Suture with openings for use in prosthetic devices

Abstract

The prosthetic valve can have a reinforcing member designed to protect various components of the valve and surrounding tissue from damage. The reinforcing member can include a suture with a plurality of apertures. The reinforcing member can be utilized within or as a reinforcing member that can be attached to the prosthetic valve to reinforce the prosthetic valve.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 984,959, filed March 4, 2020, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to aspects of prosthetic valves and sutures used to provide improved structural integrity and strength thereto. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases that can lead to significant cardiac dysfunction and ultimately require replacement of the natural valve with a prosthetic valve.

[0004] When a native valve is replaced, surgical implantation of a prosthetic valve requires open-chest surgery during which the heart is stopped and the patient is placed on cardiopulmonary bypass (a so-called "heart-lung machine"). Due to the drawbacks associated with traditional open-chest surgery, percutaneous and minimally invasive surgical approaches have received increasing attention. In one technique, prosthetic valves are configured to be implanted in a much less invasive procedure via catheterization. For example, U.S. Patent Nos. 5,629,997 and 5,629,997, both incorporated herein by reference, describe a collapsible transcatheter heart valve that is percutaneously introduced in a compressed state onto a catheter and can be percutaneously introduced to a desired location by balloon inflation or by utilizing a self-expanding frame or stent.

[0005] A critical design parameter for transcatheter heart valves is ensuring the integrity of all valve components. Many of the prosthetic valve components are connected with various sutures. These same sutures are also used to connect the valve components to the appropriate surrounding tissue. One drawback of this design is that the sutures can cut through the tissue, causing unnecessary damage to the valve that can result in valve dysfunction. Therefore, there is a need for a reinforcing member and method of attachment that substantially eliminates these tissues, improving patient safety. These and other needs are met, at least in part, by the present disclosure. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 5,411,522 [Patent Document 2] U.S. Patent No. 6,730,118 [Patent Document 3] U.S. Patent No. 10,463,484 [Patent Document 4] U.S. Patent Application Publication No. 2012 / 0123529 Summary of the Invention [Means for solving the problem]

[0007] Aspects of the present disclosure relate to prosthetic valves. Some aspects relate to prosthetic valves including at least one reinforcing member configured to be attached to one or more components of the prosthetic valve with an attachment member. In such aspects, the at least one reinforcing member can include a suture having a longitudinal axis and a transverse axis perpendicular to the longitudinal axis, at least a portion of the suture including a plurality of openings. Furthermore, in certain aspects, each of the plurality of openings is configured to receive an attachment member for coupling the suture to the prosthetic valve.

[0008] An embodiment of the prosthetic valve can include an attachment member with one or more stitches. In certain embodiments, the stitches are used to attach a suture to the prosthetic valve. In such embodiments, the stitches pass through multiple openings in at least one of the sutures to attach the suture to the device.

[0009] Also disclosed herein are embodiments including methods for making the disclosed prosthetic valves. In one embodiment, the method includes providing at least one reinforcing member and attaching the at least one reinforcing member to one or more components of the prosthetic valve with a first attachment member, wherein the at least one reinforcing member comprises a suture having a longitudinal axis and a transverse axis perpendicular to the longitudinal axis, at least a portion of the suture comprising a plurality of openings, each of the plurality of openings configured to receive an attachment member for coupling the suture to the prosthetic valve. In another embodiment, and similar to the above, the first attachment member can comprise one or more stitches. Furthermore, it is understood that the embodiments described in the methods for making the disclosed valves can comprise any of the disclosed sutures described above.

[0010] Also disclosed herein are kits including at least one suture having a longitudinal axis and a transverse axis perpendicular to the longitudinal axis, at least a portion of the suture including a plurality of openings, each of the plurality of openings configured to receive an attachment member for coupling the suture to an object. In these embodiments, the first attachment member can include one or more stitches, a flexible connector, or any combination thereof.

[0011] The foregoing and other features and advantages of the disclosure will become more apparent from the following detailed description, which begins with reference to the accompanying drawings. [Brief explanation of the drawings]

[0012] [Figure 1A] FIG. 1 is a top plan view of an exemplary suture. [Figure 1B] FIG. 1 is a top plan view of an exemplary suture. [Figure 1C] 1 is a photograph of an exemplary suture. [Figure 2] FIG. 1 is a front view of an exemplary embodiment of a prosthetic heart valve. [Figure 3] FIG. 3 is a side view of the prosthetic heart valve of FIG. 2 with the outer skirt removed to show the inner skirt and valve leaflet structure mounted on the frame. [Figure 4] FIG. 4 is a rotated front view of the prosthetic heart valve of FIG. 3. [Figure 5A] 1 is an enlarged partial cross-sectional view of a prosthetic heart valve, according to some embodiments. [Figure 5B] 1 is an enlarged partial cross-sectional view of a prosthetic heart valve, according to some embodiments. [Figure 6] 1 is an enlarged partial cross-sectional view of a prosthetic heart valve according to one embodiment. [Figure 7] FIG. 3 is a top view of the prosthetic heart valve of FIG. 2. [Figure 8] FIG. 1 is a side view of an exemplary valve leaflet shown in a flat configuration. [Figure 9] 3 is a perspective view of an exemplary frame of the prosthetic heart valve of FIG. 2. [Figure 10] 3 is a perspective view of an exemplary frame of the prosthetic heart valve of FIG. 2. DETAILED DESCRIPTION OF THE INVENTION

[0013] The present disclosure may be more readily understood with reference to the following detailed description, examples, drawings, and claims, as well as the preceding and following descriptions. However, before the present objects, systems, and / or methods are disclosed and described, it should be understood that the disclosure is not limited to particular or exemplary embodiments of the disclosed objects, systems, and / or methods, unless otherwise specified, as such may, of course, vary. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0014] The following description of the disclosure is provided as an enabling teaching of the disclosure in its best currently known mode. To this end, those skilled in the art will recognize and understand that many changes can be made to the various aspects of the disclosure described herein while still obtaining beneficial results of the disclosure. Also, some of the desired advantages of the disclosure can be obtained by selecting some of the characteristics of the disclosure without utilizing other characteristics. Thus, those skilled in the art will recognize that many modifications and adaptations to the disclosure are possible and may even be desirable in certain circumstances and are a part of this disclosure. Thus, the following description is again provided as an illustration of the principles of the disclosure, and not as a limitation thereof.

[0015] definition As used in this application and the claims, the singular forms "a," "an," and "the" include the plural forms unless the content clearly dictates otherwise. Thus, for example, reference to a "suture" includes embodiments having two or more such sutures unless the content clearly dictates otherwise.

[0016] It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. As used in the specification and claims, the term "comprising" can include the embodiments "consisting of" and "consisting essentially of." Additionally, the term "including" means "comprising."

[0017] The terms "for example" and "such as," and their grammatical equivalents, are understood to be followed by the phrase "without limitation," unless expressly stated otherwise.

[0018] 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 embodiment includes from the one particular value and / or to the other particular value. Similarly, when values ​​are expressed as approximations, it will be understood that the particular value forms another embodiment by use of the antecedent "about." Further, it should be understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

[0019] Throughout this disclosure, various aspects of the disclosure can be expressed in range form. It should be understood that the description in range form is merely for convenience and brevity and should not be construed as an indefinite limitation on the scope of the disclosure. Thus, the description of a range should be considered to specifically disclose all possible subranges and individual numerical values ​​within the range. For example, the description of a range such as 1 to 6 should be considered to specifically disclose subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as individual numbers within that range, e.g., 1, 2, 2.7, 3, 4, 5, 5.3, 6, and any whole or partial increments therebetween. This is true regardless of the breadth of the range.

[0020] Furthermore, the terms "coupled" and "associated" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or connected, and do not exclude the presence of intermediate elements between the coupled or associated items.

[0021] As used herein, the term "suture" refers to a multifilament yarn, where the filaments are braided together to form a thread having predetermined dimensions. In certain aspects, the sutures described herein can comprise two or more threads (cords) fused together. It is understood that the sutures of the present disclosure do not comprise woven or nonwoven fabrics.

[0022] As used herein, the term "suture" refers to a monofilament or multifilament thread used as an attachment member. Some exemplary suture sutures can have sizes from 6-0 to 4-0.

[0023] As used herein, the terms or phrases "effective," "effective amount," or "effective conditions" refer to such amounts or conditions capable of performing the function or property for which the effective amount or condition is indicated. As noted below, the exact amount or specific conditions required will vary from one embodiment to another, depending on recognized variables such as the materials utilized and the process conditions observed. Thus, it is not always possible to specify an exact "effective amount" or "effective condition." However, it should be understood that an appropriate effective amount can be readily determined by one of ordinary skill in the art using only routine experimentation.

[0024] Although the operations of exemplary embodiments of the disclosed methods may be described in a particular order for convenient presentation, it should be understood that the disclosed embodiments may include orders of operations other than the particular order disclosed. For example, operations described in order may, in some cases, be rearranged or performed simultaneously. Furthermore, descriptions and disclosures provided with respect to one particular embodiment are not limited to that embodiment and may apply to any disclosed embodiment.

[0025] Moreover, for purposes of simplicity, the accompanying drawings may not show the various ways in which the disclosed systems, methods, and apparatus can be used in combination with other systems, methods, and apparatus, which would be readily discernible by one of ordinary skill in the art based on this disclosure. Additionally, the description sometimes uses terms such as "produce" and "provide" to describe the disclosed methods. These terms are high-level abstractions of actual operations that may take place. The actual operations corresponding to these terms may vary depending on the particular implementation and would be readily discernible by one of ordinary skill in the art based on this disclosure.

[0026] In one aspect, disclosed herein is a prosthetic valve including at least one reinforcing member configured to be attached to one or more components of the prosthetic valve with a first attachment member, the at least one reinforcing member comprising a suture having a longitudinal axis and a transverse axis perpendicular to the longitudinal axis, at least a portion of the suture comprising a plurality of openings, each of the plurality of openings configured to receive a first attachment member for connecting the suture to the prosthetic valve. However, it should be understood that a suture as disclosed herein does not have to act as a reinforcing member, but can be used as a member configured to connect various components or simple objects of the prosthetic valve.

[0027] In certain embodiments, and as described herein, a suture comprises a multifilament yarn. In such embodiments, the yarn comprises two or more filaments, and the filaments have a thickness of from about 0.02 mm to about 0.5 mm, with exemplary values ​​of about 0.03 mm, about 0.04 mm, about 0.05 mm, about 0.06 mm, about 0.07 mm, about 0.1 mm, about 0.12 mm, about 0.15 mm, about 0.17 mm, about 0.2 mm, about 0.22 mm, about 0.25 mm, about 0.27 mm, about 0.3 mm, about 0.32 mm, about 0.35 mm, about 0.37 mm, about 0.4 mm, about 0.42 mm, about 0.45 mm, and about 0.47 mm. It should further be understood that each filament within a yarn can have the same or different thicknesses.

[0028] In yet another embodiment, the suture can comprise two or more threads joined together. In such exemplary embodiment, each thread can comprise two or more filaments, as disclosed above. In yet another embodiment, the threads can be about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1.0 mm, about 1.2 mm, about 1.5 mm, about 1.8 mm, about 2 mm, about 2.2 mm, about 2.5 mm, about 2.8 mm, about 3 mm, about 3.2 mm, about 3.5 mm, about 3.8 mm, about 4 mm, about 4.2 mm, about 4.5 mm, about 4.8 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm, about 51 mm, about 52 mm, about 53 mm, about 54 mm, about 55 mm, The suture may have a width between about 0.1 mm and about 10 mm, including exemplary values ​​of about 5 mm, about 5.2 mm, about 5.5 mm, about 5.8 mm, about 6 mm, about 6.2 mm, about 6.5 mm, about 6.8 mm, about 7 mm, about 7.2 mm, about 7.5 mm, about 7.8 mm, about 8 mm, about 8.2 mm, about 8.5 mm, about 8.8 mm, about 9 mm, about 9.2 mm, about 9.5 mm, and about 9.8 mm. It is understood that the suture width may have any value between any two of the aforementioned values.

[0029] 1A-1C show an exemplary embodiment of a reinforcement member comprising a suture 100. FIGS. 1A and 1B, for example, show suture 100 having a longitudinal axis 103 and a transverse axis 101. Suture 100 also comprises a centerline 102. In FIG. 1A, exemplary suture 100 is a multifilament thread (cord) having a rectangular shape and having a plurality of openings 104 disposed along at least a portion of the centerline. The plurality of openings 104 form openings extending through all or a portion of suture 100. FIG. 1B shows a braided suture 100 having a plurality of openings 104 braided within suture 100. FIG. 1C shows a photograph of exemplary suture 100 comprising two separate braided threads 105 and 107 fused together to form the plurality of openings 104.

[0030] In certain embodiments, openings 104 can be positioned within at least a portion of centerline 102. That is, the openings formed by openings 104 are positioned laterally (i.e., along transverse axis 101 of suture 100) along at least a portion of centerline 102 and along all or a portion of the length of suture 100. For example, openings 104 can be centered along centerline 102 of suture 100. That is, the transverse centers of openings 104 are aligned with centerline 102. Furthermore, in other embodiments, multiple openings 104 can be positioned along centerline 102 such that the centers of openings 104 are not aligned with centerline 102. For example, the transverse centers of each (or a subset) of the multiple openings 104 are not aligned with centerline 102 of suture 100, but rather are offset from centerline 102, e.g., along transverse axis 101 of suture 100. In another embodiment, all or a portion of the plurality of openings 104 are positioned along the suture 100 such that the openings 104 are not aligned with the centerline 102. In such exemplary embodiments, some of the plurality of openings are positioned along the suture 100 such that the openings 104 are not aligned with the centerline 102, while others are aligned. In some exemplary embodiments, portions of the openings do not overlap / align with the centerline 102 of the suture 100.

[0031] Without limitation to certain embodiments, the openings 104 present in the suture 100 can have any design that enables the desired result. For example, the openings 104 can have any regular or irregular shape, including, for example, curved (e.g., circular, elliptical, oval) or linear (e.g., square, rectangular, trapezoidal, diamond, triangular, star-shaped). The various openings of the plurality of openings can have the same or different shapes. In certain embodiments, the plurality of openings 104 can be positioned in one longitudinally extending row along the length of the suture 100, while in other embodiments, the plurality of openings 104 can be positioned in two or more longitudinally extending rows along the length of the suture 100. In certain embodiments, when the plurality of openings 104 are positioned in two or more longitudinally extending rows, the openings 104 can be positioned in the same line along the transverse axis or can be shifted / offset relative to one another. It should be understood that the present disclosure is not intended to limit the design and particular positioning of the plurality of openings 104 within the suture 100.

[0032] The various openings of the plurality of openings 104 in the suture 100 can have the same size or can have different sizes. The size of each of the plurality of openings 104 is substantially large enough to allow a needle and suture to pass therethrough. In certain embodiments and without limitation, the size of each of the plurality of openings 104 can be about 0.002 mm, about 0.005 mm, about 0.008 mm, about 0.01 mm, about 0.02 mm, about 0.05 mm, about 0.08 mm, about 0.1 mm, about 0.2 mm, about 0.5 mm, about 0.8 mm, about 1.0 mm, about 1.2 mm, about 1.5 mm, about 1.8 mm, about 2.0 mm, about 2.2 mm, about 2.5 mm, about 2.8 mm, about 3.0 mm, about 3.2 mm, about 3.5 mm, about 3.6 mm, about 3.8 mm, about 4.0 mm, about 4.6 mm, about 4.8 mm, about 4.9 mm, about 5.0 mm, about 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, about 5.5 mm, about 5.6 mm, about 5.8 mm, about 5.9 mm, about 6.0 mm, about 6.1 mm, about 6.2 mm, about 6.3 mm, about 6.4 mm, about 6.5 mm, about 6.6 mm, about 6.7 mm, about 6.8 mm, about 6.9 mm, about 6.9 mm, about 7.0 mm, about 7.1 mm, about 7.2 mm, about 7.3 mm, about 7.4 mm, about 7.5 mm, about 7.6 mm, about 7.7 mm, about 7.8 mm, about 7.9 mm, about 7.9 mm, about The preferred range is between about 0.001 mm and about 1 cm, including exemplary values ​​of about 0.8 mm, about 4.0 mm, about 4.2 mm, about 4.5 mm, about 4.8 mm, about 5.0 mm, about 5.2 mm, about 5.5 mm, about 5.8 mm, about 6.0 mm, about 6.2 mm, about 6.5 mm, about 6.8 mm, about 7.0 mm, about 7.2 mm, about 7.5 mm, about 7.8 mm, about 8.0 mm, about 8.2 mm, about 8.5 mm, about 8.8 mm, about 9.0 mm, about 9.2 mm, about 9.5 mm, and about 9.8 mm. For example, and without limitation, in some embodiments, a portion of the plurality of openings in suture 100 can have a different size than another portion of the plurality of openings 104. Even in other embodiments, two adjacent openings 104 in the plurality of openings 104 can have the same size or different sizes. It should be understood that sizes as defined herein refer to diameters or maximum diametric lengths, depending on the particular shape and type of opening 104 .

[0033] In yet another embodiment, the openings of the plurality of openings 104 are spaced apart along the length of the suture 100 by a spacing increment d. The spacing d is measured between the proximal end of the opening of a first opening and the distal end of the opening of an adjacent / second opening. It should be understood that in some embodiments, the spacing increment d between any two adjacent openings of the plurality of openings 104 is consistent among the plurality. In other embodiments, the spacing increment d between any two adjacent openings of the plurality of openings 104 varies among the plurality. In yet another embodiment, the spacing increment d can have any value that is substantially sufficient to ensure the structural integrity of the suture 100. In certain embodiments, the spacing increment d between any two adjacent openings is at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100%, or at least about 150% of the maximum size opening of the plurality of openings present in the suture.

[0034] It should be understood that the suture 100 disclosed herein is configured to be attached to one or more components of a prosthetic valve with a first attachment member and / or a second attachment member. The first attachment member or second attachment member can be any member configured to permanently, semi-permanently, and / or removably attach the suture 100 to the prosthetic valve. In certain embodiments, the first attachment member and the second attachment member are the same, while in other embodiments, they are different. In certain embodiments, the first attachment member (and / or the second attachment member) comprises a suture. In still other embodiments, the first attachment member (and / or the second attachment member) comprises any flexible connector known in the art and applicable to the desired application. The suture (or any other attachment member as known in the art) passes through one or more openings 104 to couple the suture to the prosthetic valve. In certain embodiments, a needle can be used to pass the suture (or any other attachment member as known in the art) through one or more openings 104. In certain embodiments, the seams comprise mono- or multifilament yarns with filaments having a thickness of from 6-0 to 4-0. In still other embodiments, the seams comprise mono- or multifilament yarns with filaments having a thickness of from about 0.02 mm to about 0.5 mm, with exemplary values ​​of about 0.03 mm, about 0.04 mm, about 0.05 mm, about 0.06 mm, about 0.07 mm, about 0.1 mm, about 0.12 mm, about 0.15 mm, about 0.17 mm, about 0.2 mm, about 0.22 mm, about 0.25 mm, about 0.27 mm, about 0.3 mm, about 0.32 mm, about 0.35 mm, about 0.37 mm, about 0.4 mm, about 0.42 mm, about 0.45 mm, and about 0.47 mm.

[0035] In yet another embodiment, the suture 100 can comprise filaments made of various materials. In certain embodiments, the suture 100 can comprise polyester material, polyethylene, ultra-high molecular weight polyethylene, silicone, polyurethane, Teflon, polyetheretherketone (PEEK), or natural tissue, or a combination thereof. In still another embodiment, the suture 100 can comprise an engineered material. In such embodiments, the engineered material can comprise, for example, a biological element filament. In some exemplary embodiments, the biological element filament can be present in a core-sheath configuration, a side-by-side configuration, or an island-on-sea configuration. It should be understood that each component of the biological element filament can be selected depending on the desired application. Furthermore, it should be understood that in certain embodiments, a suture 100 comprising a multifilament yarn can comprise filaments comprising the same material. In some alternative embodiments, the suture 100 can comprise filaments comprising different materials.

[0036] In yet another aspect, one or more components of the prosthetic valve can comprise, for example, but not limited to, a leaflet, a skirt, a support layer, a frame, or any combination thereof.

[0037] Some exemplary embodiments for the use of sutures in prosthetic valves are shown in the figures and description that follow.

[0038] For example, Figures 2 and 7 show side and top views, respectively, of an exemplary prosthetic heart valve 10 having an inflow end 80 and an outflow end 82, according to one embodiment. The exemplary prosthetic heart valve 10 is described in U.S. Patent Application Publication No. 2013 / 0129999, entitled "Prosthetic Heart Valve Having Leaflet Inflow Below Frame," which is incorporated herein by reference. The illustrated prosthetic valve 10 is adapted to be implanted within the native aortic valve annulus, but in other embodiments, it may be adapted to be implanted within other native valve annulus of the heart (e.g., the mitral, pulmonary, and tricuspid valves). The prosthetic valve 10 may have one or more of the following components: a stent or frame 12, a heart valve structure 14, and an inner skirt or sealing member 16. The valve 10 may also include an outer skirt or sealing member 18. As can be seen in these figures, and as discussed in more detail below, sutures 100 can be used to attach various portions of the prosthetic valve together. The location of the sutures 100 in these figures is merely exemplary and non-limiting. Suture 100 may be utilized in any location or position configured to join two or more components of a valve together.

[0039] In certain embodiments, the prosthetic valve 10 can include one or more leaflets 20, each having a first surface and an opposing second surface, a leaflet inflow edge, and a leaflet outflow edge. In some exemplary embodiments, and as shown in FIG. 7, the valvular structure 14 can include three leaflets 20 that collectively form a valvular structure that can be arranged to collapse in a tricuspid valve configuration. The lower edge of the valvular structure 14 desirably has a wavy, curved, scallop shape. Forming the leaflets 20 with this scallop geometry reduces stress on the leaflets, thereby improving the durability of the valve 10. Furthermore, the scallop shape can eliminate or at least minimize folds and waves in the belly (the central region of each leaflet) of each leaflet 20, which can lead to premature calcification in these regions. The scallop geometry also reduces the amount of tissue material used to form the valvular structure 14, thereby allowing for a smaller, flatter wave profile at the inflow end of the valve. The valve leaflets 20 may be formed from pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or various other suitable natural or synthetic materials known in the art and such as those described in U.S. Patent No. 6,223,629, which is incorporated herein by reference.

[0040] As noted above, the cardiac valve structure 14 in the illustrated non-limiting embodiment can include three flexible leaflets 20 (although a greater or lesser number can be used). An exemplary leaflet 20 is shown in FIG. 8 . Each leaflet 20 can have a suture 100, as disclosed herein, secured to a first attachment member 61 through a plurality of openings 59 in a first surface of a lower edge portion 56. In the illustrated configuration, each leaflet 20 can have an upper (outflow) free edge 48 extending between opposing upper tabs 50 on opposite sides of the leaflet 20. Beneath each upper tab 50 can be a notch 52 that separates the upper tab 50 from a corresponding lower tab 54. The lower (inflow) edge portion 56 of the leaflet, extending between the respective ends of the lower tabs 54, may include vertical, or axial, edge portions 60 on either side of the leaflet extending downward from the corresponding lower tab 54, and a substantially V-shaped intermediate edge portion 62 at the lower end of the leaflet, having a smoothly curved apex portion 64 and a pair of sloped portions 66 extending between the axial edge portion 60 and the apex portion 64. The sloped portions 66 may have a larger radius of curvature than the apex portion 64. The leaflets may have a variety of other shapes and / or configurations in other embodiments. For example, the leaflets need not have a V-shaped or scallop-shaped inflow edge; instead, each leaflet may have a square or rectangular shape defining a straight inflow edge. The presence of the sutures 100 may protect the pericardial tissue of the valve leaflets 20 from undesired damage. A specific exemplary embodiment of the suture 100 positioning is shown in FIG. 5A. On the right side of Figure 5A, suture 100 is positioned on a first surface of the lower edge portion of the leaflet, and on the left side of Figure 5A, suture 100 is positioned on both the first and opposing second surfaces of the lower edge portion of the leaflet such that the leaflet is sandwiched between the two sutures. The sutures in this embodiment can be the same or different and can include any shape, size, or design of multiple openings as disclosed herein.

[0041] Exemplary leaflets 20 are coupled to a frame of a prosthetic valve 12 (e.g., as shown in FIGS. 2-4 ). An exemplary bare frame 12 is shown in FIGS. 9 and 10 . The frame 12 has an inflow end 22, an outflow end 24, and a central longitudinal axis 26 extending from the inflow end 22 to the outflow end 24. The frame 12 can be made from any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol), as known in the art. If constructed from a plastically expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially compressed state on a delivery catheter and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. If constructed from a self-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially compressed state and constrained in the compressed state by insertion of the delivery catheter into a sheath or equivalent mechanism. Once inside the body, the valve can be advanced from the delivery sheath, allowing the valve to expand to its functional size. Suitable plastically expandable materials that can be used to form the frame 12 include, but are not limited to, stainless steel, nickel-based alloys (e.g., cobalt-chromium or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In certain embodiments, the frame 12 can be made of a nickel-cobalt-chromium-molybdenum alloy such as MP35N™ (a trade name of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 contains, by weight, 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum. The use of MP35N to form the frame 12 has been found to provide superior structural results over stainless steel. Notably, when MP35N is used as the frame material, less material is required to achieve the same or better performance in radial crush force resistance, fatigue resistance, and corrosion resistance. Additionally, because less material is required, the wavy profile of the frame can be reduced, thereby providing a lower profile valve assembly for percutaneous delivery to a treatment location in the body.

[0042] 9 and 10 , in some exemplary and non-limiting embodiments, the frame 12 may include a first lower row I of circumferentially extending angled struts 28 disposed end-to-end at the inflow end of the frame, a second row II of circumferentially extending angled struts 30, a third row III of circumferentially extending angled struts 32, and a fourth row IV of circumferentially extending angled struts 34 at the outflow end of the frame 12. The fourth row IV of angled struts 34 may be connected to the third row III of angled struts 32 by a plurality of axially extending window frame portions 36 (defining seam windows 38) and a plurality of axially extending struts 40. Each axial strut 40 and each frame portion 36 extends from a location defined by the convergence of the lower ends of two angled struts 34 to another location defined by the convergence of the upper ends of two angled struts 32.

[0043] Each joint window frame portion 36 attaches to a respective joint 74 of the leaflet structure 14. As can be seen, each frame portion 36 is secured at its upper and lower ends to adjacent rows of struts to provide a robust configuration that improves the valve's fatigue resistance under cyclic loading, compared to known cantilever struts for supporting the joints of leaflet structures. This configuration allows for a reduction in frame wall thickness to achieve a smaller undulating diameter of the valve. In certain embodiments, the thickness of the frame 12, measured between the inner and outer diameters, is about 0.48 mm or less.

[0044] The frame struts and frame portions collectively define a plurality of open cells in the frame. At the inflow end 22 of frame 12, struts 28 and 30 define a lower row of cells that define aperture 42. The second and third rows of struts 30 and 32, respectively, define a middle row of cells that define aperture 44. The third and fourth rows of struts 32 and 34, together with frame portion 36 and strut 40, define an upper row of cells that define aperture 46. Opening 46 is relatively large and sized to allow portions of the valvular structure 14 to protrude or bulge into and / or through opening 46 when frame 12 is wavy to minimize a wavy profile.

[0045] The frame 12 can have other configurations or shapes in other embodiments. For example, the frame 12 can include multiple perimeter rows of angled columns 28, 30, 32, 34 that are directly connected to one another without vertical columns 40 or frame portions 36 between the columns of adjacent rows, or the columns 28, 30, 32, 34 of a row can be further spaced apart with vertical columns 40 and / or frame portions 36 extending therebetween. In other embodiments, the frame can include a braided structure woven from one or more metal wires.

[0046] The leaflets 20 can be sutured together to form an assembled heart valve structure 14, which can then be secured to the frame 12. When the leaflets 20 are sutured together, it should be understood that each of the leaflets can include the suture 100 disclosed herein, which has multiple openings 104. Attachment of two or more sutures to one another can be achieved by passing a first attachment member through the multiple openings. It should be understood that the sutures can be positioned on the first and / or second surfaces of the leaflets. In yet another embodiment, when two or more leaflets are attached together, for example, the sutures can be positioned parallel to one another. In general, it should be understood that the sutures can be positioned anywhere that an attachment member needs to pass through the leaflets or any other tissue. In certain embodiments, as described herein, the disclosed sutures are designed to reinforce tissue and prevent tearing. For example, the leaflets 20 can be secured together at their adjacent sides to form a seam 74 in the heart valve structure. As can be seen in FIG. 3 , sutures 100 can be used to form such a seam. Multiple flexible connectors (not shown) can be used to interconnect adjacent pairs of leaflets and attach the leaflets to the seam window frame portion 30, as discussed further below. It should further be understood that such attachment can be achieved through the use of sutures when the flexible connectors pass through multiple openings present in the leaflets. The leaflets 20 can additionally and / or alternatively be secured together through adjacent sub-seam portions (not shown) of the two leaflets, which can be sutured directly to each other with the use of one or more sutures described herein.

[0047] In yet another exemplary embodiment, one or more leaflets 20 can be attached to the inner skirt 16, as shown, for example, in FIG. 5B. In such an embodiment, a suture 100, as disclosed herein, can be positioned along the lower (inflow) edge portion 56 of the leaflet 20 to reinforce the leaflet and prevent any undesired damage. The reinforcing suture 100 allows for a secure suturing and protects the pericardial tissue of the valvular structure 14 from tearing. The valvular structure 14 can be sandwiched between the inner skirt 16 and the suture 100. A first attachment member 70 (FIG. 3) secures the suture 100 (FIG. 3) to the inner skirt 16. It should be understood that the first attachment member can be any member described herein and can comprise, for example, a stitch, such as an Ethibond suture. The attachment member 70 can follow the curvature of the bottom edge of the valvular structure 14 and is collectively referred to as a scallop line 72. In other exemplary and non-limiting embodiments, instead of or in addition to sutures 100 along the inner surface of the leaflet, sutures 100 can be positioned between the inner skirt 16 and the inflow edge portion (FIG. 5B).

[0048] The inner skirt 16 can have multiple functions, including helping to secure the cardiac valve structure 14 and / or the outer skirt to the frame 12 and helping to form a superior seal between the valve 10 and the native annulus by blocking blood flow below the lower edge of the valve leaflets. The inner skirt 16 can comprise a sturdy, tear-resistant material such as polyethylene terephthalate (PET), although a variety of other synthetic or natural materials can be used. The skirt thickness is desirably less than 6 mil or 0.15 mm, desirably less than 4 mil or 0.10 mm, and more desirably less than about 2 mil or 0.05 mm. In certain embodiments, the skirt 16 can have a variable thickness; for example, the skirt can be thicker at its edges than at its center. In one implementation, the skirt 16 can comprise a PET skirt having a thickness of 0.07 mm at its edges and about 0.06 mm at its center. A thicker skirt can provide better ripple performance and provide a better perivalvular seal.

[0049] 3 and 4 show the frame 12, cardiac valve structure 14, and inner skirt 16 after the use of sutures 100 to secure the valvular structure 14 to the inner skirt 16 and then the use of sutures 100 to secure these components to the frame 12. The inner skirt 16 can be secured to the inside of the frame 12 via sutures 68. The sutures 100 can be utilized to mitigate damage to the inner skirt 16. As shown in FIGS. 3-4, a portion of the inflow edge 56 of the leaflet 20 is positioned between the diagonal line defined by the struts 28, 30 of the first and second circumferential rows of struts (as shown in FIGS. 9 and 10). In some embodiments, the inflow edge 56 of the leaflet 20 can track the diagonal line defined by the struts 28, 30. In such embodiments, the portion of the inflow edge 56 on the inflow end of the frame can be connected to adjacent struts 28, 30 using the disclosed sutures 100.

[0050] The outflow end portion of the valvular structure 14 can be secured to the window frame portion 36 with sutures 100. In particular, each leaflet 20 can have opposing tab portions, each paired with an adjacent tab portion of another leaflet to form a seam 74. In such embodiments, it should be understood that each leaflet tab portion is joined to an adjacent tab portion of another leaflet with the use of sutures 100. Furthermore, it should be understood that in such embodiments, one or more sutures 100 can be present. In some embodiments, each tab can be sandwiched between at least two sutures 100, or sutures can be positioned on only one surface of each tab. Furthermore, it should be understood that two adjacent tabs can have sutures positioned on the same or different surfaces of the tabs. As shown in FIG. 2, the seam 74 can extend through the window 38 of each window frame portion 36, and an attachment member can pass through the leaflets and sutures 100 to hold them in place. Further details of the joints 74, methods for assembling the joints and attaching them to the frame are disclosed in US Pat. No. 6,223,999, which is incorporated herein by reference.

[0051] The inner skirt 16 may terminate short of the window frame portion 36 and does not extend the full length of the frame 12. In alternative embodiments, the inner skirt 16 may extend the full length or substantially the full length of the frame 12 from below the inlet end 22 to the outlet end 24. In other embodiments, the inner skirt 16 may extend to the second row of angled struts 30.

[0052] In certain embodiments, as shown in FIGS. 2-4 , the cardiac valve structure 14 can extend axially beyond the inflow end 22 of the frame 12 such that at least a portion of the inflow end 56 of each leaflet is not supported by the frame 12. For example, the apex portion 64 of the leaflet 20 can extend axially beyond the frame 12 and be unsupported by the frame 12. Additionally and / or alternatively, the sloped portion 66 and the apex portion 64 can extend axially beyond the frame 12 and be unsupported by the frame 12. Additionally and / or alternatively, the intermediate portion 62, sloped portion 66, and apex portion 64 can extend axially beyond the frame 12 and be unsupported by the frame 12. Additionally and / or alternatively, the vertical edge portion 60, intermediate portion 62, sloped portion 66, and apex portion 64 can extend axially beyond the frame 12 and be unsupported by the frame 12. In some embodiments, each leaflet portion 76 extends axially below the inflow end 22 of the frame a length L1 that is equal to or greater than the length L2 of each cell opening 42. In some embodiments, L1 ranges in length between about 2 mm and 8 mm, with 4 mm being a specific example. Additionally and / or alternatively, L1 may be up to 12 mm. In some embodiments, L2 may range in length between about 3 mm and 5 mm, with 4 mm being a specific example. Additionally and / or alternatively, L2 may range in length between 2 mm and 7 mm.

[0053] Additionally and / or alternatively, as shown in FIG. 5B , the inner skirt 16 can include a first portion 84, also referred to as a supported portion, that extends circumferentially around the central longitudinal axis of the prosthetic valve along the inner surface of the frame 12, and a second portion, also referred to as an unsupported portion 78, at the inflow end 80 of the prosthetic valve. The unsupported portion 78 is not supported by the frame 12. The unsupported portion 78 can extend circumferentially around the central longitudinal axis of the prosthetic valve to form an unsupported circumferential surface at the inflow end 80. As shown in FIG. 5B , the portion of each leaflet 20 that is not supported by the frame 12 can be connected to the inner skirt 16. In some embodiments, the length L3 of the unsupported portion 78 is equal to or greater than the length L2 of the opening 42. In some embodiments, L3 can be 2 to 3 mm longer than L1. Additionally and / or alternatively, L3 can range from the same length as L1 to 5 mm longer than L1. In some embodiments, L3 can range in length from approximately 2 mm to 11 mm, with 6 mm being a specific example. Additionally and / or alternatively, L3 may be up to 15 mm.

[0054] In certain embodiments, the prosthetic valve, as described herein, can also include an outer skirt 18. The outer skirt 18 can be laser cut or otherwise formed from a strong, durable piece of material such as woven PET, although other synthetic or natural materials can be used. The outer skirt 18 can be secured to the lower edge of the inner skirt 16 at the inflow end of the prosthetic valve, such as by suturing, welding, and / or gluing with or without sutures 100. In certain embodiments, the lower edge of the outer skirt 18 is securely sutured (with or without sutures 100) or otherwise secured (e.g., by welding or gluing) to the inner skirt 16. Furthermore, it should be understood that each attachment location can utilize the disclosed sutures 100.

[0055] The absence of metal components of a frame or other rigid members along the inflow end portion of the prosthetic valve advantageously reduces mechanical compression of the native valve annulus (e.g., the aortic annulus) and the left ventricular outflow tract (if implanted in the aortic position), thereby reducing the risk of trauma to surrounding tissue.

[0056] As shown in FIG. 6 , some embodiments of the prosthetic valve 10 may not include an inner skirt 16, but instead may include a support layer 110 radially disposed between the frame 12 and the outer skirt 18. In such embodiments, the support layer 110 and the outer skirt 18 form an outer sealing member, with the support layer 110 forming an inner wall or layer of the sealing member and the outer skirt forming an outer wall or layer of the sealing member. A first portion 112 of the support layer 110 may extend circumferentially around the central longitudinal axis of the prosthetic valve along the outer surface of the frame 12, and a second portion 114 of the support layer 110 may extend circumferentially around the central longitudinal axis axially beyond the inflow end 22 of the frame. The unsupported portions 76 of the valve leaflets may be connected to the support layer 110 (e.g., by sutures, adhesives, and / or welding) similar to how the leaflets are connected to the inner skirt in the embodiment of FIGS. 5A-5B . More particularly, in such embodiments, inflow edge portion 56 is sewn to sutures 100 and support layer 110, with the inflow edge portion being sandwiched between support layer 110 and sutures 100. Additionally and / or alternatively, sutures 100 can be positioned between inflow edge portion 56 and support layer 110, with the sutures securing these layers together. Additionally and / or alternatively, outer skirt 18 can be connected to second portion 114 of the support layer with or without sutures 100 (e.g., by sutures, adhesive, and / or welding).

[0057] It should further be understood that the attachment members described herein can comprise first attachment members, second attachment members, or any other attachment members. It should further be understood that the numbers describing attachment members are used solely to indicate that the attachment members may be the same or different. For example, in some embodiments, the attachment of suture 100 to any component of the valve can be made with stitches comprising the same material or stitches comprising different materials. In still other embodiments, the attachment can be made with stitches, flexible connectors, wires, or any other attachment member known in the art appropriate for the desired application.

[0058] Aspects of the present disclosure also relate to a method for making a prosthetic valve, the method including providing at least one reinforcing member and attaching the at least one reinforcing member to one or more components of the prosthetic valve with a first attachment member, wherein the at least one reinforcing member comprises a suture having a longitudinal axis and a transverse axis perpendicular to the longitudinal axis, at least a portion of the suture comprising a plurality of openings, each of the plurality of openings configured to receive an attachment member for coupling the suture to the prosthetic valve.

[0059] It should be understood that any of the sutures described herein can be used to create a prosthetic valve. In certain embodiments, the multiple openings are braided within the suture. In such embodiments, the multiple openings are formed by braiding. In still other embodiments, the multiple openings are formed by combining two or more threads and fusing them together to form the desired openings. It should further be understood that in the methods disclosed herein, the prosthetic valve can include any of the components described above. It should further be understood that any of the attachment members described above can be used to connect the suture to any of the prosthetic valve components.

[0060] Also disclosed herein are kits including at least one suture having a suture with a longitudinal axis and a transverse axis perpendicular to the longitudinal axis, at least a portion of the suture including a plurality of openings, each of the plurality of openings configured to receive an attachment member for attaching the suture to an object. It should be understood that these kits can be used in any known application requiring the attachment of two or more members. In yet another aspect, the kits disclosed herein can be used in any known application requiring the attachment member to be protected from tearing or any other damage. For example, but not limited to, the object to which the suture is configured to be attached can include fabric, tissue, a prosthetic valve, or any combination thereof. In yet another aspect, the suture present in the kit is configured to be a reinforcing member. In other aspects, the suture does not act as a reinforcing member, but is merely used as a member configured to attach various components of an object.

[0061] Any of the sutures described herein may be present in the disclosed kits. In certain embodiments, a first attachment member may also be present in the kit. In other embodiments, the first attachment member is not part of the kit, and any attachment member known in the art suitable for the desired application may be used. In certain embodiments, the first attachment member may comprise one or more stitches, a flexible connector, or any combination thereof. In yet other embodiments, the suture present in the kit comprises a centerline positioned along its length. In some exemplary embodiments, a plurality of openings may be positioned within at least a portion of the centerline of the suture. In other embodiments, a plurality of openings may be positioned along the entire length of the suture. In alternative embodiments, each of the plurality of openings is spaced apart by a spacing increment d along the length of the suture. It should be understood that in some embodiments, the spacing increment d between any two adjacent openings of the plurality of openings is the same. In other embodiments, the spacing increment d between any two adjacent openings of the plurality of openings is different. In yet another embodiment, the sutures present in the kit can comprise polyester material, polyethylene, ultra-high molecular weight polyethylene, silicone, polyurethane, Teflon, polyetheretherketone (PEEK), or natural tissue, or combinations thereof. In yet another embodiment, the suture comprises multiple openings that can be braided within the suture. In other embodiments, the suture can comprise two or more cords fused together to form multiple openings.

[0062] (Exemplary Embodiment) Example 1 1. A prosthetic valve comprising at least one reinforcing member configured to be attached to one or more components of the prosthetic valve with a first attachment member, wherein the at least one reinforcing member comprises a suture having a longitudinal axis and a transverse axis perpendicular to the longitudinal axis, at least a portion of the suture comprising a plurality of openings, each of the plurality of openings configured to receive a first attachment member for coupling the suture to the prosthetic valve.

[0063] Example 2 The prosthetic valve of any embodiment herein, particularly embodiment 1, wherein the first attachment member comprises one or more stitches.

[0064] Example 3 The prosthetic valve of any of the embodiments herein, particularly embodiment 1 or 2, wherein the suture comprises a centerline positioned along the longitudinal axis thereof.

[0065] Example 4 The prosthetic valve of any of the embodiments herein, particularly embodiment 3, wherein the plurality of openings are positioned within at least a portion of a centerline of the suture.

[0066] Example 5 The prosthetic valve of any of the embodiments herein, particularly embodiments 1 to 4, wherein each of the plurality of openings is spaced apart by a spacing increment d along the length of the suture.

[0067] Example 6 The prosthetic valve of any example herein, particularly example 5, wherein the spacing increment d between any two adjacent openings of the plurality of openings is the same.

[0068] Example 7 The prosthetic valve of any of the Examples herein, particularly Example 5, wherein the spacing increments d between any two adjacent openings of the plurality of openings are different.

[0069] Example 8 The prosthetic valve of any of the embodiments herein, particularly embodiments 1 to 7, wherein the suture comprises a polyester material, polyethylene, ultra-high molecular weight polyethylene, silicone, polyurethane, Teflon, polyetheretherketone (PEEK), or native tissue, or a combination thereof.

[0070] Example 9 The prosthetic valve of any of the embodiments herein, particularly embodiments 1 to 8, wherein the plurality of openings are braided within the suture.

[0071] Example 10 The prosthetic valve of any of the embodiments herein, particularly embodiments 1 to 8, wherein the suture comprises two or more cords fused together to form multiple openings.

[0072] Example 11 The prosthetic valve of any of the embodiments herein, particularly embodiments 1 to 10, wherein one or more components of the prosthetic valve comprise a leaflet, a skirt, a support layer, a frame, or any combination thereof.

[0073] Example 12 The prosthetic valve of any of the embodiments herein, particularly embodiments 1 to 11, further comprising an annular frame having an inflow end, an outflow end, and a central longitudinal axis extending from the inflow end to the outflow end.

[0074] Example 13 12. The prosthetic valve of any of the Examples herein, particularly Examples 1 to 11, further comprising one or more leaflets, each of the one or more leaflets having a first surface and an opposing second surface, a leaflet inflow edge, and a leaflet outflow edge.

[0075] Example 14 The prosthetic valve of any embodiment herein, particularly embodiment 13, wherein the leaflet inflow edge is at least partially positioned outside the frame.

[0076] Example 15 The prosthetic valve of any of the embodiments herein, particularly embodiment 13 or 14, wherein the leaflet outflow edges are positioned within the frame.

[0077] Example 16 The prosthetic valve of any of the embodiments herein, particularly embodiments 13 to 15, wherein at least a portion of the leaflet inflow edge is not supported by the frame.

[0078] Example 17 The prosthetic valve of any of the Examples herein, particularly Examples 13 to 16, wherein at least one reinforcing member is positioned adjacent to the first surface or the second surface of one or more leaflets along the leaflet inflow edge.

[0079] Example 18 The prosthetic valve of any of the Examples herein, particularly Examples 13 to 17, wherein at least one reinforcing member is positioned adjacent a first surface of one or more leaflets along the leaflet inflow edge and at least one reinforcing member is positioned adjacent a second surface of one or more leaflets along the leaflet inflow edge, whereby one or more leaflets are sandwiched between the two reinforcing members.

[0080] Example 19 The prosthetic valve of any of the embodiments herein, particularly embodiments 13 to 18, wherein the valve comprises at least two leaflets, and wherein every two of the adjacent leaflets are fixed to one another.

[0081] Example 20 The prosthetic valve of any of the Examples herein, particularly Example 19, wherein at least one reinforcing member is positioned adjacent to the first and / or second surface of each of at least two valve leaflets such that the attachment members pass through the multiple openings in the suture to secure the adjacent leaflets to one another.

[0082] Example 21 The prosthetic valve of any of the embodiments herein, particularly embodiments 12 to 20, further comprising an inner skirt having a first portion extending circumferentially about the central longitudinal axis along an inner surface of the frame and supported by the frame, and a second portion extending circumferentially about the central longitudinal axis outside the frame and not supported by the frame.

[0083] Example 22 The prosthetic valve of any of the embodiments herein, particularly embodiment 21, wherein the reinforcing member is positioned between one or more leaflets and at least a portion of the inner skirt such that the attachment member passes through the plurality of stitches to secure the one or more leaflets to at least a portion of the inner skirt.

[0084] Example 23 The prosthetic valve of any of the embodiments herein, particularly embodiment 21 or 22, wherein one or more leaflets are sandwiched between at least two reinforcing members and at least a portion of the inner skirt.

[0085] Example 24 The prosthetic valve of any of the Examples herein, particularly Examples 13 to 23, wherein the at least one reinforcing member is positioned adjacent to at least a portion of the inflow edge of one or more leaflets such that the second attachment member passes through the plurality of openings to secure at least a portion of the inflow edge of the one or more leaflets to the frame.

[0086] Example 25 The prosthetic valve of any embodiment herein, particularly embodiment 24, wherein the second attachment member is the same as or different from the first attachment member.

[0087] Example 26 The prosthetic valve of any of the embodiments herein, particularly embodiments 13 to 15, wherein each of the one or more leaflets is secured to one or more components of the prosthetic valve with at least one reinforcing member.

[0088] Example 27 1. A method comprising the steps of providing at least one reinforcing member and attaching the at least one reinforcing member to one or more components of a prosthetic valve with a first attachment member, wherein the at least one reinforcing member comprises a suture having a longitudinal axis and a transverse axis perpendicular to the longitudinal axis, at least a portion of the suture comprising a plurality of openings, each of the plurality of openings configured to receive a first attachment member to couple the suture to the prosthetic valve.

[0089] Example 28 The method of any embodiment herein, particularly embodiment 27, wherein the first attachment member comprises one or more stitches.

[0090] Example 29 The method of any embodiment herein, particularly embodiment 27 or 28, wherein the suture comprises a centerline positioned along its longitudinal axis.

[0091] Example 30 The method of any embodiment herein, particularly embodiment 29, wherein the plurality of openings are positioned within at least a portion of a centerline of the suture.

[0092] Example 31 The method of any embodiment herein, particularly embodiments 27-30, wherein each of the plurality of openings is spaced apart along the length of the suture by spacing increments d.

[0093] Example 32 The method of any example herein, particularly example 31, wherein the spacing increment d between any two adjacent openings of the plurality of openings is the same.

[0094] Example 33 The method of any example herein, particularly example 31, wherein the spacing increments d between any two adjacent openings of the plurality of openings are not the same.

[0095] Example 34 The method of any of the embodiments herein, particularly embodiments 27 to 33, wherein the suture comprises a polyester material, polyethylene, ultra-high molecular weight polyethylene, silicone, polyurethane, Teflon, polyetheretherketone (PEEK), or natural tissue, or a combination thereof.

[0096] Example 35 The method of any of the embodiments herein, particularly embodiments 27 to 34, wherein the plurality of openings are knitted within a suture.

[0097] Example 36 The method of any embodiment herein, particularly embodiments 27 to 35, wherein the suture comprises two or more cords fused together to form a plurality of openings.

[0098] Example 37 The method of any of the embodiments herein, particularly embodiments 27 to 36, wherein one or more components of the prosthetic valve comprise a leaflet, a skirt, a support layer, a frame, or any combination thereof.

[0099] Example 38 The method of any of the embodiments herein, particularly embodiments 27 to 37, wherein the prosthetic valve comprises an annular frame having an inflow end, an outflow end, and a central longitudinal axis extending from the inflow end to the outflow end.

[0100] Example 39 The method of any of the Examples herein, particularly Examples 27 to 38, wherein the prosthetic valve comprises one or more leaflets, each of the one or more leaflets having a first surface and an opposing second surface, a leaflet inflow edge, and a leaflet outflow edge.

[0101] Example 40 The method of any embodiment herein, particularly embodiment 39, wherein the leaflet inflow edge is at least partially positioned outside the frame.

[0102] Example 41 The method of any embodiment herein, particularly embodiment 39 or 40, wherein the leaflet outflow edge is positioned within the frame.

[0103] Example 42 The method of any of the embodiments herein, particularly embodiments 39 to 41, wherein at least a portion of the leaflet inflow edge is not supported by the frame.

[0104] Example 43 The method of any of the embodiments herein, particularly embodiments 39 to 42, wherein at least one reinforcing member is attached to the first surface or the second surface of one or more leaflets along the leaflet inflow edge.

[0105] Example 44 The method of any of the embodiments herein, particularly embodiments 39 to 43, wherein at least one reinforcing member is attached to a first surface of one or more leaflets along the leaflet inflow edge and at least one reinforcing member is attached to a second surface of one or more leaflets along the leaflet inflow edge, whereby one or more leaflets are sandwiched between the two reinforcing members.

[0106] Example 45 The method of any of the embodiments herein, particularly embodiments 39 to 44, wherein the prosthetic valve comprises at least two leaflets, and two adjacent leaflets are fixed to each other.

[0107] Example 46 The method of any example herein, particularly example 45, wherein at least one reinforcing member is positioned adjacent to the first and / or second surface of each of at least two valve leaflets such that the attachment members pass through the multiple openings in the suture to secure the adjacent leaflets to one another.

[0108] Example 47 The method of any of the embodiments herein, particularly embodiments 38 to 46, wherein the prosthetic valve further comprises an inner skirt having a first portion extending circumferentially about the central longitudinal axis along an inner surface of the frame and supported by the frame, and a second portion extending circumferentially about the central longitudinal axis outside the frame and not supported by the frame.

[0109] Example 48 The method of any embodiment herein, particularly embodiment 47, wherein a reinforcing member is attached to be positioned between one or more leaflets and at least a portion of the inner skirt to secure the one or more leaflets to at least a portion of the inner skirt, and a first attachment member passes through the plurality of stitches to attach the reinforcing member.

[0110] Example 49 The method of any embodiment herein, particularly embodiment 47 or 48, wherein the one or more leaflets are sandwiched between at least two reinforcing members and at least a portion of the inner skirt.

[0111] Example 50 The method of any of the embodiments herein, particularly embodiments 39-49, wherein at least one reinforcing member is attached adjacent to at least a portion of the inflow edge of one or more leaflets such that at least a portion of the inflow edge of the one or more leaflets is secured to the frame, and a second attachment member passes through the plurality of openings to attach the reinforcing member.

[0112] Example 51 The method of any embodiment herein, particularly embodiment 50, wherein the second attachment member is the same as or different from the first attachment member.

[0113] Example 52 The method of any of the embodiments herein, particularly embodiments 39 to 51, wherein each of the one or more valve leaflets is attached to one or more components of the prosthetic valve with at least one reinforcing member.

[0114] Example 53 A kit comprising at least one suture having a suture having a longitudinal axis and a transverse axis perpendicular to the longitudinal axis, at least a portion of the suture comprising a plurality of openings, each of the plurality of openings configured to receive an attachment member for coupling the suture to an object.

[0115] Example 54 The kit of any example herein, particularly example 53, wherein the first attachment member comprises one or more stitches, a flexible connector, or any combination thereof.

[0116] Example 55 The kit of any example herein, particularly example 53 or 54, wherein the suture comprises a centerline positioned along the longitudinal axis thereof.

[0117] Example 56 The kit of any example herein, particularly example 55, wherein the plurality of openings are positioned within at least a portion of a centerline of the suture.

[0118] Example 57 The kit of any example herein, particularly Examples 53 to 56, wherein each of the plurality of openings is spaced apart along the length of the suture by spacing increments d.

[0119] Example 58 The kit of any example herein, particularly Example 57, wherein the spacing increment d between any two adjacent openings of the plurality of openings is the same.

[0120] Example 59 The kit of any example herein, particularly Example 57, wherein the spacing increments d between any two adjacent openings of the plurality of openings are not the same.

[0121] Example 60 The kit of any example herein, particularly Examples 53 to 59, wherein the suture comprises a polyester material, polyethylene, ultra-high molecular weight polyethylene, silicone, polyurethane, Teflon, polyetheretherketone (PEEK), or natural tissue, or a combination thereof.

[0122] Example 61 The kit of any embodiment herein, particularly embodiments 53 to 60, wherein the plurality of openings are braided within a suture.

[0123] Example 62 The kit of any example herein, particularly examples 53 to 61, wherein the suture comprises two or more cords fused together to form multiple openings.

[0124] Example 63 The kit of any of the embodiments herein, particularly embodiments 53 to 62, wherein the object comprises a prosthetic valve.

[0125] Example 64 The kit of any embodiment herein, particularly embodiments 53 to 63, wherein the suture is the reinforcing member.

[0126] In view of the many possible embodiments to which the principles of the disclosed disclosure may be applied, it should be understood that the illustrated embodiments are merely some examples of the disclosure and should not be construed as limiting the scope of the disclosure. Rather, the scope of the disclosure is defined by the following claims. Accordingly, we claim as our disclosure all that comes within the scope and spirit of these claims. [Explanation of symbols]

[0127] 10. Artificial Heart Valves 12 Stent or frame 14 Heart valve structure 16 Inner skirt or sealing member 18 Outer skirt or sealing member 20 leaflets 22 Inlet end 24 Outlet end 26 Central Longitudinal Axis 28 Posts 30 pillars 32 Pillar 34 Post 36 Window frame part 38 Seam Window 40 pillars 42 Aperture 44 Aperture 46 Aperture 48 Upper (outflow) free edge 50 Upper tab 52 Notch 54 Bottom tab 56 Lower edge part 59 Opening 60 Vertical or axial edge portion 61 first mounting member 62 Middle edge part 64 Vertex part 66 Slope section 68 Sutures 70 Mounting material 72 Scallop Line 74 Seams 78 Unsupported Parts 80 Inlet end 82 Outlet end 84 First Part 100 sutures 101 Horizontal axis 102 Center line 103 Longitudinal axis 104 Opening 105 Braided Yarn 107 Braided Yarn 110 Support Layer 112 First Part 114 Second Part

Claims

1. A frame (12); one or more valve leaflets (20), each of the one or more valve leaflets (20) having a first surface and an opposite second surface, a leaflet inflow edge (56), and a leaflet outflow edge, the leaflet inflow edge (56) being at least partially positioned outside the frame (12); at least one reinforcing member (100) configured to be attached to one or more components of a prosthetic valve with a first attachment member (61, 70), said one or more components of the prosthetic valve including a valve leaflet (20); An artificial valve comprising: said at least one reinforcing member (100) comprising a suture having a longitudinal axis (103) and a transverse axis (101) perpendicular to said longitudinal axis (103); At least a portion of the suture comprises a plurality of openings (104); each of the plurality of openings (104) configured to receive the first attachment member (61, 70) for coupling the suture to one or more components of the prosthetic valve; the at least one reinforcing member (100) is positioned adjacent a first surface or a second surface of the one or more leaflets (20) along the leaflet inflow edge (56); each of the plurality of openings (104) being spaced apart at spacing increments d along the length of the suture; The artificial valve, wherein the spacing increments d between any two adjacent openings of the plurality of openings (104) are different.

2. The prosthetic valve of claim 1 , wherein the first attachment member (61, 70) comprises one or more stitches.

3. The suture has a centerline (102) positioned along its longitudinal axis (103).

3. The prosthetic valve of claim 1 or 2, wherein optionally, a plurality of openings (104) are positioned within at least a portion of the centerline (102) of the suture.

4. 4. The prosthetic valve of any one of claims 1 to 3, wherein the suture comprises a polyester material, polyethylene, ultra-high molecular weight polyethylene, silicone, polyurethane, Teflon, polyetheretherketone (PEEK), natural tissue, or a combination thereof.

5. 5. The prosthetic valve of claim 1, wherein the plurality of openings (104) are braided within the suture or the suture comprises two or more cords fused together to form the plurality of openings (104).

6. 6. The prosthetic valve of claim 1, wherein the frame (12) comprises an annular frame (12) having an inflow end (22), an outflow end (24), and a central longitudinal axis (26) extending from the inflow end (22) to the outflow end (24).

7. The prosthetic valve of claim 6, wherein the leaflet outflow edge is positioned within the frame (12).

8. The prosthetic valve of claim 7, wherein at least a portion of the leaflet inflow edge (56) is unsupported by the frame (12).

9. 9. The prosthetic valve of claim 8, wherein the reinforcing member (100) comprises two reinforcing members (100), the two reinforcing members (100) comprising a first reinforcing member (100) positioned adjacent a first surface of the one or more leaflets along the leaflet inflow edge (56) and a second reinforcing member (100) positioned adjacent a second surface of the one or more leaflets along the leaflet inflow edge (56), whereby the one or more leaflets (20) are sandwiched between the two reinforcing members (100).

10. The artificial valve comprises at least two leaflets (20), with each two adjacent leaflets (20) fixed to one another; 10. The prosthetic valve of claim 9, wherein optionally, the at least one reinforcing member (100) is positioned adjacent a first surface or a second surface of each of the at least two valve leaflets (20) such that an attachment member passes through the plurality of openings (104) in the suture to secure the adjacent valve leaflets (20) to one another.

11. an inner skirt (16) having a first portion (84) extending circumferentially about the central longitudinal axis (26) along an inner surface of the frame (12) and supported by the frame (12), and a second portion (78) extending circumferentially about the central longitudinal axis (26) outside the frame (12) and not supported by the frame; 11. The prosthetic valve of claim 6, wherein optionally, the reinforcing member (100) is positioned between the one or more leaflets (20) and at least a portion of the inner skirt (16), whereby the one or more leaflets (20) are secured to at least a portion of the inner skirt (16) with attachment members passing through a plurality of openings (104).

12. The prosthetic valve of claim 11, wherein the one or more leaflets (20) are sandwiched between the at least two reinforcing members (100) and at least a portion of the inner skirt (16).

13. The prosthetic valve of claim 12, wherein each of the one or more leaflets (20) is secured to one or more components of the prosthetic valve with at least one reinforcing member (100).

14. A method for making an artificial valve according to any one of claims 1 to 13, comprising: providing at least one reinforcing member (100); Attaching the at least one reinforcing member (100) to one or more components of a prosthetic valve with a first attachment member (61, 70); A method comprising: The prosthetic valve comprises a frame (12) and one or more leaflets (20), each of the one or more leaflets (20) having a first surface and an opposing second surface, a leaflet inflow edge (56), and a leaflet outflow edge; the leaflet inflow edge (56) is positioned at least partially outside the frame (12); the one or more components of the prosthetic valve include a valve leaflet (20); the at least one reinforcing member (100) comprises a suture having a longitudinal axis (103) and a transverse axis perpendicular to the longitudinal axis (103), at least a portion of the suture comprising a plurality of openings (104); each of the plurality of openings (104) configured to receive the first attachment member (61, 70) for coupling the suture to one or more components of the prosthetic valve; at least one reinforcing member (100) positioned adjacent a first or second surface of said one or more leaflets (20) along said leaflet inflow edge (56); each of the plurality of openings (104) being spaced apart at spacing increments d along the length of the suture; A method wherein the spacing increment d between any two adjacent openings of said plurality of openings (104) is different.

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