Assembly and method for attaching prosthetic valve components to a prosthetic heart valve frame

Abstract

A method for attaching a component to a frame of a prosthetic heart valve is disclosed. By way of example, the method includes forming a stitch line along an edge of an outer skirt for the prosthetic valve with an in-out stitch extending along the edge and spaced from a free edge of the edge, and a plurality of loops spaced apart in the direction of the in-out stitch, each loop surrounding the free edge and extending between the edge and an intersection of two adjacent in-out stitches. The method further includes attaching the edge to struts of the prosthetic valve frame by extending a whip stitch through the loops and around the struts such that the free edge is positioned relative to a radially outward-facing surface of the strut and away from a leaflet disposed inside the frame.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 402,808, filed August 31, 2022, and U.S. Provisional Patent Application No. 63 / 450,544, filed March 7, 2023, which are incorporated by reference in their entireties.

[0002] The present disclosure relates to prosthetic heart valves, and in particular to outer coverings or skirts and / or leaflets for prosthetic heart valves, and methods for attaching the outer skirts and / or leaflets to the frame of the prosthetic heart valve. [Background technology]

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

[0004] Most expandable prosthetic heart valves include a cylindrical metal frame or stent with prosthetic valve leaflets mounted inside the frame. These valves may also include an outer covering or skirt disposed around the exterior of the frame. The outer skirt may be configured to establish a seal with natural tissue (and thus may be referred to as a sealing member) when the prosthetic heart valve is placed at the implantation site. Summary of the Invention

[0005] Prosthetic heart valves, delivery devices, and methods for implanting the prosthetic heart valve are described herein. In particular, examples of an outer skirt for a prosthetic heart valve and a method for attaching the outer skirt to a frame of the prosthetic heart valve are described herein. The prosthetic heart valve may include a frame and a leaflet assembly disposed inside the frame. The prosthetic heart valve may include an outer skirt disposed on the outer surface of the frame around the periphery. The outer skirt may include a circumferentially extending edge positioned at the level of the valve leaflets and thus contacting the leaflets. In some embodiments, the edge (which may be an outflow edge of the outer skirt having a rougher surface relative to other portions of the outer skirt) may be secured to the frame using an overcast or loop stitch pattern sewn along the edge or edges of the outer skirt. As an example, the stitch pattern along the edge of the outer skirt may include multiple stitches forming loops over the free edge of the edge, connected by an in-out stitch line along the outer skirt spaced apart from the free edge. The whip stitch may then be extended through the loop and around the struts of the frame to attach the free edge of the outer skirt to the frame. Such an attachment method may not only position the free edge of the outer skirt on the outer surface of the frame strut, away from the valve leaflets, but may also distribute pulling forces from the whip stitch to the outer skirt, away from the free edge. In some embodiments, a similar stitch pattern may be used to attach the leaflet edges to the frame or skirt of the prosthetic heart valve, thereby providing a better flow pattern across the inflow edges of the leaflets during operation of the prosthetic valve. Thus, the devices and methods disclosed herein may, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves.

[0006] The method may include forming a stitch line along an edge of a first component for a prosthetic heart valve, the stitch line including a plurality of in-out stitches extending along the edge and a plurality of loops spaced apart from one another in the direction of the in-out stitches. Each loop surrounds an outer edge of the edge and extends between the edge and an intersection of two adjacent in-out stitches. The method further includes attaching the edge to a second component of the prosthetic heart valve by extending a plurality of whip stitches through the plurality of loops and around or through the second component.

[0007] In some embodiments, the first component is an outer skirt and the second component is a frame of the prosthetic heart valve.

[0008] In some embodiments, the first component is an outer skirt and the second component is a fabric configured to be secured to a frame of a prosthetic heart valve.

[0009] In some embodiments, the first component is a leaflet edge of a leaflet of a valve assembly of a prosthetic heart valve, and the second component is a woven component configured to be secured inside a frame of the prosthetic heart valve.

[0010] In some embodiments, the first component is a leaflet edge of a leaflet of a valve assembly of a prosthetic heart valve, and the second component is a strut of a frame of the prosthetic heart valve.

[0011] In some embodiments, the first component is a leaflet edge of a valve leaflet of a valve assembly of a prosthetic heart valve, and the second component is a suture wrapped directly around a strut of a frame of the prosthetic heart valve.

[0012] In some embodiments, the method may include forming a stitch line along an edge of an outer skirt for a prosthetic heart valve or along the cusp of a valve leaflet, the stitch line comprising a plurality of in-out stitches extending along the edge and a plurality of loops spaced apart from one another in the direction of the in-out stitches. Each loop encircles a free edge of the edge, and the plurality of loops space the plurality of in-out stitches from the free edge. The method may further include attaching the edge to an additional component of the prosthetic heart valve by extending a plurality of whip stitches through the plurality of loops and around the additional component. The additional component may be a strut of a row of circumferentially extending struts of an annular frame of the prosthetic heart valve, one or more sutures extending around the struts, or a fabric (such as a skirt or connecting component) configured to be secured to the frame.

[0013] In some embodiments, the method includes forming a stitch line along an edge of an outer skirt for a prosthetic heart valve, the stitch line comprising a plurality of in-out stitches extending along the edge and a plurality of loops spaced apart from one another in the direction of the in-out stitches. Each loop surrounds a free edge of the edge, and the plurality of loops space the plurality of in-out stitches from the free edge. The method further includes attaching the edge to struts of a row of circumferentially extending struts of an annular frame of the prosthetic heart valve by extending a plurality of whip stitches through the plurality of loops and around the struts such that the free edge of the edge is positioned relative to a radially outward-facing surface of the strut and away from leaflets disposed inside the annular frame.

[0014] In some embodiments, the method includes forming a stitch line along an edge of an outer skirt for a prosthetic heart valve, the stitch line including a plurality of in-out stitches extending along the edge spaced from a free edge of the edge and a plurality of loops spaced from one another in the direction of the in-out stitches. Each loop surrounds the free edge of the edge and extends between the edge and an intersection of two adjacent in-out stitches. The method further includes attaching the edge to struts of a row of circumferentially extending struts of an annular frame of the prosthetic heart valve by extending a plurality of whip stitches through the plurality of loops and around the struts such that the free edges of the edge are positioned relative to a radially outward-facing surface of the struts and away from leaflets disposed inside the annular frame.

[0015] In some embodiments, the method includes forming a stitch line along an edge of an outer skirt for a prosthetic heart valve, the stitch line comprising a plurality of in-out stitches extending along the edge spaced from a free edge of the edge and a plurality of pairs of loops spaced from one another in the direction of the in-out stitches. Each pair of loops includes a first loop and a second loop, the first loop surrounding the free edge of the edge and extending between the free edge and the second loop, and the second loop extending between the first loop and an intersection of two adjacent in-out stitches of the plurality of in-out stitches. The method further includes attaching the edge to struts of a row of circumferentially extending struts of an annular frame of the prosthetic heart valve by extending a whip stitch through the first loop of each pair of loops and around the struts such that the free edge of the edge is positioned relative to a radially outward-facing surface of the strut and away from leaflets disposed inside the annular frame.

[0016] In some embodiments, a method includes forming a stitch line along a leaflet edge of a prosthetic heart valve, the stitch line comprising a plurality of in-out stitches extending along the leaflet edge spaced from an outermost leaflet edge of the leaflet, and a plurality of loops spaced apart from one another in the direction of the in-out stitches, each loop surrounding a leaflet edge of the leaflet and extending between the leaflet and an intersection of two adjacent in-out stitches. The method further includes attaching the leaflet to a target component of the prosthetic heart valve by extending a plurality of whip stitches through the plurality of loops, around or through the target component, such that the leaflet edge of the leaflet is sewn against the target component.

[0017] In some embodiments, the method includes forming a stitch line along an edge of a first component for a prosthetic heart valve, the stitch line comprising a plurality of in-out stitches extending along the edge spaced from an outermost edge of the edge and a plurality of loops spaced from one another in the direction of the in-out stitches, each loop circumscribing an edge of the edge and extending between the edge and an intersection of two adjacent in-out stitches. The method further includes attaching the edge to a second component of the prosthetic heart valve by extending a plurality of whip stitches through the plurality of loops, around or through the second component, such that the edge of the edge is joined to and sewn to the second component.

[0018] In some embodiments, the method includes one or more of the features listed in Examples 1-56, 94-107, 128-136, and 145 below.

[0019] The prosthetic heart valve may include a frame and a valve structure coupled to the frame. In addition to these components, the prosthetic heart valve may further include one or more of the components disclosed herein.

[0020] In some examples, the prosthetic heart valve may include a sealing member configured to reduce paravalvular leakage.

[0021] In some embodiments, the sealing member may be an outer sealing member disposed around the outer surface of the frame.

[0022] In some examples, the outer sealing member may include an outflow edge having a free outflow edge, the outflow edge comprising a stitch line comprising a plurality of in-out stitches extending along the outflow edge parallel to but spaced apart from the outflow edge, and a plurality of loop stitches spaced apart from one another in the direction of the plurality of in-out stitches, each loop stitch circumscribing the outflow edge and extending between the outflow edge and an intersection of corresponding two adjacent in-out stitches of the plurality of in-out stitches.

[0023] In some embodiments, the outflow edge may be attached to the frame posts by additional stitches that extend through the plurality of loop stitches.

[0024] In some embodiments, a prosthetic heart valve may include a frame, a valve structure coupled to the frame, and an outer sealing member disposed around an outer surface of the frame. The outer sealing member may include an outflow edge having a free outflow edge, the outflow edge including a stitch line extending circumferentially around the frame and including a plurality of in-out stitches extending along the outflow edge parallel to but spaced from the outflow edge, and a plurality of loop stitches spaced apart from one another in the direction of the plurality of in-out stitches. Each loop stitch surrounds the outflow edge and extends between the outflow edge and an intersection of corresponding two adjacent in-out stitches of the plurality of in-out stitches. The outflow edge is attached to the struts of the frame by additional stitches extending through the plurality of loop stitches.

[0025] In some embodiments, a prosthetic heart valve may include a frame and a valve structure coupled to the frame, the valve structure including a plurality of leaflets, each leaflet having a leaflet edge attached to an inner skirt configured to be attached to the interior of the frame by a stitch line formed along a portion of an angled strut of the frame or along the leaflet edge, the stitch line including a plurality of in-out stitches extending along the leaflet edge parallel to but spaced from the free edge of the leaflet, and a plurality of loop stitches spaced apart from one another in the direction of the plurality of in-out stitches. Each loop stitch surrounds the leaflet edge and extends between the leaflet and an intersection of corresponding two adjacent in-out stitches of the plurality of in-out stitches. The prosthetic heart valve further includes a plurality of stitches extending through the plurality of loop stitches, around a portion of the angled struts, around one or more sutures extending around a portion of the angled struts, or through the inner skirt, such that the leaflet is coupled to the angled struts and / or a portion of the inner skirt.

[0026] In some embodiments, a prosthetic heart valve comprises an annular frame including a plurality of interconnected struts arranged in a plurality of circumferentially extending strut rows, including a first circumferentially extending strut row positioned closer to the outflow end than the inflow end of the frame. The prosthetic heart valve further comprises an outer skirt disposed around an outer surface of the frame and including an outflow edge having a free outflow edge. The outflow edge includes a stitch line extending circumferentially around the frame and including a plurality of in-out stitches extending along the outflow edge parallel to but spaced from the outflow edge, and a plurality of loop stitches spaced apart from one another in the direction of the plurality of in-out stitches. Each loop stitch surrounds the outflow edge and extends between the outflow edge and an intersection of corresponding two adjacent in-out stitches of the plurality of in-out stitches. The prosthetic heart valve further comprises a plurality of whip stitches extending through the plurality of loop stitches and around the first circumferentially extending strut row of the struts such that the outflow edge is attached to the strut against a radially outward-facing surface of the strut.

[0027] In some embodiments, the prosthetic heart valve comprises an annular frame including a plurality of interconnected struts arranged in a plurality of circumferentially extending strut rows between an inflow end and an outflow end of the frame, the plurality of circumferentially extending strut rows including a first circumferentially extending strut row. The prosthetic heart valve further comprises an outer skirt disposed around an outer surface of the frame and including a rim having a free edge, the rim including a stitch line extending circumferentially around the frame and including a plurality of in-out stitches extending along the edge parallel to but spaced from the free edge, and a plurality of pairs of loop stitches spaced apart from one another in the direction of the plurality of in-out stitches. Each pair of loop stitches includes a first loop stitch and a second loop stitch, the first loop stitch circumferentially surrounding the free edge and extending between the free edge and the second loop, and the second loop extending between the first loop and an intersection of corresponding two adjacent in-out stitches of the plurality of in-out stitches. The prosthetic heart valve further comprises a plurality of whip stitches extending through a first loop stitch of each pair of loop stitches and around the struts of the first circumferentially extending row of struts such that the free edges are attached to the struts against radially outward facing surfaces of the struts.

[0028] In some embodiments, a prosthetic heart valve comprises an annular frame including a plurality of interconnected struts arranged in a plurality of circumferentially extending rows of angled struts between an inflow end and an outflow end of the frame, and a plurality of leaflets disposed on an interior of the frame, each leaflet having a leaflet edge extending between opposing side portions disposed on opposing ends of an outflow edge of the leaflet, the leaflet edge being attached to a portion of the angled struts of the plurality of circumferentially extending rows of angled struts by a stitch line formed along the leaflet edge, the stitch line comprising a plurality of in-out stitches extending along the leaflet edge parallel to but spaced from the free edge of the leaflet, and a plurality of loop stitches spaced from one another in the direction of the plurality of in-out stitches, each loop stitch surrounding the leaflet edge and extending between the leaflet edge and an intersection of corresponding two adjacent in-out stitches of the plurality of in-out stitches. The prosthetic heart valve further comprises a plurality of whip stitches extending through the plurality of loop stitches and around a portion of the angled strut or around one or more sutures extending around a portion of the angled strut such that the cusp is joined to and sewn against the portion of the angled strut.

[0029] In some embodiments, a prosthetic heart valve comprises an annular frame including a plurality of interconnected struts arranged in a plurality of circumferentially extending rows of angled struts between an inflow end and an outflow end of the frame, an inner skirt configured to be secured to a portion of the angled struts of the plurality of circumferentially extending rows of angled struts inside the frame, and a plurality of leaflets disposed on the interior of the frame, each leaflet having a leaflet edge extending between opposing lateral portions disposed on opposing ends of an outflow edge of the leaflet, the leaflet edge being attached to the inner skirt by a stitch line formed along the leaflet edge, the stitch line comprising a plurality of in-out stitches extending along the leaflet edge parallel to but spaced from the free edge of the leaflet, and a plurality of loop stitches spaced from one another in the direction of the plurality of in-out stitches, each loop stitch surrounding a leaflet edge and extending between the leaflet edge and an intersection of corresponding two adjacent in-out stitches of the plurality of in-out stitches. The prosthetic heart valve further comprises a plurality of whip stitches extending through the plurality of loop stitches and through the inner skirt such that the leaflets are joined to and sewn against the inner skirt.

[0030] In some embodiments, a prosthetic heart valve comprises: a frame including a plurality of interconnected struts; a plurality of leaflets disposed within the frame and configured to regulate unidirectional blood flow through the frame, each leaflet comprising a leaflet edge; at least one suture extending along the leaflet edge of at least a first leaflet of the plurality of leaflets; a plurality of in-out stitches extending through the suture and the leaflet edge of the first leaflet; and a plurality of first stitches extending around selected struts of the plurality of interconnected struts and a portion of the in-out stitches to couple the leaflet edge of the first leaflet to the frame.

[0031] In some embodiments, the prosthetic heart valve comprises one or more of the components listed in Examples 57-93, 108-127, and 137-144 below.

[0032] The various innovations of this disclosure may be used in combination or individually. 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. These and other objects, features, and advantages of the present disclosure will become more apparent from the following Detailed Description, the claims, and the accompanying drawings. [Brief explanation of the drawings]

[0033] [Figure 1] FIG. 1 is a side view of a prosthetic heart valve according to one embodiment. [Figure 2] 2 is a side view of the frame of the prosthetic heart valve of FIG. 1. FIG. [Figure 3] FIG. 3 is a side view of a portion of the frame of FIG. 2, showing the portion of the frame in a straight (non-annular) state. [Figure 4] FIG. 4 is a side view of an exemplary delivery device configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site. [Figure 5] FIG. 5 is a side view of an outer skirt for a prosthetic heart valve, according to one embodiment, showing the outer skirt in a flat configuration. [Figure 6] FIG. 6 is a schematic diagram of a portion of an outer skirt and an exemplary stitch line along the edge of the outer skirt, where the stitch line includes an in-out stitch that is spaced from the free edge of the edge by multiple spaced single loops of the stitch line. [Figure 7A] FIG. 7A is a schematic diagram of the outer skirt and stitch lines of FIG. 6 showing the edges secured to the struts of the prosthetic device frame using whip stitches that extend around the struts and through loops in the stitch lines. [Figure 7B] 7B is a cross-sectional view showing the edge of the outer skirt of FIG. 7A secured to the post of a frame using a whip stitch that extends around the post and through the loop of the stitch line of FIG. 6. [Figure 8A] FIG. 8A is a schematic diagram of a portion of an outer skirt and an exemplary stitch line along the edge of the outer skirt, where the stitch line includes an in-out stitch that is spaced from the free edge of the edge by multiple spaced-apart paired loops of the stitch line. [Figure 8B] FIG. 8B is a schematic diagram of the outer skirt and stitch lines of FIG. 8A showing a second pass of alternating in-out stitches within the stitch lines. [Figure 9A] FIG. 9A shows an example of the stitch line of FIG. 8A applied to the contoured edge of the outer skirt with a first pass of in-out stitching. [Figure 9B] FIG. 9B shows an example of the stitch line of FIG. 9A including a second pass of in-out stitching. [Figure 10A] FIG. 10A shows an external view of a portion of a prosthetic valve frame, in which an outer skirt with the stitching lines of FIGS. 9A and 9B is disposed around the outer surface of the frame and secured to the struts of the frame by whip stitches that extend around the struts and through the loops of the stitching lines. [Figure 10B] FIG. 10B shows an internal view of the frame and outer skirt of FIG. 10A, with the edges of the outer skirt attached to the frame posts by whip stitches that extend through the loops of the stitch line. [Figure 11] FIG. 11 is a schematic diagram of the outer skirt and stitchline of FIG. 8A showing the edges secured to the struts of the prosthetic device frame using a whip stitch that extends around the struts and doubles around the loops of the stitchline. [Figure 12A] 12A-12G show an exemplary process for forming the whip stitch of FIG. 11 to extend through the double loop and the loops of the stitch line around the frame struts to secure the edge of the outer skirt to the prosthetic valve frame. [Figure 12B]12A-12G show an exemplary process for forming the whip stitch of FIG. 11 to extend through the double loop and the loops of the stitch line around the frame struts to secure the edge of the outer skirt to the prosthetic valve frame. [Figure 12C] 12A-12G show an exemplary process for forming the whip stitch of FIG. 11 to extend through the double loop and the loops of the stitch line around the frame struts to secure the edge of the outer skirt to the prosthetic valve frame. [Figure 12D] 12A-12G show an exemplary process for forming the whip stitch of FIG. 11 to extend through the double loop and the loops of the stitch line around the frame struts to secure the edge of the outer skirt to the prosthetic valve frame. [Figure 12E] 12A-12G show an exemplary process for forming the whip stitch of FIG. 11 to extend through the double loop and the loops of the stitch line around the frame struts to secure the edge of the outer skirt to the prosthetic valve frame. [Figure 12F] 12A-12G show an exemplary process for forming the whip stitch of FIG. 11 to extend through the double loop and the loops of the stitch line around the frame struts to secure the edge of the outer skirt to the prosthetic valve frame. [Figure 12G] 12A-12G show an exemplary process for forming the whip stitch of FIG. 11 to extend through the double loop and the loops of the stitch line around the frame struts to secure the edge of the outer skirt to the prosthetic valve frame. [Figure 13] FIG. 13 is a perspective view of an outer skirt attached to a prosthetic valve frame using the stitch lines and whip stitches of FIG. 11 according to the process presented in FIGS. 11 and 12A-12G. [Figure 14]FIG. 14 is a schematic illustration of a leaflet for a prosthetic heart valve and an exemplary stitch line along the leaflet edge of the valve leaflet, where the stitch line includes an in-out stitch that separates the stitch line from the leaflet edge by multiple spaced-apart single loops of the stitch line, and multiple whip stitches that connect the stitch line to additional components for the prosthetic heart valve. [Figure 15] FIG. 15 is a detailed view of a portion of the cusp, stitch lines, and additional components of FIG. [Figure 16] FIG. 16 is a plan view of an exemplary valve leaflet with the stitch line of FIG. 14 formed along the leaflet edge and multiple in-out stitches extending through the sutures extending along the leaflet edge. [Figure 17] FIG. 17 is a plan view of a leaflet assembly including multiple leaflets of FIG. 16 secured together, with the stitch lines of FIG. 16 formed along the leaflet edges of each leaflet. [Figure 18] 18 is a perspective view of a frame of a prosthetic heart valve in which the leaflet assembly of FIG. 17 is disposed within the frame with the commissures of the leaflet assembly coupled to the frame. [Figure 19] FIG. 19 is a detailed view of the inflow end of the frame with the leaflets of the leaflet assembly of FIG. 17 joined to the struts of the frame using stitch lines along the leaflets. [Figure 20] FIG. 20 is another detailed view of the inflow end of the frame showing the leaflets of the leaflet assembly of FIG. 17 joined to the struts of the frame using stitch lines along the leaflets. [Figure 21] FIG. 21 is another detailed view of the inflow end of the frame showing the leaflet assembly of FIG. 17 attached to the frame and an outer skirt disposed around the outer surface of the frame. [Figure 22] FIG. 22 is a plan view of a leaflet assembly in a flat configuration, with the leaflets of the assembly secured together with connecting sutures placed along the edge of each of the leaflets. [Figure 23] FIG. 23 is a plan view of one leaflet with connecting sutures secured to the leaflet edges. [Figure 24]24 is a schematic cross-sectional view of a portion of a prosthetic valve showing the leaflets of FIG. 23 secured to the outer skirt of the prosthetic heart valve with stitches extending through the struts of the frame and the connecting sutures. [Figure 25] 25 is a perspective view of a portion of a prosthetic valve showing the leaflets of FIG. 23 secured to the struts of a frame of the prosthetic heart valve with stitches extending around the in-out stitches of the connecting sutures. [Figure 26] FIG. 26 is a perspective view of a portion of a prosthetic valve showing the leaflets of FIG. 23 secured to the struts of a frame of the prosthetic heart valve, with stitches extending around the in-and-out stitches of the connecting sutures, around the struts of the frame, and through an outer skirt disposed around the outer surface of the frame. DETAILED DESCRIPTION OF THE INVENTION

[0034] General Considerations For purposes of this specification, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone, in various combinations with each other, and in various subcombinations with each other. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more particular advantages exist or problems be solved.

[0035] Although some operations in the disclosed embodiments are described in a particular sequential order for convenience of presentation, it should be understood that aspects of the description encompass reordering unless a specific order is required by specific language set forth below. For example, operations described sequentially may, in some cases, be reordered or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various aspects in which the disclosed methods may be used in combination with other methods. Additionally, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual actions that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0036] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Furthermore, the term "coupled" generally means to physically, mechanically, chemically, magnetically, and / or electrically couple or connect, and does not exclude the existence of intermediate elements between coupled or associated members, unless specific language to the contrary exists.

[0037] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and farther away from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is farther away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of a device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial," unless expressly defined otherwise, refer to axes extending in proximal and distal directions.

[0038] Overview of the disclosed technology As introduced above, a prosthetic heart valve may include a frame including interconnected struts, leaflets mounted inside the frame, and an outer skirt disposed around the outer surface of the frame. In some embodiments, the edge of the outer skirt, which is disposed across the frame at the level of the leaflets, may be jagged, rough, or otherwise polished (e.g., by exposed fibers comprising the skirt or from a fused edge formed by melting fibers along the edge to reduce chafing of the outer skirt fabric). Thus, the edge of the outer skirt may contact the leaflets during operation of the prosthetic heart valve, shortening the lifespan of the leaflets. To prevent the leaflets from contacting the edge of the outer skirt during operation of the prosthetic heart valve, in some cases, the edge of the outer skirt may be folded outward, away from the frame and the leaflets. The folded edge may then be secured to the frame by stitches extending through the folded edge of the skirt and around the struts of the frame. In some embodiments, the stitches may pass through the folded skirt layer near the edge of the skirt, which may cause chafing or unraveling of the skirt edge. Additionally, skirt attachment methods that involve folding the edges of the skirt over before suturing can increase assembly time for the prosthetic heart valve (as such a process cannot be easily automated).

[0039] In some examples, the cusp edges (or scalloped edges) of the valve leaflets may be sutured to a frame or replacement component (e.g., a fabric skirt) in a manner that creates stepped edges that can cause undesirable flow disturbances (e.g., uneven or turbulent flow) in these areas. Such flow disturbances can reduce the efficiency of the prosthetic heart valve.

[0040] Described herein are various methods for attaching (e.g., sewing) the outer skirt to the frame of the prosthetic heart valve, which positions the edge of the outer skirt (which may be positioned at the level of the valve leaflets) away from the leaflets while transferring the pulling force on the skirt from the stitches used to attach the outer skirt to the frame away from the skirt edge. As a result, the durability and lifespan of the prosthetic heart valve may be increased, while also reducing the time and effort required to assemble the prosthetic heart valve.

[0041] Also described herein are methods for attaching (e.g., suturing) the leaflet edges to a target component of a prosthetic heart valve (such as a fabric skirt, sutures extending around or directly onto frame struts of a frame, etc.) that result in the leaflet edges being securely sewn to the target component. As a result, a more continuous or smooth geometry can be created at the inflow edge of the leaflet, thereby reducing the likelihood of blood flow obstruction along the inflow edge. Therefore, the efficiency of the prosthetic heart valve can be increased.

[0042] The prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be crimped onto or held by an implant delivery device in a radially compressed state while being advanced through the patient's vasculature on the delivery device. Once the prosthetic valve reaches the implantation site, it can be expanded to a radially expanded state. It will be understood that the prosthetic valves disclosed herein can be used with a variety of implant delivery devices and implanted via a variety of delivery techniques, examples of which are discussed in more detail below.

[0043] Figure 1 illustrates an exemplary prosthetic device (e.g., a prosthetic heart valve) including a frame, leaflets secured to the inside of the frame, and an outer skirt disposed around the outer surface of the frame. In some embodiments, the frame may include a plurality of interconnected angled struts at the inflow and outflow ends of the frame, and apex regions extending and / or curved between the angled struts, as shown in Figures 2 and 3. The prosthetic device may be advanced through a patient's vasculature to a native heart valve or the like by a delivery device, such as the exemplary delivery device shown in Figure 4.

[0044] An exemplary outer skirt for a prosthetic heart valve is shown in FIG. 5. The outer skirt can include an edge, such as an outflow edge or edge, configured to be secured to the struts of a frame. In some embodiments, the edge of the outer skirt can be secured to the frame using an overcast stitch pattern sewn along the edge of the outer skirt. As an example, the stitch pattern along the edge of the outer skirt can include multiple stitches forming loops on the outside or free edge of the edge, connected by an in-out stitch line along the outer skirt that is spaced apart from the free edge (FIG. 6). A whip stitch can then be extended through the loops and around the struts of the frame to attach the edge of the outer skirt to the frame (FIGS. 7A and 7B).

[0045] 8A-13 show another example of a similar overcast stitch pattern used to attach the outer skirt edge to the frame, but the overcast stitch pattern includes two loops between the free edge of the outer skirt and the in-out stitch line. This stitch pattern may better hold in place the loops of the overcast stitch line and the whip stitch that extends through the second loop around the skirt edge.

[0046] Such a stitch pattern positions and holds the outer skirt edge (e.g., rough edge) along the radially outward-facing surface of the frame struts, thereby positioning the skirt edge away from the valve leaflets (Figures 10B, 12F, 12G, and 13).

[0047] 14-16 show examples of overcast stitch patterns that are sutured along the cusp edges of the prosthetic heart valve leaflets, thereby resulting in an overcast stitch line that includes multiple in-out stitches and loops. The cusp edges can be attached to additional components by multiple whip stitches that extend through the loops of the overcast stitch line, around or through the additional component. In some examples, as shown in FIGS. 17-21, the cusp edges of the valve leaflets can be secured to the struts of the prosthetic valve frame using the overcast stitch line.

[0048] In some embodiments, the leaflet edges may include an in-out stitch line, as shown in Figures 22 and 23. The leaflet edges may then be secured to the frame by stitches that extend through or around the in-out stitches of the in-out stitch line and around the struts of the frame, as shown in Figures 24-26.

[0049] Examples of the disclosed technology FIG. 1 illustrates a prosthetic heart valve 100 (artificial valve) according to one embodiment. While all of the prosthetic valves disclosed herein are configured for implantation in the native aortic valve annulus, in other embodiments, they may be adapted for implantation in other native heart valve annulus locations (such as the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves may also be implanted within blood vessels leading to the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), the superior vena cava, or the inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, or blood vessels of a patient. The disclosed prosthetic valves may also be implanted within a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0050] In some embodiments, the disclosed prosthetic valves can be implanted within a docking device or anchoring device that is implanted within a native heart valve or blood vessel. For example, in one embodiment, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another embodiment, the disclosed prosthetic valves can be implanted within a docking device implanted within or into a native mitral valve, such as disclosed in International Publication No. WO 2020 / 247907, which is incorporated herein by reference. In another embodiment, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava to replace the function of a diseased tricuspid valve, such as disclosed in U.S. Patent Application Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0051] The prosthetic heart valve 100 may include a stent or frame 102, a valvular structure 104, and a valve-circumferential outer sealing member or outer skirt 106. The prosthetic heart valve 100 (and frame 102) may have an inflow end 108 and an outflow end 110. The valvular structure 104 may be disposed inside the frame 102, while the outer skirt 106 is disposed around the outer surface of the frame 102.

[0052] The valvular structure 104 may include a plurality of leaflets 112 (e.g., three leaflets as shown in FIG. 1 ) collectively forming a leaflet structure that may be arranged to collapse in a tricuspid configuration. The leaflets 112 may be secured to one another at adjacent sides (e.g., commissure tabs) to form commissures 114 of the valvular structure 104. For example, each leaflet 112 may include opposing commissure tabs located on opposite sides of each leaflet 112 and leaflet edges extending between the opposing commissure tabs. The leaflet edges of the leaflets 112 may have an undulating, curved, scalloped shape and may be secured directly to the frame 102 (e.g., with sutures). However, in alternative embodiments, the leaflet edges of the leaflets 112 may be secured to an inner skirt, which is then secured to the frame 102. In some embodiments, the leaflets 112 may be formed from pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or a variety of other suitable natural or synthetic materials known in the art and described in U.S. Pat. No. 6,730,118, which is incorporated herein by reference.

[0053] In some embodiments, the outer skirt 106 may be an annular skirt. In some cases, the outer skirt 106 may include one or more skirt sections connected together and / or individually to the frame 102. The outer skirt 106 may include a woven or polymeric material, such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, and the like. In some cases, instead of having a relatively straight upper edge as shown in FIG. 1 , the outer skirt 106 may have a contoured upper edge that extends along and is secured to the angled struts 134. Examples of such outer skirts, as well as various other outer skirts that may be used with the frame 102, may be described in U.S. Provisional Patent Application No. 63 / 366,599, filed June 17, 2022, which is incorporated herein by reference.

[0054] Frame 102 may be radially compressible and expandable between a radially compressed (or collapsed) configuration and a radially expanded configuration (the expanded configuration is shown in FIG. 1). Frame 102 is shown alone in FIG. 2, and a portion of frame 102 in a linear (non-annular) configuration is shown in FIG. 3.

[0055] Frame 102 can be made of any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol). If constructed from a plastically expandable material, frame 102 (and thus valve 100) can be crimped into a radially compressed state on a delivery catheter and then expanded within the patient's body by an inflatable balloon or equivalent expansion mechanism. If constructed from a self-expandable material, frame 102 (and therefore valve 100) can be crimped into a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism on the delivery catheter. Once introduced into the body, the valve can be advanced from the delivery sheath, allowing the valve to expand to its functional size.

[0056] Suitable plastically expandable materials that can be used to form the frames (e.g., frame 102) disclosed herein include metal alloys, polymers, or combinations thereof. Exemplary metal alloys can include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some embodiments, frame 102 can include stainless steel. In some embodiments, frame 102 can include cobalt-chromium. In some embodiments, frame 102 can include nickel-cobalt-chromium. In some embodiments, frame 102 can include a nickel-cobalt-chromium alloy, such as MP35N™ (a trade name of SPS Technologies), which is equivalent to UNS R30035 (certified per ASTM F562-02). MP35N™ / UNS R30035 includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight.

[0057] 2 and 3, the frame 102 can include a plurality of interconnected struts 116 that form multiple rows of open cells 118 between the outflow end 110 and the inflow end 108 of the frame 102. In some embodiments, as shown in FIGS. 2 and 3, the frame 102 is comprised of three rows of cells 118, with a first row (the upper row in the orientation shown in FIGS. 2 and 3) of cells 120 disposed at the outflow end 110. The cells 120 in the first row include cells 118 that are axially elongated (relative to a central longitudinal axis 122 of the frame 102) compared to the cells 118 in the remaining rows. For example, the cells 118 of the first row of cells 120 may have a longer axial length 124 (FIG. 3) than the cells 118 of the remaining rows, which include the cells 126 of the second row and the cells 128 of the third row, with the cells 128 of the third row being disposed at the inflow end 108 and the cells 126 of the second row being disposed between the cells 120 of the first row and the cells 128 of the third row.

[0058] 2, each column of cells includes nine cells 118. Thus, in such an embodiment, frame 102 may be referred to as a nine-cell frame.

[0059] In alternative embodiments, frame 102 may include more than three rows of cells (e.g., four or five rows) and / or may include more than ten cells or fewer than eight cells per row. In some embodiments, cells 118 in first row of cells 120 may not be elongated compared to cells 118 in the remaining rows of cells of frame 102 (second row of cells 126 and third row of cells 128).

[0060] The interconnected struts 116 may include a plurality of angled struts 130, 132, 134, and 136 arranged in multiple rows of circumferentially extending rows of angled struts, which rows are arranged along the length of the frame 102 between the outflow end 110 and the inflow end 108. For example, the frame 102 may include a first row of circumferentially extending angled struts 130, a second row of circumferentially extending angled struts 132, a third row of circumferentially extending angled struts 134, and a fourth row of circumferentially extending angled struts 136 at the outflow end 110 of the frame 102, disposed end-to-end. The fourth row of angled struts 136 may be connected to the third row of angled struts 134 by a plurality of axially extending window struts 138 (or window strut portions) and a plurality of axial (e.g., axially extending) struts 140. The axially extending window struts 138 (which may also be referred to as axial struts including commissural windows) are spaced apart circumferentially around the frame 102 and define commissural windows (e.g., open windows) 142 adapted to receive a pair of commissural tabs of a pair of adjacent leaflets 112 disposed at a commissure (e.g., commissure 114 shown in FIG. 1 ). In some examples, the commissural windows 142 and / or the axially extending window struts 138 defining the commissural windows 142 may be referred to herein as commissural mechanisms or commissural supports, with each commissural mechanism or support configured to receive and / or be secured to a pair of commissural tabs of a pair of adjacent leaflets.

[0061] One or more (e.g., two as shown in FIGS. 2 and 3 ) axial struts 140 may be positioned circumferentially between two commissural fenestrae 142 formed by the fenestrations 138. Because the frame 102 may include fewer cells per row (e.g., nine) and fewer axial struts 140 between each commissural fene 142 compared to some more conventional prosthetic heart valves, each cell 118 may have an increased width (circumferentially), thereby providing a larger opening for blood flow and / or coronary access.

[0062] Each axial strut 140 and each window strut 138 extends from a location defined by the convergence of the lower ends (e.g., the ends disposed inwardly and furthest from the outflow end 110) of two angled struts 136 (which may also be referred to as upper strut junctions or upper elongated strut junctions) to another location defined by the convergence of the upper ends (e.g., the ends disposed closer to the outflow end 110) of two angled struts 134 (which may also be referred to as lower strut junctions or lower elongated strut junctions). Each axial strut 140 and each window strut 138 forms the axial sides of two adjacent ones of the first row of cells 120.

[0063] In some embodiments, as shown in FIG. 3, each axial strut 140 can have a width 144 ( FIG. 3 ) that is greater than the width of the angled struts 130, 132, 134, and 136. As used herein, the "width" of a strut is measured between opposite locations on opposite faces of the strut extending between the radially-facing inner and outer faces of the strut (relative to the central longitudinal axis 122 of the frame 102). The "thickness" of a strut is measured between opposite locations on the radially-facing inner and outer faces of the strut and is perpendicular to the strut's width. In some embodiments, the width 144 of the axial strut 140 is greater (e.g., twice as great) than the width of the angled struts of the frame 102 by 50% to 200%, 75% to 150%, or at least 100%.

[0064] By providing axial struts 140 with widths 144 that are greater than the widths of the other angled struts of frame 102, a larger contact area is provided when leaflets 112 contact the wider axial struts 140 during systole, thereby distributing stress and reducing the extent to which leaflets 112 may collapse radially outward through cells 118 onto axial struts 140, which may increase the long-term durability of leaflets 112.

[0065] Because the cells 118 of the frame 102 may have a relatively large width compared to alternative prosthetic valves having more than nine cells per row (as introduced above), wider axial struts 140 may be more easily incorporated into the frame 102 without sacrificing open space for blood flow and / or coronary access.

[0066] The commissure tabs 115 of adjacent leaflets 112 can be secured together to form a commissure 114 ( FIG. 1 ). Each commissure 114 of the prosthetic heart valve 100 includes two paired commissure tabs 115, one from each of two adjacent leaflets 112, that extend through commissure windows 142 in the frame 102. Each commissure 114 can be secured to a window strut 138 that forms the commissure window 142.

[0067] The leaflet edge (e.g., scallop edge) of each leaflet 112 may be secured to the frame 102 via one or more fasteners (e.g., sutures). In some embodiments, the leaflet edge of each leaflet 112 may be secured directly to struts (e.g., angled struts 130, 132, and 134) of the frame 102. For example, the leaflet edge of the leaflet 112 may be sutured to the angled struts 130, 132, and 134 that generally follow the contour of the leaflet edge of the leaflet 112.

[0068] In some embodiments, the cusp edges of the leaflets 112 may be secured to an inner skirt, which may then be secured directly to the frame 102 .

[0069] Various methods for securing the leaflets 112 to a frame, such as the frame 102, are disclosed in U.S. Provisional Patent Application No. 63 / 278,922, filed November 12, 2021, and U.S. Provisional Patent Application No. 63 / 300,302, filed January 18, 2022, both of which are incorporated herein by reference.

[0070] 2 and 3 , in some embodiments, one or more or each of the axial struts 140 may include an inflow end portion 146 (e.g., the end portion closest to the inflow end 108) and an outflow end portion 148 that are wider relative to an intermediate portion 150 (which may be defined by a width 144) of the axial strut 140. In some cases, the inflow end portion 146 of the axial strut 140 may include an opening 147. The opening 147 may be configured to receive a fastener (e.g., suture) for attaching the soft components of the prosthetic heart valve 100 to the frame 102. For example, in some cases, the outer skirt 106 may be positioned around the outer surface of the frame 102, and the top or outflow edge of the outer skirt 106 may be secured to the opening 147 by a fastener 149 (e.g., suture), as shown in FIG.

[0071] The interconnected struts 116 may also include horizontal struts 182 extending between adjacent cells 118 of a row of cells of the frame 102 ( FIGS. 2 and 3 ). The horizontal struts 182 may extend circumferentially and may also be referred to as circumferentially extending struts 182. The horizontal struts 182 may connect angled struts of angled struts of two adjacent rows of the frame 102 to one another. For example, each horizontal strut 182 may connect to two angled struts of one row of struts (e.g., strut 134 shown in FIG. 3 ) and to two angled struts of another adjacent row of struts (e.g., strut 132 shown in FIG. 3 ). As a result, the angled struts 184 extending between the axially extending window struts 138 and the horizontal struts 182, and the angled struts 186 extending between the horizontal struts 182 and another horizontal strut 182 disposed adjacent the inflow end 108 of the frame 102, may be aligned along angled lines that may follow the scallop lines of the valve leaflets (when the leaflets are attached to the frame 102). Thus, the horizontal struts 182 may cause the angled struts to follow a shape that more closely matches the shape of the scallop lines of the valve leaflets when the frame 102 is in the radially expanded configuration (as shown in FIGS. 2 and 3). Additionally, the horizontal struts 182 may function as spacers that may maintain a specified gap between the angled struts when the frame 102 is in the radially compressed configuration, thereby reducing the risk of the leaflets becoming pinched between the struts in the radially compressed configuration.

[0072] The frame 102 may further include a plurality of apex regions 152 formed at the inflow end 108 and the outflow end 110, with each apex region 152 extending between and forming a junction between two of the angled struts 130 at the inflow end 108 or two of the angled struts 136 at the outflow end 110. Thus, the apex regions 152 are circumferentially spaced apart from one another at the inflow end 108 and the outflow end 110.

[0073] Each apex region 152 may include an apex 154 (the axially highest or outermost extending point) and two thinned (or narrowed) strut portions 156, one extending from each side of the apex 154 to a corresponding wider angled strut 136 (outflow end 110) or angled strut 130 (inflow end 108) ( FIG. 3 ). In this manner, each apex region 152 at the outflow end 110 may form a narrowed transition region between and to the two angled struts 136 extending from the corresponding apex region 152, and each apex region 152 at the inflow end 108 may form a narrowed transition region between and to the two angled struts 130 extending from the corresponding apex region 152.

[0074] The thinned strut portion 156 of the apex region 152 can have a width 158 that is smaller than the width 160 of the angled struts 130 or 136 (FIG. 3). In some embodiments, the width 158 can be a uniform width (e.g., along the entire length of the strut portion 156). In some embodiments, the width 158 of the thinned strut portion 156 can be smaller than the width 160 of the angled struts 130 and / or 136 by approximately 0.06 to 0.15 mm.

[0075] The thin-walled strut portions 156 of the apex region 152 can have a first length 162 (FIG. 3). In some embodiments, the first length 162 is in the range of 0.8-1.4 mm, 0.9-1.2 mm, 0.95-1.05 mm, or about 1.0 mm (e.g., ±0.03 mm). In alternative embodiments, the first length 162 is in the range of 0.3-0.7 mm, 0.4-0.6 mm, 0.45-0.55 mm, or about 0.5 mm (e.g., ±0.03 mm).

[0076] Thus, each outflow apex region 152 may include two thin-walled strut portions 156 having a first length 162, each strut portion extending outward from the apex 154 relative to a central longitudinal axis 164 of the cell 118. Thus, the total length of the apex region 152 may be twice the first length 162.

[0077] The two corresponding angled struts 136 in each apex region 152 and outflow end 110 may form an outflow strut 166 , and the two corresponding angled struts 130 in each apex region 152 and inflow end 108 may form an inflow strut 168 .

[0078] Each outflow strut 166 and inflow strut 168 may have a length that includes the apex region 152 and the two angled struts 136 or 130 (or strut portions) on either side of the apex region 152. In FIG. 3 , half of the total length of each outflow strut 166 and inflow strut 168 is shown as length 170, which extends from the end of one angled strut 136 or 130 to the central longitudinal axis 164. Thus, the length of each outflow strut 166 and inflow strut 168 is twice the length 170. In some embodiments, the length 170 for one half of each inflow strut 168 may be different from the length 170 for the other half of each outflow strut 166.

[0079] In some cases, the length of each thinned strut portion 156 may be at least 25% of the length 170 of the corresponding half outflow strut 166 or inflow strut 168. Stated another way, the length of each apex region 152 (whose total length is twice the first length 162) may be at least 25% of the total length (twice the length 170) of the outflow strut 166 or inflow strut 168. In some embodiments, the length of each apex region 152 may be more than 25%, e.g., 25-35%, of the total length of the corresponding outflow strut 166 or inflow strut 168.

[0080] In some embodiments, each apex region 152 may include a curved, axially-facing outer surface 172 and an arcuate or curved, axially-facing inner recess 174 that forms the thin-walled post portion 156. For example, the curved inner recess 174 may be recessed from the inner surface of the angled post portion 156 toward the curved outer surface 172, thereby forming a thinner-walled post portion 156 with a smaller width. Thus, the curved inner recess 174 may be formed on the cell side of the apex region 152 (e.g., as opposed to the outside of the apex region 152).

[0081] In some embodiments, the curved outer surface 172 of each apex region 152 may form a single continuous curve from one angled strut portion 156 on a first side of the apex region 152 to another angled strut portion 156 on an opposite second side of the apex region 152 (e.g., the curved outer surface 172 may have a constant convex curvature).

[0082] Each apex region 152 may have a radius of curvature 176 along its curved outer surface 172 (e.g., in some cases, along the entire or full length of the curved outer surface 172) (FIG. 3). In some cases, the radius of curvature 176 at the apex 154 and / or along the entire curved outer surface 172 of the apex region 152 may be greater than 1 mm. In some cases, the radius of curvature 176 may be in a range of 1 to 20 mm, 3 to 16 mm, or 8 to 14 mm. In some cases, the radius of curvature 176 may be greater than 10 mm. The radius of curvature 176 may depend on (and thus vary due to) the width 158 (e.g., the amount of reduction in width from the angled strut portion 130 or 136) and the first length 162 of the thin-walled strut portion 156.

[0083] Additionally, the height (axial height) 178 of the apex region 152, which may be defined axially from the outer surfaces of the two angled struts 130 or 136 to the curved outer surface 172 of the apex region 152 at the apex 154, may be the width 158 of the thin-walled strut portion 156 ( FIG. 3 ). In this manner, the height 178 of the apex region 152 may be relatively small and may not add much height to the overall axial height of the radially expanded frame 102. Thus, the leaflets 112 ( FIG. 1 ) secured to the frame 102 may be positioned closer to the inflow end 108, thereby leaving more open space at the outflow end 110 of the frame 102 that is not blocked by the leaflets 112.

[0084] In some embodiments, each vertex region 152 may form an angle 180 between two angled struts 130 or 136 extending from either side of the corresponding vertex region 152 ( FIG. 3 ). In some cases, angle 180 may range from (but not limited to) 120 degrees to 140 degrees (e.g., angle 180 is greater than 120 degrees and less than or equal to 140 degrees).

[0085] Further details and examples of prosthetic heart valve frames, including apex regions, can be found in PCT Application No. PCT / US2022 / 025687, which is incorporated herein by reference.

[0086] 4 illustrates an embodiment of a delivery device 200 that may be used to implant an expandable prosthetic heart valve (e.g., the prosthetic heart valve 100 of FIG. 1 and / or any other prosthetic heart valve described herein). In some embodiments, the delivery device 200 is specifically adapted for use in introducing the prosthetic valve into the heart.

[0087] 4 is a balloon catheter including a handle 202 and a steerable outer shaft 204 extending distally from the handle 202. The delivery device 200 may further include a mid-shaft 206 (which may also be referred to as a balloon shaft) extending proximally and distally from the handle 202, the portion extending distally from the handle 202 extending coaxially through the outer shaft 204. In addition, the delivery device 200 may further include an inner shaft 208 extending coaxially through the mid-shaft 206 and outer shaft 204 distally from the handle 202 and coaxially through the mid-shaft 206 proximally from the handle 202.

[0088] The outer shaft 204 and the intermediate shaft 206 may be configured to translate (e.g., move) longitudinally relative to one another along a central longitudinal axis 220 of the delivery device 200 to facilitate delivery and positioning of the prosthetic valve at an implantation site within a patient's body.

[0089] The midshaft 206 may include a proximal end portion 210 that extends proximally from the proximal end of the handle 202 to an adapter 212. A rotatable knob 214 may be mounted on the proximal end portion 210 and configured to rotate the midshaft 206 relative to the outer shaft 204 about a central longitudinal axis 220.

[0090] The adapter 212 may include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 240 may be fluidly coupled to the inner lumen of the midshaft 206.

[0091] The midshaft 206 may further include a distal end portion that extends distally beyond the distal end of the outer shaft 204 when the distal end of the outer shaft 204 is positioned away from the inflatable balloon 218 of the delivery device 200. The distal end portion of the inner shaft 208 may extend distally beyond the distal end portion of the midshaft 206.

[0092] The balloon 218 may be coupled to the distal end portion of the midshaft 206 .

[0093] In some embodiments, the distal end of the balloon 218 may be coupled to the distal end of the delivery device 200, such as a nosecone 222 (as shown in FIG. 4 ), or to an alternative component at the distal end (e.g., a distal shoulder) of the delivery device 200. An intermediate portion of the balloon 218 may cover a valve mounting portion 224 at the distal end portion of the delivery device 200, and the distal end portion of the balloon 218 may cover a distal shoulder 226 of the delivery device 200. The valve mounting portion 224 and the intermediate portion of the balloon 218 may be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 4 , a prosthetic heart valve 250 (which may be one of the prosthetic valves described herein) may be mounted around the balloon 218 at the valve mounting portion 224 of the delivery device 200.

[0094] The balloon shoulder assembly, including the distal shoulder 226, is configured to maintain the prosthetic heart valve 250 (or other medical device) in a fixed position on the balloon 218 during delivery through the patient's vasculature.

[0095] The outer shaft 204 may include a distal tip portion 228 mounted on its distal end. The outer shaft 204 and the intermediate shaft 206 may be axially translated relative to one another to position the distal tip portion 228 adjacent the proximal end of the valve mounting portion 224 when the prosthetic valve 250 is mounted in radial compression on the valve mounting portion 224 (as shown in FIG. 4 ) and during delivery of the prosthetic valve to the target implantation site. Thus, the distal tip portion 228 may be configured to resist axial, proximal movement of the prosthetic valve 250 relative to the balloon 218 when the distal tip portion 228 is positioned adjacent the proximal side of the valve mounting portion 224.

[0096] An annular space may be defined between the outer surface of the inner shaft 208 and the inner surface of the midshaft 206 and may be configured to receive fluid from a fluid source via the second port 240 of the adapter 212. The annular space may be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 208 and the inner surface of the balloon 218. Thus, fluid from the fluid source may flow from the annular space into the fluid passageway, inflating the balloon 218 and radially expanding and deploying the prosthetic valve 250.

[0097] The inner lumen of the inner shaft may be configured to receive a guidewire therethrough for navigating the distal end portion of the delivery device 200 to the target implantation site.

[0098] The handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 200. In the illustrated embodiment, for example, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, that is operably coupled to a proximal end portion of a pull wire. The pull wire can extend distally from the handle 202 through the outer shaft 204 and have a distal end portion secured to the outer shaft 204 at or near its distal end. By rotating the knob 260, the tension in the pull wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 200. Further details regarding steering or bending mechanisms for delivery devices can be found in U.S. Pat. No. 9,339,384, which is incorporated herein by reference.

[0099] The handle 202 may further include an adjustment mechanism 261 that includes an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism that includes another adjustment member configured as a rotatable knob 278. The adjustment mechanism 261 is configured to adjust the axial position of the intermediate shaft 206 relative to the outer shaft 204 (e.g., for fine positioning at the implantation site). Further details regarding the delivery device 200 may be found in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference.

[0100] As mentioned above, in some embodiments, the edge of the outer skirt of the prosthetic heart valve may be relatively rough or abrasive. For example, the edge may be a finished edge that is "fused" by melting fibers along the edge to reduce fraying of the outer skirt fabric. In other embodiments, the skirt edge may have exposed fibers or loops. When the prosthetic heart valve is in operation and the leaflets are in an open state, the prosthetic heart valve may contact the edge (e.g., the outer or free edge) of the outer skirt. Such contact may, in some cases, result in undesirable abrasion or wear of the leaflets.

[0101] In some cases, to prevent the leaflets from contacting the edge of the outer skirt during operation of the prosthetic heart valve, the edge of the outer skirt may be folded outward, away from the frame and the leaflets. The folded edge may then be secured to the frame with stitches that extend through the folded edge of the skirt and around the struts of the frame. In some examples, the stitches may pass through the folded skirt layer near the skirt edge. Thus, pulling forces from the stitches on the skirt may cause the skirt edge to chafe or unravel.

[0102] Accordingly, the inventors herein have recognized that it is desirable to provide a stitching line along the edge (e.g., outflow edge) of the outer skirt where the outer skirt may be attached to the frame posts so that the skirt edge is positioned away from the valve leaflets (does not contact the valve leaflets during valve operation) and so that the skirt edge remains intact (e.g., does not fray or fray).

[0103] 6-13 illustrate an exemplary method for forming stitch lines along the edge of an outer skirt and using the stitch lines to attach the edge of the outer skirt to the struts of a frame of a prosthetic heart valve, so that the free edge of the edge is positioned relative to the outer surface of the struts and away from the leaflets of the prosthetic heart valve. The methods described below with reference to FIGS. 6-13 can be used with various combinations of frames and outer skirts. Thus, the outer skirts and frames shown in FIGS. 6-13 are exemplary, and the disclosed methods can be applied to outer skirts and frames with different configurations, such as various balloon-, self-, and mechanically expandable frames, and various skirts (which may have straight, contoured, or alternatively shaped outflow edges or alternative edges). Furthermore, while the methods below are described as being applied to the outflow edge of the outer skirt, in alternative embodiments, the stitch lines described herein can be used on another edge of the skirt (such as the inflow edge of the skirt, which may be secured to the inflow end of the frame).

[0104] Referring first to FIG. 5, an exemplary outer skirt 300 for a prosthetic device, such as the prosthetic heart valve 100 of FIG. 1 (or the prosthetic heart valve frame 550 of FIG. 13), is shown in a flat configuration. The outer skirt 300, as well as other outer skirts disclosed herein, may be used with balloon-expandable prosthetic valves (e.g., the valve 100 of FIGS. 1-3), mechanically expandable prosthetic valves, and / or self-expanding prosthetic valves. Further details regarding balloon-expandable prosthetic valves may be found in U.S. Pat. No. 9,393,110, which is incorporated herein by reference, and PCT Application No. PCT / US2022 / 025687, which has previously been incorporated herein by reference. Additional details regarding mechanically expandable prosthetic valves may be found in International Application No. PCT / US2021 / 052745, which is incorporated herein by reference. Additional details regarding self-expanding prosthetic valves can be found in US Pat. No. 8,652,202, which is incorporated herein by reference.

[0105] The outer skirt 300 may be wrapped and mounted around the outer surface of the prosthetic device frame (the surface facing radially outward relative to the central longitudinal axis of the prosthetic device), thereby transitioning to an annular configuration (e.g., as shown in FIG. 1 or FIG. 13).

[0106] 5, the outer skirt 300 may include opposing first and second edges 302, 304 (which may also be referred to as short edges or short edges), each extending between an outflow edge 306 and an inflow edge 308 of the outer skirt 300. In some embodiments, the first and second edges 302, 304 may be non-perpendicular to the inflow edge 308. For example, the first and second edges 302, 304 may extend at an angle of approximately 45 degrees (or in a range of 40-50 degrees) relative to the inflow edge 308. Thus, the overall general shape of the outer skirt 300 is a diamond or parallelogram.

[0107] In some embodiments, the first and second edges 302, 304 may each include a plurality of apertures 310 extending therethrough. Thus, when the outer skirt 300 is converted into its annular configuration (e.g., when worn around a prosthesis as shown in FIG. 13 ), the first and second edges 304, 302 may overlap one another with their respective apertures 310 also overlapping. Sutures may then be used to form a plurality of stitches in an in-and-out pattern through the overlapping apertures 310, thereby securing the first and second edges 302, 304 together and forming the annular configuration of the outer skirt 300.

[0108] The outflow edge 306 (e.g., when disposed around the prosthetic valve as shown in FIG. 13, which is positioned closer to the outflow end of the prosthetic valve than the inflow edge 308) may be formed with a plurality of protrusions 312 that define an undulating shape that generally follows the shape or contour of the struts of the frame to which they are secured (e.g., struts 134 of frame 102 or struts 552 of frame 550 shown in FIG. 2).

[0109] In alternative embodiments, the outflow edges 306 may have a different shape than that shown in FIG. 5, such as being relatively straight (e.g., parallel to the inflow edges 308, the same as or similar to those shown in FIGS. 6-8B), or a different non-linear shape that may or may not follow the shape or contour of the support posts of the frame to which they are secured.

[0110] In some embodiments, the outer skirt 300 may also be formed with slots 314 (or recesses) to facilitate attachment of the skirt to a frame. For example, each slot 314 may be disposed between two adjacent protrusions 312. In some embodiments, the slots 314 may be shaped and dimensioned such that they can fit over and / or be wrapped or secured around struts or support posts of the frame.

[0111] When the outer skirt 300 is disposed around the outer surface of a prosthetic device frame (e.g., as shown in FIGS. 1 and 13), sutures may be used to secure the outflow edge 306 of the outer skirt 300 to the struts of the frame. In some embodiments, additional sutures may be used to secure the inflow edge 308 of the outer skirt 300 to the prosthetic device frame and / or leaflets (e.g., such as the sutures shown in FIG. 13, as described further below).

[0112] In some embodiments, outer skirt 300 may include one or more rows of openings 318 that may be configured to receive sutures of a stitchline (such as stitchline 402 shown in FIGS. 6-7B or stitchline 502 shown in FIGS. 8A-13) therethrough. In alternative embodiments, outer skirt 300 does not include pre-formed openings 318 for stitchlines; instead, openings or holes in the fabric of outer skirt 300 may be formed by needles during formation of the stitchline along outflow edge 306.

[0113] The outer skirt 300 and other skirts or coverings described herein may comprise a variety of synthetic materials, including woven fabrics (e.g., woven polyethylene terephthalate fabrics (PET fabrics) or woven ultra-high molecular weight polyethylene (UHMWPE) fabrics), polytetrafluoroethylene (PTFE), thermoplastic polyurethane (TPU), hybrid materials comprising one or more woven fabrics or polymeric materials (e.g., PET coated on TPU), or natural tissue (e.g., pericardial tissue).

[0114] 6-7B show a detailed portion of the outer skirt 300 having a stitch line 402 disposed along the outflow edge 306. In FIGS. 6 and 7A, the outflow edge 306 is shown as being relatively straight with a wavy outflow edge 320 (which may be referred to herein as the free edge or outer edge of the outer skirt 300). The outflow edge 320 is shown as wavy for illustrative purposes only to illustrate that the edge 320 of the outflow edge 306 may be roughened and / or melted (e.g., an edge formed by melting fibers of a woven skirt along the edge, as described above, and / or an edge with exposed fibers or loops that may be abrasive). Furthermore, while the outflow edge 306 is shown in FIGS. 6 and 7A as being relatively straight (for ease of illustration), in some examples, the outflow edge 306 may have an undulating edge (with protrusions 312, as shown in FIG. 5). In such an embodiment, stitch lines 402 may follow the contours of the contoured outflow edge, similar to those shown in Figures 9A-10B and 12A-13, as described below.

[0115] The stitch line 402 includes an in-out stitch line 404 spaced apart from the outflow edge 320 of the outflow edge 306 (and including a plurality of in-out stitches 406, 408), and a plurality of loops 410 (which may also be referred to as curved or loop stitches) that surround the outflow edge 320 and are spaced apart from one another in the circumferential direction (or in the direction of the in-out stitches). For example, the loops 410 may be connected together within the stitch line 402 by the in-out stitches 406, 408.

[0116] In some cases, the stitch line 402 may be formed by extending the suture 412 from one opening 318 to an adjacent opening 318 on the first surface 322 of the outer skirt 300 (e.g., the radially outer surface facing out of the page in the views of FIGS. 5-7 ) in a direction parallel to the outflow edge 320, thereby forming an in-out stitch 406 across the first surface 322. The suture 412 may then extend through the adjacent opening 318, across the second surface 324 of the outer skirt 300 (e.g., the radially inward-facing surface opposite the first surface 322, as may be depicted in FIGS. 12E and 12F ), toward the outflow edge 320, over the outflow edge 320, and back across the first surface 322 to the same opening 318, thereby forming a loop 410. After passing through the same opening 318, the suture 412 may then extend across the second surface 324 (behind the fabric in the view of FIG. 6) to the next adjacent opening 318, thereby forming an in-out stitch 408 across the second surface 324. (The in-out stitches 408 are shown in dashed lines in FIGS. 6 and 7A to indicate their positioning across the second surface 324, or behind the outer skirt 300 in the views of FIGS. 6 and 7A.) ​​This process is then repeated to form subsequent loops 410 and in-out stitches 406, 408, as shown in FIG. 6. For example, the method for forming the stitch line 402 described above is repeated alternately across the first surface 322 and the second surface 324 of the outer skirt 300 to form multiple in-out stitches 406, 408 and multiple loops 410 of the stitch line 402. In some embodiments, this stitch pattern may be referred to as an overcast stitch pattern or stitch pattern. In FIG. 6, arrows are shown indicating exemplary directions for stitching stitch line 402, as described above.

[0117] In some cases, the in-out stitch line 404 may include a second pass of in-out stitches 414, 416, with alternating stitches 414 extending across the first surface 322 and stitches 416 extending across the second surface 324 ( FIG. 7A ). For example, the in-out stitches 414, 416 may alternate with the in-out stitches 406, 408 such that the in-out stitches 406, 408 and the in-out stitches 414, 416 extend across opposing surfaces (the first surface 322 and the second surface 324) of the outer skirt 300 between each corresponding pair of adjacent openings 318.

[0118] The second pass of in-out stitches 414, 416 may be formed with the first suture 412 or the second suture. In this manner, the in-out stitch line 404 may include in-out stitches across both the first surface 322 and the second surface 324 between each pair of adjacent openings 318.

[0119] 6 , the in-out stitch line 404 is spaced from the outflow edge 320 by a distance 418. The distance 418 may be specified such that the in-out stitch line 404 is spaced sufficiently from the outflow edge 320 to prevent chafing or peeling of the outflow edge 320. In some embodiments, the distance 418 may be within a range of approximately 0.5-2 mm, 1.0-2.0 mm, 1.5-2.0 mm, or 1.4-2.1 mm. Accordingly, the loop 410 may have a length similar to and / or resulting in the distance 418.

[0120] 7A and 7B, an additional stitch 420 (e.g., a whip stitch) may extend through loop 410 of stitch line 402 and around strut 422 (or struts) of the prosthetic valve frame (strut 422 may be replaced by strut 134 or strut 134 of frame 102 or strut 552 of frame 550), thereby attaching outflow edge 306 of outer skirt 300 to strut 422 via stitch line 402. As a result, pulling force exerted on outer skirt 300 by stitch 420 may be transferred by loop 410 to in-out stitch line 404, away from outflow edge 320. Because in-out stitch line 404, which is spaced a distance 418 from outflow edge 320, receives the pulling force, the integrity of outflow edge 320 may be maintained, thereby extending the life of outer skirt 300.

[0121] Further, as shown in FIG. 7B, such an attachment method may result in the outflow lip 320 being positioned behind or above the radially outward-facing surface 424 of the struts 422 (e.g., closer to the opposite radially inward-facing surface 426 of the struts 422, a surface facing away from the leaflets disposed on the interior of the frame), thereby hiding the outflow lip 320 away from the leaflets of the prosthetic valve. The stitch 420 is shown in an unfastened stage in FIG. 7A for illustrative purposes only. When the stitch 420 is fastened, the outflow lip 320 is positioned against the radially outward-facing surface 424 of the struts 422, as shown in FIG. 7B.

[0122] 8A-9B show another example of a stitch line 502 disposed within and along the outflow edge 306 of the outer skirt 300. The stitch line 502 is similar to and may be similarly implemented as the stitch line 402 described above, except that the loop 410 is replaced with double loops 510, 512 (e.g., two loops in a figure-eight pattern, as described in further detail below). In some cases, the outer skirt 300 may include additional rows of preformed openings 318 (such as first opening 318a and second opening 318b, as shown in FIGS. 8A and 8B) to receive the double loops 510, 512. In some cases, the additional rows of openings may not be preformed, but instead may be formed by stitching with a needle through the fabric of the outer skirt 300. For example, as shown in Figures 9A and 9B, the second opening 318b may not be pre-formed, but instead may be formed as the stitch line 502 is formed (e.g., as the needle holding the suture extends through the fabric of the outer skirt 300 in the position shown in Figures 9A and 9B).

[0123] For ease of illustration, outflow edge 320 and outflow edge 306 are shown as relatively straight in Figures 8A and 8B. However, Figures 9A and 9B show outer skirt 300 having contoured outflow edge 306 and outflow edge 320 (as described above with reference to Figure 5). Stitch lines 502 can be applied to outer skirts having straight, contoured, or differently shaped edges using the same method described below with reference to Figures 8A-13.

[0124] Similar to stitch line 402, stitch line 502 includes an in-out stitch line 504 spaced apart from the outflow edge 320 of outflow edge 306 and a plurality of pairs of loops spaced apart from one another in the direction of the in-out stitching (e.g., circumferentially and / or parallel to the outflow edge 320). In-out stitch line 504 includes a plurality of in-out stitches 506, 508. Each pair of loops includes a first loop 510 and a second loop 512, where first loop 510 surrounds the outflow edge 320 of outflow edge 306 and extends between the outflow edge 320 and the second loop 512, and second loop 512 extends between the first loop 510 and an intersection of two adjacent in-out stitches 506, 508 of the plurality of in-out stitches 506, 508 of in-out stitch line 504. The second loops 512 are connected together within the stitch line 504 by in-out stitches 506, 508.

[0125] In some cases, the stitch line 502 may be formed by extending a first suture 513 on the first surface 322 of the outer skirt 300 in a direction parallel to the outflow edge 320 from one second opening 318b to an adjacent second opening 318b, thereby forming an in-out stitch 506 across the first surface 322 (FIGS. 8A and 9A). The suture 513 then extends through the adjacent second opening 318b, across the second surface 324 of the outer skirt 300, through the first opening 318a (closer to the outflow edge 320 than the second opening 318b), across the first surface 322 of the outer skirt 300 toward the outflow edge 320, over the outflow edge 320, across the second surface 324 back to the same first opening 318a, through the first opening 318a, back across the first surface 322, and to the same second opening 318b. As a result, the first loop 510 and the second loop 512 are formed between the outflow edge 320 and the in-out stitch line 504. As shown in FIGS. 8A-9B , the first loop 510 and the second loop 512 are connected to one another. The first loop 510 and the second loop 512 may be stitched and formed in a figure-eight pattern across the outflow edge 306, as described above. The intersections of the first loop 510 and the second loop 512 or the figure-eight stitch pattern may help prevent lateral (or circumferential, if the outer skirt is disposed around an annular frame) displacement of the first loop 510 and / or the second loop 512 (which may better keep the encircling whip stitch through the first loop 510 in place, as described further below).

[0126] After passing through the same second opening 318b, the suture 513 may extend across the second surface 324 (behind the fabric in the views of FIGS. 8A-9B) to the next adjacent second opening 318b, thereby forming an in-out stitch 508 across the second surface 324. (In the views of FIGS. 8A-9B, the in-out stitches 508 are shown with dotted lines in FIGS. 8A-9B to indicate their position across the second surface 324, or behind the outer skirt 300.) This process is then repeated (but alternating passes over opposing surfaces of the skirt 300 than described above for each stitch) to form subsequent first and second loops 510, 512 and in-out stitches 506, 508, as shown in FIGS. 8A and 9A. In some cases, this stitch pattern may be referred to as an overcast stitch or stitch pattern.

[0127] In some cases, the in-out stitch line 504 may include a second pass of in-out stitches 514, 516, including alternating stitches 514 extending across the first surface 322 and stitches 516 extending across the second surface 324 ( FIGS. 8A and 9A ). In some cases, the second pass of in-out stitches 514, 516 may be formed with the first suture thread 513. In some cases, the second pass of in-out stitches 514, 516 may be formed with a different second suture thread. In this manner, the in-out stitch line 504 may include in-out stitches across both the first surface 322 and the second surface 324 between each pair of adjacent second openings 318 b.

[0128] As shown in FIGS. 8A and 8B , the in-out stitch line 504 is spaced a distance 518 from the outflow edge 320. The distance 518 may extend in a direction perpendicular to the outflow edge 320. The distance 518 may be specified so that the in-out stitch line 504 is sufficiently spaced from the outflow edge 320 to prevent chafing or peeling of the outflow edge 320. The first loop 510 has a length 520 (which may be the same as or similar to the distance between the outflow edge 320 and the first opening 318 a). In some cases, the length 520 is less than the distance between the first opening 318 a and the second opening 318 b (e.g., the length of the second loop 512 or the difference between the distance 518 and the length 520).

[0129] For example, in some cases, the distance 518 may be approximately 2 mm (e.g., ±0.1 mm), and the length 520 of the first loop 510 may be approximately 0.5 mm (and therefore the second loop 512 may be approximately 1.5 mm). In some cases, the distance 518 may be in the range of 1.5-2.0 mm, and the length 520 of the first loop 510 may be approximately 0.3 mm (and therefore the second loop 512 may be approximately 1.2-1.7 mm). In some cases, the distance 518 may be in the range of 1.4-2.1 mm, and the length 520 of the first loop 510 may be in the range of 0.2-0.6 mm (and therefore the second loop 512 may be approximately 0.8-1.9 mm in length).

[0130] 10A and 10B show an exterior view (FIG. 10A) and an interior view (FIG. 10B) of a frame 550 for a prosthetic heart valve, in which an outer skirt 300 with stitch lines 502 is disposed around the outer surface of the frame 550. The frame 550 may be similar to the frame 102 of FIG. 2, as described above. In some embodiments, the frame 102 of FIG. 2 may be used in place of the frame 550 of FIGS. 10A-13. Furthermore, as described above, the outer skirt 300 with stitch lines 502 may be attached to a variety of other frames using methods described herein (e.g., frames having different numbers of rows of struts, different shapes of cells or struts, or the like).

[0131] 10B, an additional stitch 522 (which may be referred to as a whip stitch) extends through a first loop 510 of the stitch line 502 and around a post 552 of the frame 550 to attach the outflow edge 306 of the outer skirt 300 to the post 552 via the stitch line 502. In some cases, the post 552 may be an angled post of a second row of angled posts of the frame 550 that is positioned adjacent to a first row of angled posts that define the outflow end of the post (e.g., the same as or similar to the post 134 of the frame 102, as shown in FIG. 13 , showing the entire frame 550).

[0132] 10A , a needle 524 (such as a blunt needle without a sharp tip) may be used, and without penetrating the material of the outer skirt 300, the needle 524 and suture 526 may be passed through the first loop 510 and then around one of the struts 552, thereby forming a whip stitch 522 with the suture 526 (this process is then repeated around the frame 550 and outer skirt 300). In other words, the whip stitch 522 passes only through the first loop 510 and not through another portion of the outer skirt 300. Furthermore, the in-out stitch line 504 is offset (or spaced) from the whip stitch 522 by at least the length of the second loop 512 (which may be the same or similar to the difference between the distance 518 and the length 520).

[0133] As a result, the pulling force exerted on the outer skirt 300 from the whip stitch 522 may be transferred by the first loop 510 and the second loop 512, away from the outflow edge 320, to the in-out stitch line 504. Because the in-out stitch line 504, which is spaced a distance 518 from the outflow edge 320, receives the pulling force, the integrity of the outflow edge 320 may be maintained, thereby extending the life of the outer skirt 300.

[0134] By including the first loop 510 in addition to the second loop 512, lateral movement of the second loop 512 relative to the outer skirt 300 may be prevented. Additionally, the paired loop configuration of the stitch line 502 may prevent movement of the whip stitch 522 along the first loop 510 in a vertical or axial direction (which may be in the direction of the central longitudinal axis 558 of the frame 550, as shown in FIG. 13 ).

[0135] As shown in FIG. 10B, the whip stitch 522 passes through the first loop 510 and around the strut 552, thereby preventing the outer skirt 300 from sliding over the whip stitch 522 and keeping the outflow edge 320 positioned behind ( FIG. 10B ) or on the radially outward facing surface 554 of the strut 552 (e.g., the surface facing away from the leaflets disposed on the interior of the frame), thereby hiding the outflow edge 320 away from the leaflets of the prosthetic valve.

[0136] In some embodiments, one or more of the whip stitches 522 may double wrap around the corresponding first loop 510. For example, at least one whip stitch 522 along the same strut 552 may double wrap around the corresponding first loop 510. In some cases, two or more or all of the whip stitches 522 along the same strut 552 may double wrap around their corresponding first loop 510. FIG. 11 is a schematic diagram showing multiple whip stitches 522 around a strut 552 formed with a double loop 528 around the corresponding first loop 510. Note that the whip stitch 420 shown in FIG. 11 may also double wrap around the loop 410 in the same manner as described below.

[0137] 12A-12G show an exemplary process for forming a whip stitch 522 around a frame post 552 with a double loop 528, through a first loop 510. For the first whip stitch 522, the suture 526 used to form the whip stitch 522 is first passed (e.g., using a needle 524) from around the post 552 (FIG. 12A) and through the first loop 510 (FIG. 12B), then wrapped back over the edge of the first loop 510 and through the same first loop 510 a second time (as shown in FIG. 12C, where the needle 524 passes through the first loop 510 a second time, and in FIG. 12D, which shows the second loop of the double loop 528 formed within the first loop 510). Finally, the suture returns toward and extends around the post 552, and this process can be repeated on the next whip stitch 522 (or a selected number of following whip stitches 522).

[0138] FIG. 12E shows an interior view of the frame 550 with the whip stitches 522 and their double loops 528 formed along the outflow edge 306 of the outer skirt 300. FIG. 12F shows another interior view of a smaller portion of the frame 550, with the double loops 528 in each whip stitch 522. As shown in FIGS. 12F and the exterior views of FIG. 12G, the double loops 528 of the whip stitches 522 tighten around the first loop 510, pulling the outflow edge 320 of the outer skirt 300 against the radially outward-facing surfaces 554 of the struts 552 (opposite the radially inward-facing surfaces 556 of the struts 552). As a result, the outflow edge 320 of the outer skirt 300 can be positioned away from the leaflets of the prosthetic heart valve (which are disposed interiorly of the frame and face the radially inward-facing surfaces 556 of the struts 552).

[0139] FIG. 13 is a perspective view of an entire frame 550 in which the outer skirt 300 is attached to the outer surface of the frame 550 using stitch lines 502 and a whip stitch 522 with double loops 528 (as described above with reference to FIGS. 11-12G). As shown in FIG. 13, the outflow edge 306 of the outer skirt 300 is secured to the angled struts 552, and the outflow edge 320 rests on the exterior of the frame on the radially outward-facing surfaces 554 of the struts 552. Thus, when the leaflets are disposed within the interior of the frame 550 (the same as or similar to that shown in FIG. 1), the outflow edge 320 is separated from the leaflets by the struts 552, thereby preventing the leaflets from abrading from the outflow edge 320 during operation of the prosthetic heart valve.

[0140] As shown in FIG. 13 , the struts 552 may define a first circumferentially extending row of struts for the frame 550, and the frame 550 may further include a second circumferentially extending row of outflow struts 562 defining an outflow end of the frame 550 and positioned adjacent to the row of struts 552. The frame 550 may further include a third circumferentially extending row of inflow struts 564 defining an inflow end of the frame 550. The frame 550 may include one or more additional circumferentially extending rows of struts (such as an additional row of struts positioned between the inflow struts 564 and the struts 552, as shown in FIG. 13 ). As shown in FIG. 13 , the inflow edge 308 of the outer skirt 300 is secured to the inflow struts 564 via a plurality of whip stitches 560 extending through the outer skirt and around the inflow struts 564 (without additional stitch lines). In an alternative embodiment, stitch lines 502 or 402 may be applied to the inflow edge 308 and used to secure the inflow edge 308 to the inflow post 564, similar to those described above with reference to Figures 8A-12G or Figures 6-7B.

[0141] In some cases, not all whip stitches 522 connecting the stitch line 502 to the frame 550 include double loops 528. For example, only one or a portion of the whip stitches along the same strut 552 may include a double loop 528, while the remaining whip stitches 522 along the same strut 552 include only a single loop. In some embodiments, only a portion of the struts 552 in a row of struts 552 may include whip stitches 522 with double loops 528. The number of whip stitches along the same strut 552 that include double loops 528 may be specified so that the outflow edge 306 of the outer skirt 300 is securely attached to the frame 550 in a manner that hides the outflow edge 320 on the outer surface of the frame 550 (the struts 552 separate the outflow edge 320 and the leaflets from each other).

[0142] In some embodiments, the outer skirt 300 may be attached to a frame 550 with stitch lines 502 (or another similar frame, such as frame 102 of FIG. 2) without double loops 528 (as shown in FIGS. 8A-10B) or by stitch lines 402 (e.g., the support posts 422 shown in FIGS. 7A and 7B may instead be one of the support posts 552 of the frame 550).

[0143] Frame 550 is exemplary, and in some embodiments, frame 102 of FIG. 2 may be used in place of frame 550, with outer skirt 300 attached to support posts 134 in the same manner as shown in FIGS. 11-13, 8A-10B, or 6-7B.

[0144] The methods described herein for attaching an outer skirt edge to the struts of a frame of a prosthetic heart valve may be applied to a variety of frames for prosthetic heart valves or alternative implantable medical devices (such as stents). Additionally, the methods described herein may be applied to a variety of skirts and skirt edges, such as edges having a variety of shapes (straight, undulating, or alternative shapes), and edges configured to attach to a variety of points on the frame (e.g., the outflow end, the inflow end, or a portion of the frame located between the inflow and outflow ends).

[0145] The method described herein for attaching the edge of the outer skirt to the struts of the frame using a stitch line with one or more loops that offset the in-out stitch of the stitch line from the free edge of the edge results in the free edge being positioned against the surface of the strut (e.g., the radially outward-facing surface), which is the opposite surface of the strut that faces the leaflet or other flexible component disposed on the interior of the frame, thereby preventing the free edge of the skirt from contacting the leaflet. Furthermore, the stitch line described herein allows loads or pulling forces from the whip stitch (which extends around the strut and through the loops of the stitch line) to be transferred away from the free edge of the skirt, thereby reducing the risk of chafing of the free edge and increasing the durability and lifespan of the outer skirt. Still further, by using the stitch line and method described herein, the edge of the outer skirt can be attached to the frame without folding, thereby allowing the suturing process on the skirt to be performed in a flat configuration (outside the frame). As a result, the stitching of the outer skirt (to form the stitch lines) can be automated because the stitches are all in the same plane, thereby reducing assembly time and increasing the efficiency and accuracy of assembling the outer skirt and prosthetic device.

[0146] In some embodiments, a stitch line comprising multiple in-out stitches and multiple loops spaced apart from one another in the direction of the in-out stitches can be applied to different or additional components of a prosthetic valve, such as the leaflets of a valve structure. Such stitch lines can be positioned along the leaflet edges, with the loops encircling the leaflet edges and spacing the in-out stitches away from the leaflet edges. In some embodiments, the leaflet edges can then be attached to additional components, such as a fabric skirt, sutures extending around or directly onto the frame struts, without puncturing the tissue of the leaflet, using the stitch line. As a result, the leaflet edges can be secured to the frame of the prosthetic valve in a manner that tightly presses the leaflet edges against the additional components and reduces blood flow obstruction through the prosthetic valve.

[0147] 14-16 illustrate certain embodiments of stitch lines 612 formed along leaflet edges 602 of an exemplary leaflet 600 for a prosthetic valve. In some embodiments, the leaflet 600 may be one of the leaflets 112 of FIG. 1. The leaflet 600 comprises an outflow edge 604, two opposing commissure tabs 606 disposed on opposite sides of the leaflet 600, and a leaflet edge 602 extending between the opposing commissure tabs 606. The leaflet edge 602 comprises an outermost leaflet edge 608 (or free edge). The leaflet edge 608 of the leaflet 600 may have an undulating, curved, scallop shape and may form the inflow edge or inflow end of the leaflet 600. It should be noted that the leaflet 600 is exemplary, and that the stitch lines 612 may be applied to the leaflet edges of various leaflets, such as leaflets having differently shaped leaflet edges, commissure tabs, outflow edges, and / or the like.

[0148] The stitch line 612 includes an in-out stitch line 614 spaced apart from the pointed edge 608 of the pointed portion 602, the in-out stitch line including a plurality of in-out stitches 616, 618. The in-out stitches 616, 618 may extend tangentially or parallel to the pointed edge 608. The stitch line 612 further includes a plurality of loops 620 (which may also be referred to as curved or loop stitches) that wrap around over the pointed edge 608 and are spaced apart from one another in the direction of the in-out stitches 616, 618. For example, the loops 620 may be connected together within the stitch line 612 by the in-out stitches 616, 618.

[0149] In some cases, the stitch line 612 may be formed by extending the suture 622 toward the leaflet edge 602, over a first side 624 (or surface) of the leaflet 600 (e.g., a rough or smooth side of the leaflet 600), through the leaflet edge 602, and to an opposing second side 626 of the leaflet 600 (as shown in FIGS. 18-21 ), thereby forming an in-out stitch 616 across the first side 624. The suture 622 may then extend across the second side 626 of the leaflet 600 (the side “behind” the first side 624 in the views of FIGS. 14-16 ), toward the leaflet edge 608, over the leaflet edge 608, back across the first side 624, and to the same in-out stitch 616, thereby forming a loop 620. The suture 622 may then be passed again through the same opening created by the in-out stitch 616, then extend across the second side 626, through the leaflet edge 602 and back to the first side 624, thereby forming an in-out stitch 618 across the second side 626. (The in-out stitches 618 are shown in dashed lines in FIGS. 14 and 15 to indicate their positioning across the second side 626, or behind the leaflet 600 in the views of FIGS. 14 and 15.) This process is then repeated to form the subsequent loop 620 and in-out stitches 616, 618, as shown in FIG.

[0150] For example, the method for forming the stitch line 612 described above may be repeated alternately along the leaflet 602 (e.g., from a first end 610a of the leaflet 602 positioned adjacent one commissure tab 606 to a second end 610b of the leaflet 602 positioned adjacent the commissure tab 606 on the opposite side of the leaflet 600, as shown in FIG. 16 ) and across the first and second sides 624, 626 of the leaflet 600 to form multiple in-out stitches 616, 618 and multiple loops 620 of the stitch line 612. In some embodiments, this stitch pattern may be referred to as an overcast stitch pattern or stitch pattern. In FIGS. 14 and 15 , arrows are shown indicating exemplary directions for suturing the stitch line 612, as described above.

[0151] In some embodiments, the leaflet edge 602 may include a plurality of pre-formed openings through which the in-out stitches 616, 618 extend between the first side 624 and the second side 626 of the leaflet 600.

[0152] In some cases, the in-out stitch line 614 may include a second pass of in-out stitching (as shown in FIG. 16 ), including alternating stitches 628 extending across the first side 624 and the second side 626 of the leaflet. For example, the in-out stitches 628 may alternate with the in-out stitches 616, 618 such that the in-out stitches 616, 618 and the in-out stitches 628 extend across opposing surfaces of the leaflet 600 (the first side 624 and the second side 626) between each pair of loops 620.

[0153] The second pass of in-out stitch 628 may be formed with either the first suture 622 or the second suture (as shown in FIG. 16 ). In this manner, the in-out stitch line 614 may include an in-out stitch across both the first side 624 and the second side 626 between each pair of adjacent loops 620.

[0154] As shown in detail 625 of FIG. 15 , in-out stitch line 614 is spaced from sharp edge 608 by a distance 630. In some cases, distance 630 may be the same as or similar to distance 418 described above. For example, in some embodiments, distance 630 is within a range of 0.5 to 2.0 mm.

[0155] In some cases, the distance 630 can be specified such that the length of the loop 620 is sufficient to receive a stitch therethrough and secure the leaflet 602 to another component in a manner that presses the leaflet 608 against the component and reduces flow disturbance across the surface of the valve leaflet 600.

[0156] 16 , one or more main sutures (referred to herein as thicker sutures or first sutures) 636 may be placed along the leaflet edge 602. In some cases, the main sutures 636 are thicker than the sutures 622 forming the stitch line 612. The in-out stitches 616, 618, and / or 628 of the in-out stitch line 614 may extend through the main suture 636, thereby securing the main suture 636 to the leaflet edge 602.

[0157] In some embodiments, a single main suture 636 may extend along a first side 624 of the leaflet 600, then be wrapped around the first end 610a and extend along a second side 626 of the leaflet 600. In this manner, the main suture 636 may extend along both leaflet edges 602 of the leaflet 600.

[0158] In some embodiments, two main sutures 636 may extend along the apical edge 602, one along the first side 624 and the other along the second side 626.

[0159] The suture tail 638 of the main suture 636 (or two first sutures 636) can be used to form a wedge member 640 (FIG. 17), as shown in FIG. 16 and described further below in some embodiments. Further details of the main suture 636 and wedge member 640 formed from the suture tails 638, as well as additional examples of such configurations, are further described with reference to FIGS. 22 and 23, and in U.S. Provisional Patent Application No. 63 / 343,359, which is incorporated herein by reference in its entirety.

[0160] As shown in Figures 14 and 15, additional stitches 632 (e.g., whip stitches) may extend through the loops 620 of the stitch line 612, around or through the target component 634 in a manner that, when the stitches 632 are pulled tight, firmly connects the leaflet edge 608 of the valve leaflet 600 to the target component 634 (these are shown more loosely in Figures 14 and 15 for illustrative purposes only).

[0161] In some embodiments, the targeting component 634 can be a woven component, such as a skirt (e.g., an inner skirt) or a piece of fabric or attachment member configured to be secured to the inside of a frame of a prosthetic valve. For example, the woven component can be attached to the struts of the frame on the inside of the frame after the leaflet edge 602 of the valve leaflet 600 is sutured to the woven component, thereby securing the valve leaflet 600 to the frame. In some embodiments, the inner skirt is attached to a portion of the angled strut that extends from a first commissural support portion of the frame (e.g., commissural support portion 644 shown in FIG. 18 or the axially extending window strut 138 shown in FIGS. 1-3) to the inflow end of the frame and from the inflow end of the frame to a second commissural support portion of the frame (e.g., commissural support portion 644 shown in FIG. 18 or the axially extending window strut 138 shown in FIGS. 1-3), the first and second commissural support portions being disposed adjacent the outflow end of the frame.

[0162] In some cases, the skirt or fabric attachment member may include a plurality of pre-formed openings configured to receive whip stitches 632 therethrough. In some cases, the openings in the skirt or fabric attachment member may not be pre-formed, but instead may be formed as the needle threads the whip stitches 632 through the skirt or fabric attachment member.

[0163] In some embodiments, the targeting component 634 may be a strut of the frame and / or a suture wrapped directly around the strut of the frame (e.g., a strut that follows the scallop line of the leaflet and extends between the adjacent commissure support portion of the frame and the inflow end of the frame).

[0164] Exemplary methods for attaching leaflets 600 directly to the struts of a frame (or directly to the struts via sutures wrapped around the struts of the frame) using stitch lines 612 are described below with reference to Figures 17-21. While leaflets 600 are shown in Figures 18-21 as being attached to frame 650, leaflets 600 may be attached in a similar manner to the struts of various other frames, such as frame 102, frame 550, or prosthetic valve frames of different configurations. In some embodiments, frame 650 may be the same as or similar to frame 102, except that it includes additional circumferentially extending rows of angled struts, thereby forming the additional rows of cells of frame 650.

[0165] As shown in Figure 17, multiple leaflets 600 (e.g., three) can be assembled together in a flat configuration (outside the frame). In some embodiments, stitch lines 612 can be formed along the leaflet edge 602 of each leaflet 600 (e.g., in-out stitches 616, 618, 628 extending through the leaflet 600 and main sutures 636 extending along either side of the leaflet edge 602), as described above with reference to Figure 16.

[0166] In some cases, the stitch lines 612 of multiple leaflets 600 may be connected to one another.

[0167] In some cases, the suture tails 638 of the main sutures 636 may be woven or threaded together with the adjacent commissure tabs 606 of the adjacent leaflets 600 to form wedge members 640 (FIG. 17).

[0168] The leaflets 600 may then be mounted within a frame 650 and attached directly to the struts of the frame 650 after forming the leaflets or valve assembly shown in FIG. 17. In particular, FIG. 18 shows the leaflets 600 mounted within the frame 650 and the commissures 642 secured to the commissure support portions 644 of the frame 650 (e.g., axially extending window struts such as the axially extending window struts 138 of the frame 102). Each commissure 642 may be formed by securing adjacent commissure tabs 606 together around the wedge member 640 to the commissure support portions 644 of the frame 650.

[0169] The stitch line 612 may then follow the leaflet edge 602 of the leaflet 600 and be attached to angled struts 646 that extend from one commissure support portion 644 to the inflow end 648 of the frame 650 and from the inflow end 648 to the adjacent commissure support portion 644. For example, the stitch line 612 may be attached to the angled struts 646 by extending a whip stitch 632 through the loop 620 of the stitch line 612 and around the struts 646, as shown in FIGS.

[0170] In some embodiments, after the leaflets 600 are secured to the struts 646 of the frame 650 on the interior of the frame 650, an outer skirt 652 (or sealing member) may be attached to the frame 650 around the outer surface of the frame 650, as shown in FIG. 21.

[0171] In some cases, stitching 654 may be used to secure the inflow edge of the outer skirt 652 to the angled struts 646 at the inflow end 648 of the frame 650 (e.g., at the inflow apex region of the frame 650).

[0172] In some cases, interlocking of the whip stitch 632 (e.g., passing the whip stitch 632 through the suture that forms the whip stitch 632) may be used to ensure stability of the loop 620 (e.g., to prevent the loop 620 from moving along the pointed edge 608).

[0173] In some cases, the double loop may be formed with a whip stitch 632 (similar to that shown in FIG. 11 for the double loop 528) around the loop 620, thereby preventing the loop 620 from sliding along the whip stitch 632.

[0174] Although the prosthetic valve 656 in FIG. 21 is shown with only an outer skirt 652, it should be understood that in some embodiments, the leaflets 600 may be sutured along their leaflet edges 602 to an inner skirt or piece of fabric using stitch lines 612 and whip stitches in a manner similar to that described above (rather than directly to the struts of the frame 650).

[0175] Advantageously, the suture configuration described above utilizing stitch lines 612 and whip stitches 632 firmly presses the edges 608 of the leaflets 600 against the inner surface of the frame struts (or alternatively, against the inner skirt or fabric) to which they are attached, without forming distally extending free portions (e.g., without forming stepped coaptation surfaces) between the suture lines and the edges 608. As a result, a relatively continuous geometry along the inflow aspects of the leaflets is formed, thereby reducing the likelihood of blood flow obstruction along these inflow regions.

[0176] In some embodiments, as described below with reference to FIGS. 22-26, connecting sutures formed along the leaflet edges of the valve leaflets can be used to secure the leaflets to the frame of the prosthetic heart valve and / or additional components of the prosthetic heart valve.

[0177] 22 and 23, leaflets 702 are shown secured together in an exemplary leaflet assembly 700 (or valve assembly), with connecting sutures 704 disposed along the leaflet edges of each of the leaflets 702. As will be explained further below, the connecting sutures 704 are configured to allow the leaflet assembly 700 to be secured directly to the frame of a prosthetic heart valve (e.g., the frame 102 of FIGS. 1-3 as shown in FIGS. 24-26) during assembly, without having to extend or thread sutures through the material of the leaflets 702 to the frame.

[0178] As used herein, a "connecting suture" may be defined as a line of multiple sutures extending along the leaflet edge on at least one side of at least one leaflet, including at least one first suture extending along the leaflet edge on at least one side of at least one leaflet, and multiple in-out stitches (e.g., formed with a second suture) extending through the at least one first suture and the leaflet edge. The in-out stitches may secure the first suture to the leaflet. The connecting suture may be formed on the leaflet while the leaflet is detached from the frame. Furthermore, the connecting suture may be formed (e.g., sewn) manually or automatically.

[0179] 22 and 23, each leaflet 702 may include opposing commissure tabs 706 located on opposite sides of the leaflet 702 and leaflet edges 708 (similar to leaflets 600 described above) extending between the opposing commissure tabs 706. FIG. 23 shows a single leaflet 702, and FIG. 22 shows a plan view of a leaflet assembly 700 including three leaflets 702 secured together along their leaflet edges 708 by connecting sutures 704.

[0180] To form the connecting sutures 704, one or more first sutures (referred to herein as first thicker sutures or first main sutures) 710 may be placed on one side of the leaflet 702 along the leaflet edge 708 ( FIGS. 22 and 23 ). In some embodiments, one or more second sutures (referred to herein as second thicker sutures or second main sutures) 712 may be placed on the opposing side of the leaflet 702 along the leaflet edge 708.

[0181] In some embodiments, the same first thicker suture 710 and second thicker suture 712 may extend along the leaflet edges 708 of each and all (e.g., three as shown in FIG. 22 ) of the leaflets 702 of the leaflet assembly 700, thereby connecting the leaflets 702 together. In other words, a single first thicker suture 710 may extend continuously along the leaflet edges of all of the leaflets 702 on one side of the leaflet, and a single second thicker suture 712 may extend continuously along the leaflet edges of all of the leaflets 702 on the opposite side of the leaflet.

[0182] In some embodiments, each leaflet 702 can include two thicker sutures 710 and 712 (or two strands of thicker suture or portions of the same thicker suture) extending along its leaflet edge 708 and on each side of the leaflet 702, and the two thicker sutures 710 and 712 may or may not connect to the two thicker sutures 710 and 712 of the other leaflets 702 of the leaflet assembly 700.

[0183] In some embodiments, the leaflet assembly 700 may be formed with one main or thicker suture (e.g., second suture 712) extending along a first side (e.g., medial or rougher side 720) of the leaflet edges 708 of all three leaflets 702, and three separate (or individual) first thicker sutures 710, each extending along a second side (e.g., lateral or smoother side 722) of the leaflet edges 708 of a corresponding leaflet 702, thereby resulting in two suture end portions (also referred to as suture tails or suture segments) on either side of the leaflet edges 708 that may extend beyond the commissure tabs 706. As a result, the end portions (or tails) of each pair of adjacent sutures from adjacent leaflets 702 may be brought together to form a united wedge member during commissure assembly (similar to that introduced above with reference to FIG. 17 ).

[0184] In some embodiments, the leaflet assembly 700 may be formed with three individual first thicker sutures 710, each extending along both a first side and a second side of the leaflet edge 708 of a corresponding leaflet 702. For example, for each leaflet 702, one first thicker suture 710 may be folded over (e.g., halfway over) one end of the leaflet edge 708, with the resulting first and second suture portions then extending along the first and second sides of the leaflet edge 708, respectively, and past opposite ends of the leaflet edge 708, such that two suture tails or segments are formed at opposite ends of the leaflet edge 708.

[0185] To further form the connecting suture 704 and connect the first thicker suture 710 and / or the second thicker suture 712 to the valve leaflet 702, a suture suture (or third suture) 714 is sewn in a running stitch pattern (e.g., an in-and-out pattern) through the first thicker suture 710 and / or the second thicker suture 712 and the valve leaflet 702 (e.g., through the thickness of the tissue of the valve leaflet 702). For example, if the leaflet 702 includes a first thicker suture (or strand or portion of suture) 710 on a first side thereof and a second thicker suture 712 (or strand or portion of suture) on a second side thereof, the suturing suture 714 may secure both the first thicker suture 710 and the second thicker suture 712 to the leaflet edge 708 of the leaflet 702. The suturing suture 714 may form multiple in-out stitches 715, each of which may extend through the first suture 710, the leaflet edge 708 of the leaflet 702, and the second suture 712.

[0186] In certain embodiments, the suturing suture 714 is thinner than the sutures 710 and / or 712, facilitating threading of the suturing suture 714 through the sutures 710, 712. Accordingly, the suturing suture 714 may be referred to as a "thinner suture" in the following description. In such embodiments, the suturing suture 714 has a smaller diameter and a higher gauge than the sutures 710, 712. However, it should be noted that in some embodiments, the suturing suture 714 need not be thinner than the sutures 710, 712. In such embodiments, the suturing suture 714 may have the same diameter (and gauge) as the sutures 710, 712, or a larger diameter (and lower gauge) than the sutures 710, 712.

[0187] FIG. 23 shows a view of one leaflet 702 in which a thinner suture 714 has been sewn in a running stitch pattern through a first thicker suture 710, the leaflet edge 708 of the leaflet 702, and a second thicker suture 712 (positioned behind the leaflet 702 in the view of FIG. 23), thereby joining the first thicker suture 710 and the second thicker suture 712 (or two suture portions of the same suture, as described above) to the leaflet 702 and creating a connecting suture 704.

[0188] Thus, a leaflet assembly 700 including assembled leaflets 702 (e.g., three leaflets) with connecting sutures 704 can be formed in a flat configuration, away from the frame of the prosthetic heart valve (as shown in FIG. 22 ). By assembling the leaflet assembly 700 in a flat configuration, away from the frame, the leaflet assembly 700 can be formed more easily and quickly. For example, this may allow the connecting sutures 704 to be sewn automatically (e.g., using a suturing machine) across the flattened leaflets 702. Advantageously, this may significantly reduce manufacturing time and costs.

[0189] The leaflet assembly 700 may be attached to the inner surface of a frame of a prosthetic heart valve (e.g., frame 102 shown in FIGS. 1-3) after the leaflet assembly 700 is formed. For example, as shown in FIGS. 24-26, a plurality of stitches 730 (e.g., "tuck" sutures) may extend under the in-out stitch 715 (between the in-out stitch 715 and the second, thicker suture 712) and then wrap around the angled struts of the frame (e.g., angled struts 130, 132, or 134), thereby connecting the connecting sutures 704 of the leaflet edges 708 of the leaflets 702 to the angled struts of the frame 102 ( FIGS. 24-26 ).

[0190] In some cases, the stitch 730 may extend underneath the second, thicker suture 712, between the second, thicker suture 712 and the leaflet 702), and then wrap around the angled struts of the frame.

[0191] In some embodiments, as shown in Figures 24 and 26, the stitches 730 may also extend through the outer skirt 106 of the prosthetic valve, thereby firmly securing the leaflet edges 708 of the leaflets 702 to the angled struts and the outer skirt 106.

[0192] In some embodiments, additional stitches 732 may be used to secure an inflow edge 734 of the outer skirt 106 to the inflow strut 168 (such as the apex region 152 of the inflow strut 168) (FIGS. 25 and 26).

[0193] Further details regarding connecting sutures such as connecting suture line 704 may be found in US Provisional Patent Application No. 63 / 343,359, previously incorporated herein by reference above.

[0194] delivery technology To implant a prosthetic valve into the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted within the native aortic valve via a transapical procedure, in which the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a mini-thoracotomy in the right parasternal region, and then advanced through the ascending aorta toward the native aortic valve.

[0195] To implant a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted within the native mitral valve via a transapical procedure, in which the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0196] To implant a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used to implant a prosthetic valve within the native pulmonary valve or pulmonary artery, except the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0197] Another delivery approach is the transatrial approach, whereby the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and an incision is made through the atrial wall (of the right or left atrium) to access either of the native heart valves. Atrial delivery can also be performed intravascularly, such as from a pulmonary vein. Yet another delivery approach is the transventricular approach, where the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and an incision is made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve within the native tricuspid valve, within the native pulmonary valve, or within the pulmonary artery.

[0198] In all delivery approaches, the delivery device may be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed herein may be implanted using any of a variety of delivery techniques and any of a variety of delivery devices known in the art.

[0199] Any of the systems, devices, instruments, etc. herein may be sterilized (e.g., using heat, radiation, and / or chemicals, etc.) to ensure safety for patient use, and any of the methods herein may include sterilization of the associated system, device, instrument, etc. as one of the method steps. Examples of heat / thermal sterilization include steam sterilization and autoclave sterilization. Examples of radiation used for sterilization include, but are not limited to, gamma rays, ultraviolet light, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Hydrogen peroxide sterilization may be performed, for example, using hydrogen peroxide plasma. [Example]

[0200] Additional Examples of the Disclosed Technology In view of the implementations described above with respect to the disclosed subject matter, the present application discloses the following additional embodiments: It should be noted that one feature of an embodiment individually, or two or more features of that embodiment in combination, and optionally in combination with one or more features of one or more additional embodiments, are also additional embodiments that are also included within the disclosure of the present application.

[0201] Example 1 1. A method comprising: forming a stitch line along an edge of an outer skirt for a prosthetic heart valve, the stitch line comprising a plurality of in-out stitches extending along the edge and a plurality of loops spaced apart from one another in the direction of the in-out stitches, each loop encircling a free edge of the edge and the plurality of loops spacing the plurality of in-out stitches from the free edge; and attaching the edge to struts of a row of circumferentially extending struts of an annular frame of the prosthetic heart valve by extending a plurality of whip stitches through the plurality of loops and around the struts such that the free edge of the edge is positioned against a radially outward-facing surface of the struts and away from the valve leaflets arranged on the inside of the annular frame.

[0202] Example 2. 10. The method of any of the embodiments herein, particularly embodiment 1, wherein the plurality of in-out stitches extend along the edge parallel to the free edge, and the plurality of in-out stitches are spaced a distance from the free edge.

[0203] Example 3. The method of any of the Examples herein, particularly Example 2, wherein the distance is in the range of 0.5 to 2.0 mm.

[0204] Example 4. The method of any of the Examples herein, particularly Example 2, wherein the distance is in the range of 1.5 to 2.0 mm.

[0205] Example 5. The method of any embodiment herein, particularly any one of embodiments 2-4, wherein the distance is equal to the length of each loop of the plurality of loops.

[0206] Example 6 The method of any one of Examples 1 to 5, particularly wherein the plurality of in-out stitches is a first pass of first in-out stitches formed along the edge, each first in-out stitch extending between two adjacent openings in a row of spaced-apart openings in the outer skirt, and forming a stitch line further comprises forming a second pass of second in-out stitches along the edge alternating with the first in-out stitches so that the first and second in-out stitches each extend across opposing surfaces of the outer skirt between corresponding pairs of two adjacent openings.

[0207] Example 7 and extending the suture thread back through the second opening, across the second surface of the outer skirt toward the free edge, to form a first loop; and extending the suture thread back through the second opening, across the second surface of the outer skirt opposite the first surface, to form a first loop. The method for forming the stitch line may include forming a plurality of in-out stitches and a plurality of loops, the method being repeated alternately across the first and second surfaces of the outer skirt to form the plurality of in-out stitches and a plurality of loops of the stitch line.

[0208] Example 8 and extending the suture thread back through the outer skirt, across the second surface toward the free edge, to an end of the first in-out stitch, thereby forming a first loop; and extending the suture thread back through the outer skirt, across the second surface, and back through the outer skirt to the first surface, thereby forming a second in-out stitch across the second surface, thereby forming a plurality of in-out stitches and a plurality of loops.

[0209] Example 9. The method of any embodiment herein, particularly any one of embodiments 1-8, wherein the plurality of loops is a single loop extending between the plurality of in-out stitches and the free edge of the outer skirt.

[0210] Example 10. The plurality of loops are a plurality of first loops, and forming the stitch line comprises extending the suture in a direction parallel to the free edge, onto a first surface of the outer skirt from a first opening in the outer skirt to an adjacent second opening, thereby forming a first in-out stitch across the first surface; extending the suture through the second opening, across a second surface of the outer skirt opposite the first surface toward the free edge, through a third opening offset from the second opening toward the free edge, across the first surface toward the free edge, onto the free edge, back across the second surface to the third opening, and through the third opening, back across the first surface to the second opening, thereby forming a first loop of the plurality of first loops and a second loop of the plurality of second loops between the free edge and the in-out stitch. and passing the suture back through the second opening and across the second surface and through an adjacent fourth opening in the outer skirt, thereby forming a second in-out stitch across the second surface, thereby forming a plurality of in-out stitches, a plurality of first loops, and a plurality of second loops, wherein the method for forming the stitch line is repeated alternately across the first and second surfaces of the outer skirt to form a plurality of in-out stitches, a plurality of first loops, and a plurality of second loops in the stitch line.

[0211] Example 11 The method of any embodiment herein, particularly embodiment 10, wherein at least a portion of the first, second, third, and fourth openings are preformed openings in the outer skirt.

[0212] Example 12 The method of any example herein, particularly any example 10 or example 11, wherein at least a portion of the first, second, third, and fourth openings are not preformed openings but are formed by the needle as the needle passes through the outer skirt and through the suture between the first and second surfaces.

[0213] Example 13 The method of any embodiment herein, particularly embodiment 10, wherein the first, second, third, and fourth openings are pre-formed openings in the outer skirt.

[0214] Example 14. The plurality of loops are a plurality of first loops, and forming the stitch line comprises extending the suture in a direction parallel to the free edge, onto a first surface of the outer skirt from a first point on the outer skirt to an adjacent second point on the outer skirt, thereby forming a first in-out stitch across the first surface; extending the suture through the outer skirt at the second point, across a second surface of the outer skirt opposite the first surface toward the free edge, through a third point on the outer skirt offset from the second point toward the free edge, across the first surface toward the free edge, onto the free edge, back across the second surface to the third point, and through the outer skirt at the third point, back across the first surface to the second point, thereby connecting a first loop of the plurality of first loops and a second loop of the plurality of second loops to the free edge. and passing the suture thread back through the outer skirt at the second point and across the second surface to an adjacent fourth point on the outer skirt, thereby forming a second in-out stitch across the second surface, thereby forming a plurality of in-out stitches, a plurality of first loops, and a plurality of second loops; wherein the method for forming the stitch line is repeated alternately across the first and second surfaces of the outer skirt to form the plurality of in-out stitches, a plurality of first loops, and a plurality of second loops in the stitch line.

[0215] Example 15. The method of any of the embodiments herein, particularly any one of Embodiments 1-6 or 10-14, wherein the plurality of loops is a plurality of first loops, and forming the stitch line further includes forming the stitch line with a plurality of second loops spaced apart from one another in a direction of the in-out stitches, each second loop of the plurality of second loops extending from a corresponding first loop of the plurality of first loops to an intersection of two adjacent in-out stitches of the plurality of in-out stitches.

[0216] Example 16. The method of any example herein, particularly Example 15, wherein each second loop is shorter than each first loop.

[0217] Example 17. The method of any embodiment herein, particularly any one of embodiments 1-16, wherein the edge is an outflow edge disposed opposite the inflow edge of the outer skirt, and the row of circumferentially extending struts to which the outflow edge is attached is a first row of circumferentially extending struts of the frame, the method further comprising securing the inflow edge of the outer skirt to a second row of circumferentially extending struts of the frame, the second row defining an inflow end of the frame and spaced axially from the first row of circumferentially extending struts of the frame.

[0218] Example 18. The method of any embodiment herein, particularly embodiment 17, wherein the first row of circumferentially extending struts of the frame are disposed adjacent to the third row of circumferentially extending struts of the frame that define an outflow end of the frame.

[0219] Example 19. The method of any embodiment herein, particularly any one of embodiments 1-18, wherein the edge extends circumferentially when the outer skirt is disposed around the outer surface of the frame.

[0220] Example 20. The method of any embodiment herein, particularly any one of embodiments 1-19, wherein the edge comprises a plurality of protrusions that define an undulating shape of the edge that follows the contours of the struts in the circumferentially extending row of struts.

[0221] Example 21. The method of any embodiment herein, particularly any one of embodiments 1-20, wherein attaching the edge to the post by extending a plurality of whip stitches through a plurality of loops and around the post comprises extending at least a portion of a whip stitch around each post and through a corresponding loop of the plurality of loops to form a double loop around the corresponding loop.

[0222] Example 22. 1. A method comprising: forming a stitch line along an edge of an outer skirt for a prosthetic heart valve, the stitch line comprising a plurality of in-out stitches extending along the edge spaced from a free edge of the edge, and a plurality of loops spaced from one another in the direction of the in-out stitches, each loop circumferentially surrounding a free edge of the edge and extending between the edge and an intersection of two adjacent in-out stitches; and attaching the edge to struts of a row of circumferentially extending struts of an annular frame of the prosthetic heart valve by extending a plurality of whip stitches through the plurality of loops and around the struts such that the free edge of the edge is positioned relative to a radially outward-facing surface of the strut, away from an inwardly disposed leaflet of the annular frame.

[0223] Example 23. The method of any embodiment herein, particularly embodiment 22, wherein the loops of the plurality of loops are spaced apart from one another in a direction parallel to the free edge.

[0224] Example 24. The method of any of the embodiments herein, particularly any of Embodiments 22 or 23, wherein the plurality of in-out stitches extend end-to-end along an edge parallel to the free edge, and the plurality of in-out stitches are spaced apart from the free edge by a distance perpendicular to the free edge.

[0225] Example 25. The method of any example herein, particularly example 24, wherein the distance is in the range of 0.5 to 2.0 mm.

[0226] Example 26. The method of any example herein, particularly example 24, wherein the distance is in the range of 1.4 to 2.1 mm.

[0227] Example 27. The method of any embodiment herein, particularly any one of embodiments 24-26, wherein the distance is equal to the length of each loop of the plurality of loops.

[0228] Example 28. The method of any one of Examples 22-27, particularly wherein the plurality of in-out stitches are a first pass of first in-out stitches formed along the edge, each first in-out stitch extending between two adjacent openings in a row of spaced-apart openings in the outer skirt, and forming a stitch line further comprises forming a second pass of second in-out stitches along the edge alternating with the first in-out stitches so that the first and second in-out stitches each extend across opposing surfaces of the outer skirt between corresponding pairs of two adjacent openings.

[0229] Example 29. The method of any example herein, particularly example 28, wherein the array of spaced-apart openings comprises preformed openings extending through the outer skirt and between opposing first and second surfaces of the outer skirt.

[0230] Example 30. and passing the suture through the second opening and across the second surface to an adjacent third opening in the outer skirt, thereby forming a second in-out stitch across the second surface, thereby forming a plurality of in-out stitches and a plurality of loops. The method of any one of Examples 22-29 herein, particularly any one of Examples 22-29, further includes: extending a suture in a direction parallel to the free edge onto a first surface of the outer skirt from a first opening in the outer skirt to an adjacent second opening, thereby forming a first in-out stitch across the first surface; extending the suture through the second opening, across a second surface of the outer skirt opposite the first surface toward the free edge, back across the first surface onto the free edge, and passing the suture through the second opening and across the second surface to an adjacent third opening in the outer skirt, thereby forming a second in-out stitch across the second surface, thereby forming a plurality of in-out stitches and a plurality of loops.

[0231] Example 31. and passing the suture back through the outer skirt, across the second surface, and back through the outer skirt to the first surface, thereby forming a second in-out stitch, thereby forming a plurality of in-out stitches and a plurality of loops. The method of any one of Examples 22-29 herein, particularly any one of Examples 22-29, further includes: extending the suture in a direction parallel to the free edge onto a first surface of the outer skirt, through the outer skirt, and to a second surface of the outer skirt opposite the first surface, thereby forming a first in-out stitch across the first surface; extending the suture across the second surface toward the free edge, over the free edge, and back across the first surface to an end of the first in-out stitch, thereby forming a first loop; and passing the suture back through the outer skirt, across the second surface, and through the outer skirt to the first surface, thereby forming a second in-out stitch across the second surface, thereby forming a plurality of in-out stitches and a plurality of loops.

[0232] Example 32. The method of any embodiment herein, particularly any one of embodiments 22-31, wherein attaching the edge to the post by extending a plurality of whip stitches through a plurality of loops and around the post comprises extending at least a portion of a whip stitch around each post and through a corresponding loop of the plurality of loops such that a double loop is formed around the corresponding loop.

[0233] Example 33. The method of any embodiment herein, particularly any one of embodiments 22-32, wherein the edge is an outflow edge disposed opposite the inflow edge of the outer skirt, and the row of circumferentially extending struts to which the outflow edge is attached is a first row of circumferentially extending struts of the frame, the method further comprising securing the inflow edge of the outer skirt to a second row of circumferentially extending struts of the frame that defines an inflow end of the frame and that are axially spaced from the first row of circumferentially extending struts of the frame.

[0234] Example 34. The method of any embodiment herein, particularly embodiment 33, wherein a first row of circumferentially extending struts of the frame are disposed adjacent to a third row of circumferentially extending struts of the frame that define an outflow end of the frame.

[0235] Example 35. The method of any embodiment herein, particularly any one of embodiments 22-34, wherein the edge extends circumferentially when the outer skirt is disposed around the outer surface of the frame.

[0236] Example 36. The method of any embodiment herein, particularly any one of embodiments 22-35, wherein the edge comprises a plurality of protrusions that define an undulating shape of the edge that follows the contours of the struts in the circumferentially extending row of struts.

[0237] Example 37. 1. A method comprising: forming a stitch line along an edge of an outer skirt for a prosthetic heart valve, the stitch line comprising a plurality of in-out stitches extending along the edge spaced from a free edge of the edge, and a plurality of pairs of loops spaced from one another in the direction of the in-out stitches, each pair of loops including a first loop and a second loop, the first loop surrounding the free edge of the edge and extending between the free edge and the second loop, and the second loop extending between the first loop and an intersection of two adjacent in-out stitches of the plurality of in-out stitches; and attaching the edge to struts of a row of circumferentially extending struts of an annular frame of the prosthetic heart valve by extending a whip stitch through the first loop of each pair of loops and around the struts such that the free edge of the edge is positioned relative to a radially outward-facing surface of the strut and away from an inwardly disposed leaflet of the annular frame.

[0238] Example 38. The method of any of the embodiments herein, particularly embodiment 37, wherein the plurality of in-out stitches extend along the edge parallel to the free edge and the plurality of in-out stitches are spaced apart from the free edge by a distance perpendicular to the free edge.

[0239] Example 39. The method of any example herein, particularly Example 38, wherein the distance is in the range of 0.5 to 2.0 mm.

[0240] Example 40. The method of any example herein, particularly Example 38, wherein the distance is in the range of 1.4 to 2.1 mm.

[0241] Example 41. The method of any example herein, particularly any one of Examples 38-40, wherein the distance is equal to the combined length of the first loop and the second loop of each pair of loops of the plurality of paired loops.

[0242] Example 42. The method of any one of Examples 37-41, particularly wherein the plurality of in-out stitches are a first pass of first in-out stitches formed along the edge, each first in-out stitch extending between two adjacent openings in a row of spaced-apart openings in the outer skirt, and forming a stitch line further comprises forming a second pass of second in-out stitches along the edge alternating with the first in-out stitches so that the first and second in-out stitches each extend across opposing surfaces of the outer skirt between corresponding pairs of two adjacent openings.

[0243] Example 43. The method of any example herein, particularly example 42, wherein the array of spaced-apart openings comprises preformed openings extending through the outer skirt and between opposing first and second surfaces of the outer skirt.

[0244] Example 44. Forming the stitch line includes extending the suture in a direction parallel to the free edge, onto a first surface of the outer skirt from a first opening in the outer skirt to an adjacent second opening, thereby forming a first in-out stitch across the first surface; extending the suture through the second opening, across a second surface of the outer skirt opposite the first surface toward the free edge, through a third opening offset from the second opening toward the free edge, across the first surface toward the free edge, onto the free edge, back across the second surface to the third opening, and through the third opening, back across the first surface to the second opening, thereby forming a first in-out stitch across a corresponding pair of loops of the plurality of pairs of loops. and passing the suture thread back through the second opening and across the second surface to an adjacent fourth opening in the outer skirt, thereby forming a second in-out stitch across the second surface, thereby forming a plurality of in-out stitches and a plurality of pairs of loops, wherein the method for forming the stitch line is repeated alternately across the first and second surfaces of the outer skirt to form a plurality of in-out stitches and a plurality of pairs of loops in the stitch line.

[0245] Example 45. The method of any embodiment herein, particularly embodiment 44, wherein at least a portion of the first, second, third, and fourth openings are preformed openings in the outer skirt.

[0246] Example 46 The method of any example herein, particularly any of Example 44 or Example 45, wherein at least a portion of the first, second, third, and fourth openings are not preformed openings but are formed by the needle as the needle passes through the outer skirt and through the suture between the first and second surfaces.

[0247] Example 47. The method of any embodiment herein, particularly embodiment 44, wherein the first, second, third, and fourth openings are preformed openings in the outer skirt.

[0248] Example 48. Forming the stitch line includes extending the suture thread in a direction parallel to the free edge, onto a first surface of the outer skirt from a first point on the outer skirt to an adjacent second point on the outer skirt, thereby forming a first in-out stitch across the first surface; extending the suture thread through the outer skirt at the second point, across a second surface of the outer skirt opposite the first surface toward the free edge, through a third point on the outer skirt offset from the second point toward the free edge, across the first surface toward the free edge, onto the free edge, back across the second surface to the third point, and through the outer skirt at the third point, back across the first surface to the second point, thereby forming a plurality of pairs of loops. and passing the suture back through the outer skirt at the second point and across the second surface to an adjacent fourth point on the outer skirt, thereby forming a second in-out stitch across the second surface, thereby forming a plurality of in-out stitches and a plurality of paired loops, wherein the method for forming the stitch line is repeated alternately across the first and second surfaces of the outer skirt to form the plurality of in-out stitches and a plurality of paired loops of the stitch line.

[0249] Example 49. The method of any example herein, particularly any one of Examples 37-48, wherein each second loop is shorter than each first loop.

[0250] Example 50. The method of any example herein, particularly example 49, wherein each first loop is in the range of 0.2 to 0.6 mm.

[0251] Example 51. The method of any example herein, particularly example 50, wherein each second loop is in the range of 0.8 to 1.9 mm.

[0252] Example 52. The method of any embodiment herein, particularly any one of embodiments 37-51, wherein the edge is an outflow edge located opposite the inflow edge of the outer skirt, and the row of circumferentially extending struts to which the outflow edge is attached is a first row of circumferentially extending struts of the frame, the method further comprising securing the inflow edge of the outer skirt to a second row of circumferentially extending struts of the frame that defines an inflow end of the frame and that are axially spaced from the first row of circumferentially extending struts of the frame.

[0253] Example 53. The method of any embodiment herein, particularly embodiment 52, wherein a first row of circumferentially extending struts of the frame are disposed adjacent to a third row of circumferentially extending struts of the frame that define an outflow end of the frame.

[0254] Example 54. The method of any example herein, particularly any one of Examples 37-53, wherein the edge extends circumferentially when the outer skirt is disposed around the outer surface of the frame.

[0255] Example 55. The method of any embodiment herein, particularly any one of embodiments 37-54, wherein the edge comprises a plurality of protrusions that define an undulating shape of the edge that follows the contours of the struts in the circumferentially extending row of struts.

[0256] Example 56. The method of any of the embodiments herein, particularly any one of embodiments 37-55, wherein attaching the edge to the support by extending a plurality of whip stitches through a plurality of loops and around the support includes extending at least a portion of a whip stitch around each support and through a corresponding first loop of a plurality of pairs of loops, such that a double loop is formed around the corresponding first loop.

[0257] Example 57. 1. A prosthetic heart valve comprising: an annular frame including a plurality of interconnected struts arranged in a plurality of circumferentially extending strut rows, including a first circumferentially extending strut row located closer to the outflow end than the inflow end of the frame; an outer skirt disposed around an outer surface of the frame, the outer skirt including an outflow edge having a free outflow edge, the outflow edge including a stitch line extending circumferentially around the frame and including a plurality of in-out stitches extending along the outflow edge parallel to but spaced from the outflow edge, and a plurality of loop stitches spaced apart from one another in the direction of the plurality of in-out stitches, each loop stitch surrounding the outflow edge and extending between the outflow edge and an intersection of corresponding two adjacent in-out stitches of the plurality of in-out stitches; and a plurality of whip stitches extending through the plurality of loop stitches and around struts of the first circumferentially extending strut row such that the outflow edge is attached to the strut against a radially outward-facing surface of the strut.

[0258] Example 58. The prosthetic heart valve of any example herein, particularly example 57, wherein the outflow edge is rougher than the remainder of the outflow edge of the outer skirt.

[0259] Example 59. A prosthetic heart valve as described in any of the examples herein, particularly any of Example 57 or Example 58, further comprising a plurality of leaflets fixed to the inside of the frame, the plurality of leaflets facing the radially inward-facing surfaces of the struts.

[0260] Example 60. 59. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 57-59, wherein the plurality of rows of circumferentially extending struts further includes a second row of circumferentially extending struts defining an outflow end of the frame, and wherein the first row of circumferentially extending struts is disposed adjacent to the second row of circumferentially extending struts.

[0261] Example 61. A prosthetic heart valve as described in any of the examples herein, particularly any one of Examples 57-60, wherein the outer skirt has a row of spaced apart openings extending along the outflow edge, parallel to but spaced apart from the outflow edge, and a plurality of in-out stitches and a plurality of loop stitches extending through the spaced apart openings.

[0262] Example 62. The prosthetic heart valve of any embodiment herein, particularly embodiment 61, wherein the spaced apart openings are pre-formed in the outer skirt.

[0263] Example 63. A prosthetic heart valve as described in any of the examples herein, particularly any of Example 61 or Example 62, wherein the plurality of in-out stitches includes a first pass of first in-out stitches extending along the outflow edge, each first in-out stitch extending between adjacent openings of a corresponding pair of spaced apart openings in the row.

[0264] Example 64. The prosthetic heart valve of any of the embodiments herein, particularly embodiment 63, wherein the plurality of in-out stitches further includes a second pass of second in-out stitches extending along the outflow edge, each second in-out stitch extending between a corresponding pair of adjacent openings, and the second in-out stitches alternating with the first in-out stitches such that the first and second in-out stitches extend across opposing surfaces of the outer skirt between each corresponding pair of adjacent openings.

[0265] Example 65. The prosthetic heart valve of any of the Examples herein, particularly any one of Examples 57 to 64, wherein the loop stitches of the plurality of loop stitches are spaced apart from one another in a direction parallel to the outflow edge.

[0266] Example 66. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 57-65, wherein the plurality of in-out stitches are spaced from the outflow edge by a distance extending perpendicular to the outflow edge.

[0267] Example 67. The prosthetic heart valve described in any example herein, particularly example 66, wherein the distance is in the range of 0.5 to 2.0 mm.

[0268] Example 68. The prosthetic heart valve of any of the Examples herein, particularly Example 66, wherein the distance is in the range of 1.4 to 2.1 mm.

[0269] Example 69. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 66-68, wherein the distance is equal to the length of each loop stitch of the plurality of loop stitches.

[0270] Example 70. 69. A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 57 to 69, wherein each loop stitch has a first portion extending along a first surface of the outer skirt and a second portion extending along an opposing second surface of the outer skirt between the outflow edge and an intersection of corresponding two adjacent in-out stitches.

[0271] Example 71. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 57-70, wherein for each strut in the first circumferentially extending row of struts, at least one whip stitch of the plurality of whip stitches extending around the strut forms a double loop around a corresponding loop stitch.

[0272] Example 72. A prosthetic heart valve as described in any of the examples herein, particularly any one of Examples 57 to 71, wherein the outer skirt has an inflow edge disposed opposite the outflow edge, and the inflow edge is fixed to a third row of circumferentially extending struts among the plurality of rows of circumferentially extending struts that define the inflow end of the frame.

[0273] Example 73. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 57-72, wherein the outflow edge extends circumferentially around the outer surface of the frame.

[0274] Example 74. A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 57 to 73, wherein the outflow edge comprises a plurality of protrusions that define an undulating shape of the outflow edge that follows the contours of the first circumferentially extending row of struts.

[0275] Example 75. 1. A prosthetic heart valve comprising: an annular frame including a plurality of interconnected struts arranged in a plurality of circumferentially extending rows of struts between an inflow end and an outflow end of the frame, the plurality of circumferentially extending rows of struts including a first circumferentially extending row of struts; and an outer skirt disposed around an outer surface of the frame, the outer skirt including a rim having a free edge, the rim extending circumferentially around the frame and including a plurality of in-out stitches extending along the rim parallel to but spaced from the free edge; and a plurality of pairs of loop stitches spaced apart from each other in the direction of the plurality of in-out stitches. an outer skirt including a stitch line, each pair of loop stitches including a first loop stitch and a second loop stitch, the first loop stitch surrounding a free edge and extending between the free edge and the second loop, the second loop extending between the first loop and an intersection of two corresponding adjacent in-out stitches of the plurality of in-out stitches; and a plurality of whip stitches extending through the first loop stitch of each pair of loop stitches and around struts of a first circumferentially extending row of struts such that the free edge is attached to the struts against a radially outward-facing surface of the strut.

[0276] Example 76. The prosthetic heart valve of any of the embodiments herein, particularly embodiment 75, wherein the first circumferentially extending row of struts is positioned closer to the outflow end of the frame than the inflow end, the edge is an outflow edge, and the free edge is an outflow edge of the outer skirt.

[0277] Example 77. The prosthetic heart valve of any example herein, particularly any of example 75 or example 76, wherein the free edge is rougher than the remainder of the edge of the outer skirt.

[0278] Example 78. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 75-77, further comprising a plurality of leaflets secured to the interior of the frame, the leaflets facing the radially inward-facing surfaces of the struts.

[0279] Example 79. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 75-78, wherein the plurality of rows of circumferentially extending struts further includes a second row of circumferentially extending struts defining an outflow end of the frame, and wherein the first row of circumferentially extending struts is disposed adjacent to the second row of circumferentially extending struts.

[0280] Example 80. 79. The prosthetic heart valve of any one of the embodiments herein, particularly any one of embodiments 75-79, wherein the outer skirt comprises a first row of spaced-apart first openings extending along the edge parallel to but spaced apart from the free edge, and a second row of spaced-apart second openings extending along the edge parallel to but spaced apart from the first row of spaced-apart first openings, the second row of spaced-apart second openings being spaced further away from the free edge than the first row of spaced-apart first openings, the plurality of in-out stitches extending through the second row of second openings, and the first loop stitch and the second loop stitch of each pair of loop stitches extending through the first opening in the first row.

[0281] Example 81. The prosthetic heart valve of any embodiment herein, particularly embodiment 80, wherein the first and second openings are pre-formed in the outer skirt.

[0282] Example 82. A prosthetic heart valve as described in any of the examples herein, particularly any of Example 80 or Example 81, wherein the plurality of in-out stitches includes a first path of first in-out stitches extending along the edge, each first in-out stitch extending between adjacent second openings of a corresponding pair of spaced second openings in the second row.

[0283] Example 83. The prosthetic heart valve of any of the embodiments herein, particularly embodiment 82, wherein the plurality of in-out stitches further comprises a second pass of second in-out stitches extending along the edge, each second in-out stitch extending between a corresponding pair of adjacent second openings, and the second in-out stitches alternating with the first in-out stitches such that the first and second in-out stitches extend across opposing surfaces of the outer skirt between each corresponding pair of adjacent second openings.

[0284] Example 84. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 75 to 83, wherein pairs of loop stitches among the plurality of pairs of loop stitches are spaced apart from each other in a direction parallel to the free edge.

[0285] Example 85. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 75 to 84, wherein the plurality of in-out stitches are spaced from the free edge by a distance extending perpendicular to the free edge.

[0286] Example 86. The prosthetic heart valve of any of the examples herein, particularly example 85, wherein the distance is in the range of 0.5 to 2.0 mm.

[0287] Example 87. The prosthetic heart valve of any example herein, particularly example 85, wherein the distance is in the range of 1.4 to 2.1 mm.

[0288] Example 88. The prosthetic heart valve of any of the examples herein, particularly any one of Examples 85-87, wherein the distance is equal to the combined length of the first loop stitch and the second loop stitch of each pair of loop stitches.

[0289] Example 89. A prosthetic heart valve as described in any of the examples herein, particularly any one of Examples 75 to 88, wherein for each pair of loop stitches, the first loop stitch has a first portion extending along the first surface of the outer skirt and a second portion extending along the opposing second surface of the outer skirt between the free edge and the second loop stitch, and the second loop stitch has a first portion extending along the first surface of the outer skirt and a second portion extending along the second surface of the outer skirt between the first loop stitch and an intersection of two corresponding adjacent in-out stitches.

[0290] Example 90. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 75-89, wherein for each strut in the first circumferentially extending row of struts, at least one whip stitch in the plurality of whip stitches extending around the strut forms a double loop around a corresponding first loop stitch.

[0291] Example 91. A prosthetic heart valve as described in any of the examples herein, particularly any one of Examples 75 to 90, wherein the edge is an outflow edge of the outer skirt, the outer skirt including an inflow edge disposed opposite the outflow edge, the inflow edge being secured to a third row of circumferentially extending struts among a plurality of rows of circumferentially extending struts defining the inflow end of the frame.

[0292] Example 92. The prosthetic heart valve of any embodiment herein, particularly any one of embodiments 75-91, wherein the rim extends circumferentially around the outer surface of the frame.

[0293] Example 93. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 75-92, wherein the edge comprises a plurality of protrusions that define an undulating shape of the edge that follows the contours of the first circumferentially extending row of struts.

[0294] Example 94. 1. A method comprising: forming a stitch line along a leaflet edge of a prosthetic heart valve, the stitch line comprising a plurality of in-out stitches extending along the leaflet edge spaced from an outermost leaflet edge of the leaflet, and a plurality of loops spaced from one another in the direction of a whip stitch, each loop surrounding the leaflet edge of the leaflet and extending between the leaflet and an intersection of two adjacent in-out stitches; and attaching the leaflet to a target component of the prosthetic heart valve by extending a plurality of whip stitches through the plurality of loops, around or through the target component, such that the leaflet edge of the leaflet is sewn against the target component.

[0295] Example 95. The method of any embodiment herein, particularly embodiment 94, wherein the targeting component is a textile skirt configured to be attached to the inner surface of the annular frame of the prosthetic heart valve.

[0296] Example 96. The method of any embodiment herein, particularly embodiment 94, wherein the targeting component is a strut of the annular frame of the prosthetic heart valve that follows the scallop line of the cusp edge.

[0297] Example 97. The method described in any example herein, particularly example 96, wherein the strut to which the pointed edge is attached is an angled strut extending from a first commissure support portion of the frame to the inflow end of the frame and from the inflow end of the frame to a second commissure support portion of the frame, the first and second commissure support portions being positioned adjacent to the outflow end of the frame.

[0298] Example 98. The method described in any of the examples herein, particularly Example 96 or Example 97, wherein attaching the pointed edge to the target component comprises extending a plurality of whip stitches through a plurality of loops and around the support post.

[0299] Example 99. The method of any of the embodiments herein, particularly any of embodiment 96 or embodiment 97, wherein attaching the pointed edge to the target component comprises extending a plurality of whip stitches through or around a suture that extends through a plurality of loops and around the support.

[0300] Example 100. The method of any of the embodiments herein, particularly any of embodiments 94-99, wherein the plurality of in-out stitches extend along the apical edge parallel to the apical edge, and the plurality of in-out stitches are spaced a distance from the apical edge.

[0301] Example 101. The method of any example herein, particularly example 100, wherein the distance is in the range of 0.5 to 2.0 mm.

[0302] Example 102. The method of any embodiment herein, particularly any of embodiment 100 or embodiment 101, wherein the distance is equal to the length of each loop of the plurality of loops.

[0303] Example 103. The method of any of the embodiments herein, particularly any one of embodiments 94-102, wherein the plurality of in-out stitches is a first pass of a first in-out stitch formed along the cusp edge, and forming the stitch line further comprises forming a second pass of a second in-out stitch along the cusp edge, alternating with the first in-out stitch so that the first and second in-out stitches extend across opposite sides of the valve leaflet between adjacent loops of each pair of the plurality of loops.

[0304] Example 104. Forming the stitch line includes extending the suture over a first side of the leaflet in a direction parallel to the leaflet edge, extending the suture through the leaflet edge to a second side of the leaflet opposite the first side, thereby forming a first in-out stitch across the first side, extending the suture across the second side of the leaflet toward the leaflet edge, over the leaflet edge, and back across the first side to the first in-out stitch, thereby forming a first loop, and extending the suture through the leaflet edge. and passing the stitch line across the second side in a direction parallel to the leaflet edge and back to the second side, thereby forming a second in-out stitch across the second side, thereby forming a plurality of in-out stitches and a plurality of loops, wherein the method for forming the stitch line is repeated alternately across the first and second sides of the leaflet to form the plurality of in-out stitches and a plurality of loops in the stitch line.

[0305] Example 105. The method of any of the embodiments herein, particularly any one of embodiments 94-104, wherein the leaflets include opposing commissure tabs disposed at opposing ends of the outflow edge of the leaflet, and the leaflet edge extends between the opposing commissure tabs and is curved to form the inflow edge of the leaflet.

[0306] Example 106. The method of any of the embodiments herein, particularly embodiment 105, wherein the prosthetic heart valve includes a plurality of leaflets, and the method includes forming a stitch line along a leaflet edge of each leaflet of the plurality of leaflets, and attaching the leaflet edge of each leaflet to a target component.

[0307] Example 107. The method of any embodiment herein, particularly embodiment 106, further comprising, for each pair of adjacent commissure tabs of two adjacent valve leaflets, fixing the pair of adjacent commissure tabs together to form a commissure, and attaching the commissure to a commissure support portion of the frame.

[0308] Example 108. A prosthetic heart valve comprising: an annular frame including a plurality of interconnected struts arranged in a plurality of circumferentially extending rows of angled struts between an inflow end and an outflow end of the frame; and a plurality of leaflets disposed on an interior of the frame, each leaflet having a leaflet edge extending between opposing sides disposed on opposing ends of an outflow edge of the leaflet, the leaflet edge being attached to a portion of an angled strut of the plurality of circumferentially extending rows of angled struts by a stitch line formed along the leaflet edge, the stitch line extending along the leaflet edge parallel to but spaced from the free edge of the leaflet. a plurality of leaflets comprising a plurality of in-out stitches interposing therebetween; and a plurality of loop stitches spaced from one another in the direction of the plurality of in-out stitches, each loop stitch surrounding a leaflet edge and extending between the leaflet edge and an intersection of corresponding two adjacent in-out stitches of the plurality of in-out stitches; and a plurality of whip stitches extending through the plurality of loop stitches and around a portion of the angled struts or around one or more sutures extending around a portion of the angled struts, such that the leaflet edge is joined to and sewn against the portion of the angled struts.

[0309] Example 109. The prosthetic heart valve of any embodiment herein, particularly embodiment 108, wherein opposing lateral portions of each leaflet are opposing commissure tabs, and the commissure tab of each leaflet mates with an adjacent commissure tab of an adjacent leaflet to form a commissure that is secured to the commissure support portion of the frame.

[0310] Example 110. The prosthetic heart valve of any of the embodiments herein, particularly embodiment 109, wherein the portion of the angled strut to which the cusp is attached is an angled strut extending from a first commissure support portion of the frame to the inflow end of the frame and from the inflow end of the frame to a second commissure support portion of the frame, the first and second commissure support portions being positioned adjacent to the outflow end of the frame.

[0311] Example 111. The prosthetic heart valve of any embodiment herein, particularly any one of embodiments 108-110, further comprising an outer skirt disposed around an outer surface of the frame.

[0312] Example 112. A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 108 to 111, wherein the plurality of in-out stitches includes a first pass of first in-out stitches extending along the cusp edge, each first in-out stitch extending between adjacent loop stitches of a corresponding pair of the plurality of loop stitches.

[0313] Example 113. The prosthetic heart valve of any of the embodiments herein, particularly embodiment 112, wherein the plurality of in-out stitches further includes a second pass of second in-out stitches extending along the leaflet edge, each second in-out stitch extending between a corresponding pair of adjacent loop stitches, and the second in-out stitches alternating with the first in-out stitches such that the first and second in-out stitches extend across opposite sides of the leaflet between each corresponding pair of adjacent loop stitches.

[0314] Example 114. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 108 to 113, wherein the loop stitches of the plurality of loop stitches are spaced apart from one another in a direction parallel to the cusp edge.

[0315] Example 115. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 108-114, wherein the plurality of in-out stitches are spaced from the cusp edge by a distance extending perpendicular to the outflow edge.

[0316] Example 116. The prosthetic heart valve of any embodiment herein, particularly embodiment 115, wherein the distance is equal to the length of each loop stitch of the plurality of loop stitches.

[0317] Example 117. 11. A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 108 to 116, wherein each loop stitch has a first portion extending along a first side of the valve leaflet and a second portion extending along an opposing second side of the valve leaflet between the leaflet edge and an intersection of corresponding two adjacent in-out stitches.

[0318] Example 118. A prosthetic heart valve comprising: an annular frame including a plurality of interconnected struts arranged in a plurality of circumferentially extending rows of angled struts between an inflow end and an outflow end of the frame; an inner skirt configured to be secured on an interior side of the frame to a portion of an angled strut of the plurality of circumferentially extending rows of angled struts; and a plurality of leaflets disposed on the interior of the frame, each leaflet having a leaflet edge extending between opposing sides disposed on opposing ends of an outflow edge of the leaflet, the leaflet edge being attached to the inner skirt by a stitch line formed along the leaflet edge. a plurality of leaflets, each loop stitch surrounding a leaflet and extending between the leaflet and an intersection of two corresponding adjacent in-out stitches of the plurality of in-out stitches; and a plurality of whip stitches extending through the plurality of loop stitches and through the inner skirt such that the leaflet is joined to and sewn against the inner skirt.

[0319] Example 119. The prosthetic heart valve of any embodiment herein, particularly embodiment 118, wherein opposing lateral portions of each leaflet are opposing commissure tabs, and wherein the commissure tab of each leaflet mates with an adjacent commissure tab of an adjacent leaflet to form a commissure that is secured to the commissure support portion of the frame.

[0320] Example 120. The prosthetic heart valve of any of the embodiments herein, particularly embodiment 119, wherein the portions of the angled struts to which the inner skirt is attached are angled struts that extend from a first commissure support portion of the frame to the inflow end of the frame and from the inflow end of the frame to a second commissure support portion of the frame, and the first and second commissure support portions are positioned adjacent to the outflow end of the frame.

[0321] Example 121. The prosthetic heart valve of any embodiment herein, particularly any one of embodiments 118-120, further comprising an outer skirt disposed around an outer surface of the frame.

[0322] Example 122. A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 118 to 121, wherein the plurality of in-out stitches includes a first pass of first in-out stitches extending along the cusp edge, each first in-out stitch extending between adjacent loop stitches of a corresponding pair of the plurality of loop stitches.

[0323] Example 123. The prosthetic heart valve of any of the embodiments herein, particularly embodiment 122, wherein the plurality of in-out stitches further includes a second pass of second in-out stitches extending along the leaflet edge, each second in-out stitch extending between a corresponding pair of adjacent loop stitches, and the second in-out stitches alternating with the first in-out stitches such that the first and second in-out stitches extend across opposite sides of the leaflet between each corresponding pair of adjacent loop stitches.

[0324] Example 124. The prosthetic heart valve of any of the Examples herein, particularly any one of Examples 118 to 123, wherein the loop stitches of the plurality of loop stitches are spaced apart from one another in a direction parallel to the cusp edge.

[0325] Example 125. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 118-124, wherein the plurality of in-out stitches are spaced from the cusp edge by a distance extending perpendicular to the outflow edge.

[0326] Example 126. The prosthetic heart valve of any embodiment herein, particularly embodiment 125, wherein the distance is equal to the length of each loop stitch of the plurality of loop stitches.

[0327] Example 127. A prosthetic heart valve as described in any of the Examples herein, particularly any one of Examples 118 to 126, wherein each loop stitch has a first portion extending along a first side of the valve leaflet and a second portion extending along an opposing second side of the valve leaflet between the leaflet edge and an intersection of corresponding two adjacent in-out stitches.

[0328] Example 128. 1. A method comprising: forming a stitch line along an edge of a first component for a prosthetic heart valve, the stitch line comprising a plurality of in-out stitches extending along the edge spaced from an outermost edge of the edge and a plurality of loops spaced from one another in the direction of the in-out stitches, each loop circumscribing an edge of the edge and extending between the edge and an intersection of two adjacent in-out stitches; and attaching the edge to a second component of the prosthetic heart valve by extending a plurality of whip stitches through the plurality of loops, around or through the second component, such that the edge of the edge is joined to and sewn to the second component.

[0329] Example 129. The method of any embodiment herein, particularly embodiment 128, wherein the first component is a leaflet of a prosthetic heart valve and the edge is a leaflet edge of the leaflet.

[0330] Example 130. The method of any embodiment herein, particularly embodiment 129, wherein the second component is a textile skirt configured to be attached to the inner surface of the annular frame of the prosthetic heart valve.

[0331] Example 131. The method of any embodiment herein, particularly embodiment 129, wherein the second component is a strut of an annular frame of the prosthetic heart valve that follows the scallop line of the cusp edge.

[0332] Example 132. The method of any of the embodiments herein, particularly embodiment 131, wherein the struts to which the pointed edges are attached are angled struts extending from a first commissure support portion of the frame to the inflow end of the frame and from the inflow end of the frame to a second commissure support portion of the frame, the first and second commissure support portions being positioned adjacent to the outflow end of the frame.

[0333] Example 133. The method of any example herein, particularly example 131 or example 132, wherein attaching the edge to the second component comprises extending a plurality of whip stitches through a plurality of loops and around the post.

[0334] Example 134. The method of any example herein, particularly any of Example 131 or Example 132, wherein attaching the edge to the second component comprises extending a plurality of whip stitches through or around a suture that extends through a plurality of loops and around the support.

[0335] Example 135. The method of any embodiment herein, particularly embodiment 128, wherein the first component is an outer skirt of a prosthetic heart valve and the edge is an outflow edge of the outer skirt.

[0336] Example 136. The method of any embodiment herein, particularly embodiment 135, wherein the second component is a strut in a row of circumferentially extending struts of an annular frame of the prosthetic heart valve.

[0337] Example 137. 1. A prosthetic heart valve comprising: a frame including a plurality of interconnected struts; a plurality of leaflets disposed within the frame and configured to regulate blood flow through the frame in one direction, each leaflet having a leaflet edge; and at least one suture extending along the leaflet edge of at least a first leaflet of the plurality of leaflets, a suture and a plurality of in-out stitches extending through the leaflet edge of the first leaflet, and a plurality of first stitches extending around selected struts of the plurality of interconnected struts and a portion of the in-out stitches to couple the leaflet edge of the first leaflet to the frame.

[0338] Example 138. 137. The prosthetic heart valve of any of the embodiments herein, particularly Embodiment 137, wherein at least one suture comprises first and second sutures disposed on opposing sides of the leaflet edge of the first leaflet, and an in-out stitch extending through the first suture, the leaflet edge of the first leaflet, and the second suture.

[0339] Example 139. 137. The prosthetic heart valve of any of the embodiments herein, particularly embodiment 137, wherein at least one suture comprises a first portion of the first suture extending along a first side of the first leaflet to a second end of the leaflet edge and a second portion of the first suture extending from an opposing second side of the first leaflet to the second end of the leaflet edge, the first suture being folded over the first end of the leaflet edge of the first leaflet, and an in-out stitch extending through the first portion of the first suture, the leaflet edge of the first leaflet, and the second portion of the first suture.

[0340] Example 140. 139. The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 137-139, wherein the first stitch extends between the suture and the plurality of in-out stitches without extending through the first valve leaflet.

[0341] Example 141. A prosthetic heart valve as described in any of the examples herein, particularly any one of Examples 137-140, further comprising an outer skirt disposed around the outer surface of the frame, wherein at least a portion of the plurality of first stitches extend through the outer skirt such that the leaflet edge of the first leaflet is coupled to the frame and the outer skirt.

[0342] Example 142. The prosthetic heart valve described in any of the examples herein, particularly any one of Examples 137-141, wherein the selected struts include angled struts extending from one commissure support portion of the frame to the inflow end of the frame and from the inflow end of the frame to an adjacent commissure support portion of the frame.

[0343] Example 143. A prosthetic heart valve as described in any of the examples herein, particularly any one of Examples 137 to 141, wherein at least one suture and a plurality of in-out stitches are spaced apart from the outer cusp edge of the cusp in a direction perpendicular to the cusp edge.

[0344] Example 144. The prosthetic heart valve according to any one of Examples 1 to 143, wherein the prosthetic heart valve is sterilized.

[0345] Example 145. A method comprising sterilizing a prosthetic heart valve, device, and / or assembly according to any of the embodiments.

[0346] Any feature described herein with respect to any embodiment may be combined with any other feature described with respect to any one or more of the other embodiments, unless otherwise stated. For example, any one or more features of one skirt may be combined with any one or more features of another skirt. As another example, any one or more features of one prosthetic heart valve may be combined with any one or more features of another prosthetic heart valve or device.

[0347] In view of the many possible ways in which the principles of this disclosure may be applied, it should be recognized that the illustrated arrangements represent examples of the disclosed technology and should not be taken as limiting the scope of the disclosure and the claims that follow. Rather, the scope of claimed subject matter is defined by the following claims and their equivalents.

Claims

1. 1. A method comprising: forming a stitch line along an edge of an outer skirt for a prosthetic heart valve with a plurality of in-out stitches extending along the edge and spaced apart from a free edge of the edge, and a plurality of loops spaced apart from one another in the direction of the in-out stitches, each loop surrounding the free edge of the edge and extending between the free edge and an intersection of two adjacent in-out stitches; attaching the rim to a row of struts of the circumferentially extending annular frame by extending a plurality of whip stitches through the plurality of loops and around the struts such that a free edge of the rim is positioned against a radially outwardly facing surface of the strut and away from an inner-positioned leaflet of the annular frame of the prosthetic heart valve.

2. 2. The method of claim 1, wherein the plurality of in-out stitches extend end-to-end along the edge parallel to the free edge, and the plurality of in-out stitches are spaced apart from the free edge by a distance perpendicular to the free edge.

3. The method of claim 2, wherein the distance is in the range of 0.5 to 2.0 mm.

4. 4. The method of claim 1, wherein the plurality of in-out stitches is a first pass of first in-out stitches formed along the edge, each first in-out stitch extending between two adjacent openings in a row of spaced-apart openings in the outer skirt, and wherein forming the stitch line further comprises forming a second pass of second in-out stitches along the edge alternating with the first in-out stitches such that first and second in-out stitches each extend across opposing surfaces of the outer skirt between corresponding pairs of two adjacent openings.

5. forming the stitch lines extending a suture in a direction parallel to the free edge onto and through a first surface of the outer skirt and to a second surface of the outer skirt opposite the first surface, thereby forming a first in-out stitch across the first surface; extending the suture across the second surface toward the free edge, over the free edge, and back across the first surface to the end of the first in-out stitch, thereby forming a first loop; and 5. The method of claim 1, further comprising forming the plurality of in-out stitches and a plurality of loops by passing the suture through the outer skirt, across the second surface, and back through the outer skirt to the first surface, thereby forming a second in-out stitch across the second surface, wherein the method for forming the stitch line is repeated alternately across the first and second surfaces of the outer skirt to form the plurality of in-out stitches and a plurality of loops in the stitch line.

6. 6. The method of any one of claims 1 to 5, wherein attaching the edge to the strut by extending the plurality of whip stitches through the plurality of loops and around the strut comprises extending at least a portion of the whip stitch through a corresponding loop of the plurality of loops, around each strut and around the corresponding loop, such that a double loop is formed around the corresponding loop.

7. 7. The method of claim 1, wherein the edge is an outflow edge located opposite an inflow edge of the outer skirt, the row of circumferentially extending struts to which the outflow edge is attached is a first row of circumferentially extending struts of the frame, the method further comprising fixing the inflow edge of the outer skirt to a second row of circumferentially extending struts of the frame that defines an inflow end of the frame and that are axially spaced from the first row of circumferentially extending struts of the frame.

8. 8. The method of claim 7, wherein the first row of circumferentially extending struts of the frame is positioned adjacent to a third row of circumferentially extending struts of the frame that define an outflow end of the frame.

9. 1. A prosthetic heart valve, comprising: an annular frame comprising a plurality of interconnected struts arranged into a plurality of circumferentially extending strut rows, including a first circumferentially extending strut row located closer to an outflow end of the frame than to an inflow end of the frame; an outer skirt disposed about an outer surface of the frame and including an outflow edge having a free outflow edge, the outflow edge extending circumferentially around the frame and including a stitchline, the stitchline comprising: a plurality of in-out stitches extending along the outflow edge parallel to but spaced from the outflow edge; an outer skirt comprising a plurality of loop stitches spaced apart from one another in a direction of the plurality of in-out stitches, each loop stitch surrounding the outflow edge and extending between the outflow edge and an intersection of two corresponding adjacent in-out stitches of the plurality of in-out stitches; a plurality of whip stitches extending through the plurality of loop stitches and around the struts of the first circumferentially extending row of struts such that the outflow edges are attached to the struts against radially outward-facing surfaces of the struts.

10. 10. The prosthetic heart valve of claim 9, wherein the outflow edge is rougher than the remainder of the outflow edge of the outer skirt.

11. 11. The prosthetic heart valve of claim 9, further comprising a plurality of leaflets secured to the interior of the frame, the leaflets facing radially inwardly facing surfaces of the struts.

12. 12. The prosthetic heart valve of claim 9, wherein the plurality of circumferentially extending rows of struts further comprises a second circumferentially extending row of struts defining the outflow end of the frame, the first circumferentially extending row of struts being disposed adjacent to the second circumferentially extending row of struts.

13. 13. The prosthetic heart valve of claim 9, wherein the outer skirt comprises a row of spaced apart openings extending along the outflow edge parallel to but spaced apart from the outflow edge, and wherein the plurality of in-out stitches and the plurality of loop stitches extend through the spaced apart openings in the row of spaced apart openings.

14. The prosthetic heart valve of any one of claims 9 to 13, wherein the plurality of in-out stitches are spaced from the outflow edge by a distance extending perpendicular to the outflow edge.

15. The prosthetic heart valve of claim 14, wherein the distance is in the range of 0.5 to 2.0 mm.

16. 16. The prosthetic heart valve of any one of claims 9 to 15, wherein the outflow edge comprises a plurality of protrusions that define an undulating shape of the outflow edge that follows the contours of the first circumferentially extending row of struts.

17. 1. A method comprising: forming a stitch line along an edge of a leaflet for a prosthetic heart valve with a plurality of in-out stitches extending along the edge away from an outermost edge of the edge, and a plurality of loops spaced apart from one another in the direction of the in-out stitches, each loop surrounding the edge of the leaflet and extending between the edge and an intersection of two adjacent in-out stitches; attaching the tip to the target component of the prosthetic heart valve by extending a plurality of whip stitches through the plurality of loops and around or through the target component such that the tip of the tip is sewn against the target component.

18. 18. The method of claim 17, wherein the targeting component is a fabric skirt configured to be attached to an inner surface of an annular frame of the prosthetic heart valve.

19. 18. The method of claim 17, wherein the target components are struts of an annular frame of the prosthetic heart valve along the scalloped line of the cusp.

20. 20. The method of any one of claims 17-19, wherein the plurality of in-out stitches is a first pass of a first in-out stitch formed along the leaflet edge, and forming the stitch line further comprises forming a second pass of a second in-out stitch along the leaflet edge alternating with the first in-out stitches such that first and second in-out stitches extend across opposite sides of the leaflet between each pair of adjacent loops of the plurality of loops.

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