Bioresorbable filament medical devices

Abstract

Various aspects of the present disclosure relate to devices, systems, and methods including a filament and a membrane disposed about the filament. The membrane may be configured to retain debris of the filament and maintain the structure of the membrane in response to breakage or degradation of the filament.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of Provisional Patent Application No. 62 / 794,387, filed January 18, 2019, which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] The present disclosure generally relates to implantable medical devices. More specifically, the present disclosure generally relates to implantable medical devices including absorbable or biodegradable filaments. Background Art

[0004] Medical stents are well known. One use of medical stents is to support body cavities such as blood vessels, whose diameters shrink due to the effects of lesions such as atheroma or the occurrence of cancerous tumors. Atherosclerosis refers to lesions within arteries, including plaque accumulation that can hinder blood flow through blood vessels. Over time, the size and thickness of the plaques increase and eventually lead to clinically significant narrowing of the arteries, or even complete occlusion. When expanded against a body cavity whose diameter has shrunk, medical stents provide a tubular support structure within the body cavity. Sometimes, stents are lined or covered with a thin biocompatible material. These are called stent grafts and can be used for endovascular repair of aneurysms. Stents are typically tubular and can expand or self-expand from a relatively small diameter to a larger diameter. Stents and stent grafts have also found use in veins and arteries, as well as bronchial, tracheal, urinary and gastrointestinal applications. Stents can also be used to form occluders, vascular closure devices or other similar devices for closing tissue openings (e.g., patent foramen ovale (PFO) or atrial septal defect (ASD)). Summary of the invention

[0005] According to one example ("Example 1"), a medical device includes: a filament; and a septum disposed around the filament and configured to contain (retain) debris of the filament in response to breakage or degradation of the filament and maintain the structure of the septum.

[0006] According to another example ("Example 2") further than the medical device of Example 1, the filament is absorbable and configured to degrade over time.

[0007] According to another example ("Example 3") further to the medical device of Example 2, the septum is configured to contain (retain) debris of the filament during degradation.

[0008] According to another example ("Example 4") further to the medical device of any of Examples 1-3, the membrane is configured to promote tissue ingrowth, tissue attachment, or tissue encapsulation.

[0009] According to another example ("Example 5") further to the medical device of any of Examples 1-3, the membrane is configured to prevent tissue ingrowth.

[0010] According to another example ("Example 6") further to the medical device of any of Examples 1-5, the membrane is configured to enhance the tensile strength of the filament.

[0011] According to another example ("Example 7") further to the medical device of any of Examples 1-6, the device further includes an additional diaphragm layer disposed around the diaphragm, the additional diaphragm layer having different material properties than the diaphragm.

[0012] According to another example ("Example 8") further to the medical device of any of Examples 1-7, the filament includes a cross-section that is at least one of irregular (non-uniform / uneven), jagged, star-shaped, and polygonal.

[0013] According to one example ("Example 9"), the stent includes: a plurality of filaments configured to form a framework; and a plurality of septa disposed around each of the plurality of filaments and configured to accommodate (retain) debris of the plurality of filaments in response to breakage or degradation of the filaments and maintain the structure of the framework.

[0014] According to another example ("Example 10") further than the stent of Example 9, a plurality of filaments are braided to form a framework, and the plurality of filaments are absorbable and configured to degrade over time.

[0015] According to another example ("Example 11") further than the stent of Example 10, the plurality of diaphragms are configured to reduce friction between the plurality of filaments.

[0016] According to another example ("Example 12") further than the stent of Example 10, at least a portion of the plurality of septa is radiopaque.

[0017] According to another example ("Example 13") further than the stent of Example 10, at least a portion of the plurality of septa includes a drug eluting layer.

[0018] According to another example ("Example 14") further to the example stent, the scaffold includes non-absorbable filaments configured to remain in place after degradation of the plurality of filaments.

[0019] According to one example ("Example 15"), an implantable medical device includes a structural element formed by one or more absorbable filaments, the one or more absorbable filaments being configured to degrade over time after implantation into multiple fragments, the fragments including one or more fragments of a first minimum size; and a sheath element at least partially covering the structural element, the sheath element including a septum and being configured to capture and retain one or more fragments of the first minimum size during degradation of the one or more absorbable filaments.

[0020] According to one example ("Example 16"), a method for manufacturing an implantable medical device includes: setting a plurality of diaphragms around each of a plurality of absorbable filaments to form a covered absorbable filament, the plurality of diaphragms being configured to accommodate (retain) debris of the plurality of absorbable filaments in response to breakage or degradation of the plurality of filaments; and setting the covered absorbable filaments together to form a framework.

[0021] According to another example ("Example 17") further to the method of Example 16, arranging the covered absorbable filaments together includes braiding the covered absorbable filaments to form a framework.

[0022] According to one example ("Example 18"), a method for treating an opening in a patient's body to reduce the risk of releasing particulate degradation products and / or to reduce adverse events caused by embolism in the vascular system caused by the degradation products, the method comprising delivering a framework into the opening at the treatment site, wherein the framework comprises a plurality of absorbable filaments and a plurality of septa disposed around each of the plurality of filaments, and the plurality of septa are configured to contain (retain) debris of the plurality of absorbable filaments within the plurality of septa in response to breakage or degradation of the plurality of filaments.

[0023] According to one example ("Example 19"), a method of stabilizing tissue includes: setting a suture to span an opening in tissue, the suture comprising a filament and a septum, the septum being set around the filament and configured to accommodate (retain) debris of the filament in response to breakage or degradation of the filament and to maintain the structure of the septum; and structurally supporting the tissue to promote healing.

[0024] According to another example ("Example 20") further than the method of Example 19, the filament includes at least one of a textured, non-linear, and patterned outer surface.

[0025] According to another example ("Example 21") further than the method of Example 19, the filament includes an eyelet disposed at one or both ends, and further includes wrapping the suture around itself through the eyelet.

[0026] The foregoing examples are merely examples and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided by the present disclosure. Although a number of examples are disclosed, other examples will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative examples of the present invention. Therefore, the drawings and detailed description should be considered illustrative in nature and not restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The accompanying drawings are used to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments and together with the description serve to explain the principles of the present disclosure.

[0028] Figure 1 is a diagram of an exemplary filament according to an embodiment; and

[0029] Figure 2 is a diagram of another exemplary filament according to an embodiment;

[0030] Figure 3 is a diagram of an exemplary implantable medical device according to an embodiment;

[0031] Figure 4 is an exemplary braid of an exemplary implantable medical device according to an embodiment;

[0032] Figures 5A-5C is a diagram of an exemplary filament cross section according to an embodiment;

[0033] Figure 6 are an exemplary filament and an exemplary diaphragm according to an embodiment;

[0034] Figure 7 is another exemplary filament and an exemplary diaphragm according to an embodiment;

[0035] Figure 8 is an exemplary filament for use as a suture according to an embodiment;

[0036] Figures 9A-9C is a diagram of an exemplary filament according to an embodiment;

[0037] Fig. 10A is an exemplary filament for use as a suture in a first configuration according to an embodiment;

[0038] Fig. 10B According to an embodiment, the second configuration Fig. 10A The filaments shown in ; and

[0039] Fig.11 An exemplary stabilization of debris of an exemplary filament according to an embodiment is shown. DETAILED DESCRIPTION

[0040] Definitions and terminology

[0041] Those skilled in the art will readily appreciate that various aspects of the present invention may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the drawings referenced herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in this regard, the drawings should not be construed as limiting.

[0042] This disclosure is not intended to be read in a limiting manner. For example, the terms used in this application should be read broadly in the context of the meanings that those skilled in the art would attribute to such terms.

[0043] With respect to imprecise terms, the terms "about" and "approximately (approximately)" are used interchangeably to refer to measurements that include the stated measurement, and also include any measurements that are reasonably close to the stated measurement. As understood and readily determined by one of ordinary skill in the relevant art, measurements that are reasonably close to the stated measurement deviate from the stated measurement by a relatively small amount. For example, such deviations may be due to measurement error or minor adjustments made to optimize performance. If it is determined that a person of ordinary skill in the relevant art would not easily determine the value of such a reasonably minor difference, the terms "about" and "approximately" may be understood to be plus or minus 10% of the stated value.

[0044] Description of various embodiments

[0045] Various aspects of the present disclosure relate to absorbable filaments (e.g., biodegradable or bioerodible) that include one or more membrane layers. The membrane can remain during and after degradation of the absorbable filament. The membrane can retain (contain) fragments or debris (or particles) of the absorbable filament during and after degradation. The membrane can reduce the likelihood of embolic release.

[0046] Various aspects of the present disclosure relate to a medical device having one or more absorbable filaments arranged to form a medical device. The absorbable filaments (which may be struts, fibers, braided fibers, woven fibers, composite fibers or other structural elements) may be degraded or dissolved by one or more chemical and / or biological mechanisms, which may cause a tissue reaction suitable for the intended implant application. A diaphragm or sheath may be arranged together with at least a portion of one or more filaments or attached to at least a portion of one or more absorbable filaments. The diaphragm may be configured to structurally enhance and / or maintain the integrity of the absorbable filaments during degradation or fracture. The diaphragm is designed to allow degradation processes, but does not allow degradation products to pass through, until the degradation products are degraded to a size that allows them to pass through the pores in the diaphragm. The medical device may include, for example, a stent or stent graft or other similar device. In some cases, the absorbable filaments may be configured to structurally enhance or support the space (e.g., blood vessel) into which the medical device is implanted.

[0047] In some cases, the absorbable filaments degrade while the membrane promotes healthy tissue ingrowth or regrowth. This tissue attachment ensures fixation within the anatomical structure, making the structure provided by the absorbable filaments unnecessary. In addition, the membrane can be fully encapsulated and provide a porous jacket material (porous material with a jacket) around one or more filaments. The membrane surrounding the filaments may include tensile strength and toughness to provide continuous structural integrity while allowing degradation and fluid or moisture to be exchanged to the filaments through the open pores of the membrane.

[0048] Absorbable refers to materials that can be absorbed by the body in this article, whether directly absorbed by dissolving or indirectly absorbed by degrading the implant into smaller components that are subsequently absorbed. The term "absorbable" used herein also encompasses various alternative terms that have been interchangeably used (but intermittently differentiated) within and across surgical disciplines in history. These terms include, for example, absorbable and derivatives thereof, degradable and derivatives thereof, biodegradable and derivatives thereof, resorbable and derivatives thereof, bioabsorbable and derivatives thereof, and biocorrodible and derivatives thereof. As used herein, the term "absorbable" may include a variety of degradation mechanisms, including but not limited to corrosion and ester hydrolysis. Other terms related to absorbable may further refer to the Appendix X4 of ASTM F2902-16.

[0049] In addition, the filaments discussed herein may include monofilaments, which may also be described as a single fiber, strand, line, rod, bead or other non-rigid, elongated, substantially cylindrical embodiment, whose longitudinal dimension exceeds 100 times its cross-section. The monofilament may optionally have one or more covering coatings or other surface modifications to provide features not inherent to the underlying base structure.

[0050] Figure 1is an illustration of an exemplary filament 100 according to an embodiment. The filament 100 together with the septum 102 may form part of a medical device, as discussed in further detail below, or a medical device may be used with the filament 100 and the septum 102. In some cases, the septum 102 may be disposed around the filament and configured to initially contain (retain) debris (or particles) of the filament 100 and maintain the structure of the septum 102 in response to breakage or degradation of the filament 100. The septum 102 may be coupled to or adhered to the filament 100 using a medical adhesive.

[0051] In some cases, filament 100 is absorbable and is configured to degrade over time. Septum 102 is configured to accommodate (keep) debris (or particles) of filament 100 during degradation and absorption into tissue. After filament 100 providing a more solid framework than septum 102 without filament 100 has degraded, septum 102 can remain in place. For example, filament 100 can be a structural component that provides a temporary framework for tissue. The temporary framework provided by filament 100 before degradation can promote the strengthening of tissue, the regrowth of tissue or the growth of healthy tissue. Septum 102 remains in the patient's body and provides structure, unlike the metal frame residue that will occur when using non-degradable implantable devices. In some cases, filament 100 as a temporary framework structure is configured to provide enough outward force and / or pressure to allow septum 102 to support against tissue during the initial time period (e.g., 30-60 days) in the body to maintain contact. This may allow tissue ingrowth, tissue attachment, or tissue encapsulation (tissue encapsulation) to initiate and provide early critical anchoring of the filament 100 or device formed from a plurality of filaments 100 within the tissue bed. The goal will be tissue ingrowth, tissue attachment, or tissue encapsulation to completely encapsulate the membrane 102 (or device) to maintain its intended shape and position while preventing any embolization of the device.

[0052] In some cases, the diaphragm 102 is configured to promote tissue ingrowth, tissue attachment or tissue encapsulation, while in other cases, the diaphragm 102 is configured to prevent tissue ingrowth. These two states may be affected by designing the diaphragm component to be porous and controlling the pore size. The porosity of the diaphragm 102 can control the rate at which the filament 100 degrades. The filament 100 and the diaphragm 102 can be implanted in the patient to enhance or repair unhealthy tissue. Tissue ingrowth into the diaphragm 102 (or tissue attachment or tissue encapsulation) can promote the growth of healthy tissue and the recovery of tissue structural integrity. In some cases, unlike metal or semi-metal filaments, the degradable filament 100 allows the initial reinforcement of unhealthy tissue when the diaphragm 102, which is usually more biocompatible, remains in place. In some cases, there may be areas with different needs in the same device, so a combination of the porosity of the diaphragm 102 (in the same device) can be used to promote and prevent tissue ingrowth at the same time.

[0053] In some cases, the diaphragm 102 may be configured to enhance the tensile strength of the filament 100. In some cases, the tensile strength of the diaphragm itself is stronger than the filaments applied by the diaphragm. This thin and strong covering is conducive to the manufacturing process. The filaments are now strong enough to be woven or braided. The diaphragm 102 may be configured to accommodate (maintain) the byproducts of the degradation process over a period of time. The diaphragm 102 may accommodate (maintain) fragments or debris of the degraded absorbable filaments 102, which may reduce the possibility of emboli release that may be caused by the release of the debris of the absorbable filaments 102 into the patient's bloodstream. The diaphragm 102 may accommodate (maintain) or limit the product until their physical or chemical size is reduced to a size that allows them to pass through the hole and / or the resulting diaphragm / tissue complex. In some cases, the diaphragm 102 may be configured to maintain the debris before the debris is reduced to a size small enough to enable it to be benignly absorbed by the patient so as not to move away from the treatment site.

[0054] In some cases, the diaphragm 102 can be absorbable or partially absorbable. If the diaphragm 102 is absorbable, the diaphragm can have the same or shorter lifespan as the absorbable filament 100. The diaphragm 102 can enhance / reinforce the tissue coverage on the absorbable filament 100 of the bottom layer (underlying). The diaphragm 102 can effectively limit or accommodate (maintain) the migration of debris or particles that may be emitted from the absorbable filament 100 during the degradation or breakage of the absorbable filament 100. Similar to non-absorbable diaphragms, the degradable diaphragm 102 can allow the tissue attachment and / or ingrown of the stable upper (upper) tissue, so it can accommodate (maintain / control) or substantially inhibit the migration of debris and particulate matter emitted by the degraded filament. Preferred is a porous absorbable diaphragm 102, which can maintain strength and / or provide the ability of the upper tissue to be stable and strengthened over a longer period of time than the degraded filament 100.

[0055] Figure 2 is an illustration of another exemplary filament 100 according to an embodiment. The filament 100 may include a first septum 102 and a second septum 204. In some cases, the septum 102 is disposed around the filament and is configured to contain (retain) debris of the filament 100 and maintain the structure of the septum 102 in response to breakage or degradation of the filament 100.

[0056] In some cases, the filament 100 is absorbable and configured to degrade over time. The septum 102 is configured to retain debris of the filament 100 during degradation. The second septum 204 is an additional septum disposed around the (first) septum 102 that has different material properties than the septum.

[0057] After the filament 100, which provides a stronger framework than the separate membranes 102, 204, has degraded, one or both of the membranes 102, 204 may remain in place. For example, the filament 100 may be a structural component that provides a temporary framework for the tissue. The temporary framework provided by the filament 100 before degradation may promote the strengthening of the tissue, the re-growth of the tissue, or the growth of healthy tissue. In some cases, one of the membranes 102, 204 may degrade as well as the filament 100. The membranes 102, 204 may promote the degradation of the filament 100 at different rates compared to only one of the membranes 102, 204. In addition, one of the membranes 102, 204 may be a drug eluting layer.

[0058] For example, filament 100 can be an absorbable metal (such as magnesium), and diaphragm 102 can be a degradable polymer, including a degradable polymer containing a therapeutic agent. Diaphragm 204 can be a non-degradable polymer (such as ePTFE). If filament 100 is formed by a metal degradable material, the device can also provide radiopacity and initial strength due to the metal frame of filament 100, or if diaphragm 204 absorbs radiopaque materials, the device may include radiopaque. These two covers can delay the degradation of metal by inhibiting the biocorrosion process. Diaphragm 102 will begin to degrade and release the therapeutic agent. Diaphragm 204 will have an engineered porosity that controls the release of therapeutic drugs, accommodating (maintaining) degradation products until they degrade to a size that allows them to pass through the hole and allows tissue ingrowth, tissue attachment or tissue encapsulation. In some cases, filament 100 may include a hydrophilic treated diaphragm for improving wetting and chemical diffusion during degradation.

[0059] Figure 3 is an illustration of an exemplary implantable medical device 300 according to an embodiment. The implantable medical device 300 may include one or more absorbable filaments 100. The absorbable filaments 100 may be biocorrodible, biodegradable, or both biocorrodible and biodegradable (e.g., a combination thereof). In addition, the absorbable filaments 100 may include a sheath element at least partially covering the one or more absorbable filaments 100. The one or more absorbable filaments 100 may form a structural element, and thus, the sheath element may at least partially cover the structural element, such as Figure 3 In some cases, the sheath element covers the entire structural element. The sheath element may include a septum 102.

[0060] In some cases and as Figure 3As shown, each of the one or more absorbable filaments 100 is individually covered by a septum 102. In addition, the absorbable filaments 100 can be configured to degrade into multiple fragments over time after implantation. The multiple fragments can include one or more fragments of a first minimum size. The septum 102 is configured to capture and retain one or more fragments having a first minimum size during the degradation of the one or more absorbable filaments 100.

[0061] As described above, the absorbable (e.g., biodegradable, bioerodible) filament 100 is configured to structurally reinforce or support the space (e.g., a vessel) in which the medical device 300 is implanted. In some cases, the absorbable filament 100 degrades, and the membrane 102 (e.g., a membrane) promotes healthy tissue ingrowth or regrowth, tissue attachment, or tissue encapsulation, such that the structure provided by the absorbable filament 100 may become unnecessary.

[0062] The absorbable filaments 100 forming the medical device 300 can be self-expanding and / or plastically deformable. The absorbable filaments 100 and sheath elements can be less abrasive to tissues than medical devices having metal-based structural elements. In this regard, the absorbable filaments 100 can conform to structures that have involuntary motion (e.g., pulsating blood vessels, beating hearts, expanding lungs). In some cases, the absorbable filaments 100 can absorb involuntary motion.

[0063] Additionally, the sheath element may include at least a portion of the septum 102 having a microstructure (e.g., ePTFE) that promotes tissue ingrowth, tissue attachment, or tissue encapsulation. In some cases, tissue ingrowth may occur in each of the septum microstructure and macrostructure of the absorbable filament 100. In some cases, the medical device 300 may be occlusive without a covering (e.g., hydrophobic ePTFE).

[0064] As described above, each of the one or more absorbable filaments 100 may be individually covered by a septum 102. Thus, the medical device 300 may include a plurality of septa disposed around each of the plurality of filaments 100 or around a portion of the plurality of filaments. The plurality of septa 102 may be configured to contain (retain) debris of the plurality of filaments 100 in response to breakage or degradation of the plurality of filaments 100 and maintain the structure of the medical device 300.

[0065] In some cases, such as reference Figure 4Further described in detail, absorbable filaments 100 can form a braided medical device 300. Filaments (e.g., absorbable or non-absorbable) 100 can be braided to form a framework, and absorbable filaments 100 are configured to degrade over time. In addition, diaphragms 102, 204 can be configured to reduce friction between multiple filaments 100. Diaphragm 102 can be a material with a very low coefficient of friction (e.g., ePTFE). Diaphragm 102 with a low coefficient of friction will allow the absorbable filaments 100 of the braid to slide over each other. In some cases, absorbable filaments 100 and diaphragms 102 with a low coefficient of friction (e.g., lower than uncovered) help form compact and well-deployed equipment (and can include a smoother surface than uncovered filaments 100). As previously mentioned, diaphragm 102 can increase the tensile strength and lubricity of the filaments, which helps many manufacturing processes (e.g., braiding). In some cases, the braid provides a scaffold structure that is inherently flexible and compliant, allowing the device 300 to naturally conform to tissue and anatomical structures. The braided construction is also balanced with the filaments 100 being helically wound and interwoven in even numbers in multiple directions. The balance of the braid can allow the device 300 to naturally expand into its intended shape by reducing internal binding twisting or bending forces.

[0066] In some cases and as shown, the implantable medical device 300 can be a stent implanted in the patient's vascular system. In other cases, the filaments 100 can be woven into a plug or other implantable medical devices 300 to be implanted in the patient's tissue opening or defect. In either case, the implantable medical device 300 can form a framework for delivery in the opening at the treatment site. The framework includes a plurality of septa 102 arranged around each of the plurality of absorbable filaments 100. The plurality of absorbable filaments 100 can be degraded by the plurality of septa 102. During degradation and in response to the breakage or degradation of the plurality of filaments 100, the debris of the plurality of absorbable filaments 100 is accommodated (retained) in the plurality of septa 102. After and during degradation of the plurality of filaments 100, the framework of the device 300 is formed by a plurality of septa 102, which remain at the patient's treatment site. Therefore, the framework is maintained in the opening after the plurality of filaments 100 are degraded.

[0067] The membrane 102 promotes healthy tissue ingrowth or regrowth or tissue attachment or tissue encapsulation. Such tissue attachment with the membrane 102 ensures fixation within the anatomical structure, so that the structure provided by the absorbable filament 100 may become unnecessary. The membrane 102 may have a surface structure that can stabilize the absorbable filament 100 so that the movement of debris of the absorbable filament 100 from the treatment site (movement away from the treatment site) is limited.

[0068] In addition, the membrane 102 can be fully encapsulated and provide a porous jacket material around one or more filaments. The membrane 102 surrounding the filaments 102 can include tensile strength and toughness to provide continuous structural integrity while allowing degradation and fluid or moisture exchange to the filaments 100 through the open pores of the membrane 102 (allowing fluid or moisture exchange to the filaments 100 through the open pores of the membrane 102). In some cases, the filaments 100 as a temporary framework are configured to provide sufficient outward force and / or pressure to allow the membrane 102 to be supported against the tissue during the initial period of time (e.g., 30-60 days) in the body and maintain the framework structure of the tissue after the filaments 102 are degraded.

[0069] Compared to uncovered absorbable filaments, containing (holding) and / or limiting the debris of the plurality of absorbable filaments 100 reduces the risk of releasing particulate degradation products. In addition, containing (holding) and / or limiting the debris of the plurality of absorbable filaments 100 can reduce the likelihood of migration and potential adverse events caused by thrombosis or the generation of emboli in the vascular system.

[0070] In some cases, the device 300 (and other devices discussed herein) can be formed of absorbable and non-absorbable filaments 100. In these cases, some of the framework of the device 300 formed of non-absorbable filaments 100 can be left in place. In the case where the device 300 (and other devices discussed herein) includes absorbable and non-absorbable filaments 100, in addition to the septum 102 remaining in the body by the non-absorbable filaments 102 remaining in the body, the structural integrity of the tissue can also be supported.

[0071] Figure 4 is an exemplary braid of an exemplary implantable medical device 300 according to an embodiment. The medical device 300 may include a framework of absorbable filaments 100, each of which is individually covered with a septum 102. A plurality of septa 102 are disposed around each of the plurality of filaments and are configured to contain (hold) and / or restrict debris of the plurality of filaments 102 in response to breakage or degradation of the plurality of filaments 102 and maintain the structure of the framework.

[0072] In some cases, the filament 102 may be Figure 4 The braided medical device 300 can be self-expanding and / or plastically deformable, so that the braid conforms to a variety of shapes for various applications. In addition, the membrane 102 can be disposed around the filaments 102 to form the covered absorbable filaments 102 before being disposed together. In some cases, the covered absorbable filaments 102 can be braided, interwoven, interlocked, or otherwise disposed together to form the medical device 300.

[0073] In some cases, the membrane 102 can wrap around the absorbable filament 102 (wrap around the absorbable filament). The wrapper can be used as a continuous strength component or member along the braid or filament path, which allows the absorbable filament 100 inside to be intentionally weakened or broken to see the initial breakpoint. In addition, after braiding or during braiding, the absorbable filament 102 covered can be shaped as the shape of medical device 300. In some cases, (one or more) membranes 102 can use heat setting process to provide the enhancement of filament 100 and prevent the stretched filament 100 from shrinking and growing in cross-sectional area. This can allow the use of higher heat setting and potentially improve the crystallization (intensity) of filament 100, while keeping the smooth and non-twisted of braided construction. The shaping process can also be carried out using solvent, and can also be carried out by other means, such as by the polymer absorption (impregnation) of suitable fluid or heat setting.

[0074] Figure 5A -C is a diagram of an example filament 100 cross section according to an embodiment. As shown and discussed in detail above, filament 100 may include a substantially circular cross section. In other cases and as Figure 5A As shown in -C, filament 100 may include a cross-section that is not substantially circular in cross-section.

[0075] For example, the filament 100 may be formed or drawn to include a star-shaped cross section. Compared to the filament 100 having a substantially circular cross section, the filament 100 may be formed or drawn to include a star-shaped cross section. Figure 5A -C can increase the surface area of ​​the filament 100. Therefore, the degradation curve of the filament 100 can be customized based on the cross-section of the filament 100. For example, the filament 100 can have a faster degradation curve or rate with a larger surface area. Figure 5A -C includes a particular shape, but the filaments 100 discussed herein may include uneven (irregular / uneven / bumpy), jagged or patchy edges, or include edges that are larger than Figure 5A - More or fewer sides than shown in C (eg, triangle, square, pentagon, hexagon). In some cases, a filament 100 as discussed herein can be hollow (eg, micro-tubing).

[0076] Figure 61 is an exemplary filament 100 and an exemplary septum 102 according to an embodiment. The filament 100 together with the septum 102 may form part of a medical device, as discussed in further detail below, or a medical device may be used with the filament 100 and the septum 102. In some cases, the septum 102 is disposed around the filament 100 and is configured to initially contain (retain) debris of the filament 100 and maintain the structure of the septum 102 in response to breakage or degradation of the filament 100. The septum 102 may be coupled to or adhered to the filament 100 using a medical adhesive. As discussed in detail above, the septum 102 may be non-absorbable and the filament 100 may be absorbable.

[0077] In some cases, the diaphragm 102 may be compressed in one or more directions (e.g., the "x" direction). Compression of the diaphragm 102 may introduce "bends" or structures that are out of plane (i.e., in the "z" direction). Such an approach is generally disclosed in U.S. Patent Publication No. 2016 / 0167291 to Zaggl et al., in which the diaphragm 102 is applied to a stretchable substrate in a stretched state such that the diaphragm 102 reversibly adheres to the stretched stretchable substrate.

[0078] Figure 7 1 is another exemplary filament 100 and an exemplary septum 102 according to an embodiment. The filament 100 together with the septum 102 may form part of a medical device, as discussed in further detail below, or a medical device may be used with the filament 100 and the septum 102. In some cases, the septum 102 is disposed around the filament 100 and is configured to initially retain debris of the filament 100 and maintain the structure of the septum 102 in response to breakage or degradation of the filament 100. The septum 102 may be coupled to or adhered to the filament 100 using a medical adhesive. As discussed in detail above, the septum 102 may be non-absorbable, while the filament 100 may be absorbable.

[0079] As shown, the diaphragm 102 can be wrapped around the filament 100 (wound around the filament). In some cases, the diaphragm 102 is spirally wrapped around the filament 100. In these cases, the diaphragm 102 can partially overlap adjacent windings. The diaphragm 102 can be adhered to the filament 100 and / or the overlapping portions of adjacent diaphragm 102 windings. The diaphragm 102 can be adhered to the filament 100 and / or itself using an adhesive (e.g., fluorinated ethylene propylene (FEP)).

[0080] In some cases, the filaments 100 can be set into a desired shape. The shape-set (shaped) filaments 100 can be spirally wound, braided together to form a pattern, or include additional shapes for a desired application (e.g., needleless sutures for soft tissue repair, staple replacements).

[0081] Figure 8FIG. 1 is an exemplary filament 100 for use as a suture according to one embodiment. Figure 8 As shown, filament 100 (wrapped / wrapped with septum 102) can be used for tissue 820 repair. As shown, filament 100 (wrapped / wrapped with septum 102) can be used as suture to repair tissue 820. Filament 100 and septum 102 can be arranged to span the opening in tissue 820. Before degradation, filament 100 can support tissue 820 structurally during healing. As tissue 850 heals, filament 100 degrades and becomes more compliant. As tissue 850 heals, less structure is needed. Filament 100 degraded in this way can promote faster tissue 820 healing.

[0082] In some cases, the filaments 100 can be set into a desired shape. The shape-set (shaped) filaments 100 can be spirally wound, braided together to form a pattern, or include additional shapes for a desired application (e.g., needleless sutures for soft tissue repair, staple replacements).

[0083] Fig. 9A -C is a diagram of an exemplary filament 100 according to an embodiment. As shown, the filament 100 may include a textured, nonlinear (non-linear) or patterned outer surface. For example, Fig. 9A As shown, the filament 100 includes a wavy structure. In some cases and as Fig. 9B -C, the filament 100 may include one or more protrusions 930. As shown, the protrusions 930 may be serrated (e.g., Fig. 9B ), semicircular ( Fig. 9C ), disposed on one circumferential side of the filament 100 or disposed on both circumferential sides of the filament 100. When the filament 100 is used, for example, as a suture or thread, the protrusion 930 can facilitate the formation of a knot and facilitate the retention of the knot. The protrusion 930 can enhance the friction of the filament 100 to facilitate the tightening of the knot. In addition, the protrusion 930 can be formed in the filament 100 and / or a diaphragm (not shown) disposed around the filament 100.

[0084] Fig. 10A -B shows an exemplary filament 100 for use as a suture in a first configuration (wherein the filament 100 is not knotted) and in a second configuration (wherein the filament 100 is knotted) according to one embodiment. Fig. 10A As shown, the filament 100 includes a protrusion 930. The filament 100 may also include an eyelet 1040 disposed at one or both ends of the filament 100. Fig. 10B As shown, the filament 100 may be wrapped around itself (wrap around itself) through the eyelet 1040. The protrusion 930 may frictionally engage or capture the eyelet 1040 to facilitate knot formation in the filament 100.

[0085] Fig.11 An exemplary stabilization of debris of an exemplary filament 100 according to one embodiment is shown. Fig.11 As shown, the diaphragm 102 can be formed by a framework structure (e.g., woven, knitted, non-woven, absorbable or non-absorbable) component 1122, 1124. As the filament 100 degrades, the components 1122, 1124 can accommodate (hold) structural components and debris. In some cases, the components 1122, 1124 can also include porosity to stabilize debris and / or particles that may be generated due to the degradation of the filament 100 and / or the diaphragm 102. In some cases, for example, the bottom component (the underlying component) 1122 can degrade, and the covering (upper) component 1124 can stabilize the underlying component 1122. In this way, the diaphragm 102 can also degrade and promote stability, as described in detail above.

[0086] The bottom component (underlying component) 1122 can stabilize the filament 100 and the upper (covering) component 1124 when degrading. The physical reduction of the overall structure can promote the degradation of the filament 100 and the parts of the diaphragm 102 while integrating the diaphragm 102 into the tissue. The upper component (covering component) 1124 can degrade and the lower component 1122 can integrate into the tissue. The degradable upper component (covering component) 1124 (or only the filament 100 degrades, while the entirety of the diaphragm 102 is not degradable) can promote continuous tissue coverage and maturation. The upper component 1124 and the lower component 1122 can form a continuous diaphragm 102, or the upper component 1124 and the lower component 1122 can be separate structures. In the case where the upper component 1124 and the lower component 1122 are separate structures, the upper component 1124 can be the diaphragm 1202 and the lower component 1122 can be an absorbent layer.

[0087] Examples of absorbable filaments include, but are not limited to, absorbable metals such as magnesium and magnesium alloys, ferrous materials such as iron, aluminum, and aluminum alloys, and other similar materials.

[0088] Examples of absorbable polymers that can be used in the filament or diaphragm component include, but are not limited to, polymers, copolymers (including terpolymers), and blends that can include, in whole or in part, polyesteramides, polyhydroxyalkanoates (PHAs), poly(3-hydroxyalkanoates), such as poly(3-hydroxypropionate), poly(3-hydroxybutyrate), poly(3-hydroxyvalerate), poly(3-hydroxyhexanoate), poly(3-hydroxyheptanoate), and poly(3-hydroxyoctanoate), poly(4-hydroxyoctanoate), poly(4-hydroxyhexanoate), poly(3-hydroxyheptanoate), and poly(3-hydroxyoctanoate). hydroxybutyrate), poly(4-hydroxyvalerate), poly(4-hydroxyhexanoate), poly(4-hydroxyheptanoate), poly(4-hydroxyoctanoate), poly(L-lactide-co-glycolide) and copolymer variants, poly(D,L-lactide), poly(L-lactide), polyglycolide, poly(D,L-lactide-co-glycolide), poly(L-lactide-co-glycolide), polycaprolactone, poly(lactide-co-caprolactone), poly (glycolide-caprolactone), poly(dioxanone), poly(orthoesters), poly(trimethylene carbonate), polyphosphazenes, poly(anhydrides), poly(tyrosine carbonate) and derivatives thereof, poly(tyrosine esters) and derivatives thereof, poly(imino carbonates), poly(lactic acid-trimethylene carbonate), poly(glycolic acid-trimethylene carbonate), polyphosphates, polyphosphate urethanes, poly(amino acids), poly(ethylene glycol) (PEG), copoly(ether esters) (e.g., PEO / PLA), polyalkylene oxides such as poly(ethylene oxide), poly(propylene oxide), poly(ether esters), polyalkylene oxalates, poly(aspirin), biomolecules such as collagen, chitosan, alginate, fibrin, fibrinogen, cellulose, starch, collagen, dextran, dextrin, fragments and derivatives of hyaluronic acid, heparin, fragments and derivatives of heparin, glycosaminoglycans (GAGs), GAG derivatives, polysaccharides, elastin, chitosan, alginate, or combinations thereof.

[0089] Examples of synthetic polymers suitable as membrane materials (which can be used as membranes) include, but are not limited to, nylon, polyacrylamide, polycarbonate, polyoxymethylene, polymethyl methacrylate, polytetrafluoroethylene, polychlorotrifluoroethylene, polyvinyl chloride, polyurethane, elastomeric silicone polymers, polyethylene, polyurethane, polyglycolic acids, polyesters, polyamides, and mixtures, blends, and copolymers thereof. In one embodiment, the membrane is made of (a class of) polyesters, polyfluorocarbons, and porous or non-porous polyurethanes, such as polyethylene terephthalate, including and and polyaramids, such as The above-mentioned polyfluorocarbons are hexafluoropropylene ( or ) of polytetrafluoroethylene (PTFE). In some cases, the diaphragm includes an expanded fluorocarbon polymer (particularly ePTFE) material. Included in this class of preferred fluoropolymers are polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), tetrafluoroethylene (TFE) and perfluoro (propyl vinyl ether) copolymers (PFA), homopolymers of polytrifluorochloroethylene (PCTFE), and copolymers thereof with TFE, ethylene-trifluorochloroethylene (ECTFE), copolymers of ethylene-tetrafluoroethylene (ETFE), polyvinylidene fluoride (PVDF) and polyvinyl fluoride (PVF). ePTFE is particularly preferred due to its widespread use in vascular prostheses. In some embodiments, the diaphragm includes a combination of the materials listed above. In some cases, the diaphragm is substantially impermeable to body fluids. The substantially impermeable diaphragm can be made of a material that is substantially impermeable to body fluids, or can be constructed of a permeable material that is processed or manufactured (e.g., by laminating different types of materials described above or known in the art) that is substantially impermeable to body fluids.

[0090] Other examples of diaphragm materials include, but are not limited to, vinylidene fluoride / hexafluoropropylene hexafluoropropylene (HFP), tetrafluoroethylene (TFE), vinylidene fluoride, 1-hydropentafluoropropylene, perfluoro(methyl vinyl ether), chlorotrifluoroethylene (CTFE), pentafluoropropylene, trifluoroethylene, hexafluoroacetone, hexafluoroisobutylene, fluorinated poly(ethylene-co-propylene) (FPEP), poly(hexafluoropropylene) (PHFP), poly(chlorotrifluoroethylene) (PCTFE), poly(vinylidene fluoride) (PVDF), poly(vinylidene fluoride-co-tetrafluoroethylene) (PVDF-TFE), poly(vinylidene fluoride-co-hexafluoropropylene) (PVDF-HFP), poly(tetrafluoroethylene-co-hexafluoropropylene) Poly(PTFE-HFP), poly(tetrafluoroethylene-co-vinyl alcohol) (PTFE-VAL), poly(tetrafluoroethylene-co-vinyl acetate) (PTFE-VAC), poly(tetrafluoroethylene-co-propylene) (PTFEP), poly(hexafluoropropylene-co-vinyl alcohol) (PHFP-VAL), poly(ethylene-co-tetrafluoroethylene) (PETFE), poly(ethylene-co-hexafluoropropylene) (PEHFP), poly(vinylidene fluoride-co-chlorotrifluoroethylene-ethylene) (PVDF-CTFE) and combinations thereof, and other polymers and copolymers described in U.S. Publication No. 2004 / 0063805, the entire contents of which are incorporated herein by reference for all purposes. Other polyfluoropolymers include tetrafluoroethylene (TFE) / perfluoroalkyl vinyl ether (PAVE). PAVE can be perfluoromethyl vinyl ether (PMVE), perfluoroethyl vinyl ether (PEVE) or perfluoropropyl vinyl ether (PPVE). Other polymers and copolymers include: polylactide, polycaprolactone-glycolide, polyorthoesters, polyanhydrides; polyamino acids; polysaccharides; polyphosphazenes; poly(ether-ester) copolymers such as PEO-PLLA or blends thereof, polydimethylsiloxane; poly(ethylene-vinyl acetate); acrylate-based polymers or copolymers such as poly(hydroxyethyl methyl methacrylate), polyvinylpyrrolidone; fluorinated polymers such as polytetrafluoroethylene; cellulose esters and any polymers and copolymers.

[0091] The invention of the present application has been described above generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and changes may be made to the embodiments without departing from the scope of the present disclosure. Therefore, the embodiments are intended to cover modifications and changes of the present invention as long as they fall within the scope of the appended claims and their equivalents.

Claims

1. A medical device comprising: at least one filament, the at least one filament forming a first framework; as well as A diaphragm is arranged around the filament and is configured to accommodate debris of the filament in response to breakage or degradation of the filament and maintain the structure of the first frame, the diaphragm includes a second frame, the second frame is defined by a degradable first structural component and a non-degradable second structural component, the first structural component and the second structural component define the diaphragm as a continuous diaphragm.

2. The medical device according to claim 1, characterized in that The filaments are absorbable and configured to degrade over time.

3. The medical device according to claim 2, characterized in that The septum is configured to contain debris of the filament during degradation.

4. The medical device according to any one of claims 1 to 3, characterized in that: The membrane is configured to promote tissue ingrowth, tissue attachment, or tissue encapsulation.

5. The medical device according to any one of claims 1 to 3, characterized in that: The membrane is configured to prevent tissue ingrowth.

6. The medical device according to any one of claims 1 to 3, characterized in that: The membrane is configured to enhance the tensile strength of the filament.

7. The medical device according to any one of claims 1 to 3, characterized in that: Also included is an additional diaphragm layer disposed around the diaphragm, the additional diaphragm layer having different material properties than the diaphragm.

8. The medical device according to any one of claims 1 to 3, characterized in that: The filaments include a cross-section that is at least one of irregular, jagged, star-shaped, and polygonal.

9. A bracket, comprising: a plurality of filaments configured to form a framework; as well as a plurality of membranes disposed around each of the plurality of filaments and configured to contain debris of the plurality of filaments and maintain the structure of the framework in response to breakage or degradation of the plurality of filaments, wherein at least one of the plurality of membranes is non-biodegradable, wherein at least one of the plurality of membranes comprises a second architecture defined by a first degradable structural component and a second non-degradable structural component, the first structural component and the second structural component defining a continuous membrane, And wherein the framework comprises non-absorbable filaments configured to remain in place after the plurality of filaments degrade.

10. The bracket according to claim 9, characterized in that The plurality of filaments are braided to form the framework, and the plurality of filaments are absorbable and configured to degrade over time.

11. The bracket according to claim 10, characterized in that The plurality of diaphragms is configured to reduce friction between the plurality of filaments.

12. The bracket according to claim 10, characterized in that At least a portion of the plurality of septa is radiopaque.

13. The bracket according to claim 10, characterized in that: At least a portion of the plurality of membranes comprises a drug eluting layer.

14. An implantable medical device, the device comprising: a structural element formed from one or more absorbable filaments configured to degrade over time after implantation into a plurality of fragments, the plurality of fragments including one or more fragments of a first minimum size; as well as A sheath element at least partially covers the structural element, the sheath element including a septum, and the sheath element is configured to capture and retain one or more debris of the first minimum size during degradation of the one or more absorbable filaments, wherein the septum includes a framework defined by a degradable first structural component and a non-degradable second structural component, the first structural component and the second structural component defining the sheath element as a continuous septum.

15. A method of manufacturing an implantable medical device, the method comprising: a plurality of septa disposed about each of a plurality of absorbable filaments to form covered absorbable filaments, the plurality of septa configured to contain debris of the plurality of absorbable filaments in response to breakage or degradation of the plurality of filaments, and at least one of the plurality of septa being non-biodegradable, wherein at least one of the plurality of septa comprises a second framework defined by a degradable first structural component and a non-degradable second structural component, the first structural component and the second structural component defining a continuous septum; and The covered absorbable filaments are arranged together to form a framework.

16. The method according to claim 15, characterized in that Arranging the covered absorbable filaments together includes braiding the covered absorbable filaments to form the framework.

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