Heart valve and method

Abstract

Disclosed herein is a heart valve having an inflow end and an outflow end and comprising: (a) a stent comprising: (i) a frame having an inner surface and an outer surface, and (ii) a support band having an inner surface and an outer surface, (b) a unitary leaflet structure comprising a plurality of flexible leaflets, wherein the unitary' leaflet structure has an inner surface and an outer surface and a first edge and a second edge; and wherein the outer surface of the unitary leaflet structure is suturelessly attached to at least a portion of the inner surface of the frame, and the inner surface of the unitary leaflet structure is suturelessly attached to at least a portion of the outer surface of the support band along a first edge portion of the unitary leaflet structure, such that at least a portion of the first edge portion of the unitary leaflet structure is sandwiched between the frame and the support band.

Description

SSHSV-23182US01 1,286,286_1 HEART VALVE AND METHOD CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Patent Application No.63 / 645,450, filed May 10, 2024, the contents of which are incorporated herein by reference in their entirety. FIELD

[0002] The present invention relates generally to medical devices and particularly to a prosthetic heart valve having an integrated stent and sewing ring. BACKGROUND

[0003] The heart can suffer from various valvular diseases or malformations that result in significant malfunctioning of the heart and ultimately require the replacement of the native heart valve with an artificial valve. Human heart valves, which include the aortic, pulmonary, mitral, and tricuspid valves, function essentially as one-way valves operating in synchronization with the pumping heart. The valves allow blood to flow downstream but block blood from flowing upstream. Diseased heart valves exhibit impairments such as narrowing of the valve or regurgitation, which inhibits the valves’ ability to control blood flow. Such impairments reduce the heart’s blood-pumping efficiency and can be a debilitating and life-threatening condition. For example, valve insufficiency can lead to conditions such as heart hypertrophy and dilation of the ventricle. Thus, extensive efforts have been made to develop methods and apparatuses to repair or replace impaired heart valves.

[0004] Prostheses exist to correct problems associated with impaired heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace impaired native heart valves. More recently, substantial effort has been dedicated to developing replacement heart valves, particularly tissue-based replacement heart valves that can be delivered with less trauma to the patient than through open-heart surgery. Replacement valves are being designed to be delivered through minimally invasive procedures and even percutaneous procedures. Such replacement valves often include a tissue-based valve body that is connected to an expandable frame that is then delivered to the native valve’s annulus.

[0005] One of the heart valve prostheses is a surgical bioprosthetic valve (BHV). Surgical bioprosthetic valves do not require anticoagulant therapy and demonstrate excellent hemodynamic properties like those of native valves; nonetheless, their durability is limited because of inevitable structural valve degeneration (SVD), an irreversible process manifested by gradual degenerative changes in the prosthesis, such as pannus growth, leaflet fibrosis,SSHSV-23182US01 1,286,286_1 and calcification. Mechanisms underlying SVD are still incompletely understood, but recent studies have provided evidence that multiple active processes are involved in SVD pathogenesis, including long-term immune rejection and atherosclerosis-like tissue remodeling. Because of the high prevalence of BHVs in surgical practice, there is an increasing need to delay SVD development and develop novel treatment modalities for SVD prevention. Red blood cells have been shown to penetrate the bovine pericardium-based leaflets in BHV through the extracellular matrix disintegration which then causes calcium deposition and further oxidation-driven degradation of the tissue leaflets.

[0006] These needs and others are at least partially satisfied by the present disclosure. SUMMARY

[0007] Some of the aspects of the present disclosure relate to heart valves. Some aspects relate to the heart valve having an inflow end and an outflow end and comprising: (a) a stent comprising: (i) a frame having an inner surface and an outer surface, and (ii) a support band having an inner surface and an outer surface, (b) a unitary leaflet structure comprising a plurality of flexible leaflets, wherein the unitary leaflet structure has an inner surface and an outer surface and a first edge and a second edge; and wherein the outer surface of the unitary leaflet structure is suturelessly attached to at least a portion of the inner surface of the frame, and the inner surface of the unitary leaflet structure is suturelessly attached to at least a portion of the outer surface of the support band along a first edge portion of the unitary leaflet structure, such that at least a portion of the first edge portion of the unitary leaflet structure is sandwiched between the frame and the support band.

[0008] In still further aspects, disclosed are the heart valve wherein at least a portion of the unitary leaflet structure comprises a reinforcing material.

[0009] Also disclosed herein are aspects wherein any of the disclosed heart valves further comprise a suture-permeable sewing ring attached to a periphery of the stent, wherein the suture-permeable sewing ring is configured to secure the valve to a native annulus.

[0010] Also disclosed herein are aspects are methods of making such heart valves.

[0011] Additional aspects of the disclosure will be set forth, in part, in the detailed description, figures, and claims that follow, and in part will be derived from the detailed description or can be learned by practice of the disclosure. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure as disclosed.SSHSV-23182US01 1,286,286_1 BRIEF DESCRIPTION OF THE DRAWINGS

[0012] FIGURES 1A–1E show exemplary elements of an exemplary heart valve in one aspect.

[0013] FIGURE 2 shows a schematic of the unitary leaflet structure according to one aspect.

[0014] FIGURE 3 shows a schematic construction of an exemplary heart valve in one aspect.

[0015] FIGURE 4 shows a schematic construction of an exemplary heart valve in one aspect.

[0016] FIGURE 5 shows a schematic of an exemplary sewing ring for an exemplary heart valve according to one aspect.

[0017] FIGURES 6A–6B show a schematic of an exemplary heart valve according to one aspect.

[0018] FIGURE 7 shows a schematic of an exemplary heart valve according to one aspect. DETAILED DESCRIPTION

[0019] The present disclosure can be understood more readily by reference to the following detailed description, examples, drawings, and claims, and their previous and following description. However, before the present articles, systems, and / or methods are disclosed and described, it is to be understood that this disclosure is not limited to the specific or exemplary aspects of articles, systems, and / or methods disclosed unless otherwise specified, as such can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.

[0020] The following description of the disclosure is provided as an enabling teaching of the disclosure in its best, currently known aspect. To this end, those skilled in the relevant art will recognize and appreciate that many changes can be made to the various aspects of the disclosure described herein while still obtaining the beneficial results of the present disclosure. It will also be apparent that some of the desired benefits of the present disclosure can be obtained by selecting some of the features of the present disclosure without utilizing other features. Accordingly, those of ordinary skill in the pertinent art will recognize that many modifications and adaptations to the present disclosure are possible and can even be desirable in certain circumstances and are a part of the present disclosure. Thus, theSSHSV-23182US01 1,286,286_1 following description is again provided as illustrative of the principles of the present disclosure and not in limitation thereof. DEFINITIONS

[0021] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Thus, for example, reference to a “yarn” includes aspects having two or more such yarns unless the context clearly indicates otherwise.

[0022] It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting. As used in the specification and in the claims, the term “comprising” can include the aspects “consisting of” and “consisting essentially of.” Additionally, the term “includes” means “comprises.”

[0023] For the terms “for example,” “exemplary,” and “such as,” and grammatical equivalences thereof, the phrase “and without limitation” is understood to follow unless explicitly stated otherwise.

[0024] Ranges can be expressed herein as from “about” one particular value and / or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It should be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint and independently of the other endpoint. Unless stated otherwise, the term “about” means within 5% (e.g., within 2% or 1%) of the particular value modified by the term “about.”

[0025] Throughout this disclosure, various aspects of the disclosure can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, a description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, 6 and any whole and partial increments therebetween. This applies regardless of the breadth of the range.

[0026] As used herein, the terms “optional” or “optionally” mean that the subsequently described event or circumstance can or cannot occur and that the description includes instances where said event or circumstance occurs and instances where it does not.SSHSV-23182US01 1,286,286_1

[0027] Further, the terms “coupled” and “associated” generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked and do not exclude the presence of intermediate elements between the coupled or associated items.

[0028] It will be understood that when an element is referred to as being “connected” or “coupled” to another element, it can be directly connected or coupled to the other element, or intervening elements can be present. In contrast, when an element is referred to as being “directly connected” or “directly coupled” to another element, there are no intervening elements present. Other words used to describe the relationship between elements or layers should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” “on” versus “directly on”).

[0029] It will be understood that although the terms “first,” “second,” etc., can be used herein to describe various elements, components, regions, layers, and / or sections. These elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer, or section from another element, component, region, layer, or a section. Thus, a first element, component, region, layer, or section discussed below could be termed a second element, component, region, layer, or section without departing from the teachings of example aspects.

[0030] Spatially relative terms, such as,” “beneath,” “below,” “lower,” “above,” “upper,” “upward,” “downward,” “top,” “bottom,” and the like, can be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the term “below” can encompass both an orientation of above and below. The device can be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein are interpreted accordingly.

[0031] Terms such as “proximal,” “distal,” “radially outward,” “radially inward,” “outer,” “inner,” and “side” describe the orientation and / or location of portions of the components or elements within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the components or elements under discussion. Such terminology can include the words specifically mentioned above, derivatives thereof, and words of similar import. Similarly, the terms “first,” “second,” andSSHSV-23182US01 1,286,286_1 other such numerical terms referring to structures neither imply a sequence nor order unless clearly indicated by the context.

[0032] As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items. It is also understood that the term “and / or” includes where one or another of the associated listed items is present, and the aspects where both of the associated listed items are present or any combinations of the associated listed items are present.

[0033] As used herein, the term or phrase “effective,” “effective amount,” or “conditions effective to” refers to such amount or condition that is capable of performing the function or property for which an effective amount or condition is expressed. As will be pointed out below, the exact amount or particular condition required will vary from one aspect to another, depending on recognized variables such as the materials employed and the processing conditions observed. Thus, it is not always possible to specify an exact “effective amount” or “condition effective to.” However, it should be understood that an appropriate effective amount will be readily determined by one of ordinary skill in the art using only routine experimentation.

[0034] The terms “fiber” or “filament” can be used interchangeably.

[0035] The terms “fiber” (or “filament”) and “material comprising a plurality of fibers (filaments)” are used herein according to their broad and ordinary meanings and can refer to any type of natural or synthetic substance or material that is significantly longer than it is wide, including any elongate or relatively fine, slender, and / or threadlike piece, filament, cord, yarn, plie, strand, line, string, or portion thereof. Furthermore, “fiber” or “material comprising a plurality of fibers” can refer to a single filament or collectively to a plurality of filaments. Examples of material comprising a plurality of fibers in accordance with aspects of the present disclosure include but are not limited to, any type of cloth, fabric, or textile. It is understood that in certain unlimiting aspects, the term “material comprising a plurality of fibers” can refer to cloth, fabric, textile, or interlocking-fiber material that can cover or form certain features of the disclosed devices.

[0036] The term “fiber,” as used herein, includes fibers of extreme or indefinite length (e.g., filaments) and fibers of short length (e.g., staple fibers).

[0037] As used herein, the term “substantially” means that the subsequently described event or circumstance completely occurs or that the subsequently described event or circumstance generally, typically, or approximately occurs.

[0038] Still further, the term “substantially” can, in some aspects, refer to at least about 90 %, at least about 91 %, at least about 92 %, at least about 93 %, at least about 94 %, atSSHSV-23182US01 1,286,286_1 least about 95 %, at least about 96 %, at least about 97 %, at least about 98 %, at least about 99 %, or about 100 % of the stated property, component, composition, or other condition for which substantially is used to characterize or otherwise quantify an amount.

[0039] As used herein, the term “substantially,” in, for example, the context “substantially identical” or “substantially similar,” refers to a method or a system, or a component that is at least about 90%, at least about 91%, at least about 92%, at least about 93%, at least about 94%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, or about 100% by similar to the method, system, or the component it is compared to.

[0040] As disclosed herein, it is understood that when the reference is done to a thickness of the indicated member, the referred thickness is a thickness of the member wall.

[0041] Although the operations of exemplary aspects of the disclosed method can be described in a particular, sequential order for convenient presentation, it should be understood that disclosed aspects can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially can, in some cases, be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular aspect are not limited to that aspect and can be applied to any aspect disclosed.

[0042] Moreover, for the sake of simplicity, the attached figures cannot show the various ways (readily discernable, based on this disclosure, by one of ordinary skill in the art) in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses. Additionally, the description sometimes uses terms such as “produce” and “provide” to describe the disclosed method. These terms are high-level abstractions of the actual operations that can be performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are, based on this disclosure, readily discernible by one of ordinary skill in the art. HEART VALVE

[0043] The disclosed herein is a heart valve having an inflow end and an outflow end and comprising: (a) a stent comprising: (i) a frame having an inner surface and an outer surface, and (ii) a support band having an inner surface and an outer surface. An exemplary stent is shown in FIGs.1A–1C. FIG.1A shows an exemplary frame 102, having an inflow end 106 and an outflow end 108. The frame 102 has a plurality of curvilinear cusps 104. FIG.1B shows an exemplary support band having an inflow end 206 and an outflow end 208. The exemplary support band comprises a plurality of curvilinear cusps 204 that are followed by a plurality of upstanding commissures 210. FIG.1C shows an exemplary stent 1000 where the frameSSHSV-23182US01 1,286,286_1 and support band are interposed on each other. In still further aspects, the heart valve disclosed herein comprises a unitary leaflet structure 302 comprising a plurality of flexible leaflets, as shown in FIG.1D. In this exemplary and unlimiting aspect, the unitary leaflet structure 302 comprises three leaflets 304. However, it is understood that such unitary leaflet structures can comprise 2, 3, 4, or any other number of leaflets, depending on the specific application of the valve. The unitary leaflet structure 302 has a first end (an inflow end) 306 and a second end (an outflow end) 308. In aspects disclosed herein, the unitary leaflet structure 302 is formed for a single continuous sheet 300 (as shown in FIG.1E). In such exemplary aspects, the plurality of flexible leaflets 304 are suturelessly directly coupled to each other at at least one location 305.

[0044] In still further aspects, and as shown in FIG.2, the unitary leaflet structure 402, having a plurality of leaflets 404, is positioned such that the outer surface is suturelessly attached to at least a portion of the inner surface of frame 406 along the inflow end 408. Yet in still further aspects, and as shown in FIG.3, the inner surface of the unitary leaflet structure 402 is suturelessly attached to at least a portion of the outer surface of the support band 202 along a first edge portion (inflow) of the unitary leaflet structure, such that at least a portion of the first edge portion of the unitary leaflet structure is sandwiched between the frame 102 and the support band 202.

[0045] In still further aspects, the plurality of flexible leaflets are formed from a continuous sheet 300 (FIG.1E) that can comprise one or more layers of a polymeric material. It is understood that in such aspects, the formed leaflets are comprised of polymeric material instead of commonly used bovine pericardia leaflets or leaflets made of porcine tissues. The unitary leaflet structures described herein are shown to have equivalent to bovine pericardial tissue leaflets’ hemodynamic performance with a dense nature that will prevent red blood cell penetration into leaflets. In such exemplary aspects, each layer of the one or more layers can comprise the same polymeric material or different polymeric material. In certain aspects, the one or more layers comprise a textile material, a film, or a combination thereof. In still further aspects, the continuous sheet is a film comprising at least one layer of polytetrafluoroethylene (PTFE), polyethylenes, such as ultra-high molecular weight polyethylene (UHMWPE), polypropylene, polyurethane, PEEK, polyvinyl alcohol, silicone, or combinations thereof. Yet, in other aspects, the continuous sheet is a textile material comprising a plurality of fibers. In such aspects, the plurality of fibers can comprise one or more of polytetrafluoroethylene (PTFE), polyethylenes, such as ultra-high molecular weight polyethylene (UHMWPE), polypropylene, polyurethane, PEEK, polyvinyl alcohol, silicone, or combinations thereof. In yet still further aspects, the continuous sheet can comprise two or more layers of a thermoplastic polyurethane. In such aspects, the two orSSHSV-23182US01 1,286,286_1 more layers of the thermoplastic polyurethane can be two or more layers of the film or two or more layers of a textile.

[0046] In still further aspects, at least a portion of the unitary leaflet structure can comprise a reinforcing material. In such exemplary and unlimiting aspects, the one or more layers of the reinforcing material can comprise a film or a textile. In certain and unlimiting aspects, the reinforcing material is disposed within the continuous sheet and forms an integral portion of the sheet. In still further aspects, the reinforcing material can be positioned along an entire length and width of the continuous sheet. Yet, in other aspects, the reinforcing material is positioned in predetermined portions along the length / or width of the continuous sheet, depending on the desired application. In still further aspects, the reinforcing material can be positioned in a predetermined pattern, depending on the desired application. In still further aspects, the reinforcing material is positioned only within the first edge portion of the unitary leaflet structure that is sandwiched between the frame and the support band.

[0047] In some exemplary and unlimiting aspects, the one or more layers of the reinforcing material are disposed between and bonded to two layers of thermoplastic polyurethane. In still further aspects, the reinforcing material can comprise a polymeric material. In such exemplary and unlimiting aspects, the polymeric material can comprise a polyamide, polyester (e.g. PET), polypropylene PP, polyether ketone PEEK, polyvinyl PVDF, polycaprolactone PCL, polyglycolide PGA, poly lactic-co-glycolic acid PLGA, polydioxanone PDO, poly(4-hydroxybutyrate) P4HB, polyvinyl alcohol PVA, polytetrafluorethylene PTFE, polyethylene (e.g. UHMWPE).

[0048] Yet, in other aspects, the reinforcing material can comprise a textile comprising polymeric fibers, natural fibers, semi-synthetic fibers, carbon fibers, or a combination thereof. In aspects where the reinforcing material is a textile, such a textile can comprise polymeric fibers comprising any above-listed polymers. Yet in further aspects, where the reinforcing material is a textile comprising natural fiber, such natural fibers can comprise silk, linen, cotton, hemp, or a combination thereof. In still further exemplary and unlimiting aspects, the semi-synthetic fibers can comprise rayon.

[0049] In exemplary and unlimiting aspects, the continuous sheet is formed such that the one or more layers of reinforcing material are positioned between the two layers of thermoplastic polyurethane and thermally bonded together. However, in other exemplary and unlimiting aspects, where it is technologically possible, the reinforcing material can be coextruded with the other layers of the continuous sheet if desired. In still further aspects. In still further aspects, the film of the continuous sheet can be formed, for example, by spray coating the reinforcing material on at least one layer and disposing the second layer on top ofSSHSV-23182US01 1,286,286_1 it. In yet other aspects, the layers of the continuous film can be formed by dissolving all the polymers and spray coating or dip coating these polymers in the desired sequence on a substrate. In certain aspects, the substrate can be sacrificial. Yet, in other aspects, the substrate can represent a part of the structure.

[0050] In still further aspects, the unitary leaflet structure can be formed by compression molding, laser welding or ultrasonic welding.

[0051] In yet still further aspects, the reinforcing material can comprise one or more layers of polyamide, such as nylon, for example.

[0052] In certain aspects, if the continuous sheet comprises one or more layers of thermoplastic polyurethane, the thermoplastic polyurethane can have a durometer of about 60 to about 75 Shore A (about 60 to about 70 Shore A, about 60 to about 65 Shore A, about 65 to 75 Shore A, about 70 to about 75 Shore A). In still further aspects, each of the thermoplastic polyurethane layers can have a thickness of about 0.05 mm to about 0.1 mm (or about 0.05 mm to about 0.095, about 0.05 mm to about 0.09, about 0.05 mm to about 0.085, about 0.05 mm to about 0.080, about 0.05 mm to about 0.075, about 0.05 mm to about 0.070, about 0.05 mm to about 0.065, about 0.05 mm to about 0.060, or about 0.055 mm to about 0.1 mm, about 0.060 mm to about 0.1 mm, about 0.065 mm to about 0.1 mm, about 0.070 mm to about 0.1 mm, about 0.075 mm to about 0.1 mm, about 0.080 mm to about 0.1 mm, about 0.085 mm to about 0.1 mm, about 0.090 mm to about 0.1 mm, or about 0.095 mm to about 0.1 mm).

[0053] In still further aspects, the reinforcing layer can have a thickness of about 0.01 mm to about 0.06 mm (or about 0.015 mm to about 0.06 mm, about 0.02 mm to about 0.06 mm, about 0.025 mm to about 0.06 mm, about 0.025 mm to about 0.06 mm, about 0.03 mm to about 0.06 mm, about 0.035 mm to about 0.06 mm, about 0.04 mm to about 0.06 mm, about 0.045 mm to about 0.06 mm, about 0.050 mm to about 0.06 mm, about 0.055 mm to about 0.06 mm, or about 0.01 mm to about 0.055 mm, about 0.01 mm to about 0.05 mm, about 0.01 mm to about 0.045 mm, about 0.01 mm to about 0.04 mm, about 0.01 mm to about 0.035 mm, about 0.01 mm to about 0.030 mm, about 0.01 mm to about 0.025 mm, about 0.01 mm to about 0.02 mm, about 0.01 mm to about 0.015 mm).

[0054] In still further aspects, disclosed herein is a heart valve where the support band exhibits a first flexibility, and the frame exhibits a second flexibility, wherein the first flexibility is greater than the second flexibility. It is understood that such a structure allows a relatively rigid positioning within the anatomical environment while allowing the flexibility of the leaflets.SSHSV-23182US01 1,286,286_1

[0055] In still further aspects, and as shown in FIG.4, a heart valve structure 500 comprises the upstanding commissures that are at least partially coupled with at least a portion of the leaflet 402 of the plurality of leaflets in the unitary leaflet structure. In such aspects, the outer tabs 410 (FIG.3 and FIG.4) of the leaflets can be coupled or, in some aspects, wrap around at least a portion of commissures 210 of the support band. In still further aspects, the coupling of the outer tabs or other portions of the leaflets with the commissures is sutureless and can be done through a heat treatment or any other methods known in the art.

[0056] In still further aspects, the frame can be constructed from any material having the desired flexibility and biocompatibility. In certain aspects, the frame can comprise Co-Cr-Ni alloy, nitinol, biodegradable magnesium alloy, stretchy carbon fiber, PEEK, PEK, or any combination thereof.

[0057] In still further aspects, the support band can also be constructed from any material having the desired flexibility and biocompatibility. The exemplary and unlimiting support band can comprise a polymeric material. In yet still further aspects, the polymeric material can comprise polyester, PEEK, PEK, or any combination thereof.

[0058] The exemplary frames and support bands can be found, for example, in the U.S. Patent Nos.10,695,170 and 10,238,486, the contents of which are incorporated herein in their entireties for all purposes.

[0059] In still further aspects, the valve can comprise a suture-permeable sewing ring attached to a periphery of the stent, wherein the suture-permeable sewing ring is configured to secure the valve to a native annulus. Yet, in certain aspects, the sewing ring is encompassed by a fabric.

[0060] It is understood that the fabric is biocompatible. In such exemplary and unlimiting aspects, the biocompatible fabric-covered sewing ring or cuff on the valve body provides a platform for attaching the valve to the annulus of the particular valve being replaced.

[0061] FIG.5 illustrates an exemplary and unlimiting suture-permeable sewing ring 502 (without the fabric) that can be used in the construction of the mitral heart valve. The ring 502 is generally annular and includes a solid, preferably curvilinear inflow surface 504, a solid, generally tubular inner wall 506, and an open-celled outflow face 508. The sewing ring 502 may be molded of a biocompatible material such as silicone rubber and can, for example, include a plurality of internal ribs 510 defining optional voids 512 therebetween to make up the open-celled construction. An outer edge 514 of the outflow face 508 is desirably circular and in one plane, while the inner edge 516 (formed by the outflow edge of the innerSSHSV-23182US01 1,286,286_1 wall 506) can include a series of depressions 518. In aspects where the valve comprises three leaflets, there are three depressions. The depressions 518 receive cusp portions of a frame and help prevent axial movement of the frame and leaflets with respect to the sewing ring. Exemplary constructions of the sewing rings are shown in U.S. Pat. No.5,928,281, and U.S. Pat. No.10,238,486, which disclosures are hereby expressly incorporated by reference for all purposes. In still other aspects, the exemplary sewing ring 502 can have a uniform thickness about its circumference, although non-uniform configurations are possible.

[0062] As disclosed herein, the sewing ring is attached to a generally annular periphery of a heart valve. In certain aspects, the sewing ring is configured to pivot from a first position substantially adjacent to the periphery to a second position outward from the first position. The sewing ring can further comprise a fabric cover. The sewing ring may be substantially planar. The fabric covering the sewing ring can also cover a portion of the heart valve. Moreover, the fabric covering both the sewing ring and a portion of the heart valve also preferably connects the ring to the heart valve periphery. It is understood that the fabric covering can comprise any fibers that are biocompatible. In certain exemplary aspects, the fabric is PET material. However, it is understood that other materials can be used to form the fabric cover.

[0063] In certain and unlimiting aspects, the sewing ring can be movable between two positions, wherein in the first position, the sewing ring extends generally toward the outflow end of the valve, and in the second position, generally toward the inflow end of the valve.

[0064] In still further aspects, the sewing ring can comprise a pharmaceutically active material. In such exemplary and unlimiting aspects, the pharmaceutically active material can be controllably released into native anatomy over a predetermined period of time. In further aspects, the pharmaceutically active material can comprise one or more of corticosteroids, anticoagulants, antibiotics, vasodilators, inotropic agents, or any combination thereof. In still further aspects, the pharmaceutically active material can be dexamethasone acetate, or glucocorticosteroid, or any combination thereof.

[0065] In still further aspects, the valve can further comprise a wireform positioned along the outflow edge of the support band such that it does not overlay the unitary leaflet structure. The exemplary valve 2000 oriented along a flow axis 602 is shown in FIG.6A and 6B. The valve 2000 can comprise leaflets 404 according to the aspects of this disclosure. The wireform 604 can be positioned such that it does not overlay the leaflets themselves. The wireform 604 can be formed from a suitably elastic metal, such as a Co-Cr-Ni alloy, for example, Elgiloy® alloy. As seen in FIG.6B, outer tabs 608 of adjacent leaflets 404 wrap around a portion of the commissures 606 of the support band. In such aspects, the leafletsSSHSV-23182US01 1,286,286_1 can be coaptated at the free edge by thermal processing, for example, by compression molding or the use of low energy laser to bend leaflets to have a better coaptation.

[0066] It should be understood that a leaflet support structure defining alternating cusps and commissures is provided for many prosthetic heart valves and that such a support structure may or may not include a wireform.

[0067] FIG.7 shows the wireform 704 that is also covered by the fabric to facilitate assembly and reduce direct blood exposure after implant.

[0068] The implantable medical devices disclosed herein can include prosthetic heart valves or other forms of implants, such as stents or filters, or diagnostic devices, among others. The implantable medical devices can be expandable implants configured to move from a compressed or undeployed state to an expanded or deployed state. METHODS

[0069] The present disclosure also provides a method of forming the disclosed herein valve. In such methods, the unitary leaflet structure can be formed from a continuous sheet. The forming of the unitary leaflet structure can be done by laser cutting or ultrasonic cutting to the desired shape. Any other methods of cutting can be utilized depending on the desired application.

[0070] Other elements of the valve can be formed, for example, as described in the U.S. Patent Nos.10,695,170 and 10,238,486, the contents of which are incorporated herein in their entireties for all purposes.

[0071] In still further aspects, the pharmaceutically active material can be incorporated in the sewing ring such that it is designed to be released at the desirable rate. In certain aspects, the drug release rate can be controlled by adjusting the hydrophobicity of the silicone sewing ring. EXEMPLARY ASPECTS

[0072] In view of the described processes and compositions, hereinbelow are described certain more particularly described aspects of the disclosures. These particularly recited aspects should not, however, be interpreted to have any limiting effect on any different claims containing different or more general teachings described herein, or that the “particular” aspects are somehow limited in some way other than the inherent meanings of the language and formulas literally used therein.

[0073] Example 1: A heart valve having an inflow end and an outflow end and comprising: (a) a stent comprising: (i) a frame having an inner surface and an outer surface, and (ii) a support band having an inner surface and an outer surface, (b) a unitary leaflet structure comprising a plurality of flexible leaflets, wherein the unitary leaflet structure hasSSHSV-23182US01 1,286,286_1 an inner surface and an outer surface and a first edge and a second edge; and wherein the outer surface of the unitary leaflet structure is suturelessly attached to at least a portion of the inner surface of the frame, and the inner surface of the unitary leaflet structure is suturelessly attached to at least a portion of the outer surface of the support band along a first edge portion of the unitary leaflet structure, such that at least a portion of the first edge portion of the unitary leaflet structure is sandwiched between the frame and the support band.

[0074] Example 2. The heart valve of any of the examples herein, particularly Example 1, wherein the plurality of flexible leaflets are suturelessly directly coupled to each other at at least one location.

[0075] Example 3. The heart valve of any of the examples herein, particularly any of Example 1 or 2, wherein the plurality of flexible leaflets are formed from a continuous sheet comprising one or more layers of a polymeric material.

[0076] Example 4. The heart valve of any of the examples herein, particularly any of Example 3, wherein each layer of the one or more layers comprises the same polymeric material or different polymeric material.

[0077] Example 5. The heart valve of any of the examples herein, particularly any of Example 3 or 4, wherein the one or more layers comprise a textile material, a film, or a combination thereof.

[0078] Example 6. The heart valve of any of the examples herein, particularly any of Examples 3–5, wherein the continuous sheet is a film comprising at least one layer of polytetrafluoroethylene (PTFE), polyethylenes, such as ultra-high molecular weight polyethylene (UHMWPE), polypropylene, polyurethane, PEEK, polyvinyl alcohol, silicone, or combinations thereof.

[0079] Example 7. The heart valve of any of the examples herein, particularly any of Examples 3–6, wherein the continuous sheet comprises two or more layers of a thermoplastic polyurethane.

[0080] Example 8. The heart valve of any of the examples herein, particularly any of Examples 1–7, wherein at least a portion of the unitary leaflet structure comprises a reinforcing material.

[0081] Example 9. The heart valve of any of the examples herein, particularly any of Example 8, wherein the reinforcing material is incorporated within at least a portion of the continuous sheet.SSHSV-23182US01 1,286,286_1

[0082] Example 10. The heart valve of any of the examples herein, particularly any of Example 8 or 9, wherein the reinforcing material is present as one or more layers within the continuous sheet.

[0083] Example 11. The heart valve of any of the examples herein, particularly any of Example 10, wherein the one or more layers comprise a film or a textile.

[0084] Example 12. The heart valve of any of the examples herein, particularly any of Examples 9–11, wherein the reinforcing material is positioned only within the first edge portion of the unitary leaflet structure that is sandwiched between the frame and the support band.

[0085] Example 13. The heart valve of any of the examples herein, particularly any of Examples 10–12, wherein the one or more layers of the reinforcing material are disposed between and bonded to two layers of thermoplastic polyurethane.

[0086] Example 14. The heart valve of any of the examples herein, particularly any of Examples 8–13, wherein the reinforcing material comprises a polymeric material.

[0087] Example 15. The heart valve of any of the examples herein, particularly Example 14, wherein the polymeric material comprises a polyamide, polyester (e.g. PET), polypropylene PP, polyether ketone PEEK, polyvinyl PVDF, polycaprolactone PCL, polyglycolide PGA, poly lactic-co-glycolic acid PLGA, polydioxanone PDO, poly(4- hydroxybutyrate) P4HB, polyvinyl alcohol PVA, polytetrafluorethylene PTFE, polyethylene (e.g. UHMWPE).

[0088] Example 16. The heart valve of any of the examples herein, particularly any of Examples 8–14, wherein the reinforcing material comprises a textile comprising polymeric fibers, natural fibers, semi-synthetic fibers, carbon fibers, or a combination thereof.

[0089] Example 17. The heart valve of any of the examples herein, particularly Example16, wherein polymer fibers comprise polyamide, polyester (e.g. PET), polypropylene PP, polyether ketone PEEK, polyvinyl PVDF, polycaprolactone PCL, polyglycolide PGA, poly lactic-co-glycolic acid PLGA, polydioxanone PDO, poly(4- hydroxybutyrate) P4HB, polyvinyl alcohol PVA, polytetrafluorethylene PTFE, polyethylene (e.g., UHMWPE).

[0090] Example 18. The heart valve of any of the examples herein, particularly any of Example 16 or 17, wherein the natural fibers comprise silk, linen, cotton, hemp, or a combination thereof.

[0091] Example 19. The heart valve of any of the examples herein, particularly any of Examples 16–18, wherein the semi-synthetic fibers comprise rayon.SSHSV-23182US01 1,286,286_1

[0092] Example 20. The heart valve of any of the examples herein, particularly any of Examples 13–19, wherein the thermoplastic polyurethane layer has a durometer of about 60 to about 75 Shore A.

[0093] Example 21. The heart valve of any of the examples herein, particularly any of Examples 13–20, wherein the thermoplastic polyurethane layer has a thickness of about 0.05 mm to about 0.1 mm.

[0094] Example 22. The heart valve of any of the examples herein, particularly any of Examples 13–21, wherein the reinforcing layer has a thickness of about 0.01 mm to about 0.06 mm.

[0095] Example 23. The heart valve of any of the examples herein, particularly any of Examples 1–22, wherein the support band exhibits a first flexibility, and the frame exhibits a second flexibility, wherein the first flexibility is greater than the second flexibility.

[0096] Example 24. The heart valve of any of the examples herein, particularly any of Examples 1–23, wherein the support band comprises an outflow edge that alternates between curvilinear cusps and upstanding commissures.

[0097] Example 25. The heart valve of any of the examples herein, particularly any of Example 24, wherein the frame comprises an outflow edge comprising curvilinear cusps juxtaposed with the curvilinear cusps of the support band.

[0098] Example 26. The heart valve of any of the examples herein, particularly any of Examples 24–25, wherein the upstanding commissures are at least partially coupled with at least a portion of the leaflet of the plurality of leaflets in the unitary leaflet structure.

[0099] Example 27. The heart valve of any of the examples herein, particularly any of Examples 1–26, wherein the frame comprises Co-Cr-Ni alloy, nitinol, biodegradable magnesium alloy, stretchy carbon fiber, PEEK, PEK, or any combination thereof.

[0100] Example 28. The heart valve of any of the examples herein, particularly any of Examples 24–27, wherein the support band comprises a polymeric material.

[0101] Example 29. The heart valve of any of the examples herein, particularly Example 28, wherein the polymeric material comprises polyester, PEEK, PEK, or any combination thereof.

[0102] Example 30. The heart valve of any of the examples herein, particularly any of Examples 1–29, further comprising a suture-permeable sewing ring attached to a periphery of the stent, wherein the suture-permeable sewing ring is configured to secure the valve to a native annulus.SSHSV-23182US01 1,286,286_1

[0103] Example 31. The heart valve of any of the examples herein, particularly Example 30, wherein the sewing ring is encompassed by a fabric.

[0104] Example 32. The heart valve of any of the examples herein, particularly any of Example 30 or 31, wherein the sewing ring comprises silicon.

[0105] Example 33. The heart valve of any of the examples herein, particularly any of Examples 30–32, wherein the sewing ring comprises a pharmaceutically active material.

[0106] Example 34. The heart valve of any of the examples herein, particularly Example 33, wherein the pharmaceutically active material is controllably released into native anatomy over a predetermined period of time.

[0107] Example 35. The heart valve of any of the examples herein, particularly Example 34, wherein the pharmaceutically active material comprises one or more of corticosteroids, anticoagulants, antibiotics, vasodilators, inotropic agents, or any combination thereof.

[0108] Example 36. The heart valve of any of the examples herein, particularly any of Examples 1–35, further comprising a wireform positioned along the outflow edge of the support band such that it does not overlay the unitary leaflet structure.

[0109] Although several aspects of the disclosure have been disclosed in the foregoing specification, it is understood by those skilled in the art that many modifications and other aspects of the disclosure will come to mind to which the disclosure pertains, having the benefit of the teaching presented in the foregoing description and associated drawings. Thus, it is understood that the disclosure is not limited to the specific aspects disclosed hereinabove and that many modifications and other aspects are intended to be included within the scope of the appended claims. Moreover, although specific terms are employed herein, as well as in the claims that follow, they are used only in a generic and descriptive sense and not for the purposes of limiting the described disclosure nor the claims which follow. Therefore, we claim as our disclosure all that comes within the scope and spirit of these claims.

Claims

SSHSV-23182US01 1,286,286_1 WE CLAIM:

1. A heart valve having an inflow end and an outflow end and comprising: a stent comprising: a frame having an inner surface and an outer surface, and a support band having an inner surface and an outer surface, a unitary leaflet structure comprising a plurality of flexible leaflets, wherein the unitary leaflet structure has an inner surface and an outer surface and a first edge and a second edge; and wherein the outer surface of the unitary leaflet structure is suturelessly attached to at least a portion of the inner surface of the frame, and the inner surface of the unitary leaflet structure is suturelessly attached to at least a portion of the outer surface of the support band along a first edge portion of the unitary leaflet structure, such that at least a portion of the first edge portion of the unitary leaflet structure is sandwiched between the frame and the support band.

2. The heart valve of claim 1, wherein the plurality of flexible leaflets are suturelessly directly coupled to each other at at least one location, and / or wherein the plurality of flexible leaflets are formed from a continuous sheet comprising one or more layers of a polymeric material.

3. The heart valve of claim 2, wherein the one or more layers comprise a textile material, a film, or a combination thereof.

4. The heart valve of any one of claims 2-3, wherein the continuous sheet is a film comprising at least one layer of polytetrafluoroethylene (PTFE), polyethylenes, ultra- high molecular weight polyethylene (UHMWPE), polypropylene, polyurethane, PEEK, polyvinyl alcohol, silicone, or combinations thereof.

5. The heart valve of any one of claims 2–4, wherein the continuous sheet comprises two or more layers of a thermoplastic polyurethane.

6. The heart valve of any one of claims 1–5, wherein at least a portion of the unitary leaflet structure comprises a reinforcing material.

7. The heart valve of claim 6, wherein the reinforcing material is incorporated within at least a portion of the continuous sheet and / or wherein the reinforcing material is present as one or more layers within the continuous sheet.

8. The heart valve of claim 7, wherein the one or more layers comprise a film or a textile.SSHSV-23182US01 1,286,286_1 9. The heart valve of any one of claims 7–8, wherein the reinforcing material is positioned only within the first edge portion of the unitary leaflet structure that is sandwiched between the frame and the support band.

10. The heart valve of claim 7-9, wherein the one or more layers of the reinforcing material are disposed between and bonded to two layers of thermoplastic polyurethane.

11. The heart valve of any one of claims 6–10, wherein the reinforcing material comprises a polymeric material, and wherein the polymeric material comprises polyamide, polyester, PET, polypropylene (PP), polyether ketone (PEEK), polyvinyl (PVDF), polycaprolactone (PCL), polyglycolide (PGA), poly lactic-co-glycolic acid (PLGA), polydioxanone (PDO), poly(4-hydroxybutyrate) (P4HB), polyvinyl alcohol (PVA), polytetrafluorethylene (PTFE), polyethylene, or UHMWPE.

12. The heart valve of any one of claims 6–11, wherein the reinforcing material comprises a textile comprising polymeric fibers, natural fibers, semi-synthetic fibers, carbon fibers, or a combination thereof.

13. The heart valve of claim 12, wherein polymer fibers comprise polyamide, polyester, PET, polypropylene (PP), polyether ketone (PEEK), polyvinyl (PVDF), polycaprolactone (PCL), polyglycolide (PGA), poly lactic-co-glycolic acid (PLGA), polydioxanone (PDO), poly(4-hydroxybutyrate) (P4HB), polyvinyl alcohol (PVA), polytetrafluorethylene (PTFE), polyethylene, or UHMWPE; and / or wherein the natural fibers comprise silk, linen, cotton, hemp, or a combination thereof, and / or wherein the semi- synthetic fibers comprise rayon.

14. The heart valve of any one of claims 10–13, wherein the thermoplastic polyurethane layer has a durometer of about 60 to about 75 Shore A, and / or wherein the thermoplastic polyurethane layer has a thickness of about 0.05 mm to about 0.1 mm.

15. The heart valve of any one of claims 10–14, wherein the reinforcing layer has a thickness of about 0.01 mm to about 0.06 mm.

16. The heart valve of any one of claims 1–15, wherein the support band exhibits a first flexibility, and the frame exhibits a second flexibility, wherein the first flexibility is greater than the second flexibility.

17. The heart valve of any one of claims 1–16, wherein the support band comprises an outflow edge that alternates between curvilinear cusps and upstanding commissures.

18. The heart valve of claim 17, wherein the frame comprises an outflow edge comprising curvilinear cusps juxtaposed with the curvilinear cusps of the support band.SSHSV-23182US01 1,286,286_1 19. The heart valve of any one of claims 17-18, wherein the upstanding commissures are at least partially coupled with at least a portion of the leaflet of the plurality of leaflets in the unitary leaflet structure.

20. The heart valve of any one of claims 1–19, wherein the frame comprises Co- Cr-Ni alloy, nitinol, biodegradable magnesium alloy, stretchy carbon fiber, PEEK, PEK, or any combination thereof.

21. The heart valve of any one of claims 17-20, wherein the support band comprises a polymeric material and wherein the polymeric material comprises polyester, PEEK, PEK, or any combination thereof.

22. The heart valve of any one of claims 1–21, further comprising a suture- permeable sewing ring attached to a periphery of the stent, wherein the suture-permeable sewing ring is configured to secure the valve to a native annulus.

23. The heart valve of claim 22, wherein the sewing ring is encompassed by a fabric and / or wherein the sewing ring comprises silicon.

24. The heart valve of any one of claims 22-23, wherein the sewing ring comprises a pharmaceutically active material, wherein the pharmaceutically active material is controllably released into native anatomy over a predetermined period of time, and wherein the pharmaceutically active material comprises one or more of corticosteroids, anticoagulants, antibiotics, vasodilators, inotropic agents, or any combination thereof.

25. The heart valve of any one of claims 1–24, further comprising a wireform positioned along the outflow edge of the support band such that it does not overlay the unitary leaflet structure.

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