Artificial valve leaflet with a sharp-edge reinforcing structure

Abstract

A valve leaflet subassembly for an artificial heart valve may include a valve leaflet having an edge portion and an opposing major surface. A reinforcement structure may be attached to the valve leaflet along the edge portion. The reinforcement structure may include a first reinforcement member and a second reinforcement member disposed on the opposing major surface of the valve leaflet. An artificial heart valve may include a frame and the valve leaflet subassembly. The valve leaflet subassembly may include a valve leaflet and a reinforcement structure attached to the valve leaflet along the edge portion of the valve leaflet. The edge portion may be coupled to the frame via the reinforcement structure. A method of assembling an artificial heart valve may include disposing the valve leaflet at least partially within the frame and attaching the valve leaflet to the frame by extending a suture through a reinforcement member attached to the opposing major surface of the valve leaflet.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 369,156, filed Jul. 22, 2022, which is hereby incorporated by reference in its entirety.

[0002] The present disclosure relates to an artificial heart valve and to methods and assemblies for forming a valve leaflet assembly and attaching it to a frame of such an artificial heart valve.

Background Art

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

[0004] Most expandable artificial heart valves include an annular frame or stent and an artificial valve leaflet mounted within the frame. The leaflet may be attached to the frame along the leading edge portion of the leaflet and by commissural tabs of the leaflet. Mechanically expandable artificial heart valves (i.e., artificial valves that rely on a mechanical actuator for expansion), as well as some balloon-expandable and self-expandable valves, elongate axially when radially compressed for delivery to a patient. This can potentially over-elongate the leaflets axially, which can deform and / or damage the leaflets.

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0005] What is described herein is an artificial heart valve, a delivery device, and a method for implanting an artificial heart valve. The disclosed artificial heart valve, delivery device, and method can, for example, provide an improvement in the structural integrity of the artificial heart valve. In particular, described herein is a leaflet having a reinforced leading edge portion that is resistant to tearing when sutured to a frame of an artificial heart valve or to a skirt attached to the frame of the artificial heart valve. Thus, the devices and methods disclosed herein can, inter alia, overcome one or more deficiencies associated with typical artificial heart valves and their delivery devices.

MEANS FOR SOLVING THE PROBLEMS

[0006] A leaflet subassembly for an artificial heart valve can include a leaflet having a leading edge portion and a reinforcement structure attached to the leaflet along the leading edge portion. In addition to these components, the leaflet subassembly can further include one or more of the components disclosed herein.

[0007] In some embodiments, the leaflet subassembly can include a leaflet having a tip section, a first major surface, and a second major surface, the first and second major surfaces being separated by the thickness of the leaflet.

[0008] In some embodiments, the reinforcement structure of the valve leaflet sub-assembly can be attached to the valve leaflet along the edge portion.

[0009] In some embodiments, the reinforcement structure can include a first reinforcement member disposed on the first major surface and a second reinforcement member disposed on the second major surface.

[0010] In some embodiments, the first reinforcement member and the second reinforcement member can be aligned across the thickness of the valve leaflet.

[0011] In some embodiments, the reinforcement structure can be attached to the valve leaflet by a suture extending through both the first reinforcement member and the second reinforcement member and a portion of the valve leaflet between the first reinforcement member and the second reinforcement member.

[0012] In some embodiments, the first reinforcement member can include a plurality of openings spaced along the length of the first reinforcement member, the second reinforcement member can include a plurality of openings spaced along the length of the second reinforcement member, and the suture can extend through the openings of the first reinforcement member and the second reinforcement member.

[0013] In some embodiments, the valve leaflet can include a plurality of openings aligned with the plurality of openings of the first reinforcement member and the second reinforcement member.

[0014] In some embodiments, the first reinforcement member and the second reinforcement member can follow the curvature of the edge portion.

[0015] In some embodiments, a valve leaflet sub-assembly for an artificial heart valve includes a valve leaflet and a reinforcement structure. The valve leaflet includes an edge portion, a first major surface, and a second major surface. The first and second major surfaces are separated by the thickness of the valve leaflet. The reinforcement structure is attached to the valve leaflet along the edge portion. The reinforcement structure includes a first reinforcement member disposed on the first major surface and a second reinforcement member disposed on the second major surface.

[0016] In some embodiments, the leaflet subassembly includes one or more of the components listed in Examples 1-8 below.

[0017] The artificial heart valve can include a frame and a leaflet subassembly coupled to the frame. In addition to these components, the artificial heart valve can further include one or more components disclosed herein.

[0018] In some embodiments, the leaflet subassembly can include at least one leaflet and a reinforcement structure.

[0019] In some embodiments, the leaflet can include a leading edge portion, a first major surface, and a second major surface such that the first and second major surfaces are separated by the thickness of the leaflet.

[0020] In some embodiments, the reinforcement structure can be attached to the leaflet along the leading edge portion.

[0021] In some embodiments, the reinforcement structure can include a first reinforcement member disposed on the first major surface and a second reinforcement member disposed on the second major surface.

[0022] In some embodiments, the leading edge portion of the leaflet can be coupled to the frame via the reinforcement structure.

[0023] In some embodiments, the frame can include a plurality of struts, and the leading edge portion can be coupled to at least one of the plurality of struts by at least one suture extending through the reinforcement structure.

[0024] In some embodiments, the first reinforcement member can include a plurality of openings spaced along the length of the first reinforcement member, the second reinforcement member can include a plurality of openings spaced along the length of the second reinforcement member, and at least one suture can extend through one of the openings of the first reinforcement member and one of the openings of the second reinforcement member.

[0025] In some embodiments, at least one suture can form a loop that extends around at least one strut.

[0026] In some embodiments, the artificial heart valve can include an inner skirt that extends along the inner surface of the frame, and at least one suture can extend through the inner skirt and connect the tip portion to the inner skirt.

[0027] In some embodiments, the artificial heart valve can include an outer skirt disposed around the outer surface of the frame, and at least one suture can extend through the outer skirt and connect the inner skirt to the outer skirt.

[0028] In some embodiments, the artificial heart valve includes a frame and a leaflet subassembly. The frame is configured to be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The leaflet subassembly is at least partially located within the frame. The leaflet subassembly includes at least one leaflet and a reinforcement structure. The at least one leaflet includes a tip portion, a first major surface, and a second major surface. The first and second major surfaces are separated by the thickness of the leaflet. The reinforcement structure is attached to the leaflet along the tip portion. The reinforcement structure includes a first reinforcement member disposed on the first major surface and a second reinforcement member disposed on the second major surface. The tip portion of the leaflet is connected to the frame via the reinforcement structure.

[0029] In some embodiments, the artificial heart valve includes one or more of the components listed in Examples 18-39 below.

[0030] A method of assembling an artificial heart valve can include disposing a leaflet at least partially within a frame and attaching the leaflet to the frame. In addition to these steps, the method of assembling an artificial heart valve can further include one or more steps disclosed herein.

[0031] In some embodiments, a method of assembling an artificial heart valve may include attaching the valve leaflets to the frame by extending suture threads through a first reinforcing member along the edge portion of the valve leaflets and through a second reinforcing member attached to the opposing major surface of the valve leaflets, through an inner skirt disposed on the inner surface of the frame, and around the struts of the frame.

[0032] In some embodiments, the suture threads may extend through the inner skirt at two spaced-apart locations.

[0033] In some embodiments, the suture threads can extend through an outer skirt disposed around the outer surface of the frame at two spaced-apart locations, and the suture threads can extend on the outer surface of the outer skirt.

[0034] In some embodiments, the method may include forming a connecting portion between the inner skirt and the outer skirt such that the struts are enclosed within a space formed between the inner skirt, the outer skirt, and the connecting portion.

[0035] In some embodiments, a method of assembling an artificial heart valve includes disposing the valve leaflets at least partially within the frame and attaching the valve leaflets to the frame by extending suture threads through a first reinforcing member along the edge portion of the valve leaflets and through a second reinforcing member attached to the opposing major surface of the valve leaflets, through an inner skirt disposed on the inner surface of the frame, and around the struts of the frame.

[0036] In some embodiments, a method of assembling an artificial heart valve includes one or more of the steps listed in Examples 40 - 47 below.

[0037] The various innovations in this disclosure can be used in combination or individually. This summary is provided to introduce, in a simplified form, a selection of concepts that are further described in the following detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings.

Brief Description of the Drawings

[0038]

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[0039] General Considerations For the purposes of this specification, specific aspects, advantages, and novel features in examples of the present disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as being in any way limiting. 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 specific aspect, feature, or combination thereof, and it is not necessary for the disclosed examples to have any one or more specific advantages or to solve any problems.

[0040] The operations in some of the disclosed examples are described in a particular sequential order for presentation convenience. However, it should be understood that this mode of description encompasses permutations unless a particular order is required by the specific language described below. For example, operations described sequentially may, in some cases, be permuted or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various ways in which the disclosed method can be used in combination with other methods. Additionally, in the description, terms such as "provide" or "achieve" are sometimes used to describe the disclosed method. These terms are high-level abstractions regarding the actual operations to be performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are readily recognizable by those skilled in the art.

[0041] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "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 a specific contrary language is provided.

[0042] As used herein, the term "proximal" refers to the position, orientation, or portion of the device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to the position, orientation, or portion of the device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to an axis extending in the proximal and distal directions, unless otherwise explicitly defined.

[0043] As used herein, "e.g." means "for example" and "i.e." means "that is".

[0044] Introduction to the Disclosed Technology FIG. 1 shows an exemplary artificial valve 100 according to one embodiment. Any artificial valve disclosed herein is adapted to be implanted in the native aortic valve annulus, although in other embodiments it may be adapted to be implanted in other native valve annuli of the heart (pulmonary valve, mitral valve, and tricuspid valve). The disclosed artificial valve can also be implanted inside a blood vessel in communication with the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), the superior or inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of the patient. The disclosed artificial valve can also be implanted inside an artificial valve previously implanted in a valve-in-valve procedure (which can be an artificial surgical valve or an artificial transcatheter heart valve).

[0045] In some examples, an artificial heart valve can be implanted inside a docking device or an anchor device that is implanted inside a natural heart valve or blood vessel. In one example, the artificial heart valve can be implanted inside a docking device implanted in 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 artificial heart valve can be implanted inside a natural mitral valve or inside a docking device implanted at the location of the natural mitral valve, as disclosed in, for example, International Patent Application Publication No. WO2020 / 247907, which is incorporated herein by reference. In another example, the artificial heart valve can be implanted inside a docking device implanted in 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.

[0046] In some embodiments, a leaflet subassembly that can be used for the valve structure of an artificial heart valve includes a leaflet and a reinforcement structure attached to the leaflet. In some embodiments, the reinforcement structure includes a pair of reinforcement members attached to both sides of the leaflet and adjacent to the edge portion of the leaflet. The reinforcement structure can protect the edge portion from tearing when the edge portion is sutured to the frame of the artificial heart valve.

[0047] Examples of the Disclosed Technology

[0048] FIG. 1 shows an exemplary artificial heart valve 100 according to one embodiment. The artificial heart valve 100 may be radially compressible and expandable between a radially compressed configuration for delivery to a patient and a radially expanded configuration. In the illustrated example, the artificial heart valve 100 includes a frame 102 (or stent) and a valve structure 104 coupled to the frame. The artificial heart valve 100 may include an inner skirt 106 disposed and / or coupled to the inner surface of the frame 102. The artificial heart valve 100 may include an outer skirt 108 (or pericardial outer sealing member) disposed and / or coupled to the outer surface of the frame 102. In the illustrated embodiment, the outer skirt 108 is attached to the frame 102 by sutures 130, 132.

[0049] The frame 102 can be formed from any of a variety of suitable, plastically expandable materials (such as stainless steel, for example) or self-expanding materials (such as nitinol, for example), as is known in the art. When constructed from a plastically expandable material, the frame 102 (and thus the artificial heart valve 100) can be crimped in a radially compressed state on a delivery catheter and then expanded in the patient's body by an inflatable balloon or equivalent expansion mechanism. When constructed from a self-expanding material, the frame 102 (and thus the artificial heart valve 100) can be crimped into a radially compressed state and constrained in the compressed state by insertion into the sheath of a delivery catheter or equivalent mechanism. Once inside the body, the artificial heart valve can be advanced from the delivery sheath, thereby enabling the artificial heart valve to expand to its functional size.

[0050] Suitable plastically expandable materials that can be used to form the frame disclosed herein (e.g., frame 102) include metal alloys, polymers, or combinations thereof. Exemplary metal alloys can include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some embodiments, frame 102 can include stainless steel. In some embodiments, frame 102 can include cobalt-chromium. In some embodiments, frame 102 can include nickel-cobalt-chromium. In some embodiments, frame 102 can include a nickel-cobalt-chromium-molybdenum alloy such as MP35N™ (a trademark of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 includes 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium, and 10 wt% molybdenum.

[0051] The valve structure 104 is configured to regulate the flow of blood through the artificial heart valve 100 from the inflow end 110 to the outflow end 113 of the artificial heart valve 100. The valve structure 104 can include one or more valve leaflets. In one example, the valve structure 104 includes three valve leaflets 114 formed in a valve leaflet assembly 118, which may be arranged to collapse in a tricuspid configuration. In some examples, the valve leaflets 114 can be formed from pericardial tissue (e.g., bovine pericardial tissue), from a biocompatible synthetic material, or from various other suitable natural or synthetic materials as known in the art and as described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0052] The valve leaflets 114 can be fixed to each other at the adjacent side portions to form the cross - link 126 of the valve structure 104. The cross - link 126 can be used to connect the valve structure 104 to the frame 102. For example, the frame 102 can have a plurality of circumferentially spaced slots 124 (or cross - link windows) adapted to attach the cross - link 126 of the valve structure 104 to the frame. In some examples, the lower edge of the valve structure 104 can have a scalloped shape with undulations and can be fixed to the inner skirt 106 by a suture (not shown). The inner skirt 106 can be fixed to the frame 102 to connect the lower edge of the valve structure 104 to the frame.

[0053] Additional details regarding the artificial heart valve 100 and its various components are described in International Patent Application Publication No. WO2018 / 222799, which is hereby incorporated by reference in its entirety.

[0054] Figures 2A and 2B show an exemplary artificial heart valve 200 according to another example. In the illustrated example, the artificial heart valve 200 includes a frame 202 (or stent), a valve structure 204, and a sealing member 206. The valve structure 204 can include three valve leaflets 208 that collectively form a valve leaflet assembly 210 arranged to collapse in a tricuspid valve configuration. Each valve leaflet 208 can be coupled to the frame 202 at the cross - link 214 of the valve structure 204 along the leading edge portion 212 of the valve leaflet (i.e., the inflow edge or lower edge of the valve leaflet in the figure) and where the adjacent portions of two valve leaflets 208 are connected to each other. In some examples, a reinforcing element (not shown), such as a fabric strip, can be connected directly to the leading edge portion of the valve leaflet 208 and to the struts 216 of the frame 202 to couple the leading edge portion 212 of the valve leaflet 208 to the frame 202.

[0055] Similar to the frame 102 of FIG. 1, the frame 202 is known in the art and can be made from any of a variety of suitable plastically expandable or self-expanding materials, as described above. The frame 202 in the illustrated embodiments of FIGS. 2A and 2B comprises a plurality of circumferentially extending rows of angled struts 216 that define rows of cells 218 (or apertures) of the frame 202. The frame 202 can have a cylindrical or substantially cylindrical shape with a constant diameter from the inflow end 220 to the outflow end 222 of the frame, as shown, or the diameter of the frame can vary along the height of the frame, as disclosed in U.S. Patent Publication No. 2012 / 0239142, which is incorporated herein by reference.

[0056] In the illustrated embodiment, the sealing member 206 is attached to the outside of the frame 202 and functions to create a seal against the surrounding tissue (e.g., native leaflets and / or native valve annulus) to prevent or at least minimize paravalvular leakage. The sealing member 206 can have an inner layer 224 and an outer layer 226. In the illustrated embodiment, the inner layer 224 is disposed in contact with the outer surface of the frame 202, while the outer layer 226 is disposed radially outward of the inner layer 224. The sealing member 206 can be connected to the frame 202 using suitable techniques or mechanisms. For example, the sealing member 206 can be sutured to the frame 202 via suture threads that extend around the struts 216 and through the inner layer 224. In other embodiments, the inner layer 224 can be attached to the inner surface of the frame 202, while the outer layer 226 is attached to the outer surface of the frame 202.

[0057] In some examples, the outer layer 226 can be configured or shaped to extend radially outward from the inner layer 224 and the frame 202 when the artificial heart valve 200 is deployed. When the artificial heart valve is fully expanded outside the patient's body, the outer layer 226 can expand away from the inner layer 224 to create a space between the two layers. Thus, when implanted inside the body, this allows the outer layer 226 to expand into contact with the surrounding tissue, such as the native valve annulus.

[0058] Additional details regarding the artificial heart valve 200 and its various components are described in U.S. Patent Application Publication No. 2018 / 0028310, which is incorporated herein by reference.

[0059] Figures 3A and 3B illustrate, by way of example, a leaflet subassembly 500. The valve structure for an artificial heart valve may include one or more leaflet subassemblies 500. In the illustrated example, the leaflet subassembly 500 includes a leaflet 501 and a leading edge reinforcement structure 502 attached to the leaflet 501 to increase the strength of the leading edge portion (508 in Figures 3A and 3B) of the leaflet 501. The leading edge reinforcement structure 502 can prevent tearing at the leading edge portion of the leaflet 501 when the leading edge portion is sutured to the frame of the artificial heart valve, either directly or via an inner skirt attached to the frame.

[0060] The leaflet 501 includes a body 503 having a first major surface 504a (as shown in Figure 3A) and a second major surface 504b (as shown in Figure 3B), a leading edge portion 508 (which may also be referred to as the inflow edge portion or the lower edge portion of the leaflet), a free edge portion 510 (which may also be referred to as the upper edge portion of the leaflet), and a pair of commissural tabs 512 on opposite side edges of the body 503. The major surfaces 504a, 504b are separated by the thickness of the leaflet 501 (and form the opposing major surfaces of the leaflet). The free edge portion 510 can engage the free edge portion of an adjacent leaflet when the leaflet assembly is in a closed position under pressure from blood backflow. The commissural tabs 512 of adjacent leaflets can be connected together to form the leaflet assembly of the valve structure.

[0061] As described for the leaflet 104, the leaflet 501 can be formed from pericardial tissue (e.g., bovine pericardial tissue), from a biocompatible synthetic material, or from various other suitable natural or synthetic materials, as known in the art and as described in U.S. Patent No. 6,730,118, which is incorporated herein by reference for reference purposes.

[0062] The sharp-edge reinforcing structure 502 includes a first reinforcing member 514 and a second reinforcing member 516. The first reinforcing member 514 is disposed on the first main surface 504a along the sharp-edge portion 508. The second reinforcing member 516 is disposed on the second main surface 504b along the sharp-edge portion 508. The first reinforcing member 514 and the second reinforcing member 516 are attached to the valve tip 501, for example, by a suture 515 (or a plurality of sutures 515). In some embodiments, the sharp-edge portion 508 may have a curved shape. The attachment of the reinforcing members 514, 516 to the valve tip 501 (e.g., via the suture 515) can be such that the reinforcing members 514, 516 follow the curvature of the sharp-edge portion 508.

[0063] In some embodiments, the position of the first reinforcing member 514 on the first main surface 504a corresponds to the position of the second reinforcing member 516 on the second main surface 504b such that the suture 515 can extend through both of the reinforcing members 514, 516 in a direction perpendicular to the main surfaces 504a, 504b (i.e., the reinforcing members 514, 516 are aligned across the thickness of the valve tip 501). In the illustrated example, the first reinforcing member 514 is offset from the sharp edge 509 by an edge 517. Similarly, the second reinforcing member 516 is offset from the sharp edge 509 by an edge 519. The edges 517, 519 can be selected such that the suture 515 is offset inwardly from the sharp edge 509 (as shown in FIGS. 3A and 3B).

[0064] In some embodiments, as shown in FIGS. 3A and 3B, openings 520, 522 (or stitching holes) are pre-formed in the reinforcement members 514, 516 to receive a needle (or other instrument) carrying a suture for forming a stitch. The spacing between the openings 520, 522 on each of the reinforcement members 514, 516 can be equal or unequal (e.g., it may be desirable to have the openings closer together where the radius of curvature of the member is smaller and farther apart where the radius of curvature of the member is larger). The valve tip 501 can have pre-formed holes or openings that align with the openings 520, 522 of the reinforcement members 514, 516 (e.g., 530a, 530b as shown in FIGS. 5A and 5B). The openings 520, 522 can be used when attaching the reinforcement members 514, 516 to the valve tip 501 and when attaching the edge portion 508 to a frame or an inner skirt attached to the frame.

[0065] The reinforcing members 514, 516 can be in the form of cords or strips. In certain embodiments, the reinforcing members 514, 516 can be braided sutures that can be formed from natural suture materials or synthetic suture materials (e.g., polyester sutures such as Ethibond sutures). In some embodiments, the suture 515 that attaches the reinforcing members 514, 516 to the valve tip 501 can have a smaller diameter compared to the diameter of either of the reinforcing members 514, 516. In some embodiments, the suture 515 can be a braided suture such as an Ethibond suture having a suture size (gauge) in the range of 3-0 to 5-0, with 4-0 being a particular example, and the reinforcing members 514, 516 can be braided sutures such as Ethibond sutures having a suture size (gauge) in the range of 2-0 to 3-0, with 3-0 being a particular example. The suture 515 can be made of any suitable suture material. In another embodiment, the reinforcing members 514, 516 can be braided sutures, while the suture 515 can be a monofilament suture. In other embodiments, the reinforcing members 514, 516 can include fabrics such as woven, braided, or knitted fabrics such as PET or UHMW fabrics. In further embodiments, the reinforcing members 514, 516 can include layers of natural tissue (e.g., pericardial tissue) or non-woven materials made from any of various polymers such as TPU, for example.

[0066] The valve tip assembly can be formed using two or more valve tip sub-assemblies 500. FIG. 4 shows an example of three valve tip sub-assemblies 500a, 500b, 500c that are connected together to form a valve tip assembly. For example, the crosslink 513 can be formed between adjacent crosslink tabs 512 of adjacent valve tips. In some embodiments, the crosslink 513 can include an attachment member 517 (e.g., a fabric flexible polymer, etc.) attached to both ends of the crosslink tab 512. The outer crosslink tabs 512a, 512c of the valve tip assembly can be connected together with another attachment member 517 to form a third crosslink 513 and form a valve tip assembly having an annular shape. The crosslink 513 formed between the valve tip sub-assemblies can be used to connect the valve tip assembly to the frame of the artificial heart valve.

[0067] In some embodiments, the edge reinforcement structure 502 can be attached to the valve tip 501 before attaching the valve tip 501 to other valve tips to form a valve tip assembly. In other embodiments, the edge reinforcement structure 502 can be attached to the valve tip 501 after attaching the valve tip 501 to other valve tips to form a valve tip assembly.

[0068] In some embodiments, the adjacent ends of the first reinforcing member 514 on adjacent valve tips of the valve tip assembly can be connected together to form a single reinforcing member that extends continuously along the first major surface of all the valve tips (or a portion of the single reinforcing member that extends around the first major surface of the valve tip assembly can provide the first reinforcing member 514 on the first major surface of the valve tips of the valve tip assembly). Similarly, in some embodiments, the adjacent ends of the second reinforcing member 516 on adjacent valve tips of the valve tip assembly can be connected together to form a single reinforcing member that extends continuously along the second major surface of all the valve tips (or a portion of the single reinforcing member that extends around the second major surface of the valve tip assembly can provide the second reinforcing member 516 on the second major surface of the valve tips of the valve tip assembly).

[0069] Figures 5A - 5C show the attachment of the edge reinforcement structure 502 to the valve tip 501. In this embodiment, an in - and - out stitching pattern (or running stitch pattern) is used, but any stitching pattern that can securely fix the edge reinforcement structure 502 to the valve tip 501 can be used in other embodiments.

[0070] FIG. 5A shows a portion 524a of a yarn 524 (or suture thread) that extends through a first opening 520a of a first reinforcement member 514, through an opening 530a of a valve tip 501 (i.e., an opening extending from a first major surface 504a to a second major surface 504b), through a first opening 522a of a second reinforcement member 516, and completes the “in” portion of a first stitch. FIG. 5B shows another portion 524b of the yarn 524 that extends through a second opening 522b of the second reinforcement member 516 offset from the first opening 522a, through an opening 530b of the valve tip 501 aligned with the second opening 522b, through a second opening 520b of the first reinforcement member 514 offset from the first opening 520a and aligned with the openings 522b, 530b, and completes the “out” portion of the first stitch. This stitching sequence may be repeated at other openings along the reinforcement members 514, 516 and the valve tip 501. FIG. 5C shows a completed suture 515 extending along the length of the reinforcement structure 502. The ends of the yarn 524 may be knotted (as shown at 526, 528) or otherwise fixed in place.

[0071] FIGS. 6A - 6C show an exemplary artificial heart valve 300 incorporating a valve tip sub - assembly 500. The artificial heart valve 300 includes a frame 302 and a valve structure 304 disposed within the frame 302. In the illustrated embodiment, the valve structure 304 comprises a valve tip assembly consisting of three valve tip sub - assemblies 500 as described herein. The three valve tip sub - assemblies 500 are arranged to collapse in a tricuspid valve configuration. In other embodiments, the valve structure 304 may have a greater or fewer number of valve tips (e.g., one or more of the valve tip sub - assemblies 500). The valve tip sub - assemblies 500 are fixed to each other via a commissure 513 and are fixed to the frame 302 at the commissure 513.

[0072] In the illustrated embodiment, the frame 302 includes an inlet end 310 and an outlet end 312. The frame 302 includes a plurality of interconnected angled struts 308 arranged in a plurality of rows extending circumferentially of the angled struts 308 between the inlet end 310 and the outlet end 312. The rows of struts 308 define rows of cells 314 (or openings) of the frame 302. The struts 308 can intersect at the inlet end 310 and the outlet end 312 to form a plurality of tips 316 spaced along the perimeter of the frame 302. The struts 308 can further intersect at a location between the inlet end 310 and the outlet end 312 to form strut junctions 318. In the illustrated example, the frame 302 is similar to the frame 202 shown in FIGS. 2A and 2B. In other embodiments, the frame 302 can have a different structure, such as the structure shown in FIG. 1.

[0073] The artificial heart valve 300 can include an inner skirt 306 that extends along the inner surface of the frame 302 and covers at least a portion of the inside of the struts 308. The inner skirt 306 can cover the inner surfaces of the struts 308 along a scallop line pattern (as shown in FIG. 6B). There can be one inner skirt 306 that extends continuously along the inner surface of the frame 302, or there can be multiple inner skirts 306, each inner skirt extending along a portion of the frame 302 corresponding to an attachment area for one of the valve leaflets 501, for the cusp edge region 508. The inner skirt 306 can be made of a suitable tear-resistant material (e.g., a transplantable polymer such as polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), or thermoplastic polyurethane (TPU) in the form of a woven or non-woven material).

[0074] The artificial heart valve 300 can include an outer skirt 305 (or outer valve perimeter sealing member) that extends around the outer surface of the frame 302 and covers at least a portion of the outside of the struts 308. The outer skirt 305 can be made of a suitable tear-resistant material (e.g., a transplantable polymer such as polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), or thermoplastic polyurethane (TPU) in the form of a woven or non-woven material).

[0075] The inner skirt and / or the outer skirt can be formed entirely or partially from any suitable biological material, synthetic material (e.g., any of various polymers), or combinations thereof. In some embodiments, the inner skirt and / or the outer skirt can include a fabric having woven threads or fibers, such as in the form of a woven fabric, braid, or knit. In some embodiments, the fabric can have a plush nap or pile. Exemplary fabrics having a plush nap or pile include velour, velvet, beechin, corduroy, terry cloth, fleece, and the like. In some embodiments, the inner skirt and / or the outer skirt can include a fabric that does not have woven or randomly woven threads or fibers, such as felt or an electrospun fabric. Exemplary materials (with or without woven threads or fibers) that can be used to form such fabrics include, but are not limited to, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide, and the like. In some embodiments, the inner skirt and / or the outer skirt can include a non-fiber or non-woven material, such as a film made from any of various polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU), etc.). In some embodiments, the inner skirt and / or the outer skirt can include a sponge material or a foam, such as a polyurethane foam. In some embodiments, the inner skirt and / or the outer skirt can include a natural tissue, such as a pericardium (e.g., bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0076] In some embodiments, the tip edge portion 508 of the valve tip 501 can be attached to the frame 302 via the suture 324, and the suture 324 forms a stitch that passes through the reinforcement structure 502 of the valve tip subassembly 500, through one or both of the inner skirt 306 and the outer skirt 305, and extends around the strut 308. In the examples illustrated in FIGS. 6B and 6C, the inner skirt 306 is attached to both the valve tip 501 (via the reinforcement structure 502) and the outer skirt 305. In some embodiments, the inner skirt 306 can be connected to the outer skirt 305 along the undulating struts 308 of the frame 302 (e.g., according to a scallop line pattern). In other embodiments, the suture 324 can pass through the tip edge portion of the valve tip (e.g., through the reinforcement structure 502), through the inner skirt 306, and extend around a selected strut 308 of the frame, but not through the outer skirt 305 (which can be fixed to a selected strut of the frame 302 with a separate suture).

[0077] In some embodiments, the suture 324 can be relatively loose, and the stitching of the outer skirt 305 to the inflow end 310 or the outflow end 312 of the frame 302 (as illustrated for the outer skirt 108 in FIG. 1) can be omitted so that the outer skirt 305 can slide relative to the frame 302 during the transition of the frame 302 between the compressed state and the expanded state without being stretched longitudinally.

[0078] FIG. 7 shows the configuration of the suture 324 according to one embodiment. In the embodiment, the suture 324 extends in a radially outward direction through the openings of the reinforcement structure 502 and the valve tip 501 (such as shown at 324a), and through portions of the inner skirt 306 and the outer skirt 305 above the strut 308 (such as shown at 324b). The suture 324 is looped over the outside of the outer skirt 305 (as shown at 324c). The suture 324 extends rearward through portions of the outer skirt 305 and the inner skirt 306 below the strut 308 (as shown at 324d), and through the opening of the reinforcement structure 502 (as shown at 324e). The ends of the suture 324 can be tied together (as shown at 324f) or fixed in another way. In this way, the suture 324 forms a loop around the strut 308. By forming a plurality of spaced sutures 324 that loop around each strut 308 and extend through the skirts 305, 306, the reinforcement structure 502, and the valve tip 501 (as shown in FIGS. 6B and 6C), the leading edge portion 508 of the valve tip 501 can be connected to the frame 302. The suture 324 can be formed along the strut 308 along a wavy path such that the leading edge region 508 of the valve tip 501 is connected to the frame 302 according to a scallop line pattern.

[0079] In some embodiments, the connected portion 360 is formed between the inner skirt 306 and the outer skirt 305 and around the skirt seam (formed by suture 324), such that the strut 308 is encapsulated within the space 328 between the inner skirt 306 and the outer skirt 305. The connected portion 360 provides a relatively smooth and gradual transition between the strut 308 and the outer skirt 305 to facilitate proper washout and reduce the risk of flow stagnation areas that could otherwise promote thrombus or pannus formation over time. The connected portion 360 can be formed by joining or stitching the inner skirt 306 to the outer skirt 305 at a location above the suture 324 (e.g., along the path 370 shown in FIG. 6D). For example, one or both of the skirts 305, 306 can carry an adhesive layer that can be used to join the skirts together to form the connected portion. In some embodiments, the inner skirt 306 can be made of a material capable of being joined or fused to the outer skirt 305 via heat and / or pressure, such as ePTFE or TPU. In some such embodiments, the inner skirt 306 can be fused to the outer skirt 305 at the connected portion 306 without stitches or a separate adhesive layer.

[0080] In the illustrated example of FIG. 7, the suture 324 extends through the space 328 and avoids the connected portion 360 (in other words, the suture 324 does not extend along the connected portion 306 through the inner skirt and the outer skirt). FIG. 8 shows an alternative embodiment in which the suture 326 can extend through the connected portion 362 formed between the inner skirt 306 and the outer skirt 305. In the embodiment of FIG. 8, the suture 326 extends in an outward direction through the opening of the reinforcement structure 502 and the valve tip 501 (as shown at 326a), and through the connected portion 362a formed between the portion of the inner skirt 306 above the support 308 and the outer skirt 305 (as shown at 326b). The suture 326 extends over the outside of the outer skirt 305 (as shown at 326c). The suture 326 extends rearward through the connecting portion 362b formed between the portion of the outer skirt 305 below the support 308 and the inner skirt 306 (as shown at 326d), and through the opening of the reinforcement structure 502 (as shown at 326e). The ends of the suture 326 can be tied together (as shown at 326f) or fixed in another way. The embodiment illustrated in FIG. 8 can extend the durability of the attachment of the valve tip subassembly to the frame by suturing (e.g., by reducing the possibility of the holes formed in the skirts 305, 306 over time due to the passage of the suture 326 through the skirts).

[0081] Figure 9 shows another example of attaching the valve tip subassembly 510 to the frame. In the embodiment shown in Figure 9, the inner skirt 306' is looped around the strut 308 of the frame such that the strut 308 is encapsulated within the inner skirt. The connected portion 364 is formed between the inner skirt 306' and the outer skirt 305 to attach the inner skirt 306' to the outer skirt 305. The connected portion 364 can be formed, for example, by joining (e.g., fusing) a portion of the inner skirt 306' to a portion of the outer skirt 305. The edge portion 508 of the valve tip 501 can be coupled to the frame 302 by a suture 330. In the embodiment, the suture 330 extends in an outward direction through the reinforcing structure 502 and an opening (such as shown at 330a) of the valve tip 501, above the encapsulated strut 308, and through the outer skirt 305 (such as shown at 330b). The suture 330 extends over the outside of the outer skirt 305 (as shown at 330c). The suture 330 extends rearward through the outer skirt 305 (as shown at 330d) and through an opening of the reinforcing structure 502 (as shown at 330e). The ends of the suture 330 can be tied together (as shown at 330f) or otherwise secured. In the embodiment of Figure 9, the suture 330 does not penetrate the inner skirt 306'. In other embodiments, the suture 330 penetrates the inner skirt 306'. A plurality of spaced sutures 330 that loop around the strut 308 encapsulated within the inner skirt 306' and extend through the outer skirt 305, the reinforcing structure 502, and the valve tip 501 can be formed to connect the edge portion 508 of the valve tip 501 to the frame 302.

[0082] Figure 10 shows a delivery device 400 according to one embodiment. The delivery device 400 can be used to implant an expandable heart valve (e.g., the artificial heart valve 100 of Figure 1, the artificial heart valve 200 of Figures 2A - 2B, the artificial heart valve 300 of Figures 6A - 6D, or any of the other artificial heart valves described herein). In some embodiments, the delivery device 400 is specifically adapted to be used when introducing the artificial heart valve into the heart.

[0083] In the illustrated example, the delivery device 400 is a balloon catheter having a handle 402 and a steerable outer shaft 404 extending distally from the handle 402. The delivery device 400 can further include an intermediate shaft 406 (which may also be referred to as a balloon shaft) extending proximally from the handle 402 and distally from the handle 402, with the portion extending distally from the handle 402 also extending coaxially through the outer shaft 404. Additionally, the delivery device 400 can further include an inner shaft 408 extending distally from the handle 402 coaxially through the intermediate shaft 406 and the outer shaft 404 and proximally from the handle 402 coaxially through the intermediate shaft 406.

[0084] The outer shaft 404 and the intermediate shaft 406 can be configured to translate longitudinally relative to each other along the central longitudinal axis 420 of the delivery device 400 to facilitate delivering and positioning an artificial heart valve at a implantation site within a patient's body.

[0085] The intermediate shaft 406 can include a proximal end portion 410 extending proximally from the proximal end of the handle 402 to the adapter 412. A rotatable knob 414 can be attached onto the proximal end portion 410 and configured to rotate the intermediate shaft 406 relative to the outer shaft 404 about the central longitudinal axis 420. The adapter 412 can include a first port 438 configured to receive a guide wire therethrough and a second port 440 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 440 can be fluidly coupled to the inner lumen of the intermediate shaft 406.

[0086] The intermediate shaft 406 can further include a distal end portion that extends distally beyond the distal end of the outer shaft 404 when the distal end of the outer shaft 404 is positioned away from the inflatable balloon 418 of the delivery device 400. The distal end portion of the inner shaft 408 can extend distally beyond the distal end portion of the intermediate shaft 406. The balloon 418 can be coupled to the distal end portion of the intermediate shaft 406.

[0087] In some examples, the distal end of the balloon 418 can be coupled to the distal end of the delivery device 400, such as a nose cone 422 (as shown in FIG. 10), or to an alternative component (e.g., a distal shoulder) at the distal end of the delivery device 400. The intermediate portion of the balloon 418 can cover the valve attachment portion 424 of the distal end portion of the delivery device 400, and the distal end portion of the balloon 418 can cover the distal shoulder 426 of the delivery device 400. The valve attachment portion 424 and the intermediate portion of the balloon 418 can be configured to receive an artificial heart valve in a radially compressed state. For example, as schematically shown in FIG. 10, an artificial heart valve 450 (which can be one of the artificial heart valves described herein) can be attached around the balloon 418 at the valve attachment portion 424 of the delivery device 400.

[0088] The balloon shoulder assembly, including the distal shoulder 426, is configured to maintain the artificial heart valve 450 (or other medical device) in a fixed position on the balloon 418 during delivery through the patient's vasculature.

[0089] The outer shaft 404 can include a distal tip portion 428 attached to its distal end. The outer shaft 404 and the intermediate shaft 406 can be axially translated relative to each other to position the distal tip portion 428 adjacent to the proximal end of the valve attachment portion 424 when the artificial heart valve 450 is mounted in a radially compressed state on the valve attachment portion 424 (as shown in FIG. 4) and during delivery of the artificial heart valve to the target implantation site. Thus, the distal tip portion 428 can be configured to axially resist movement of the artificial heart valve 450 relative to the balloon 418 proximally when the distal tip portion 428 is disposed adjacent to the proximal side of the valve attachment portion 424.

[0090] An annular space can be defined between the outer surface of the inner shaft 408 and the inner surface of the intermediate shaft 406, and this annular space can be configured to receive fluid from a fluid source via a second port 440 of the adapter 412. 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 408 and the inner surface of the balloon 418. Thus, fluid from the fluid source can flow from the annular space into the fluid passage, thereby expanding the balloon 418 and radially expanding and deploying the artificial heart valve 450.

[0091] The inner lumen of the inner shaft 408 can be configured to receive a guide wire therethrough for steering the distal end portion of the delivery device 400 to the target implantation site.

[0092] The handle 402 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 400. In the illustrated example, the handle 402 includes an adjustment member such as the rotatable knob 460 shown, which is operably coupled to the proximal end portion of a tension wire. The tension wire can extend distally from the handle 402 through the outer shaft 404 and has a distal end portion fixed to the outer shaft 404 at or near the distal end of the outer shaft 404. By rotating the knob 460, the tension of the tension wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 400. Further details regarding the steering mechanism or bending mechanism in the delivery device can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0093] The handle 402 can further include an adjustment mechanism 461 including an adjustment member such as the rotatable knob 462 shown, and an associated lock mechanism including another adjustment member configured as a rotatable knob 478. The adjustment mechanism 461 is configured to adjust the axial position of the intermediate shaft 406 relative to the outer shaft 404 (e.g., for fine positioning at the implantation site). Further details regarding the delivery device 400 can be found in International Publication No. WO2022 / 046585, which is incorporated herein by reference.

[0094] Delivery Technology To implant an artificial valve into the native aortic valve via a transfemoral delivery approach, the artificial valve is mounted in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced through the descending aorta and through the descending aorta, around the aortic arch and through the ascending aorta. The artificial valve is positioned inside the native aortic valve and expanded radially (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the artificial valve from a sheath to make the artificial valve self-expanding). Alternatively, the artificial valve can be implanted inside the native aortic valve via a transapical procedure, in which case the artificial valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve is positioned inside the native aortic valve. Alternatively, in a transaortic procedure, the artificial valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, by a partial J sternotomy or a small right parasternal thoracotomy, and then advanced through the ascending aorta towards the native aortic valve.

[0095] To implant an artificial valve into the native mitral valve via a transseptal delivery approach, the artificial valve is mounted in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced through the inferior vena cava and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made within the atrial septum), into the left atrium, and towards the native mitral valve. Alternatively, the artificial valve can be implanted into the native mitral valve via a transapical procedure, in which case the artificial valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve is positioned inside the native mitral valve.

[0096] To implant an artificial valve inside the native tricuspid valve, the artificial valve is mounted in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into the inferior vena cava and through the inferior vena cava into the right atrium, where the artificial valve is positioned inside the native tricuspid valve. A similar approach can be used to implant the artificial valve inside the native pulmonary valve or the pulmonary artery, except that the artificial valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0097] Another delivery approach is the transatrial approach, in which the artificial valve (on the distal end portion of the delivery device) is inserted through a chest incision and an incision formed through the atrial wall (of the right atrium or left atrium) to access any of the native heart valves. Atrial delivery can also be performed from within a blood vessel, such as from a pulmonary vein, for example. Yet another delivery approach is the transventricular approach, in which the artificial valve (on the distal end portion of the delivery device) is inserted through a chest incision and 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 the pulmonary artery.

[0098] 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.

[0099] Any system, device, apparatus, etc. described in this specification can be sterilized (e.g., using heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use for patients, and any method described in this specification can include sterilizing the associated system, device, apparatus, etc. as one of the steps of the method. Examples of sterilization by heat / thermal include sterilization by steam and sterilization by autoclave. Examples of radiation used for sterilization include, but are not limited to, gamma rays, ultraviolet rays, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization by hydrogen peroxide may be achieved, for example, using hydrogen peroxide plasma.

[0100] Additional Examples

[0101] In view of the implementations described above with respect to the disclosed subject matter, this application discloses the additional embodiments listed below. It should be noted that two or more features of an embodiment taken in isolation, or in combination, and optionally in combination with one or more features of one or more further embodiments, are further embodiments that equally fall within the disclosure of this application.

[0102] Example 1: A valve tip subassembly for an artificial heart valve comprises a valve tip having an edge portion, a first major surface, and a second major surface, the first and second major surfaces being separated by the thickness of the valve tip, and a reinforcement structure attached to the valve tip along the edge portion, the reinforcement structure comprising a first reinforcement member disposed on the first major surface and a second reinforcement member disposed on the second major surface.

[0103] Example 2: The valve tip subassembly according to any embodiment of this specification, particularly Example 1, wherein the first reinforcement member and the second reinforcement member are aligned across the thickness of the valve tip.

[0104] Example 3: The valve tip subassembly according to any one of the embodiments described herein, particularly any one of Embodiments 1 to 2, wherein the reinforcing structure is attached to the valve tip by a suture extending through both the first and second reinforcing members and a portion of the valve tip between the first and second reinforcing members.

[0105] Example 4: The valve tip subassembly according to any one of the embodiments described herein, particularly the valve tip subassembly described in Example 3, wherein the first reinforcing member includes a plurality of openings spaced along the length of the first reinforcing member, and the second reinforcing member includes a plurality of openings spaced along the length of the second reinforcing member.

[0106] Example 5: The valve tip subassembly according to any one of the embodiments described herein, particularly the valve tip subassembly described in Example 4, wherein the suture extends through the openings of the first and second reinforcing members.

[0107] Example 6: The valve tip subassembly according to any one of the embodiments described herein, particularly any one of Embodiments 4 to 5, wherein the valve tip includes a plurality of openings aligned with the plurality of openings of the first and second reinforcing members.

[0108] Example 7: The valve tip subassembly according to any one of the embodiments described herein, particularly any one of Embodiments 1 to 6, wherein the first and second reinforcing members follow the curvature of the edge portion.

[0109] Example 8: The valve tip subassembly according to any one of the embodiments described herein, particularly any one of Embodiments 1 to 7, wherein each of the first and second reinforcing members includes a braided suture.

[0110] Example 9: The valve leaflet assembly for an artificial heart valve comprises a plurality of valve leaflet sub-assemblies, each valve leaflet sub-assembly comprising a valve leaflet having an edge portion, a first major surface, and a second major surface, the first and second major surfaces being separated by the thickness of the valve leaflet, the valve leaflet assembly comprising a reinforcement structure attached to the valve leaflet along the edge portion, the reinforcement structure including a first reinforcement member disposed on the first major surface and a second reinforcement member disposed on the second major surface, the valve leaflet assembly comprising a plurality of cross-links connecting the valve leaflet sub-assemblies together.

[0111] Example 10: The valve leaflet assembly according to any embodiment of the present specification, particularly Example 9, wherein the first reinforcement member and the second reinforcement member of each valve leaflet sub-assembly are aligned across the thickness of the valve leaflet of the valve leaflet sub-assembly.

[0112] Example 11: The valve leaflet assembly according to any embodiment of the present specification, particularly any one of Examples 9 to 10, wherein the reinforcement structure of each valve leaflet sub-assembly is attached to the valve leaflet of each valve leaflet sub-assembly by a suture extending through both the first reinforcement member and the second reinforcement member of the reinforcement structure and a portion of the valve leaflet between the first reinforcement member and the second reinforcement member of the reinforcement structure.

[0113] Example 12: The valve leaflet assembly according to any embodiment of the present specification, particularly Example 11, wherein the first reinforcement member of each valve leaflet sub-assembly includes a plurality of openings spaced along the length of the first reinforcement member, and the second reinforcement member of each valve leaflet sub-assembly includes a plurality of openings spaced along the length of the second reinforcement member.

[0114] Example 13: The valve leaflet assembly according to any embodiment of the present specification, particularly Example 12, wherein the suture of each valve leaflet sub-assembly extends through the openings of the first reinforcement member and the second reinforcement member of the valve leaflet sub-assembly.

[0115] Example 14: The valve tip assembly of any example herein, particularly any one of Examples 12 - 13, wherein the valve tip of each valve tip sub - assembly includes a plurality of openings aligned with a plurality of openings of the first and second reinforcing members of the valve tip sub - assembly.

[0116] Example 15: The valve tip assembly of any example herein, particularly any one of Examples 9 - 14, wherein the reinforcing structure of each valve tip sub - assembly follows the curvature of the edge portion of each valve tip sub - assembly.

[0117] Example 16: The valve tip assembly of any example herein, particularly any one of Examples 9 - 15, wherein each of the first and second reinforcing members of each valve tip sub - assembly includes a braided suture.

[0118] Example 17: The valve tip assembly of any example herein, particularly any one of Examples 9 - 16, wherein each valve tip sub - assembly includes a pair of cross - connecting tabs located on both sides of the valve tip of the valve tip sub - assembly, and each cross - connection is formed between adjacent cross - connecting tabs of adjacent valve tip sub - assemblies.

[0119] Example 18: The artificial heart valve comprises a frame configured to be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, and a valve tip sub - assembly at least partially located within the frame. The valve tip sub - assembly includes at least one valve tip having an edge portion, a first major surface, and a second major surface, wherein the first and second major surfaces are separated by the thickness of the valve tip, and a reinforcing structure attached to the valve tip along the edge portion, the reinforcing structure including a first reinforcing member disposed on the first major surface and a second reinforcing member disposed on the second major surface, and the edge portion of the valve tip is coupled to the frame via the reinforcing structure.

[0120] Example 19: The artificial heart valve of any example herein, particularly the artificial heart valve described in Example 18, wherein the frame includes a plurality of struts.

[0121] Example 20: An artificial heart valve according to any embodiment herein, particularly embodiment 19, wherein the sharp edge portion is coupled to at least one of the plurality of struts by at least one suture extending through a reinforcing structure.

[0122] Example 21: An artificial heart valve according to any embodiment herein, particularly embodiment 20, wherein the first reinforcing member includes a plurality of openings spaced along the length of the first reinforcing member, the second reinforcing member includes a plurality of openings spaced along the length of the second reinforcing member, and at least one suture extends through one of the openings of the first reinforcing member and one of the openings of the second reinforcing member.

[0123] Example 22: An artificial heart valve according to any embodiment herein, particularly any one of embodiments 20 - 21, wherein at least one suture forms a loop extending around at least one strut.

[0124] Example 23: The artificial heart valve according to any embodiment herein, particularly any one of embodiments 20 - 22, further includes an inner skirt extending along the inner surface of the frame, and at least one suture extends through the inner skirt to connect the sharp edge portion to the inner skirt.

[0125] Example 24: An artificial heart valve according to any embodiment herein, particularly embodiment 23, wherein at least one suture extends through the inner skirt on both sides of at least one strut.

[0126] Example 25: The artificial heart valve according to any embodiment herein, particularly any one of embodiments 23 - 24, further includes an outer skirt disposed around the outer surface of the frame, and at least one suture extends through the outer skirt to connect the inner skirt to the outer skirt.

[0127] Example 26: An artificial heart valve according to any embodiment herein, particularly embodiment 25, wherein at least one suture extends through the outer skirt on both sides of at least one strut and extends across a portion outside the outer skirt.

[0128] Example 27: An artificial heart valve according to any embodiment herein, particularly any one of Embodiments 25-26, wherein the connected portion is formed between the inner skirt and the outer skirt on both sides of at least one strut, and at least one strut is encapsulated within the space between the inner skirt, the outer skirt, and the connected portion.

[0129] Example 28: An artificial heart valve according to any embodiment herein, particularly the artificial heart valve described in Example 27, wherein the connected portion includes a part of the outer skirt and the inner skirt that are joined together.

[0130] Example 29: An artificial heart valve according to any embodiment herein, particularly the artificial heart valve described in Example 27, wherein the connected portion includes a part of the outer skirt and the inner skirt that are stitched together.

[0131] Example 30: An artificial heart valve according to any embodiment herein, particularly any one of Embodiments 27-29, wherein at least one suture extends through the space between the inner skirt and the outer skirt.

[0132] Example 31: An artificial heart valve according to any embodiment herein, particularly any one of Embodiments 27-29, wherein at least one suture extends through the connected portion.

[0133] Example 32: An artificial heart valve according to any embodiment herein, particularly any one of Embodiments 20-22, further comprising an inner skirt that encapsulates at least one strut.

[0134] Example 33: An artificial heart valve according to any embodiment herein, particularly the artificial heart valve described in Example 32, further comprising an outer skirt disposed around the outer surface of the frame and a connected portion formed between the outer skirt and the inner skirt.

[0135] Example 34: An artificial heart valve according to any example herein, particularly Example 33, wherein at least one suture extends through the outer skirt and connects the edge portion to the outer skirt.

[0136] Example 35: An artificial heart valve according to any example herein, particularly any one of Examples 19 - 34, wherein the first reinforcing member and the second reinforcing member follow the curvature of the edge portion.

[0137] Example 36: An artificial heart valve according to any example herein, particularly any one of Examples 19 - 35, wherein each of the first reinforcing member and the second reinforcing member includes a braided suture.

[0138] Example 37: An artificial heart valve according to any example herein, particularly Example 19, further comprising an inner skirt extending along the inner surface of the frame, and the valve leaflets are sutured to the inner skirt via a reinforcing structure and along at least one of a plurality of struts.

[0139] Example 38: An artificial heart valve according to any example herein, particularly Example 37, further comprising an outer skirt disposed around the outer surface of the frame, and the inner skirt is sutured to the outer skirt along at least one strut.

[0140] Example 39: An artificial heart valve according to any example herein, particularly any one of Examples 18 - 38, wherein the valve leaflet assembly includes a plurality of valve leaflets.

[0141] Example 40: A method of assembling an artificial heart valve includes at least partially disposing the valve leaflets within the frame and attaching the valve leaflets to the frame by extending sutures through a first reinforcing member along the edge portion of the valve leaflets and a second reinforcing member attached to the opposing major surface of the valve leaflets, through an inner skirt disposed on the inner surface of the frame, and around the struts of the frame.

[0142] Example 41: The method according to any example herein, particularly the method according to Example 40, wherein the suture extends through the inner skirt at two spaced positions.

[0143] Example 42: The method according to any example herein, particularly any one of Examples 40 - 41, wherein the suture extends through an outer skirt disposed around the outer surface of the frame.

[0144] Example 43: The method according to any example herein, particularly the method according to Example 42, wherein the suture extends through the outer skirt at two spaced positions.

[0145] Example 44: The method according to any example herein, particularly the method according to Example 42, wherein the suture extends on the outer surface of the outer skirt.

[0146] Example 45: Further comprising forming a connecting portion between the inner skirt and the outer skirt, and the strut is encapsulated within a space formed between the inner skirt, the outer skirt, and the connecting portion; the method according to any example herein, particularly the method according to Example 42.

[0147] Example 46: The method according to any example herein, particularly the method according to Example 45, wherein the suture extends through the space.

[0148] Example 47: The method according to any example herein, particularly the method according to Example 45, wherein the suture extends through the connecting portion.

[0149] Example 48: The delivery assembly comprises a delivery device and an artificial heart valve coupled to the delivery device. The artificial heart valve includes a frame that is radially collapsible and expandable between a collapsed configuration and an expanded configuration, at least one valve leaflet having an edge portion and opposing major surfaces, and a reinforcement structure attached to the valve leaflet along the edge portion, the reinforcement structure including a first reinforcement member and a second reinforcement member disposed on the opposing major surfaces of the valve leaflet, and the edge portion of the valve leaflet being coupled to the frame via the reinforcement structure.

[0150] Example 49: The delivery assembly according to any example herein, particularly the delivery assembly described in Example 48, wherein the frame includes a plurality of struts.

[0151] Example 50: The delivery assembly according to any example herein, particularly the delivery assembly described in Example 49, wherein the sharp edge portion is coupled to at least one of the plurality of struts by at least one suture extending through the reinforcement structure and the valve tip.

[0152] Example 51: The delivery assembly according to any example herein, particularly any one of Examples 48 - 50, further comprising an inner skirt disposed around the inner surface of the frame, wherein the sharp edge portion of the valve tip is coupled to the frame via the reinforcement structure and the inner skirt.

[0153] Example 52: The delivery assembly according to any example herein, particularly the delivery assembly described in Example 49, further comprising an outer skirt disposed around the outer surface of the frame, wherein the inner skirt is attached to the outer skirt such that at least one strut is encapsulated between the inner skirt and the outer skirt.

[0154] Example 53: The delivery assembly according to any example herein, particularly any one of Examples 48 - 52, wherein a first reinforcement member and a second reinforcement member follow the curvature of the sharp edge portion.

[0155] Example 54: The delivery assembly includes a delivery device and an artificial heart valve coupled to the delivery device. The artificial heart valve includes a frame that is radially collapsible and expandable between a collapsed configuration and an expanded configuration, and a plurality of valve tip sub - assemblies coupled to the frame. Each of the valve tip sub - assemblies includes a valve tip having a sharp edge portion and an opposing major surface, and a reinforcement structure attached to the valve tip along the sharp edge portion. The reinforcement structure includes a first reinforcement member and a second reinforcement member disposed on the opposing major surface of the valve tip, and the sharp edge portion of the valve tip is coupled to the frame via the reinforcement structure.

[0156] Example 55: The tip subassembly, tip assembly, artificial heart valve, or delivery assembly of any example herein, particularly the tip subassembly, tip assembly, artificial heart valve, or delivery assembly described in any one of Examples 1-39 and Examples 48-54, is sterilized.

[0157] Example 56: A method comprising sterilizing the tip subassembly, tip assembly, artificial heart valve, or delivery assembly of any example herein, particularly any one of Examples 1-39 and Examples 48-54.

[0158] For each feature described herein with respect to any example, unless otherwise specified, it can be combined with any one or more other features described in any one or more other examples. For example, any one or more features of one tip assembly can be combined with any one or more features of another tip assembly. As another example, any one or more features of one artificial heart valve can be combined with any one or more features of another artificial heart valve.

[0159] Considering the many possible aspects to which the principles of the present disclosure can be applied, it will be appreciated that the illustrated configurations are illustrative of examples related to the disclosed technology and should not be construed as limiting the scope of the present disclosure or the scope of the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A valve tip subassembly for an artificial heart valve, wherein the valve tip subassembly comprises a valve tip having a leading edge portion, a first major surface, and a second major surface, the first and second major surfaces being separated by the thickness of the valve tip, a reinforcement structure attached to the valve tip along the leading edge portion, the reinforcement structure including a first reinforcement member disposed on the first major surface and a second reinforcement member disposed on the second major surface.

2. The valve tip subassembly according to claim 1, wherein the first reinforcement member and the second reinforcement member are aligned across the thickness of the valve tip.

3. The valve tip subassembly according to any one of claims 1 to 2, wherein the reinforcement structure is attached to the valve tip by a suture extending through both the first reinforcement member and the second reinforcement member and a portion of the valve tip between the first reinforcement member and the second reinforcement member.

4. The valve tip subassembly according to claim 3, wherein the first reinforcement member includes a plurality of openings spaced along the length of the first reinforcement member, the second reinforcement member includes a plurality of openings spaced along the length of the second reinforcement member, and the suture extends through the openings of the first reinforcement member and the second reinforcement member.

5. The valve tip subassembly according to claim 4, wherein the valve tip includes a plurality of openings aligned with the plurality of openings of the first reinforcement member and the second reinforcement member.

6. The valve tip subassembly according to any one of claims 1 to 5, wherein the first reinforcement member and the second reinforcement member follow the curvature of the leading edge portion.

7. An artificial heart valve, comprising a frame configured to be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, a valve tip subassembly at least partially located within the frame, the valve tip subassembly comprising at least one valve tip having a leading edge portion, a first major surface, and a second major surface, the first and second major surfaces being separated by the thickness of the valve tip, A reinforcing structure attached to the valve tip along the sharp edge portion, the reinforcing structure including a first reinforcing member disposed on the first main surface and a second reinforcing member disposed on the second main surface, and the sharp edge portion of the valve tip being coupled to the frame via the reinforcing structure, a valve tip subassembly including the reinforcing structure, an artificial heart valve comprising the valve tip subassembly.

8. The artificial heart valve according to claim 7, wherein the frame includes a plurality of struts, and the sharp edge portion is coupled to at least one of the plurality of struts by at least one suture extending through the reinforcing structure.

9. The artificial heart valve according to claim 8, wherein the first reinforcing member includes a plurality of openings spaced along the length of the first reinforcing member, the second reinforcing member includes a plurality of openings spaced along the length of the second reinforcing member, and the at least one suture extends through one of the openings of the first reinforcing member and one of the openings of the second reinforcing member.

10. The artificial heart valve according to any one of claims 8 to 9, wherein the at least one suture forms a loop extending around the at least one strut.

11. The artificial heart valve according to any one of claims 8 to 10, further comprising an inner skirt extending along the inner surface of the frame, the at least one suture extending through the inner skirt and connecting the sharp edge portion to the inner skirt.

12. The artificial heart valve according to claim 11, further comprising an outer skirt disposed around the outer surface of the frame, the at least one suture extending through the outer skirt and connecting the inner skirt to the outer skirt.

13. The artificial heart valve according to claim 12, wherein a connected portion is formed between the inner skirt and the outer skirt on both sides of the at least one strut, and the at least one strut is enclosed within a space between the inner skirt, the outer skirt, and the connected portion.

14. The artificial heart valve according to claim 13, wherein the connected portion includes a portion of the outer skirt and the inner skirt that are joined together and / or stitched together.

15. The artificial heart valve according to any one of claims 13 to 14, wherein the at least one suture extends through the space between the inner skirt and the outer skirt.

16. The artificial heart valve according to any one of claims 13 to 15, wherein the at least one suture extends through the connected portion.

17. An inner skirt enclosing the at least one strut, An outer skirt disposed around the outer surface of the frame, The artificial heart valve according to any one of claims 8 to 16, further comprising a connected portion formed between the outer skirt and the inner skirt.

18. The artificial heart valve according to claim 17, wherein the at least one suture extends through the outer skirt and connects the cusp portion to the outer skirt.

19. The artificial heart valve according to claim 8, further comprising an inner skirt extending along the inner surface of the frame and an outer skirt disposed around the outer surface of the frame, wherein the valve cusp is sutured to the inner skirt via the reinforcing structure and along at least one of the plurality of struts, and the inner skirt is sutured to the outer skirt along the at least one strut.

20. A method of assembling an artificial heart valve, the method comprising: Disposing a valve cusp at least partially within a frame; Attaching the valve cusp to the frame by extending a suture through an inner skirt disposed on the inner surface of the frame, through a first reinforcing member along the cusp edge portion of the valve cusp and a second reinforcing member attached to the opposing major surface of the valve cusp, and around a strut of the frame.

21. The method according to claim 20, wherein the suture extends through the inner skirt at two spaced positions.

22. The method according to any one of claims 20 to 21, wherein the suture extends through an outer skirt disposed around the outer surface of the frame at two spaced positions and the suture extends on the outer surface of the outer skirt.

23. The method according to claim 22, further comprising forming a connected portion between the inner skirt and the outer skirt, wherein the strut is enclosed within a space formed between the inner skirt, the outer skirt, and the connected portion.

24. The method according to claim 23, wherein the suture extends through the space. **Claim 25** The method according to claim 23, wherein the suture extends through the connected portion.

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