Artificial heart valve

Abstract

The artificial valve can include an annular frame that is radially expandable and compressible, a skirt member attached to the annular frame, and a protective member attached to the inner surface of the skirt member. The protective member has low wear properties compared to the skirt member and extends circumferentially around at least a portion of the annular frame.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority of U.S. Provisional Application No. 63 / 368,238, filed on July 12, 2022, which is hereby incorporated by reference herein for all purposes.

[0002] The present disclosure relates to implantable and radially expandable artificial devices, such as artificial heart valves, and further relates to methods, assemblies, and devices for delivering, expanding, implanting, and deploying such artificial heart valves.

Background Art

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

[0004] The artificial valve can include a radially compressible and expandable frame and a valve tip structure attached inside the frame. Depending on the situation, the artificial valve can have a sealing member such as an outer skirt attached to the outer surface of the frame. The outer skirt is configured to seal the surrounding natural tissue, thereby reducing perivalvular leakage through the artificial valve.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

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Patent Document 3

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Patent Document 21

Summary of the Invention

Problems to be Solved by the Invention

[0006] Despite recent advancements in percutaneous artificial valve technology, improved transcatheter artificial valves are still in demand.

Means for Solving the Problems

[0007] The present disclosure relates to methods and devices for treating valvular heart disease. Specifically, the present disclosure is directed to implantable and radially expandable artificial devices such as artificial heart valves, and further to methods, assemblies, and devices for delivering, expanding, implanting, and deploying such artificial devices.

[0008] According to certain aspects of the present disclosure, an artificial valve can include an annular frame that is radially expandable and compressible, a skirt member attached to the annular frame, and a protective member attached to the inner surface of the skirt member. The protective member is less abrasive against the valve tip of the artificial valve compared to the skirt member and extends circumferentially around at least a portion of the annular frame.

[0009] According to certain aspects of the present disclosure, an artificial valve can include an annular frame that is radially expandable and compressible, and a skirt assembly attached to the annular frame. The skirt assembly can include a skirt member and a protective member attached to the inner surface of the skirt member. The protective member can be disposed at the outflow end portion of the skirt member and extends circumferentially around at least a portion of the annular frame.

[0010] According to certain aspects of the present disclosure, an artificial valve can include an annular frame that is radially expandable and compressible, and a skirt member attached to the annular frame. The skirt member can include a body portion and an outflow end portion. The outflow end portion is less abrasive than the body portion.

[0011] According to certain aspects of the present disclosure, an artificial valve can include an annular frame that is radially expandable and compressible, a plurality of valve tips attached inside the annular frame, a skirt member attached to the annular frame, and a protective member attached to the inner surface of the skirt member. The plurality of valve tips can be movable between an open configuration and a closed configuration. In the open configuration, the plurality of valve tips can contact the protective member in some examples.

[0012] According to certain aspects of the present disclosure, an artificial valve can include an annular frame that is radially expandable and compressible, a skirt member attached to the annular frame, and a protective member attached to the inner surface of the skirt member. The protective member can be configured to shield the end of the skirt member from contacting one or more valve tips attached inside the annular frame.

[0013] Certain aspects of the present disclosure also relate to a skirt assembly for an artificial valve. The skirt assembly can include a skirt member having an annular shape and a protective member attached to the outflow end portion of the skirt member. The protective member can extend circumferentially around the inner surface of the skirt member. The protective member is of lower wear against the valve tip of the artificial valve compared to the skirt member.

[0014] Certain aspects of the present disclosure also relate to an assembly that includes any of the artificial valves described above and a delivery device configured to deliver the artificial valve in a radially compressed state to a target position.

[0015] Certain aspects of the present disclosure also relate to a method for assembling an artificial valve. The method can include providing a skirt member having an annular shape and securing a protective member to the outflow end portion of the skirt member. The protective member surrounds the inner surface of the skirt member. The protective member is of lower wear against the valve tip of the artificial valve compared to the skirt member.

[0016] Certain aspects of the present disclosure relate to a method that includes delivering an artificial device in a radially compressed state to a target position and radially expanding the artificial device to a radially expanded state. The artificial device can be any of the artificial valves described above.

[0017] The above method can be implemented on a living animal or can be implemented in simulation on a cadaver, a cadaver heart, an anthropomorphic ghost, a simulator (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0018] In some examples, the prosthetic valve includes one or more components described in Examples 1-108 described in the section "Additional Examples Related to the Disclosed Technology" below.

[0019] The above and other objects, features, and advantages related to the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings.

Brief Description of the Drawings

[0020]

Figure 1

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[0021] General Considerations For the purposes of this specification, specific aspects, advantages, and novel features in the examples of the present disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects related to the various disclosed examples, alone, in various combinations with each other, and in various sub-combinations with each other. The methods, apparatuses, and systems are not limited to any particular aspect, feature, or combination thereof, and the methods, apparatuses, and systems do not require the presence of any one or more specific advantages, nor do they require problems to be solved.

[0022] Although the operations in some of the disclosed examples are described in a particular sequential order for purposes of presentation, it should be understood that this mode of description encompasses permutations unless a particular order is required by the specific language set forth below. For example, operations described sequentially may, in some cases, be permuted or may be performed concurrently. Additionally, for the sake of simplicity, the accompanying drawings may not show various aspects in which the disclosed methods may be used in conjunction with other methods. Additionally, in the description, terms such as "provide" or "achieve" are sometimes used to describe the disclosed methods. These terms are high-level abstractions related to the actual operations being performed. The actual operations corresponding to these terms may vary depending on the particular implementation and will be readily recognizable to those of ordinary skill in the art.

[0023] 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 physically, mechanically, chemically, magnetically, and / or electrically coupled or connected and does not exclude the presence of intervening elements between the coupled or associated members unless specific contrary language is provided. Further, as used herein, "and / or" means "and" or "or", and also means "and" and "or".

[0024] As used herein, the term "proximal" refers to the position, orientation, or portion of a device that is closer to the user and is spaced from the implantation site. As used herein, the term "distal" refers to the position, orientation, or portion of a device that is spaced from the user and is closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site and towards the user (e.g., out of the patient's body), while distal movement of a device is movement of the device away from the user and towards the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to an axis extending in the proximal-distal direction unless specifically defined otherwise.

[0025] Directions and other relative references (e.g., inside, outside, upper, lower, etc.) may be used herein for ease of illustration of the drawings and description of the principles, but are not intended to be limiting. For example, specific terms such as "inside", "outside", "upper", "lower", "interior", "exterior", and the like may be used. Such terms are used when appropriate to clarify the description to some extent when dealing with relative relationships, particularly with respect to the specifically illustrated examples. However, such terms are not intended to imply absolute relationships, positions, or directions. For example, by simply turning an object over, the "upper" portion may become the "lower" portion. Nevertheless, it remains the same part, and the object remains the same.

[0026] General Overview of Prosthetic Valves The prosthetic valves disclosed herein can be compressible in the radial direction and can be expanded between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be placed in a radially compressed state and compressed or held by an implant delivery device and advanced through the patient's vasculature on the delivery device. After the prosthetic valve reaches the implantation site, the prosthetic valve can be expanded to a radially expanded state. It is understood that the prosthetic valves disclosed herein can be used with various implant delivery devices and implanted via various delivery procedures, and examples of various delivery procedures will be described in more detail hereinafter.

[0027] According to certain examples, any artificial valve disclosed herein can be configured to be implanted into the native aortic valve annulus. In other examples, any artificial valve disclosed herein can be configured to be implanted within other native valve annuli of the heart (e.g., pulmonary valve, mitral valve, and / or tricuspid valve). In certain examples, the disclosed artificial valve can also be implanted within a blood vessel in communication with the heart, such as 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. Additionally, the disclosed artificial valve can also be implanted within a previously implanted artificial valve (which can be an artificial surgical valve or an artificial transcatheter heart valve) in a valve-in-valve procedure.

[0028] In some examples, the disclosed artificial valve can be implanted within a docking device or an anchoring device that is implanted within a native heart valve or blood vessel. For example, in one example, the disclosed artificial valve can be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in, for example, U.S. Patent Publication No. 2017 / 0231756, which is incorporated herein by reference. In another example, the disclosed artificial valve can be implanted within a docking device implanted within or adjacent to the native mitral valve, as disclosed in, for example, PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In another example, the disclosed artificial valve can be implanted within a docking device implanted within the superior vena cava or inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in, for example, U.S. Patent Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0029] Exemplary Components of an Artificial Valve FIG. 1 illustrates an exemplary artificial valve 10 that can be advanced through a patient's vasculature to a native heart valve or the like by a delivery device, such as the exemplary delivery device shown in FIG. 3.

[0030] The artificial valve 10 can include a stent or frame 12, a valve leaflet structure 14, and a perivalvular outer seal member or outer skirt 18. An exemplary frame 12 is illustrated in FIG. 2.

[0031] The frame 12 can have an inflow end 15 and an outflow end 19. The valve leaflet structure 14 can be configured to allow fluid (e.g., blood) to flow through the artificial valve 10 in one direction. In a particular example, the valve leaflet structure 14 can include a plurality of leaflets 40 that collectively form a leaflet structure. The plurality of leaflets 40 can transition between an open configuration and a closed configuration. The artificial valve 10 is configured to be implanted within a native aortic valve annulus. During systole of the left ventricle, the leaflet structure is configured to permit blood to flow from the inflow end 15 to the outflow end 19 (e.g., the leaflets are in an open configuration). During diastole of the left ventricle, the leaflet structure is configured to prevent blood from flowing from the outflow end 19 to the inflow end 15 (e.g., the leaflets are in a closed configuration).

[0032] In a particular example, the valve leaflet structure 14 can include three leaflets 40, and these three leaflets 40 can be arranged to collapse in a tricuspid arrangement. In other examples, more or fewer leaflets can be provided (e.g., one leaflet, two leaflets, or four or more leaflets).

[0033] The leaflets 40 can be fixed to each other at adjacent sides so as to form commissures 22 (or "commissure tabs") of the leaflet structure. The lower (or inflow side) edge of the valve leaflet structure 14 can define a curved scalloped shape having undulations, and for this reason, it may be referred to as a "scallop line". In some examples, the leaflets 40 can be formed from pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or various other suitable natural or synthetic materials known in the art and as described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0034] Additional examples regarding the valve tip assembly and methods for attaching the valve tip assembly to the frame are described in U.S. Provisional Patent Application No. 63 / 300,302, filed January 18, 2022, and U.S. Provisional Patent Application No. 63 / 278,922, filed November 12, 2021, which are hereby incorporated by reference herein for their entireties.

[0035] Frame 12 can be radially compressible (crushable) and can be expandable (e.g., a radially expanded configuration is shown in FIG. 1). Frame 12 can include a plurality of interconnected angled struts 24. At the inlet end 15 and the outlet end 19 of frame 12, a plurality of circumferentially spaced-apart peaks 26 can be formed. In FIG. 1, only the peaks 26 at the outlet end 19 (also referred to as outlet peaks) are visible, and the peaks 26 at the inlet end 15 (also referred to as inlet peaks) are covered by the outer skirt 18. Each peak 26 can be formed at the junction between two angled struts 24, either at the inlet end 15 or the outlet end 19.

[0036] The angled struts 24 can be arranged in a plurality of rows between the inlet end 15 and the outlet end 19. For example, FIG. 2 shows four rows of angled struts 24, i.e., a first row 32 of angled struts that defines the outlet end 19, a second row 34 of angled struts located upstream of the first row 32 of angled struts, a third row 36 of angled struts located upstream of the second row 34 of angled struts, and a fourth row 38 of angled struts that defines the inlet end 15. The angled struts of the first row 32 can also be referred to as outlet struts, and the angled struts of the fourth row 38 can also be referred to as inlet struts. In other examples, frame 12 can include fewer (e.g., three) or more (e.g., five, six, or more) rows of angled struts.

[0037] As described herein, a valve component (e.g., an inclined strut of a row) is considered to be upstream of a reference object (e.g., an inclined strut of another row) when the valve component is closer to the inlet end 15 (i.e., farther from the outlet end 19) compared to the reference object.

[0038] The frame 12 can be formed with a plurality of interconnected windows 20 spaced circumferentially apart, and the interconnected windows 20 are configured to attach the interconnection 22 of the valve membrane structure 14 to the frame 12. For example, the frame 12 can include a plurality of axial frame members 28 that bridge two adjacent rows (e.g., the inclined struts of the first row 32 and the second row 34 that are closest to the outlet end 19). The interconnected window 20 can be formed as an opening (e.g., an axially extending slot) that penetrates the thickness on a selected axial frame member 28. The interconnection 22 can be inserted through the interconnected window 20 and fixed to the selected axial frame member 28. Thus, a selected axial frame member 28 having an interconnected window 20 can also be referred to as an interconnection support.

[0039] In other examples, the interconnection of the valve tip can be fixed to the frame in various other manners. For example, in some examples, the frame can be formed without having interconnected windows, and the interconnection can be fixed to the frame using, for example, suture threads, using fabrics, and / or using other means for joining. Additional information regarding joining the interconnection to the frame and additional information regarding other frame configurations can be found, for example, in PCT Application No. PCT / US2022 / 012873 and U.S. Application [Attorney Docket No. 12783US01], both of which are incorporated herein by reference for their disclosures.

[0040] The axial frame member 28, together with the inclined struts of the first row 32 and the inclined struts of the second row 34, can form a circumferentially extending row consisting of the open outflow cells 30. The inclined struts of the first row 32 can form the upper edge, i.e., the outflow edge, of the outflow cell, and the inclined struts of the second row 34 can form the lower edge, i.e., the inflow edge, of the outflow cell 30. The rows of inclined struts located upstream of the first row 32 (e.g., rows 34, 36, 38) can be interconnected to form additional rows consisting of open cells. For example, FIG. 2 shows an intermediate cell 42 of the second row disposed proximate the middle portion of the frame 12 and an inflow cell 45 of the third row disposed at the inflow end 15 of the frame 12. The outflow cell 30 can have a hexagonal shape when the frame 12 is radially expanded. In a particular example, the outflow cell 30 can be axially longer and can have a larger opening area compared to the intermediate cell 42 and the inflow cell 45.

[0041] The outer skirt 18 can be disposed on the outer surface of the frame 12 and / or can be coupled to the outer surface of the frame 12. The outer skirt 18 (and any other outer skirt described herein) can be formed from any of a variety of suitable biocompatible materials, including woven fabrics (e.g., polyethylene terephthalate fabric) or natural tissues (e.g., pericardial tissue). The outer skirt 18 can function as a sealing member for the artificial valve 10 by sealing the tissue of the native valve annulus, thereby assisting in reducing paravalvular leakage through and / or around the artificial valve 10.

[0042] The outer skirt 18 can extend from the inlet end 15 to the outlet end 19 of the frame 12. In some examples, the outer skirt 18 can be fixed to the struts of the frame 12 at the inlet end 15 by one or more stitching threads 44. In some examples, the outlet end portion 50 of the outer skirt 18 can be fixed to the lower end of the axial frame member 28 and / or to the upper end of the inclined struts of the second row 34 by one or more stitching threads 46. In some examples, a portion of the stitching thread 46 can extend through an opening 52 located at the lower end of the axial frame member 28 (the opening 52 shown by a dashed circle in FIG. 1 to indicate that it is located directly below the outer skirt 18) and can be fixed to the opening 52.

[0043] In some examples, the stitching threads 46 and / or 44 can be in-and-out stitches. In some examples, the stitching thread 46 can be continuous between adjacent openings 52 (e.g., extending inside and outside the outer skirt 18). In other examples, the stitching thread 46 can be a separate member that individually connects the outlet end portion 50 of the outer skirt 18 to the corresponding axial frame member 28.

[0044] In some examples, an additional stitching thread 48, which can be configured as a whipstitch, can further fix the outer skirt 18 between the inlet end 15 of the frame 12 and the lower end of a selected axial frame member 28 (e.g., the axial frame member 28 having the cross-linked window 20) and to the inclined struts extending therebetween.

[0045] In some examples, the outlet end portion 50 of the outer skirt 18 can have substantially the same height around the periphery of the frame 12 (e.g., having a substantially constant axial distance from the inlet end 15). Thus, the outer skirt 18 can cover at least the lower portion of the outlet cell 30, and the outlet edge 54 of the outer skirt 18 can extend between adjacent axial frame members 28.

[0046] In certain examples, the protective member 60 can be disposed on the inner surface of the outer skirt 18. The protective member can be fixed to the outer skirt 18 in various manners (e.g., by the stitching thread 46). In FIG. 1, the lower end of the protective member 60 is indicated by a dashed line.

[0047] The protective member 60 is less wear-resistant with respect to the valve tip 40 (i.e., has less wear on the valve tip 40) compared to the outer skirt 18, and is configured to shield the end 58 of the outer skirt 18 from contacting the valve tip 40, particularly when the valve tip 40 is in an open configuration. In some examples, the outflow end portion 50 of the outer skirt 18 can be folded back such that the end 58 is located below the outflow edge 54 of the outer skirt 18. In other examples, no fold is formed at the outflow end portion 50, and the outflow edge 54 becomes the end 58 of the outer skirt 18. In some cases, the end 58 of the outer skirt 18 (which can define the outflow edge 54 or be located below the outflow edge 54) is cut. In some examples, the outer skirt is cut by heat and / or pre-treated by heat. By heat treatment, the fabric can be melted and then cooled, thereby forming a relatively hard edge. Thus, by shielding the end 58 of the outer skirt 18 from contacting the valve tip 40, the protective member 60 can not only reduce wear and tearing on the valve tip 40, for example, but also protect the edge of the outer skirt 18. Exemplary skirt assemblies having a protective member will be described in more detail below with reference to FIGS. 4 - 7.

[0048] In some examples, as shown in FIG. 2, the frame 12 can further include steps of support members 64 extending between the axial frame members 28. The outflow end portion 50 of the outer skirt 18 can be further attached to the support member 64. The support member 64 can provide additional structural support to the outer skirt 18, for example, to reduce the possibility that the outflow end portion 50 of the outer skirt 18 extends through or hangs loosely across the outflow cell 30 (e.g., due to the relatively large size of the outflow cell 30). Additional examples of frames having steps of support members are described in U.S. Patent Application No. 63 / 343,986, which is incorporated herein by reference for its teachings.

[0049] In certain examples, the prosthetic valve 10 can further include an inner skirt (not shown) disposed on and / or coupled to the inner surface of the frame 12. The inner skirt can be formed from any of a variety of suitable biocompatible materials, including woven fabrics (e.g., polyethylene terephthalate fabric) or natural tissues (e.g., pericardial tissue). The inner skirt can function as a seal member to prevent or reduce perivalvular leakage, to anchor the valve leaflets 40 to the frame 12, and / or to protect the valve leaflets 40 from damage due to contact with the frame 12 during compression and / or during the operating cycle of the prosthetic valve 10. In some examples, the inflow edge of the valve leaflet 40 can be stitched to the inner skirt generally along a scallop line. The inner skirt can be stitched to adjacent inclined struts 24 of the frame 12. In other examples, the valve leaflet 40 can be stitched directly to the frame 12 generally along a scallop line via stitches.

[0050] Further details regarding the prosthetic valve, and also regarding the various components of the prosthetic valve, including related delivery devices / catheters / systems, are described in WIPO Patent Application Publication No. WO2018 / 222799, which is hereby incorporated by reference herein for all purposes.

[0051] Exemplary skirt assembly having a protective member As described above, the outer skirt can cover at least the lower portion of the outflow cells of the annular frame, and the cutting edge of the outer skirt can extend between adjacent axial frame members. As described herein, a non-abrasive or (compared to the outer skirt) low-abrasion protective member can be fixed to the outer skirt to shield the cutting edge from the valve tip, thereby reducing abrasion and tearing against the valve tip and / or protecting the cutting of the outer skirt.

[0052] Figures 4A-4C and 6 illustrate examples of an outer skirt assembly 200 that can be incorporated within any prosthetic valve (e.g., 10) described herein. For example, the outer skirt 18 of FIG. 1 can be part of an outer skirt assembly 200 disposed on the outer surface of the annular frame 12.

[0053] The outer skirt assembly 200 can include an outer skirt 202 and a protective member 204. The outer skirt 202 has an inner surface 206 and an outer surface 208. The protective member 204 can be attached to the inner surface 206 of the outer skirt 202. Thus, when attached to the annular frame, the inner surface 206 of the outer skirt 202 and the protective member 204 can face the internal space of the annular frame.

[0054] The protective member 204 is configured to shield the end 218 of the outer skirt 202 (which can be a cut portion where the yarns are fused to each other by thermal heating or other means) from contacting one or more valve tips 40 of the artificial valve. For example, as schematically illustrated in FIG. 4C, when the valve tip 40 is in the open configuration, the valve tip 40 contacts the protective member 204 rather than the end 218 of the outer skirt 202. When the valve tip 40 is in the closed configuration, the valve tip 40 is crushed inwardly and spaced apart from the protective member 204. In FIG. 4C, the sizes of the outer skirt 202, the protective member 204, and the valve tip 40 are not shown to scale for a clearer illustration of the protective member 204.

[0055] As shown in FIG. 6, when attached to the annular frame 12, the protective member 204 can extend circumferentially around at least a portion of the annular frame 12 (the valve tip is not shown in FIG. 6 for clarity). In some examples, the protective member 204 can be a band or ribbon having a ring shape and can surround the entire peripheral edge of the annular frame 12. In other examples, the protective member 204 can include a plurality of separate parts. For example, in some embodiments, the protective member can include 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 parts. In a particular example, the protective member can include separate parts that extend between adjacent pairs of axial frame members 28 of the frame 12.

[0056] The protective member 204 has lower wear resistance compared to the outer skirt 202. The wear resistance of a material can be measured by the friction coefficient of the material. The greater the friction coefficient, the greater the wear resistance of the material. As described in this specification, the protective member 204 has a friction coefficient of less than 0.15. For example, the friction coefficient of the protective member 204 can be 0.1 to 1.0, and more specifically, can be 0.4 to 0.6. Further, the protective member 204 is configured to have sufficient wear resistance so that the protective member 204 can withstand periodic contact with the valve tip 40 during the life of the artificial valve 10.

[0057] In a specific example, the outer skirt 202 can include a woven material such as polyethylene terephthalate (PET). The woven material of the outer skirt can be configured, for example, to reduce PVL and / or to assist in reducing the movement of the artificial valve relative to the natural tissue. In a specific example, the outer skirt 202 can include a first set of yarns and a second set of yarns that are woven together. The first set of yarns can be oriented at an angle of 45 degrees with respect to the longitudinal axis of the frame. The second set of yarns can be perpendicular to the first set of yarns. As described in this specification, the yarns can include multifilament yarns (yarns including multiple fibers or multiple filaments) or monofilament yarns (yarns including a single fiber or a single filament). The diameter of each filament can be 5 μm to 20 μm (for example, about 10 μm). In other examples, the outer skirt 202 can include natural tissue (for example, pericardial tissue).

[0058] In some examples, the protective member 204 can include polytetrafluoroethylene (PTFE). As described above, the material of the protective member can be selected to protect the artificial valve leaflet. For example, the protective member 204 can be a thick monofilament PTFE suture (e.g., size 2-0, size 3-0, etc.). In some examples, the protective member 204 can include thermoplastic polyurethane (TPU). In some examples, the protective member 204 can include microfilaments. As described herein, each microfilament has a diameter of less than 1 μm. In a particular example, the material forming the microfilaments can be PET.

[0059] In some examples, the protective member 204 can be attached to the outflow end portion 210 of the outer skirt 202. The outer skirt 202 has an outflow edge 212. When attached to the frame, the outflow edge 212 defines the upper boundary of the outer skirt 202. The outflow edge 212 can be located at a different height relative to the frame 12. For example, the outflow edge 212 can be located closer to the outflow end 19 or farther from the outflow end 19 compared to the example illustrated in FIG. 6. The protective member 204 has an outflow end 220 and an inflow end 222, and these ends define the upper and lower boundaries of the protective member 204, respectively. As described herein, the "upper" portion of the components of the outer skirt assembly 200 is disposed closer to the outflow end of the frame compared to the "lower" portion of the components when the outer skirt assembly 200 is attached to the frame.

[0060] In some examples, the outflow edge 212 can be a fold formed by folding back the outflow end portion 210 of the outer skirt 202. As shown in FIGS. 4A - 4C, by folding the outflow end portion 210 around the outflow edge 212, a double layer including a first layer portion 214 and a second layer portion 216 can be formed. The end 218 of the outer skirt 202 is located on the second layer portion 216. In the illustrated example, the outflow end portion 210 is folded outward, whereby the first layer portion 214 (which can also be referred to as the "inner layer portion") is disposed between the second layer portion 216 (which can also be referred to as the "outer layer portion") and the protection member 204. Thus, in this configuration, the outer layer portion has the end 218. In the illustrated example, the end 218 of the outer skirt 202 is located below the inflow end 222 of the protection member 204. In other examples, the end 218 of the outer skirt 202 can be located between the outflow end 220 and the inflow end 222 of the protection member 204. In any case, the end 218 of the outer skirt 202 can be shielded from the valve tip 40 by the protection member 204.

[0061] In another example, by folding the outflow end portion 210 inward around the outflow edge 212, a double layer including a first layer portion 214 and a second layer portion 216 can be formed. Similarly, the end 218 of the outer skirt 202 is located on the second layer portion 216. In this configuration, the second layer portion 216 is disposed between the first layer portion 214 and the protection member 204. Thus, the first layer portion 214 becomes the outer layer portion and the second layer portion 216 becomes the inner layer portion. In this configuration, the inner layer portion has the end 218. Further, the end 218 of the outer skirt 202 can be located between the outflow end 220 and the inflow end 222 of the protection member 204. Thus, the end 218 of the outer skirt 202 can still be shielded from the valve tip 40 by the protection member 204.

[0062] In the example illustrated in FIGS. 4A-4C, the outflow end 220 of the protection member 204 is aligned with the outflow edge 212 of the outer skirt 202. Thus, when attached to the frame, the axial distance between the outflow end of the frame and the outflow end 220 of the protection member 204 is approximately the same as the axial distance between the outflow end of the frame and the outflow edge 212 of the outer skirt 202.

[0063] In another example, the outflow end 220 of the protection member 204 can be disposed above the outflow edge 212 of the outer skirt 202. Thus, when attached to the frame, the outflow end 220 of the protection member 204 is positioned closer to the outflow end of the frame as compared to the outflow edge 212 of the outer skirt 202. In such a situation, the fold-back of the outflow end portion 210 of the outer skirt 202 can be made optional. For example, the outflow edge 212 can be the end 218 of the outer skirt 202. Since the protection member 202 extends above the outflow edge 212, the protection member 202 can still prevent the outflow edge 212 from contacting the valve tip 40.

[0064] In another example, the outflow end 220 of the protection member 204 can be disposed below the outflow edge 212 of the outer skirt 202. Thus, when attached to the frame, the outflow edge 212 of the outer skirt 202 is positioned closer to the outflow end of the frame as compared to the outflow end 220 of the protection member 204. In such a situation, the outflow edge 212 can be the fold-back formed in the outflow end portion 210 of the outer skirt 202 as described above. Due to the fold-back, even if the valve tip 40 could contact the outflow edge 212, the end 218 of the outer skirt 202 can still be shielded from the valve tip 40 by the protection member 202.

[0065] In yet another example, the protective member 204 can be folded back around the outflow edge 212 of the outer skirt 202. For example, by folding the protective member 204 outwardly, a pocket can be formed and the outflow edge 212 of the outer skirt 202 can be received within that pocket. In such a situation, the outflow edge 212 can be the end 218 of the outer skirt 202. Thus, the pocket formed by the protective member 204 can prevent the end 218 of the outer skirt 202 from contacting the valve tip 40.

[0066] In a particular example, the protective member 204 can be stitched to the outer skirt 202 via one or more suture threads 224. When the outflow end portion 210 of the outer skirt 202 forms a fold-back, the suture threads 224 can extend through both the first layer portion 214 and the second layer portion 216, as illustrated in FIG. 4C.

[0067] In some examples, one or more suture threads 224 can form a stitch line 226 that is substantially parallel to the outflow edge 212 of the outer skirt 202. In some examples, the stitch line 226 and the outflow edge 212 can be spaced apart by between 1 and 5 yarns of the outer skirt 202. In some examples, the stitch line 226 can be spaced apart from the outflow edge 212 by a distance of between 0.1 mm and 0.5 mm, or by a distance of between 0.2 mm and 0.3 mm.

[0068] In some examples, the suture 224 is hidden when viewed from inside the frame. For example, as shown in FIG. 4C, the protective member 204 can have an outer surface 228 that contacts the outer skirt 202 and an inner surface 230 facing the valve tip 40. The suture 224 can extend through the outer surface 228 but does not extend from the inner surface 230. As a result, the suture 224 can also be shielded from the valve tip 40 by the protective member 204. In the illustrated example, both the inner surface 230 and the outer surface 228 are flat or substantially flat. Note in FIG. 4C that the thickness of the protective member 204 (measured between the inner surface 230 and the outer surface 228) is exaggerated to illustrate the sutures 224 embedded inside. In practice, the thickness of the protective member 204 can be approximately the same as the thickness of the outer skirt 202 or can be thinner than the thickness of the outer skirt 202.

[0069] In some examples, as shown in FIGS. 4A-4B, the suture 224 can extend from the inner surface 230 of the protective member 204 and can be exposed to the valve tip 40. In such cases, the suture 224 can be configured to be less wear-resistant than the outer skirt 202, similar to the protective member 204. For example, the suture 224 can include a low wear material having a lower coefficient of friction (compared to fabric), such as PTFE, TPU, etc. As another example, the suture 224 can include microfilaments having a diameter of less than 1 μm. In one example, the material forming the microfilaments can be PET.

[0070] In addition to and / or instead of the suture 224, the protective member 204 can be connected to the outer skirt 202 by other means. For example, the protective member 204 can be adhered to the outflow end portion 210 of the outer skirt 202. In another example, the protective member 204 can be heat-sealed to the outflow end portion 210 of the outer skirt 202.

[0071] FIG. 5A shows a straightened protective member 304 according to an example. In certain embodiments, the protective member 304 can include a plurality of filaments extending along the longitudinal axis 332 of the protective member 304. If all of the filaments are parallel to the longitudinal axis 332, the suture 224 forming the stitch line 226 can extend between some of the filaments but will not lock any of the filaments.

[0072] In some examples, the protective member 304 can be twisted along the longitudinal axis 332 (as indicated by the two arrows). The degree of twist can be predefined. In a particular example, the protective member 304 can be twisted between 5 and 50 revolutions per inch (25.4 mm). Specifically, the protective member 304 can be twisted between 10 and 14 revolutions per inch (25.4 mm).

[0073] The twisting of the protective member 304 facilitates securely attaching the protective member 304 to the outer skirt 202 by the suture 224. For example, by twisting the protective member 304, the filaments within the protective member 304 will also be twisted along the longitudinal axis 332, which allows the suture 224 (which also extends along the longitudinal axis 332) to be woven through and locked to at least some of the filaments.

[0074] Figure 5B shows a straightened protective member 404 according to another example. Similar to 304, the protective member 404 can be twisted along its longitudinal axis. Additionally, by compressing the twisted protective member 404 at a high temperature, the protective member 404 can be shaped into a flat configuration. For example, the protective member 404 can be shaped to have a flat inner surface 430 and a flat outer surface 428. The thickness (T) of the protective member 404 can be measured between the inner surface 430 and the outer surface 428. The width (W) of the protective member 404 can be measured between the outflow end 420 and the inflow end 422 of the protective member 404. In the flat configuration, the protective member 404 has a smaller thickness compared to the width. For example, the thickness of the protective member 404 can be less than 80%, less than 70%, less than 60%, less than 50%, less than 40%, less than 30%, less than 20%, or less than 10% compared to the width of the protective member 404. By thinning the thickness of the protective member 404, the influence of the protective member 404 on the compression profile (e.g., minimum diameter) of the artificial valve can be reduced.

[0075] In the above-described examples, the outer skirt assembly 200 is described as including the outer skirt 202 and further as having a protective member 204 (or 304, 404) attached to the outer skirt 202. In other examples, the protective member 204 (or 304, 404) can be considered part of the outer skirt 202. For example, the outer skirt 202 can be considered to have a body portion corresponding to the portion of the outer skirt located below the protective member 204 (or 304, 404) and an outflow end portion where the protective member 204 (or 304, 404) is located. The outflow end portion can have a fabric portion, and the protective member 204 (or 304, 404) can be attached to the fabric portion, for example, by stitching, adhesives, or other attachment means. Thus, the outflow end portion has low wear compared to the body portion. Similarly, the protective member 204 (or 304, 404) can shield the end of the fabric portion from the valve tip of the artificial valve.

[0076] In some examples, the protective member can be an integral part of the outer skirt. For example, a non-abrasive material or a low-abrasion material having a low coefficient of friction, such as PTFE, TPU, etc., can be coated on the outflow end portion of the outer skirt to form a protective film fused to the filaments of the outer skirt. The protective film can cover the outflow end portion of the outer skirt and prevent the valve tip from contacting the end of the outer skirt.

[0077] In some examples, a protective member similar to 204, 304, or 404 can also be added to the inner skirt of the artificial valve to form the inner skirt assembly. For example, FIG. 7 shows a part of the artificial valve 10 and shows an inner skirt 502 attached to the inner surface of the annular frame 12. For clarity, the outer skirt 202 disposed on the outer surface of the frame 12 and the valve tip are not shown in FIG. 7. As shown, a protective member 504 having lower abrasion resistance than the inner skirt 502 can be attached to the inner surface of the inner skirt 502 (e.g., via a suture 524 similar to 224 or by other means). Thus, when the inner skirt 502 is attached to the frame 12, the protective member 504 will face the internal space of the annular frame 12 (and the valve tip of the artificial valve).

[0078] In some examples, the protective member 504 can be substantially the same as the protective member 204 (or 304 in FIG. 5A, 404 in FIG. 5B) described above with reference to FIGS. 4A-4C. In some examples, the protective member 504 can be attached to the inner skirt 502 in substantially the same manner as the protective member 204 is attached to the outer skirt 202 (e.g., the protective member 204 and the outer skirt 202 in FIGS. 4A-4C can be replaced with the protective member 504 and the inner skirt 502, respectively).

[0079] Similar to the outer skirt 202, the inner skirt 502 has an outflow edge 512, which can be formed by folding back the outflow end portion of the inner skirt (thus forming a double layer), or can be the end of the inner skirt. The outflow edge 512 can be located at a different height compared to the frame 12. For example, the outflow edge 512 can be located closer to the outflow end 19 or further away from the outflow end 19 compared to the example shown in FIG. 7. Similar to the protective member 204 (or 304, 404) that can shield the end of the outer skirt 202 so as not to contact the valve tip of the artificial valve, the protective member 504 can also be configured to shield the end of the inner skirt 502 so as not to contact the valve tip of the artificial valve. Thus, the protective member 504 can, for example, reduce wear and tearing against the valve tip and / or protect the end of the inner skirt 502.

[0080] To assemble the artificial valve, a skirt member having an annular shape (e.g., outer skirt 202 or inner skirt 502) can be prepared. Next, a protective member (e.g., 204, 304, 404, 504) having lower wear characteristics than the skirt member can be fixed to the outflow end portion of the skirt member and can surround the inner surface of the skirt member. The protective member can be fixed to the skirt member by stitching, by an adhesive, by thermal bonding, or by other means for fixation. In some examples, the protective member can be twisted along its length before being fixed to the skirt member. In some examples, as described above, the twisted protective member can be shaped to have a flat configuration by compressing it at a predetermined temperature. In some examples, before fixing the protective member, the outflow end portion of the skirt member can be folded (outwardly or inwardly) to form a double layer, thereby positioning the end of the skirt member below the outflow edge of the skirt member. After the protective member is fixed to the skirt member, the skirt member can be attached to the annular frame of the artificial valve. For example, if the skirt member is an outer skirt, the skirt member can be attached to the outer surface of the frame (e.g., via sutures or other means). If the skirt member is an inner skirt, the skirt member can be attached to the inner surface of the frame (e.g., via sutures or other means).

[0081] Any system, device, apparatus, etc. herein can be sterilized (e.g., using heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use for patients, and any method herein can include sterilizing related systems, devices, apparatuses, etc. as one step in the method. Examples of sterilization by heat / thermal include sterilization by steam and sterilization by autoclave. Examples of radiation for use in sterilization include, but are not limited to, gamma rays, ultraviolet rays, and electron beams. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization by hydrogen peroxide may be carried out, for example, using hydrogen peroxide plasma.

[0082] Exemplary delivery device FIG. 3 shows a delivery device 100 according to an example that can be used to implant an expandable prosthetic valve (e.g., prosthetic valve 10 and / or any other prosthetic valve described herein). In some examples, the delivery device 100 can be specifically configured to be used when introducing a prosthetic valve into the heart.

[0083] The delivery device 100 in the example illustrated in FIG. 3 is a balloon catheter and includes a handle 102 and a steerable outer shaft 104 extending distally from the handle 102. The delivery device 100 can further include an intermediate shaft 106 (which can also be referred to as a balloon shaft) extending proximally and distally from the handle 102, and the portion extending distally from the handle 102 also extends coaxially through the outer shaft 104. Additionally, the delivery device 100 can 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.

[0084] The outer shaft 104 and the intermediate shaft 106 can be configured to translate (e.g., move) longitudinally relative to each other along the central longitudinal axis 120 of the delivery device 100 to facilitate delivering and positioning the prosthetic valve at the implantation site within the patient's body.

[0085] The intermediate shaft 106 can include a proximal end portion 110 that extends proximally from the proximal end of the handle 102 to the adapter 112. A rotatable knob 114 can be attached onto the proximal end portion 110 and configured to rotate the intermediate shaft 106 relative to the outer shaft 104 about the central longitudinal axis 120.

[0086] The adapter 112 can include a first port 138 configured to receive a guidewire therethrough and a second port 140 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 140 can be fluidly coupled to the lumen of the intermediate shaft 106.

[0087] 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 spaced apart 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.

[0088] The balloon 118 can be coupled to the distal end portion of the intermediate shaft 106.

[0089] In some examples, the distal end of balloon 118 can be coupled to the distal end of delivery device 100, such as nose cone 122, or to an alternative component (e.g., distal shoulder) at the distal end of delivery device 100. The intermediate portion of balloon 118 can cover the valve attachment portion 124 of the distal end portion of delivery device 100, and the distal end portion of balloon 118 can cover the distal shoulder 126 of delivery device 100. The valve attachment portion 124 and the intermediate portion of balloon 118 can be configured to receive an artificial valve in a radially compressed state. For example, as schematically shown in FIG. 3, an artificial valve, such as artificial valve 10, can be attached around balloon 118 at the valve attachment portion 124 of delivery device 100.

[0090] The balloon shoulder assembly, including distal shoulder 126, can be configured to maintain artificial valve 10 (or other medical device) at a fixed position on balloon 118 during delivery through a patient's vasculature.

[0091] Outer shaft 104 can include a distal tip portion 128 attached on its distal end. Outer shaft 104 and intermediate shaft 106 can be axially translated relative to each other such that distal tip portion 128 is positioned adjacent to the proximal end of valve attachment portion 124 when artificial valve 10 is attached in a radially compressed state on valve attachment portion 124 and when delivering the artificial valve to a target implantation site. In this way, distal tip portion 128 can be configured to resist movement of artificial valve 10 in an axially proximal direction relative to balloon 118 when distal tip portion 128 is disposed adjacent to the proximal side of valve attachment portion 124.

[0092] 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 this annular space 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 308 and the inner surface of the balloon 118. Thus, fluid from the fluid source can flow from the annular space into the fluid passage, thereby expanding the balloon 118 and radially expanding and deploying the prosthetic valve 10.

[0093] The lumen of the inner shaft can be configured to receive a guide wire therethrough for maneuvering the distal end portion of the delivery device 100 to a target implantation site.

[0094] The handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 100. In the illustrated example, for instance, the handle 102 includes an adjustment member such as the illustrated rotatable knob 160, which can be operably coupled to the proximal end portion of a tension wire. The tension wire can extend distally from the handle 102 through the outer shaft 104 and have a distal end portion fixed to or near the distal end of the outer shaft 104. By rotating the knob 160, the tension of the tension wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 100. Further details regarding the steering or bending mechanism in the delivery device can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0095] The handle 102 can further include an adjustment mechanism 161 including an adjustment member such as the illustrated rotatable knob 162, and an associated locking mechanism including another adjustment member configured as a rotatable knob 178. The adjustment mechanism 161 can be 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). Further details regarding the delivery device 100 can be found in PCT Application No. PCT / US2021 / 047056, which is hereby incorporated by reference.

[0096] Although the delivery device 100 illustrated in FIG. 3 is specifically configured to deliver a balloon-expandable prosthetic valve, it will be understood that variants of the delivery device 100 can be configured to deliver a self-expandable prosthetic valve and / or to deliver a mechanically-expandable prosthetic valve, as described in the document incorporated by reference above.

[0097] Exemplary delivery techniques To implant an artificial valve into the natural aortic valve via a transfemoral delivery approach, the artificial valve can be attached in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device can be inserted into the femoral artery and then advanced through the descending aorta, around the aortic arch, and through the ascending aorta. The artificial valve can be positioned inside the natural aortic valve and radially expanded (e.g., by inflating a balloon, driving one or more actuators of the delivery device, or deploying the artificial valve from a sheath to make the artificial valve self-expanding). Alternatively, the artificial valve can be implanted inside the natural aortic valve via a transapical procedure, in which case the artificial valve (on the distal end portion of the delivery device) can be introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve can be positioned inside the natural aortic valve. Alternatively, in a transaortic procedure, the artificial valve (on the distal end portion of the delivery device) can be introduced into the aorta through a surgical incision in the ascending aorta, for example, by a partial J sternotomy or a small right parasternal thoracotomy, and then advanced through the ascending aorta towards the natural aortic valve.

[0098] To implant an artificial valve into the natural mitral valve via a transseptal delivery approach, the artificial valve can be attached in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device can be inserted into the femoral vein and then advanced through the inferior vena cava, through the inferior vena cava and the inferior vena cava, into the right atrium, across the atrial septum (e.g., through a puncture performed within the atrial septum), into the left atrium, and towards the natural mitral valve. Alternatively, the artificial valve can be implanted into the natural mitral valve via a transapical procedure, in which case the artificial valve (on the distal end portion of the delivery device) can be introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve can be positioned inside the natural mitral valve.

[0099] To implant an artificial valve inside a native tricuspid valve, the artificial valve can be attached in a radially compressed state along the distal end portion of a delivery device. The artificial valve and the distal end portion of the delivery device can be inserted into the femoral vein and then advanced into the inferior vena cava and through the inferior vena cava into the right atrium, where the artificial valve can be positioned inside the native tricuspid valve. A similar approach can be used to implant an artificial valve inside a native pulmonary valve or pulmonary artery, except that the artificial valve can be advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0100] Another delivery approach is the transatrial approach, in which the artificial valve (on the distal end portion of the delivery device) can be inserted through a chest incision and through an incision formed through the atrial wall (the atrial wall of the right atrium or left atrium) to access any of the native heart valves. Atrial delivery can also be performed intravascularly, for example, from a pulmonary vein. Yet another delivery approach is the transventricular approach, in which the artificial valve (on the distal end portion of the delivery device) can be inserted through a chest incision and through an incision formed through the wall of the right ventricle (typically at or near the base of the heart) to implant the artificial valve inside the native tricuspid valve or inside the native pulmonary valve or inside the pulmonary artery.

[0101] In all delivery approaches, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any artificial valve disclosed herein can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0102] Exemplary expansion mechanisms for an artificial valve For any prosthetic valve described herein, the frame can be made from any of a variety of suitable plastically expandable materials. When constructed from a plastically expandable material, the frame (and thus the prosthetic valve) can be compressed into a radially collapsed configuration on a delivery catheter or on a delivery device and then expanded inside the patient by an inflatable balloon or an equivalent expansion mechanism. In certain examples, upon delivery to the implantation site, the prosthetic valve can be protected from contacting the patient's vasculature, such as when advancing the prosthetic valve through the femoral artery, by placing the prosthetic valve inside a delivery capsule or delivery sheath. The capsule can also hold the prosthetic valve in a radially compressed state with a slightly smaller diameter and compression profile compared to what is possible in the absence of the capsule, by preventing any recoil (expansion) of the frame after the prosthetic valve has been compressed onto the delivery device.

[0103] Suitable plastically expandable materials that can be used to form the frame include, but are not limited to, stainless steel, biocompatible high-strength alloys (such as cobalt-chromium alloys or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In certain examples, the frame is formed from a nickel-cobalt-chromium-molybdenum alloy, including, for example, MP35N® alloy (SPS Technolgies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (covered by ASTM F562-02). The MP35N® alloy / UNS R30035 alloy contains 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium, and 10 wt% molybdenum.

[0104] Additional details regarding the balloon-expandable prosthetic valve can be found in U.S. Patent No. 9,393,110, 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 / 279,96 filed on November 13, 2021, all of which are incorporated herein by reference.

[0105] Any prosthetic valve described herein can be self-expandable. For example, the frame of the prosthetic valve can include a shape memory material (e.g., nitinol). When the prosthetic valve is made self-expandable, the frame (and thus the prosthetic valve) can be compressed into a radially compressed configuration and constrained in that compressed configuration by insertion into the sheath of a delivery catheter or an equivalent mechanism. When it reaches the desired implantation site within the body, the prosthetic valve can be deployed or released from the delivery sheath, whereby the prosthetic valve is enabled to expand to its functional size. In some examples, the frame (and thus the prosthetic valve) can partially self-expand from a radially compressed configuration to a partially radially expanded configuration. The frame (and thus the prosthetic valve) can be further radially expanded from the partially expanded configuration to a further radially expanded configuration via one or more drive assemblies of the delivery device (e.g., an inflatable balloon and / or one or more mechanical actuators).

[0106] Additional details regarding exemplary self-expandable prosthetic valves and related delivery devices / delivery catheters / delivery systems are described in U.S. Patent No. 8,652,202, U.S. Patent No. 9,155,619, and U.S. Patent No. 9,867,700, all of which are incorporated herein by reference.

[0107] Additionally and / or alternatively, any prosthetic valve described herein can be made mechanically expandable. For example, the struts of the frame can be pivotally coupled to each other at one or more pivot joints along the length of each strut. As a result, an axial force applied to the frame (e.g., pressing the inflow and outflow ends of the frame towards each other or pulling the inflow and outflow ends of the frame apart from each other) can expand or compress the prosthetic valve radially. The axial force can be generated by driving one or more mechanical actuators in a delivery device operably coupled to the frame.

[0108] Additional details regarding exemplary mechanically expandable prosthetic valves and related delivery devices / delivery catheters / delivery systems are described in U.S. Patent Application Publication No. 2018 / 0153689, U.S. Patent Application Publication No. 2018 / 0311039, U.S. Patent Application Publication No. 2019 / 0060057, and PCT Patent Application Publication No. WO / 2021 / 188476, all of which are incorporated herein by reference.

[0109] Sterilization Any system, device, apparatus, etc. herein can be sterilized (e.g., using heat / temperature, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use on a patient, and any method herein can include as a step of the method sterilizing the associated system, device, apparatus, etc. Examples of sterilization by heat / temperature include sterilization by steam and sterilization by autoclave. Examples of radiation for use in sterilization include, but are not limited to, gamma rays, ultraviolet rays, and electron beams. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization by hydrogen peroxide may be performed, for example, using hydrogen peroxide plasma.

Examples

[0110] Additional Examples Related to the Disclosed Technology In view of the implementations described above with respect to the disclosed subject matter, this application discloses the additional examples listed below. It should be noted that one individual feature in one embodiment, or two or more features in combination in that embodiment, and optionally, a combination with one or more features in one or more further embodiments, are also further embodiments that fall within the disclosure of this application.

[0111] Example 1. An artificial valve, comprising an annular frame that is radially expandable and compressible, a skirt member attached to the annular frame, and a protective member attached to the inner surface of the skirt member, wherein the protective member has low wear resistance with respect to the valve tip of the artificial valve compared to the skirt member and extends circumferentially around at least a part of the annular frame.

[0112] Example 2. The artificial valve according to claim 1, wherein the skirt member is an outer skirt disposed on the outer surface of the annular frame.

[0113] Example 3. The artificial valve according to any embodiment described herein, particularly the artificial valve according to Example 1, wherein the skirt member is an inner skirt disposed on the inner surface of the annular frame.

[0114] Example 4. The artificial valve according to any embodiment described herein, particularly any one of Examples 1 to 3, wherein the protective member comprises polytetrafluoroethylene (PTFE) and the skirt member comprises polyethylene terephthalate (PET).

[0115] Example 5. The artificial valve according to any embodiment described herein, particularly any one of Examples 1 to 4, wherein the protective member is attached to the outflow end portion of the skirt member.

[0116] Example 6. An artificial valve as described in any example of this specification, particularly Example 5, wherein the outflow end of the protection member is aligned with the outflow edge of the skirt member.

[0117] Example 7. An artificial valve as described in any example of this specification, particularly Example 5, wherein the outflow end of the protection member is closer to the outflow end of the frame compared to the outflow edge of the skirt member.

[0118] Example 8. An artificial valve as described in any example of this specification, particularly Example 5, wherein the outflow edge of the skirt member is closer to the outflow end of the frame compared to the outflow end of the protection member.

[0119] Example 9. An artificial valve as described in any example of this specification, particularly any one of Examples 1 to 5, wherein the protection member is folded back around the outflow edge of the skirt member.

[0120] Example 10. An artificial valve as described in any example of this specification, particularly any one of Examples 6 to 9, wherein the skirt member is folded back around the outflow edge to form an inner layer portion and an outer layer portion, and the inner layer portion is disposed between the outer layer portion and the protection member.

[0121] Example 11. An artificial valve as described in any example of this specification, particularly Example 10, wherein the outer layer portion includes the end of the skirt member.

[0122] Example 12. An artificial valve as described in any example of this specification, particularly Example 10, wherein the inner layer portion includes the end of the skirt member.

[0123] Example 13. The protective member is sutured to the skirt member via one or more suturing threads, and is an artificial valve according to any embodiment described herein, particularly any one of Embodiments 1 to 12.

[0124] Embodiment 14. One or more suturing threads are hidden when viewed from inside the frame, and it is an artificial valve according to any embodiment described herein, particularly the artificial valve described in Embodiment 13.

[0125] Embodiment 15. The protective member has a first flat surface in contact with the skirt member and a second flat surface located on the side opposite to the first flat surface, and is an artificial valve according to any embodiment described herein, particularly any one of Embodiments 1 to 14.

[0126] Embodiment 16. The protective member is twisted along the longitudinal axis of the protective member, and is an artificial valve according to any embodiment described herein, particularly any one of Embodiments 1 to 15.

[0127] Embodiment 17. An artificial valve including an annular frame that is radially expandable and compressible, and a skirt assembly attached to the annular frame, the skirt assembly including a skirt member and a protective member attached to the inner surface of the skirt member, the protective member being disposed at the outflow end portion of the skirt member and extending circumferentially around at least a part of the annular frame.

[0128] Embodiment 18. The skirt member is an outer skirt disposed on the outer surface of the annular frame, and is an artificial valve according to any embodiment described herein, particularly the artificial valve described in Embodiment 16.

[0129] Embodiment 19. The skirt member is an inner skirt disposed on the inner surface of the annular frame, and is an artificial valve according to any embodiment described herein, particularly the artificial valve described in Embodiment 16.

[0130] Example 20. The protection member is an artificial valve according to any embodiment of the present specification, particularly any one of Embodiments 17 to 19, which has lower wear resistance with respect to the valve tip of the artificial valve than the skirt member.

[0131] Example 21. The protection member is an artificial valve according to any embodiment of the present specification, particularly any one of Embodiments 17 to 20, which contains polytetrafluoroethylene (PTFE).

[0132] Example 22. The protection member is an artificial valve according to any embodiment of the present specification, particularly any one of Embodiments 17 to 21, which contains thermoplastic polyurethane (TPU).

[0133] Example 23. The protection member is an artificial valve according to any embodiment of the present specification, particularly any one of Embodiments 17 to 22, which contains microfilaments having a diameter of less than 1 μm.

[0134] Example 24. The protection member is an artificial valve according to any embodiment of the present specification, particularly any one of Embodiments 17 to 23, which is sutured to the skirt member via one or more sutures.

[0135] Example 25. One or more sutures are an artificial valve according to any embodiment of the present specification, particularly the artificial valve according to Embodiment 24, which contains polytetrafluoroethylene (PTFE).

[0136] Example 26. One or more sutures are an artificial valve according to any embodiment of the present specification, particularly the artificial valve according to Embodiment 24 or 25, which contains microfilaments having a diameter of less than 1 μm.

[0137] Example 27. The protective member has a first surface that contacts the skirt member and a second surface that is located on the side opposite to the first surface, and one or more sutures do not extend from the second surface. An artificial valve according to any embodiment described herein, particularly any one of Embodiments 24 to 26.

[0138] Embodiment 28. The skirt member includes a fold that defines an outflow edge of the skirt member, and the fold is formed by an inner layer portion and an outer layer portion, and the inner layer portion is disposed between the outer layer portion and the protective member. An artificial valve according to any embodiment described herein, particularly any one of Embodiments 24 to 27.

[0139] Embodiment 29. One or more sutures are sutured to both the inner layer portion and the outer layer portion. An artificial valve according to any embodiment described herein, particularly the artificial valve described in Embodiment 28.

[0140] Embodiment 30. The outer layer portion includes the end of the skirt member. An artificial valve according to any embodiment described herein, particularly the artificial valve described in Embodiment 28 or 29.

[0141] Embodiment 31. The inner layer portion includes the end of the skirt member, and the end is shielded by the protective member. An artificial valve according to any embodiment described herein, particularly the artificial valve described in Embodiment 28 or 29.

[0142] Embodiment 32. The protective member is twisted along the longitudinal axis of the protective member. An artificial valve according to any embodiment described herein, particularly any one of Embodiments 17 to 31.

[0143] Embodiment 33. The protective member has a flat inner surface and an outer surface. An artificial valve according to any embodiment described herein, particularly any one of Embodiments 17 to 32.

[0144] Embodiment 34. The skirt member is an artificial valve according to any embodiment described herein, including polyethylene terephthalate (PET), and particularly according to any one of Embodiments 17 to 33.

[0145] Example 35. An artificial valve comprising an annular frame that is radially expandable and compressible, and a skirt member attached to the annular frame, the skirt member including a body portion and an outflow end portion, the outflow end portion having lower wear characteristics than the body portion.

[0146] Example 36. The skirt member is an outer skirt disposed on the outer surface of the annular frame, an artificial valve according to any embodiment described herein, and particularly according to Example 35.

[0147] Example 37. The skirt member is an inner skirt disposed on the inner surface of the annular frame, an artificial valve according to any embodiment described herein, and particularly according to Example 35.

[0148] Example 38. The outflow end portion of the skirt member includes a fabric portion and a protective member attached to the fabric portion, the protective member extending circumferentially around at least a portion of the frame, an artificial valve according to any embodiment described herein, and particularly according to any one of Examples 35 to 37.

[0149] Example 39. The protective member includes polytetrafluoroethylene (PTFE), an artificial valve according to any embodiment described herein, and particularly according to Example 38.

[0150] Example 40. The protective member includes thermoplastic polyurethane (TPU), an artificial valve according to any embodiment described herein, and particularly according to Example 38 or 39.

[0151] Example 41. The protective member is an artificial valve according to any embodiment described herein, particularly any one of Embodiments 38 to 40, including microfilaments having a diameter of less than 1 μm.

[0152] Example 42. The protective member is an artificial valve according to any embodiment described herein, particularly any one of Embodiments 38 to 41, attached to the inner surface of the fabric portion.

[0153] Example 43. The protective member is an artificial valve according to any embodiment described herein, particularly any one of Embodiments 38 to 42, stitched to the fabric portion via one or more sutures.

[0154] Example 44. One or more sutures are an artificial valve according to any embodiment described herein, particularly Example 43, including polytetrafluoroethylene (PTFE).

[0155] Example 45. One or more sutures are an artificial valve according to any embodiment described herein, particularly Examples 43 or 44, including microfilaments having a diameter of less than 1 μm.

[0156] Example 46. The protective member has a first surface in contact with the fabric portion and a second surface located on the opposite side of the first surface, and one or more sutures do not extend from the second surface. It is an artificial valve according to any embodiment described herein, particularly any one of Embodiments 43 to 45.

[0157] Example 47. The fabric portion is folded back around the outflow edge of the skirt member to form an inner layer portion in contact with the protective member and an outer layer portion spaced apart from the protective member by the inner layer portion. It is an artificial valve according to any embodiment described herein, particularly any one of Embodiments 43 to 46.

[0158] Example 48. An artificial valve according to any embodiment of the present specification, particularly according to Example 47, wherein one or more sutures are sutured to both the inner layer portion and the outer layer portion.

[0159] Example 49. An artificial valve according to any embodiment of the present specification, particularly according to Example 47 or 48, wherein the outer layer portion includes the end of the skirt member.

[0160] Example 50. An artificial valve according to any embodiment of the present specification, particularly according to any one of Examples 46 to 49, wherein one or more sutures are separated from the outflow edge of the skirt member by a distance in the range of 0.1 mm to 0.5 mm.

[0161] Example 51. An artificial valve according to any embodiment of the present specification, particularly according to Example 50, wherein one or more sutures are separated from the outflow edge of the skirt member by a distance in the range of 0.2 mm to 0.3 mm.

[0162] Example 52. An artificial valve according to any embodiment of the present specification, particularly according to any one of Examples 38 to 51, wherein the protective member is adhered to the fabric portion.

[0163] Example 53. An artificial valve according to any embodiment of the present specification, particularly according to any one of Examples 38 to 52, wherein the protective member is twisted along the longitudinal axis of the protective member.

[0164] Example 54. An artificial valve according to any embodiment of the present specification, particularly according to Example 53, wherein the protective member is twisted 5 to 50 revolutions per inch (25.4 mm).

[0165] Example 55. The protective member is twisted 10 to 14 revolutions per inch (25.4 mm), an artificial valve according to any embodiment described herein, particularly embodiment 54.

[0166] Example 56. The protective member has a flat inner surface and an outer surface, an artificial valve according to any embodiment described herein, particularly any one of embodiments 35 to 55.

[0167] Example 57. The body portion includes polyethylene terephthalate (PET), an artificial valve according to any embodiment described herein, particularly any one of embodiments 35 to 56.

[0168] Example 58. The body portion includes a first set of yarns and a second set of yarns. The first set of yarns is oriented at an angle of 45 degrees with respect to the longitudinal axis of the frame, and the second set of yarns is perpendicular to the first set of yarns. An artificial valve according to any embodiment described herein, particularly any one of embodiments 35 to 57.

[0169] Example 59. The annular frame includes an inflow end, an outflow end, a first row of inclined struts defining the outflow end, a second row of inclined struts located closer to the inflow end compared to the first row of inclined struts, and a plurality of axial frame members bridging the first row of inclined struts and the second row of inclined struts. The outflow end portion of the skirt member is attached to the plurality of axial frame members. An artificial valve according to any embodiment described herein, particularly any one of embodiments 35 to 58.

[0170] Example 60. A valve tip structure disposed inside the annular frame, further including a valve tip structure configured to allow blood to flow from the inflow end to the outflow end and configured to prevent blood from flowing from the outflow end to the inflow end. An artificial valve according to any embodiment described herein, particularly embodiment 59.

[0171] Example 61. Further including an inner skirt attached to the inner surface of the annular frame, the valve tip structure being connected to the inner skirt, an artificial valve as described in any embodiment of this specification, particularly as described in Example 60.

[0172] Example 62. The first row of inclined struts, the second row of inclined struts, and the plurality of axial frame members define a plurality of outflow cells of the annular frame, and the skirt member covers at least a part of the outflow cells, an artificial valve as described in any embodiment of this specification, particularly as described in any one of Examples 59 to 61.

[0173] Example 63. An artificial valve including an annular frame that is radially expandable and compressible, a plurality of valve tips attached inside the annular frame, a skirt member attached to the annular frame, and a protective member attached to the inner surface of the skirt member, the plurality of valve tips being movable between an open configuration and a closed configuration, and when in the open configuration, the plurality of valve tips contacting the protective member.

[0174] Example 64. The skirt member is an outer skirt disposed on the outer surface of the annular frame, an artificial valve as described in any embodiment of this specification, particularly as described in Example 63.

[0175] Example 65. The skirt member is an inner skirt disposed on the inner surface of the annular frame, an artificial valve as described in any embodiment of this specification, particularly as described in Example 63.

[0176] Example 66. The protective member has lower wear resistance to the valve tip compared to the skirt member, an artificial valve as described in any embodiment of this specification, particularly as described in any one of Examples 63 to 65.

[0177] Example 67. The protective member is an artificial valve as described in any embodiment of this specification, particularly in any one of Embodiments 63 to 66, extending circumferentially around at least a part of the annular frame.

[0178] Embodiment 68. The protective member is an artificial valve as described in any embodiment of this specification, particularly in any one of Embodiments 63 to 67, containing polytetrafluoroethylene (PTFE).

[0179] Embodiment 69. The skirt member is an artificial valve as described in any embodiment of this specification, particularly in any one of Embodiments 63 to 68, containing polyethylene terephthalate (PET).

[0180] Embodiment 70. The protective member is an artificial valve as described in any embodiment of this specification, particularly in any one of Embodiments 63 to 69, shielding the end of the skirt member from a plurality of valve tips when the plurality of valve tips are in an open configuration.

[0181] Embodiment 71. The skirt member includes a fold formed by an inner layer portion and an outer layer portion, and the fold defines an outflow edge of the skirt member. The artificial valve is as described in any embodiment of this specification, particularly in Embodiment 70.

[0182] Embodiment 72. The outer layer portion includes the end of the skirt member. The artificial valve is as described in any embodiment of this specification, particularly in Embodiment 71.

[0183] Embodiment 73. The inner layer portion includes the end of the skirt member. The artificial valve is as described in any embodiment of this specification, particularly in Embodiment 71.

[0184] Embodiment 74. The protective member is sutured to the skirt member via one or more sutures. The artificial valve is as described in any embodiment of this specification, particularly in any one of Embodiments 63 to 73.

[0185] Example 75. One or more sutures are included in an artificial valve according to any embodiment of the present specification, particularly according to Example 74, including polytetrafluoroethylene (PTFE).

[0186] Example 76. One or more sutures do not extend from the inner surface of the protective member in an artificial valve according to any embodiment of the present specification, particularly according to Example 74 or 75.

[0187] Example 77. The thickness of the protective member measured along the radial axis of the frame is smaller compared to the width of the protective member measured along the axial axis of the frame in an artificial valve according to any embodiment of the present specification, particularly according to any one of Examples 63 to 76.

[0188] Example 78. The protective member is twisted along the longitudinal axis of the protective member in an artificial valve according to any embodiment of the present specification, particularly according to any one of Examples 63 to 77.

[0189] Example 79. An artificial valve comprising an annular frame that is radially expandable and compressible, a skirt member attached to the annular frame, and a protective member attached to the inner surface of the skirt member, wherein the protective member is configured to shield the end of the skirt member from contacting one or more valve tips attached inside the annular frame.

[0190] Example 80. The skirt member is an outer skirt disposed on the outer surface of the annular frame in an artificial valve according to any embodiment of the present specification, particularly according to Example 79.

[0191] Example 81. The skirt member is an inner skirt disposed on the inner surface of the annular frame, for the artificial valve according to any embodiment described in this specification, particularly the artificial valve described in Embodiment 79.

[0192] Embodiment 82. The artificial valve further includes one or more valve leaflets attached inside the annular frame, and the one or more valves are configured to allow blood to flow from the inflow end to the outflow end of the artificial valve and to prevent blood from flowing from the outflow end to the inflow end of the artificial valve, for the artificial valve according to any embodiment described in this specification, particularly the artificial valve described in any one of Embodiments 79 to 81.

[0193] Embodiment 83. The protection member has low wear resistance with respect to one or more valve leaflets as compared to the skirt member, for the artificial valve according to any embodiment described in this specification, particularly the artificial valve described in any one of Embodiments 79 to 82.

[0194] Embodiment 84. The protection member surrounds the annular frame, for the artificial valve according to any embodiment described in this specification, particularly the artificial valve described in any one of Embodiments 79 to 83.

[0195] Embodiment 85. The skirt member includes a fold formed by an inner layer portion and an outer layer portion, for the artificial valve according to any embodiment described in this specification, particularly the artificial valve described in any one of Embodiments 79 to 84.

[0196] Embodiment 86. The outer layer portion includes the end of the skirt member, for the artificial valve according to any embodiment described in this specification, particularly the artificial valve described in Embodiment 85.

[0197] Embodiment 87. The inner layer portion includes the end of the skirt member, for the artificial valve according to any embodiment described in this specification, particularly the artificial valve described in Embodiment 85.

[0198] Embodiment 88. The protective member is sutured to the skirt member via one or more suturing threads, and is an artificial valve as described in any embodiment of this specification, particularly any one of Embodiments 85 to 87.

[0199] Embodiment 89. The one or more suturing threads extend through both the inner layer portion and the outer layer portion, and is an artificial valve as described in any embodiment of this specification, particularly as described in Embodiment 88.

[0200] Embodiment 90. The protective member is twisted along the longitudinal axis of the protective member, and is an artificial valve as described in any embodiment of this specification, particularly any one of Embodiments 79 to 89.

[0201] Embodiment 91. A skirt assembly for an artificial valve, comprising a skirt member having an annular shape and a protective member attached to the outflow end portion of the skirt member, the protective member extending circumferentially around the inner surface of the skirt member, and the protective member being of lower wear resistance with respect to the valve tip of the artificial valve as compared to the skirt member.

[0202] Embodiment 92. The skirt member is an outer skirt configured to be disposed on the outer surface of the annular frame of the artificial valve, and is a skirt assembly as described in any embodiment of this specification, particularly as described in Embodiment 91.

[0203] Embodiment 93. The skirt member is an inner skirt configured to be disposed on the inner surface of the annular frame of the artificial valve, and is an artificial valve as described in any embodiment of this specification, particularly as described in Embodiment 91.

[0204] Embodiment 94. The protective member includes polytetrafluoroethylene (PTFE) or thermoplastic polyurethane (TPU), and is a skirt assembly as described in any embodiment of this specification, particularly any one of Embodiments 91 to 93.

[0205] Example 95. The protective member includes microfilaments having a diameter of less than 1 μm, and is a skirt assembly as described in any embodiment of this specification, particularly in any one of Embodiments 91 to 94.

[0206] Example 96. The protective member is sutured to the skirt member via one or more sutures, and is an artificial valve as described in any embodiment of this specification, particularly in any one of Embodiments 91 to 95.

[0207] Example 97. The protective member is twisted along the longitudinal axis of the protective member, and is a skirt assembly as described in any embodiment of this specification, particularly in Embodiment 96.

[0208] Example 98. One or more sutures are woven through the twisted filaments of the protective member, and are a skirt assembly as described in any embodiment of this specification, particularly in Embodiment 97.

[0209] Example 99. The protective member has a first surface in contact with the outflow end portion of the skirt member and a second surface located on the opposite side of the first surface, and one or more sutures do not extend from the second surface. It is a skirt assembly as described in any embodiment of this specification, particularly in any one of Embodiments 96 to 98.

[0210] Example 100. The first surface and the second surface are flat, and are a skirt assembly as described in any embodiment of this specification, particularly in Embodiment 99.

[0211] Example 101. One or more sutures include polytetrafluoroethylene (PTFE), and are a skirt assembly as described in any embodiment of this specification, particularly in any one of Embodiments 96 to 100.

[0212] Example 102. One or more suture threads include microfilaments having a diameter of less than 1 μm, and are for a skirt assembly according to any embodiment herein, particularly according to any one of Embodiments 96 to 101.

[0213] Example 103. The skirt member includes polyethylene terephthalate (PET), and is for a skirt assembly according to any embodiment herein, particularly according to any one of Embodiments 91 to 102.

[0214] Example 104. The outflow end portion of the skirt member is folded outwardly so as to define a fold aligned with the outflow end of the protective member, and is for a skirt assembly according to any embodiment herein, particularly according to any one of Embodiments 91 to 103.

[0215] Example 105. An assembly comprising an artificial valve according to any embodiment herein, particularly according to any one of Embodiments 1 to 90, and a delivery device configured to deliver the artificial valve to a target position in a radially compressed state.

[0216] Example 106. The delivery device includes a balloon shaft and a balloon attached to a distal end portion of the balloon shaft, and the artificial valve is compressed on the balloon when the artificial valve is delivered to the target position, and is for an assembly according to any embodiment herein, particularly according to Embodiment 105.

[0217] Example 107. The artificial valve is self-expandable from a radially compressed state to a radially expanded state, and the delivery device includes an outer sheath configured to hold the artificial valve in a radially compressed state when the artificial valve is delivered to the target position, and is for an assembly according to any embodiment herein, particularly according to Embodiment 105 or 106.

[0218] Example 108. The delivery device includes an actuator coupled to the inflation mechanism of the artificial valve and is configured to expand the artificial valve from a radially compressed state to a radially expanded state by driving the actuator, as described in any of the embodiments of this specification, particularly any one of embodiments 105 to 107, assembly.

[0219] Example 109. A method for assembling an artificial valve, comprising preparing a skirt member having an annular shape and fixing a protective member to an outflow end portion of the skirt member, the protective member surrounding the inner surface of the skirt member, and the protective member having low wear resistance with respect to the valve tip of the artificial valve as compared to the skirt member, method.

[0220] Example 110. Fixing includes suturing the protective member to the inner surface of the skirt member, as described in any of the embodiments of this specification, particularly the method described in Example 109.

[0221] Example 111. Fixing includes adhering the protective member to the inner surface of the skirt member, as described in any of the embodiments of this specification, particularly the method described in Example 109 or 110.

[0222] Example 112. Fixing includes thermally adhering the protective member to the inner surface of the skirt member, as described in any of the embodiments of this specification, particularly the method described in any one of Examples 109 to 111.

[0223] Example 113. Further including twisting the protective member along the longitudinal axis of the protective member, as described in any of the embodiments of this specification, particularly the method described in any one of Examples 109 to 112.

[0224] Example 114. The method according to any embodiment described herein, particularly any one of Embodiments 109 to 113, further comprising shaping the protective member to have a flat inner surface and an outer surface by compressing the protective member at a predetermined temperature.

[0225] Example 115. The method according to any embodiment described herein, particularly any one of Embodiments 109 or 110, further comprising folding the skirt member outward along the outflow end of the protective member.

[0226] Example 116. The method according to any embodiment described herein, particularly any one of Embodiments 109 to 115, further comprising attaching the skirt member to the outer surface of the annular frame of the artificial valve.

[0227] Example 117. The method according to any embodiment described herein, particularly any one of Embodiments 109 to 115, further comprising attaching the skirt member to the inner surface of the annular frame of the artificial valve.

[0228] Example 118. A method comprising delivering an artificial device in a radially compressed state to a target position and radially expanding the artificial device to a radially expanded state, wherein the artificial device is an artificial valve according to any embodiment described herein, particularly any one of Embodiments 1 to 90.

[0229] Example 119. A method comprising sterilizing an artificial valve according to any embodiment described herein, particularly any one of Embodiments 1 to 90, sterilizing a skirt assembly according to any embodiment described herein, particularly any one of Embodiments 91 to 104, or sterilizing an assembly according to any embodiment described herein, particularly any one of Embodiments 105 to 108.

[0230] For any embodiment, each feature described herein can be combined with any one or more other features described in any one or more other embodiments, unless otherwise stated. For example, any one or more features of a particular prosthetic valve can be combined with any one or more features of another prosthetic valve.

[0231] Considering the many possible aspects to which the principles of the disclosed technology can be applied, it will be appreciated that the illustrated embodiments are merely preferred embodiments of the technology and should not be construed as limiting the scope of the disclosure. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. It is an artificial valve, An annular frame (12) that is expandable and compressible in the radial direction, A skirt member (202; 502) attached to the annular frame (12), Includes a protective member (204; 504) attached to the inner surface of the skirt member (202; 502), The protective members (204; 504) are less abrasive to the valve leaflets (40) of the artificial valve compared to the skirt members (202; 502), and extend circumferentially around at least a portion of the annular frame (12). The protective member (204; 504) is sutured to the skirt member (202; 502) via one or more sutures (224; 524). Artificial valve.

2. The artificial valve according to claim 1, wherein the skirt member (202; 502) is an outer skirt (202) disposed on the outer surface of the annular frame (12).

3. The artificial valve according to claim 1, wherein the skirt member (202; 502) is an inner skirt (502) disposed on the inner surface of the annular frame (12).

4. The artificial valve according to any one of claims 1 to 3, wherein the protective member (204; 504) comprises polytetrafluoroethylene (PTFE) and the skirt member (202; 502) comprises polyethylene terephthalate (PET).

5. The artificial valve according to any one of claims 1 to 3, wherein the protective member (204; 504) is attached to the outflow end portion (210) of the skirt member (202; 502).

6. The artificial valve according to claim 5, wherein the outflow end (220) of the protective member (204; 504) is aligned with the outflow edge (212; 512) of the skirt member (202; 502).

7. The artificial valve according to claim 5, wherein the outflow end (220) of the protective member (204; 504) is located closer to the outflow end (19) of the annular frame (12) than the outflow edge (212; 512) of the skirt member (202; 502).

8. The artificial valve according to claim 5, wherein the outflow edge (212; 512) of the skirt member (202; 502) is located closer to the outflow end of the annular frame (12) than to the outflow end of the protective member (204; 504).

9. The artificial valve according to any one of claims 1 to 3, wherein the protective member (204; 504) is folded back around the outflow edge (212; 512) of the skirt member (202; 502).

10. The artificial valve according to claim 6, wherein the skirt member (202; 502) is folded back around the outflow edge (212; 512) to form an inner layer portion (214) and an outer layer portion (216), and the inner layer portion (214) is positioned between the outer layer portion (216) and the protective member (204; 504).

11. The artificial valve according to claim 1, wherein the one or more sutures (224; 524) are hidden when viewed from inside the annular frame (12).

Images