Textiles, implantable medical devices using the same, and processes for manufacturing the same

Abstract

A 3D honeycomb textile can include a textured yarn. The textile can exhibit a thermal shrinkage of about 10% to about 60%. The textile can be configured to reversibly change its dimensions under applied stress. A prosthetic valve can include the disclosed textile as a sealing member. Furthermore, a prosthetic valve can utilize the disclosed textile as a cushioning material. Furthermore, methods of manufacturing the disclosed textile and prosthetic valve are described.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 991,447, filed on March 18, 2020, entitled “Textiles and Implantable Medical Devices Using the Same,” the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present application relates to various aspects of a textile material made from textured yarn, wherein at least a portion of the textile material has a 3D honeycomb pattern having a plurality of honeycomb cells. The present application also relates to various aspects of an implantable medical device comprising such a textile material. Background Art

[0004] The heart may develop a variety of valve diseases or malformations that can lead to serious malfunction and ultimately require replacement of the native heart valves with artificial valves. The human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, essentially act as one-way valves that work in sync with the beating heart. The valves allow blood to flow downstream but prevent blood from flowing upstream. Diseased heart valves can develop damage such as valve narrowing or regurgitation, which inhibits the valve's ability to control blood flow. This damage reduces the heart's pumping efficiency and can be a life-threatening condition that leads to slow failure. For example, valvular insufficiency can lead to conditions such as cardiac hypertrophy and ventricular enlargement. Therefore, extensive efforts have been made to develop methods and devices to repair or replace damaged heart valves.

[0005] There are prostheses that correct the problems associated with damaged heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace damaged native heart valves. Recently, a lot of effort has been devoted to developing replacement heart valves, particularly tissue-based replacement heart valves, which are less invasive to the patient than by open heart surgery. Replacement valves are designed to be delivered by minimally invasive surgery or even percutaneous surgery. Such replacement valves typically include a tissue-based valve body that is connected to an expandable frame that is then delivered to the annulus of the native valve.

[0006] These replacement valves are generally intended to at least partially block blood flow. However, problems arise when blood flows around the valve on the outside of the prosthesis. For example, paravalvular leak has proven particularly challenging in the case of replacement heart valves. Another challenge relates to the ability to affix such a prosthesis in a non-invasive manner relative to intraluminal tissue (e.g., tissue within any body lumen or cavity). Further challenges arise when attempting to controllably deliver and secure such a prosthesis in a location such as the native mitral valve. These replacement valves are generally intended to at least partially block blood flow.

[0007] Due to the disadvantages associated with traditional open heart surgery, percutaneous and minimally invasive surgical approaches are gaining widespread attention. In one technique, a prosthetic valve is constructed to be implanted via a catheter in a much less invasive procedure. For example, U.S. Patent Nos. 5,411,522 and 6,730,118, incorporated herein by reference, describe collapsible transcatheter heart valves that can be percutaneously introduced onto a catheter in a compressed state and expanded to a desired position by balloon inflation or by utilizing a self-expanding frame or stent. In yet another example, U.S. Publication Nos. 2014 / 0277390, 2014 / 0277422, 2014 / 0277427, 2015 / 0328000, and 2019 / 0328515 (each of which is incorporated herein by reference in its entirety) describe a heart valve prosthesis for replacing a native mitral valve, the heart valve prosthesis comprising a self-expanding frame having a plurality of anchoring members designed to be deployed within a body cavity and to prevent axial flow of fluid around the exterior of the prosthesis.

[0008] However, problems can still arise. For example, in the case of heart valve replacements, paravalvular leaks have proven particularly challenging.

[0009] Another challenge relates to the ability to atraumatically secure such a prosthesis relative to endoluminal tissue (e.g., tissue within any body lumen or cavity). Further challenges arise when attempting to controllably deliver and secure such a prosthesis in a location such as a native mitral valve.

[0010] The present disclosure at least in part satisfies these needs and others. Summary of the Invention

[0011] Some aspects of the present disclosure relate to textiles. Some aspects relate to a textile defined by a first surface and an opposing second surface and having a longitudinal axis and a transverse axis and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn in the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn having a heat shrinkage of about 10% to about 60%; wherein the textile has a first dimension along the longitudinal axis, the transverse axis, and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width, or the first length, and wherein the textile is configured to reversibly reach a second dimension under application of stress, wherein the second dimension is defined by a second thickness, second width, or second length, and return to the first dimension upon removal of the stress, and wherein the textile is biocompatible; and wherein the textile exhibits a first stress relaxation response.

[0012] However, further disclosed herein is an aspect wherein the plurality of warp yarns and the plurality of weft yarns as described in any of the preceding aspects comprise textured yarns. Still further disclosed herein is an aspect wherein the textured yarn present in the textile as described in any of the preceding aspects is selected from friction textured yarns, pin textured yarns, air textured yarns, belt textured yarns, stuffer box textured yarns, or any combination thereof.

[0013] Also disclosed herein are aspects including a tissue scaffold material comprising a textile as described in any of the preceding aspects.

[0014] Yet another aspect described herein relates to an implantable medical device comprising: an annular frame having an inflow end, an outflow end, and a longitudinal axis; and a sealing element secured to the frame, wherein the sealing element comprises: a textile defined by a first surface and an opposing second surface and having a longitudinal axis and a transverse axis, and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns being arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns is a yarn having a heat shrinkage rate of approximately 10% to about 60% textured yarn; wherein the textile has a first dimension along the longitudinal axis, the transverse axis and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width or the first length, and wherein the textile is configured to reversibly reach a second dimension under the application of stress, wherein the second dimension is defined by a second thickness, a second width or a second length, and return to the first dimension after the stress is removed and wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response; and wherein the implantable medical device is configured to radially collapse to a collapsed structure and radially expand to an expanded structure.

[0015] Still further, aspects disclosed herein relate to an implantable medical device comprising: a self-expanding frame having an upper region, a middle region, and a lower region, wherein the frame is configured to radially expand and contract for deployment within a body cavity, and wherein the self-expanding frame comprises a plurality of anchoring members disposed along the lower region; wherein at least a portion of at least some of the plurality of anchoring members are encapsulated within a textile material, wherein the textile material is defined by a first surface and an opposing second surface, has a longitudinal axis and a transverse axis, and has a first thickness, a first width, and a first length, and comprises: a plurality of weft yarns and a plurality of anchoring members. warp yarns, the plurality of weft yarns and the plurality of warp yarns are arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb units, wherein at least one yarn among the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn having a heat shrinkage rate of about 10% to about 60%; wherein the textile exhibits a first stress relaxation response; and wherein the textile material is biocompatible and acts as a cushion and exhibits a compressibility of 50-95% of the first thickness under a load force of about 45 to about 56 pounds (lbs).

[0016] Also disclosed herein is a method comprising weaving a plurality of weft yarns and a plurality of warp yarns to form a textile, wherein the formed textile is defined by a first surface and an opposing second surface and has a longitudinal axis and a transverse axis, and has a first thickness, a first width, and a first length, and wherein at least a portion of the first surface and / or the second surface has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn among the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn having a heat shrinkage of about 10% to about 60%; wherein the textile has a first dimension along the longitudinal axis, the transverse axis, and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width, or the first length, and wherein the textile is configured to reversibly reach a second dimension upon application of stress, wherein the second dimension is defined by a second thickness, a second width, or a second length, and return to the first dimension upon removal of the stress and wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response.

[0017] Still further aspects relate to a method of manufacturing an implantable medical device, the method comprising: providing a sealing element, the sealing element comprising a textile material, the textile material being defined by a first surface and an opposing second surface and having a longitudinal axis and a transverse axis, and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns being arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns has a heat shrinkage of approximately 10%. to about 60% textured yarn; wherein the textile has a first dimension along the longitudinal axis, the transverse axis and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width or the first length, and wherein the textile is configured to reversibly reach a second dimension upon application of stress, wherein the second dimension is defined by a second thickness, a second width or a second length, and return to the first dimension upon removal of the stress and wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response; and securing the sealing element to the annular frame of the implantable medical device.

[0018] Also disclosed is a method of manufacturing an implantable medical device, the method comprising: providing a self-expanding frame having an upper region, a middle region, and a lower region, wherein the frame is configured to radially expand and contract for deployment within a body cavity, and wherein the self-expanding frame comprises a plurality of anchoring members disposed along the lower region; wherein at least a portion of at least some of the plurality of anchoring members are encapsulated within a textile material, wherein the textile material is defined by a first surface and an opposing second surface, has a longitudinal axis and a transverse axis, and has a first thickness, a first width, and a first length, and comprises: a plurality of weft yarns and a plurality of warp yarns; wherein the plurality of weft yarns and the plurality of warp yarns are arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn among the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn having a heat shrinkage of about 10% to about 60%; wherein the textile exhibits a first stress relaxation response; and wherein the textile material is biocompatible and acts as a cushion and exhibits a compressibility of 50-95% of the first thickness under a load force of about 45 to about 56 pounds (lbs). It will be appreciated that in some aspects described herein, the encapsulating step can include forming one or more layers of the textile material around at least a portion of at least some of the plurality of anchoring members.

[0019] Additional aspects of the present disclosure will be set forth in part in the following detailed description, drawings, and claims, and in part will be derived from the detailed description or can be learned through practice of the present disclosure. It will be understood that the foregoing general description and the following detailed description are only exemplary and explanatory and are not restrictive of the disclosed disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 An exemplary textile having a 3D honeycomb pattern with a plurality of repeating honeycomb cells in an unfinished form is shown.

[0021] Figure 2 An exemplary textile having a 3D honeycomb pattern with a plurality of repeating honeycomb cells is shown after being subjected to heat setting conditions at 90° C. for 10 minutes.

[0022] Figure 3 An exemplary textile having a 3D honeycomb pattern with a plurality of repeating honeycomb cells is shown after being subjected to heat setting conditions at 120° C. for 10 minutes.

[0023] Figure 4 An exemplary textile having a 3D honeycomb pattern with a plurality of repeating honeycomb cells is shown after being subjected to heat setting conditions at 180° C. for 10 minutes.

[0024] Figure 5 A perspective view of an exemplary implantable medical device (eg, a prosthetic heart valve) including exemplary aspects of an exemplary textile for use as a paravalvular leak seal is shown.

[0025] Figure 6 Shown are perspective views illustrating an exemplary implantable medical device (eg, a prosthetic heart valve) including another aspect of a paravalvular leak seal including an exemplary textile for use as a paravalvular leak seal.

[0026] Figure 7 is a front view of one aspect of a frame for use in an exemplary implantable medical device.

[0027] Figure 8 is an elevational view of one aspect of a frame (in an expanded state) for use in another exemplary implantable medical device.

[0028] Figures 9A-9B Shown in collapsed configuration ( Figure 9A ) and expansion structures ( Figure 9B ) of an exemplary anchoring tip.

[0029] Figure 10 A photograph of an exemplary implantable medical device with an exemplary anchor is shown. Figure 7 -9 shows an exemplary textile used as a cushion.

[0030] Figure 11 A heat setting fixture used to form an exemplary textile is shown. DETAILED DESCRIPTION

[0031] The present disclosure may be more readily understood by reference to the following detailed description, examples, drawings, and claims, as well as their preceding and following descriptions. However, before disclosing and describing the present articles, systems, and / or methods, it is to be understood that, unless otherwise indicated, the present disclosure is not limited to the specific or exemplary aspects of the disclosed articles, systems, and / or methods, as such, of course, may vary. It is further understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.

[0032] The following description of the present disclosure is provided as an implementation teaching of the best, currently known aspects of the present disclosure. For this reason, those skilled in the relevant art will recognize and understand that many changes can be made to the various aspects of the present disclosure described herein while still obtaining the beneficial results of the present disclosure. It will also be apparent that some expected benefits of the present disclosure can be obtained by selecting some features of the present disclosure without utilizing other features. Therefore, those of ordinary skill in the relevant art will recognize that many modifications and adaptations to the present disclosure are possible, and in some cases may even be desirable and are a part of the present disclosure. Therefore, the following description is again provided as an illustration of the principles of the present disclosure rather than a limitation thereof.

[0033] definition

[0034] As used in this application and the claims, the singular forms "a," "an," and "the" include plural referents 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 dictates otherwise.

[0035] It will be further 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 claims, the term "comprising" may include aspects of "consisting of" and "consisting essentially of." Additionally, the term "including" means "including."

[0036] The terms "for example," "exemplary," and "such as," and their grammatical equivalents, unless expressly stated otherwise, may be understood to follow the phrase "and not limited to."

[0037] Ranges may be expressed herein as from "about" one particular value and / or to "about" another particular value. When such a range is expressed, another aspect includes from the one particular value and / or to the other particular value. Similarly, when values ​​are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each range are significant relative to and independent of the other endpoint.

[0038] As used herein, the terms "optional" or "optionally" mean that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.

[0039] Furthermore, the terms “coupled” and “associated” generally refer to electrical, electromagnetic, and / or physical (eg, mechanical or chemical) connections or links, and do not exclude the presence of intervening elements between the coupled or associated items.

[0040] As used herein, the term "and / or" includes any and all combinations of one or more associated listed items. It will be further understood that the term "and / or" includes the presence of one or the other of the associated listed items as well as the presence of any combination of both or any combination of the associated listed items.

[0041] As used herein, the term or phrase "effective," "effective amount," or "conditions effective for" refers to an amount or condition that is capable of performing the function or property expressed as the effective amount or condition. As will be noted below, the exact amount or specific conditions required will vary from one aspect to another, depending on recognized variables such as the materials employed and the observed processing conditions. Thus, it is not always possible to specify an exact "effective amount" or "conditions effective for." However, it will be understood that a suitable effective amount will be readily determined by one of ordinary skill in the art using only routine experimentation.

[0042] As used herein, the term "fiber" includes fibers of extremely long or infinite length (ie, filaments) and fibers of short length (ie, staple fibers for spinning).

[0043] As used herein, the term "polyester" refers to a class of polymers comprising an ester functional group in its main chain. Polyesters disclosed herein include naturally occurring chemicals, such as the cutin of plant cuticles, and synthetics produced by step-growth polymerization. In some examples, polyesters include polyethylene terephthalate (PET) homopolymers and copolymers, polypropylene terephthalate (PPT) homopolymers and copolymers, and polybutylene terephthalate (PBT) homopolymers and copolymers, including those containing comonomers such as cyclohexanedimethanol, cyclohexanedicarboxylic acid, isophthalic acid, and the like.

[0044] As used herein, the term "polyamide" is defined as any long-chain polymer wherein the functional group linked is an amide (-CO-NH-) bond. The term polyamide is further defined as including copolymers, terpolymers, and homopolymers, and also includes blends of two or more polyamides. In some aspects, multiple polyamide fibers include one or more nylon 6, nylon 66, nylon 10, nylon 612, nylon 12, nylon 11, or any combination thereof. In other aspects, multiple polyamide fibers include nylon 6 or nylon 66. In yet other aspects, multiple polyamide fibers are nylon 6. In yet another aspect, multiple polyamide fibers are nylon 66.

[0045] As defined herein, the term "polyolefin" refers to a polyolefin composed of simple olefins (also known as polyolefins having the general formula C n H 2nAny class of polymers produced using an olefin (e.g., an olefin) as a monomer. In some aspects, polyolefins include, but are not limited to, polyethylene, polypropylene, both homopolymers and copolymers, poly(1-butene), poly(3-methyl-1-butene), poly(4-methyl-1-pentene), and the like, as well as combinations or mixtures of two or more thereof.

[0046] As defined herein, the term "polyurethane" refers to any class of polymers composed of chains of organic units connected by urethane (urethane, R1-O-CO-NR2-R3, where R1, R2 and R3 are the same or different) linkers.

[0047] As defined herein, the term "polyether" refers to any class of polymers consisting of chains of organic units linked by ether groups.

[0048] As defined herein, the term "polyurea" refers to any class of polymers in which alternative monomer units of isocyanate and amine react with each other to form urea linkages.

[0049] Although the operations of the exemplary aspects of the disclosed methods may be described in a particular sequential order for ease of presentation, it is understood that the disclosed aspects may encompass operations in a sequence that differs from the particular sequence disclosed. For example, in some cases, the operations described sequentially may be rearranged or performed simultaneously. Furthermore, the descriptions and disclosures provided in conjunction with a particular aspect are not limited to that aspect and may apply to any aspect disclosed.

[0050] Furthermore, for the sake of simplicity, the accompanying figures may not illustrate the various ways in which the disclosed systems, methods, and apparatuses can be used in combination with other systems, methods, and apparatuses (which will be readily discernible to one of ordinary skill in the art based on this disclosure). Furthermore, the description sometimes uses terms such as "produce" and "provide" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that can be performed. The actual operations corresponding to these terms can vary depending on the specific implementation and will be readily discernible to one of ordinary skill in the art based on this disclosure.

[0051] textile

[0052] Disclosed herein is a textile defined by a first surface and an opposing second surface and having a longitudinal axis and a transverse axis and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn having a heat shrinkage of about 10% to about 60%; wherein the textile has a first dimension along the longitudinal axis, the transverse axis, and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width, or the first length, and wherein the textile is configured to reversibly reach a second dimension upon application of stress, wherein the second dimension is defined by a second thickness, a second width, or a second length, and return to the first dimension upon removal of the stress and wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response.

[0053] In further aspects, the first textile thickness can be from about 0.1 millimeter (mm) to about 10 mm, including exemplary values ​​of about 0.2 mm, about 0.3 mm, about 0.4 mm, 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 6.5 mm, about 7 mm, about 8.5 mm, about 9 mm, and about 9.5 mm. In still other aspects, the first textile thickness can have any value between any two of the aforementioned values.

[0054] In a further aspect, when the first textile has a length of about 1 mm to about 100 mm, exemplary values ​​include about 2 mm, about 5 mm, about 7 mm, about 10 mm, about 12 mm, about 15 mm, about 17 mm, about 20 mm, about 22 mm, about 25 mm, about 27 mm, about 30 mm, about 32 mm, about 35 mm, about 37 mm, about 40 mm, about 42 mm, about 45 mm, about 47 mm, about 50 mm, about 52 mm, about 55 mm, about 57 mm, about 60 mm, about 62 mm, about 65 mm, about 67 mm, about 70 mm, about 72 mm, about 75 mm, about 77 mm, about 80 mm, about 82 mm, about 85 mm, about 87 mm, about 90 mm, about 92 mm, about 95 mm, and about 97 mm. It will be understood that these values ​​are exemplary and non-limiting, and that the textile can have any length value between any two of the aforementioned values. It will further be appreciated that the first length may be about 150 mm, about 200 mm, or about 1 meter (m) if desired for a particular application.

[0055] In a further aspect, wherein the textile has a width of about 1 mm to about 100 mm, including exemplary values ​​of about 2 mm, about 5 mm, about 7 mm, about 10 mm, about 12 mm, about 15 mm, about 17 mm, about 20 mm, about 22 mm, about 25 mm, about 27 mm, about 30 mm, about 32 mm, about 35 mm, about 37 mm, about 40 mm, about 42 mm, about 45 mm, about 47 mm, about 50 mm, about 52 mm, about 55 mm, about 57 mm, about 60 mm, about 62 mm, about 65 mm, about 67 mm, about 70 mm, about 72 mm, about 75 mm, about 77 mm, about 80 mm, about 82 mm, about 85 mm, about 87 mm, about 90 mm, about 92 mm, about 95 mm, and about 97 mm, it will be understood that these values ​​are exemplary and non-limiting, and that the textile can have any width value between any two of the aforementioned values. It will further be appreciated that the first width may be approximately 150 mm, approximately 200 mm, or approximately 1 m, if desired for a particular application.

[0056] It will be appreciated that, in various aspects of the present invention, when a comparison is made between a first dimension and a second dimension, the comparison is actually between the first length in the relaxed position and the second length under stress, or between the first width in the relaxed position and the second width under stress, or between the first thickness in the relaxed position and the second thickness under stress. It will further be appreciated that the comparison between the first dimension and the second dimension is made in the same direction in which the stress is applied. For example, in aspects where the stress applies tension along a longitudinal axis, the comparison is made between the first length along the longitudinal axis and the second length along the same tension axis. In yet further aspects, where the stress applies tension along a transverse axis, the comparison is made between the first width along the transverse axis and the second width along the same tension axis. In still further aspects, where the stress applies compression across a first thickness of the textile, the comparison is made between the first thickness before the load is applied and the second thickness achieved after the load has been applied.

[0057] In further aspects, the stress can include stretching the textile. In other aspects, the stress can include compression of the textile.

[0058] In aspects where the stress comprises stretching the textile in one or more directions along the longitudinal axis, the transverse axis, or across the textile, the second dimension selected from the second length or width is greater than 0 to about 300% of the first dimension selected from the first length or width (as measured in the direction of stretching), including exemplary values ​​of about 1%, about 5%, about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 100%, about 120%, about 150%, about 170%, about 200%, about 220%, about 250%, and about 260%. It will be further understood that the textiles disclosed herein can have different responses to the same stress measured along the width, length, or thickness of the textile. For example, when the textile is stressed by stretching, the first length of the textile can change from a relaxed position to a second length that is greater than 0% to about 300% of the first length. However, it will also be understood that in certain aspects, if the textile is stressed, for example by stretching along a first length or along a longitudinal axis, and the second length can be greater than 0% to about 300%, the second width can shrink to greater than 0% to about 300% of the first width, including exemplary values ​​of about 1%, about 5%, about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 100%, about 120%, about 150%, about 170%, about 200%, about 220%, about 250% and about 260%. Similarly, in certain aspects, if a textile is stressed, for example, by stretching along a first length or along a longitudinal axis, and the second length can be greater than 0% to about 300%, the second thickness can be reduced by greater than 0% to about 300% of the first thickness, including exemplary values ​​of about 1%, about 5%, about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 100%, about 120%, about 150%, about 170%, about 200%, about 220%, about 250%, and about 260%. It will be further appreciated that, for example, the percentage increase in the first length can be the same as or different from the percentage decrease in the first width or thickness. It will be further appreciated that the change in length, width, and / or thickness can depend on the direction of the applied stress. For example, but not limited to, in some aspects, when a textile disclosed herein is stretched by about 100-125% in all directions, the textile can have a second thickness that is about 90-95% of the first thickness. However, in other aspects, the disclosed textiles can become stiffer and / or have a significantly greater thickness and be less compressible if stretched in only one direction.

[0059] In further aspects, the second dimension along each direction can be the same as or different from the second dimension along the remaining one or more directions. In some exemplary aspects, when, for example, the stress comprises stretching the textile along its longitudinal axis, the second dimension defined by the second length can be the same as or different when compared to stretching the textile along its transverse axis or across the textile.

[0060] In a further aspect, the stress comprises a compressive force across a first thickness of the textile, and the textile exhibits a compressibility of 50-95% of the first thickness under a load force of about 45 to about 56 lbs (including exemplary values ​​of about 46 lbs, about 47 lbs, about 48 lbs, about 49 lbs, about 50 lbs, about 51 lbs, about 52 lbs, about 53 lbs, about 54 lbs, and about 55 lbs), including exemplary values ​​of about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, and about 90%. It will be appreciated that the compressibility can depend on the first thickness of the textile. In a further aspect, it will be appreciated that the compressibility can be measured based on the textile layers. In some aspects, the first thickness of the textile will be defined by the total thickness of each of the thicknesses of each textile layer.

[0061] In certain aspects, at least a portion of the first surface and the second surface have a 3D honeycomb pattern.

[0062] It is understood that the yarn paths in a honeycomb fabric can include interwoven curves and straight yarn jumps. The length and height of the yarn jumps (whether in the warp or weft direction) gradually increase and then gradually decrease. In such exemplary aspects, the periodicity and repetition of inverted pyramid-shaped spaces can be formed on both surfaces of the fabric. However, in other aspects, the honeycomb design can be formed only on one surface of the fabric. In some exemplary aspects, in a honeycomb fabric, the portion of the warp yarns below the weft jumps are warp jumps. In further aspects, two layers of jumps can form a closed interior space. Without wishing to be bound by any theory, it is hypothesized that the periodic repetition of the inverted pyramid-shaped spaces and the closed interior space in the honeycomb fabric can provide good sound absorption and moisture absorption, good insulation and quick drying rate. In general, due to the interweaving of the yarns, the tensile strength of the fabric with an interwoven plain weave is the highest. However, without wishing to be bound by any theory, it is hypothesized that due to the presence of straight yarn jumps, the mechanical properties (e.g., bursting strength, compressibility and shearing force) of the textile can be improved when compared with the fabric with an interwoven plain weave.

[0063] In further aspects, the plurality of warp yarns and the plurality of weft yarns can comprise textured yarns. It will be appreciated that the textured yarns can be produced by any method known in the art. In certain aspects, the textured yarns can be selected from friction textured yarns, pin textured yarns, air textured yarns, belt textured yarns, stuffer box textured yarns, or any combination thereof. Furthermore, in further exemplary and non-limiting aspects, the textured yarns can be produced by friction texturing, or pin or false twist texturing, air texturing, stuffer box texturing, or any combination thereof. In further exemplary aspects, the textured yarns are friction textured yarns.

[0064] In further aspects, the textured yarn can exhibit a heat shrinkage of about 10% to about 60%, including exemplary values ​​of about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 40%, about 45%, about 50%, and about 55%. It will be appreciated that the heat shrinkage value of the textured yarn can be between any two of the aforementioned values.

[0065] It will be further understood that various textured yarns can have varying degrees of texture. The degree of texture is assessed by measuring the crimp shrinkage, stretch potential, and volume ratio of the textured yarn. Without wishing to be bound by any theory, it is hypothesized that the degree of texture can affect the shrinkage properties of the textile and the ultimate bulk of the textile.

[0066] In some aspects and as disclosed herein, each yarn in a plurality of weft yarns and / or warp yarns can include a plurality of fibers. In further aspects, the textured yarn can include polyester, copolyester, ultra-high molecular weight polyethylene, polyethylene, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyvinylidene fluoride, polyurethane, polyether, polyurea, nylon, its copolymer or their combination. It is understood that the plurality of yarns present in the textile can include the same or different yarns. For example, in some aspects but not limited to, all yarns in the plurality of yarns are textured. In further aspects, all textured yarns are the same. However, in other aspects, not all yarns include the same textured yarn. In some aspects, the yarns can be different due to the type of material or the type of texture method. Similarly, the plurality of yarns in the weft direction and the warp direction can be the same or different.

[0067] In a further aspect, each yarn in the plurality of weft and / or warp textured yarns can have a denier of about 10 to about 200 denier, including exemplary values ​​of about 20 denier, about 50 denier, about 70 denier, about 100 denier, about 120 denier, about 150 denier, and about 170 denier. It will be appreciated that each yarn in the plurality of weft and / or warp yarns can have a denier value between any two of the aforementioned values. For example, but not limited to, each yarn in the plurality of weft and / or warp yarns can have a denier value of about 12 denier to about 25 denier, or about 30 denier to about 85 denier, or about 110 denier to about 185 denier.

[0068] In further aspects, each yarn in the plurality of weft and / or warp textured yarns can comprise from about 8 to about 150 fibers, including exemplary values ​​of about 10 fibers, about 15 fibers, about 20 fibers, about 50 fibers, about 70 fibers, about 100 fibers, and about 120 fibers. It will be appreciated that each yarn in the plurality of weft and / or warp yarns can comprise any number of fibers between any two of the aforementioned values. For example, but not limited to, each yarn in the plurality of weft and / or warp yarns can comprise from about 8 to 25 fibers, or from about 27 fibers to about 85 fibers, or from about 110 fibers to about 145 fibers.

[0069] In further aspects, the fibers can have any diameter suitable for the desired application. In certain aspects, the fibers can have a diameter of about 1 μm to about 25 μm, including exemplary values ​​of about 2 μm, about 5 μm, about 7 μm, about 10 μm, about 12 μm, about 15 μm, about 17 μm, about 20 μm, and about 22 μm. It will be appreciated that the fibers can have any diameter between any two of the aforementioned values. For example, but not limited to, the fibers can have a diameter of about 3 μm to about 8 μm, or about 11 μm to about 22 μm, or about 15 μm to about 25 μm.

[0070] In further aspects, the textured yarn can have a second stress relaxation response. It will be appreciated that the second stress relaxation response of the textured yarn can be the same as or different from the first stress relaxation response of the textile. It will be further appreciated that in some exemplary aspects, the second stress relaxation response of the textured yarn is provided by the yarn manufacturer. In other aspects, the second stress relaxation response can be provided to the yarn by a skilled practitioner prior to weaving the yarn into a textile.

[0071] In a further aspect, the first stress relaxation response can be defined by a first heat setting condition of the textile and a second stress relaxation response.As discussed in detail above, the first stress relaxation response can be the same as or different from the second stress relaxation response.

[0072] In certain aspects and as disclosed herein, the first heat setting condition and / or the second heat setting condition can include a heat setting temperature of about 90°C to about 220°C, including exemplary values ​​of about 95°C, about 100°C, about 110°C, about 120°C, about 130°C, about 140°C, about 150°C, about 160°C, about 170°C, about 180°C, about 190°C, about 200°C, and about 210°C. It will be appreciated that the heat setting temperature values ​​for the first heat setting condition and / or the second heat setting condition can be any value between any two of the aforementioned values. For example, but not limited to, the heat setting temperature can be about 90°C to about 120°C, or about 100°C to about 180°C, or about 150°C to about 220°C.

[0073] In a further aspect, the first heat setting condition and / or the second heat setting condition may include a heat setting time of about 2 minutes to about 1 hour, including exemplary values ​​of about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 25 minutes, about 30 minutes, about 35 minutes, about 40 minutes, about 45 minutes, about 50 minutes, and about 55 minutes. It will be appreciated that the first heat setting condition and / or the second heat setting condition may have any heat setting time between any two of the aforementioned values. For example, but not limited to, the heat setting time may be about 5 minutes to about 20 minutes, or about 7 minutes to about 25 minutes, or about 15 minutes to about 60 minutes.

[0074] In a further aspect, the first heat setting condition and / or the second heat setting condition can include a heat setting temperature of about 90°C to about 220°C (including exemplary values ​​of about 95°C, about 100°C, about 110°C, about 120°C, about 130°C, about 140°C, about 150°C, about 160°C, about 170°C, about 180°C, about 190°C, about 200°C, and about 210°C) and a heat setting time of about 2 minutes to about 1 hour (including exemplary values ​​of about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 25 minutes, about 30 minutes, about 35 minutes, about 40 minutes, about 45 minutes, about 50 minutes, and about 55 minutes).

[0075] In further aspect and as disclosed above, multiple warp yarns and / or multiple weft yarns can further optionally comprise at least one yarn selected from polyolefin, polyamide, polyester, copolyester, polyurethane, natural fiber, polytetrafluoroethylene, polyvinylidene fluoride, polyether, polyurea, its copolymer or their combination.In some aspects, this yarn can also comprise composite fiber.It is understood that, as used herein, composite fiber relates to the fiber that can comprise one or more different materials.In some aspects, composite fiber is the bicomponent fiber that can have any structure, such as but not limited to side by side structure, core sheath structure, segmented structure, island structure or its any combination.

[0076] In a further aspect, the yarn other than the textured yarn can have a denier of about 10 to about 200, including exemplary values ​​of about 20, about 50, about 70, about 100, about 120, about 150, and about 170 denier. It will be appreciated that each yarn in the plurality of weft and / or warp yarns can have a denier value between any two of the aforementioned values. For example, but not limited to, each yarn in the plurality of weft and / or warp yarns can have a denier value of about 12 to about 25, or about 30 to about 85, or about 110 to about 185. It will be further appreciated that the untextured yarn and the textured yarn can have the same or different denier values.

[0077] In further aspects, each yarn in the plurality of weft yarns and / or untextured warp yarns can comprise from about 8 to about 150 fibers, including exemplary values ​​of about 10 fibers, about 15 fibers, about 20 fibers, about 50 fibers, about 70 fibers, about 100 fibers, and about 120 fibers. It will be appreciated that each yarn in the plurality of weft yarns and / or warp yarns can comprise any number of fibers between any two of the aforementioned values. For example, and without limitation, each yarn in the plurality of weft yarns and / or warp yarns can comprise from about 8 to 25 fibers, or from about 27 fibers to about 85 fibers, or from about 110 fibers to about 145 fibers. It will be further appreciated that the untextured yarns and the textured yarns can have the same number of fibers or different numbers of fibers.

[0078] In further aspects, the fibers in the untextured yarn can have any diameter suitable for the desired application. In certain aspects, the fibers in the untextured yarn can have a diameter of about 1 μm to about 25 μm, including exemplary values ​​of about 2 μm, about 5 μm, about 7 μm, about 10 μm, about 12 μm, about 15 μm, about 17 μm, about 20 μm, and about 22 μm. It will be appreciated that the fibers can have any diameter between any two of the aforementioned values. For example, but not limited to, the fibers can have a diameter of about 3 μm to about 8 μm, or about 11 μm to about 22 μm, or about 15 μm to about 25 μm. It will be further appreciated that the fibers present in the untextured yarn and the textured yarn can have the same or different diameters.

[0079] It will be further understood that aspects described herein include biocompatible yarns. Aspects of yarns comprising permanent implant grade polymers are also disclosed herein. In further aspects, permanent implant grade polymers may include, but are not limited to, polyesters, copolyesters, ultra-high molecular weight polyethylene, polyethylene, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyvinylidene fluoride, polyurethanes, polyethers, polyureas, nylons, copolymers thereof, or combinations thereof.

[0080] In a further aspect, the textile disclosed herein can include a first edge and an opposing second edge. It will be appreciated that in certain aspects, at least a portion of the textile adjacent to the first edge and / or the second edge comprises a plain weave, a twill weave, a satin weave, any derivatives thereof, or any combination thereof.

[0081] In a further aspect, the plurality of repeating cell units present in the textile can include about 1 to about 30 cells / inch, including exemplary values ​​of about 2 cells / inch, about 7 cells / inch, about 5 cells / inch, about 10 cells / inch, about 12 cells / inch, about 15 cells / inch, about 17 cells / inch, about 20 cells / inch, about 22 cells / inch, about 25 cells / inch, and about 27 cells / inch.

[0082] In still further aspects, each of the plurality of repeating cell units comprises about 8 to 40 pick replicates, including exemplary values ​​of about 12 pick replicates, about 16 pick replicates, about 20 pick replicates, about 24 pick replicates, about 28 pick replicates, about 32 pick replicates, and about 36 pick replicates.

[0083] In further aspects, textiles are configured to be sutured. It will be appreciated that any suture known in the art can be used. In some exemplary and non-limiting aspects, suture is a textile filament. In other aspects, suture is any filament that can be used for a desired application.

[0084] In a further aspect, disclosed herein is also a tissue scaffold material, which may comprise the textile disclosed herein.

[0085] Exemplary aspects of the disclosed textiles are Figure 1-4 and described in more detail in the experimental section.

[0086] Implantable medical devices

[0087] Paravalvular leak (PVL) is a complication associated with the implantation of artificial heart valves. PVL refers to the passage of blood between the structure of the implanted valve and the heart tissue due to a lack of a proper seal. Most PVLs are crescent-shaped, elliptical, or circular, and their trajectory can be parallel, perpendicular, or serpentine. Transcatheter heart valve (THV) surgery typically uses essentially inelastic woven fabrics or stretchable knitted fabrics for PVL sealing.

[0088] When comparing woven fabrics to knitted fabrics for PVL seals, the largely inelastic woven fabrics offer the advantage of providing greater dimensional stability, which aids in surgeries involving the use of sutures and laser-cut components to join valve components. Furthermore, the pore size and density in woven fabrics can be designed to balance sealing and tissue ingrowth. Knitted fabrics, on the other hand, offer greater stretchability than woven fabric constructions. This stretchability helps reduce stress on the tissue to which the medical device containing the textile is attached.

[0089] One of the requirements for next generation THV frame designs, as frame sizes continue to change, is to have a PVL sealing cloth and / or an inner frame cloth to accommodate the changing frame size. Therefore, a cloth with controlled stretchability and a lower profile is needed to provide improved conformability by reducing potential stress at the site where the cloth is secured to the body cavity.

[0090] The present disclosure describes various aspects of addressing the aforementioned issues. In one aspect, an implantable medical device is described herein, comprising: an annular frame having an inflow end, an outflow end, and a longitudinal axis; and a sealing element secured to the frame, wherein the sealing element comprises: a textile defined by a first surface and an opposing second surface and having a longitudinal axis and a transverse axis, and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns being arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one of the plurality of warp yarns and / or the plurality of weft yarns is a yarn having a heat shrinkage rate of approximately 10% to about 60% textured yarn; wherein the textile has a first dimension along the longitudinal axis, the transverse axis and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width or the first length, and wherein the textile is configured to reversibly reach a second dimension under the application of stress, wherein the second dimension is defined by a second thickness, a second width or a second length, and return to the first dimension after the stress is removed and wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response; and wherein the implantable medical device is configured to radially collapse to a collapsed structure and radially expand to an expanded structure.

[0091] It will be appreciated that any of the textiles described above may be used in the disclosed implantable medical devices.

[0092] In a further aspect, the applied stress can include stretching the textile in one or more directions along the longitudinal axis, the transverse axis, or across the textile, wherein a second dimension selected from the second length or width is greater than 0 to about 300% of a first dimension selected from the first length or width (as measured in the direction of stretching), including exemplary values ​​of about 1%, about 5%, about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 100%, about 120%, about 150%, about 170%, about 200%, about 220%, about 250%, and about 260%. It will be further understood that the textiles disclosed herein can have different responses to the same stress measured along the width, length, or thickness of the textile. For example, when the textile is stressed by stretching, the first length of the textile can change from a relaxed position to a second length that is greater than 0% to about 300% of the first length. However, it will also be appreciated that in certain aspects, if the textile is stressed, for example, by stretching along the first length or along the longitudinal axis, while the second length may be greater than 0% to about 300%, the second width may shrink to a value greater than 0% to about 300% of the first width. Similarly, in certain aspects, if the textile is stressed, for example, by stretching along the first length or along the longitudinal axis, while the second length may be greater than 0% to about 300%, the second thickness may shrink to a value greater than 0% to about 300% of the first thickness. It will be appreciated that the textiles used in these devices may include any textile having any of the properties described above.

[0093] In further aspects, the applied stress can include a compressive force across a first thickness of the textile, and wherein the textile exhibits a compressibility of 50-95% of the first thickness under a load force of about 45 to about 56 lbs (including exemplary values ​​of about 46 lbs, about 47 lbs, about 48 lbs, about 49 lbs, about 50 lbs, about 51 lbs, about 52 lbs, about 53 lbs, about 54 lbs, and about 55 lbs), including exemplary values ​​of about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, and about 90%. In other aspects, the applied stress can include expansion of the medical device to achieve an expanded configuration.

[0094] Exemplary aspects of implantable medical devices are Figure 5-6 One exemplary and non-limiting aspect encompasses a medical device that is an artificial heart valve. For example, but not limited to, Figure 5Illustrated are exemplary aspects of a radially collapsible and expandable prosthetic valve 10, which is shown in its expanded, deployed configuration. The prosthetic valve may include an annular stent or frame 12, and a leaflet structure 14 positioned within and coupled to the frame 12. The frame 12 may have an inflow end portion 16 and an outflow end portion 18. The leaflet structure may include a plurality of leaflets 22. In certain aspects, the leaflet structure may include three leaflets. In such exemplary aspects, such three leaflets may be arranged to collapse in a tricuspid arrangement similar to an aortic valve. Alternatively, the prosthetic valve may include two leaflets 22 configured to collapse in a mitral arrangement similar to a mitral valve, or may include more than three leaflets, depending on the particular application. The prosthetic valve 10 may define a longitudinal axis 24 extending through the inflow end portion 16 and the outflow end portion 18.

[0095] The frame 12 can be made of various biocompatible materials, such as stainless steel or a nickel-titanium alloy ("NiTi"), such as Nitinol. Figure 5 , the frame 12 can include a plurality of interconnected lattice struts 26 arranged in a lattice-type pattern and forming a plurality of apexes 28 at the outflow end 18 of the prosthetic valve. The struts 26 can also form similar apexes at the inflow end 16 of the prosthetic valve (which are covered by a skirt 30 described in more detail below). The lattice struts 26 are shown as being diagonally positioned or offset at an angle relative to the longitudinal axis 24 of the prosthetic valve and radially offset from the longitudinal axis 24 of the prosthetic valve. It will be appreciated that Figure 5 The depicted configuration is exemplary only, and in other aspects, the lattice struts 26 may be offset up to Figure 5 , or some or all of the lattice struts 26 may be positioned parallel to the longitudinal axis of the prosthetic valve.

[0096] The lattice struts 26 can be pivotally coupled to one another. In the illustrated aspect, for example, the end portions of the struts 26 forming vertices 28 at the outflow end 18 and inflow end 16 of the frame can have corresponding openings 32. The struts 26 can also be formed with apertures 34 between the opposing ends of the struts. Corresponding hinges can be formed at the vertices 28 and at the locations where the struts 26 overlap each other between the ends of the frame via fasteners 36, which can include rivets or pins extending through the apertures 32, 34. The hinges can allow the struts 26 to pivot relative to one another when the frame 12 expands or contracts (e.g., during assembly, preparation, or implantation of the artificial valve 10). For example, the frame 12 (and therefore the artificial valve 10) can be manipulated into a radially compressed or contracted configuration, coupled to a delivery device, and inserted into the patient's body for implantation. Once in the body, the artificial valve 10 can be manipulated into an expanded state and then released from the delivery device. Additional details about the frame 12, the delivery device, and the apparatus and techniques for radially expanding and collapsing the frame can be found in U.S. Publication No. 2018 / 0153689, which is incorporated herein by reference. Additional details about this exemplary artificial valve can also be found in U.S. Publication No. 2019 / 0046314, which is incorporated herein by reference.

[0097] like Figure 5 As further shown, the artificial valve 10 can include a sealing element configured as a skirt 30. As shown herein, the skirt 30 can include any textile material disclosed above. It will be understood that in some aspects, the skirt 30 is an outer skirt. In such aspects, another skirt (not shown), referred to as an inner skirt, can be attached to a frame below the outer skirt 30. However, in some aspects, the textile material used in the outer skirt 30 can also be used in the inner skirt (not shown here). However, in some aspects, the inner skirt does not include the textile material used in the outer skirt. In further aspects, only one skirt is used. In such aspects, such a skirt can include any textile material described herein.

[0098] The skirt 30 can be configured to establish a seal with autologous tissue at the treatment site to reduce or prevent paravalvular leakage. The skirt 30 can include a main body portion 38 that is disposed about the outer circumference of the frame 12. The skirt 30 can be secured to the frame by, for example, a plurality of sutures 41 that extend in a zigzag pattern along selected strut members 26 between a first edge portion (e.g., an inflow edge portion) 40 and a second edge portion (e.g., an outflow edge portion) 42 of the skirt 30. For example, in some aspects, the skirt 30 can be sutured to the frame 12 along sutures 66 that correspond to the scalloped edges defined by the leaflets 22, which can allow the valve to expand and contract radially without interference or compression by the skirt. Further details regarding transcatheter prosthetic heart valves, including the manner in which leaflets 22 may be coupled to frame 12, may be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,652,202, the entire contents of which are incorporated herein by reference.

[0099] It will be appreciated that the skirt 30 comprising the textile material disclosed herein provides greater dimensional stability, which aids in surgeries involving the use of sutures and laser-cut components to join valve components together. In a further aspect, it will be appreciated that the presence of the 3D honeycomb cellular structure of the disclosed textile can balance sealing and tissue ingrowth functions. In yet a further aspect, the controlled stretchability of the disclosed textile allows for reduced valve stress on tissue to which a medical device comprising the textile is attached. The disclosed textile allows the skirt 30 to adapt to changing frame sizes and provides a low profile for such a skirt.

[0100] Figure 6 The prosthetic valve 10 is illustrated as including another aspect of a sealing member or skirt 600. In the illustrated and non-limiting aspect, the skirt 600 comprises a textile material as described herein and configured as a fabric strip 602 having a rim portion 608. In certain exemplary aspects, the skirt 600 can be secured to the struts 26 to form a skirt layer (not shown). It will further be appreciated that any configuration of the skirt coupled to the frame can be used depending on the desired application.

[0101] The textile materials described herein can be used in any sealing element aspect and can be used in any combination with any artificial valve and / or frame aspect.It will be understood that an artificial heart valve can also include any textile material described herein or portions thereof in any combination.

[0102] The textiles of the artificial sealing member described herein can be configured to promote biological reactions so as to form a seal between the artificial valve and the surrounding anatomical structure. In certain configurations, the sealing element described herein can be configured to form a seal within a selected time period. For example, in certain aspects, the presence of a 3D honeycomb honeycomb pattern, the openness of filaments, yarns, etc., and the porous nature can allow a selected amount of paravalvular leakage to occur around the artificial valve within a time period after implantation. Since the biological reaction to the textile causes blood coagulation, thrombosis, etc., the amount of paravalvular leakage through the sealing structure can gradually decrease within a selected time period. In some aspects, the sealing member, in particular the 3D honeycomb honeycomb pattern of the textiles, filaments, yarns, etc. of the paravalvular sealing structure can be treated with one or more reagents that inhibit the biological reaction to the sealing structure. For example, in certain exemplary aspects, textiles with 3D honeycomb honeycomb patterns or separated yarns and fibers can be treated with heparin. In certain aspects, the amount or concentration of the (one or more) reagents can be selected so that the reagent is exhausted after a selected time period (e.g., a few days, weeks, or months) after valve implantation. As the agent(s) are depleted, the biological response to the textile or yarn or fiber of the sealing structure increases, thereby gradually forming a paravalvular seal over a selected period of time. This is advantageous for patients with left atrial remodeling (e.g., due to mitral regurgitation) because the regurgitant flow through the prosthetic valve gradually decreases, providing an opportunity for remodeling to reverse.

[0103] In yet a further aspect, an implantable medical device is disclosed, comprising: a self-expanding frame having an upper region, a middle region, and a lower region, wherein the frame is configured to radially expand and contract for deployment within a body cavity, and wherein the self-expanding frame comprises a plurality of anchoring members disposed along the lower region; wherein at least a portion of at least some of the plurality of anchoring members are encapsulated within a textile material, wherein the textile material is defined by a first surface and an opposing second surface, has a longitudinal axis and a transverse axis, and has a first thickness, a first width, and a first length, and comprises: a plurality of weft yarns and a plurality of warp yarns , the plurality of weft yarns and the plurality of warp yarns are arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn among the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn having a heat shrinkage of about 10% to about 60%; wherein the textile exhibits a first stress relaxation response; and wherein the textile material is biocompatible and acts as a cushion and exhibits a compressibility of 50-95% of the first thickness under a load force of about 45 to about 56 pounds (lbs). These exemplary aspects of this implantable medical device are Figure 7-10 An exemplary aspect of a possible framework is shown in Figure 7. Such an exemplary frame 720 can have a proximal end 722 and a distal end 724. In some aspects, such as the aspect shown, the frame 720 can include a middle portion 726 having a larger diameter than the diameter of the frame 720 at the proximal end 722 and / or the distal end 724 when the frame 720 is in the expanded configuration. In some aspects, such as the aspect shown, the frame 720 can include a middle portion 726 having a larger cross-sectional area than the cross-sectional area of ​​the frame 720 at the proximal end 722 and / or the distal end 724 when the frame 720 is in the expanded configuration. The frame 720 can be designed to expand and contract radially for deployment within a body lumen, for example, at a heart valve site such as the mitral valve. For example, as described in more detail in U.S. Publication Nos. 2014 / 0277390, 2014 / 0277422, and 2014 / 0277427, the frame 720 can include a plurality of struts defining a plurality of foreshortened cells. In some aspects, the frame 720 can be designed to radially and radially contract from a longitudinal axis 728 extending through the frame 720.

[0104] In a further aspect, Figure 7 The exemplary frame shown in can include one or more distal anchors 730. The distal anchors 730 can be positioned along or near the distal end 724 of the frame 720 and can be connected to the frame 720. The distal anchors 730 can be designed such that when the frame 720 is in the expanded configuration, an end or tip 732 of each distal anchor 730 is positioned radially outward from the frame 720 and extends generally in the proximal direction. In some aspects, the disclosed exemplary implantable medical device can optionally include one or more proximal anchors 734. The proximal anchors 734 can be positioned along or near the proximal end 722 of the frame 720 and can be connected to the frame 720. The proximal anchors 734 can be designed such that when the frame 720 is in the expanded configuration, an end or tip 736 of each proximal anchor 734 is positioned radially outward from the frame 720 and extends generally in the distal direction.

[0105] Another aspect of the exemplary framework 800 is Figure 8. In one such aspect, frame 800 is shown in an expanded configuration. Frame 800 can include a frame portion 802 having an upper region 810, a middle region 820, and a lower region 830. In certain aspects, when frame 800 is in the expanded configuration, middle region 820 has a diameter that is larger than the diameter of frame 800 at proximal end 810 and / or distal end 830. In some aspects, such as the aspect shown, frame 800 can include middle portion 820 having a cross-sectional area that is larger than the cross-sectional area of ​​frame 800 at proximal end 810 and / or distal end 830 when frame 800 is in the expanded configuration. A longitudinal axis (not shown) of frame 800 can be defined as a central axis extending through the center of frame 800 between the upper and lower ends of frame 800. In some aspects, frame 800 can be oriented such that upper region 810 is the proximal portion and lower region 830 is the distal portion. The frame 800 can include a plurality of anchor members 850. In some aspects, the frame 800 can be oriented such that the plurality of anchor members 850 are distal anchor members. As shown in the illustrated aspects, the plurality of anchor members 850 can include one or more anchors. For example, but not limited to, as shown in the illustrated aspects, the plurality of anchor members 850 can include nine anchors, each anchor including a strut 852 extending from the lower region 830 of the frame body 802 and a tip 853.

[0106] An exemplary and non-limiting anchor member 900 is provided in Figure 9A and Figure 9B It will be appreciated that the anchoring member 900 is merely exemplary and that any other configuration of anchoring members may exist. The exemplary member 900 may be in a collapsed configuration (e.g., Figure 9A as shown) and expansion structure (as shown) Figure 9B When transitioning from the contracted structure to the expanded structure, the lateral dimension (or width) of the anchoring member 900 increases. The anchoring member 900 can be attached to the frame body (not shown) via one or more struts 910. The exemplary anchoring member 900 can also include one or more prongs 920, 930 having tips 922, 932. In a further aspect, the tips 922 and 932 can slide relative to each other when transitioning between the collapsed structure and the expanded structure. Other non-limiting and exemplary anchoring members can be found in U.S. Patent Application Publication No. 2019 / 0328515, the entire contents of which are incorporated herein by reference.

[0107] In a further aspect, at least a portion of at least some of the plurality of anchoring members are encapsulated within any of the textile materials disclosed herein. In a further exemplary aspect, the textile material for the disclosed encapsulation can be defined by a first surface and an opposing second surface, having a longitudinal axis and a transverse axis, and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns being arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn having a heat shrinkage of about 10% to about 60%; wherein the textile exhibits a first stress relaxation response; and wherein the textile material is biocompatible and acts as a cushion and exhibits a compressibility of 50-95% of the first thickness under a load force of about 45 to about 56 pounds (lbs). Exemplary and non-limiting aspects are Figure 10 Shown in. Figure 10 Shown with Figure 8 , a frame similar to the one shown in FIG, having a plurality of anchoring members 850, each anchoring member 850 having a strut 852 and a tip 853. The textile material described herein is used to form a cushion 1000 around the struts and tips of the plurality of anchoring members. In some aspects, the cushion 1000 can be formed from two separate pieces of the disclosed textile, such as an inner portion positioned within a cover, such that the cover forms a layer surrounding the inner portion. In other aspects, the cushion 1000 can be formed by encapsulating at least a portion of at least some of the plurality of anchoring members with one or more layers of textile material. It will be appreciated that these layers of textile material can be formed from separate fabrics or from a fabric wrapped around the anchoring members in any desired manner.

[0108] In further aspects, the encapsulation can optionally include other materials than the disclosed textile materials. For example, but not limited to, if the encapsulation includes an inner portion and an outer portion, the inner portion can include a textile structure, such as a braided, knitted, or woven cloth cover, while the outer portion includes the textile material disclosed herein. It will be appreciated that the use of the cushioning pad 1000 on the anchoring member can maintain a smaller form factor when the implantable medical device is in a collapsed state for delivery. It will be appreciated that aspects described herein include aspects in which only some of the plurality of anchoring members are encapsulated in the disclosed textile. Still other aspects described herein include all of the plurality of anchoring members being encapsulated in the disclosed textile. In further aspects, only a portion of the anchoring members are encapsulated, while in other aspects, the entire body of the anchoring member is encapsulated with the textile material.

[0109] It will be appreciated that in some aspects, a cushion (similar to but not limited to Figure 10 ) can advantageously increase the contact area of ​​the multiple anchoring members on the tissue. It can further reduce trauma between the multiple anchoring members and such tissue. In addition, this can promote tissue growth in and / or around the multiple anchoring members. Further, the cushioning pads disclosed herein can also advantageously reduce any potential trauma that may be caused when the anchoring members adjacent to the cushioned anchoring members do not have the disclosed cushioning pads. It will further be understood that the final thickness of each of the encapsulations around any or all of the multiple anchoring members can be the same or different and can be selected based on the specific application. Some of the multiple anchoring members can have an encapsulation within the disclosed textile so that the final thickness of the encapsulation can be thicker than the final thickness of the encapsulation. It will be understood that if the frame of the medical device includes both distal anchors and proximal anchors, any portion of any of these anchors can also be encapsulated in the textile material disclosed herein. In a further aspect, an additional covering can be positioned on the cushioning pad made of the disclosed textile material.

[0110] In a further aspect and as disclosed herein, the self-expanding frame comprises one or more struts, and at least a portion of the one or more struts can also be encapsulated within the disclosed textile material.In a further aspect, the textile material can be sutured with any suture suitable for the desired application.

[0111] It will be appreciated that the disclosed textile materials can be used as cushioning in any of the implantable medical devices disclosed herein.In other aspects, the implantable medical device is a prosthetic mitral valve.

[0112] method

[0113] The present disclosure also provides a method comprising weaving a plurality of weft yarns and a plurality of warp yarns to form a textile, wherein the formed textile is defined by a first surface and an opposing second surface and has a longitudinal axis and a transverse axis and has a first thickness, a first width, and a first length, and wherein at least a portion of the first surface and / or the second surface has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn among the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn having a heat shrinkage of about 10% to about 60%; wherein the textile has a first dimension along the longitudinal axis, the transverse axis, and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width, or the first length, and wherein the textile is configured to reversibly reach a second dimension upon application of stress, wherein the second dimension is defined by a second thickness, a second width, or a second length, and return to the first dimension upon removal of the stress and wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response.

[0114] It will be appreciated that any method known in the art can be used to form a 3D honeycomb pattern. In a further aspect, the textile formed by the disclosed method can include any of the textiles disclosed above. In a further aspect and as disclosed herein, the textured yarn used to form the disclosed textile can have a second stress relaxation response.

[0115] In an even further aspect, the methods disclosed herein include the step of exposing the textile to first heat setting conditions effective to provide a first stress relaxation response of the textile.

[0116] In some aspects, it is understood that the first stress relaxation response of a textile can be defined solely by the first heat setting condition. In other aspects, the first stress relaxation response of a textile can be defined by a combination of the first heat setting condition and the second stress relaxation response of a textured yarn used in the textile. It is understood that the second stress relaxation response of the textured yarn can be achieved by a second heat setting condition. It is further understood that the second heat setting condition can be applied to the textured yarn during yarn manufacturing or at any other step as permitted by manufacturing conditions.

[0117] In a further aspect, the first heat setting condition and / or the second heat setting condition can be achieved by a heat setting temperature or a heat exposure time or a combination of both.

[0118] In certain aspects and as disclosed herein, the first heat setting condition and / or the second heat setting condition can include a heat setting temperature of about 90°C to about 220°C, including exemplary values ​​of about 95°C, about 100°C, about 110°C, about 120°C, about 130°C, about 140°C, about 150°C, about 160°C, about 170°C, about 180°C, about 190°C, about 200°C, and about 210°C. It will be appreciated that the heat setting temperature values ​​for the first heat setting condition and / or the second heat setting condition can be any value between any two of the aforementioned values. For example, but not limited to, the heat setting temperature can be about 90°C to about 120°C, or about 100°C to about 180°C, or about 150°C to about 220°C.

[0119] In a further aspect, the first heat setting condition and / or the second heat setting condition may include a heat setting time of about 2 minutes to about 1 hour, including exemplary values ​​of about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 25 minutes, about 30 minutes, about 35 minutes, about 40 minutes, about 45 minutes, about 50 minutes, and about 55 minutes. It will be appreciated that the first heat setting condition and / or the second heat setting condition may have any heat setting time between any two of the aforementioned values. For example, but not limited to, the heat setting time may be about 5 minutes to about 20 minutes, or about 7 minutes to about 25 minutes, or about 15 minutes to about 60 minutes.

[0120] In a further aspect, the first heat setting condition and / or the second heat setting condition can include a heat setting temperature of about 90°C to about 220°C (including exemplary values ​​of about 95°C, about 100°C, about 110°C, about 120°C, about 130°C, about 140°C, about 150°C, about 160°C, about 170°C, about 180°C, about 190°C, about 200°C, and about 210°C) and a heat setting time of about 2 minutes to about 1 hour (including exemplary values ​​of about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 25 minutes, about 30 minutes, about 35 minutes, about 40 minutes, about 45 minutes, about 50 minutes, and about 55 minutes).

[0121] It will be further understood that any heating method may be used depending on the desired application. In certain and non-limiting aspects, heat setting may be performed using a hot air environment while the textile is in a relaxed state. However, it will be understood that in some aspects, heat setting may also be performed on the textile while stress is applied to the textile if the desired application so requires.

[0122] Exemplary heat setting features are Figure 11. This feature is used to control the tension in the fabric in two or all four directions during the heat setting process. This tensioning system with heat setting parameters allows the fabric to have a controlled shrinkage rate. The example tensioning system includes a rectangular base having a threaded rod extending between opposite sides of the base. Pin holders 1104 are mounted to the threaded rods. Each of the pin holders 1104 includes at least one pin that couples to / engages the fabric. The fabric is mounted on each of the pin holders 1104, and a tensioning knob 1102 is used to control the tension on the fabric by moving the pin holders 1104 along the threaded rods. For example, moving the pin holders 1104 outward / toward the sides of the base increases the tension, thereby stretching the fabric. Moving the pin holders 1104 inward releases the tension, thereby loosening the fabric.

[0123] In a further aspect, any of the textiles described above can be produced by the methods disclosed herein.

[0124] The present disclosure also provides a method of manufacturing an implantable medical device, comprising: providing a sealing element comprising a textile material, the textile material being defined by a first surface and an opposing second surface and having a longitudinal axis and a transverse axis, and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns being arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns has a heat shrinkage of about 10% to about 60%. a textured yarn; wherein the textile has a first dimension along the longitudinal axis, the transverse axis and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width or the first length, and wherein the textile is configured to reversibly reach a second dimension upon application of stress, wherein the second dimension is defined by a second thickness, a second width or a second length, and return to the first dimension upon removal of the stress and wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response; and a ring-shaped frame for securing a sealing element to an implantable medical device.

[0125] In a further aspect, any implantable medical device disclosed herein can be formed using such methods. In a further aspect, any textile disclosed herein can be used to form a sealing element of the device. In a further aspect, any method commonly used to secure a sealing element to an annular frame can be used, such as, but not limited to, sutures can be used to secure the sealing element to the annular frame of the device. Any suture known in the art can be used. In some exemplary and non-limiting aspects, the suture can include a textile-based material. However, it will be understood that any suture suitable for the desired application can be used.

[0126] Also disclosed herein is a method for manufacturing an implantable medical device, comprising: providing a self-expanding frame having an upper region, a middle region, and a lower region, wherein the frame is configured to radially expand and contract for deployment within a body cavity, and wherein the self-expanding frame includes a plurality of anchoring members arranged along the lower region; encapsulating at least a portion of at least some of the plurality of anchoring members within a textile material, wherein the textile material is defined by a first surface and an opposing second surface, has a longitudinal axis and a transverse axis, and has a first thickness, a first width, and a first length, and comprises: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns being arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn having a heat shrinkage of about 10% to about 60%; wherein the textile exhibits a first stress relaxation response; and wherein the textile exhibits a compressibility of 50-95% of the first thickness under a load force of about 45 to about 56 pounds (lbs). It will be appreciated that in some aspects described herein, the encapsulating step can include forming one or more layers of the textile material around at least a portion of at least some of the plurality of anchoring members.

[0127] It will be appreciated that any implantable medical device disclosed herein can be manufactured using these methods. It will be further appreciated that any of the disclosed textiles can be used to encapsulate at least a portion of at least one yarn of the plurality of anchoring members. In a further aspect, the encapsulating step can include forming one or more layers of textile material around at least a portion of at least some of the plurality of anchoring members. It will be further appreciated that in some aspects, the step of forming one or more layers can include forming the layers by wrapping the textile around at least a portion of at least one yarn of the plurality of anchoring members. However, in other aspects, the step of forming one or more layers can include encapsulating at least a portion of at least one yarn of the plurality of anchoring members with a separate layer of textile.

[0128] In a further aspect, the methods disclosed herein may include the step of impregnating any of the textile materials disclosed herein with a pharmaceutically active agent, depending on the desired application. In a further aspect, the methods disclosed herein may include the step of coating any of the textile materials disclosed herein with a material known in the art that can provide any additional desired properties.

[0129] Example

[0130] The following examples are presented to provide those of ordinary skill in the art with a complete disclosure and description of how the compounds, compositions, articles, devices and / or methods claimed herein are prepared and evaluated, and are intended to be exemplary only and not to limit the present disclosure. Efforts have been made to ensure accuracy with respect to numbers (e.g., amounts, temperatures, etc.), but some errors and deviations should be accounted for.

[0131] Unless indicated otherwise, parts are parts by weight, temperature is in degrees Celsius or is at ambient temperature, and pressure is at or near atmospheric or is a full vacuum.

[0132] like Figure 1 As shown, a textile 100 having a longitudinal axis 102 (y-axis) and a transverse axis 104 (x-axis) is manufactured, for example, on a loom. The textile structure uses a 16-pick repeating honeycomb weave using 40 denier / 27 filament textured yarn in the warp and weft directions. As described above, in some exemplary aspects, the weave pattern forms a repeating pattern of inverted and raised spaces on both surfaces of the textile 100. Figure 1-4 As shown, the honeycomb structure results in a repeating pattern of cells 106 and ridges 108, shown here on one side of the textile 100. The cells 106 are defined between adjacent longitudinally and transversely extending ridges 108. Figure 1-4 As provided, ridges 108a extend substantially parallel to the longitudinal axis 102 of textile 100, while ridges 108b extend substantially parallel to the transverse axis 104 of textile 100. The spacing between longitudinal ridges 108a and transverse ridges 108b is generally determined based on the pick repeat of the pattern (i.e., the number of cells 106 per square inch of the honeycomb pattern). Figure 1-4 As shown, the longitudinal ridges 108a and the transverse ridges 108b can be equally spaced along the width and length of the textile 100, respectively. Although not shown, other weave patterns are contemplated to vary the spacing between the longitudinal ridges 108a and the transverse ridges 108b. For example, the transverse ridges 108b can have increased spacing compared to the spacing of the longitudinal ridges 108a, or vice versa. Similarly, the spacing between adjacent longitudinal ridges 108a and transverse ridges 108b can vary along the length and width of the textile. Similarly, other weave patterns are contemplated to vary the orientation / angle of the longitudinal ridges 108a and transverse ridges 108b (relative to the longitudinal axis 102 and the transverse axis 104, respectively). For example, the longitudinal ridges 108a can be oriented at an angle relative to the longitudinal axis 102 and / or the transverse ridges 108b can be oriented at an angle relative to the transverse axis 104 of the textile. Figure 1-4The illustration shows ridges 108 defining square / straight cells 106. Cells 106 of varying shapes (e.g., rectangular, diamond-shaped) can be formed based on variations in the spacing and / or orientation of longitudinal ridges 108a and transverse ridges 108b in the weave pattern. As described above, the honeycomb structure in some aspects forms a 3D honeycomb pattern, creating inverted spaces on both surfaces of textile 100. That is, in such exemplary aspects, on each side of the textile, at least a portion of cells 106 extend in a direction away from ridges 108 (e.g., in a direction along the z-axis of textile 100 (perpendicular to both longitudinal axis 102 and transverse axis 104)). Figure 2-4 Shows the same textile exposed to different heat setting conditions. Figure 2 In the experiment, the textiles were exposed to 90℃ for 10 minutes, while Figure 3 In the experiment, the textiles were exposed to 120℃ for 10 minutes, while Figure 4 The textile was exposed to 180°C for 10 minutes. Increasing the temperature and duration of heat exposure results in corresponding increases in the thickness, compressibility, and stretchability of at least one yarn in the textile. For example, a higher temperature and time combination results in higher thickness, compressibility, and stretchability. However, increases in each of these properties are limited by the available space between yarns, which is related to the density of the yarns in the fabric.

[0133] Exemplary Aspects

[0134] In view of the described processes and compositions, certain more particularly described aspects of the present disclosure are described below. However, these specifically stated aspects should not be construed as having any limiting effect on any different claims incorporating different or more general teachings described herein, or that "particular" aspects are subject to some limitation in some way other than the inherent meaning of the language and the formula literally used therein.

[0135] Example 1: A textile defined by a first surface and an opposing second surface, having a longitudinal axis and a transverse axis, and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern, the 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn having a heat shrinkage of about 10% to about 60%; wherein the textile has a first dimension along the longitudinal axis, the transverse axis, and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width, or the first length, and wherein the textile is configured to reversibly reach a second dimension upon application of stress, wherein the second dimension is defined by a second thickness, a second width, or a second length, and return to the first dimension upon removal of the stress and wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response.

[0136] Example 2: According to any example herein, in particular the textile of Example 1, when the stress comprises stretching the textile in one or more directions along the longitudinal axis, the transverse axis and across the textile, the second dimension selected from the second length or width is greater than 0 to about 300% of the first dimension selected from the first length or width, as measured in the direction of stretching.

[0137] Example 3: The textile according to any example herein, in particular Example 2, wherein the second dimension along each direction is the same as or different from the second dimension along the rest of the one or more directions.

[0138] Example 4: The textile according to any example herein, particularly Examples 1-3, wherein when the stress comprises compression across the first thickness of the textile, the textile exhibits a compressibility of 50-95% to the first thickness under a load force of about 45 to about 56 lbs.

[0139] Example 5: The textile according to any example herein, in particular examples 1-4, wherein the at least a portion of the first surface and the second surface has the 3D honeycomb pattern.

[0140] Example 6: The textile according to any example herein, in particular examples 1-5, wherein the plurality of warp yarns and the plurality of weft yarns comprise the textured yarns.

[0141] Example 7: The textile according to any example herein, in particular examples 1-6, wherein the textured yarn is selected from friction textured yarn, pin textured yarn, air textured yarn, belt textured yarn, stuffer box textured yarn, or any combination thereof.

[0142] Example 8: A textile according to any example herein, in particular examples 1-7, wherein the textured yarn is a friction textured yarn.

[0143] Example 9: The textile according to any example herein, in particular examples 1-8, wherein each yarn of the plurality of weft yarns and / or warp yarns comprises a plurality of fibers.

[0144] Example 10: The textile according to any example herein, in particular Examples 1-9, wherein the textured yarn comprises polyester, copolyester, ultra-high molecular weight polyethylene, polyethylene, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyvinylidene fluoride, polyurethane, polyether, polyurea, nylon, copolymers thereof, or combinations thereof.

[0145] Example 11: The textile according to any example herein, in particular examples 1-10, wherein each yarn of the plurality of weft and / or warp yarns has a denier of about 10 to about 200.

[0146] Example 12: The textile according to any example herein, in particular examples 9-11, wherein each yarn of the plurality of weft and / or warp yarns comprises from about 8 to about 150 fibers.

[0147] Example 13: The textile according to any example herein, in particular examples 9-12, wherein the fibers have a diameter of about 1 μm to about 25 μm.

[0148] Example 14: The textile according to any example herein, in particular examples 1-13, wherein the textured yarn has a second stress relaxation response.

[0149] Example 15: The textile according to any example herein, in particular Example 14, wherein the first stress relaxation response is defined by a first heat setting condition of the textile and the second stress relaxation response.

[0150] Example 16: The textile according to any example herein, in particular example 14 or 15, wherein the second stress relaxation response is defined by a second heat setting condition of the textured yarn.

[0151] Example 17: The textile according to any example herein, in particular examples 15 or 16, wherein the first heat setting conditions and / or the second heat setting conditions comprise a heat setting temperature of about 90°C to about 220°C.

[0152] Example 18: The textile according to any example herein, in particular Examples 15-17, wherein the first heat setting condition and / or the second heat setting condition comprises a heat setting time of about 2 minutes to about 1 hour.

[0153] Example 19: The textile according to any example herein, in particular examples 15-18, wherein the first heat setting conditions are the same as or different from the second heat conditions.

[0154] Example 20: A textile according to any example herein, in particular examples 1-19, wherein the plurality of warp yarns and / or the plurality of weft yarns further comprise at least one yarn selected from polyolefins, polyamides, polyesters, copolyesters, polyurethanes, natural fibers, polytetrafluoroethylene, polyvinylidene fluoride, polyethers, polyureas, copolymers thereof, or combinations thereof.

[0155] Example 21: The textile according to any example herein, in particular Example 20, wherein the at least one yarn comprises a composite fiber.

[0156] Example 22: The textile according to any example herein, in particular examples 1-21, wherein the textile comprises a first edge and an opposing second edge.

[0157] Example 23: The textile according to any example herein, in particular Example 22, wherein at least a portion of the textile adjacent to the first edge and / or the second edge comprises a plain weave, a twill weave, a satin weave, any derivatives thereof, or any combination thereof.

[0158] Example 24: The textile according to any example herein, in particular examples 1-23, wherein the plurality of repeating cell units comprises from about 1 to about 30 cells per inch.

[0159] Example 25: The textile according to any example herein, in particular examples 1-24, wherein each of the plurality of repeating cell units comprises about 8 to 40 pick repeats.

[0160] Example 26: A textile according to any example herein, in particular examples 1-25, wherein the textile is configured to be stitched.

[0161] Example 27: A tissue scaffold material comprising a textile according to any example herein, particularly Examples 1-26.

[0162] Example 28: An implantable medical device comprising: an annular frame having an inflow end, an outflow end, and a longitudinal axis; and a sealing element secured to the frame, wherein the sealing element comprises: a textile defined by a first surface and an opposing second surface, having a longitudinal axis and a transverse axis, and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns being arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns has a heat shrinkage rate of approximately 1 0% to about 60% textured yarn; wherein the textile has a first dimension along the longitudinal axis, the transverse axis and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width or the first length, and wherein the textile is configured to reversibly reach a second dimension under the application of stress, wherein the second dimension is defined by a second thickness, a second width or a second length, and return to the first dimension after the stress is removed and wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response; and wherein the implantable medical device is configured to radially collapse to a collapsed structure and radially expand to an expanded structure.

[0163] Example 29: According to any example herein, in particular an implantable medical device of Example 28, when the stress includes stretching the textile in one or more directions along the longitudinal axis, the transverse axis and across the textile, the second dimension selected from the second length or width is greater than 0 to about 300% of the first dimension selected from the first length or width, as measured in the stretching direction.

[0164] Example 30: The implantable medical device according to any example herein, in particular Example 29, wherein the second dimension along each direction is the same as or different from the second dimension along the rest of the one or more directions.

[0165] Example 31: An implantable medical device according to any example herein, in particular Examples 28-30, wherein when the stress comprises compression across the first thickness of the textile, the textile exhibits a compressibility of 50-95% of the first thickness under a load force of about 45 to about 56 lbs.

[0166] Example 32: The implantable medical device according to any example herein, in particular examples 28-31, wherein the stress comprises expansion of the medical device to achieve the expanded configuration.

[0167] Example 33: The implantable medical device according to any example herein, in particular examples 28-32, wherein the at least a portion of the first surface and the second surface has the 3D honeycomb pattern.

[0168] Example 34: The implantable medical device according to any example herein, in particular examples 28-33, wherein the plurality of warp yarns and the plurality of weft yarns comprise the textured yarns.

[0169] Example 35: The implantable medical device according to any example herein, in particular examples 28-34, wherein the textured yarn is selected from friction textured yarn, pin textured yarn, air textured yarn, belt textured yarn, stuffer box textured yarn, or any combination thereof.

[0170] Example 36: The implantable medical device according to any example herein, in particular examples 28-35, wherein the textured yarn is a friction textured yarn.

[0171] Example 37: The implantable medical device according to any example herein, in particular examples 28-36, wherein each yarn of the plurality of weft yarns and / or warp yarns comprises a plurality of fibers.

[0172] Example 38: An implantable medical device according to any example herein, particularly Examples 28-37, wherein the textured yarn comprises polyester, copolyester, ultra-high molecular weight polyethylene, polyethylene, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyvinylidene fluoride, polyurethane, polyether, polyurea, nylon, copolymers thereof, or combinations thereof.

[0173] Example 39: The implantable medical device according to any example herein, in particular examples 28-38, wherein each yarn of the plurality of weft yarns and / or warp yarns has a denier size of about 10 to about 200.

[0174] Example 40: The implantable medical device of any example herein, in particular examples 37-39, wherein each yarn of the plurality of weft and / or warp yarns comprises from about 8 to about 150 fibers.

[0175] Example 41: The implantable medical device according to any example herein, in particular examples 37-40, wherein the fiber has a diameter of about 1 μm to about 25 μm.

[0176] Example 42: The implantable medical device according to any example herein, in particular examples 27-41, wherein the textured yarn has a second stress relaxation response.

[0177] Example 43: The implantable medical device according to any example herein, in particular examples 27-42, wherein the first stress relaxation response is defined by a first heat setting condition of the textile and the second stress relaxation response.

[0178] Example 44: The implantable medical device according to any example herein, in particular example 43 or 44, wherein the second stress relaxation response is defined by a second heat setting condition of the textured yarn.

[0179] Example 45: The implantable medical device according to any example herein, in particular example 43 or 44, wherein the first heat setting condition and / or the second heat setting condition comprises a heat setting temperature of about 90°C to about 220°C.

[0180] Example 46: The implantable medical device according to any example herein, in particular examples 43-45, wherein the first heat setting condition and / or the second heat setting condition comprises a heat setting time of about 2 minutes to about 1 hour.

[0181] Example 47: The implantable medical device according to any example herein, in particular examples 43-46, wherein the first heat setting condition is the same as or different from the second heat condition.

[0182] Example 48: An implantable medical device according to any example herein, in particular Examples 28-47, wherein the plurality of warp yarns and / or the plurality of weft yarns further comprise at least one yarn selected from polyolefins, polyamides, polyesters, copolyesters, polyurethanes, natural fibers, polytetrafluoroethylene, polyvinylidene fluoride, polyethers, polyureas, copolymers thereof, or combinations thereof.

[0183] Example 49: The implantable medical device according to any example herein, in particular Example 48, wherein the at least one yarn comprises a composite fiber.

[0184] Example 50: An implantable medical device according to any example herein, in particular examples 28-49, wherein the textile comprises a first edge and an opposing second edge.

[0185] Example 51: An implantable medical device according to any example herein, in particular example 50, wherein at least a portion of the textile adjacent to the first edge and / or the second edge comprises a plain weave, a twill weave, a satin weave, any derivatives thereof, or any combination thereof.

[0186] Example 52: The implantable medical device according to any example herein, in particular examples 28-51, wherein the plurality of repeating cell units comprises about 1 to about 30 cells per inch.

[0187] Example 53: The implantable medical device according to any example herein, in particular examples 28-52, wherein each of the plurality of repeating cell units comprises about 8 to 40 shuttle repetitions.

[0188] Example 54: An implantable medical device according to any example herein, in particular examples 28-53, wherein the textile is coupled to the frame by sutures.

[0189] Example 55: An implantable medical device according to any example herein, in particular examples 28-54, wherein the medical device is a prosthetic heart valve.

[0190] Example 56: The implantable medical device according to any example herein, in particular examples 28-55, wherein the sealing element is configured to prevent paravalvular leakage.

[0191] Example 57: An implantable medical device comprising: a self-expanding frame having an upper region, a middle region, and a lower region, wherein the frame is configured to radially expand and contract for deployment within a body cavity, and wherein the self-expanding frame comprises a plurality of anchoring members disposed along the lower region; wherein at least a portion of at least some of the plurality of anchoring members are encapsulated within a textile material, wherein the textile material is defined by a first surface and an opposing second surface, has a longitudinal axis and a transverse axis, and has a first thickness, a first width, and a first length, and comprises: a plurality of weft yarns and a plurality of warp yarns, The plurality of weft yarns and the plurality of warp yarns are arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn among the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn having a heat shrinkage rate of about 10% to about 60%; wherein the textile exhibits a first stress relaxation response; and wherein the textile material is biocompatible and acts as a cushion and exhibits a compressibility of 50-95% of the first thickness under a load force of about 45 to about 56 lbs.

[0192] Example 58: The implantable medical device according to any example herein, in particular Example 57, wherein the self-expanding frame comprises one or more struts, and wherein at least a portion of the one or more struts are encapsulated within the textile material.

[0193] Example 59: The implantable medical device of any example herein, particularly Examples 57-58, wherein the textile material is configured to function as a tissue scaffold.

[0194] Example 60: The implantable medical device according to any example herein, in particular examples 57-59, wherein the textile material is defined by a first dimension selected from a first textile thickness, a first textile width, or a first textile length.

[0195] Example 61: The implantable medical device according to any example herein, in particular examples 57-60, wherein the at least a portion of the first surface and the second surface of the textile has the 3D honeycomb pattern.

[0196] Example 62: The implantable medical device of any example herein, particularly Examples 57-61, wherein the plurality of warp yarns and the plurality of weft yarns of the textile material comprise the textured yarn.

[0197] Example 63: An implantable medical device according to any example herein, in particular examples 57-62, wherein the textured yarn is selected from friction textured yarn, pin textured yarn, air textured yarn, belt textured yarn, stuffer box textured yarn, or any combination thereof.

[0198] Example 64: An implantable medical device according to any example herein, in particular examples 57-63, wherein the textured yarn is a friction textured yarn.

[0199] Example 65: The implantable medical device according to any example herein, in particular examples 57-64, wherein each yarn of the plurality of weft yarns and / or warp yarns of the textile material comprises a plurality of fibers.

[0200] Example 66: An implantable medical device according to any example herein, in particular Examples 57-65, wherein the textured yarn comprises polyester, copolyester, ultra-high molecular weight polyethylene, polyethylene, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyvinylidene fluoride, polyurethane, polyether, polyurea, nylon, copolymers thereof, or combinations thereof.

[0201] Example 67: The implantable medical device of any example herein, in particular examples 57-66, wherein each yarn of the plurality of weft yarns and / or warp yarns has a denier size of about 10 to about 200.

[0202] Example 68: The implantable medical device of any example herein, in particular examples 65-67, wherein each yarn of the plurality of weft and / or warp yarns comprises from about 8 to about 150 fibers.

[0203] Example 69: The implantable medical device according to any example herein, in particular examples 65-68, wherein the fiber has a diameter of about 1 μm to about 25 μm.

[0204] Example 70: The implantable medical device according to any example herein, in particular examples 57-69, wherein the textured yarn has a second stress relaxation response.

[0205] Example 71: An implantable medical device according to any example herein, in particular examples 57-70, wherein the first stress relaxation response is defined by a first heat setting condition of the textile and the second stress relaxation response.

[0206] Example 72: The implantable medical device according to any example herein, in particular example 70 or 71, wherein the second stress relaxation response is defined by a second heat setting condition of the textured yarn.

[0207] Example 73: The implantable medical device according to any example herein, in particular example 71 or 72, wherein the first heat setting condition and / or the second heat setting condition comprises a heat setting temperature of about 90°C to about 220°C.

[0208] Example 74: The implantable medical device according to any example herein, in particular examples 71-73, wherein the first heat setting condition and / or the second heat setting condition comprises a heat setting time of about 2 minutes to about 1 hour.

[0209] Example 75: The implantable medical device according to any example herein, in particular examples 71-74, wherein the first heat setting condition is the same as or different from the second heat condition.

[0210] Example 76: An implantable medical device according to any example herein, in particular Examples 57-75, wherein the plurality of warp yarns and / or the plurality of weft yarns further comprise at least one yarn selected from polyolefins, polyamides, polyesters, copolyesters, polyurethanes, natural fibers, polytetrafluoroethylene, polyvinylidene fluoride, polyethers, polyureas, copolymers thereof, or combinations thereof.

[0211] Example 77: The implantable medical device according to any example herein, in particular Example 76, wherein the at least one yarn comprises a composite fiber.

[0212] Example 78: An implantable medical device according to any example herein, in particular examples 57-77, wherein the textile comprises a first edge and an opposing second edge.

[0213] Example 79: An implantable medical device according to any example herein, in particular Example 78, wherein at least a portion of the textile adjacent to the first edge and / or the second edge comprises a plain weave, a twill weave, a satin weave, any derivatives thereof, or any combination thereof.

[0214] Example 80: The implantable medical device according to any example herein, in particular examples 57-79, wherein the plurality of repeating cell units comprises about 1 to about 30 cells per inch.

[0215] Example 81: The implantable medical device according to any example herein, in particular examples 57-80, wherein each of the plurality of repeating cell units comprises about 8 to 40 shuttle repetitions.

[0216] Example 82: The implantable medical device of any example herein, particularly Examples 57-81, wherein the textile material is sutureable.

[0217] Example 83: The implantable medical device according to any example herein, in particular examples 57-82, wherein the encapsulation of at least a portion of at least some of the plurality of anchoring members is formed by one or more layers of the textile material.

[0218] Example 84: The implantable medical device according to any example herein, in particular Examples 57-83, wherein the medical device is a prosthetic mitral valve.

[0219] Example 85: A method comprising: weaving a plurality of weft yarns and a plurality of warp yarns to form a textile, wherein the formed textile is defined by a first surface and an opposing second surface and has a longitudinal axis and a transverse axis and has a first thickness, a first width, and a first length, and wherein at least a portion of the first surface and / or the second surface has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn having a heat shrinkage of about 10% to about 60%; wherein the textile has a first dimension along the longitudinal axis, the transverse axis, and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width, or the first length, and wherein the textile is configured to reversibly reach a second dimension upon application of stress, wherein the second dimension is defined by a second thickness, a second width, or a second length, and return to the first dimension upon removal of the stress and wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response.

[0220] Example 86: The method according to any example herein, in particular Example 85, wherein the method comprises exposing the textile to conditions effective to obtain the first stress relaxation response.

[0221] Example 87: The method according to any example herein, in particular Example 86, wherein the conditions effective to obtain the first stress relaxation response include heat setting the textile at a predetermined temperature and time.

[0222] Example 88: The method according to any example herein, in particular examples 85-86, wherein the formed textile is a textile according to any example herein, in particular examples 1-26.

[0223] Example 89: A method of manufacturing an implantable medical device, comprising: providing a sealing element, the sealing element comprising a textile material, the textile material being defined by a first surface and an opposing second surface and having a longitudinal axis and a transverse axis, and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns being arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns has a heat shrinkage of about 10% to about 60% textured yarn; wherein the textile has a first dimension along the longitudinal axis, the transverse axis and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width or the first length, and wherein the textile is configured to reversibly reach a second dimension under the application of stress, wherein the second dimension is defined by a second thickness, a second width or a second length, and return to the first dimension after the stress is removed and wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response; and securing the sealing element to the annular frame of the implantable medical device.

[0224] Example 90: A method of manufacturing an implantable medical device, comprising: providing a self-expanding frame having an upper region, a middle region, and a lower region, wherein the frame is configured to radially expand and contract for deployment within a body cavity, and wherein the self-expanding frame includes a plurality of anchoring members disposed along the lower region; enclosing at least a portion of at least some of the plurality of anchoring members within a textile material, wherein the textile material is defined by a first surface and an opposing second surface, has a longitudinal axis and a transverse axis, and has a first thickness, a first width, and a first length, and comprises: a plurality of weft yarns and a plurality of warp yarns; yarn, the plurality of weft yarns and the plurality of warp yarns being arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn among the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn having a heat shrinkage rate of about 10% to about 60%; wherein the textile exhibits a first stress relaxation response; and wherein the textile material is biocompatible and acts as a cushion and exhibits a compressibility of 50-95% of the first thickness under a load force of about 45 to about 56 lbs.

[0225] Example 91: Any of the examples herein, in particular the method of Example 90, wherein the step of encapsulating comprises forming one or more layers of the textile material around the at least a portion of at least some of the plurality of anchoring members.

[0226] While several aspects of the present disclosure have been disclosed in the foregoing description, it will be appreciated by those skilled in the art that many modifications and other aspects of the present disclosure will readily occur to those skilled in the art having the benefit of the teachings presented in the foregoing description and the associated drawings. It will be understood, therefore, that the present disclosure is not limited to the specific aspects disclosed above, and that many modifications and other aspects are intended to be included within the scope of the appended claims. Furthermore, although specific terms are used herein and in the claims that follow, they are used in a generic and descriptive sense only and not for the purpose of limiting the disclosed content or the claims that follow. We therefore claim as our disclosure all that comes within the scope and spirit of these claims.

Claims

1. A textile defined by a first surface and an opposing second surface, the textile having a longitudinal axis and a transverse axis, and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns being arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn exhibiting a thermal shrinkage of 10% to 60%; wherein the textile has a first dimension along the longitudinal axis, the transverse axis, and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width, or the first length, and wherein the textile is configured to reversibly reach a second dimension upon application of stress, wherein the second dimension is defined by a second thickness, a second width, or a second length, and return to the first dimension upon removal of the stress, wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response, Each of the plurality of repeating cell units comprises 8 to 40 shuttle repetitions.

2. The textile according to claim 1, when the stress comprises stretching the textile in one or more directions along the longitudinal axis, the transverse axis, and across the textile, the second dimension selected from the second length or the second width is greater than 0 to 300% of the first dimension selected from the first length or the first width, as measured in the direction of stretching.

3. The textile of claim 2, wherein the second dimension along each direction is the same as or different from the second dimension along the rest of the one or more directions.

4. The textile of any one of claims 1-3, wherein when the stress comprises compression across the first thickness of the textile, the textile exhibits a compressibility of 50-95% of the first thickness under a load force of 45 to 56 lbs.

5. The textile according to any one of claims 1-3, wherein the textured yarn is selected from the group consisting of friction textured yarn, pin textured yarn, air textured yarn, belt textured yarn, stuffer box textured yarn, or any combination thereof.

6. The textile according to any one of claims 1-3, wherein each yarn of the plurality of weft yarns and / or warp yarns comprises a plurality of fibers, wherein the plurality of fibers comprises 8 to 150 fibers having a diameter of 1 μm to 25 μm.

7. The textile of any one of claims 1-3, wherein the textured yarn comprises polyester, copolyester, ultra-high molecular weight polyethylene, polyethylene, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyvinylidene fluoride, polyurethane, polyether, polyurea, nylon, copolymers thereof, or combinations thereof.

8. The textile according to any one of claims 1-3, wherein each yarn of the plurality of weft yarns and / or warp yarns has a denier size of 10 to 200.

9. The textile of any one of claims 1-3, wherein the textured yarn has a second stress relaxation response.

10. The textile of claim 9, wherein the first stress relaxation response is defined by a first heat set condition of the textile and the second stress relaxation response is defined by a second heat set condition of the textured yarn.

11. The textile product of claim 10, wherein the first heat setting condition and / or the second heat setting condition comprises a heat setting temperature of 90°C to 220°C.

12. The textile according to any one of claims 10-11, wherein the first heat setting condition and / or the second heat setting condition comprises a heat setting time of 2 minutes to 1 hour.

13. The textile according to any one of claims 10-11, wherein the first heat setting conditions are the same as or different from the second heat setting conditions.

14. The textile according to any one of claims 1 to 3, wherein the plurality of warp yarns and / or the plurality of weft yarns further comprise at least one yarn selected from polyolefins, polyamides, polyesters, copolyesters, polyurethanes, natural fibers, polytetrafluoroethylene, polyvinylidene fluoride, polyethers, polyureas, copolymers thereof, or combinations thereof.

15. The textile according to claim 14, wherein the at least one yarn comprises a composite fiber.

16. The textile of any one of claims 1-3, wherein the textile comprises a first edge and an opposing second edge, and wherein at least a portion of the textile adjacent to the first edge and / or the second edge comprises a plain weave, a twill weave, a satin weave, any derivatives thereof, or any combination thereof.

17. The textile of any one of claims 1-3, wherein the plurality of repeating cell units comprises 1 to 30 cells per inch.

18. The textile of any one of claims 1-3, wherein the textile is configured to be stitched.

19. A tissue scaffold material comprising the textile according to any one of claims 1 to 18.

20. An implantable medical device comprising: an annular frame having an inflow end, an outflow end, and a longitudinal axis; as well as a sealing element secured to the annular frame, wherein the sealing element comprises: a textile defined by a first surface and an opposing second surface, the textile having a longitudinal axis and a transverse axis and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns being arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn exhibiting a thermal shrinkage of 10% to 60%; wherein the textile has a first dimension along the longitudinal axis, the transverse axis, and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width, or the first length, and wherein the textile is configured to reversibly reach a second dimension upon application of a stress, wherein the second dimension is defined by a second thickness, a second width, and / or a second length, and return to the first dimension upon removal of the stress, wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response; wherein the implantable medical device is configured to radially collapse to a collapsed configuration and radially expand to an expanded configuration; and wherein the annular frame includes a plurality of anchoring members, and at least a portion of at least some of the plurality of anchoring members are enclosed within the textile.

21. The implantable medical device of claim 20, wherein the textile is coupled to the annular frame by sutures.

22. An implantable medical device according to claim 20, wherein when the stress comprises stretching the textile in one or more directions along the longitudinal axis, the transverse axis and across the textile, the second dimension selected from the second length or the second width is greater than 0 to 300% of the first dimension selected from the first length or the first width, as measured in the stretching direction.

23. The implantable medical device of claim 22, wherein the second dimension along each direction is the same as or different from the second dimension along the rest of the one or more directions.

24. The implantable medical device of any one of claims 20-23, when the stress comprises compression across the first thickness of the textile, the textile exhibits a compressibility of 50-95% of the first thickness under a load force of 45 to 56 lbs.

25. The implantable medical device of any one of claims 20-23, wherein the stress comprises expansion of the medical device to achieve the expanded configuration.

26. The implantable medical device of any one of claims 20-23, wherein the plurality of warp yarns and the plurality of weft yarns comprise the textured yarns.

27. The implantable medical device of any one of claims 20-23, wherein the textured yarn is selected from the group consisting of friction textured yarn, pin textured yarn, air textured yarn, belt textured yarn, stuffer box textured yarn, or any combination thereof.

28. The implantable medical device of any one of claims 20-23, wherein each yarn of the plurality of weft yarns and / or warp yarns comprises a plurality of fibers.

29. The implantable medical device of any one of claims 20-23, wherein the textured yarn comprises polyester, copolyester, ultra-high molecular weight polyethylene, polyethylene, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyvinylidene fluoride, polyurethane, polyether, polyurea, nylon, copolymers thereof, or combinations thereof.

30. The implantable medical device of any one of claims 20-23, wherein each yarn of the plurality of weft and / or warp yarns has a denier size of 10 to 200.

31. The implantable medical device of any one of claims 20-23, wherein each yarn of the plurality of weft and / or warp yarns comprises 8 to 150 fibers.

32. An implantable medical device according to any one of claims 31, wherein the fibres have a diameter of 1 μm to 25 μm.

33. The implantable medical device of any one of claims 20-23, wherein the textured yarn has a second stress relaxation response.

34. The implantable medical device of claim 33, wherein the first stress relaxation response is defined by a first heat set condition of the textile and the second stress relaxation response.

35. The implantable medical device of claim 34, wherein the second stress relaxation response is defined by a second heat set condition of the textured yarn.

36. The implantable medical device of claim 35, wherein the first heat set condition and / or the second heat set condition comprises a heat set temperature of 90°C to 220°C.

37. The implantable medical device of claim 35, wherein the first heat setting condition and / or the second heat setting condition comprises a heat setting time of 2 minutes to 1 hour.

38. The implantable medical device of any one of claims 36-37, wherein the first heat setting condition is the same as or different from the second heat setting condition.

39. The implantable medical device of any one of claims 20-23, wherein the plurality of warp yarns and / or the plurality of weft yarns further comprise at least one yarn selected from polyolefins, polyamides, polyesters, copolyesters, polyurethanes, natural fibers, polytetrafluoroethylene, polyvinylidene fluoride, polyethers, polyureas, copolymers thereof, or combinations thereof.

40. The implantable medical device of claim 39, wherein the at least one yarn comprises a composite fiber.

41. The implantable medical device of any one of claims 20-23, wherein the textile comprises a first edge and an opposing second edge.

42. The implantable medical device of any one of claims 41, wherein at least a portion of the textile adjacent the first edge and / or the second edge comprises a plain weave, a twill weave, a satin weave, any derivatives thereof, or any combination thereof.

43. The implantable medical device of any one of claims 20-23, wherein the plurality of repeating cell units comprises 1 to 30 cells per inch.

44. The implantable medical device of any one of claims 20-23, wherein each of the plurality of repeating cell units comprises 8 to 40 shuttle repetitions.

45. The implantable medical device of any one of claims 20-23, wherein the medical device is a prosthetic heart valve.

46. ​​The implantable medical device of any one of claims 20-23, wherein the sealing element is configured to prevent paravalvular leakage.

47. An implantable medical device comprising: a self-expanding frame having an upper region, a middle region, and a lower region, wherein the self-expanding frame is configured to radially expand and contract for deployment within a body lumen, and wherein the self-expanding frame includes a plurality of anchor members disposed along the lower region; wherein at least a portion of at least some of the plurality of anchoring members are enclosed within a textile material, wherein the textile material is defined by a first surface and an opposing second surface, the textile material having a longitudinal axis and a transverse axis, and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns being arranged such that at least a portion of the first surface and / or the second surface of the textile material has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn exhibiting a thermal shrinkage of 10% to 60%; wherein the textile material exhibits a first stress relaxation response; and wherein the textile material is biocompatible and acts as a cushion and exhibits a compressibility of 50-95% of the first thickness under a load force of 45 to 56 lbs.

48. The implantable medical device of claim 47, wherein the self-expanding frame comprises one or more struts, and wherein at least a portion of the one or more struts are encapsulated within the textile material.

49. The implantable medical device of claim 47, wherein the textile material is configured to function as a tissue scaffold.

50. The implantable medical device of any one of claims 47-49, wherein the textile material is defined by a first dimension selected from a first textile thickness, a first textile width, or a first textile length.

51. The implantable medical device of any one of claims 47-49, wherein the textured yarn is selected from the group consisting of friction textured yarn, pin textured yarn, air textured yarn, belt textured yarn, stuffer box textured yarn, or any combination thereof.

52. An implantable medical device according to any one of claims 47-49, wherein each yarn of the plurality of weft yarns and / or warp yarns of the textile material comprises a plurality of fibers, and the plurality of fibers comprises 8 to 150 fibers, and wherein the fibers have a diameter of 1 μm to 25 μm.

53. The implantable medical device of any one of claims 47-49, wherein the textured yarn comprises polyester, copolyester, ultra-high molecular weight polyethylene, polyethylene, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyvinylidene fluoride, polyurethane, polyether, polyurea, nylon, copolymers thereof, or combinations thereof.

54. The implantable medical device of any one of claims 47-49, wherein each yarn of the plurality of weft and / or warp yarns has a denier size of 10 to 200.

55. The implantable medical device of any one of claims 47-49, wherein the textured yarn has a second stress relaxation response.

56. The implantable medical device of claim 55, wherein the first stress relaxation response is defined by a first heat set condition of the textile material and the second stress relaxation response is defined by a second heat set condition of the textured yarn.

57. The implantable medical device of claim 56, wherein the first heat set condition and / or the second heat set condition comprises a heat set temperature of 90°C to 220°C.

58. The implantable medical device of claim 56, wherein the first heat setting condition and / or the second heat setting condition comprises a heat setting time of 2 minutes to 1 hour.

59. The implantable medical device of claim 56, wherein the first heat set condition is the same as or different from the second heat set condition.

60. The implantable medical device of any one of claims 47-49, wherein the plurality of warp yarns and / or the plurality of weft yarns further comprise at least one yarn selected from polyolefins, polyamides, polyesters, copolyesters, polyurethanes, natural fibers, polytetrafluoroethylene, polyvinylidene fluoride, polyethers, polyureas, copolymers thereof, or combinations thereof.

61. The implantable medical device of claim 60, wherein the at least one yarn comprises a composite fiber.

62. An implantable medical device according to any one of claims 47-49, wherein the textile material comprises a first edge and an opposing second edge, and wherein at least a portion of the textile material adjacent to the first edge and / or the second edge comprises a plain weave, a twill weave, a satin weave, any derivatives thereof, or any combination thereof.

63. The implantable medical device of any one of claims 47-49, wherein the plurality of repeating cell units comprises 1 to 30 cells per inch.

64. The implantable medical device of any one of claims 47-49, wherein each of the plurality of repeating cell units comprises 8 to 40 shuttle repetitions.

65. The implantable medical device of any one of claims 47-49, wherein the encapsulation of at least a portion of at least some of the plurality of anchoring members is formed by one or more layers of the textile material.

66. The implantable medical device of any one of claims 47-49, wherein the medical device is a prosthetic mitral valve.

67. A method for forming a textile, comprising: weaving a plurality of weft yarns and a plurality of warp yarns to form the textile, wherein the formed textile is defined by a first surface and an opposing second surface and has a longitudinal axis and a transverse axis and has a first thickness, a first width, and a first length, and wherein at least a portion of the first surface and / or the second surface has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn exhibiting a thermal shrinkage of 10% to 60%; wherein the textile has a first dimension along the longitudinal axis, the transverse axis, and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width, or the first length, and wherein the textile is configured to reversibly reach a second dimension upon application of stress, wherein the second dimension is defined by a second thickness, a second width, or a second length, and return to the first dimension upon removal of the stress, and wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response, Each of the plurality of repeating cell units comprises 8 to 40 shuttle repetitions.

68. The method of claim 67, wherein the method comprises exposing the textile to conditions effective to obtain the first stress relaxation response.

69. The method of claim 68, wherein the conditions effective to obtain the first stress relaxation response comprise heat setting the textile at a predetermined temperature and time.

70. A method of manufacturing an implantable medical device, comprising: A sealing element is provided, the sealing element comprising a textile defined by a first surface and an opposing second surface and having a longitudinal axis and a transverse axis, and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns being arranged such that at least a portion of the first surface and / or the second surface of the textile has a 3D honeycomb pattern, the 3D honeycomb pattern having a plurality of repeating honeycomb units, each of the plurality of repeating honeycomb units comprising 8 to 40 pick repeats, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn exhibiting a thermal shrinkage of 10% to 60%; wherein the textile has a first dimension along the longitudinal axis, the transverse axis, and across the textile in a relaxed position, wherein the first dimension is defined by the first thickness, the first width, or the first length, and wherein the textile is configured to reversibly reach a second dimension upon application of a stress, wherein the second dimension is defined by a second thickness, a second width, or a second length, and return to the first dimension upon removal of the stress, and wherein the textile is biocompatible; and wherein the textile exhibits a first stress-relaxation response; The sealing element is secured to the annular frame of the implantable medical device.

71. A method of manufacturing an implantable medical device, comprising: providing a self-expanding frame having an upper region, a middle region, and a lower region, wherein the self-expanding frame is configured to radially expand and contract for deployment within a body lumen, and wherein the self-expanding frame includes a plurality of anchor members disposed along the lower region; enclosing at least a portion of at least some of the plurality of anchoring members within a textile material, wherein the textile material is defined by a first surface and an opposing second surface, the textile material having a longitudinal axis and a transverse axis, and having a first thickness, a first width, and a first length, and comprising: a plurality of weft yarns and a plurality of warp yarns, the plurality of weft yarns and the plurality of warp yarns being arranged such that at least a portion of the first surface and / or the second surface of the textile material has a 3D honeycomb pattern having a plurality of repeating honeycomb cells, wherein at least one yarn of the plurality of warp yarns and / or the plurality of weft yarns is a textured yarn exhibiting a thermal shrinkage of 10% to 60%; wherein the textile material exhibits a first stress relaxation response; and wherein the textile material is biocompatible and acts as a cushion and exhibits a compressibility of 50-95% of the first thickness under a load force of 45 to 56 lbs.

72. The method of claim 71, wherein the step of encapsulating comprises forming one or more layers of the textile material around the at least a portion of at least some of the plurality of anchoring members.

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