Outer skirt for an expandable artificial heart valve

Abstract

An outer skirt for an artificial heart valve is disclosed. As an example, the artificial heart valve can include an annular frame including a plurality of interconnected struts, a plurality of axially extending window struts forming a plurality of cross-linked windows spaced around the frame, and an outer skirt disposed around the outer surface of the frame. The outer skirt can include a first edge portion disposed at a first end of the frame, a second edge portion disposed at an intermediate portion of the frame, and one or more extension portions extending axially from the second edge portion and covering at least a portion of each of the plurality of cross-linked windows of the plurality of cross-linked windows.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 342,269, filed May 16, 2022, which is hereby incorporated by reference in its entirety.

[0002] This disclosure relates to an expandable artificial heart valve that includes an outer skirt for an artificial heart valve.

Background Art

[0003] The human heart can be affected by various valvular diseases. These valvular diseases can cause severe heart dysfunction and may ultimately require either repairing the native valve or replacing the native valve with an artificial valve. Numerous repair devices (e.g., stents) and artificial valves are known, and numerous methods for implanting those devices and valves into the human body are also known. By using percutaneous and minimally invasive surgical approaches in various procedures, artificial medical devices can be delivered to locations within the patient's body that are not easily accessible surgically and to locations where access without surgery is desirable. In one specific example, an artificial heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) to reach the implantation site within the heart. The artificial valve can then be expanded to its functional size, for example, by inflating a balloon to which the artificial valve is attached, or by driving a mechanical actuator that applies an expansion force to the artificial valve, or by deploying the artificial valve from the sheath of the delivery device so that the artificial valve self - expands to its functional size.

[0004] Most expandable artificial heart valves include a cylindrical metal frame, i.e., a stent, that is radially expandable and compressible, and an artificial valve leaflet attached to the inside of the frame. The commissures can be formed by connecting the commissure tabs of adjacent pairs of leaflets to each other and to commissure windows formed within the frame. The artificial heart valve can also include an outer covering or skirt disposed around the outer surface of the frame. In some embodiments, the artificial heart valve can be radially compressed (crimped) onto a delivery device and then advanced through a delivery sheath inserted into a patient's blood vessel using the delivery device. The delivery sheath can provide a path to the target implantation site for the delivery device to pass through. However, in some instances, the pushing force experienced by the user in advancing the delivery device through the delivery sheath can be greater than desired. Thus, improvements to the artificial heart valve that reduce these pushing forces are desirable. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0005] An artificial heart valve, a delivery device, and a method for implanting an artificial heart valve are described herein. In particular, examples of outer covering materials for an artificial heart valve, and methods for making and using such outer skirts are described. The artificial heart valve can include a frame, and a valve tip assembly disposed on the inner surface of the frame. The commissures can be formed by connecting commissure tabs of adjacent pairs of valve tips to each other and to a commissure window formed within the frame. The artificial heart valve can include an outer skirt disposed around the perimeter of the frame and on the outer surface of the frame. The outer skirt can include one or more extension portions that extend axially outwardly from an edge portion of the outer skirt. Each extension portion can be configured to cover at least a portion of a corresponding commissure, thereby reducing the pushing force when advancing a radially compressed artificial heart valve attached to a delivery device through a delivery sheath that extends through a patient's blood vessel toward a target implantation site. Thus, the skirt and artificial heart valve disclosed herein can, among other things, overcome one or more of the deficiencies of typical artificial heart valves and their delivery devices.

[0006] The artificial heart valve can include a frame, and a valve structure coupled to the frame. In addition to these components, the artificial heart valve can further include one or more of the components disclosed herein.

[0007] In some embodiments, the artificial heart valve can include a seal member configured to reduce paravalvular leakage.

[0008] In some embodiments, the seal member can be an outer skirt disposed around the outer surface of the frame, the outer skirt including a first edge portion, a second edge portion disposed in an intermediate portion of the frame disposed between a first end and a second end of the frame, and one or more extension portions extending axially from the second edge portion.

[0009] In some embodiments, the frame can have a plurality of interconnected struts including a plurality of axially extending window struts that form a plurality of intersecting windows spaced around the frame, and one or more extension portions can extend across at least a portion of each of the plurality of intersecting windows.

[0010] In some embodiments, the valve structure can be disposed inside the frame and include a plurality of valve leaflets that are fixed to each other at adjacent ends to form intersections, with each intersection connected to a respective intersection feature of the frame. One or more extension portions can extend axially from a second edge portion, and each extension portion covers at least a portion of a corresponding intersection on the outside of the frame.

[0011] In some embodiments, one or more extension portions include a plurality of extension portions.

[0012] In some embodiments, the outer skirt can include a first stitch line and a second stitch line that extend circumferentially along an inflow portion of the outer skirt including a first edge portion. The first stitch line and the second stitch line are axially spaced from each other and each include a plurality of in-and-out stitches.

[0013] In some embodiments, the artificial heart valve has an annular frame including a plurality of interconnected struts, the plurality of interconnected struts having a plurality of axially extending window struts that form a plurality of intersecting windows spaced around the frame. The artificial heart valve further includes an outer skirt disposed around an outer surface of the frame, the outer skirt including a first edge portion, a second edge portion disposed in an intermediate portion of the frame disposed between a first end and a second end of the frame, and one or more extension portions that extend axially from the second edge portion and across at least a portion of each of the plurality of intersecting windows.

[0014] In some embodiments, the artificial heart valve includes an annular frame having a plurality of commissural features and disposed within the frame, a plurality of valve leaflets that are fixed to each other at adjacent ends to form commissures, and each commissure is connected to a respective commissural feature of the frame. The artificial heart valve further includes an outer skirt disposed around the outer surface of the frame, the outer skirt including a first edge portion, a second edge portion fixed to an intermediate portion of the frame disposed between a first end and a second end of the frame, and a plurality of extension portions extending axially from the second edge portion, each extension portion covering at least a portion of a corresponding commissure external to the frame.

[0015] In some embodiments, the artificial heart valve includes a plurality of interconnected struts, an annular frame having an inflow end and an outflow end, and an outer skirt disposed around the outer surface of the frame. The outer skirt includes an inflow edge portion disposed at the inflow end, an outflow edge portion disposed at an intermediate portion of the frame, a plurality of extension portions extending axially from the outflow edge portion and circumferentially spaced from each other, each extension portion extending toward the outflow end of the frame, and a first stitch line and a second stitch line extending circumferentially along an inflow portion of the outer skirt including the inflow edge portion. The first stitch line and the second stitch line are axially spaced from each other and each includes a plurality of in-and-out stitches.

[0016] In some embodiments, the artificial heart valve includes an annular frame including a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end portion and an outflow end portion of the frame, the plurality of interconnected struts including a plurality of outflow-side struts defining the outflow end portion and a plurality of inflow-side struts defining the inflow end portion. The artificial heart valve further includes an outer skirt disposed around an outer surface of the frame, the outer skirt including an outflow edge portion disposed at an intermediate portion of the frame, an inflow portion including an inflow edge portion, a first stitch line extending circumferentially along the inflow portion adjacent to the inflow edge portion, and a second stitch line extending circumferentially along the inflow portion adjacent to and axially spaced from the first stitch line. The inflow portion is wound around the plurality of inflow-side struts such that the first stitch line is disposed inside the frame and the second stitch line is disposed outside the frame.

[0017] In some embodiments, the artificial heart valve includes one or more of the components listed in Examples 1-55 below.

[0018] The various innovations in the present disclosure can be used in combination or individually. This summary is provided to introduce, in a simplified form, a selection of the various concepts that are further described in the detailed description below. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The above and other objects, features, and advantages of the present disclosure will become more apparent from the following detailed description, from the claims, and from the accompanying drawings.

Brief Description of the Drawings

[0019]

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[0020] General Considerations For the purposes of this specification, specific aspects, advantages, and novel features in the examples of the present disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects regarding various disclosed examples, alone and in various combinations and sub-combinations thereof. The methods, apparatuses, and systems are not limited to any specific aspect or feature, or combination thereof, and the disclosed examples do not require the presence of any one or more specific advantages or the solution of any problems.

[0021] The operations in some of the disclosed examples are described in a particular sequential order for the sake of presentation, but it should be understood that this mode of description encompasses permutations unless the specific language described below requires a particular order. For example, operations described sequentially may, in some cases, be permuted or may be performed simultaneously. Additionally, for the sake of simplicity, the accompanying drawings may not show all of the various ways in which the disclosed methods may be used in combination with other methods. Additionally, in the description, terms such as "provide" or "achieve" may be used to describe the disclosed methods. These terms are high-level abstractions with respect to the actual operations being performed. The actual operations corresponding to these terms may vary depending on the particular implementation and will be readily recognizable to one of ordinary skill in the art.

[0022] As used in this application and the claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "comprising" means "including." Further, the term "coupled" generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or connected, and does not exclude the presence of intervening elements between the coupled or associated members unless a specific contrary language is provided.

[0023] As used herein, the term "proximal" refers to the position, direction, or portion of the device that is closer to the user and spaced from the implantation site. As used herein, the term "distal" refers to the position, direction, or portion of the device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to an axis extending in the proximal and distal directions, unless otherwise explicitly defined.

[0024] Summary of the Disclosed Technology As introduced above, an artificial heart valve can include valve leaflets that are fixed to each other at their adjacent sides (e.g., commissural tabs) to form commissures that are fixed to the frame of the artificial heart valve. In some embodiments, the commissures can extend through commissure windows within the frame of the artificial heart valve and can then be fixed to the frame struts that form the commissure windows. Thus, a portion of the commissure can extend radially outwardly away from the outer surface of the frame. This can create a stepped or protruding feature external to the artificial heart valve. For delivery to the implantation site, the artificial heart valve is radially compressed around the distal end portion of the delivery device and is then inserted into the patient's blood vessel and navigated through a delivery sheath that extends toward the implantation site. As the delivery device moves through the delivery sheath, the protruding commissures contact the inner wall of the delivery sheath such that the commissures can be folded rearward and / or pressed against the inner wall of the delivery sheath as the radially compressed artificial heart valve is pushed through the delivery sheath. As a result, the pushing force felt by the user when advancing the delivery device through the delivery sheath can increase.

[0025] In this specification, various embodiments of an outer skirt of an artificial heart valve will be described that can be disposed around the outer surface of the artificial heart valve and are configured to form a seal against native tissue during implantation of the artificial heart valve, thereby reducing paravalvular leakage (PVL) through the artificial heart valve when expanded against the natural anatomical structure. The outer skirt described herein can include a vertical (or axial) extension at the outflow end portion of the outer skirt, and the vertical extension can cover at least the inflow end portion of the commissure, thereby facilitating easier advancement of the artificial heart valve through the delivery sheath and thus providing a tapered and smoother surface that can reduce the pushing force felt by the user.

[0026] The artificial valve disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the artificial valve can be crimped onto an implant delivery device in a radially compressed state or held by the implant delivery device while being advanced through the patient's vasculature on the delivery device. The artificial valve can expand to a radially expanded state when the artificial valve reaches the implantation site. It is understood that the artificial valves disclosed herein can be used with various implant delivery devices and can be implanted via various delivery procedures, and those embodiments will be discussed in more detail below.

[0027] FIG. 1 shows an exemplary artificial device (e.g., an artificial heart valve) including a frame, valve leaflets fixed inside the frame, and an outer skirt disposed around the outer surface of the frame. In some embodiments, the frame can include a plurality of interconnected and angled struts at the inflow and outflow ends of the frame, and a vertex region that extends and / or curves between the angled struts, as shown in FIGS. 2 and 3. The artificial device can be advanced through the patient's vasculature to the native heart valve by a delivery device such as the exemplary delivery device shown in FIG. 4.

[0028] In some embodiments, an outer skirt for an artificial heart valve, such as the outer skirts shown in FIGS. 5-7, can be composed of an axially extending extension portion that extends outwardly from the outflow edge portion of the outer skirt. The extension portion can be configured to extend across a portion of the commissure that projects radially outwardly from the commissure window of the frame (as shown in FIG. 9). The extension portion can provide a tapered and / or smoother (or lower friction) surface that covers the inflow portion of the commissure, thereby reducing the pushing force felt by the user as the radially compressed artificial heart valve advances through the delivery sheath via the delivery device.

[0029] In some embodiments, as shown in FIG. 6, the outer skirt can further include two spaced-apart stitch lines that extend circumferentially along the inflow portion of the outer skirt and include a plurality of in-and-out stitches. As shown in FIGS. 7-11, the inflow portion of the outer skirt is wrapped around the inflow end of the frame, and (as shown in FIG. 11) the first stitch line is disposed outside the frame and the second stitch line is disposed inside the frame. The first and second stitches are then fixed together, thereby fixing the outer skirt over and around the inflow end of the frame. As a result, the inflow side struts that define the inflow end of the frame are covered, thereby reducing potential wear of the inflow side struts against the delivery sheath and / or further reducing the pushing force as the artificial heart valve advances through the delivery sheath.

[0030] Embodiments of the disclosed technology Figure 1 shows an artificial heart valve 100 (artificial valve) according to one embodiment. Although all of the artificial valves disclosed herein are configured to be implanted in the native aortic valve annulus, in other embodiments, they can also be configured to be implanted in other native valve annuli of the heart (pulmonary valve, mitral valve, and tricuspid valve). The disclosed artificial valves can also be implanted into blood vessels communicating with the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), or the superior vena cava or inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of the patient. The disclosed artificial valves can also be implanted within a previously implanted artificial valve (which can be an artificial surgical valve or an artificial transcatheter heart valve) in a valve - in - valve procedure.

[0031] In some embodiments, the disclosed artificial valve can be implanted within a docking device or an anchor device that is implanted within a native heart valve or blood vessel. For example, in one embodiment, the disclosed artificial valve can be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in U.S. Patent Application Publication No. 2017 / 0231756, which is incorporated herein by reference. In another embodiment, the disclosed artificial valve can be implanted within a docking device implanted within or into the native mitral valve, as disclosed in, for example, International Publication No. 2020 / 247907, which is incorporated herein by reference. In another embodiment, the disclosed artificial valve may be implanted within a docking device implanted within the superior vena cava or inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in, for example, U.S. Patent Application Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0032] The artificial heart valve 100 can include a stent or frame 102, a valve structure 104, and an outer seal member or outer skirt 106 around the valve. The artificial 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 inside the frame 102, and the outer skirt 106 is disposed around the outer surface of the frame 102.

[0033] The valve structure 104 can include a plurality of valve leaflets 112 (e.g., three valve leaflets as shown in FIG. 1) that collectively form a valve leaflet structure that can be arranged to collapse in a tricuspid configuration. The valve leaflets 112 can be fixed to each other at adjacent sides (e.g., commissural tabs) to form a commissure 114 of the valve structure 104. For example, each valve leaflet 112 can include an opposing commissural tab disposed on the opposite side of each valve leaflet 112, and a pointed edge portion extending between the opposing commissural tabs. The pointed edge portion of the valve leaflet 112 can have a scalloped shape with undulations and can be fixed directly to the frame 102 (e.g., by suture). However, in an alternative embodiment, the pointed edge portion of the valve leaflet 112 can be fixed to an inner skirt, and then the inner skirt can be fixed to the frame 102. In some embodiments, the valve leaflets 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.

[0034] In some embodiments, the outer skirt 106 can be an annular skirt. In some examples, the skirt 106 can include one or more skirt portions that are connected together and / or individually to the frame 102. The outer skirt 106 can include a woven or polymeric material such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc. In some examples, as shown in FIG. 1, instead of having a relatively straight upper edge portion, the outer skirt 106 can have a wavy upper edge portion that extends along and is fixed to the angled struts 134. Such outer skirts, and various other outer skirt examples that can be used with the frame 102, can be found in the provisional patent application of Attorney Edward Docket No. 12131US01, which is incorporated herein by reference.

[0035] The frame 102 can be radially compressible and expandable between a radially compressed configuration and a radially expanded configuration (the expanded configuration is shown in FIG. 1). The frame 102 is shown alone in FIG. 2, and a portion of the frame 102 in a straight (non-annular) configuration is shown in FIG. 3.

[0036] The frame 102 can be formed from any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol). When constructed from a plastically expandable material, the frame 102 (and thus the valve 100) can be crimped in 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 constructed from a self-expandable material, the frame 102 (and thus the valve 100) can be crimped into a radially compressed state and constrained in the compressed state by insertion into the sheath of a delivery catheter or an equivalent mechanism. After being introduced into the body, the valve can be advanced out of the delivery sheath, whereby the valve can expand to its functional size.

[0037] Suitable plastically expandable materials that can be used to form the frame 102 include metal alloys, polymers, or combinations thereof. Exemplary metal alloys can include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some embodiments, the frame 102 can include stainless steel. In some embodiments, the frame 102 can include cobalt-chromium. In some embodiments, the frame 102 can include nickel-cobalt-chromium. In some embodiments, the frame 102 includes a nickel-cobalt-chromium-molybdenum alloy such as MP35N (trademark) (a trade name of SPS Technologies), which is equivalent to UNS R30035 (coated by ASTM F562-02). MP35N (trademark) / UNS R30035 includes 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium, and 10 wt% molybdenum.

[0038] As shown in FIGS. 2 and 3, the frame 102 can 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 embodiments, as shown in FIGS. 2 and 3, the frame 102 is composed of three rows of cells 118, and the cells 120 of the first row (the upper side in the direction shown in FIGS. 2 and 3) are disposed at the outflow end 110. The cells 120 of the first row include cells 118 that are axially elongated (with respect to the central longitudinal axis 122 of the frame 102) compared to the cells 118 of the cells of the remaining rows. For example, the cells 118 of the cells 120 of the first row can have an axial length 124 (FIG. 3) that is longer than that of the cells 118 of the remaining rows, and the cells of the remaining rows include the cells 126 of the second row and the cells 128 of the third row. The cells 128 of the third row are disposed at the inflow end 108, and the cells 126 of the second row are disposed between the cells 120 of the first row and the cells 128 of the third row.

[0039] In some embodiments, as shown in FIG. 2, each column of cells includes nine cells 118. Thus, in such embodiments, the frame 102 can be referred to as nine cell frames.

[0040] In alternative embodiments, the frame 102 can include four or more columns of cells (e.g., four or five columns), and / or can include ten or more cells or eight or fewer cells per column. In some embodiments, the cells 118 within the cells 120 of the first column may not be elongated as compared to the cells 118 within the cells of the remaining columns of the frame 102 (the cells 126 of the second column and the cells 128 of the third column).

[0041] The interconnected struts 116 can include a plurality of angled struts 130, 132, 134, and 136 arranged in a plurality of circumferentially extending rows, and these 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 can include a first row of angled struts 130 that are arranged end-to-end at the inflow end 108 of the frame and extend circumferentially, a second row of angled struts 132 that extend circumferentially, a third row of angled struts 134 that extend circumferentially, and a fourth row of angled struts 136 that extend circumferentially at the outflow end 110 of the frame 102. The fourth row of angled struts 136 can 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 axially (e.g., axially extending) struts 140. The axially extending window struts 138 (which are also referred to as shaft struts including cross-linked windows) are circumferentially spaced apart from each other around the frame 102 and define a cross-linked window (e.g., an open window) 142 that is adapted to receive a pair of cross-linked tabs of a pair of adjacent valve leaflets 112 arranged in cross-linking (e.g., the cross-linking 114 shown in FIG. 1). In some embodiments, the cross-linked window 142 and / or the axially extending window struts 138 that define the cross-linked window 142 can be referred to herein as cross-linking features or cross-linking supports, and each cross-linking feature or support is configured to receive and / or be fixed to a pair of cross-linked tabs of a pair of adjacent valve leaflets.

[0042] One or more (e.g., two as shown in FIGS. 2 and 3) axial struts 140 can be circumferentially positioned between two cross-linked windows 142 formed by the window struts 138. The frame 102 can include fewer cells per row (e.g., nine) and fewer axial struts 140 between each cross-linked window 142 compared to a conventional artificial heart valve, so that each cell 118 can increase in width (circumferentially), thereby providing a larger opening for blood flow and / or access to the coronary arteries.

[0043] Each axial strut 140 and each window strut 138 extend from a position defined by the convergence of the lower ends (e.g., the ends disposed inwardly of the outflow end 110 and farthest from the outflow end 110) of two angled struts 136 (which may also be referred to as upper strut joints or upper elongated strut joints) to another position defined by the convergence of the (e.g., the ends disposed closer to the outflow end 110) of two angled struts 134 (which may also be referred to as lower strut joints or lower elongated strut joints). Each axial strut 140 and each window strut 138 form the axial sides of two adjacent cells in the first row of cells 120.

[0044] In some embodiments, as shown in FIG. 3, each axial strut 140 can have a greater width 144 (FIG. 3) compared to the widths of the angled struts 130, 132, 134, and 136. As used herein, the "width" of a strut is measured between opposing positions on opposing surfaces of the strut that extend between the radially opposed inner and outer surfaces of the strut (with respect to the central longitudinal axis 122 of the frame 102). The "thickness" of a strut is measured between opposing positions on the radially opposed inner and outer surfaces of the strut and is perpendicular to the width of the strut. In some embodiments, the width 144 of the axial strut 140 is 50% to 200%, 75% to 150%, or at least 100% greater (e.g., twice as large) compared to the width of the angled struts of the frame 102.

[0045] By providing an axial strut 140 having a greater width 144 than the widths of the other angled struts of the frame 102, a larger contact area is provided when the valve tip 112 contacts the wider axial strut 140 during systole, thereby reducing the degree to which stress is distributed and the valve tip 112 can be folded radially outwardly onto the axial strut 140 through the cell 118. As a result, the long-term durability of the valve tip 112 can be increased.

[0046] The cells 118 of the frame 102 can have a relatively large width compared to alternative prosthetic valves having more than nine cells per column (as introduced above), so that the wider axial struts 140 can be more easily incorporated within the frame 102 without sacrificing open space for blood flow and / or coronary access.

[0047] By securing together the commissural tabs 115 of adjacent valve leaflets 112, commissures 114 can be formed (Figure 1). Each commissure 114 of the prosthetic heart valve 100 includes a pair of commissural tabs 115 that extend one each from two adjacent valve leaflets 112 through the commissure window 142 of the frame 102. Each commissure 114 can be secured to the window struts 138 that form the commissure window 142.

[0048] The pointed edge portion (e.g., scalloped edge) of each valve leaflet 112 can be secured to the frame 102 via one or more fastening members (e.g., sutures). In some embodiments, the pointed edge portion of each valve leaflet 112 can be secured directly to struts of the frame 102 (e.g., angled struts 130, 132, and 134). For example, the pointed edge portion of the valve leaflet 112 can be sutured to angled struts 130, 132, and 134 that generally follow the contour of the pointed edge portion of the valve leaflet 112.

[0049] In some embodiments, the pointed edge portion of the valve leaflet 112 can be secured to the inner skirt, and the inner skirt can be secured directly to the frame 102.

[0050] Various methods for securing valve leaflets 112 to a frame such as frame 102 are disclosed in U.S. Provisional Patent Application No. 63 / 278,922, filed November 12, 2021, and 63 / 300,302, filed January 18, 2022, both of which are incorporated herein by reference.

[0051] As shown in FIGS. 2 and 3, in some embodiments, one or each of the axial struts 140 can include an enlarged inflow end portion 146 (e.g., the end closest to the inflow end 108) and an outflow end portion 148 that are wider relative to the intermediate portion 150 (which can be defined by the width 144) of the axial strut 140. In some examples, the inflow end portion 146 of the axial strut 140 can include an opening 147. The opening 147 can be configured to receive a fastening member (e.g., a suture) for attaching a soft component of the artificial heart valve 100 to the frame 102. For example, in some examples, the outer skirt 106 can be positioned around the outer surface of the frame 102, and an upper or outflow edge portion of the outer skirt 106 can be fixed to the opening 147 by a fastening member 149 (e.g., a suture) as shown in FIG. 1.

[0052] The frame 102 can further include a plurality of vertex regions 152 formed at the inflow end 108 and the outflow end 110, and each vertex region 152 extends between two angled struts 130 of the inflow end 108 or two angled struts 136 of the outflow end 110 to form a junction. In this way, the vertex regions 152 are circumferentially spaced apart from each other at the inflow end 108 and the outflow end 110.

[0053] Each vertex region 152 can include a vertex 154 (the point that is highest axially or extends most outwardly) and two thin (or narrowed) strut portions 156, and one thin strut portion 156 extends from both sides of the vertex 154 to the corresponding wide angled strut 136 (outflow end 110) or angled strut 130 (inflow end 108) of the corresponding width (FIG. 3). In this way, each vertex region 152 of the outflow end 110 can form a narrowed transition region between and relative to two angled struts 136 extending from the corresponding vertex region 152, and each vertex region 152 of the inflow end 108 can form a narrowed transition region between and relative to two angled struts 130 extending from the corresponding vertex region 152.

[0054] The thin support column portion 156 of the vertex region 152 may have a width 158 that is smaller than the width 160 of the angled support columns 130 or 136 (FIG. 3). In some embodiments, the width 158 can be a uniform width (e.g., along the entire length of the support column portion 156). In some embodiments, the width 158 of the thin support column portion 156 can be approximately 0.06 to 0.15 mm smaller than the width 160 of the angled support columns 130 and / or 136.

[0055] The thin support column portion 156 of the vertex region 152 may have a first length 162 (FIG. 3). In some embodiments, the first length 162 ranges from 0.8 to 1.4 mm, 0.9 to 1.2 mm, 0.95 to 1.05 mm, or about 1.0 mm (e.g., ±0.03 mm). In alternative embodiments, the first length 162 ranges from 0.3 to 0.7 mm, 0.4 to 0.6 mm, 0.45 to 0.55 mm, or about 0.5 mm (e.g., ±0.03 mm).

[0056] Thus, each outflow vertex region 152 can include two thin support column portions 156 having a first length 162, and each support column portion 156 extends outwardly from the vertex 154 with respect to the central longitudinal axis 164 of the cell 118. Thus, the total length of the vertex region 152 can be twice the first length 162.

[0057] The corresponding two angled support columns 136 of each vertex region 152 and the outflow end 110 can form an outflow side support 166, and the corresponding two angled support columns 130 of each vertex region 152 and the inflow end 108 can form an inflow side support 168.

[0058] Each outflow-side support column 166 and inflow-side support column 168 may have a length including the apex region 152 and two angled support columns 136 or 130 (or support column portions) respectively on both sides of the apex region 152. In FIG. 3, half of the total length of the outflow-side support column 166 and inflow-side support column 168 is shown as length 170, and the length 170 extends from the end of one angled support column 136 or 130 to the central longitudinal axis 164. Thus, the length of each outflow-side support column 166 and each inflow-side support column 168 is twice the length 170. In some embodiments, half of the length 170 of each inflow-side support column 168 may be different from half of the length 170 of each outflow-side support column 166.

[0059] In some examples, the length of each thin-walled support column portion 156 may be at least 25% of the length 170 of the corresponding half of the outflow-side support column 166 or inflow-side support column 168. In other words, the length of each apex region 152 (the total length is twice the first length 162) may be at least 25% of the total length of the outflow-side support column 166 or inflow-side support column 168 (twice the length 170). In some embodiments, the length of each apex region 152 may be more than 25%, for example, 25 - 35% of the total length of the corresponding outflow-side support column 166 or inflow-side support column 168.

[0060] In some embodiments, each apex region 152 may include a curved, axially facing outer surface 172 and an arcuate or curved, axially facing inner recess 174 forming the thin-walled support column portion 156. For example, the curved inner recess 174 may be recessed from the inner surface of the angled support column portion 156 towards the curved outer surface 172, thereby forming a thin-walled support column portion 156 with a smaller width. Thus, the curved inner recess 174 can be formed on the cell side of the apex region 152 (e.g., as opposed to the outside of the apex region 152).

[0061] In some embodiments, the curved outer surface 172 of each apex region 152 can form a single continuous curve from an angled support column portion 156 on one side of the apex region 152 to another angled support column portion 156 on the opposite second side of the apex region 152.

[0062] Each vertex region 152 may have a radius of curvature 176 along the curved outer surface 172 (e.g., in some examples, along the entire or full length of the curved outer surface 172) (FIG. 3). In some examples, the radius of curvature 176 at the vertex 154 and / or along the curved outer surface 172 of the vertex region 152 may exceed 1 mm. In some examples, the radius of curvature 176 may be in the range of 1 mm to 20 mm, 3 mm to 16 mm, or 8 mm to 14 mm. In some examples, the radius of curvature 176 may exceed 10 mm. The radius of curvature 176 can depend on the width 158 of the thin-walled strut portion 156 (e.g., the amount of reduction in width from the angled strut portions 130 or 136) and the first length 162 (and thus can vary due to changes in those width and length).

[0063] Furthermore, the height (axial height) 178 of the vertex region 152 that can be defined axially from the outer surfaces of the two angled struts 130 or 136 to the curved outer surface 172 of the vertex region 152 at the vertex 414 may be the width 158 of the thin-walled strut portion 156 (FIG. 3). In this way, the height 178 of the vertex region 152 can be relatively small and may not add much height to the overall axial height of the radially expanded frame 102. Thus, the valve tip 112 (FIG. 1) fixed to the frame 102 can be disposed in a closed manner with respect 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 valve tip 112.

[0064] In some embodiments, each vertex region 152 can form an angle 180 between two angled struts 130 or 136 extending from both sides of the corresponding vertex region 152 (FIG. 3). In some examples, the angle 180 can be in the range of 120 degrees (excluding this value) to 140 degrees (e.g., such that the angle 180 is greater than 120 degrees and less than or equal to 140 degrees).

[0065] Further details and examples of the frame of the artificial heart valve including the apex region can be found in U.S. Provisional Patent Application Nos. 63 / 178,416, filed April 22, 2021, 63 / 194,830, filed May 28, 2021, and 63 / 279,096, filed November 13, 2021, all of which are incorporated herein by reference.

[0066] FIG. 4 shows a delivery device 200 according to an example that can be used to implant an expandable artificial heart valve (e.g., the artificial heart valve 100 of FIG. 1 and / or any other artificial heart valve described herein). In some embodiments, the delivery device 200 is specifically configured for use in introducing the artificial valve into the heart.

[0067] The delivery device 200 in the embodiment illustrated in FIG. 4 is a balloon catheter that includes a handle 202 and a steerable outer shaft 204 that extends distally from the handle 202. The delivery device 200 can further include an intermediate shaft 206 (which can also be referred to as a balloon shaft) that extends proximally and distally from the handle 202, and the portion that extends distally from the handle 202 also extends coaxially through the outer shaft 204. Additionally, the delivery device 200 can further include an inner shaft 208 that extends distally from the handle 202 coaxially through the intermediate shaft 206 and the outer shaft 204, and proximally from the handle 202 coaxially through the intermediate shaft 206.

[0068] The outer shaft 204 and the intermediate shaft 206 can be configured to translate (e.g., move) longitudinally relative to each other along the central longitudinal axis 220 of the delivery device 200 to facilitate delivering and positioning the artificial valve at the implantation site within the patient's body.

[0069] The intermediate shaft 206 can include a proximal end portion 210 that extends proximally from the proximal end portion of the handle 202 to the adapter 212. A rotatable knob 214 can be attached to the proximal end portion 210 and configured to rotate the intermediate shaft 206 relative to the outer shaft 204 about the central longitudinal axis 220.

[0070] The adapter 212 can include a first port 238 configured to receive a guide wire therethrough and a second port 240 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 240 can be fluidly coupled to the inner lumen of the intermediate shaft 206.

[0071] The intermediate shaft 206 can further include a distal end portion that extends distally beyond the distal end of the outer shaft 204 when the distal end of the outer shaft 204 is positioned spaced apart from the inflatable balloon 218 of the delivery device 200. The distal end portion of the inner shaft 208 can extend distally beyond the distal end portion of the intermediate shaft 206.

[0072] The balloon 218 can be coupled to the distal end portion of the intermediate shaft 206.

[0073] In some embodiments, the distal end of balloon 218 can be connected to the distal end of delivery device 200, such as nose cone 222 (as shown in FIG. 4), or to a replacement part at the distal end (e.g., distal shoulder) of delivery device 200. The intermediate portion of balloon 218 can cover the valve attachment portion 224 of the distal end portion of delivery device 200, and the distal end portion of balloon 218 can cover the distal shoulder 226 of delivery device 200. The valve attachment portion 224 and the intermediate portion of balloon 218 can be configured to receive an artificial heart valve in a radially compressed state. For example, as schematically shown in FIG. 4, an artificial heart valve 250 (which can be one of the artificial valves described herein) can be attached around balloon 218 at the valve attachment portion 224 of delivery device 200.

[0074] The balloon shoulder assembly, including distal shoulder 226, is configured to maintain artificial heart valve 250 (or other medical device) at a fixed position on balloon 218 during delivery through the patient's vasculature.

[0075] Outer shaft 204 can include a distal tip portion 228 attached on its distal end. Outer shaft 204 and intermediate shaft 206 can be axially translated relative to each other such that distal tip portion 228 is positioned adjacent to the proximal end of valve attachment portion 224 when artificial valve 250 is attached in a radially compressed state on valve attachment portion 224 (as shown in FIG. 4) and when delivering the artificial valve to the target implantation site. In this way, distal tip portion 228 can be configured to resist axial, proximal movement of artificial valve 250 relative to balloon 218 when distal tip portion 228 is disposed adjacent to the proximal side of valve attachment portion 224.

[0076] An annular space can be defined between the outer surface of the inner shaft 208 and the inner surface of the intermediate shaft 206, and this annular space can be configured to receive fluid from a fluid source via the second port 240 of the adapter 212. The annular space can be fluidly coupled to a fluid passage formed between the outer surface of the distal end portion of the inner shaft 208 and the inner surface of the balloon 218. Thus, fluid from the fluid source can flow from the annular space into the fluid passage, thereby expanding the balloon 218 and radially expanding and deploying the prosthetic valve 250.

[0077] The inner lumen of the inner shaft can be configured to receive a guidewire therethrough for navigating the distal end portion of the delivery device 200 to a target implantation site.

[0078] The handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 200. In the illustrated example, for instance, the handle 202 includes an adjustment member such as the illustrated rotatable knob 260, which is operably coupled to the proximal end portion of a tension wire. The tension wire can extend distally from the handle 202 through the outer shaft 204 and has a distal end portion fixed to the outer shaft 204 at or near the distal end of the outer shaft 204. By rotating the knob 260, the tension of the tension wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 200. Further details regarding the steering or bending mechanism in the delivery device can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0079] The handle 202 can further include an adjustment mechanism 261 that includes an adjustment member such as the illustrated rotatable knob 262, and a related locking mechanism that includes another adjustment member configured as a rotatable knob 278. The adjustment mechanism 261 is configured to adjust the axial position of the intermediate shaft 206 relative to the outer shaft 204 (e.g., for fine positioning at the implantation site). Further details regarding the delivery device 200 can be found in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference.

[0080] As introduced above, the commissures formed in the valve leaflet assembly can extend through the commissure window within the frame of the prosthetic heart valve, such that a portion of the commissure will extend radially outwardly from the outer surface of the frame (e.g., as shown in FIG. 1 for commissure 114). The inventors herein have recognized that this can form a stepped protrusion feature that can contact the inner wall of the delivery sheath through which the delivery device is navigated on its way to the implantation site, outside of the radially compressed prosthetic heart valve. For example, the delivery sheath can be inserted into a patient's blood vessel and extend into the patient's heart towards the implantation site, and then the delivery device, with the prosthetic heart valve mounted thereon in a radially compressed configuration, can be navigated through the interior of the delivery sheath to the implantation site. As the delivery device moves through the delivery sheath, the protruding commissure contacts the inner wall of the delivery sheath, such that the commissure can be folded rearwardly as the radially compressed prosthetic heart valve is pushed through the delivery sheath. As a result, the pushing force felt by the user when navigating the delivery device through the delivery sheath can be greater than desired.

[0081] In some embodiments, the outer skirt for an artificial heart valve (e.g., artificial heart valve 100) can include one or more axially extending (or perpendicular) extensions or extension portions configured to extend over and cover a portion of the commissure of the artificial heart valve. The extension portions of the outer skirt can slide more easily (e.g., with reduced friction) relative to the delivery sheath as the radially compressed artificial heart valve advances toward the implantation site through the delivery sheath using a delivery device, and / or can be configured to prevent folding of the commissure. As a result, the pushing force felt by the user when advancing the delivery device through the delivery sheath can be reduced.

[0082] FIG. 5 shows an example of a flat configuration of an outer skirt 300 of an artificial device such as the artificial heart valve 100 of FIG. 1. As will be described in more detail below, the outer skirt 300 can include one or more extension portions (three shown in FIG. 5) that extend outwardly from an outflow edge portion of the outer skirt 300 configured to at least partially cover the commissure of the artificial heart valve. The outer skirt 300 can be used with mechanically expandable artificial valves, balloon-expandable artificial valves (e.g., the artificial heart valve 100 of FIG. 1), and / or self-expandable artificial valves. Further details regarding balloon-expandable artificial valves can be found in U.S. Patent No. 9,393,110, U.S. Provisional Patent Application No. 63 / 178,416, filed April 22, 2021, U.S. Provisional Patent Application No. 63 / 194,830, filed May 28, 2021, and U.S. Provisional Patent Application No. 63 / 279,096, filed November 13, 2021, which are hereby incorporated by reference herein. Further details regarding mechanically expandable artificial valves can be found in International Application PCT / US2021 / 052745, filed September 30, 2021, which is hereby incorporated by reference herein. Further details regarding self-expandable artificial valves can be found in U.S. Patent No. 8,652,202, which is hereby incorporated by reference herein.

[0083] The outer skirt 300 can be wound and attached around the outer surface of the frame of the artificial device (the radially outward-facing surface with respect to the central longitudinal axis of the artificial device), thereby transitioning to an annular configuration (e.g., as shown in FIG. 7). As an example, the outer skirt 300 is shown disposed around and fixed to the outer surface of the frame 102 (FIGS. 7-11).

[0084] As shown in FIG. 5, the outer skirt 300 can include opposing first and second edge portions 302, 304 (which may also be referred to as short edges or short edge portions), each extending between the outflow edge portion 306 and the inflow edge portion 308 of the outer skirt 300. In some examples, the first and second edge portions 302, 304 can be non-parallel with respect to the central longitudinal axis of the frame of the artificial device (when attached around the frame), and / or non-perpendicular to the outflow edge portion 306. For example, the first and second edge portions 302, 304 can extend at an angle of about 45 degrees (or within the range of 40-50 degrees) with respect to a line extending in the inflow edge portion 306 and / or the circumferential direction of the frame. Thus, the overall general shape of the outer skirt 300 is a rhombus or a parallelogram.

[0085] In some examples, the first and second edge portions 302, 304 can each include a plurality of openings 310 extending therethrough (e.g., openings spaced apart and extending in a row along the first and second edge portions 302, 304). Thus, when the outer skirt 300 is converted to its annular configuration (e.g., when attached around the frame of the artificial device as shown in FIG. 7), the first and second edge portions 302, 304 can overlap each other with their respective openings 310 also overlapping. Then, using suture threads, a plurality of stitches can be formed in an in-and-out pattern through the overlapping openings 310, so that the first and second edge portions 302, 304 are fixed together and the annular configuration of the outer skirt 300 is formed.

[0086] As shown in the detailed view of a portion of the outer skirt 300 in FIGS. 5 and 6, the outer skirt 300 may include one or more extension portions 312 (or flaps) that extend outwardly (axially with respect to the central longitudinal axis of the frame to which the outer skirt 300 is attached) from the outflow edge portion 306 (FIGS. 5 and 6). In some examples, the outer skirt 300 may include a plurality of extension portions 312 (e.g., one for each commissural window of the frame to which the outer skirt 300 is attached) that are spaced apart from each other along the outflow edge portion 306. The spacing between adjacent extension portions 312 may be selected such that when attached to the frame of the artificial heart valve, each extension portion aligns with the commissural window 142 and corresponding commissure of the artificial heart valve (e.g., as shown in FIG. 7).

[0087] Each extension portion 312 may have a width 314 (circumferential) and an axial length 316 (FIG. 6) sized to at least cover the inflow portion of the commissure 114 that extends externally through the commissural window 142 of the frame 102, as shown in the schematic cross-sectional view of FIG. 9. In some embodiments, the width 314 may be specified to cover the width of the commissure (and the commissural tab 115 forms the commissure 114) that extends outwardly from the commissural window 142 (the commissural tab 115 of the commissure 114 shown in FIGS. 1 and 9), or another commissure support or feature of the frame to which the commissure is attached. Thus, the extension portions 312 can be dimensioned to extend over at least the inflow portion of each commissural window 142 and corresponding window strut 138 (or alternative commissure support or feature of the frame), as shown in FIG. 7.

[0088] In some embodiments, the length 316 can be specified to cover the lower half of the inflow portion or junction 114 (as shown in FIG. 9) and / or the junction window 142 (as shown in FIG. 7). In alternative embodiments, the length 316 can be longer than that shown in FIGS. 7 and 9 and can cover a larger portion or the entirety of the junction 114 and / or the junction window 142, thereby covering a larger portion (e.g., more than half) of the junction 114 that extends radially outward from the junction window 142. In yet other embodiments, the length 316 can be specified to cover 25% to 75% or 40% to 60% of the length of the junction 114.

[0089] In some embodiments, the outflow edge portion 306 can be relatively straight (as shown in FIGS. 5-7). However, in alternative embodiments, the outflow edge portion 306 can have a contoured shape as shown in the provisional patent application of Edwards Attorney Docket No. 12131US01, as already referenced above. In such embodiments, the extension portion 312 can extend from the peak of the contoured outflow edge portion.

[0090] As shown in FIG. 9, each extension portion 312 covering the corresponding commissure 114 can form a cover that tapers gradually on the inflow portion of the commissure 114 (e.g., tapers radially of the frame 102). For example, when radially compressed around the distal end of a delivery device (e.g., the delivery device 200 of FIG. 4), the inflow end 108 of the frame can be positioned closest to the distal (or tip) end of the delivery device. Thus, as the delivery device and the radially compressed artificial heart valve advance through the delivery sheath, the direction of the sliding or frictional force from the delivery sheath to the artificial heart valve can be from the inflow end 108 towards the outflow end 110, as indicated by arrow 318 in FIG. 9. By providing a gradual increase in the radial width or thickness from the first portion 320 of the outer skirt 300 covering the intermediate portion of the frame 102 to the extension portion 312 covering the radially projecting commissure 114, the radially compressed artificial heart valve can be advanced more easily through the delivery sheath on the way towards the implantation site. For example, the extension portion 312 can prevent the commissure 114 from being folded back under the pressure from the delivery sheath. As a result, the pushing force felt by the user when advancing the delivery device through the delivery sheath may be reduced.

[0091] The extension portions 312 can be fixed to the respective commissures 114 via one or more fastening members such as one or more sutures 360 (FIG. 9). In some embodiments, as shown in FIG. 6, each extension portion 312 can include one or more apertures 362 passing through the material of the extension portion 312 configured to receive a suture 360 (or alternative fastening member) and to enable the extension portion 312 to be more easily fixed to the commissure 114. As shown in FIG. 6, each extension portion 312 includes two apertures 362. However, in alternative embodiments, the extension portion 312 can include more than three or less than two apertures 362 (e.g., one, three, four, etc.), or the extension portion 312 can include no apertures and instead can be fixed to the commissure 114 by a needle extending through the material of the outer skirt 300 through the piercing material.

[0092] The outer skirt 300 described in this specification can include various synthetic materials, including cloth (e.g., polyethylene terephthalate (PET) cloth or ultra-high molecular weight polyethylene (UHMWPE) cloth), polytetrafluoroethylene (PTFE), thermoplastic polyurethane (TPU), a hybrid material including one or more cloths or polymeric materials (e.g., PET coated with TPU), or autologous tissue (e.g., pericardial tissue). In some embodiments, the material of the outer skirt 300 can be selected to further reduce the friction between the outer skirt 300 and the inner wall of the delivery sheath during the advancement of the prosthetic heart valve radially compressed through the delivery sheath.

[0093] In some embodiments, the outer skirt 300 can include two circumferentially extending stitch lines (or suture lines) adjacent to the inflow edge portion 308, including a first stitch line 322 and a second stitch line 324 (FIG. 6). The first stitch line 322 is disposed adjacent to the inflow edge portion 308 but at an axial position spaced from the inflow edge portion 308, and can include a plurality of in-and-out stitches 326 that extend circumferentially through and along the outer skirt 300 from the first edge portion 302 to the second edge portion 304. The second stitch line 324 is disposed adjacent to the first stitch line 322 but spaced from the first stitch line 322, and at an axial position adjacent to the inflow edge portion 308, and can include a plurality of in-and-out stitches 328 that extend circumferentially through and along the outer skirt 300 from the first edge portion 302 to the second edge portion 304. For example, as shown in FIG. 6, the second stitch line 324 is disposed between the inflow edge portion 308 and the first stitch line 322, and a gap 330 separating the first stitch line 322 and the second stitch line 324 is provided.

[0094] In some embodiments, the first stitch line 322 and the second stitch line 324 can be parallel to each other. In alternative embodiments, the first stitch line 322 and the second stitch line 324 can be non-parallel to each other. For example, in some instances, the gap 330 can be constant between the first stitch line 322 and the second stitch line 324 circumferentially along the outer skirt 300. In alternative instances, the gap 330 can vary along the outer skirt 300, such as being larger at a position aligned with the apex region 152 at the inflow end 108 of the frame 102 (when the outer skirt 300 is attached around the frame 102 as shown in FIG. 7). In such embodiments, a pocket of excess skirt material can be formed between the first stitch line 322 and the second stitch line 324 at the apex region 152, thereby facilitating elongation of the artificial heart valve when the artificial heart valve is radially compressed (e.g., when being crimped onto a delivery device).

[0095] In some instances, as shown in FIGS. 5 and 6, the stitches 326 of the first stitch line 322 can extend through a pre-formed opening 332 (or perforation) of the outer skirt 300 from a first surface 342 (outer surface) to a second surface 344 (inner surface) of the outer skirt 300, and the stitches 328 of the second stitch line 324 can extend through a pre-formed opening 334 (or perforation) of the outer skirt 300. In alternative instances, the stitches 326 of the first stitch line 322 and the stitches 328 of the second stitch line 324 can extend through the material of the outer skirt 300 (thereby forming an opening with a needle, for example).

[0096] As shown in FIGS. 5 and 6, one or both of the first stitch line 322 and the second stitch line 324 can have a wavy shape that generally follows the shape of the inflow side strut 168 of the frame 102 (as shown in FIG. 7).

[0097] As shown in FIG. 7, when the outer skirt 300 is disposed around the outer surface of the frame 102, the inflow portion of the outer skirt 300 including the second stitch line 324 and the inflow edge portion 308 can be wound around the inflow side support 168 (as shown in the schematic cross-sectional view of FIG. 10). In some embodiments, as schematically shown in the detailed cross-sectional view 364 of FIG. 11, the in-and-out stitches 328 of the second stitch line 324 are disposed inside 338 (or inside) the frame 102 (both the first surface 342 and the second surface 344 of the outer skirt 300), and the in-and-out stitches 326 of the first stitch line 322 are disposed outside 340 (or outside) the frame 102 (both the first surface 342 and the second surface 344 of the outer skirt 300), so that the inflow portion of the outer skirt 300 can be wound around the inflow side support 168. In this configuration, due to the gap 330, the first stitch line 322 and the second stitch line 324 can be aligned with each other in the radial direction (e.g., above the inflow side support 168 in FIG. 1). Then, the first stitch line 322 and the second stitch line 324 can be fixed together around the inflow side support 168.

[0098] For example, in some examples, the suture 336 (or other fastening member) can extend through the stitches 326 of the first stitch line 322 and the stitches 328 of the second stitch line 324 disposed on the second surface 344 (inner surface) of the outer skirt 300 (FIG. 11), thereby connecting the first stitch line 322 and the second stitch line 324 around the inflow side support 168 and covering the inflow side support 168 with the material of the outer skirt 300. As shown in FIG. 11, the stitches 326 and 328 are fixed together around the axially inward-facing surface 366 of the inflow side support 168, and the outer skirt 300 can cover the axially outward-facing surface 368, the radially outward-facing surface 370, and the radially inward-facing surface 372 of the inflow side support 168.

[0099] In an alternative embodiment, the suture (or other fastening member) may extend through stitch 326 of first stitch line 322 disposed on second surface 344 of outer skirt 300 and stitch 328 of second stitch line 324 disposed on first surface 342 of outer skirt 300.

[0100] In some embodiments, outer skirt 300 may also include a third stitch line 346 that follows the pointed edge of the valve tip when the valve tip and outer skirt 300 are secured to frame 102. Thus, third stitch line 346 can also be referred to as a scallop stitch line. For example, as shown in FIG. 6, third stitch line 346 may include a plurality of in-and-out stitches 348 that form a wavy pattern between outflow edge portion 306 of outer skirt 300 and first stitch line 322. As shown in FIGS. 6 and 7, third stitch line 346 may have peaks adjacent to extension portion 312 (and crossover window 142) and valleys of first stitch line 322 (thus, in some instances, third stitch line 346 and first stitch line 322 may overlap, intersect, or be formed from the same stitches proximate inflow edge portion 308).

[0101] In some instances, as shown in FIGS. 5 and 6, stitches 348 of third stitch line 346 may extend through pre-formed openings 350 (or perforations) in outer skirt 300. In an alternative instance, stitches 348 of third stitch line 346 may extend through the material of outer skirt 300 (thereby, for example, forming an opening with a needle).

[0102] As shown in FIGS. 6 and 7, in some embodiments, the outer skirt 300 may also include a fourth stitch line 352 that undulates along the outflow portion of the outer skirt 300 (adjacent the outflow edge portion 306) such that when the outer skirt 300 is disposed around the frame 102, the fourth stitch line 352 extends along a third row of angled struts 134 of the angled struts (angled struts connected to the axial struts 140 and the window struts 138). The fourth stitch line 352 may include a plurality of in-and-out stitches 354. In some instances, a portion of the fourth stitch line 352 may overlap, intersect, or be formed from the same stitch as the third stitch line 346 (e.g., along the angled strut 134 extending along the pointed edge of the valve tip or the scallop line).

[0103] In some instances, as shown in FIGS. 5 and 6, the fourth stitch line 352 may extend through a pre-formed opening 356 (or perforation) in the outer skirt 300. In an alternative instance, the stitches 254 of the fourth stitch line 352 may extend through the material of the outer skirt 300 (thereby forming an opening with a needle, for example).

[0104] Fastening members such as whip stitches 358 may be used to secure the outer skirt 300 to the struts of the frame 102 via the stitches of the third stitch line 346 and the fourth stitch line 352 (FIG. 7). For example, as shown in FIG. 7, the whip stitch 358 may extend around the angled struts of the frame 102 and around the stitches 348 and 354 (between the stitches and the material of the outer skirt 300) that extend along the second surface 344 of the outer skirt 300 (which may be the inner surface of the outer skirt 300 disposed opposite the outer surface of the struts of the frame). In this way, the outer skirt 300 can be easily secured to the frame 102 without the whip stitch 358 extending through the material of the outer skirt 300.

[0105] Delivery technology To implant an artificial valve into the native aortic valve via a transfemoral delivery approach, the artificial valve is mounted in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral artery and driven forward through the descending aorta, around the aortic arch, and through the ascending aorta. The artificial valve is positioned inside the native aortic valve and expanded radially (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the artificial valve from the sheath to make the artificial valve self-expanding). Alternatively, the artificial valve can be implanted inside the native aortic valve via a transapical procedure, in which case the artificial valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve is positioned inside the native aortic valve. Alternatively, in a transaortic procedure, the artificial valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, by a partial J sternotomy or a small right parasternal thoracotomy, and driven forward through the ascending aorta towards the native aortic valve.

[0106] To implant an artificial valve into the native mitral valve via a transseptal delivery technique, the artificial valve is mounted in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end of the delivery device are inserted into the femoral vein and advanced through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture performed within the atrial septum), into the left atrium, and towards the native mitral valve. Alternatively, the artificial valve can be implanted inside the native mitral valve via a transapical procedure, in which case the artificial valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve is positioned inside the native mitral valve.

[0107] To implant an artificial valve inside the native tricuspid valve, the artificial valve is attached in a radially compressed state along the distal end of the delivery device. The artificial valve and the distal end of the delivery device are inserted into the femoral vein and advanced into the inferior vena cava and through the inferior vena cava into the right atrium, where the artificial valve is positioned inside the native tricuspid valve. A similar approach can be used to implant an artificial valve inside the native pulmonary valve or the pulmonary artery, except that the artificial valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0108] Another delivery approach is the transatrial approach, where the artificial valve (on the distal end of the delivery device) is inserted through a chest incision that is formed through the atrial wall (the atrial wall of the right atrium or the left atrium) to access any of the native heart valves. Atrial delivery can also be performed intravascularly, for example, from the pulmonary vein. Yet another delivery approach is the transventricular approach, where the artificial valve (on the distal end portion of the delivery device) is inserted through a chest incision that is formed through the wall of the right ventricle (typically at or near the base of the heart) to implant the artificial valve inside the native tricuspid valve or inside the native pulmonary valve or the pulmonary artery.

[0109] In all delivery approaches, the delivery device may be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any artificial valve disclosed herein can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0110] The systems, devices, apparatuses, etc. described in this specification can all be sterilized (e.g., using heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure safety in use with patients, and all the methods described in this specification can include the sterilization of related systems, devices, apparatuses, etc. as one of the steps of the method. Examples of sterilization by heating / heat include sterilization by steam and sterilization by autoclave. Examples of radiation used for sterilization include, but are not limited to, gamma rays, ultraviolet rays, 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 by hydrogen peroxide may be performed, for example, using hydrogen peroxide plasma.

[0111] Additional embodiments of the disclosed technology In view of the above-described implementations of the disclosed subject matter, this application discloses the additional embodiments listed below. It should be noted that one feature separated from one embodiment or two or more features adopted in combination, and optionally, a combination with one or more features of one or more further embodiments, are also further embodiments that fall within the disclosure of this application.

[0112] Example 1. An artificial heart valve comprising an annular frame including a plurality of interconnected struts, the plurality of interconnected struts having a plurality of axially extending window struts that form a plurality of interconnected windows spaced around the frame, and an outer skirt disposed around the outer surface of the frame, the outer skirt including a first edge portion, a second edge portion disposed in an intermediate portion of the frame disposed between a first end portion and a second end portion of the frame, and one or more extension portions extending axially from the second edge portion and covering at least a portion of each of the plurality of interconnected windows.

[0113] Example 2. An artificial heart valve according to any embodiment herein, particularly embodiment 1, wherein a plurality of interconnected struts includes a row extending circumferentially of a first strut defining a first end of the frame, a first edge portion is fixed to the first strut, and a second edge portion is fixed to an intermediate portion of the frame.

[0114] Example 3. An artificial heart valve according to any embodiment herein, particularly embodiment 2, wherein a plurality of interconnected struts includes a row of second struts extending circumferentially defining a second end of the frame, a row of third struts extending circumferentially, a plurality of struts extending axially, and a plurality of window struts extending axially extending between the second struts and the third struts, and a second edge portion is fixed to an end of a strut extending axially of each of a plurality of axially extending struts connected to the third strut.

[0115] Example 4. An artificial heart valve according to any embodiment herein, particularly embodiment 3, wherein a second edge portion is fixed to an opening at an end of a strut extending axially of each of a plurality of axially extending struts connected to the third strut.

[0116] Example 5. An artificial heart valve according to any embodiment herein, particularly either embodiment 3 or embodiment 4, wherein an outer skirt is fixed to a third strut by a plurality of whip stitches extending around the third strut and around a plurality of in-and-out stitches within the outer skirt.

[0117] Example 6. An artificial heart valve according to any embodiment herein, particularly any one of embodiments 2 to 5, wherein an outer skirt is disposed adjacent to a first edge portion and includes two stitch lines spaced apart from each other, each stitch line includes a plurality of in-and-out stitches, and a portion of the outer skirt including the first stitch line of the two stitch lines disposed closest to the first edge portion and the first edge portion is wound around the first strut such that the outer skirt covers the first strut and the two stitch lines are aligned in a radial direction of the frame.

[0118] Example 7. An artificial heart valve according to any example herein, particularly Example 6, wherein two stitch lines are secured together to the axially inward-facing surface of the first strut by a suture thread that is wound around the in-and-out stitches of the two stitch lines.

[0119] Example 8. An artificial heart valve according to any example herein, particularly any one of Examples 1 to 7, wherein the first end is the outflow end of the frame and the second end is the inflow end of the frame.

[0120] Example 9. An artificial heart valve according to any example herein, particularly any one of Examples 1 to 8, further comprising a plurality of valve leaflets disposed within the frame, each valve leaflet of the plurality of valve leaflets including two cross-linking tabs disposed on opposite sides of the valve leaflet and a pointed edge portion extending between the two cross-linking tabs, and the cross-linking tabs of adjacent valve leaflets forming mating cross-links.

[0121] Example 10. An artificial heart valve according to any example herein, particularly Example 9, wherein each cross-link extends through and is fixed to a corresponding cross-linking window such that a portion of the cross-link extends radially outward from the cross-linking window on the exterior of the frame.

[0122] Example 11. An artificial heart valve according to any example herein, particularly Example 10, wherein each extension extends over at least a portion of the corresponding cross-link and covers at least a portion of the corresponding cross-link.

[0123] Example 12. An artificial heart valve according to any example herein, particularly either Example 10 or Example 11, wherein each extension extends over and covers the first half of the corresponding cross-link that is disposed closer to the first end of the frame than the second half of the corresponding cross-link.

[0124] Example 13. An artificial heart valve according to any example herein, particularly any one of Examples 10 to 12, wherein each extension has a width sized to cover the width of the corresponding cross-link and each extension is fixed to the corresponding cross-link.

[0125] Example 14. A plurality of interconnected struts includes a plurality of circumferentially extending rows of angled struts, and an outer skirt includes a stitch line including a plurality of in-and-out stitches having undulations between a first edge portion and a second edge portion, and the outer skirt is fixed to the angled struts along the sharp edge portions of a plurality of valve tips extending around the angled struts and by a plurality of whip stitches extending between the plurality of in-and-out stitches of the stitch line and the material of the outer skirt. An artificial heart valve according to any embodiment herein, particularly any one of Embodiments 9 to 13.

[0126] Example 15. An artificial heart valve comprising an annular frame including a plurality of commissure features, and a plurality of valve tips disposed inside the frame and fixed to each other at adjacent ends to form commissures, each commissure being connected to a respective commissure feature of the frame, the plurality of valve tips, and an outer skirt disposed around the outer surface of the frame, the outer skirt including a first edge portion, a second edge portion fixed to an intermediate portion of the frame disposed between a first end portion and a second end portion of the frame, and a plurality of extension portions axially extending from the second edge portion, each extension portion covering at least a portion of a corresponding commissure on the outside of the frame.

[0127] Example 16. An artificial heart valve according to any embodiment herein, particularly Example 15, wherein each extension portion is formed as a flap having a width and a length sized to cover at least a portion of the width and length of the corresponding commissure.

[0128] Example 17. An artificial heart valve according to any embodiment herein, particularly either Example 15 or Example 16, wherein each commissure projects radially outwardly from a respective commissure feature and the outer surface of the frame such that each extension portion covering the corresponding commissure forms an outer covering of the frame that tapers gradually radially from the extension portion covering the commissure to the second edge portion of the outer skirt.

[0129] Example 18. An artificial heart valve includes three commissures and three extension portions, with a first edge portion fixed to a first end of the frame, the first end being the inflow end of the frame and the second end being the outflow end of the frame, the artificial heart valve according to any example herein, particularly any one of Examples 15 - 17.

[0130] Example 19. An annular frame includes a plurality of interconnected struts, and a plurality of commissure features are axially extending window struts spaced around the frame, each axially extending window strut defining a commissure window, and each commissure extending through and being fixed to the commissure window of the respective axially extending window strut, the artificial heart valve according to any example herein, particularly any one of Examples 15 - 18.

[0131] Example 20. A plurality of interconnected struts define a plurality of rows of cells disposed between a first end and a second end of the frame, and axially extending window struts form an axial side portion of a first row of cells of a plurality of rows of cells disposed at the first end of the frame, the artificial heart valve according to any example herein, particularly Example 19.

[0132] Example 21. The cells of the first row of cells are axially elongated relative to the cells of the remaining rows of cells of the plurality of rows of cells, the artificial heart valve according to any example herein, particularly Example 20.

[0133] Example 22. A plurality of interconnected struts include a circumferentially extending row of a first strut defining a second end of the frame, a circumferentially extending row of a second strut, and a plurality of axial struts, and a plurality of axially extending window struts and the plurality of axial struts extend between the row of the first strut and the row of the second strut, the artificial heart valve according to any example herein, particularly any one of Examples 19 - 21.

[0134] Example 23. An artificial heart valve according to any example herein, particularly Example 22, wherein the second edge portion is fixed to the first end of an axial strut connected to the row of second struts.

[0135] Example 24. An artificial heart valve according to any example herein, particularly Example 23, wherein the first end of each axial strut includes an opening to which the second edge portion is fixed.

[0136] Example 25. An artificial heart valve according to any example herein, particularly any one of Examples 22 - 24, wherein the outer skirt includes a corrugated stitch line including a plurality of in-and-out stitches disposed adjacent to the second edge portion, the outer skirt extends around the second strut, and is fixed to the second strut by a plurality of whip stitches between the plurality of in-and-out stitches and the material of the outer skirt.

[0137] Example 26. An artificial heart valve according to any example herein, particularly any one of Examples 22 - 25, wherein a plurality of interconnected struts includes a row extending circumferentially of a third strut defining a first end of the frame, and the first edge portion is wound around the inner surface of the third strut and disposed on the inner surface of the third strut.

[0138] Example 27. An artificial heart valve according to any example herein, particularly Example 26, wherein the outer skirt includes a first stitch line extending circumferentially including a plurality of in-and-out stitches and a second stitch line extending circumferentially including a plurality of in-and-out stitches, the first stitch line and the second stitch line are axially spaced from each other, and the second stitch line is disposed adjacent to the first edge portion.

[0139] Example 28. An artificial heart valve according to any example herein, particularly Example 27, wherein a first stitch line and a second stitch line are radially aligned with each other such that the material of the outer skirt disposed between the first stitch line and the second stitch line covers the radially inward-facing surface, the radially outward-facing surface, and the axially outward-facing surface of a third strut, and is disposed on both sides of the third strut.

[0140] Example 29. An artificial heart valve according to any example herein, particularly Example 28, wherein a first stitch line and a second stitch line are fixed together on the axially inward-facing surface of a third strut by a suture wound around the in-and-out stitches of the first stitch line and the in-and-out stitches of the second stitch line disposed on the inner surface of the outer skirt.

[0141] Example 30. An artificial heart valve comprising an annular frame including a plurality of interconnected struts and having an inflow end and an outflow end, and an outer skirt disposed around the outer surface of the frame, the outer skirt having an inflow edge portion disposed at the inflow end, an outflow edge portion disposed at an intermediate portion of the frame, and a plurality of extension portions extending axially from the outflow edge portion and spaced circumferentially from each other, each extension portion extending toward the outflow end of the frame, and a first stitch line and a second stitch line extending circumferentially along the inflow portion of the outer skirt including the inflow edge portion, the first stitch line and the second stitch line being axially spaced from each other and each including a plurality of in-and-out stitches, the artificial heart valve having the outer skirt including the first stitch line and the second stitch line.

[0142] Example 31. A plurality of interconnected struts define a plurality of rows of cells disposed between an inflow end and an outflow end, the plurality of interconnected struts including a plurality of axially extending window struts that form a plurality of cross-linked windows spaced around a frame, each extension extending across the inflow portion of a corresponding cross-linked window of the plurality of cross-linked windows, the artificial heart valve according to any embodiment of the present specification, particularly Example 30.

[0143] Example 32. Further including a plurality of valve leaflets disposed inside the frame, each valve leaflet of the plurality of valve leaflets including two cross-linked tabs disposed on the opposite side of the valve leaflet and a pointed edge portion extending between the two cross-linked tabs, the cross-linked tabs of adjacent valve leaflets forming a paired cross-link, the artificial heart valve according to any embodiment of the present specification, particularly Example 31.

[0144] Example 33. Each cross-link extends through a corresponding cross-linked window and is fixed to the corresponding cross-linked window such that a part of the cross-link extends radially outward from the cross-linked window on the outside of the frame, each extension extending across the inflow portion of the corresponding cross-link and covering the inflow portion of the corresponding cross-link, the artificial heart valve according to any embodiment of the present specification, particularly Example 32.

[0145] Example 34. Each extension has a width sized to cover the width of the corresponding cross-link, and each extension is fixed to the corresponding cross-link, the artificial heart valve according to any embodiment of the present specification, particularly Example 33.

[0146] Example 35. The plurality of interconnected struts includes a plurality of circumferentially extending rows of angled struts, the outer skirt including a third stitch line including a plurality of in-and-out stitches that undulate between an inflow edge portion and an outflow edge portion, the outer skirt being fixed to the angled struts along the pointed edge portions of the plurality of valve leaflets that extend by a plurality of whip stitches extending around the angled struts and between the plurality of in-and-out stitches of the stitch line and the material of the outer skirt, the artificial heart valve according to any embodiment of the present specification, particularly any one of Examples 32 to 34.

[0147] Example 36. A plurality of circumferentially extending rows of angled struts include a first row of struts and a second row of struts that define an outflow end, and a plurality of axially extending window struts extend between the first row of struts and the second row of struts, the artificial heart valve according to any example herein, particularly Example 35.

[0148] Example 37. A plurality of interconnected struts extend between the first row of struts and the second row of struts, and a plurality of axial struts disposed between adjacent axially extending window struts are included, each axial strut including an inflow end including an opening, the inflow end being connected to the angled struts of the second row of struts, and an outflow edge portion being fixed to the opening of each axial strut, the artificial heart valve according to any example herein, particularly Example 36.

[0149] Example 38. The outer skirt includes a fourth stitch line including a plurality of in-and-out stitches that undulate along the outflow portion of the outer skirt, and the outflow portion of the outer skirt is fixed to the angled struts of the second row of struts by a plurality of whip stitches that extend around the angled struts of the second row of struts and between the plurality of in-and-out stitches of the fourth stitch line and the material of the outer skirt, the artificial heart valve according to any example herein, particularly either Example 36 or Example 37.

[0150] Example 39. The inflow portion of the outer skirt is wound around a circumferentially extending row of inflow-side struts that define an inflow end of the frame such that a first stitch line is disposed on the outer surface of the frame and a second stitch line is disposed on the inner surface of the frame, and the in-and-out stitches of the first stitch line and the second stitch line are radially aligned with each other across the inflow-side struts, the artificial heart valve according to any example herein, particularly any one of Examples 30 - 38.

[0151] Example 40. An artificial heart valve according to any example herein, particularly Example 39, wherein a part of a plurality of in-and-out stitches of a first stitch line and a second stitch line disposed on the inner surface of the outer skirt is fixed together to the axially inward-facing surface of the inflow-side strut by a suture wound around a part of the plurality of in-and-out stitches.

[0152] Example 41. An artificial heart valve according to any example herein, particularly any one of Examples 30 to 40, wherein the annular frame is radially compressible and expandable between a radially compressed configuration and a radially expanded configuration.

[0153] Example 42. An artificial heart valve comprising an annular frame including a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end portion and an outflow end portion of the frame, the plurality of interconnected struts including a plurality of outflow-side struts defining the outflow end portion and a plurality of inflow-side struts defining the inflow end portion, and an outer skirt disposed around the outer surface of the frame, the outer skirt including an outflow edge portion disposed at an intermediate portion of the frame, an inflow edge portion, a first stitch line extending circumferentially along the inflow portion adjacent to the inflow edge portion, and a second stitch line extending circumferentially along the inflow portion adjacent to and axially spaced from the first stitch line, the inflow portion being wound around the plurality of inflow-side struts such that the first stitch line is disposed inside the frame and the second stitch line is disposed outside the frame.

[0154] Example 43. An artificial heart valve according to any example herein, particularly Example 42, wherein the material of the outer skirt disposed between the first stitch line and the second stitch line covers the axially outward-facing surfaces of the plurality of inflow-side struts.

[0155] Example 44. An artificial heart valve according to any example herein, particularly either Example 42 or Example 43, wherein a first stitch line includes a plurality of first in-and-out stitches extending through the material of the outer skirt, and a second stitch line includes a plurality of second in-and-out stitches extending through the material of the outer skirt.

[0156] Example 45. An artificial heart valve according to any example herein, particularly Example 44, wherein a plurality of first in-and-out stitches extend through a plurality of pre-formed first openings in the outer skirt, and a plurality of second in-and-out stitches extend through a plurality of pre-formed second openings in the outer skirt.

[0157] Example 46. An artificial heart valve according to any example herein, particularly either Example 44 or Example 45, wherein the first stitch line and the second stitch line are fixed together to the axially inward-facing surfaces of a plurality of inflow side struts by one or more suture threads extending around a part of the first in-and-out stitches disposed on the inner surface of the outer skirt and a part of the second in-and-out stitches disposed on the inner surface of the outer skirt.

[0158] Example 47. An artificial heart valve according to any example herein, particularly any one of Examples 42 to 46, wherein the first stitch line and the second stitch line are parallel to each other and undulate along the inflow portion of the outer skirt.

[0159] Example 48. An artificial heart valve according to any example herein, particularly any one of Examples 42 to 47, further including a plurality of valve leaflets disposed inside the frame, each valve leaflet of the plurality of valve leaflets including two cross-link tabs disposed on the opposite side of the valve leaflet and a pointed edge portion extending between the two cross-link tabs, and the cross-link tabs of adjacent valve leaflets forming a paired cross-link.

[0160] Example 49. The second stitch line overlaps with a third stitch line having undulations along the outer skirt between the outflow edge portion and the second stitch line, the third stitch line includes a plurality of third in-and-out stitches, and the outer skirt is fixed to the angled struts of the frame that follow the pointed edge portion of each valve tip by a plurality of whip stitches extending around the angled struts and between the plurality of third in-and-out stitches and the material of the outer skirt. The artificial heart valve according to any embodiment of the present specification, particularly Example 48.

[0161] Example 50. The outer skirt further includes a fourth stitch line having undulations along the outflow portion of the outer skirt adjacent to the outflow edge portion and partially overlapping with the third stitch line, the fourth stitch line includes a plurality of fourth in-and-out stitches, and the outer skirt is fixed to the angled struts arranged in a circumferential direction and extending in a circumferential direction of the frame at an intermediate portion of the frame by a plurality of whip stitches extending around the angled struts and between the plurality of fourth in-and-out stitches and the material of the outer skirt. The artificial heart valve according to any embodiment of the present specification, particularly Example 49.

[0162] Example 51. The plurality of interconnected struts further includes a circumferentially extending row of angled struts arranged at intervals in the circumferential direction around the frame and a plurality of axially extending window struts, the plurality of axially extending window struts extend between the plurality of outflow side struts and the row of angled struts, each axially extending window strut defines an interconnected window, and each interconnection extends through a corresponding interconnected window on the outside of the frame and projects radially outward from the corresponding interconnected window. The artificial heart valve according to any embodiment of the present specification, particularly any one of Examples 48 to 50.

[0163] Example 52. An artificial heart valve according to any example herein, particularly Example 51, wherein the outer skirt includes a plurality of extension portions that extend outwardly from the outflow edge portion toward the outflow end of the frame, and each extension portion extends over at least a portion of the corresponding commissure and covers at least a portion of the corresponding commissure.

[0164] Example 53. An artificial heart valve according to any example herein, particularly Example 52, wherein each extension portion is fixed to the corresponding commissure via a suture that extends through the extension portion and the commissure on the outside of the frame.

[0165] Example 54. A method comprising sterilizing an artificial heart valve, device, and / or assembly of any example.

[0166] Example 55. An artificial heart valve according to any one of Examples 1 - 53, wherein the artificial heart valve is sterilized.

[0167] For any example, the various features described herein can be combined with any one or more other features described in any one or more other examples, unless otherwise stated. For example, any one or more features regarding a certain frame can be combined with any one or more features regarding another frame. As another example, any one or more features regarding a certain outer skirt can be combined with any one or more features regarding another outer skirt.

[0168] Considering the many possible aspects to which the principles of the present disclosure can be applied, it will be appreciated that the illustrated configurations are illustrative of examples related to the disclosed technology and should not be construed as limiting the scope of the present disclosure or the scope of the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

**Claim 1** An artificial heart valve, comprising an annular frame including a plurality of interconnected struts, the plurality of interconnected struts having a plurality of axially extending window struts that form a plurality of cross-linked windows spaced around the frame, the annular frame; an outer skirt disposed around an outer surface of the frame, the outer skirt including a first edge portion; a second edge portion disposed in an intermediate portion of the frame disposed between a first end and a second end of the frame; and the outer skirt including one or more extension portions extending axially from the second edge portion and covering at least a portion of each of the plurality of cross-linked windows, the artificial heart valve. **Claim 2** The plurality of interconnected struts includes a circumferentially extending row of first struts defining the first end of the frame, the first edge portion being fixed to the first struts, and the second edge portion being fixed to the intermediate portion of the frame. The artificial heart valve according to claim 1. **Claim 3** The plurality of interconnected struts includes a circumferentially extending row of second struts defining the second end of the frame, a circumferentially extending row of third struts, and a plurality of axially extending struts, the plurality of axially extending struts and the plurality of axially extending window struts extending between the second struts and the third struts, and the second edge portion being fixed to an end of each of the plurality of axially extending struts connected to the third struts and extending axially. The artificial heart valve according to claim 2. **Claim 4** The outer skirt is disposed adjacent to the first edge portion and includes two stitch lines spaced from each other, each stitch line including a plurality of in-and-out stitches, and a portion of the outer skirt including the first edge portion and the first stitch line of the two stitch lines disposed closest to the first edge portion is wound around the first strut such that the outer skirt covers the first strut and the two stitch lines are radially aligned with the frame. The artificial heart valve according to any one of claims 2 to 3. **Claim 5** The artificial heart valve according to claim 4, wherein the two stitch lines are fixed together to the axially inward-facing surface of the first strut by a suture thread wound around the in-and-out stitch of the two stitch lines.

6. The artificial heart valve according to any one of claims 1 to 5, wherein the first end is the outflow end of the frame and the second end is the inflow end of the frame.

7. The artificial heart valve according to any one of claims 1 to 6, further comprising a plurality of valve leaflets disposed inside the frame, each valve leaflet including two cross-link tabs disposed on the opposite side of the valve leaflet and a pointed edge portion extending between the two cross-link tabs, and the cross-link tabs of adjacent valve leaflets forming a paired cross-link.

8. The artificial heart valve according to claim 7, wherein each cross-link extends through a corresponding cross-link window and is fixed to the corresponding cross-link window such that a part of the cross-link extends radially outward from the cross-link window on the outside of the frame, and each extension extends over at least a part of the corresponding cross-link and covers at least a part of the corresponding cross-link.

9. An artificial heart valve, comprising: an annular frame including a plurality of cross-link features; a plurality of valve leaflets disposed inside the frame and fixed to each other at adjacent ends to form a cross-link, each cross-link being connected to a respective cross-link feature of the frame; an outer skirt disposed around the outer surface of the frame, the outer skirt including: a first edge portion; a second edge portion fixed to an intermediate portion of the frame disposed between a first end and a second end of the frame; and a plurality of extension portions extending axially from the second edge portion, each extension portion covering at least a part of a corresponding cross-link on the outside of the frame.

10. The artificial heart valve according to claim 9, wherein each extension portion is formed as a flap having a width and a length sized to cover at least a part of the width and length of the corresponding cross-link.

11. The artificial heart valve according to any one of claims 9 or 10, wherein each crosslink, each extension portion covering the corresponding crosslink, forms an outer covering material of the frame that gradually tapers radially from the extension portion covering the crosslink to the second edge portion of the outer skirt. Each of the respective crosslink features and the outer surface of the frame projects radially outward.

12. The artificial heart valve according to any one of claims 9 to 11, wherein the artificial heart valve includes three crosslinks and three extension portions, the first edge portion is fixed to the first end of the frame, the first end is the inflow end of the frame, and the second end is the outflow end of the frame.

13. The artificial heart valve according to any one of claims 9 to 12, wherein the annular frame includes a plurality of interconnected struts, the plurality of crosslink features are a plurality of axially extending window struts spaced around the frame, each axially extending window strut defines a crosslink window, and each strut extends through and is fixed to the crosslink window of the axially extending window strut.

14. The artificial heart valve according to claim 13, wherein the plurality of interconnected struts include a circumferentially extending row of first struts defining the second end of the frame, a circumferentially extending row of second struts, and a plurality of axial struts, and the plurality of axially extending window struts and the plurality of axial struts extend between the row of first struts and the row of second struts.

15. The artificial heart valve according to claim 14, wherein the second edge portion is fixed to the first end of the axial strut connected to the row of second struts.

16. The artificial heart valve according to any one of claims 14 or 15, wherein the plurality of interconnected struts include a circumferentially extending row of third struts defining the first end of the frame, and the first edge portion is wound around and disposed on the inner surface of the third strut.

17. The outer skirt includes a first stitch line extending in the circumferential direction including a plurality of in-and-out stitches, and a second stitch line extending in the circumferential direction including a plurality of in-and-out stitches, the first stitch line and the second stitch line are arranged axially spaced apart from each other, and the second stitch line is disposed adjacent to the first edge portion. The artificial heart valve according to claim 16.

18. The first stitch line and the second stitch line are radially aligned with each other such that the material of the outer skirt disposed between the first stitch line and the second stitch line covers the radially inward face, the radially outward face, and the axially outward face of the third strut, and is disposed on both sides of the third strut. The artificial heart valve according to claim 17.

19. An artificial heart valve, including a plurality of interconnected struts and an annular frame having an inflow end and an outflow end, an outer skirt disposed around the outer surface of the frame, the outer skirt including an inflow edge portion disposed at the inflow end, an outflow edge portion disposed at an intermediate portion of the frame, a plurality of extension portions extending axially from the outflow edge portion and circumferentially spaced apart from each other, each extension portion extending toward the outflow end of the frame, a plurality of extension portions, a first stitch line and a second stitch line extending circumferentially along the inflow portion of the outer skirt including the inflow edge portion, the first stitch line and the second stitch line being axially spaced apart from each other and each including a plurality of in-and-out stitches. The outer skirt including the first stitch line and the second stitch line. The artificial heart valve having the outer skirt.

20. The plurality of interconnected struts define a plurality of rows of cells disposed between the inflow end and the outflow end, the plurality of interconnected struts including a plurality of axially extending window struts that form a plurality of cross-linked windows spaced around the frame, and each extension portion extending across the inflow portion of the corresponding cross-linked window of the plurality of cross-linked windows. The artificial heart valve according to claim 19.

21. The inflow portion of the outer skirt is wound around a circumferentially extending row of the inflow side struts defining the inflow end of the frame such that the first stitch line is disposed on the outer surface of the frame, the second stitch line is disposed on the inner surface of the frame, and the in-and-out stitches of the first stitch line and the second stitch line are radially aligned with each other across the inflow side struts. The artificial heart valve according to any one of claims 19 or 20.

22. A part of the plurality of in-and-out stitches of the first stitch line and the second stitch line disposed on the inner surface of the outer skirt are fixed together to an axially inward-facing surface of the inflow side strut by a suture wound around the part of the plurality of in-and-out stitches. The artificial heart valve according to claim 21.

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