Natural fibers with absorbability and hydrophobicity for manufacturing surgical sutures and surgical meshes
By using absorbable and hydrophobic natural fibers to form multifilament sutures, the problems of high friction and high risk of infection of existing materials have been solved, resulting in a suture material with high biocompatibility and tensile strength, suitable for a variety of surgical procedures.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-05-07
- Publication Date
- 2026-04-07
AI Technical Summary
Existing surgical sutures and mesh materials have problems such as high friction, high tissue resistance, high risk of infection, and reduced knot safety due to coatings in certain clinical scenarios.
It uses absorbable and hydrophobic natural fibers, such as milkweed, combined in a twisted pattern to form multifilament sutures, and can optionally be coated with a biocompatible coating to reduce bacterial adhesion and tissue resistance.
It provides suture materials with suitable biocompatibility and tensile strength, reducing the risk of bacterial colonization and infection, and is suitable for a variety of medical applications, including soft tissue repair with a high risk of infection.
Smart Images

Figure CN121816205A_ABST
Abstract
Description
Technical Field
[0001] The technical field relates to medical devices for treating damaged tissue, such as surgical sutures and surgical mesh. More specifically, the technical field relates to natural fibers used in the manufacture of surgical sutures and surgical mesh. background
[0002] Surgical sutures and surgical meshes are medical devices that can be used in a wide range of surgical procedures. For example, after biological tissue has undergone injury or surgery, surgical sutures can be used to approximate parts of the tissue, which can then promote the natural healing process. Surgical meshes can be used as tissue scaffolds or structural supports to promote the growth of new biological tissue at target tissue sites in patients, such as to close openings in organ walls or repair tendons or hernias.
[0003] Surgical sutures and surgical meshes are typically made of biocompatible materials (such as synthetic and natural biocompatible materials), which can be non-absorbable or absorbable under physiological conditions. These biocompatible materials can also be further classified according to their physical structure, corresponding to monofilaments or multifilaments.
[0004] The choice of suture material for a given surgical procedure, whether suture or mesh, can be based on a variety of factors, including the tensile strength of the suture material, its resistance to infection, the friction it generates, and the inflammatory response it may trigger. For example, in the case of surgical sutures, the material is typically chosen to allow for the apposition of healthy tissue edges with minimal tension, ideally without contamination or infection, and with adequate blood supply.
[0005] However, while currently available surgical materials may perform well enough in certain clinical scenarios, each of these materials also has drawbacks that can impair the healing process. For example, surgical materials provided in multifilament form are generally stronger than those provided in monofilament form, but multifilaments can also generate high friction and tissue drag when passing through tissue, leading to additional trauma. Furthermore, the gaps defined between adjacent filaments in multifilament sutures can increase capillary action and provide an ideal site for bacterial growth, potentially leading to a higher risk of infection. While these drawbacks can be mitigated by coating treatments, these coatings are known to undesirably reduce knot security.
[0006] Therefore, many challenges remain regarding surgical sutures and surgical meshes, particularly those related to the selection of surgical materials for their fabrication. Overview
[0007] According to one aspect, a multifilament suture is provided for use as a surgical suture, the multifilament suture comprising: Multiple filaments are combined according to a twinned pattern, at least one of which contains natural fibers that are absorbable and hydrophobic under physiological conditions.
[0008] In some embodiments, the natural fibers in at least one filament can be absorbed through protein hydrolysis and / or hydrolysis.
[0009] In some embodiments, at least one of the plurality of filaments is configured to prevent bacteria from adhering to the gap defined between adjacent filaments of the plurality of filaments.
[0010] In some implementations, natural fibers include cellulose plant fibers.
[0011] In some embodiments, the cellulose plant fiber includes milkweed fiber.
[0012] In some embodiments, milkweed fibers include Syrian milkweed ( Asclepias Syriaca ) fiber and beautiful milkweed ( Asclepias Speciosa One or more of the following fibers.
[0013] In some embodiments, the multiple filaments further comprise additional natural fibers that are different from milkweed fibers.
[0014] In some implementations, the additional natural fiber comprises cellulose plant fiber.
[0015] In some embodiments, the additional natural fibers include one or more of the following: kapok fiber, bamboo fiber, flax fiber, cotton fiber, abaca fiber, acetate fiber, banana fiber, coconut fiber, flax fiber, hemp fiber, jute fiber, kenaf fiber, lyocell fiber, modal fiber, piña fiber, raffia fiber, ramie fiber, rayon fiber, sisal fiber, and soybean protein fiber.
[0016] In some implementations, the additional natural fibers include animal fibers.
[0017] In some embodiments, the additional natural fibers include one or more of the following: spider silk fibers, wool fibers, alpaca fibers, Angora rabbit fibers, azlon fibers, byssal silk fibers, camel hair fibers, cashmere fibers, chiengora fibers, lambswool fibers, llama fibers, mohair fibers, qiviut fibers, rabbit hair fibers, silk fibers, castor silk fibers, vicuña fibers, and yak fibers.
[0018] In some embodiments, the plurality of filaments further comprise synthetic fibers.
[0019] In some embodiments, the synthetic fiber comprises one or more of the following: acrylic fiber, Kevlar fiber, etc. TM Fiber, modified acrylic fiber, Nomex TM Fibers, including nylon fibers, polyester fibers, spandex fibers, and rayon fibers.
[0020] In some implementations, the synthetic fiber is an absorbable synthetic fiber.
[0021] In some embodiments, the absorbable synthetic fiber comprises one or more of polyglactin, lactide, polyglycolic acid, polylactic acid, glycolide, p-dioxanone, ε-caprolactone, and trimethylene carbonate.
[0022] In some embodiments, the plurality of filaments further comprise mineral-based fibers.
[0023] In some implementations, the mineral-based fiber comprises one or more of glass fiber and fiberglass fiber.
[0024] In some embodiments, the filaments in a plurality of filaments are woven or interwoven in a twisting pattern.
[0025] In some implementations, the weave pattern is a one-over-one weave pattern.
[0026] In some implementations, the weave pattern is a one-over-two weave pattern.
[0027] In some implementations, the weave pattern is a two-over-two weave pattern.
[0028] In some implementations, the twisted pattern defines the core and the braided sheath provided around the core.
[0029] In some embodiments, the filaments of a plurality of filaments are combined together to form a yarn, and the braided sheath comprises the braided yarn.
[0030] In some embodiments, the multifilament suture further includes a biocompatible coating provided on the outer surface of the multifilament suture.
[0031] In some implementations, the biocompatible coating is configured to reduce tissue resistance of the multifilament suture.
[0032] In some embodiments, the thickness of the biocompatible coating is at least one-quarter of the average diameter of the filaments in the plurality of filaments.
[0033] In some embodiments, the thickness of the biocompatible coating is at least half the average diameter of the filaments in the plurality of filaments.
[0034] In some embodiments, the biocompatible coating comprises an absorbable polymer.
[0035] In some embodiments, the biocompatible coating contains bioactive agents with therapeutic properties.
[0036] In some embodiments, the bioactive agent comprises one or more of cell growth promoters, cell growth inhibitors, antibiotics, cytokines, healing promoters, coagulation regulators, anti-inflammatory agents, and anti-scarring agents.
[0037] In some embodiments, the diameter of the multifilament suture is from about 0.01 mm to about 0.7 mm.
[0038] In some embodiments, the diameter of the multifilament suture is from about 0.1 mm to about 0.5 mm.
[0039] According to another aspect, a surgical mesh is provided for implantation at a surgical site, the surgical mesh comprising: Multiple multifilament sutures, each containing filaments, are arranged in a mesh pattern. At least one of the filaments contains natural fibers that are absorbable and hydrophobic under physiological conditions.
[0040] In some embodiments, the natural fibers in at least one filament can be absorbed through protein hydrolysis and / or hydrolysis.
[0041] In some embodiments, at least one filament is configured to prevent bacteria from adhering to the gap defined between adjacent filaments.
[0042] In some implementations, natural fibers include cellulose plant fibers.
[0043] In some implementations, the cellulose plant fiber includes milkweed fiber.
[0044] In some embodiments, milkweed fibers include one or more of Syrian milkweed fibers and beautiful milkweed fibers.
[0045] In some embodiments, the multiple filaments further comprise additional natural fibers that are different from milkweed fibers.
[0046] In some implementations, the additional natural fiber comprises cellulose plant fiber.
[0047] In some embodiments, the additional natural fibers include one or more of the following: kapok fiber, bamboo fiber, flax fiber, cotton fiber, abaca fiber, acetate fiber, banana fiber, coconut shell fiber, flax fiber, hemp fiber, jute fiber, kenaf fiber, lyocell fiber, modal fiber, pineapple fiber, raffia fiber, ramie fiber, rayon fiber, sisal fiber, and soybean protein fiber.
[0048] In some implementations, the additional natural fibers include animal fibers.
[0049] In some embodiments, the additional natural fibers include one or more of the following: spider silk fibers, wool fibers, alpaca fibers, Angora rabbit hair fibers, azlon fibers, byssal silk fibers, camel hair fibers, cashmere fibers, dog hair fibers, lambswool fibers, llamas fibers, mohair fibers, musk ox hair fibers, rabbit hair fibers, silk fibers, castor silk fibers, vicuña hair fibers, and yak fibers.
[0050] In some embodiments, the plurality of filaments further comprise synthetic fibers.
[0051] In some embodiments, the synthetic fiber comprises one or more of the following: acrylic fiber, Kevlar fiber, etc. TM Fiber, modified acrylic fiber, Nomex TM Fibers, including nylon fibers, polyester fibers, spandex fibers, and rayon fibers.
[0052] In some implementations, the synthetic fiber is an absorbable synthetic fiber.
[0053] In some embodiments, the synthetic fiber is one or more of polyglactin, lactide, polyglycolic acid, polylactic acid, glycolide, p-dioxanone, ε-caprolactone, and trimethylene carbonate.
[0054] In some embodiments, the plurality of filaments further comprise mineral-based fibers.
[0055] In some embodiments, the mineral-based fibers comprise one or more of glass fibers and fiberglass fibers.
[0056] In some implementations, the surgical mesh defines a porous matrix configured to promote tissue growth at the surgical site.
[0057] In some implementations, the mesh pattern includes a woven pattern, a knitted pattern, a warp-knitted pattern, or a nonwoven pattern.
[0058] In some implementations, the surgical mesh is configured as a corrugated surgical mesh.
[0059] In some embodiments, the surgical mesh further comprises a non-mesh material, and the combination of the surgical mesh and the non-mesh material forms a surgical scaffold configured to provide support for tissues surrounding the surgical site.
[0060] According to another aspect, a suturing device is provided for partially apposing biological soft tissue, the suturing device comprising: Multifilament suture, comprising: Multiple filaments combined according to a twisted weave pattern, at least one of which contains natural fibers that are absorbable and hydrophobic under physiological conditions; and A suture needle having a needle tip configured to penetrate tissue and a suture engagement end configured to engage with a multifilament suture.
[0061] In some embodiments, the natural fibers in at least one filament can be absorbed through protein hydrolysis and / or hydrolysis.
[0062] In some embodiments, at least one of the plurality of filaments is configured to prevent bacteria from adhering to the gap defined between adjacent filaments of the plurality of filaments.
[0063] In some implementations, natural fibers include cellulose plant fibers.
[0064] In some implementations, the cellulose plant fiber includes milkweed fiber.
[0065] In some embodiments, milkweed fibers include one or more of Syrian milkweed fibers and beautiful milkweed fibers.
[0066] In some embodiments, the multiple filaments further comprise additional natural fibers that are different from milkweed fibers.
[0067] In some implementations, the additional natural fiber comprises cellulose plant fiber.
[0068] In some embodiments, the additional natural fibers include one or more of the following: kapok fiber, bamboo fiber, flax fiber, cotton fiber, abaca fiber, acetate fiber, banana fiber, coconut shell fiber, flax fiber, hemp fiber, jute fiber, kenaf fiber, lyocell fiber, modal fiber, pineapple fiber, raffia fiber, ramie fiber, rayon fiber, sisal fiber, and soybean protein fiber.
[0069] In some implementations, the additional natural fibers include animal fibers.
[0070] In some embodiments, the additional natural fibers include one or more of the following: spider silk fibers, wool fibers, alpaca fibers, Angora rabbit hair fibers, azlon fibers, byssal silk fibers, camel hair fibers, cashmere fibers, dog hair fibers, lambswool fibers, llamas fibers, mohair fibers, musk ox hair fibers, rabbit hair fibers, silk fibers, castor silk fibers, vicuña hair fibers, and yak fibers.
[0071] In some embodiments, the plurality of filaments further comprise synthetic fibers.
[0072] In some embodiments, the synthetic fiber comprises one or more of the following: acrylic fiber, Kevlar fiber, etc. TM Fiber, modified acrylic fiber, Nomex TM Fibers, including nylon fibers, polyester fibers, spandex fibers, and rayon fibers.
[0073] In some implementations, the synthetic fiber is an absorbable synthetic fiber.
[0074] In some embodiments, the absorbable synthetic fiber comprises one or more of polyglactin, lactide, polyglycolic acid, polylactic acid, glycolide, p-dioxanone, ε-caprolactone, and trimethylene carbonate.
[0075] In some embodiments, the plurality of filaments further comprise mineral-based fibers.
[0076] In some embodiments, the mineral-based fibers comprise one or more of glass fibers and fiberglass fibers.
[0077] In some embodiments, the suture needle includes a hollow body, and the suture joining end of the suture needle is a swagged end, which is configured to crimp the end of the multifilament suture into the hollow body of the suture needle.
[0078] In some embodiments, the suture needle comprises one or more of a straight needle body, a curved needle body, and a serpentine needle body.
[0079] According to another aspect, a suturing device is provided for partially apposing biological soft tissue, the suturing device comprising: Multifilament suture, comprising: Multiple filaments are combined according to a twisted weave pattern, at least one of which contains natural fibers that are absorbable and hydrophobic under physiological conditions; and Provides a biocompatible coating on the surface of multifilament sutures.
[0080] In some embodiments, the natural fibers in at least one filament can be absorbed through protein hydrolysis and / or hydrolysis.
[0081] In some embodiments, at least one of the plurality of filaments is configured to prevent bacteria from adhering to the gap defined between adjacent filaments of the plurality of filaments.
[0082] In some implementations, natural fibers include cellulose plant fibers.
[0083] In some implementations, the cellulose plant fiber includes milkweed fiber.
[0084] In some embodiments, milkweed fibers include one or more of Syrian milkweed fibers and beautiful milkweed fibers.
[0085] In some embodiments, the multiple filaments further comprise additional natural fibers that are different from milkweed fibers.
[0086] In some implementations, the additional natural fiber comprises cellulose plant fiber.
[0087] In some embodiments, the additional natural fibers include one or more of the following: kapok fiber, bamboo fiber, flax fiber, cotton fiber, abaca fiber, acetate fiber, banana fiber, coconut shell fiber, flax fiber, hemp fiber, jute fiber, kenaf fiber, lyocell fiber, modal fiber, pineapple fiber, raffia fiber, ramie fiber, rayon fiber, sisal fiber, and soybean protein fiber.
[0088] In some implementations, the additional natural fibers include animal fibers.
[0089] In some embodiments, the additional natural fibers include one or more of the following: spider silk fibers, wool fibers, alpaca fibers, Angora rabbit hair fibers, azlon fibers, byssal silk fibers, camel hair fibers, cashmere fibers, dog hair fibers, lambswool fibers, llamas fibers, mohair fibers, musk ox hair fibers, rabbit hair fibers, silk fibers, castor silk fibers, vicuña hair fibers, and yak fibers.
[0090] In some embodiments, the plurality of filaments further comprise synthetic fibers.
[0091] In some embodiments, the synthetic fiber comprises one or more of the following: acrylic fiber, Kevlar fiber, etc. TM Fiber, modified acrylic fiber, Nomex TM Fibers, including nylon fibers, polyester fibers, spandex fibers, and rayon fibers.
[0092] In some implementations, the synthetic fiber is an absorbable synthetic fiber.
[0093] In some embodiments, the absorbable synthetic fiber comprises one or more of polyglactin, lactide, polyglycolic acid, polylactic acid, glycolide, p-dioxanone, ε-caprolactone, and trimethylene carbonate.
[0094] In some embodiments, the plurality of filaments further comprise mineral-based fibers.
[0095] In some embodiments, the mineral-based fibers comprise one or more of glass fibers and fiberglass fibers.
[0096] In some implementations, the biocompatible coating is configured to reduce tissue resistance of the multifilament suture.
[0097] In some embodiments, the biocompatible coating comprises an absorbable polymer.
[0098] In some embodiments, the biocompatible coating contains bioactive agents with therapeutic properties.
[0099] In some embodiments, the bioactive agent comprises one or more of cell growth promoters, cell growth inhibitors, antibiotics, cytokines, healing promoters, coagulation regulators, anti-inflammatory agents, and anti-scarring agents.
[0100] According to another aspect, a multifilament suture is provided for use as a surgical suture, the multifilament suture comprising: The first group of filaments comprises natural fibers that are absorbable and hydrophobic under physiological conditions; and The first and second sets of filaments are combined together in a twisted pattern to form a multifilament suture. The second set of filaments contains absorbable synthetic suture material.
[0101] In some embodiments, the natural fibers in the first group of filaments can be absorbed through protein hydrolysis and / or hydrolysis.
[0102] In some embodiments, the first set of filaments is configured to prevent bacteria from adhering to the gaps defined between adjacent filaments of the first set of filaments.
[0103] In some implementations, natural fibers include cellulose plant fibers.
[0104] In some implementations, the cellulose plant fiber includes milkweed fiber.
[0105] In some embodiments, milkweed fibers include one or more of Syrian milkweed fibers and beautiful milkweed fibers.
[0106] In some embodiments, the synthetic suture material comprises one or more of polyglactin, lactide, polyglycolic acid, polylactic acid, glycolide, p-dioxanone, ε-caprolactone, and trimethylene carbonate.
[0107] According to another aspect, a multifilament suture is provided for use as a surgical suture, the multifilament suture comprising: Multiple filaments are combined according to a twisted weave pattern, and at least one of the multiple filaments contains milkweed fibers.
[0108] In some embodiments, the multifilament suture includes one or more features as defined above.
[0109] According to another aspect, a suturing device is provided for partially apposing biological soft tissue, the suturing device comprising: Multifilament suture, comprising: Multiple filaments are combined according to a twisted weave pattern, at least one of which contains milkweed fibers; and A suture needle having a needle tip configured to penetrate tissue and a suture engagement end configured to engage with a multifilament suture.
[0110] In some embodiments, the multifilament suture includes one or more features as defined above.
[0111] According to another aspect, a multifilament suture is provided for use as a surgical suture, the multifilament suture comprising: The first group of filaments comprises natural fibers that are absorbable and hydrophobic under physiological conditions; and The second group of filaments comprises one or more of the following: natural fibers, synthetic fibers, and mineral-based fibers that are different from the natural fibers in the first group of filaments. The first and second groups of filaments are combined together in a twisted pattern to form a multifilament suture.
[0112] In some embodiments, the natural fibers in the first group of filaments can be absorbed through protein hydrolysis and / or hydrolysis.
[0113] In some embodiments, the first set of filaments is configured to prevent bacteria from adhering to the gaps defined between adjacent filaments of the first set of filaments.
[0114] In some embodiments, the natural fibers in the first group of filaments comprise cellulose plant fibers.
[0115] In some implementations, the cellulose plant fiber includes milkweed fiber.
[0116] In some embodiments, milkweed fibers include one or more of Syrian milkweed fibers and beautiful milkweed fibers.
[0117] In some embodiments, the natural fibers in the second set of filaments comprise cellulose plant fibers.
[0118] In some embodiments, the natural fibers in the second group of filaments include one or more of the following: kapok fiber, bamboo fiber, flax fiber, cotton fiber, abaca fiber, acetate fiber, banana fiber, coconut shell fiber, flax fiber, hemp fiber, jute fiber, kenaf fiber, lyocell fiber, modal fiber, pineapple fiber, raffia fiber, ramie fiber, rayon fiber, sisal fiber, and soybean protein fiber.
[0119] In some embodiments, the natural fibers in the second set of filaments include animal fibers.
[0120] In some embodiments, the natural fibers in the second group of filaments include one or more of the following: spider silk fibers, wool fibers, alpaca fibers, Angora rabbit hair fibers, azlon fibers, byssal silk fibers, camel hair fibers, cashmere fibers, dog hair fibers, lambswool fibers, llamas fibers, mohair fibers, musk ox hair fibers, rabbit hair fibers, silk fibers, castor silk fibers, vicuña hair fibers, and yak fibers.
[0121] In some embodiments, the synthetic fiber comprises one or more of the following: acrylic fiber, Kevlar fiber, etc. TM Fiber, modified acrylic fiber, Nomex TM Fibers, including nylon fibers, polyester fibers, spandex fibers, and rayon fibers.
[0122] In some implementations, the synthetic fiber is an absorbable synthetic fiber.
[0123] In some embodiments, the absorbable synthetic fiber comprises one or more of polyglactin, lactide, polyglycolic acid, polylactic acid, glycolide, p-dioxanone, ε-caprolactone, and trimethylene carbonate.
[0124] In some embodiments, the mineral-based fibers comprise one or more of glass fibers and fiberglass fibers. Brief description of the attached diagram
[0125] The accompanying drawings illustrate various features, aspects, and implementations of the technology described herein.
[0126] Figure 1 This is a perspective view of a multifilament suture according to one embodiment.
[0127] Figure 2 This is a perspective view of a multifilament suture according to another embodiment.
[0128] Figure 3 This is a perspective view of a surgical mesh according to one embodiment.
[0129] Figure 4A This is a top view of a surgical mesh comprising filaments provided in a knitted pattern according to one embodiment.
[0130] Figure 4B This is a top view of a surgical mesh including filaments provided in a warp-knitted pattern according to one embodiment.
[0131] Figure 4C This is a top view of a surgical mesh comprising filaments provided in a nonwoven pattern according to one embodiment.
[0132] Figure 4D This is a top view of a surgical mesh comprising filaments provided in a weaving pattern according to one embodiment. Detailed Explanation
[0133] The technology described herein relates to suture materials for the production of medical devices, including surgical sutures and surgical meshes, which can be used in the context of medical procedures such as tissue occlusion and tissue repair. Suture materials can include natural fibers with desired properties, such as being hydrophobic and absorbable under physiological conditions, and can be suitable for manufacturing multifilament sutures and meshes containing multifilament sutures. These desired properties, in turn, can provide suitable biocompatibility and tensile strength. Providing suture materials made of absorbable and hydrophobic natural fibers can have several benefits. For example, absorbable suture materials can be selected for ligating tissues that are inaccessible after implantation, and because they degrade over time, they do not need to be removed after healing. Hydrophobic materials can reduce cell adhesion, thereby limiting bacterial colonization. Therefore, combining these two properties into a single suture material made of natural fibers can provide resulting multifilament surgical sutures or surgical meshes with unique technical features that make them suitable for a variety of medical applications, including those with a high risk of infection. These medical applications include soft tissue repair, such as, for example, repairing fibrous tissue (e.g., muscles, ligaments, or tendons), attaching soft tissue to bone, or any other tissue repair during cardiology, laparoscopic surgery, urology, or plastic surgery or other surgical procedures performed on a patient.
[0134] As used herein, the term "natural fiber" refers to a hair-like raw material whose diameter is negligible compared to its length and which is derived from a plant. Natural fibers can be spun into filaments, and a given number of filaments can optionally be combined to produce yarn. For example, natural fibers can include cellulose plant fibers. In some embodiments and as described above, the natural fibers described herein can be absorbent and hydrophobic. An example of such a natural fiber is milkweed fiber. Milkweed fiber, also known as milkweed fluff, is a plant seed fiber obtained from the seeds of milkweed plants (Asclepias) and other plants in the Asclepiadaceae subfamily. Milkweed fiber is typically in the form of a soft, lustrous, and buoyant fiber, and is pale yellow or white. A single milkweed fiber can typically have a length of about 1 to 3 cm and an average diameter of about 20 to 50 micrometers. Milkweed fiber can have a g / cm³ ratio of about 0.10 to about 0.35 g / cm³. 3 The density.
[0135] As used herein, the term "absorbable" refers to a material whose tensile strength decreases significantly within 60 days after implantation into tissue (i.e., under physiological conditions), although it should be understood that the material may subsequently take several more weeks to be fully absorbed. The absorbability of a material stems from its susceptibility to breakdown, decomposition, degradation, reabsorption, and / or dissolution under the influence of biological processes such as enzymatic reactions and / or hydrolysis. In some cases, absorbable suture materials may be completely absorbed within months. In some cases, absorbable suture materials may further be biodegradable and therefore capable of being broken down by bacteria or other living organisms. It should be understood that, as used herein, the term "absorbable" is intended as a generic term and may also include implantable devices that are bioresorbable, reabsorbable, biodegradable, or biodegradable in living tissue or tissue. Therefore, the term "absorbable" is contrasted with the term "non-absorbable," which refers to implantable devices permanently placed in living tissue or tissue.
[0136] As used herein, the term "multifilament suture" refers to a suture comprising a plurality of filaments arranged together in a substantially random manner or in a twisted pattern. The twisted pattern may be in accordance with a predetermined structure. In some embodiments, when the filaments are arranged in a substantially random manner, the filaments may be considered simply to be bound together. In some embodiments, when the twisted pattern is in accordance with a predetermined structure, the filaments may be organized in a twisted manner.
[0137] As used herein, the term "twisting" can be understood as referring to two or more filaments entwined into a cohesive structure. In some embodiments, the filaments can be woven or interlaced when the twist pattern is performed according to a predetermined structure, with some filaments interlacing with other filaments. Furthermore, the expression "twisting pattern" is intended to cover embodiments in which portions of filaments are combined together and optionally interlocked to form yarns, and then the selected yarns are combined according to a desired twist pattern. Thus, the filaments themselves can be twisted or interlaced, or yarns made from filaments can be twisted.
[0138] In some embodiments, when the weave pattern comprises filaments or yarns interlaced, the weave pattern can be, for example, a one-up-one-down weave, a one-up-two-down weave, or a two-up-two-down weave. It should be understood that other types of weave patterns known in the art for producing multifilament sutures may also be suitable. In some embodiments, the weave pattern can result in the multifilament suture having a predetermined number of twists / defined length, for example, about 10 to about 1,000 twists per meter of multifilament suture.
[0139] As indicated above, natural fibers used to manufacture filaments, multifilament sutures, and surgical meshes as described herein can be hydrophobic while being absorbable. The hydrophobicity of natural fibers can help repel or inhibit fluid penetration into the spaces defined between adjacent filaments or yarns of multifilament sutures used to form surgical sutures or surgical meshes. The hydrophobicity of natural fibers can also help prevent bacterial adhesion to the filaments of multifilament sutures used to form surgical sutures or surgical meshes. These combined benefits can then help prevent or reduce the formation of bacterial biofilms, and thus prevent or reduce surgical site infections. While other types of natural fibers, and more specifically, natural fibers from plant sources, can be hydrophobic, these natural fibers are currently known to be non-absorbable. For example, under physiological conditions, complete biodegradation of silk is considered to occur within two years after implantation. Silk is also known to induce microorganisms (e.g., bacteria) to attach to it, leading to inflammation. Examples of hydrophobic and non-absorbable natural fibers include, for example, silk (which has been widely used as a suture material to date).
[0140] Various implementations and features of multifilament sutures used as surgical sutures and for the production of surgical mesh will now be described in more detail in the following paragraphs.
[0141] Multifilament sutures used for surgical sutures refer to Figure 1 An exemplary embodiment of a multifilament suture 100 is shown. In the illustrated embodiment, the multifilament suture 100 comprises a plurality of filaments 102 made of natural fibers, the filaments 102 being elongated and substantially continuous. The plurality of filaments 102 are combined together in a twisted pattern, wherein the filaments 102 are slightly twisted but not interlaced. Therefore, it should be understood that although Figure 1 The filaments 102 of the multifilament suture 100 shown are not interlaced, but these filaments are still considered twisted because they achieve a predetermined structure through twisting. Optionally, and as described above, the filaments can be combined in a substantially random manner, such as in bundles, or the filaments of the multifilament suture 100 can be provided according to any suitable twisting pattern. For example, in Figure 1In the illustrated embodiment, the filament 102 is provided as an independent natural fiber filament, rather than by combining portions of the filament together to form a yarn (such as...). Figure 2 As shown). When the filaments are combined to form a yarn, the yarn can then be wound in a desired twist pattern (which can be, for example, a one-up-one-down twist pattern, a one-up-two-down twist pattern, a two-up-two-down twist pattern, etc.).
[0142] In the illustrated embodiment, the multifilament suture 100 comprises forty intertwined filaments 102. It should be understood that the multifilament suture 100 may comprise any other suitable number of filaments 102. For example, in some embodiments, the multifilament suture 100 may comprise one to two hundred filaments 102. Optionally, the multifilament suture 100 may comprise forty to sixty filaments 102.
[0143] Now for reference Figure 2 Another embodiment of the multifilament suture 200 is shown. In this embodiment, the multifilament suture 200 includes a plurality of filaments 212 provided according to a twill pattern defining a braided sheath 210 surrounding a core 220. In this embodiment, first portions of the filaments are combined together to form a first yarn, second portions of the filaments are combined together to form a second yarn, and so on, and then selected yarns of the first yarn, second yarn, etc., are woven according to a desired twill pattern to form the braided sheath 210. In the illustrated embodiment, the twill pattern can be considered to correspond to an up-and-down twill pattern. In the illustrated embodiment, the yarn 214 of the braided sheath 210 has a substantially elliptical cross-section and includes a plurality of filaments 212 made of natural fibers arranged longitudinally to each other. In other embodiments, the yarn 214 may have a circular, polygonal, or any other suitable cross-section and may be combined together in a manner different from that shown in the example. For example, the filaments 212 may be arranged according to... Figure 1 The twill pattern shown provides that the filaments 212 are slightly twisted but not interlaced.
[0144] Also refer to Figure 2 The core 220 of the multifilament suture 200 comprises a plurality of yarns 221 provided in a slightly twisted twill pattern. In the illustrated embodiment, each yarn 221 comprises a plurality of filaments 222 made of the natural fibers described herein. Alternatively, the yarns 221 may be bundles of filaments combined together in any other manner.
[0145] In some embodiments, the multifilament sutures 100, 200 can be configured to be flexible enough to form knots. The knots of the multifilament sutures 100, 200 can secure them to the surgical site to prevent, for example, slippage after surgery, and to maintain tension. In such embodiments, the multifilament sutures 100, 200 can be secured to the surgical site independently, i.e., without the need for additional tools (e.g., suture anchors or surgical clips) for surgeries involving tissue approximation. In other embodiments, the multifilament sutures 100, 200 can be configured to work in conjunction with suture anchors or surgical clips.
[0146] One or more of the filaments 102, 212, and 222 of the multifilament sutures 100 and 200 are made of natural fibers that are absorbable and hydrophobic. More specifically, the filaments 102, 212, and 222 of the multifilament sutures 100 and 200 may have mechanical properties that change after a given period of time, which may correspond to a predetermined time point after surgery. Therefore, the filaments 102, 212, and 222 can be configured to degrade over time and thus do not need to be removed after the surgical site has healed.
[0147] In some embodiments, the natural fiber may include cellulose plant fibers, such as milkweed fiber. Milkweed fiber may include at least one of Syrian milkweed fiber and beautiful milkweed fiber. It should be understood that in other embodiments, the natural fiber may include milkweed fiber from other species of the Milkweed genus. In such embodiments, the milkweed fibers of the interwoven filaments 102, 212, 222 can be naturally biodegraded under physiological conditions while retaining their hydrophobicity. The filaments 102, 212, 222 of the multifilament sutures 100, 200 made of milkweed fiber are further hydrophobic, which can help repel or inhibit fluid penetration into the gaps defined between adjacent filaments or adjacent yarns of the multifilament sutures 100, 200. The hydrophobicity of the filaments 102, 212, 222 provided by milkweed fiber can further prevent bacterial adhesion thereto, which in turn can help prevent surgical site infection.
[0148] In some embodiments, at least a portion of the multifilament sutures 100, 200 may be absorbed during the postoperative absorption period. As used herein, "absorption period" refers to the time during which the multifilament sutures 100, 200 are substantially completely absorbed in the biological environment, and more specifically, the time during which the filaments 102, 212, 222 are biodegraded under physiological conditions via proteolysis or hydrolysis. The absorption period can vary depending on a variety of factors. Such factors may include, for example, the number of filaments 102, 212, 222 of the multifilament sutures 100, 200, the average diameter of the multifilament sutures 100, 200, the type of natural fibers of the filaments 102, 212, 222, the type of surgical site and the associated required repair, the patient's physiological characteristics, and the physiological conditions of the implantation site of the multifilament sutures 100, 200. In some embodiments, the absorption period of the multifilament sutures 100, 200 may, for example, be from about one week to about eight weeks, or from about two weeks to nine weeks. In other embodiments, the multifilament sutures 100, 200 can be configured such that the absorption period can be any other suitable time period.
[0149] In some embodiments, the filaments 102, 212, 222 of the multifilament sutures 100, 200 may include natural fibers from different sources. For example, when the filaments include milkweed fibers, other natural fibers different from milkweed fibers may be combined with the milkweed fibers to produce the filaments. The other natural fibers may include, for example, cellulose plant fibers or other types of natural fibers.
[0150] In some embodiments, additional natural fibers may include one or more natural fibers from the group consisting of: kapok fiber, bamboo fiber, flax fiber, cotton fiber, abaca fiber, acetate fiber, banana fiber, coconut fiber, flax fiber (used for making flax products), hemp fiber, jute fiber, kenaf fiber, lyocell fiber, modal fiber, pineapple fiber, raffia fiber, ramie fiber, rayon fiber, sisal fiber, bast fiber, cedar bark fiber, esparto fiber, fique fiber, papyrus fiber, straw fiber, and soybean protein fiber.
[0151] In some embodiments, additional natural fibers may include one or more natural fibers from the group consisting of: spider silk, wool, alpaca, Angora rabbit hair, azlon, byss silk, camel hair, cashmere, dog hair, lambswool, llama, mohair, musk ox hair, rabbit hair, silk, castor silk, vicuña hair, and yak hair. Some of the natural fibers listed above may also be referred to as animal fibers.
[0152] In some embodiments, the additional natural fibers may have at least one property that enables them to be used compatibly with other natural fibers forming the filaments. For example, when the natural fibers in the filaments include milkweed fibers, the selected additional natural fibers (e.g., cellulose plant fibers) may also be absorbable and potentially hydrophobic.
[0153] In some embodiments, the additional natural fibers may have at least one property that complements the properties of the natural fibers forming filaments 102, 212, 222. For example, when the natural fibers in the filaments include milkweed fibers, additional natural fibers with increased tensile strength relative to those natural fibers may be selected, for example, to improve the tensile properties of filaments 102, 212, 222.
[0154] In other embodiments, the multifilament sutures 100, 200 may include a first set of filaments and a second set of filaments. The first set of filaments is made of natural fibers, such as cellulose plant fibers (e.g., milkweed fibers), and the second set of filaments is made of natural fibers different from those in the first set of filaments, or of synthetic fibers (also referred to as synthetic materials or synthetic suture materials) or mineral-based fibers. Again, the natural fibers, synthetic fibers, or mineral-based fibers in the second set of filaments may have at least one property that allows them to be used compatiblely with the natural fibers in the first set of filaments for the intended use of the multifilament sutures 100, 200. For example, when the natural fibers in the first set of filaments include milkweed fibers, the natural fibers, synthetic fibers, or mineral-based fibers in the selected second set of filaments may also be absorbable and potentially hydrophobic. Examples of absorbable synthetic materials include, for example, polyglactin (e.g., polyglactin 910 (Vicryl®)), polyglycolic acid, polylactic acid, p-dioxanone, and trimethylene carbonate. Furthermore, the natural, synthetic, or mineral-based fibers in the second group of filaments may possess at least one property that complements the properties of the natural fibers forming filaments 102, 212, and 222. For example, when the natural fibers in the filaments include milkweed fibers, the natural, synthetic, or mineral-based fibers in the second group of filaments with increased tensile strength relative to those natural fibers may be selected, for example, to improve the tensile properties of filaments 102, 212, and 222.
[0155] In addition to the synthetic fibers mentioned above, other examples of synthetic fibers may include, for example, polyester, acrylic fibers, and Kevlar. TM Fiber, modified acrylic fiber, Nomex TMFibers, including nylon fibers, polyester fibers, spandex fibers, and rayon fibers.
[0156] Examples of mineral-based fibers may include, for example, glass fibers (e.g., fibers based on borosilicate glass, such as those described in US 8,173,154, which are incorporated herein by reference in their entirety; CaO-B2O3-SiO2 glass fibers and borate glass 13-93B3) and fiber glass fibers.
[0157] Accordingly, the multifilament sutures 100 and 200 may include filaments 102, 212, and 222 made of different suture materials. Therefore, in some embodiments, the multifilament sutures 100 and 200 may include a first set of filaments and a second set of filaments, the first set comprising natural fibers that are absorbable and hydrophobic under physiological conditions, and the second set comprising absorbable synthetic suture material, the first and second sets of filaments being combined in a twisted pattern to form the multifilament suture.
[0158] While one of the overall objectives of the multifilament sutures 100, 200 described herein is absorbability, it is envisioned that in alternative implementations, depending on the clinical scenario in which the multifilament sutures are intended to be used and the associated medical needs, the second set of filaments 102, 212, 222 may include synthetic fibers, mineral-based fibers, or natural fibers that may be non-absorbable.
[0159] In some embodiments, one or more of the filaments 102, 212, 222 of the multifilament sutures 100, 200 may be made of any type of fiber or combination of fibers selected from the natural fibers, synthetic fibers and mineral-based fibers described herein. As described above, examples of natural fibers may include milkweed fiber, kapok fiber, bamboo fiber, flax fiber, cotton fiber, abaca fiber, acetate fiber, banana fiber, coconut shell fiber, flax fiber, hemp fiber, jute fiber, kenaf fiber, lyocell fiber, modal fiber, pineapple fiber, raffia fiber, ramie fiber, rayon fiber, sisal fiber, bast fiber, conifer bark fiber, needlegrass fiber, fir leaf fiber, papyrus fiber, straw fiber, soybean protein fiber, spider silk fiber, wool fiber, alpaca fiber, Angora rabbit hair fiber, azlon fiber, byss silk fiber, camel hair fiber, cashmere fiber, dog hair fiber, lambswool fiber, llama fiber, mohair fiber, musk ox hair fiber, rabbit hair fiber, silk fiber, castor silk fiber, vicuña hair fiber, and yak fiber. Some of the natural fibers listed above may also be referred to as animal fibers. Examples of synthetic fibers may include polyester, acrylic fiber, Kevlar, etc. TM Fiber, modified acrylic fiber, Nomex TMFibers, including nylon fibers, polyester fibers, spandex fibers, and rayon fibers. Examples of mineral-based fibers may include glass fibers, such as borosilicate glass-based fibers, CaO-B2O3-SiO2 glass fibers, and borate glass 13-93B3, as well as fiber glass fibers. In some embodiments, filaments 102, 212, 222 may comprise a single type of fiber, such as a single type of fiber selected from the group consisting of natural fibers, synthetic fibers, and mineral-based fibers, or a combination of fibers selected from the group consisting of natural fibers, synthetic fibers, and mineral-based fibers, and the fibers having at least one complementary property relative to each other. In such embodiments, the composition or properties of the filaments can be selected such that the resulting multifilament sutures are suitable for the clinical scenarios or related medical needs in which the multifilament sutures 100, 200 are intended to be used. Therefore, it is understood that in some embodiments, the filaments of the multifilament sutures may not include cellulose plant fibers, such as milkweed fibers.
[0160] The multifilament sutures 100 and 200 are configured to have tensile strength suitable for surgical procedures, for example, to enable the multifilament sutures 100 and 200 to be knotted and secured to the surgical site. The tensile strength of the multifilament sutures 100 and 200 is partially defined by the diameter of the multifilament sutures 100 and 200. In some embodiments, the multifilament sutures 100 and 200 may have a diameter of about 0.01 mm to about 0.7 mm or about 0.1 mm to about 0.5 mm. Alternatively, the multifilament sutures 100 and 200 may have any other diameter that provides suitable tensile strength.
[0161] In some embodiments, the multifilament sutures 100, 200 may include a biocompatible coating. The biocompatible coating may be deposited on the outer surface of the multifilament sutures 100, 200, or on the outer surface of the filaments 102, 212, 222. In some embodiments, the biocompatible coating may help provide a smoother (i.e., more "slippery") outer surface of the multifilament sutures 100, 200 compared to not using a coating. Providing a smoother outer surface for the multifilament sutures 100, 200 may, for example, benefit from reducing frictional forces generated when the multifilament sutures 100, 200 pass through tissue; such frictional forces may also be referred to as "tissue resistance." In some embodiments, the reduction in tissue resistance may be due to the biocompatible coating being thick enough to significantly reduce or eliminate irregularities on the outer surface of the multifilament sutures 100, 200, such as protrusions associated with gaps formed between the filaments 102, 212. In some embodiments, a biocompatible coating can be bonded to the outer surface of the multifilament sutures 100, 200 without necessarily penetrating the gap defined between adjacent filaments 102, 212. The biocompatible coating can be further deposited on the outer surface of the multifilament sutures 100, 200 to prevent peeling, detachment, or separation during surgical procedures.
[0162] In some embodiments, the biocompatible coating may include silicone. In some embodiments, a silicone-containing biocompatible coating may help prolong the absorption period of the multifilament sutures 100, 200. In some embodiments, a silicone-containing biocompatible coating may provide an outer surface of the multifilament sutures 100, 200 that is resistant to harmful changes under physiological conditions, and may also result in a smoother outer surface for the multifilament sutures compared to the absence of silicone in the biocompatible coating. As described above, providing multifilament sutures with a smooth outer surface may help reduce tissue resistance as the multifilament sutures 100, 200 pass through tissue. In some embodiments, a silicone-containing biocompatible coating may also reduce potentially adverse or undesirable interactions with blood present near the multifilament sutures, such as blood crusting on the outer surface of the multifilament sutures 100, 200.
[0163] In some embodiments, the thickness of the biocompatible coating may be at least one-quarter of the diameter of the filaments 102, 212. In other embodiments, the thickness of the biocompatible coating may be at least half the diameter of the filaments 102, 212.
[0164] Biocompatible coatings can be made of absorbable materials, such as absorbable polymers, for example. In some embodiments, the biocompatible coating can be made of absorbable materials that have antibacterial or antifungal properties. Examples of biocompatible coatings may include poloxamer 188 and calcium stearate, etc.
[0165] In some embodiments, the biocompatible coating may include a bioactive agent having therapeutic properties and configured to induce or promote a desired biological response. The bioactive agent may include, for example, cell growth promoters, cell growth inhibitors, antibiotics, cytokines, healing promoters, coagulation modifiers, anti-inflammatory agents, and anti-scarring agents. In some embodiments, the bioactive agent may include osteoconductive bone binders, calcium carbonate, fatty acids, lubricants, and / or antiseptic chemicals. In some embodiments, the bioactive agent may be combined with filaments 102, 212, 222 without passing through the biocompatible coating.
[0166] In some embodiments, the filaments 102, 212, and 222 of the multifilament sutures 100 and 200 may be chemically treated to produce chemically treated filaments. In some embodiments, the chemical treatment may be selected to modify one or more properties of the filaments 102, 212, and 222. Examples of such properties may include, for example, tensile strength, susceptibility of the chemically treated filaments to triggering an inflammatory response, the rate at which the chemically treated filaments are absorbed, and biocompatibility. For example, the chemical treatment may be selected to produce chemically treated filaments with higher tensile strength for clinical applications seeking to reduce the susceptibility of multifilament sutures to breakage. In some embodiments, the chemical treatment may be selected to sterilize the filaments 102, 212, and 222, and said chemical treatment may include, for example, gas sterilization of the multifilament sutures using ethylene oxide. Therefore, it should be understood that the filaments 102, 212, and 222 are configured to be sterilized to produce sterile filaments 102, 212, and 222 and sterile multifilament sutures 100 and 200.
[0167] suture device In some embodiments, a suturing device is provided, comprising multifilament sutures 100, 200 as described herein and a suture needle. The suture needle includes a needle tip configured to penetrate biological tissue and a suture engagement end configured to engage with the multifilament suture via a releasable engagement or a fixed engagement. The releasable engagement of the suture needle can be, for example, an eye attachment. The fixed engagement of the suture can be, for example, via a crimping end. The crimping end is configured to incorporate the end of the multifilament suture 100, 200 into a hollow body of the suture needle, which is then crimped to secure the end of the multifilament suture therein. In other embodiments, the multifilament sutures 100, 200 can be secured to the suture engagement end of the needle by friction or adhesive. The suture needle can be any type of suture needle known in the art and can have, for example, a straight needle body, a curved needle body, a serpentine needle body, or a needle body with any other suitable shape.
[0168] Multifilament sutures for surgical mesh Now for reference Figure 3 An exemplary embodiment of surgical mesh 300 is illustrated. Surgical mesh 300 can provide a porous matrix for reinforcement, support, and / or repair of hard or soft tissue during healing or surgical procedures. This includes, but is not limited to, chest wall defects, suture reinforcement, muscle flap reinforcement, hernia repair, soft tissue reconstruction procedures (including plastic and reconstructive surgical applications), and reinforcement of soft tissue repaired with sutures or suture anchors. The porous matrix of surgical mesh 300 can allow tissue infiltration to incorporate into surgical mesh 300, thereby promoting tissue regeneration within body cavities such as, for example, abdominal openings.
[0169] In the illustrated embodiment, the surgical mesh 300 includes a plurality of filaments 102, 212, 222 as described herein, which are spaced apart from each other and provided in an alternating pattern at intersection 306, such that the twisted pattern corresponds to the mesh pattern. The filaments comprise natural fibers that are absorbable and hydrophobic, such as, for example, milkweed fibers. In some embodiments, the filaments may be configured as multifilament sutures 100, 200 as described herein. Accordingly, the surgical mesh 300 may have mechanical properties that change after a given period of time, so that, for example, it does not need to be removed after the surgical site has healed, while preventing or reducing bacterial adhesion to the surgical mesh 300 and the formation of bacterial biofilms, thereby preventing surgical site infection.
[0170] For example, in some embodiments, the mesh pattern of the surgical mesh 300 may be a knitted pattern, a warp-knitted pattern, a nonwoven pattern, a woven pattern, or a combination thereof. Figures 4A to 4D Examples of each of the following patterns are shown: knitting, warp knitting, nonwoven, and weaving. Liu et al. Further examples of warp-knitting patterns suitable as mesh patterns for surgical mesh 300 are disclosed in Table 1 of RSC Adv., 2019, 9, 17679 (which is incorporated herein by reference in its entirety). It should be understood that other types of mesh patterns may also be suitable, and the examples given above are for illustrative purposes only.
[0171] Return to reference Figure 3 The surgical mesh 300 includes a plurality of first multifilament sutures 302 extending along a first direction of the surgical mesh, and a plurality of second multifilament sutures 304 extending along a second direction of the surgical mesh, which is different from the first direction. In the illustrated embodiment, the first multifilament sutures 302 and the second multifilament sutures 304 intersect at substantially perpendicular angles. It should be understood that in other embodiments, the plurality of first multifilament sutures 302 may intersect the plurality of second multifilament sutures 304 at acute or obtuse angles.
[0172] The weaving pattern of the first and second multifilament sutures 302, 304 defines the gaps 310 into which cells of the biological tissue implanted in the surgical mesh can migrate and proliferate. Therefore, the migration and proliferation of hard or soft tissue cells can promote the growth of hard or soft tissue surrounding the porous matrix of the surgical mesh 300. The distance between adjacent first and second multifilament sutures 302, 304 defines the size of the gaps 310. Therefore, in some embodiments, the distance between adjacent first and second multifilament sutures 302, 304 can be reduced if desired to reduce the size of the gaps 310 and provide a denser mesh, which can result in a mesh with lower permeability.
[0173] In some embodiments, the surgical mesh 300 may include multiple mesh layers. When the surgical mesh 300 includes multiple mesh layers, these mesh layers may be multiple layers of the surgical mesh as described above, or these mesh layers may include at least some mesh layers made of a material different from the multifilament sutures described herein. Furthermore, the configuration of the first and second multifilament sutures 302, 304 may remain constant or vary between layers. For example, the size and / or angle of the gap 310 between adjacent multifilament sutures of the first and second multifilament sutures 302, 304 may vary between the mesh layers of the surgical mesh 300.
[0174] In some embodiments, the first and second multifilament sutures 302, 304 of the surgical mesh 300 may include bioactive agents having therapeutic properties and configured to induce or promote a desired biological response. For example, in some embodiments, the first and second multifilament sutures 302, 304 may include antimicrobial substances or antibiotics that are active against bacteria within the infected surgical site, thereby promoting healing. In other embodiments, the first and second multifilament sutures 302, 304 may include cell growth promoters, cytokines, healing promoters, coagulation modifiers, or anti-inflammatory agents to promote surgical site healing.
[0175] In other embodiments, the surgical mesh 300 can be implanted into an infected surgical site to promote a healing response. Given the hydrophobicity of the filaments of the first and second multifilament sutures 302, 304 forming the surgical mesh 300 and as described above, the first and second multifilament sutures 302, 304 can prevent bacterial adhesion to the filaments and prevent further bacterial proliferation at the surgical site (which might occur with other types of surgical meshes that do not contain hydrophobic filaments), thereby promoting healing of the infected surgical site. Therefore, the hydrophobicity of the filaments of the first and second multifilament sutures 302, 304 forming the surgical mesh 300 can be considered to have intrinsic antibacterial activity, making it suitable for applications where a pre-existing infection exists at the surgical site.
[0176] In the illustrated embodiment, the surgical mesh 300 is shown as having a substantially square shape, extending in a substantially common plane. In other embodiments, the surgical mesh may have any other suitable shape, which may be determined based on its intended medical use. For example, in some embodiments, the surgical mesh may be in the form of a corrugated surgical mesh, which includes a series of undulating grooves and ridges. In some embodiments, the surgical mesh 300 may be further combined with non-mesh materials (such as, for example, rods, fillers) to form a surgical scaffold with a desired shape and structural strength. For example, such a surgical scaffold may be used to reinforce soft tissue with defects or weaknesses, provide support for internal organs, and for applications such as treating surgical or traumatic wounds.
[0177] To provide a more concise description, some quantitative expressions provided herein are qualified with the term “about.” It should be understood that, whether or not the term “about” is explicitly used, each quantity listed herein is intended to refer to an actual given value, and also to an approximation of that given value that can be reasonably inferred by one of ordinary skill in the art, including approximations resulting from the experimental and / or measurement conditions under which the given value was obtained.
[0178] This document describes and illustrates several alternative embodiments and examples. The embodiments of the invention described above are intended to be exemplary only. Those skilled in the art will understand the characteristics of the various embodiments, as well as the possible combinations and variations of the components. Those skilled in the art will further understand that any embodiment can be provided in any combination with other embodiments disclosed herein. It should be understood that the invention can be implemented in other specific forms without departing from its core characteristics. Therefore, the present examples and embodiments should be considered exemplary and not restrictive in all respects, and the invention is not limited to the details given herein. Thus, while specific embodiments have been shown and described, many modifications are contemplated. Therefore, the scope of the invention is intended to be limited only by the scope of the appended claims.
Claims
1. A multifilament suture for use as a surgical suture, the multifilament suture comprising: Multiple filaments are combined according to a twisted pattern, at least one of the multiple filaments containing natural fibers that are absorbable and hydrophobic under physiological conditions.
2. The multifilament suture according to claim 1, wherein the natural fibers in the at least one filament can be absorbed through protein hydrolysis and / or hydrolysis.
3. The multifilament suture according to claim 1 or 2, wherein at least one of the plurality of filaments is configured to prevent bacteria from adhering to the gap defined between adjacent filaments of the plurality of filaments.
4. The multifilament suture according to any one of claims 1 to 3, wherein the natural fiber comprises cellulose plant fiber.
5. The multifilament suture according to claim 4, wherein the cellulose plant fiber comprises milkweed fiber.
6. The multifilament suture according to claim 5, wherein the milkweed fiber comprises Syrian milkweed ( Asclepias Syriaca ) fiber and beautiful milkweed ( Asclepias Speciosa One or more of the following fibers.
7. The multifilament suture according to claim 5 or 6, wherein the plurality of filaments further comprises additional natural fibers different from the milkweed fibers.
8. The multifilament suture of claim 7, wherein the additional natural fiber comprises cellulose plant fiber.
9. The multifilament suture according to claim 7 or 8, wherein the additional natural fiber comprises one or more of the following: kapok fiber, bamboo fiber, flax fiber, cotton fiber, abaca fiber, acetate fiber, banana fiber, coconut shell fiber, flax fiber, hemp fiber, jute fiber, kenaf fiber, lyocell fiber, modal fiber, pineapple fiber, raffia fiber, ramie fiber, rayon fiber, sisal fiber, and soybean protein fiber.
10. The multifilament suture of claim 7, wherein the additional natural fiber comprises animal fiber.
11. The multifilament suture according to claim 7 or 10, wherein the additional natural fiber comprises one or more of the following: spider silk fiber, wool fiber, alpaca fiber, Angora rabbit hair fiber, azlon fiber, byssal silk fiber, camel hair fiber, cashmere fiber, dog hair fiber, lambswool fiber, llama fiber, mohair fiber, musk ox hair fiber, rabbit hair fiber, silk fiber, castor silk fiber, vicuña hair fiber, and yak fiber.
12. The multifilament suture according to any one of claims 1 to 11, wherein the plurality of filaments further comprises synthetic fibers.
13. The multifilament suture of claim 12, wherein the synthetic fiber comprises one or more of the following: acrylic fiber, Kevlar fiber, etc. TM Fiber, modified acrylic fiber, Nomex TM Fibers, including nylon fibers, polyester fibers, spandex fibers, and rayon fibers.
14. The multifilament suture according to claim 12, wherein the synthetic fiber is an absorbable synthetic fiber.
15. The multifilament suture of claim 14, wherein the absorbable synthetic fiber comprises one or more of polyglactin, lactide, polyglycolic acid, polylactic acid, glycolide, p-dioxanone, ε-caprolactone, and trimethylene carbonate.
16. The multifilament suture according to any one of claims 1 to 15, wherein the plurality of filaments further comprises mineral-based fibers.
17. The multifilament suture of claim 16, wherein the mineral-based fiber comprises one or more of glass fibers and fiberglass fibers.
18. The multifilament suture according to any one of claims 1 to 17, wherein the filaments of the plurality of filaments are woven or interlaced in a twisted pattern.
19. The multifilament suture according to claim 18, wherein the twisting pattern is an up-and-down twisting pattern.
20. The multifilament suture according to claim 18, wherein the twisting pattern is a one-up-two-down twisting pattern.
21. The multifilament suture according to claim 18, wherein the twisting pattern is a two-up, two-down twisting pattern.
22. The multifilament suture according to any one of claims 1 to 17, wherein the twist pattern defines a core and a braided sheath provided around the core.
23. The multifilament suture of claim 22, wherein the filaments of the plurality of filaments are combined together to form a yarn, and the braided sheath comprises braided yarn.
24. The multifilament suture according to any one of claims 1 to 23, further comprising a biocompatible coating provided on the outer surface of the multifilament suture.
25. The multifilament suture of claim 24, wherein the biocompatible coating is configured to reduce tissue resistance of the multifilament suture.
26. The multifilament suture of claim 24 or 25, wherein the thickness of the biocompatible coating is at least one-quarter of the average diameter of the filaments among the plurality of filaments.
27. The multifilament suture of claim 24 or 25, wherein the thickness of the biocompatible coating is at least half the average diameter of the filaments among the plurality of filaments.
28. The multifilament suture according to any one of claims 24 to 27, wherein the biocompatible coating comprises an absorbable polymer.
29. The multifilament suture according to any one of claims 24 to 28, wherein the biocompatible coating comprises a bioactive agent having therapeutic properties.
30. The multifilament suture of claim 29, wherein the bioactive agent comprises one or more of a cell growth promoter, a cell growth inhibitor, an antibiotic, a cytokine, a healing promoter, a coagulation regulator, an anti-inflammatory agent, and an anti-scarring agent.
31. The multifilament suture according to any one of claims 1 to 30, wherein the diameter of the multifilament suture is from about 0.01 mm to about 0.7 mm.
32. The multifilament suture of claim 31, wherein the diameter of the multifilament suture is from about 0.1 mm to about 0.5 mm.
33. A surgical mesh for implantation at a surgical site, the surgical mesh comprising: Multiple multifilament sutures, each multifilament suture comprising filaments, the multiple multifilament sutures being arranged in a mesh pattern, at least one of the multiple multifilament sutures comprising natural fibers, the natural fibers being absorbable and hydrophobic under physiological conditions.
34. The surgical mesh of claim 33, wherein the natural fibers in the at least one filament can be absorbed through protein hydrolysis and / or hydrolysis.
35. The surgical mesh of claim 33 or 34, wherein the at least one filament is configured to prevent bacteria from adhering to the gap defined between adjacent filaments.
36. The surgical mesh according to any one of claims 33 to 35, wherein the natural fiber comprises cellulose plant fiber.
37. The surgical mesh of claim 36, wherein the cellulose plant fiber comprises milkweed fiber.
38. The surgical mesh of claim 37, wherein the milkweed fiber comprises one or more of Syrian milkweed fiber and beautiful milkweed fiber.
39. The surgical mesh according to any one of claims 37 or 38, wherein the plurality of filaments further comprises additional natural fibers different from the milkweed fibers.
40. The multifilament suture of claim 39, wherein the additional natural fiber comprises cellulose plant fiber.
41. The multifilament suture according to claim 39 or 40, wherein the additional natural fiber comprises one or more of the following: kapok fiber, bamboo fiber, flax fiber, cotton fiber, abaca fiber, acetate fiber, banana fiber, coconut fiber, flax fiber, hemp fiber, jute fiber, kenaf fiber, lyocell fiber, modal fiber, pineapple fiber, raffia fiber, ramie fiber, rayon fiber, sisal fiber, and soybean protein fiber.
42. The multifilament suture of claim 39, wherein the additional natural fiber comprises animal fiber.
43. The multifilament suture according to claim 39 or 42, wherein the additional natural fiber comprises one or more of the following: spider silk fiber, wool fiber, alpaca fiber, Angora rabbit hair fiber, azlon fiber, byssal silk fiber, camel hair fiber, cashmere fiber, dog hair fiber, lambswool fiber, llama fiber, mohair fiber, musk ox hair fiber, rabbit hair fiber, silk fiber, castor silk fiber, vicuña hair fiber, and yak fiber.
44. The surgical mesh according to any one of claims 25 to 31, wherein the plurality of filaments further comprises synthetic fibers.
45. The multifilament suture of claim 44, wherein the synthetic fiber comprises one or more of the following: acrylic fiber, Kevlar fiber, etc. TM Fiber, modified acrylic fiber, Nomex TM Fibers, including nylon fibers, polyester fibers, spandex fibers, and rayon fibers.
46. The multifilament suture of claim 44, wherein the synthetic fiber is an absorbable synthetic fiber.
47. The surgical mesh according to claim 46, wherein the synthetic fiber is one or more of polyglactin, lactide, polyglycolic acid, polylactic acid, glycolide, p-dioxanone, ε-caprolactone, and trimethylene carbonate.
48. The multifilament suture according to any one of claims 33 to 47, wherein the plurality of filaments further comprises mineral-based fibers.
49. The multifilament suture of claim 48, wherein the mineral-based fiber comprises one or more of glass fibers and fiberglass fibers.
50. The surgical mesh according to any one of claims 33 to 49, wherein the surgical mesh defines a porous matrix configured to promote tissue growth at the surgical site.
51. The surgical mesh according to any one of claims 33 to 50, wherein the mesh pattern comprises a woven pattern, a knitted pattern, a warp-knitted pattern, or a nonwoven pattern.
52. The surgical mesh according to any one of claims 33 to 50, wherein the surgical mesh is configured as a corrugated surgical mesh.
53. The surgical mesh according to any one of claims 33 to 52, further comprising a non-mesh material, the combination of the surgical mesh and the non-mesh material forming a surgical scaffold configured to provide support to tissue surrounding the surgical site.
54. A suturing apparatus for partially aligning biological soft tissue, the suturing apparatus comprising: Multifilament suture, the multifilament suture comprising: Multiple filaments are combined according to a twisted weave pattern, at least one of the multiple filaments comprising natural fibers that are physiologically absorbable and hydrophobic; and A suture needle having a needle tip configured to penetrate tissue and a suture engagement end configured to engage with the multifilament suture.
55. The suture device according to claim 54, wherein the natural fibers in the at least one filament can be absorbed through protein hydrolysis and / or hydrolysis.
56. The suturing apparatus of claim 54 or 55, wherein at least one of the plurality of filaments is configured to prevent bacteria from adhering to the gap defined between adjacent filaments of the plurality of filaments.
57. The suturing device according to any one of claims 54 to 56, wherein the natural fiber comprises cellulose plant fiber.
58. The suturing apparatus of claim 57, wherein the cellulose plant fiber comprises milkweed fiber.
59. The suturing device according to claim 58, wherein the milkweed fiber comprises one or more of Syrian milkweed fiber and beautiful milkweed fiber.
60. The multifilament suture according to claim 58 or 59, wherein the plurality of filaments further comprises additional natural fibers different from the milkweed fibers.
61. The multifilament suture of claim 60, wherein the additional natural fiber comprises cellulose plant fiber.
62. The multifilament suture according to claim 60 or 61, wherein the additional natural fiber comprises one or more of the following: kapok fiber, bamboo fiber, flax fiber, cotton fiber, abaca fiber, acetate fiber, banana fiber, coconut shell fiber, flax fiber, hemp fiber, jute fiber, kenaf fiber, lyocell fiber, modal fiber, pineapple fiber, raffia fiber, ramie fiber, rayon fiber, sisal fiber, and soybean protein fiber.
63. The multifilament suture of claim 60, wherein the additional natural fiber comprises animal fiber.
64. The multifilament suture according to claim 60 or 63, wherein the additional natural fiber comprises one or more of the following: spider silk fiber, wool fiber, alpaca fiber, Angora rabbit hair fiber, azlon fiber, byssal silk fiber, camel hair fiber, cashmere fiber, dog hair fiber, lambswool fiber, llama fiber, mohair fiber, musk ox hair fiber, rabbit hair fiber, silk fiber, castor silk fiber, vicuña hair fiber, and yak fiber.
65. The multifilament suture according to any one of claims 54 to 64, wherein the plurality of filaments further comprises synthetic fibers.
66. The multifilament suture of claim 65, wherein the synthetic fiber comprises one or more of the following: acrylic fiber, Kevlar fiber, etc. TM Fiber, modified acrylic fiber, Nomex TM Fibers, including nylon fibers, polyester fibers, spandex fibers, and rayon fibers.
67. The multifilament suture of claim 65, wherein the synthetic fiber is an absorbable synthetic fiber.
68. The multifilament suture of claim 67, wherein the absorbable synthetic fiber comprises one or more of polyglactin, lactide, polyglycolic acid, polylactic acid, glycolide, p-dioxanone, ε-caprolactone, and trimethylene carbonate.
69. The multifilament suture according to any one of claims 54 to 68, wherein the plurality of filaments further comprises mineral-based fibers.
70. The multifilament suture of claim 69, wherein the mineral-based fiber comprises one or more of glass fibers and fiberglass fibers.
71. The suturing apparatus according to any one of claims 54 to 70, wherein the suture needle comprises a hollow body, and wherein the suture engagement end of the suture needle is a forged end, the forged end being configured to crimp the end of the multifilament suture into the hollow body of the suture needle in a crimping configuration.
72. The suturing device according to any one of claims 54 to 71, wherein the suturing needle comprises one or more of a straight needle body, a curved needle body, and a serpentine needle body.
73. A suturing apparatus for partially aligning biological soft tissue, the suturing apparatus comprising: Multifilament suture, the multifilament suture comprising: Multiple filaments are combined according to a twisted weave pattern, at least one of the multiple filaments comprising natural fibers that are physiologically absorbable and hydrophobic; and A biocompatible coating is provided on the surface of the multifilament suture.
74. The suture device according to claim 73, wherein the natural fibers in the at least one filament can be absorbed through protein hydrolysis and / or hydrolysis.
75. The suturing apparatus of claim 73 or 74, wherein at least one of the plurality of filaments is configured to prevent bacteria from adhering to the gap defined between adjacent filaments of the plurality of filaments.
76. The sewing device according to any one of claims 73 to 75, wherein the natural fiber comprises cellulose plant fiber.
77. The suturing apparatus of claim 76, wherein the cellulose plant fiber comprises milkweed fiber.
78. The suturing device according to claim 77, wherein the milkweed fiber comprises one or more of Syrian milkweed fiber and beautiful milkweed fiber.
79. The multifilament suture according to claim 77 or 78, wherein the plurality of filaments further comprises additional natural fibers different from the milkweed fibers.
80. The multifilament suture of claim 79, wherein the additional natural fiber comprises cellulose plant fiber.
81. The multifilament suture according to claim 79 or 80, wherein the additional natural fiber comprises one or more of the following: kapok fiber, bamboo fiber, flax fiber, cotton fiber, abaca fiber, acetate fiber, banana fiber, coconut shell fiber, flax fiber, hemp fiber, jute fiber, kenaf fiber, lyocell fiber, modal fiber, pineapple fiber, raffia fiber, ramie fiber, rayon fiber, sisal fiber, and soybean protein fiber.
82. The multifilament suture of claim 79, wherein the additional natural fiber comprises animal fiber.
83. The multifilament suture according to claim 79 or 82, wherein the additional natural fiber comprises one or more of the following: spider silk fiber, wool fiber, alpaca fiber, Angora rabbit hair fiber, azlon fiber, byssal silk fiber, camel hair fiber, cashmere fiber, dog hair fiber, lambswool fiber, llama fiber, mohair fiber, musk ox hair fiber, rabbit hair fiber, silk fiber, castor silk fiber, vicuña hair fiber, and yak fiber.
84. The multifilament suture according to any one of claims 73 to 83, wherein the plurality of filaments further comprises synthetic fibers.
85. The multifilament suture of claim 84, wherein the synthetic fiber comprises one or more of the following: acrylic fiber, Kevlar fiber, etc. TM Fiber, modified acrylic fiber, Nomex TM Fibers, including nylon fibers, polyester fibers, spandex fibers, and rayon fibers.
86. The multifilament suture according to claim 84, wherein the synthetic fiber is an absorbable synthetic fiber.
87. The multifilament suture of claim 86, wherein the absorbable synthetic fiber comprises one or more of polyglactin, lactide, polyglycolic acid, polylactic acid, glycolide, p-dioxanone, ε-caprolactone, and trimethylene carbonate.
88. The multifilament suture according to any one of claims 73 to 87, wherein the plurality of filaments further comprises mineral-based fibers.
89. The multifilament suture of claim 88, wherein the mineral-based fiber comprises one or more of glass fibers and fiberglass fibers.
90. The suturing apparatus according to any one of claims 73 to 89, wherein the biocompatible coating is configured to reduce tissue resistance of the multifilament suture.
91. The suture device according to any one of claims 73 to 90, wherein the biocompatible coating comprises an absorbable polymer.
92. The suture device according to any one of claims 73 to 91, wherein the biocompatible coating comprises a bioactive agent having therapeutic properties.
93. The suturing device according to claim 92, wherein the bioactive agent comprises one or more of cell growth promoters, cell growth inhibitors, antibiotics, cytokines, healing promoters, coagulation regulators, anti-inflammatory agents, and anti-scarring agents.
94. A multifilament suture for use as a surgical suture, the multifilament suture comprising: The first group of filaments comprises natural fibers that are absorbable and hydrophobic under physiological conditions; and The first and second sets of filaments are combined together in a twisted pattern to form the multifilament suture. The first and second sets of filaments contain absorbable synthetic suture material.
95. The multifilament suture of claim 94, wherein the natural fibers in the first group of filaments can be absorbed through protein hydrolysis and / or hydrolysis.
96. The multifilament suture of claim 95 or 96, wherein the first set of filaments is configured to prevent bacteria from adhering to the gaps defined between adjacent filaments of the first set of filaments.
97. The multifilament suture according to any one of claims 94 to 95, wherein the natural fiber comprises cellulose plant fiber.
98. The multifilament suture of claim 97, wherein the cellulose plant fiber comprises milkweed fiber.
99. The multifilament suture of claim 98, wherein the milkweed fiber comprises one or more of Syrian milkweed fiber and beautiful milkweed fiber.
100. The multifilament suture according to any one of claims 94 to 99, wherein the synthetic suture material comprises one or more of polyglactin, lactide, polyglycolic acid, polylactic acid, glycolide, p-dioxanone, ε-caprolactone, and trimethylene carbonate.
101. A multifilament suture for use as a surgical suture, the multifilament suture comprising: A plurality of filaments are combined in a twisted pattern, at least one of the plurality of filaments comprising milkweed fibers.
102. The multifilament suture of claim 101, comprising one or more features as defined in any one of claims 2 to 4 and 6 to 32.
103. A suturing apparatus for partially aligning biological soft tissue, the suturing apparatus comprising: Multifilament suture, the multifilament suture comprising: Multiple filaments are combined according to a twisted weave pattern, at least one of the multiple filaments comprising milkweed fibers; and A suture needle having a needle tip configured to penetrate tissue and a suture engagement end configured to engage with the multifilament suture.
104. The suturing apparatus of claim 103, wherein the multifilament suture comprises one or more features as defined in any one of claims 2 to 4 and 6 to 32.
105. A multifilament suture for use as a surgical suture, the multifilament suture comprising: The first group of filaments comprises natural fibers that are absorbable and hydrophobic under physiological conditions; and The second group of filaments comprises one or more of the following: natural fibers, synthetic fibers, and mineral-based fibers that are different from the natural fibers in the first group of filaments. The first and second groups of filaments are combined together in a twisted pattern to form the multifilament suture.
106. The multifilament suture of claim 105, wherein the natural fibers in the first group of filaments can be absorbed through protein hydrolysis and / or hydrolysis.
107. The multifilament suture of claim 105 or 106, wherein the first set of filaments is configured to prevent bacteria from adhering to the gaps defined between adjacent filaments of the first set of filaments.
108. The multifilament suture according to any one of claims 105 to 107, wherein the natural fibers in the first group of filaments comprise cellulose plant fibers.
109. The multifilament suture of claim 108, wherein the cellulose plant fiber comprises milkweed fiber.
110. The multifilament suture of claim 109, wherein the milkweed fiber comprises one or more of Syrian milkweed fiber and beautiful milkweed fiber.
111. The multifilament suture according to any one of claims 105 to 110, wherein the natural fibers in the second set of filaments comprise cellulose plant fibers.
112. The multifilament suture according to claim 105 or 111, wherein the natural fibers in the second group of filaments comprise one or more of the following: kapok fiber, bamboo fiber, flax fiber, cotton fiber, abaca fiber, acetate fiber, banana fiber, coconut shell fiber, flax fiber, hemp fiber, jute fiber, kenaf fiber, lyocell fiber, modal fiber, pineapple fiber, raffia fiber, ramie fiber, rayon fiber, sisal fiber, and soybean protein fiber.
113. The multifilament suture according to any one of claims 105 to 110, wherein the natural fibers in the second set of filaments comprise animal fibers.
114. The multifilament suture according to claim 105 or 113, wherein the natural fibers in the second group of filaments comprise one or more of the following: spider silk fibers, wool fibers, alpaca fibers, Angora rabbit fibers, azlon fibers, byssal silk fibers, camel hair fibers, cashmere fibers, dog hair fibers, lambswool fibers, llamas fibers, mohair fibers, musk ox hair fibers, rabbit hair fibers, silk fibers, castor silk fibers, vicuña hair fibers, and yak fibers.
115. The multifilament suture according to any one of claims 105 to 114, wherein the synthetic fiber comprises one or more of the following: acrylic fiber, Kevlar... TM Fiber, modified acrylic fiber, Nomex TM Fibers, including nylon fibers, polyester fibers, spandex fibers, and rayon fibers.
116. The multifilament suture according to any one of claims 105 to 114, wherein the synthetic fiber is an absorbable synthetic fiber.
117. The multifilament suture of claim 116, wherein the absorbable synthetic fiber comprises one or more of polyglactin, lactide, polyglycolic acid, polylactic acid, glycolide, p-dioxanone, ε-caprolactone, and trimethylene carbonate.
118. The multifilament suture according to any one of claims 105 to 117, wherein the mineral-based fiber comprises one or more of glass fibers and fiberglass fibers.
Citation Information
Patent Citations
Boron trioxide glass-based fibers and particles in dressings, sutures, surgical glue, and other wound care compositions
US8173154B2