Textile and implantable medical device using a textile

Abstract

Disclosed herein is a 3-D unitary braided article comprising: a) a tubular member having a lumen; b) a cushioning member, wherein a portion of the cushioning member comprises a central cavity housing a portion of the lumen; and c) a braided seal positioned at a distal end of the cushioning member.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Patent Application No. 63 / 587,408, filed October 2, 2023, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field

[0003] This application relates to various aspects of textile materials that can be used in implantable medical devices. More specifically, this application relates to woven, one-piece textile materials used as cushioning materials in implantable devices. Background Technology

[0004] The heart can suffer from various valvular diseases or malformations, leading to significant cardiac dysfunction and ultimately requiring the replacement of natural heart valves with artificial ones. The human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, function essentially like one-way valves that work in sync with the pumping heart. Valves allow blood to flow downstream but prevent it from flowing upstream. Diseased heart valves exhibit damage such as valvular stenosis or regurgitation, which inhibits the valve's ability to control blood flow. Such damage reduces the heart's pumping efficiency and can lead to debilitating and life-threatening conditions. For example, valvular insufficiency can cause conditions such as cardiac hypertrophy and ventricular dilatation. Therefore, considerable effort has been made to develop methods and devices to repair or replace damaged heart valves.

[0005] Prostheses exist to correct problems associated with damaged heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace damaged autologous heart valves. Recently, significant efforts have been devoted to developing replacement heart valves, particularly tissue-based replacement heart valves, which can be delivered with less trauma to the patient than through open-heart surgery. Replacement valves are designed for delivery via minimally invasive surgery and even percutaneous procedures. Such replacement valves typically consist of a tissue-based valve body connected to an expandable frame, which is then delivered to the annulus of the natural valve.

[0006] These replacement valves are typically designed to at least partially stop blood flow. However, problems arise when blood flows around the valve on the outside of the prosthesis. For example, addressing paravalvular leakage has proven particularly challenging in the case of heart valve replacement. Additional challenges involve the ability of such prostheses to be secured relative to intraluminal tissue (e.g., any tissue within a lumen or body cavity) in a way that prevents injury. Further challenges arise when attempting to deliver and secure such prostheses in a controlled manner at locations such as the natural mitral valve. These replacement valves are typically designed to at least partially stop blood flow.

[0007] Due to the drawbacks associated with conventional open-heart surgery, percutaneous and minimally invasive surgical approaches have garnered significant attention. In one technique, prosthetic valves are configured for implantation via catheter insertion, a procedure that is far less invasive. For example, U.S. Patents 10,716,664, 9,681,951, 10,583,000, and 11,224,507, and International Patent Publications WO2018017886 and WO2019 / 169087 (the entire contents of which are incorporated herein by reference for all purposes) describe heart valve prostheses for replacing natural valves, comprising a self-expanding frame with multiple anchoring members designed to be deployed within the body cavity and to prevent axial flow of fluid around the prosthesis.

[0008] However, problems still arise. For example, some challenges involve the ability to secure the prosthesis relative to intraluminal tissue (e.g., any tissue within a lumen or body cavity) in a way that prevents damage. Further challenges arise when attempting to deliver and secure such a prosthesis in a controlled manner in a particular location.

[0009] This disclosure at least partially satisfies these and other needs. Summary of the Invention

[0010] Some aspects of this disclosure relate to textiles. Some aspects relate to a woven article defined by a proximal end and a distal end, wherein the woven article is a 3D monolithic article and includes: a) a tubular member having a lumen disposed between a first open end of the tubular member and a second end of the tubular member; wherein the tubular member has a first thickness, wherein the first open end defines the proximal end of the woven article; wherein the lumen has a diameter d1 and a length l1; b) a cushioning member having a second thickness, wherein the outer surface of the tubular member seamlessly transitions to the outer surface of the cushioning member at a length l2 from the first open end of the tubular member, thereby forming the proximal end of the cushioning member, wherein l2 is less than l1, wherein a portion of the cushioning member includes a central cavity having a portion of length l3 that accommodates the lumen, such that the second end of the tubular member is positioned within the central cavity of the cushioning member; and c) a woven seal positioned at the distal end of the cushioning member.

[0011] Furthermore, this document further discloses aspects in which the tubular member has a plain weave pattern, a twill weave pattern, a satin weave pattern, any derived weave pattern, or any combination thereof. This document also further discloses aspects in which the cushioning member has a 3D honeycomb pattern having multiple repeating channel units.

[0012] This article also discloses an aspect in which the woven article further includes a cover member having a third thickness and defined by an inner surface and an outer surface and having a proximal end and a distal end, wherein the proximal end of the cover member is coupled to a woven seal and wherein the distal end is open.

[0013] This article also discloses aspects in which woven fabrics are configured to be assembled in an implantable medical device, the implantable medical device including: one or more anchors, each of the one or more anchors being configured to anchor the implantable medical device to the patient's natural anatomy.

[0014] In some respects, the woven article is configured to receive one or more anchors through a first open end of the tubular member, such that the anchors are positioned within the lumen of the tubular member, and such that a second end of the tubular member substantially prevents further movement of the anchors within the article.

[0015] In other respects, this document discloses an implantable medical device comprising one or more anchors, each of which is configured to anchor the implantable medical device to a portion of a patient’s natural anatomy, wherein each anchor is positioned within any woven fabric disclosed herein.

[0016] Other aspects described herein relate to implantable devices comprising a self-expanding frame having an upper region, a middle region, and a lower region, wherein the frame is configured to expand and contract radially for deployment within a body cavity, and wherein the self-expanding frame includes one or more anchors disposed along the lower region; each of the one or more anchors is configured to anchor the implantable medical device to a portion of a patient's natural anatomy, and at least a portion of the one or more anchors is positioned within a braided article; wherein the braided article includes a tubular member having a first open end disposed on the tubular member and a second end disposed on the tubular member. A tubular member having a first thickness, wherein a first open end defines a proximal end of a braided article; wherein the tubular member has a diameter d1 and a length l1; a buffer member having a second thickness, wherein the outer surface of the tubular member seamlessly transitions to the outer surface of the buffer member at a length l2 from the first open end of the tubular member, thereby forming a proximal end of the buffer member, wherein l2 is less than l1, wherein a portion of the buffer member includes a central cavity having a portion of length l3 that accommodates the tubular member, such that a second end of the tubular member is positioned within the central cavity of the buffer member; and a braided seal positioned at a distal end of the buffer member.

[0017] Some aspects disclosed herein relate to a method that includes weaving any of the woven products disclosed herein.

[0018] Some aspects disclosed herein relate to methods of manufacturing any implantable medical device disclosed herein, wherein the method includes: a) providing a device comprising one or more anchors, wherein each of the one or more anchors is configured to anchor the implantable medical device to a portion of a patient’s natural anatomy, and b) inserting each anchor into any woven fabric disclosed herein.

[0019] This document also discloses a method comprising the following steps: deploying a prosthetic valve to a patient’s heart’s natural valve, the prosthetic valve comprising: a plurality of prosthetic valve leaflets, one or more anchors connected to the plurality of prosthetic valve leaflets, and each anchor being configured to anchor to a portion of the patient’s heart, wherein each of the one or more anchors is inserted into any one of the braided fabrics disclosed herein.

[0020] Further aspects of this 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 may be learned by practice of this disclosure. It should be understood that the foregoing general description and the following detailed description are merely exemplary and explanatory and do not limit the scope of the disclosure. Attached Figure Description

[0021] Figure 1 A framework for an exemplary implantable medical device is shown according to one aspect.

[0022] Figures 2A to 2B An exemplary woven article is shown positioned on an exemplary implantable medical device in one aspect. Figure 2A ) and close-up views of exemplary woven products ( Figure 2B ).

[0023] Figure 3 A schematic construction of an exemplary woven article according to one aspect is shown.

[0024] Figure 4 An exemplary woven article formed according to one aspect is shown.

[0025] Figure 5 A schematic construction of an exemplary woven article according to another aspect is shown.

[0026] Figures 6A to 6C It shows that according to Figure 5 An exemplary woven product formed by the schematic diagram.

[0027] Figure 7A cross-sectional schematic diagram of an exemplary assembled woven article connected to an anchor according to one aspect is shown.

[0028] Figure 8A A perspective view of an exemplary implantable medical device according to one aspect is shown.

[0029] Figure 8B It shows that according to one aspect Figure 8A A top view of an exemplary implantable medical device shown.

[0030] Figure 9A It shows that according to one aspect, such as Figure 4 The exemplary woven article shown is attached to an anchor of an exemplary implantable medical device.

[0031] Figure 9B It shows that according to one aspect, such as Figures 6A to 6C The exemplary woven article shown is attached to an anchor of an exemplary implantable medical device.

[0032] Figure 10 A view of the surface of a buffer member according to one aspect is shown.

[0033] Figure 11 A perspective view showing a representation of the surface of a cushioning member with a woven pattern according to one aspect is shown.

[0034] Figure 12A A photograph of the woven cushioning component is shown.

[0035] Figure 12B This illustrates the process following an exemplary treatment based on one aspect. Figure 12A A photograph of the buffer component shown.

[0036] Figure 13 An example of a delivery device from one perspective is shown.

[0037] Figure 14A A cross-sectional view of the implant holding area is shown according to one aspect of a delivery device.

[0038] Figure 14B An example is given based on one aspect. Figure 14A The cross-sectional view of the implant retention area shown.

[0039] Figure 15 An example of a delivery device for the mitral valve is shown.

[0040] Figure 16A A side perspective view of a valve deployed from a delivery device is shown, according to one aspect.

[0041] Figure 16B A side perspective view of a valve deployed from a delivery device is shown, according to one aspect.

[0042] Figure 16C A side perspective view of a valve deployed from a delivery device is shown, according to one aspect.

[0043] Figure 17 A schematic diagram illustrating the deployment of a valve to the mitral valve according to one aspect is shown. Detailed Implementation

[0044] This disclosure can be more readily understood by referring to the following detailed description, examples, drawings, and claims, as well as the description preceding and following them. However, before disclosing and describing the articles, systems, and / or methods of this disclosure, it should be understood that, unless otherwise stated, this disclosure is not limited to the specific or exemplary aspects of the disclosed articles, systems, and / or methods, and therefore variations are naturally possible. It should also be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.

[0045] The following description of this disclosure is provided as a teaching on what can be achieved in its best, currently known aspects. Therefore, those skilled in the art will recognize and understand that many changes can be made to various aspects of this disclosure as described herein, while still obtaining the beneficial results of this disclosure. It will also be apparent that some of the desired benefits of this disclosure can be obtained by selecting some features of this disclosure without utilizing others. Therefore, those skilled in the art will recognize that many modifications and changes to this disclosure are possible, and in some cases even desirable, and are part of this disclosure. Thus, the following description is again provided as an illustration of the principles of this disclosure, and not as a limitation thereof.

[0046] definition

[0047] As used in this application and claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly specifies otherwise. Thus, for example, unless the context clearly specifies otherwise, reference to “yarn” includes aspects having two or more such yarns.

[0048] It should also be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting. As used in the specification and claims, the term "comprising" may include aspects that are "composed of" and "substantially composed of". Additionally, the term "include" means "comprise".

[0049] The terms “for example,” “exemplary,” and “such as,” and their grammatical equivalents, unless otherwise expressly stated, shall be understood to follow the phrase “but not limited to.”

[0050] A range may be expressed herein as from “about” one specific value and / or to “about” another specific value. When such a range is expressed, the other side includes from one specific value and / or to another specific value. Similarly, when a numerical value is expressed as an approximation using the antecedent “about”, it will be understood that the specific value constitutes the other side. It should also be understood that the endpoints of each range are significant both relative to and independent of the other endpoint. Unless otherwise stated, the term “about” means within 5% (e.g., within 2% or 1%) of the specific value modified by the term “about”. It should also be understood that if the term “about 1” is disclosed, the term “1” is also disclosed.

[0051] Throughout this disclosure, various aspects of this disclosure may be presented in the form of ranges. It should be understood that the description in range form is merely for convenience and brevity and should not be construed as an immutable limitation on the scope of this disclosure. Therefore, the description of a range should be considered as having specifically disclosed all possible subranges and individual numerical values ​​within that range. For example, a description of a range such as from 1 to 6 should be considered as having specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and individual numbers within that range, such as 1, 2, 2.7, 3, 4, 5, 5.3, 6, and any integers and partial increments between them. This applies regardless of the width of the range.

[0052] As used herein, the terms “optional” or “optionally” mean that an event or situation described below may or may not occur, and the description includes instances where the event or situation occurs and instances where it does not occur.

[0053] Furthermore, the terms “link” and “association” generally mean an electrical, electromagnetic, and / or physical (e.g., mechanical or chemical) connection or link, and do not exclude the existence of intermediate elements between the linked or associated items.

[0054] It should be understood that when an element is referred to as “connected” or “linked” to another element, it may be directly connected or linked to the other element, or there may be intermediate elements. Conversely, when an element is referred to as “directly connected” or “directly linked” to another element, there are no intermediate elements. Other terms used to describe relationships between elements or layers should be interpreted in a similar manner (e.g., “between” vs. “directly between”, “adjacent” vs. “directly adjacent”, “on” vs. “directly above”).

[0055] It should be understood that although the terms “first,” “second,” etc., may be used herein to describe various elements, components, regions, layers, and / or parts, these elements, components, regions, layers, and / or parts should not be limited by these terms. These terms are used only to distinguish one element, component, region, layer, or part from another. Therefore, without departing from the teachings of the examples, the first element, component, region, layer, or part discussed below may be referred to as the second element, component, region, layer, or part.

[0056] For ease of description, this document uses spatial relative terms such as “below,” “under,” “lower,” “above,” “upper,” “upward,” “downward,” “top,” “bottom,” etc., to describe the relationship of one element or feature to another, as shown in the figures. It will be understood that, in addition to the orientation depicted in the figures, the spatial relative terms are also intended to cover different orientations of the device during use or operation. For example, if the device in the figures is flipped, an element described as “below” or “under” other elements or features will be oriented “above” other elements or features. Thus, the term “below” can encompass both upward and downward orientations. The device may be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial relative descriptors used herein will be interpreted accordingly.

[0057] Terms such as “proximal,” “farthest,” “radial outward,” “radial inward,” “external,” “internal,” and “side” describe the orientation and / or position of parts of a component or element within a consistent but arbitrary frame of reference, which becomes clear by referring to the text describing the component or element in question and the associated drawings. Such terms may include the words specifically mentioned above, their derivatives, and words with similar meanings. Similarly, unless the context clearly indicates otherwise, the terms “first,” “second,” and other such numerical terms referring to structures do not imply order or sequence.

[0058] As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items. It should also be understood that the term “and / or” includes situations where one or the other of the associated listed items is present, as well as aspects where two of the associated listed items are present or any combination of the associated listed items is present.

[0059] As used herein, the terms or phrases “effective,” “effective quantity,” or “condition effective for” refer to the quantity or condition that enables the realization of the function or property represented by the effective quantity or condition. As will be noted below, the exact quantity or specific condition required will vary depending on recognized variables, such as the materials used and the observed processing conditions. Therefore, it is not always possible to specify an exact “effective quantity” or “condition effective for”. However, it should be understood that a person skilled in the art can readily determine a suitable effective quantity using only routine experiments.

[0060] The terms "fiber" or "filament" are used interchangeably.

[0061] The terms “fiber” (or “filament”) and “material comprising multiple fibers (filaments)” are used herein in their broad and general sense and may refer to any type of natural or synthetic substance or material whose length is significantly greater than its width, including any elongated or relatively thin, elongated and / or filamentous sheets, filaments, ropes, yarns, ply yarns, strands, cords, cords, or portions thereof. Furthermore, “fiber” or “material comprising multiple fibers” may refer to a single filament or collectively to multiple filaments. Examples of materials comprising multiple fibers according to aspects of this disclosure include, but are not limited to, any type of cloth, fabric, or textile. It should be understood that, in some non-limiting aspects, the term “material comprising multiple fibers” may refer to cloth, fabric, textile, or interlocking fiber material that can cover or form certain features of the disclosed apparatus.

[0062] As used herein, the term "fiber" includes fibers of extreme or infinite length (e.g., filaments) and fibers of short length (e.g., staple fibers).

[0063] As used herein, the term “substantially” means that the events or circumstances subsequently described have occurred completely, or that the events or circumstances subsequently described are generally, usually, or substantially likely to occur.

[0064] Furthermore, in some respects, the term “substantially” may refer to at least about 90%, at least about 91%, at least about 92%, at least about 93%, at least about 94%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, or about 100% of the said property, component, composition, or other condition, wherein “substantially” is used to characterize or otherwise quantify the quantity.

[0065] As used herein, the term “substantially”, such as in the context of “substantially identical” or “substantially similar”, means a method, system or component that is at least about 90%, at least about 91%, at least about 92%, at least about 93%, at least about 94%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, or about 100% similar to the method, system or component being compared.

[0066] As disclosed herein, it should be understood that when referring to the thickness of an indicated component, the thickness referred to is the thickness of the component wall.

[0067] While the operations of exemplary aspects of the disclosed methods may be described in a specific order for ease of presentation, it should be understood that the disclosed aspects may encompass an order of operations other than the specific order disclosed. For example, in some cases, the operations described in the order may be rearranged or performed simultaneously. Furthermore, the descriptions and disclosures provided in association with a particular aspect are not limited to that aspect and may be applied to any aspect disclosed.

[0068] Furthermore, for simplicity, the accompanying drawings do not illustrate the various ways in which the disclosed systems, methods, and apparatus can be combined with other systems, methods, and apparatuses (which will be readily apparent to those skilled in the art based on this disclosure). Additionally, this specification sometimes uses terms such as “produce” and “provide” to describe the disclosed methods. These terms are high-level abstractions of actual, executable operations. The actual operations corresponding to these terms may vary depending on the specific implementation and will be readily apparent to those skilled in the art based on this disclosure.

[0069] woven products

[0070] The woven articles disclosed herein are 3D monolithic articles in which the components (or parts) are constructed together during the weaving process. It should be understood that, depending on the intended application, the articles may include any or some of the components disclosed herein. Figure 3 An exemplary woven 3D monolithic article is shown.

[0071] This document discloses a braided article defined by a proximal end 3100 and a distal end 3200. In some aspects, the disclosed braided article 3000 includes a tubular member 3002 having a lumen 3001 disposed between a first open end 3003 and a second end 3005 of the tubular member 3002. In some aspects, the first open end 3003 defines the proximal end 3100 of the braided article. In some aspects, the tubular member has a first thickness. In some other aspects, the lumen has a diameter d1 and a length l1.

[0072] In another aspect, the woven article 3000 further includes a cushioning member 3007 having a second thickness, wherein the outer surface of the tubular member seamlessly transitions to the outer surface of the cushioning member at a length l2 from the first open end of the tubular member, thereby forming a proximal end 3009 of the cushioning member, wherein l2 is less than l1. In another aspect, a portion of the cushioning member includes a central cavity 3011 that receives a portion 3004 of the tubular member having a length l3, such that a second end 3005 of the tubular member is positioned within the central cavity of the cushioning member. It is understood that the length l3 is equal to l1 ≈ l2. In the aspects disclosed herein, the outer surface of the cushioning member is formed by transitioning the outer surface of the tubular member, while the inner surface of the cushioning member defines at least a portion of the central cavity of the cushioning member.

[0073] In the aspects disclosed herein, the first thickness of the tubular member can be from about 0.06 mm to about 0.15 mm, including exemplary values ​​of about 0.07 mm, about 0.08 mm, about 0.09 mm, about 0.1 mm, about 0.11 mm, about 0.12 mm, about 0.13 mm, and about 0.14 mm. In another aspect, the first thickness can have any value falling between any two of the foregoing values, or can fall within a range formed by any two of the foregoing values. For example, but not limited to, the first thickness can be about 0.06 mm to about 0.14 mm, about 0.06 mm to about 0.13 mm, about 0.06 mm to about 0.12 mm, about 0.06 mm to about 0.11 mm, about 0.06 mm to about 0.10 mm, about 0.06 mm to about 0.09 mm, about 0.06 mm to about 0.08 mm, about 0.08 mm to about 0.15 mm, about 0.10 mm to about 0.15 mm, about 0.12 mm to about 0.15 mm, and so on.

[0074] In some respects, the first thickness may be uniform along length l1. In other respects, the first thickness may be uniform along some portions of the tubular member, while gradually varying along other portions. For example, but not limited to, the thickness along l2 may be the same as, but different from, the thickness along l3. In another exemplary respect, the thickness along l3 may be uniform, or it may vary gradually along l3. In another respect, the thickness may vary along l2 and / or l3 in any desired pattern. It should also be understood that the thickness may vary circumferentially as well as along the longitudinal axis. For example, it should be understood that the first thickness may, but does not necessarily, be uniform along the circumference of the tubular member. In another respect, the first thickness (or any thickness disclosed herein) may be thicker at the surface of the article adjacent to the natural anatomical structure when compared to the surface of the article further away from the natural anatomical structure.

[0075] In some aspects, l2 is greater than or equal to about 10 mm to about 16 mm, including exemplary values ​​of about 10.5 mm, about 11 mm, about 11.5 mm, about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, about 15 mm, and about 15.5 mm. In other aspects, l3 is about 2.5 mm to about 6 mm, including exemplary values ​​of about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, and about 5.5 mm. In still other aspects, l2 may have any value falling between any two of the foregoing values, or may fall within a range formed by any two of the foregoing values. For example, but not limited to, l2 can be about 10 mm to about 15 mm, about 10 mm to about 14 mm, about 10 mm to about 13 mm, about 10 mm to about 12 mm, about 10 mm to about 11 mm, about 11 mm to about 16 mm, about 12 mm to about 16 mm, about 14 mm to about 16 mm, and so on.

[0076] In another aspect, the diameter d1 of the tubular member can be the same or different along the length l1. In another aspect, d1 can be the same along l2, for example, as... Figure 3 As shown. In another aspect, d1 can gradually change along l2 (not shown). In another aspect, the diameter d1 can change along l2 to d1', d1''. 和 / or d1'''. It should be understood that in some respects, d1' is the same as d1'' and / or d1'''. In other respects, d1', d1'', and / or d1''' are all different depending on the intended application.

[0077] In another aspect, d1', d1'', and / or d1''' may have values ​​from about 2 mm to about 4 mm, including exemplary values ​​of about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, about 3.7 mm, about 3.8 mm, and about 3.9 mm. In another aspect, d1', d1'', and / or d1''' may have any value falling between any two of the foregoing values, or may fall within a range formed by any two of the foregoing values. For example, but not limited to, d1', d1" and / or d1"' can be about 2mm to about 3.7mm, about 2mm to about 3.5mm, about 2mm to about 3.3mm, about 2mm to about 3mm, about 2mm to about 2.7mm, about 2mm to about 2.5mm, about 2.2mm to about 4mm, about 2.5mm to about 4mm, about 2.7mm to about 4mm, about 3mm to about 4mm, about 3.2mm to about 4mm, about 3.5mm to about 4mm, and so on.

[0078] In another aspect, the woven article may also include a woven seal 3012 positioned at the distal end 3019 of the cushioning member 3007.

[0079] In another respect, each component of the disclosed article may have one or more layers, if required.

[0080] In other aspects, the cushioning member 3007 can have any desired shape. In some aspects, the cushioning member can have a regular or irregular shape. For example, the cushioning member can be spherical, cubic, cuboid, pyramidal, oval, conical, or prism-shaped. In other aspects, the cushioning member 3007 can have a regular or irregular cross-sectional shape. The cross-sectional shape of the cushioning member can be circular, oval, elliptical, rectangular, square, or any combination thereof. In some aspects, the cushioning member is symmetrical. In other aspects, the cushioning member is asymmetrical. It should also be understood that because the cushioning member is made of textile material, its shape is not rigid and can deviate from its original shape during use.

[0081] In another aspect, the cross-sectional shape is defined by a length a1 along at least one of the x-axis or y-axis. For example, as Figure 3As shown, the buffer member may have a length a1 along the x-axis. In such exemplary and non-limiting aspects, the length a1 is the maximum length defining the cross-sectional shape. It should be understood that in some aspects, the length along the y-axis may also be a1. In other aspects, the length along the y-axis may be a1', which is different from a1. It should also be understood that in such aspects, a1 is greater than a1'. However, it should be understood that in other exemplary aspects, a1 may be along the y-axis and may be greater than a1' along the x-axis.

[0082] In another aspect, a1 can be from about 3 mm to about 5 mm, including exemplary values ​​of about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, about 3.7 mm, about 3.8 mm, about 3.9 mm, about 4 mm, about 4.1 mm, about 4.2 mm, about 4.3 mm, about 4.4 mm, about 4.5 mm, about 4.6 mm, about 4.7 mm, about 4.8 mm, or about 4.9 mm. In another aspect, a1 can have any value falling between any two of the foregoing values, or can fall within a range formed by any two of the foregoing values. For example, but not limited to, a1 can be about 3mm to about 4.7mm, about 3mm to about 4.5mm, about 3mm to about 4.2mm, about 3mm to about 4mm, about 3mm to about 3.7mm, about 3mm to about 3.5mm, about 3mm to about 3.2mm, about 3.2mm to about 5mm, about 3.5mm to about 5mm, about 3.7mm to about 5mm, about 4mm to about 5mm, about 4.2mm to about 5mm, about 4.5mm to about 5mm, and so on.

[0083] In another respect, the woven products described herein include multiple warp yarns and multiple weft yarns.

[0084] In other respects, multi-warp and multi-weft yarns include biocompatible materials. In some respects, multi-warp yarns may be the same as or different from multi-weft yarns.

[0085] In some respects, at least one of the multiple warp yarns and / or multiple weft yarns may include one or more biocompatible textured multifilament yarns, biocompatible textured high-shrinkage multifilament yarns, biocompatible flat multifilament yarns, twisted multifilament yarns, or any combination thereof.

[0086] In another aspect, the multiple warp yarns and multiple weft yarns may comprise textured yarns. It should be understood that textured yarns can be prepared by any method known in the art. In some aspects, textured yarns may be selected from friction textured yarns, false-twist textured yarns, needle-textured yarns, air-textured yarns, belt textured yarns, box-stuffed textured yarns, or any combination thereof. Furthermore, in another exemplary and non-limiting aspect, textured yarns can be produced by friction texturing, or needle-texturing or false-twist texturing, air texturing, box-stuffing texturing, or any combination thereof. In another exemplary aspect, the textured yarn is a friction textured yarn.

[0087] In another aspect, the yarn used in the disclosed article may be configured to shrink during processing. In this aspect, the yarn may exhibit a heat shrinkage rate from 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%. In another aspect, the yarn may exhibit a heat shrinkage rate having a value falling between any two of the foregoing values ​​or falling within a range formed by any two of the foregoing values. For example, but not limited to, the yarn may exhibit a heat shrinkage rate of about 10% to about 55%, about 10% to about 50%, about 10% to about 45%, about 10% to about 40%, about 10% to about 35%, about 10% to about 30%, about 10% to about 20%, about 20% to about 60%, about 30% to about 60%, about 40% to about 60%, about 50% to about 60%, etc.

[0088] It should also be understood that various textured yarns can exhibit different degrees of deformation. The degree of deformation is assessed by measuring the crimp shrinkage, tensile potential, and bulk ratio of the textured yarn. Without being bound by any theory, it is assumed that the degree of texturing can influence the shrinkage properties of the finished product and the final bulkiness of various components of the product.

[0089] In some aspects, and as disclosed herein, each yarn in a plurality of weft and / or warp yarns may comprise a plurality of filaments. It should be understood that the plurality of yarns present in an article may comprise the same or different yarns. For example, in some aspects, but not limited thereto, all yarns in a plurality of yarns are textured. In other aspects, all textured yarns are identical. However, in other aspects, not all yarns comprise the same textured yarn. In some aspects, the yarns may differ depending on the type of material or the type of texturing method. Similarly, the plurality of yarns in the weft and warp directions may be the same or different. It should be understood that the plurality of weft and warp yarns may have various combinations of filaments and filament numbers. Furthermore, in other aspects, various yarn numbers, yarn texture types, and yarn texture degrees may be utilized.

[0090] In another aspect, the size of each yarn in the multiple weft yarns and / or textured warp yarns can be from about 10 denier 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 should be understood that each yarn in the multiple weft yarns and / or warp yarns can have a denier value between any two of the foregoing values. For example, but not limited to, each yarn in the multiple weft yarns 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.

[0091] In another aspect, each yarn in the multiple weft and / or warp yarns may comprise from about 8 to about 150 filaments, including exemplary values ​​of about 10 filaments, about 15 filaments, about 20 filaments, about 50 filaments, about 70 filaments, about 100 filaments, and about 120 filaments. It should be understood that each yarn in the multiple weft and / or warp yarns may comprise any number of fibers between any two of the foregoing values. For example, but not limited to, each yarn in the multiple weft and / or warp yarns may comprise from about 8 to 50 filaments, from about 25 filaments to about 85 filaments, or from about 110 filaments to about 145 filaments.

[0092] In another aspect, the filament may have any diameter suitable for the desired application. In some aspects, the filament may 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 should be understood that the filament may have any diameter between any two of the foregoing values. For example, but not limited to, the filament may 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.

[0093] In another aspect, multiple warp and multiple weft yarns include polyesters, aliphatic polyesters, copolyesters, polyolefins, fluoropolymers, polyurethanes, polyethers, polyureas, nylons, natural fibers, copolymers thereof, or combinations thereof.

[0094] In another aspect, multiple warp and multiple weft yarns may include ultra-high molecular weight polyethylene, polyethylene, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyvinylidene fluoride, or any combination thereof.

[0095] In another aspect, multiple warp and multiple weft yarns include non-absorbable yarns, bioabsorbable yarns, or combinations thereof. For example, but not limited to, bioabsorbable yarns comprise one or more aliphatic polyesters or copolyesters, or combinations thereof. In another aspect, bioabsorbable yarns may include polyglycolic acid (PGA), poly(l-lactic acid) (PLLA), polycaprolactone (PCL), polylactide-glycolic acid copolymer (PLGA), copolymers thereof, or combinations thereof.

[0096] In some respects, such yarns may also include composite filaments. It should be understood that, as used herein, composite filaments refer to filaments that may include one or more different materials. In some respects, composite filaments are bicomponent filaments that may have any configuration, such as, but not limited to, side-by-side configurations, core / sheath configurations, segmented configurations, island configurations, or any combination thereof.

[0097] The tubular components of the woven articles disclosed herein may have any woven pattern suitable for the desired application. For example, but not limited to, the tubular components may have plain weave patterns, twill weave patterns, satin weave patterns, any derivative weave patterns, or any combination thereof.

[0098] In some aspects, the cushioning member has a 3D honeycomb pattern having multiple repeating channel units. It should be understood that this also includes aspects where a portion of the cushioning member has a 3D honeycomb pattern. In other aspects, the entire cushioning member has a 3D honeycomb pattern.

[0099] In another aspect, the plurality of repeating channel units may comprise approximately 1 to approximately 32 channels per inch, including exemplary values ​​of approximately 2 channels per inch, approximately 5 channels per inch, approximately 8 channels per inch, approximately 10 channels per inch, approximately 12 channels per inch, approximately 15 channels per inch, approximately 18 channels per inch, approximately 20 channels per inch, approximately 22 channels per inch, approximately 25 channels per inch, approximately 28 channels per inch, and approximately 30 channels per inch. In another aspect, the plurality of repeating channel units may have any value falling between any two of the foregoing values, or may fall within a range formed by any two of the foregoing values. For example, but not limited to, multiple repeating channel units can be about 1 channel / inch to about 28 channels / inch, about 1 channel / inch to about 24 channels / inch, about 1 channel / inch to about 20 channels / inch, about 1 channel / inch to about 16 channels / inch, about 1 channel / inch to about 8 channels / inch, about 8 channels / inch to about 32 channels / inch, about 16 channels / inch to about 32 channels / inch, about 20 channels / inch to about 32 channels / inch, about 24 channels / inch to about 32 channels / inch, and so on.

[0100] In another aspect, each of the plurality of repeating channel units includes approximately 8 weft insertion repeats / linear inches to approximately 50 weft insertion repeats / linear inches, including exemplary values ​​of approximately 10 weft insertion repeats / linear inches, approximately 12 weft insertion repeats / linear inches, approximately 15 weft insertion repeats / linear inches, approximately 18 weft insertion repeats / linear inches, approximately 20 weft insertion repeats / linear inches, approximately 22 weft insertion repeats / linear inches, approximately 25 weft insertion repeats / linear inches, approximately 28 weft insertion repeats / linear inches, approximately 30 weft insertion repeats / linear inches, approximately 32 weft insertion repeats / linear inches, approximately 35 weft insertion repeats / linear inches, approximately 38 weft insertion repeats / linear inches, approximately 40 weft insertion repeats / linear inches, approximately 42 weft insertion repeats / linear inches, approximately 45 weft insertion repeats / linear inches, and approximately 48 weft insertion repeats / linear inches. In another aspect, the number of weft insertion repetitions per linear inch can have any value falling between any two of the foregoing values, or can fall within a range formed by any two of the foregoing values. For example, but not limited to, the number of weft insertion repetitions per linear inch can be about 8 to about 45, about 8 to about 40, about 8 to about 30, about 8 to about 20, about 10 to about 50, about 16 to about 50, about 24 to about 50, and so on.

[0101] Exemplary cellular patterns are described, for example, in WO2022 / 226090 and WO2021 / 188405, the contents of which are incorporated herein by reference for all purposes.

[0102] Figure 10 The diagram illustrates an exemplary and non-limiting aspect of a honeycomb pattern representing a planar representation 10 of a cushioning material. In this example, the honeycomb weave pattern may include a repeating pattern of channels 12. Channels 12 may have portions of different heights, with the central portion 14 (in...) Figure 11 (represented in the middle) has a larger outer portion than 16 (in the middle) Figure 11 (The text indicates a lower height.) The central portion 14 can form a recess surrounded by the outer portion 16. The outer portion 16 can include raised walls surrounding the recess of the central portion 14. Each channel 12 can include a recess surrounded by walls. In some aspects, the recess can have various shapes, including an inverted pyramid shape, a dome shape, or another shape as required. The channel 12 can have a square or rectangular shape, such as... Figures 10 to 11 As shown, it can also have another shape as needed.

[0103] The channel 12 can repeat along the length 18 and width 20 of the plane of the cushioning material 10. It should be understood that, since the cushioning material described herein has a 3-D shape, the channel 12 can repeat along all perimeters of the cushioning material. The channels 12 can be adjacent to each other, wherein the outer portion 16 of each channel 12 is adjacent to the outer portion 16 of the adjacent channel, for example, as... Figure 11 As shown. Figure 10 and Figure 11 As shown, in the example, the channels can be aligned with each other along length 18 (by column) and width 20 (by row), or other patterns can be used as needed. For example, in the example, channels 12 can be aligned diagonally or on another pattern as needed. Channels 12 can repeat in an irregular configuration; for example, a channel 12 can have a square configuration, such as... Figure 11 As shown, and in the example, adjacent channels may have a different configuration.

[0104] In another aspect, the honeycomb weave pattern can be formed by warp and weft threads, which interweave and float in a manner that produces an outer portion 16 (e.g., walls) and a central portion 14 (e.g., recesses) of a regular pattern. In some aspects, warp and weft floats can be arranged around the center of the plain weave and can be partially woven on a plain weave area surrounded by ridges of long floats. Other configurations can be utilized as needed.

[0105] However, it should be understood that other weaving configurations can also be used. For example, in some aspects, four-end cell repeats to thirty-two-end cell repeats can be used. In some aspects, configurations larger than thirty-two-end cell repeats can be used. In some aspects, a range between four-end cell repeats and sixteen-end cell repeats can be used. In some aspects, a range between sixteen-end cell repeats and thirty-two-end cell repeats can be used. Other configurations can be used as needed.

[0106] In some respects, honeycomb weave patterns may include honeycomb weave derivative weave patterns, such as improved honeycomb weave patterns or other derivative weave patterns as required.

[0107] Figure 11 A perspective view illustrating a honeycomb weave pattern according to the aspects disclosed herein is shown. In some aspects, certain details of the weave pattern may be excluded from the view.

[0108] In some respects, the repeating pattern of the channels 12 is visible, including a recess in the central portion 14 surrounded by the walls of the outer portion 16 for each channel 12. The variation in height between the recess in the central portion 14 and the walls of the outer portion 16 is visible.

[0109] In another aspect, the cushioning member may have a second thickness. The second thickness may be from about 1.5 mm to about 5 mm, including exemplary values ​​of about 1.8 mm, about 2 mm, about 2.2 mm, about 2.5 mm, about 2.8 mm, about 3 mm, about 3.2 mm, about 3.5 mm, about 3.8 mm, about 4 mm, about 4.2 mm, about 4.5 mm, and about 4.8 mm. In another aspect, the second thickness may have any value falling between any two of the foregoing values, or may fall within a range formed by any two of the foregoing values. For example, but not limited to, the second thickness may be from about 1.5 mm to about 4.5 mm, 1.5 mm to about 4 mm, 1.5 mm to about 3.5 mm, 1.5 mm to about 3 mm, 1.5 mm to about 2.5 mm, 1.5 mm to about 2 mm, 2 mm to about 4.5 mm, 2.5 mm to about 4.5 mm, 3 mm to about 4.5 mm, 3.5 mm to about 4.5 mm, and so on.

[0110] In another aspect, the first thickness of the tubular member is less than the second thickness of the cushioning member. In another aspect, the second thickness is the same or different along the circumference and / or periphery and / or along the length of the cushioning member.

[0111] As disclosed above, yarns used to construct the articles disclosed herein can exhibit heat shrinkage when heated at a desired temperature for a desired time. Examples of this heat shrinkage are... Figures 12A to 12B As shown in the image. For example, Figure 12A A portion of the surface of the buffer member 10 prior to heat treatment is illustrated. The length 17 and width 19 of the exemplary channel unit 12 are marked. Figure 12B Examples are given after heat treatment. Figure 12A A portion of the surface of the buffer member 10 shown, wherein the length 17 and width 19 of the channel unit 12 have been reduced, while the second thickness of the buffer member has been increased.

[0112] In another aspect, a buffer gradient can be achieved by changing the weave density, the number of repeating channel units, the number of weft insertions in multiple weft yarns, the denier of the weft yarns, the weft texture, or a combination thereof. A buffer gradient can be achieved by changing the number of repeating channel units within the buffer member. For example, as discussed above, the number of repeating channel units can vary from about 1 channel / inch to about 32 channel / inch, including repeating units with values ​​of about 2 channel / inch, about 5 channel / inch, about 8 channel / inch, about 10 channel / inch, about 12 channel / inch, about 15 channel / inch, about 18 channel / inch, about 20 channel / inch, about 22 channel / inch, about 25 channel / inch, about 28 channel / inch, and about 30 channel / inch. The number of channels per inch can fall between any two of the aforementioned values ​​or within any range formed by any two of the aforementioned values. For example, but not limited to, about 1 channel / inch to about 30 channels / inch, about 1 to about 28 channels / inch, about 1 to about 24 channels / inch, about 1 to about 20 channels / inch, about 1 to about 16 channels / inch, about 1 to about 10 channels / inch, about 5 to about 32 channels / inch, about 8 to about 32 channels / inch, about 10 to about 32 channels / inch, about 12 to about 32 channels / inch, about 16 to about 32 channels / inch, and so on.

[0113] By varying the weft insertion amount as discussed above, a buffer gradient can be further achieved within the buffer member, from approximately 8 weft insertion repeats / linear inches to approximately 50 weft insertion repeats / linear inches, including exemplary values ​​of approximately 10 weft insertion repeats / linear inches, approximately 12 weft insertion repeats / linear inches, approximately 15 weft insertion repeats / linear inches, approximately 18 weft insertion repeats / linear inches, approximately 20 weft insertion repeats / linear inches, approximately 22 weft insertion repeats / linear inches, approximately 25 weft insertion repeats / linear inches, approximately 28 weft insertion repeats / linear inches, approximately 30 weft insertion repeats / linear inches, approximately 32 weft insertion repeats / linear inches, approximately 35 weft insertion repeats / linear inches, approximately 38 weft insertion repeats / linear inches, approximately 40 weft insertion repeats / linear inches, approximately 42 weft insertion repeats / linear inches, approximately 45 weft insertion repeats / linear inches, and approximately 48 weft insertion repeats / linear inches. It should be understood that the buffer member may have any number of weft insertion repetitions per linear inch falling between any two of the aforementioned values ​​or within the range formed by any two of the aforementioned values.

[0114] A buffer gradient can also be achieved by varying the weft yarn denier from about 10 denier 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 should be understood that the weft yarn denier can have any value falling between any two of the foregoing values ​​or within the range formed by any two of the foregoing values. For example, the weft yarn denier can be about 10 to about 150 denier, about 10 to about 100 denier, about 10 to about 70 denier, about 10 to about 50 denier, about 50 to about 200 denier, about 70 to about 200 denier, about 100 to about 200 denier, about 150 to about 200 denier, and so on. Furthermore, a buffer gradient can be achieved by changing the weft yarn from undeformed (flat or FDY yarn) to a highly deformed yarn.

[0115] Return to reference Figure 3 As can be seen, as disclosed herein, the woven article can transition into the cushioning member 3007 at the proximal end 3009 of the cushioning member, such that a first outwardly tapered portion 3015 is formed in the cushioning member 3007. In such an exemplary and non-limiting aspect, the first outwardly tapered portion 3015 can be formed by increasing the spacing between multiple warp yarns during weft insertion in the weaving process. In other exemplary and non-limiting aspects, the first outwardly tapered portion 3015 is formed by adding at least one warp yarn during the weaving process. In some aspects, the outwardly tapered portion can be measured by the offset of an imaginary line 3300 extending from the outer surface of the tubular member along the longitudinal axis z of the article. In such aspects, the length 3320 measured at the midpoint of the offset can be from about 0.5 mm to about 1.5 mm, including exemplary values ​​of about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, and about 1.4 mm. The length can also be any value that falls between any two of the foregoing values ​​or within the range formed by any two of the foregoing values. For example, the length can be about 0.5 mm to about 1.2 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 0.8 mm, about 0.8 mm to about 1.5 mm, about 1 mm to about 1.5 mm, about 1.2 mm to about 1.5 mm, and so on.

[0116] In another aspect, the first outwardly tapered portion 3015 may have a length 3006 of about 2 mm to about 3 mm, including exemplary values ​​of about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, and about 2.9 mm. The length may also have any value falling between any two of the foregoing values ​​or within the range formed by any two of the foregoing values. For example, the length may be about 2 mm to about 2.9 mm, about 2 mm to about 2.7 mm, about 2 mm to about 2.5 mm, about 2 mm to about 2.2 mm, about 2.2 mm to about 3 mm, about 2.5 mm to about 3 mm, about 2.7 mm to about 3 mm, and so on.

[0117] Furthermore, the distal portion of the cushioning member 3007 may include a first inwardly tapered portion 3017. In this respect, the first inwardly tapered portion 3017 terminates in the distal end 3019 of the cushioning member 3007, wherein the distal end of the cushioning member transitions into the braided seal 3012. In another aspect, the first inwardly tapered portion 3017 is formed by reducing the spacing between multiple warp yarns during weft insertion during the weft yarn insertion process. In another aspect, the first inwardly tapered portion 3017 is formed by removing at least one warp yarn during the weft insertion process. In yet another aspect, the first inwardly tapered portion 3017 is terminated by the braided seal 3012.

[0118] In some aspects, the first inwardly tapered portion can be measured by offset from an imaginary line 3300 extending from the outer surface of the tubular member along the longitudinal axis z of the article. In such aspects, the length 3340 measured at the midpoint of the offset can be from about 0.5 mm to about 1.5 mm, including exemplary values ​​of about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, and about 1.4 mm. The length can also have any value falling between any two of the foregoing values ​​or within the range formed by any two of the foregoing values. For example, the length can be from about 0.5 mm to about 1.2 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 0.8 mm, from about 0.8 mm to about 1.5 mm, from about 1 mm to about 1.5 mm, from about 1.2 mm to about 1.5 mm, and so on.

[0119] In another aspect, the first inwardly tapered portion 3017 may have a length 3008 of about 2 mm to about 3 mm, including exemplary values ​​of about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, and about 2.9 mm. The length may also have any value falling between any two of the foregoing values ​​or within the range formed by any two of the foregoing values. For example, the length may be about 2 mm to about 2.9 mm, about 2 mm to about 2.7 mm, about 2 mm to about 2.5 mm, about 2 mm to about 2.2 mm, about 2.2 mm to about 3 mm, about 2.5 mm to about 3 mm, about 2.7 mm to about 3 mm, and so on.

[0120] It should be understood that, depending on the desired shape, the length of the offset of the first outwardly tapered portion and the length of the offset of the first inwardly tapered portion can be the same or different.

[0121] In another aspect, the portion of the buffer member disposed between the first outwardly tapered portion and the first inwardly tapered portion may have a length 3010 of about 2 mm to about 3 mm, including exemplary values ​​of about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, and about 2.9 mm. The length may also have any value falling between any two of the foregoing values ​​or within the range formed by any two of the foregoing values. For example, the length may be about 2 mm to about 2.9 mm, about 2 mm to about 2.7 mm, about 2 mm to about 2.5 mm, about 2 mm to about 2.2 mm, about 2.2 mm to about 3 mm, about 2.5 mm to about 3 mm, about 2.7 mm to about 3 mm, and so on.

[0122] In some aspects, the woven seal 3012 has a length 3013 of about 1 mm to about 3 mm in the longitudinal direction, including exemplary values ​​of about 1.2 mm, about 1.5 mm, about 1.8 mm, about 2 mm, about 1.2 mm, about 1.5 mm, and about 1.8 mm. The length may also have any value falling between any two of the foregoing values ​​or within the range formed by any two of the foregoing values. For example, the length may be about 1 mm to about 2.9 mm, about 1 mm to about 2.7 mm, about 1 mm to about 2.5 mm, about 1 mm to about 2.2 mm, about 1 mm to about 2 mm, about 1 mm to about 1.8 mm, about 1 mm to about 1.5 mm, about 1.2 mm to about 3 mm, about 1.5 mm to about 3 mm, about 1.8 mm to about 3 mm, about 2 mm to about 3 mm, about 2.2 mm to about 3 mm, about 2.5 mm to about 3 mm, about 2.7 mm to about 3 mm, and so on.

[0123] In another aspect, the braided seal 3012 may have a length of about 2 mm to about 3 mm along the x-axis, including exemplary values ​​of about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, and about 2.9 mm. The length may also have any value falling between any two of the foregoing values ​​or within the range formed by any two of the foregoing values. For example, the length may be about 2 mm to about 2.9 mm, about 2 mm to about 2.7 mm, about 2 mm to about 2.5 mm, about 2 mm to about 2.2 mm, about 2.2 mm to about 3 mm, about 2.5 mm to about 3 mm, about 2.7 mm to about 3 mm, and so on.

[0124] In another aspect, the second end 3005 of the tubular member 3002, located within the central cavity 3011 of the cushioning member, is closed. In some aspects, the portion 3004 of the lumen located within the central cavity 3011 of the cushioning member 3007 functions as an inner bag of the article.

[0125] Figure 4 An exemplary woven article 4000 is shown disposed on a mandrel 4002, the exemplary woven article having a tubular member 4004, a cushioning member 4006, and a woven seal 4008. As disclosed above, the portion of the tubular member forming an inner bag is not shown.

[0126] In another aspect, the length from the proximal end of the opening of the tubular member to the article of the braided seal can be from about 17 mm to about 20 mm, including exemplary values ​​of about 17.2 mm, about 17.5 mm, about 17.8 mm, about 18 mm, about 18.2 mm, about 18.5 mm, about 18.8 mm, about 19 mm, about 19.2 mm, about 19.5 mm, and about 19.8 mm. The length can also have any value falling between any two of the foregoing values ​​or within the range formed by any two of the foregoing values. For example, the length can be from about 17 mm to about 19.5 mm, from about 17 mm to about 19 mm, from about 17 mm to about 18.5 mm, from about 17 mm to about 18 mm, from about 17.5 mm to about 20 mm, from about 18.5 mm to about 20 mm, from about 19 mm to about 20 mm, and so on.

[0127] In another aspect, the woven article may also include a covering component 5002, such as Figure 5As shown in the diagram. In this respect, the cover member may have a third thickness of about 0.06 mm to about 0.15 mm, including exemplary values ​​of about 0.07 mm, about 0.08 mm, about 0.09 mm, about 0.1 mm, about 0.11 mm, about 0.12 mm, about 0.13 mm, and about 0.14 mm. The thickness may also have any value falling between any two of the foregoing values ​​or within the range formed by any two of the foregoing values. For example, the thickness may be about 0.06 mm to about 0.12 mm, about 0.06 mm to about 0.1 mm, about 0.06 mm to about 0.08 mm, about 0.08 mm to about 0.15 mm, about 0.1 mm to about 0.15 mm, about 0.12 mm to about 0.15 mm, and so on. In another aspect, the third thickness may be the same or different along the circumference and / or periphery and / or along the length of the cover member.

[0128] In some aspects, the cover member is defined by an inner surface and an outer surface. In some aspects, the cover member 5002 has a proximal end 5003 and a distal end 5005, wherein the proximal end 5005 of the cover member is coupled to the braided seal 3012, similar to... Figure 3 The braided seal described herein. Furthermore, the distal end 5005 is open.

[0129] In another aspect, the connection between the braided seal 3012 and the proximal end 5003 of the cover member is formed during the braiding process, thereby forming a one-piece article.

[0130] In other aspects, the covering member 5002 can have any desired shape. In some aspects, the covering member can have a regular or irregular shape. For example, the covering member can be spherical, cubic, cuboid, pyramidal, oval, conical, or prismatic. In other aspects, the cushioning member 5002 can have a regular or irregular cross-sectional shape. The cross-sectional shape of the covering member can be circular, oval, elliptical, rectangular, square, or any combination thereof. In some aspects, the covering member is symmetrical. In other aspects, the covering member is asymmetrical. It should also be understood that because the covering member is made of textile material, its shape is not rigid and can deviate from its original shape during use.

[0131] In another aspect, the cross-sectional shape of the covering member is defined by a length a2 along at least one of the x-axis or y-axis. For example, as Figure 5As shown, the covering member may have a2 along the x-axis. In such exemplary and non-limiting aspects, length a2 is the maximum length defining the cross-sectional shape. It should be understood that in some aspects, the length along the y-axis may also be a2. In other aspects, the length along the y-axis may be a2', which is different from a2. It should also be understood that in such aspects, a2 is greater than a2'. However, it should be understood that in other exemplary aspects, a2 may be along the y-axis, and it may be greater than a1' along the x-axis.

[0132] In another respect, the length a2 of the covering member along at least one of the x-axis or y-axis is greater than the length a1 of the buffer member.

[0133] In other aspects, the covering member has a plain weave pattern, a twill weave pattern, a satin weave pattern, any derived weave pattern, or any combination thereof. In some aspects, the weave pattern of the covering member may be the same as that of the tubular member. However, in other aspects, the weave patterns of the covering member and the tubular member are different. In other aspects, the covering member may have a higher density than the tubular member. In other aspects, the covering member may have a lower density than the tubular member. In other aspects, the tubular member and the covering member have the same density.

[0134] In another aspect, the covering member includes a second outwardly tapered portion 5007 positioned outwardly and upwardly from the proximal end 5003 of the covering member 5002. In other exemplary and non-limiting aspects, the second outwardly tapered portion 5007 is formed by adding at least one warp yarn during the weaving process. In some aspects, the outwardly tapered portion 5007 can be measured by offset from an imaginary line 3300 extending along the longitudinal axis z of the article from the outer surface of the tubular member. In such aspects, the length 5011 measured at the midpoint of the offset can be from about 0.5 mm to about 1.5 mm, including exemplary values ​​of about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, and about 1.4 mm. In another aspect, the second outwardly tapered portion 5007 may have a length 5004 of about 2 mm to about 3 mm, including exemplary values ​​of about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, and about 2.9 mm. The lengths 5011 and 5004 may have any value falling between any two of the respective foregoing values ​​or within the range formed by any two of the respective foregoing values.

[0135] In another aspect, the covering member may include a second inwardly tapered portion 5009 at a distal portion of the covering member, wherein the second inwardly tapered portion terminates at an open distal end 5020 of the covering member having a length a3 along at least one of the x-axis or y-axis. In another aspect, a3 may be less than a2 and equal to or greater than a1.

[0136] Furthermore, the distal portion of the cover member 5002 may include a second inwardly tapered portion 5009. In this respect, the second inwardly tapered portion 5009 terminates at an open distal end 5020 of the cover member 5002. In a further respect, the second inwardly tapered portion 5009 is formed by reducing the spacing between multiple warp yarns during weft insertion in the weft yarn insertion process. In another respect, the second inwardly tapered portion 5009 is formed by removing at least one warp yarn during the weft insertion process. The cover member also has an intermediate portion 5008 disposed between 5007 and 5009.

[0137] In some aspects, the second inwardly tapered portion can be measured by offset from an imaginary line 3300 extending along the longitudinal axis z of the article from the outer surface of the tubular member. In such aspects, the length 5013 measured at the midpoint of the offset can be from about 0.5 mm to about 1.5 mm, including exemplary values ​​of about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, and about 1.4 mm. The length 5013 can also have any value falling between any two of the foregoing values ​​or within the range formed by any two of the foregoing values. For example, the length can be from about 0.5 mm to about 1.2 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 0.8 mm, from about 0.8 mm to about 1.5 mm, from about 1 mm to about 1.5 mm, from about 1.2 mm to about 1.5 mm, and so on.

[0138] In another aspect, the second inwardly tapered portion 5009 may have a length 5006 of about 2 mm to about 3 mm, including exemplary values ​​of about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, and about 2.9 mm. The length 5006 may also have any value falling between any two of the foregoing values ​​or within the range formed by any two of the foregoing values. For example, the length may be about 2 mm to about 2.9 mm, about 2 mm to about 2.7 mm, about 2 mm to about 2.5 mm, about 2 mm to about 2.2 mm, about 2.2 mm to about 3 mm, about 2.5 mm to about 3 mm, about 2.7 mm to about 3 mm, and so on.

[0139] It should be understood that, depending on the desired shape, the offset length of the second outwardly tapered portion and the offset length of the second inwardly tapered portion may be the same or different. It should also be understood that, depending on the desired shape, the offset lengths of the first outwardly tapered portion and the second outwardly tapered portion, as well as the offset lengths of the first inwardly tapered portion and the second inwardly tapered portion, may be the same or different.

[0140] In another aspect, a portion of the covering member located between the second outwardly tapered portion and the second inwardly tapered portion may have a length of about 2 mm to about 3 mm, including exemplary values ​​of about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, and about 2.9 mm. The length may also have any value falling between any two of the foregoing values ​​or within the range formed by any two of the foregoing values. For example, the length may be about 2 mm to about 2.9 mm, about 2 mm to about 2.7 mm, about 2 mm to about 2.5 mm, about 2 mm to about 2.2 mm, about 2.2 mm to about 3 mm, about 2.5 mm to about 3 mm, about 2.7 mm to about 3 mm, and so on.

[0141] In another aspect, the covering member is configured to fold over the buffer member as schematically shown by arrow 5010, such that the outer surface of the covering member is positioned above the outer surface of the buffer member, and the inner surface of the covering member is exposed to the surrounding environment.

[0142] Exemplary articles including cover elements, such as Figures 6A to 6C As shown. For example, as Figure 6A As shown, the woven fabric 6000 is positioned on the mandrel 6002, wherein the tubular member 6004 transitions to the cushioning member 6006, and the cover member 6010 begins to fold over the cushioning member. Figures 6B to 6C In the middle, the buffer member 6006 is below the covering member 6010.

[0143] In another aspect, the woven article is configured to be sewn or attached to a desired substrate by any method known in the art. In some aspects, the woven article may include one or more holes arranged circumferentially (or along the periphery of different components) and / or longitudinally at predetermined locations. In such aspects, one or more holes are configured to receive fastening members for attaching the woven article to the substrate. In such aspects, the fastening member may be a sewing thread. However, it may also be any other fastening member suitable for the desired application. It should be understood that any sewing thread known in the art may be used. In some exemplary and non-limiting aspects, the sewing thread is a textile filament. In other aspects, the sewing thread is any filament suitable for the desired application.

[0144] In some respects, the woven articles disclosed herein can be used in implantable medical devices. In the aspects disclosed herein, the woven articles discussed above can be configured to be assembled in an implantable medical device comprising: one or more anchors, wherein each of the one or more anchors is configured to anchor the implantable medical device to a patient's natural anatomy.

[0145] In another aspect, the woven garment is configured to receive one or more anchors through a first open end of the tubular member, such that the anchors are positioned within the lumen of the tubular member, and a second end of the tubular member substantially prevents further movement of the anchors within the garment. In another aspect, a cushioning member protects the patient's natural anatomy. And in yet another aspect, a covering member (if present) is configured to form a substantially smooth surface exposed to the patient's natural anatomy.

[0146] In a further aspect, woven fabrics are configured to promote tissue response. In another aspect, woven fabrics can act as transplant materials.

[0147] Implantable medical devices

[0148] It should be understood that any of the products described above can be used in implantable medical devices.

[0149] In some aspects, an exemplary implantable medical device may include a frame 1000, such as Figure 1As shown. In this respect, frame 1000 is shown in an expanded configuration. Frame 1000 may include a frame portion 1002 having an upper region 1004, a middle region 1006, and a lower region 1008. In some aspects, when frame 1000 is in the expanded configuration, the middle region 1006 may have a larger diameter than the diameter of frame 1000 at its proximal (adjacent to the upper region) and / or distal (adjacent to the lower region) ends. In some aspects, such as the illustrated aspect, frame 1000 may include a middle region 1006 that, when frame 1000 is in the expanded configuration, has a larger cross-sectional area than the cross-sectional area of ​​frame 1000 at its proximal end (against the upper region) and / or distal end (against the lower region). The longitudinal axis (not shown) of frame 1000 may be defined as a central axis extending between the upper and lower ends of frame 1000 and passing through the center of frame 1000. In some aspects, the frame 1000 may be oriented such that the upper region 1004 is a proximal portion and the lower region 1008 is a distal portion. The frame 1000 may include a plurality of anchoring members 1010. In some aspects, the frame 1000 may be oriented such that the plurality of anchoring members 1010 are distal anchoring members. As shown in the illustrated aspects, the plurality of anchoring members 1010 may include one or more anchors. For example, but not limited to, as shown in the illustrated aspects, the plurality of anchoring members 1010 may include nine anchors, each anchor including a neck 1012 and an arm 1013 extending from the lower region 1008 of the frame portion 1002, and a tip 1014. However, it should be understood that the implantable device may have more than nine anchors or fewer than nine anchors. For example, the device may have 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 anchors. Figure 1 As shown, in some aspects, each of the one or more anchors has a hook shape. In some aspects, the one or more anchors include ventricular anchors.

[0150] In another aspect, one or more anchoring elements of the medical device are positioned within the article of manufacture disclosed herein.

[0151] In another aspect, the implantable device is an artificial valve, which is configured to be deployed as a natural valve into the heart. Exemplary prosthetic valves are shown in... Figures 2A to 2B and Figures 8A to 8B It is shown in the figure and described in more detail below.

[0152] refer to Figure 2A In this respect, the prosthetic valve 2000 includes a frame 2002 having an upper region 2004, a middle region 2006, and a lower region 2008. The valve also includes multiple prosthetic leaflets 2020, an inner skirt 2016, and an outer skirt 2018.

[0153] In another aspect, the implantable medical device has an inflow end 2040 and an outflow end 2030, and one or more anchors 2010 are positioned at the outflow end of the prosthetic valve. Figure 2A and Figure 2B The anchor 2010 shown is positioned within the woven article disclosed herein. The anchor may be defined by a neck 2012, an arm 2013, and a tip 2014 (or head).

[0154] In another aspect, implantable medical devices are configured to be deployed onto a natural valve of the heart, wherein the prosthetic valve also includes multiple prosthetic leaflets as shown herein, wherein one or more anchors are attached to the multiple prosthetic leaflets, and each anchor is configured to be anchored to a portion of the heart.

[0155] Figure 7 An exemplary anchor enclosed within the article disclosed herein is shown. It can be seen that the anchor 7000 has a hook shape. Furthermore, the anchor includes a radially inward-facing surface 59 and a radially outward-facing surface 61. The anchor has a neck 7012, an arm 7013, and a head or tip 7014. The anchor is inserted into the braided article 6000 and positioned within the lumen 6003 of the tubular member, such that the cushioning member 6006 is positioned around the tip 7014. A cover member 6010 folds over portions of the cushioning member and the tubular member 6004. It should be understood that the edge 7015 of the cover member seals with the rest of the braided article after its folding. It should be understood that such sealing can be achieved by any method known in the art, such as sewing, laser welding, ultrasonic welding, etc.

[0156] In some aspects, each of one or more anchors is configured to hook around the natural valve leaflet with its surface radially inward toward the natural valve leaflet, and wherein a second thickness of a buffer member disposed on the inner surface of the anchor is greater than a second thickness of a buffer member disposed on the outer surface of the anchor.

[0157] As detailed herein, implantable medical devices may also include sealing elements or outer skirts (2018). Figure 2A The outer skirt or sealing element can be used for periploidal leak sealing.

[0158] In such exemplary and non-limiting aspects, a portion of the sealing element may include a fabric having a 3-D honeycomb pattern. In such aspects, the textile may include a weave pattern substantially identical to that of the cushioning member. In another aspect, the textile may include multiple weft yarns and / or multiple warp yarns substantially identical to those of the cushioning member. For example, as... Figure 2AAs shown, a portion of the sealing element may extend circumferentially between adjacent anchors of the plurality of anchors. In another aspect, a portion of the sealing element may be positioned relative to each of the plurality of anchors.

[0159] Additional examples of implantable medical devices are in Figure 8A and Figure 8B As shown in the image. Figure 8A and Figure 8B An example of a prosthetic valve 40 that can be used with the systems, devices, and methods disclosed herein is illustrated. The prosthetic valve 40 includes a prosthetic heart valve and can be configured to be deployed into the heart as a natural valve. The prosthetic valve 40 may include a distal anchor 42 and a plurality of prosthetic valve leaflets 44 (in... Figure 8B (Seen more clearly in the top view). The prosthetic valve 40 may include a valve body 41 that can support a plurality of prosthetic valve leaflets 44. In some aspects, the valve body 41 may include an outer skirt 46 (or an inner skirt, not shown) and may include one or more frames.

[0160] The outer skirt 46 surrounds the outer surface of the valve body 41 and contacts a portion of the autologous heart valve (such as an autologous heart valve leaflet) to seal with these portions. The frame 49 of the valve body 41 (in...) Figure 8B The center marker (indicated by the outer frame) can support multiple artificial valve leaflets 44. In this exemplary aspect, the frame 49 may include an inner frame that can be positioned on the outer frame 47 (in the outer frame). Figure 8A The radial inner side of the inner frame 49 (marked in the middle). In this respect, the outer frame 47 may surround the inner frame 49.

[0161] The outer frame 47 may include a portion of the sealing body, which may include an outer skirt 46 for sealing with a portion of the natural heart valve. The outer skirt 46 may reduce the likelihood of leakage outside the flow passage of the prosthetic valve (e.g., paravalvular leakage). It should be understood that the valve shown herein is merely exemplary, and other configurations of the frame or valve body may be considered.

[0162] The implantable medical device may also include struts 48 forming a frame 49 of the prosthetic valve 40, and the outer frame 47 may also include struts. Some of the struts 48 may terminate at end tab portions 50, which are configured to be coupled to a part of a delivery device. For example, the end tab portions 50 may be configured to engage a coupling 52 of the delivery device (as in...). Figure 14A and Figure 14B (marked in the middle) to attach the prosthetic valve 40 to the delivery device. The end tab portion 50 may, if necessary, include an open semi-dome shape or another shape to attach to the connector 52. Figure 8B A top view of the prosthetic valve 40 is shown.

[0163] The valve body 41 can surround the flow channel 45 (in Figure 8A (marked in the middle), the central axis of the prosthetic valve 40 can extend along the flow channel. The artificial valve leaflet 44 can extend radially inward from the valve body 41 toward the flow channel 45.

[0164] Multiple prosthetic valve leaflets 44 can be configured to open and close to replicate the operation of a natural valve. Figure 8A and Figure 8B In the example shown, the upper end 51 of the prosthetic valve 40 may include the inflow end of the prosthetic valve 40, and the lower end 53 of the prosthetic valve 40 may include the outflow end of the prosthetic valve 40. The prosthetic valve leaflet 44 can open and close to allow flow from the inflow end to the outflow end and to block flow from the outflow end to the inflow end.

[0165] Figure 8A and Figure 8B The prosthetic valve 40 shown is configured as a prosthetic mitral valve; however, other forms of implants may be used as needed. For example, prosthetic aortic valves, tricuspid valves, or pulmonary valves may be used with the systems, devices, and methods disclosed herein. Furthermore, other forms of implants, such as stents or other implants, may also be used with the systems, devices, and methods disclosed herein.

[0166] Figure 8A and Figure 8B The prosthetic valve 40 shown can be engaged with the ventricular side of a valve (such as a mitral or tricuspid valve) using a distal anchor 42. The distal anchor 42 may include a ventricular anchor positioned at the outflow end of the prosthetic valve 40. The distal anchor 42 may have a hook shape, allowing each distal anchor 42 to hook around the leaflet of the natural valve to secure the prosthetic valve 40 to the natural valve. Each anchor 42 may include an elongated arm of a certain length. In some aspects, the prosthetic valve 40 may also include a proximal anchor 55, which can engage the atrial side of the mitral valve, such as... Figure 16C and Figure 17 The anchors are marked in the middle. It should be understood that in some respects, such anchors 55 exist, while in others they are excluded. One or more anchors may be attached to multiple artificial valve leaflets 44, and each artificial valve leaflet is configured to be anchored to a part of the heart. Other forms of anchors may be used, as well as other forms of implants may be used in other respects.

[0167] Features of the implants that can be used are disclosed in U.S. Patent Application No. 16 / 028,172, the entire contents of which are incorporated herein by reference. Additional details and example designs of implants and prostheses that can be used in the examples herein are described in U.S. Patent Nos. 8,403,983, 8,414,644, 8,652,203 and U.S. Patent Publications Nos. 2011 / 0313515, 2012 / 0215303, 2014 / 0277390, 2014 / 0277422, 2014 / 0277427, 2018 / 0021129 and 2018 / 0055629, the entire contents of which are incorporated herein by reference for all purposes and are a part of this specification. Further details and examples of heart valve or prosthesis replacements and their implantation methods are described in U.S. Publication Nos. 2015 / 0328000 and 2016 / 0317301, the entire contents of which are incorporated herein by reference and form part of this specification.

[0168] The prosthetic valve 40 is compressible, allowing it to be compressed radially toward the longitudinal axis or central axis around which it surrounds. For example, the frame of the prosthetic valve 40 can be flexible to allow for compression. When compressed radially toward the longitudinal axis, the prosthetic valve 40 can longitudinally increase in length along the longitudinal axis (whereby the end flap portion 50 and the distal anchor 42 extend in opposite directions along the longitudinal axis, e.g., as...). Figure 14A (As shown). In some examples, the prosthetic valve 40 can be configured to compress in a radial direction toward the longitudinal axis without increasing the length of the prosthetic valve 40.

[0169] like Figure 8A and Figure 8B As shown, anchor 42 is inserted into the woven article disclosed herein, wherein the cushioning members of the article help cushion the anchor 42 against the natural structure of the patient's heart. Anchor 42 may, for example, include a rigid structure. In some aspects, anchor 42 may be coupled to frame 49 and integral with the struts 48 of frame 49. Similar to the anchors disclosed above, anchor 42 may include hook-shaped arms that are rigid and could potentially damage the natural structure of the patient's heart if they come into direct contact with it. The woven article disclosed herein covers anchor 42 to protect the natural structure from such contact.

[0170] Figure 9AThe steps of attaching the woven article 25 to the arm 56 of the anchor 42 are illustrated. The “cutout” of the article shown indicates that the arm 56 is positioned within the article. The neck 28 is positioned within the tubular part of the article, while the cushioning member 26 is positioned around the tip of the anchor. The cover member is shown before it is folded onto the cushioning member.

[0171] Figure 9B An exemplary assembly of a woven article on an anchor 42 on a frame 49 is shown. In this exemplary aspect, it can be seen that a cushioning member 37 covers the head of the anchor, and a tubular member 97 covers the arms and neck of the anchor. A covering member 99 is shown folded and then attached to the other parts of the woven article.

[0172] The woven fabric of this disclosure provides improved compressibility to cushion the anchor 42. This improved compressibility may be desirable compared to existing forms of liner that may include foam or another closed-cell material. The improved compressibility can further provide benefits during the deployment of the prosthetic valve 40.

[0173] For example, Figure 13 Aspects of a delivery device 60 are illustrated herein, which may be utilized and used to deploy implants such as prosthetic valve 40, according to the examples herein. Delivery device 60 may include an elongated shaft 62 having a proximal end coupled to a handle 64 and a distal end including an implant holding region 66 for the prosthetic valve 40, a nasal cone 68, and a sac-like member 70 extending over the implant holding region 66. The elongated shaft 62 may be deflectable to position the prosthetic valve 40 in a desired location relative to the implantation site. Features of the available delivery device and methods of deployment using the delivery device are disclosed in U.S. Patent Application No. 16 / 028,172, filed July 5, 2018, and published as U.S. Patent Publication No. 2019 / 0008640, the entire contents of which are incorporated herein by reference.

[0174] [For example, such as] Figure 14A As shown, the prosthetic valve 40 can be rolled into an elongated configuration within the sac-like element 70 prior to deployment. For clarity, in Figure 14A Only the frame 49 of the prosthetic valve 40 is shown. The distal anchor 42 is compressed and extends longitudinally along the longitudinal axis or central axis of the elongated axis 62. The compressive force of the sac 70 on the distal anchor 42 is preferably low to reduce the deployment force required to deploy the prosthetic valve 40 from the sac 70.

[0175] Figure 14B An example is a prosthetic valve 40 that is not present in the slender axis 62.

[0176] The deployment of the prosthetic valve 40 can occur in various forms, including surgical methods that involve access via the femoral artery or into the patient's heart. Figure 15 An exemplary procedure utilizing femoral access is illustrated. The elongated shaft 62 of the delivery device 60 may pass through the femoral vein, as well as other access points. Figure 15 An example is illustrated where the elongated shaft 62 of the delivery device 60 reaches the right atrium 71 via the femoral artery, and then the left atrium 72 of the patient's heart 74 via the septum. The elongated shaft 62 can be deflected to position the prosthetic valve 40 for deployment to the mitral valve. The elongated shaft 62 can be deflected toward the left ventricle 76.

[0177] Figures 16A to 16C The steps in the deployment of a prosthetic valve 40 are illustrated, wherein the sac-like element 70 is retracted relative to the prosthetic valve 40. The prosthetic valve 40 is deployed to the natural valve of the patient's heart. The prosthetic valve 40 extends out of an opening 80 in the sac-like element 70. Distal anchors 42 can extend distally and then deflect proximally to hook around the natural valve leaflet during deployment. Each of the distal anchors 42 can hook around the natural valve leaflet. The braided articles disclosed herein ( Figures 16A to 16C (Not shown in the image) The cushioning anchor 42 can be used during deployment, and the compressibility of the pad can reduce the deployment force of the prosthetic valve 40.

[0178] Figure 16B and Figure 16C An example is shown of a sac-like element 70 that is further retracted to deploy the prosthetic valve 40.

[0179] Figure 17 An example is shown of a prosthetic valve 40 deployed to a natural mitral valve, wherein a distal anchor 42 is hooked around the natural valve leaflet. In this example, the distal anchor 42 may be hooked around the natural valve leaflet and may be hooked around the chordae tendineae 82 if desired.

[0180] In some respects, other deployment methods can be utilized. For example, balloon-inflatable prosthetic valves can be used. Such valves can be positioned on the inflatable balloon upon entry into the patient's body, or can slide onto the inflatable balloon after entry into the patient's body. The inflatable balloon can be inflated with fluid to expand and deploy the prosthetic valve. Mechanically inflatable prosthetic valves, as well as self-expanding valves and other forms of deployment, can be further utilized.

[0181] In some respects, the prosthetic valve 40 can be deployed to other valves, such as the tricuspid valve in the example. In the examples presented herein, other forms of prosthetic valves could be used to deploy to other valves, such as the aortic or pulmonary valve, or to other parts of the patient's body.

[0182] The implantable medical devices disclosed herein may include mitral or tricuspid valve replacements, as well as other forms of valves (e.g., aortic valve replacements, lung valve replacements, or other valves). The implantable medical devices disclosed herein may include prosthetic heart valves or other forms of implants, such as stent filters, or diagnostic devices. An implantable medical device may be an inflatable implant configured to move from a compressed or undeployed state to an inflated or deployed state. An implantable medical device may be a compressible implant configured to compress inward to have a reduced external profile and to move the implant to a compressed or undeployed state.

[0183] Various delivery devices can be used in conjunction with the examples disclosed herein. The delivery devices disclosed herein can also be used for replacement and repair of the aorta, mitral valve, tricuspid valve, and lung. Delivery devices may include delivery devices for other forms of implants, such as stent filters or diagnostic devices.

[0184] The implantable medical devices and systems disclosed herein can be used for transcatheter aortic valve implantation (TAVI) or replacement of other natural heart valves (e.g., mitral, tricuspid, or pulmonary valves). The delivery devices and systems disclosed herein can be used for transarterial access (including via the femoral artery) to a patient's heart. The delivery devices and systems can be used for percutaneous transcatheter procedures (including transarterial procedures), which can be via the femoral artery or the jugular vein. Transapical procedures, etc., can also be utilized. Other procedures can be utilized as needed. The features of the examples can be modified, replaced, excluded, or combined across various aspects as needed.

[0185] method

[0186] This disclosure also provides a method comprising weaving any of the woven articles disclosed herein to form a 3D monolithic article. The article is woven onto known equipment in the art. In another aspect, the weaving of each component is completed in a separate plane, simultaneously producing the desired 3D monolithic article. In yet another aspect, the woven articles disclosed herein may be exposed to heat treatment conditions at predetermined temperatures and times, wherein the heat treatment conditions are effective in providing the desired mechanical properties of each component. It should be understood that the article may be exposed to heat treatment when the entire article is formed or, as needed, at any step of the weaving process.

[0187] In another aspect, this document also discloses a method for manufacturing the implantable medical device disclosed herein, wherein the method includes providing a device comprising one or more anchors, wherein each of the one or more anchors is configured to anchor the implantable medical device to a portion of a patient’s natural anatomy, and inserting each anchor into the disclosed woven fabric.

[0188] A method is also disclosed, comprising: deploying a prosthetic valve to a patient's heart of a natural valve, the prosthetic valve comprising: a plurality of prosthetic valve leaflets, one or more anchors coupled to the plurality of prosthetic valve leaflets, and each anchor being configured to anchor to a portion of the patient's heart, wherein each of the one or more anchors is inserted into a braided fabric disclosed herein. In this aspect, the one or more anchors include ventricular anchors. In another aspect, the method further comprises hooking each of one or more anchors around a natural valve leaflet. In yet another aspect, the natural valve is a natural mitral valve or a natural tricuspid valve.

[0189] Exemplary aspects

[0190] In view of the described methods and compositions, certain more specific aspects of this disclosure are described below. However, these specifically enumerated aspects should not be construed as limiting any different claims that incorporate the different or more general teachings set forth herein, or as limiting the “specific” aspects in any way, rather than in the inherent meaning of the literal language and formulas used.

[0191] Example 1: A braided article defined by a proximal end and a distal end, wherein the braided article is a 3-D one-piece article and comprises: a) a tubular member having a cavity disposed between a first open end of the tubular member and a second end of the tubular member; wherein the tubular member has a first thickness, wherein the first open end defines the proximal end of the braided article; wherein the cavity has a diameter d1 and a length l1; b) a cushioning member having a second thickness, wherein the outer surface of the tubular member seamlessly transitions to the outer surface of the cushioning member at a length l2 from the first open end of the tubular member, thereby forming the proximal end of the cushioning member, wherein l2 is less than l1, wherein a portion of the cushioning member includes a central cavity having a portion of a length l3 that accommodates the cavity, such that the second end of the tubular member is positioned within the central cavity of the cushioning member; and c) a braided seal positioned at the distal end of the cushioning member.

[0192] Example 2: A woven product as described in any of the embodiments herein, particularly Example 1, wherein the length l3 is equal to l1-l2.

[0193] Example 3: A woven article as described in any of the embodiments herein, particularly Example 1 or 2, wherein the cushioning member has a regular or irregular shape.

[0194] Example 4: A woven article as described in any of the embodiments herein, particularly Example 3, wherein the cushioning member has a spherical, cubic, cuboid, pyramidal, oval, conical, or prismatic shape.

[0195] Example 5: A woven article as described in any of the embodiments herein, particularly Example 3 or 4, wherein the cushioning member has a regular or irregular cross-sectional shape.

[0196] Example 6: A woven article as described in any of the embodiments herein, particularly Example 5, wherein the cushioning member has a circular, oval, elliptical, rectangular, square, cross-sectional shape or any combination thereof.

[0197] Example 7: A woven article as described in any of the embodiments herein, particularly Examples 5 and 6, wherein the cross-sectional shape is defined by a length a1 along at least one of the x-axis or the y-axis.

[0198] Example 8: A woven article as described in any of the examples herein, particularly Examples 1 to 7, wherein the woven article comprises multiple warp and weft yarns.

[0199] Example 9: A woven article as described in any of the embodiments herein, particularly Examples 1 to 8, wherein the tubular member has a plain weave pattern, a twill weave pattern, a satin weave pattern, any derivative weave pattern, or any combination thereof.

[0200] Example 10: A woven article as described in any of the embodiments herein, particularly Examples 1 to 9, wherein the cushioning member has a 3D honeycomb pattern having a plurality of repeating channel units.

[0201] Example 11: A woven article as described in any of the embodiments herein, particularly Example 10, wherein the plurality of repeating channel units comprise from about 1 channel / inch to about 32 channels / inch.

[0202] Example 12: A woven article as described in any of the embodiments herein, particularly Example 10 or Example 11, wherein each of the plurality of repeating channel units comprises approximately 8 to 50 weft insertion repeats / linear inches.

[0203] Example 13: A woven article as described in any of the embodiments herein, particularly Examples 1 to 12, wherein the tubular member transitions into the cushioning member at the proximal end of the cushioning member, thereby forming a first outwardly tapered portion of the cushioning member.

[0204] Example 14: Weaving as described in any of the embodiments herein, particularly Example 13, wherein the first outwardly tapered portion is formed by increasing the spacing between multiple warp yarns during the weft insertion process.

[0205] Example 15: A woven article as described in any of the embodiments herein, particularly Examples 13 and 14, wherein the first outwardly tapered portion is formed by adding at least one warp yarn during the weaving process.

[0206] Example 16: A woven article as described in any of the embodiments herein, particularly Examples 1 to 15, wherein the distal portion of the cushioning member includes a first inwardly tapered portion.

[0207] Example 17: As described in any of the embodiments herein, particularly Example 16, wherein the first tapering portion terminates at the distal end of the buffer member, wherein the distal end of the buffer member transitions into the braided seal.

[0208] Example 18: Weaving as described in any of the embodiments herein, particularly Example 16 or 17, wherein the first inwardly tapered portion is formed by reducing the spacing between multiple warp yarns during weft insertion in the weaving process.

[0209] Example 19: A woven article as described in any of the embodiments herein, particularly Examples 16 to 18, wherein the first inwardly tapered portion is formed by removing at least one warp yarn during the weaving process.

[0210] Example 20: A woven article as described in any of the embodiments herein, particularly Examples 16 to 19, wherein the first inwardly tapered portion is terminated by the woven seal.

[0211] Example 21: A woven article as described in any of the embodiments herein, particularly Examples 1 to 20, wherein the first thickness is less than the second thickness.

[0212] Example 22: A woven article as described in any of the embodiments herein, particularly Examples 1 to 21, wherein the first thickness is the same or different along the circumference of the tubular member and / or along the length l2.

[0213] Example 23: A woven article as described in any of the embodiments herein, particularly Examples 1 to 22, wherein the second thickness is the same or different along the circumference and / or periphery and / or along the length of the cushioning member.

[0214] Example 24: A woven article as described in any of the embodiments herein, particularly Examples 1 to 23, wherein the cushioning member is defined by a cushioning gradient.

[0215] Example 25: A woven article as described in any of the embodiments herein, particularly Example 24, wherein the buffer gradient is achieved by changing the weave density, changing the number of repeating channel units, changing the number of weft insertions in the plurality of weft yarns, changing the denier of the weft yarns, changing the texture of the weft yarns, or by a combination thereof.

[0216] Example 26: A woven product as described in any of the examples herein, particularly Examples 1 to 25, wherein l2 is equal to or greater than 10 mm.

[0217] Example 27: A woven article as described in any of the examples herein, particularly Examples 1 to 26, wherein d1 is about 2.5 mm to about 3.5 mm.

[0218] Example 28: A woven article as described in any of the examples herein, particularly Examples 7 to 27, wherein a1 is about 3 mm to about 5 mm.

[0219] Example 29: A woven article as described in any of the embodiments herein, particularly Examples 13 to 28, wherein the first outwardly tapered portion is about 0.5 mm to about 1.5 mm.

[0220] Example 30: A woven article as described in any of the embodiments herein, particularly Examples 17 to 29, wherein the first inwardly tapered portion is about 0.5 mm to about 1.5 mm.

[0221] Example 31: A braided article as described in any of the embodiments herein, particularly Examples 1 to 30, wherein the braided seal has a length of about 1 mm to about 3 mm in the longitudinal direction.

[0222] Example 32: A woven article as described in any of the embodiments herein, particularly Examples 1 to 31, wherein the second end of the tubular member positioned within the central cavity of the cushioning member is closed.

[0223] Example 33: A woven article as described in any of the embodiments herein, particularly Examples 1 to 32, wherein the portion of the lumen located within the central cavity of the cushioning member serves as an inner bag for the article.

[0224] Example 34: A woven article as described in any of the embodiments herein, particularly Examples 1 to 33, further comprising a cover member having a third thickness and defined by an inner surface and an outer surface, and having a proximal end and a distal end, wherein the proximal end of the cover member is coupled to the woven seal, and wherein the distal end is open.

[0225] Example 35: A woven article as described in any of the embodiments herein, particularly Example 34, wherein the third thickness is the same or different along the circumference and / or periphery and / or along the length of the covering element.

[0226] Example 36: A braided article as described in any of the embodiments herein, particularly Example 35 or 36, wherein the connection between the braided seal and the proximal end of the cover member is formed during the braiding process.

[0227] Example 37: A woven article as described in any of the embodiments herein, particularly Examples 34 to 36, wherein the covering member includes a second outwardly tapered portion positioned outwardly and upwardly from the proximal end of the covering member.

[0228] Example 38: A woven article as described in any of the embodiments herein, particularly Examples 34 to 37, wherein the covering member has a regular or irregular shape.

[0229] Example 39: A woven article as described in any of the embodiments herein, particularly Example 38, wherein the covering member has a length a2 along at least one of the x-axis or y-axis, wherein a2 is greater than a1.

[0230] Example 40: A woven article as described in any of the embodiments herein, particularly Examples 34 to 39, wherein the covering member has a plain weave pattern, a twill weave pattern, a satin weave pattern, any derivative weave pattern, or any combination thereof.

[0231] Example 41: A woven article as described in any of the embodiments herein, particularly Examples 34 to 40, wherein the covering member includes a second inwardly tapered portion at the distal portion of the covering member, wherein the second inwardly tapered portion terminates at the open distal end of the covering member having a length a3 along at least one of the x-axis or y-axis.

[0232] Example 42: A woven article as described in any of the embodiments herein, particularly Example 41, wherein a3 is less than a2 and equal to or greater than a1.

[0233] Example 43: A woven article as described in any of the embodiments herein, particularly Examples 34 to 42, wherein the covering member is configured to fold over the cushioning member such that the outer surface of the covering member is positioned above the outer surface of the cushioning member, and the inner surface of the covering member is exposed to the surrounding environment.

[0234] Example 44: A woven article as described in any of the embodiments herein, particularly Examples 8 to 43, wherein the multiple warp yarns and the multiple weft yarns comprise biocompatible materials.

[0235] Example 45: A woven article as described in any of the embodiments herein, particularly Examples 8 to 44, wherein the plurality of warp yarns are the same as or different from the plurality of weft yarns.

[0236] Example 46: A woven article as described in any of the embodiments herein, particularly Examples 8 to 45, wherein at least one of the multiple warp yarns and / or multiple weft yarns comprises one or more biocompatible textured multifilament yarns, biocompatible textured high-shrinkage multifilament yarns, biocompatible flat multifilament yarns, twisted multifilament yarns, or any combination thereof.

[0237] Example 47: A woven article as described in any of the examples herein, particularly Examples 8 to 46, wherein the multiple warp and multiple weft yarns comprise polyester, aliphatic polyester, copolyester, polyolefin, fluoropolymer, polyurethane, polyether, polyurea, nylon, natural fibers, copolymers thereof, or combinations thereof.

[0238] Example 48: A woven article as described in any of the examples herein, particularly Example 47, wherein the multiple warp and multiple weft yarns comprise ultra-high molecular weight polyethylene, polyethylene, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyvinylidene fluoride, or any combination thereof.

[0239] Example 49: A woven article as described in any of the embodiments herein, particularly Examples 8 to 48, wherein the multiple warp yarns and multiple weft yarns comprise non-absorbable yarns, bioabsorbable yarns, or combinations thereof.

[0240] Example 50: A woven article as described in any of the embodiments herein, particularly Example 49, wherein the bioabsorbable yarn comprises one or more aliphatic polyesters or copolyesters, or combinations thereof.

[0241] Example 51: A woven article as described in any of the examples herein, particularly Example 50, wherein the bioabsorbable yarn comprises polyglycolic acid (PGA), poly(l-lactic acid) (PLLA), polycaprolactone (PCL), poly(lactic acid)-glycolic acid copolymer (PLGA), copolymers thereof, or combinations thereof.

[0242] Example 52: A woven article as described in any of the embodiments herein, particularly Examples 1 to 51, wherein the woven article is configured to be assembled in an implantable medical device comprising: one or more anchors, wherein each of the one or more anchors is configured to anchor the implantable medical device to a patient’s natural anatomy.

[0243] Example 53: Weaving as described in any of the embodiments herein, particularly Example 52, wherein the woven article is configured to receive an anchor among the one or more anchors through the first open end of the tubular member, such that the anchor is positioned within the lumen of the tubular member, and the second end of the tubular member substantially prevents further movement of the anchor within the article.

[0244] Example 54: The weave as described in any of the embodiments herein, particularly Example 52 or Example 53, wherein the cushioning member protects the patient's natural anatomy.

[0245] Example 55: A woven article as described in any of the embodiments herein, particularly Examples 34 to 54, wherein the covering member (if present) is configured to form a substantially smooth surface exposed to the patient’s natural anatomy.

[0246] Example 56: A woven article as described in any of the examples herein, particularly Examples 1 through 55, wherein the article is configured to promote tissue response.

[0247] Example 57: A woven article as described in any of the embodiments herein, particularly Examples 1 to 56, wherein the woven article includes one or more holes circumferentially disposed in predetermined locations, wherein the one or more holes are configured to receive fastening members for attaching the woven article to a substrate.

[0248] Example 58: An implantable medical device comprising one or more anchors, wherein each of the one or more anchors is configured to anchor the implantable medical device to a portion of a patient’s natural anatomy, wherein each of the anchors is positioned within a woven article as described in any of the embodiments disclosed herein, particularly Examples 1 through 57.

[0249] Example 59: An implantable medical device as described in any of the embodiments herein, particularly Example 58, wherein the implantable device is a prosthetic valve configured to be deployed to a natural valve of the heart, wherein the valve further includes a plurality of prosthetic leaflets, wherein one or more anchors are coupled to the plurality of prosthetic leaflets, and each prosthetic leaflet is configured to be anchored to a portion of the heart.

[0250] Example 60: An implantable medical device as described in any of the embodiments herein, particularly Example 59, wherein the prosthetic valve includes an inflow end and an outflow end, and the one or more anchors are positioned at the outflow end of the prosthetic valve.

[0251] Example 61: An implantable medical device as described in any of the embodiments herein, particularly Example 58 or Example 59, wherein one or more anchors include ventricular anchors.

[0252] Example 62: An implantable medical device as described in any of the embodiments herein, particularly Examples 58 to 61, wherein each of the one or more anchors has a hook shape.

[0253] Example 63: An implantable medical device as described in any of the embodiments herein, particularly Examples 59 to 62, wherein each of the one or more anchors includes a radially inward surface and a radially outward surface.

[0254] Example 64: An implantable medical device as described in any of the embodiments herein, particularly Example 63, wherein each of the one or more anchors is configured to hook around a natural valve leaflet with its surface radially inward toward the natural valve leaflet, and wherein the second thickness of the buffer member disposed on the inner surface of the anchor is greater than the second thickness of the buffer member disposed on the outer surface of the anchor.

[0255] Example 65: An implantable medical device as described in any of the embodiments herein, particularly Examples 59 to 64, further comprising a frame supporting the plurality of prosthetic leaflets, wherein one or more anchors are coupled to the frame.

[0256] Example 66: An implantable medical device as described in any of the embodiments herein, particularly Examples 59 to 65, further comprising a sealing element secured to a frame, wherein a portion of the sealing element comprises a textile having a 3-D honeycomb pattern.

[0257] Example 67: An implantable medical device as described in any of the embodiments herein, particularly Example 66, wherein the fabric comprises a weave pattern substantially identical to that of the cushioning member.

[0258] Example 68: An implantable medical device as described in any of the embodiments herein, particularly Example 66 or Example 67, wherein the textile comprises multiple weft yarns and / or multiple warp yarns substantially identical to the multiple weft yarns and / or multiple warp yarns of the cushioning member.

[0259] Example 69: An implantable medical device as described in any of the embodiments herein, particularly Examples 66 to 68, wherein the portion of the sealing element extends circumferentially between adjacent anchors of the plurality of anchors.

[0260] Example 70: An implantable medical device as described in any of the embodiments herein, particularly Examples 66 to 69, wherein the portion of the sealing element is positioned opposite each of the plurality of anchors.

[0261] Example 71: An implantable device comprising a self-expanding frame having an upper region, a middle region, and a lower region, wherein the frame is configured to expand and contract radially for deployment within a body cavity, and wherein the self-expanding frame includes one or more anchors disposed along the lower region; each of the one or more anchors is configured to anchor the implantable medical device to a portion of a patient's natural anatomy, and at least a portion of the one or more anchors is positioned within a braided article; wherein the braided article comprises: a tubular member having a lumen disposed between a first open end of the tubular member and a second end of the tubular member; wherein the tubular member has ... A tubular member having a first thickness, wherein the first open end defines the proximal end of the braided article; wherein the lumen has a diameter d1 and a length l1; a cushioning member having a second thickness, wherein the outer surface of the tubular member seamlessly transitions to the outer surface of the cushioning member at a length l2 from the first open end of the tubular member, thereby forming the proximal end of the cushioning member, wherein l2 is less than l1, wherein a portion of the cushioning member includes a central cavity having a portion of length l3 that accommodates the lumen, such that the second end of the tubular member is positioned within the central cavity of the cushioning member; and a braided seal positioned at the distal end of the cushioning member.

[0262] Example 72: A method comprising weaving any of the embodiments herein, particularly the woven articles described in Examples 1 to 57, to form a 3-D monolithic article.

[0263] Example 73: A method for manufacturing an implantable medical device according to any embodiment herein, particularly Examples 58 to 71, wherein the method comprises: a) providing an apparatus including one or more anchors, wherein each of the one or more anchors is configured to anchor the implantable medical device to a portion of a patient’s natural anatomy, and b) inserting each anchor into a woven article according to any embodiment herein, particularly Examples 1 to 57.

[0264] Example 74: A method comprising: deploying a prosthetic valve to a natural valve of a patient's heart, the prosthetic valve comprising: a plurality of prosthetic valve leaflets, one or more anchors coupled to the plurality of prosthetic valve leaflets, and each anchor being configured to anchor to a portion of the patient's heart, wherein each of the one or more anchors is inserted into a woven fabric described in any of the embodiments herein, particularly Examples 1 to 57.

[0265] Example 75: The method as described in any of the embodiments herein, particularly Example 74, wherein the one or more anchors include ventricular anchors.

[0266] Example 76: The method as described in any of the embodiments herein, particularly Example 74 or Example 75, further includes hooking each of the one or more anchors around the natural valve leaflet.

[0267] Example 77: The method described in any of the embodiments herein, particularly Examples 74 to 76, wherein the natural valve is a natural mitral valve or a natural tricuspid valve.

[0268] Although several aspects of this disclosure have been disclosed in the foregoing description, those skilled in the art will understand that many modifications and other aspects of this disclosure will arise from the teachings presented in the foregoing description and the accompanying drawings. Therefore, it should be understood that this disclosure is not limited to the specific aspects disclosed above, and many modifications and other aspects are intended to be included within the scope of the appended claims. Furthermore, although specific terminology has been used herein and in the appended claims, it is used only in a general and descriptive sense and not for the purpose of limiting the described disclosure or the appended claims. Therefore, all claims falling within the scope and spirit of these claims are considered our disclosure.

Claims

1. A woven article defined by a proximal end and a distal end, wherein the woven article is a 3D one-piece article and comprises: (a) A tubular member having a cavity disposed between a first open end of the tubular member and a second end of the tubular member; The tubular member has a first thickness. The first open end defines the proximal end of the woven article; The lumen has a diameter d1 and a length l1; (b) A buffer member having a second thickness. The outer surface of the tubular member seamlessly transitions to the outer surface of the buffer member at a distance l2 from the first open end of the tubular member, thereby forming the proximal end of the buffer member, wherein l2 is less than l1. A portion of the buffer member includes a central cavity that accommodates a portion of the tubular lumen having a length of l3, such that the second end of the tubular member is positioned within the central cavity of the buffer member; and (c) A braided seal, which is positioned at the distal end of the buffer member.

2. The woven article as claimed in claim 1, wherein the length l3 is equal to l1-l2.

3. The woven article as claimed in claim 1 or 2, wherein the cushioning member has a regular or irregular shape and / or a regular or irregular cross-sectional shape.

4. The woven article of claim 3, wherein the cross-sectional shape is defined by a length a1 along at least one of the x-axis or y-axis.

5. The woven article as claimed in any one of claims 1 to 4, wherein the tubular member has a plain weave pattern, a twill weave pattern, a satin weave pattern, any derivative weave pattern, or any combination thereof.

6. The woven article of any one of claims 1 to 5, wherein the cushioning member has a 3D honeycomb pattern having a plurality of repeating channel units, such that the plurality of repeating channel units comprise from about 1 channel / inch to about 32 channels / inch, and / or each of the plurality of repeating channel units comprises from about 8 weft insertion repeats / linear inches to 50 weft insertion repeats / linear inches.

7. The woven article of any one of claims 1 to 6, wherein the tubular member transitions into the cushioning member at the proximal end of the cushioning member, thereby forming a first outwardly tapered portion of the cushioning member.

8. The woven article of claim 7, wherein the first outwardly tapered portion is formed by increasing the spacing between multiple warp yarns during weft insertion in the weaving process, and / or wherein the first tapered portion is formed by adding at least one warp yarn during the weaving process.

9. The braided article of any one of claims 1 to 8, wherein the distal portion of the cushioning member includes a first inwardly tapered portion, wherein the first inwardly tapered portion terminates at the distal end of the cushioning member, wherein the distal end of the cushioning member transitions into the braided seal; and / or The first inwardly tapered portion is formed by reducing the spacing between multiple warp yarns during weft insertion in the weaving process; and / or The first inwardly tapered portion is formed by removing at least one warp yarn during the weaving process; and / or The first inwardly tapered portion terminates at the braided seal.

10. The woven article as claimed in any one of claims 1 to 9, wherein the first thickness is less than the second thickness.

11. The woven article according to any one of claims 1 to 10, wherein the first thickness is the same or different along the circumference of the tubular member and / or along the length l2; and / or wherein the second thickness is the same or different along the circumference and / or periphery of the cushioning member and / or along the length of the cushioning member.

12. The woven article according to any one of claims 1 to 11, wherein the cushioning member is defined by a cushioning gradient, the cushioning gradient being achieved by changing the weave density, changing the number of repeating channel units, changing the number of weft insertions in a plurality of weft yarns, changing the denier of the weft yarns, changing the texture of the weft yarns, or by a combination thereof.

13. The woven article of any one of claims 1 to 12, wherein the second end of the tubular member positioned within the central cavity of the cushioning member is closed; and / or wherein the portion of the tubular member positioned within the central cavity of the cushioning member constitutes an inner bag of the article.

14. The woven article of any one of claims 1 to 13, further comprising a cover member having a third thickness and defined by an inner surface and an outer surface and having a proximal end and a distal end, wherein the proximal end of the cover member is coupled to the woven seal, and wherein the distal end is open, and wherein the third thickness is the same or different along the circumference and / or periphery and / or along the length of the cover member.

15. The braided article of claim 14, wherein the connection between the braided seal and the proximal end of the cover member is formed during the braiding process.

16. The woven article of any one of claims 14 to 15, wherein the covering member includes a second outwardly tapered portion positioned outwardly and upwardly from the proximal end of the covering member, wherein the covering member has a regular or irregular shape; and the covering member has a length a2 along at least one of the x-axis or y-axis, wherein a2 is greater than a1.

17. The woven article of any one of claims 14 to 16, wherein the covering member includes a second inwardly tapered portion at the distal portion of the covering member, wherein the second inwardly tapered portion terminates at the open distal end of the covering member having a length a3 along at least one of the x-axis or y-axis; and wherein a3 is less than a2 and equal to or greater than a1.

18. The woven article of any one of claims 14 to 17, wherein the covering member is configured to fold over the cushioning member such that the outer surface of the covering member is positioned above the outer surface of the cushioning member, and the inner surface of the covering member is exposed to the surrounding environment.

19. The woven article of any one of claims 1 to 18, wherein the article is configured to be assembled in an implantable medical device, the implantable medical device comprising: 。 20. One or more anchors, wherein each of the one or more anchors is configured to anchor the implantable medical device to a patient’s natural anatomy, such that the woven article is configured to receive one of the one or more anchors through a first open end of the tubular member, such that the anchor is positioned within the lumen of the tubular member, such that a second end of the tubular member substantially prevents further movement of the anchor within the article.

21. An implantable medical device comprising one or more anchors, wherein each of the one or more anchors is configured to anchor the implantable medical device to a portion of a patient’s natural anatomy, wherein each of the anchors is positioned within a woven article as claimed in any one of claims 1 to 19.

22. The implantable medical device of claim 20, further comprising a sealing element secured to a frame, wherein a portion of the sealing element comprises: Textiles with 3-D honeycomb patterns.

23. 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 expand and contract radially for deployment within a body cavity, and wherein the self-expanding frame includes one or more anchors disposed along the lower region. Each of the one or more anchors is configured to anchor the implantable medical device to a portion of the patient’s natural anatomy, and at least a portion of the one or more anchors is positioned within a woven fabric. The woven articles mentioned above include: A tubular member having a cavity disposed between a first open end of the tubular member and a second end of the tubular member; wherein the tubular member has a first thickness. The first open end defines the proximal end of the woven article; The lumen has a diameter d1 and a length l1; A buffer member having a second thickness. The outer surface of the tubular member seamlessly transitions to the outer surface of the buffer member at a distance l2 from the first open end of the tubular member, thereby forming the proximal end of the buffer member, wherein l2 is less than l1. A portion of the buffer member includes a central cavity that accommodates a portion of the tubular lumen having a length of l3, such that the second end of the tubular member is positioned within the central cavity of the buffer member; and A braided seal is positioned at the distal end of the cushioning member.

24. A method comprising weaving a woven article as described in any one of claims 1 to 19 to form a 3D monolithic article.

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