Outer skirt for 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 and an outer skirt disposed about an outer surface of the frame. The outer skirt may include: a first portion comprising a polymeric material; and a second portion comprising a fabric wherein the polymer material has a greater antithrombotic property than the fabric. The second portion is fixed to an inflow end of the frame and extends toward a middle portion of the frame, and the first portion extends from the second portion and toward an outflow end of the frame.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 366,599, filed on June 17, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to prosthetic heart valves, and in particular to an outer cover or skirt comprising multiple layers 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 natural valve or replacing the natural valve with an artificial valve. There are many known repair devices (e.g., stents) and artificial 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 by 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 on which a prosthetic valve is installed, 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 cylindrical metal frame or stent, and prosthetic leaflets mounted inside the frame. These valves may also include one or more covers (or skirts) that span the perimeter of the frame on the inner or outer surface of the frame. These covers can be configured to establish a seal with natural tissue when the prosthetic heart valve is placed at the implantation site (and can therefore be referred to as a sealing member). However, natural tissue (e.g., the natural valve annulus or arterial wall around the natural valve) can have an irregular shape, while the frame of the prosthetic heart valve is generally cylindrical. Therefore, when the prosthetic heart valve is implanted in the natural heart valve annulus, a gap can be formed between the prosthetic heart valve and the natural heart valve annulus even when the cover is included on the prosthetic heart valve. Therefore, there is a need for an improved cover or outer skirt for a prosthetic heart valve. Summary of the invention

[0006] Prosthetic heart valves, delivery devices, and methods for implanting prosthetic heart valves are described herein. Specifically, examples of outer skirts for prosthetic heart valves and methods for making and using such outer skirts are described herein. The prosthetic heart valve may include a frame and a leaflet assembly arranged on an inner surface of the frame. The prosthetic heart valve may include an outer skirt arranged around the circumference of the frame and the outer surface of the frame. The outer skirt may include two or more parts or layers comprising different materials. For example, the outer skirt may include: a first part, the first part comprising a polymer material; and a second part, the second part comprising a fabric, the first part extending further toward the outflow end of the frame than the second part. In some examples, the first part may be an inner layer of the outer skirt, and the second part may be an outer layer of the outer skirt. The thrombotic resistance of the first part may be higher than the thrombotic resistance of the second part. In this way, the skirt and prosthetic heart valve disclosed herein may (especially) overcome one or more defects of typical prosthetic heart valves.

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

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

[0009] In some examples, the sealing member can be an outer skirt disposed around an outer surface of the frame.

[0010] In some examples, the outer skirt may include a first portion comprising a polymer material and a second portion comprising a fabric.

[0011] In some examples, the second portion is secured to an inflow end of the frame and extends toward a middle portion of the frame, and the first portion extends from the second portion and toward an outflow end of the frame.

[0012] In some examples, the outer skirt includes an outer layer comprising a fabric; and an inner layer comprising a polymer material and covering an inner surface of the outer layer.

[0013] In some examples, the inner layer extends beyond an outflow edge portion of the outer layer toward an outflow end of the frame.

[0014] In some examples, the outer fabric layer is releasably attached to the inner layer.

[0015] In some examples, the sealing member includes at least one layer including a plurality of microscale scales formed on a surface thereof.

[0016] In some instances, the sealing member includes a base layer comprising a polymer material disposed against an outer surface of the frame; and a plurality of outwardly extending yarns adhered to the outer surface of the base layer and extending radially outward and away from the base layer.

[0017] In some examples, a prosthetic heart valve includes an annular frame having an inflow end, an outflow end, and a middle portion disposed between the inflow end and the outflow end; and an outer skirt disposed around an outer surface of the frame. The outer skirt includes: a first portion, the first portion includes a polymer material; and a second portion, the second portion includes a fabric. The polymer material has a greater thrombogenicity than the fabric, the second portion is fixed to the inflow end of the frame and extends toward the middle portion, and the first portion extends from the second portion and toward the outflow end of the frame.

[0018] In some examples, a prosthetic heart valve comprises an annular frame; and an outer skirt disposed around an outer surface of the frame. The outer skirt comprises an outer layer comprising a fabric and forming an exposed surface for contacting tissue; and an inner layer comprising a polymer material and covering an inner surface of the outer layer, wherein the inner layer extends beyond an outflow edge portion of the outer layer toward an outflow end of the frame.

[0019] In some examples, a prosthetic heart valve comprises an annular frame having an inflow end, an outflow end, and a middle portion disposed between the inflow end and the outflow end; and an outer skirt disposed around an outer surface of the frame. The outer skirt comprises an inner layer comprising a polymer material; and an outer layer comprising a fabric and attached to the inner layer. The outer layer comprises a first outer layer portion and a second outer layer portion, wherein the first outer layer portion extends from the inflow end of the frame toward the middle portion of the frame, and wherein the second outer layer portion extends from the first outer layer portion toward the outflow end. An outflow edge portion of the inner layer extends axially beyond an outflow edge portion of the second outer layer portion toward the outflow end of the frame, such that the outflow edge portion of the inner layer is disposed closer to the outflow end of the frame than the outflow edge portion of the second outer layer portion.

[0020] In some examples, a prosthetic heart valve comprises an annular frame having an inflow end and an outflow end; and an outer skirt disposed around an outer surface of the frame. The outer skirt comprises an inner layer and a fabric outer layer, the fabric outer layer being releasably attached to the inner layer by a plurality of whip sutures and a traction suture. The plurality of whip sutures extend around the traction sutures and through the inner layer and the outer layer, and the traction sutures are configured to be pulled through and away from the whip sutures, thereby separating the outer layer from the inner layer.

[0021] In some instances, a prosthetic heart valve includes an annular frame; a valve structure disposed in the frame and configured to regulate blood flow through the frame in one direction; and a skirt coupled to the frame, the skirt including at least one layer including a plurality of micrometer-sized scales formed on a surface thereof.

[0022] In some examples, a prosthetic heart valve comprises an annular frame; and an outer skirt disposed around an outer surface of the frame. The outer skirt comprises a base layer comprising a polymer material disposed against the outer surface of the frame; and a plurality of outwardly extending yarns adhered to the outer surface of the base layer and extending radially outward and away from the base layer.

[0023] In some examples, a prosthetic heart valve includes one or more of the components described in Examples 1-78 below.

[0024] 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 specific embodiments 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 specific embodiments, claims and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 is a perspective view of a prosthetic heart valve according to one embodiment.

[0026] Figure 2 is a side view of an example of a delivery device configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site.

[0027] Figure 3 is a perspective view of a prosthetic heart valve including a fabric outer skirt disposed around an outer surface of a frame of the prosthetic heart valve.

[0028] Figure 4 yes Figure 3 Cross-sectional side view of the frame and outer skirt of a prosthetic heart valve.

[0029] Figure 5 is a cross-sectional side view of an exemplary prosthetic heart valve including an outer skirt having a polymer inner layer and a fabric outer layer.

[0030] Figure 6 yes Figure 5 A cross-sectional side view of a prosthetic heart valve of , showing an example in which the outflow end portion of the inner layer of the outer skirt is folded over the outflow end portion of the outer layer.

[0031] Figure 7 yes Figure 5 A cross-sectional side view of a prosthetic heart valve showing an example in which the outflow end portion and the inflow end portion of the inner layer of the outer skirt are folded over the outflow end portion and the inflow end portion of the outer layer, respectively.

[0032] Fig. 8A yes Figure 5 A cross-sectional side view of a prosthetic heart valve showing an example in which the outflow end portion and the inflow end portion of the inner layer of the outer skirt are folded over the outflow end portion and the inflow end portion of the outer layer, respectively, and fused together to form a ring at the outflow end portion and the inflow end portion of the outer skirt.

[0033] Figure 8B yes Fig. 8A A cross-sectional side view of a prosthetic heart valve of the type shown in FIG. 1 , wherein the outer layer comprises a fabric base layer and a plurality of yarns extending outwardly.

[0034] Figure 8C yes Fig. 8A A cross-sectional side view of a prosthetic heart valve of the type shown in FIG. 1 , wherein the outer layer comprises a plurality of outwardly extending yarns directly adhered to the inner layer.

[0035] Fig. 9 is a perspective view of another example of a prosthetic heart valve comprising a frame having a row of elongated cells at an outflow end of the frame and an outer skirt disposed about an outer surface of the frame and extending from the inflow ends of the elongated cells to the inflow end of the frame.

[0036] Fig.10 is a schematic diagram of an exemplary skirt for a prosthetic heart valve in a flat configuration, wherein the skirt includes a polymer first portion and a fabric second portion disposed adjacent to each other.

[0037] Fig.11 Shows Fig.10A portion of an outer skirt is disposed around an outer surface of a portion of a frame of a prosthetic heart valve.

[0038] Fig. 12A yes Fig.11 A cross-sectional side view of the outer skirt and frame.

[0039] Fig. 12B It is arranged in Fig.11 A cross-sectional side view of another exemplary outer skirt on an outer surface of a frame, wherein a polymer first portion of the outer skirt forms an inner layer covering a fabric second portion of the outer skirt.

[0040] FIG. 13A is a SEM image of a shark skin surface containing rib structures at 50× magnification.

[0041] FIG. 13B is a SEM image of a shark skin surface containing rib structures at 200× magnification.

[0042] FIG. 13C is a SEM image of a shark skin surface comprising rib structures at 1000× magnification.

[0043] FIG. 14A is a schematic diagram illustrating a method for replicating a shark skin surface via PDMS elastomer molding.

[0044] FIG. 14B is a schematic diagram showing another method for replicating shark skin surface via PDMS embedded elastomer molding.

[0045] Fig.15 is a cross-sectional side view of an outer skirt comprising simulated micron-scale scales on a layer of the outer skirt and attached to a frame of a prosthetic heart valve.

[0046] Fig.16 is a side view of a portion of another example of an outer skirt disposed around an outer surface of a portion of an exemplary frame for a prosthetic heart valve, the outer skirt comprising a polymer inner layer and a fabric outer layer, the fabric outer layer comprising two fabric outer layer portions, the inner layer extending beyond the fabric outer layer toward an outflow end of the frame.

[0047] Fig.17 yes Fig.16 A schematic cross-sectional side view of an outer skirt of FIG. 1 showing a first outer layer portion of the outer layer and a floating yarn segment of a second outer layer portion of the outer layer extending from the first outer layer portion.

[0048] Fig.18 is against Fig.16 The outer surface of the frame is placed Fig.16 Schematic cross-sectional side view of an outer skirt of FIG. 1 , wherein an end portion of the second outer layer portion is wrapped around an inflow apex of the frame.

[0049] Fig.19 is a side view of a portion of another example of an outer skirt disposed around an outer surface of a portion of an exemplary frame for a prosthetic heart valve, the outer skirt comprising a polymer inner layer and a fabric outer layer, the fabric outer layer being releasably attached to the inner layer by pull sutures and whip sutures, the inner layer extending beyond the fabric outer layer toward an outflow end of the frame.

[0050] Fig. 20 yes Fig.19 A schematic cross-sectional view of an outer skirt and frame of FIG. 1 showing a traction suture extending along an upper edge portion of the outer layer and a whip stitch extending around the traction suture and through the outer skirt and the inner skirt.

[0051] Fig.21 yes Fig.19 A perspective view of an outer skirt disposed around an outer surface of a frame of a prosthetic heart valve. DETAILED DESCRIPTION

[0052] General considerations

[0053] 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.

[0054] Although the operations of some of the disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this manner of description encompasses rearrangement unless the specific language set forth below requires a particular ordering. For example, in some cases, the operations described in sequence may be rearranged 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. Additionally, 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 according to the specific implementation and are easily discernible by those of ordinary skill in the art.

[0055] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises". Further, the term "coupled" generally means physical, mechanical, chemical, magnetic, and / or electrical coupling or connection, and does not exclude the presence of intervening elements between coupled or associated items absent specific language to the contrary.

[0056] As used herein, the term "proximal" refers to a device that is closer to the user and further away from the location, direction or part of the implantation site. As used herein, the term "distal" refers to a device that is further away from the user and closer to the location, direction or part of the implantation site. Therefore, for example, the proximal movement of the device is the movement of the device away from the implantation site and toward the user (e.g., leaving the patient's body), and the distal movement of the device is the movement of the device away from the user and toward the implantation site (e.g., entering the patient's body). The terms "longitudinal" and "axial" refer to the axis extending in the proximal and distal directions, unless otherwise clearly defined.

[0057] As used herein, "such as" means "for example," and "ie" means "that is to say."

[0058] Overview of Public Technology

[0059] 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.

[0060] As described above, most prosthetic heart valves can include an outer skirt disposed around the outer surface of the annular frame of the prosthetic heart valve. The outer skirt can be 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 the native anatomical structure. Figure 1 An exemplary prosthetic device (e.g., a prosthetic heart valve) is shown that includes a frame, leaflets secured to the inner side of the frame, and an outer skirt disposed around the outer surface of the frame. The prosthetic device can be delivered by a delivery device (e.g., Figure 2 The exemplary delivery device shown) is advanced through the patient's vasculature, such as to a native heart valve.

[0061] In some embodiments, an outer skirt (eg, Figure 3 and 4 The outer skirt (depicted in ) can be configured with a portion extending radially outward (toward the surrounding native anatomy) from the frame of the prosthetic heart valve to increase the PVL seal to the native anatomy. For example, Figure 3 and 4 The outer skirt as shown can include a relatively dense arrangement of outwardly projecting yarns. However, in some cases, such a configuration can increase the curling profile of the prosthetic heart valve when the prosthetic heart valve is radially compressed onto a delivery device. Thus, in some cases, the outer skirt can include an inner anti-thrombotic layer and an outer fabric layer that includes a less dense arrangement of outwardly projecting yarns, such as Figure 5-8B Thus, the density of the outwardly protruding yarns of the fabric layer can be reduced so that the overall curl profile of the prosthetic heart valve is reduced while still maintaining an effective PVL seal (via the anti-thrombotic inner layer).

[0062] In some examples, a frame of a prosthetic heart valve can include a circumferentially extending first elongated first cell row (at the outflow end of the frame). The outflow end of the outer skirt of the prosthetic heart valve can be fixed to the frame along the lower struts forming the first cell row, such as Fig. 9 as shown. However, such a configuration may cause the outer skirt to have a relatively short axial height, thereby leaving less surface area for sealing with the native anatomical structure at the implantation site. If the outflow end of the outer skirt were to extend over a portion of the first unit row (e.g., the inflow end portion or the lower end portion above the first unit), more surface area for PVL sealing would be created. However, due to the slender axial length of the first unit, the portion of the outer skirt that extends across the first unit (between the axial struts that form the upper unit) can extend or flutter into the interior of the prosthetic heart valve (through the first unit). Therefore, in some cases, the outer skirt may include an outflow (or upper) portion, the outflow (or upper) portion comprising a polymer material (e.g., thermoplastic polyurethane (TPU)); and an inflow (or lower) portion, the inflow (or lower) portion comprising a reinforcing fabric (e.g., a woven fabric that promotes tissue ingrowth and PVL sealing to native tissue), wherein the outflow portion is configured to stretch around and cover a portion of the first unit, such as Figure 10-12B Thus, without the need for the outer skirt to extend to the interior of the frame through the elongated first unit, an increased surface area for PVL sealing can be created.

[0063] In some examples, the surface of the prosthetic heart valve (such as the inner surface of the outer skirt) can include a micron-scale scale structure that is configured to reduce drag and, in some cases, simulate shark scales. Such surfaces and examples of forming these surfaces are shown in Figures 13A-15. Thus, the inner surface of the outer skirt can be configured to reduce debris accumulation and / or calcification thereon, thereby increasing the long-term durability of the outer skirt.

[0064] Additionally, in some examples, the outer skirt can include an inner layer comprising a polymer material (e.g., TPU); and an outer layer attached to the inner layer and comprising one or more fabric portions configured to contact tissue at the implantation site, such as Figure 16-21 As shown. The outflow edge portion of the inner layer can extend beyond the outflow edge portion of the outer layer. In some cases, the outer layer can include two fabric portions, the fabric portions including a first outer layer portion, the first outer layer portion including a fabric wrapped around the inflow apex of the frame; and a second outer layer portion, the second outer layer portion including a plurality of floating fibers extending between the leno yarns of the second outer layer portion. The second outer layer portion can extend from the first outer layer portion toward the outflow end of the frame, wherein the outflow edge portion of the second outer layer portion is axially offset from the upper edge portion of the inner layer. In some cases, the outer layer can be releasably attached to the inner layer by a traction suture ( Fig.19 and 20 ). Thus, during an explantation procedure, the prosthetic heart valve including the inner layer of the frame and the outer skirt may be more easily explanted.

[0065] Examples of the disclosed technology

[0066] Figure 1 An exemplary prosthetic valve 10 according to one example is shown. Any of the prosthetic valves disclosed herein is suitable for implantation in the native aortic annulus, but in other instances, 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 blood 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 blood 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.

[0067] In some examples, the disclosed prosthetic valve can be implanted in a docking or anchoring device implanted in a natural heart valve or vessel. For example, in one example, the disclosed prosthetic valve can be implanted in a docking device implanted in the pulmonary artery to replace the function of a diseased pulmonary valve, 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 natural 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.

[0068] The prosthetic valve 10 includes four major components: a stent or frame 12, a valve structure 14, an inner skirt 16, and a perivalvular sealing member or outer skirt 18. The prosthetic valve 10 can have an inflow end portion 15, a middle portion 17, and an outflow end portion 19. The inner skirt 16 can be disposed on and / or coupled to an inner surface of the frame 12, while the outer skirt 18 can be disposed on and / or coupled to an outer surface of the frame 12.

[0069] The valve structure 14 can include three leaflets 40 that together form a leaflet structure that can be arranged to collapse in a tricuspid valve arrangement, but in other instances, there can be a greater or lesser number of leaflets (e.g., one or more leaflets 40). The leaflets 40 can be secured to each other at their adjacent sides to form the commissures 22 of the leaflet structure 14. The lower edge of the valve structure 14 can have a wavy curved fan shape and can be secured to the inner skirt 16 by sutures (not shown). In some instances, the leaflets 40 can be formed of pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or various other suitable natural or synthetic materials as known in the art and described in U.S. Pat. No. 6,730,118, which is incorporated herein by reference.

[0070] The frame 12 may be radially compressible (collapsible) and expandable (e.g., Figure 1 The expanded configuration shown in FIG. 10 ) and includes a plurality of interconnected struts 24. A plurality of circumferentially spaced apexes 26 are formed at the inflow end portion 15 and the outflow end portion 19 of the frame 12 (at Figure 1 Only the vertices 26 at the outflow end portion 19 are visible. Each vertex 26 is formed at the junction between two angled struts 24 at the inflow end portion 15 or the outflow end portion 19. Figure 1 A known frame design is depicted having an apex 26 that forms a U-shaped bend between two angled struts 24. In some examples, the angle 30 between the two angled struts 24 connected at the apex 26 may be in the range of 90 to 120 degrees.

[0071] The framework 12 can be formed with grooves or commissure windows 20 that are suitable for mounting the commissure 22 of the valve structure 14 to a plurality of circumferential intervals of the framework. The framework 12 can be made of any material in various suitable plastic expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol). When constructed by plastic expandable materials, the framework 12 (and therefore the prosthetic valve 10) can be curled to a radially collapsed configuration on a delivery catheter or device, and then expanded in the patient's body by an inflatable balloon or an equivalent expansion mechanism. When constructed by self-expandable materials, the framework 12 (and therefore the prosthetic valve 10) can be curled to a radially collapsed configuration, and be suppressed in a collapsed configuration by being inserted into a sheath or an equivalent mechanism of a delivery catheter. Once entering the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0072] Suitable plastic expandable materials that can be used to form the frame 12 include metal alloys, polymers, or combinations thereof. Example metal alloys can include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some instances, the frame 12 can include stainless steel. In some instances, the frame 12 can include a cobalt-chromium alloy. In some instances, the frame 12 can include nickel-cobalt-chromium. In some instances, the frame 12 includes a nickel-cobalt-chromium-molybdenum alloy, such as MP35N. TM (Trade name of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N TM / UNSR30035 contains by weight 35% nickel, 35% cobalt, 20% chromium and 10% molybdenum.

[0073] Additional details regarding the prosthetic valve 10 and its various components are described in WIPO patent application publication WO2018 / 222799, which is incorporated herein by reference.

[0074] Figure 2 A delivery device 100 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 100 is particularly suitable for introducing a prosthetic valve into the heart.

[0075] Figure 2 The delivery device 100 in the illustrated example is a balloon catheter including a handle 102 and a steerable outer shaft 104 extending distally from the handle 102. The delivery device 100 may further include an intermediate shaft 106 (which may also be referred to as a balloon shaft) extending proximally from the handle 102 and extending distally from the handle 102, the portion extending distally from the handle 102 also coaxially extending through the outer shaft 104. Additionally, the delivery device 100 may further include an inner shaft 108 extending distally from the handle 102 coaxially through the intermediate shaft 106 and the outer shaft 104, and extending proximally from the handle 102 coaxially through the intermediate shaft 106.

[0076] The outer shaft 104 and the intermediate shaft 106 can be configured to longitudinally translate (eg, move) relative to each other along a central longitudinal axis 120 of the delivery device 100 to facilitate delivery and positioning of a prosthetic valve at an implantation site within a patient.

[0077] The intermediate shaft 106 may include a proximal end portion 110 extending proximally from the proximal end of the handle 102 to the adapter 112. A rotatable knob 114 may be mounted on the proximal end portion 110 and may be configured to rotate the intermediate shaft 106 about the central longitudinal axis 120 and relative to the outer shaft 104.

[0078] The adapter 112 can include a first port 138 configured to receive a guidewire therethrough and a second port 140 configured to receive a fluid (eg, an inflation fluid) from a fluid source. The second port 140 can be fluidly coupled to the inner lumen of the intermediate shaft 106.

[0079] The intermediate shaft 106 can further include a distal end portion that extends distally beyond the distal end of the outer shaft 104 when the distal end of the outer shaft 104 is positioned away from the inflatable balloon 118 of the delivery device 100. The distal end portion of the inner shaft 108 can extend distally beyond the distal end portion of the intermediate shaft 106.

[0080] The balloon 118 can be coupled to the distal end portion of the intermediate shaft 106 .

[0081] In some examples, the distal end of the balloon 118 can be coupled to the distal end of the delivery device 100, such as to the nose cone 122 (eg, Figure 2100 ), or an alternative component (e.g., a distal shoulder) coupled to the distal end of the delivery device 100. The middle portion of the balloon 118 can cover the valve mounting portion 124 of the distal end portion of the delivery device 100, and the distal end portion of the balloon 118 can cover the distal shoulder 126 of the delivery device 100. The valve mounting portion 124 and the middle portion of the balloon 118 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as Figure 2 As schematically shown in , a prosthetic heart valve 150 , which may be one of the prosthetic valves described herein, may be mounted around a balloon 118 at a valve mounting portion 124 of the delivery device 100 .

[0082] The balloon shoulder assembly, including the distal shoulder 126, is configured to maintain the prosthetic heart valve 150 (or other medical device) in a fixed position on the balloon 118 during delivery through the patient's vasculature.

[0083] The outer shaft 104 may include a distal tip portion 128 mounted on its distal end. Figure 2 ), and during delivery of the prosthetic valve to a target implantation site, the outer shaft 104 and the intermediate shaft 106 can be axially translated relative to each other to position the distal tip portion 128 adjacent to the proximal end of the valve mounting portion 124. Thus, the distal tip portion 128 can be configured to resist proximal movement of the prosthetic valve 150 relative to the balloon 118 in an axial direction when the distal tip portion 128 is disposed adjacent to the proximal side of the valve mounting portion 124.

[0084] An annular space can be defined between the outer surface of the inner shaft 108 and the inner surface of the intermediate shaft 106, and can be configured to receive fluid from a fluid source via the second port 140 of the adapter 112. The annular space can be fluidly coupled to a fluid passage formed between the outer surface of the distal end portion of the inner shaft 108 and the inner surface of the balloon 118. Thus, fluid from the fluid source can flow from the annular space to the fluid passage to inflate and radially expand the balloon 118 and deploy the prosthetic valve 150.

[0085] The inner lumen of the inner shaft can be configured to receive a guidewire therethrough for guiding the distal end portion of the delivery device 100 to a target implantation site.

[0086] The handle 102 may include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 100. In the illustrated example, for example, the handle 102 includes an adjustment member, such as a rotatable knob 160 as illustrated, which is in turn operatively coupled to the proximal end portion of the traction wire. The traction wire may extend distally from the handle 102 through the outer shaft 104 and have a distal end portion fixed to the outer shaft 104 at or near the distal end of the outer shaft 104. Rotating the knob 160 may increase or decrease the tension in the traction wire, thereby adjusting the curvature of the distal end portion of the delivery device 100. Further details on the steering or flexing mechanism for the delivery device may be found in U.S. Pat. No. 9,339,384, which is incorporated herein by reference.

[0087] The handle 102 can further include an adjustment mechanism 161 and an associated locking mechanism, the adjustment mechanism including an adjustment member, such as a rotatable knob 162 as shown, the locking mechanism including another adjustment member configured as a rotatable knob 178. The adjustment mechanism 161 is configured to adjust the axial position of the intermediate shaft 106 relative to the outer shaft 104 (e.g., for fine positioning at the implantation site). Additional details about the delivery device 100 can be found in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference.

[0088] Figure 3 and 4 Another exemplary outer skirt 206 for a prosthetic heart valve 200 is depicted that is configured to increase the PVL leak seal with the native anatomy once the prosthetic heart valve 200 has been radially expanded within the native anatomy, such as at the native heart valve annulus. Figure 3 In the example of FIG. 1 , an outer skirt 206 is shown disposed around the outer surface of a radially expandable and compressible annular frame 202 of a prosthetic heart valve, while a plurality of leaflets 204 are secured to and disposed on the interior of the frame 202. The frame 202 may be similar to Figure 1 The frame 12 of the prosthetic valve 10. In some cases, the outer skirt 206 can be used to replace the outer skirt 18 on the prosthetic valve 10.

[0089] The outer skirt 206 can include a fabric body formed from a plurality of strands or yarns that are woven, knitted, or otherwise secured together. In some cases, the outer skirt 206 can include a woven or knitted fabric that includes a fabric base layer 207 that extends radially outward and away from the frame 202 and a plurality of pile yarns (e.g., loop yarns) or floating yarns 208 ( Figure 3 and 4). For example, the base layer 207 may include warp and weft yarns knitted into a mesh structure, and the pile yarns or floating yarns 208 may be knitted or woven into the base layer 207 and extend outwardly from the base layer.

[0090] The pile yarn or floating yarn 208 can give the outer skirt 206 a fluffy, plush or velvety appearance. In addition, the floating yarn 208 protruding outward can be relatively densely packed together (such as Figure 4 ) and is configured to increase the PVL seal with the native anatomical structure when the prosthetic heart valve 200 is implanted. However, the densely packed floating yarns 208 can increase the radial compression of the prosthetic heart valve 200 to the delivery device (such as Figure 2 The curling profile when on the delivery device 100).

[0091] Additional details regarding skirts for prosthetic heart valves comprising knitted or woven material and pile or floating yarns are disclosed in U.S. Patent Publication 2019 / 0374337 and International Patent Publication WO 2021 / 202636, which are incorporated herein by reference.

[0092] In some instances, such as Figure 3 and 4 As shown, the outer skirt 206 can further include a plurality of loops 210 extending along an upper edge portion or outflow edge portion 212 of the outer skirt 206. However, when the leaflets 204 are in an open state, the leaflets can contact the loops 210 or floating yarns 208 (e.g., when the loops 210 are not included). In some cases, such contact may cause undesirable wear or abrasion of the leaflets 204.

[0093] Thus, the inventors herein have recognized that it is desirable to provide a prosthetic heart valve (or alternative prosthetic device) having an outer skirt that includes an inner anti-thrombotic layer or coating (which may include a polymer layer, such as TPU) and an outer fabric layer that may include a plurality of outwardly protruding yarns. Due to the presence of the inner TPU layer configured to reduce or prevent PVL leakage, the density of the outwardly protruding yarns may be reduced relative to the yarns 208 of the outer skirt 206, thereby reducing the curling profile of the prosthetic heart valve to which the outer skirt is mounted.

[0094] Figure 5-8C An exemplary frame 302 is shown surrounding a prosthetic heart valve (which may be Figure 3 Frame 202 or Figure 1 An example of such an outer skirt is disposed on an outer surface 306 of the frame 12 (similar or identical to the frame 12). Figure 5-8CAs schematically shown in , the leaflets 304 of the prosthetic heart valve can be seated on (or within) an inner surface 308 of a frame 302, and the frame 302 can have a central longitudinal axis 309. Figure 5-8C The frame 302 is schematically shown in FIG. 3 , but the frame may have any of a variety of configurations, such as Figure 1 Frame 302 may be a frame 12 of a prosthetic heart valve, or any of a variety of frames that are balloon expandable, self-expandable, or mechanically expandable. In addition, frame 302 may be part of a prosthetic heart valve that includes one or more of the components described above for prosthetic valve 10, including leaflets 40 and inner skirt 16. In some examples, Figure 5-8C The prosthetic heart valve depicted in the can be prosthetic valve 10, except that the outer skirt 18 is replaced by the outer skirt 300. Additional details about balloon-expandable prosthetic valves can be found in U.S. Patent No. 9,393,110, and U.S. Provisional Application No. 63 / 178,416 filed on April 22, 2021, U.S. Provisional Application No. 63 / 194,830 filed on May 28, 2021, and U.S. Provisional Application No. 63 / 279,096 filed on 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, and additional details about self-expanding prosthetic valves can be found in U.S. Patent No. 8,652,202, all of which are incorporated herein by reference.

[0095] First turn Figure 5 , the outer skirt 300 can include an inner layer 310 disposed against the outer surface 306 of the frame 302 and an outer layer 312 attached to and separated from the frame 302 by the inner layer 310. In some examples, the inner layer 310 can be flush against the outer surface 306 of the frame 302. In addition, in some cases, the outer layer 312 can be directly adhered or bonded to the inner layer 310, such as by an adhesive or by chemical bonding (e.g., heating). As further explained below, Figure 5-8B Various arrangements of end portions of the inner layer 310 relative to the outer layer 312 are shown.

[0096] The inner layer 310 may comprise a polymer material. In some cases, the polymer material may be relatively thrombogenic, or the thrombogenicity of the polymer material may be greater than that of the fabric. In addition, the polymer material may be relatively non-abrasive or smooth. For example, in some cases, the polymer material of the inner layer 310 may be TPU. In other cases, the inner layer 310 may comprise a different relatively thrombogenic material, such as polytetrafluoroethylene (PTFE). In this way, tissue ingrowth may not occur on the inner layer 310, and contact between the leaflet 304 and the inner layer 310 may not result in wear of the leaflet 304. The inner layer 310 may be a relatively thin layer having a thickness in the range of 10-20 μm.

[0097] The outer layer 312 may be a fabric layer including a plurality of outwardly extending yarns 314, such as Figure 8B For example, the outwardly extending yarns 314 can extend radially outwardly and away from the inner layer 310 and the frame 302.

[0098] In some cases, the outwardly extending yarns 314 can be knitted or woven into and extend outwardly from a base layer 316 of an outer layer 312, which can include a woven fabric of one or more fibers or yarns. For example, in some cases, the outer layer 312 can be similar to the outer skirt 206 described above. In some cases, the outer layer 312 can include rows of circumferentially extending woven portions, wherein the outwardly extending yarns 314 extend between adjacent woven portions. For such an outer layer 312, due to the inclusion of an inner layer 310 (which can prevent leakage through the outer skirt 300), Figure 4 Compared to the outer skirt 206, the density of the yarns 314 extending outwardly can be reduced.

[0099] In other cases, the outwardly extending yarns 314 of the outer layer 312 may be separate textured yarns 314 that are directly adhered to the inner layer 310 (e.g., without a fabric base layer 316 in between). Figure 8CAs depicted in , the outer skirt 350 can include an inner layer 310 and an outer layer, the outer layer including a plurality of outwardly extending yarns 314 directly adhered or bonded (e.g., by an adhesive or chemical bonding, such as by heating or another bonding method) to the inner layer 310. The outwardly extending yarns 314 can be spaced apart from each other across the outer surface of the inner layer 310. Since the outwardly extending yarns 314 can be individually bonded directly to the polymer inner layer 310, rather than being woven or knitted into a fabric structure or base layer, the density or number or outwardly extending yarns 314 can be further reduced and selected to achieve the desired curling profile of the selected prosthetic heart valve while still providing an adequate seal with natural tissue (when the prosthetic heart valve is implanted). Therefore, the outer layer including the outwardly extending yarns 314 can be more easily customized for the selected prosthetic heart valve and / or application.

[0100] In some examples, the outer layer 312 may include a plurality of rings ( Figure 8B 311 ) shown in cross-section, the plurality of rings extending along an upper edge 318 (or outflow edge) of the outer layer 312 (e.g., similar to Figure 3 In such examples, the upper edge portion 322 (or outflow edge portion) of the inner layer 310 may extend beyond (at Figure 5 The upper edge 318 ( Figure 5 In some cases, the upper edge portion 322 can extend far enough beyond the upper edge 318 (in the axial direction) so that the upper edge portion 322 of the inner layer 310 covers the rings 311 and / or the outwardly extending yarns 314 of the upper edge 318 of the outer layer 312 and blocks them from contacting the leaflets 304.

[0101] In some cases, such as Figure 6 As shown, the upper edge portion 322 of the inner layer 310 can be wrapped around the upper edge 318 of the outer layer 312, thereby forming a "J" shape with the upper edge portion 322. Therefore, the upper edge portion 322 of the inner layer 310 can extend above the loop 311 extending from the upper edge 318 of the outer layer 312, and in some cases cover the loop (e.g. Figure 8B shown).

[0102] In some instances, such as Figure 5 and 6 As shown, the lower edge portion 324 (or inflow edge portion) of the inner layer 310 may extend beyond (at Figure 5 and 6The lower edge 320 (or inflow edge) of the outer layer 312 is shown in the figure. In some cases, the lower edge portion 324 can extend beyond the lower edge 320 and beyond the inflow end of the frame 302 by a quarter to a third of the outer diameter of the frame 302.

[0103] In some cases, such as Figure 7 As shown, the lower edge portion 324 of the inner layer 310 can be wrapped around the lower edge 320 of the outer layer 312, thereby forming a "J" shape with the lower edge portion 324. Therefore, the lower edge portion 324 can extend above the lower edge 320 and cover a portion of the outer surface of the lower edge portion of the outer layer 312.

[0104] By extending the lower edge portion 324 of the inner layer 310 beyond the lower edge 320 ( Figure 5 and 6 ) and / or wrapping the lower edge portion around the lower edge and over a portion of the outer surface of the outer layer 312 ( Figure 7 ), tissue ingrowth in this area of ​​the outer skirt 300 can be reduced, thereby making it easier to access the lower portion of the prosthetic heart valve (e.g., at or below the native valve annulus) during the explantation procedure. Therefore, it is easier to explant the prosthetic heart valve from the native valve annulus.

[0105] In some instances, such as Fig. 8A and 8B As shown, the upper edge portion 322 and / or the lower edge portion 324 of the inner layer 310 can be folded and fused to form a loop 326 extending above or below the corresponding upper edge 318 or lower edge 320 of the outer layer 312, while the remaining portion (e.g., the loose or free end portion) of the folded upper edge portion 322 or lower edge portion 324 further extends above the corresponding upper edge 318 or lower edge 320. In addition, in some cases, the remaining portion folded over the upper edge portion 322 or lower edge portion 324 can extend along a portion of the outer surface 328 of the outer layer 312 so that the corresponding upper edge 318 or lower edge 320 is covered ( Figures 8A-8B ).

[0106] Fig. 9Another exemplary prosthetic heart valve 400 is depicted, comprising a radially expandable and / or compressible annular frame 402, a plurality of leaflets 404 mounted within the frame 402, and an outer skirt 406 secured to and surrounding an outer surface 434 of the frame 402. The frame 402 may include a plurality of interconnected struts 414 and a plurality of vertices (outflow vertices 408 and inflow vertices 438) circumferentially spaced about an inflow end 416 (or "inflow end portion") and an outflow end 418 (or "outflow end portion") of the frame 402. Each vertex 408, 438 is formed at a junction between two angled struts 414 at the inflow end 416 or the outflow end 418. The frame 402 includes a plurality of axially extending struts 410 (referred to herein as "axial struts 410"), some of which define commissure windows therein. The commissure tabs of adjacent leaflets 404 can be paired together and extend through the commissure windows, thereby forming a commissure 412 fixed to the frame 402. The axial struts 410, together with the first strut row 414 forming the outflow end 418 and the second strut row disposed adjacent to the first strut row (in the axial direction), can form a circumferentially extending outflow cell row 426 (which may also be referred to as a "first cell" or "upper cell"). The outflow cells 426 can be elongated in the axial direction relative to the cells in the remaining cell rows of the frame 402 (e.g., a second intermediate cell row 425 disposed near the middle portion 417 of the frame 402 and a third inflow cell row 427 disposed at the inflow end 416 of the frame 402). Additional details about the prosthetic heart valve 400 (including details about the frame 402) can be found in U.S. Provisional Application No. 63 / 279,096, as incorporated by reference above.

[0107] The outer skirt 406 of the prosthetic heart valve 400 may include an inflow edge portion 420 (or lower edge portion) that is secured to the prosthesis by one or more fasteners (e.g., Fig. 9 The whip stitch 424 shown is fixed to the struts 414 (inflow struts 415) forming the inflow end 416 of the frame 402. The outer skirt 406 can also include an outflow edge portion 422 (or upper edge portion) that is fixed to the struts 414 in the second strut row that form the lower edge or inflow edge of the outflow unit 426. In some cases, such as Fig. 9As shown, the outflow edge portion 422 of the outer skirt 406 can extend along and follow the shape of the struts 414 forming the inflow edge of the outflow unit 426, thereby making the outflow edge portion 422 follow the zigzag pattern of the struts 414 of the outflow unit 426. Although such a configuration can make the outflow edge portion 422 of the outer skirt 406 tightly attached to the frame 402, the configuration may also make the outer skirt 406 have a relatively short and small axial height 428 (e.g., the height of the portion of the outer skirt 406 extending axially from the non-apex joint at the inflow end 416 to the bottom joint of the outflow unit 426) ( Fig. 9 ).

[0108] The inventors herein have recognized that while it may be desirable to have the outer skirt extend beyond the inflow struts 414 of the outflow cell 426 (e.g., toward the outflow end 418 and closer to the mid-height of the outflow cell 426) in order to increase the surface area for PVL sealing at the implantation site, this may cause the portion of the outer skirt 406 that extends across the outflow cell 426 to extend into the outflow cell 426 or to hang loosely across the outflow cell (due to the relatively large size of the outflow cell 426).

[0109] In some instances, such as Figure 10-12A As shown, for prosthetic heart valves (such as Fig. 9 An outer skirt 500 of a prosthetic heart valve 400) can include a first portion 502, the first portion comprising a first material (e.g., a fabric); and a second portion 504, the second portion comprising a second material (e.g., a polymer material). The first portion 502 can define an inflow edge portion 506 of the outer skirt 500, which, in some cases, is configured to be secured to an inflow end of a frame of the prosthetic heart valve. The second portion 504 can define an outflow edge portion 508 of the outer skirt 500, the outflow edge portion being configured to extend toward the outflow end of the frame, and in some cases, extend over a portion of an elongated outflow unit of the frame. In some instances, instead of being relatively straight and parallel to the outflow edge portion 508, the inflow edge portion 506 of the outer skirt 500 can have a wavy shape that matches and follows the shape of the struts at the inflow end of the frame (e.g., as Fig.11 shown).

[0110] Although the outer skirt 500 and additional outer skirts (e.g., outer skirts 650, 700, and 800) described herein are depicted as being fixed to the frame 402, the frame may have any of a variety of configurations, such as Figure 1 The frame 12 may be a balloon expandable, self-expandable, or mechanically expandable frame, or any of a variety of frames, such as those disclosed in the above-mentioned applications.

[0111] In some instances, such as Fig.11 As shown, the inflow edge portion 506 of the outer skirt 500 can be fixed to the support 414 that defines the inflow end 416 of the frame 402. The second portion 504 extends from the upper end or outflow end of the first portion 502 (around the middle portion 417 of the frame 402) toward the outflow end 418 and over a portion of the elongated outflow unit 426 of the frame 402. In some cases, such as Fig.11 As shown, the outflow edge portion 508, which is the upper edge or free edge of the second portion 504, can extend circumferentially along the frame 402 at the middle portion (or middle height in the axial direction) of the elongated outflow unit 426. For example, the outflow edge portion 508 can extend across the axial strut 410 at about the middle height of the axial strut (e.g., between the inflow end and the outflow end of the axial strut 410). In some cases, the outflow edge portion 508 can be positioned higher than the outflow end. Fig.11 418 closer to the outflow end 418 of the frame 402 such that the second portion 504 extends across approximately ½ to ¾ of the axial height of the outflow unit 426 .

[0112] The interface 510 (or intersection) between the first portion 502 and the second portion 504 of the outer skirt 500 on the outer surface 512 (the radially outwardly facing surface that faces radially outward and away from the frame 402) of the outer skirt 500 can be disposed along the frame 402 near or adjacent to the lower apex or inflow apex 430 of the outflow unit 426. Fig.11 ). In some cases, the interface 510 may be Fig.11 416, so that the first portion 502 extends only to the inflow apex 430 of the outflow unit 426. In other words, the first portion 502 can have an axial height 520 ( Fig.10 ), the axial height is specified so that the first portion 502 covers a portion of the frame 402 disposed between the inflow end 416 of the outflow unit 426 and the inflow apex 430.

[0113] In some examples, first portion 502 and second portion 504 can be secured together along interface 510 by one or more fasteners (e.g., sutures). In some cases, first portion 502 and second portion 504 can at least partially overlap one another along interface 510 and can be secured together by an adhesive or a bond (e.g., a chemical bond).

[0114] The first portion 502 may be a reinforcement layer comprising a fabric (e.g., a woven fabric). In some cases, the first portion 502 may include a reinforcement layer having outwardly extending fibers 514 (e.g., Figure 4 The outwardly extending or protruding yarn 208 or Fig. 8Aand 8B The outwardly extending or protruding yarns 314 in the same or similar fabric (such as polyethylene terephthalate or PET fabric) ( Fig. 12A ). In some cases, outwardly extending fibers 514 can be leno yarns or fibers woven with a leno weave pattern with a base fabric layer 515 of first portion 502, as disclosed in U.S. Patent Publication 2019 / 0374337, which has been incorporated by reference above. In some cases, first portion 502 can include a fabric formed of fibers woven together and at an angle of approximately 45° relative to a horizontal or circumferential direction (when positioned around frame 402), as disclosed in U.S. Patent Publication 2019 / 0374337, which has been incorporated by reference above. Fig.10 and 11 Schematically depicted in ( Fig.10 A reference axis is shown illustrating a circumferential direction 516 and an axial direction 518 that may be relative to the frame 402 ( FIG. 1 ) when the outer skirt 500 is disposed about the outer surface of the frame 402. Fig. 9 )'s central longitudinal axis 432, such as Fig.11 When the prosthetic heart valve is radially compressed into a compressed configuration (e.g., for use in a delivery device (e.g., Figure 2 The angled fibers of the first portion 502 may provide increased longitudinal extensibility (in the axial direction 518) to the outer skirt 500 when delivered on a delivery device as shown in FIG. 5 .

[0115] The second part 504 can be a polymer layer containing a polymer material. In some instances, the thrombotic resistance of the polymer material can be greater than the thrombotic resistance of the fabric of the first part 502. In some cases, the polymer material is a non-textile. In addition, in some cases, the polymer material is elastic and is configured to stretch circumferentially when the frame 402 is radially expanded from a radially compressed configuration to a radially expanded configuration. Therefore, when the frame 402 is in a radially expanded configuration, the second part 504 can form a snug fit around the frame 402. Therefore, the second part 504 can extend along the outer surface 434 of the frame 402 without trembling along the outflow unit 426 or extending through the outflow unit into the frame 402 (for example, toward the leaflet 404). It should be noted that, as used herein, "elasticity" or "elastic material" can refer to elastic and partially elastic materials (for example, into plasticity), as long as the material maintains its structural integrity (for example, not tearing) under tension.

[0116] In some examples, the polymer material of the second portion 504 can be TPU. In alternative examples, the second portion 504 can include a different polymer material, such as ePTFE. In some cases, the second portion 504 can be configured to stretch in both the axial direction 518 and the circumferential direction 516.

[0117] In some instances, such as Fig. 12A , the first portion 502 and the second portion 504 can be disposed adjacent to each other (or connected to each other at an interface 510) such that the second portion 504 extends from an upper end or outflow end 522 of the first portion 502. Thus, in some cases, the outer skirt 500 can include a single layer, with the first portion 502 forming a lower portion of the outer skirt 500 and the second portion 504 forming an upper portion of the outer skirt 500. In such examples, both the inner surface 524 of the first portion 502 and the inner surface 526 of the second portion 504 can be disposed adjacent to the outer surface 434 of the frame 402 without any additional intermediate layers therebetween. In some cases, at least the inner surface 526 of the second portion 504 can be flush with the outer surface 434 of the frame 402.

[0118] In an alternative embodiment, if Fig. 12B , although the outer skirt 550 may include a first portion 502 and a second portion 504, the second portion 504 may extend along the inner surface 524 of the first portion 502 such that the second portion 504 covers all or a majority of the inner surface 524 of the first portion 502. Thus, the inner surface 526 of the second portion 504 may be positioned against the outer surface 434 of the frame 402 and between (separating) the frame 402 and the first portion 502. Thus, in some cases, the outer skirt 550 may include two layers, wherein the second portion 504 forms a first inner layer of the outer skirt 500 and the first portion 502 forms a second outer layer of the outer skirt 550, the second outer layer extending from the inflow edge portion 506 to a position at a mid-portion of the outer skirt 550 between the inflow edge portion 506 and the outflow edge portion 508 (at a mid-portion of the outer skirt 550). Fig. 12B In other words, the outer skirt 550 may include an outflow portion or upper portion, which includes only the polymer second portion 504; and an inflow portion or lower portion, which includes the fabric first portion 502 (as an outer layer) and the polymer second portion 504 (as an inner layer) ( Fig. 12B ).

[0119] In some cases, instead of the fibers 514 of the first portion 502 extending outwardly from the base fabric layer 515 of the first portion 502, the fibers 514 forming the first portion 502 can be at least partially embedded in and extend outwardly from the lower region of the second portion 504 (e.g., the region between the inflow edge portion 506 and the interface 510). For example, in some cases, the fibers 514 forming the second portion 502 can be directly adhered or bonded to the lower region of the second portion 504, similar to the above reference Figure 8C described.

[0120] In some cases, the outer surface 528 of the first portion 502 can also be covered by the second portion 504. For example, in some cases, the first portion 502 can be encapsulated by and between layers of the second portion 504. However, the second portion 504 can still extend beyond the first portion 502 over a portion of the outflow unit 426, as described above, such that an upper portion or outflow portion of the outer skirt 500 includes only the second portion 504 and lacks the fabric or fibers of the first portion 502.

[0121] In this manner, second portion 504 can be configured to reduce or prevent PVL across frame 402 (e.g., above the upper region of the scallop line of the leaflets), while first portion 502 further serves to prevent PVL along the axial direction of the prosthetic heart valve at the portion between frame 402 and native tissue at the implantation site. Additionally, first portion 502 can promote tissue ingrowth therein.

[0122] In some cases, because stretchable or elastic materials can creep over time, a prosthetic heart valve including outer skirt 500 can be stored in a partially compressed state (rather than a fully expanded state), thereby preventing creep and loss of tension in second portion 504 prior to valve implantation. For example, a prosthetic heart valve can be radially expanded and then partially compressed to a diameter that is less than the fully expanded diameter and then stored in that state until ready for implantation.

[0123] In some instances, a component of a prosthetic heart valve, such as an inner skirt (e.g., Figure 1 The inner skirt 16), the outer skirt (for example, Figure 1 The outer skirt 18, Figure 3 The outer skirt 206, Figure 5-8B The outer skirt 300, Fig. 9 The outer skirt 406, Figure 10-12B The outer skirt 500, Figure 16-18 Outer skirt 700 or Figure 19-21 The outer skirt 800 of the prosthetic heart valve (or any of the outer skirts 800 of the prosthetic heart valve) or the alternative skirt) or the connecting component can have a surface configured to mimic the structure of shark skin. In this way, flow resistance over the surface can be reduced. Therefore, when implanted in a patient, the skirt or connecting component of the prosthetic heart valve can be more resistant to calcification and / or debris accumulation. It should be noted that the micron-scale scale structure described below can also be implemented on the surface of another implantable medical device such as a stent.

[0124] Figures 13A-13B show SEM images of shark skin surface 600 at magnifications of 50x (Figure 13A), 200x (Figure 13B), and 1000x (Figure 13C). Figures 13A-13B show the rib structure or ribs 602 of shark skin surface 600 (see, for example, Xia et al. Using Bio-Replicated Forming Technologies to Fabricate Shark-Skin Surface. "Brazil. Arch. Biol. Technol. 2015; 60). The ribs 602 of shark skin surface 600 can reduce the flow resistance on shark skin surface 600.

[0125] The shark skin surface (such as the shark skin surface 600 of Figures 13A-13C) can be replicated (on microscale scales) by PDMS elastomer impression method (as shown in Figure 14A) or by PDMS embedded elastomer impression method (Figure 14B) (see, for example, Xia et al. Fabrication of shark skin surface using bioreplication molding technology. "Brazilian Biology and Technology Archives" 2015; 60). As shown in Figures 14A and 14B, the shark skin sample 610 can be inserted into a plate 612 filled with PDMS 614 (Figure 14A) or pressed into a plate 612 containing PDMS 614 (Figure 14B) to form a negative mold 616 of the shark skin sample 610. Then, the negative mold 616 can be filled with a desired material (such as TPU, ePTFE, etc.) to form a material layer 618 containing simulated microscale scales 620.

[0126] In some cases, the microscale scale structure can be formed on a surface of a skirt of a prosthetic heart valve.In some instances, the surface can be an inner surface (eg, a surface facing radially inward toward a central longitudinal axis of the prosthetic heart valve).

[0127] In some cases, the simulated microscale scale structure can be formed on the surface of one of the layers or portions of the outer skirt described herein. As an example, Fig.15As shown, the outer skirt 650 can include an inner layer 652, the inner layer including simulated micro-scale scales; an intermediate layer 654, the intermediate layer can include a polymer material (e.g., the same or similar to the second portion 504 described above); and an outer layer 656, the outer layer including a fabric (e.g., the same or similar to the first portion 502 described above). In some cases, the intermediate layer 654 extends beyond the outer layer 656 toward the outflow end 418 of the frame 402, and the inner layer 652 can cover all or most of the inner surface 658 of the intermediate layer 654. In other cases, the inner layer 652 can be a part of the intermediate layer 654 (formed integrally with the intermediate layer), such that the inner layer 652 is an inner surface formed on the intermediate layer 654 (e.g., the material of the intermediate layer 654 is used in the negative mold 616 of the shark skin described above, thereby forming a material layer having one relatively smooth surface and an opposing surface including simulated micro-scale scales).

[0128] In other cases, the simulated micron-scale flake structure can be applied to an alternative skirt as an inner layer containing simulated micron-scale flakes. For example, a more traditional fabric skirt (such as Figure 1 or Figure 3 The outer skirt of the prosthetic heart valve may include an inner layer, coating or covering comprising simulated micro-scale flakes adhered to the inner surface of the skirt fabric. Thus, the simulated micro-scale flakes may face the frame and leaflets of the prosthetic heart valve.

[0129] By forming an outer skirt having an inner surface, coating, or layer comprising simulated micron-sized scales (e.g., simulating the surface of shark skin), accumulation of debris and / or calcification on the inner surface of the outer skirt can be reduced or avoided, thereby increasing the long-term durability and lifespan of the prosthetic heart valve.

[0130] Figure 16-21 1 and 2. Further examples of outer skirts for prosthetic heart valves are shown, which can include a polymer inner layer and a fabric outer layer attached to the inner layer. In some cases, the outer layer is attached to the inner layer by fasteners (such as sutures). The polymer inner layer can include a polymer material (e.g., similar to the second portion 504 of the outer skirt 500, as described above with reference to Figure 10-12B In some cases, the polymer inner layer may extend over a portion of an outflow unit of the frame (e.g., an elongated outflow unit disposed at the outflow end of the frame). Additionally, in some cases, the fabric outer layer may include two or more fabric portions that are removably attached to the polymer inner layer by traction sutures. Thus, the prosthetic heart valve to which the outer skirt is attached may be effectively sealed with the native anatomical structure at the implantation site while also being more easily removed (explanted) from the native anatomical structure.

[0131] Figure 16-18 A first example of such an outer skirt 700 that may be secured about an outer surface of an exemplary frame 402 is shown (however, in alternative examples, the outer skirt 700 may be secured about a frame of a different configuration, such as one of those mentioned above). Fig.16 A side view of a portion of the outer skirt 700 secured to a portion of the frame 402 is shown, and Fig.17 and 18 The outer skirt 700 is shown before being fixed to the frame 402 ( Fig.17 ) and after ( Fig.18 ) is a schematic cross-sectional side view of .

[0132] The outer skirt 700 can include an inner layer 702 and an outer layer 704 attached to the inner layer 702. The inner layer 702 can include a polymer material and the outer layer 704 can include a fabric. In some examples, the outer layer 704 can include two outer layers or outer layer portions, including a first outer layer portion 706 (also referred to as an upper outer layer portion or an outflow outer layer portion) and a second outer layer portion 708 (also referred to as a lower outer layer portion or an inflow outer layer portion). In addition, in some cases, the outer layer 704 can extend axially beyond the outflow edge portion 722 of the first outer layer portion 706 toward the outflow end 418 of the frame 402.

[0133] Inner layer 702 can include a polymer material, such as one of the materials described herein with reference to second portion 504 of outer skirt 500 (e.g., TPU, ePTFE, etc.). In some cases, inner layer 702 can be formed as a relatively thin layer so that inner layer 702 does not increase the curling profile of the prosthetic heart valve. For example, the thickness of inner layer 702 can be in the range of 5 μm to 20 μm.

[0134] In some cases, inner layer 702 can include a sheet of polymer material (e.g., TPU). In some cases, inner layer 702 can include reinforcing members embedded in the polymer material, which are configured to increase strength and tear resistance, such as weft and warp yarns (e.g., arranged at a non-zero angle, such as approximately 45 degrees, relative to the central longitudinal axis of the frame). In addition, the polymer material of inner layer 702 can be configured so that if the leaflets of the prosthetic heart valve contact inner layer 702, no wear occurs on the leaflets.

[0135] The inner layer 702 may extend from or adjacent to the inflow end 416 of the frame 402 toward the outflow end 418 of the frame 402 ( Fig.16 and 18 In some cases, the inflow edge portion 710 of the inner layer 702 can extend over at least a portion of each inflow strut 415 .

[0136] Additionally, in some examples, the outflow edge portion 712 of the inner layer 702 may extend over at least a portion (eg, an inflow portion) of the elongated outflow element 426. Fig.16 ). In some cases, such as Fig.16 As shown, the outflow edge portion 712 can extend over and be secured to the inflow end portion of the axial strut 410 forming the outflow unit 426, such as by being secured to the hole 440 in the axial strut 410 by a fastener 714 (e.g., suture). As described above, the polymer material of the inner layer 702 can be elastic and configured to stretch (circumferentially) when the frame is radially expanded. Thus, when the frame is radially expanded, the polymer material of the inner layer 702 can form a snug fit around the outer surface of the frame 402 so that it lies flat on the frame without excessive slack that protrudes outwardly or inwardly into the frame (e.g., through the outflow unit 426).

[0137] In alternative examples, the outer skirt 700 may be used with a frame of a different configuration, such as Figure 1 Framework 12, Figure 3 The frame 202 of the present invention may be any of a variety of balloon expandable, self-expandable, or mechanically expandable frames, such as those disclosed in the above-referenced applications. Thus, in some cases, the outflow edge portion 712 of the inner layer 702 may not extend over the outflow cells of the frame (e.g., cells disposed in a row of cells defining the outflow end of the frame), and may instead extend to a middle portion of the frame, such as Figure 1 and 3 However, in such cases, the inner layer 702 can still extend beyond the outer layer 704 toward the outflow end of the frame, as further described below.

[0138] The second outer layer portion 708 can include a woven fabric, such as a PET fabric. In alternative examples, the woven material of the second outer layer portion 708 can be another type of woven fabric. In some cases, the second outer layer portion 708 can include weft yarns and warp yarns woven together in a plain weave. In some examples, the weft yarns and the warp yarns can be at a 45 degree angle (relative to the axial direction), such as Fig.16 In some cases, second outer layer portion 708 can include a woven fabric without any pile or floating fibers or yarns.

[0139] The second outer layer portion 708 can be fixed to the inner layer 702 and extend from the first outer layer portion 706 toward the inflow end 416 of the frame 402 and beyond the inner layer 702 ( Fig.16 and 18 Thus, the second outer layer portion 708 may be axially offset from the inflow edge portion 710 of the inner layer 702 ( Fig.17 ).

[0140] The second outer layer portion 708 may cover at least a portion of the inflow support 415 ( Fig.16 ), and may wrap around the inflow vertex 438 at the inflow end 416 of the frame ( Fig.16 and 18 In this manner, the second outer portion 708 may be wrapped from the outer surface 434 of the frame 402 around the inflow vertex 438 and across the inner surface 436 of the frame (the inner surface of the inflow strut 415). Fig.18 In some examples, the end portion of the second outer layer portion 708 that wraps around the inflow vertex 438 and wraps to the inner surface 436 of the frame 402 can be secured to the inflow edge portion of the first outer layer portion 706 and the inflow edge portion 710 of the inner layer 702 (e.g., by sutures 726, such as Fig.18 shown).

[0141] By wrapping the second outer layer portion 708 around the inflow apex 438 so that the inflow apex 438 is covered by the second outer layer portion 708, the apex 438 can be prevented from rubbing against the inner surface of the guide sheath (or guide catheter) through which the prosthetic heart valve is advanced on the delivery device toward the implantation site. Therefore, the thrust felt by the user advancing the delivery device and the prosthetic heart valve through the guide sheath can be reduced.

[0142] The first outer layer portion 706 may be a floating yarn or fiber portion comprising a plurality of circumferentially extending floating leno threads 716 (or woven portions) axially spaced apart from one another and a plurality of floating yarn segments 718 (or woven portions) disposed between adjacent floating leno threads 716. Figure 16-18 ). Each floating yarn segment 718 can include a plurality of floating yarns 720 (or fibers) extending axially between and woven into adjacent leno threads 716. The floating yarns 720 can extend radially outward between the leno threads 716, thereby forming a textured outer surface on the first outer layer portion 706, which can be configured to increase tissue ingrowth after implantation of a prosthetic heart valve.

[0143] like Figure 16-18 , the first outer layer portion 706 may include a first leno thread 716a disposed adjacent to the second outer layer portion 708, a second leno thread 716b disposed at a middle portion of the first outer layer portion 706, and a third leno thread 716c defining an outflow edge portion 722 of the first outer layer portion 706. In addition, the first outer layer portion 706 may include a first floating yarn segment 718a extending axially between the first leno thread 716a and the second leno thread 716b and a second floating yarn segment 718b extending axially between the second leno thread 716b and the third leno thread 716c.

[0144] Although in Figure 16-18 In the example shown, three floating leno threads 176a, 716b, 716c are shown, but in other cases, the first outer layer portion 706 may include two floating leno threads 716 (for example, at the outflow edge portion and the inflow edge portion of the first outer layer portion 706, thereby defining a single floating yarn segment 718 therebetween) or more than three floating leno threads (for example, four, five, etc.) and therefore include more than two floating yarn segments 718.

[0145] The above-described configuration of first outer layer portion 706 in combination with inner layer 702 allows for a reduced number or density of floating yarns 720 (eg, compared to a skirt without an inner polymer layer), thereby reducing the crimp profile of the prosthetic heart valve.

[0146] In some examples, in addition to the floating yarns 720 (which may be textured and extend outwardly, as described above), the floating yarn segments 718 may include one or more shorter yarns or strings that are shorter than the floating yarns 720 and are sized to limit the maximum axial length of the outer skirt 700 when the prosthetic heart valve is in a radially compressed configuration. For example, it may be desirable to limit the elongation of the outer skirt 700 when the prosthetic heart valve is radially compressed to an amount similar to that of the frame. Thus, the additional shorter yarns may be sized to match the elongation of the frame that occurs during radial compression of the prosthetic heart valve.

[0147] like Figure 16-18 As shown, the outflow edge portion 722 of the first outer layer portion 706 is axially offset from the outflow edge portion 712 of the inner layer 702, thereby defining a yarn-deficient outflow portion 724 of the inner layer 702. Thus, the outflow portion 724 can be configured to reduce paravalvular leakage across or through the frame 402 (e.g., above the upper region of the scallop line), while the first outer layer portion 706 can be configured to reduce or prevent paravalvular leakage between the frame and native tissue along the axial direction of the prosthetic heart valve.

[0148] In some examples, the first outer layer portion 706 and the second outer layer portion 708 of the outer layer 704 can be secured to the inner layer 702 by a plurality of fasteners (e.g., sutures). Fig.16 As shown, the first outer layer portion 706 and the second outer layer portion 708 of the outer layer 704 may be secured to the inner layer 702 ( Fig.16 and 19 ).

[0149] The outer skirt 700 can then be secured to the frame 402 (or an alternative frame, as described above) by whip stitches, in-and-out stitches, or the like extending along portions of the prosthetic heart valve that follow the scalloping lines of the leaflets and / or the outflow edge portion 712 of the outer skirt 700. As an example, Fig.16 As shown, the outer skirt 700 can be secured to the struts 414 of the frame 402 extending along the fan line of the leaflets by whip stitches 728 and to the holes 440 in the axial struts 410 by fasteners 714 (e.g., sutures). In an alternative example, the outer skirt 700 can be secured to the inflow struts 415 at its inflow edge portion and to the axial struts 410 (or an alternative strut across which the outflow edge portion 712 extends) at its outflow edge portion.

[0150] In some instances, after implanting a prosthetic heart valve within native tissue at an implantation site (e.g., in a native valve annulus), the prosthetic heart valve may need to be explanted (removed from the implantation site). However, because the fabric skirt of the prosthetic heart valve may be configured to promote tissue ingrowth, it may be difficult to release the fabric skirt from the tissue and explant the prosthetic heart valve.

[0151] Thus, the inventors herein have recognized that it would be advantageous to provide a prosthetic heart valve having a fabric outer skirt that can reduce paravalvular leakage and that can be removably coupled to a frame of the prosthetic heart valve, thereby increasing the ease of explantation of the prosthetic heart valve.

[0152] Fig.19 Another example of an outer skirt 800 that can be secured around the outer surface of the exemplary frame 402 is shown. Figure 16-18 The outer skirt 800 may include an inner layer 802 (which may be similar to the inner layer 702 described above) and an outer layer 804 attached to the inner layer 802. The inner layer 802 may include a polymer material and the outer layer 804 may include a fabric. Fig.19 As shown, the outer layer 804 may include only the first outer layer portion 706, as described above with reference to Figure 16-19 As described, the inner layer 802 extends over and wraps around the inflow apex 438 of the frame 402. However, in alternative examples, although the inner layer 802 can extend over the inflow struts 415 (e.g., as Fig.16 ), but may not wrap around the inflow apex 438.

[0153] Similar to the outer skirt 700, the outer layer 804 can be attached to the inner layer 802, as described above with reference to Fig.16However, the outer layer 804 can be releasably attached to the inner layer 802 by a plurality of whip sutures 812 and traction sutures 810. Thus, during an explantation procedure, the outer layer 804 can be released from the inner layer 802 (and the rest of the prosthetic heart valve, including the frame 402), and thus the prosthetic heart valve can be more easily removed from the implantation site (because the outer layer 804 can have tissue adhered or grown onto it).

[0154] like Fig.19 As shown, the traction stitch 810 can extend along the upper edge portion 806 of the outer layer 804 and, in some cases, along the third leno thread 716c ( Fig.19 ).like Fig. 20 As shown in more detail in the schematic cross-sectional view of , the whip suture 812 can extend around the traction suture 810 and extend through the outer layer 804 and the inner layer 802.

[0155] For example, Fig. 20 As shown, inner surface 814 of outer layer 804 contacts or rests against outer surface 816 of inner layer 802, and inner layer 802 rests adjacent to or rests against outer surfaces 434 of struts 414 of frame 402. Pull suture 810 contacts or rests against outer surface 818 of outer layer 804.

[0156] The whip stitch 812 of the suture 820 can extend through the material of the inner layer 802 in a whip stitch pattern along the length of the upper edge portion 806 of the outer layer 804, through the material of the outer layer 804 (e.g., through and disposed within a plurality of holes 822 in the material of the outer layer 804), and around the traction suture 810. In some cases, the traction suture 810 can be passed through and disposed within a plurality of preformed holes 824 in the inner layer 802.

[0157] Each whip suture 812 includes a leading end portion 813a that extends through the material of the inner layer 802, or alternatively extends through an aperture 824 in the inner layer 802, extends outwardly through an aperture 822 in the outer layer 804, extends around the traction suture 810 and transitions to a trailing end portion 813b that extends inwardly through the same aperture 822 in the outer layer 804 and extends through a different aperture 824 in the inner layer 802 (or extends through the material of the inner layer 802), wherein the trailing end portion 813b transitions to the leading end portion ( Fig. 20 ). In this manner, each whip stitch 812 passes through a single opening or hole 822 in the outer layer 804 and two different but adjacent holes 824 in the inner layer 802. Fig. 20As can be seen in FIG. 4 , when the traction suture 810 is positioned along the suture line across the upper edge portion 806, the traction suture 810 prevents the whip suture 812 from being pulled through the hole 822. Therefore, when the traction suture is passed through the suture line and positioned across the upper edge portion 806, the outer layer 804 can be secured to the inner layer 802 by the force exerted by the whip suture 812 on the traction suture 810 and the inner surface 826 of the inner layer 802, which is secured to the frame 402 ( Fig.19 ).

[0158] In some examples, the holes 822 in the material of the outer layer 804 and / or the holes 824 in the material of the inner layer 802 can be pre-formed, such as by laser drilling, cutting, punching, or other suitable techniques known in the art. In other examples, the holes 822 in the material of the outer layer 804 and / or the holes 824 in the material of the inner layer 802 can be formed when the whip stitch 812 is stitched through the material of the outer layer 804 and / or the material of the inner layer 802.

[0159] When the suture 810 is removed (e.g., by pulling one of the loose ends 828a or 828b in a direction parallel to the suture or outwardly from the frame 402), Fig. 20 )), the whip suture 812 is no longer held by the traction suture 810. Therefore, when the outer layer 804 is pulled away from the inner layer 802 and the frame 402 (or the inner layer 802 and the frame 402 are pulled away from the outer layer 804), the whip suture 812 can be pulled out through the hole 822 of the outer layer 804, thereby separating (or detaching or decoupling) the outer layer 804 from the inner layer 802, and the whip suture 812 remains attached to the inner layer 802.

[0160] Because the inner layer 802 can include an anti-thrombotic polymer (or a polymer material that is more thrombotic than the fabric material of the outer layer 804), the inner layer 802 can resist tissue ingrowth and allow the inner layer 802 to be more easily separated from the outer layer 804 and the tissue at the implantation site.

[0161] In some cases, the suture 820 of the whip stitch 812 can be a thinner fiber, yarn, or suture relative to the thicker traction suture 810. In some cases, the suture 820 forming the whip stitch 812 can include a thinner high tensile strength biocompatible material (such as ultra-high molecular weight polyethylene (UHMPE)). ) or other similar materials or combinations thereof. In a specific embodiment, suture 820 can be formed of UHMPE force fibers and can be thin enough and resistant to force so that when inner layer 802 is separated from outer layer 804, whip suture 812 can cut through the overgrown tissue on the outer surface of outer layer 804. In some cases, traction suture 810 can include thicker high tensile strength biocompatible materials (such as monofilaments containing polypropylene (e.g., Prolene 4-0), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE)) or other similar materials or combinations thereof. In a specific embodiment, traction suture 810 can be a microfilament containing Prolene, which is configured to be easily separated from or pulled away from any surrounding ingrowing tissue when the surgeon is pulling during explant surgery.

[0162] In some instances, the traction suture 810 can have different coloring or color coatings (e.g., green, black or blue coloring or coatings), can be radiopaque, and / or can be otherwise marked so that the traction suture can be identified by a surgeon during an explantation operation. In some cases, the entire length of the traction suture 810 can, for example, include bright colored materials or have bright colored coatings. In other cases, a portion of the traction suture 810 (e.g., the free or loose end portion 828a / 828b of the traction suture 810) can include colored materials, have bright colored coatings, and / or can include bright colored labels or fins attached thereto. In other cases, the traction suture 810 or a portion thereof can include materials, coatings or labels that can be visualized using a dedicated visualization device. For example, the traction suture 810 can include radiopaque materials or one or more radiopaque markers that can be visualized by fluoroscopic or x-ray devices. For example, the one or more radiopaque markers can be embedded in the outer surface of the traction suture 810 or attached to the outer surface.

[0163] In some examples, the loose ends 828a, 828b of the traction suture 810 can be tethered to the commissures of the prosthetic heart valve (e.g., Fig.21 Thus, during explantation of a prosthetic heart valve, the loose ends 828a or 828b of the traction suture 810 can be easily and quickly located and pulled by the surgeon, thereby pulling the traction suture 810 away from the outer skirt 800 and separating the outer layer 804 from the inner layer 802.

[0164] Fig.21A prosthetic heart valve 850 is shown, which includes a frame 402, an outer skirt 800 disposed around and secured to an outer surface of the frame 402, and a valve structure 852 including a plurality of leaflets 854 disposed within an interior of the frame. The commissure tabs of adjacent leaflets 854 are secured together within the commissure windows of the frame 402, thereby forming commissures 856. Fig.21 As depicted in , the floating yarns 720 of the first outer layer portion 706 of the outer layer 804 of the outer skirt 800 can form a furry, plush or textured outer surface 858 that is configured to contact native tissue when the prosthetic heart valve 850 is radially expanded and implanted at the implantation site. As described herein, the textured outer surface 858 can be configured to promote tissue ingrowth therein, thereby increasing the paravalvular leak seal to the native tissue. At the same time, because the outer layer 804 is removably coupled to the inner layer 802, as described above with reference to Fig.19 and 20 As described above, the prosthetic heart valve 850 can therefore be more easily removed from the native tissue during an explantation procedure.

[0165] Delivery Technology

[0166] In order to implant the prosthetic valve in the natural aortic valve via the transfemoral delivery method, the prosthetic valve is installed along the distal end portion of the delivery device under radial compression. The distal end portion of the prosthetic valve and the delivery device is 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 natural 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 natural aortic valve in a transapical surgery, whereby the prosthetic valve (on the distal end 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 natural aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, through a partial J-shaped sternotomy or a right parasternal mini-thoracotomy, and is then advanced through the ascending aorta toward the native aortic valve.

[0167] 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 end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, 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 end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0168] To implant the prosthetic valve into the native tricuspid valve, the prosthetic valve is installed along the distal end portion of the delivery device in a radially compressed state. The prosthetic valve and the distal end 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.

[0169] Another delivery method is a transatrial approach, in which the prosthetic valve (on the distal end 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 end 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, the native pulmonary valve, or the pulmonary artery.

[0170] 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.

[0171] 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 associated systems, devices, equipment, etc. as one of the steps of the method. The example of heating / thermal sterilization includes 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 utilizing hydrogen peroxide can be accomplished using hydrogen peroxide plasma.

[0172] Additional Examples of the Disclosed Technology

[0173] Considering 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.

[0174] Example 1. A prosthetic heart valve, comprising: an annular frame having an inflow end, an outflow end, and a middle portion disposed between the inflow end and the outflow end; and an outer skirt disposed around an outer surface of the frame, the outer skirt comprising: a first portion comprising a polymer material; and a second portion comprising a fabric, wherein the polymer material has a greater anti-thrombotic property than the fabric, wherein the second portion is fixed to the inflow end of the frame and extends toward the middle portion, and wherein the first portion extends from the second portion and toward the outflow end of the frame.

[0175] Example 2. A prosthetic heart valve according to any example herein, in particular Example 1, wherein the frame comprises a plurality of interconnected struts, the plurality of interconnected struts defining a plurality of circumferentially extending cell rows, the plurality of circumferentially extending cell rows including a first outflow cell row, the first outflow cell row being disposed at the outflow end, wherein the outflow cells in the first outflow cell row are elongated in an axial direction relative to the remaining cell rows in the plurality of cell rows, and wherein the first portion of the outer skirt covers a portion of each outflow cell in the first outflow cell row.

[0176] Example 3. A prosthetic heart valve according to any example herein, in particular Example 2, wherein the portion of the outflow unit is an inflow half of the outflow unit positioned closer to the inflow end than the outflow end of the frame.

[0177] Example 4. A prosthetic heart valve according to any example herein, in particular example 2 or example 3, wherein the interface between the first portion and the second portion of the outer skirt extends circumferentially around the frame at an axial position adjacent to the inflow apex of the outflow unit.

[0178] Example 5. A prosthetic heart valve according to any example herein, in particular any one of Examples 2 to 3, wherein the plurality of circumferentially extending cell rows further include a second intermediate cell row and a third inflow cell row, and wherein the second portion extends across the second intermediate cell row and the third inflow cell row.

[0179] Example 6. A prosthetic heart valve according to any example herein, in particular any one of Examples 1 to 5, wherein the polymer material is elastic and configured to stretch circumferentially when the frame radially expands from a radially compressed configuration to a radially expanded configuration.

[0180] Example 7. A prosthetic heart valve according to any example herein, in particular any one of Examples 1 to 6, wherein the polymer material is configured to form a snug fit around the outer surface of the frame when the frame is in a radially expanded configuration.

[0181] Example 8. A prosthetic heart valve according to any example herein, in particular any one of examples 1 to 7, wherein the polymer material is a non-textile.

[0182] Example 9. A prosthetic heart valve according to any example herein, in particular any one of examples 1 to 8, wherein the polymer material is thermoplastic polyurethane.

[0183] Example 10. A prosthetic heart valve according to any example herein, in particular any one of examples 1 to 9, wherein the fabric of the second portion is a woven fabric comprising polyethylene terephthalate.

[0184] Example 11. A prosthetic heart valve according to any example herein, in particular any one of Examples 1 to 10, wherein the fabric of the second portion is a reinforced fabric comprising weft fibers and warp fibers that are at a non-zero angle relative to a central longitudinal axis of the prosthetic heart valve.

[0185] Example 12. A prosthetic heart valve according to any example herein, in particular any one of Examples 1 to 11, wherein the fabric of the second portion comprises a plurality of radially outwardly extending fibers configured to contact tissue and seal against the tissue.

[0186] Example 13. A prosthetic heart valve according to any example herein, in particular any one of Examples 1 to 12, wherein the first portion further extends across the inner surface of the second portion, so that the first portion forms an inner layer of the outer skirt positioned against the outer surface of the frame, and the second portion forms an outer layer of the outer skirt, the inner layer extending beyond the outer layer in an axial direction toward the outflow end of the frame.

[0187] Example 14. A prosthetic heart valve according to any example herein, in particular Example 13, wherein the first portion further extends across an outer surface of the second portion and encapsulates the second portion therein.

[0188] Example 15. A prosthetic heart valve according to any of the examples herein, in particular Example 13, wherein the second part is releasably attached to the first part by a plurality of whip sutures and traction sutures, wherein the plurality of whip sutures extend around the traction sutures and extend through the second part and the first part, and wherein the traction sutures are configured to be pulled through the whip sutures and away from the whip sutures, thereby detaching the second part from the first part.

[0189] Example 16. A prosthetic heart valve according to any example herein, in particular any one of Examples 1 to 15, wherein the outer skirt further comprises a layer comprising a plurality of micron-sized scales formed on a surface thereof, the plurality of micron-sized scales being arranged across the inner surfaces of one or more of the first part and the second part.

[0190] Example 17. A prosthetic heart valve according to any example herein, in particular any one of Examples 1 to 16, further comprising a valve structure disposed in the frame and configured to regulate blood flow through the frame in one direction.

[0191] Example 18. A prosthetic heart valve, comprising: an annular frame; and an outer skirt disposed around an outer surface of the frame, the outer skirt comprising: an outer layer comprising fabric and forming an exposed surface for contacting tissue; and an inner layer comprising a polymer material and covering an inner surface of the outer layer, wherein the inner layer extends beyond an outflow edge portion of the outer layer toward an outflow end of the frame.

[0192] Example 19. A prosthetic heart valve according to any example herein, in particular Example 18, wherein the inflow edge portion of the outer layer is disposed at the inflow end of the frame.

[0193] Example 20. A prosthetic heart valve according to any example herein, in particular Example 18 or Example 19, wherein the frame comprises a plurality of interconnected struts defining a plurality of circumferentially extending cell rows, the plurality of circumferentially extending cell rows including a first outflow cell row disposed at the outflow end of the frame, wherein the first outflow cell row is longer in the axial direction relative to the remaining cell rows in the plurality of cell rows, and wherein the inner layer of the outer skirt covers at least a portion of each outflow cell in the outflow cell row.

[0194] Example 21. A prosthetic heart valve according to any example herein, in particular Example 20, wherein an outflow edge portion of the inner layer is secured to an inflow end portion of an axial strut of the frame defining the first outflow cell row.

[0195] Example 22. A prosthetic heart valve according to any example herein, in particular any one of Examples 18 to 21, wherein the polymer material is elastic and configured to stretch circumferentially when the frame radially expands from a radially compressed configuration to a radially expanded configuration.

[0196] Example 23. A prosthetic heart valve according to any example herein, in particular any one of Examples 18 to 22, wherein the polymer material has greater thrombotic resistance than the fabric and the polymer material is configured to form a snug fit around the outer surface of the frame when the frame is in a radially expanded configuration.

[0197] Example 24. A prosthetic heart valve according to any example herein, in particular any one of examples 18 to 23, wherein the polymer material is thermoplastic polyurethane.

[0198] Example 25. A prosthetic heart valve according to any example herein, in particular any one of Examples 18 to 24, wherein the outer layer comprises a first outer layer portion, the first outer layer portion comprising a plurality of floating yarns extending radially outward and away from the outer skirt and the frame.

[0199] Example 26. A prosthetic heart valve according to any of the examples herein, in particular Example 25, wherein the first outer layer portion comprises a plurality of circumferentially extending floating leno threads, the plurality of circumferentially extending floating leno threads being axially spaced apart from each other; and a plurality of floating yarn segments, the plurality of floating yarn segments being disposed between adjacent floating leno threads, each floating yarn segment comprising a floating yarn of the plurality of floating yarns that extends axially between adjacent leno threads and is woven into the adjacent leno threads.

[0200] Example 27. A prosthetic heart valve according to any example herein, in particular Example 25 or Example 26, wherein the outflow edge portion of the first outer layer portion is attached to the inner layer by a plurality of whip sutures extending through the inner layer and the first outer layer portion.

[0201] Example 28. A prosthetic heart valve according to any of the examples herein, in particular Example 27, wherein a traction suture extends along the outer surface of the outflow edge portion of the first outer layer portion, and wherein the first outer layer portion is releasably attached to the inner layer by the traction suture and the multiple whip sutures, and the multiple whip sutures further extend around the traction suture.

[0202] Example 29. A prosthetic heart valve according to any example herein, in particular any one of Examples 25 to 28, wherein the outer layer further comprises a second outer layer portion, the second outer layer portion being fixed to the inflow edge portion of the first outer layer portion and extending from the first outer layer portion toward the inflow end of the frame.

[0203] Example 30. A prosthetic heart valve according to any example herein, in particular Example 29, wherein the second outer layer portion extends beyond the inner layer toward the inflow end of the frame and wraps around the inflow apex at the inflow end of the frame.

[0204] Example 31. A prosthetic heart valve according to any example herein, in particular Example 30, wherein the end portion of the second outer layer portion wrapped around the inflow apex is fixed to the inflow edge portion of the first outer layer portion and the inflow edge portion of the inner layer.

[0205] Example 32. A prosthetic heart valve according to any example herein, in particular any one of examples 29 to 31, wherein the second outer layer portion comprises a woven fabric.

[0206] Example 33. A prosthetic heart valve according to any example herein, in particular any one of Examples 18 to 12, further comprising a valve structure disposed in the frame and configured to regulate blood flow through the frame in one direction.

[0207] Example 34. A prosthetic heart valve, comprising: an annular frame having an inflow end, an outflow end and a middle portion disposed between the inflow end and the outflow end; and an outer skirt disposed around the outer surface of the frame, the outer skirt comprising: an inner layer comprising a polymer material; and an outer layer comprising a fabric and attached to the inner layer, the outer layer comprising a first outer layer portion and a second outer layer portion, wherein the first outer layer portion extends from the inflow end of the frame toward the middle portion of the frame, and wherein the second outer layer portion extends from the first outer layer portion toward the outflow end, and wherein the outflow edge portion of the inner layer extends axially toward the outflow end of the frame beyond the outflow edge portion of the second outer layer portion, so that the outflow edge portion of the inner layer is disposed closer to the outflow end of the frame than the outflow edge portion of the second outer layer portion.

[0208] Example 35. A prosthetic heart valve according to any example herein, in particular Example 34, wherein the frame comprises a plurality of interconnected struts defining a plurality of circumferentially extending cell rows, the plurality of circumferentially extending cell rows including a first outflow cell row disposed at the outflow end of the frame, wherein the first outflow cell row is longer in the axial direction relative to the remaining cell rows in the plurality of cell rows, and wherein the outer layer of the outer skirt covers at least a portion of each outflow cell in the outflow cell row.

[0209] Example 36. A prosthetic heart valve according to any example herein, in particular Example 35, wherein the outflow edge portion of the inner layer is secured to holes in the inflow end portions of the frame defining the axial struts of the first outflow cell row.

[0210] Example 37. A prosthetic heart valve according to any example herein, in particular Example 35 or Example 36, wherein the frame is radially expandable between a radially compressed configuration and a radially expanded configuration, and wherein the polymer material is elastic and configured to stretch circumferentially when the frame radially expands from the radially compressed configuration to the radially expanded configuration.

[0211] Example 38. A prosthetic heart valve according to any example herein, in particular any one of Examples 34 to 37, wherein the polymer material is configured to lie flat on the outer surface of the frame without excessive slack bulging outwardly or inwardly into the frame when the frame is in a radially expanded configuration.

[0212] Example 39. A prosthetic heart valve according to any example herein, in particular any one of examples 34 to 38, wherein the polymer material has a greater thrombotic resistance than the fabric.

[0213] Example 40. A prosthetic heart valve according to any example herein, in particular any one of examples 34 to 39, wherein the polymer material is thermoplastic polyurethane.

[0214] Example 41. A prosthetic heart valve according to any example herein, in particular any one of Examples 34 to 40, wherein the first outer layer portion comprises a woven fabric.

[0215] Example 42. A prosthetic heart valve according to any example herein, in particular any one of Examples 34 to 41, wherein the first outer layer portion extends axially beyond the inflow edge portion of the inner layer toward the inflow end of the frame and wraps around the inflow apex at the inflow end of the frame.

[0216] Example 43. A prosthetic heart valve according to any example herein, in particular Example 42, wherein the end portion of the first outer layer portion that surrounds the inflow apex and wraps over the inner surface of the frame is fixed to the inflow edge portion of the second outer layer portion and the inflow edge portion of the inner layer.

[0217] Example 44. A prosthetic heart valve according to any example herein, in particular any one of Examples 34 to 43, wherein the second outer layer portion comprises a plurality of floating yarns extending radially outward and away from the frame.

[0218] Example 45. A prosthetic heart valve according to any of the examples herein, in particular Example 44, wherein the second outer layer portion comprises a plurality of circumferentially extending floating leno threads, the plurality of circumferentially extending floating leno threads being axially spaced apart from each other; and a plurality of floating yarn segments, the plurality of floating yarn segments being disposed between adjacent floating leno threads, each floating yarn segment comprising a floating yarn of the plurality of floating yarns that extends axially between adjacent leno threads and is woven into the adjacent leno threads.

[0219] Example 46. A prosthetic heart valve according to any example herein, in particular any one of Examples 34 to 45, wherein the outflow edge portion of the second outer layer portion is attached to the inner layer by a plurality of sutures extending through the inner layer and the second outer layer portion.

[0220] Example 47. A prosthetic heart valve according to any of the examples herein, in particular Example 46, wherein a traction suture extends along the outer surface of the outflow edge portion of the second outer layer portion, and wherein the second outer layer portion is releasably attached to the inner layer by the traction suture and the multiple sutures, and the multiple sutures further extend around the traction suture.

[0221] Example 48. A prosthetic heart valve according to any example herein, in particular any one of Examples 34 to 47, further comprising a valve structure disposed in the frame and configured to regulate blood flow through the frame in one direction.

[0222] Example 49. A prosthetic heart valve comprising an annular frame having an inflow end and an outflow end; and an outer skirt disposed around an outer surface of the frame, the outer skirt comprising: an inner layer; and a fabric outer layer, the fabric outer layer being releasably attached to the inner layer by a plurality of whip sutures and traction sutures, wherein the plurality of whip sutures extend around the traction sutures and extend through the inner layer and the outer layer, and wherein the traction sutures are configured to be pulled through the whip sutures and away from the whip sutures, thereby detaching the outer layer from the inner layer.

[0223] Example 50. A prosthetic heart valve according to any example herein, in particular Example 49, wherein the traction suture extends on the outer surface of the outer layer along the outflow edge portion of the outer layer.

[0224] Example 51. A prosthetic heart valve according to any example herein, in particular example 49 or example 50, wherein each whip suture passes through a single hole in the outer layer and two adjacent holes in the inner layer.

[0225] Example 52. A prosthetic heart valve according to any example herein, in particular any one of examples 49 to 51, wherein the inner layer comprises a polymer material.

[0226] Example 53. A prosthetic heart valve according to any of the examples herein, in particular Example 52, wherein the frame is radially expandable between a radially compressed configuration and a radially expanded configuration, and wherein the polymer material is elastic and configured to stretch circumferentially when the frame radially expands from the radially compressed configuration to the radially expanded configuration.

[0227] Example 54. A prosthetic heart valve according to any example herein, in particular Example 52 or Example 53, wherein the polymer material is configured to lie flat on the outer surface of the frame without excessive slack bulging outwardly or inwardly into the frame when the frame is in a radially expanded configuration.

[0228] Example 55. A prosthetic heart valve according to any example herein, in particular any one of Examples 52 to 54, wherein the thrombotic resistance of the polymer material is greater than the thrombotic resistance of the fabric of the outer layer.

[0229] Example 56. A prosthetic heart valve according to any example herein, in particular any one of Examples 52 to 55, wherein the polymer material is thermoplastic polyurethane.

[0230] Example 57. A prosthetic heart valve according to any example herein, in particular any one of Examples 52 to 56, wherein the outflow edge portion of the inner layer extends beyond the outflow edge portion of the outer layer toward the outflow end of the frame.

[0231] Example 58. A prosthetic heart valve according to any example herein, in particular any one of Examples 52 to 57, wherein the inner layer is fixed to struts of the frame.

[0232] Example 59. A prosthetic heart valve according to any example herein, in particular any one of Examples 52 to 58, wherein the inflow edge portion of the inner layer extends around the inflow end of the frame.

[0233] Example 60. A prosthetic heart valve according to any example herein, in particular any one of Examples 52 to 59, wherein the outer layer comprises a plurality of floating yarns extending radially outward and away from the frame.

[0234] Example 61. A prosthetic heart valve according to any of the examples herein, in particular Example 60, wherein the outer layer comprises a plurality of circumferentially extending floating leno threads, the plurality of circumferentially extending floating leno threads being axially spaced apart from each other; and a plurality of floating yarn segments, the plurality of floating yarn segments being disposed between adjacent floating leno threads, each floating yarn segment comprising a floating yarn among the plurality of floating yarns that extends axially between adjacent leno threads and is woven into the adjacent leno threads.

[0235] Example 62. A prosthetic heart valve according to any example herein, in particular any one of Examples 52 to 61, further comprising a valve structure disposed in the frame and configured to regulate blood flow through the frame in one direction.

[0236] Example 63. A prosthetic heart valve comprising: an annular frame; a valve structure disposed in the frame and configured to regulate blood flow through the frame in one direction; and a skirt connected to the frame, the skirt comprising at least one layer comprising a plurality of micrometer-sized scales formed on a surface thereof.

[0237] Example 64. A prosthetic heart valve according to any example herein, in particular Example 63, wherein the plurality of micron-scale scales are configured to reduce drag across the surface of the skirt.

[0238] Example 65. A prosthetic heart valve according to any example herein, in particular example 63 or example 64, wherein the skirt is an outer skirt disposed around an outer surface of the frame.

[0239] Example 66. A prosthetic heart valve according to any example herein, in particular Example 65, wherein the layer comprising the plurality of micron-sized scales is an inner layer of the skirt disposed against the frame, and the skirt further comprises an outer layer comprising fabric.

[0240] Example 67. A prosthetic heart valve according to any example herein, in particular Example 63 or Example 64, wherein the skirt is an inner skirt disposed around an inner surface of the frame between the valve structure and the frame.

[0241] Example 68. A prosthetic heart valve according to any example herein, in particular any one of Examples 63 to 67, wherein the surface of the skirt including the layer of microscale scales formed thereon is a radially inward facing surface facing the valve structure.

[0242] Example 69. A prosthetic heart valve comprising: an annular frame; and an outer skirt disposed around an outer surface of the frame, the outer skirt comprising: a base layer comprising a polymer material, the base layer disposed against the outer surface of the frame; and a plurality of outwardly extending yarns adhered to the outer surface of the base layer and extending radially outward and away from the base layer.

[0243] Example 70. A prosthetic heart valve according to any example herein, in particular Example 69, wherein the polymer material has a greater thrombotic resistance than the plurality of outwardly extending yarns.

[0244] Example 71. A prosthetic heart valve according to any example herein, in particular example 69 or example 70, wherein the polymer material is thermoplastic polyurethane.

[0245] Example 72. A prosthetic heart valve according to any example herein, in particular any one of Examples 69 to 71, wherein the yarns of the plurality of outwardly extending yarns are individual yarns spaced apart from one another across the outer surface of the base layer.

[0246] Example 73. A prosthetic heart valve according to any example herein, in particular any one of Examples 69 to 72, wherein the yarns of the plurality of outwardly extending yarns are adhered to the base layer with an adhesive.

[0247] Example 74. A prosthetic heart valve according to any example herein, in particular any one of Examples 69 to 72, wherein the yarns of the plurality of outwardly extending yarns are adhered to the base layer by chemical bonding.

[0248] Example 75. A prosthetic heart valve according to any of the examples herein, in particular any of Examples 69 to 74, wherein the plurality of outwardly extending yarns are arranged across a middle portion of the base layer, and wherein an outflow edge portion of the base layer lacking outwardly extending yarns extends beyond the middle portion toward an outflow end of the frame.

[0249] Example 76. A prosthetic heart valve according to any example herein, in particular Example 75, wherein the inflow edge portion of the base layer lacking outwardly extending yarns extends beyond the middle portion toward the inflow end of the frame.

[0250] Example 77. A method comprising sterilizing a prosthetic heart valve, device, and / or assembly according to any example.

[0251] Example 78. A prosthetic heart valve according to any one of Examples 1 to 76, wherein the prosthetic heart valve is sterilized.

[0252] 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 outer skirt for a prosthetic heart valve may be combined with any one or more of the features of another outer skirt for a prosthetic heart valve. As another example, any one or more of the features of one frame for a prosthetic heart valve may be combined with any one or more of the features of another frame for a prosthetic heart valve.

[0253] 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 having an inflow end, an outflow end, and a middle portion disposed between the inflow end and the outflow end; and an outer skirt disposed around an outer surface of the frame, the outer skirt comprising: a first portion, the first portion comprising a polymeric material; and a second portion, the second portion comprising a fabric, wherein the polymer material has a thrombogenicity greater than the thrombogenicity of the fabric, wherein the second portion is fixed to the inflow end of the frame and extends toward the intermediate portion, and wherein the first portion extends from the second portion and toward the outflow end of the frame.

2. A prosthetic heart valve according to claim 1, wherein the frame includes a plurality of interconnected struts, the plurality of interconnected struts defining a plurality of circumferentially extending cell rows, the plurality of circumferentially extending cell rows including a first outflow cell row, the first outflow cell row being disposed at the outflow end, wherein the outflow cells in the first outflow cell row are elongated in an axial direction relative to the remaining cell rows in the plurality of cell rows, and wherein the first portion of the outer skirt covers a portion of each outflow cell in the first outflow cell row.

3. The prosthetic heart valve of claim 2, wherein an interface between the first and second portions of the outer skirt extends circumferentially around the frame at an axial location adjacent an inflow apex of the outflow cell.

4. The prosthetic heart valve of any one of claims 1 to 3, wherein the polymer material is elastic and is configured to stretch circumferentially when the frame radially expands from a radially compressed configuration to a radially expanded configuration.

5. The prosthetic heart valve of any one of claims 1 to 4, wherein the polymer material is a non-textile.

6. The prosthetic heart valve of any one of claims 1 to 5, wherein the polymer material is thermoplastic polyurethane.

7. The prosthetic heart valve of any one of claims 1 to 6, wherein the fabric of the second portion is a woven fabric comprising polyethylene terephthalate.

8. The prosthetic heart valve of any one of claims 1 to 7, wherein the fabric of the second portion comprises a plurality of radially outwardly extending fibers configured to contact and seal against tissue.

9. A prosthetic heart valve according to any one of claims 1 to 8, wherein the first portion further extends across the inner surface of the second portion, so that the first portion forms an inner layer of the outer skirt that is positioned against the outer surface of the frame, and the second portion forms an outer layer of the outer skirt, and the inner layer extends beyond the outer layer in an axial direction toward the outflow end of the frame.

10. A prosthetic heart valve, comprising: Ring frame; and an outer skirt disposed around an outer surface of the frame, the outer skirt comprising: an outer layer comprising a fabric and forming an exposed surface for contacting tissue; and An inner layer comprises a polymer material and covers an inner surface of the outer layer, wherein the inner layer extends beyond an outflow edge portion of the outer layer toward an outflow end of the frame.

11. The prosthetic heart valve of claim 10, wherein the inflow edge portion of the outer layer is disposed at an inflow end of the frame.

12. A prosthetic heart valve according to claim 10 or claim 11, wherein the frame comprises a plurality of interconnected struts, the plurality of interconnected struts defining a plurality of circumferentially extending cell rows, the plurality of circumferentially extending cell rows including a first outflow cell row, the first outflow cell row being disposed at the outflow end of the frame, wherein the first outflow cell row is longer in an axial direction relative to the remaining cell rows in the plurality of cell rows, and wherein the inner layer of the outer skirt covers at least a portion of each outflow cell in the outflow cell row.

13. A prosthetic heart valve according to any one of claims 10 to 12, wherein the polymer material has a greater thrombotic resistance than the fabric and the polymer material is configured to form a snug fit around the outer surface of the frame when the frame is in a radially expanded configuration.

14. The prosthetic heart valve of any one of claims 10 to 13, wherein the outer layer comprises a first outer layer portion comprising a plurality of floating yarns extending radially outwardly and away from the outer skirt and the frame.

15. The prosthetic heart valve of claim 14, wherein the outer layer further comprises a second outer layer portion secured to an inflow edge portion of the first outer layer portion and extending from the first outer layer portion toward an inflow end of the frame.

16. The prosthetic heart valve of claim 15, wherein the second outer layer portion extends beyond the inner layer toward the inflow end of the frame and wraps around an inflow apex at the inflow end of the frame.

17. A prosthetic heart valve according to any one of claims 15 to 16, wherein the second outer layer portion comprises a woven fabric.

18. A prosthetic heart valve comprising: Ring frame; and an outer skirt disposed around an outer surface of the frame, the outer skirt comprising: a base layer comprising a polymer material, the base layer being disposed against the outer surface of the frame; and A plurality of outwardly extending yarns are adhered to the outer surface of the base layer and extend radially outwardly and away from the base layer.

19. The prosthetic heart valve of claim 18, wherein the polymer material has a thrombotic resistance greater than that of the plurality of outwardly extending yarns.

20. A prosthetic heart valve according to claim 18 or claim 19, wherein the polymer material is thermoplastic polyurethane.

21. The prosthetic heart valve of any one of claims 18 to 20, wherein the yarns of the plurality of outwardly extending yarns are individual yarns spaced apart from one another across the outer surface of the base layer.

22. A prosthetic heart valve according to any one of claims 18 to 21, wherein the plurality of outwardly extending yarns are disposed across a middle portion of the base layer, and wherein an outflow edge portion of the base layer lacking outwardly extending yarns extends beyond the middle portion toward an outflow end of the frame.

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