Furcated sutures, articles comprising the same, and methods of making and using the same

Abstract

Disclosed herein is a furcated suture comprising a first portion comprising two or more core yarns and a body yarn, wherein the furcated suture comprises a second portion comprising two or more branches, and wherein each branch comprises at least one yarn of the two or more core yarns of the first portion. Also disclosed are delivery systems and devices utilizing the described herein furcated sutures. Methods of making the same are also enclosed.

Description

FURCATED SUTURES, ARTICLES COMPRISING THE SAME, AND METHODS OF MAKING AND USING THE SAMECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Patent Application No. 63 / 660,717, filed June 17, 2024, the entire disclosure which is incorporated by reference for all purposes.TECHNICAL FIELD

[0002] The present invention relates generally to furcated sutures and their use in medical devices. Particularly, the present invention relates to furcated sutures and their use as a release mechanism for the implantation of prosthetic heart valves.BACKGROUND

[0003] 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 inhibit 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 prosthetic valve leaflets that are connected to an expandable frame that is then delivered to the native valve’s annulus.

[0005] Development of prostheses, including but not limited to replacement heart valves that can be compacted for delivery7and then controllably expanded for controlled placement, has proven to be particularly challenging. An additional challenge relates to the ability of such prostheses to be secured relative to intraluminal tissue, e.g., tissue within any body lumen or cavity, in an atraumatic manner.

[0006] Delivering a prosthesis to a desired location in the human body, for example, delivering a replacement heart valve to the mitral valve or tricuspid valve, can also be- 7 -challenging. Obtaining access to perform procedures in the heart or other anatomical locations may require the delivery of devices percutaneously through tortuous vasculature or through open or semi-open surgical procedures. The ability to control the deployment of the prosthesis at the desired location can also be challenging.

[0007] These needs and others are at least partially satisfied by the present disclosure.SUMMARY

[0008] Some of the aspects of the present disclosure relate to sutures for use in medical devices. In certain aspects, the disclosed sutures are furcated sutures. Also disclosed are articles comprising such sutures and methods of making the same.

[0009] Some aspects relate to a furcated suture comprising: a first portion having a first proximal end and a first distal end and a first predetermined length therebetween, wherein the first distal end defines a furcation point, a second portion having a second proximal end and a second distal end, and a second predetermined length therebetween, wherein the second proximal end defines two or more branches extending from the furcation point; wherein the first portion comprises two or more core yarns and a body yarn that encompasses the two or more core yarns; wherein each of the two or more core yarns of the first portion separately extends into each of the two or more branches of the second portion at the furcation point, wherein each of the two or more core yarns in the each of the tw o or more branches is encompassed into a body yarn that is a continuation of the body yarn of the first portion.

[0010] In still further aspects, the disclosed herein furcated sutures can be a braid, a woven article, a knitted article, or a combination thereof.

[0011] Also disclosed is a delivery system for an implant comprising one or more of any of the disclosed herein furcated sutures.

[0012] Yet still further disclosed is a device comprising one or more of any of the disclosed herein furcated sutures.

[0013] Still further disclosed is a system comprising: a prosthetic heart valve including a frame and a plurality of leaflets disposed within a lumen of the frame; a delivery catheter having an elongated shaft for advancing the prosthetic heart valve through a patient’s vasculature to the native atrioventricular valve; a tether assembly extending through the elongate shaft of the delivery catheter and comprising a plurality of coupling tethers disposed along a distal end portion of the tether assembly, the coupling tethers sized to extend through openings in the prosthetic heart valve; and a release assembly comprising one or more of any of the disclosed herein furcated sutures, wherein the one or more furcated sutures is configured to extend through loop portions of the coupling tethers to secure theprosthetic heart valve to the tether assembly, wherein the one or more furcated sutures are retractable for removal from the one or more loop portions and thereby allowing the tether assembly to be released from the prosthetic heart valve; wherein the prosthetic heart valve is deployed and allowed to expand and operate while still attached to the tether assembly and wherein the prosthetic heart valve is released from the tether assembly after confirming proper deployment and operation within the native atrioventricular valve.

[0014] Also is disclosed a method of making the one or more of any of the disclosed herein furcated sutures, wherein the method comprises a step of a continuous braiding, weaving, or knitting of a continuous furcated suture, wherein the continuous braiding, weaving, or knitting comprises: (a) forming the first portion having a proximal and distal end and the first predetermined length therebetween, (b) forming a furcation point at the distal end of the first portion, (c) forming a second portion having a proximal end and the second predetermined length, wherein the proximal end is defined by the furcation point and wherein the second portion comprises two or more branches; (d) converging the two or more branches to a converging point, wherein a converging portion of the two or more branches has a predetermined converging length and (e) wherein the converging point extends into a further first portion of a further predetermined length.

[0015] 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 exemplaiy and explanatory only and are not restrictive of the disclosure as disclosed.BRIEF DESCRIPTION OF THE DRAWINGS

[0016] FIGURE 1 shows an exemplary furcated suture.

[0017] FIGURES 2A-2B show an exemplary structure of the furcated suture shown in FIG. 1.

[0018] FIGURES 2C-2D show exemplary furcated suture structures in a different aspect.

[0019] FIGURE 2E shows an exemplary furcated suture structure in a different aspect.

[0020] FIGURES 3A-3B show an exemplary method of making the furcated suture shown in FIG. 1.

[0021] FIGURE 4 shows an exemplary valve having a release assembly comprising one or more furcated sutures shown in FIG. 1.

[0022] FIGURES 5A-5B show a schematic of the furcated suture shown in FIG. 1 extending through loop portions of exemplary coupling tethers in a valve shown in FIG. 4.

[0023] FIGURE 6 shows a schematic of the release assembly shown in FIG.4 when activated.

[0024] FIGURES 7A-7C show a schematic of exemplary furcated sutures in a different aspect.DETAILED DESCRIPTION

[0025] The present disclosure can be understood more readily by reference to the follow! ng detailed description, examples, drawings, and claims, and their previous and follow ing 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.

[0026] The following description of the disclosure is provided as an enabling teaching of the disclosure in its best, currently known aspect. To this end, those skilled in the relevant art will recognize and appreciate that many changes can be made to the various aspects of the disclosure described herein while still obtaining the beneficial results of the present disclosure. It will also be apparent that some of the desired benefits of the present disclosure can be obtained by selecting some of the features of the present disclosure without utilizing other features. Accordingly, those of ordinary skill in the pertinent art will recognize that many modifications and adaptations to the present disclosure are possible and can even be desirable in certain circumstances and are a part of the present disclosure. Thus, the folio-wing description is again provided as illustrative of the principles of the present disclosure and not in limitation thereof.DEFINITIONS

[0027] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Thus, for example, reference to a “yarn” includes aspects having two or more such yarns unless the context clearly indicates otherwise.

[0028] 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.”

[0029] For the terms “for example,” “exemplary ,” and “such as,” and grammatical equivalences thereof, the phrase “and without limitation” is understood to follow^ unless explicitly stated otherwise.

[0030] Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It w ill be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint and independently of the other endpoint. Unless stated otherwise, the term “about” means within 5% (e.p., within 2% or 1%) of the particular value modified by the term “about.”

[0031] 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,” w hether or not expressly stated to be such. Where “about,” “approximate,” or “at or about” is used before a quantitative value, the parameter also includes the specific quantitative value itself unless expressly stated otherwise.

[0032] 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.

[0033] 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, e.g., 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, e.g., ‘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 w ell as the ranges of ‘greater than x,’ greater than y,’ ‘greater than z,’ or ‘greater than about x,’ greater than about y,’ ‘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’.

[0034] 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 (e.g., 1%, 2%, 3%, and 4%) and the sub-ranges (e.g., 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.

[0035] Further, 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.

[0036] 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.

[0037] 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 t, 2, 3, 4, 5, 6, 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.

[0038] As used herein, the terms “optional” or “optionally” mean that the subsequently described event or circumstance can or cannot occur and that the description includes instances w here said event or circumstance occurs and instances where it does not.

[0039] Further, the terms “coupled” and “associated” generally mean electrically, electromagnetically, and / or physically (e.p., mechanically or chemically) coupled or linked and do not exclude the presence of intermediate elements between the coupled or associated items.

[0040] It will be understood that when an element is referred to as being “connected” or “coupled” to another element, it can be directly connected or coupled to the other element, or intervening elements can be present. In contrast, when an element is referred to as being “directly connected” or “directly coupled” to another element, there are no intervening elements present. Other words used to describe the relationship between elements or layers should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” “on” versus “directly on”).

[0041] It will be understood that the terms “first,” “second,” etc., can be used herein to describe various elements, components, regions, layers, and / or sections. These elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer, or section from another element, component, region, layer, or a section. Thus, a first element, component, region, layer, or section discussed below could be termed a second element, component, region, layer, or section without departing from the teachings of example aspects.

[0042] Spatially relative terms, such as,” “beneath,” “below,” “lower,” “above,” “upper,” “upward,” “downward,” “top,” “bottom,” and the like, can be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It wi 11 be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the term “below” can encompass both an orientation of above and below. The device can be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein are interpreted accordingly.

[0043] Terms such as “proximal,” “distal,” “radially outward,” “radially inward,” “outer,” “inner,” and “side” describe the orientation and / or location of portions of the components or elements within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the components or elements under discussion. Such terminology can include the words specifically mentioned above, derivatives thereof, and words of similar import.

[0044] As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items. It is also understood that the term “and / or” includes where one or another of the associated listed items is present, and the aspects where both of the associated listed items are present, or any combinations of the associated listed items are present.

[0045] The terms “fiber” and “filament” can be used interchangeably. The terms “fiber” (or “filament”) and “material comprising a plurality of fibers (filaments)” are used herein according to their broad and ordinary meanings and can refer to any natural or synthetic substance or material that is significantly longer than it is wide, including any elongate or relatively fine, slender, and / or threadlike piece, filament, cord, yarn, plie, strand, line, string, or portion thereof. Furthermore, “fiber” or “material comprising a plurality of fibers” can refer to a single filament or collectively to a plurality of filaments. Examples of material comprising a plurality of fibers in accordance with aspects of the present disclosure include but are not limited to any cloth, fabric, or textile. It is understood that in certain unlimiting aspects, the term “material comprising a plurality of fibers” can refer to cloth, fabric, textile, or interlocking-fiber material that can cover or form certain features of the disclosed devices.

[0046] The term “fiber,” as used herein, includes fibers of extreme or indefinite length (e.p., bulk continuous filaments) and fibers (or filaments of short length (e.c / ., staple fibers, filaments).

[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 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] 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.

[0050] Although the operations of exemplary aspects of the disclosed method can be described in a particular, sequential order for convenient presentation, it should beunderstood that disclosed aspects can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially can, in some cases, be rearranged or performed concurrently. Further, descriptions and disclosures provided in association w ith one particular aspect are not limited to that aspect and can be applied to any aspect disclosed.

[0051] Moreover, for the sake of simplicity, the attached figures cannot show the various ways (readily discernable, based on this disclosure, by one of ordinary skill in the art) in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses. Additionally, the description sometimes uses terms such as “produce” and “provide” to describe the disclosed method. These terms are high-level abstractions of the actual operations that can be performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are, based on this disclosure, readily discernible by one of ordinary skill in the art.SUTURES

[0052] Disclosed herein is a furcated suture comprising. In certain aspects, the furcated suture comprises a first portion having a first proximal end, a first distal end, and a first predetermined length therebetween. In still further aspects, the first distal end defines a furcation point. In still further aspects, the furcated suture comprises a second portion having a second proximal end and a second distal end and a second predetermined length therebetween. In such exemplary aspects, the second proximal end defines two or more branches extending from the furcation point.

[0053] An exemplary and unlimiting furcated suture too is shown in FIG. 1. The suture too has a first portion 102, a furcation point 106, and a second portion defined by three branches 104a, 104b, and 104c.

[0054] In still further aspects, the first portion comprises two or more core yarns and a body yarn that encompasses the two or more core yarns. In such exemplary’ aspects, each of the two or more core yarns of the first portion separately extends into each of the two or more branches of the second portion at the furcation point, wherein each of the two or more core yarns in the each of the two or more branches is encompassed into a body yarn that is a continuation of the body yarn of the first portion. An exemplary’ structure of the disclosed herein furcated suture can be seen in FIGs. 2A-2B. For example, as shown in FIG. 2A, the first portion 102 (or a main body’ of the suture) can comprise three core y arns 103 (FIG. 2B), that is encompassed by’ a body yarn 101 (FIG. 2B) and the second portion (or branches) 104 can comprise, for example, 3 branches 104a, 104b, 104c (FIG. 2A), where each of the branches comprises one core, extended from the first portion (1033-1030), where each coreis encompassed by a body yarn 101’ that is a continuation of the body yarn 101 of the first portion.

[0055] In still further aspects, a first predetermined length can be any length that is needed for the desired application. For example, and without limitations, if the suture is used in a release assembly, as disclosed below, the first predetermined length can have a length between 10 inches (25.4 cm) to too inches (254 cm), including exemplary values of 12 inches (30.5 cm), 15 inches (38.1 cm), 20 (50.8 cm) inches, 25 inches (63.5 cm), 30 inches (76.2 cm), 35 inches (88.9 cm), 40 inches (101.6 cm), 45 inches (114.3 cm), 50 inches (127 cm), 55 inches (139.7 cm), 60 inches (152.4 cm), 65 inches (165.1 cm), 70 inches (177.8 cm), 75 inches (190.5 cm), 80 inches (203.2 cm), 85 inches (215.9 cm), 90 inches (228.6 cm), and 95 inches (241.3 cm). In yet still further aspects, the first predetermined length can have any value that falls between any two foregoing values, or it can fall with i n a range formed by any foregoing values. For example, and without limitations, the first predetermined length can be 10 inches (25.4 cm) to 20 inches (50.8 cm), 10 inches (25.4 cm) to 40 inches (101.6 cm), 10 inches (25.4 cm) to 60 inches (152.4 cm), 10 inches (25.4 cm) to 80 inches (203.2 cm), 10 inches (25.4 cm) to 90 inches (228.6 cm), 12 inches (30.5 cm) to 100 inches (254 cm), 20 inches (50.8 cm) to 100 inches (254 cm), 40 (101.6 cm) inches to 100 inches (254 cm), 50 inches (127 cm) to 100 inches (254 cm), or 60 inches (152.4 cm) to 100 inches (254 cm). It is understood, however, that the first predetermined length is dependent on the application and can be less than 10 inches (25.4 cm) or more than 100 inches (254 cm).

[0056] In still further aspects, a second predetermined length can be any length that is needed for the desired application. In certain aspects, if desired, the first and predetermined lengths can be the same. In other aspects, the first predetermined length can be greater than the second predetermined length. In yet still further aspects, if it is needed for the application, the second predetermined length can be greater than the first predetermined length. For example, and without limitations, if the suture is used in a release assembly, as disclosed below, the second predetermined length can have a length between 5 inches (12.7 cm) to 20 inches (50.8 cm), including exemplary values of 6 inches (15.2 cm), 7 inches (17.8 cm), 8 inches (20.3 cm), 9 inches (22.9 cm), 10 inches (25.4 cm), 11 inches (27.9 cm), 12 inches (30.5 cm), 13 inches (33 cm), 14 inches (35. 6 cm), 15 inches (38.1 cm), 16 inches (40.6 cm), 17 inches (43.2 cm), 18 inches (45.7 cm), and 19 inches (48.3 cm). In yet still further aspects, the second predetermined length can have any value that falls between any two foregoing values, or it can fall within a range formed by any foregoing values. For example, and w ithout limitations, the second predetermined length can be 5 inches (12.7 cm) to 19 inches (48.39 cm), 5 inches (12.7 cm) to 15 inches (38.1 cm), 5 inches (12.7 cm) to 12 inches (30.5 cm), 5 inches (12.7 cm) to 10 inches (25.4 cm), 7 inches (17.8 cm) to 20 inches(50.8 cm), 10 inches (25.4 cm) to 20 inches (50.8 cm), 12 inches (27.9 cm) to 20 inches (50.8 cm), or 15 (38.1 cm) inches to 20 inches (50.8 cm). It is understood, however, that the first predetermined length is dependent on the application and can be less than 5 inches (12.7 cm) or more than 20 inches (50.8 cm).

[0057] In still further aspects, the number of core yarns in the first portion can be any number equal to or greater than 2. In certain aspects, the number of core yarns in the first portion can be 2, 3, 4, 5, 6, 7, 8, 9, 10, and so on. In still further aspects, the second portion can comprise a number of branches that is equal to or less than the number of core yarns present in the first portion. For example, the number of branches present in the second portion can be 2, 3, 4, 5, 6, 7, 8, 9, 10, and so on. In certain aspects, the number of cores in the first portion is larger than the number of branches in the second portion. In such aspects, each branch of the second portion can comprise more than one core. Yet, in still further aspects, when the number of cores in the first portion is greater than the number of branches in the second portion, the number of cores in each branch after the furcation can be the same or different.

[0058] In still further aspects, each of the two or more core yarns can comprise one or more yarns. For example, and without limitations, as shown in FIG. 2B, each of the three core yarns present in the suture comprises three yarns 103’ (103a’ in a second portion area, for example) combined together to form one core yarn 103. In still further aspects, the two or more core yarns can comprise one yarn. It is understood that regardless of how many yarns are present in each of the two or more core yarns, an overall denier of the one or more yarns of the two or more core yarns is 20 D to 900 D, including exemplary values of 30 D, 40 D, 50 D, 60 D, 80 D, too D, 120 D, 160 D, 180 D, 200 D, 220 D, 240 D, 260 D, 280 D, 300 D, 320 D, 340 D, 360 D, 380 D, 400 D, 420 D, 460 D, 480 D, 500 D, 520 D, 540 D, 560 D, 580 D, 600 D, 620 D, 660 D, 680 D, 700 D, 720 D, 740 D, 760 D, 780 D, 800 D, 820 D, 860 D, 880 D, 900 D, 920 D, 940 D, 960 D, and 980 D. The overall denier of the one or more yarns can fall between any two foregoing values or in a range formed by any two foregoing values. For example and without limitations, the overall denier of the one or more yarns can be 20 D to 900 D, 20 D to 850 D, 20 D to 800 D, 20 D to 740 D, 20 D to 700 D, 20 D to 600 D, 20 D to 500 D, 20 D to 400 D, 20 D to 300 D, 20 D to 250 D, 400 D to 900 D, 100 D to 900 D, 200 D to 900 D, 300 D to 900 D, 400 D to 900 D and so on. For example, and without limitations, each of the core yarns can have one yarn of 300 D, or three yarns, each has 100 D. It is understood that these are only exemplary aspects. In certain aspects, each of the core yarns can have one yarn, two yarns, three yarns, four yarns, and so on, depending on the final desired thickness of the suture. It is understood, however, that in the exemplary aspects disclosed above, the three yarns do not have to have the same denier. For example, if threeyarns are present in the core yarn, one can have too D, one can have 120 D, and one will have 180 D. Again, these numbers are only exemplary, and any combinations of yarn having an overall denier falling within the disclosed range can be used.

[0059] In certain aspects, yarn can be twisted or not twisted. In certain aspects, where more than one yarn is present, such individual yarns can have, for example, a Z twist. Yet in other aspects, when two or more yarns having Z twist are combined, the plied yarn can be then twisted in the S direction to improve the suture’s stability and rigidity. The opposite twist in the construction can also remove the liveliness of the final plied yarn. When a significant size of yarn is used as a core of braided structure, it adds longitudinal rigidity and stiffness to the suture. This stiffness can be useful when the suture is used in a release assembly as disclosed below, such that the release suture and the manifold do not pass through the eyelet of the frame apices.

[0060] In yet still further aspects, any of the disclosed herein yarns can be a monofilament or multifilament yarn. In aspects where the yarn is a multifilament yarn, it can comprise any number of filaments suitable for the desired application.

[0061] In yet in other aspects, each of the core yarns can have a different number of yarns. For example, if the first portion comprises three core yarns, one core yarn can have one yarn having a disclosed denier, another core yarn can have two yarns having an overall denier falling within the disclosed range, and the third yarn can have three yarns having an overall denier falling within the disclosed range.

[0062] In still further aspects, the one or more yarns present in each of the core yarns can be any yarn known in the art. In some aspects, the yarn is flat. Yet, in other aspects, the yarn is twisted. In aspects where the twisted yarn is present, the twisted yarn can have 0-15 twists per inch (TPI) (per 2.5 cm), including exemplary values of o, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15. It is understood that any number of twist that falls betw een any two foregoing values or fall within the range formed by any tw o foregoing values. For example, yarns can have 1-14 TPI, 1-12 TPI, 1-10 TPI, 1-8 TPI, 1-6 TPI, 1-4 TPI, 2-15 TPI, 5-15 TPI, 8-15 TPI, 10-15 TPI, 12-15 TPI, and so on.

[0063] In still further aspects, the body yarn that encompasses the two or more core yarns present in the first portion can comprise one or more yarns. In such aspects, an overall denier of the one or more yarns of the body yarns is 20 D to 900 D, including exemplaiy values of including exemplary values of 30 D, 40 D, 50 D, 60 D, 80 D, 100 D, 120 D, 160 D, 180 D, 200 D, 220 D, 240 D, 260 D, 280 D, 300 D, 320 D, 340 D, 360 D, 380 D, 400 D, 420 D, 460 D, 480 D, 500 D, 520 D, 540 D, 560 D, 580 D, 600 D, 620 D, 660 D, 680 D, 700 D, 720 D, 740 D, 760 D, 780 D, 800 D, 820 D, 860 D, 880 D, 900 D, 920 D, 940 D, 960 D, and980 D. The overall denier of the one or more yarns can fall between any two foregoing values or in a range formed by any two foregoing values. For example and w ithout limitations, the overall denier of the one or more yarns can be 20 D to 900 D, 20 D to 850 D, 20 D to 800 D, 20 D to 740 D, 20 D to 700 D, 20 D to 600 D, 20 D to 500 D, 20 D to 400 D, 20 D to 300 D, 20 D to 250 D, 400 D to 900 D, 100 D to 900 D, 200 D to 900 D, 300 D to 900 D, 400 D to 900 D and so on. For example, and without limitations, each of the body yarns can have one yarn of 300 D, or three yarns, each has too D. It is understood that these are only exemplary’ aspects. In certain aspects, each of the body yarns can have one yarn, two yarns, three yarns, four yarns, and so on, depending on the final desired thickness of the suture. It is understood, however, that in the exemplary aspects disclosed above, the three yarns do not have to have the same denier. For example, if three yarns are present in the body yarn, one can have too D, one can have 120 D, and one will have 180 D. Again, these numbers are only exemplary, and any combinations of yarn having an overall denier falling within the disclosed range can be used.

[0064] In still further aspects, the one or more yarns present in the body yarn can be any yarn know n in the art. In some aspects, the yarn is flat. Yet, in other aspects, the yarn is twisted. In aspects where the twisted yarn is present, the twisted yarn can have 0-15 twists per inch (TPI) (per 2.5 cm), including exemplary values of 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15. It is understood that any number of twists that falls betw een any two foregoing values or falls within the range formed by any two foregoing values. For example, yarns can have 1-14 TPI, 1-12 TPI, 1-10 TPI, 1-8 TPI, 1-6 TPI, 1-4 TPI, 2-15 TPI, 5-15 TPI, 8-15 TPI, 10-15 TPI, 12-15 TPI, and so on.

[0065] In still further aspects, each of the core yarns and / or body yarns can comprise one or more filaments comprising polyester, polyethylene, polyamide, polylactic acid, performance polylactic acid, or any combination thereof. For example, and without limitations, the polyester can comprise polyethylene terephthalate (PET) homopolymer and copolymers, HT PET, polypropylene terephthalate (PPT) homopolymer and copolymers and polybutylene terephthalate (PBT) homopolymer and copolymers, and the like, including those that contain comonomers such as cyclohexanedimethanol, cyclohexanedicarboxylic acid, isophthalic acid, and the like. In other aspects, polyethylene can comprise ultra-high molecular weight polyethylene (UHMWPE), LDPE, HDPE, PU, TPU, or any combination thereof. In still further aspects, the polyamide can comprise any know n type of Nylon (e.g., Nylon-6, Nylon-66, Nylon 6 / 6-6, Nylon 6 / 9, Nylon 6 / 10, Nylon 6 / 12, Nylon 11, and / or Nylon 12). In still further aspects, any of the disclosed herein yarns (core or body) can comprise aramid (e.g., Kevlar® aramid (DuPont), Technora® aramid (Teijin)), PTFE,ePTFE, carbon fiber, stainless steel, nitinol, superalloys (for example, cobalt-chromium alloys, e.g., UNS R30035 alloy (e.g., MP35N alloy (SPS Industries)), and so on.

[0066] In yet further aspects, each of the core yarns and / or body yarns can comprise a fully-drawn yarn, spin-drawn yarn, low- or not-twisted yarn, twisted yarn, a flat yarn, a textured yarn, a high (HS) stretch textured yarn, a high-bulk textured yarn, a high shrinkage yarn, flat braided yarn, round braided yarn, flat woven yarn, tubular woven yarn, or any combination thereof. In still further aspects, and as disclosed above, each yarn can be twisted in the Z direction, and plied yarn would need to get the opposite tw ist, e.g. S tw ist in this case. This will add bulk and stiffness if used in the core.

[0067] In still further aspects, the furcated suture can be a braid, a woven article, a knitted article, or a combination thereof. For example, and without limitations, the suture shown in FIG. 1 is a braided suture. However, it is understood that it can be a woven article or a knitted article or can comprise portions that are braided, woven, and / or knitted. In still further aspects, the suture disclosed herein is a braid.

[0068] In still further aspects, the braid can have any shape and any pattern. In certain exemplary and unlimiting aspects, the first portion and the second portion of the braid can have the same shape or different shapes. In still further aspects, the first portion and the second portion of the braid can have the same pattern or different patterns. In still further aspects, the first portion of the suture can have a substantially round shape and has a twill pattern, a flat braid, diamond pattern, plain braid, regular braid, hercules braid, flat braid, triaxial braid pattern, or any combination thereof. In still further aspects, the first portion of the braid can have 4 to 256 strands, including exemplary values of 6, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 172, 176, 180, 200, 220, 240, 256 In still further aspects, the braid can have 8 to 64 strands, 8 to 96 strands, or 16 to 144 strands, and so on. In still further aspects, each of the two or more branches of the second portion can be a braid having a substantially round shape and a twill pattern, a flat braid, a diamond pattern, a plain braid, a regular braid, a hercules braid, a flat braid, a triaxial braid pattern, or any combination thereof. In still further aspects, each of the two or more branches has a total amount of strands in the first portion divided by the number of branches in the second portion. Again, it is understood that while the exemplary aspects describe braid configuration, the suture’s main body (first portion) and the branches (second portion) can also be woven or knitted, or any combination thereof.

[0069] In still further aspects, the first portion has a pick density of to to 150, including a pick density of 10 to 120, to to too, to to 80, 10 to 50, 15 to 150, 20 to 150, 30 to 150 ppi, and so on. In still further aspects, the first portion can have any pick density value that falls within any of the disclosed values, for example, it can be 10, 15, 20, 25, 30, 35, 40, 45, 50, 55,60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, and 145. In still further aspects, the second portion has a pick density of 10 to 150, including a pick density of 10 to 120, 10 to too, 10 to 80, to to 50, 15 to 150, 20 to 150, 30 to 150 ppi, and so on. In still further aspects, the second portion can have any pick density value that falls within any of the disclosed values, for example, it can be 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, too, 105, 110, 115, 120, 125, 130, 135, 140, and 145.

[0070] In still further aspects, and as shown in FIG. 2C, the second distal end 105 of the second portion defines a distal end of each of the two or more branches. In certain aspects, the second distal end 105 of the second portion 104 forms a converging point 108, such that the two or more branches of the second portion converge into a third portion 112 (FIG. 2D). In such exemplary and unlimiting aspects, each core yarn of the two or more branches converge to form two or more core yarns of the third portion and wherein the body yarn encompassing each of the core yarns of the tw o or more branches converge to form a body yarn encompassing the two or more core yarns of the third portion. In such aspects, the third portion is defined by a proximal edge (that is equivalent to the converging point 108 and a distal edge (not show n in FIG. 2D), and a third predetermined length therebetween. In still further aspects, the third predetermined length is the same or different from the first and / or second predetermined lengths. An additional aspect of the furcated suture is illustrated in FIG. 2E. The main body 102 can have any of the disclosed above first predetermined lengths. The first portion 102 comprises 4 single-ply cores 103. When the bifurcated suture, e.g., the second portion 104 having 2 branches- 104 and 104 b, is formed, each of the branches can comprise two single-ply cores 103’. The branches then can further furcate at a second furcation point 106 to form two additional branches that then converge at converging point 108 into an additional portion 111. Again, it is understood that any of the disclosed herein portions can have any length as disclosed above. In such aspects, the length L, for example, can be smaller than the second predetermined length of the second portion. In this specific and unlimiting aspect, the first portion can be 16 strand end round braid, and each of the branches in the second portion can be 8 strand end round braid having 2 single-ply cores in each branch. The loop formed by the second furcation point 106’ and converging point 108 can have 6 total picks.

[0071] Also disclosed herein are additional furcated sutures. In such exemplary aspects, and as show n in FIG. 7A, the distal end 105 of at least one of the two or more branches 104 (show n as iO4a-tO4d) forms a second furcation point 106’ w here the least one of the tw o or more branches furcates to additional two or more branches 109a and 109b, for example, thereby forming a fourth portion having a proximal end and a distal end and a fourth predetermined length therebetween, w herein the proximal end is defined by the secondfurcation point. In still further aspects, and as shown in FIG. 7B, the distal end of the fourth portion 109a and 109b converges at converging point 108 into a fifth portion 115 haying a fifth predetermined length. It is understood that in such aspects, the first portion comprises a number of cores that allow this secondary furcation.

[0072] In such exemplary and unlimiting aspects, each of the additional two or more branches (109a and 109b, for example) of the fourth portion comprises at least one core yarn that is an extension of at least one of the core yarns in at least one of the two or more branches (104a for example) of the second portion. Yet in still further aspects, each of the additional two or more branches of the fourth portion comprises a body yarn that encompasses the at least one core yarn of the fourth portion. In still further aspects, the fifth portion 115 comprises a number of core yarns equal to a total core yarns in each of the additional two or more branches (109a and 109b) of the fourth portion. In still further aspects, the fifth portion 115 comprises a body yarn that is an extension of the body yarn encompassing the at least one core yarn of the fourth portion (formed, for example, by 109a and 109b).

[0073] FIG. 7C shows an additional aspect of the furcated suture, where the distal end (iO5a-tO5c) of each of the two or more branches (1043-1040) of the second portion loops back to the furcation point (106).

[0074] In still further aspects, any of the disclosed herein furcated sutures can be hot or cold stretched to substantially reduce residual elongation and / or constructional stretch of the suture.

[0075] It is understood that the sutures disclosed herein can be used in various applications. In certain aspects, the disclosed sutures are used in medical applications. In still further exemplary and unlimiting aspects, the sutures disclosed herein can be used in the systems for implant delivery . The disclosed sutures have exhibited many benefits that are not known in other sutures. For example, the first portion of the disclosed sutures exhibits a more stable and static structure when compared to the sutures prepared by different methods. Also, the disclosed sutures exhibit an increased tensile strength of the furcation point as compared to the other sutures known in the field and used for similar purposes. Still further, improved flexibility is observed at the furcation point of the suture when compared to the other sutures known in the field and used for similar purposes. The presence of the one or more core yarns provides a longitudinal rigidity of the suture as compared to the other sutures known in the field and used for similar purposes.

[0076] In still further aspects, the sutures disclosed herein can be used in a heart valve delivery system.

[0077] Also disclosed herein is a delivery7system comprising any of the disclosed herein sutures and a heart valve.

[0078] In certain aspects, and as schematically shown in FIG.4, disclosed is a system comprising a prosthetic heart valve 200 including a frame and a plurality of leaflets (not shown) disposed with in a lumen of the frame for allowing one-way flow of blood. Still further, the system comprises a delivery’ catheter 300 having an elongated shaft for advancing the prosthetic heart valve through a patient’s vasculature to the native atrioventricular valve. In still further aspects, the system comprises a tether assembly extending through the elongated shaft of the delivery catheter and comprising a plurality of coupling tethers 120 disposed along a distal end portion of the tether assembly, the coupling tethers 120 sized to extend through openings 124 in the prosthetic heart valve (FIG. 5A and 5B). In still further aspects, the system further comprises release assembly comprising any? of the disclosed herein one or more furcated sutures (1043-1040, FIG. 4, 104a, FIGs. 5A-5B). In the system disclosed herein, the one or more furcated sutures are configured to extend through loop portions 122 of the coupling tethers 120 (FIG. 5A) to secure the prosthetic heart valve to the tether assembly. In a still further aspect, the one or more furcated sutures are retractable for removal from the one or more loop portions and, thereby, allowing the tether assembly to be released from the prosthetic heart valve. The sutures disclosed herein and used for the release assembly’ are configured not to pass through the openings 124 in the prosthetic heart valve. The sutures present in the release assembly can be positioned such that the first portion of the furcated suture is positioned within the elongated shaft while the two or more branches extend through loop portions of coupling tethers. For example, and without limitations and as shown in FIGs. 4 and 6, the release assembly can comprise a trifurcated suture having branches tO4a-tO4b passing through the loops of coupling tethers 120. FIG. 6 shows the final stages of the release of the heart valve 200 by moving the release assembly (the branches of the furcated suture 1043-1040) from the loops of the coupling tethers.

[0079] In still further aspects, the disclosed delivery system allows the prosthetic heart valve to be deployed and to expand and operate w hile still attached to the tether assembly. In still further aspects, the prosthetic heart valve can be released from the tether assembly? after confirming proper deploy?ment and operation w?ithin the native atrioventricular valve.

[0080] A detailed description of the disclosed herein delivery systems and their exemplary components can be found in PCT Application No. PCT / US2023 / 085397, U.S. Provisional Applications No. 63 / 436051 and 63 / 533458, the contents of w?hich are incorporated herein in their whole entirety.

[0081] In still further aspects, the disclosed sutures can also be used in heart valve replacement and repair therapies, including, for example, mitral or tricuspid valve repair / replacement, transcatheter shunt therapies, and / or surgical valve repair / reconstruction.METHODS

[0082] In still further aspects disclosed herein are methods of making any of the described herein furcated sutures. In such aspects, the method comprises a step of continuous braiding, weaving, or knitting of a continuous furcated suture. It is further understood that if desired and if the intended application requires it, the methods can include steps combining continuous braiding, weaving, and / or knitting of the furcated suture. In still further aspects, the steps of the continuous braiding, weaving, and / or knitting can comprise: (a) forming the first portion having proximal and distal ends and the first predetermined length therebetween, (b) forming a furcation point at the distal end of the first portion, (c) forming a second portion having a proximal end and the second predetermined length, wherein the proximal end is defined by the furcation point and wherein the second portion comprises two or more branches; (d) converging the two or more branches to a converging point, wherein a converging portion of the tw o or more branches has a predetermined converging length and (e) wherein the converging point extends into a further first portion of a further predetermined length. The exemplary schematic of such a method is shown in FIGs. 3A-3B. For example, as shown in FIG. 3A, the first and second portions can be formed continuously, where the first portion furcates at a furcation point 106 to form a desired number of branches (three branches are formed in this particular example). The branches can then converge at the converging point 108 and extend again in the first portion of the next suture. It is further understood that an infinite number of sutures can be produced as desired. FIG 3B shows a close-up photograph showing the furcation point where core yarns are furcated into the branches and encompassed with the body yarn.

[0083] To form separate sutures, the branches are cut at the desired locations to form second portions of the predetermined length. In such aspects, the cutting of the continuous furcated suture at the second predetermined length of the second portion forms a distal end of the second portion. In still further aspects, the methods can comprise cutting the first portion formed in step e) at the further predetermined length to form the proximal end of the first portion.

[0084] It is understood that the cutting can be done by any known in the art methods that ensure the clean cut of the suture. The cut can also be done at any angle as desired, without any limitations. For example, and without limitations, the cutting steps can be done using laser cutting, ultrasonic cut, hot knife blade cutting, shears / scissors cutting, bladespinching together like wire cutters, or any combination thereof. It is further understood that if needed, each second distal end of each branch can be further hot sealed.

[0085] In still further aspects, also disclosed are methods of forming additional furcated sutures as described herein. In such aspects, the continuous process can include forming a fourth portion that results in furcating at least one of the two or more branches of the second portion before converging to form the further first portion. Yet in still further aspects, the continuous process can include forming the fifth portion as described above before again converging various branches to form the first portion.

[0086] In certain aspects, the predetermined converging length can be substantially identical to the second predetermined length. Yet, in other aspects, if the second predetermined length and the converging length do not have to be the same. In such aspects, however, after the cutting, when the converging length becomes a further second length, the branches of this suture can have a different further second length from the previous suture.

[0087] In still further aspects, the methods can comprise a hot or cold stretch of the furcated suture. In such aspects, the hot or cold stretch steps can be applied to remove constructional elongation from the braid and reduce residual elongation in the final suture. In such aspects, the heat and a set of rollers move at increasingly faster speeds to draw the suture along the long axis of the braid. In aspects where the braid is cold-stretched, the process comprises using a set of rollers without the application of heat. As a result, the proper mechanical displacement of the braided suture can be achieved.

[0088] A similar process can be adapted if the suture is woven or knitted.EXEMPLARY ASPECTS

[0089] In view of the described processes and compositions, herein below 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 furcated suture comprising: a first portion having a first proximal end and a first distal end, and a first predetermined length therebetween, wherein the first distal end defines a furcation point, a second portion having a second proximal end and a second distal end, and a second predetermined length therebetween, wherein the second proximal end defines two or more branches extending from the furcation point; wherein the first portion comprises two or more core yarns and a body yarn that encompasses the two or more core yarns; wherein each of the two or more core yarns of the first portion separatelyextends into each of the two or more branches of the second portion at the furcation point, wherein each of the two or more core yarns in the each of the two or more branches is encompassed into a body yarn that is a continuation of the body yarn of the first portion.

[0091] Example 2. The furcated suture of any one of the examples herein, particularly example 1, wherein the furcated suture is a braid, a woven article, a knitted article, or a combination thereof.

[0092] Example 3. The furcated suture of any one of the examples herein, particularly example 1 or 2, wherein each of the two or more core yarns comprise one or more yarns.

[0093] Example 4. The furcated suture of any one of the examples herein, particularly example 3, wherein an overall denier of the one or more yarns of the two or more core yarns is 20 D to 900 D.

[0094] Example 5. The furcated suture of any one of the examples herein, particularly example 3 or 4, wherein each of the two or more core yarns comprise one yarn having a denier of 20 D to 900 D.

[0095] Example 6. The furcated suture of any one of the examples herein, particularly example 3 or 4, wherein each of the two or more core yarns comprise two or more yarns wherein the overall denier of the two or more yarns is 20 D to 900 D, and wherein the denier of each of the two or more yarns is the same or different.

[0096] Example 7. The furcated suture of any one of the examples herein, particularly examples 3-6, wherein the one or more yarns are twisted having TPI of 0-15.

[0097] Example 8. The furcated suture of any one of the examples herein, particularly examples 1-7, wherein the body yarn comprises one or more yarns.

[0098] Example 9. The furcated suture of any one of the examples herein, particularly example 8, wherein an overall denier of the one or more yarns of the body yarns is 20 D to 800 D.

[0099] Example 10. The furcated suture of any one of the examples herein, particularly example 8 or 9, wherein the body yarn comprises one yarn having a denier of 20 D to 900 D.

[0100] Example 11. The furcated suture of any one of the examples herein, particularly example 8 or 9, wherein the body yarn comprises two or more yarns wherein the overall denier of the two or more yarns is 20 D to 900 D, and wherein the denier of each of the two or more yarns is the same or different.

[0101] Example 12. The furcated suture of any one of the examples herein, particularly any one of examples 8-11, wherein the one or more yarns are twisted having TPI of 0-15.

[0102] Example 13 The furcated suture of any one of the examples herein, particularly examples 2-12, wherein the suture is a braid.

[0103] Example 14. The furcated suture of any one of the examples herein, particularly example 13, wherein the first portion of the suture has a substantially round shape and has a twill pattern, a flat braid, diamond pattern, plain braid, regular braid, hercules braid, flat braid, triaxial braid pattern or any combination thereof, or any combination thereof.

[0104] Example 15. The furcated suture of any one of the examples herein, particularly example 13 or 14, wherein the first portion has 4 to 256 strands.

[0105] Example 16. The furcated suture of any one of the examples herein, particularly examples 13-15, wherein each of the two or more branches of the second portion is a braid having a substantially round shape and has a twill pattern, a flat braid, diamond pattern, plain braid, regular braid, hercules braid, flat braid, triaxial braid pattern or any combination thereof.

[0106] Example 17. The furcated suture of any one of the examples herein, particularly example 16, wherein each of the two or more branches has a total amount of strands in the first portion divided by a number of branches in the second portion.

[0107] Example 18. The furcated suture of any one of the examples herein, particularly examples 1-17, wherein the second portion has 2 to 10 branches.

[0108] Example 19. The furcated suture of any one of the examples herein, particularly examples 1-18, wherein the first predetermined length is greater than the second predetermined length.

[0109] Example 20. The furcated suture of any one of the examples herein, particularly examples 1-19, wherein the second distal end of the second portion defines a distal end of each of the two or more branches.

[0110] Example 21. The furcated suture of any one of the examples herein, particularly example 20, wherein the second distal end of the second portion forms a convergence point, such that the two or more branches of the second portion converge into a third portion.

[0111] Example 22. The furcated suture of any one of the examples herein, particularly example 21, wherein each core yarn of the two or more branches converge to form two or more core yarns of the third portion and wherein the body yarn encompassing each of the core yarns of the two or more branches converge to form a body yarn encompassing the two or more core yarns of the third portion.

[0112] Example 23. The furcated suture of any one of the examples herein, particularly example 21 or 22, wherein the third portion is defined by a proximal edge and a distal edge and a third predetermined length therebetween.

[0113] Example 24. The furcated suture of any one of the examples herein, particularly example 23, wherein the third predetermined length is the same or different from the first and / or second predetermined lengths.

[0114] Example 25. The furcated suture of any one of the examples herein, particularly example 20, wherein the distal end of at least one of the two or more branches forms a second furcation point where the least one of the two or more branches furcates to an additional two or more branches, thereby forming a fourth portion having a proximal end and a distal end and a fourth predetermined length therebetween, wherein the proximal end is defined by the second furcation point.

[0115] Example 26. The furcated suture of any one of the examples herein, particularly example 25, wherein the distal end of the fourth portion converges into a fifth portion having a fifth predetermined length.

[0116] Example 27. The furcated suture of any one of the examples herein, particularly example 25 or 26, wherein each of the additional two or more branches of the fourth portion comprise at least one core yarn that is an extension of the core yarn in at least one of the two or more branches of the second portion.

[0117] Example 28. The furcated suture of any one of the examples herein, particularly example 27, wherein each of the additional two or more branches of the fourth portion comprise a body yarn that encompasses the at least one core yarn of the fourth portion.

[0118] Example 29. The furcated suture of any one of the examples herein, particularly examples 27-28, wherein the fifth portion comprises a number of core yarns equal to a total core yarns in each of the additional two or more branches of the fourth portion.

[0119] Example 30. The furcated suture of any one of the examples herein, particularly examples 27-29, wherein the fifth portion comprises a body yarn that is an extension of the body yarn encompassing the at least one core yarn of the fourth portion.

[0120] Example 31. The furcated suture of any one of the examples herein, particularly examples 1-30, wherein the first portion has a pick density of 10 to 150 ppi.

[0121] Example 32. The furcated suture of any one of the examples herein, particularly examples 1-20, wherein the distal end of each of the two or more branches of the second portion loops back to the furcated point.

[0122] Example 33. The furcated suture of any one of the examples herein, particularly examples 1-32, wherein each of the core yarns and / or body yarns comprise one or more filaments comprising polyester, polyethylene, polyamide, polylactic acid, performance polylactic acid, aramid (e.p., Kevlar® aramid (DuPont), Technora® aramid (Teijin)), PTFE, ePTFE, carbon fiber, stainless steel, nitinol, superalloys (for example, cobalt-chromium alloys, e.g., UNS R30035 alloy (e.p., MP35N alloy (SPS Industries)), or any combination thereof.

[0123] Example 34. The furcated suture of any one of the examples herein, particularly examples 1-33, wherein each of the core yarns and / or body yarns comprises fully drawn yarn, monofilament, twisted, plied yarn, braided structure, or any combination thereof.

[0124] Example 35. The furcated suture of any one of the examples herein, particularly examples 1-33, wherein the furcated suture is hot or cold stretched to substantially reduce residual elongation and / or constructional stretch of the suture.

[0125] Example 36. A delivery system for an implant comprising one or more furcated sutures of any one of the examples herein, particularly examples 1-35.

[0126] Example 37. The delivery system of any one of the examples herein, particularly example 36, further comprising a heart valve.

[0127] Example 38. The delivery system of any one of the examples herein, particularly example 37, wherein the one or more furcated sutures are configured to ripcord release the heart valve at an implantation location.

[0128] Example 39. A device comprising one or more furcated sutures of any one of the examples herein, particularly examples 1-34.

[0129] Example 40. A system comprising: a prosthetic heart valve including a frame and a plurality of leaflets disposed within a lumen of the frame; a delivery catheter having an elongated shaft for advancing the prosthetic heart valve through a patient’s vasculature to the native atrioventricular valve; a tether assembly extending through the elongate shaft of the delivery catheter and comprising a plurality of coupling tethers disposed along a distal end portion of the tether assembly, the coupling tethers sized to extend through openings in the prosthetic heart valve; and a release assembly comprising one or more furcated sutures of any one of the examples herein, particularly examples 1-35, wherein the one or more furcated sutures is configured to extend through loop portions of the coupling tethers to secure the prosthetic heart valve to the tether assembly, wherein the one or more furcated sutures are retractable for removal from the one or more loop portions and thereby allowing the tether assembly to be released from the prosthetic heart valve; wherein the prosthetic heart valve is deployed and allowed to expand and operate while still attached to the tetherassembly and wherein the prosthetic heart valve is released from the tether assembly after confirming proper deployment and operation within the native atrioventricular valve.

[0130] Example 41. The system of any one of the examples herein, particularly example 40, wherein the release assembly comprises at least one trifurcated suture.

[0131] Example 42. A method of making the one or more furcated sutures of any one of the examples herein, particularly examples 1-57, wherein the method comprises a step of a continuous braiding, weaving, or knitting of a continuous furcated suture, wherein the continuous braiding, weaving, or knitting comprises: (a) forming the first portion having a proximal and distal ends and the first predetermined length therebetween, (b) forming a furcation point at the distal end of the first portion, (c) forming a second portion having a proximal end and the second predetermined length, wherein the proximal end is defined by the furcation point and wherein the second portion comprises two or more branches; (d) converging the two or more branches to a converging point, wherein a converging portion of the two or more branches has a predetermined converging length and (e) wherein the converging point extends into a further first portion of a further predetermined length.

[0132] Example 43. The method of any one of the examples herein, particularly example 42, further comprising continuously repeating steps (b) through (e) a predetermined number of times.

[0133] Example 44. The method of any one of the examples herein, particularly example 42 or 43, w herein the predetermined converging length is substantially identical to the second predetermined length.

[0134] Example 45. The method of any one of the examples herein, particularly examples 42-44, further comprising cutting the continuous furcated suture at the second predetermined length of the second portion to form a distal end of the second portion.

[0135] Example 46. The method of any one of the examples herein, particularly examples 42-45, further comprising cutting the first portion formed in step e) at the further predetermined length to form the proximal end of the first portion.

[0136] Example 47. The method of any one of the examples herein, particularly examples 42-46, further comprises a hot or cold stretch of the furcated suture.

[0137] 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 w-hich the disclosure pertains, havi ng 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 disclosedhereinabove 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 that follow. Therefore, we claim as our disclosure all that comes within the scope and spirit of these claims.

Claims

WHAT IS CLAIMED IS:

1. A furcated suture comprising: a first portion having a first proximal end and a first distal end, and a first predetermined length therebetween, wherein the first distal end defines a furcation point, a second portion having a second proximal end and a second distal end, and a second predetermined length therebetween, wherein the second proximal end defines two or more branches extending from the furcation point; and wherein the first portion comprises two or more core yarns and a body yarns that encompasses the two or more core yarns; wherein each of the two or more core yarns of the first portion separately extends into each of the two or more branches of the second portion at the furcation point, wherein each of the two or more core yarns in the each of the two or more branches is encompassed into a body yarn that is a continuation of the body yarn of the first portion.

2. The furcated suture of claim t, wherein the furcated suture is a braid, a woven article, a knitted article, or a combination thereof.

3. The furcated suture of claim 1 or 2, wherein each of the two or more core yarns comprise one or more yarns, wherein an overall denier of the one or more yarns of the two or more core yarns is20 D to 900 D, and / or wherein each of the two or more core yarns comprise one yarn having a denier of 20 D to 900 D.

4. The furcated suture of claim 3, wherein each of the two or more core yarns comprise two or more yarns wherein the overall denier of the two or more yarns is 20 D to 900 D, and wherein the denier of each of the two or more yarns is the same or different.

5. The furcated suture of any one of claims 3-4, wherein the one or more yarns are twisted having TPI of 0-15.

6. The furcated suture of any one of claims 1-5, wherein the body yarn comprises one or more yarns, wherein an overall denier of the one or more yarns of the body yarns is 20 D to 900 D, and / or wherein the body yarn comprises one yarn having a denier of 20 D to 900 D.

7. The furcated suture of claim 6, wherein the body yarn comprises two or more yarns wherein the overall denier of the two or more yarns is 20 D to 900 D, and wherein the denier of each of the two or more yarns is the same or different.

8. The furcated suture of any one of claims 6 or 7, wherein the one or more yarns are twisted having TPI of 0-15.

9. The furcated suture of any one of claims 2-8, wherein the furcated suture is a braid, and wherein the first portion of the furcated suture has a substantially round shape and has a twill pattern, flat braid, diamond pattern, plain braid, regular braid, hercules braid or any combination thereof.

10. The furcated suture of claim 9, wherein the first portion has 4 to 256 strands.

11. The furcated suture of any one of claims 9-10, wherein each of the two or more branches of the second portion is a braid having a substantially round shape and has a twill pattern, a flat braid, diamond pattern, plain braid, regular braid, hercules braid, flat braid, triaxial braid pattern or any combination thereof.

12. The furcated suture of claim 11, wherein each of the two or more branches has a total amount of strands in the first portion divided by a number of branches in the second portion.

13. The furcated suture of any one of claims 1-12, wherein the second distal end of the second portion defines a distal end of each of the two or more branches.

14. The furcated suture of claim 13, wherein the second distal end of the second portion forms a convergence point, such that the two or more branches of the second portion converge into a third portion.

15. The furcated suture of claim 14, wherein each core yarn of the two or more branches converge to form two or more core yarns of the third portion and wherein the body yarn encompassing each of the core yarns of the two or more branches converge to form a body yarn encompassing the two or more core yarns of the third portion.

16. The furcated suture of claim 14 or 15, wherein the third portion is defined by a proximal edge and a distal edge and a third predetermined length therebetween; and wherein the third predetermined length is the same or different from the first and / or second predetermined lengths.

17. The furcated suture of claim 13, wherein the distal end of at least one of the two or more branches forms a second furcation point where the least one of the two or more branches furcates to an additional two or more branches, thereby forming a fourth portion having a proximal end and a distal end and a fourth predetermined length therebetween, wherein the proximal end is defined by the second furcation point, and wherein the distal end of the fourth portion optionally converges into a fifth portion having a fifth predetermined length.

18. The furcated suture of claim 17, wherein each of the additional two or more branches of the fourth portion comprise at least one core yarn that is an extension of the at least one core yarn in at least one of the two or more branches of the second portion, and wherein each of the additional two or more branches of the fourth portion comprise a body yarn that encompasses the at least one core yarn of the fourth portion.

19. The furcated suture of any one of claims 17-18, wherein the fifth portion, if present, comprises a number of core yarns equal to a total core yarns in each of the additional two or more branches of the fourth portion, and / orwherein the fifth portion, if present, comprises a body yarn that is an extension of the body yarn encompassing the at least one core yarn of the fourth portion.

20. The furcated suture of any one of claims 1-19, wherein the first portion has a pick density of 10 to 150 ppi.

21. The furcated suture of any one of claims 1-13, wherein the distal end of each of the two or more branches of the second portion loops back to the furcated point.

22. A delivery system for an implant comprising one or more furcated sutures of any one of claims 1-21, wherein the system further comprises a heart valve, and wherein the one or more furcated sutures are configured to ripcord release the heart valve at an implantation location.

23. A system comprising: a prosthetic heart valve including a frame and a plurality of leaflets disposed within a lumen of the frame; a delivery7catheter having an elongated shaft for advancing the prosthetic heart valve through a patient’s vasculature to the native atrioventricular valve; a tether assembly extending through the elongated shaft of the delivery7catheter and comprising a plurality of coupling tethers disposed along a distal end portion of the tether assembly, the coupling tethers sized to extend through openings in the prosthetic heart valve; and a release assembly comprising one or more furcated sutures of any one of claims 1- 21, wherein the one or more furcated sutures are configured to extend through loop portions of the coupling tethers to secure the prosthetic heart valve to the tether assembly, wherein the one or more furcated sutures are retractable for removal from the one or more loop portions and thereby allowing the tether assembly to be released from the prosthetic heart valve; wherein the prosthetic heart valve is deployed and allowed to expand and operate w hile still attached to the tether assembly^ and w herein the prosthetic heartvalve is released from the tether assembly after confirming proper deployment and operation within the native atrioventricular valve.

24. A method of making the one or more furcated sutures of any one of claims 1-21, wherein the method comprises a step of a continuous braiding, weaving, or knitting of a continuous furcated suture, wherein the continuous braiding, weaving, or knitting comprises:(a) forming the first portion having a proximal end and a distal end, and the first predetermined length therebetween,(b) forming a furcation point at the distal end of the first portion,(c) forming a second portion having a proximal end and the second predetermined length, wfterein the proximal end is defined by the furcation point and w herein the second portion comprises tw o or more branches;(d) converging the two or more branches to a converging point, w herein a converging portion of the tw o or more branches has a predetermined converging length, and(e) w herein the converging point extends into a further first portion of a further predetermined length.

Images