Outer skirt for expandable prosthetic heart valve

Abstract

An outer skirt for a prosthetic heart valve is disclosed. As one example, a prosthetic heart valve may include an annular frame including a plurality of interconnected struts, the plurality of interconnected struts including a plurality of axially extending window struts, the plurality of axially extending window struts forming a plurality of commissioning windows spaced about the frame; and an outer skirt disposed around an outer surface of the frame. The outer skirt includes a first edge portion disposed at the first end of the frame, a second edge portion disposed at the intermediate portion of the frame, and one or more extension portions extending axially from the second edge portion and over at least a portion of a respective one of the plurality of commissioning windows.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 342,269, filed on May 16, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to an expandable prosthetic heart valve including an outer skirt for a prosthetic heart valve. Background Art

[0004] The human heart may suffer from various valvular diseases. These valvular diseases may cause significant dysfunction of the heart and ultimately require repairing the native valve or replacing the native valve with a prosthetic valve. There are many known repair devices (e.g., stents) and prosthetic valves, as well as many known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various surgeries to deliver prosthetic medical devices to a position that is not easily accessible to surgery inside the body or a position that is expected to be accessible without surgery. In a specific example, a prosthetic heart valve can be installed on the distal end of a delivery device in a crimped state and is advanced through the patient's vascular system (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site in the heart. Then, for example, by inflating a balloon with a prosthetic valve mounted thereon, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying a prosthetic valve from a sheath of a delivery device so that the prosthetic valve can self-expand to its functional size, the prosthetic valve is expanded to its functional size.

[0005] Most expandable prosthetic heart valves include a radially expandable and compressible cylindrical metal frame or stent and prosthetic valve leaflets mounted inside the frame. The commissures can be formed by connecting pairs of commissure tabs of adjacent valve leaflets to each other and to commissure windows formed in the frame. The prosthetic heart valve may also include an outer covering or skirt disposed around the outer surface of the frame. In some instances, the prosthetic heart valve may be radially compressed (curled) onto a delivery device, and then the delivery device is used to advance through a delivery sheath inserted into the patient's vasculature. The delivery sheath may provide a path to the target implant site for the delivery device to pass through. However, in some cases, the thrust experienced by the user to advance the delivery device through the delivery sheath may be greater than desired. Therefore, it is desirable to improve the prosthetic heart valve that reduces these thrusts. Summary of the invention

[0006] Prosthetic heart valves, delivery devices, and methods for implanting prosthetic heart valves are described herein. Specifically, an outer covering or skirt for a prosthetic heart valve, and examples of methods for making and using such an outer skirt are described herein. The prosthetic heart valve may include a frame, and a leaflet assembly arranged on the inner surface of the frame. Commissures may be formed by connecting pairs of commissure tabs of adjacent leaflets to each other and to commissure windows formed in the frame. The prosthetic heart valve may include an outer skirt arranged around the circumference of the frame and arranged on the outer surface of the frame. The outer skirt may include one or more extensions extending axially outward from an edge portion of the outer skirt. Each extension may be configured to cover at least a portion of a corresponding commissure, thereby reducing thrust when a radially compressed prosthetic heart valve mounted on a delivery device is advanced through a delivery sheath that extends through a patient's vasculature toward a target implantation site. Thus, the skirt and prosthetic heart valve disclosed herein may particularly overcome one or more of the defects of typical prosthetic heart valves and their delivery devices.

[0007] A prosthetic heart valve may include a frame, and a valve structure coupled to the frame.In addition to these components, a prosthetic heart valve may include one or more of the components disclosed herein.

[0008] In some examples, a prosthetic heart valve may include a sealing member configured to reduce paravalvular leakage.

[0009] In some instances, the sealing member can be an outer skirt disposed around an outer surface of the frame, the outer skirt including a first edge portion, a second edge portion disposed at a middle portion of the frame between a first end and a second end of the frame, and one or more extension portions extending axially from the second edge portion.

[0010] In some instances, the frame may include a plurality of interconnected struts including a plurality of axially extending window struts forming a plurality of commissures spaced apart around the frame, and the one or more extension portions may extend over at least a portion of a corresponding commissure of the plurality of commissures.

[0011] In some examples, the valve structure may include a plurality of leaflets arranged within an interior of the frame and secured to each other at adjacent ends to form commissures, wherein each commissure is connected to a corresponding commissure feature of the frame. The one or more extensions may extend axially from the second edge portion, each extension covering at least a portion of a corresponding commissure on an exterior of the frame.

[0012] In some examples, the one or more extension portions include a plurality of extension portions.

[0013] In some examples, the outer skirt may include a first stitch line and a second stitch line extending circumferentially along an inflow portion of the outer skirt including the first edge portion. The first stitch line and the second stitch line are axially spaced from each other and each include a plurality of entry and exit stitches.

[0014] In some examples, a prosthetic heart valve includes an annular frame including a plurality of interconnected struts including a plurality of axially extending window struts forming a plurality of commissures spaced apart around the frame. The prosthetic heart valve also 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 at a mid-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 and over at least a portion of a corresponding commissure of the plurality of commissures.

[0015] In some examples, a prosthetic heart valve includes an annular frame including a plurality of commissure features, and a plurality of leaflets arranged within an interior of the frame and secured to one another at adjacent ends to form commissures, wherein each commissure is connected to a corresponding commissure feature of the frame. The prosthetic heart valve also includes an outer skirt disposed around an outer surface of the frame, the outer skirt including a first edge portion, a second edge portion secured to a middle 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 on an exterior of the frame.

[0016] In some examples, a prosthetic heart valve includes: an annular frame including a plurality of interconnected struts and having an inflow end and an outflow end; and an outer skirt disposed around an outer surface of the frame. The outer skirt includes an inflow edge portion disposed at the inflow end, an outflow edge portion disposed at a middle portion of the frame, a plurality of extension portions extending axially from the outflow edge portion and circumferentially spaced from each other, wherein each extension portion extends 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 are axially spaced from each other and each include a plurality of entry and exit stitches.

[0017] In some examples, a prosthetic heart valve includes an annular frame including a plurality of interconnected struts defining a plurality of rows of pores disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. The prosthetic heart valve also includes an outer skirt disposed around an outer surface of the frame, the outer skirt including: an outflow edge portion disposed at a middle portion of the frame; and an inflow portion, the 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 the first stitch line but axially spaced apart from the first stitch line. The inflow portion is wrapped around the plurality of inflow struts such that the first stitch line is disposed on an interior portion of the frame and the second stitch line is disposed on an exterior portion of the frame.

[0018] In some examples, a prosthetic heart valve includes one or more of the components described in Examples 1-55 below.

[0019] The various innovations of the present disclosure may be used in combination or alone. The present disclosure is provided to introduce a series of concepts further described in the following detailed description in a simplified form. The present disclosure is not intended to identify the key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features and advantages of the present disclosure will become more apparent from the following detailed description, claims and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a side view of a prosthetic heart valve according to one embodiment.

[0021] Figure 2 yes Figure 1 Side view of the frame of a prosthetic heart valve.

[0022] Figure 3 yes Figure 2 A side view of a portion of a frame of , showing the portion of the frame in a straightened (non-annular) state.

[0023] Figure 4 is a side view of an exemplary delivery device configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site.

[0024] Figure 5 is a side view of an outer skirt for a prosthetic heart valve according to an example, the outer skirt is shown in a flat configuration and includes an extension portion extending outwardly from an edge portion of the outer skirt in an axial direction.

[0025] Figure 6 yes Figure 5 Detail view of a portion of an outer skirt showing multiple stitch lines spanning the outer skirt.

[0026] Figure 7 is a side view of an exemplary prosthetic heart valve, wherein Figure 5 An outer skirt is disposed around and secured to an outer surface of a frame of a prosthetic heart valve.

[0027] Figure 8 yes Figure 7 A detail view of the inflow end portion of a prosthetic heart valve showing the inflow portion wrapped around the inflow struts of the frame and secured to the outer skirt of the inflow struts.

[0028] Fig. 9 yes Figure 7 A first cross-sectional view of a prosthetic heart valve of FIG. 1 is shown showing an extension of the outer skirt covering a portion of the commissures of the prosthetic heart valve.

[0029] Fig.10 yes Figure 7 A second cross-sectional view of a prosthetic heart valve showing the inflow portion of the outer skirt wrapped around the inflow struts of the frame.

[0030] Fig.11 yes Fig.10 Detail view of a portion of FIG. 1 showing the inflow portion of the outer skirt secured to the inflow strut using a first stitch line and a second stitch line of the outer skirt. DETAILED DESCRIPTION

[0031] General considerations

[0032] For the purposes of this specification, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Rather, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed examples require the presence of any one or more specific advantages or solutions to problems.

[0033] Although the operations of some disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this description encompasses reordering unless the specific language set forth below requires a specific ordering. For example, in some cases, the operations described in sequence may be reordered or performed simultaneously. In addition, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, this specification sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are easily discernible by a person of ordinary skill in the art.

[0034] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly indicates otherwise. In addition, the term "include" means "comprise". Furthermore, the term "coupled" generally means physical, mechanical, chemical, magnetic and / or electrical coupling or connection, and does not exclude the presence of intermediate elements between coupled or associated items absent specific language to the contrary.

[0035] As used herein, the term "proximal" refers to a position, direction or part of a device that is closer to a user and further away from an implantation site. As used herein, the term "distal" refers to a position, direction or part of a device that is further away from a user and closer to an implantation site. Thus, for example, the proximal motion of a device is the motion of the device away from an implantation site and toward a user (e.g., away from a patient's body), while the distal motion of a device is the motion of the device away from a user and toward an implantation site (e.g., into a patient's body). The terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions, unless otherwise expressly defined.

[0036] Overview of Public Technology

[0037] As described above, the prosthetic heart valve may include leaflets that are fixed to each other at their adjacent sides (e.g., commissure tabs) to form a commissure that is fixed to the frame of the prosthetic heart valve. In some instances, the commissure may extend through a commissure window in the frame of the prosthetic heart valve and then be fixed to the frame struts that form the commissure window. Therefore, a portion of the commissure may extend radially outward and away from the outer surface of the frame. This may form a stepped or protruding feature on the outside of the prosthetic heart valve. In order to be delivered to the implantation site, the prosthetic heart valve is radially compressed around the distal portion of the delivery device and then passes through a delivery sheath that has been inserted into the patient's vasculature and extends toward the implantation site. When the delivery device moves through the delivery sheath, the protruding commissure may contact the inner wall of the delivery sheath, thereby folding the commissure backward and / or pressing against the inner wall of the delivery sheath when the radially compressed prosthetic heart valve is pushed through the delivery sheath. As a result, the thrust felt by the user pushing the delivery device through the delivery sheath may increase.

[0038] Various examples of outer skirts for prosthetic heart valves are described herein that can be disposed about an outer surface of a prosthetic heart valve and configured to form a seal against native tissue when the prosthetic heart valve is implanted, thereby reducing paravalvular leakage (PVL) through the prosthetic heart valve when expanded against native anatomy. The outer skirts described herein can include vertical (or axial) extensions at an outflow end portion of the outer skirt that cover at least an inflow end portion of the commissures, thereby providing a tapered and smoother surface that can facilitate easier advancement of the prosthetic heart valve through a delivery sheath and thereby reduce the pushing force felt by the user.

[0039] The prosthetic valve disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be curled on or held by an implant delivery device in a radially compressed state while being advanced through the patient's vascular system on the delivery device. Once the prosthetic valve reaches the implantation site, the prosthetic valve can be expanded to a radially expanded state. It should be understood that the prosthetic valve disclosed herein can be used with a variety of implant delivery devices and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0040] Figure 1 An exemplary prosthetic device (e.g., a prosthetic heart valve) is shown, which includes a frame, a valve leaflet fixed inside the frame, and an outer skirt disposed around an outer surface of the frame. Figure 2 and 3 As shown in , the frame may include a plurality of interconnected and angled struts and an apex region that extends and / or curves between the angled struts at the inflow and outflow ends of the frame. The prosthetic device may be delivered by a delivery device such as Figure 4 The exemplary delivery device shown in ) is advanced through the patient's vasculature, such as to a native heart valve.

[0041] In some instances, an outer skirt for a prosthetic heart valve (e.g. Figure 5-7 The outer skirt (as depicted in FIG. 1 ) may be configured with an axially extending extension extending outwardly from the outflow edge portion of the outer skirt. The extension may be configured to extend over a portion of the commissure protruding radially outwardly from the commissure window of the frame (e.g., Fig. 9 ). The extensions can provide a tapered and / or smoother (or lower friction) surface covering the inflow portion of the commissures, thereby reducing the pushing force felt by the user when the radially compressed prosthetic heart valve is advanced through the delivery sheath via the delivery device.

[0042] In some instances, such as Figure 6 As depicted in , the outer skirt may also include two spaced apart stitch lines extending circumferentially along the inflow portion of the outer skirt and including a plurality of inlet and outlet stitches. Figure 7-11 As shown in , the inflow portion of the outer skirt can be wrapped around the inflow end of the frame so that the first stitch line is disposed on the exterior of the frame and the second stitch line is disposed on the interior of the frame (eg, Fig.11 ). The stitches of the first stitch and the second stitch can then be secured together, thereby securing the outer skirt over the inflow end of the frame and securing the outer skirt around the inflow end of the frame. As a result, the inflow struts defining the inflow end of the frame can be covered, thereby reducing potential wear of the inflow struts on the delivery sheath and / or further reducing thrust when the prosthetic heart valve is advanced through the delivery sheath.

[0043] Examples of Disclosed Technologies

[0044] Figure 1 A prosthetic heart valve 100 (prosthetic valve) according to one example is shown. Any of the prosthetic valves disclosed herein is suitable for implantation in the native aortic valve annulus, but in other examples, it may be suitable for implantation in other native valve annuli of the heart (pulmonary, mitral and tricuspid valves). The disclosed prosthetic valves may also be implanted in vessels connected to 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 vessels of the patient. The disclosed prosthetic valves may also be implanted in a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) during a valve-in-valve procedure.

[0045] In some examples, the disclosed prosthetic valve can be implanted in a docking or anchoring device implanted in a native heart valve or vessel. For example, in one example, the disclosed prosthetic valve can be implanted in a docking device implanted in the pulmonary artery to replace the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another example, the disclosed prosthetic valve can be implanted in a docking device implanted in or at a native mitral valve, such as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valve can be implanted in a docking device implanted in the superior or inferior vena cava to replace the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0046] The prosthetic heart valve 100 can include a stent or frame 102, a valve structure 104, and a paravalvular outer sealing member or outer skirt 106. The prosthetic heart valve 100 (and the frame 102) can have an inflow end 108 and an outflow end 110. The valve structure 104 can be disposed on the interior of the frame 102, while the outer skirt 106 is disposed around the outer surface of the frame 102.

[0047] The valve structure 104 may include a plurality of leaflets 112 (e.g., three leaflets, such as Figure 1 ), which together form a leaflet structure that can be arranged to collapse in a tricuspid arrangement. The leaflets 112 can be secured to each other at adjacent sides thereof (e.g., commissure tabs) to form commissures 114 of the valve structure 104. For example, each leaflet 112 can include opposing commissure tabs disposed on opposing sides of the leaflet 112 and a cusp edge portion extending between the opposing commissure tabs. The cusp edge portions of the leaflets 112 can have an undulating curved fan-like shape and can be directly secured to the frame 102 (e.g., by sutures). However, in alternative examples, the cusp edge portions of the leaflets 112 can be secured to an inner skirt, which is then secured to the frame 102. In some examples, the 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 as are known in the art and described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0048] In some examples, the outer skirt 106 can be an annular skirt. In some cases, the outer skirt 106 can include one or more skirt portions connected together and / or individually connected to the frame 102. The outer skirt 106 can include a fabric or polymer material such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc. In some cases, instead of Figure 1 106 may have an undulating upper edge portion that extends along and is secured to the angled struts 134. Examples of such an outer skirt and various other outer skirts that may be used with the frame 102 may be found in the provisional patent application under Attorney Docket No. 12131US01 to Edwards, which is incorporated herein by reference.

[0049] The frame 102 can be radially compressed and expanded between a radially compressed configuration and a radially expanded configuration (the expanded configuration is Figure 1 ). The frame 102 is Figure 2 102 and a portion of the frame 102 in a straightened (non-annular) configuration is shown separately in FIG. Figure 3 Shown in.

[0050] The frame 102 can be made of any of a variety of suitable plastic expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol). When composed of plastic expandable materials, the frame 102 (and therefore the valve 100) can be curled to a radially compressed state on a delivery catheter and then expanded in the patient's body by an inflatable balloon or equivalent expansion mechanism. When composed of self-expandable materials, the frame 102 (and therefore the valve 100) can be curled to a radially compressed state and limited to a compressed state by being inserted into a sheath or equivalent mechanism of a delivery catheter. Once in the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0051] Suitable plastic expansion materials that can be used to form the framework 102 include metal alloys, polymers, or combinations thereof. Example metal alloys may include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some instances, the framework 102 may include stainless steel. In some instances, the framework 102 may include a cobalt-chromium alloy. In some instances, the framework 102 may include a nickel-cobalt-chromium alloy. In some instances, the framework 102 includes a nickel-cobalt-chromium-molybdenum alloy, such as MP35NTM (a trade name of SPS Technologies), which is equivalent to UNSR30035 (covered by ASTM F562-02). MP35NTM / UNS R30035 includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight.

[0052] like Figure 2 and 3 As shown in , the frame 102 may include a plurality of interconnected struts 116 that form a plurality of rows of open cells 118 between the outflow end 110 and the inflow end 108 of the frame 102. In some examples, such as Figure 2 and 3 As shown in FIG. 1 , the frame 102 may include three rows of wells 118, wherein the first row (in Figure 2 and 3 The first row of cells 120 (in the orientation shown in FIG. 1 ) is disposed at the outflow end 110. The first row of cells 120 includes cells 118 that are elongated in the axial direction (relative to a central longitudinal axis 122 of the frame 102) compared to the cells 118 in the remaining rows of cells. For example, the cells 118 in the first row of cells 120 may have a longer axial length 124 ( 125 ) than the cells 118 in the remaining rows of cells. Figure 3 ), the remaining rows of pore chambers may include a second row of pore chambers 126 and a third row of pore chambers 128, the third row of pore chambers 128 being disposed at the inflow end 108, and the second row of pore chambers 126 being disposed between the first row of pore chambers 120 and the third row of pore chambers 128.

[0053] In some instances, such as Figure 2 As shown in , each row of cells includes nine cells 118. Thus, in such an example, the frame 102 can be referred to as a nine-cell frame.

[0054] In alternative examples, the frame 102 may include more than three rows of cells (e.g., four or five rows) and / or more or fewer than nine cells per row. In some examples, the cells 118 in the first row of cells 120 may not be elongated compared to the cells 118 in the remaining rows of cells (the second row of cells 126 and the third row of cells 128) of the frame 102.

[0055] The interconnected struts 116 may include a plurality of angled struts 130, 132, 134, and 136 arranged in a plurality of circumferentially extending rows of angled struts arranged along the length of the frame 102 between the outflow end 110 and the inflow end 108. For example, the frame 102 may include: a first row of angled struts 130 arranged end-to-end and extending circumferentially at the inflow end 108 of the frame; a second row of circumferentially extending angled struts 132; a third row of circumferentially extending angled struts 134; and a fourth row of circumferentially extending angled struts 136 at the outflow end 110 of the frame 102. The fourth row of angled struts 136 may be connected to the third row of angled struts 134 by a plurality of axially extending window struts 138 (or window strut portions) and a plurality of axial (e.g., axially extending) struts 140. Axially extending window struts 138 (which may also be referred to as axial struts including commissure windows) define commissure windows (e.g., open windows) 142 that are spaced apart from one another in a circumferential direction around the frame 102 and are adapted to receive a commissure disposed to a commissure (e.g., Figure 1 In some examples, the commissure windows 142 and / or the axially extending window struts 138 defining the commissure windows 142 may be referred to herein as commissure features or commissure supports, each of which is configured to receive and / or secure to a pair of commissure tabs in a pair of adjacent leaflets.

[0056] One or more (e.g., two, such as Figure 2 and 3 ) axial struts 140 may be positioned in a circumferential direction between two commissures 142 formed by window struts 138. Because frame 102 may include fewer pores (e.g., nine) per row and fewer axial struts 140 may be included between each commissure fenestration 142 than some more conventional prosthetic heart valves, each pore 118 may have an increased width (in the circumferential direction), thereby providing a larger opening for blood flow and / or coronary artery access.

[0057] Each axial strut 140 and each window strut 138 extends from a position defined by the convergence of lower ends (e.g., ends disposed inside and farthest from the outflow end 110) of two angled struts 136 (which may also be referred to as upper strut junctions or upper elongated strut junctions) to another position defined by the convergence of upper ends (e.g., ends disposed closer to the outflow end 110) of two angled struts 134 (which may also be referred to as lower strut junctions or lower elongated strut junctions). Each axial strut 140 and each window strut 138 form axial sides of two adjacent cells in the first row of cells 120.

[0058] In some instances, such as Figure 3 As shown in FIG. 1 , each axial strut 140 may have a width 144 ( Figure 3 ), which is greater than the width of the angled struts 130, 132, 134, and 136. As used herein, the "width" of a strut is measured between relative locations on opposing surfaces of the strut that extend between the radially inward-facing surface and the radially outward-facing surface of the strut (relative to the central longitudinal axis 122 of the frame 102). The "thickness" of the strut is measured between relative locations on the radially inward-facing surface and the radially outward-facing surface of the strut and is perpendicular to the width of the strut. In some examples, the width 144 of the axial strut 140 is 50-200%, 75-150%, or at least 100% (e.g., twice) greater than the width of the angled struts of the frame 102.

[0059] By providing axial struts 140 with a width 144 that is greater than the width of other angled struts of frame 102, a greater contact area is provided when leaflets 112 contact the wider axial struts 140 during systole, thereby distributing stresses and reducing the extent to which leaflets 112 may fold over axial struts 140, radially outward through ostium 118. As a result, the long-term durability of leaflets 112 may be improved.

[0060] Because the pores 118 of the frame 102 can have a relatively large width compared to alternative prosthetic valves having more than nine pores per row (as described above), wider axial struts 140 can be more easily incorporated into the frame 102 without sacrificing open space for blood flow and / or coronary artery access.

[0061] The commissure tabs 115 of adjacent leaflets 112 may be secured together to form commissures 114 ( Figure 1 Each commissure 114 of the prosthetic heart valve 100 includes two commissure tabs 115 that mate together and extend through a commissure window 142 of the frame 102, one for each of two adjacent leaflets 112. Each commissure 114 may be secured to a window post 138 that forms a commissure window 142.

[0062] The cusp edge portion (e.g., scalloped edge) of each leaflet 112 can be secured to frame 102 via one or more fasteners (e.g., sutures). In some examples, the cusp edge portion of each leaflet 112 can be secured directly to a strut (e.g., angled struts 130, 132, and 134) of frame 102. For example, the cusp edge portion of leaflet 112 can be sutured to angled struts 130, 132, and 134 that generally follow the contour of the cusp edge portion of leaflet 112.

[0063] In some examples, the cusp edge portions of the leaflets 112 may be secured to the inner skirt, and the inner skirt may then be secured directly to the frame 102 .

[0064] Various methods for securing the leaflets 112 to a frame such as frame 102 are disclosed in U.S. Provisional Patent Application No. 63 / 278,922 filed on November 12, 2021 and U.S. Provisional Patent Application No. 63 / 300,302 filed on January 18, 2022, both of which are incorporated herein by reference.

[0065] like Figure 2 and Figure 3 As shown in , in some examples, one or more or each of the axial struts 140 may include an inflow end portion 146 (e.g., the end portion closest to the inflow end 108) and an outflow end portion 148 that are widened relative to a middle portion 150 (which may be defined by a width 144) of the axial strut 140. In some cases, the inflow end portion 146 of the axial strut 140 may include an orifice 147. The orifice 147 may be configured to receive a fastener (e.g., a suture) to attach the soft component of the prosthetic heart valve 100 to the frame 102. For example, in some cases, such as Figure 1 As shown in FIG. 1 , the outer skirt 106 can be positioned around the outer surface of the frame 102 , and the upper or outflow edge portion of the outer skirt 106 can be secured to the aperture 147 by fasteners 149 (eg, sutures).

[0066] The frame 102 may further include a plurality of apex regions 152 formed at the inflow end 108 and the outflow end 110, each apex region 152 extending and forming a junction between two angled struts 130 at the inflow end 108 or a junction between two angled struts 136 at the outflow end 110. Thus, the apex regions 152 are spaced apart from each other in the circumferential direction at the inflow end 108 and the outflow end 110.

[0067] Each apex region 152 may include an apex 154 (the point that is highest or extends most outward in the axial direction) and two thinned (or narrowed) strut portions 156, one thinned strut portion 156 extending from either side of the apex 154 to a corresponding wider angled strut 136 (at the outflow end 110) or angled strut 130 (at the inflow end 108) ( Figure 3 ). In this way, each of the vertex regions 152 at the outflow end 110 can form a narrowed transition region between and relative to the two angled struts 136 extending from the corresponding vertex region 152, and each of the vertex regions 152 at the inflow end 108 can form a narrowed transition region between and relative to the two angled struts 130 extending from the corresponding vertex region 152.

[0068] The thinned strut portion 156 of the apex region 152 may have a width 158 (160) that is less than the width 160 of the angled struts 130 or 136. Figure 3 ). In some examples, width 158 can be a uniform width (e.g., along the entire length of strut portion 156). In some examples, width 158 of thinned strut portion 156 can be approximately 0.06 mm-0.15 mm less than width 160 of angled struts 130 and / or 136.

[0069] The thinned strut portion 156 of the apex region 152 may have a first length 162 ( Figure 3 ). In some examples, the first length 162 is in the range of 0.8-1.4 mm, 0.9-1.2 mm, 0.95-1.05 mm, or about 1.0 mm (e.g., ± 0.03 mm). In alternative examples, the first length 162 is in the range of 0.3-0.7 mm, 0.4-0.6 mm, 0.45-0.55 mm, or about 0.5 mm (e.g., ± 0.03 mm).

[0070] Thus, each outflow apex region 152 may include two thinned strut portions 156 having a first length 162, each extending outwardly from the apex 154 relative to a central longitudinal axis 164 of the cell 118. Thus, the total length of the apex region 152 may be twice the first length 162.

[0071] Each apex region 152 and two corresponding angled struts 136 at the outflow end 110 may form an outflow strut 166 , and each apex region 152 and two corresponding angled struts 130 at the inflow end 108 may form an inflow strut 168 .

[0072] Each outflow strut 166 and inflow strut 168 may have a length that includes the apex region 152 and two angled struts 136 or 130 (or strut portions) on either side of the apex region 152. Half of the total length of each outflow strut 166 and inflow strut 168 is within Figure 3 1 and 16. The length 170 extending from the end of one angled strut 136 or 130 to the central longitudinal axis 164 is shown in FIG. Thus, the length of each outflow strut 166 and inflow strut 168 is twice the length 170. In some examples, the length 170 of one half of each inflow strut 168 may be different than the length 170 of one half of each outflow strut 166.

[0073] In some cases, the length of each thinned strut portion 156 can be at least 25% of the length 170 of the corresponding half of the outflow strut 166 or the inflow strut 168. In other words, the length of each apex region 152 (the total length is twice the first length 162) can be at least 25% of the total length (twice the length 170) of the outflow strut 166 or the inflow strut 168. In some examples, the length of each apex region 152 can be greater than 25%, such as 25-35%, of the total length of the corresponding outflow strut 166 or the inflow strut 168.

[0074] In some examples, each apex region 152 may include a curved axially facing outer surface 172 and an arcuate or curved axially facing inner recess 174 forming a thinned strut portion 156. For example, the curved inner recess 174 may be recessed from the inner surface of the angled strut portion 156 toward the curved outer surface 172, thereby forming a thinned strut portion 156 of smaller width. Thus, the curved inner recess 174 may be formed on the bore side of the apex region 152 (e.g., opposite the exterior of the apex region 152).

[0075] In some examples, the curved outer surface 172 of each apex region 152 can form a single continuous curve from one angled strut portion 156 on a first side of the apex region 152 to another angled strut portion 156 on an opposing second side of the apex region 152 .

[0076] Each vertex region 152 can have a radius of curvature 176 along the curved outer surface 172 (e.g., in some cases, along the entirety or entire length of the curved outer surface 172) ( Figure 3 ). In some cases, the radius of curvature 176 of the entire curved outer surface 172 at the vertex 154 and / or along the vertex region 152 can be greater than 1 mm. In some cases, the radius of curvature 176 can be in the range of 1-20 mm, 3-16 mm, or 8-14 mm. In some cases, the radius of curvature 176 can be greater than 10 mm. The radius of curvature 176 can depend on the width 158 of the thinned strut portion 156 (e.g., the amount of reduction from the width of the angled struts 130 or 136) and the first length 162 (and thus change due to changes in the width and the first length).

[0077] Additionally, the height (axial height) 178 of the apex region 152 may be the width 158 ( Figure 3), the height can be defined in the axial direction from the outer surface of the two angled struts 130 or 136 to the curved outer surface 172 of the apex region 152 at the apex 414. In this way, the height 178 of the apex region 152 can be relatively small and does not add to the overall axial height of the radially expanded frame 102. Figure 1 ) can be arranged near the inflow end 108, thereby leaving a larger open space at the outflow end 110 of the frame 102 that is not blocked by the leaflets 112.

[0078] In some examples, each of the apex regions 152 may form an angle 180 (°C) between two angled struts 130 or 136 extending from either side of the corresponding apex region 152. Figure 3 ). In some cases, angle 180 can be in the range of 120 (exclusive) to 140 degrees (eg, such that angle 180 is greater than 120 degrees and less than or equal to 140 degrees).

[0079] Additional details and examples of frames for prosthetic heart valves including apex regions may be found in U.S. Provisional Patent Applications Nos. 63 / 178,416 (filed on April 22, 2021), 63 / 194,830 (filed on May 28, 2021), and 63 / 279,096 (filed on November 13, 2021), all of which are incorporated herein by reference.

[0080] Figure 4 A delivery device 200 is shown according to an example that can be used to implant an expandable prosthetic heart valve (e.g., Figure 1 In some examples, delivery device 200 is particularly suitable for introducing a prosthetic valve into a heart.

[0081] Figure 4 The delivery device 200 in the illustrated example is a balloon catheter, which includes a handle 202 and a steerable outer shaft 204 extending distally from the handle 202. The delivery device 200 may also include an intermediate shaft 206 (also referred to as a balloon shaft) extending proximally from the handle 202 and extending distally from the handle 202, and the portion extending distally from the handle 202 also coaxially extends through the outer shaft 204. In addition, the delivery device 200 may also include an inner shaft 208, which coaxially extends distally from the handle 202 through the intermediate shaft 206 and the outer shaft 204, and coaxially extends proximally from the handle 202 through the intermediate shaft 206.

[0082] Outer shaft 204 and intermediate shaft 206 may be configured to longitudinally translate (eg, move) relative to one another along central longitudinal axis 220 of delivery apparatus 200 to facilitate delivery and positioning of a prosthetic valve at an implantation site within a patient.

[0083] The intermediate shaft 206 may include a proximal portion 210 extending proximally from the proximal end of the handle 202 to an adapter 212. A rotatable knob 214 may be mounted on the proximal portion 210 and may be configured to rotate the intermediate shaft 206 about the central longitudinal axis 220 and relative to the outer shaft 204.

[0084] The adapter 212 can include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive a fluid (eg, an inflation fluid) from a fluid source. The second port 240 can be fluidly coupled to the inner lumen of the intermediate shaft 206.

[0085] The intermediate shaft 206 may also include a distal portion that extends distally beyond the distal end of the outer shaft 204 when the distal end of the outer shaft 204 is positioned away from the inflatable balloon 218 of the delivery device 200. The distal portion of the inner shaft 208 may extend distally beyond the distal portion of the intermediate shaft 206.

[0086] The balloon 218 can be coupled to the distal portion of the intermediate shaft 206 .

[0087] In some examples, the distal end of balloon 218 can be coupled to the distal end of delivery device 200, such as to nose cone 222 (eg, Figure 4 ), or an alternative component (e.g., a distal shoulder) coupled to the distal end of the delivery device 200. The middle portion of the balloon 218 can overlie the valve mounting portion 224 of the distal portion of the delivery device 200, and the distal portion of the balloon 218 can overlie the distal shoulder 226 of the delivery device 200. The valve mounting portion 224 and the middle portion of the balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as Figure 4 As schematically shown in , a prosthetic heart valve 250 , which may be one of the prosthetic valves described herein, may be mounted around a balloon 218 at a valve mounting portion 224 of a delivery device 200 .

[0088] The balloon shoulder assembly, including the distal shoulder 226, is configured to maintain the prosthetic heart valve 250 (or other medical device) in a fixed position on the balloon 218 during delivery through the patient's vasculature.

[0089] The outer shaft 204 may include a distal tip portion 228 mounted on its distal end. Figure 4 ), and during delivery of the prosthetic valve to a target implantation site, the outer shaft 204 and the intermediate shaft 206 can be axially translated relative to each other to position the distal tip portion 228 adjacent to the proximal end of the valve mounting portion 224. Thus, the distal tip portion 228 can be configured to resist proximal movement of the prosthetic valve 250 relative to the balloon 218 in an axial direction relative to the balloon 218 when the distal tip portion 228 is disposed adjacent to the proximal side of the valve mounting portion 224.

[0090] 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 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 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 to the fluid passage to inflate the balloon 218 and radially expand and deploy the prosthetic valve 250.

[0091] The lumen of the inner shaft can be configured to receive a guidewire therethrough for guiding the distal portion of the delivery device 200 to a target implantation site.

[0092] The handle 202 may include a steering mechanism configured to adjust the curvature of the distal portion of the delivery device 200. In the example shown, for example, the handle 202 includes an adjustment member, such as a rotatable knob 260 shown, which is in turn operably connected to the proximal portion of the traction wire. The traction wire can extend distally from the handle 202 through the outer shaft 204 and have a distal portion fixed to the outer shaft 204 at or near the distal end of the outer shaft 204. Rotating the knob 260 can increase or decrease the tension in the traction wire, thereby adjusting the curvature of the distal portion of the delivery device 200. Further details about the steering or flexing mechanism for the delivery device can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0093] The handle 202 may also include an adjustment mechanism 261, which includes an adjustment member, such as the rotatable knob 262 shown, and an associated locking mechanism, which 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). Additional details about the delivery device 200 can be found in PCT Application No. PCT / US202 1 / 047056, which is incorporated herein by reference.

[0094] As described above, the commissures formed with the leaflet assembly can extend through the commissure windows in the frame of the prosthetic heart valve, resulting in a portion of the commissures extending radially outward from the outer surface of the frame (e.g., as shown in FIG. Figure 1 114). The inventors herein have recognized that this can form a stepped protruding feature on the exterior of a radially compressed prosthetic heart valve that can contact the inner wall of a delivery sheath through which a delivery device traverses toward an implantation site. For example, a delivery sheath can be inserted into a patient's vasculature and extended into the patient's heart toward the implantation site, and then the delivery device can traverse through the interior of the delivery sheath to the implantation site, with the prosthetic heart valve mounted around the delivery device in a radially compressed configuration. As the delivery device moves through the delivery sheath, the protruding commissures may contact the inner wall of the delivery sheath, causing the commissures to fold back as the radially compressed prosthetic heart valve is pushed through the delivery sheath. As a result, the push force felt by the user passing the delivery device through the delivery sheath may be higher than expected.

[0095] In some examples, an outer skirt for a prosthetic heart valve (e.g., prosthetic heart valve 100) can include one or more axially extending (or vertical) extensions or portions configured to extend over and cover a portion of the commissures of the prosthetic heart valve. The extensions of the outer skirt can be configured to more easily (e.g., with reduced friction) slide against the delivery sheath and / or prevent the commissures from folding back when the radially compressed prosthetic heart valve is advanced through the delivery sheath toward the implantation site using the delivery device. As a result, the thrust felt by the user advancing the delivery device through the delivery sheath can be reduced.

[0096] Figure 5 A prosthetic device (such as Figure 1 As described in further detail below, the outer skirt 300 may include one or more extensions ( Figure 5 The outer skirt 300 may be used in mechanically expandable prosthetic valves, balloon expandable prosthetic valves (e.g., Figure 1Prosthetic heart valve 100) and / or self-expanding prosthetic valve. Additional details about balloon-expandable prosthetic valves can be found in U.S. Patent No. 9,393,110 and U.S. Provisional 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. Additional details about mechanically expandable prosthetic valves can be found in International Application PCT / US2021 / 052745 filed on September 30, 2021, which is incorporated herein by reference. Additional details about self-expanding prosthetic valves can be found in U.S. Patent No. 8,652,202, which is incorporated herein by reference.

[0097] The outer skirt 300 can be wrapped around and mounted to the outer surface of the frame of the prosthetic device (the surface facing radially outward relative to the central longitudinal axis of the prosthetic device) to transform into an annular configuration (e.g., as Figure 7 For example, the outer skirt 300 is shown disposed around and secured to the outer surface of the frame 102 ( Figure 7-11 ).

[0098] like Figure 5 As shown in , the outer skirt 300 may include opposing first and second edge portions 302, 304 (which may also be referred to as short edges or edge portions) that each extend between an outflow edge portion 306 and an inflow edge portion 308 of the outer skirt 300. In some cases, the first and second edge portions 302, 304 may be non-parallel to a central longitudinal axis of a frame of the prosthetic device (when mounted about the frame) and / or non-perpendicular to the outflow edge portion 306. For example, the first and second edge portions 302, 304 may extend at an angle of about 45 degrees (or within a range of 40 to 50 degrees) relative to the outflow edge portion 306 and / or a line extending in a circumferential direction of the frame. Thus, the overall general shape of the outer skirt 300 may be a rhombus or parallelogram shape.

[0099] In some examples, the first edge portion 302 and the second edge portion 304 can each include a plurality of apertures 310 extending therethrough (e.g., apertures spaced apart and extending in a row along the first edge portion 302 and the second edge portion 304). Thus, when the outer skirt 300 is converted to its annular configuration (e.g., when mounted around a frame of a prosthetic device, such as, for example, Figure 7), the first edge portion 302 and the second edge portion 304 can overlap each other, and their corresponding apertures 310 also overlap. Then, the suture can be used to form a plurality of stitches in and out of the overlapping apertures 310, thereby fixing the first edge portion 302 and the second edge portion 304 together and forming the annular configuration of the outer skirt 300.

[0100] like Figure 5 In Figure 6 As shown in the detailed view of a portion of the outer skirt 300 in FIG. 1 , the outer skirt 300 may include an outflow edge portion 306 ( Figure 5 and Figure 6 ) extending outwardly (in an axial direction relative to the central longitudinal axis of the frame to which the outer skirt 300 is attached). In some cases, the outer skirt 300 may include multiple extensions 312 spaced apart from each other along the outflow edge portion 306 (e.g., one extension for each commissure of the frame to which the outer skirt 300 is attached). The spacing between adjacent extensions 312 may be selected so that each extension mates with the commissure window 142 and the corresponding commissure of the prosthetic heart valve when attached to the frame of the prosthetic heart valve (e.g., as shown in FIG. 1 ). Figure 7 ).

[0101] like Fig. 9 As shown in the schematic cross-sectional view of FIG. , each extension portion 312 may have a width 314 (in the circumferential direction) and an axial length 316 ( Figure 6 ), which is sized to cover at least the inflow portion of the commissure 114 extending through the commissure fenestration 142 of the frame 102 and outside the commissure fenestration. In some examples, width 314 can be specified so that it covers the inflow portion of the commissure 114 extending from the commissure fenestration 142 ( Figure 1 and Fig. 9 The width of the commissure (and the commissure tabs 115 forming the commissure 114) extending outwardly from the commissure support or feature of the frame to which the commissure is attached. Figure 7 , the extension portions 312 may be sized such that they extend over at least the inflow portion of the respective commissure windows 142 and corresponding window posts 138 (or alternative commissure supports or features of the frame).

[0102] In some examples, length 316 can be specified such that it covers commissure 114 (eg, Fig. 9 ) and / or the commissure window 142 (as shown in Figure 7 In an alternative embodiment, the length 316 may be greater than Figure 7 and 9, and covers a greater portion or the entirety of commissures 114 and / or commissure fenestrations 142, thereby covering a greater portion (e.g., more than half) of commissures 114 extending radially outward from commissure fenestrations 142. In still other examples, length 316 may be specified such that 25-75% or 40-60% of the length of commissures 114 is covered.

[0103] In some examples, the outflow edge portion 306 may be relatively straight (eg, Figure 5-7 However, in an alternative example, the outflow edge portion 306 may have an undulating shape, such as shown in the provisional patent application under Edwards attorney docket number 12131US01 as already mentioned above. In such an example, the extension portion 312 may extend from the peak of the undulating outflow edge portion.

[0104] like Fig. 9 As shown in , each extension portion 312 covering the corresponding commissure 114 can form a gradually tapered cover (e.g., tapered in the radial direction of the frame 102) over the inflow portion of the commissure 114. For example, when surrounding the distal portion of the delivery device (e.g., Figure 4 When the delivery device 200 of the embodiment of the present invention is radially compressed, the inflow end 108 of the frame can be arranged to be closest to the distal end (or front end) of the delivery device. Fig. 9 As shown by arrow 318 in FIG. 1 , when the delivery device and the radially compressed prosthetic heart valve are advanced through the delivery sheath, the direction of the sliding or frictional force from the delivery sheath on the prosthetic heart valve can be from the inflow end 108 toward the outflow end 110. By providing a gradual increase in width or thickness in the radial direction from the first portion 320 of the outer skirt 300 covering the middle portion of the frame 102 to the extension portion 312 covering the radially protruding commissure 114, the radially compressed prosthetic heart valve can be more easily advanced through the delivery sheath to the implantation site. For example, the extension portion 312 can prevent the commissure 114 from folding back under pressure from the delivery sheath. As a result, the thrust felt by the user advancing the delivery device through the delivery sheath can be reduced.

[0105] The extension portion 312 may be secured via one or more fasteners, such as one or more sutures 360 ( Fig. 9 )) are fixed to their corresponding joints 114. In some examples, such as Figure 6 As shown in , each extension portion 312 may include one or more apertures 362 through the material of the extension portion 312 that are configured to receive a suture 360 ​​(or alternative fasteners) and enable the extension portion 312 to be more easily secured to the joint 114. Figure 6, the extension portions 312 each include two apertures 362. However, in alternative examples, the extension portions 312 may include more or less than two apertures 362 (e.g., one, three, four, etc.), or the extension portions 312 may not include any apertures and may be secured to the commissures 114 by a needle piercing and extending through the material of the outer skirt 300.

[0106] The outer skirt 300 can include a variety of synthetic materials, including fabrics (e.g., polyethylene terephthalate fabric (PET) fabric or ultra-high molecular weight polyethylene (UHMWPE) fabric), polytetrafluoroethylene (PTFE), thermoplastic polyurethane (TPU), hybrid materials including one or more fabrics or polymer materials (e.g., PET coated with TPU), or autologous tissue (e.g., pericardial tissue). In some examples, the material of the outer skirt 300 can be selected to further reduce friction between the outer skirt 300 and the inner wall of the delivery sheath during advancement of the radially compressed prosthetic heart valve through the delivery sheath.

[0107] In some examples, the outer skirt 300 may include two circumferentially extending stitch lines (or suture lines) proximate the inflow edge portion 308, including a first stitch line 322 and a second stitch line 324 ( Figure 6 ). The first stitch line 322 may include a plurality of entry and exit stitches 326 extending through the outer skirt 300 at an axial position and extending circumferentially along the outer skirt from the first edge portion 302 to the second edge portion 304, the axial position being disposed adjacent to the inflow edge portion 308 but spaced apart from the inflow edge portion. The second stitch line 324 may include a plurality of entry and exit stitches 328 extending through the outer skirt 300 at an axial position and extending circumferentially along the outer skirt from the first edge portion 302 to the second edge portion 304, the axial position being disposed adjacent to the first stitch line 322 but spaced apart from the first stitch line and adjacent to the inflow edge portion 308. For example, Figure 6 As shown in FIG. 3 , the second stitch line 324 is disposed between the inflow edge portion 308 and the first stitch line 322 , wherein a gap 330 separates the first stitch line 322 from the second stitch line 324 .

[0108] In some examples, the first stitch line 322 and the second stitch line 324 can be parallel to each other. In alternative examples, the first stitch line 322 and the second stitch line 324 can be non-parallel to each other. For example, in some cases, the gap 330 can be constant circumferentially along the outer skirt 300 between the first stitch line 322 and the second stitch line 324. In alternative cases, the gap 330 can vary along the outer skirt 300, such as being larger at the inflow end 108 of the frame 102 aligned with the apex region 152 (when the outer skirt 300 is installed around the frame 102, such as Figure 7 In such cases, 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, which can facilitate elongation of the prosthetic heart valve during radial compression of the prosthetic heart valve (e.g., when crimping it onto a delivery device).

[0109] In some cases, such as Figure 5 and Figure 6 As shown in FIG, the stitches 326 of the first stitch line 322 may extend through the preformed apertures 332 (or perforations) in the outer skirt 300, extending from the first surface 342 (outer surface) to the second surface 344 (inner surface) of the outer skirt 300, and the stitches 328 of the second stitch line 324 may extend through the preformed apertures 334 (or perforations) in the outer skirt 300. In the alternative, the stitches 326 of the first stitch line 322 and the stitches 328 of the second stitch line 324 may extend through the material of the outer skirt 300 (to form the apertures, for example, with a needle).

[0110] like Figure 5 and Figure 6 As shown in FIG. 1 , one or both of the first and second stitch lines 322, 324 may have an undulating shape that generally tracks the shape of the inflow support 168 of the frame 102 (eg, Figure 7 ).

[0111] When the outer skirt 300 is disposed around the outer surface of the frame 102, as shown Figure 7 As shown in FIG. 1 , the inflow portion of the outer skirt 300 including the second stitch line 324 and the inflow edge portion 308 may be wrapped around the inflow support 168 (eg, Fig.10 In some examples, as shown in the schematic cross-sectional view of Fig.11 As schematically shown in the detailed cross-sectional view 364 of FIG. 1 , the inflow portion of the outer skirt 300 can be wrapped around the inflow struts 168 such that the entry and exit stitches 328 of the second stitch line 324 are disposed on the inner side 338 (or interior) of the frame 102 (on both the first surface 342 and the second surface 344 of the outer skirt 300), and the entry and exit stitches 326 of the first stitch line 322 are disposed on the outer side 340 (or exterior) of the frame 102 (on both the first surface 342 and the second surface 344 of the outer skirt 300). In this configuration, and 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., in Figure 1 The first stitch line 322 and the second stitch line 324 can then be secured together around the inflow support 168.

[0112] For example, in some cases, the stitches 336 (or other fasteners) may extend through the outer skirt 300 ( Fig.11 ), thereby connecting the first stitch line 322 and the second stitch line 324 around the inflow support 168, and covering the inflow support 168 with the material of the outer skirt 300. Fig.11 As shown in FIG. 1 , stitches 326 and 328 are secured together around an axially inwardly facing surface 366 of the inflow strut 168 , and the outer skirt 300 may cover the axially outwardly facing surface 368 , the radially outwardly facing surface 370 , and the radially inwardly facing surface 372 of the inflow strut 168 .

[0113] In the alternative, the stitches (or other fasteners) may extend through the stitches 326 of the first stitch line 322 disposed on the second surface 344 of the outer skirt 300 and the stitches 328 of the second stitch line 324 disposed on the first surface 342 of the outer skirt 300 .

[0114] In some examples, the outer skirt 300 may also include a third stitch line 346 that follows the cusp edge of the leaflet when the leaflet and the outer skirt 300 are secured to the frame 102. Thus, the third stitch line 346 may also be referred to as a scalloped stitch line. Figure 6 As shown in , the third stitch line 346 may include a plurality of in and out stitches 348 that form an undulating pattern between the outflow edge portion 306 and the first stitch line 322 of the outer skirt 300. Figure 6 and Figure 7 As shown in FIG. , the third stitch line 346 may have a peak adjacent to the extension portion 312 (and the fusion window 142) and a valley at the first stitch line 322 (and thus in some cases, the third stitch line 346 and the first stitch line 322 may overlap, intersect, or be formed by the same stitch near the inflow edge portion 308).

[0115] In some cases, such as Figure 5 and Figure 6 As shown in FIG. 3 , the stitches 348 of the third stitch line 346 may extend through a preformed aperture 350 (or perforation) in the outer skirt 300. In the alternative, the stitches 348 of the third stitch line 346 may extend through the material of the outer skirt 300 (forming the aperture, for example, with a needle).

[0116] like Figure 6 and Figure 7As shown in FIG. 1 , in some examples, the outer skirt 300 may further include a fourth stitch line 352 that undulates along the outflow portion of the outer skirt 300 (adjacent to the outflow edge portion 306) so that when the outer skirt 300 is disposed around the frame 102 ( Figure 7 ), a fourth stitch line 352 extends along an angled strut 134 in the third row of angled struts (the angled struts connected to the axial struts 140 and the window struts 138). The fourth stitch line 352 may include a plurality of entry and exit stitches 354. In some cases, a portion of the fourth stitch line 352 may overlap, intersect, or be formed by the same stitch as the third stitch line 346 (e.g., along an angled strut 134 that extends along the cusp edge or scallop line of the leaflet).

[0117] In some cases, such as Figure 5 and Figure 6 As shown in FIG. 3 , the fourth stitch line 352 may extend through a preformed aperture 356 (or perforation) in the outer skirt 300. In the alternative, the stitches 254 of the fourth stitch line 352 may extend through the material of the outer skirt 300 (forming the aperture, for example, with a needle).

[0118] Fasteners, such as lock stitches 358, may be used to secure the outer skirt 300 to the support posts (eg, the outer skirt 300 of the frame 102) via the stitches of the third stitch line 346 and the fourth stitch line 352. Figure 7 ). For example, Figure 7 , the lockstitch stitch 358 can extend around the angled posts of the frame 102 and around the stitches 348 and 354 extending along the second surface 344 of the outer skirt 300 (which can be the inner surface of the outer skirt 300 disposed against the outer surface of the posts of the frame) (between the stitches and the material of the outer skirt 300). In this way, the outer skirt 300 can be more easily secured to the frame 102 without the lockstitch stitch 358 extending through the material of the outer skirt 300.

[0119] Delivery Technology

[0120] In order to implant the prosthetic valve in the native aortic valve via the transfemoral delivery method, the prosthetic valve is installed along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch and through the ascending aorta. The prosthetic valve is positioned in the native aortic valve and radially expanded (e.g., by inflating the balloon, actuating one or more actuators of the delivery device, or deploying the prosthetic valve from the sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted in the native aortic valve in a transapical surgery, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through the surgical opening in the chest and the apex, and the prosthetic valve is positioned in the native aortic valve. Alternatively, in a transaortic approach, the prosthetic valve (on the distal portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-shaped sternotomy or a right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0121] To implant a prosthetic valve into the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted in a radially compressed state along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (through a perforation made in the atrial septum), into the left atrium, and advanced toward the native mitral valve. Alternatively, the prosthetic valve can be implanted into the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0122] To implant the prosthetic valve into the native tricuspid valve, the prosthetic valve is mounted along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar method can be used to implant the prosthetic valve into the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0123] Another delivery method is a transatrial approach, in which the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (of the right or left atrium) to access any native heart valve. Atrial delivery can also be performed intravascularly, such as from the pulmonary veins. Yet another delivery method is a transventricular approach, in which the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision made through the wall of the right ventricle (usually at or near the base of the heart) to implant the prosthetic valve into the native tricuspid valve, native pulmonary valve, or pulmonary artery.

[0124] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery methods are not intended to be limited. Any prosthetic valve disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0125] Any of the systems, devices, equipment, etc. herein can be sterilized (e.g., with heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure that it is safe for use by patients, and any method herein can include sterilization of the associated systems, devices, equipment, etc. as one of the steps of the method. Examples of heating / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. For example, sterilization using hydrogen peroxide can be accomplished using hydrogen peroxide plasma.

[0126] Additional Examples of Disclosed Technology

[0127] In view of the above-mentioned embodiments of the disclosed subject matter, the present application discloses the additional examples listed below. It should be noted that one feature of a separate example or one or more features of the examples adopted in combination, and optionally combined with one or more features of one or more additional examples, are additional examples that also fall within the disclosure of the present application.

[0128] Example 1. A prosthetic heart valve, comprising: an annular frame, the annular frame including a plurality of interconnected struts, the plurality of interconnected struts including a plurality of axially extending window struts, the plurality of axially extending window struts forming a plurality of commissures spaced apart around the frame; and an outer skirt arranged around an outer surface of the frame, the outer skirt comprising: a first edge portion; a second edge portion arranged at a middle portion of the frame between a first end and a second end of the frame; and one or more extension portions, the one or more extension portions extending axially from the second edge portion and above at least a portion of a corresponding commissure of the plurality of commissures.

[0129] Example 2. A prosthetic heart valve according to any example herein, in particular Example 1, wherein the plurality of interconnected struts include a row of first struts extending circumferentially defining a first end of the frame, wherein the first edge portion is fixed to the first struts, and wherein the second edge portion is fixed to a middle portion of the frame.

[0130] Example 3. A prosthetic heart valve according to any example herein, particularly Example 2, wherein the plurality of interconnected struts include a row of second struts extending circumferentially to define the second end of the frame, a row of third struts extending circumferentially, and a plurality of axially extending struts and the plurality of axially extending window struts extending between the second struts and the third struts, and wherein the second edge portion is fixed to the end of each axially extending strut of the plurality of axially extending struts connected to the third strut.

[0131] Example 4. A prosthetic heart valve according to any example herein, particularly Example 3, wherein the second edge portion is secured to an aperture in the end of each axially extending strut connected to the third strut.

[0132] Example 5. A prosthetic heart valve according to any example herein, particularly example 3 or example 4, wherein the outer skirt is secured to the third post by a plurality of lock stitches extending around the third post and around a plurality of entry and exit stitches in the outer skirt.

[0133] Example 6. A prosthetic heart valve according to any example herein, specifically any one of Examples 2-5, wherein the outer skirt comprises two stitch lines, the two stitch lines being arranged adjacent to the first edge portion and spaced apart from each other, wherein each stitch line comprises a plurality of entry and exit stitches, and a portion of the outer skirt including the first edge portion and a first stitch line of the two stitch lines that is closest to the first edge portion is wrapped around the first pillar so that the outer skirt covers the first pillar and the two stitch lines are aligned in the radial direction of the frame.

[0134] Example 7. A prosthetic heart valve according to any example herein, particularly Example 6, wherein the two stitch lines are secured together at the axially inward facing surface of the first strut by sutures wrapped around the entry and exit stitches of the two stitch lines.

[0135] Example 8. A prosthetic heart valve according to any example herein, particularly any one of examples 1-7, wherein the first end is an inflow end of the frame, and wherein the second end is an outflow end of the frame.

[0136] Example 9. According to any example herein, in particular any one of Examples 1-8, the prosthetic heart valve further includes a plurality of leaflets arranged within the interior of the frame, wherein each of the plurality of leaflets includes two commissure tabs disposed on opposite sides of the leaflet and a cusp edge portion extending between the two commissure tabs, and wherein the commissure tabs of adjacent leaflets are paired together to form a commissure portion.

[0137] Example 10. A prosthetic heart valve according to any example herein, particularly Example 9, wherein each commissure extends through and is secured to a corresponding commissure window such that a portion of the commissure extends radially outward from the commissure window on an exterior of the frame.

[0138] Example 11. The prosthetic heart valve of any example herein, particularly Example 10, wherein each extension extends over and covers at least a portion of a corresponding commissure.

[0139] Example 12. A prosthetic heart valve according to any example herein, particularly Example 10 or Example 11, wherein each extension portion extends over and covers a first half of the corresponding joint, and the first half is arranged closer to the first end of the frame than the second half of the corresponding joint.

[0140] Example 13. A prosthetic heart valve according to any example herein, particularly any of Examples 10-12, wherein each extension portion has a width sized to cover a width of a corresponding commissure, and wherein each extension portion is secured to the corresponding commissure.

[0141] Example 14. A prosthetic heart valve according to any example herein, specifically any one of Examples 9-13, wherein the plurality of interconnected struts include a plurality of rows of angled struts extending circumferentially, wherein the outer skirt includes a stitch line, the stitch line including a plurality of entry and exit stitches, the plurality of entry and exit stitches undulating between the first edge portion and the second edge portion, and wherein the outer skirt is secured to the angled struts by a plurality of lockstitch stitches, the cusp edge portions of the plurality of leaflets extending along the angled struts, the plurality of lockstitch stitches surrounding the angled struts and extending between the plurality of entry and exit stitches of the stitch line and the material of the outer skirt.

[0142] Example 15. A prosthetic heart valve, comprising: an annular frame, the annular frame including a plurality of connection features; a plurality of leaflets, the plurality of leaflets being arranged within an interior of the frame and fixed to each other at adjacent ends to form a connection portion, wherein each connection portion is connected to a corresponding connection feature of the frame; and an outer skirt arranged around an outer surface of the frame, the outer skirt comprising: a first edge portion; a second edge portion fixed to a middle portion of the frame arranged 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 connection portion on the outside of the frame.

[0143] Example 16. A prosthetic heart valve according to any example herein, in particular Example 15, wherein each extension portion is formed as a flap having a width and a length, wherein the width and the length are sized to cover at least a portion of the width and length of the corresponding joint.

[0144] Example 17. A prosthetic heart valve according to any example herein, particularly Example 15 or Example 16, wherein each commissure protrudes radially outward from a corresponding commissure feature and an outer surface of the frame, such that each extension portion covering the corresponding commissure forms an outer covering for the frame, and the outer covering gradually tapers in a radial direction from the extension portion covering the commissure to a second edge portion of the outer skirt.

[0145] Example 18. A prosthetic heart valve according to any example herein, specifically any one of Examples 15-17, wherein the prosthetic heart valve comprises three commissures and three extension portions, wherein the first edge portion is fixed to a first end of the frame, and wherein the first end is an inflow end of the frame, and wherein the second end is an outflow end of the frame.

[0146] Example 19. A prosthetic heart valve according to any example herein, particularly any one of Examples 15-18, wherein the annular frame comprises a plurality of interconnected struts, wherein the plurality of commissure features are a plurality of axially extending window struts spaced around the frame, each axially extending window strut defining a commissure window, and wherein each commissure extends through the commissure window of a corresponding axially extending window strut and is secured to the commissure window.

[0147] Example 20. A prosthetic heart valve according to any example herein, in particular Example 19, wherein the plurality of interconnected struts define a plurality of rows of pores arranged between a first end and a second end of the frame, and wherein the axially extending window struts form an axial side of a first row of pores in the plurality of rows of pores disposed at the first end of the frame.

[0148] Example 21. A prosthetic heart valve according to any example herein, particularly Example 20, wherein the pores in the first row of pores are elongated in the axial direction relative to the pores in the remaining rows of pores in the plurality of rows of pores.

[0149] Example 22. A prosthetic heart valve according to any example herein, particularly any one of Examples 19-21, wherein the plurality of interconnected struts include a row of first struts extending circumferentially defining the second end of the frame, a row of second struts extending circumferentially, and a plurality of axial struts, and wherein 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.

[0150] Example 23. A prosthetic heart valve according to any example herein, particularly Example 22, wherein the second edge portion is fixed to the first end of the axial strut connected to the row of second struts.

[0151] Example 24. A prosthetic heart valve according to any example herein, particularly Example 23, wherein the first end of each axial strut includes an orifice therein, and the second edge portion is secured to the orifice.

[0152] Example 25. A prosthetic heart valve according to any example herein, specifically any one of Examples 22-24, wherein the outer skirt includes an undulating stitch, the undulating stitch includes a plurality of entry and exit stitches arranged adjacent to the second edge portion, and wherein the outer skirt is secured to the second pillar by a plurality of lockstitch stitches, the plurality of lockstitch stitches surround the second pillar and extend between the plurality of entry and exit stitches and the material of the outer skirt.

[0153] Example 26. A prosthetic heart valve according to any example herein, particularly any one of Examples 22-25, wherein the plurality of interconnected struts include a row of third struts extending circumferentially defining the first end of the frame, and wherein the first edge portion is wrapped around and disposed on the inner surface of the third struts.

[0154] Example 27. A prosthetic heart valve according to any example herein, in particular Example 26, wherein the outer skirt comprises: a circumferentially extending first stitch line comprising a plurality of entry and exit stitches and a circumferentially extending second stitch line comprising a plurality of entry and exit stitches, the first stitch line and the second stitch line being axially spaced apart from each other, and wherein the second stitch line is disposed adjacent to the first edge portion.

[0155] Example 28. A prosthetic heart valve according to any example herein, specifically Example 27, wherein the first stitch line and the second stitch line are radially aligned with each other and are arranged on opposite sides of the third pillar, so that the material of the outer skirt arranged between the first stitch line and the second stitch line covers the radially inward surface, the radially outward surface and the axially outward surface of the third pillar.

[0156] Example 29. A prosthetic heart valve according to any example herein, particularly Example 28, wherein the first stitch line and the second stitch line are fixed together at the axially inward surface of the third support by sutures, and the sutures are wrapped around the entry and exit stitches of the first stitch line and the entry and exit stitches of the second stitch line arranged on the inner surface of the outer skirt.

[0157] Example 30. A prosthetic heart valve, comprising: an annular frame, the annular frame including a plurality of interconnected struts and having an inflow end and an outflow end; and an outer skirt arranged around the outer surface of the frame, the outer skirt comprising: an inflow edge portion, the inflow edge portion being arranged at the inflow end; an outflow edge portion, the outflow edge portion being arranged at the middle portion of the frame; a plurality of extension portions extending axially from the outflow edge portion and circumferentially spaced from each other, wherein each extension portion extends 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, and wherein the first stitch line and the second stitch line are axially spaced from each other and each include a plurality of entry and exit stitches.

[0158] Example 31. A prosthetic heart valve according to any example herein, in particular Example 30, wherein the plurality of interconnected struts define a plurality of rows of orifice chambers arranged between the inflow end and the outflow end, wherein the plurality of interconnected struts include a plurality of axially extending window struts forming a plurality of commissures spaced apart around the frame, and wherein each extension portion extends above an inflow portion of a corresponding commissure of the plurality of commissures.

[0159] Example 32. According to any example herein, in particular the prosthetic heart valve of Example 31, it also includes a plurality of leaflets arranged within the interior of the frame, wherein each of the plurality of leaflets includes two commissure tabs disposed on opposite sides of the leaflet and a cusp edge portion extending between the two commissure tabs, and wherein the commissure tabs of adjacent leaflets are paired together to form a commissure portion.

[0160] Example 33. A prosthetic heart valve according to any example herein, in particular Example 32, wherein each commissure extends through and is fixed to a corresponding commissure window such that a portion of the commissure extends radially outward from the commissure window on the outside of the frame, and wherein each extension portion extends over and covers the inflow portion of the corresponding commissure.

[0161] Example 34. A prosthetic heart valve according to any example herein, particularly Example 33, wherein each extension portion has a width sized to cover a width of a corresponding commissure, and wherein each extension portion is secured to the corresponding commissure.

[0162] Example 35. A prosthetic heart valve according to any example herein, specifically any one of Examples 32-34, wherein the plurality of interconnected struts include a plurality of rows of angled struts extending circumferentially, wherein the outer skirt includes a third stitch line that undulates between the inflow edge portion and the outflow edge portion and includes a plurality of entry and exit stitches, and wherein the outer skirt is secured to the angled struts by a plurality of lockstitch stitches, the cusp edge portions of the plurality of leaflets extending along the angled struts, the plurality of lockstitch stitches surrounding the angled struts and extending between the plurality of entry and exit stitches of the third stitch line and the material of the outer skirt.

[0163] Example 36. A prosthetic heart valve according to any example herein, particularly Example 35, wherein the circumferentially extending multiple rows of angled struts include a first row of struts defining the outflow end, and a second row of struts, and wherein the multiple axially extending window struts extend between the first row of struts and the second row of struts.

[0164] Example 37. A prosthetic heart valve according to any example herein, particularly Example 36, wherein the plurality of interconnected struts include a plurality of axial struts extending between the first row of struts and the second row of struts and disposed between adjacent axially extending window struts, wherein each axial strut includes an inflow end including an orifice connected to an angled strut in the second row of struts, and wherein the outflow edge portion is fixed to the orifice of each axial strut.

[0165] Example 38. A prosthetic heart valve according to any example herein, particularly Example 36 or Example 37, wherein the outer skirt includes a fourth stitch line that undulates along the outflow portion of the outer skirt and includes a plurality of entry and exit stitches, and wherein the outflow portion of the outer skirt is secured to the angled struts in the second row of struts by a plurality of lockstitch stitches that surround the angled struts in the second row of struts and extend between the plurality of entry and exit stitches of the fourth stitch line and the material of the outer skirt.

[0166] Example 39. A prosthetic heart valve according to any example herein, specifically any one of Examples 30-38, wherein the inflow portion of the outer skirt is wrapped around a row of inflow struts extending circumferentially defining the inflow end of the frame, so that the first stitch line is arranged on the outer surface of the frame and the second stitch line is arranged on the inner surface of the frame, wherein the entry and exit stitches of the first stitch line and the second stitch line are radially aligned with each other across the inflow struts.

[0167] Example 40. A prosthetic heart valve according to any example herein, in particular Example 39, wherein a portion of the multiple entry and exit stitches of the first stitch line and the second stitch line disposed on the inner surface of the outer skirt are fixed together at the axially inward surface of the inflow support by sutures, and the sutures are wrapped around the portions of the multiple entry and exit stitches.

[0168] Example 41. A prosthetic heart valve according to any example herein, particularly any one of Examples 30-40, wherein the annular frame is radially compressible and expandable between a radially compressed configuration and a radially expanded configuration.

[0169] Example 42. A prosthetic heart valve, comprising: an annular frame, the annular frame including a plurality of interconnected struts, the plurality of interconnected struts defining a plurality of rows of orifice chambers arranged between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end; and an outer skirt arranged around an outer surface of the frame, the outer skirt including: an outflow edge portion, the outflow edge portion being arranged at a middle portion of the frame; and an inflow portion, the 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 the first stitch line but axially spaced apart from the first stitch line, wherein the inflow portion is wrapped around the plurality of inflow struts so that the first stitch line is arranged on the inside of the frame and the second stitch line is arranged on the outside of the frame.

[0170] Example 43. The prosthetic heart valve of any example herein, particularly Example 42, wherein the material of the outer skirt disposed between the first suture and the second suture covers the axially outward facing surfaces of the plurality of inflow struts.

[0171] Example 44. A prosthetic heart valve according to any example herein, particularly Example 42 or Example 43, wherein the first stitch line includes a plurality of first entry and exit stitches extending through the material of the outer skirt, and the second stitch line includes a plurality of second entry and exit stitches extending through the material of the outer skirt.

[0172] Example 45. A prosthetic heart valve according to any example herein, in particular Example 44, wherein the plurality of first entry and exit stitches extend through a plurality of preformed first orifices in the outer skirt, and the plurality of second entry and exit stitches extend through a plurality of preformed second orifices in the outer skirt.

[0173] Example 46. A prosthetic heart valve according to any example herein, particularly Example 44 or Example 45, wherein the first stitch line and the second stitch line are secured together at the axially inwardly facing surfaces of the plurality of inflow struts by one or more sutures extending around a portion of the first entry and exit stitches, the one or more sutures extending around a portion of the first entry and exit stitches disposed on the inner surface of the outer skirt, and a portion of the second entry and exit stitches disposed on the inner surface of the outer skirt.

[0174] Example 47. A prosthetic heart valve according to any example herein, particularly any one of Examples 42-46, 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.

[0175] Example 48. A prosthetic heart valve according to any example herein, specifically any one of Examples 42-47, further comprising a plurality of leaflets arranged within the interior of the frame, wherein each of the plurality of leaflets comprises two commissure tabs disposed on opposite sides of the leaflet and a cusp edge portion extending between the two commissure tabs, and wherein the commissure tabs of adjacent leaflets are paired together to form a commissure portion.

[0176] Example 49. A prosthetic heart valve according to any example herein, particularly Example 48, wherein the second stitch line overlaps with a third stitch line, the third stitch line undulates along the outer skirt between the outflow edge portion and the second stitch line, the third stitch line includes a plurality of third entry and exit stitches, and wherein the outer skirt is secured to the angled struts of the frame using a plurality of lockstitch stitches, the angled struts following the cusp edge portion of each leaflet, the plurality of lockstitch stitches surrounding the angled struts and extending between the plurality of third entry and exit stitches and the material of the outer skirt.

[0177] Example 50. A prosthetic heart valve according to any example herein, particularly Example 49, wherein the outer skirt further comprises a fourth stitch line, the fourth stitch line partially overlapping the third stitch line and undulating along the outflow portion of the outer skirt adjacent to the outflow edge portion, the fourth stitch line comprising a plurality of fourth entry and exit stitches, and wherein the outer skirt is secured to a circumferentially extending row of angled struts of the frame disposed at a middle portion of the frame by a plurality of lockstitch stitches, the plurality of lockstitch stitches surrounding the angled struts in the circumferentially extending row of angled struts and extending between the plurality of fourth entry and exit stitches and the material of the outer skirt.

[0178] Example 51. A prosthetic heart valve according to any example herein, particularly any one of Examples 48-50, wherein the plurality of interconnected struts further comprises a row of angled struts extending circumferentially and a plurality of axially extending window struts spaced circumferentially around the frame, the plurality of axially extending window struts extending between the plurality of outflow struts and the row of angled struts, wherein each axially extending window strut defines a commissure, and wherein each commissure extends through a corresponding commissure window on the exterior of the frame and protrudes radially outward from the corresponding commissure window.

[0179] Example 52. A prosthetic heart valve according to any example herein, in particular Example 51, wherein the outer skirt includes a plurality of extension portions extending outward from the outflow edge portion toward the outflow end of the frame, and wherein each extension portion extends over and covers at least a portion of a corresponding joint portion.

[0180] Example 53. A prosthetic heart valve according to any example herein, particularly Example 52, wherein each extension portion is secured to the corresponding commissure via sutures extending through the extension portion and the commissure on the exterior of the frame.

[0181] Example 54. A method comprising sterilizing the prosthetic heart valve, device, and / or component of any example.

[0182] Example 55. A prosthetic heart valve according to any of Examples 1-53, wherein the prosthetic heart valve is sterilized.

[0183] Unless otherwise stated, features described herein with respect to any example may be combined with other features described in any one or more of the other examples. For example, any one or more of the features of one frame may be combined with any one or more of the features of another frame. As another example, any one or more of the features of one skirt may be combined with any one or more of the features of another skirt.

[0184] In view of the many possible ways in which the principles of the present disclosure can be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure, nor should they be taken as limiting the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A prosthetic heart valve, comprising: an annular frame including a plurality of interconnected struts including a plurality of axially extending window struts forming a plurality of commissure windows spaced about the frame; as well as An outer skirt is arranged around the outer surface of the frame, and the outer skirt comprises: a first edge portion; a second edge portion disposed at a middle portion of the frame disposed between the first end and the second end of the frame; and One or more extension portions extend axially from the second edge portion and over at least a portion of a corresponding commissure of the plurality of commissures.

2. A prosthetic heart valve according to claim 1, wherein the plurality of interconnected struts include a row of first struts extending circumferentially defining a first end of the frame, wherein the first edge portion is secured to the first struts, and wherein the second edge portion is secured to a mid-portion of the frame.

3. A prosthetic heart valve according to claim 2, wherein the plurality of interconnected struts include a row of second struts extending circumferentially defining the second end of the frame, a row of third struts extending circumferentially, and a plurality of axially extending struts, wherein the plurality of axially extending struts and the plurality of axially extending window struts extend between the second struts and the third struts, and wherein the second edge portion is fixed to the end of each axially extending strut of the plurality of axially extending struts connected to the third strut.

4. A prosthetic heart valve according to any one of claims 2-3, wherein the outer skirt includes two stitch lines, the two stitch lines are arranged adjacent to the first edge portion and spaced apart from each other, wherein each stitch line includes a plurality of entry and exit stitches, and a portion of the outer skirt including the first edge portion and a first stitch line of the two stitch lines that is closest to the first edge portion is wrapped around the first pillar so that the outer skirt covers the first pillar and the two stitch lines are aligned in the radial direction of the frame.

5. The prosthetic heart valve of claim 4, wherein the two stitch lines are secured together at the axially inwardly facing surface of the first strut by sutures wrapped around the two stitch lines with passing stitches.

6. The prosthetic heart valve of any one of claims 1-5, wherein the first end is an inflow end of the frame, and wherein the second end is an outflow end of the frame.

7. The prosthetic heart valve according to any one of claims 1-6 further comprises a plurality of leaflets arranged within the interior of the frame, wherein each of the plurality of leaflets comprises two commissure tabs disposed on opposite sides of the leaflet and a cusp edge portion extending between the two commissure tabs, and wherein the commissure tabs of adjacent leaflets are paired together to form a commissure portion.

8. A prosthetic heart valve according to claim 7, wherein each commissure extends through and is fixed to a corresponding commissure window, so that a portion of the commissure extends radially outward from the commissure window on the exterior of the frame, and wherein each extension portion extends over and covers at least a portion of the corresponding commissure.

9. A prosthetic heart valve, comprising: an annular frame comprising a plurality of commissure features; a plurality of leaflets disposed within an interior of the frame and secured to one another at adjacent ends to form commissures, wherein each commissure is connected to a corresponding commissure feature of the frame; as well as An outer skirt is arranged around the outer surface of the frame, and the outer skirt comprises: a first edge portion; a second edge portion secured to a middle portion of the frame disposed between the first end and the second end of the frame; and A plurality of extensions extend axially from the second edge portion, each extension covering at least a portion of a corresponding commissure on an exterior of the frame.

10. The prosthetic heart valve of claim 9, wherein each extension 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.

11. A prosthetic heart valve according to claim 9 or claim 10, wherein each commissure protrudes radially outward from a corresponding commissure feature and an outer surface of the frame, so that each extension portion covering the corresponding commissure forms an outer covering for the frame, and the outer covering gradually tapers in a radial direction from the extension portion covering the commissure to a second edge portion of the outer skirt.

12. A prosthetic heart valve according to any one of claims 9-11, wherein the prosthetic heart valve comprises three commissures and three extension portions, wherein the first edge portion is fixed to a first end of the frame, and wherein the first end is an inflow end of the frame, and wherein the second end is an outflow end of the frame.

13. A prosthetic heart valve according to any one of claims 9-12, wherein the annular frame includes a plurality of interconnected struts, wherein the plurality of commissure features are a plurality of axially extending window struts spaced around the frame, each axially extending window strut defining a commissure window, and wherein each commissure extends through the commissure window of a corresponding axially extending window strut and is secured to the commissure window.

14. A prosthetic heart valve according to claim 13, wherein the plurality of interconnected struts include a row of first struts extending circumferentially defining the second end of the frame, a row of second struts extending circumferentially, and a plurality of axial struts, and wherein 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 prosthetic heart valve of claim 14, wherein the second edge portion is secured to a first end of the axial strut connected to the row of second struts.

16. A prosthetic heart valve according to claim 14 or claim 15, wherein the plurality of interconnected struts include a row of third struts extending circumferentially defining the first end of the frame, and wherein the first edge portion is wrapped around and disposed on the inner surface of the third struts.

17. The prosthetic heart valve of claim 16, wherein the outer skirt comprises: A circumferentially extending first stitch line including a plurality of entry and exit stitches and a circumferentially extending second stitch line including a plurality of entry and exit stitches, the first stitch line and the second stitch line being axially spaced apart from each other and wherein the second stitch line is disposed adjacent to the first edge portion.

18. A prosthetic heart valve according to claim 17, wherein the first stitch line and the second stitch line are radially aligned with each other and are arranged on opposite sides of the third pillar, so that the material of the outer skirt arranged between the first stitch line and the second stitch line covers the radially inward surface, the radially outward surface and the axially outward surface of the third pillar.

19. A prosthetic heart valve, comprising: an annular frame comprising a plurality of interconnected struts and having an inflow end and an outflow end; as well as An outer skirt is arranged around the outer surface of the frame, and the outer skirt comprises: an inflow edge portion disposed at the inflow end; an outflow edge portion disposed at a middle portion of the frame; a plurality of extensions extending axially from the outflow edge portion and circumferentially spaced from one another, wherein each extension extends toward an outflow end of the frame; and A first stitch line and a second stitch line extend circumferentially along an inflow portion of the outer skirt including the inflow edge portion, and wherein the first stitch line and the second stitch line are axially spaced from each other and each include a plurality of entry and exit stitches.

20. A prosthetic heart valve according to claim 19, wherein the plurality of interconnected struts define a plurality of rows of aperture chambers arranged between the inflow end and the outflow end, wherein the plurality of interconnected struts include a plurality of axially extending window struts forming a plurality of commissures spaced apart around the frame, and wherein each extension portion extends above an inflow portion of a corresponding commissure of the plurality of commissures.

21. A prosthetic heart valve according to claim 19 or claim 20, wherein the inflow portion of the outer skirt is wrapped around a row of inflow struts extending circumferentially defining the inflow end of the frame, so that the first stitch line is arranged on the outer surface of the frame and the second stitch line is arranged on the inner surface of the frame, wherein the entry and exit stitches of the first stitch line and the second stitch line are radially aligned with each other across the inflow struts.

22. A prosthetic heart valve according to claim 21, wherein a portion of the multiple entry and exit stitches of the first stitch line and the second stitch line arranged on the inner surface of the outer skirt are fixed together by sutures at the axially inward surface of the inflow support, and the sutures are wrapped around the portions of the multiple entry and exit stitches.

Images