Prosthetic heart valve

Abstract

The present application relates to a prosthetic heart valve. A method for attaching a component to a frame of a prosthetic heart valve is disclosed. As one example, a method includes forming a suture path along an edge portion of an outer skirt for a prosthetic valve, the suture path having an incoming and outgoing trace extending along the edge portion and spaced apart from a free edge of the edge portion, and a plurality of loops spaced apart from each other in a direction of the incoming and outgoing trace, each ring surrounds a free edge and extends between the edge and an intersection of two adjacent inlet and outlet traces. The method further includes attaching the edge portion to one of the struts of the frame of the prosthetic valve by extending a lockstitch trace through the ring and around the strut such that the free edge is positioned against a radially facing outward surface of the strut and away from a leaflet disposed inside the frame.

Description

Technical Field

[0001] 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 a frame of a prosthetic heart valve. Background Art

[0002] The human heart may suffer from various valvular diseases. These valvular diseases can lead to serious dysfunction of the heart, and ultimately require repairing the natural valve or replacing the natural valve with an artificial valve. There are a variety of known repair devices (e.g., stents) and artificial valves, as well as a variety of known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used for various procedures to deliver prosthetic medical devices to a position in the body that is not easily accessible by surgery or is expected to be accessible without surgery. In a specific example, a prosthetic heart valve can be mounted on the distal end of a delivery device in a curled state and is advanced through the patient's vascular system (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by expanding the balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from the sheath of the delivery device so that the prosthetic valve can be self-expanded to its functional size.

[0003] Most expandable prosthetic heart valves include a cylindrical metal frame or stent and prosthetic leaflets mounted inside the frame. These valves may also include an outer covering or skirt disposed around the outer surface of the frame. The outer skirt may be configured to establish a seal with natural tissue when the prosthetic heart valve is placed at the implant site (and may therefore be referred to as a sealing member). Utility Model Content

[0004] Prosthetic heart valves, delivery devices and methods for implanting prosthetic heart valves are described herein. In particular, examples of methods for attaching an outer skirt for a prosthetic heart valve and such an outer skirt to a frame of a prosthetic heart valve are described herein. The prosthetic heart valve may include a frame and a leaflet assembly arranged on the inner side of the frame. The prosthetic heart valve may include an outer skirt arranged around the circumference of the frame and on the outer surface of the frame. The outer skirt may include an edge (an edge extending circumferentially) disposed at the level of the leaflet, and may therefore contact the leaflet. In some examples, the edge (which may be an outflow edge of the outer skirt, which has a rougher surface relative to other parts of the outer skirt) may be fixed to the frame using an overcast or looped stitch pattern sewn along the edge or edge portion of the outer skirt. As an example, the stitch pattern along the edge portion of the outer skirt may include a plurality of stitches forming a ring on the free edge of the edge portion, and the plurality of stitches are connected by an in-and-out stitch route away from the free edge along the outer skirt. The whip stitch can then extend through the ring and around the struts of the frame to attach the free edge of the outer skirt to the frame. Such an attachment method can position the free edge of the outer skirt away from the leaflets on the outer surface of the frame struts, and distribute the tension from the whip stitch away from the free edge on the outer skirt. In some examples, a similar stitch pattern can be used to attach the tip edge of the leaflet to the frame or skirt of a prosthetic heart valve, thereby resulting in a better flow pattern across the inflow edge of the leaflet during operation of the prosthetic valve. Therefore, the devices and methods disclosed herein can overcome one or more deficiencies of typical prosthetic heart valves, among other things.

[0005] A method may include forming a suture route along an edge portion of a first component for a prosthetic heart valve, the suture route having a plurality of entry and exit stitches and a plurality of loops, the plurality of entry and exit stitches extending along the edge portion, the plurality of loops being spaced apart from one another in the direction of the entry and exit stitches. Each loop loops around an outer edge of the edge portion and extends between the edge and an intersection of two adjacent entry and exit stitches. The method also includes attaching the edge portion to a second component of the prosthetic heart valve by extending a plurality of lockstitch stitches through the plurality of loops and around or through the second component.

[0006] In some examples, the first component is an outer skirt and the second component is a frame of the prosthetic heart valve.

[0007] In some examples, the first component is an outer skirt and the second component is a fabric configured to be secured to a frame of the prosthetic heart valve.

[0008] In some examples, the first component is a tip edge portion of a leaflet of a valve component of the prosthetic heart valve, and the second component is a fabric component configured to be secured to an inner side of a frame of the prosthetic heart valve.

[0009] In some examples, the first component is a tip edge portion of a leaflet of a valve component of the prosthetic heart valve, and the second component is a strut of a frame of the prosthetic heart valve.

[0010] In some examples, the first component is a tip edge portion of a leaflet of a valve component of the prosthetic heart valve, and the second component is a suture wrapped directly around a strut of a frame of the prosthetic heart valve.

[0011] In some examples, a method may include forming a suture route along an edge portion of an outer skirt or a tip edge of a leaflet for a prosthetic heart valve, the suture route having a plurality of entry and exit stitches and a plurality of loops, the plurality of entry and exit stitches extending along the edge portion, the plurality of loops being spaced apart from one another in the direction of the entry and exit stitches. Each loop surrounds a free edge of the edge portion, and the plurality of loops space the plurality of entry and exit stitches from the free edge. The method also includes extending a plurality of lockstitch stitches through the plurality of loops and around an additional component of the prosthetic heart valve to attach the edge portion to the additional component. The additional component may be a strut in a circumferentially extending row of 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 a connecting component) configured to be secured to the frame.

[0012] In some examples, a method includes forming a suture route along an edge portion of an outer skirt for a prosthetic heart valve, the suture route having a plurality of entry and exit stitches and a plurality of loops, the plurality of entry and exit stitches extending along the edge portion, the plurality of loops being spaced apart from one another in the direction of the entry and exit stitches. Each loop encircles a free edge of the edge portion, and the plurality of loops space the plurality of entry and exit stitches apart from the free edge. The method also includes attaching the edge portion to a strut in a circumferentially extending strut row of an annular frame of the prosthetic heart valve by extending a plurality of lockstitch stitches through the plurality of loops and around the struts, such that the free edge of the edge portion is positioned against a radially outwardly facing surface of the strut and away from a leaflet disposed on an inner side of the annular frame.

[0013] In some examples, a method includes forming a suture route along an edge portion of an outer skirt for a prosthetic heart valve, the suture route having a plurality of entry and exit stitches and a plurality of loops, the plurality of entry and exit stitches extending along the edge portion, spaced apart from a free edge of the edge portion, the plurality of loops being spaced apart from one another in the direction of the entry and exit stitches. Each loop loops around the free edge of the edge portion and extends between the edge and an intersection of two adjacent entry and exit stitches. The method also includes attaching the edge portion to a strut in a circumferentially extending strut row of an annular frame of the prosthetic heart valve by extending a plurality of lockstitch stitches through the plurality of loops and around the struts, such that the free edge of the edge portion is positioned against a radially outwardly facing surface of the strut and away from a leaflet disposed on an inner side of the annular frame.

[0014] In some examples, a method includes forming a suture route along an edge portion of an outer skirt for a prosthetic heart valve, the suture route having a plurality of in-and-out stitches and a plurality of pairs of rings, the plurality of in-and-out stitches extending along the edge portion, spaced apart from a free edge of the edge portion, the plurality of pairs of rings spaced apart from one another in the direction of the in-and-out stitches. Each pair of rings includes a first ring and a second ring, the first ring encircling the free edge of the edge portion and extending between the free edge and the second ring, and the second ring extending between the first ring and an intersection of two adjacent in-and-out stitches of the plurality of in-and-out stitches. The method also includes attaching the edge portion to a circumferentially extending strut row of an annular frame of the prosthetic heart valve by extending a lockstitch stitch through the first ring of each pair of rings and around the strut, such that the free edge of the edge portion is positioned against a radially outwardly facing surface of the strut and away from a leaflet disposed on an inner side of the annular frame.

[0015] In some examples, a method includes forming a suture route along a tip edge portion of a leaflet for a prosthetic heart valve, the suture route having a plurality of entry and exit stitches and a plurality of loops, the plurality of entry and exit stitches extending along the tip edge portion, spaced apart from an outermost tip edge of the tip edge portion, the plurality of loops spaced apart from one another in the direction of the entry and exit stitches, wherein each loop loops around the tip edge of the tip edge portion and extends between the tip edge and an intersection point of two adjacent entry and exit stitches. The method also includes attaching the tip edge portion to a target component of the prosthetic heart valve by extending a plurality of lockstitch stitches through the plurality of loops and around or through the target component, such that the tip edge of the tip edge portion is gathered against the target component.

[0016] In some examples, a method includes forming a suture route along an edge portion of a first component for a prosthetic heart valve, the suture route having a plurality of entry and exit stitches and a plurality of loops, the plurality of entry and exit stitches extending along the edge portion and spaced apart from an outermost edge of the edge portion, the plurality of loops being spaced apart from one another in the direction of the entry and exit stitches, wherein each loop loops around the edge of the edge portion and extends between the edge and an intersection point of two adjacent entry and exit stitches. The method also includes attaching the edge portion to a second component of the prosthetic heart valve by extending a plurality of lockstitch stitches through the plurality of loops and around or through the second component such that the edge of the edge portion is coupled to and gathered against the second component.

[0017] In some examples, a method includes one or more of the features described in Examples 1-56, 94-107, 128-136, and 145 below.

[0018] A prosthetic heart valve may include a frame and a valve structure coupled to the frame.In addition to these components, a prosthetic heart valve may include one or more of the components disclosed herein.

[0019] In some examples, a prosthetic heart valve can include a sealing member configured to reduce paravalvular leakage.

[0020] In some examples, the sealing member may be an outer sealing member disposed around an outer surface of the frame.

[0021] In some examples, the outer sealing member may include an outflow edge portion having a free outflow edge, the outflow edge portion including a stitching route, the stitching route including a plurality of in-and-out stitches and a plurality of loop stitches, the plurality of in-and-out stitches extending along the outflow edge portion parallel to the outflow edge but spaced apart from the outflow edge, the plurality of loop stitches being spaced apart from each other in the direction of the plurality of in-and-out stitches. Each loop stitch forms a loop around the outflow edge and extends between the intersection of the outflow edge and corresponding two adjacent in-and-out stitches of the plurality of in-and-out stitches.

[0022] In some examples, the outflow edge portion may be attached to the struts of the frame by additional stitches extending through the plurality of annular stitches.

[0023] In some examples, a prosthetic heart valve may include a frame, a valve structure, and an outer sealing member, wherein the valve structure is coupled to the frame and the outer sealing member is arranged around the outer surface of the frame. The outer sealing member may include an outflow edge portion having a free outflow edge, the outflow edge portion extending circumferentially around the frame, and including a suture route, the suture route including a plurality of in-outlet stitches and a plurality of annular stitches, the plurality of in-outlet stitches extending along the outflow edge portion parallel to the outflow edge but spaced apart from the outflow edge, the plurality of annular stitches being spaced apart from each other in the direction of the plurality of in-outlet stitches. Each annular stitch is looped around the outflow edge and extends between the intersection of the outflow edge and corresponding two adjacent in-outlet stitches of the plurality of in-outlet stitches. The outflow edge portion is attached to a support of the frame by an additional stitch extending through the plurality of annular stitches.

[0024] In some examples, a prosthetic heart valve may include a frame and a valve structure coupled to the frame, the valve structure including a plurality of leaflets, wherein a tip edge portion of each leaflet is attached to a portion of an angled strut or inner skirt of the frame, the inner skirt being configured to be attached to an interior of the frame via a suture route formed along the tip edge portion, the suture route including: a plurality of in-and-out stitches extending along the tip edge portion parallel to a free tip edge of the tip edge portion but spaced apart from the free tip edge; and a plurality of annular stitches spaced apart from one another in the direction of the plurality of in-and-out stitches. Each annular stitch loops around the tip edge and extends between the intersection of the tip edge and corresponding two adjacent in-and-out stitches of the plurality of in-and-out stitches. The prosthetic heart valve also includes a plurality of stitches extending through the plurality of annular stitches and around the partially angled struts, around one or more sutures extending around the partially angled struts, or through the inner skirt so that the tip edge is coupled to the partially angled struts and / or the inner skirt.

[0025] In some examples, a prosthetic heart valve includes an annular frame including a plurality of interconnected struts arranged into a plurality of circumferentially extending strut rows, the plurality of circumferentially extending strut rows including a first circumferentially extending strut row disposed closer to an outflow end than an inflow end of the frame. The prosthetic heart valve also includes an outer skirt disposed around an outer surface of the frame and including an outflow edge portion having a free outflow edge. The outflow edge portion extends circumferentially around the frame and includes a suture route including a plurality of in-outflow stitches and a plurality of annular stitches extending along the outflow edge portion parallel to the outflow edge but spaced apart from the outflow edge, the plurality of annular stitches being spaced apart from each other in the direction of the plurality of in-outflow stitches. Each annular stitch loops around the outflow edge and extends between the outflow edge and an intersection point of two corresponding adjacent in-outflow stitches of the plurality of in-outflow stitches. The prosthetic heart valve also includes a plurality of lock stitches extending through the plurality of annular stitches and around struts in 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.

[0026] In some examples, a prosthetic heart valve includes an annular frame including a plurality of interconnected struts between an inflow end and an outflow end of the frame, the plurality of interconnected struts being arranged into a plurality of circumferentially extending strut rows, wherein the plurality of circumferentially extending strut rows include a first circumferentially extending strut row. The prosthetic heart valve also includes an outer skirt disposed around an outer surface of the frame and including a rim portion having a free edge, wherein the rim portion extends circumferentially around the frame, and includes a suture route, the suture route including: a plurality of in-and-out stitches and a plurality of pairs of annular stitches extending along the rim portion parallel to the free edge but spaced apart from the free edge, the plurality of pairs of annular stitches being spaced apart from each other in the direction of the plurality of in-and-out stitches. Each pair of annular stitches includes a first annular stitch and a second annular stitch, wherein the first annular stitch loops around the free edge and extends between the free edge and the second loop, and wherein the second loop extends between the first loop and an intersection point of corresponding two adjacent in-and-out stitches of the plurality of in-and-out stitches. The prosthetic heart valve also includes a plurality of lock stitches extending through the first annular stitch in each pair of annular stitches and around a strut in the first circumferentially extending strut row such that the free edge is attached to the strut against a radially outwardly facing surface of the strut.

[0027] In some examples, a prosthetic heart valve includes an annular frame, a plurality of leaflets, the annular frame including a plurality of interconnected struts between an inflow end and an outflow end of the frame, the plurality of interconnected struts being arranged into a plurality of circumferentially extending angled strut rows, the plurality of leaflets being disposed on an interior of the frame, wherein each leaflet includes a tip edge portion extending between opposite side portions disposed on opposite ends of an outflow edge of the leaflet, and wherein the tip edge portion is attached to a portion of the angled struts in the plurality of circumferentially extending angled strut rows by a suture route formed along the tip edge portion. The suture route includes a plurality of in-and-out stitches and a plurality of annular stitches extending along the tip edge portion parallel to a free tip edge of the tip edge portion but spaced apart from the free tip edge, the plurality of annular stitches being spaced apart from one another in the direction of the plurality of in-and-out stitches, wherein each annular stitch loops around the tip edge and extends between the intersection of the tip edge and corresponding two adjacent in-and-out stitches of the plurality of in-and-out stitches. The prosthetic heart valve also includes a plurality of lock stitches extending through the plurality of annular stitches and around the partially angled struts or around one or more sutures extending around the partially angled struts such that the tip edge is coupled to the partially angled struts and retracted against the partially angled struts.

[0028] In some examples, a prosthetic heart valve includes an annular frame, an inner skirt, and a plurality of leaflets, wherein the annular frame includes a plurality of interconnected struts between an inflow end and an outflow end of the frame, the plurality of interconnected struts being arranged into a plurality of circumferentially extending angled strut rows, the inner skirt being configured to be fixed to a portion of the angled struts of the plurality of circumferentially extending angled strut rows on an inner side of the frame, the plurality of leaflets being disposed on an interior of the frame, wherein each leaflet includes a tip edge portion extending between opposite side portions disposed on opposite ends of an outflow edge of the leaflet, and wherein the tip edge portion is attached to the inner skirt by a suture route formed along the tip edge portion. The suture route includes a plurality of in-and-out stitches and a plurality of loop stitches, the plurality of in-and-out stitches extending along the tip edge portion parallel to the free tip edge of the tip edge portion but spaced apart from the free tip edge, the plurality of loop stitches spaced apart from each other in the direction of the plurality of in-and-out stitches, wherein each loop stitch forms a loop around the tip edge and extends between the intersection of the tip edge and corresponding two adjacent in-and-out stitches of the plurality of in-and-out stitches. The prosthetic heart valve also includes a plurality of lock stitches extending through the plurality of loop stitches and through the inner skirt, so that the tip edge is coupled to the inner skirt and gathered against the inner skirt.

[0029] In some examples, a prosthetic heart valve includes a frame, a plurality of leaflets, and at least one suture, a plurality of entry and exit stitches, and a plurality of first stitches, the frame including a plurality of interconnected struts, the plurality of leaflets being disposed within the frame and configured to regulate the flow of blood through the frame in one direction, each leaflet including a tip edge portion, the at least one suture extending along the tip edge portion of at least a first leaflet of the plurality of leaflets, the plurality of entry and exit stitches extending through the suture and the tip edge portion of the first leaflet, and the plurality of first stitches extending around a selected one of the plurality of interconnected struts and a portion of the entry and exit stitches to couple the tip edge portion of the first leaflet to the frame.

[0030] In some examples, an assembly includes one or more of the components described in Examples 57-93, 108-127, and 137-144 below.

[0031] The various innovations of the present disclosure may be used in combination or individually. This summary is provided to introduce some ideas in a simplified form, which are further described in the detailed description below. This summary is not intended to identify the key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. The foregoing and other objects, features and advantages of the present disclosure will become more apparent through the following detailed description, the appended claims and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 is a side view of a prosthetic heart valve according to an example.

[0033] Figure 2 yes Figure 1 Side view of the frame of a prosthetic heart valve.

[0034] Figure 3 yes Figure 2 A side view of a portion of a frame of , showing the portion of the frame in a straightened (non-annular) state.

[0035] Figure 4 is a side view of an exemplary delivery device configured to deliver a radially expandable prosthetic heart valve and implant it at an implantation site.

[0036] Figure 5 is a side view of an outer skirt for a prosthetic heart valve according to an example, the outer skirt being shown in a flat configuration.

[0037] Figure 6is a schematic diagram of a portion of an outer skirt and an exemplary stitching route along an edge portion of the outer skirt, the stitching route including in and out stitches spaced from a free edge of the edge portion through a plurality of spaced-apart unitary loops of the stitching route.

[0038] Fig. 7A yes Figure 6 Schematic diagram of an outer skirt and suture route showing an edge portion of a strut secured to a frame of a prosthetic device using a lock stitch extending around the strut and through a loop of the suture route.

[0039] Figure 7B It is shown Fig. 7A A schematic cross section of an edge portion of an outer skirt extending around a support and passing through Figure 6 The loops of sewing routes are secured to the struts of the frame by lockstitching.

[0040] Fig. 8A is a schematic diagram of a portion of an outer skirt and an exemplary stitching route along an edge portion of the outer skirt, the stitching route including in and out stitches spaced from a free edge of the edge portion through a plurality of spaced apart loop pairs of the stitching route.

[0041] Figure 8B yes Fig. 8A Schematic diagram of the outer skirt and stitching route, showing the alternating in and out stitches of the second pass in the stitching route.

[0042] Fig. 9A A first pass of in and out stitches is shown applied to the wavy edge portion of the outer skirt. Fig. 8A Example of a stitching route.

[0043] Fig. 9B Shows the in and out stitches including the second pass Fig. 9A Example of a stitching route.

[0044] Fig. 10A An external view of a portion of a prosthetic valve frame is shown having Fig. 9A and Fig. 9B The suture routes of the outer skirt are arranged around the outer surface of the frame and are secured to the struts of the frame by lock stitches extending around the struts and passing through loops of the suture routes.

[0045] Fig. 10B Shows Fig. 10A An interior view of the frame and outer skirt, wherein the edge portion of the outer skirt is attached to the frame support by lockstitch stitches extending through loops of the sewing route.

[0046] Fig.11 yes Fig. 8ASchematic diagram of an outer skirt and suture route showing an edge portion of a strut secured to a frame of a prosthetic device using a double loop of a lock stitch extending around the strut and a loop around the suture route.

[0047] Figure 12A-12G Shown is the method for forming Fig.11 An exemplary process of locking sutures such that they extend in a double loop through the ring of the suture course and around the frame struts to secure the edge portion of the outer skirt to the prosthetic valve frame.

[0048] Fig.13 is based on Fig.11 and Figure 12A-12G The process presented in Fig.11 Perspective view of the suture routes and lockstitch stitches attached to the outer skirt of a prosthetic valve frame.

[0049] Fig.14 A schematic diagram of a leaflet for a prosthetic heart valve, an exemplary suture route along a tip edge portion of the leaflet (the suture route including entry and exit stitches spaced from the tip edge of the tip edge portion through multiple spaced-apart single loops of the suture route), and multiple lock stitches connecting the suture route to another component for a prosthetic heart valve.

[0050] Fig.15 yes Fig.14 Detailed view of the tip edge portion, suture route and a portion of additional components.

[0051] Fig.16 It has a ridge along the tip edge of the leaflet. Fig.14 A plan view of an exemplary leaflet showing a suture route and multiple entry and exit stitches extending through a suture extending along a tip edge portion of the leaflet.

[0052] Fig.17 Includes fixed together Fig.16 A plan view of a leaflet assembly of multiple leaflets, wherein Fig.16 The suture route is formed along the tip edge portion of each leaflet.

[0053] Fig.18 is a perspective view of a frame of a prosthetic heart valve, wherein Fig.17 The leaflet assembly is disposed on an interior portion of the frame, wherein commissures of the leaflet assembly are coupled to the frame.

[0054] Fig.19 is a detailed view of the inflow end of the frame, where Fig.17 The tip edge portion of the leaflet assembly is coupled to the struts of the frame using suture routes along the tip edge portion.

[0055] Fig. 20is another detailed view of the inflow end of the frame showing the struts coupled to the frame using suture routes along the edge portion of the tip. Fig.17 The tip edge portion of the leaflet component.

[0056] Fig.21 is another detailed view of the inflow end of the frame, showing the Fig.17 The invention also provides a leaflet assembly and an outer skirt disposed around an outer surface of the frame.

[0057] Fig. 22 is a plan view of a leaflet assembly in a flat configuration wherein the leaflets of the leaflet assembly are secured together using connecting suture routes disposed along a tip edge portion of each leaflet.

[0058] Fig.23 is a plan view of a leaflet with the connecting suture route secured to the tip edge portion of the leaflet.

[0059] Fig.24 is a schematic cross-sectional view of a portion of a prosthetic valve showing struts and an outer skirt secured to a frame of a prosthetic heart valve using stitches extending through connecting suture lines Fig.23 of leaflets.

[0060] Fig.25 is a perspective view of a portion of a prosthetic valve showing the attachment of struts to a frame of a prosthetic heart valve using stitches extending around in and out stitches of a connecting suture line Fig.23 of leaflets.

[0061] Fig.26 is a perspective view of a portion of a prosthetic valve showing the attachment of a suture line around the struts of the frame secured to the struts of the frame of the prosthetic heart valve using stitches extending around the attachment suture line, around the struts of the frame and through an outer skirt disposed around the outer surface of the frame Fig.23 of leaflets. DETAILED DESCRIPTION

[0062] General considerations

[0063] For the purposes of this description, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, devices, and systems should not be interpreted as limiting in any way. Alternatively, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually or in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages exist or problems be solved.

[0064] Although the operations of some disclosed examples are described in a specific sequential order for convenience of presentation, it should be understood that this description includes reordering unless a specific order is required by the specific language described below. For example, the operations described in sequence may be reordered or performed simultaneously in some cases. In addition, for the sake of brevity, the accompanying drawings may not show the various ways in which the disclosed method can be used in combination with other methods. In addition, the description sometimes uses terms such as "providing" or "implementing" to describe the disclosed method. These terms are highly abstract of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation method and are easily discernible by a person of ordinary skill in the art.

[0065] As used in this application and the appended claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "comprising" means "including". Furthermore, the term "coupled" generally means a physical, mechanical, chemical, magnetic, and / or electrical coupling or connection, and does not exclude the presence of intermediate elements between the coupled or associated items in the absence of specific language to the contrary.

[0066] As used herein, the term "proximal" refers to a position, direction or part of a device that is closer to a user and further away from an implantation site. As used herein, the term "distal" refers to a position, direction or part of a device that is further away from a user and closer to an implantation site. Thus, for example, the proximal motion of a device is the motion of a device away from an implantation site and toward a user (e.g., leaving the patient's body), while the distal motion of a device is the motion of a device away from a user and toward an implantation site (e.g., entering the patient's body). The terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions, unless otherwise clearly defined.

[0067] Overview of the Disclosed Technology

[0068] As described above, a prosthetic heart valve may include a frame including interconnected struts, leaflets mounted inside the frame, and an outer skirt disposed around the outer surface of the frame. In some examples, the edge of the outer skirt disposed across the frame at the level of the leaflets may be jagged, rough, or otherwise abrasive (e.g., due to exposed fibers constituting the skirt or from a molten edge formed by melting fibers along the edge to reduce wear of the fabric of the outer skirt). Therefore, during operation of the prosthetic heart valve, the edge of the outer skirt may contact the leaflets and reduce the life of the leaflets. In order to avoid the leaflets 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 fixed to the frame using stitches extending 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 edge of the skirt, which may cause wear or unraveling of the edge of the skirt. In addition, a skirt attachment method including folding the edge of the skirt before suturing may increase the assembly time of the prosthetic heart valve (because such a process cannot be easily automated).

[0069] In some examples, the tip edge portions (or scalloped edges) of the leaflets can be sewn to the frame or replacement component (e.g., a fabric skirt) in a manner that creates a stepped edge that can create undesirable flow disturbances (e.g., uneven flow or turbulent flow) in these areas. Such flow disturbances can reduce the efficiency of the prosthetic heart valve.

[0070] Various methods are described herein for attaching (e.g., suturing) an outer skirt to a frame of a prosthetic heart valve that result in the edge of the outer skirt (which may be located at the level of the leaflets) being located away from the leaflets while also transferring tension from the stitches used to attach the outer skirt to the frame to the skirt away from the edge of the skirt. Thus, the durability and life of the prosthetic heart valve may be increased while also reducing the time and effort used to assemble the prosthetic heart valve.

[0071] Also described herein are methods for attaching (e.g., suturing) the tip edge of a leaflet to a target component of a prosthetic heart valve (e.g., a fabric skirt, sutures extending around a frame strut of a frame, or directly attached to a frame strut), which results in the tip edge being tightly tucked to the target component. Thus, a more continuous or smooth geometry can be created at the inflow edge of the leaflet, thereby reducing the likelihood of blood flow disturbances along the inflow edge of the leaflet. Thus, the efficiency of the prosthetic heart valve can be increased.

[0072] The prosthetic valve disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Therefore, when being advanced through the patient's vascular system on a delivery device, the prosthetic valve can be curled on an implant delivery device or maintained in a radially compressed state by an implant delivery device. Once the prosthetic valve reaches the implantation site, the prosthetic valve can be expanded to a radially expanded state. It should be understood that the prosthetic valve disclosed herein can be used in conjunction with various implant delivery devices and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0073] Figure 1 An exemplary prosthetic device (e.g., a prosthetic heart valve) is illustrated that includes a frame, leaflets secured to the inner side of the frame, and an outer skirt disposed around an outer surface of the frame. In some examples, the frame can include a plurality of interconnected and angled struts, and apex regions extending and / or curved between the angled struts at the inflow and outflow ends of the frame, such as Figure 2 and Figure 3 The prosthetic device can be delivered by a delivery device (e.g. Figure 4 The exemplary delivery device shown) is advanced through the patient's vasculature, such as to a native heart valve.

[0074] exist Figure 5 An exemplary outer skirt for a prosthetic heart valve is shown in . The outer skirt may include an edge, such as an outflow edge or edge portion, configured to be secured to a strut of the frame. In some examples, the edge portion of the outer skirt may be secured to the frame using a hemming stitch pattern sewn along the edge portion of the outer skirt. As an example, the stitch pattern along the edge portion of the outer skirt may include a plurality of stitches forming a loop on an outer edge or free edge of the edge portion, the plurality of stitches being connected by in-and-out stitch routes spaced apart from the free edge along the outer skirt ( Figure 6 The lockstitch stitch may then be extended through the loop and around the struts of the frame to attach the edge of the outer skirt to the frame ( Fig. 7A and Figure 7B ).

[0075] Figure 8A-Figure 13 Another example of a similar hemming stitch pattern for connecting the edge portion of the outer skirt to the frame is shown, but the hemming stitch pattern includes two loops between the free edge and the in and out stitch routes in the outer skirt. This stitch pattern can better hold the hemming stitch in place with the loop of the hemming stitch route and the second loop extending through around the skirt edge.

[0076] This suture pattern causes the edge of the outer skirt (eg, a rougher edge) to be positioned and retained along the radially outwardly facing surface of the frame struts, thereby positioning the skirt edge away from the leaflets (eg, Fig. 10B , Fig.12F , Figure 12G and Fig.13 ).

[0077] Figure 14-16 An example of a hemming stitch pattern is shown for sewing along the tip edge portion of a leaflet of a prosthetic heart valve resulting in an hemming stitch path including multiple in and out stitches and a loop. The tip edge portion can be attached to another component by multiple hemming stitches extending through the loop of the hemming stitch path and around or through the other component. In some examples, such as Figure 17-Figure 21 As shown, the tip edge portion of the leaflet can be secured to the struts of the frame of the prosthetic valve using a serging stitch route.

[0078] In some examples, such as Fig. 22 and Fig.23 As shown, the tip edge portion of the leaflet may include an in-and-out stitch route. The tip edge portion of the leaflet may then be secured to the frame by stitches extending through or around the in-and-out stitch route and around the struts of the frame, such as Figure 24-26 shown.

[0079] Examples of the Disclosed Technology

[0080] Figure 1 A prosthetic heart valve 100 (prosthetic valve) according to one example is shown. Any of the prosthetic valves disclosed herein are configured to be implanted in the native aortic valve annulus, but in other examples, they can be configured to be implanted in other native valve annuli of the heart (pulmonary, mitral and tricuspid valves). The disclosed prosthetic valves can also be implanted in vessels connected to the heart, including the pulmonary artery (to take over the function of a diseased pulmonary valve), or the superior vena cava or inferior vena cava (to take over the function of a diseased tricuspid valve) or various other veins, arteries and vessels of the patient. The disclosed prosthetic valves can also be implanted in a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0081] In some examples, the disclosed prosthetic valve can be implanted in a docking or anchoring device that is implanted in a natural heart valve or vessel. For example, in one example, the disclosed prosthetic valve can be implanted in a docking device implanted in the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in U.S. Publication No. 2017 / 0231756 (which is incorporated herein by reference). In another example, the disclosed prosthetic valve can be implanted in a docking device implanted in or at a natural mitral valve, as disclosed in PCT Publication No. WO2020 / 247907 (which is incorporated herein by reference). In another example, the disclosed prosthetic valve can be implanted in a docking device implanted in the superior vena cava or the inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in U.S. Publication No. 2019 / 0000615 (which is incorporated herein by reference).

[0082] The prosthetic heart valve 100 can include a stent or frame 102, a valve structure 104, and a paravalvular outer sealing member or outer skirt 106. The prosthetic heart valve 100 (and the frame 102) can have an inflow end 108 and an outflow end 110. The valve structure 104 can be disposed on the interior of the frame 102, while the outer skirt 106 is disposed around the outer surface of the frame 102.

[0083] The valve structure 104 may include a plurality of leaflets 112 (e.g., three leaflets, such as Figure 1 ), the leaflet structure can be arranged to collapse in a tricuspid arrangement. The leaflets 112 can be fixed to each other at their adjacent sides (e.g., commissure tabs) to form commissures 114 of the valve structure 104. For example, each leaflet 112 can include opposing commissure tabs disposed on opposing sides of the leaflet 112 and a tip edge portion extending between the opposing commissure tabs. The tip edge portion of the leaflet 112 can have a wavy, curved fan-like shape and can be directly fixed to the frame 102 (e.g., by sutures). However, in alternative examples, the tip edge portion of the leaflet 112 can be fixed to an inner skirt, which is then fixed to the frame 102. In some examples, the leaflet 112 can be formed of pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or various other suitable natural or synthetic materials known in the art and described in U.S. Patent No. 6,730,118 (which is incorporated herein by reference).

[0084] In some examples, the outer skirt 106 can be an annular skirt. In some cases, the outer skirt 106 can include one or more skirt portions connected together and / or individually connected to the frame 102. The outer skirt 106 can include a fabric or polymer material such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc. In some cases, instead of having a relatively straight upper edge portion, such as Figure 1 As shown, the outer skirt 106 can have a wavy upper edge portion extending along and fixed to the angled struts 134. Examples of such outer skirts and various other outer skirts that can be used with the frame 102 can be found in publication number WO2023244612A1 filed on June 17, 2022, which is incorporated herein by reference.

[0085] The frame 102 can be in a radially compressed (or collapsed) configuration and a radially expanded configuration (the expanded configuration is Figure 1 ) between radial compression and expansion. Figure 2 Frame 102 is shown separately in FIG. Figure 3 1. A portion of the frame 102 is shown in a straightened (non-circular) configuration.

[0086] The frame 102 can be made of any of various suitable plastic expansion materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol) known in the art. When composed of plastic expansion materials, the frame 102 (and therefore the valve 100) can be curled to a radially compressed state on a delivery catheter and then expanded in the patient's body by an inflatable balloon or equivalent expansion mechanism. When composed of self-expanding materials, the frame 102 (and therefore the valve 100) can be curled to a radially compressed state and restricted in a compressed state by being inserted into a sheath or equivalent mechanism of a delivery catheter. Once in the body, the valve can be pushed out of the delivery sheath, which allows the valve to expand to its functional size.

[0087] Suitable plastic expansion materials that can be used to form the frames disclosed herein (e.g., frame 102) include metal alloys, polymers, or combinations thereof. Exemplary metal alloys may include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some examples, frame 102 may include stainless steel. In some examples, frame 102 may include cobalt-chromium. In some examples, frame 102 may include nickel-cobalt-chromium. In some examples, frame 102 includes a nickel-cobalt-chromium-molybdenum alloy, such as MP35N. TM (Trademark of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). By weight, MP35N TM / UNS R30035 contains 35% nickel, 35% cobalt, 20% chromium and 10% molybdenum.

[0088] like Figure 2 and Figure 3 As shown, the frame 102 may include a plurality of interconnected struts 116 that form a plurality of rows of open cells 118 between the outflow end 110 and the inflow end 108 of the frame 102. In some examples, such as Figure 2 and 3 As shown, the frame 102 may include three rows of units 118, wherein the first (in Figure 2 and Figure 3 1. In the orientation shown, the first row of cells 120 is disposed at the outflow end 110. The first row of cells 120 includes cells 118 that are elongated in the axial direction (relative to the central longitudinal axis 122 of the frame 102) compared to the cells 118 in the remaining rows of cells. For example, the cells 118 of the first row of cells 120 may have a longer axial length 124 (124 mm) than the cells 118 in the remaining rows of cells. Figure 3 ), the remaining row units may include a second row unit 126 and a third row unit 128, the third row unit 128 is disposed at the inflow end 108, and the second row unit 126 is disposed between the first row unit 120 and the third row unit 128.

[0089] In some examples, such as Figure 2 As shown, each row of cells includes nine cells 118. Thus, in such an example, the frame 102 may be referred to as a nine-cell frame.

[0090] In alternative examples, the frame 102 may include more than three rows of cells (e.g., four or five rows) and / or more or fewer than nine cells per row. In some examples, the cells 118 in the first row of cells 120 may not be elongated compared to the cells 118 in the remaining rows of cells (the second row of cells 126 and the third row of cells 128) of the frame 102.

[0091] The interconnected struts 116 may include a plurality of angled struts 130, 132, 134, and 136 arranged in a plurality of rows of circumferentially extending angled struts, wherein the 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 angled struts 130 arranged end-to-end and extending circumferentially at the inflow end 108 of the frame; 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. 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 (or axially extending) struts 140. The axially extending window struts 138 (which may also be referred to as axial struts including commissure windows) define commissure windows (e.g., open windows) 142 that are spaced apart from one another in a circumferential direction about the frame 102 and that are adapted to receive a commissure disposed to the commissures (e.g., Figure 1 In some examples, the commissure windows 142 and / or the axially extending window struts 138 defining the commissure windows 142 may be referred to herein as commissure features or commissure supports, each of which is configured to receive and / or secure to a pair of commissure tabs of a pair of adjacent leaflets.

[0092] One or more (e.g., two, such as Figure 2 and Figure 3 Axial struts 140 (shown in FIG. 1 ) can be positioned in the circumferential direction between two commissure windows 142 formed by window struts 138. Because frame 102 can include fewer cells per row (e.g., 9) and fewer axial struts 140 between each commissure window 142 than some more conventional prosthetic heart valves, each cell 118 can have an increased width (in the circumferential direction) to provide a larger opening for blood flow and / or coronary artery access.

[0093] Each axial strut 140 and each window strut 138 extends from a position defined by the convergence of lower ends (e.g., ends disposed inward from and farthest 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 position defined by the convergence of upper ends (e.g., ends disposed closest to the outflow end 110) of two angled struts 136 (which may also be referred to as lower strut junctions or lower elongated strut junctions). Each axial strut 140 and each window strut 138 form axial sides of two adjacent cells of the first row of cells 120.

[0094] In some examples, such as Figure 3 As shown, each axial strut 140 may have a width 144 (eg, greater than the width of the angled struts 130, 132, 134, and 136). Figure 3 ). The "width" of a strut is measured between relative locations on opposing surfaces of the strut that extend between the radially facing inner and outer surfaces of the strut (relative to the central longitudinal axis 122 of the frame 102). The "thickness" of a strut is measured between relative locations on the radially facing inner and outer surfaces of the strut and is perpendicular to the width of the strut. In some examples, the width 144 of the axial strut 140 is 50-200%, 75-150%, or at least 100% (e.g., twice) greater than the width of the angled struts of the frame 102.

[0095] By providing an axial strut 140 having a greater width 144 than the width of other angled struts of the frame 102, a greater contact area is provided when the leaflets 112 contact the wider axial struts 140 during systole, thereby distributing stresses and reducing the extent to which the leaflets 112 may fold radially outwardly on the axial struts 140 by the cells 118. Thus, the long-term durability of the leaflets 112 may be increased.

[0096] Because the cells 118 of the frame 102 can have a relatively larger width than alternative prosthetic valves having more than 9 cells per row (as described above), wider axial struts 140 can be more easily incorporated into the frame 102 without sacrificing open space for blood flow and / or coronary artery access.

[0097] The commissure tabs 115 of adjacent leaflets 112 may be secured together to form commissures 114 ( Figure 1 Each commissure tab 114 of the prosthetic heart valve 100 includes two commissure tabs 115 that are paired together, and the commissure tabs 115 come from each of two adjacent leaflets 112 and extend through the commissure windows 142 of the frame 102. Each commissure 114 can be fixed to a window post 138 that forms the commissure window 142.

[0098] The tip edge portion (e.g., scalloped edge) of each leaflet 112 can be secured to the frame 102 via one or more fasteners (e.g., sutures). In some examples, the tip edge portion of each leaflet 112 can be secured directly to a strut (e.g., angled struts 130, 132, and 134) of the frame 102. For example, the tip edge portion of the leaflet 112 can be sutured to the angled struts 130, 132, and 134 that generally follow the contour of the tip edge portion of the leaflet 112.

[0099] In some examples, the tip edge portions of the leaflets 112 may be secured to the inner skirt, and the inner skirt may then be secured directly to the frame 102 .

[0100] Various methods for securing leaflets 112 to a frame (such as frame 102) are disclosed in U.S. Provisional Patent Application 63 / 278,922 filed on November 12, 2021 and U.S. Provisional Patent Application 63 / 300,302 filed on January 18, 2022, both of which are incorporated herein by reference.

[0101] like Figure 2 and Figure 3 As shown, in some examples, one or more or each of the axial struts 140 can include an inflow end portion 146 (e.g., an end portion closest to the inflow end 108) and an outflow end portion 148 that are widened relative to a middle portion 150 of the axial strut 140 (which can be defined by a width 144). In some cases, the inflow end portion 146 of the axial strut 140 can include an orifice 147. The orifice 147 can be configured to receive a fastener (e.g., a suture) for attaching a soft component of the prosthetic heart valve 100 to the frame 102. For example, in some cases, the outer skirt 106 can be positioned around an outer surface of the frame 102, and an upper edge portion or an outflow edge portion of the outer skirt 106 can be secured to the orifice 147 by a fastener 149 (e.g., a suture), such as Figure 1 shown.

[0102] The interconnected struts 116 may also include horizontal struts 182 extending between adjacent cells 118 of a row of cells of the frame 102. Figure 2 and Figure 3 ). The horizontal struts 182 can extend in the circumferential direction and are also referred to as circumferentially extending struts 182. The horizontal struts 182 can connect the angled struts in two adjacent rows of angled struts of the frame 102 to each other. For example, each horizontal strut 182 can connect to two angled struts in a strut row ( Figure 3 The pillar 134 shown) and two angled pillars in another adjacent pillar row ( Figure 3 132 shown). Thus, the angled struts 184 extending between the axially extending window struts 138 and the horizontal struts 182 and the angled struts 186 extending between the horizontal struts 182 and another horizontal strut 182 disposed adjacent the inflow end 108 of the frame 102 can be aligned along angled lines that can follow the fanning lines of the leaflets when the leaflets are attached to the frame 102. Thus, when the frame 102 is in a radially expanded configuration (e.g., Figure 2 and Figure 3), the horizontal struts 182 can allow the angled struts to follow a shape that more closely matches the shape of the fan line of the leaflets. In addition, the horizontal struts 182 can act as spacers that can maintain a specific gap between the angled struts when the frame 102 is in a radially compressed configuration, thereby reducing the risk of the leaflets being pinched between the struts in the radially compressed configuration.

[0103] The frame 102 may further include a plurality of vertex regions 152 formed at the inflow end 108 and the outflow end 110, each vertex region 152 extending between and forming a junction between two angled struts 130 at the inflow end 108 or two angled struts 136 at the outflow end 110. Therefore, the vertex regions 152 are spaced apart from each other in the circumferential direction at the inflow end 108 and the outflow end 110.

[0104] Each apex region 152 may include an apex 154 (the highest or most outwardly extending point in the axial direction) and two thinned (or narrowed) strut portions 156, one thinned strut portion 156 extending from either side of the apex 154 to a corresponding wider angled strut 136 (at the outflow end 110) or angled strut 130 (at the inflow end 108) ( Figure 3 ). In this way, each of the apex regions 152 at the outflow end 110 can form a narrowed transition region between and relative to the two angled struts 136 extending from the corresponding apex region 152, and each of the apex regions 152 at the inflow end 108 can form a narrowed transition region between and relative to the two angled struts 130 extending from the corresponding apex region 152.

[0105] The thinned strut portion 156 of the apex region 152 may have a greater thickness than the angled struts 130 or 136 ( Figure 3 ) can have a smaller width 158 than a width 160 of the angled struts 130 and / or 136. In some examples, width 158 can be a uniform width (e.g., along the entire length of strut portion 156). In some examples, width 158 of thinned strut portion 156 can be approximately 0.06-0.15 mm smaller than width 160 of angled struts 130 and / or 136.

[0106] The thinned strut portion 156 of the apex region 152 may have a first length 162 ( Figure 3). In some examples, 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 examples, 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).

[0107] Thus, each outflow apex region 152 may include two thinned strut portions 156 having a first length 162, each thinned strut portion 156 extending outwardly 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.

[0108] Each apex region 152 and two corresponding angled struts 136 at the outflow end 110 may form an outflow strut 166 , and each apex region 152 and two corresponding angled struts 130 at the inflow end 108 may form an inflow strut 168 .

[0109] Each outflow strut 166 and inflow strut 168 may have a length that includes the apex region 152 and two angled struts 136 or 130 (or strut portions) on either side of the apex region 152. Half of the total length of each outflow strut 166 and inflow strut 168 is within Figure 3 1 and 16. As shown in FIG. 1 , the length 170 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 examples, the length 170 for half of each inflow strut 168 may be different than the length 170 for half of each outflow strut 166.

[0110] In some examples, the length of each thinned strut portion 156 can be at least 25% of the length 170 of the corresponding half of the outflow strut 166 or the inflow strut 168. In other words, the length of each apex region 152 (the total length is twice the first length 162) can be at least 25% of the total length (twice the length 170) of the outflow strut 166 or the inflow strut 168. The length of each apex region 152 can be greater than 25% of the total length of the corresponding outflow strut 166 or the inflow strut 168, such as 25%-35%.

[0111] In some examples, each apex region 152 can include a curved axially facing outer surface 172 and an arcuate or curved axially facing inner recess 174 that forms a thinned strut portion 156. For example, the curved inner recess 174 can be depressed from the inner surface of the angled strut portion 156 toward the curved outer surface 172, thereby forming a thinned strut portion 156 of smaller width. Thus, the curved inner recess 174 can be formed on the cell side of the apex region 152 (e.g., rather than the outer side of the apex region 152).

[0112] In some examples, the curved outer surface 172 of each apex region 152 can 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 can have a constant curvature).

[0113] Each vertex region 152 can have a radius of curvature 176 (eg, along all or the entire length of the curved outer surface 172) along the curved outer surface 172 (eg, in some cases, along all or the entire length of the curved outer surface 172). Figure 3 ). In some cases, the radius of curvature 176 of the entire curved outer surface 172 at the vertex 154 and / or along the vertex region 152 can be greater than 1 mm. In some cases, the radius of curvature 176 can be in the range of 1-20 mm, 3-16 mm, or 8-14 mm. In some cases, the radius of curvature 176 can be greater than 10 mm. The radius of curvature 176 can depend on the width 158 (e.g., the amount of reduction in width from the angled struts 130 or 136) and the first length 162 of the thinned strut portion 156 (and therefore vary due to variations thereof).

[0114] Additionally, the height (axial height) 178 of the apex region 152 may be the width 158 ( Figure 3 ), the height (axial height) 178 can be defined in the axial direction from the outer surface of the two angled struts 130 or 136 to the curved outer surface 172 of the apex region 152 at the apex 154. In this way, the height 178 of the apex region 152 can be relatively small and does not increase the overall axial height of the radial expansion frame 102 too much. Figure 1 )'s leaflets 112 may be disposed proximal to the inflow end 108 , thereby leaving a larger open space at the outflow end 110 of the frame 102 that is not blocked by the leaflets 112 .

[0115] In some examples, each of the apex regions 152 may form an angle 180 (°) between two angled struts 130 or 136 extending from either side of the corresponding apex region 152. Figure 3 ). In some cases, angle 180 can be in the range of 120 degrees (exclusive) to 140 degrees (eg, such that angle 180 is greater than 120 degrees and less than or equal to 140 degrees).

[0116] Additional details and examples of frames for prosthetic heart valves including apex regions may be found in Publication No. US 2022 / 025687 A1, which is incorporated herein by reference.

[0117] Figure 4 A method according to an example that can be used to implant an expandable prosthetic heart valve (e.g., Figure 1 The invention relates to a delivery device 200 for use with a prosthetic heart valve 100 or any of the other prosthetic heart valves disclosed herein. In some examples, the delivery device 200 is particularly suitable for use when introducing a prosthetic valve into the heart.

[0118] Figure 4 The delivery device 200 in the illustrated example is a balloon catheter that includes a handle 202 and a steerable outer shaft 204 extending distally from the handle 202. The delivery device 200 may also include an intermediate shaft 206 (which may also be referred to as a balloon shaft) extending proximally from the handle 202 and distally from the handle 202, with the portion extending distally from the handle 202 also extending coaxially through the outer shaft 204. In addition, the delivery device 200 may also include an inner shaft 208 extending distally from the handle 202, coaxially through the intermediate shaft 206 and the outer shaft 204, and extending proximally from the handle 202, coaxially through the intermediate shaft 206.

[0119] Outer shaft 204 and intermediate shaft 206 may be configured to translate (eg, move) longitudinally relative to one another along a central longitudinal axis 220 of delivery device 200 to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient's body.

[0120] The intermediate shaft 206 may include a proximal portion 210 extending proximally from the proximal end of the handle 202 to an adapter 212. A rotatable knob 214 may be mounted on the proximal portion 210 and may be configured to rotate the intermediate shaft 206 about the central longitudinal axis 220 and relative to the outer shaft 204.

[0121] The adapter 212 may include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive a fluid (eg, an inflation fluid) from a fluid source. The second port 240 may be fluidly coupled to the inner lumen of the intermediate shaft 206.

[0122] The intermediate shaft 206 may also include a distal 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 expandable balloon 218 of the delivery device 200. The distal portion of the inner shaft 208 may extend distally beyond the distal portion of the intermediate shaft 206.

[0123] The balloon 218 may be coupled to the distal portion of the intermediate shaft 206 .

[0124] In some examples, the distal end of the balloon 218 can be coupled to the distal end of the delivery device 200 (such as the nose cone 222 (eg, Figure 4 200) or an alternative component (e.g., a distal shoulder) at the distal end of the delivery device 200. The middle portion of the balloon 218 can overlap the valve mounting portion 224 of the distal portion of the delivery device 200, and the distal portion of the balloon 218 can overlap the distal shoulder 226 of the delivery device 200. The valve mounting portion 224 and the middle portion of the balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as Figure 4 As schematically shown in , a prosthetic heart valve 250 , which may be one of the prosthetic valves described herein, may be mounted about a balloon 218 at a valve mounting portion 224 of the delivery device 200 .

[0125] The balloon shoulder assembly, including distal shoulder 226 , is configured to maintain a prosthetic heart valve 250 (or other medical device) in a fixed position on balloon 218 during delivery through the patient's vasculature.

[0126] The outer shaft 204 may include a distal tip portion 228 mounted on its distal end. When the prosthetic valve 250 is mounted on the valve mounting portion 224 in a radially compressed state (e.g., Figure 4 ) and during delivery of the prosthetic valve to a target implantation site, the outer shaft 204 and the intermediate shaft 206 can be axially translated relative to each other to position the distal tip portion 228 near the proximal end of the valve mounting portion 224. Thus, the distal tip portion 228 can be configured to prevent movement of the prosthetic valve 250 relative to the balloon 218 proximally in an axial direction relative to the balloon 218 when the distal tip portion 228 is disposed near the proximal side of the valve mounting portion 224.

[0127] An annular space may be defined between an outer surface of the inner shaft 208 and an inner surface of the intermediate shaft 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 passage formed between an outer surface of a distal portion of the inner shaft 208 and an inner surface of the balloon 218. Thus, fluid from the fluid source may flow from the annular space to the fluid passage to inflate the balloon 218 and radially expand and deploy the prosthetic valve 250.

[0128] The inner lumen of the inner shaft can be configured to receive a guidewire therethrough to facilitate navigation of the distal portion of the delivery device 200 to a target implantation site.

[0129] The handle 202 may include a steering mechanism configured to adjust the curvature of the distal portion of the delivery device 200. In the illustrated example, for example, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, which in turn is operatively coupled to the proximal portion of a pull wire. The pull wire may extend distally from the handle 202 through the outer shaft 204 and have a distal portion attached to the outer shaft 204 at or near the distal end of the outer shaft 204. Rotating the knob 260 may increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal portion of the delivery device 200. Further details on steering or flexing mechanisms for delivery devices may be found in U.S. Pat. No. 9,339,384, which is incorporated herein by reference.

[0130] The handle 202 may also include an adjustment mechanism 261 including an adjustment member (such as the illustrated rotatable knob 262) and an associated locking mechanism including 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 on the delivery device 200 may be found in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference.

[0131] As described above, in some examples, the edge of the outer skirt of the prosthetic heart valve can be relatively rough or abrasive. For example, the edge can be a finished edge that is "melted" by melting fibers along the edge to reduce wear of the fabric of the outer skirt. In other examples, the skirt edge can have exposed fibers or rings. When the prosthetic heart valve is operating and the leaflets are in an open state, they can contact the edge of the outer skirt (e.g., the outer edge or free edge). In some cases, such contact can cause undesirable wear or abrasion of the leaflets.

[0132] 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 can be folded outward away from the frame and the leaflets. The folded edge can then be secured to the frame using stitches extending through the folded edge of the skirt and around the struts of the frame. In some examples, the stitches can pass through the folded skirt layer near the edge of the skirt. The pulling force from the stitches against the skirt can cause fraying or unraveling of the outer edge of the skirt.

[0133] Thus, the inventors have recognized that it is desirable to provide a suture route along an edge portion of the outer skirt (e.g., the outflow edge portion) that allows the outer skirt to be attached to the struts of the frame so that the skirt edge is positioned away from the leaflets (so that it does not contact the leaflets during valve operation) and so that the skirt edge remains intact (e.g., does not fray or unravel).

[0134] Figure 6-Figure 13 An exemplary method for forming a suture route along an edge portion of an outer skirt and attaching the edge portion of the outer skirt to a post of a frame of a prosthetic heart valve using the suture route such that the free edge of the edge portion abuts against an outer surface of the post and is positioned away from the leaflets of the prosthetic heart valve is illustrated. Figure 6-Figure 13 The method described can be used for various combinations of frame and outer skirt. Figure 6-Figure 13 The outer skirt and frame shown are exemplary, and the disclosed methods can be applied to outer skirts and frames with different configurations, such as various balloons, self and mechanically expandable frames, and various skirts (which can have straight, wavy or alternatively shaped outflow edge portions or alternative edge portions). In addition, although the following methods are described as being applied to the outflow edge portion of the outer skirt, in alternative examples, the suture routes described herein can be used on another edge of the skirt (e.g., the inflow edge portion of the skirt that can be fixed to the inflow end of the frame).

[0135] First go to Figure 5 , for prosthetic devices (such as Figure 1 Prosthetic heart valve 100 (or Fig.13 The exemplary outer skirt 300 of the prosthetic heart valve frame 550 of the embodiment of the present invention is shown in a flat configuration. The outer skirt 300 and other outer skirts disclosed herein can be used for balloon expandable prosthetic valves (e.g., Figure 1-Figure 3The invention also provides a valve 100 of the present invention, a mechanically expandable prosthetic valve, and / or a self-expandable prosthetic valve. Additional details about balloon-expandable prosthetic valves can be found in publication number US2012123529A1, which is incorporated herein by reference, and publication number US2022 / 025687A1, which has been incorporated herein by reference. Additional details about mechanically expandable prosthetic valves can be found in publication number US2021 / 052745A1, which is incorporated herein by reference. Additional details about self-expanding prosthetic valves can be found in publication number US2010049313A1, which is incorporated herein by reference.

[0136] The outer skirt 300 can be wrapped around and mounted to the outer surface (the surface facing radially outward relative to the central longitudinal axis of the prosthetic device) of the frame of the prosthetic device, thereby transforming into an annular configuration (e.g., as Figure 1 or Fig.13 shown).

[0137] like Figure 5 As shown, the outer skirt 300 may include opposing first and second edge portions 302, 304 (which may also be referred to as short edges or edge portions), each extending between an outflow edge portion 306 and an inflow edge portion 308 of the outer skirt 300. In some examples, the first and second edge portions 302, 304 may not be perpendicular to the inflow edge portion 308. For example, the first and second edge portions 302, 304 may extend at an angle of approximately 45 degrees (or within a range of 40 to 50 degrees) relative to the inflow edge portion 308. Thus, the overall general shape of the outer skirt 300 may be a rhombus or parallelogram shape.

[0138] In some examples, the first edge portion 302 and the second edge portion 304 can each include a plurality of apertures 310 extending therethrough. Thus, when the outer skirt 300 is transformed into its annular configuration (e.g., when installed around a prosthetic device, such as Fig.13 As shown in FIG. 3 , the first edge portion 302 and the second edge portion 304 can overlap each other, wherein their corresponding apertures 310 also overlap. Then, the suture can be used to form a plurality of in and out stitch patterns through the overlapping apertures 310, thereby fixing the first edge portion 302 and the second edge portion 304 together and forming the annular configuration of the outer skirt 300.

[0139] Outflow edge portion 306 (when arranged around a prosthetic valve, it is disposed closer to the outflow end of the prosthetic valve than inflow edge portion 308, e.g., as Fig.13 ) may be formed with a plurality of protrusions 312 that define struts that generally follow the contour of the frame to which they are secured (e.g., Figure 2The wavy shape of the shape or contour of the support 134 of frame 102 or the support 552 of frame 550).

[0140] In an alternative example, the outflow edge portion 306 may have a Figure 5 Different shapes are shown, such as relatively straight (eg, parallel to the inflow edge portion 308, with Figure 6-Figure 8B The same or similar (as shown) or different non-straight shapes that may or may not follow the shape or contour of the struts of the frame to which they are secured.

[0141] In some examples, the outer skirt 300 may also be formed with slots 314 (or grooves) to facilitate attachment of the skirt to the frame, for example, each slot 314 may be disposed between two adjacent protrusions 312. In some examples, the slots 314 may be shaped and sized so that the slots 314 fit over and / or may be wrapped or secured around a post or support column of the frame.

[0142] When the outer skirt 300 is disposed about the outer surface of the frame of the prosthetic device (e.g., as Figure 1 and Fig.13 In some examples, additional sutures may be used to secure the inflow edge portion 308 of the outer skirt 300 to the frame and / or leaflets of the prosthetic device (such as Fig.13 as shown, as further described below).

[0143] In some examples, the outer skirt 300 may include a portion that may be configured to receive a suture route (such as Figure 6-7B The suture route 402 shown or Figure 8A-13 In an alternative example, the outer skirt 300 may not include preformed apertures 318 for the suture route, but rather the apertures or holes in the fabric of the outer skirt 300 may be formed by a needle during the formation of the suture route along the outflow edge portion 306.

[0144] The outer skirt 300 and other skirts or coverings described herein may include a variety of synthetic materials, including fabrics (e.g., polyethylene terephthalate fabric (PET fabric) or ultra-high molecular weight polyethylene (UHMWPE) fabric), polytetrafluoroethylene (PTFE), thermoplastic polyurethane (TPU), hybrid materials including one or more fabrics or polymer materials (e.g., PET coated in TPU), or natural tissue (e.g., pericardial tissue).

[0145] Figure 6-7BA detail portion of the outer skirt 300 is shown, wherein the stitching route 402 is arranged along the outflow edge portion 306. Figure 6 and Fig. 7A , the outflow edge portion 306 is depicted as being relatively straight with an undulating outflow edge 320 (which may be referred to herein as a free edge or outer edge of the outer skirt 300). The outflow edge 320 is depicted as undulating for illustration purposes only and to indicate that the edge 320 of the outflow edge portion 306 may be rough and / or molten (e.g., an edge formed by melting fibers of the fabric skirt along the edge and / or may be abrasive with exposed fibers or loops, as described above). Additionally, although the outflow edge portion 306 is Figure 6 and Fig. 7A 306 is shown as relatively straight (for ease of illustration), but in some examples, the outflow edge portion 306 may have a wavy edge (with a protrusion 312, such as Figure 5 In such an example, the stitching route 402 may follow the contour of the wavy outflow edge portion, similar to Figures 9A-10B and Figure 12A-Figure 13 As shown below.

[0146] The stitching route 402 includes an in-and-out stitching route 404 (and includes a plurality of in-and-out stitches 406, 408) spaced apart from the outflow edge 320 of the outflow edge portion 306 and a plurality of loops 410 (which may also be referred to as loops or looped stitches) looped on the outflow edge 320 and spaced apart from each other in the circumferential direction (or in the direction of the in-and-out stitches). For example, the loops 410 may be connected together within the stitching route 402 by the in-and-out stitches 406, 408.

[0147] In some cases, the stitching route 402 may be formed by making the stitching route 412 run parallel to the outflow edge 320 on the first surface 322 of the outer skirt 300 (e.g., at Figure 5 - radially outwardly facing surface facing out of the page in the view of FIG. 7) extending from one aperture 318 to an adjacent aperture 318, thereby forming an in-and-out stitch 406 across the first surface 322. The stitch 412 can then extend through the adjacent apertures 318, across the second surface 324 of the outer skirt 300 (e.g., opposite the first surface 322 and can be in Fig.12E and 12F The suture 412 is then passed through the first surface 322 (the radially inwardly facing surface seen in FIG. 4 ) toward the outflow edge 320, over the outflow edge 320, and back across the first surface 322 to the same orifice 318, thereby forming a loop 410. After returning through the same orifice 318, the suture 412 can then be passed across the second surface 324 (at Figure 6The view of the fabric behind the fabric) extends to the next adjacent aperture 318, thereby forming an in-and-out stitch 408 across the second surface 324 (the in-and-out stitch 408 is in the Figure 6 and Fig. 7A The dashed line is depicted in FIG. 1 to indicate that it crosses the second surface 324 or Figure 6 and Fig. 7A The process is then repeated to form subsequent loops 410 and in and out stitches 406, 408, as shown in FIG. Figure 6 As shown. The above method for forming the stitching route 402 is repeated in an alternating manner on the first surface 322 and the second surface 324 of the outer skirt 300 to form a plurality of in and out stitches 406, 408 and a plurality of loops 410 of the stitching route 402. In some examples, the stitching pattern may be referred to as a hemming stitch pattern or a stitch pattern. Figure 6 , arrows are depicted showing exemplary directions for sewing the suture route 402 as described above.

[0148] In some cases, the in-and-out stitching route 404 may include a second pass of in-and-out stitches 414, 416 that include alternating stitches 414 extending across the first surface 322 and stitches 416 extending across the second surface 324 (in Fig. 7A For example, the in-and-out stitches 414, 416 may alternate with the in-and-out stitches 406, 408 such that the in-and-out stitches 406, 408 and the in-and-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 holes 318.

[0149] The in and out stitches 414, 416 of the second pass can be formed using either the first stitch 412 or the second stitch. In this manner, the in and out stitching route 404 can include in and out stitches across both the first surface 322 and the second surface 324 between each pair of adjacent apertures 318.

[0150] like Figure 6 As shown, the inlet and outlet stitching route 404 is spaced apart from the outflow edge 320 by a distance 418. The distance 418 can be specified so that the inlet and outlet stitching route 404 is spaced apart from the outflow edge 320 far enough to prevent the outflow edge 320 from fraying or unraveling. In some examples, the distance 418 can be in the range of about 0.5-2 mm, 1.0-2.0 mm, 1.5-2.0 mm, or 1.4-2.1 mm. Thus, the ring 410 can have a length similar to and / or resulting from the distance 418.

[0151] like Fig. 7A and Figure 7BAs shown, additional sutures 420 (e.g., lock stitches) can extend through the ring 410 of the suture route 402 and around the struts 422 (or multiple struts) of the prosthetic valve frame (wherein the struts 422 can be replaced by the struts 134 or multiple struts 134 of the frame 102 or the struts 552 of the frame 550), thereby attaching the outflow edge portion 306 of the outer skirt 300 to the struts 422 via the suture route 402. Therefore, the tension from the stitches 420 on the outer skirt 300 can be transferred away from the outflow edge 320 and transferred to the in-out suture route 404 through the ring 410. Since the in-out suture route 404, which is spaced a distance 418 from the outflow edge 320, receives the tension, the integrity of the outflow edge 320 can be maintained, thereby increasing the life of the outer skirt 300.

[0152] In addition, if Figure 7B As shown, this method of attachment can result in the outflow edge 320 being positioned behind or on a radially outwardly facing surface 424 of the strut 422 (e.g., a surface facing away from the leaflets disposed on the interior of the frame and closer to an opposing radially inwardly facing surface 426 of the strut 422), thereby hiding the outflow edge 320 away from the leaflets of the prosthetic valve. Fig. 7A The stitch 420 is shown in the untightened stage for illustration purposes only. When the stitch 420 is tightened, the outflow edge 320 is positioned against the radially outwardly facing surface 424 of the support 422, such as Figure 7B shown.

[0153] Figures 8A-9B Another example of a stitching route 502 disposed in and along the outflow edge portion 306 of the outer skirt 300 is shown. The stitching route 502 can be similar to and implemented similarly to the stitching route 402 described above, except that the ring 410 is replaced by a double ring 510, 512 (e.g., two rings in a figure-8 pattern, as explained in further detail below). In some cases, the outer skirt 300 may include an additional row of pre-formed apertures 318 to receive the double ring 510 (such as a first aperture 318a and a second aperture 318b, such as Fig. 8A and Figure 8B In some cases, the additional rows of apertures may not be preformed, but may be formed by sewing through the fabric of the outer skirt 300 using a needle. Fig. 9A and Fig. 9B As shown, the second orifice 318b may not be pre-formed, but may be formed when the suture route 502 is formed (e.g., when the needle holding the suture is in the Fig. 9A and Fig. 9B When the fabric of the outer skirt 300 is extended through the outer skirt 300 at the position shown) is formed.

[0154] For ease of explanation, the outflow edge 320 and the outflow edge portion 306 are Fig. 8A and Figure 8B is shown as being relatively straight. However, Fig. 9A and Fig. 9B Depicted is an outer skirt 300 having a wavy outflow edge portion 306 and an outflow edge 320 (as described above with reference to Figure 5 The suture route 502 may be used as described below. Figure 8A-Figure 13 The same method described applies to outer skirts having straight, wavy or differently shaped edge portions.

[0155] Similar to the stitching route 402, the stitching route 502 includes an in-out stitching route 504 spaced apart from the outflow edge 320 of the outflow edge portion 306 and a plurality of pairs of loops spaced apart from each other in the direction of the in-out stitches (e.g., the circumferential direction and / or the direction parallel to the outflow edge 320). The in-out stitching route 504 includes a plurality of in-out stitches 506, 508. Each pair of loops includes a first loop 510 and a second loop 512, the first loop 510 surrounds the outflow edge 320 of the outflow edge portion 306 and extends between the outflow edge 320 and the second loop 512, and the second loop 512 extends between the first loop 510 and the intersection of two adjacent in-out stitches 506, 508 of the plurality of in-out stitches 506, 508 of the in-out stitching route 504. The second loop 512 is connected together by the in-out stitches 506, 508 within the stitching route 504.

[0156] In some cases, the stitching route 502 can be formed by extending the first stitching route 513 from one second orifice 318b to an adjacent second orifice 318b on the first surface 322 of the outer skirt 300 in a direction parallel to the outflow edge 320, thereby forming an inlet and outlet stitch 506 ( Fig. 8A and Fig. 9A ). The stitch 513 can then extend through the adjacent second aperture 318b, across the second surface 324 of the outer skirt 300, through the first aperture 318a (which is closer to the outflow edge 320 than the second aperture 318b), across the first surface 322 of the outer skirt 300 toward the outflow edge 320, across the outflow edge 320, back to the same first aperture 318a across the second surface 324, through the first aperture 318a, and back to the same second aperture 318b across the first surface 322. Thus, the first loop 510 and the second loop 512 are formed between the outflow edge 320 and the in-and-out stitching route 504. As shown in FIG. Figures 8A-9BAs shown, the first ring 510 and the second ring 512 are connected to each other. The first ring 510 and the second ring 512 can be sewn on the outflow edge portion 306 and form an 8-shaped pattern across the outflow edge portion 306, as described above. The cross or 8-shaped stitching pattern for the first ring 510 and the second ring 512 can help prevent lateral (or circumferential when the outer skirt is arranged around the annular frame) displacement of the first ring 510 and / or the second ring 512 (this can better maintain the lock stitch looped through the first ring 510 in place, as described further below).

[0157] After returning through the same second aperture 318b, the suture 513 may then be threaded across the second surface 324 (at Figures 8A-9B The inlet and outlet stitches 508 are formed across the second surface 324 (behind the fabric in the view of FIG. 31 ). Figures 8A-9B is shown in dashed lines to indicate that it crosses the second surface 324 or Figures 8A-9B The process is then repeated (but in an alternating manner over the opposing surfaces of the skirt 300, rather than as described above for each stitch) to form subsequent first and second loops 510, 512 and in and out stitches 506, 508, as shown. Fig. 8A and Fig. 9A In some cases, the stitching pattern may be referred to as a hemming stitch or a stitch pattern.

[0158] In some cases, the in-and-out stitching route 504 may include a second pass of in-and-out stitches 514, 516 that include alternating stitches 514 extending across the first surface 322 and stitches 516 extending across the second surface 324 (in Fig. 8A and 9A In some cases, the second pass in and out stitches 514, 516 can be formed using the first suture 513. In some cases, the second pass in and out stitches 514, 516 can be formed using a different second suture. The in and out stitching route 504 can include in and out stitches across both the first surface 322 and the second surface 324 between each pair of adjacent second orifices 318b.

[0159] like Fig. 8A and Figure 8BAs shown, the inlet and outlet stitching route 504 is spaced apart from the outflow edge 320 by a distance 518. The distance 518 can extend in a direction perpendicular to the outflow edge 320. The distance 518 can be specified so that the inlet and outlet stitching route 504 is spaced apart from the outflow edge 320 far enough to prevent wear or unraveling of the outflow edge 320. The first ring 510 has a length 520 (which can be the same or similar to the distance between the outflow edge 320 and the first orifice 318a). In some cases, the length 520 is less than the distance between the first orifice 318a and the second orifice 318b (e.g., the length of the second ring 512 or the difference between the distance 518 and the length 520).

[0160] For example, in some cases, the distance 518 can be about 2 mm (e.g., ±0.1 mm), and the length 520 of the first loop 510 can be about 0.5 mm (and thus the length of the second loop 512 can be about 1.5 mm). In some cases, the distance 518 can be in the range of 1.5-2.0 mm, and the length 520 of the first loop 510 can be about 0.3 mm (and thus the length of the second loop 512 can be about 1.2-1.7 mm). In some cases, the distance 518 can be in the range of 1.4-2.1 mm, and the length 520 of the first loop 510 can be in the range of 0.2-0.6 mm (and thus the length of the second loop 512 can be about 0.8-1.9 mm).

[0161] Figure 10A-10B An external view of a frame 550 for a prosthetic heart valve is shown ( Fig. 10A ) and internal views ( Fig. 10B ), wherein the outer skirt 300 having the suture path 502 is arranged around the outer surface of the frame 550. The frame 550 can be similar to the Figure 2 In some examples, Figure 2 The frame 102 can be replaced by Figure 10A-Figure 13 In addition, as described above, the outer skirt 300 having the suture route 502 can be attached to various other frames (e.g., frames having different numbers of rows of struts, different shapes of cells or struts, etc.) using the methods described herein.

[0162] like Fig. 10BAs shown, an additional stitch 522 (which may be referred to as a lockstitch stitch) extends through the first loop 510 of the suture route 502 and around the strut 552 of the frame 550 to attach the outflow edge portion 306 of the outer skirt 300 to the strut 552 via the suture route 502. The strut 552 may be an angled strut in a second row of angled struts of the frame 550 that is disposed adjacent to the outflow end of the strut (e.g., the same or similar to the strut 134 of the frame 102, and as shown in the complete frame 550 Fig.13 shown).

[0163] For example, Fig. 10A As shown, a needle 524 (such as a blunt needle without a sharp tip) can be used to form a lockstitch stitch 522 with the suture 526 by passing the needle 524 and suture 526 through the first loop 510 and then around one of the struts 552 without penetrating the material of the outer skirt 300 (the process is then repeated around the frame 550 and the outer skirt 300). In other words, the lockstitch stitch 522 only passes through the first loop 510 and not through another portion of the outer skirt 300. In addition, the in-and-out suture route 504 is offset (or spaced apart) from the lockstitch stitch 522 by at least the length of the second loop 512 (which can be the same or similar to the difference between the distance 518 and the length 520).

[0164] Therefore, the tension from the lockstitch 522 on the outer skirt 300 can be transferred away from the outflow edge 320 and transferred to the sewing route 504 through the first loop 510 and the second loop 512. Since the sewing route 504, which is spaced a distance 518 from the outflow edge 320, receives the tension, the integrity of the outflow edge 320 can be maintained, thereby increasing the life of the outer skirt 300.

[0165] By including the first ring 510 in addition to the second ring 512, lateral movement of the second ring 512 relative to the outer skirt 300 can be prevented. In addition, the paired ring configuration of the suture route 502 can prevent the lock stitch 522 from moving along the first ring 510 in a vertical or axial direction (which can be the direction of the central longitudinal axis 558 of the frame 550, such as Fig.13 movement on the

[0166] like Fig. 10B As shown, by passing through the first ring 510 and around the struts 552, the lockstitch stitches 522 can prevent the outer skirt 300 from sliding on the lockstitch stitches 522 and maintain the outflow edge 320 positioned behind the radially outwardly facing surface 554 of the struts 552 (e.g., the surface facing away from the leaflets arranged on the interior of the frame) (at the Fig. 10B view) or above, thereby hiding the outflow edge 320 away from the leaflets of the prosthetic valve.

[0167] In some examples, one or more of the lock stitches 522 can double loop around the corresponding first loop 510. For example, at least one lock stitch 522 along the same strut 552 can double loop around the corresponding first loop 510. More than one or all of the lock stitches 522 along the same strut 552 can double loop around its corresponding first loop 510. Fig.11 is a schematic diagram showing a plurality of lock stitches 522 formed with double loops 528 around the corresponding first loop 510 around the pillar 552. It should be noted that Fig.11 The illustrated lockstitch 420 may also be double looped around loop 410 in the same manner as described below.

[0168] Figure 12A-12G An exemplary process for forming a lockstitch stitch 522 having a double loop 528 passing through a first loop 510 and around a frame strut 552 is shown. For the first lockstitch stitch 522, the stitch 526 used to form the lockstitch stitch 522 is first drawn from around the strut 552 ( Fig. 12A ) through (eg, using needle 524) first loop 510 ( Fig. 12B ) and then wraps around the edge of the first loop 510 and passes back through the same first loop 510 a second time (eg Fig. 12C As shown, the needle 524 passes through the first ring 510 for the second time, and Fig.12D The second loop of the double loop 528 formed in the first loop 510 is shown.) Finally, the stitching extends back toward and around the strut 552, and the process can be repeated on the next lockstitch stitch 522 (or a selected number of subsequent lockstitch stitches 522).

[0169] Fig.12E An interior view of the frame 550 is shown with the lock stitch 522 and its double loop 528 formed along the outflow edge portion 306 of the outer skirt 300 . Fig.12F Another interior view of a smaller portion of the frame 550 is shown with a double ring 528 at each lock stitch 522. The double rings 528 of the lock stitch 522 are tightened around the first ring 510 and pull the outflow edge 320 of the outer skirt 300 against the radially outward facing surfaces 554 of the struts 552, which are opposite the radially inward facing surfaces 556 of the struts 552. Thus, the outflow edge 320 of the outer skirt 300 can be positioned away from the leaflets of the prosthetic heart valve, which are disposed on the interior of the frame and face the radially inward facing surfaces 556 of the struts 552.

[0170] Fig.13 is a perspective view of a completed frame 550 in which the outer skirt 300 is attached to the outer surface of the frame 550 using a stitching route 502 and a lock stitch 522 having a double loop 528 (as shown above with reference to Figure 11-12G as described). Fig.13 As shown, the outflow edge portion 306 of the outer skirt 300 is fixed to the angled struts 552, and the outflow edge 320 is retained on the exterior of the frame on the radially outwardly facing surface 554 of the struts 552. Figure 1 The outflow edge 320 is separated from the leaflets by the support 552, thereby preventing the outflow edge 320 from abrading the leaflets during operation of the prosthetic heart valve.

[0171] like Fig.13 As shown, struts 552 can define a first circumferentially extending strut row of frame 550, and frame 550 can also include a second circumferentially extending row of outflow struts 562 that define the outflow end of frame 550 and are disposed adjacent to strut row 552. Frame 550 can also include a third circumferentially extending row of inflow struts 564 that define the inflow end of frame 550. Frame 550 can include one or more additional circumferentially extending strut rows (such as additional strut rows disposed between inflow struts 564 and struts 552, such as Fig.13 As shown in Fig.13 As shown, the inflow edge portion 308 of the outer skirt 300 is secured to the inflow support 564 via a plurality of lockstitch stitches 560 extending through the outer skirt and around the inflow support 564 (in the case of an alternative suture route). In an alternative example, the suture route 502 or 402 can be applied to the inflow edge portion 308 and used to secure the inflow edge portion 308 to the inflow support 564, similar to the above reference Figures 8A-12G or Figure 6-7B as described.

[0172] In some examples, not all of the lock stitches 522 connecting the suture course 502 to the frame 550 include double loops 528. For example, one or only a portion of the lock stitches along the same strut 552 may include double loops 528, while the remaining lock stitches 522 along the same strut 552 include only single loops. In some examples, only a portion of the struts 552 in the strut row 552 may include lock stitches 522 having double loops 528. The number of lock stitches including double loops 528 along the same strut 552 may be specified so that the outflow edge portion 306 of the outer skirt 300 is tightly attached to the frame 550 in a manner that hides the outflow edge 320 on the outer surface of the frame 550 (where the struts 552 separate the outflow edge 320 and the leaflets from each other).

[0173] In some examples, the outer skirt 300 may utilize a stitching route 502 without the double loop 528 (eg, Figures 8A-10B ) or using a suture route 402 (e.g., Fig. 7A and Figure 7BThe strut 422 shown may alternatively be one of the struts 552 of the frame 550) attached to the frame 550 (or another similar frame, such as Figure 2 Frame 102).

[0174] Frame 550 is exemplary, and in some examples, Figure 2 The frame 102 can be used instead of the frame 550, wherein the outer skirt 300 is connected with the Figure 11-13 , Figures 8A-10B or Figure 6-7B Attached to support post 134 in the same manner as shown.

[0175] The methods described herein for attaching the edge portion of the outer skirt to the struts of the frame of the prosthetic heart valve can be applied to various frames for prosthetic heart valves or alternative implantable medical devices (such as stents). In addition, the methods described herein can be applied to various skirts and skirt edge portions, such as edges having various shapes (straight, wavy, or alternative shapes) and edges configured to be attached to various points of the frame (e.g., the outflow end, the inflow end, or a portion of the frame disposed between the inflow end and the outflow end).

[0176] The method described herein for attaching the edge portion of the outer skirt to the struts of the frame using a suture route including one or more loops causes the free edge to be positioned against the surface of the strut (e.g., the radially outwardly facing surface), thereby preventing the free edge of the skirt from contacting the leaflet, wherein the one or more loops offset the in-and-out stitches of the suture route from the free edge of the edge portion, the surface of the strut being the relative surface of the strut facing the leaflet or other soft parts arranged on the interior of the frame. In addition, the suture route described herein allows the load or tension from the lockstitch stitch (which extends around the strut and passes through the loop of the suture route) to be transmitted away from the free edge of the skirt, thereby reducing the risk of free edge wear and increasing the durability and life of the outer skirt. In addition, by using the suture route and method described herein, the edge portion of the outer skirt can be attached to the frame without folding, thereby allowing the suture process to be performed on the skirt in a flat configuration (away from the frame). Therefore, since the stitches are all in the same plane, the suturing of the outer skirt (to form the suture route) can be automated, thereby reducing assembly time and increasing the efficiency and accuracy of assembling the outer skirt and the prosthetic device.

[0177] In some examples, a suture route including multiple entry and exit stitches and multiple loops spaced apart from each other in the direction of the entry and exit stitches can be applied to different or additional components of a prosthetic valve, such as the leaflets of a valve structure. Such a suture route can be set along the tip edge portion of the leaflet, wherein the loop is looped around the tip edge of the leaflet and separates the entry and exit stitches from the tip edge. In some examples, the tip edge portion of the leaflet can then be attached to another component (such as a fabric skirt, sutures extending around the struts of the frame) or attached to the struts of the frame using the suture route and without piercing the tissue of the leaflet. Therefore, the tip edge portion of the leaflet can be fixed to the frame of the prosthetic valve in a manner that tightly gathers the tip edge to the other component and reduces interference with blood flow through the prosthetic valve.

[0178] Figure 14-16 An example of a suture route 612 formed along a tip edge portion 602 of an exemplary leaflet 600 for a prosthetic valve is shown. In some examples, the leaflet 600 may be Figure 1 The leaflet 600 is one of the leaflets 112 of the present invention. The leaflet 600 includes an outflow edge 604, two opposing commissure tabs 606 disposed on opposite sides of the leaflet 600, and a tip edge portion 602 extending between the opposing commissure tabs 606. The tip edge portion 602 includes an outermost tip edge 608 (or a free tip edge). The tip edge 608 of the leaflet 600 can have a wavy, curved fan-like shape and can form an inflow edge or inflow end of the leaflet 600. It should be noted that the leaflet 600 is exemplary and the suture route 612 can be applied to the tip edge portions of various leaflets, such as leaflets having tip edge portions, commissure tabs, outflow edges, etc. with different shapes.

[0179] The stitching route 612 includes an in-and-out stitching route 614 spaced apart from the tip edge 608 of the tip edge portion 602, the in-and-out stitching route including a plurality of in-and-out stitches 616, 618. The in-and-out stitches 616, 618 may extend in a direction tangential to or parallel to the tip edge 608. The stitching route 612 also includes a plurality of loops 620 (which may also be referred to as loops or looped stitches) looped on the tip edge 608 and spaced apart from each other in the direction of the in-and-out stitches 616, 618. For example, the loops 620 may be connected together within the stitching route 612 by the in-and-out stitches 616, 618.

[0180] In some cases, suture route 612 can be formed by extending suture 622 on a first side 624 (or surface) of leaflet 600 (e.g., a rough or smooth side of leaflet 600) in the direction of tip edge portion 602 and through tip edge portion 602 to an opposite second side 626 of leaflet 600 (e.g., Figure 18-Figure 21), thereby forming an in-and-out stitch 616 across the first side 624. The suture 622 can then be directed across the second side 626 of the leaflet 600 (at Figure 14-16 The stitch 622 may then extend across the second side 626 and through the tip edge portion 602 back to the first side 624, thereby forming the in-and-out stitch 618 across the second side 626 (the in-and-out stitch 618 is at the end of the loop 620). Fig.14 and Fig.15 The dashed line is depicted in FIG. 6 to indicate that it crosses the second side 626 or Fig.14 and Fig.15 The process is then repeated to form subsequent loops 620 and in and out stitches 616, 618, as shown in FIG. Fig.14 shown.

[0181] For example, a method for forming the above-described suture route 612 is to form a suture route 612 along the tip edge portion 602 of the leaflet 600 (e.g., from a first end 610a of the leaflet edge portion 602 disposed adjacent one commissure tab 606 of the leaflet 600 to a second end 610b of the leaflet edge portion 602 disposed adjacent the opposite commissure tab 606 of the leaflet 600, such as Fig.16 ) is repeated in an alternating manner across the first side 624 and the second side 626 of the leaflet 600 to form a plurality of in and out stitches 616 and a plurality of loops 620 of the suture route 612. In some examples, this suture pattern may be referred to as a hemming pattern or a stitch pattern. Fig.14 and Fig.15 , arrows are depicted showing exemplary directions for suturing suturing route 612 as described above.

[0182] In some examples, the tip edge portion 602 can include a plurality of pre-formed apertures between the first side 624 and the second side 626 of the leaflet 600 through which the entry and exit stitches 616 , 618 extend.

[0183] In some cases, the in-and-out suture route 614 may include a second pass of in-and-out stitches including alternating stitches 628 extending across the first side 624 and the second side 626 of the leaflet (eg, Fig.16 For example, the in-and-out stitches 628 can alternate with the in-and-out stitches 616 , 618 such that the in-and-out stitches 616 , 618 and the in-and-out stitches 628 extend across opposing surfaces (the first side 624 and the second side 626 ) of the leaflet 600 between each pair of rings 620 .

[0184] The second in and out stitches 628 may be formed using the first suture 622 or a second suture route (eg, Fig.16 In this manner, the in-and-out suture route 614 can include in-and-out stitches across both the first side 624 and the second side 626 between each pair of adjacent loops 620.

[0185] like Fig.15 As shown, the in and out suture route 614 is spaced apart from the tip edge 608 by a distance 630. In some examples, the distance 630 can be the same or similar to the above-described distance 418. For example, in some examples, the distance 630 is in the range of 0.5-2.0 mm.

[0186] In some cases, distance 630 may be specified such that loop 620 is long enough to receive a stitch therethrough and secure tip edge portion 602 to another component in a manner that tucks tip edge 608 to that component and reduces flow disturbance across the surface of leaflet 600 .

[0187] In some examples, such as Fig.16 As shown, one or more main sutures (referred to herein as thicker sutures or first sutures) 636 can be placed along the tip edge portion 602 of the leaflet. In some cases, the main suture(s) 636 are thicker than the sutures 622 that form the suture route 612. The in-and-out stitches 616, 618, and / or 628 of the in-and-out suture route 614 can extend through the main suture(s) 636, thereby securing the main suture(s) 636 to the tip edge portion 602.

[0188] In some examples, a single main suture 636 can extend along the first side 624 of the leaflet 600 and then wrap around the first end 610a and extend along the second side 626 of the leaflet 600. In this manner, the main suture 636 can extend along the tip edge portion 602 on both sides of the leaflet 600.

[0189] In some examples, two main stitches 636 may extend along tip edge portion 602 , one along first side 624 and another along second side 626 .

[0190] The tail 638 of the main suture 636 (or the two first sutures 636) is Fig.16 and in some examples can be used to form a wedge-shaped member 640 ( Fig.17 ), as further described below. Further details about the main suture 636 and the wedge-shaped member 640 formed by the suture tail 638 and other examples of this configuration are provided below in reference Fig. 22 and 23and further described in publication number WO2023086548A1, which is incorporated herein by reference in its entirety.

[0191] like Fig.14 and Fig.15 As shown, additional stitches 632 (e.g., lock stitches) may be formed when stitches 632 are tightened (for illustrative purposes only, they are Fig.14 and Fig.15 The tip edge 608 of the leaflet 600 is tightly coupled to the target component 634 in a manner that extends through the ring 620 of the suture route 612 and around or through the target component 634 (shown more loosely in FIG. 6A ).

[0192] In some examples, the target component 634 can be a fabric component, such as a skirt (e.g., an inner skirt) or a strip of fabric or an attachment member, which is configured to be secured on the inside of a frame of a prosthetic valve. For example, after the tip edge portion 602 of the leaflet 600 is sutured to the fabric component, the fabric component can then be attached to the struts of the frame on the inside of the frame, thereby securing the leaflet 600 to the frame. In some examples, the inner skirt is attached to a portion of an angled strut that extends from a first commissure support portion of the frame (e.g., Fig.18 The commissure support portion 644 or Figure 1-Figure 3 The axially extending window struts 138 shown extend to the inflow end of the frame and extend from the inflow end of the frame to the second commissure support portion of the frame (e.g., Fig.18 The commissure support portion 644 or Figure 1-Figure 3 An axially extending window strut 138 is shown, wherein the first commissure support portion and the second commissure support portion are disposed adjacent the outflow end of the frame.

[0193] In some cases, the skirt or fabric attachment member may include a plurality of pre-formed apertures configured to receive lockstitch stitches 632 therethrough. In some cases, the apertures in the skirt or fabric attachment member may not be pre-formed, but may be formed as the needle passes lockstitch stitches 632 through the skirt or fabric attachment member.

[0194] In some examples, target components 634 can be struts of the frame and / or sutures wrapped directly around struts of the frame (e.g., struts that follow the scallop lines of the leaflets and extend between adjacent commissure support portions of the frame and the inflow end of the frame).

[0195] Reference below Figure 17-Figure 21 An exemplary method of attaching the leaflet 600 directly to the struts of the frame using suture route 612 (or directly to the struts by wrapping sutures around the struts of the frame) is described. Figure 18-Figure 21 650, but leaflets 600 can be attached to struts of various other frames (such as frame 102, frame 550, or a prosthetic valve frame of a different configuration) in a similar manner. Frame 650 can be the same as or similar to frame 102, except that it includes additional circumferentially extending rows of angled struts, thereby forming additional rows of units of frame 650.

[0196] like Fig.17 As shown, multiple leaflets 600 (e.g., three) can be assembled together in a flat configuration (away from the frame). In some examples, a suture route 612 can be formed along the tip edge portion 602 of each leaflet 600 (e.g., with in and out stitches 616, 618, 628 extending through the leaflet 600 and a main stitch 636 extending along both sides of the tip edge portion 602), as described above with reference to Fig.16 as described.

[0197] In some cases, suture routes 612 of multiple leaflets 600 can be connected to each other.

[0198] In some cases, the suture tails 638 of the main suture 636 can be braided or threaded together at adjacent commissure tabs 606 of adjacent leaflets 600 to form a wedge-shaped member 640 ( Fig.17 ).

[0199] In the formation Fig.17 After the leaflet or valve assembly is shown, the leaflet 600 can then be mounted within the frame 650 and attached directly to the struts of the frame 650. In particular, Fig.18 The leaflets 600 are shown mounted within the interior of a frame 650 and the commissures 642 are secured to commissure support portions 644 (e.g., axially extending window struts, such as the axially extending window struts 138 of the frame 102) of the frame 650. Each commissure 642 can be formed by securing adjacent commissure tabs 606 together around a wedge-shaped member 640 and to the commissure support portions 644 of the frame 650.

[0200] The suture route 612 can then be attached to the angled struts 646, which follow the tip edge portion 602 of the leaflet 600 and extend between 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 suture route 612 can be attached to the angled struts 646 by extending the lockstitch stitch 632 through the loop 620 of the suture route 612 and around the struts 646, as shown in FIG. Figure 19-21 As depicted in .

[0201] In some examples, after the leaflets 600 are secured to the struts 646 of the frame 650 on the interior of the frame 650, the outer skirt 652 (or sealing member) can be attached to the frame 650 around the outer surface of the frame 650, such as Fig.21 shown.

[0202] 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 (eg, to the inflow apex region of the frame 650 ).

[0203] In some cases, interlocking of hemming stitches 632 (eg, passing hemming stitches 632 through the sutures forming hemming stitches 632) may be utilized to ensure stability of loop 620 (eg, to prevent loop 620 from traveling or moving along tip edge 608).

[0204] In some cases, a double loop can be formed using hemming stitch 632 around loop 620 (similar to Fig.11 As shown for double loop 528 , the loop 620 is prevented from sliding along the hemming stitch 632 .

[0205] Although Fig.21 The prosthetic valve 656 in FIG. 6 is shown as having only an outer skirt 652, but it will be understood that in some examples, the leaflet 600 may be sutured to the inner skirt or fabric strip along its tip edge portion 602 in a similar manner as described above (rather than directly to the struts of the frame 650) using suture routes 612 and lock stitches.

[0206] Advantageously, the above-described suturing configuration utilizing suture routes 612 and lock stitches 632 tightly gathers the tip edges 608 of the leaflets 600 to the inner surface of the framework struts to which they are attached (or alternatively to the inner skirt or fabric) without forming a distally extending free portion (e.g., without forming a stepped interface) between the suture routes and the tip edges 608. Thus, a relatively continuous geometry along the inflow aspects of the leaflets is formed, thereby reducing the likelihood of blood flow disturbances along these inflow regions.

[0207] In some examples, a connecting suture route formed along the tip edge portion of the leaflet can be used to secure the leaflet to the frame of the prosthetic heart valve and / or to another component of the prosthetic heart valve, as described below with reference to Figure 22-Figure 26 as described.

[0208] First go to Fig. 22 and Fig.23, leaflets 702 are shown secured together into an exemplary leaflet assembly 700 (or valve assembly) with connecting suture routes 704 disposed along the tip edge portion of each leaflet 702. As further described below, connecting suture routes 704 are configured to enable the leaflet assembly 700 to be secured directly to a frame of a prosthetic heart valve (e.g., Figure 1-Figure 3 The framework 102, such as Figure 24-26 ), without having to extend sutures through or through the material of the leaflet 702 during assembly to the frame.

[0209] As used herein, a "connecting suture route" can be defined as a route of multiple sutures that extends along the tip edge portion on at least one side of at least one leaflet and includes at least one first suture extending along the tip edge portion on at least one side of at least one leaflet and multiple entry and exit stitches (e.g., formed using a second suture) extending through the at least one first suture and the tip edge portion of the leaflet. The entry and exit stitches can secure the first suture to the leaflet. The connecting suture route can be formed on the leaflet as the leaflet leaves the frame. In addition, the connecting suture route can be formed manually or automatically (e.g., suturing).

[0210] Back to Fig. 22 and 23 , each leaflet 702 can include opposing commissure tabs 706 disposed on opposing sides of the leaflet 702 and a tip edge portion 708 extending between the opposing commissure tabs 706 (similar to the leaflet 600 described above). Fig.23 A single leaflet 702 is shown, while Fig. 22 A plan view of a leaflet assembly 700 comprising three leaflets 702 secured together along tip edge portions 708 thereof by connecting suture routes 704 is shown.

[0211] To form the connecting suture route 704, one or more first sutures (referred to herein as first thicker sutures or first main sutures) 710 may be placed along the tip edge portion 708 on one side of the leaflet 702 ( Fig. 22 and Fig.23 In some examples, one or more second sutures (referred to herein as second thicker sutures or second main sutures) 712 can be placed along the tip edge portion 708 on the opposite side of the leaflet 702.

[0212] In some examples, the same first thicker suture 710 and second thicker suture 712 can be provided along the leaflet 702 (eg, Fig. 22The first thicker suture 710 may extend continuously along the tip edge portion 708 of each of the three (shown) leaflets 702, thereby connecting the leaflets 702 together. In other words, a single first thicker suture 710 may extend continuously along the tip edge portion of all leaflets 702 on one side of the leaflets, and a single second thicker suture 712 may extend continuously along the tip edge portion of all leaflets 702 on the opposite side of the leaflets.

[0213] In some examples, each leaflet 702 can include two thicker sutures 710 and 712 (or two thicker suture strands or portions of the same thicker suture) extending along a tip edge portion 708 thereof on each side of the leaflet 702, and the two thicker sutures 710 and 712 can or can not be connected to the two thicker sutures 710 and 712 of the other leaflets 702 of the leaflet assembly 700.

[0214] In some examples, the leaflet assembly 700 can be formed using one main suture or thicker suture (e.g., the inner or rougher side 720) extending along the first side (e.g., the inner side or rougher side 720) of the tip edge portions 708 of all three leaflets 702 and three separate (or individual) first thicker sutures 710, each of which extends along the second side (e.g., the outer or smoother side 722) of the tip edge portion 708 of the corresponding leaflet 702, thereby producing two suture end portions (also referred to as suture tails or suture segments) on either end of the tip edge portions 708 of the leaflets that can extend beyond the commissure tabs 706. Thus, during commissure assembly, each pair of adjacent suture end portions (or tails) from adjacent leaflets 702 can be joined to form an integral wedge-shaped member (similar to the above reference suture assembly). Fig.17 introduced).

[0215] In some examples, the leaflet assembly 700 can be formed using three separate first thicker sutures 710, each of which extends along both the first and second sides of the tip edge portion 708 of the corresponding leaflet 702. For example, for each leaflet 702, one first thicker suture 710 can be folded (e.g., folded in half) over one end of the tip edge portion 708, and then the resulting first and second suture portions can extend along the first and second sides of the tip edge portion 708, respectively, and pass through opposite ends of the tip edge portion 708, such that two suture tails or segments are formed at opposite ends of the tip edge portion 708.

[0216] To further form the connecting suture route 704 and connect the first thicker suture(s) 710 and / or the second thicker suture(s) 712 to the leaflet 702, a suture suture (or third suture) 714 is sutured through the first thicker suture 710 and / or the second thicker suture 712 and the leaflet 702 (e.g., through the thickness of the tissue of the leaflet 702) in a continuous stitch pattern (e.g., an in-and-out pattern). For example, if the leaflet 702 includes a first thicker suture 710 (or suture strands or portions) on a first side thereof and a second thicker suture 712 (or suture strands or portions) on a second side thereof, the suture suture 714 can secure both the first thicker suture 710 and the second thicker suture 712 to the tip edge portion 708 of the leaflet 702. The suturing stitches 714 can form a plurality of in and out stitches 715 , each of which can extend through the first stitch 710 , the tip edge portion 708 of the leaflet 702 , and the second stitch 712 .

[0217] In some examples, suture suture 714 is thinner than suture(s) 710 and / or suture(s) 712, so as to facilitate suture suture 714 to be sutured through sutures 710, 712. Therefore, suture suture 714 may be referred to as "thinner suture" in the following description. In such examples, suture suture 714 has a smaller diameter and a higher gauge than sutures 710, 712. However, it should be noted that in some examples, suture suture 714 does not need to be thinner than sutures 710, 712. In such examples, suture suture 714 can have the same diameter (and gauge) as sutures 710, 712 or a larger diameter (and lower gauge) than sutures 710, 712.

[0218] Fig.23 A view of a leaflet 702 is shown with a thinner suture 714 sewn in a continuous stitch pattern through a first thicker suture 710, a tip edge portion 708 of the leaflet 702, and a second thicker suture 712 (at Fig.23 ), thereby coupling 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 route 704.

[0219] Thus, a leaflet assembly 700 including leaflets 702 (eg, three leaflets) assembled together with connecting suture routes 704 can be formed in a flat configuration (eg, 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 can allow the connecting suture route 704 to be automatically sewn across the flat leaflet 702 (e.g., using a sewing machine). Advantageously, this can significantly reduce manufacturing time and cost.

[0220] After forming the leaflet assembly 700, the leaflet assembly 700 may be attached to a frame of a prosthetic heart valve (e.g., Figure 1-Figure 3 The inner surface of the frame 102 shown in FIG. Figure 24-26 As shown, a plurality of stitches 730 (e.g., "tucking" stitches) can extend below the in-and-out stitches 715 (between the in-and-out stitches 715 and the second, thicker stitch 712) and then loop around an angled strut (e.g., angled strut 130, 132, or 134) of the frame, thereby connecting the connecting suture route 704 of the tip edge portion 708 of the leaflet 702 to the angled strut (e.g., angled strut 130, 132, or 134) of the frame 102. Figure 24-26 ).

[0221] In some cases, stitch 730 may extend beneath second thicker suture 712 (between second thicker suture 712 and leaflet 702) and then loop around the angled struts of the frame.

[0222] In some examples, such as Fig.24 and Fig.26 As shown, the stitches 730 may also extend through the outer skirt 106 of the prosthetic valve, thereby tightly securing the tip edge portions 708 of the leaflets 702 to the angled struts and the outer skirt 106 .

[0223] In some examples, additional stitches 732 may be used to secure the inflow edge 734 of the outer skirt 106 to the inflow strut 168 (such as to the apex region 152 of the inflow strut 168). Fig.25 and Fig.26 ).

[0224] Further details regarding connecting suture routes, such as connecting suture route 704, may be found in publication number WO2023086548A1, which has been incorporated herein by reference as above.

[0225] Delivery Technology

[0226] In order to implant the prosthetic valve in the natural aortic valve by the transfemoral delivery method, the prosthetic valve is installed along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral artery and are advanced into and through the descending aorta, bypassing the aortic arch and passing through the ascending aorta. The prosthetic valve is positioned in the natural aortic valve and is radially expanded (e.g., by inflating the balloon, actuating one or more actuators of the delivery device, or deploying the prosthetic valve from the sheath to allow the prosthetic valve to self-expand). Optionally, the prosthetic valve can be implanted in the natural aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through the surgical opening of the chest and the apex of the heart, and the prosthetic valve is positioned in the natural aortic valve. Optionally, in a transaortic procedure, the prosthetic valve (on the distal portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta (such as through a partial J-shaped sternotomy or a right parasternal mini-thoracotomy) and then advanced through the ascending aorta toward the native aortic valve.

[0227] To implant a prosthetic valve within the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted in a radially compressed state along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (through a perforation 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 in a transapical procedure, whereby the prosthetic valve (on the distal 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.

[0228] To implant the prosthetic valve within the native tricuspid valve, the prosthetic valve is installed in a radially compressed state along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar method can be used to implant the prosthetic valve within the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the left ventricle and toward the pulmonary valve / pulmonary artery.

[0229] Another delivery method is a transatrial approach, whereby the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and an incision made through the atrial wall (of the right or left atrium) to access any native heart valve. Atrial delivery can also be performed intravascularly, such as from the pulmonary veins. Yet another delivery method is a transventricular approach, whereby the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and an incision made through the right ventricular wall (generally at or near the base of the heart) to implant the prosthetic valve in the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0230] In all delivery methods, the delivery device can be advanced over a guidewire that has been previously inserted into the patient's vasculature. In addition, the disclosed delivery methods are not intended to be limited. Any prosthetic valve disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0231] Any system, device, equipment, etc. herein can be sterilized (e.g., with heat, radiation, and / or chemicals, etc.) to ensure that it is safe for use by patients, and any method herein can include sterilization of related systems, devices, equipment, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclave sterilization. Examples of radiation used for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization using hydrogen peroxide can be accomplished using, for example, hydrogen peroxide plasma.

[0232] Additional Examples of the Disclosed Technology

[0233] In view of the above embodiments of the disclosed subject matter, the present application discloses other examples listed below. It should be noted that a single feature of an example or a combination of more than one feature of an example and optionally a combination of one or more features of one or more further examples are further examples that also fall within the disclosure of the present application.

[0234] Example 1. A method comprising: forming a suture route along an edge portion of an outer skirt for a prosthetic heart valve, the suture route having a plurality of entry and exit stitches and a plurality of rings, the plurality of entry and exit stitches extending along the edge portion, the plurality of rings being spaced apart from each other in the direction of the entry and exit stitches, wherein each ring surrounds a free edge of the edge portion, and wherein the plurality of rings space the plurality of entry and exit stitches apart from the free edge; and attaching the edge portion to a strut in a circumferentially extending strut row of an annular frame of the prosthetic heart valve by extending a plurality of lock stitches through the plurality of rings and around the struts so that the free edge of the edge portion is positioned against a radially outwardly facing surface of the strut and away from a leaflet arranged on the inner side of the annular frame.

[0235] Example 2. The method according to any example herein (particularly Example 1), wherein the plurality of in and out stitches extend along the edge portion parallel to the free edge, and wherein the plurality of in and out stitches are spaced apart from the free edge by a certain distance.

[0236] Example 3. The method according to any example in this document (especially Example 2), wherein the distance is in the range of 0.5-2.0 mm.

[0237] Example 4. A method according to any example herein (especially Example 2), wherein the distance is in the range of 1.5-2.0 mm.

[0238] Example 5. A method according to any example in this document (especially any one of Examples 2-4), wherein the distance is equal to the length of each ring in the plurality of rings.

[0239] Example 6. A method according to any of the examples herein (particularly any of Examples 1-5), wherein the plurality of in-and-out stitches are first in-and-out stitches of a first pass formed along the edge portion, wherein each first in-and-out stitch extends between two adjacent orifices in a row of spaced-apart orifices in the outer skirt, and wherein forming the sewing route also includes forming second in-and-out stitches of a second pass along the edge portion, the second in-and-out stitches alternating with the first in-and-out stitches so that the first in-and-out stitches and the second in-and-out stitches extend across the relative surfaces of the outer skirt between each corresponding pair of two adjacent orifices.

[0240] Example 7. A method according to any of the examples herein (particularly any of Examples 1-6), wherein forming the suture route includes forming the multiple entry and exit stitches and multiple loops in the following manner: extending the suture from a first orifice in the outer skirt to an adjacent second orifice above the first surface of the outer skirt in a direction parallel to the free edge, thereby forming a first entry and exit stitch across the first surface; extending the suture through the second orifice, extending across a second surface of the outer skirt opposite to the first surface toward the free edge, crossing the free edge and returning to the second orifice across the first surface, thereby forming a first loop; and delivering the suture back through the second orifice and across the second surface to an adjacent third orifice in the outer skirt, thereby forming a second entry and exit stitch across the second surface, and wherein the method for forming the suture route is repeated in an alternating manner across the first and second surfaces of the outer skirt to form the multiple entry and exit stitches and multiple loops of the suture route.

[0241] Example 8. A method according to any of the examples herein (particularly any of Examples 1-6), wherein forming the suture route includes forming the multiple entry and exit stitches and the multiple loops in the following manner: extending the suture above the first surface of the outer skirt in a direction parallel to the free edge and passing through the outer skirt to the second surface of the outer skirt opposite to the first surface, thereby forming a first entry and exit stitch across the first surface; extending the suture across the second surface toward the free edge, over the free edge and returning across the first surface to the end of the first entry and exit stitch, thereby forming a first loop; and delivering the suture back through the outer skirt and across the second surface and through the outer skirt to the first surface, thereby forming a second entry and exit stitch across the second surface, and wherein the method for forming the suture route is repeated in an alternating manner across the first surface and the second surface of the outer skirt to form the multiple entry and exit stitches and the multiple loops of the suture route.

[0242] Example 9. The method according to any example herein, in particular any one of Examples 1-8, wherein the plurality of loops are a single loop extending between the plurality of inlet and outlet stitches and the free edge of the outer skirt.

[0243] Example 10. A method according to any of the examples herein (particularly any of Examples 1-6), wherein the plurality of loops are a plurality of first loops, and wherein forming the suture route includes forming the plurality of entry and exit stitches, the plurality of first loops, and the plurality of second loops in the following manner: extending the suture from a first orifice in the outer skirt to an adjacent second orifice above the first surface of the outer skirt in a direction parallel to the free edge, thereby forming a first entry and exit stitch across the first surface; extending the suture through the second orifice, extending across a second surface of the outer skirt opposite to the first surface toward the free edge, passing through a third orifice offset from the second orifice toward the free edge, extending across the first surface and toward the free edge, crossing the free edge, and returning across the second surface to the free edge. The method comprises delivering the suture back through the second orifice and across the second surface to the outer skirt to form a second in-and-out stitch across the second surface, and wherein the method for forming the suture route is repeated in an alternating manner across the first and second surfaces of the outer skirt to form the plurality of in-and-out stitches, the plurality of first loops, and the plurality of second loops of the suture route.

[0244] Example 11. A method according to any example herein, in particular Example 10, wherein at least a portion of the first, second, third and fourth apertures are pre-formed apertures in the outer skirt.

[0245] Example 12. A method according to any of the examples herein (particularly Example 10 or Example 11), wherein at least a portion of the first, second, third and fourth orifices are not pre-formed orifices, but are formed between the first surface and the second surface using the needle when the needle delivers the suture through the outer skirt.

[0246] Example 13. A method according to any example herein (particularly Example 10), wherein the first, second, third and fourth apertures are pre-formed apertures in the outer skirt.

[0247] Example 14. A method according to any of the examples herein (particularly any of Examples 1-6), wherein the plurality of loops are a plurality of first loops, and wherein forming the suture route includes forming the plurality of entry and exit stitches, the plurality of first loops, and the plurality of second loops in the following manner: extending a suture from a first point in the outer skirt to an adjacent second point in the outer skirt above a first surface of the outer skirt in a direction parallel to the free edge, thereby forming a first entry and exit stitch across the first surface; extending the suture through the outer skirt at the second point, extending across a second surface of the outer skirt opposite to the first surface toward the free edge, passing through a third point in the outer skirt offset from the second point toward the free edge, extending across the first surface and toward the free edge, crossing the free edge, and returning across the second surface Returning to the third point, passing through the outer skirt at the third point and returning across the first surface to the second point, 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-and-out stitches, wherein the first loop and the second loop are connected to each other, and wherein the first loop extends around the free edge and the second loop intersects the in-and-out stitches; and delivering the suture at the second point back through the outer skirt and across the second surface to an adjacent fourth point in the outer skirt, thereby forming a second in-and-out stitch across the second surface, and wherein the method for forming the suture route is repeated in an alternating manner across the first and second surfaces of the outer skirt to form the plurality of in-and-out stitches, the plurality of first loops and the plurality of second loops of the suture route.

[0248] Example 15. A method according to any of the examples herein (particularly any of Examples 1-6 or 10-14), wherein the plurality of loops are a plurality of first loops, wherein forming the stitching route also includes forming a stitching route having a plurality of second loops, wherein the plurality of second loops are spaced apart from each other in the direction of the in-and-out stitches, and wherein each of the plurality of second loops extends from a corresponding first loop of the plurality of first loops to an intersection point of two adjacent in-and-out stitches of the plurality of in-and-out stitches.

[0249] Example 16. A method according to any example herein (particularly Example 15), wherein each second loop is shorter than each first loop.

[0250] Example 17. A method according to any of the examples herein (particularly any of Examples 1-16), wherein the edge portion is an outflow edge portion arranged opposite to the inflow edge portion of the outer skirt, wherein the circumferentially extending column row to which the outflow edge portion is attached is a first circumferentially extending column row of the frame, and wherein the method further includes fixing the inflow edge portion of the outer skirt to a second circumferentially extending column row of the frame, the second circumferentially extending column row defining the inflow end of the frame and being axially spaced apart from the first circumferentially extending column row of the frame.

[0251] Example 18. A method according to any of the examples herein (particularly Example 17), wherein the first circumferentially extending row of struts of the frame is disposed adjacent to a third circumferentially extending row of struts of the frame, the third circumferentially extending row of struts defining an outflow end of the frame.

[0252] Example 19. A method according to any example herein, in particular any one of Examples 1-18, wherein when the outer skirt is arranged around the outer surface of the frame, the edge portion extends in a circumferential direction.

[0253] Example 20. A method according to any of the examples herein (in particular any of Examples 1-19), wherein the edge portion includes a plurality of protrusions defining a wavy shape of the edge portion, the wavy shape following the contour of the pillars in the circumferentially extending row of pillars.

[0254] Example 21. A method according to any of the examples herein (particularly any of Examples 1-20), wherein the edge portion is attached to the pillar by extending the plurality of lockstitch stitches through the plurality of loops and around the pillar, comprising extending at least a portion of the lockstitch stitches around each pillar, through a corresponding loop of the plurality of loops and around the corresponding loop to form a double loop around the corresponding loop.

[0255] Example 22. A method comprising: forming a suture route along an edge portion of an outer skirt for a prosthetic heart valve, the suture route having a plurality of entry and exit stitches and a plurality of rings, the plurality of entry and exit stitches extending along the edge portion and spaced apart from a free edge of the edge portion, the plurality of rings spaced apart from one another in the direction of the entry and exit stitches, wherein each ring surrounds the free edge of the edge portion and extends between the edge and an intersection point of two adjacent entry and exit stitches; and attaching the edge portion to a strut in a circumferentially extending strut row of an annular frame of the prosthetic heart valve by extending a plurality of lock stitches through the plurality of rings and around the struts so that the free edge of the edge portion is positioned against a radially outwardly facing surface of the strut and away from a leaflet arranged on an inner side of the annular frame.

[0256] Example 23. A method according to any of the examples herein (particularly Example 22), wherein the rings in the plurality of rings are spaced apart from each other in a direction parallel to the free edge.

[0257] Example 24. A method according to any of the examples herein (particularly Example 22 or Example 23), wherein the plurality of inlet and outlet stitches extend end-to-end along the edge portion parallel to the free edge, and wherein the plurality of inlet and outlet stitches are spaced apart from the free edge at a distance perpendicular to the free edge.

[0258] Example 25. A method according to any example herein (particularly Example 24), wherein the distance is in the range of 0.5-2.0 mm.

[0259] Example 26. A method according to any example in the present document (especially Example 24), wherein the distance is in the range of 1.4-2.1 mm.

[0260] Example 27. A method according to any of the examples herein (particularly any of Examples 24-26), wherein the distance is equal to the length of each of the multiple rings.

[0261] Example 28. A method according to any of the examples herein (particularly any of Examples 22-27), wherein the plurality of in-and-out stitches are first in-and-out stitches of a first pass formed along the edge portion, wherein each first in-and-out stitch extends between two adjacent orifices in a row of spaced-apart orifices in the outer skirt, and wherein forming the sewing route also includes forming second in-and-out stitches of a second pass along the edge portion, the second in-and-out stitches alternating with the first in-and-out stitches so that the first in-and-out stitches and the second in-and-out stitches extend across the relative surfaces of the outer skirt between each corresponding pair of two adjacent orifices.

[0262] Example 29. A method according to any of the examples herein (particularly Example 28), wherein the row of spaced-apart orifices comprises preformed orifices extending through the outer skirt between opposing first and second surfaces of the outer skirt.

[0263] Example 30. A method according to any of the examples herein (particularly any of Examples 22-29), wherein forming the suture route includes forming the multiple entry and exit stitches and the multiple loops by: extending the suture from a first orifice in the outer skirt to an adjacent second orifice above the first surface of the outer skirt in a direction parallel to the free edge, thereby forming a first entry and exit stitch across the first surface; extending the suture through the second orifice, across a second surface of the outer skirt opposite to the first surface toward the free edge, over the free edge and returning to the second orifice across the first surface, thereby forming a first loop; and delivering the suture back through the second orifice and across the second surface to an adjacent third orifice in the outer skirt, thereby forming a second entry and exit stitch across the second surface, and wherein the method for forming the suture route is repeated in an alternating manner across the first and second surfaces of the outer skirt to form the multiple entry and exit stitches and the multiple loops of the suture route.

[0264] Example 31. A method according to any of the examples herein (particularly any of Examples 22-29), wherein forming the suture route includes forming the multiple entry and exit stitches and the multiple loops in the following manner: extending the suture above the first surface of the outer skirt in a direction parallel to the free edge and passing through the outer skirt to the second surface of the outer skirt opposite to the first surface, thereby forming a first entry and exit stitch across the first surface; extending the suture across the second surface toward the free edge, over the free edge and returning across the first surface to the end of the first entry and exit stitch, thereby forming a first loop; and delivering the suture back through the outer skirt and across the second surface and through the outer skirt to the first surface, thereby forming a second entry and exit stitch across the second surface, and wherein the method for forming the suture route is repeated in an alternating manner across the first surface and the second surface of the outer skirt to form the multiple entry and exit stitches and the multiple loops of the suture route.

[0265] Example 32. A method according to any of the examples herein (in particular any of Examples 22-31), wherein the edge portion is attached to the pillar by extending the multiple lockstitch stitches through the multiple loops and around the pillar, including extending at least a portion of the lockstitch stitches around each pillar, through a corresponding loop of the multiple loops and around the corresponding loop, so that a double loop is formed around the corresponding loop.

[0266] Example 33. A method according to any of the examples herein (particularly any of Examples 22-32), wherein the edge portion is an outflow edge portion arranged opposite to the inflow edge portion of the outer skirt, wherein the circumferentially extending row of struts to which the outflow edge portion is attached is a first circumferentially extending row of struts of the frame, and wherein the method further includes fixing the inflow edge portion of the outer skirt to a second circumferentially extending row of struts of the frame, the second circumferentially extending row of struts defining an inflow end of the frame and being axially spaced apart from the first circumferentially extending row of struts of the frame.

[0267] Example 34. A method according to any of the examples herein (particularly Example 33), wherein the first circumferentially extending row of struts of the frame is disposed adjacent to a third circumferentially extending row of struts of the frame, the third circumferentially extending row of struts defining an outflow end of the frame.

[0268] Example 35. A method according to any of the examples herein (particularly any of Examples 22-34), wherein when the outer skirt is arranged around the outer surface of the frame, the edge portion extends in a circumferential direction.

[0269] Example 36. A method according to any of the examples herein (in particular any of Examples 22-35), wherein the edge portion includes a plurality of protrusions, the plurality of protrusions defining a wavy shape of the edge portion, the wavy shape following the contour of the pillars in the circumferentially extending row of pillars.

[0270] Example 37. A method comprising: forming a suture route along an edge portion of an outer skirt for a prosthetic heart valve, the suture route having a plurality of entry and exit stitches and a plurality of pairs of rings, the plurality of entry and exit stitches extending along the edge portion and spaced apart from a free edge of the edge portion, the plurality of pairs of rings spaced apart from one another in the direction of the entry and exit stitches, wherein each pair of rings comprises a first ring and a second ring, the first ring encircling the free edge of the edge portion and extending between the free edge and the second ring, and the second ring extending between the first ring and an intersection point of two adjacent entry and exit stitches of the plurality of entry and exit stitches; and attaching the edge portion to a strut in a circumferentially extending strut row of an annular frame of the prosthetic heart valve by extending a lockstitch stitch through the first ring in each pair of rings and around the strut so that the free edge of the edge portion is positioned against a radially outwardly facing surface of the strut and away from a leaflet arranged on an inner side of the annular frame.

[0271] Example 38. A method according to any of the examples herein (particularly Example 37), wherein the plurality of inlet and outlet stitches extend along the edge portion parallel to the free edge, and wherein the plurality of inlet and outlet stitches are spaced apart from the free edge at a distance perpendicular to the free edge.

[0272] Example 39. A method according to any of the examples herein (particularly Example 38), wherein the distance is in the range of 0.5-2.0 mm.

[0273] Example 40. A method according to any of the examples herein (particularly Example 38), wherein the distance is in the range of 1.4-2.1 mm.

[0274] Example 41. A method according to any of the examples herein (particularly any of Examples 38-40), wherein the distance is equal to the combined length of the first ring and the second ring in each pair of the multiple pairs of rings.

[0275] Example 42. A method according to any of the examples herein (particularly any of Examples 37-41), wherein the plurality of in-and-out stitches are first in-and-out stitches of a first pass formed along the edge portion, wherein each first in-and-out stitch extends between two adjacent orifices in a row of spaced-apart orifices in the outer skirt, and wherein forming the sewing route also includes forming second in-and-out stitches of a second pass along the edge portion, the second in-and-out stitches alternating with the first in-and-out stitches so that the first in-and-out stitches and the second in-and-out stitches extend across the relative surfaces of the outer skirt between each corresponding pair of two adjacent orifices.

[0276] Example 43. A method according to any of the examples herein (particularly Example 42), wherein the row of spaced-apart orifices comprises preformed orifices extending through the outer skirt between opposing first and second surfaces of the outer skirt.

[0277] Example 44. A method according to any of the examples herein (particularly any of Examples 37-43), wherein forming the suture route includes forming the multiple entry and exit stitches and the multiple pairs of loops in the following manner: extending the suture from a first orifice in the outer skirt to an adjacent second orifice above the first surface of the outer skirt in a direction parallel to the free edge, thereby forming a first entry and exit stitch across the first surface; extending the suture through the second orifice, across a second surface of the outer skirt opposite to the first surface toward the free edge, through a third orifice offset from the second orifice toward the free edge, across the first surface and toward the free edge , crossing the free edge, returning to the third orifice across the second surface, passing through the third orifice and returning to the second orifice across the first surface, thereby forming the first and second loops in a corresponding pair of loops in the multiple pairs of loops between the free edge and the entry and exit stitches; and delivering the suture back through the second orifice and across the second surface to an adjacent fourth orifice in the outer skirt, thereby forming a second entry and exit stitch across the second surface, and wherein the method for forming the suture route is repeated in an alternating manner across the first and second surfaces of the outer skirt to form the multiple entry and exit stitches and the multiple pairs of loops of the suture route.

[0278] Example 45. A method according to any of the examples herein (particularly Example 44), wherein at least a portion of the first, second, third and fourth orifices are pre-formed orifices in the outer skirt.

[0279] Example 46. A method according to any of the examples herein (particularly Example 44 or Example 45), wherein at least a portion of the first, second, third and fourth orifices are not pre-formed orifices, but are formed between the first surface and the second surface using the needle when the needle delivers the suture through the outer skirt.

[0280] Example 47. A method according to any of the examples herein (particularly Example 44), wherein the first, second, third and fourth orifices are pre-formed orifices in the outer skirt.

[0281] Example 48. A method according to any of the examples herein (particularly any of Examples 37-43), wherein forming the suture route includes forming the multiple entry and exit stitches and the multiple pairs of loops in the following manner: extending the suture from a first point in the outer skirt above the first surface of the outer skirt in a direction parallel to the free edge to an adjacent second point in the outer skirt, thereby forming a first entry and exit stitch across the first surface; extending the suture at the second point through the outer skirt, across a second surface of the outer skirt opposite to the first surface toward the free edge, through a third point in the outer skirt offset from the second point toward the free edge, across the first surface and toward the free edge The method of claim 1, wherein the suture is extended from the free edge to the third point, passes through the outer skirt at the third point, and returns across the first surface to the second point, thereby forming the first loop and the second loop in a corresponding pair of loops in the multiple pairs of loops between the free edge and the entry and exit stitches; and delivering the suture at the second point back through the outer skirt and across the second surface to an adjacent fourth point in the outer skirt, thereby forming a second entry and exit stitch across the second surface, and wherein the method for forming the suture route is repeated in an alternating manner across the first surface and the second surface of the outer skirt to form the multiple entry and exit stitches and the multiple pairs of loops of the suture route.

[0282] Example 49. A method according to any of the examples herein (particularly any of Examples 37-48), wherein each second loop is shorter than each first loop.

[0283] Example 50. A method according to any of the examples herein (particularly Example 49), wherein each first ring is in the range of 0.2-0.6 mm.

[0284] Example 51. A method according to any of the examples herein (particularly Example 50), wherein each second ring is in the range of 0.8-1.9 mm.

[0285] Example 52. A method according to any of the examples herein (particularly any of Examples 37-51), wherein the edge portion is an outflow edge portion arranged opposite to the inflow edge portion of the outer skirt, wherein the circumferentially extending row of struts to which the outflow edge portion is attached is a first circumferentially extending row of struts of the frame, and wherein the method further includes fixing the inflow edge portion of the outer skirt to a second circumferentially extending row of struts of the frame, the second circumferentially extending row of struts defining an inflow end of the frame and being axially spaced apart from the first circumferentially extending row of struts of the frame.

[0286] Example 53. A method according to any of the examples herein (particularly Example 52), wherein the first circumferentially extending row of struts of the frame is arranged adjacent to a third circumferentially extending row of struts of the frame, and the third circumferentially extending row of struts defines an outflow end of the frame.

[0287] Example 54. A method according to any of the examples herein (particularly any of Examples 37-53), wherein when the outer skirt is arranged around the outer surface of the frame, the edge portion extends in a circumferential direction.

[0288] Example 55. A method according to any of the examples herein (in particular any of Examples 37-54), wherein the edge portion includes a plurality of protrusions that define a wavy shape of the edge portion, the wavy shape following the contour of the struts in the circumferentially extending row of struts.

[0289] Example 56. A method according to any of the examples herein (particularly any of Examples 37-55), wherein the edge portion is attached to the pillar by extending the multiple lockstitch stitches through the multiple loops and around the pillar, including extending at least a portion of the lockstitch stitches around each pillar, through a corresponding first loop of the multiple pairs of loops and around the corresponding first loop, so that a double loop is formed around the corresponding first loop.

[0290] Example 57. A prosthetic heart valve, comprising: an annular frame, the annular frame comprising a plurality of interconnected struts, the plurality of interconnected struts being arranged into a plurality of circumferentially extending strut rows, the plurality of circumferentially extending strut rows comprising a first circumferentially extending strut row disposed closer to an outflow end than an inflow end of the frame; an outer skirt disposed around an outer surface of the frame and comprising an outflow edge portion having a free outflow edge, wherein the outflow edge portion extends circumferentially around the frame and comprises a suture route, the suture route comprising: a plurality of inlet and outlet stitches extending along the inflow end of the frame; An outflow edge portion extends parallel to the outflow edge but spaced apart from the outflow edge; and a plurality of annular stitches, the plurality of annular stitches being spaced apart from each other in the direction of the plurality of in-and-out stitches, wherein each annular stitch forms a loop around the outflow edge and extends between intersection points of the outflow edge and corresponding two adjacent in-and-out stitches of the plurality of in-and-out stitches; and a plurality of lockstitch stitches, the plurality of lockstitch stitches extending through the plurality of annular stitches and around the pillars in the first circumferentially extending pillar row so that the outflow edge is attached to the pillar against the radially outward surface of the pillar.

[0291] Example 58. A prosthetic heart valve according to any of the examples herein, in particular Example 57, wherein the outflow edge is rougher than the remainder of the outflow edge portion of the outer skirt.

[0292] Example 59. The prosthetic heart valve according to any of the examples herein (particularly Example 57 or Example 58) further includes a plurality of leaflets fixed on the inner side of the frame, and wherein the plurality of leaflets face the radially inward surface of the struts.

[0293] Example 60. A prosthetic heart valve according to any of the examples herein (particularly any of Examples 57-59), wherein the plurality of circumferentially extending strut rows also includes a second circumferentially extending strut row defining the outflow end of the frame, and wherein the first circumferentially extending strut row is disposed adjacent to the second circumferentially extending strut row.

[0294] Example 61. A prosthetic heart valve according to any of the examples herein, in particular any of Examples 57-60, wherein the outer skirt includes a row of spaced-apart orifices extending along the outflow edge portion parallel to the outflow edge but spaced apart from the outflow edge, and wherein the plurality of entry and exit stitches and the plurality of annular stitches extend through the spaced-apart orifices.

[0295] Example 62. A prosthetic heart valve according to any of the examples herein, in particular Example 61, wherein the spaced apart orifices are pre-formed in the outer skirt.

[0296] Example 63. A prosthetic heart valve according to any of the examples herein (particularly Example 61 or Example 62), wherein the plurality of entry and exit traces include a first pass of first entry and exit traces extending along the outflow edge portion, and wherein each first entry and exit trace extends between a corresponding pair of adjacent orifices in the row of spaced-apart orifices.

[0297] Example 64. A prosthetic heart valve according to any of the examples described herein (particularly Example 63), wherein the multiple inlet and outlet stitches also include a second pass of second inlet and outlet stitches extending along the outflow edge portion, wherein each second inlet and outlet stitch extends between a corresponding pair of adjacent orifices, and wherein the second inlet and outlet stitches alternate with the first inlet and outlet stitches so that the first inlet and outlet stitches and the second inlet and outlet stitches extend across relative surfaces of the outer skirt between each corresponding pair of adjacent orifices.

[0298] Example 65. A prosthetic heart valve according to any of the examples herein, in particular any of Examples 57-64, wherein the annular traces of the plurality of annular traces are spaced apart from one another in a direction parallel to the outflow edge.

[0299] Example 66. A prosthetic heart valve according to any of the examples herein, in particular any of Examples 57-65, wherein the plurality of entry and exit traces are spaced apart from the outflow edge by a distance extending perpendicular to the outflow edge.

[0300] Example 67. A prosthetic heart valve according to any of the examples herein (particularly Example 66), wherein the distance is in the range of 0.5-2.0 mm.

[0301] Example 68. A prosthetic heart valve according to any of the examples herein (particularly Example 66), wherein the distance is in the range of 1.4-2.1 mm.

[0302] Example 69. A prosthetic heart valve according to any of the examples herein, in particular any of Examples 66-68, wherein the distance is equal to the length of each of the plurality of annular traces.

[0303] Example 70. A prosthetic heart valve according to any of the Examples herein (in particular any of Examples 57-69), wherein each annular stitch has a first portion extending along a first surface of the outer skirt between the outflow edge and the intersection point of the corresponding two adjacent inlet and outlet stitches and a second portion extending along an opposite second surface of the outer skirt.

[0304] Example 71. A prosthetic heart valve according to any of the Examples herein (in particular any of Examples 57-70), wherein for each strut in the first circumferentially extending row of struts, at least one of the multiple lock stitches extending around the strut forms a double ring around the corresponding annular stitch.

[0305] Example 72. A prosthetic heart valve according to any of the Examples herein (in particular any of Examples 57-71), wherein the outer skirt includes an inflow edge portion arranged opposite to the outflow edge portion, and wherein the inflow edge portion is fixed to a third circumferentially extending strut row of the plurality of circumferentially extending strut rows, the third circumferentially extending strut row defining the inflow end of the frame.

[0306] Example 73. A prosthetic heart valve according to any of the examples herein, in particular any of Examples 57-72, wherein the outflow edge portion extends in a circumferential direction around the outer surface of the frame.

[0307] Example 74. A prosthetic heart valve according to any of the Examples herein, in particular any of Examples 57-73, wherein the outflow edge portion comprises a plurality of protrusions defining a wavy shape of the outflow edge portion, the wavy shape following the contour of the first circumferentially extending row of struts.

[0308] Example 75. A prosthetic heart valve comprising: an annular frame comprising a plurality of interconnected struts between an inflow end and an outflow end of the frame, the plurality of interconnected struts being arranged into a plurality of circumferentially extending strut rows, wherein the plurality of circumferentially extending strut rows include a first circumferentially extending strut row; an outer skirt disposed about an outer surface of the frame and comprising an edge portion having a free edge, wherein the edge portion extends circumferentially about the frame and comprises a suture route, the suture route comprising: a plurality of inlet and outlet stitches extending along the edge portion parallel to the free edge but spaced apart from the free edge; and a plurality of pairs of annular Stitches, the multiple pairs of looped stitches are spaced apart from each other in the direction of the multiple in-and-out stitches, wherein each pair of looped stitches includes a first looped stitch and a second looped stitch, wherein the first looped stitch forms a loop around the free edge and extends between the free edge and the second loop, and wherein the second loop extends between the first loop and the intersection point of two corresponding adjacent in-and-out stitches in the multiple in-and-out stitches; and a plurality of lock stitches, the plurality of lock stitches extending through the first looped stitch in each pair of looped stitches and around the struts in the first circumferentially extending strut row so that the free edge is attached to the strut against the radially outward surface of the strut.

[0309] Example 76. A prosthetic heart valve according to any of the Examples herein (particularly Example 75), wherein the first circumferentially extending row of struts is disposed closer to the outflow end than the inflow end of the frame, and wherein the edge portion is an outflow edge portion, and the free edge is the outflow edge of the outer skirt.

[0310] Example 77. A prosthetic heart valve according to any of the examples herein (particularly Example 75 or Example 76), wherein the free edge is rougher than the rest of the edge portion of the outer skirt.

[0311] Example 78. The prosthetic heart valve according to any of the examples herein (particularly any of Examples 75-77) further comprises a plurality of leaflets fixed on the inner side of the frame, and wherein the plurality of leaflets face the radially inward surface of the struts.

[0312] Example 79. A prosthetic heart valve according to any of the examples herein (particularly any of Examples 75-78), wherein the plurality of circumferentially extending strut rows also includes a second circumferentially extending strut row defining the outflow end of the frame, and wherein the first circumferentially extending strut row is disposed adjacent to the second circumferentially extending strut row.

[0313] Example 80. A prosthetic heart valve according to any of the examples herein (particularly any of Examples 75-79), wherein the outer skirt includes a first row of spaced-apart first orifices and a second row of spaced-apart second orifices, the first row of spaced-apart first orifices extending along the edge portion parallel to the free edge but spaced apart from the free edge, the second row of spaced-apart second orifices extending along the edge portion parallel to the first row of spaced-apart first orifices but spaced apart from the first row of spaced-apart first orifices, wherein the second row of spaced-apart second orifices are spaced farther from the free edge than the first row of spaced-apart first orifices, and wherein the plurality of entry and exit stitches extend through the second row of second orifices, and the first annular stitch and the second annular stitch in each pair of annular stitches extend through the first orifice of the first row.

[0314] Example 81. A prosthetic heart valve according to any of the examples herein, in particular Example 80, wherein the first orifice and the second orifice are pre-formed in the outer skirt.

[0315] Example 82. A prosthetic heart valve according to any of the Examples herein (particularly Example 80 or Example 81), wherein the plurality of entry and exit stitches include a first pass of first entry and exit stitches extending along the edge portion, and wherein each first entry and exit stitch extends between a corresponding pair of adjacent second orifices of the second row of spaced-apart second orifices.

[0316] Example 83. A prosthetic heart valve according to any of the examples described herein (particularly Example 82), wherein the multiple entry and exit stitches also include a second run of second entry and exit stitches extending along the edge portion, wherein each second entry and exit stitch extends between a corresponding pair of adjacent second orifices, and wherein the second entry and exit stitches alternate with the first entry and exit stitches so that the first entry and exit stitches and the second entry and exit stitches extend across relative surfaces of the outer skirt between each corresponding pair of adjacent second orifices.

[0317] Example 84. A prosthetic heart valve according to any of the Examples herein, in particular any of Examples 75-83, wherein pairs of annular stitches in the plurality of pairs of annular stitches are spaced apart from one another in a direction parallel to the free edge.

[0318] Example 85. A prosthetic heart valve according to any of the examples herein, in particular any of Examples 75-84, wherein the plurality of entry and exit traces are spaced apart from the free edge by a distance extending perpendicular to the free edge.

[0319] Example 86. A prosthetic heart valve according to any of the examples herein (particularly Example 85), wherein the distance is in the range of 0.5-2.0 mm.

[0320] Example 87. A prosthetic heart valve according to any of the examples herein (particularly Example 85), wherein the distance is in the range of 1.4-2.1 mm.

[0321] Example 88. A prosthetic heart valve according to any of the Examples herein, in particular any of Examples 85-87, wherein the distance is equal to the combined length of the first annular trace and the second annular trace in each pair of annular traces.

[0322] Example 89. A prosthetic heart valve according to any of the Examples herein (in particular any of Examples 75-88), wherein, for each pair of annular stitches, the first annular stitch has a first portion extending along the first surface of the outer skirt between the free edge and the second annular stitch and a second portion extending along the opposite second surface of the outer skirt, and the second annular stitch has a first portion extending along the first surface of the outer skirt between the intersection of the first annular stitch and the corresponding two adjacent entry and exit stitches and a second portion extending along the second surface of the outer skirt.

[0323] Example 90. A prosthetic heart valve according to any of the Examples herein (in particular any of Examples 75-89), wherein for each strut in the first circumferentially extending row of struts, at least one of the multiple lock stitches extending around the strut forms a double ring around the corresponding first annular stitch.

[0324] Example 91. A prosthetic heart valve according to any of the examples herein (in particular any of Examples 75-90), wherein the edge portion is an outflow edge portion of the outer skirt, wherein the outer skirt includes an inflow edge portion arranged opposite to the outflow edge portion, and wherein the inflow edge portion is fixed to a third circumferentially extending strut row among the plurality of circumferentially extending strut rows, the third circumferentially extending strut row defining the inflow end of the frame.

[0325] Example 92. A prosthetic heart valve according to any of the Examples herein, in particular any of Examples 75-91, wherein the edge portion extends in a circumferential direction around the outer surface of the frame.

[0326] Example 93. A prosthetic heart valve according to any of the examples herein, in particular any of Examples 75-92, wherein the edge portion comprises a plurality of protrusions defining a wavy shape of the edge portion, the wavy shape following the contour of the first circumferentially extending row of struts.

[0327] Example 94. A method comprising: forming a suture route along a tip edge portion of a leaflet for a prosthetic heart valve, the suture route having a plurality of entry and exit stitches and a plurality of rings, the plurality of entry and exit stitches extending along the tip edge portion and spaced apart from an outermost tip edge of the tip edge portion, the plurality of rings spaced apart from one another in the direction of the entry and exit stitches, wherein each ring surrounds the tip edge of the tip edge portion and extends between the tip edge and an intersection point of two adjacent entry and exit stitches; and attaching the tip edge portion to a target component of the prosthetic heart valve by extending a plurality of lock stitches through the plurality of rings and around or through the target component so that the tip edge of the tip edge portion is retracted against the target component.

[0328] Example 95. A method according to any of the examples herein (particularly Example 94), wherein the target component is a fabric skirt configured to be attached to an inner surface of an annular frame of the prosthetic heart valve.

[0329] Example 96. A method according to any of the examples herein (particularly Example 94), wherein the target component is a strut of an annular frame of the prosthetic heart valve, the strut following the scalloped line of the tip edge portion.

[0330] Example 97. A method according to any of the examples herein (particularly Example 96), wherein the strut to which the tip edge portion is attached is an angled strut extending from a first joint support portion of the frame to an inflow end of the frame and from the inflow end of the frame to a second joint support portion of the frame, and wherein the first joint support portion and the second joint support portion are arranged adjacent to the outflow end of the frame.

[0331] Example 98. A method according to any of the examples herein (particularly Example 96 or Example 97), wherein attaching the tip edge portion to the target component includes extending the plurality of lockstitch stitches through the plurality of loops and around the struts.

[0332] Example 99. A method according to any of the examples herein (particularly Example 96 or Example 97), wherein attaching the tip edge portion to the target component includes extending the plurality of lockstitch stitches through the plurality of loops and through or around a suture extending around the support.

[0333] Example 100. A method according to any of the examples herein (particularly any of Examples 94-99), wherein the plurality of inlet and outlet stitches extend along the tip edge portion parallel to the tip edge, and wherein the plurality of inlet and outlet stitches are spaced a certain distance from the tip edge.

[0334] Example 101. A method according to any example in the present document (especially Example 100), wherein the distance is in the range of 0.5-2.0 mm.

[0335] Example 102. A method according to any example in the present document (particularly Example 100 or Example 101), wherein the distance is equal to the length of each ring in the multiple rings.

[0336] Example 103. A method according to any of the examples herein (particularly any of Examples 94-102), wherein the multiple entry and exit stitches are first entry and exit stitches formed along the tip edge portion for a first time, and wherein forming the suture route also includes forming second entry and exit stitches for a second time along the tip edge portion, the second entry and exit stitches alternating with the first entry and exit stitches so that the first entry and exit stitches and the second entry and exit stitches extend across opposite sides of the leaflet between each pair of adjacent rings in the multiple rings.

[0337] Example 104. A method according to any of the examples herein (particularly any of Examples 94-103), wherein forming the suture route includes forming the multiple entry and exit stitches and the multiple loops by: extending the suture over the first side of the leaflet in a direction parallel to the tip edge and extending the suture through the tip edge portion to the second side of the leaflet opposite to the first side, thereby forming a first entry and exit stitch across the first side; extending the suture across the second side of the leaflet toward the tip edge, over the tip edge and returning to the first entry and exit stitch across the first side, thereby forming a first loop; and delivering the suture back through the tip edge portion to the second side and across the second side in a direction parallel to the tip edge, thereby forming a second entry and exit stitch across the second side, and wherein the method for forming the suture route is repeated in an alternating manner across the first and second sides of the leaflet to form the multiple entry and exit stitches and the multiple loops of the suture route.

[0338] Example 105. A method according to any of the examples herein (particularly any of Examples 94-104), wherein the leaflet includes opposing commissure tabs disposed on opposite ends of the outflow edge of the leaflet, and wherein the tip edge portion extends and bends between the opposing commissure tabs and forms the inflow edge of the leaflet.

[0339] Example 106. A method according to any of the examples herein (particularly Example 105), wherein the prosthetic heart valve includes a plurality of leaflets, and wherein the method includes forming the suture route along the tip edge portion of each of the plurality of leaflets and attaching the tip edge portion of each leaflet to the target component.

[0340] Example 107. The method according to any of the examples herein (particularly Example 106) further includes: for each pair of adjacent commissure tabs of two adjacent leaflets, fixing the pair of adjacent commissure tabs together to form a commissure, and attaching the commissure to the commissure support portion of the frame.

[0341] Example 108. A prosthetic heart valve, comprising: an annular frame, the annular frame including a plurality of interconnected struts between an inflow end and an outflow end of the frame, the plurality of interconnected struts being arranged into a plurality of circumferentially extending rows of angled struts; a plurality of leaflets, the plurality of leaflets being disposed on an interior of the frame, wherein each leaflet includes a tip edge portion extending between opposite side portions disposed on opposite ends of an outflow edge of the leaflet, and wherein the tip edge portion is attached to a portion of the angled struts in the plurality of circumferentially extending rows of angled struts by a suture route formed along the tip edge portion, the suture route comprising: a plurality of entry and exit stitches extending along the The tip edge portion extends parallel to the free tip edge of the tip edge portion but spaced apart from the free tip edge; and a plurality of looped stitches, the plurality of looped stitches being spaced apart from each other in the direction of the plurality of in-and-out stitches, wherein each looped stitch forms a loop around the tip edge and extends between the intersection of the tip edge and corresponding two adjacent in-and-out stitches of the plurality of in-and-out stitches; and a plurality of lock stitches, the plurality of lock stitches extending through the plurality of looped stitches and around the portion of the angled strut or around one or more stitches extending around the portion of the angled strut, so that the tip edge is coupled to the portion of the angled strut and is gathered against the portion of the angled strut.

[0342] Example 109. A prosthetic heart valve according to any of the examples described herein (particularly Example 108), wherein the opposing side portions of each leaflet are opposing commissure tabs, and wherein the commissure tabs of each leaflet are paired with adjacent commissure tabs of adjacent leaflets to form a commissure that is fixed to a commissure support portion of the frame.

[0343] Example 110. A prosthetic heart valve according to any of the examples herein (particularly Example 109), wherein the portion of the angled strut to which the tip edge portion 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, and wherein the first commissure support portion and the second commissure support portion are disposed adjacent to the outflow end of the frame.

[0344] Example 111. The prosthetic heart valve according to any of the examples herein (particularly any of Examples 108-110) further includes an outer skirt arranged around the outer surface of the frame.

[0345] Example 112. A prosthetic heart valve according to any of the examples herein (particularly any of Examples 108-111), wherein the plurality of entry and exit traces include a first entry and exit trace extending along the tip edge portion, and wherein each first entry and exit trace extends between a corresponding pair of adjacent annular traces of the plurality of annular traces.

[0346] Example 113. A prosthetic heart valve according to any of the examples herein (particularly Example 112), wherein the multiple entry and exit stitches also include a second pass of second entry and exit stitches extending along the tip edge portion, wherein each second entry and exit stitch extends between a corresponding pair of adjacent annular stitches, and wherein the second entry and exit stitches alternate with the first entry and exit stitches so that the first entry and exit stitches and the second entry and exit stitches extend across opposite sides of the leaflet between each corresponding pair of adjacent annular stitches.

[0347] Example 114. A prosthetic heart valve according to any of the Examples herein, in particular any of Examples 108-113, wherein the annular traces of the plurality of annular traces are spaced apart from one another in a direction parallel to the tip edge.

[0348] Example 115. A prosthetic heart valve according to any of the examples herein, in particular any of Examples 108-114, wherein the plurality of entry and exit traces are spaced apart from the tip edge by a distance extending perpendicular to the outflow edge.

[0349] Example 116. A prosthetic heart valve according to any of the examples herein (particularly Example 115), wherein the distance is equal to the length of each of the plurality of annular traces.

[0350] Example 117. A prosthetic heart valve according to any of the Examples herein (in particular any of Examples 108-116), wherein each annular stitch has a first portion extending along a first side of the leaflet between the tip edge and the intersection of the corresponding two adjacent entry and exit stitches and a second portion extending along an opposite second side of the leaflet.

[0351] Example 118. A prosthetic heart valve, comprising: an annular frame, the annular frame including a plurality of interconnected struts between an inflow end and an outflow end of the frame, the plurality of interconnected struts being arranged into a plurality of circumferentially extending angled strut rows; an inner skirt, the inner skirt being configured to be fixed to a portion of the angled struts of the plurality of circumferentially extending angled strut rows on an inner side of the frame; a plurality of leaflets, the plurality of leaflets being disposed on an interior of the frame, wherein each leaflet includes a tip edge portion extending between opposite side portions disposed on opposite ends of an outflow edge of the leaflet, and wherein the tip edge portion is secured by a suture route formed along the tip edge portion. Attached to the inner skirt, the sewing route includes: a plurality of in-and-out stitches, which extend along the tip edge portion parallel to the free tip edge of the tip edge portion but spaced apart from the free tip edge; and a plurality of loop stitches, which are spaced apart from each other in the direction of the plurality of in-and-out stitches, wherein each loop stitch forms a loop around the tip edge and extends between the intersection of the tip edge and corresponding two adjacent in-and-out stitches of the plurality of in-and-out stitches; and a plurality of lock stitches, which extend through the plurality of loop stitches and through the inner skirt so that the tip edge is coupled to the inner skirt and gathered against the inner skirt.

[0352] Example 119. A prosthetic heart valve according to any of the examples described herein (particularly Example 118), wherein the opposing side portions of each leaflet are opposing commissure tabs, and wherein the commissure tabs of each leaflet are paired with adjacent commissure tabs of adjacent leaflets to form a commissure that is fixed to a commissure support portion of the frame.

[0353] Example 120. A prosthetic heart valve according to any of the examples herein (particularly Example 119), wherein the portion of the angled struts to which the inner skirt 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, and wherein the first commissure support portion and the second commissure support portion are arranged adjacent to the outflow end of the frame.

[0354] Example 121. The prosthetic heart valve according to any of the examples herein (particularly any of Examples 118-120) further includes an outer skirt arranged around the outer surface of the frame.

[0355] Example 122. A prosthetic heart valve according to any of the examples herein (particularly any of Examples 118-121), wherein the plurality of entry and exit traces include a first entry and exit trace extending along the tip edge portion, and wherein each first entry and exit trace extends between a corresponding pair of adjacent annular traces of the plurality of annular traces.

[0356] Example 123. A prosthetic heart valve according to any of the examples described herein (particularly Example 122), wherein the multiple entry and exit stitches also include a second pass of second entry and exit stitches extending along the tip edge portion, wherein each second entry and exit stitch extends between a corresponding pair of adjacent annular stitches, and wherein the second entry and exit stitches alternate with the first entry and exit stitches so that the first entry and exit stitches and the second entry and exit stitches extend across opposite sides of the leaflet between each corresponding pair of adjacent annular stitches.

[0357] Example 124. A prosthetic heart valve according to any of the Examples herein, in particular any of Examples 118-123, wherein the annular traces of the plurality of annular traces are spaced apart from one another in a direction parallel to the tip edge.

[0358] Example 125. A prosthetic heart valve according to any of the examples herein, in particular any of Examples 118-124, wherein the plurality of entry and exit traces are spaced apart from the tip edge by a distance extending perpendicular to the outflow edge.

[0359] Example 126. A prosthetic heart valve according to any of the examples herein (particularly Example 125), wherein the distance is equal to the length of each of the plurality of annular traces.

[0360] Example 127. A prosthetic heart valve according to any of the Examples herein (in particular any of Examples 118-126), wherein each annular stitch has a first portion extending along a first side of the leaflet between the tip edge and the intersection of the corresponding two adjacent entry and exit stitches and a second portion extending along an opposite second side of the leaflet.

[0361] Example 128. A method comprising: forming a suture route along an edge portion of a first component for a prosthetic heart valve, the suture route having a plurality of entry and exit stitches and a plurality of rings, the plurality of entry and exit stitches extending along the edge portion and spaced apart from an outermost edge of the edge portion, the plurality of rings spaced apart from one another in the direction of the entry and exit stitches, wherein each ring encircles the edge of the edge portion and extends between the edge and an intersection point of two adjacent entry and exit stitches; and attaching the edge portion to the second component by extending a plurality of lock stitches through the plurality of rings and around or through the second component of the prosthetic heart valve, such that the edge of the edge portion is coupled to the second component and gathered against the second component.

[0362] Example 129. A method according to any of the examples herein (particularly Example 128), wherein the first component is a leaflet of the prosthetic heart valve and the edge portion is a tip edge portion of the leaflet.

[0363] Example 130. A method according to any of the examples herein (particularly Example 129), wherein the second component is a fabric skirt configured to be attached to an inner surface of an annular frame of the prosthetic heart valve.

[0364] Example 131. A method according to any of the examples herein (particularly Example 129), wherein the second component is a strut of an annular frame of the prosthetic heart valve that follows the scalloped line of the tip edge portion.

[0365] Example 132. A method according to any of the examples herein (particularly Example 131), wherein the strut to which the tip edge portion is attached is an angled strut extending from a first connection portion support portion of the frame to an inflow end of the frame and from the inflow end of the frame to a second connection portion support portion of the frame, and wherein the first connection portion support portion and the second connection portion support portion are arranged adjacent to the outflow end of the frame.

[0366] Example 133. A method according to any of the examples herein (particularly Example 131 or Example 132), wherein attaching the edge portion to the second component includes extending the plurality of lockstitch stitches through the plurality of loops and around the struts.

[0367] Example 134. A method according to any of the examples herein (particularly Example 131 or Example 132), wherein attaching the edge portion to the second component includes extending the plurality of lockstitch stitches through the plurality of loops and through or around a suture extending around the strut.

[0368] Example 135. A method according to any of the examples herein (particularly Example 128), wherein the first component is an outer skirt of the prosthetic heart valve, and the edge portion is an outflow edge portion of the outer skirt.

[0369] Example 136. A method according to any of the examples herein (particularly Example 135), wherein the second component is a strut in a circumferentially extending row of struts of an annular frame of the prosthetic heart valve.

[0370] Example 137. A prosthetic heart valve comprising: a frame comprising a plurality of interconnected struts; a plurality of leaflets disposed within the frame and configured to regulate the flow of blood through the frame in one direction, each leaflet comprising a tip edge portion; and at least one suture, a plurality of entry and exit stitches, and a plurality of first stitches, the at least one suture extending along the tip edge portion of at least a first leaflet of the plurality of leaflets, the plurality of entry and exit stitches extending through the suture and the tip edge portion of the first leaflet, the plurality of first stitches extending around selected ones of the plurality of interconnected struts and a portion of the entry and exit stitches to couple the tip edge portion of the first leaflet to the frame.

[0371] Example 138. A prosthetic heart valve according to any of the examples herein (particularly Example 137), wherein the at least one suture includes a first suture and a second suture disposed on opposite sides of the tip edge portion of the first leaflet, and the entry and exit stitches extend through the first suture, the tip edge portion of the first leaflet, and the second suture.

[0372] Example 139. A prosthetic heart valve according to any of the examples herein (particularly Example 137), wherein the at least one suture includes a first suture folded over a first end of the tip edge portion of the first leaflet, wherein a first portion of the first suture extends along a first side of the first leaflet to a second end of the tip edge portion, and a second portion of the first suture extends along an opposite second side of the first leaflet to the second end of the tip edge portion, and wherein the entry and exit stitches extend through the first portion of the first suture, the tip edge portion of the first leaflet, and the second portion of the first suture.

[0373] Example 140. A prosthetic heart valve according to any of the Examples herein, in particular any of Examples 137-139, wherein the first stitch extends between the suture and the plurality of entry and exit stitches without extending through the first leaflet.

[0374] Example 141. A prosthetic heart valve according to any of the examples herein (particularly any of Examples 137-140), further comprising an outer skirt disposed around an outer surface of the frame, and wherein at least a portion of the plurality of first sutures extend through the outer skirt such that the tip edge portion of the first leaflet is coupled to the frame and the outer skirt.

[0375] Example 142. A prosthetic heart valve according to any of the Examples herein, in particular any 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.

[0376] Example 143. A prosthetic heart valve according to any of the Examples herein, in particular any of Examples 137-141, wherein the at least one suture and the plurality of entry and exit stitches are spaced apart from an outer tip edge of the tip edge portion in a direction perpendicular to the tip edge.

[0377] Example 144. A prosthetic heart valve according to any of Examples 1-143, wherein the prosthetic heart valve is sterilized.

[0378] Example 145. A method comprising sterilizing a prosthetic heart valve, device, and / or assembly according to any of the examples.

[0379] Unless otherwise stated, features described herein with respect to any example may be combined with other features described in any one or more of the other examples. 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 or device may be combined with any one or more features of another prosthetic heart valve or device.

[0380] In view of the fact that the principles of the present disclosure can be applied in many possible ways, it should be appreciated that the exemplary configurations depict examples of the disclosed technology and should not be considered to limit the scope of the present disclosure and the claims. Rather, the scope of the claimed subject matter is defined by the appended claims and their equivalents.

Claims

1. A prosthetic heart valve, characterized in that include: 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 disposed closer to an outflow end of the frame than an inflow end; an outer skirt disposed around an outer surface of the frame and comprising an outflow edge portion having a free outflow edge, wherein the outflow edge portion extends circumferentially around the frame and comprises a stitching path comprising: a plurality of inlet and outlet stitches extending along the outflow edge partially parallel to the outflow edge but spaced apart from the outflow edge; and a plurality of looped stitches spaced apart from one another in the direction of the plurality of in-and-out stitches, wherein each looped stitch loops around the outflow edge and extends between the outflow edge and intersection points of corresponding two adjacent in-and-out stitches of the plurality of in-and-out stitches; and A plurality of lock stitches extend through the plurality of annular stitches and around the struts of the first circumferentially extending strut row such that the outflow edge is attached to the strut against a radially outwardly facing surface of the strut.

2. The prosthetic heart valve according to claim 1, characterized in that: Wherein the outflow edge is rougher than a remainder of the outflow edge portion of the outer skirt.

3. The prosthetic heart valve according to claim 1 or claim 2, characterized in that Also included is a plurality of leaflets secured inside the frame, and wherein the plurality of leaflets face the radially inwardly facing surface of the struts.

4. The prosthetic heart valve according to claim 1 or claim 2, characterized in that: Wherein the plurality of circumferentially extending strut rows further comprises a second circumferentially extending strut row defining the outflow end of the frame, and wherein the first circumferentially extending strut row is disposed adjacent to the second circumferentially extending strut row.

5. The prosthetic heart valve according to claim 1 or claim 2, characterized in that: wherein the outer skirt comprises a row of spaced apart apertures extending along the outflow edge portion parallel to the outflow edge but spaced apart from the outflow edge, and wherein the plurality of in and out stitches and the plurality of looped stitches extend through the spaced apart apertures in the row of spaced apart apertures.

6. The prosthetic heart valve according to claim 1 or claim 2, characterized in that: The plurality of inlet and outlet stitches are spaced apart from the outflow edge by a distance extending perpendicular to the outflow edge.

7. The prosthetic heart valve according to claim 6, characterized in that: The distance is in the range of 0.5-2.0 mm.

8. The prosthetic heart valve according to any one of claims 1 to 2 and 7, characterized in that: Wherein the outflow edge portion comprises a plurality of protrusions defining an undulating shape of the outflow edge portion, the undulating shape following a contour of the first circumferentially extending row of struts.

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