Prosthetic heart valve

Abstract

The utility model relates to a prosthetic heart valve. Reinforcing components for an outer skirt of a prosthetic heart valve are 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 including: a sealing layer including an outflow edge portion secured to the frame and an inflow edge portion secured to the frame; and a deformable reinforcing member attached to the sealing layer. The reinforcing member extends circumferentially along the sealing layer and is configured to extend radially outward from the frame such that the sealing layer projects radially outward from the frame and away from the frame when the frame is radially expanded from a radially compressed state to a radially expanded state. The reinforcement member includes a row of circumferentially extending cells or undulating shapes.

Description

[0001] This application is a divisional application of Chinese patent application 2023215873467, filed on June 21, 2023, entitled “Prosthetic Heart Valve”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 366,799, filed on June 22, 2022, the entirety of which is incorporated herein by reference. Technical Field

[0004] The present disclosure relates to prosthetic heart valves, and in particular to an outer cover or skirt having a deformable sealing member for a prosthetic heart valve. Background Art

[0005] 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 a prosthetic valve. There are many known repair devices (such as stents) and prosthetic valves, as well as many known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various surgeries to deliver prosthetic medical devices to a position that is not easily accessible by surgery or a position that is expected to be accessible without surgery. In a specific example, a prosthetic heart valve can be mounted on the distal end of a delivery device in a curled state and advance through the patient's vascular system (for example, through the femoral artery and aorta) until the prosthetic valve reaches the implantation site in the heart. Then, for example, by inflating a balloon with a prosthetic valve mounted thereon, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying a prosthetic valve from the 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.

[0006] Most inflatable prosthetic heart valves include a cylindrical metal frame or stent, and prosthetic leaflets mounted within the frame. These valves may also include one or more covers (or skirts) on the inner or outer surface of the frame that span the circumference of the frame. These covers may be configured to establish a seal with autologous tissue when the prosthetic heart valve is placed at the implantation site (and may therefore be referred to as a sealing member). However, autologous tissue (e.g., the autologous valve annular area or arterial wall around the autologous valve) may 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 autologous heart valve annular area, a gap may be formed between the prosthetic heart valve and the autologous heart valve annular area even when the cover is included on the prosthetic heart valve.

[0007] Accordingly, there is a need for an improved cover or outer skirt for a prosthetic heart valve that can better fill the gap between native tissue and the prosthetic heart valve. Utility Model Content

[0008] Prosthetic heart valves, delivery devices, and methods for implanting prosthetic heart valves are described herein. Specifically, examples of covers for prosthetic heart valves and methods of manufacturing and using such covers are described herein. The prosthetic heart valve may include a frame, and a leaflet assembly arranged on the inner surface of the frame. The prosthetic heart valve may include a cover (or outer skirt) arranged around the circumference of the frame and on the outer surface of the frame. The outer skirt may include one or more reinforcement members (or sealing members) that are deformable (or bendable) and configured to protrude radially outward from the frame and away from the frame. In some examples, the one or more reinforcement members may extend circumferentially around the frame. The one or more reinforcement members may be configured so that the prosthetic heart valve, once implanted, better conforms to the shape of the surrounding autologous tissue. In this way, the skirt and prosthetic heart valve disclosed herein may (especially) overcome one or more defects of typical prosthetic heart valves.

[0009] A prosthetic heart valve may include a frame, and a valve structure coupled to the frame.In addition to these components, a prosthetic heart valve may include one or more of the components disclosed herein.

[0010] In some examples, a prosthetic heart valve may include a sealing component configured to reduce paravalvular leakage.

[0011] A prosthetic heart valve may include a frame and a sealing component configured to reduce paravalvular leakage.In addition to these components, a prosthetic heart valve may also include one or more of the components disclosed herein.

[0012] In some examples, the sealing member is an outer skirt disposed about an outer surface of the frame.

[0013] In some examples, the outer skirt may include a sealing layer including an outflow edge portion secured to the frame and an inflow edge portion secured to the frame; and a deformable reinforcement member attached to the sealing layer.

[0014] In some examples, the reinforcement member extends circumferentially along the sealing layer.

[0015] In some examples, the reinforcement member may include an array of circumferentially extending cells or undulating shapes.

[0016] In some examples, the reinforcement member may include a shape memory material and may be movable between a first shape and a second shape.

[0017] In some examples, the reinforcement member may include a row of circumferentially extending cells.

[0018] In some examples, a prosthetic heart valve includes: an annular frame, and an outer skirt disposed around an outer surface of the frame. The outer skirt includes: a sealing layer including an outflow edge portion fixed to the frame and an inflow edge portion fixed to the frame; and a deformable reinforcement member attached to the sealing layer, the reinforcement member extending circumferentially along the sealing layer. The reinforcement member is configured to extend radially outward from the frame so that when the frame radially expands from a radially compressed state to a radially expanded state, the sealing layer protrudes radially outward from the frame and away from the frame. The reinforcement member includes a row of circumferentially extending cells or a wavy shape.

[0019] In some instances, a prosthetic heart valve includes: a radially expandable and compressible annular frame configured to move between a radially compressed configuration and a radially expanded configuration; and an outer skirt disposed around an outer surface of the frame. The outer skirt includes: a sealing layer including an outflow edge portion secured to the frame and an inflow edge portion secured to an inflow end of the frame; and a reinforcement member coupled to the sealing layer and extending circumferentially along the sealing layer at an axial position between the outflow edge portion and the inflow edge portion. The reinforcement member includes a shape memory material and is movable between a first shape and a second shape, wherein in the first shape, the reinforcement member is elongated in an axial direction relative to the second shape and disposed closer to the frame, and wherein in the second shape, the reinforcement member is shortened in an axial direction relative to the first shape and protrudes radially outward from the frame and away from the frame.

[0020] 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 sealing layer disposed around an outer surface of the frame, and a deformable reinforcement member coupled to the sealing layer, the reinforcement member extending circumferentially along the sealing layer and comprising a row of circumferentially extending units.

[0021] In some examples, a prosthetic heart valve includes: an annular frame, and an outer skirt disposed around an outer surface of the frame. The outer skirt includes a sealing layer disposed around the outer surface of the frame, and a shape memory reinforcement wire including a row of circumferentially extending cells supported by the sealing layer.

[0022] In some examples, a prosthetic heart valve includes an annular frame and an outer skirt disposed around an outer surface of the frame. The outer skirt includes: a sealing layer disposed around the outer surface of the frame; and a deformable reinforcement member coupled to the sealing layer, the reinforcement member extending circumferentially along the sealing layer and including a plurality of axially extending members circumferentially spaced from each other around the outer skirt.

[0023] In some examples, a prosthetic heart valve includes one or more of the components described in Examples 1-50, 57-64, and 66-68 below.

[0024] A method may include radially expanding a prosthetic valve from a radially compressed configuration to a radially expanded configuration within a native anatomical structure, wherein the prosthetic heart valve includes an annular frame and an outer skirt disposed about an outer surface of the frame including a sealing layer secured to the frame. The method may further include transitioning a reinforcement member embedded within a portion of the sealing layer not attached to the frame from a first configuration to a second configuration during radial expansion, wherein in the first configuration the reinforcement member is disposed adjacent to the frame, and wherein in the second configuration the reinforcement member extends radially outward from and away from the frame.

[0025] In some examples, a method includes radially expanding a prosthetic heart valve from a radially compressed configuration to a radially expanded configuration within a native valve annulus of a heart, wherein the prosthetic heart valve includes an annular frame, a plurality of leaflets secured within the frame, and an outer skirt disposed around an outer surface of the frame including a sealing layer secured to the frame at an outflow edge portion of the sealing layer and an inflow edge portion of the sealing layer. The method further includes, during radial expansion, transitioning a reinforcement component embedded within a portion of the sealing layer not attached to the frame from a first configuration to a second configuration, wherein in the first configuration the reinforcement component is disposed adjacent to the frame and is longer in an axial direction relative to the second configuration, and wherein in the second configuration the reinforcement component extends radially outward from the frame and away from the frame.

[0026] The above methods may be performed on a live animal or on a simulated object, such as a cadaver, a cadaver heart, an anthropomorphic ghost, a simulator (eg, having simulated body parts, hearts, tissues, etc.).

[0027] In some examples, a method includes one or more of the features described in Examples 51-56 and 65 below.

[0028] The various innovations of the present disclosure may be used in combination or alone. The present disclosure is provided to introduce some concepts in a simplified form, which will be further described in the following detailed description. The present disclosure is not intended to identify the key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features and advantages of the present disclosure will become more apparent from the following detailed description, claims and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1is a perspective view of a prosthetic heart valve according to one embodiment.

[0030] Figure 2 is a perspective view of a delivery device for a prosthetic heart valve according to one example.

[0031] Figure 3 is a side view of an outer skirt for a prosthetic heart valve according to one example, the outer skirt being shown in a flat configuration and including reinforcement features.

[0032] Figure 4A is a diagram showing an exemplary frame arrangement around a prosthetic device. Figure 3 Schematic diagram of an outer skirt, the frame is in a radially compressed configuration and the reinforcement component is in a first configuration.

[0033] Figure 4B is a diagram showing the arrangement of the prosthetic device around the frame Figure 3 Schematic diagram of an outer skirt, the frame is in a radially expanded configuration and the reinforcing member is in a second configuration.

[0034] Figure 5 is a schematic diagram showing a prosthetic device implanted (radially expanded) within an exemplary native valve annulus having a depression therein, the prosthetic device comprising a prosthesis extending into the depression of the native valve annulus Figure 3 External skirt.

[0035] Figure 6 is a schematic diagram showing a prosthetic device implanted (radially expanded) within an exemplary native valve annulus including a calcified nodule, the prosthetic device including a prosthesis extending into a recess in the native valve annulus disposed adjacent to the calcified nodule Figure 3 External skirt.

[0036] Figure 7 is a side view of an outer skirt for a prosthetic heart valve according to another example, the outer skirt being shown in a flat configuration and including reinforcement features shaped along horizontally extending lines of the outer skirt.

[0037] Figure 8 is a side view of an outer skirt for a prosthetic heart valve according to another example, the outer skirt being shown in a flat configuration and including reinforcement features forming a zigzag pattern along the outer skirt.

[0038] Fig. 9 is a side view of an outer skirt for a prosthetic heart valve according to another example, the outer skirt being shown in a flat configuration and including reinforcement members shaped as axially extending rectangles spaced apart from one another along the outer skirt. DETAILED DESCRIPTION

[0039] General considerations

[0040] 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.

[0041] Although the operations of some disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language set forth below requires a particular order. For example, the operations described in sequence may be rearranged or performed simultaneously in some cases. In addition, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, this specification sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation, and are easily discernible by those of ordinary skill in the art.

[0042] 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. In addition, the term "comprising" means "including". Furthermore, the term "coupled" generally means a physical, mechanical, chemical, magnetic, and / or electrical connection or coupling, and in the absence of specific language to the contrary does not exclude the presence of intervening elements between the coupled or associated items.

[0043] As used herein, the term "proximal" refers to a position, direction or part of a device that is closer to a user and further away from an implantation site. As used herein, the term "distal" refers to a position, direction or part of a device that is further away from a user and closer to an implantation site. Thus, for example, the proximal motion of a device is the motion of a device away from an implantation site and toward a user (e.g., leaving the patient's body), while the distal motion of a device is the motion of a device away from a user and toward an implantation site (e.g., entering a patient's body). The terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions, unless otherwise clearly defined.

[0044] As used herein, "such as" means "for example," and "ie" means "that is,."

[0045] Overview of Public Technology

[0046] The prosthetic valve disclosed herein can be radially compressed and expanded between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be crimped onto or held by an implant delivery device in a radially compressed state while being advanced through the patient's vasculature on the delivery device. Once the prosthetic valve reaches the implantation site, 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.

[0047] Figure 1 It can be shown that Figure 2 An exemplary prosthetic device (e.g., a prosthetic heart valve) is advanced through the vasculature of a patient, such as to a native heart valve, by an exemplary delivery device such as the exemplary delivery device shown in . The prosthetic heart valve may include an outer covering or skirt disposed about an outer surface of a frame of the prosthetic heart valve. The outer skirt may include one or more sealing or reinforcement components that are deformable and protrude radially outward from the frame. Thus, such outer skirts are configured to improve the sealing of the prosthetic heart valve against the native tissue at the implantation site. Various examples of deformable reinforcement or sealing components for the outer skirt and methods of forming such reinforcement components are described in . Figure 3-9 Displayed in.

[0048] Examples of Public Technology

[0049] 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 annular regions of the heart (pulmonary, mitral and tricuspid valves). The disclosed prosthetic valves may also be implanted in vessels connected to the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), or the superior vena cava or inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries and vessels of the patient. The disclosed prosthetic valves may also be implanted in a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) during a valve-in-valve procedure.

[0050] In some examples, the disclosed prosthetic valve can be implanted in a docking or anchoring device implanted in a natural heart valve or blood 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 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 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.

[0051] The prosthetic valve 10 may have four major components: a stent or frame 12, a valve structure 14, an inner skirt 16, and a paravalvular outer sealing member or outer skirt 18. The prosthetic valve 10 may have an inflow end portion 15, a mid-portion 17, and an outflow end portion 19.

[0052] The valve structure 14 may include three leaflets 40 that together form a leaflet structure that can be arranged to collapse in a tricuspid arrangement, but in other examples, there may be a greater or lesser number of leaflets (e.g., one or more leaflets 40). The leaflets 40 may be secured to each other at their adjacent sides to form the commissures 22 of the valve (e.g., leaflet) structure 14. The lower edge of the valve structure 14 may have a wavy curved fan-like shape and may be fastened to the inner skirt 16 by sutures (not shown). In some examples, the leaflets 40 may 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. Patent 6,730,118, which is incorporated herein by reference.

[0053] The frame 12 can be formed with a plurality of circumferentially spaced grooves or commissure windows 20 suitable for mounting the commissures 22 of the valve structure 14 to the frame. The frame 12 can be made of any of various suitable plastic expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloy (NiTi), such as Nitinol), as known in the art. When composed of plastic expandable materials, the frame 12 (and therefore the prosthetic valve 10) can be crimped to a radially telescoping (or compressed) configuration on a delivery catheter and then expanded to a radially expanded configuration in the patient's body by an inflatable balloon or an equivalent expansion mechanism. When constructed of self-expandable materials, the frame 12 (and therefore the prosthetic valve 10) can be curled into a radially collapsed configuration and restrained in a collapsed configuration by being inserted into a sheath or an equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0054] Suitable plastically expandable materials that can be used to form the frame 12 include metal alloys, polymers, or combinations thereof. Example metal alloys may include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some examples, the frame 12 may include stainless steel. In some examples, the frame 12 may include a cobalt-chromium alloy. In some examples, the frame 12 may include a nickel-cobalt-chromium alloy. 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 / UNS R30035 contains, by weight, 35% nickel, 35% cobalt, 20% chromium and 10% molybdenum.

[0055] Additional details regarding the prosthetic valve 10 and its various components are described in WIPO patent application publication WO 2018 / 222799, which is incorporated herein by reference.

[0056] The frame 12 may include a plurality of interconnected struts 32 forming open cells in the frame.

[0057] In some instances, such as Figure 1, an upper edge portion 28 (also referred to as an outflow edge portion) of the outer skirt 18 can be secured to the frame 12 by sutures 24, and a lower edge portion 30 (also referred to as an inflow edge portion) of the outer skirt 18 can be secured to the frame 12 by sutures 26 extending along the inflow end portion 15 of the prosthetic valve 10. For example, the sutures 24 can wrap around struts 32 of the frame 12, thereby forming a row of circumferentially extending struts 32 at the middle portion 17 of the prosthetic valve 10. Furthermore, in some examples, the sutures 26 can wrap around struts 32 of the frame 12, thereby forming a row of circumferentially extending struts 32 at the inflow end portion 15 of the prosthetic valve 10.

[0058] Figure 2 A delivery apparatus 100 is shown that can be used to implant an expandable prosthetic heart valve (eg, prosthetic valve 10) or another type of expandable prosthetic medical device (eg, a stent) according to one example. In some examples, delivery apparatus 100 is particularly suitable for introducing a prosthetic valve into a heart.

[0059] Figure 2 The delivery device 100 in the illustrated example of is a balloon catheter, which includes a handle 102, a steerable outer shaft 104 extending from the handle 102, an intermediate shaft extending coaxially from the handle 102 through the steerable outer shaft 104, and an inner shaft 106 extending coaxially from the handle 102 through the intermediate shaft and the steerable outer shaft 104, an inflatable balloon (e.g., a balloon) 108 extending from the distal end of the intermediate shaft, and a nose cone 110 disposed at the distal end of the delivery device 100. The distal portion 112 of the delivery device 100 includes the balloon 108, the nose cone 110, and a balloon shoulder assembly. A prosthetic medical device, such as a prosthetic heart valve, can be mounted on the valve retaining portion of the balloon 108. The balloon shoulder assembly is configured to maintain the prosthetic heart valve or other medical device in a fixed position on the balloon 108 during delivery through the patient's vasculature. In some examples, the balloon shoulder assembly may include a proximal shoulder 120 and / or a distal shoulder 122 .

[0060] The balloon 108 may include a central portion (which may be generally cylindrical when inflated, such as Figure 2 ), and two tapered end portions connected to the delivery device 100 (e.g., to one or more shafts and / or a nose cone of the delivery device).

[0061] The handle 102 may include a steering mechanism configured to adjust the curvature of the distal portion of the delivery device. In the illustrated example, for example, the handle 102 includes an adjustment component, such as a rotatable knob 134, which in turn is operably coupled to a proximal portion of a pull wire (not shown). The pull wire extends distally from the handle 102 via the outer shaft 104 and has a distal portion attached to the outer shaft at or near the distal end of the outer shaft 104. Rotating the knob 134 can effectively increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal portion of the delivery device.

[0062] The delivery device 100 can be configured to be advanced over a guidewire, which can be received within a guidewire lumen defined by the innermost shaft of the delivery device 100 .

[0063] In some examples, the delivery device (or another similar delivery device) can be configured to position and implant a prosthetic heart valve (e.g., Figure 1 Prosthetic valve 10). Additional details about this delivery device can be found in International Application No. PCT / US2021 / 047056, which is incorporated herein by reference.

[0064] As an example, in a device for implanting an expandable prosthetic heart valve (e.g., Figure 1 During an implantation procedure of a prosthetic heart valve 10 of the invention, the distal portion of the delivery device 100 (or another similar delivery device or balloon catheter) can be advanced (over a guidewire) to a target implantation site (e.g., a native valve annulus). The balloon 108 can then be inflated to radially expand and implant the prosthetic heart valve within the native valve annulus.

[0065] The native valve annulus and / or the surrounding anatomical structure of the implantation site (e.g., arterial wall) may have an irregular shape that may include concave areas, calcified nodules, and / or alternating protrusions. However, because the prosthetic heart valve may have a generally cylindrical shape, gaps (e.g., voids or channels) may form between the prosthetic heart valve and the native valve annulus when the prosthetic heart valve is implanted within the native valve annulus. Such gaps may increase the probability of paravalvular leakage through the prosthetic heart valve.

[0066] Therefore, it may be desirable to provide the outer skirt with a reinforcement member configured to extend or project radially outwardly from the frame of the prosthetic heart valve and into a recessed region of the native valve annulus, thereby providing an increased paravalvular leak seal against the native valve annulus.

[0067] Figure 3-4B Depicted is a prosthetic device 250 (e.g. Figure 1SUMMARY OF THE INVENTION The present invention provides an example of an outer skirt 200 (also referred to as a sealing member) of a prosthetic heart valve 10 of the present invention, the outer skirt including a reinforcing member 202 configured to extend radially outward from a frame 220 of a prosthetic device 250 when the prosthetic device 250 is radially expanded (e.g., when implanted in a native valve annulus or an alternative implantation site). The outer skirt 200, as well as other outer skirts disclosed herein, can be mechanically attached to an expandable prosthetic valve, a balloon expandable prosthetic valve (e.g., Figure 1 The invention relates to a prosthetic valve 10) and / or a self-expanding prosthetic valve. Additional details about balloon-expandable prosthetic valves can be found in U.S. Patent No. 9,393,110, and U.S. Provisional Application 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, which is incorporated herein by reference. Additional details about self-expanding prosthetic valves can be found in U.S. Patent No. 8,652,202, which is incorporated herein by reference.

[0068] Figure 3 The outer skirt 200 is shown in a flat configuration, and Figure 4A and 4B The outer skirt 200 is shown in an annular configuration disposed about and secured to the outer surface of a frame 220 of a prosthetic device (e.g., a prosthetic heart valve). Figure 4A , frame 220 is in a radially compressed configuration, which may be the configuration of the prosthetic device when the prosthetic device is mounted on a delivery device (eg, Figure 2 (shown in the). Figure 4B , the frame 220 is in a radially expanded configuration, which may be the configuration of the prosthetic device when the prosthetic device is radially expanded and implanted in a patient at an implantation site (e.g., Figure 1 Although the frame 220 is schematically shown in Figures 4A-4B , but the frame can have any of a variety of configurations, such as Figure 1The prosthetic device 250 may be a prosthetic valve including one or more of the components described above for the prosthetic valve 10, including the leaflets 40 and the inner skirt 16. In some examples, the prosthetic device 250 may be a prosthetic valve 10, except that the outer skirt 18 is replaced by the outer skirt 200.

[0069] The outer skirt 200 may include a base material 204 (which may also be referred to as a base layer or sealing layer). The base material 204 of the outer skirt 200 and other skirts or covers described herein may include various synthetic materials, including fabrics (e.g., polyethylene terephthalate fabric (PET) fabric) or ultra-high molecular weight polyethylene (UHMWPE) fabric), polytetrafluoroethylene (PTFE), thermoplastic polyurethane (TPU), hybrid materials including one or more fabrics or polymeric materials (e.g., PET coating in TPU), or autologous tissue (e.g., pericardial tissue). In some examples, the base material 204 of the outer skirt 200 may include a braided material (e.g., braided PET) formed by braiding two or more sets of braided fibers, strands, or yarns together.

[0070] The reinforcement member 202 may be formed of one or more of sutures, yarns, strings, or wires (e.g., shape memory wires, such as Nitinol wires) and attached to a base material 204 (also referred to as "material") of the outer skirt 200. In other examples, the reinforcement member 202 may be a self-expanding stent or ring, such as made of Nitinol, which may be formed, for example, by laser cutting the reinforcement member from a metal tube or other techniques known in the art for forming stents. Thus, the reinforcement member 202 may be supported by the base material 204 of the outer skirt 200. In some examples, the reinforcement member 202 may be embedded within or woven into the base material 204 of the outer skirt. For example, when the base material 204 includes braided fibers, the sutures, yarns, strings, or wires that make up the reinforcement member 202 may be woven into the braided fibers that make up the base material 204. In alternative examples, the reinforcement member 202 can be attached to the base material 204 by one or more fasteners, such as sutures, or adhesives. In such examples, the reinforcement member 202 can be secured to an inner surface of the base material 204 or an outer surface of the base material.

[0071] The outer skirt 200 may include opposing first and second edge portions 206, 208 (which may also be referred to as short edges or edge portions), each extending between an outflow edge portion 210 (also referred to herein as an "upper edge portion") and an inflow edge portion 212 (also referred to herein as a "lower edge portion") of the outer skirt 200.

[0072] Although the first and second edge portions 206, 208 are Figure 3 206, 208 may not be perpendicular to the inflow edge portion 212. For example, in an alternative example, the first and second edge portions 206, 208 may extend at an angle of about 45 degrees (or in the range of 40 to 50 degrees) relative to the inflow edge portion 212. Thus, the overall general shape of the outer skirt 200 may be a rhombus or a parallelogram or a rectangle (such as Figure 3 shown) shape.

[0073] When the outer skirt 200 is converted to its annular configuration (e.g., when mounted around the frame of a prosthetic device, such as Figure 4A and 4B ), the first and second edge portions 206, 208 may be disposed adjacent to or overlapping each other, and may then be secured together via one or more fasteners (eg, sutures).

[0074] The outflow edge portion 210 of the outer skirt 200 can be positioned closer to the outflow end 222 of the frame 220 of the prosthetic device than the inflow edge portion 212 when the outer skirt 200 is arranged around the frame 220 of the prosthetic device, such as Figure 4A and 4B As shown in . Figure 3-4B Outflow edge portion 210 is depicted as being relatively straight and parallel to inflow edge portion 212. However, in alternative examples, outflow edge portion 210 may have an alternative shape, such as formed with a plurality of protrusions defining an undulating shape that generally follows the shape or contour of a strut of a frame to which outflow edge portion 210 is secured.

[0075] The inflow edge portion 212 of the outer skirt 200 may be disposed at the inflow end 224 of the frame 220 of the prosthetic device ( Figure 4A and 4B ). In this manner, the outer skirt 200 may extend from the inflow end 224 of the frame 220 toward the outflow end 222 of the frame 220, but be spaced apart from the outflow end.

[0076] Both the outflow edge portion 210 and the inflow edge portion 212 of the outer skirt 200 may be (directly) secured to the frame 220 (eg, via sutures secured to struts of the frame, such as Figure 1 ), while the remainder of the outer skirt 200 disposed between the inflow edge portion 212 and the outflow edge portion 210 is not attached to the frame 220 ( Figure 4A and 4B). In some examples, the reinforcing member 202 can be attached to the middle portion 214 (or mid-portion) of the outer skirt 200 disposed between (and spaced apart from) the inflow edge portion 212 and the outflow edge portion 210. Thus, the reinforcing member 202 can also be unattached from the frame 220, but rather freely extend radially outward and away from the frame 220 relative to the central longitudinal axis 226 of the frame 220.

[0077] The frame 220 is desirably configured so that when the frame is moved from a radially compressed state ( Figure 4A ) radial expansion to radial expansion state ( Figure 4B ) When the frame is radially expanded, the outflow edge portion 210 and the inflow edge portion 212 can move closer together, thereby forming a redundant portion or excess material in the base material 204 between the inflow edge portion and the outflow edge portion.

[0078] In some examples, the reinforcement member 202 may be referred to as a deformable reinforcement member 202 due to its ability to be deformed from the frame 220 in a radially compressed configuration (eg, Figure 4A 230 changes or transforms into a first shape or first configuration 230 in which the frame 220 is in a radially expanded configuration (as shown in FIG. Figure 4B A second shape or second configuration 232 when shown).

[0079] In its first configuration 230 ( Figure 4A ), the reinforcing member 202 may be elongated in the axial direction and disposed closer to the frame 220 in the radial direction than when in the second configuration 232. For example, when the reinforcing member 202 is in its first configuration 230, the height 216 (in the axial direction) of the reinforcing member 202 may be greater than when in the second configuration 232. In some examples, the height 216 of the reinforcing member 202 may be specified so that the reinforcing member 202 is spaced apart from the outflow edge portion 210 and the inflow edge portion 212 in both the first configuration 230 and the second configuration 232.

[0080] In contrast, when the reinforcement member 202 is in the second configuration 232 ( Figure 4B ), the height 216 of the reinforcement member 202 may be shorter than when in the first configuration 230. Furthermore, in the second configuration 232, the reinforcement member 202 may extend or protrude radially outward and away from the outer surface of the frame 220, thereby causing the redundant portion or excess base material 204 along the middle portion 214 of the outer skirt 200 (to which the reinforcement member 202 is attached or embedded) to extend or protrude radially outward from the frame 220 ( Figure 4B ).

[0081] The ability of the reinforcement member 202 to change between the first configuration 230 and the second configuration 232 may be attributed to the material of the reinforcement member 202. For example, as described above, the reinforcement member 202 may include a stent, a suture, a braid, or a wire (or a plurality of sutures, braids, and / or wires integrated together), such as a shape memory braid or wire (e.g., a nitinol braid or wire), which may be configured to assume the first configuration 230 ( ) when the frame 220 is radially compressed and the outer skirt 200 is axially extended relative to the frame 220. Figure 4A ), and transforms into a second configuration 232 when the frame 220 expands radially and the outer skirt 200 shortens axially relative to the frame 220.

[0082] As an example, the reinforcement member 202 may be shaped so that when the frame 220 is in the radially expanded configuration ( Figure 4B ) radially outwardly protruding or convex shape. This can be referred to as the "free state" of the reinforcement member 202. The material of the reinforcement member 202 can be configured so that when the frame is radially compressed, the reinforcement member 202 can be deformed into its first configuration 230. As described above, in this deformed first configuration 230, the reinforcement member can be axially extended and pressed closer against the frame 220, thereby sandwiching or pressing the middle portion 214 of the outer skirt 200 against the outer surface of the frame 220. This can help reduce the friction when radially compressed around the delivery device (e.g., Figure 2 ) The overall crimping configuration of a radially compressed prosthetic device.

[0083] When the frame 220 is radially expanded (e.g., when placed at an implantation site by a delivery device), the reinforcement members 202 can return to their free state, or second configuration 232. In some examples, the reinforcement members 202 can be tuned to have a specified amount of radial strength and / or a specified amount of radial extension away from the frame 220. In this way, the reinforcement members 202 can have more predictable and repeatable behavior by being made of a shape memory material and tuning the behavior of the shape memory material.

[0084] In some instances, such as Figure 3-4B , the reinforcing member 202 may include a row of circumferentially extending cells 234 arranged end-to-end around the outer skirt 200. Each cell 234 may have an axial height that is the height 216 of the reinforcing member 202, and a width 218 (in the circumferential direction). The height 216 of each cell 234 may be 216 in the first configuration 230 ( Figure 4A ) is longer and shorter in the second configuration 232 ( Figure 4B). In addition, the width 218 of each unit 234 can be shorter in the first configuration 230 than in the second configuration 232. In the example shown, the unit 234 is a four-sided diamond unit. In other examples, the unit 234 can have any of a variety of other shapes, such as hexagonal, elliptical, circular, or a combination thereof.

[0085] The reinforcement member 202 may have a thickness 228. The thickness 228 may be selected so that when the frame 220 is in the radially expanded configuration ( Figure 4B ), the reinforcement component 202 extends radially outwardly from the frame 220 of the prosthetic device 250 by a specified amount.

[0086] The reinforcing member 202 may also form a closed loop around the circumference of the outer skirt 200, such as Figure 4A and 4B By being formed as a closed loop and being formed of a deformable material (e.g., a metal wire, or a shape memory material, as described above), the reinforcement member 202 can better conform to the native anatomical structure (e.g., the native valve annulus) after implantation. Figure 5 and 6 As shown in , the reinforcement member 202 can be configured such that when one region of the reinforcement member 202 is pressed radially inwardly by a portion of the native anatomical structure at the native valve annular region 300, the adjacent region of the reinforcement member 202 further bulges or extends radially outwardly (e.g., to maintain the outer perimeter of the ring of the reinforcement member 202). Figure 5 and 6 As shown in , this allows the reinforcement member 202 to conform to the shape of the surrounding anatomy at the native valve annulus 300 (or an alternative implantation site for a prosthetic device).

[0087] exist Figure 5 and 6 In the embodiment, the prosthetic device 250 is a prosthetic heart valve, which includes a frame 220, leaflets 252 mounted inside the frame, and an outer skirt 200 disposed around the outer surface of the frame. Figure 5 and 6 A cross-section of a prosthetic heart valve taken along mid-portion 314 in the region of reinforcement member 202 is shown.

[0088] Steering Figure 5, the prosthetic device 250 is implanted (radially expanded) in the native valve annular area 300, which includes an exemplary depression 302. Such irregularities in the native valve annular area 300 may be caused by calcification of the native ring. The portion of the native valve annular area 300 adjacent to the depression 302 may be narrower and pressed radially inward against the reinforcing member 202, thereby causing a portion or area 304 of the reinforcing member 202 not to be pressed inward by the native valve annular area 300 to extend radially outward into the depression 302, thereby allowing the outer skirt to seal against the native tissue in the depression. Therefore, the gap between the prosthetic device 250 and the native valve annular area 300 can be reduced, thereby minimizing paravalvular leakage.

[0089] As another example, Figure 6 As shown, the native valve annular region 300 may include one or more calcified nodules 306. As the one or more calcified nodules 306 are pressed radially inward against the first portion 308 (or first segment) of the reinforcement member 202, the second portion 310 (or segment) of the reinforcement member 202 disposed adjacent to the first portion 308 further bulges radially outward to fill the gap in the native valve annular region 300 around the calcified nodules 306.

[0090] Thus, reinforcement component 202 provides prosthetic device 250 with improved paravalvular leak sealing against native anatomy without applying unnecessary forces against calcified nodules 306 .

[0091] In some examples, the reinforcement component 202 may include multiple rows of circumferentially extending cells. In some embodiments, each cell in a row may be connected to one or more cells in an adjacent row. In other embodiments, each row of cells may be spaced apart from each other in the axial direction along the height of the base material 204. In this way, each row of cells may be a separate reinforcement component coupled to the base layer.

[0092] In some instances, the reinforcement element 202 may have alternative shapes (other than an annular array of closed cells) that extend circumferentially along (and around) the outer skirt, such as a zigzag shape arranged end-to-end around the circumference of the outer skirt, a plurality of axially extending lines, circumferentially extending rings, or a plurality of circles, figures of eight, triangles, etc.

[0093] Figure 7-9 Additional examples of reinforcement components for an outer skirt of a prosthetic device are shown. Figure 7-9 The reinforcement components shown in the figure may be similar to those in the reference Figure 3-4B The reinforcing member 202 described above. Similar to the reinforcing member 202, Figure 7-9The reinforcement components shown in FIG. 202 may be attached to the base material 204 of the outer skirt, for example, by sewing, weaving, adhesive or otherwise embedding the reinforcement components 202 within the base material 204. Figure 7 , 8 The outer skirts 400, 500, and 600 shown in FIGS. 1 and 9 are shown in a flat configuration outside the frame of the prosthetic device. However, the outer skirts 400, 500, and 600 may be attached to the frame of the prosthetic device, similar to Figure 4A and 4B As shown for the outer skirt 200.

[0094] First, turn to Figure 7 , the outer skirt 400 may include one or more reinforcing members 402 ( Figure 7 ), each reinforcing member 402 is shaped as a line or loop extending horizontally (or circumferentially once wrapped around the cylindrical frame of the prosthetic device) along the outer skirt 400. For example, Figure 7 As shown, each reinforcing member 402 may be shaped as a wire having a thickness 404. The thickness 404 may be selected so that when the frame is in a radially expanded configuration (e.g., similar to Figure 4B ), each reinforcement member 402 extends radially outward from the frame of the prosthetic device to which the outer skirt 400 is attached.

[0095] In some instances, such as Figure 7 As shown, each reinforcement member 402 can extend from the first edge portion 206 to the second edge portion 208 of the outer skirt 400 such that the reinforcement members 402 form a loop around the outer skirt 400 when the outer skirt is in an annular configuration around the frame of the prosthetic device.

[0096] In some instances, such as Figure 7 As shown, the outer skirt 400 may include a plurality of reinforcing members 402 (e.g., two, three, four, five, etc.) spaced apart from each other in the axial direction. Similar to the outer skirt 200, the reinforcing members 402 may be disposed in the middle portion 214 of the outer skirt 400 and spaced apart from the inflow edge portion 212 and the outflow edge portion 210.

[0097] Figure 8 Another exemplary outer skirt 500 is shown including a reinforcing member 502 having an undulating shape, such as a zigzag pattern or a sinusoidal shape as shown extending in a circumferential direction along the outer skirt 500. In some examples, the reinforcing member 502 can extend from the first edge portion 206 to the second edge portion 208 of the outer skirt 500, thereby forming a (closed) loop around the outer skirt 500 when the outer skirt is in an annular configuration around the frame of the prosthetic device.

[0098] The undulating shape of the reinforcement member 502 may include a plurality of peaks 504 (or outflow apexes) and a plurality of valleys 506 (or inflow apexes) spaced apart from the outflow edge portion 210 and the inflow edge portion 212 of the outer skirt 500 , respectively.

[0099] The thickness 508 of the reinforcing member 502 may be selected so that when the frame is in a radially expanded configuration (e.g., similar to Figure 4B ), the reinforcement members 502 extend radially outward from the frame of the prosthetic device to which the outer skirt 500 is attached.

[0100] Fig. 9 Another exemplary outer skirt 600 is shown including a plurality of reinforcing members 602 spaced apart from one another in the circumferential direction along the outer skirt 600 from the first edge portion 206 to the second edge portion 208 of the outer skirt 600. Each reinforcing member 602 may be shaped as a vertical line or an axially extending rectangle having a thickness 604. In alternative examples, each reinforcing member 602 may be configured as an axially extending member having an alternative shape, such as an elliptical, curved, or S-shaped, with its longest dimension in the axial direction.

[0101] The thickness 604 of the reinforcing member 602 may be selected so that when the frame is in a radially expanded configuration (e.g., similar to Figure 4B 500 is attached to the outer skirt 500. In addition, the spacing 606 (in the circumferential direction) between adjacent reinforcement members 602 can be selected so that when the prosthetic device is in the radially expanded configuration, the base material 204 of the outer skirt 600 at the intermediate portion 214 bulges radially outward all the way around the circumference of the outer skirt 600.

[0102] The height 608 (defined in the axial direction) of each reinforcing member 602 may be selected such that the ends of each reinforcing member 602 are spaced apart from the inflow edge portion 212 and the outflow edge portion 210 of the outer skirt 610, and each reinforcing member 602 is disposed within the middle portion 214 of the outer skirt 600. In other examples, one or more of the reinforcing members 602 may extend the entire height of the outer skirt from the inflow edge to the outflow edge.

[0103] In this way, by having one or more deformable reinforcement components arranged circumferentially along the outer skirt, the prosthetic device (e.g., a prosthetic heart valve) can better conform to the irregular geometry at the implantation site (e.g., the native valve annular region), thereby providing an improved seal against the native anatomical structure. In some instances, by forming a closed loop, portions of the reinforcement component can extend radially outward into a recess in the native valve annular region as other portions of the reinforcement component are pressed radially inward by a protrusion in the native valve annular region. In addition, in instances in which the reinforcement component is formed by a shape memory material (e.g., a wire), the reinforcement component of the outer skirt can be configured to axially extend and be positioned closer to the frame of the prosthetic device when the prosthetic device is in a radially compressed configuration, and then extend radially outward from the frame when the prosthetic device is in a radially expanded configuration. Therefore, the outer skirt of the prosthetic device can provide an increased paravalvular leak seal, yet also reduce the overall crimping configuration of the prosthetic device (e.g., when mounted around a delivery device).

[0104] Delivery Technology

[0105] 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 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, such as through a partial J-shaped sternotomy or a right parasternal mini-thoracotomy, and is subsequently advanced through the ascending aorta toward the native aortic valve.

[0106] To implant a prosthetic valve into the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted 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, 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.

[0107] To implant the prosthetic valve into the native tricuspid valve, the prosthetic valve is mounted 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.

[0108] 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) for access to 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 right ventricular wall (usually at or near the base of the heart) for implantation of the prosthetic valve into the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0109] 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.

[0110] Any system, device, equipment, etc. herein can be sterilized (e.g., with heating / heat, pressure, steam, radiation and / or chemicals, etc.) to ensure that they are safe for use by patients, and as one of the steps of the method, any method herein can include the sterilization of associated systems, equipment, devices, etc. The example of heating / thermal sterilization includes steam sterilization and autoclave. The example of radiation for sterilization includes but is not limited to gamma radiation, ultraviolet radiation and electron beam. The example of chemicals for sterilization includes but is not limited to ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde and glutaraldehyde. Sterilization with hydrogen peroxide can be completed using, for example, hydrogen peroxide plasma.

[0111] The therapeutic techniques, methods, steps, etc. described or suggested herein or in the references incorporated herein can be performed on living animals or on non-living analogs, such as cadavers, cadaver hearts, anthropomorphic phantoms, simulators (e.g., having simulated body parts, tissues, etc.), etc.

[0112] Additional Examples of Disclosure Techniques

[0113] Considering the above implementation 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 other examples, are other examples that also fall within the disclosure of the present application.

[0114] Example 1. A prosthetic heart valve, comprising: an annular frame; and an outer skirt disposed around the outer surface of the frame, the outer skirt comprising: a sealing layer comprising an outflow edge portion fixed to the frame and an inflow edge portion fixed to the frame; and a deformable reinforcement component attached to the sealing layer, the reinforcement component extending circumferentially along the sealing layer, wherein the reinforcement component is configured to extend radially outward from the frame so that when the frame radially expands from a radially compressed state to a radially expanded state, the sealing layer protrudes radially outward from the frame and away from the frame, and wherein the reinforcement component comprises a row of circumferentially extending units or a wavy shape.

[0115] Example 2. A prosthetic heart valve according to any example herein, in particular example 1, wherein the reinforcement component comprises a shape memory material.

[0116] Example 3. A prosthetic heart valve according to any example herein, in particular example 1 or example 2, wherein the reinforcement component comprises a nitinol braid or a nitinol wire.

[0117] Example 4. A prosthetic heart valve according to any example herein, in particular any one of examples 1-3, wherein the sealing layer comprises a fabric.

[0118] Example 5. A prosthetic heart valve according to any example herein, in particular any one of examples 1-4, wherein the reinforcement component is woven into the sealing layer.

[0119] Example 6. A prosthetic heart valve according to any example herein, in particular any one of examples 1-5, wherein the reinforcement member forms a closed loop around the circumference of the outer skirt.

[0120] Example 7. A prosthetic heart valve according to any example herein, in particular any one of examples 1-6, wherein the reinforcement component is spaced apart from the outflow edge portion and the inflow edge portion of the sealing layer.

[0121] Example 8. A prosthetic heart valve according to any example herein, in particular any one of examples 1-7, wherein the reinforcement member is not attached to the outer surface of the frame and is radially spaced apart from the outer surface.

[0122] Example 9. A prosthetic heart valve according to any example herein, in particular any one of examples 1-8, wherein the reinforcement member comprises a row of circumferentially extending diamond-shaped units arranged end-to-end around the outer skirt.

[0123] Example 10. A prosthetic heart valve according to any example herein, in particular any one of examples 1-8, wherein the reinforcement component is sewn into the sealing layer.

[0124] Example 11. A prosthetic heart valve according to any example herein, in particular any one of examples 1-8, wherein the reinforcing member forms a zigzag pattern around the outer skirt, and wherein the peaks and valleys of the reinforcing member are spaced apart from the outflow and inflow edge portions of the sealing layer.

[0125] Example 12. A prosthetic heart valve according to any example herein, in particular any one of examples 1-8, wherein when the frame radially expands, the inflow and outflow edge portions of the sealing layer move closer together to form a redundant portion along the middle portion of the sealing layer.

[0126] Example 13. A prosthetic heart valve according to any example herein, in particular any one of examples 1-12, further comprising a plurality of leaflets arranged inside the frame.

[0127] Example 14. A prosthetic heart valve, comprising: a radially expandable and compressible annular frame configured to move between a radially compressed configuration and a radially expanded configuration; and an outer skirt disposed around an outer surface of the frame, the outer skirt comprising: a sealing layer comprising an outflow edge portion fixed to the frame and an inflow edge portion fixed to an inflow end of the frame; and a reinforcement component connected to the sealing layer and extending circumferentially along the sealing layer at an axial position between the outflow edge portion and the inflow edge portion, wherein the reinforcement component comprises a shape memory material and is movable between a first shape and a second shape, wherein in the first shape, the reinforcement component is elongated in an axial direction relative to the second shape and disposed closer to the frame, and wherein in the second shape, the reinforcement component is shortened in an axial direction relative to the first shape and protrudes radially outward from the frame and away from the frame.

[0128] Example 15. A prosthetic heart valve according to any example herein, in particular Example 14, wherein the reinforcement component is in a first shape when the frame is in a radially compressed configuration, and wherein the reinforcement component is in a second shape when the frame is in a radially expanded configuration.

[0129] Example 16. A prosthetic heart valve according to any example herein, in particular example 14 or example 15, wherein the sealing layer comprises a fabric and the reinforcement component is woven into the fabric.

[0130] Example 17. A prosthetic heart valve according to any one of the examples herein, in particular any one of examples 14-16, wherein the reinforcement component comprises nitinol.

[0131] Example 18. A prosthetic heart valve according to any example herein, in particular any one of examples 14-17, wherein the first shape is a deformed configuration of the reinforcement component and the second shape is a free configuration of the reinforcement component.

[0132] Example 19. A prosthetic heart valve according to any example herein, in particular any one of examples 14-18, wherein the reinforcement component forms a ring around the circumference of the sealing layer.

[0133] Example 20. A prosthetic heart valve according to any example herein, in particular any one of examples 14-19, wherein the reinforcement member comprises a row of circumferentially extending cells arranged end-to-end around the outer skirt.

[0134] Example 21. A prosthetic heart valve according to any example herein, in particular Example 20, wherein the width of each cell is greater in the second shape than in the first shape.

[0135] Example 22. A prosthetic heart valve according to any example herein, particularly any of Examples 14-19, wherein the reinforcement member comprises a plurality of rings axially spaced apart from one another around the circumference of the outer skirt.

[0136] Example 23. A prosthetic heart valve according to any example herein, in particular any one of Examples 14-19, wherein the reinforcement member forms a zigzag pattern around the outer skirt, and wherein the peaks and valleys of the reinforcement member are spaced apart from the outflow and inflow edge portions of the outer skirt.

[0137] Example 24. A prosthetic heart valve according to any of the examples herein, in particular any of Examples 14-19, wherein the reinforcement member comprises a plurality of axially extending members circumferentially spaced apart from one another around the outer skirt, and wherein the ends of each axially extending member are spaced apart from the outflow and inflow edge portions of the outer skirt.

[0138] Example 25. A prosthetic heart valve according to any example herein, in particular any one of examples 14-24, further comprising a plurality of leaflets arranged inside the frame.

[0139] Example 26. A prosthetic heart valve according to any example herein, in particular any of examples 14-25, wherein when the reinforcement member is in the second shape, the entire reinforcement member is radially spaced apart from the frame.

[0140] Example 27. 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 sealing layer disposed around an outer surface of the frame; and a deformable reinforcement component connected to the sealing layer, the reinforcement component extending circumferentially along the sealing layer and comprising a row of circumferentially extending units.

[0141] Example 28. A prosthetic heart valve according to any example herein, in particular Example 27, wherein the cells are rhombus-shaped.

[0142] Example 29. A prosthetic heart valve according to any example herein, in particular any one of examples 27-28, wherein the cells are arranged end to end with each other and form a closed loop around the circumference of the sealing layer.

[0143] Example 30. A prosthetic heart valve according to any example herein, especially any one of Examples 27-29, wherein the reinforcement component is disposed in a middle portion of the sealing layer, the middle portion being disposed between the outflow edge portion and the inflow edge portion of the sealing layer and spaced apart from the outflow edge portion and the inflow edge portion of the sealing layer.

[0144] Example 31. A prosthetic heart valve according to any example herein, in particular any one of examples 27-30, wherein the reinforcement member is not attached to the outer surface of the frame.

[0145] Example 32. A prosthetic heart valve according to any example herein, in particular any one of examples 27-31, wherein the reinforcement component comprises a shape memory material.

[0146] Example 33. A prosthetic heart valve according to any example herein, in particular any one of examples 27-32, wherein the reinforcement component comprises a nitinol braid, a nitinol wire, or a nitinol stent.

[0147] Example 34. A prosthetic heart valve according to any example herein, in particular any one of examples 27-33, wherein the sealing layer comprises a fabric.

[0148] Example 35. A prosthetic heart valve according to any example herein, in particular example 34, wherein the reinforcement component is woven into the fabric.

[0149] Example 36. A prosthetic heart valve according to any example herein, in particular any one of examples 27-35, wherein the reinforcement member and the portion of the sealing layer to which the reinforcement member is attached protrude radially outward from the frame and away from the frame when the frame expands radially.

[0150] Example 37. A prosthetic heart valve according to any example herein, in particular any one of examples 27-36, further comprising a plurality of leaflets arranged within the frame.

[0151] Example 38. A prosthetic heart valve according to any example herein, in particular any one of Examples 27-37, wherein the frame comprises a plurality of interconnected struts forming open cells in the frame, and wherein the frame is configured to radially compress and expand between a radially compressed configuration and a radially expanded configuration.

[0152] Example 39. A prosthetic heart valve according to any example herein, in particular any one of examples 27-38, wherein the sealing layer comprises inflow and outflow edge portions secured to the frame with sutures.

[0153] Embodiment 40. 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 sealing layer disposed around an outer surface of the frame; and a shape memory reinforcement wire comprising a row of circumferentially extending units supported by the sealing layer.

[0154] Example 41. A prosthetic heart valve according to any example herein, in particular example 40, wherein the units are rhombus-shaped.

[0155] Example 42. A prosthetic heart valve according to any example herein, in particular any one of Examples 40-41, wherein the cells are arranged end-to-end to each other and form a closed loop around the circumference of the outer skirt.

[0156] Example 43. A prosthetic heart valve according to any example herein, especially any one of Examples 40-42, wherein the reinforcement thread is disposed in a middle portion of the sealing layer, the middle portion being disposed between the outflow edge portion and the inflow edge portion of the sealing layer and spaced apart from the outflow edge portion and the inflow edge portion of the sealing layer.

[0157] Example 44. A prosthetic heart valve according to any example herein, in particular any one of Examples 40-43, wherein the reinforcement wire is not attached to the outer surface of the frame.

[0158] Example 45. A prosthetic heart valve according to any of the examples herein, in particular any of Examples 40-44, wherein the sealing layer includes excess material between an outflow edge portion and an inflow edge portion of the sealing layer, and wherein the material of the sealing layer to which the reinforcement thread is attached protrudes radially outward from the frame and away from the frame together with the reinforcement thread when the frame expands radially.

[0159] Example 46. A prosthetic heart valve according to any one of the examples herein, in particular any one of examples 40-45, wherein the reinforcing wire comprises nitinol.

[0160] Example 47. A prosthetic heart valve according to any one of the examples herein, in particular any one of examples 40-46, wherein the sealing layer comprises a fabric.

[0161] Example 48. A prosthetic heart valve according to any example herein, in particular Example 47, wherein reinforcement threads are woven into the fabric.

[0162] Example 49. A prosthetic heart valve according to any example herein, in particular any one of Examples 40-48, further comprising a plurality of leaflets arranged within the frame.

[0163] Example 50. A prosthetic heart valve according to any example herein, in particular any one of Examples 40-49, wherein the frame comprises a plurality of interconnected struts forming open cells in the frame, and wherein the frame is configured to radially compress and expand between a radially compressed configuration and a radially expanded configuration.

[0164] Example 51. A method comprising: radially expanding a prosthetic heart valve from a radially compressed configuration to a radially expanded configuration within a native valve annular region of a heart, wherein the prosthetic heart valve comprises an annular frame, a plurality of leaflets fixed inside the frame, and an outer skirt comprising a sealing layer disposed around an outer surface of the frame, the sealing layer being fixed to the frame at an outflow edge portion of the sealing layer and an inflow edge portion of the sealing layer; and during radial expansion, transforming a reinforcement component embedded in a portion of the sealing layer that is not attached to the frame from a first configuration to a second configuration, wherein in the first configuration, the reinforcement component is disposed adjacent to the frame and is longer in an axial direction relative to the second configuration, and wherein in the second configuration, the reinforcement component extends radially outward from the frame and away from the frame.

[0165] Example 52. A method according to any example herein, in particular Example 51, wherein the portion of the sealing layer not attached to the frame is a central portion axially disposed between the outflow edge portion and the inflow edge portion, and the method further comprises: during radial expansion and as the reinforcement component transitions to a second configuration, causing the central portion of the sealing layer to bulge radially outward so that it conforms to the shape of the annular area of ​​the native valve.

[0166] Example 53. The method according to any example herein, in particular Example 52, further comprises: during radial expansion, as the first section of the reinforcement component and the central portion of the sealing layer are radially compressed inward by the protruding features at the annular area of ​​the native valve, the second section of the reinforcement component and the central portion of the sealing layer radially extend into the gap formed in the annular area of ​​the native valve adjacent to the protruding features.

[0167] Example 54. A method according to any example herein, in particular example 51 or example 52, further comprising extending an adjacent second portion of the reinforcing member further radially outward in response to compressing the first portion of the reinforcing member in a radially inward direction.

[0168] Example 55. A method according to any example herein, in particular any one of Examples 51-54, wherein the reinforcing member comprises a row of circumferentially extending rhombus-shaped units arranged end-to-end around the outer skirt, and wherein each rhombus-shaped unit is shorter in the axial direction and longer in the circumferential direction in the second configuration than in the first configuration.

[0169] Example 56. A method according to any example herein, in particular any one of Examples 51-55, wherein radially expanding the prosthetic heart valve comprises shortening the sealing layer in an axial direction and expanding the sealing layer radially outward.

[0170] Example 57. 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 sealing layer disposed around an outer surface of the frame; and a deformable reinforcement component connected to the sealing layer, the reinforcement component extending circumferentially along the sealing layer and comprising a plurality of axially extending components circumferentially spaced apart from each other around the outer skirt.

[0171] Example 58. A prosthetic heart valve according to any example herein, in particular Example 57, wherein the sealing member comprises an outflow edge portion fixed to the frame and an inflow edge portion fixed to the frame, and wherein the end of each axially extending member is spaced apart from the outflow and inflow edge portions of the sealing layer.

[0172] Example 59. A prosthetic heart valve according to any example herein, in particular Example 57 or Example 58, wherein the reinforcement component is connected to a middle portion of the sealing layer, the middle portion being disposed between and spaced apart from the outflow edge portion and the inflow edge portion of the sealing layer.

[0173] Example 60. A prosthetic heart valve according to any of the examples herein, in particular any of Examples 57-59, wherein the sealing layer includes excess material between an outflow edge portion and an inflow edge portion of the sealing layer, and wherein when the frame expands radially, the material of the sealing layer to which the reinforcement member is connected protrudes radially outward from the frame and away from the frame together with the reinforcement member.

[0174] Example 61. A prosthetic heart valve according to any one of the examples herein, in particular any one of Examples 57-60, wherein the reinforcement component comprises nitinol.

[0175] Example 62. A prosthetic heart valve according to any example herein, in particular any one of Examples 57-61, wherein the sealing layer comprises fabric.

[0176] Example 63. A prosthetic heart valve according to any example herein, in particular any one of Examples 57-62, further comprising a plurality of leaflets arranged within the frame.

[0177] Example 64. A prosthetic heart valve according to any example herein, in particular any one of Examples 57-63, wherein the frame comprises a plurality of interconnected struts forming open cells in the frame, and wherein the frame is configured to radially compress and expand between a radially compressed configuration and a radially expanded configuration.

[0178] Example 65. A method comprising sterilizing the prosthetic heart valve, device, and / or assembly of any example.

[0179] Example 66. A prosthetic heart valve according to any of Examples 1-64, wherein the prosthetic heart valve is sterilized.

[0180] Example 67. A method according to any of Examples 51-56, wherein the method is performed on a living animal, or an inanimate simulation device such as a corpse, a cadaver heart, an anthropomorphic dummy target, or a simulator.

[0181] Example 68. A method of treating a heart on a simulation device, wherein the method comprises the method according to any one of Examples 51-56.

[0182] Unless otherwise specified, features described herein with respect to any example may be combined with other features described in any one or more other examples. For example, any one or more of the features of one skirt, cover, sealing component, or reinforcement component may be combined with any one or more features of another skirt, cover, sealing component, or reinforcement component. As another example, any one or more features of one prosthetic heart valve may be combined with any one or more features of another prosthetic heart valve.

[0183] 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, characterized in that: The prosthetic heart valve comprises: Ring frame; and an outer skirt disposed about an outer surface of the frame, the outer skirt comprising: a sealing layer including an outflow edge portion fixed to the frame and an inflow edge portion fixed to the frame; and A deformable reinforcement member attached to the sealing layer, the reinforcement member extending circumferentially along the sealing layer, wherein the reinforcement member is configured to extend radially outward from the frame so that when the frame radially expands from a radially compressed state to a radially expanded state, the sealing layer protrudes radially outward from the frame and away from the frame, and wherein the reinforcement member includes a row of circumferentially extending units or wavy shapes, wherein the reinforcement member is sewn to the sealing layer.

2. The prosthetic heart valve according to claim 1, characterized in that: The reinforcing member forms a zigzag pattern around the outer skirt, and wherein the peaks and valleys of the reinforcing member are spaced apart from the outflow edge portion and the inflow edge portion of the sealing layer.

3. The prosthetic heart valve according to claim 1, characterized in that: When the frame radially expands, the inflow edge portion and the outflow edge portion of the sealing layer move closer together to form a redundant portion along a middle portion of the sealing layer.

4. The prosthetic heart valve according to any one of claims 1 to 3, characterized in that: The prosthetic heart valve further includes a plurality of leaflets disposed within an interior portion of the frame.

5. A prosthetic heart valve, characterized in that: The prosthetic heart valve comprises: a radially expandable and compressible annular frame configured to move between a radially compressed configuration and a radially expanded configuration; and an outer skirt disposed about an outer surface of the frame, the outer skirt comprising: a sealing layer including an outflow edge portion fixed to the frame and an inflow edge portion fixed to an inflow end of the frame; and A reinforcing member coupled to the sealing layer and extending circumferentially along the sealing layer at an axial position between the outflow edge portion and the inflow edge portion, wherein the reinforcing member comprises a shape memory material and is movable between a first shape and a second shape, wherein in the first shape, the reinforcing member is elongated in the axial direction relative to the second shape and disposed closer to the frame, and wherein in the second shape, the reinforcing member is shortened in the axial direction relative to the first shape and protrudes radially outward and away from the frame.

6. The prosthetic heart valve according to claim 5, characterized in that: The strengthening member is in the first shape when the frame is in the radially compressed configuration, and wherein the strengthening member is in the second shape when the frame is in the radially expanded configuration.

7. The prosthetic heart valve according to claim 5, characterized in that: The sealing layer comprises a fabric, and the reinforcing member is woven into the fabric.

8. The prosthetic heart valve according to any one of claims 5 to 7, characterized in that: The reinforcement component includes Nitinol.

9. The prosthetic heart valve according to any one of claims 5 to 7, characterized in that: The first shape is a deformed configuration of the reinforcement member, and the second shape is a free configuration of the reinforcement member.

10. The prosthetic heart valve according to any one of claims 5 to 7, characterized in that: The reinforcing member forms a ring around the circumference of the sealing layer.

11. The prosthetic heart valve according to any one of claims 5 to 7, characterized in that: The reinforcing member comprises a row of circumferentially extending elements arranged end to end around the outer skirt.

12. The prosthetic heart valve according to claim 11, characterized in that The width of each cell is larger in the second shape than in the first shape.

13. The prosthetic heart valve according to any one of claims 5 to 7, characterized in that: The reinforcing member includes a plurality of rings axially spaced from one another around the circumference of the outer skirt.

14. The prosthetic heart valve according to any one of claims 5 to 7, characterized in that: The reinforcing member forms a zigzag pattern around the outer skirt, and wherein the peaks and valleys of the reinforcing member are spaced apart from the outflow edge portion and the inflow edge portion of the outer skirt.

15. The prosthetic heart valve according to any one of claims 5 to 7, characterized in that: The reinforcing member includes a plurality of axially extending members circumferentially spaced from each other around the outer skirt, and wherein an end of each axially extending member is spaced from the outflow edge portion and the inflow edge portion of the outer skirt.

16. The prosthetic heart valve according to any one of claims 5 to 7, characterized in that: The prosthetic heart valve further includes a plurality of leaflets disposed within an interior portion of the frame.

17. The prosthetic heart valve according to any one of claims 5 to 7, characterized in that: When the reinforcement member is in the second shape, the entire reinforcement member is radially spaced apart from the frame.

18. A prosthetic heart valve, characterized in that: The prosthetic heart valve comprises: Ring frame; and an outer skirt disposed about an outer surface of the frame, the outer skirt comprising: a sealing layer disposed around an outer surface of the frame; and A deformable reinforcement member is coupled to the sealing layer, the reinforcement member extending circumferentially along the sealing layer and comprising a row of circumferentially extending cells.

19. The prosthetic heart valve according to claim 18, characterized in that The unit is rhombus-shaped.

20. The prosthetic heart valve according to claim 19, characterized in that The units are arranged end to end with each other and form a closed loop around the circumference of the sealing layer.

21. The prosthetic heart valve according to any one of claims 18 to 19, characterized in that: The reinforcing member is disposed in a middle portion of the sealing layer, the middle portion being disposed between and spaced apart from an outflow edge portion and an inflow edge portion of the sealing layer.

22. The prosthetic heart valve according to any one of claims 18 to 19, characterized in that: The reinforcement member is not attached to the outer surface of the frame.

23. The prosthetic heart valve according to any one of claims 18 to 19, characterized in that: The reinforcing component includes a shape memory material.

24. The prosthetic heart valve according to any one of claims 18 to 19, characterized in that: The reinforcement component includes nitinol braid, nitinol wire or nitinol stent.

25. The prosthetic heart valve according to any one of claims 18 to 19, characterized in that: The sealing layer comprises a fabric.

26. The prosthetic heart valve according to claim 25, characterized in that The reinforcement members are woven into the fabric.

27. The prosthetic heart valve according to any one of claims 18 to 19, characterized in that: When the frame radially expands, the reinforcing member and a portion of the sealing layer to which the reinforcing member is attached protrude radially outward and away from the frame.

28. The prosthetic heart valve according to any one of claims 18 to 19, characterized in that: The prosthetic heart valve further includes a plurality of leaflets disposed within an interior portion of the frame.

29. The prosthetic heart valve according to any one of claims 18 to 19, characterized in that: The frame includes a plurality of interconnected struts forming open cells in the frame, and wherein the frame is configured to radially compress and expand between a radially compressed configuration and a radially expanded configuration.

30. The prosthetic heart valve according to any one of claims 18 to 19, characterized in that: The sealing layer includes an inflow edge portion and an outflow edge portion fixed to the frame with sutures.

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