement of the prosthetic valve relative to the balloon 118 proximally, in the axial direction, relative to the balloon 118, when the distal tip portion 128 is arranged adjacent to a proximal side of the valve mounting portion 124.

[0109] In some examples, the nose cone 122 can be disposed distal to and be coupled to the distal shoulder 126. In some examples, the nose cone 122 can be coupled to the distal end portion of the inner shaft 108.

[0110] In some examples, the delivery apparatus 100 can comprise one or more markers or marker bands 153 that are configured to indicate to a user a location of a specified component of the delivery apparatus. In some examples, the one or more marker bands 153 can be radiopaque. In some examples, one or more marker bands 153 can be radially compressed (for example, crimped) onto the inner shaft 108.

[0111] In some examples, the distal end portion 132 of the balloon 118 can include a radial depression 134 that is depressed radially inwardly, toward the central longitudinal axis 120, relative to an outermost radial surface of the distal shoulder 126 and an outermost radial surface of the nose cone 122.

[0112] An annular space 136 can be defined between an outer surface of the inner shaft 108 and an inner surface of the intermediate shaft 106. In some examples, the annular space 136 can be referred to as an inner lumen of the intermediate shaft 106. In some examples, the annular space 136 can be configured to receive an inflation fluid from a fluid source via the second port 140 of the adaptor 112 (for example, the annular space 136 can be in fluid communication with the second port 140 of the adaptor 112). The annular space 136 can beTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]fluidly coupled to a fluid passageway 142 formed between the outer surface of the distal end portion of the inner shaft 108 and an inner surface of the balloon 118. As such, fluid from the fluid source can flow to the fluid passageway 142 from the annular space 136 to inflate the balloon 118 and radially expand and deploy the prosthetic valve.

[0113] In some examples, after crimping of the prosthetic valve onto the valve mounting portion 124, the distal tip portion 128 can be advanced over the proximal end portion 133 of the balloon 118. As a result, fluid arranged within the proximal end portion 133 of the balloon 118 can be displaced and pushed distally, within the balloon 118, to the distal end portion 132 of the balloon 118. The radially depressed, distal end portion 132 of the balloon 118 can then radially expand (for example, inflate partially) as it receives the displaced fluid to an expanded state. The radial depression 134 can be configured (for example, sized) so that the distal end portion 132 can receive the displaced fluid without radial expanding the portion of the balloon 118 within the valve mounting portion 124, thereby preventing the crimped profile of the prosthetic valve from increasing.

[0114] An inner lumen 144 of the inner shaft 108 can be configured to receive a guidewire therethrough, for navigating the distal end portion 109 of the delivery apparatus 100 to the target implantation site. As introduced above, the first port 138 of the adaptor 112 can be coupled to the inner lumen 144 and configured to receive the guidewire. For example, the distal end portion 109 of the delivery apparatus 100 can be advanced over the guidewire, to the target implantation site.

[0115] As shown in FIG. 2 A, the handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion 109 of the delivery apparatus 100. For example, the handle 102 can include an adjustment member, such as the illustrated rotatable knob 160, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 102 through the outer shaft 104 and has a distal end portion affixed to the outer shaft 104 at or near the distal end of the outer shaft 104. Rotating the knob 160 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion 109 of the delivery apparatus 100. Further details on steering or flex mechanisms for the delivery apparatus are described in U. S. Patent No.9,339,384, which is incorporated by reference herein in its entirety.

[0116] The handle 102 can further include an adjustment mechanism 161 including an adjustment member, such as the illustrated rotatable knob 162. The adjustment mechanismTHVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]161 can be configured to move (thus adjust the axial position) of the intermediate shaft 106 relative to the outer shaft 104. The handle 102 can also include a locking mechanism configured to retain (for example, lock) the position of the intermediate shaft 106 relative to the handle 102. In some examples, the locking mechanism can include another adjustment member, which can be configured as a rotatable knob 178. In some examples, rotating the knob 178 to a locked position can cause the intermediate shaft 106 to frictionally engage with other components of the handle 102, thereby restraining movement of the intermediate shaft 106 for fine positioning of the prosthetic valve mounted on the distal end portion of the delivery apparatus 100. Rotating the knob 178 to an unlocked position allows axial and rotational movement of the intermediate shaft 106 relative to the proximal end portion of the handle 102. For example, rotation of the knob 162 can cause the intermediate shaft 106 to move axially relative to the outer shaft 104 (either in the proximal or distal direction, depending on the direction the knob 162 is rotated).

[0117] Further details on the adjustment mechanism and locking mechanism of the handle 102 can be found in U. S. Patent No. 9,339,384, which is incorporated by reference herein in its entirety. Additional examples of delivery apparatuses and related steering mechanism can be found in U. S. Patent No. 8,568,472, which is incorporated herein by reference in its entirety.

[0118] According to certain examples, to implant a prosthetic valve (for example, prosthetic valve 50) in a native heart valve of the patient, the delivery apparatus 100 can be introduced into vasculature of the patient. The prosthetic valve can be initially retained in a radially compressed configuration on the valve mounting portion 124 (and over the balloon 118) of the delivery apparatus 100.

[0119] In some instances, once inside the patient’s vasculature, the position (e.g., axial position) of the prosthetic valve relative to the balloon 118 can be adjusted such that the prosthetic valve 50 is centered on the balloon 118. In some instances, the axial position of the prosthetic valve relative to the balloon 118 may not be adjusted.

[0120] When navigating the prosthetic valve through an arched region of the vasculature (for example, the aortic arch), the curvature of the distal end portion 109 of the delivery apparatus 100 can be adjusted, for example, by rotating the knob 160 to increase or decrease the tension in the pull wire which extends between the handle 102 and the distal end of the outer shaft 104. The prosthetic valve can be positioned within or adjacent an annulus of the native heartTHVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]valve. Prior to inflating the balloon 118, the outer shaft 104 can be retracted proximally away from the balloon 118 for a sufficient distance so that the outer shaft does not interfere with balloon inflation. This can be accomplished, for example, by holding the adaptor 112 stationary against the operating table and rotating the knob 162 in a direction that causes the handle 102 and the outer shaft 104 to move proximally away from the balloon 118. Then, the prosthetic valve can be radially expanded and deployed by inflating the balloon 118.Inflation of the balloon 118 can radially expand the prosthetic valve 50 so that the prosthetic valve 50 contacts the native annulus. The expanded prosthetic valve 50 becomes anchored within the native aortic annulus by the radial outward force of the valve’ s frame against the surrounding tissue.

[0121] As described above, the knob 114 of the handle 102 can be configured to rotate the intermediate shaft 106, thereby rotating the balloon 118 mounted on the intermediate shaft 106 and a radially compressed prosthetic valve mounted on the balloon 118, around the valve mounting portion 124. Thus, rotating the knob 114 can rotate the prosthetic valve, around the central longitudinal axis 120, into a desired (circumferential or rotational) orientation relative to the native anatomy at the target implantation site.

[0122] For example, to implant a prosthetic valve (for example, prosthetic valve 50) at a native aortic valve, instead of deploying the prosthetic valve with the delivery apparatus 100 in a random rotational orientation relative to the aorta, which may result in commissures (for example, commissures 64) of the prosthetic valve being arranged in front of the coronary arteries, it may be desirable to deploy the prosthetic valve in a targeted rotational orientation where the commissures are positioned away from and do not block the coronary arteries (e.g., to reduce the likelihood blocking coronary access during subsequent interventional procedures). Specifically, the delivery apparatus 100 can be configured to control the rotational positioning of the prosthetic heart valve relative to the native valve, to achieve the commissure alignment, thereby increasing access to the coronary arteries. Additionally, this positioning of the prosthetic heart valve can facilitate a later, leaflet cutting procedure that provides increased access to the coronary arteries.

[0123] Further details on methods of aligning commissures of native valve with commissures of prosthetic valve after deploying the prosthetic valve are described in PCT Patent Publication No. WO 2022 / 046585, which is incorporated by reference herein in its entirety.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0124] As introduced above, when assembling leaflets to a frame of a prosthetic heart valve (such as the prosthetic valve 50 of FIGS. 1 A and IB), the cusp edge portions of the leaflets can be attached (for example, sutured) directly to the struts of the frame, or indirectly by an inner skirt (for example, the leaflets are attached to the inner skirt, which may be referred to as a connecting skirt, which is in turn attached to the frame). However, such attachment methods can restrict the leaflet geometry to the shape of the frame. For example, the shape or contour of the cusp edge portion of the leaflets may follow or match the shape of the angled struts of the frame. In some examples, this can result in the cusp edge portion of the leaflet having a long V-shape which can result in higher flow gradients and reduced leaflet mobility. An example of such a leaflet 60 is shown in FIGS. 3A and 3B (shown in dashed lines).

[0125] FIG. 3A shows a leaflet 200 superimposed over a known leaflet 60. As compared to the leaflet 60, the leaflet 200 is shorter and wider, resulting in a cusp edge portion 206 with a rounder shape (as compared to the leaflet 60). The overall shape of the leaflet 200 is more U-shaped, as compared to the truncated V-shape of the leaflet 60.

[0126] More specifically, the leaflet 200 can comprise a main body 202 with an outflow edge portion 204 (or free edge portion) and a cusp edge portion 206.

[0127] The leaflet 200 can further comprise opposing commissure tabs disposed on opposite sides of the main body 202.

[0128] In some examples, as shown in FIGS. 3 A and 4, the leaflet 200 comprises first or upper commissure tabs 208 and second or lower commissure tabs 210. The commissure tabs 208, 210 can be folded and connected to the tabs 208, 210 of an adjacent leaflet to form a commissure, which in turn can be connected to a cell of the frame. Methods for forming commissures and connecting them to a cell of the frame are further described in U. S.Publication No. 2018 / 0028310 and U. S. Publication No. 2023 / 0355383, which is incorporated herein by reference.

[0129] The cusp edge portion 206 can have a trapezoidal shape. For example, the cusp edge portion 206 can comprise a relatively linear or straight inflow edge 212 and two angled side edges 214 which form a shape that can be similar to a portion of an isosceles trapezoid. As shown in FIG. 3A, the inflow edge 212 distances the side edges 214 farther away from each other relative to the side edges of the cusp edge portion of the leaflet 60.

[0130] The height 216 of the main body 202 of the leaflet 200 (measured in an axial direction, from the outflow edge portion 204 to the inflow edge 212) can be shorter than theTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]leaflet 60 and shorter than the frame 52. As such, when it is mounted inside the frame 52 (or a similar frame), the inflow edge 212 is spaced apart from the inflow end 66 of the frame 52, toward the outflow end 68, as shown in FIG. 4.

[0131] As introduced above with reference to FIGS. 1A and IB, the frame 52 comprises a plurality of circumferentially extending rows of angled struts 72 arrayed along a length of the frame 52 between the inflow end 66 and the outflow end 68 of the frame 52. The plurality of circumferentially extending rows of struts includes a first row of first struts 82 defining the inflow end 66 of the frame 52, a second row of second struts 84 disposed downstream of the first row of first struts 82, and a third row of third struts 86 disposed downstream of the second row of second struts 84.

[0132] As shown in FIG. 4, the cusp edge portion 206 of the leaflet 200 is shaped such that it extends along a portion of the first struts 82, second struts 84, and third struts 86.

[0133] In some examples, as shown in FIG. 4, the inflow edge 212 of the leaflet 200 intersects a portion of the first struts 82 downstream of the apices 80 at the inflow end 66 (the apices 80 can be referred to herein as inflow apices).

[0134] More specifically, as shown in the example of FIG. 4, a first side edge 214 of the cusp edge portion 206 of the leaflet 200 extends along one third strut 86, one second strut 84, partially along one first strut 82; the inflow edge 212 of the cusp edge portion 206 extends circumferentially across multiple first struts 82 (transecting two cells of the frame at the inflow end of the frame): and a second side edge 214 of the cusp edge portion 206 extends partially along another first strut 82, along another second strut 84, and along another third strut 86.

[0135] In some examples, when the cusp edge portion 206 is attached to the frame (for example, via a connecting skirt, as described in detail below with reference to FIGS. 7A-16) the inflow edge 212 or an inflow end or end portion of the cusp edge portion 206 that is bounded by the inflow edge 212 is folded over itself and attached to the frame such that the inflow end of the cusp edge portion 206 of the leaflet 200 (or a similar leaflet, such as the leaflet 250 described herein) intersects and / or is attached to strut junctions 90 where two first struts 82 and two second struts 84 interconnect. In this way, the inflow end of the leaflet 200 is spaced axially away from the inflow apices 80 of the frame 52, in a downstream direction.

[0136] In some examples, coupling of the leaflet 200 to the frame 52 is performed by passing a suture (or other fastener) along the cusp edge portion 206 of the leaflet 200 andTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]corresponding struts of the frame 52. For example, one or more sutures can pass in-and-out through the cusp edge portion 206 (or through connecting sutures in the cusp edge portion) and around struts 86, 84, and / or 82 of the frame 52 extending along the cusp edge portion 206, forming whip stitches around the struts.

[0137] In some examples, coupling of the leaflet 200 to the frame 52 is performed by passing one or more sutures (or other fastener) along an inner skirt or connecting skirt, the cusp edge portion 206 of the leaflet 200, and corresponding struts of the frame 52. For example, one or more sutures can pass in-and-out through an inner skirt disposed against the leaflet 200 and the cusp edge portion 206 to form a plurality of connecting stitches securing the cusp edge portion 206 to the inner skirt. A plurality of stitches can loop around the plurality of connecting stitches and around struts 86, 84, and / or 82 of the frame 52 extending along the cusp edge portion 206 of the leaflet 200, thereby coupling the leaflet 200 to the frame 52 through the inner skirt, as further described in PCT Patent Publication No. WO 2024 / 049943.

[0138] In some examples, the cusp edge portion 206 of each leaflet 200 can be stitched to the skirt (such as with in-and-out stitches) along a first stitch line and the skirt can be secured to the frame with whip stitches extending through the skirt and around the struts 86, 84, and / or 82 along a second stitch line that extends along and tracks the shape of the cusp edge portion 206, as described in U. S. Publication No. 2023 / 0355383, which is incorporated by reference herein, and also as shown in FIGS. 7A-16, as described further below.

[0139] In some examples, the rounder shape of the leaflet 200 can reduce the volume in the neosinus and improve motion of the leaflet at the bottom of the leaflet 200.

[0140] The rounder shape of the leaflet 200 can increase leaflet mobility and improve flow across the inflow edge 212 of the leaflet 200.

[0141] FIG. 3B shows a leaflet 250 superimposed over a known leaflet 60. The leaflet 250 can be similar to the leaflet 200, and may be attached to the frame 52, the same or similar to as shown in FIG. 4 and / or FIGS. 9-17. As compared to the leaflet 60, the leaflet 250 is shorter and wider, resulting in a cusp edge portion 256 with a rounder shape (as compared to the leaflet 60). The overall shape of the leaflet 250 is more U-shaped, as compared to the tmncated V-shape of the leaflet 60.

[0142] More specifically, the leaflet 250 can comprise a main body 252 with an outflow edge portion 254 (or free edge portion) and a cusp edge portion 256.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0143] The leaflet 250 can further comprise opposing commissure tabs disposed on opposite sides of the main body 252.

[0144] In some examples, as shown in FIGS. 3B, the leaflet 250 comprises first or upper commissure tabs 258 and second or lower commissure tabs 260.

[0145] As compared to both the leaflet 60 and the leaflet 200, for leaflet 250, an angle 270 between long edges of each upper commissure tab 258 and a line 272 that is parallel to a central longitudinal axis of the leaflet 250 (which can be along double-headed arrow 266 shown in FIG. 3B) is smaller. For example, for the leaflet 250, the angle 270 is closer to zero degrees than in the leaflets 60 and 200.

[0146] In some examples, the angle 270 can be in a range of 0 to 20 degrees, 0 to 10 degrees, or 0 to 5 degrees relative to the vertical line 272 that is parallel to a central longitudinal axis of the leaflet.

[0147] Each upper commissure tab 258 can extend perpendicular to substantially perpendicular to an upper edge 261 of the respective lower commissure tab 260. During assembly, the upper tab 258 can be folded downwardly against the lower tab 260 at a fold line 263. The lower tab 260 can be folded at a vertically extending fold line. The folded upper and lower tabs of a leaflet can be paired with folded upper and lower tabs of an adjacent leaflet to form a commissure that is coupled to struts of the frame, as described above with respect to the leaflet 60. Further details for forming commissures and connecting commissures to a frame are disclosed in U. S. Publication No. 2018 / 0028310. Any of the techniques or methods for forming commissures disclosed U. S. Publication No.2018 / 0028310 can be used to form commissures from a plurality of leaflets 250.

[0148] The smaller angle 270 can alleviate tension in the main body 252 of the leaflet 250. By minimizing tension underneath the commissures (in the leaflet main body), reverse bending where the free edge of the leaflet bends backwards during closure and causes unfavorable flow patterns where blood flow is pushed back into the neosinus can be minimized. Further, the smaller angle 270 can minimize stagnation in the neosinus when included and operating in a prosthetic valve implanted in vivo. For example, the smaller angle 270 (resulting in more upright upper commissure tabs 258) allows the leaflet 250 to open further and move closer to the frame, therefore minimizing the space between the leaflet and the frame. This improves flow gradients and maximizes the blood being ejected from the neosinus.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0149] The cusp edge portion 256 can have a more trapezoidal shape. For example, the cusp edge portion 256 can comprise a relatively linear or straight inflow edge 262 and two angled side edges 264 which form a shape that can be similar to a portion of an isosceles trapezoid. As shown in FIG. 3B, the inflow edge 262 distances the side edges 264 farther away from each other relative to the side edges of the cusp edge portion of the leaflet 60, thereby creating a wider main body 252 in a region of the cusp edge portion 256. This increased width can increase leaflet mobility when included in an implanted prosthetic valve operating in vivo, and also minimize blood stagnation.

[0150] In some examples, as shown in FIG. 3B, a curved transition can be included between the inflow edge 262 and each of the two side edges 264.

[0151] The height 266 of the main body 252 of the leaflet 250 (measured in an axial direction, from the outflow edge portion 254 to the inflow edge 262, along a mid-portion or central longitudinal axis of the leaflet 250) can be shorter than the leaflet 60 and shorter than the frame 52. As such, when it is mounted inside the frame 52 (or a similar frame), the inflow edge 262 is spaced apart from the inflow end 66 of the frame 52, toward the outflow end 68, similar to as shown in FIG. 4 for leaflet 200.

[0152] As introduced above, the shorter leaflet 250 can reduce volume in the neosinus. For example, the shallower neosinus created by the shorter leaflet 250 can increase washout since it is easier for blood to flow to the bottom of the neosinus and remove any stagnant blood. Further, by moving the inflow edge 262 of the leaflet 250 away from the inflow end of the frame, the inflow edge 262 is moved further away from the host’s native anatomy, thereby reducing or preventing tissue growth along the inflow edge 262 of the leaflet 250.

[0153] In some examples, as shown in FIG. 3B, the outflow edge portion 254 of the leaflet 250 can be concave, or indented or depressed inward toward the inflow edge 262 relative to opposing ends of the outflow edge portion 254. As shown in FIG. 3B, the outflow edge portion 254 extends between the upper commissure tabs 258. A central portion of the outflow edge portion 254 extends away from the upper commissure tabs 258 (where they connect to the outflow edge portion 254) and toward the inflow edge 262. As such, the outflow edge portion 254 can be referred to as concave or dropped relative to end portions of the outflow edge portion 254 that connect to the upper commissure tabs 258. This geometry of the outflow edge portion, as compared to the straighter outflow edge portion of the leaflets 60 and 200, can minimize leaflet fluttering during operation of the prosthetic valve implantedTHVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]in a patient, as well as improve coronary access during future interventional procedures (e.g., valve-in-valve procedures).

[0154] In some examples, leaflets for a prosthetic heart valve can have a curved or rounded cusp edge, thereby giving the main body of the leaflet a rounder shape overall. This rounded leaflet shape can result in reduced flow gradients and increased leaflet mobility. An example of such a leaflet 300 is shown in FIG. 6. The leaflet 300 can comprise a main body 302 with an outflow edge portion 304 (or free edge portion) and a cusp edge portion 306. In some examples, the cusp edge portion 306 has a shape that is a portion of a circle.

[0155] The leaflet 300 can further comprise opposing commissure tabs disposed on opposite sides of the main body 302. In some examples, as shown in FIG. 6, the leaflet 300 comprises first or upper commissure tabs 308 and second or lower commissure tabs 310.

[0156] In some examples, the commissure tabs 310 are angled relative to a central longitudinal axis of the leaflet 300 toward the cusp edge portion 306.

[0157] The cusp edge portion 306 of the leaflet 300 can be referred to herein as being curved, rounded, or circular. In some examples, the curved cusp edge portion can be continuously curved from a first end of the cusp edge portion to a second end of the cusp edge portion.

[0158] In some examples, the cusp edge portion 306 has a constant radius of curvature.

[0159] In some examples, the cusp edge portion 306 has a varying radius of curvature.

[0160] In some examples, an angle or radius of curvature of the cusp edge portion 306 can be in a range of 120-170 degrees, 140-165 degrees, or 160-165 degrees.

[0161] This shape of the cusp edge portion 306 gives the main body 302 an overall round shape which increases mobility of the leaflet 300 at its inflow end 312 and can also improve flow patterns and reduce flow gradients near the inflow end 312. The improved flow patterns through such prosthetic valves can increase blood washout and reduce blood stagnation in the neosinus, thereby increasing a longevity of the prosthetic valve. As a result, a prosthetic valve including the leaflets 300 can be more efficient.

[0162] To facilitate attachment of the curved or rounded cusp edge portion 306 of the leaflets 300, the angled struts of the frame can have specified angles and / or lengths that result in the struts following a curvature of the cusp edge portion 306 of the leaflet 300, for example from a commissure of the prosthetic valve to the inflow end of the frame and back to an adjacent commissure.THVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]

[0163] FIGS. 5 and 6 show such an exemplary frame 350 for a prosthetic heart valve including leaflets 300. The frame 350 includes a plurality of circumferentially extending rows of angled struts arrayed along a length of the frame 350 between an inflow end 352 and an outflow end 354 of the frame 350. The frame 350, at each of the inflow end 352 and the outflow end 354, may comprise a plurality of apices 356 spaced apart from one another around a circumference of the frame 350.

[0164] The plurality of circumferentially extending rows of angled struts define rows of open cells 358 (or openings) of the frame 350. The cells of the frame 350 can be generally identified as cells 358 in FIG. 5, although specific cells 358a and 358b are referred to with reference to FIG. 6 and should be known to be included in “cells 358.”

[0165] Each leaflet 300 can be coupled to the frame 350 at commissures which, in some examples, can comprise a flexible attachment member arranged across a cell 358 of the frame 350. The attachment member can be secured to the struts of the frame 350 forming a cell 358a or 358b and adjacent commissure tabs (e.g., commissure tabs 308 and 310) of the two leaflets 300 can be connected to the attachment member to form the commissure.

[0166] The angled struts are sized and angled such that the angled struts create a curved shape from each commissure (e.g., one of which would be connected to first cell 358a in FIG.6) to the inflow end 352 of the frame 350 and back toward an adjacent commissure (e.g., which could be connected to second cell 358b in FIG. 6).

[0167] Referring to FIG. 5, the plurality of circumferentially extending rows of angled struts includes a first row of first struts 360 defining the inflow end 352 of the frame 350, a second row of second struts 362 disposed downstream of the first row of first struts 360, and a third row of third struts 364 disposed downstream of the second row of second struts 362.

[0168] In some examples, as shown in FIG. 5, the plurality of circumferentially extending rows of angled struts can include a fourth row of fourth struts 366 downstream of the third row of third struts 364.

[0169] As shown in FIG. 5, the plurality of circumferentially extending rows of angled struts can include a fifth row of fifth struts 368 defining the outflow end 354 of the frame 350. The fifth row of fifth struts 368 is downstream of the fourth row of fourth struts 366.

[0170] A first angle 370 is defined between connected first struts 360 of the first row of first struts, a second angle 372 is defined between connected second struts 362 of the second rowTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]of second struts, and a third angle 374 is defined between connected third struts 364 of the third row of third struts.

[0171] As shown in FIG. 5, the second angle 372 is larger than the third angle 374.

[0172] In some examples, as shown in FIG. 5, the first angle 370 is larger than the second angle 372 and the third angle 374.

[0173] The first angle 370, second angle 372, and third angle 374 can be defined such that a set of a third strut 364, a second strut 362, and a first strut 360 that are connected end-to-end along a path that extends from a commissure cell (e.g., cell 358a or 358b) to the inflow end 352 of the frame 350 to follow a curvature of one side of the cusp edge portion 306 of the leaflet 300 (as shown in FIG. 6).

[0174] In some examples, the first angle 370 is in a range of 140-150 degrees, 142-147 degrees, or 146-147 degrees. In some examples, the first angle is about 146.3 degrees.

[0175] In some examples, the second angle 372 is in a range of 80-90 degrees, 82-86 degrees, or 83-85 degrees. In some examples, the second angle 372 is about 84.1 degrees.

[0176] In some examples, the third angle 374 is in a range of 52-63 degrees, or 56-60 degrees, 57-59 degrees. In some examples, the third angle 374 is about 58.0 degrees.

[0177] A fourth angle 376 can be defined between each second strut 362 and a circumferentially extending line 375 that extends between strut junctions 380 that are junctions between second struts 362 and third struts 364.

[0178] In some examples the fourth angle 376 can be in a range of 43-53 degrees, 46-50 degrees, or 47-49 degrees. In some examples, the fourth angle 376 is about 47.9 degrees.

[0179] A fifth angle 378 can be defined between each third strut 364 and a circumferentially extending line 377 that extends between strut junctions 382 that are junctions between third struts 364 and fourth struts 366.

[0180] In some examples, the fifth angle 378 is in a range of 56-66 degrees, 59-63 degrees, or 60-62 degrees. In some examples, the fifth angle 378 is about 61.0 degrees.

[0181] As shown in FIGS. 5 and 6, in some examples, each second strut 362 has a second length (measured along the second strut 362 between a strut junction 380 and strut junction 384) that is shorter than a third length of each third strut 364 (the third length measured along the third strut 364 between a strut junction 380 and strut junction 382).THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0182] Each first strut 360 has a first length (measured along the first strut 360 between a strut junction 384 and apex 356 at the inflow end 352) that is shorter than the second length of each second strut 362.

[0183] In some examples, heights of the different rows of angled struts can be defined in an axial direction of the frame 350.

[0184] For example, the first row of first struts 360 has a first axial height 386, the second row of second struts 362 has a second axial height 388 and the third row of third struts 364 has a third axial height 390 (as depicted in FIG. 5).

[0185] As shown in FIG. 5, in some examples, the first axial height 386 is shorter than the second axial height 388 and the second axial height 388 is shorter than the third axial height 390.

[0186] In some examples, the first axial height 386 is in a range of 1-2.5 mm or 1.5-2.0 mm. In some examples, the first axial height 386 is about 1.9 mm.

[0187] In some examples, the second axial height 388 is in a range of 3-5 mm or 3.7-4.3 mm. In some examples, the second axial height 388 is about 4.0 mm.

[0188] In some examples, the third axial height 390 is in a range of 5.5-7.5 mm or 6.3-6.9 mm. In some examples, the third axial height 390 is about 6.6 mm.

[0189] The above-described axial heights and angles of the first row of first struts 360, second row of second struts 362, and third row of third struts 360 are sized to form a more rounded shape between a first commissure (for example, at a first cell 358a), the inflow end 352 of the frame 350, and to a second commissure (for example, at second cell 358b). As such, the leaflets 300 having the curved or rounded cusp edge portion 306 can be more easily attached to the first struts 360, second struts 362, and third struts 364 of the frame 350, and the resulting prosthetic valve can have reduced flow gradients and increased leaflet mobility at the inflow end. The cusp edge portions 306 of the leaflets can be directly connected to the struts 360, 362, 364 with stitches or indirectly with a skirt, as previously described.

[0190] In some examples, the axial heights and angles of the first row of first struts 360, second row of second struts 362, and third row of third struts 360 described above can be selected based on the shape and or size of the leaflets to be attached thereto. In this way, the shape and sizes of the struts of the frame can be tailored specifically to the shape of the specific leaflets to be attached to the frame.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0191] In some examples, attaching the leaflet 300 to the frame 350 is performed by passing a suture (or other fastener) along the cusp edge portion 306 of the leaflet 300 and corresponding struts of the frame 350. For example, one or more sutures can pass in-and-out through the cusp edge portion 306 (or through connecting sutures in the cusp edge portion) and around struts 360, 362, and / or 364 of the frame 350 extending along the cusp edge portion 306.

[0192] In some examples, attaching the leaflet 200 to the frame 350 is performed by passing a suture (or other fastener) along the cusp edge portion 306 of the leaflet 300 and corresponding struts of the frame 350. For example, one or more sutures can pass in-and-out through an inner skirt disposed against the leaflet 300 and the cusp edge portion 306 to form a plurality of connecting stitches securing the cusp edge portion 306 to the inner skirt. A plurality of stitches can loop around the plurality of connecting stitches and around struts 360, 362, and / or 364 of the frame 350 extending along the cusp edge portion 306 of the leaflet 300, thereby coupling the leaflet 300 to the frame 350 through the inner skirt.

[0193] In some examples, the cusp edge portion 306 of each leaflet 200 can be stitched to the skirt (such as with in-and-out stitches) along a first stitch line and the skirt can be secured to the frame with whip stitches extending through the skirt and around the struts 360, 362, and / or 364 along a second stitch line that extends along and tracks the shape of the cusp edge portion 306.

[0194] The frame 350 can be similar to the frame 52, such as comprising a similar material and being radially expandable and collapsable between radially compressed and radially expanded configurations. However, the frame 350 can have differently sized and angled struts, as described above. In some examples, the frame 350 and leaflets 300 can replace the frame 52 and leaflets 60 in the prosthetic valve 50 of FIG. 1 A.

[0195] The various combinations of leaflet and / or frame shapes described herein can result in leaflets having a rounder or more U-shaped cusp edge portion. This can result in increased leaflet mobility and improved blood flow gradients along the inflow edge portion of the leaflets when included in a prosthetic heart valve implanted in a patient. The improved flow patterns through such prosthetic valves can increase blood washout and reduce blood stagnation in the neosinus, thereby increasing a longevity of the prosthetic valve.

[0196] For example, the various combinations of the leaflets shapes (including the cusp edge shape and angling of the commissure tabs), attachment locations of the leaflets to the frames,THVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]and / or the strut configuration of the frames described herein can result in a change in the vorticity patterns at the leaflet cusp edge and at the frame which result in increased active blood removal (or washout) from the neosinus region of the prosthetic valve.

[0197] More specifically, in some examples, the various leaflet shapes and attachment mechanisms to the frames described herein can result in a clockwise average vorticity pattern located at or near the cusp edge of the leaflets and the commissures and a counterclockwise vorticity pattern located at the frame of the prosthetic valve. The net flow between these two vorticity patterns leads to active removal of blood from the neosinus region. This can result in overall improved performance and increased longevity of the implanted prosthetic valve.

[0198] FIGS. 7A and 7B depict an exemplary connecting skirt 500 for attaching a cusp edge portion of the shortened leaflets described herein (for example, the leaflet 200 or the leaflet 250) to a frame of a prosthetic heart valve (for example, the frame 52 shown in FIGS. IB and 4). As described further below, the connecting skirt 500 can be shaped such that the cusp edge portion of the leaflet (leaflet 200 or 250) can be attached higher on the frame, such as being spaced away from the inflow end, as depicted in FIG. 4. The connecting skirt 500 can also be shaped to allow it to cover inflow apices 80 of the frame 52 (for example, as depicted in FIGS. 9-11 and 13-16, as described further below).

[0199] A prosthetic valve comprising three leaflets, such as the prosthetic valve 50, can include three connecting skirts 500, each connecting a cusp edge portion of a respective leaflet to the frame. Thus, a single connecting skirt 500 is provided for the cusp edge portion of each leaflet (for example, cusp edge portion 256 of each leaflet 250) and is sized to extend along the entire length of the cusp edge portion to locations just below lower commissure tabs 260 of the leaflet (as shown in FIG. 8). In this way, each connecting skirt 500 can be attached to an individual leaflet before attaching the leaflet to the frame, as described further herein.

[0200] In some examples, instead of three individual connecting skirts, the three connecting skirts can be formed continuously with one another to form a single inner skirt for a prosthetic heart valve comprising three leaflets.

[0201] In some examples, for a prosthetic valve having a valvular assembly comprising only two leaflets, the prosthetic valve may comprise only two connecting skirts.

[0202] In some examples, the connecting skirt 500 can comprise a synthetic material, such as fabric (e.g., PET fabric), or a natural tissue material (e.g., pericardial tissue).THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0203] Although the description below can refer to attaching the connecting skirt 500 to the cusp edge portion 256 of the leaflet 250, it should be noted that, in some examples, the size and / or shape of the connecting skirt 500 can be modified for attaching the connecting skirt 500 to the cusp edge portion of the leaflet 200, or another similar leaflet.

[0204] Turning to FIG. 7A, the connecting skirt 500 is shown by itself in a flat and unfolded configuration. The connecting skirt 500 can include a central portion 504 sized to extend over a portion of the cusp edge portion 256 of the leaflet 250 that includes the inflow edge 262 of the leaflet 250 and two side portions 506 sized to extend over respective angled side portions of the cusp edge portion 256 that include a respective angled side edge 264.

[0205] Each side portion 506 of the connecting skirt 500 can include a base portion 512 (also referred to herein as a side base portion) and an extension portion 514 (also referred to as a side extension portion) which extends outwardly from the base portion 512. In some examples, the base portions 512 and the central portion 504 can be rectangular and each extension portion 514 is a quadrilateral having differently angled sides. In some examples, each extension portion 514 can have a wing -like shape defined by three angled edges of the extension portion 514.

[0206] For example, each extension portion 514 can include a first angled edge 516 that extends outward, at an angle, from and relative to a free end 510 of the base portion 512 of the corresponding side portion 506. Each extension portion 514 can further include a second angled edge 518 that extends outward, at an angle, from an end of the base portion 512 that is connected to the central portion 504 of the connecting skirt 500. The extension portion 514 can further include a third angled edge 520 that extends between the first angled edge 516 and the second angled edge 518, at a non-zero angle relative to the straight edge of the base portion 512. As such, the third angled edge 520 is non-parallel to the base portion 512.

[0207] The first angled edge 516 and the third angled edge 520 can meet at a first point 522 that is spaced outward and away from the base portion 512. The second angled edge 518 and the third angled edge 520 meet at a second point 524 that is spaced outward and away from the base portion 512 by a shorter distance than the first point 522. The second point 524 also extends inward toward the opposing extension portion 514. Thus, the extension portions 514 of the side portions 506 extend outward and past the central portion 504 of the connecting skirt 500.THVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]

[0208] In some examples, an angle 526 between the first angled edge 516 and the third angled edge 520 is an acute angle, and an angle 528 between the third angled edge 520 and the second angled edge 518 is an obtuse angle.

[0209] In some examples, together, the central portion 504 and the two base portions 512 can be referred to as a base portion of the connecting skirt 500 and the two extension portions 514 can extend outwardly and away from the base portion, thereby forming flaps that extend away from the cusp edge portion of the leaflet when the base portion is attached to the cusp edge portion, as shown in FIG. 13 which is described in further detail below.

[0210] The connecting skirt 500 further includes two tabs 530 (which can also be referred to as extensions, protrusions, or flaps) that extend outward from the central portion 504. The tabs 530 can be continuous with the central portion 504 and thus can be considered part of the central portion 504. For example, each tab 530 has a connected edge 532 that is continuous with the central portion 504 and a peak 534 that is positioned away from the central portion 504 and disposed adjacent to a respective one of the extension portions 514 (as shown in FIG.7A). The peak 534 is narrower than the connected edge 532 and can have a length that is sized to cover an inflow apex of the frame (for example, inflow apex 80 of the frame 52). Each tab 530 has side edges 536 that extend from the connected edge 532 to the peak 534.

[0211] In some examples, the side edges 536 can be angled. In some examples, the side edges 536 can include two angled straight portions that connect together at an angle.

[0212] Each tab 530 can have an overall triangular shape that is contoured to extend over two angled struts that are connected by an inflow apex of a frame. For example, an inflow end of a portion of the frame 52 is shown in FIG. 9, with the connecting skirt 500 arranged within the frame 52 such that the two tabs 530 of the connecting skirt 500 extend across inner surfaces (which can also be referred to as radially inward facing surfaces) of the first struts 82 and the inflow apices 80 that connect them. The shape of the tabs 530 follow the contour of the first struts 82 and the apices 80, thereby reducing the amount of material in this region (which can reduce bunching of the connecting skirt 500, particularly when the prosthetic valve is in a radially collapsed configuration on a delivery apparatus). As described further below and shown by arrows 564 in FIG. 9, the tabs 530 can be wrapped around the first struts 82 and apices 80 and secured therearound, thereby encasing the apices 80 within the tabs 530.

[0213] In some examples, as shown in FIGS. 7A and 7B, the connecting skirt 500 can be formed with slits 502 (which can also be referred to as notches) partially separating the sideTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]portions 506 from the central portion 504 to facilitate alignment of the connecting skirt 500 along the cusp edge portion of the leaflet, as shown in FIG. 8. For example, the slits 502 can be configured to allow the base portions 512 of the side portions 506 to bend (for example, at a non-zero angle) relative to the central portion 504.

[0214] The top slits 502 (which are spaced away from the straight edges of the side portions 506 and central portion 504) also separate each tab 530 from an adjacent extension portion 514. A shorter slit 538 disposed between the two tabs 530 spaces the tabs 530 apart from one another. As a result, each tab 530 can fold or bend individually, without causing the adjacent tab 530 or extension portion 514 to move.

[0215] In some examples, each connecting skirt 500 can include a plurality of apertures configured as suture holes that are configured to receive a stitch or suture for attaching the connecting skirt 500 to the leaflet and / or the frame of the prosthetic valve. For example, in some examples, the apertures can include a first row of spaced apart first apertures 540, a second row of spaced apart second apertures 542, a third row of spaced apart third apertures 544, and a fourth row of spaced apart fourth apertures 546 arranged along a length of the base portion 512 of each side portion 506 and the central portion 504 (as shown in FIG. 7A).

[0216] In some examples, each extension portion 514 of the connecting skirt 500 can also include one or more apertures 548 (as shown in FIGS. 7 A and 7B) that can be used to secure each extension portion 514 to another extension portion 514 of an adjacent connecting skirt 500 (for example, when the angled edges of the two adjacent extension portions 514 are overlapping, as shown in FIG. 14). In some examples, the one or more apertures 548 are disposed in the extension portion 514, adjacent to (and spaced apart along) the first angled edge 516.

[0217] To attach a connecting skirt 500 to a respective leaflet, such as a leaflet 250, the base portions 512 of the side portions 506 and the central portion 504 can first be folded over on themselves (for example, in half), as illustrated by the arrows 550 in FIG. 7A and resulting in the folded configuration shown in FIG. 7B. For example, as shown in the cross-sectional view of FIG. 12, folding the base portions 512 and the central portion 504 lengthwise (as shown in FIGS. 7A and 7B) can form two fold layers 552a, 552b, with the extension portions 514 extending outward from one of the two fold layers (for example, fold layer 552b in FIG.12). As shown in FIG. 7B, the two overlapping fold layers 552a, 552b result in the first apertures 540 overlapping the underlying fourth apertures 546 and the second apertures 542THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]overlapping the underlying third apertures 544. This creates two layers of apertures for a first, leaflet-to-connecting skirt stitch line (using the first line of layered apertures outlined by the dashed box 556 in FIG. 7B) and a second, connecting skirt-to-frame stitch line (using the second line of layered apertures, as outlined by the dashed box 554).

[0218] FIG. 8 shows the connecting skirt 500 placed along the cusp edge portion 256, on the inner surface 251 the leaflet 250, and attached to the cusp edge portion 256 of the leaflet 250. The folded connecting skirt 500 (as shown in FIG. 7B) is attached to the cusp edge portion 256 of the leaflet 250 by aligning the central portion 504 along the inflow edge 262 of the cusp edge portion 256 and aligning each base portion 512 with a respective angled side edge 264 of the cusp edge portion 256. As shown in FIG. 8, the slits 502 allow the base portions 512 to bend and be angled relative to the central portion 504, thereby following the contour of the cusp edge portion 256.

[0219] As shown in FIG. 8, in some examples, adjacent portions of the central portion 504 and each of the base portions 512 can overlap in a region of the slits 502 due to the bending of the base portions 512 relative to the central portion 504, which is facilitated by the slits 508.

[0220] The extension portions 514 and tabs 530 of the connecting skirt 500 extend away from the cusp edge portion 256 and across a portion of the inner surface 251 of the leaflet 250.

[0221] The folded base portions 512 and central portion 504 are secured to the cusp edge portion 256 of the leaflet 250 with a suture forming a plurality of in-and-out stitches 558 extending through the aligned second apertures 542 and third apertures 544, thereby forming the leaflet-to-connecting skirt stitch line 560.

[0222] In some examples, a reinforcing member or chord 596 (for example, an Ethibond suture) can be placed against the outer surface of the cusp edge portion 256 of the leaflet 250, opposite the connecting skirt 500 (as shown in FIG. 12). The reinforcing chord 596 and the fold layers 552a, 552b can be sutured to each other and to the cusp edge portion 256 with stitches 598.

[0223] Together, the leaflet 250 (or another leaflet, such as the leaflet 200) and the attached connecting skirt 500, as shown in FIG. 8, can form and be referred to herein as a leaflet assembly 570.THVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]

[0224] After each connecting skirt 500 is secured to each respective leaflet 250 to form a leaflet assembly 570, the leaflet assemblies 250 (for example, three for the prosthetic valve) can be secured together to form a valvular structure. Though the valvular structure may be described herein as comprising three leaflets 250 and leaflet assemblies 570, in some examples, a leaflet structure for the prosthetic valves discussed herein can have a different number of leaflets, such as two leaflets.

[0225] For example, three leaflet assemblies 570 can be arranged together, in a flat configuration off the frame, with the cusp edge portions 256 of the leaflets 250 forming an outer perimeter of the valvular structure. The three leaflet assemblies 570 can be secured (for example, sutured or otherwise fastened) together via one or more sutures that form a stitching line along and between each of the cusp edge portions 256 of each leaflet 250. Further details and examples of forming such leaflet assemblies can be found in U. S. Patent No. 12,004,947, which is incorporated by reference herein.

[0226] Once the leaflet assemblies 570 are secured together, the valvular structure can be arranged within an interior of a frame of a prosthetic valve, such as the frame 52, and secured to the frame, as shown in FIGS. 10-16.

[0227] Turning to FIG. 10, the leaflet assembly 570 is arranged within the frame 52, with outer surfaces of the leaflets facing the frame 52 (the outer surface 253 of one leaflet 250 is visible in FIG. 10). One leaflet assembly 462 is visible in the view of FIG. 10, as well as the stitch line 560 securing the connecting skirt 500 to the cusp edge portion 256 of the leaflet 250. The connecting skirt 500 is arranged on the inner surface of the leaflet 250, and thus not visible in FIG. 10.

[0228] For securing the cusp edge portion 256 of the leaflet 250 to the frame 52, a suture 562 can be divided into two parts and an approximate center of the suture 562 can be arranged at a middle of the cusp edge portion 256 to enable securing of the cusp edge portion 256 to a frame junction 70 (also referred to herein a “strut junction”) that interconnects four angled struts of the frame 52 (for example, two first struts 82 and two second struts 84). As shown in FIG. 10, the frame junction 70 is spaced away from the inflow end 66 of the frame 52.

[0229] The cusp edge portion 256 of the leaflet 250 can be folded upwardly such that the cusp edge of the leaflet points toward the outflow end of the frame and the extension portions 514 and the tabs 530 of the connecting skirt 500 extend downwardly toward the inflow end 66 of the frame. In this configuration, the connecting skirt 500 and the inner surface 251 ofTHVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]the leaflet 250 along the cusp edge portion 256 face the frame 52, as depicted in FIG. 11 and schematically in FIG. 12. Once positioned in this manner, the leaflet assembly 570 can be secured to the frame 52 using the connecting skirt 500.

[0230] The middle of the suture 562 can be used to create a first double stitch 572 which extends through the connecting skirt (e.g., through overlapping apertures 540 and 546 in the connecting skirt 500) and around the frame junction 70 (as shown in FIG. 11). This results in a first suture tail 561 and second suture tail 563 (shown in FIG. 10) extending from opposite sides of the double stitch 572.

[0231] The first suture tail 561 is used to form in-and-out stitches 566 through the aligned first apertures 540 and fourth apertures 546 in the central portion 504 of the connecting skirt 500, with the in-and-out stitches 566 extending in a direction of arrow 574 toward an adjacent frame junction 71 (as shown in FIG. 11). A second double stitch 576 is formed through the connecting skirt and around the frame junction 71 (as shown in FIGS. 11 and 13). The remaining portion of the first suture tail 561 can be used to form whip stitches 578 through the aligned first apertures 540 and fourth apertures 546 in the respective base portion 512 of the connecting skirt 500 and around a respective second strut 84 or a respective third strut 86. The whip stitches 578 extend from the second double stitch 576, in a direction of the arrow 575 (as shown in FIG. 13). A third double stitch 580 is formed through the connecting skirt and around another frame junction that interconnects struts to which a commissure 582 formed by two adjacent leaflets 250 is attached (as shown in FIGS. 11 and 13). In some examples, a fourth double stitch 585 is formed around a frame junction that is disposed between the frame junction 71 and the commissure 582 (as shown in FIG. 11).

[0232] The second suture tail 563 is used to form in-and-out stitches 567 through the aligned first apertures 540 and fourth apertures 546 in the central portion 504 of the connecting skirt 500, with the in-and-out stitches 567 extending in a direction of arrow 573 toward an adjacent frame junction 73 (as shown in FIG. 11). A fifth double stitch 577 is formed through the connecting skirt and around the frame junction 73 (as shown in FIG. 11). The remaining portion of the second suture tail 563 can be used to form whip stitches 579 through the aligned first apertures 540 and fourth apertures 546 in the respective base portion 512 of the connecting skirt 500 and around a respective second strut 84 or respective third strut 86. The whip stitches 579 extend from the double stitch 577 toward an adjacent commissure 582. A sixth double stitch 581 is formed through the connecting skirt and around another frameTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]junction that interconnects struts to which the commissure 582 formed by another two adjacent leaflets 250 is attached (as shown in FIG. 11). In some examples, a seventh double stitch 587 is formed around a frame junction that is disposed between the frame junction 71 and the commissure 582 (as shown in FIG. 11).

[0233] In some examples, one or more of the whip stitches 578, 579, such as all of the whip stitches 578, 579, can form an inter-locking stitch. An inter-locking stitch can be formed by forming a loop with the suture 561 that can extend through the connecting skirt, around a strut, and then through itself at the end of the loop (the suture is threaded through the filaments of the portion of the suture forming the loop) before forming the next subsequent stitch along the same strut or adjacent strut. Such a stitch can be referred to as an interlocking whip stitch. Further details of forming an inter-locking stitch are disclosed in PCT Application No. PCT / US2025 / 024244, filed April 11, 2025, which is incorporated herein by reference.

[0234] Each double stitch 572, 576, 577, 580, 581, 585, 587 includes two loops formed by the suture 561 that extend around a respective frame junction and through the connecting skirt. Any one or more of the double stitches 572, 576, 577, 580, 581, 585, 587 can include a knot. In some examples, each double stitch 572, 576, 577, 580, 581, 585, 587 includes a knot. The knot can be any type of knot, such as a simple or overhand knot formed by inserting the suture 561 through one or both loops of the double stitch and pulling it tight before proceeding to the next adjacent stitch. A double stitch 572, 576, 577, 580, 581, 585, 587 that includes a knot can be referred to a double knot stitch. In some examples, one or more of the double stitches 572, 576, 577, 580, 581, 585, 587 can be replaced with a single loop stitch that forms a single loop that extends through the connecting skirt and around a frame junction, and can include a knot or can be without a knot. Moreover, in some examples, one of more of the double stitches 572, 576, 577, 580, 581, 585, 587 can include a loop that forms a lock stitch, which can be formed by threading the suture 561 through itself prior to forming another loop or an adjacent stitch.

[0235] The view of the prosthetic valve of FIG. 13 is rotated about 60 degrees from the image shown in FIG. 11 and therefore depicts a second suture tail of an adjacent leaflet assembly 570 being used to form similar double stitches, in-and-out stitches, and whip stitches in the direction of the arrows 584.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0236] In this way, the series of double stitches, in-and-out stitches, and whip stitches can be repeated using a different suture for each leaflet assembly 570 (for example, three sutures in total for the prosthetic valve). As a result, all the leaflet assemblies 570 can be securely attached to the frame, such that the cusp edge portion 256 of the leaflets is offset from the inflow end 66 of the frame 52.

[0237] As shown in FIG. 13, an extension portion 514 from each of two adjacent connecting skirts 500 cover the inner surface of first struts 82, inflow apices 80, second struts 84, and third struts 86 that are disposed between adjacent leaflets 250. As a result, the inner surface of the apices 80 at the inflow end 66 of the frame 52 and the first struts 82, second struts 84, and third struts 86 are covered and the connecting skirts 500 can serve as a barrier between the frame 52 and a balloon of a delivery apparatus when the prosthetic heart valve is radially compressed onto and around the balloon (such as the balloon shown in FIGS. 2A and 2B).

[0238] In some examples, as shown in FIG. 13, the extension portions 514 of the two adjacent connecting skirts 500 can overlap one another at overlapping portions 586. In some examples, the overlapping portions 586 of the extension portions 514 can be stitched to one another via in-and-out stiches 583 extending through the overlapping portions 586 of the two extension portions 514, as shown in FIG. 14 (for example, using the apertures 548 shown in FIG. 7A).

[0239] In some examples, the extension portions 514 can be secured to struts of the frame 52 and / or to junctions between two or more struts, such as a frame junction which the extension portions 514 overlay.

[0240] A portion of the extension portions 514 that extend over the first struts 82 and beyond the inflow apices 80, as shown in FIG. 13, can be wrapped around the inflow apices 80 at the inflow end 66 of the frame 52, thereby at least partially covering or encasing the two apices 80 below each commissure 582 with respective extension portions 514 of adjacent leaflet assemblies 570. For example, FIG. 14 depicts a wrapped portion 588 of two extension portions 514 of adjacent leaflet assemblies 570 covering or encasing two adjacent apices 80. Whip stitches 589 can extend through the wrapped portion 588 of the two extension portions 514 and around the first struts 82 and / or inflow apices 80, thereby securing the connecting skirts 500 around a portion of the inflow apices 80 (for example, a first half of the inflow apices 80 of the frame 52).THVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]

[0241] Other inflow apices 80 (for example, the inflow apices 80 not covered by extension portions 514. which can be half of the inflow apices 80 of the frame 52) can be covered by the tabs 530 of the connecting skirts 500, as introduced above with reference to FIG. 9. For example, as shown by arrows 564 in FIG. 9, the two tabs 530 of each connecting skirt 500 can be wrapped around the first stmts 82 and inflow apices 80 and secured therearound with a plurality of whip stitches 590, as shown in FIG. 15.

[0242] FIG. 15 is a detail view, from an interior of the frame 52, of two adjacent tabs 530 of the same connecting skirt 500 wrapped around first stmts 82 and apices 80 at the inflow end 66 of the frame 52. As shown in FIG. 15, an outer skirt 592 (or a PVL skirt, which may be the same or similar to the sealing member 56 of FIG. 1A) is arranged around an outside of the frame 52 and is visible between the apices 80 covered by the tabs 530. The plurality of whip stitches 590 extend through the tabs 530 of the connecting skirt 500 and around the first stmts 82.

[0243] In some examples, the outer skirt 592 is secured to the connecting skirts 500 of the valvular assembly of the prosthetic valve. In some examples, the extension portions 514 of the connecting skirts can be wrapped around respective inflow apices 80 as well as the inflow edge of the outer skirt 592 on the outside of the valve and stitched to the frame and the outer skirt with the whip stitches 589. Thus, portions of the extension portions 514 can extend around and cover the inflow end of the frame (including apices 80) and the inflow end of the outer skirt and are retained against an outer surface of the outer skirt. Similarly, in some examples, portions of the tabs 530 of the connecting skirts can be wrapped around respective inflow apices 80 as well as the inflow edge of the outer skirt 592 on the outside of the valve and stitched to the frame and the outer skirt with the whip stitches 590. Thus, portions of the tabs 530 can extend around and cover the inflow end of the frame (including apices 80) and the inflow end of the outer skirt and are retained against an outer surface of the outer skirt. In some examples, portions 593 of the inflow edge portion of the outer skirt 592 that extend between the tabs 530 or between an extension portion 514 and an adjacent tab 530 are not coextensive with the connecting skirts 500. These portions 593 of the outer skirt 592 can extend closer to the inflow end of the frame than the connecting skirts 500 at those locations. In some examples, the portions 593 of the outer skirt may not be stitched to the frame or the connecting skirts 500, at least at locations upstream of the row of stmts 82. In lieu of or in addition to the whip stitches 589, 590, the outer skirt 592 can be stitched to the connectingTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]skirts 500 with stitches 594 (FIG. 12). In some examples, the inflow edge portion of the outer skirt 592 can be secured to the first struts 82 with separate stitches that extend through the outer skirt and around the first struts.

[0244] In some examples, six whip stitches 590 can be formed between two adjacent apices 80. Because the tabs 530 follow a contour of the first stmts 82, more whip stitches 590 can be used (for example, six rather than four), thereby securely fastening the tabs 530 to the frame 52 and reducing excess skirt fabric.

[0245] In some examples, more or less than six whip stitches 590 can be formed between two adjacent apices 80.

[0246] For example, FIG. 16 is a schematic depicting eight whip stitches 590 used to secure the tabs 530 to the first stmts 82 and an additional whip stitch 590 at each apex 80 used to secure a respective tab 530 to the apex 80.

[0247] The skirt 500 serves to connect a leaflet (such as the leaflets described herein) to the frame of a prosthetic valve, particularly downstream of the inflow end of the frame. The skirt 500 also serves to direct blood flow from the inflow end of the prosthetic valve to and through the leaflets. The shape of the skirt 500 described herein (for example, the extension portions and tabs that cover cells of the frame to the inflow end of the frame) is particularly advantageous in preventing leakage of blood from the inside of the prosthetic valve past the leaflets and through the frame.Delivery Techniques

[0248] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Additionally and / or alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aorticTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]valve. Additionally and / or alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J -sternotomy or right parasternal mini -thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0249] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the deh’ very apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve, Additionally and / or alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve,

[0250] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0251] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically atTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0252] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

[0253] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.Additional Examples of the Disclosed Technology

[0254] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0255] Example 1. A prosthetic valve comprising a frame comprising a plurality of interconnected struts forming plurality of circumferentially extending rows of angled stmts arrayed along a length of the frame between an inflow end and an outflow end of the frame, wherein the plurality of circumferentially extending rows of angled stmts includes a first row of first stmts defining the inflow end of the frame, a second row of second stmts downstream of the first row of first stmts, and a third row of third stmts downstream of the second row of second stmts; and a plurality of leaflets mounted on an inside the frame, wherein each leaflet comprises a curved cusp edge portion that is attached to a portion of stmts in each of the first row, second row, and third row, and wherein a first angle between first stmts of the first row of first stmts, a second angle between second stmts of the second row of second stmts, and a third angle between third stmts of the third row of stmts are defined such that sets of one firstTHVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]strut, one second strut, and one third strut that are connected end-to-end follow a curvature of the cusp edge portion of the leaflet.

[0256] Example 2. The prosthetic valve of any example herein, particularly example 1, wherein the cusp edge portion of each leaflet is connected to a first set of one first stmt, one second stmt, and one third stmt that are connected end-to-end and a second set of one first stmt, one second stmt, and one third stmt that are connected end-to-end.

[0257] Example 3. The prosthetic valve of any example herein, particularly either example 1 or example 2, wherein the cusp edge portion of each leaflet is attached to the portion of stmts by stitches that wrap around the portion of stmts.

[0258] Example 4. The prosthetic valve of any example herein, particularly any one of examples 1-3, wherein the curved cusp edge portion of each leaflet has a rounded shape, including a rounded inflow end.

[0259] Example 5. The prosthetic valve of any example herein, particularly example 4, wherein the rounded inflow end of each leaflet is attached to a portion of inflow apices of a plurality of inflow apices that are spaced circumferentially apart around the inflow end of the frame.

[0260] Example 6. The prosthetic valve of any example herein, particularly any one of examples 1-5, wherein the first angle is larger than the second angle.

[0261] Example 7. The prosthetic valve of any example herein, particularly any one of examples 1-6, wherein the first angle is larger than the third angle.

[0262] Example 8. The prosthetic valve of any example herein, particularly any one of examples 1-7, wherein the second angle is larger than the third angle.

[0263] Example 9. The prosthetic valve of any example herein, particularly any one of examples 1-8, wherein the first row of first stmts has a first axial height defined in an axial direction relative to a central longitudinal axis of the frame, the second row of second stmts has a second axial height defined in the axial direction, and the third row of third stmts has a third axial height defined in the axial direction, and wherein the first axial height is smaller than the second axial height and the second axial height is smaller than the third axial height.

[0264] Example 10. A prosthetic valve comprising a frame comprising a plurality of interconnected stmts forming plurality of circumferentially extending rows of angled stmts arrayed along a length of the frame between an inflow end and an outflow end of the frame, wherein the plurality of circumferentially extending rows of angled stmts includes a first rowTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]of first struts defining the inflow end of the frame, a second row of second stmts disposed downstream of the first row of stmts, and a third row of third stmts disposed downstream of the second row of stmts, and wherein each second stmt is shorter than each third stmt and each first stmt is shorter than each second stmt; and a plurality of leaflets mounted on an inside the frame, wherein each leaflet comprises an outflow edge portion and a cusp edge portion, and wherein each side of the cusp edge portion extends along one first stmt, one second stmt, and one third stmt.

[0265] Example 11. The prosthetic valve of any example herein, particularly example 10, wherein the cusp edge portion of each leaflet is curved with an angle of curvature in a range of 100-140 degrees.

[0266] Example 12. The prosthetic valve of any example herein, particularly either example 10 or example 11, wherein the frame comprises a plurality of inflow apices spaced circumferentially apart around the inflow end of the frame, wherein the cusp edge portion of each leaflet is curved with a rounded inflow end, and wherein the rounded inflow end is coupled to a portion of the plurality of inflow apices.

[0267] Example 13. The prosthetic valve of any example herein, particularly example 12, wherein the portion of the plurality of inflow apices includes two adjacent inflow apices.

[0268] Example 14. The prosthetic valve of any example herein, particularly any one of examples 10-13, wherein a first angle between first struts of the first row of first stmts is larger than a second angle between second stmts of the second row of second stmts and a third angle between third stmts of the third row of stmts.

[0269] Example 15. The prosthetic valve of any example herein, particularly example 14, wherein the second angle is larger than the third angle.

[0270] Example 16. The prosthetic valve of any example herein, particularly either example 14 or example 15, wherein the second angle is in a range of 83-85 degrees.

[0271] Example 17. The prosthetic valve of any example herein, particularly any one of examples 10-16, wherein the one first stmt, one second stmt, and one third stmt are connected end-to-end between a commissure of the prosthetic valve and the inflow end of the frame.

[0272] Example 18. The prosthetic valve of any example herein, particularly any one of examples 10-17, wherein the second row of second stmts has a first axial height defined in an axial direction relative to a central longitudinal axis of the frame and the third row of thirdTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]struts has a second axial height defined in the axial direction, and wherein the first axial height is smaller than the second axial height.

[0273] Example 19. The prosthetic valve of any example herein, particularly any one of examples 10-18, wherein each leaflet comprises a pair of commissure tabs disposed on opposite side of the outflow edge portion, and wherein each commissure tab of the pair of commissure tabs is angled relative to a central longitudinal axis of the leaflet toward the cusp edge portion.

[0274] Example 20. A prosthetic valve comprising a frame comprising a plurality of interconnected struts forming plurality of circumferentially extending rows of angled struts arrayed along a length of the frame between an inflow end and an outflow end of the frame, wherein the plurality of circumferentially extending rows of angled struts includes a first row of first struts defining the inflow end of the frame, a second row of second struts disposed downstream of the first row of struts, and a third row of third struts disposed downstream of the second row of struts, and wherein a second axial height of the second row of second stmts is larger than a first axial height of the first row of first stmt and smaller than a third axial height of the third row of third stmts; and a plurality of leaflets mounted on an inside the frame, wherein each leaflet comprises an outflow edge portion and a curved cusp edge portion, and wherein the curved cusp edge portion is attached to a portion of stmts in each of the first row, second row, and third row.

[0275] Example 21. The prosthetic valve of any example herein, particularly example 20, wherein the portion of stmts in each of the first row, second row, and third row includes a first set of one first stmt, one second stmt, and one third stmt that are connected end-to-end and a second set of one first stmt, one second stmt, and one third stmt that are connected end-to-end.

[0276] Example 22. The prosthetic valve of any example herein, particularly either example 20 or example 21, wherein the second axial height is in a range of 3-5 mm.

[0277] Example 23. The prosthetic valve of any example herein, particularly any one of examples 20-22, wherein the first axial height is in a range of 1-2.5 mm.

[0278] Example 24. The prosthetic valve of any example herein, particularly any one of examples 20-23, wherein the third axial height is in a range of 5.5-7.5 mm.

[0279] Example 25. The prosthetic valve of any example herein, particularly any one of examples 20-24, wherein the frame comprises a plurality of inflow apices spacedTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]circumferentially apart around the inflow end of the frame, and wherein an inflow end of the cusp edge portion of each leaflet is coupled to a portion of the plurality of inflow apices.

[0280] Example 26. The prosthetic valve of any example herein, particularly any one of examples 20-25, wherein an inflow end of the cusp edge portion of each leaflet is rounded and attached to the inflow end of the frame.

[0281] Example 27. The prosthetic valve of any example herein, particularly any one of examples 20-26, wherein a first angle between first struts of the first row of first struts is larger than a second angle between second struts of the second row of second struts and a third angle between third struts of the third row of struts.

[0282] Example 28. The prosthetic valve of any example herein, particularly example 27, wherein the second angle is larger than the third angle.

[0283] Example 29. The prosthetic valve of any example herein, particularly any one of examples 20-28, wherein the frame is radially expandable from a radially collapsed configuration to a radially expanded configuration.

[0284] Example 30. A prosthetic valve comprising a frame comprising a plurality of interconnected struts forming plurality of circumferentially extending rows of struts arrayed along a length of the frame between an inflow end and an outflow end of the frame, wherein the plurality of circumferentially extending rows of struts includes a first row of first struts defining the inflow end of the frame and a second row of second struts disposed downstream of the first row of struts, wherein a pair of first struts and a pair of second struts are interconnected at each of a plurality of circumferentially spaced strut junctions, and wherein the frame comprises a plurality of inflow apices spaced circumferentially apart around the inflow end of the frame, each inflow apex connected to inflow ends of two first struts of the first row of first struts; and a plurality of leaflets mounted on an inside the frame, wherein each leaflet comprises an outflow edge portion and a cusp edge portion, wherein an inflow end of the cusp edge portion is coupled to selected strut junctions of the plurality of circumferentially spaced strut junctions downstream of the plurality of inflow apices.

[0285] Example 31. The prosthetic valve of any example herein, particularly example 30, wherein the cusp edge portion has a trapezoidal shape with two angled side edges and an inflow edge extending between the two angled side edges, and wherein the inflow edge defines the inflow end of the cusp edge portion which extends in a circumferential direction relative to a central longitudinal axis of the frame.THVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]

[0286] Example 32. The prosthetic valve of any example herein, particularly example 31, wherein the plurality of circumferentially extending rows of struts includes a third row of third struts disposed downstream of the second row of second struts, and wherein each angled side edge of the two angled side edges of the cusp edge portion extends along one second strut and one third strut that are connected end-to-end.

[0287] Example 33. The prosthetic valve of any example herein, particularly example 32, further comprising a plurality of connecting skirts, wherein each connecting skirt is coupled to the cusp edge portion of a respective leaflet of the plurality of leaflets and coupled to the selected strut junctions, selected second struts, and selected third struts, thereby securing the cusp edge portion of the respective leaflet to the frame.

[0288] Example 34. The prosthetic valve of any example herein, particularly example 33, wherein each connecting skirt comprises a central portion and opposing side base portions on opposite sides of the central portion, wherein the opposing side base portions are connected to each of and disposed between the selected second struts and the selected third struts and the cusp edge portion of the respective leaflet; side extension portions that extend outward from the cusp edge portion of the leaflet and across a portion of first, second, and third struts that are disposed between cusp edge portions of adjacent leaflets; and two adjacent tabs that extend outward from the central portion of the connecting skirt, wherein each tab wraps around and covers a respective inflow apex of the plurality of inflow apices.

[0289] Example 35. The prosthetic valve of any example herein, particularly any one of examples 30-34, wherein the selected strut junctions includes three strut junctions.

[0290] Example 36. The prosthetic valve of any example herein, particularly any one of examples 30-35, wherein the plurality of interconnected struts are angled struts, and wherein each inflow apex forms a junction between two angled first struts of the first row of first struts.

[0291] Example 37. The prosthetic valve of any example herein, particularly any one of examples 30-36, wherein each leaflet comprises a main body with the outflow edge portion and the cusp edge portion, and wherein an axial length of the leaflet that is defined between the outflow edge portion and the cusp edge portion is shorter than an axial length of the frame that is defined between the inflow end and the outflow end of the frame.THVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]

[0292] Example 38. The prosthetic valve of any example herein, particularly any one of examples 30-37, wherein the frame is radially expandable from a radially collapsed configuration to a radially expanded configuration.

[0293] Example 39. A prosthetic valve comprising a frame that is radially expandable from a radially collapsed configuration to a radially expanded configuration, wherein the frame has an inflow end and an outflow end; and a plurality of leaflets mounted on an inside the frame, wherein each leaflet comprises a main body with a cusp edge portion and an outflow edge portion, wherein the cusp edge portion is formed by two angled side edges and an inflow edge extending between the two angled side edges, wherein the inflow edge defines an inflow end of the cusp edge portion which extends in a circumferential direction relative to the frame, and wherein a central portion of the outflow edge portion depresses inward toward the inflow edge relative to opposing ends of the outflow edge portion, wherein the inflow edge of each leaflet is coupled to the frame downstream of the inflow end of the frame.

[0294] Example 40. The prosthetic valve of any example herein, particularly example 39, wherein each leaflet comprises two upper tabs disposed on opposite sides of the main body, and wherein the outflow edge portion extends between the two upper tabs with the central portion of the outflow edge portion extending away from the two upper tabs.

[0295] Example 41. The prosthetic valve of any example herein, particularly example 40, wherein a side edge of each upper tab of the two upper tabs that is connected to the outflow edge portion extends at an angle relative to a central longitudinal axis of the frame that is in a range of zero to 20 degrees.

[0296] Example 42. The prosthetic valve of any example herein, particularly example 40, wherein a side edge of each upper tab of the two upper tabs that is connected to the outflow edge portion extends at an angle relative to a central longitudinal axis of the frame that is in a range of zero to 10 degrees.

[0297] Example 43. The prosthetic valve of any example herein, particularly any one of examples 39-42, wherein the frame comprises a plurality of interconnected stmts forming plurality of circumferentially extending rows of struts arrayed along a length of the frame between an inflow end and an outflow end of the frame, wherein the plurality of interconnected struts includes a first row of first struts defining the inflow end of the frame, and a second row of second struts disposed downstream of the first row of struts, wherein pairs of first struts are interconnected with respective pairs of second struts at a plurality ofTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]circumferentially spaced strut junctions, and wherein the frame comprises a plurality of inflow apices spaced circumferentially apart around the inflow end of the frame, each inflow apex connected to inflow ends of two first struts of the first row of first struts.

[0298] Example 44. The prosthetic valve of any example herein, particularly example 43, wherein the inflow end of the cusp edge portion of each leaflet is attached to selected strut junctions of the plurality of circumferentially spaced strut junctions.

[0299] Example 45. The prosthetic valve of any example herein, particularly example 44, further comprising a plurality of connecting skirts, wherein each connecting skirt is coupled to the cusp edge portion of a respective leaflet of the plurality of leaflets and coupled to the selected strut junctions, selected second struts, and selected third struts, thereby securing the cusp edge portion of the respective leaflet to the frame.

[0300] Example 46. The prosthetic valve of any example herein, particularly example 45, wherein each connecting skirt comprises a central portion and opposing side base portions on opposite sides of the central portion, wherein the opposing side base portions are connected to each of and disposed between the selected second struts and the selected third struts and the cusp edge portion of the respective leaflet; side extension portions that extend outward from the cusp edge portion of the leaflet and across a portion of first, second, and third struts that are disposed between cusp edge portions of adjacent leaflets; and two adjacent tabs that extend outward from the central portion of the connecting skirt, wherein each tab covers inner surfaces of a respective inflow apex of the plurality of inflow apices and two first struts connected to the respective inflow apex, and wherein each tab wraps around the respective inflow apex.

[0301] Example 47. A prosthetic heart valve comprising an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame comprises a plurality of struts, and wherein the plurality of struts form a plurality of inflow apices at the inflow end of the frame; and a valvular structure mounted within the frame and comprising a plurality of leaflets, wherein each leaflet comprises opposing tabs on opposite sides of the leaflet and a cusp edge portion between the tabs; wherein the cusp edge portion of each leaflet is connected to the frame by a connecting skirt, wherein each connecting skirt comprises a central portion and opposing side base portions on opposite sides of the central portion that are connected to each of and disposed between the frame and the cusp edgeTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]portion of the leaflet; side extension portions that extend from the cusp edge portion of the leaflet and across struts of the frame that are disposed between cusp edge portions of adjacent leaflets; and two adjacent tabs that extend from the central portion of the connecting skirt, wherein each tab wraps around a respective inflow apex of the plurality of inflow apices.

[0302] Example 48. The prosthetic heart valve of any example herein, particularly example 47, wherein the central portion of each connecting skirt is coupled to the cusp edge portion of a respective leaflet, and wherein the central portion of each connecting skirt is connected to the frame downstream of the plurality of inflow apices.

[0303] Example 49. The prosthetic heart valve of any example herein, particularly either example 47 or example 48, wherein the two adjacent tabs wrap around a first pair of inflow apices of the plurality of inflow apices, and wherein the side extension portions of the connecting skirt wrap around a second pair of inflow apices of the plurality of inflow apices.

[0304] Example 50. The prosthetic heart valve of any example herein, particularly any one of examples 47-49, wherein each side extension portion extends across at least one complete cell of a plurality of open cells defined by the plurality of struts, the at least one complete cell uncovered by the plurality of leaflets.

[0305] Example 51. The prosthetic heart valve of any example herein, particularly any one of examples 47-50, wherein each side extension portion is secured to an adjacent side extension portion of an adjacent connecting skirt, and wherein the side extension portion and the adjacent side extension portion are wrapped and secured around two inflow apices of the plurality of inflow apices.

[0306] Example 52. The prosthetic heart valve of any example herein, particularly any one of examples 47-51, wherein each connecting skirt includes a slit disposed between the two adjacent tabs and a plurality of slits disposed between the central portion and the side base portions that are configured to allow the side base portions to bend relative to the central portion and allow each tab of the two adjacent tabs to fold relative to one another and the central portion.

[0307] Example 53. The prosthetic heart valve of any example herein, particularly any one of examples 47-52, wherein each side extension portion has a wing-like shape that is defined by first and second angled edges that extend from opposite ends of a respective side base portion of the opposing side base portions and a third angled edge that extends between the first and second angled edges and is non-parallel to the respective side base portion.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0308] Example 54. The prosthetic heart valve of any example herein, particularly any one of examples 47-53, wherein each connecting skirt includes a plurality of rows of apertures disposed in and extending across the side base portions and the central portion, and wherein, for each leaflet, the central portion and side base portions of the connecting skirt are arranged along and secured to the cusp edge portion of the leaflet via one or more sutures extending through a first two rows of the plurality of rows of apertures.

[0309] Example 55. The prosthetic heart valve of any example herein, particularly example 54, wherein, for each leaflet, the central portion and side base portions of the connecting skirt secured to the leaflet are further secured to struts of the plurality of struts of the frame via one or more sutures extending through a second two rows of the plurality of rows of apertures.

[0310] Example 56. The prosthetic heart valve of any example herein, particularly example 55, wherein the plurality of struts forms a plurality of circumferentially extending rows of struts arrayed along a length of the frame between the inflow end and the outflow end of the frame, wherein the plurality of circumferentially extending rows of struts includes a first row of first struts defining the inflow end of the frame, a second row of second struts disposed downstream of the first row of struts, and a third row of third struts disposed downstream of the second row of struts, wherein pairs of first struts and second struts are interconnected at a plurality of circumferentially spaced strut junctions, and wherein the central portion of the connecting skirt is secured to a portion of strut junctions of the plurality of circumferentially spaced strut junctions.

[0311] Example 57. The prosthetic heart valve of any example herein, particularly example 56, wherein each side base portion of each connecting skirt is secured to a respective, interconnected second strut and third strut.

[0312] Example 58. The prosthetic heart valve of any example herein, particularly either example 56 or example 57, wherein each side extension portion covers an inner surface of a portion of first, second, and third struts that extend between cusp edge portions of adjacent leaflets.

[0313] Example 59. The prosthetic heart valve of any example herein, particularly any one of examples 55-58, wherein the central portion and the side base portions are folded over lengthwise along the cusp edge portion of the leaflet to form two folded portions such that the first two rows of the plurality of rows of apertures overlap one another and the second two rows of the plurality of rows of apertures overlap one another.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0314] Example 60. The prosthetic heart valve of any example herein, particularly any one of examples 47-59, wherein each tab of the opposing tabs of each leaflet is paired with an adjacent tab of an adjacent leaflet to form a plurality of commissures that are connected to the frame, at the outflow end of the frame.

[0315] Example 61. The prosthetic heart valve of any example herein, particularly any one of examples 47-60, wherein the cusp edge portion of each leaflet comprises two angled side edges and an inflow edge extending between the two angled side edges, wherein the inflow edge defines an inflow end of the cusp edge portion which extends in a circumferential direction relative to the frame, wherein each leaflet comprises a main body with an outflow edge portion and the cusp edge portion, and wherein an axial length of the leaflet that is defined between the outflow edge portion and the inflow edge of the cusp edge portion is shorter than an axial length of the frame that is defined between the inflow end and the outflow end of the frame.

[0316] Example 62. The prosthetic heart valve of any example herein, particularly example 61, wherein the inflow edge of the cusp edge portion of each leaflet is connected to the frame by the connecting skirt downstream of the plurality of inflow apices.

[0317] Example 63. A prosthetic heart valve comprising an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, wherein the frame comprises a plurality of stmts, and wherein the plurality of stmts form a plurality of inflow apices at the inflow end of the frame; a valvular stmcture mounted within the frame and comprising a plurality of leaflets, wherein each leaflet comprises opposing tabs on opposite sides of the leaflet and a cusp edge portion between the tabs, wherein each tab is paired with an adjacent tab of an adjacent leaflet to form a plurality of commissures that are connected to the frame; and a plurality of connecting skirts, each connecting skirt connecting a cusp edge portion of a respective leaflet of the plurality of leaflets to the frame, wherein each connecting skirt comprises two side base portions and a central portion connected to each of the cusp edge portion of the respective leaflet and a portion of struts of the plurality of struts; two side extension portions that extend away from the cusp edge portion, wherein each side extension portion of each connecting skirt extends across struts of the plurality of struts that are disposed between cusp edge portions of adjacent leaflets; and two tabs that each extendTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]from the central portion, wherein each tab wraps around a respective inflow apex of the plurality of inflow apices.

[0318] Example 64. The prosthetic heart valve of any example herein, particularly example 63, wherein the cusp edge portion of each leaflet is connected to the frame by a respective connecting skirt at a location that is spaced axially away and downstream from the plurality of inflow apices.

[0319] Example 65. The prosthetic heart valve of any example herein, particularly either example 63 or example 64, wherein the two tabs of the plurality of connecting skirts collectively cover a first half of the plurality of inflow apices, and wherein the two side extension portions of the plurality of connecting skirts collectively cover a second half of the plurality of inflow apices.

[0320] Example 66. The prosthetic heart valve of any example herein, particularly any one of examples 63-65, wherein each side extension portion of each connecting skirt connects to an adjacent side extension portion of an adjacent connecting skirt.

[0321] Example 67. The prosthetic heart valve of any example herein, particularly example 66, wherein each side extension portion and the adjacent side extension portion to which it is connected extend across two or more cells of a plurality of open cells defined by the plurality of struts, the two or more cells uncovered by the plurality of leaflets.

[0322] Example 68. The prosthetic heart valve of any example herein, particularly example 66, wherein the side extension portion and the adjacent side extension portion to which it is connected extend across three cells of a plurality of open cells defined by the plurality of struts, the three cells uncovered by the plurality of leaflets.

[0323] Example 69. The prosthetic heart valve of any example herein, particularly any one of examples 63-68, wherein the plurality of struts forms a plurality of circumferentially extending rows of struts arrayed along a length of the frame between the inflow end and the outflow end of the frame, wherein the plurality of circumferentially extending rows of struts includes a first row of first struts defining the inflow end of the frame, a second row of second struts disposed downstream of the first row of struts, and a third row of third struts disposed downstream of the second row of struts, and wherein pairs of first struts and second struts are interconnected at a plurality of circumferentially spaced strut junctions.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0324] Example 70. The prosthetic heart valve of any example herein, particularly example 69, wherein the central portion of each connecting skirt is secured to a portion of strut junctions of the plurality of circumferentially spaced strut junctions.

[0325] Example 71. The prosthetic heart valve of any example herein, particularly either example 69 or example 70, wherein each side base portion of each connecting skirt is secured to a respective, interconnected second strut and third strut.

[0326] Example 72. The prosthetic heart valve of any example herein, particularly any one of examples 69-71, wherein each side extension portion covers an inner surface of two first struts and a respective inflow apex connected between the two first struts and wraps around the inflow apex.

[0327] Example 73. The prosthetic heart valve of any example herein, particularly example 72, wherein each side extension portion covers an inner surface of each strut of a set of second and third struts that extend between cusp edge portions of adjacent leaflets.

[0328] Example 74. The prosthetic heart valve of any example herein, particularly any one of examples 63-73, wherein each connecting skirt includes a plurality of rows of apertures disposed in and extending across the two side base portions and the central portion, and wherein, for each leaflet, the central portion and two side base portions of the connecting skirt are arranged along and secured to the cusp edge portion of the leaflet via one or more sutures extending through a first two rows of the plurality of rows of apertures.

[0329] Example 75. The prosthetic heart valve of any example herein, particularly example 74, wherein, for each leaflet, the central portion and two side base portions of the connecting skirt secured to the leaflet are further secured to struts of the plurality of struts of the frame via one or more sutures extending through a second two rows of the plurality of rows of apertures.

[0330] Example 76. The prosthetic heart valve of any example herein, particularly either example 74 or example 75, wherein the central portion and the two side base portions are folded over lengthwise along the cusp edge portion of the leaflet to form two folded portions such that the first two rows of the plurality of rows of apertures overlap one another and the second two rows of the plurality of rows of apertures overlap one another.

[0331] Example 77. A method of assembling a prosthetic heart valve comprising a plurality of leaflets, comprising forming a plurality of leaflet assemblies with the plurality of leaflets, wherein each leaflet assembly is formed by securing a central portion and side base portionsTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]of a connecting skirt to a cusp edge portion of a leaflet, wherein each connecting skirt comprises two side portions, one arranged on either side of the central portion, wherein each side portion comprises a respective side base portion of the side base portions and a side extension portion extending away from the corresponding side base portion, and wherein the connecting skirt comprises two tabs extending from the central portion; and arranging the plurality of leaflet assemblies on an inside of a frame of the prosthetic heart valve; and securing the connecting skirt of each leaflet assembly to the frame such that the cusp edge portion of each leaflet is spaced away from an inflow end of the frame, in a downstream direction, the frame comprising a plurality of interconnected and angled struts and a plurality of inflow apices at the inflow end of the frame, the securing including, for each leaflet assembly securing the central portion and side base portions of the connecting skirt to a first set of struts of the plurality of interconnected and angled struts; extending each side extension portion of the connecting skirt across a second set of struts of the plurality of interconnected and angled struts that are disposed between cusp edge portions of adjacent leaflets; and wrapping each tab of the two tabs around a respective inflow apex of two adjacent inflow apices of the plurality of inflow apices and securing the tab thereto such that the inflow apex is covered by the tab.

[0332] Example 78. The method of any example herein, particularly example 77, wherein the securing further comprises wrapping each side extension portion around an inflow apex of the plurality of inflow apices that is disposed adjacent to the respective inflow apex that is wrapped by one of the two tabs.

[0333] Example 79. The method of any example herein, particularly either example 77 or example 78, wherein the securing further comprises securing each extension portion to an adjacent side extension portion of an adjacent connecting skirt.

[0334] Example 80. The method of any example herein, particularly any one of examples 77-79, wherein the connecting skirt includes a plurality of rows of apertures disposed in and extending across the side base portions and the central portion, and wherein the securing the central portion and side base portions of the connecting skirt to the cusp edge portion of the leaflet includes securing the central portion and side base portions to the cusp edge portion via a plurality of stitches extending through a first two rows of the plurality of rows of apertures.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]

[0335] Example 81. The method of any example herein, particularly example 80, wherein the securing the central portion and side base portions of the connecting skirt to the first set of struts includes securing the central portion and the side base portions to the first set of stmts via a plurality of stitches extending through a second two rows of the plurality of rows of apertures.

[0336] Example 82. The method of any example herein, particularly example 81, further comprising, prior to securing the central portion and side base portions to the first set of struts, folding the central portion and side base portions over lengthwise along the cusp edge portion of the leaflet to form two folded portions such that the first two rows overlap one another and the second two rows overlap one another.

[0337] Example 83. The method of any example herein, particularly any one of examples 77-82, wherein the plurality of interconnected and angled struts forms a plurality of circumferentially extending rows of struts arrayed along a length of the frame between the inflow end and the outflow end of the frame, wherein the plurality of circumferentially extending rows of struts includes a first row of first struts defining the inflow end of the frame, a second row of second struts disposed downstream of the first row of struts, and a third row of third struts disposed downstream of the second row of struts, and wherein pairs of first struts and second struts are interconnected at a plurality of circumferentially spaced strut junctions.

[0338] Example 84. The method of any example herein, particularly example 83, wherein securing the central portion and side base portions of the connecting skirt to the first set of struts of the plurality of struts includes securing the central portion to a portion of strut junctions of the plurality of circumferentially spaced strut junctions.

[0339] Example 85. The method of any example herein, particularly example 84, wherein the portion of strut junctions includes three strut junctions, and wherein the securing includes forming a double stitch around each strut junction and through the central portion.

[0340] Example 86. The method of any example herein, particularly any one of examples 83-85, wherein securing the central portion and side base portions of the connecting skirt to the first set of struts of the plurality of struts includes securing each side base portion to one second strut and one third strut that are connected to one another via a plurality of whip stitches.THVVA-24036WO01 FILED ELECTRONICALLY ON [DATE]

[0341] Example 87. The method of any example herein, particularly any one of examples 83-86, wherein each tab covers two first struts which are connected to one another by the respective inflow apex.

[0342] Example 88. The method of any example herein, particularly any one of examples 77-87, further comprising securing an outer skirt around an outside of the frame.

[0343] Example 89. A method comprising sterilizing the prosthetic heart valve, apparatus, and / or assembly of any example.

[0344] Example 90. A prosthetic heart valve of any one of examples 1 -89, wherein the prosthetic heart valve is sterilized.

[0345] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one prosthetic heart valve can be combined with any one or more features of another prosthetic heart valve. As another example, any one or more features of one frame for a prosthetic heart valve can be combined with any one or more features of another frame for a prosthetic heart valve.

[0346] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]We claim:

1. A prosthetic valve comprising:a frame comprising a plurality of interconnected struts forming plurality of circumferentially extending rows of struts arrayed along a length of the frame between an inflow end and an outflow end of the frame, wherein the plurality of circumferentially extending rows of struts includes a first row of first struts defining the inflow end of the frame and a second row of second struts disposed downstream of the first row of struts, wherein a pair of first struts and a pair of second struts are interconnected at each of a plurality of circumferentially spaced strut junctions, and wherein the frame comprises a plurality of inflow apices spaced circumferentially apart around the inflow end of the frame, each inflow apex connected to inflow ends of two first struts of the first row of first struts; anda plurality of leaflets mounted on an inside the frame, wherein each leaflet comprises an outflow edge portion and a cusp edge portion, wherein an inflow end of the cusp edge portion is coupled to selected strut junctions of the plurality of circumferentially spaced strut junctions downstream of the plurality of inflow apices.

2. The prosthetic valve of claim 1, wherein the cusp edge portion has a trapezoidal shape with two angled side edges and an inflow edge extending between the two angled side edges, and wherein the inflow edge defines the inflow end of the cusp edge portion which extends in a circumferential direction relative to a central longitudinal axis of the frame.

3. The prosthetic valve of claim 2, wherein the plurality of circumferentially extending rows of struts includes a third row of third struts disposed downstream of the second row of second struts, and wherein each angled side edge of the two angled side edges of the cusp edge portion extends along one second strut and one third strut that are connected end-to-end.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]4. The prosthetic valve of claim 3, further comprising a plurality of connecting skirts, wherein each connecting skirt is coupled to the cusp edge portion of a respective leaflet of the plurality of leaflets and coupled to the selected strut junctions, selected second struts, and selected third struts, thereby securing the cusp edge portion of the respective leaflet to the frame.

5. The prosthetic valve of claim 4, wherein each connecting skirt comprises: a central portion and opposing side base portions on opposite sides of the central portion, wherein the opposing side base portions are connected to each of and disposed between the selected second stmts and the selected third stmts and the cusp edge portion of the respective leaflet;side extension portions that extend outward from the cusp edge portion of the leaflet and across a portion of first, second, and third stmts that are disposed between cusp edge portions of adjacent leaflets; andtwo adjacent tabs that extend outward from the central portion of the connecting skirt, wherein each tab wraps around and covers a respective inflow apex of the plurality of inflow apices.

6. The prosthetic valve of any one of claims 1-5, wherein the plurality of interconnected struts are angled struts, and wherein each inflow apex forms a junction between two angled first struts of the first row of first struts.

7. The prosthetic valve of any one of claims 1-6, wherein each leaflet comprises a main body with the outflow edge portion and the cusp edge portion, and wherein an axial length of the leaflet that is defined between the outflow edge portion and the cusp edge portion is shorter than an axial length of the frame that is defined between the inflow end and the outflow end of the frame.

8. A prosthetic heart valve comprising:an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radiallyTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]expanded configuration, wherein the frame comprises a plurality of struts, and wherein the plurality of struts form a plurality of inflow apices at the inflow end of the frame: anda valvular structure mounted within the frame and comprising a plurality of leaflets, wherein each leaflet comprises opposing tabs on opposite sides of the leaflet and a cusp edge portion between the tabs;wherein the cusp edge portion of each leaflet is connected to the frame by a connecting skirt, wherein each connecting skirt comprises:a central portion and opposing side base portions on opposite sides of the central portion that are connected to each of and disposed between the frame and the cusp edge portion of the leaflet;side extension portions that extend from the cusp edge portion of the leaflet and across struts of the frame that are disposed between cusp edge portions of adjacent leaflets; andtwo adjacent tabs that extend from the central portion of the connecting skirt, wherein each tab wraps around a respective inflow apex of the plurality of inflow apices.

9. The prosthetic heart valve of claim 8, wherein the central portion of each connecting skirt is coupled to the cusp edge portion of a respective leaflet, and wherein the central portion of each connecting skirt is connected to the frame downstream of the plurality of inflow apices.

10. The prosthetic heart valve of either claim 8 or claim 9, wherein the two adjacent tabs wrap around a first pair of inflow apices of the plurality of inflow apices, and wherein the side extension portions of the connecting skirt wrap around a second pair of inflow apices of the plurality of inflow apices.

11. The prosthetic heart valve of any one of claims 8-10, wherein each side extension portion extends across at least one complete cell of a plurality of open cells defined by the plurality of struts, the at least one complete cell uncovered by the plurality of leaflets.THVVA-24036W001 FILED ELECTRONICALLY ON [DATE]12. The prosthetic heart valve of any one of claims 8-11, wherein each side extension portion is secured to an adjacent side extension portion of an adjacent connecting skirt, and wherein the side extension portion and the adjacent side extension portion are wrapped and secured around two inflow apices of the plurality of inflow apices.

13. The prosthetic heart valve of any one of claims 8-12, wherein each side extension portion has a wing-like shape that is defined by first and second angled edges that extend from opposite ends of a respective side base portion of the opposing side base portions and a third angled edge that extends between the first and second angled edges and is nonparallel to the respective side base portion.

14. The prosthetic heart valve of any one of claims 8-13, wherein the cusp edge portion of each leaflet comprises two angled side edges and an inflow edge extending between the two angled side edges, wherein the inflow edge defines an inflow end of the cusp edge portion which extends in a circumferential direction relative to the frame, wherein each leaflet comprises a main body with an outflow edge portion and the cusp edge portion, and wherein an axial length of the leaflet that is defined between the outflow edge portion and the inflow edge of the cusp edge portion is shorter than an axial length of the frame that is defined between the inflow end and the outflow end of the frame.

15. The prosthetic heart valve of claim 14, wherein the inflow edge of the cusp edge portion of each leaflet is connected to the frame by the connecting skirt downstream of the plurality of inflow apices.

16. A method of assembling a prosthetic heart valve comprising a plurality of leaflets, comprising:forming a plurality of leaflet assemblies with the plurality of leaflets, wherein each leaflet assembly is formed by:securing a central portion and side base portions of a connecting skirt to a cusp edge portion of a leaflet, wherein each connecting skirt comprises two side portions, one arranged on either side of the central portion, wherein each side portion comprises a respective side base portion of the side base portions and a side extension portionTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]extending away from the corresponding side base portion, and wherein the connecting skirt comprises two tabs extending from the central portion; andarranging the plurality of leaflet assemblies on an inside of a frame of the prosthetic heart valve; andsecuring the connecting skirt of each leaflet assembly to the frame such that the cusp edge portion of each leaflet is spaced away from an inflow end of the frame, in a downstream direction, the frame comprising a plurality of interconnected and angled struts and a plurality of inflow apices at the inflow end of the frame, the securing including, for each leaflet assembly:securing the central portion and side base portions of the connecting skirt to a first set of struts of the plurality of interconnected and angled struts:extending each side extension portion of the connecting skirt across a second set of struts of the plurality of interconnected and angled struts that are disposed between cusp edge portions of adjacent leaflets; andwrapping each tab of the two tabs around a respective inflow apex of two adjacent inflow apices of the plurality of inflow apices and securing the tab thereto such that the inflow apex is covered by the tab.

17. The method of claim 16, wherein the securing further comprises wrapping each side extension portion around an inflow apex of the plurality of inflow apices that is disposed adjacent to the respective inflow apex that is wrapped by one of the two tabs.

18. The method of either claim 16 or claim 17, wherein the connecting skirt includes a plurality of rows of apertures disposed in and extending across the side base portions and the central portion, and wherein the securing the central portion and side base portions of the connecting skirt to the cusp edge portion of the leaflet includes securing the central portion and side base portions to the cusp edge portion via a plurality of stitches extending through a first two rows of the plurality of rows of apertures.

19. The method of claim 18, wherein the securing the central portion and side base portions of the connecting skirt to the first set of struts includes securing the central portionTHVVA-24036W001 FILED ELECTRONICALLY ON [DATE]and the side base portions to the first set of struts via a plurality of stitches extending through a second two rows of the plurality of rows of apertures.

20. The method of claim 19, further comprising, prior to securing the central portion and side base portions to the first set of struts, folding the central portion and side base portions over lengthwise along the cusp edge portion of the leaflet to form two folded portions such that the first two rows overlap one another and the second two rows overlap one another.

Images