Heart valves and methods of making the same

Abstract

Disclosed herein is a method of manufacturing a leaflet of a heart valve. The method comprises disposing a polymeric material on a mold having a molding surface with a leaflet pattern defined therein. The leaflet pattern comprises a recessed portion that defines an edge portion of the leaflet and a support surface that defines a body portion of the leaflet. The support surface is positioned adjacent to the recessed portion. The method further comprises forming a single polymeric sheet that covers the leaflet pattern and a portion of the molding surface adjacent the leaflet pattern and cutting an excess polymeric material from the single polymeric sheet to form the leaflet. Also disclosed are leaflets and valves comprising the same that are formed by the disclosed methods.

Description

THVFN- 23255W001HEART VALVES, METHODS OF MAKING AND USING THE SAME CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Patent Application No. 63 / 756,377, filed February 10, 2025, the entire disclosure which is incorporated by reference for all purposes.FIELD

[0002] The present invention relates generally to medical devices and particularly to a leaflet of a prosthetic heart valve and a method of manufacturing a leaflet.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] Because of the drawbacks associated with conventional open-heart surgery, percutaneous and minimally-invasive surgical approaches are garnering intense attention. In one technique, a prosthetic valve is configured to be implanted in a much less invasive procedure by way of catheterization. For instance, U.S. Pat. Nos.5,411,522 and 6,730,118, 7,393,36o, 7,510,575, and 7,993,394, which are incorporated herein by reference, describeTHVFN- 23255W001collapsible transcatheter heart valves (THVs) that can be percutaneously introduced in a compressed state on a catheter and expanded in the desired position by balloon inflation or by utilization of a self-expanding frame or stent. In yet another example, U.S. Patent Publication Nos. 2014 / 0277390, 2014 / 0277422, 2014 / 0277427, 2015 / 0328000, and 2019 / 0328515, which are incorporated herein by reference in their entireties, describe heart valve prostheses for replacing a native mitral valve, including a self-expanding frame with a plurality of anchoring members that are designed be deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis.

[0006] The currently existing tissue-based and polymer-based valve prostheses require suturing of the valvular structures (or leaflets) to other valve components. While suturing works well for tissue leaflets, it presents various challenges for polymeric leaflets. Polymer leaflets often tear at the suture stitch locations. Even further, the region of the leaflet nearest to the frame is often subjected to higher stresses and, therefore, more prone to tearing.

[0007] Thus, alternative methods are needed to manufacture polymer leaflets to the prosthetic valves with stronger attachment structures to extend the durability of the device. These and other needs are at least partially satisfied by the present disclosure.

[0008] These needs and others are at least partially satisfied by the present disclosure.SUMMARY

[0009] Accordingly, there remains a need in the art for an improved to manufacture polymer leaflets to the prosthetic valves with stronger attachment structures to extend the durability of the device. Aspects of the present mold and leaflet can increase the strength of a peripheral edge of the leaflet.

[0010] In one aspect, the present disclosure provides a method of manufacturing a leaflet of a heart valve. The method comprises disposing a polymeric material on a mold having a molding surface with a leaflet pattern defined therein. The leaflet pattern comprises a recessed portion that defines an edge portion of the leaflet and a support surface that defines a body portion of the leaflet. The support surface is positioned adjacent to the recessed portion.

[0011] In some implementations, the method further comprises forming a single polymeric sheet that covers the leaflet pattern and a portion of the molding surface adjacent the leaflet pattern and cutting an excess polymeric material from the single polymeric sheet to form the leaflet.

[0012] In another aspect, the present disclosure provides a leaflet for a heart valve. The leaflet comprises a peripheral edge portion having a first thickness, and a body portionTHVFN- 23255W001adjacent the peripheral edge portion, the body portion having a second thickness that is less than first thickness.

[0013] In some implementations, the leaflet is manufactured of a polymeric material using a mold comprising a molding surface having a recessed portion that defines the peripheral edge portion of the leaflet and a support surface that defines the body portion of the leaflet.

[0014] In some implementations, a depth of the recessed portion is configured to prevent edge climbing of polymeric material during a molding process of the leaflet.

[0015] In another aspect, the present disclosure provides an implantable prosthetic valve comprising an annular frame having an inner surface and an outer surface wherein the frame has an inflow end and an outflow end, and a central longitudinal axis extending from the inflow end to the outflow end. The annular frame comprises a plurality of struts. A valvular structure comprises one or more leaflets.

[0016] In some implementations, each leaflet comprises a peripheral edge portion having a first thickness, and a body portion adjacent the peripheral edge portion.

[0017] In some implementations, the body portion has a second thickness that is less than first thickness.

[0018] In some implementations, the leaflet is manufactured of a polymeric material using a mold comprising a molding surface having a recessed portion that defines the peripheral edge portion of the leaflet and a support surface that defines the body portion of the leaflet.

[0019] In some implementations, a depth of the recessed portion is configured to prevent edge climbing of polymeric material during a molding process of the leaflet, and wherein at least a portion of an edge portion of the one or more leaflets is attached to at least a portion of the plurality of struts of the annular frame.

[0020] Also disclosed herein are aspects directed to methods of making such heart valves.

[0021] 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.BRIEF DESCRIPTION OF THE DRAWINGS

[0022] FIGURE 1 is a perspective view of a conventional sutured prosthetic heart valve.THVFN- 23255W001

[0023] FIGURE 2 shows an exemplary valvular structure.

[0024] FIGURE 3 is a perspective view of an exemplary implantable prosthetic valve according to some aspects of the disclosure.

[0025] FIGURES 4A-4C show a cast mold for manufacturing a leaflet of the heart valve with a polymer disposed within a casting cavity.

[0026] FIGURES 5A-5B show a mold having a leaflet pattern defined therein for manufacturing a leaflet according to an aspect of the disclosure.

[0027] FIGURES 6A-6B show the mold of FIGS.5A-5B with a polymer disposed in the leaflet pattern of the mold.

[0028] FIGURE 7A shows a polymer sheet with leaflets defined therein.

[0029] FIGURE 7B shows the leaflets after an excess polymeric material is removed from the polymer sheet.

[0030] FIGURES 8A-8B show the mold of FIGS.4A-4B using a manufacturing process according to an aspect of the disclosure.

[0031] FIGURES 9A-9B show the mold of FIGS.4A-4B using a manufacturing process according to another aspect of the disclosure.DETAILED DESCRIPTION

[0032] 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.

[0033] 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 may even be desirable in certain circumstances and are a part of the present disclosure. Thus, theTHVFN- 23255W001following description is again provided as illustrative of the principles of the present disclosure and not in limitation thereof.DEFINITIONS

[0034] 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 “leaflet” includes aspects having two or more such leaflets unless the context clearly indicates otherwise.

[0035] 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.”

[0036] For the terms “for example” and “such as” and grammatical equivalences thereof, the phrase “and without limitation” is understood to follow unless explicitly stated otherwise. It is further understood that these phrases are used for explanatory purposes only. It is further understood that the term “exemplary,” as used herein, means “an example of’ and is not intended to convey an indication of a preferred or ideal aspect.

[0037] The term “or” means “and / or.” Recitation of ranges of values is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. The endpoints of all ranges are included within the range and independently combinable. All methods described herein can be performed in a suitable order unless otherwise indicated herein or otherwise clearly contradicted by context.

[0038] All disclosed values also include values that fall within ±10% variation from the disclosed value unless otherwise indicated or inferred. In other words, if a range of 1 to 10 is disclosed, then a range of about 1 to about 10 is disclosed. In such aspects, it is understood that the amount or value in question can be the exact value or a value that provides equivalent results or effects as recited in the claims or taught herein. That is, amounts, sizes, formulations, parameters, and other quantities and characteristics include both exact values but also approximate, larger or smaller values as desired, reflecting tolerances, conversion factors, rounding, measurement error, and the like, and other factors known to those of skill in the art such that equivalent results or effects are obtained. In some circumstances, the value that provides equivalent results or effects cannot be reasonably determined. In general, an amount, size, formulation, parameter, or other quantity or characteristic is “about,” “approximate,” or “at or about,” whether or not expressly stated to be such. Where “about,”THVFN- 23255W001“approximate,” or “at or about” is used before a quantitative value, the parameter also includes the specific quantitative value itself unless expressly stated otherwise.

[0039] When a range is expressed, a further aspect includes from the one particular value and to the other particular value. For example, where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure, for example, the phrase “x to y” includes the range from ‘x’ to ‘y’ as well as the range greater than ‘x’ and less than ‘y’. The range can also be expressed as an upper limit, for example, ‘x, y, z, or less’ and should be interpreted to include the specific ranges of ‘x,’ ‘y,’ ‘z,’ ‘about x,’ ‘about y,’ and ‘about z’ as well as the ranges of ‘less than x,’ ‘less than y,’ or ‘less than z,’ or ‘less than about x,’ ‘less than about y,’ and ‘less than about z.’ Likewise, the phrase ‘x, y, z, or greater’ should be interpreted to include the specific ranges of ‘x,’ ‘y,’ ‘z,’ ‘about x,’ ‘about y,’ and ‘about z’ as well as the ranges of ‘greater than x,’ ‘greater than y,’ ‘greater than z,’ or ‘greater than about x,’ ‘greater than about y,’ and ‘greater than about z.’ In addition, the phrase “‘x’ to ‘y’,” where ‘x’ and ‘y’ are numerical values, also includes “’about x’ to ‘about y’.”

[0040] Such a range format is used for convenience and brevity and, thus, should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. To illustrate, a numerical range of “0.1% to 5%” should be interpreted to include not only the explicitly recited values of 0.1% to 5% but also include individual values (for example, 1%, 2%, 3%, and 4%) and the sub-ranges (for example, 0.5% to 1.1%; 5% to 2.4%; 0.5% to 3.2%, and 0.5% to 4.4%, and other possible sub-ranges) within the indicated range. In still further aspects, when the specific values are disclosed between two end values, it is understood that these end values can also be included.

[0041] Throughout this disclosure, various aspects of the invention 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 invention. 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. In still further aspects, when the range is given, and exemplary values are provided, it is understood that any ranges can be formed between any exemplary values within the broadest range. For example, if individual numbers 1, 2, 3, 4, 5,THVFN- 23255W0016, 7, etc. are disclosed, then the ranges 1-7, 2-7, 3-7, 4-7, 5-7, 6-7, 1-6, 1-5, 1-4, 1-3, 1-2, 2-6, 2-5, etc. are also disclosed.

[0042] In still further aspects, when the specific values are disclosed between two end values, it is understood that these end values can also be included.

[0043] As used herein, the terms “optional” or “optionally” mean that the subsequently described event or circumstance may or may not occur and that the description includes instances where said event or circumstance occurs and instances where it does not.

[0044] 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 may 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 (for example, “between” versus “directly between,” “adjacent” versus “directly adjacent,” “on” versus “directly on”). As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0045] It will be understood that although the terms “first,” “second,” etc., may 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 exemplary aspects.

[0046] Spatially relative terms, such as “beneath,” “below,” “lower,” “above,” “upper,” and the like, may 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 may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein are interpreted accordingly.THVFN- 23255W001

[0047] 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.

[0048] Still further, the term “substantially” can, in some aspects, refer to at least about 80 %, at least about 85 %, 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 too % of the stated property, component, composition, or other condition for which substantially is used to characterize or otherwise quantify an amount.

[0049] In other aspects, as used herein, the term “substantially free” when used in the context of a composition or component of a composition that is substantially absent but can be present as an impurity along with other components being added to the composition. In such aspects, the term “substantially free” is intended to refer to trace amounts that can be present in the batched components, for example, it can be present in an amount that is less than about 1 % by weight, for example, less than about 0.5 % by weight, less than about 0.1 % by weight, less than about 0.05 % by weight, or less than about 0.01 % by weight of the stated material, based on the total weight of the composition. Yet in other aspects, the term “substantially free,” when used in the context of surface roughness, surface smoothness, defects, and the like, is intended to indicate that the described parameters are substantially absent or at least absent to the degree that cannot affect the performance of the described elements.

[0050] 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.

[0051] 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. Although the operations of exemplary aspects of the disclosedTHVFN- 23255W001method may 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 may, 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 may be applied to any aspect disclosed.

[0052] Moreover, for the sake of simplicity, the attached figures may not 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.IMPLANTABLE MEDICAL DEVICE

[0053] FIG. 1 shows one of the currently used prosthetic valve 10. Valve 10 generally comprises a frame, or stent, 12, a valvular structure 14 supported by the frame, and a skirt 16 secured to the outer surface of the leaflet structure. Valvular structure 14 comprises leaflets 60 positioned together to mimic the natural valvular anatomy of a patient. Valve 10 typically is implanted in the annulus of the native aortic valve but can also be adapted to be implanted in other native valves of the heart or in various other ducts or orifices of the body. Valve 10 has a “lower” end 80 and an “upper” end 82. In the context of the present application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow,” respectively. Thus, for example, the lower end 80 of the valve is its inflow end, and the upper end 82 of the valve is its outflow end.

[0054] Valve 10 and frame 12 are configured to be radially collapsible to a collapsed or crimped state for introduction into the body on a delivery catheter and radially expandable to an expanded state for implanting the valve at a desired location in the body (for example, the native aortic valve).

[0055] It can be seen that all the elements of the valve 10 are attached with the use of sutures or supporting ports. For example, skirt 16 can be secured to the inside of frame 12 via sutures 56. Leaflet structure 14 can be attached to the skirt via a thin PET reinforcing strip, which enables a secure suturing and protects the pericardial tissue of the leaflet structure from tears. Leaflet structure 14 can be sandwiched between skirt 16 and the thin PET strip. Suture 58, which secures the PET strip and the leaflet structure 14 to skirt 16 can be any suitable suture, such as a polyester suture (for example, ETHIBOND polyester suture,THVFN- 23255W001Johnson & Johnson). Suture 58 desirably tracks the curvature of the bottom edge of leaflet structure 14. Further, in this exemplary valve, leaflets 60 can be secured to one another at their adjacent sides to form commissures 84 of the leaflet structure (the edges where the leaflets come together). Leaflet structure 14 can be secured to frame 12 using suitable techniques and mechanisms. For example, commissures of the leaflet structure are aligned with the support posts 18 and secured thereto using sutures.

[0056] Such valve configurations work substantially well for tissue-based (for example, bovine pericardial tissues) leaflets. However, a large number of required sutures and supporting ports is problematic when the valve comprises biocompatible synthetic materials, as it can result in uncontrollable tears, uncontrolled stretching of the suture holes, and, as a result, failure of the valve.

[0057] Here disclosed are aspects where the implantable prosthetic device comprises biocompatible polymeric leaflets that are suturelessly attached to the valve frame.

[0058] FIG. 2 shows an exemplary leaflet structure. In this exemplary aspect, the valvular structure 14 comprises three flexible leaflets 60 (although a greater or a smaller number of leaflets can be used) that can be arranged to collapse in a tricuspid arrangement. The lower edge of leaflet structure 14 can have an undulating, curved scalloped shape (not shown). By forming the leaflets with this scalloped geometry, stresses on the leaflets are reduced, which in turn improves the durability of the valve. Moreover, by virtue of the scalloped shape, folds, and ripples at the belly of each leaflet (the central region of each leaflet), which can cause early calcification in those areas, can be eliminated or at least minimized. The scalloped geometry also reduces the amount of material used to form the leaflet structure, thereby allowing a smaller, more even crimped profile at the inflow end of the valve. Various configurations of the leaflets in the valve can be found, for example, in U.S. Patent Application Publication No. 2015 / 0320556 or U.S. Patent No. 8,454,685, the contents of which are incorporated by reference in their entirety.

[0059] The leaflets 60 can be secured to one another at their adjacent sides to form commissures of the leaflet structure. A plurality of flexible connectors 124 (as shown in FIG.2) can be used to interconnect pairs of adjacent sides of the leaflets and to mount the leaflets to the commissure window frame portions 18 (FIG. 1).

[0060] FIG. 3 shows the exemplary implantable prosthetic valve 10 having polymeric leaflets 60 of valvular system 14 attached to frame 12 according to the aspects of the current disclosure.

[0061] The annular frame 12, as disclosed herein, has an inner surface and an outer surface (not shown) wherein the frame has an inflow end and an outflow end and a centralTHVFN- 23255W001longitudinal axis extending from the inflow end 80 to the outflow end 82, wherein the annular frame comprises a plurality of struts.

[0062] Frame 12 can be made of a plastically-expandable material that permits crimping of the valve to a smaller profile for delivery and expansion of the valve using an expansion device such as the balloon of a balloon catheter. In certain aspects, the expandable material can comprise stainless steel, cobalt-chromium alloy, cobalt-chromium-tungsten-nickel alloy, nickel-cobalt-chromium alloy, nickel-cobalt-chromium-molybdenum alloy, nitinol, polymer, or any combination thereof. In some exemplary and unlimiting aspects, the polymer used to form the frame can comprise polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE), ultra-high-molecular-weight polyethylene (UHMWPE), polyimide, polysulfone (PSU), polyphenylsulfone (PPSU) (filled or unfilled), or any combination thereof. In still further aspects, the polymers used for the frame can comprise radiopaque fillers such as bismuth subcarbonate, bismuth trioxide, barium sulfate, tungsten, and the like.

[0063] Exemplary plastically-expandable materials that can be used to form the frame are described below. For example, valve 10 can be a so-called self-expanding valve wherein the frame is made of a self-expanding material such as nitinol. A self-expanding valve can be crimped to a smaller profile and held in the crimped state with a restraining device such as a sheath covering the valve. When the valve is positioned at or near the target site, the restraining device is removed to allow the valve to self-expand to its expanded, functional size.

[0064] Now with reference to FIGS.4A-4C, a mold 210 for manufacturing a leaflet 260 for the valve 10. The leaflet 260 can be substantially similar to the leaflet 60 illustrated in FIGS. 1-3. In illustrated implementation, the mold 210 includes a cavity 215 that receives a vicious polymer. Due to the depth of the cavity 215, the vicious polymer inserted within the mold 210 tends to climb up a sidewall 219 of the cavity 215 when the polymer solidifies. Therefore, there is a need for an alternative mold for manufacturing leaflets to prevent edge climbing of the polymeric material during the molding process of the leaflet 260.LEAFLET AND MOLD FOR MANUFACTURING THE LEAFLET

[0065] Now with reference to FIGS.5A-6B, a mold 310 for manufacturing one or more leaflet(s) 360a, 360b (FIG. 7B) for the valve 10. The leaflet(s) 360a, 360b are used in a substantially similar manner to the leaflet 60 illustrated in FIGS. 1-3 and may be used with the exemplary valve 10 described in FIGS. 1-3 or other valves. In the illustrated implementation, the mold 310 includes a molding surface 313 with a leaflet pattern defined 317 therein. The leaflet pattern 317 comprises a recessed portion 321a, 321b and a support surface 325a, 325b positioned adjacent to the recessed portion 321a, 321b. It is understood that this mold is only exemplary and other molds having one or more than two leaflet pattersTHVFN- 23255W001can be utilized. In the illustrated aspect, the leaflet pattern 317 defines a first recessed portion 321a, a second recessed portion 321b, a first support surface 325a, and a second support surface 325b, where two separate leaflets 360a, 360b (FIG. 7B) can be manufactured. In other implementations, the leaflet pattern 317 may define less (for example, one) or more (for example, three, four, five, etc.) leaflets. Further, in the illustrated implementation, the first and second recessed portions 321a, 321b are continuous such that the recessed portion 321a, 321b define a portion of each leaflet 360a, 360b. In other implementations, there may not be continuous. In yet still further aspects, there may be a barrier between each recessed portion 321a, 321b.

[0066] Now with reference to FIGS. 6A, 6B and 7B, each of the leaflets 360a, 360b comprises a peripheral edge portion 329a, 329b and a body portion 333a, 333b adjacent the peripheral edge portion 329a, 329b. The leaflets 360a, 360b also comprise a first portion 335 (FIG. 7B) having a free edge 337a, 337b and a second portion 339 (FIG. 7B) having a substantially arcuate geometry (for example, defined by the body portion 333a, 333b and a portion of the peripheral edge portion 329a, 329b). The first portion 335 comprises a pair of opposing tabs 34ia-34id defined by the peripheral edge portion 329a, 329b and the free edge 337a, 337b. The peripheral edge portion 329a, 329b is configured to be attached to a vessel wall or a supporting structure (for example, the frame 12) of the heart valve 10.

[0067] The first and second recessed portions 321a, 321b define a cavity for the peripheral edge portion 329a, 329b to be formed and the support surface 325a, 325b defines a surface for the body portion 333a, 333b to be formed. The continuous construction of the recessed portion 321a, 321b defines the peripheral edge portion 329a, 329b of each leaflet 360a, 360b. The support surface 325a, 325b extends between respective peripheral edge portions 329a, 329b of each leaflet 360a, 360b.

[0068] In the illustrated implementation, the construction of the recessed portions 321a, 321b and the support surface 325a, 325b forms the peripheral edge portion 329a, 329b of the leaflet 360a, 360b with a first thickness Ti (FIG. 6B) and the body portion 333a, 333b of the leaflet 360a, 360b has a second thickness T2 (FIG. 6B) that is less than the first thickness Ti. Forming the peripheral edge portion 329a, 329b of the leaflets 360a, 360b with a greater thickness than the body portion 333a, 333b reinforces the peripheral edge portion of the leaflet 360a, 360b, which is connected to the vessel wall or supporting structure of the heart valve 10.

[0069] In the illustrated implementation, the recessed portion 321a, 321b has a depth Di (FIG.5A) in a range from 0.02 millimeters to 0.5 millimeters. In some implementations, the range may be 0.02 mm to 0.4 mm, 0.02 mm to 0.3 mm, 0.02 mm to 0.2 mm, 0.02 mm to 0.1 mm, 0.02 mm to 0.05 mm, 0.05 mm to 0.5 mm, 0.1 mm to 0.5 mm, 0.2 mm to 0.5 mm, 0.3THVFN- 23255W001mm to 0.5 mm, or the like. The body portion 333a, 333b of the leaflet has a thickness Ti in the range from 0.06 millimeters to 1 millimeter. In some implementations, the range of the thickness Ti may be 0.06 mm to 0.9 mm, 0.06 mm to 0.8 mm, 0.06 mm to 0.7 mm, 0.06 mm to 0.6 mm, 0.06 mm to 0.5 mm, 0.1 mm to 0.9 mm, 0.1 mm to 0.8 mm, 0.2 mm to 0.5 mm, 0.3 mm to 0.5 mm, or the like. In other words, the thickness Ti of the peripheral edge portion 329a, 329b is in the range from 0.02 millimeters to 0.5 millimeters greater than the thickness T2 of the body portion 333a, 333b. In some implementations, the range of the difference between the thickness Ti and the thickness T2 may be the range may be 0.02 mm to 0.4 mm, 0.02 mm to 0.3 mm, 0.02 mm to 0.2 mm, 0.02 mm to 0.1 mm, 0.02 mm to 0.05 mm, 0.05 mm to 0.5 mm, 0.1 mm to 0.5 mm, 0.2 mm to 0.5 mm, 0.3 mm to 0.5 mm, or the like.

[0070] The peripheral edge portion 329a, 329b has a width Wi (FIG. 7B) in a range from 0.1 mm to 4 mm. In some implementations, the range maybe 0.1 mm to 3 mm, 0.1 mm to 2 mm, 0.1 mm to 1 mm, 0.3 mm to 4 mm, 0.3 mm to 3 mm, 0.3 mm to 2 mm, 0.5 mm to 4 mm, 0.5 mm to 2 mm, 0.8 mm to 4mm, or the like. In the illustrated implementation, the peripheral edge portion 329a, 329b has a variable width. In other implementations, the peripheral edge portion 329a, 329b may have a uniform width between the opposing tabs 341a, 341b and / or 341c, 34id.

[0071] In certain aspects, a leaflet 360a, 360b for a heart valve 10 is disclosed. The leaflet 360a, 360b comprises a peripheral edge portion 329a, 329b having a first thickness Ti and a body portion 333a, 333b adjacent the peripheral edge portion 329a, 329b. The body portion 333a, 33b has a second thickness T2 that is less than first thickness Ti.

[0072] In certain aspects, the leaflet 360a, 360b is manufactured of a polymeric material using a mold 310 comprising a molding surface 313 having a recessed portion 321a, 321b that defines the peripheral edge portion 329a, 329b of the leaflet 360a, 360b and a support surface 325a, 325b that defines the body portion 333a, 333b of the leaflet 360a, 360b.

[0073] In certain aspects, a depth of the recessed portion 321a, 321b is configured to prevent edge climbing of polymeric material during a molding process of the leaflet 360a, 360b.METHOD OF MANUFACTURING THE LEAFLET

[0074] Now with reference to FIGS. 6A-7B, a method for manufacturing the leaflets 360a, 360b is illustrated. During the manufacturing process, a polymeric material is disposed on the molding surface 313 of the mold with the leaflet pattern 317 defined therein. In the illustrated implementation, the polymeric material is disposed on the molding surface 313 in a viscous form. In some implementations, a viscosity of polymer material is in a rangeTHVFN- 23255W001from 100 mPas to 100,000 mPas. In some implementations, the range maybe 100 mPas to 50,000 mPas, too mPas to 25,000 mPas, 100 mPas to 10,000 mPas, 100 mPas to 1,000 mPas 200 mPas to 100,000 mPas, 200 mPas to 50,000 mPas, 300 mPas to 10,000 mPas or the like.

[0075] In some implementations, the polymeric material comprises a polyurethane-based composition, polyurea composition, polytetrafluoroethylene (PTFE), silicon styrene isoprene butadiene (SIBS) block copolymers, or any combination thereof. In some implementations, the polymeric material can comprise the polyurethane-based composition and comprises one or more of polyfether urethanes), polyfester urethanes), polyfcarbonate urethanes), polyfsiloxane urethanes), polyurethane-polyester composite, polyurethanepolyamide composite, polyurethane-glass fiber composite, polyurethane-carbon fiber composite, or any combination thereof.

[0076] Now with reference to FIG 6B, the polymeric material may be disposed on the molding surface 313 and may be spread on the molding surface using a coating blade 345. It is understood however that other methods of disposing the polymeric material on the mold can also be utilized. For example, and without limitations, the polymeric material can be disposed by dip coating, spray coating, spin coating or any other methods known in the art and suitable for the desired application. The polymeric material on the molding surface 313 defines a single polymeric sheet 349 that covers the leaflet pattern 317 and a portion of the molding surface 313 adjacent the leaflet pattern 317. In other words, the single polymeric sheet 349 has excess material that will be removed prior to forming the final leaflets 360a, 360b. In the illustrated implementation, the single polymeric sheet 349 comprises a first surface 353 configured to be supported on the molding surface 313 and a second surface 357 spaced from the first surface 353-The coating blade 345 may move across the second surface 357 to provide a substantially flat surface. Furthermore, an overall thickness of the leaflet(s) 360a, 360b is controlled by adjusting a gap G (FIG. 6B) between the coating blade 345 and the molding surface 313 of the mold.

[0077] Once the polymeric material is solidified on the mold 310, the single polymeric sheet 349 is removed from the mold 310 (FIG. 7A). The single polymeric sheet 349 defines the first and second leaflets 360a, 360b and includes excess material connecting the leaflets 360a, 360b. The excess polymeric material is cut from the single polymeric sheet 349 to form the leaflets 360a, 360b. In some implementations, the excess polymeric material is cut by any of a laser cutting, an ultrasonic cutting, or chemical cutting process, or any combination thereof.

[0078] Now with reference to FIGS. 8A-9B, alternative manufacturing methods using the mold 310 described above. It should be appreciated that the description above related toTHVFN- 23255W001the leaflets 360a, 360b apply equally to the description of leaflets 460a, 460b (FIG. 8B) and leaflets 560a, 560b (FIG.9B) and only the differences between the leaflets 360a, 360b and the leaflets 460a, 460b, 560a, 560b are described in detail below. Further, structures are given the same reference numbers plus too or 200.

[0079] Now with reference to FIGS. 8A and 8B, to manufacture the leaflets 460a, 460b polymeric material is provided on the molding surface 313. When providing the polymeric material, a first amount of polymeric material to the recessed portion 321a, 321b of the leaflet pattern 317 to define a portion of a peripheral edge portion 429a, 429b. Once the first amount of polymeric material at least partially solidifies in the recessed portion 321a, 321b, a second amount of polymeric material is provided to the first amount of polymeric material and the support surface 325a, 325b (FIG. 8B). In some implementations, the coating blade 345 is configured to level the first amount of polymeric material in the recessed portion 321a, 321b prior to providing the second amount of polymeric material. Using the coating blade 345 to level the first amount of polymeric material in the recessed portions 321a, 321b improves the tolerances of the leaflets 460a, 460b during manufacturing.

[0080] In the illustrated implementation, the first and second amount of polymeric material are formed of the same material. In some implementations, the polymeric material comprises a polyurethane-based composition, polyurea composition, polytetrafluoroethylene (PTFE), silicon styrene isoprene butadiene (SIBS) block copolymers, or any combination thereof. In some implementations, the polymeric material comprises the polyurethane-based composition and comprises one or more of poly( ether urethanes), poly(ester urethanes), polycarbonate urethanes), poly(siloxane urethanes), polyurethane-polyester composite, polyurethane-polyamide composite, polyurethane-glass fiber composite, polyurethanecarbon fiber composite, or any combination thereof. In some implementations, the first and second amount of polymeric material are formed of the same material, but may have different mechanical properties. For example, the mechanical properties may include any of a strength, elasticity, stress, strain, plasticity, hardness, toughness, brittleness, stiffness, ductility, malleability, cohesion, impact strength, fatigue, and / or creep. In some implementations, the first amount of polymeric material may have any increased strength, elasticity, stress, strain, plasticity, hardness, toughness, brittleness, stiffness, ductility, malleability, cohesion, impact strength, fatigue, and / or creep to reinforce the peripheral edge portion of the leaflets 460a, 460b. In some aspects, the mechanical properties of the first amount of polymeric material is higher than the mechanical properties of the second amount of polymeric material. In some aspects, the mechanical properties of the first amount of polymeric material is less than the mechanical properties of the second amount of polymeric material.THVFN- 23255W001[oo8i] In certain aspects, a method of manufacturing a leaflet 360a, 360b of a heart valve 10 is disclosed. The method comprises disposing a polymeric material on a mold 310 having a molding surface 313 with a leaflet pattern 317 defined therein.

[0082] In certain aspects, the leaflet pattern 317 comprises a recessed portion 321a, 321b that defines an edge portion 329a, 329b of the leaflet 360a, 360b and a support surface 325a, 325b that defines a body portion 333a, 333b of the leaflet 360a, 360b. The support surface 325a, 325b is positioned adjacent to the recessed portion 321a, 321b.

[0083] In certain aspects, the method comprises forming a single polymeric sheet 349 that covers the leaflet pattern 317 and a portion of the molding surface 313 adjacent the leaflet pattern 317.

[0084] In certain aspects, the method comprises cutting an excess polymeric material from the single polymeric sheet 349 to form the leaflet 360a, 360b.

[0085] Now with reference to FIGS. 9A and 9B, to manufacture the leaflets 560a, 560b polymeric material is provided on the molding surface 313. When providing the polymeric material, a first amount of polymeric material to the recessed portion 321a, 321b of the leaflet pattern 317 to define a portion of a peripheral edge portion 529a, 529b. In the illustrated implementation, the first amount of polymeric material is a first type of material. Once the first amount of polymeric material at least partially solidifies in the recessed portion 321a, 321b, a second amount of polymeric material is provided to the first amount of polymeric material and the support surface 325a, 325b (FIG. 8B). In some implementations, the coating blade 345 is configured to level the first amount of polymeric material in the recessed portion 321a, 321b prior to providing the second amount of polymeric material. In the illustrated implementation, the second amount of polymeric material is a second type of polymeric material different than the first type of polymeric material. Using the coating blade 345 to level the first amount of polymeric material in the recessed portions 321a, 321b improves the tolerances of the leaflets 560a, 560b during manufacturing.

[0086] In addition, forming the leaflets 560a, 560b of different polymeric materials allows for the strength of the peripheral edge portion 529a, 529b of the leaflets 560a, 560b. For example, the first and second amount of polymeric material may comprise any combination of a polyurethane-based composition, polyurea composition, polytetrafluoroethylene (PTFE), silicon styrene isoprene butadiene (SIBS) block copolymers, or any combination thereof. In some implementations, the first and second amount of polymeric material can comprise the polyurethane-based composition and comprises one or more of poly(ether urethanes), poly(ester urethanes), polyfcarbonate urethanes), poly(siloxane urethanes), polyurethane-polyester composite, polyurethane-polyamideTHVFN- 23255W001composite, polyurethane-glass fiber composite, polyurethane-carbon fiber composite, or any combination thereof. In some implementations, the first and second amount of polymeric material are formed of the same material, but may have different mechanical properties. For example, the mechanical properties may include any of a strength, elasticity, stress, strain, plasticity, hardness, toughness, brittleness, stiffness, ductility, malleability, cohesion, impact strength, fatigue, and / or creep. In some implementations, the first amount of polymeric material may have any increased strength, elasticity, stress, strain, plasticity, hardness, toughness, brittleness, stiffness, ductility, malleability, cohesion, impact strength, fatigue, and / or creep to reinforce the peripheral edge portion of the leaflets 560a, 560b. In some aspects, the mechanical properties of the first amount of polymeric material is higher than the mechanical properties of the second amount of polymeric material. In some aspects, the mechanical properties of the first amount of polymeric material is less than the mechanical properties of the second amount of polymeric material.

[0087] The present disclosure also provides a method of forming the disclosed herein valve. In such methods, the leaflets can be formed from using the mold described herein. The forming of the leaflets 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.

[0088] 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 whole entirety.EXEMPLARY ASPECTS

[0089] 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.

[0090] Example 1: A method of manufacturing a leaflet of a heart valve, the method comprising: disposing a polymeric material on a mold having a molding surface with a leaflet pattern defined therein, wherein the leaflet pattern comprises a recessed portion that defines an edge portion of the leaflet and a support surface that defines a body portion of the leaflet, the support surface positioned adjacent to the recessed portion; forming a single polymeric sheet that covers the leaflet pattern and a portion of the molding surface adjacent the leaflet pattern; and cutting an excess polymeric material from the single polymeric sheet to form the leaflet.THVFN- 23255W001

[0091] Example 2. The method of example 1, wherein the polymeric material is spread on the molding surface using a coating blade.

[0092] Example 3. The method of any of the examples herein, particularly example 2, wherein an overall thickness of the leaflet is controlled by adjusting a gap between the coating blade and the molding surface of the mold.

[0093] Example 4. The method of any of the examples herein, particularly any of examples 2-3, wherein the single polymeric sheet comprises a first surface configured to be supported on the molding surface and a second surface spaced from the first surface.

[0094] Example 5. The method of any of the examples herein, particularly example 4, wherein the coating blade moves across the second surface to provide a substantially flat surface.

[0095] Example 6. The method of any of the examples herein, particularly any of examples 1-5, wherein once the polymeric material solidifies on the molding surface, the excess polymeric material is cut.

[0096] Example 7. The method of any of the examples herein, particularly any of examples 1-6, wherein the support surface is level with the portion of the molding surface adjacent the leaflet pattern.

[0097] Example 8. The method of any of the examples herein, particularly any of examples 1-7, further comprising removing the single polymeric sheet from the molding surface.

[0098] Example 9. The method of any of the examples herein, particularly any of examples 1-8, wherein cutting the excess polymeric material is performed by any of a laser cutting, an ultrasonic cutting, or chemical cutting process.

[0099] Example 10. The method of any of the examples herein, particularly any of examples 1-9, wherein the edge portion of the leaflet has a first thickness, and the body portion of the leaflet has a second thickness that is less than the first thickness.

[0100] Example 11. The method of any of the examples herein, particularly any of examples 1-10, wherein the recessed portion has a depth in a range from 0.02 millimeters to 0.5 millimeters.

[0101] Example 12. The method of any of the examples herein, particularly any of examples 1-11, wherein the leaflet is a first leaflet manufactured within the mold, and wherein the leaflet pattern comprises a second recessed portion and a second support surface configured to define a second leaflet, and wherein the single polymeric sheet defines the first leaflet and the second leaflet.THVFN- 23255W001

[0102] Example 13. The method of any of the examples herein, particularly any of examples 1-12, wherein the polymeric material comprises a polyurethane-based composition, polyurea composition, polytetrafluoroethylene (PTFE), silicon styrene isoprene butadiene (SIBS) block copolymers, or any combination thereof.

[0103] Example 14. The method of any of the examples herein, particularly example 13, wherein the polymeric material is the polyurethane-based composition and comprises one or more of polyfether urethanes), polyfester urethanes), polyfcarbonate urethanes), polyfsiloxane urethanes), polyurethane-polyester composite, polyurethane-polyamide composite, polyurethane-glass fiber composite, polyurethane-carbon fiber composite, or any combination thereof.

[0104] Example 15. The method of any of the examples herein, particularly any of examples 1-14, wherein a viscosity of polymer material is in a range from too mPas to 100,000 mPas.

[0105] Example 16. The method of any of the examples herein, particularly any of examples 1-15, wherein providing the polymeric material on the molding surface comprises providing a first amount of polymeric material to the recessed portion of the leaflet pattern and once the first amount of polymeric material at least partially solidifies in the recessed portion, providing a second amount of polymeric material to the support surface and a portion of the molding surface adjacent the recessed portion.

[0106] Example 17. The method of any of the examples herein, particularly any of examples 1-15, wherein providing the polymeric material on the molding surface comprises providing a first amount of polymeric material to the recessed portion of the leaflet pattern and once the first amount of polymeric material at least partially solidifies in the recessed portion, providing a second amount of polymeric material to the first amount of polymeric material and the support surface.

[0107] Example 18. The method of any of the examples herein, particularly examples 16 or 17, wherein a coating blade is configured to level the first amount of polymeric material in the recessed portion prior to providing the second amount of polymeric material.

[0108] Example 19. The method of any of the examples herein, particularly any of examples 16-18, wherein the first amount of polymeric material is a first type of polymeric material, and wherein the second amount of polymeric material is a second type of polymeric material that is the same or different than the first type of polymeric material.

[0109] Example 20. The method of any of the examples herein, particularly example 19, wherein the first type of polymeric material comprises a first set of mechanical propertiesTHVFN- 23255W001and the second type of polymeric material comprises a second set of mechanical properties that are different than the first set of mechanical properties.

[0110] Example 21. The method of any of the examples herein, particularly any of example 1-20, wherein the leaflet comprises a first portion having a free edge and a second portion having a substantially arcuate geometry, and wherein the edge portion is a peripheral edge of the leaflet and defining an outer section of the first and second portions.

[0111] Example 22. The method of any of the examples herein, particularly example 21, wherein the first portion comprises a pair of opposing tabs, wherein the edge portion defines the opposing tabs.

[0112] Example 23. The method of any of the examples herein, particularly any of examples 1-22, wherein the edge portion is configured to be attached to a vessel wall or a supporting structure of the heart valve.

[0113] Example 24. The method of any of the examples herein, particularly any of examples 1-23, wherein the edge portion has a width in a range from 0.1 mm to 4 mm.

[0114] Example 25. The method of any of the examples herein, particularly any of examples 1-24, further comprising attaching one or more leaflets to a frame of an implantable valve.

[0115] Example 26. The method of any of the examples herein, particularly example 25, wherein the frame comprises an inner surface, an outer surface, an inflow end, an outflow end, and a central longitudinal axis extending from the inflow end to the outflow end, and wherein the edge portion of the leaflet is coupled to the frame.

[0116] Example 27. A leaflet for a heart valve, the leaflet comprising: a peripheral edge portion having a first thickness; and a body portion adjacent the peripheral edge portion, the body portion having a second thickness that is less than first thickness, wherein the leaflet is manufactured of a polymeric material using a mold comprising a molding surface having a recessed portion that defines the peripheral edge portion of the leaflet and a support surface that defines the body portion of the leaflet, wherein a depth of the recessed portion is configured to prevent edge climbing of polymeric material during a molding process of the leaflet.

[0117] Example 28. The leaflet of any of the examples herein, particularly example 27, wherein the leaflet comprises a first portion having a free edge and a second portion having a substantially arcuate geometry, and wherein the peripheral edge portion defines an outer section of the first and second portions.THVFN- 23255W001[on8] Example 29. The leaflet of any of the examples herein, particularly any of examples 27-28, wherein the peripheral edge portion is configured to be attached to a vessel wall or a supporting structure of the heart valve.

[0119] Example 30. The leaflet of any of the examples herein, particularly any of examples 27-29, wherein the leaflet comprises a pair of opposing tabs, wherein the edge portion defines the opposing tabs.

[0120] Example 31. The leaflet of any of the examples herein, particularly any of examples 27-30, wherein the edge portion has a width in a range from 0.1 mm to 4 mm.

[0121] Example 32. The leaflet of any of the examples herein, particularly any of examples 27-31, wherein the peripheral edge portion has a thickness in a range from 0.02 millimeters to 0.5 millimeters.

[0122] Example 33. The leaflet of any of the examples herein, particularly any of examples 27-32, wherein leaflet is a first leaflet manufactured within the mold, and wherein the mold comprises a leaflet pattern having a second recessed portion and a second support surface configured to define a second leaflet, and wherein a single polymeric sheet defines the first leaflet and the second leaflet.

[0123] Example 34. The leaflet of any of the examples herein, particularly any of examples 27-33, wherein the leaflet comprises a polymeric material, and wherein the polymeric material comprises a polyurethane-based composition, polyurea composition, polytetrafluoroethylene (PTFE), silicon styrene isoprene butadiene (SIBS) block copolymers, or any combination thereof.

[0124] Example 35. The leaflet of any of the examples herein, particularly of example 34, wherein the polyurethane-based composition comprises one or more of polyfether urethanes), poly(ester urethanes), polycarbonate urethanes), poly(siloxane urethanes), polyurethane-polyester composite, polyurethane-polyamide composite, polyurethane-glass fiber composite, polyurethane-carbon fiber composite, or any combination thereof.

[0125] Example 36. The leaflet of any of the examples herein, particularly any of examples 34-35, wherein a viscosity of polymer material is in a range from 100 mPas to 100,000 mPas.

[0126] Example 37. The leaflet of any of the examples herein, particularly of any of examples 27-36, wherein a first amount of the polymeric material is provided within the recessed portion to form the peripheral edge portion of the leaflet and a second amount of polymeric material to the support surface and a portion of the molding surface adjacent the recessed portion to form the body portion of the leaflet.THVFN- 23255W001

[0127] Example 38. The leaflet of any of the examples herein, particularly of example 37, wherein the first amount of polymeric material is a first type of polymeric material, and wherein the second amount of polymeric material is a second type of polymeric material that is different than the first type of polymeric material.

[0128] Example 39. An implantable prosthetic valve comprising: an annular frame having an inner surface and an outer surface wherein the frame has an inflow end and an outflow end, and a central longitudinal axis extending from the inflow end to the outflow end, wherein the annular frame comprises a plurality of struts; and a valvular structure comprising one or more leaflets, each leaflet comprising a peripheral edge portion having a first thickness, and a body portion adjacent the peripheral edge portion, the body portion having a second thickness that is less than first thickness, wherein the leaflet is manufactured of a polymeric material using a mold comprising a molding surface having a recessed portion that defines the peripheral edge portion of the leaflet and a support surface that defines the body portion of the leaflet, wherein a depth of the recessed portion is configured to prevent edge climbing of polymeric material during a molding process of the leaflet, and wherein at least a portion of an edge portion of the one or more leaflets is attached to at least a portion of the plurality of struts of the annular frame.

[0129] Example 40. The implantable prosthetic valve of any of the examples herein, particularly of example 39, wherein the leaflet comprises a first portion having a free edge and a second portion having a substantially arcuate geometry, and wherein the peripheral edge portion defines an outer section of the first and second portions.

[0130] Example 41. The implantable prosthetic valve of any of the examples herein, particularly of any of examples 39-40, wherein the peripheral edge portion is configured to be attached to a vessel wall or a supporting structure of the implantable prosthetic valve.

[0131] Example 42. The implantable prosthetic valve of any of the examples herein, particularly of any of examples 39-41, wherein the leaflet comprises a pair of opposing tabs, wherein the edge portion defines the opposing tabs.

[0132] Example 43. The implantable prosthetic valve of any of the examples herein, particularly of any of examples 39-42, wherein the edge portion of the leaflet has a width in a range from 0.1 mm to 4 mm.

[0133] Example 44. The implantable prosthetic valve of any of the examples herein, particularly of any of examples 39-43, wherein the peripheral edge portion of the leaflet has a thickness in a range from 0.02 millimeters to 0.5 millimeters.

[0134] Example 45. The implantable prosthetic valve according to any of claims 39-44, wherein leaflet is a first leaflet manufactured within the mold, and wherein the moldTHVFN- 23255W001comprises a leaflet pattern having a second recessed portion and a second support surface configured to define a second leaflet, and wherein a single polymeric sheet defines the first leaflet and the second leaflet.

[0135] Example 46. The implantable prosthetic valve of any of the examples herein, particularly of any of examples 39-45, wherein the leaflet comprises a polymeric material, and wherein the polymeric material comprises a polyurethane-based composition, polyurea composition, polytetrafluoroethylene (PTFE), silicon styrene isoprene butadiene (SIBS) block copolymers, or any combination thereof.

[0136] Example 47. The implantable prosthetic valve of any of the examples herein, particularly of example 46, wherein the polyurethane-based composition comprises one or more of polyfether urethanes), polyfester urethanes), polyfcarbonate urethanes), polyfsiloxane urethanes), polyurethane-polyester composite, polyurethane-polyamide composite, polyurethane-glass fiber composite, polyurethane-carbon fiber composite, or any combination thereof.

[0137] Example 48. The implantable prosthetic valve of any of the examples herein, particularly of any of examples 46-47, wherein a viscosity of polymer material is in a range from 100 mPas to 100,000 mPas.

[0138] Example 49. The implantable prosthetic valve of any of the examples herein, particularly of any of examples 39-48, wherein a first amount of the polymeric material is provided within the recessed portion to form the peripheral edge portion of the leaflet and a second amount of polymeric material to the support surface and a portion of the molding surface adjacent the recessed portion to form the body portion of the leaflet.

[0139] Example 50. The implantable prosthetic valve of any of the examples herein, particularly of example 49, wherein the first amount of polymeric material is a first type of polymeric material, and wherein the second amount of polymeric material is a second type of polymeric material that is different than the first type of polymeric material.

[0140] 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 whichTHVFN- 23255W001follow. Therefore, we claim as our disclosure all that comes within the scope and spirit of these claims.

Claims

THVFN- 23255W001WE CLAIM:

1. A method of manufacturing a leaflet of a heart valve, the method comprising: disposing a polymeric material on a mold having a molding surface with a leaflet pattern defined therein, wherein the leaflet pattern comprises a recessed portion that defines an edge portion of the leaflet and a support surface that defines a body portion of the leaflet, the support surface positioned adjacent to the recessed portion;forming a single polymeric sheet that covers the leaflet pattern and a portion of the molding surface adjacent the leaflet pattern; andcutting an excess polymeric material from the single polymeric sheet to form the leaflet.

2. The method of claim i, wherein the polymeric material is spread on the molding surface using a coating blade, and wherein an overall thickness of the leaflet is controlled by adjusting a gap between the coating blade and the molding surface of the mold.

3. The method of claim 2, wherein the single polymeric sheet comprises a first surface configured to be supported on the molding surface and a second surface spaced from the first surface, and wherein the coating blade moves across the second surface to provide a substantially flat surface.

4. The method of any of claims 1-3, wherein the support surface is level with the portion of the molding surface adjacent the leaflet pattern.

5. The method of any of claims 1-4, wherein cutting the excess polymeric material is performed by any of a laser cutting, an ultrasonic cutting, or chemical cutting process.

6. The method of any of claims 1-5, wherein the edge portion of the leaflet has a first thickness, and the body portion of the leaflet has a second thickness that is less than the first thickness.

7. The method of any of claims 1-6, wherein the recessed portion has a depth in a range from 0.02 millimeters to 0.5 millimeters.

8. The method of any of claims 1-7, wherein the leaflet is a first leaflet manufactured within the mold, and wherein the leaflet pattern comprises a second recessed portion and a second support surface configured to define a second leaflet, and wherein the single polymeric sheet defines the first leaflet and the second leaflet.

9. The method of any of claims 1-8, wherein a viscosity of polymer material is in a range from 100 mPas to 100,000 mPas.THVFN- 23255W00110. The method of any of claims 1-9, wherein providing the polymeric material on the molding surface comprises providing a first amount of polymeric material to the recessed portion of the leaflet pattern and once the first amount of polymeric material at least partially solidifies in the recessed portion, providing a second amount of polymeric material to the support surface and a portion of the molding surface adjacent the recessed portion.

11. The method of any of claims 1-10, wherein providing the polymeric material on the molding surface comprises providing a first amount of polymeric material to the recessed portion of the leaflet pattern and once the first amount of polymeric material at least partially solidifies in the recessed portion, providing a second amount of polymeric material to the first amount of polymeric material and the support surface.

12. The method of claim 11, wherein the first amount of polymeric material is a first type of polymeric material, and wherein the second amount of polymeric material is a second type of polymeric material that is the same or different than the first type of polymeric material.

13. The method of claim 12, wherein the first type of polymeric material comprises a first set of mechanical properties and the second type of polymeric material comprises a second set of mechanical properties that are different than the first set of mechanical properties.

14. A leaflet for a heart valve, the leaflet comprising:a peripheral edge portion having a first thickness; anda body portion adjacent the peripheral edge portion, the body portion having a second thickness that is less than first thickness,wherein the leaflet is manufactured of a polymeric material using a mold comprising a molding surface having a recessed portion that defines the peripheral edge portion of the leaflet and a support surface that defines the body portion of the leaflet, andwherein a depth of the recessed portion is configured to prevent edge climbing of polymeric material during a molding process of the leaflet.

15. The leaflet of claim 14, wherein the leaflet comprises a first portion having a free edge and a second portion having a substantially arcuate geometry, and wherein the peripheral edge portion defines an outer section of the first and second portions.

16. The leaflet of any of claims 14-15, wherein the peripheral edge portion is configured to be attached to a vessel wall or a supporting structure of the heart valve.THVFN- 23255W00117- The leaflet of any of claims 14-16, wherein the leaflet comprises a pair of opposing tabs, wherein the edge portion defines the opposing tabs.

18. The leaflet of any of claims 14-17, wherein the leaflet comprises a polymeric material, and wherein the polymeric material comprises a polyurethane-based composition, polyurea composition, polytetrafluoroethylene (PTFE), silicon styrene isoprene butadiene (SIBS) block copolymers, or any combination thereof.

19. The leaflet of claim 19, wherein the polyurethane-based composition comprises one or more of polylether urethanes), polyfester urethanes), polyfcarbonate urethanes), poly(siloxane urethanes), polyurethane-polyester composite, polyurethanepolyamide composite, polyurethane-glass fiber composite, polyurethane-carbon fiber composite, or any combination thereof.

20. The leaflet of any of claims 16-19, wherein a first amount of the polymeric material is provided within the recessed portion to form the peripheral edge portion of the leaflet and a second amount of polymeric material to the support surface and a portion of the molding surface adjacent the recessed portion to form the body portion of the leaflet.

21. The leaflet of claim 20, wherein the first amount of polymeric material is a first type of polymeric material, and wherein the second amount of polymeric material is a second type of polymeric material that is different than the first type of polymeric material.

22. An implantable prosthetic valve comprising:an annular frame having an inner surface and an outer surface wherein the frame has an inflow end and an outflow end, and a central longitudinal axis extending from the inflow end to the outflow end, wherein the annular frame comprises a plurality of struts; anda valvular structure comprising one or more leaflets, each leaflet comprisinga peripheral edge portion having a first thickness, anda body portion adjacent the peripheral edge portion, the body portion having a second thickness that is less than first thickness, wherein the leaflet is manufactured of a polymeric material using a mold comprising a molding surface having a recessed portion that defines the peripheral edge portion of the leaflet and a support surface that defines the body portion of the leaflet,wherein a depth of the recessed portion is configured to prevent edge climbing of polymeric material during a molding process of the leaflet, and wherein at least a portion of an edge portion of the one or more leaflets is attached to at least a portion of the plurality of struts of the annular frame.THVFN- 23255W00123- The implantable prosthetic valve of claim 22, wherein the leaflet comprises a first portion having a free edge and a second portion having a substantially arcuate geometry, and wherein the peripheral edge portion defines an outer section of the first and second portions.

24. The implantable prosthetic valve of any of claims 22—23, wherein the peripheral edge portion is configured to be attached to a vessel wall or a supporting structure of the implantable prosthetic valve.

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