Barb device for securing tissue

Abstract

A barbed suture may include a suture body and at least one multi-directional barb formed on the outer surface of the suture body. The at least one multi-directional barb includes a first protrusion and a second protrusion extending in two different directions. In another embodiment, the barbed suture may include a suture body and at least two barbs formed on the outer surface of the suture body. Each of the at least two barbs has a first protrusion pointing in a first direction and a second protrusion pointing in a second direction, the first direction being different from the second direction. The invention also relates to a method of forming a barbed suture.

Description

Technical Field

[0001] This patent application claims priority to the following: U.S. Provisional Patent Application No. 63 / 551695, filed February 9, 2024; U.S. Provisional Patent Application No. 63 / 683523, filed August 15, 2024; U.S. Provisional Patent Application No. 63 / 721964, filed November 18, 2024; and U.S. Provisional Patent Application No. 63 / 737119, filed December 20, 2024, the entire contents of each of which are incorporated herein by reference. Background Technology

[0002] This disclosure relates in general to the field of barbed devices for fastening and securing tissues, and more specifically to barbed sutures, barbed structures, barbed meshes and barbed strips for fastening and securing tissues to other tissues and / or other devices, as well as related manufacturing and usage methods.

[0003] Fixing tissue, such as nerve tissue, to other tissues or devices involves placing sutures. Suture placement can vary depending on technique. For nerve tissue fixation, the ideal placement of sutures is within the epineurium of the nerve tissue, thus presumably preserving the internal structure of the nerve. This ideal suture placement is not always achievable. Furthermore, perfect suture placement may depend on the angle of approach (approach angle) or the location or orientation of the intended connection between tissues, such as nerve ends, or between tissue and device. These variables can make it difficult for surgeons to achieve perfect suture placement. Additionally, existing sutures may not be ideal and may not prevent the sutured tissue from shifting in multiple directions.

[0004] For example, epipineurial suture neurorrhaphy is widely considered the gold standard for peripheral nerve repair and reconstruction. However, this technique requires considerable expertise in microsurgical methods. Achieving correct microsuture placement and precise alignment of nerve ends is a highly skilled, time-consuming, and technically challenging task. Penetrating the outermost epineurium with the suture needle can damage critical fascicular structures of the nerve.

[0005] Given these inherent complexities, there is a growing need for tissue repair strategies, such as nerve repair strategies, that do not rely on sutures. These innovations can significantly improve the efficiency of nerve or other tissue repair procedures, for example, by reducing the time required and simplifying the technical demands on surgeons. Summary of the Invention

[0006] In one aspect of this disclosure, the barbed suture may include a suture body and at least one multidirectional barb formed on the outer surface of the suture body, the at least one multidirectional barb including a first protrusion and a second protrusion, wherein the first protrusion and the second protrusion extend in two different directions.

[0007] In another aspect of this disclosure, the barbed suture may include a suture body and at least two barbs formed on the outer surface of the suture body, wherein the first barb of the at least two barbs has a first protrusion pointing in a first direction, and the second barb of the at least two barbs has a first protrusion pointing in a second direction, wherein the first direction is different from the second direction.

[0008] In another aspect of this disclosure, a method for manufacturing a barbed suture may include: making a first incision in the suture body to form a first protrusion, the first protrusion being oriented in a first direction, wherein the first incision does not extend completely through the suture body; and making a second incision in the suture body to form a second protrusion, the second protrusion being oriented in a second direction, wherein the second incision does not extend completely through the suture body, wherein the first direction is different from the second direction.

[0009] In another aspect of this disclosure, the tissue repair device may include at least one mesh, the at least one mesh including a plurality of barbed sutures, the plurality of barbed sutures including at least a plurality of longitudinal barbed sutures and optionally including a plurality of lateral barbed sutures, each barbed suture including a suture body and at least one barb formed on the outer surface of the suture body.

[0010] In another aspect of this disclosure, the tissue repair device may include a base membrane and a plurality of barbs formed on the base membrane by either laser cutting or embossing.

[0011] In another aspect of this disclosure, the tissue repair device may include a basement membrane and a plurality of barbs formed on the basement membrane, the plurality of barbs being formed of resorbable ceramic and attached to the basement membrane.

[0012] In another aspect of this disclosure, the tissue repair device may include a basement membrane and at least two barbed sutures, the longitudinal length of which is greater than the width of the basement membrane, and each barbed suture includes a barbed portion and a non-barbed portion.

[0013] In another aspect of this disclosure, the tissue repair device may include a strip of basement membrane and at least two barbed sutures attached to the strip of basement membrane.

[0014] In another aspect of this disclosure, a method for fastening two tissue ends relative to each other may include: affixing the two tissue ends to a tissue repair device, the tissue repair device including at least one mesh formed of a plurality of barbed sutures, wherein the plurality of barbed sutures includes a plurality of longitudinal barbed sutures and optionally includes a plurality of lateral barbed sutures, each barbed suture including a suture body and at least one barb formed on the outer surface of the suture body; and covering the respective outer surfaces of the two tissue ends in the tissue repair device.

[0015] In another aspect of this disclosure, a method for fastening two tissue ends together may include: attaching the two tissue ends to a tissue repair device, the tissue repair device including a base membrane and a plurality of barbs formed on the base membrane, the plurality of barbs being formed by one of laser cutting and embossing; and covering the outer surfaces of the two tissue ends within the tissue repair device.

[0016] In another aspect of this disclosure, a method for fastening two tissue ends together may include: attaching the two tissue ends to a tissue repair device, the tissue repair device including a base membrane and a plurality of barbs attached to the base membrane, the plurality of barbs being formed of absorbable ceramic; and covering the outer surfaces of each of the two tissue ends within the tissue repair device.

[0017] In another aspect of this disclosure, a method for fastening two tissue ends together may include: attaching the two tissue ends to a tissue repair device, the tissue repair device including a base membrane and at least two barbed sutures, the longitudinal length of the barbed sutures being greater than the width of the base membrane, each barbed suture including a portion containing barbs and a portion without barbs; and covering the outer surfaces of each of the two tissue ends in the tissue repair device.

[0018] Other objects, features, and advantages of this disclosure will become apparent from the following detailed description. However, it should be understood that while the detailed description and examples illustrate exemplary embodiments of this disclosure, these descriptions and examples are given by way of illustration only, and various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art based on this detailed description.

[0019] In this disclosure, the singular forms “a” and “the” include plural references unless the context otherwise requires. The term “exemplary” is used herein to mean “example” rather than “ideal.” The terms “comprising,” “consisting of,” “including,” “comprises,” or other variations thereof are intended to cover non-exclusive inclusion, meaning that a combination, method, or process that comprises a set of elements or steps does not necessarily include only those elements or steps, but may also include other elements or steps not expressly listed or inherent in the combination, method, or process. Relative terms, such as “about” and “approximately,” are generally used to indicate a possible variation of ±10% in the stated or understood value, unless otherwise stated in the specification. Furthermore, the term “between” used to describe a range of values ​​is intended to include the minimum and maximum values ​​described herein. The term “or” used in the claims and specification is used to mean “and / or” unless it is expressly stated that it refers only to alternatives or that alternatives are mutually exclusive, although this disclosure supports the definition of referring only to alternatives and “and / or.” The term “another” as used herein may mean at least a second or more. Attached Figure Description

[0020] The following figures form part of this specification and are used to further illustrate certain aspects of this disclosure. A better understanding of this disclosure can be achieved by referring to one or more of these figures in conjunction with the detailed description of the exemplary embodiments presented herein.

[0021] Figure 1 This is a schematic diagram of a barbless suture and a portion of a blade.

[0022] Figure 2 This is a schematic diagram of a portion of a suture line with barbs.

[0023] Figure 3 A schematic diagram of a portion of a suture line with more than one barb.

[0024] Figure 4 is a schematic diagram of a portion of the suture line with multi-directional barbs formed thereon.

[0025] According to various implementation methods Figures 5 to 11 This is a schematic diagram of a portion of a barb suture line with different shapes of barbs.

[0026] According to various implementation methods Figures 12 to 20 This is a schematic diagram of a portion of a barb suture line with different arrangements of barbs.

[0027] Figure 21 is a schematic diagram of a barbed suture line with multiple barbs on its surface.

[0028] Figure 22 for Figure 21 Detailed view of two adjacent barbs of the barbed suture line shown.

[0029] Figure 23 This is a schematic diagram of a barbed suture line with multiple barbs on its surface.

[0030] Figure 24 Depicting Figure 23 Detailed view of three adjacent barbs of the barbed suture line shown.

[0031] Figure 25 , 26 and 27 for Figure 23 and 24 A schematic detailed view of the barbed suture line shown.

[0032] Figure 28 A schematic diagram of a barbed suture line with multiple barbs on its surface; Figure 29A Depicting Figure 28 Detailed view of three adjacent barbs along the suture line shown. Figure 29B For having attachment to it Figure 28 And an image of the tissue end of the barbed suture shown in 29A.

[0033] Figure 30 This is a schematic diagram of a double-plane barbed suture, which has several barbs on its surface; Figure 31 Depicting Figure 30 A detailed view of the three adjacent barbs of the barbed suture line shown, which are on one plane and the three adjacent barbs are on another plane; Figure 32 Depicting Figure 30 A cross-sectional view of the barbed suture line shown.

[0034] Figure 33 and 34 are the points mentioned in the previous text. Figures 30 to 32 The image shows an example of a barbed suture.

[0035] Figure 35 This is a schematic diagram of a barbed suture line with two adjacent barbs formed using mechanical cutting.

[0036] Figure 36 A schematic diagram of a barbed suture line with two adjacent barbs formed using injection microforming.

[0037] According to one or more implementation methods Figure 37 A flowchart illustrating the method for forming barbed sutures.

[0038] According to one or more implementation methods Figure 38 A flowchart illustrating the method for creating barbed sutures.

[0039] Figure 39 This is a schematic diagram of a basement membrane, which can be used to form a tissue repair device according to the embodiments described herein.

[0040] Figure 40 Detailed views are shown of the base film, barb structure 4005 as part of a barb suture or barb device, and polymer layer therebetween such as glue or adhesive.

[0041] Figure 41 and 42 This image illustrates the adhesion of the barbed suture to the basement membrane during the test.

[0042] Figure 43 The base film with barbed structure on top and the spot welding probe are shown.

[0043] Figure 44 A detailed view of the interface between the thermally bonded barbed structure and the base film.

[0044] Figure 45 Details of the alternative interface between the thermally bonded structure and the base film.

[0045] Figure 46 This illustrates one embodiment in which barbed sutures are woven through the base membrane.

[0046] Figure 47 Another embodiment is shown in which barbed sutures are sewn through the base membrane.

[0047] Figure 48 Depicts a basement membrane with barbed sutures attached by using incisions or hooks in the basement membrane.

[0048] Figure 49 Depict the basement membrane through which barbed sutures penetrate the pores in the basement membrane.

[0049] Figure 50 Show Figure 49 The dorsal side of the basement membrane and barbed suture 4905 is shown.

[0050] Figure 51 The description describes attaching the barbed suture to the base membrane by inserting the base membrane into a slit or cutting the barbed suture.

[0051] Figure 52 for Figure 51 A detailed view of the suture line shown.

[0052] Figure 53 Another embodiment is described, wherein the barbed suture is attached to the base membrane by inserting the base membrane into a slit or by cutting the barbed suture.

[0053] Figure 54 for Figure 53 A detailed view of the suture line shown.

[0054] Figure 55 The barbed sutures are depicted as being attached to the basement membrane layer by sandwiching barbed sutures between the basement membrane layers.

[0055] Figure 56 The top layer of the base membrane is depicted, having holes arranged in a specific pattern or arrangement to clamp the barbed sutures to an additional layer of the base membrane, while allowing the barbs to extend through the top layer of the base membrane.

[0056] Figure 57 , 58A Figures 58B and 59 are schematic cross-sectional views of the barbed sutures on the basement membrane.

[0057] Figure 60 , 61A Images of some examples of tissue repair devices with barbed sutures attached to the basement membrane, along with 61B.

[0058] Figure 62 and 63 Describe a tissue repair device with a basement membrane and barbed sutures.

[0059] According to one implementation method, Figure 64A This is a schematic diagram of a barbed wire mesh. Figure 64B and 64C An image of a pre-formed and rolled-up barbed wire mesh.

[0060] According to one implementation method, Figure 65 This is a schematic diagram of the barbed wire mesh configuration shown in Figure 64 during the tissue repair process.

[0061] According to another embodiment, Figure 66 The diagrams in Figures 64 and 65 illustrate the configuration of the barbed wire mesh during tissue repair, which has... Figure 39 The base film shown.

[0062] According to yet another implementation method Figure 67 For the tissue repair process Figure 64A and 65 The schematic diagram shown illustrates the configuration of the barbed wire mesh, which has... Figure 39 The base film shown.

[0063] Figure 68 It is another barbed mesh that serves as part of a tissue repair device and does not have a basement membrane.

[0064] According to one implementation method, Figure 69 Showing the accompanying tissue ends Figure 68 The tissue repair device has strips of base membrane placed on a barbed mesh.

[0065] Figure 70 This is a schematic diagram of a basement membrane with barbs.

[0066] According to one implementation method, Figure 71 This is a schematic diagram of the barbed mesh on the strip of the base film.

[0067] According to one implementation method, Figure 72 For the tissue repair process Figure 71 A schematic diagram of the configuration of two barbed meshes on the strip of the base film.

[0068] According to another embodiment, Figure 73 For the tissue repair process Figure 71 The diagram shows the two barbed meshes on the strip of the base film and the configuration of the base film.

[0069] According to yet another implementation method Figure 74 For the tissue repair process Figure 71 The diagram shows the barbed mesh on the strips of the base film and the configuration of the base film.

[0070] According to one implementation method, Figure 75 This is a schematic diagram of a strip of injection-molded base film with barbs.

[0071] According to another embodiment, Figure 76 This is a schematic diagram of a strip of base film with ceramic barbs.

[0072] According to one implementation method, Figure 77 This is a schematic diagram of two barbed sutures and the basement membrane.

[0073] According to another embodiment, Figure 78 This is a schematic diagram of two sets of side-by-side barbed sutures and a basement membrane.

[0074] According to yet another implementation method Figure 79 This is a schematic diagram of two strips or meshes with barbed sutures and a basement membrane.

[0075] According to one implementation method, Figure 80 for Figure 79 The diagram shows two strips with barbed sutures and a basement membrane during the tissue repair process.

[0076] According to yet another implementation method Figure 81 This is a schematic diagram of two strips or meshes having barbed sutures attached to the first and second base membranes.

[0077] According to one or more implementation methods Figure 82 This is a schematic diagram of a mesh of barbed sutures attached to a basement membrane.

[0078] According to one implementation method, Figure 83 for Figure 82The diagram shows a barbed suture mesh adhered to the basement membrane during the tissue repair process.

[0079] According to another embodiment, Figure 84 for Figure 82 The diagram illustrates the process of tissue repair using a barbed suture mesh adhered to the basement membrane.

[0080] According to one implementation method, Figure 85 This is a schematic diagram of a strip with barbed attachment points.

[0081] According to one implementation method, Figure 86 for Figure 85 The diagram shows two strips with barbed attachment points during the tissue repair process.

[0082] According to another embodiment, Figure 87 for Figure 85 The diagram shows two strips with barbed attachment points and a schematic diagram of the basement membrane during tissue repair.

[0083] According to another embodiment, Figure 88 This is a schematic diagram of two strips with barbed attachment points and the basement membrane during the tissue repair process.

[0084] According to another embodiment, Figures 89 to 91 This is a schematic diagram of a tissue repair device formed by strips of basement membrane and barbed mesh.

[0085] According to another embodiment, Figure 92 , 93 Figure 94 shows a tissue repair device formed by strips of basement membrane and barbed mesh.

[0086] Figure 95 , 96 Figure 97 shows another embodiment of a tissue repair device formed by a base membrane having large and small protrusions and multiple barbed sutures.

[0087] Figure 98 , 99 100 shows another embodiment of a tissue repair device formed by a base membrane having large and small protrusions and barbed mesh.

[0088] Figure 101 Another embodiment of a tissue repair device consisting of a basement membrane and multiple barbed sutures is shown.

[0089] Figure 102 Another embodiment of a tissue repair device consisting of a basement membrane and multiple barbed sutures is shown.

[0090] Figure 103Another embodiment of a tissue repair device formed by a basement membrane and barbed mesh is shown.

[0091] Figure 104 Another embodiment of a tissue repair device formed by a basement membrane and barbed mesh is shown.

[0092] According to another embodiment, Figure 105 This is a schematic diagram of a tissue repair device containing multiple barbed sutures that are installed or embedded within a basement membrane.

[0093] Figure 106 The diagram shows multiple barbed sutures, an integrated basement membrane strip, and two transversely cut tissue ends.

[0094] Figure 107 This is a schematic diagram of a tissue repair device having a base membrane with internal sutures or openings and longitudinally arranged barbed sutures. Figure 108 A schematic diagram of a tissue repair device having a base membrane with an external suture or opening and longitudinally arranged barbed sutures.

[0095] Figures 109 to 111 For example Figure 105 Images of tissue repair devices and tissue repair devices in use.

[0096] According to yet another implementation method Figure 112 This is a schematic diagram of a tissue repair device.

[0097] Figure 113 A detailed view of the barb formed by microinjection molding.

[0098] Figure 114 The tissue repair device shown in Figure 112 is covered around the tissue end.

[0099] Figures 115 to 118 The diagram shows a side cross-sectional view of the stripes and barbs.

[0100] According to one or more implementation methods Figure 119 A flowchart illustrating a method for fastening the ends of two tissues together.

[0101] Figure 120 for Figure 119 A flowchart illustrating the additional steps of the method shown.

[0102] Figure 121 Image of glass fibers extending from the surface of an absorbable polymer. Detailed Implementation

[0103] Barbed sutures can be used to fix tissue. Existing barbed sutures may contain barbs formed by cutting or slicing portions of the suture, such as... Figure 1 and2 As shown. The peripheral surface of the suture can be cut to create barbs on the outer surface. The incision may not extend completely through the suture, and the incision may be angled rather than perpendicular to the suture surface. In traditional barbed sutures, the incision is made so that all barbs face or point in one direction. Existing barbed sutures are designed to assist wound closure and allow the barbed suture to attach to soft tissue and resist movement in one direction. Existing barbed sutures are used for wound fixation and do not possess the ideal physical properties for fixation to tissues such as nerve tissue, fixation to itself, fixation to other tissues, or fixation to devices. Furthermore, existing barbed sutures are designed to fix tissue against movement in only one direction, i.e., opposite to the direction of the barbs (e.g., ...). Figure 2 Movement in the direction of A). When this barbed suture moves in a direction other than the direction in which the barbs of the suture are oriented to resist movement, the barbed suture may detach from the tissue. I. Overview

[0104] Embodiments of this disclosure may include a barbed suture having a plurality of barbs oriented in different directions. For example... Figure 3 and 4 As shown, and described in more detail below, an exemplary suture can be formed by cutting barbs at different angles relative to each other. Figure 3 In the example shown, the suture may be cut at least once to form at least one barb oriented in a first direction, and subsequently cut at another location to form at least one other barb oriented in a second direction. That is, in one embodiment, the barbed suture has multiple barbs, each with only one protrusion, wherein the protrusions of at least two barbs point in two different directions. Such a barbed suture resists movement in both directions. In other embodiments, the different barbs may be oriented in three or more directions. Barbs with protrusions pointing in different directions can be arranged in a repeating pattern, can be regularly grouped, or barbs with protrusions pointing in different directions can be randomly oriented in different directions along the suture.

[0105] Figure 4 In the example shown, the suture can be cut to form a barb with a first protrusion oriented in a first direction, and then an incision can be made near the first incision in a different direction to form a second protrusion of the same barb, the second protrusion being oriented in a second direction. In these embodiments, the barbed suture formed by multiple incisions, i.e., a multidirectional suture and / or multidirectional barbs, can provide a barbed suture capable of rapid attachment to tissue from any approach or connection angle. Furthermore, when the barbed suture is attached to tissue, it can resist movement in multiple directional angles and / or multiple directions, and thus also resist or reduce the possibility of detachment from the tissue.

[0106] Embodiments of this disclosure may include a tissue repair device comprising a plurality of barbed sutures. In some aspects, one or more barbed sutures may be attached to or used with a basement membrane. In some examples, the tissue repair device may include a mesh formed of barbed sutures. In some aspects, the barbed suture mesh may be attached to or used with a basement membrane. In some aspects, the barbed sutures may include barbed portions and barbless portions, depending on how the tissue repair device is designed to attach to tissue, to multiple tissue ends, or to a device.

[0107] In some respects, the tissue repair device may cover, surround, or otherwise attach to two tissue ends. In some examples, when using the tissue repair device, the tissue ends may be in physical contact with each other, or there may be a gap between the tissue ends. The gap between the two tissue ends may, for example, allow the tissue to retract in vivo in response to changing tension during a release procedure.

[0108] Although this disclosure discusses transverse tissue ends, for example, refer to Figures 2 to 114 The tissue repair apparatus of the described embodiments can be applied to any type of damaged tissue, whether it is completely transversely cut, for example to protect or allow the underlying tissue to heal, or to secure the tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place the two tissue ends together, but are able to wrap around or otherwise cover a portion of the intact tissue to facilitate repair or otherwise protect the underlying tissue.

[0109] In the examples shown in Figures 64 to 118, the tissue repair device may consist of strips of barbed sutures, which may or may not be connected to the basement membrane, or may or may not be used with the basement membrane, wherein the basement membrane is covered around the two tissue ends or otherwise applied to the two tissue ends.

[0110] Embodiments of this disclosure may include barbed devices and methods of manufacturing barbed devices. In some cases, the resulting barbed devices may be described as sutureless tissue coaptation devices, or more specifically, as sutureless nerve coaptation devices, although the barbed devices of this disclosure can be used not only with nerves but with any suitable tissue. As used herein, sutureless means that suturing is not required using surgical sutures independent of the devices described in this disclosure. II. Barbed sutures

[0111] Figure 1This is a schematic diagram of a portion of a barbless suture 100 (also referred to as the suture body) and a blade 105. The barbless suture 100 can be used to form the barbed suture or barb device described herein. The suture 100, and thus the barbed suture and barb device described herein, can be formed from one or more polymers. The one or more polymers can be absorbable polymers that are biodegradable over time. The one or more polymers can include homopolymers, copolymers, and / or polymerizable blends comprising one or more of the following monomers: glycolide, lactide, caprolactone, dioxanone, trimethylene carbonate, monomers of cellulose derivatives, and monomers polymerized to form polyesters. Polymers may include polydioxanone (PDO), polylactic acid (PLA), polycaprolactone (PCL), polytrimethylene carbonate, polyglycolide (PGL), polyglycolic acid (PGA), poly-3-hydroxybutyrate (PHB), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly(4-hydroxybutyrate) (P4HB), poly(propylene carbonate) (PPC), poly(butylene succinate) (PBS), and poly(propylene fumarate) (PPF). Fumarate, PPF, polyhydroxyalkanoate, copolymers thereof, or one or more other suitable materials. In some examples, one or more polymers may comprise polyester, polydioxanone (e.g., poly-p-dioxanone), poliglecaprone (e.g., poliglecaprone 25 sold under the trade name Monocryl®), polyglytone (e.g., polyglytone 6211 sold under the trade name Caprosyn®), catgut, collagen, polyglycidyl lactide, polylactic acid (e.g., poly(L-lactide)). In some respects, the barbless suture 100 may be absorbable.In other examples, barbed sutures may be formed from biodegradable metals.

[0112] In some examples, the tip of the barbed suture may have a height designed to inhibit damage to the tissue to which it is applied. For example, when used with nerve tissue, the tip of the barbed suture may be designed to be less than the thickness of the epineurium to inhibit the possibility of damage to key bundle structures of the nerve tissue. For example, the tip of the barbed suture may be less than about 500 μm, less than about 400 μm, less than about 300 μm, less than about 200 μm, less than about 100 μm, less than about 50 μm, less than about 30 μm, or less than about 1 μm. The tip of the barbed suture may be about 1 μm to about 100 μm, about 1 μm to about 200 μm, about 1 μm to about 300 μm, about 1 μm to about 400 μm, about 1 μm to about 500 μm, about 10 μm to about 400 μm, about 10 μm to about 300 μm, about 10 μm to about 200 μm, about 10 μm to about 100 μm, etc.

[0113] Figure 2 This is a schematic diagram of a 200mm barbed suture, which can be derived from... Figure 1 The barbless suture 100 shown is formed by cutting or scribing the circumferential surface of the suture 200 with a blade 205, or in other words, by making a first incision 215, thereby forming the barbed suture 200. The first incision 215 has a depth D1 relative to the vertical y-axis and a length L1 relative to the horizontal x-axis, and forms an angle θ1 relative to the longitudinal axis N-N of the suture. The first incision 215 forms the barb 210, and specifically forms the first protrusion 220 of the barb, pointing in direction A. Due to the first protrusion 220 of the barb 210, the barbed suture 200 can resist movement or displacement relative to the tissue to which it is attached in direction A. Therefore, the barbed suture 200 can resist or reduce the possibility of detachment from the tissue due to the force pulling the barbed suture 200 along the direction pointed by the barb 210.

[0114] Figure 3 A detailed schematic diagram of the surface of the 300 barbed suture is shown, similar to... Figure 2 The barbed suture 200 shown is provided with a first incision 315 and a second incision 325 made on its outer surface using a blade 305. For example... Figure 2In the illustrated embodiment, the first incision 315 may have a depth D2 relative to the y1 axis, a length L2 relative to the x-axis, and may form an angle θ2 relative to the longitudinal axis O-O of the barbed suture 300. The first incision 315 may form a first barb 310 having a first protrusion 320 pointing in the direction B. The second incision 325 may be made at another location on the outer surface of the barbed suture 300, and may have a depth D3 the same as the depth D2 of the first incision 315, and a length L3 the same as the length L2 of the first incision 315. Alternatively, the depth D3 of the second incision 325 may be greater than or less than the depth D2 of the first incision 315, and / or the length L3 of the second incision 325 may be greater than or less than the length L2 of the first incision 315. In some aspects, the second incision 325 may be formed at an angle θ3 the same as the angle θ2 of the first incision 315, or the angle θ3 of the second incision 325 may be greater than or less than the angle θ2 of the first incision 315. The second incision 325 can form a second barb 330 with a second protrusion 335 pointing in a direction C, which is different from the direction B pointed to by the first protrusion 320. In this example, the component of direction C (the horizontal component parallel to the x-axis in Figure 3) and the component of direction B ( Figure 3 The horizontal components parallel to the x-axis are different, for example, opposite, while the other components of direction C and B ( Figure 3 The perpendicular components parallel to the y1 and y2 axes are the same.

[0115] In some respects, the two cuts 315 and 325 may have the same depth or different depths, and the same length or different lengths. In some respects, the two cuts 315 and 325 may be formed to be oriented at an angle of 180° to each other, or they may be formed to be oriented at an angle greater than or less than 180° to each other.

[0116] Because the barbed suture 300 has multiple barbs (e.g., first barb 310 and second barb 330) and the protrusions (first protrusion 320 and second protrusion 335) point in different directions (directions B and C), the barbed suture 300 can resist movement or displacement in two directions. Furthermore, because the barbed suture 300 has multiple protrusions in at least two different directions (directions B and C), the barbed suture 300 can be a multidirectional barbed suture; more specifically, in... Figure 3 The embodiment shown uses a bidirectional barbed suture. Although Figure 3The multi-directional barbed suture 300 shown has two barbs 310 and 330, but the barbed suture 300 may have more than two barbs. Furthermore, the specific direction pointed to by the protrusions of the two or more barbs can vary. For example, in addition to one barb having protrusions pointing in a different direction, the barbs may be unidirectional, or some barbs may have protrusions pointing in a first direction, while the remaining barbs have protrusions pointing in a second different direction. Moreover, the multi-directional barbed suture may contain three or more barbs, wherein the protrusions of the three or more barbs point in three or more different directions.

[0117] The multidirectional barbed suture 300 of this embodiment enables rapid attachment between the barbed suture and tissue from different approach or connection angles. When the barbed suture 300 is attached to tissue, it resists movement in multiple directional angles and / or directions, and therefore also resists or inhibits detachment from tissue. The multidirectional barbs can be useful, for example, when coapting two parts of tissue, such as the two ends of a nerve, allowing the severed ends to come together or maintain a specific distance from each other, as further described herein.

[0118] Figure 4 A detailed schematic diagram of the surface of the 400 barbed suture is shown, similar to... Figure 2 The suture 200 shown is in which a first incision 415 and a second incision 425 are formed using a blade 405 within the barbed suture 400. (As shown...) Figure 2 In the embodiment shown, the first incision 415 may have a depth D4 relative to the y-axis and a length L4 relative to the x-axis, and may be formed at an angle θ4 relative to the longitudinal axis P-P of the barbed suture 400. The first incision 415 may form barbs 410 with first protrusions 420 pointing in the direction D. The second incision 425 formed in the barbed suture 400 may have a depth D5 greater than the depth D4 of the first incision 415. In some aspects, the second incision 425 may have a length L5 greater than the length L4 of the first incision 415. The second incision 425 may be formed at another angle θ5 relative to the longitudinal axis Q-Q of the barbed suture 400. The other angle θ5 of the second incision 425 may be the same as, greater than, or less than the angle θ4 of the first incision 415. The second incision 425 may extend into the barbed suture 400, thereby relative to Figure 4 The second cut 425, perpendicular to the y-axis, forms an undercut of the first cut 415 at a greater depth D5. The second cut 425 may be manufactured relatively close to or near the first cut 415, and may form part of the barb 410, and specifically, may form a second protrusion 430 in the direction E of the barb 410.

[0119] Although the shallower first incision 415 is described as being formed before the deeper second incision 425, the barbed suture 400 can also be formed by making the first incision 415 to have a relatively deep depth (e.g., D5) and the second incision 425 to have a relatively shallow depth (e.g., D4). In some respects, the two incisions 415 and 425 may have the same depth or different depths, and the same length or different lengths. For example, the depth of the first incision 415 may be the same as the depth of the second incision 425, wherein the depth ranges from about 0.02 mm to about 0.2 mm, about 0.03 mm to about 0.15 mm, or about 0.05 mm to about 0.12 mm. Furthermore, the angle θ4 of the first incision 415 and the angle θ5 of the second incision 425 may be the same, and the range may be from about 5° to about 45°, about 10° to about 40°, about 10° to about 30°, or about 10° to about 20°. In some respects, the two incisions 415 and 425 may be oriented at an angle of 180° to each other, or they may be oriented at an angle greater than or less than 180° to each other. Due to the second protrusion 430 of the barb 410, the barbed suture 400 can resist movement or displacement in direction E. Furthermore, since the barb 410 has multiple protrusions in at least two different directions (here, directions D and E), the barb 410 can be a multidirectional barb, more specifically a bidirectional barb. That is, when the multidirectional barbed suture 400 of this embodiment is attached to tissue, the multidirectional barbed suture 400 can resist movement in multiple directional angles and / or multiple directions, and therefore can also resist or inhibit detachment from the tissue.

[0120] Although the aforementioned barbed sutures 200, 300, and 400 can be formed by cutting the suture with a blade, other methods can also be used to create barbs on the suture. For example, variable geometry extrusion can be used, which produces sutures with different thicknesses or geometries. The material forming the suture can be cut or extruded to create protrusions in the suture during extrusion of different geometries. In some respects, for example, the barbs can be formed separately from the same material as the suture or a different material, and then fixed to the suture using welding, annealing, curing, fastening, bonding, lamination, molding, embossing, printing, or adhesive. In some respects, other methods can be used to fix the barbs to the suture. In some respects, for example, by roughening the surface of the suture, random or irregular barb patterns can be produced.

[0121] Furthermore, although the barbed sutures 200, 300 and 400 described above may have protrusions pointing in two directions, such as a multidirectional barbed suture 300 or a barbed suture 400 having one or more bidirectional barbs 410, barbs with different geometries may also be used.

[0122] For example, such as Figure 5 As shown, the barbs 510 on the suture 500 can be unidirectional barbs, which can be oriented approximately perpendicular to the longitudinal axis R-R of the suture 500 (i.e., parallel to the longitudinal axis R-R). Figure 5 (The y-axis), to resist movement along the longitudinal axis. In other respects, the barb 610 can be formed in the shape of a hook on the suture 600, such as... Figure 6 As shown, barbs 710 may be formed on the suture 700 to have multiple hooks, such as protrusions 720 and 730, as... Figure 7 As shown. In some respects, where the barb 810 is a bidirectional barb formed in the suture 800, the barb 810 may have two protrusions 820 and 830, facing or pointing in substantially opposite directions F and G, as shown. Figure 8 As shown, or the barbs 910 formed on the suture 900 may have two blunt protrusions 920 and 930, facing or pointing in substantially opposite directions H and I, as shown. Figure 9 As shown. Figures 5 to 9 In the embodiments shown, such as Figure 3 and 4 In the illustrated embodiment, the two incisions used to form each suture may have the same or different depths, and the same or different lengths. When the barbs are multi-directional, the barbs may consist of two or more pointed protrusions or two or more rounded protrusions.

[0123] In some respects, the barbs 1010 formed on the suture 1000 may be in the form of a circular (e.g., oblong or circular) disc, such as... Figure 10 As shown in the multiple plan views, or the barbs 1110 formed in the suture 1100, can be in the form of a single, round, or spherical protrusion 1120, such as Figure 11 As shown. Furthermore, for example, the barbs can be geometric shapes with three or more sides, such as triangles, squares, pentagons, polygonal stars, etc. In some aspects, each barb can have more than two protrusions. Similar to the embodiments described above, Figures 5 to 11 The barbed sutures shown can resist movement in multiple directions and / or directions when the barbed sutures are attached to the tissue, thus also resisting or reducing detachment from the tissue.

[0124] although Figures 4 to 11Each suture shown displays only one barb, but two or more barbs can be formed in the same manner as described above. In some aspects, the suture may contain two or more barbs of the same type (e.g., two or more hook-shaped barbs 610 or 710, or two or more ball-shaped barbs 1110). In other aspects, the suture may contain two or more different types of barbs (e.g., a mixture of hook-shaped barbs 610 or 710 and ball-shaped barbs 1110, or a mixture of hook-shaped barbs 610 and 710, ball-shaped barbs 1110 and bidirectional barbs 810). The barbs may be arranged in rows, columns, loops, or spirals on the surface of the suture, or arranged in a pattern such as a grid pattern, or in a random, misaligned arrangement.

[0125] For example, multiple barbs 1210 can be formed on the suture 1200, and these barbs 1210 form a loop around the circumference of the suture 1200. These loops can be located in a plane perpendicular to the longitudinal axis of the suture 1200, such as... Figure 12 As shown, or they may be located on a plane at an angle to the longitudinal axis of the suture, such as Figure 13 As shown, the suture 1300 has a plurality of barbs 1310. In other embodiments, the plurality of barbs may be oriented in a spiral manner along the length of the suture, rather than forming separate loops. In some aspects, a plurality of barbs 1410 may be formed along one or more longitudinal lines along the length of the suture 1400, and these barbs may be aligned with each other, such as... Figure 14 As shown, multiple barbs 1510 may be formed along the circumference of the suture 1500 at offset positions along longitudinal lines, as shown. Figure 15 As shown. In some respects, for example, barbs 1610 may be formed on a portion T of the length of the suture 1600, while barbs 1610 may be absent on another portion U of the length of the suture 1600, such as... Figure 16 As shown. Therefore, one end of the suture 1600 may include barbs 1610, while the other end may not include barbs 1610, or there may be a gap without barbs 1610 along the length of the suture 1600 (as described below). Figure 21 (As discussed in the previous discussion). In other respects, the barb 1710 may be formed on a portion V of the circumference of the suture 1700, while the barb 1710 may be absent along another portion W of the circumference of the suture 1700, as... Figure 17As shown. Thus, one side of the suture 1700 may include barbs 1710, while the other side of the suture 1700 may not include barbs 1710. In some aspects, the suture 1700 may include a row of barbs 1710 extending along one side of the suture 1700. The patterns of the T and U or V and W portions may alternate or repeat along the lengths of the corresponding sutures 1600 and 1700. Furthermore, the barbs may be formed along the length of the suture in a repeating geometric pattern (e.g., triangular patterns, square or checkerboard patterns, pentagonal patterns, hexagonal or honeycomb patterns, etc.).

[0126] Figures 12 to 17 In the text, for convenience, barbs are depicted as a "+" symbol, but it can be expected that any suitable type of suture or combination of suture types, such as those shown in the reference, will be used. Figures 3 to 11 Those depicted and discussed in these figures may use the "+" symbol as used in these diagrams. Furthermore, although the shape of the suture itself (e.g., barbed suture 100, barbed suture 200) is shown as having a circular cross-section, any suitable cross-sectional shape may be used, such as rectangle, triangle, trefoil, pentagon, hexagon, etc., as further described below.

[0127] Figure 18 A barbed suture 1800 with multiple multidirectional barbs 1810 is shown, wherein the first projections 1820 of the multidirectional barbs each point in the same direction, such as direction J, or in a direction parallel to it. In some respects, the second projections 1830 of the multidirectional barbs 1810 may point in the same direction, such as direction K, or in a direction parallel to it, and directions J and K are substantially opposite to each other, as shown in the detail drawing. Alternatively, Figure 19 A barbed suture 1900 is shown having a plurality of multidirectional barbs 1910 arranged in, for example, a regular or irregular pattern. The first protrusion 1920a of each of a first subset of the barbs 1910 points in one direction L, or a direction parallel to it, while the first protrusion 1920b of each of a second subset of the barbs 1910 points in another direction M, or a direction parallel to it. The two directions L and M can be substantially opposite, substantially perpendicular, or as... Figure 19 As shown in the detailed illustration, they are at an angle relative to each other. Similarly, when multi-directional barbs are arranged in a pattern, the second protrusion of the first subset of barbs can point in one direction, while the second protrusion of the second subset of barbs can point in another direction. These two directions can be substantially opposite, substantially perpendicular, or at an angle relative to each other.

[0128] The direction of the barbs along the length of the suture line can be arranged in a variety of different ways. For example, the barbs can be oriented so that they point parallel to the longitudinal axis of the suture line, for example... Figure 8 and 9As shown. Alternatively, for example, barbs can be oriented at an angle between about 1° and about 359° relative to the longitudinal axis of the suture. In some respects, as mentioned above, barbs can be oriented in the same direction as adjacent barbs or in a different direction relative to adjacent barbs. Furthermore, barbs can have a repetitive or random orientation. Moreover, as... Figure 20 As shown, the barbs 2010 on the suture 2000 may have a repeating directional pattern relative to the longitudinal axis S-S of the suture 2000. As a specific example of a repeating directional pattern, Figure 20 The barbs 2010 can be oriented at intervals of approximately 30° relative to the longitudinal axis S-S of the suture 2000, wherein each barb 2010 is oriented relative to adjacent barbs 2010 at adjusted angles in the following order: 0°, 30°, 60°, 90°, 120°, 150°, 180°, 210°, 240°, 270°, 300°, 330°. This pattern can be repeated at intervals of any degree between 0° and 360°, for example, intervals of approximately 20°, approximately 40°, approximately 45°, approximately 50°, approximately 60°, or approximately 90°. In some respects, the barbs can have a non-repeating pattern or an irregular directional pattern relative to the longitudinal axis of the suture (i.e., a series of barbs each having irregular degree intervals relative to the longitudinal axis of the suture).

[0129] Figure 21 This is a schematic diagram of a barbed suture line 2100 having multiple barbs 2105 on its surface. Figure 22 Depicting Figure 21 The barb 2105 of the barb suture 2100 shown is spaced apart by a distance AA. A relatively small distance AA between the barbs allows for a relatively large number of barbs 2105 on the barb suture 2100 as a whole, while a relatively large distance AA between the barbs 2105 allows for a relatively small number of barbs 2105 on the barb suture 2100 as a whole. In some respects, the distance between adjacent barbs 2105 may remain constant along the length BB of the barb suture 2100, or the distance AA between adjacent barbs 2105 may vary along the length BB of the barb suture 2100. Figure 21 In the figure, the barbs 2105 located within segments 2110a and 2110b along length CC can be spaced at regular intervals, but there may be a gap DD or a relatively large interval between segments 2110a and 2110b of the barbs 2105. The end of the barb suture or guide 2115 may be without barbs 2105 and may have a length EE, as shown in the figure, or it may have barbs 2105. Figure 21In the embodiment shown, the barbed suture 2100 has a first segment 2110a of barb 2105, a second segment 2110b of barb 2105, and a gap DD between the first segment 2110a and the second segment 2110b.

[0130] The barbs 2105 within segments 2110a and 2110b can be unidirectional (e.g., as shown in the image). Figure 1 , 2 (as shown in 3, 5, 6 and 11) or multidirectional (e.g., bidirectional, such as...) Figure 4 , 7 (as shown in 8 and 9), and can point to other barbs 2105 within the same segment 2110a, 2110b (e.g., as shown in 8 and 9). Figure 18 (as shown) in the same direction, or pointing to some or all other barbs 2105 within the same segment 2110a, 2110b (e.g., as shown) Figure 19 and 20 (as shown) different directions. In addition, the barbs 2105 in each segment 2110a, 2110b may have the same angle relative to the longitudinal axis of the barb suture line 2100, or they may have different angles (for example, as discussed and shown in Figure 3). Figure 21 In segment 2110a, the barbs 2105 each face a similar direction, which is different from the direction of the barbs 2105 in segment 2110b.

[0131] The spacing AA between adjacent barbs 2105 can be from about 0.01 mm to about 10 mm, for example, from about 0.01 mm to about 5 mm, from about 0.01 mm to about 2 mm, from about 1 mm to about 7 mm, from about 1 mm to about 5 mm, or from about 1 mm to about 3 mm. In some aspects, the spacing AA between adjacent barbs 2105 can be about 1 mm or less, for example, from about 0.5 mm to about 1 mm, from about 0.4 mm to about 0.8 mm, from about 0.4 mm, from about 0.5 mm, from about 0.6 mm, from about 0.7 mm, from about 0.8 mm, or from about 0.9 mm. The spacing AA between adjacent barbs 2105 can be determined at least in part based on the specific application of the barb suture 2100.

[0132] The total length BB of the barbed suture 2100 can vary, for example, depending on the application or specific use, but can be from about 5 mm to about 1 m, for example, from about 50 mm to about 500 mm, from about 100 mm to about 500 mm, from about 100 mm to about 300 mm, from about 200 mm to about 500 mm, or from about 200 mm to about 300 mm. The length CC of segments 2110a and 2110b can be, for example, more than about 50 mm, more than about 30 mm, more than about 10 mm, or more than about 5 mm. In some aspects, the length CC of segments 2110a and 2110b can be, for example, from about 5 mm to about 20 mm, from about 5 mm to about 40 mm, from about 10 mm to about 60 mm, from about 40 mm to about 100 mm, from about 50 mm to about 90 mm, from about 60 mm to about 80 mm, from about 60 mm, from about 70 mm, or about 80 mm. The length of CC may depend at least in part on the total length of the barbed suture 2100 and / or the intended use or application of the barbed suture 2100. The gap DD may be at least in part based on the gap length between two tissue portions, or the gap length between a tissue portion and a device secured in place by the barbed suture 2100. For example, the gap DD may be at least in part based on the gap length between two transversely cut nerves (i.e., the gap length in a nerve transverse section) or the relative desired positioning of the two nerve ends, and may be between no gap or a minimum gap of about 80 mm, a minimum gap of about 500 mm, a minimum gap of about 200 mm, a minimum gap of about 100 mm, about 0.5 mm to about 5 mm, about 1 mm to about 4 mm, about 1 mm to about 3 mm, about 0.5 mm, about 1 mm, about 2 mm, about 3 mm, or about 5 mm. The length of the gap DD may depend at least in part on the total length of the barbed suture 2100 and / or the intended use or application of the barbed suture 2100. The length EE of the guide 2115 may be approximately zero-gap or with a minimum gap, up to the length of the barbed suture 2100. In some aspects, if the guide 2115 is included, its length EE may be, for example, about 10 mm to about 60 mm, about 20 mm to about 50 mm, about 30 mm to about 40 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, or about 50 mm. If the guide 2115 is included, its length EE may depend at least in part on the total length of the barbed suture 2100 and / or the intended use or application of the barbed suture 2100.

[0133] Figure 23 A schematic diagram illustrating a specific example of a barbed suture line 2300 having multiple barbs 2305 on its surface, and Figure 24 Depicting Figure 23Detailed view of the three adjacent barbs 2305 of the barb suture line 2300 shown. Figure 23 and 24 In the illustrated embodiment, the barbed suture 2300 can be a 5-0 gauge suture, a 4-0 gauge suture, a 3-0 gauge suture, or other suitable thickness, with a diameter ranging from approximately 0.100 mm to approximately 0.339 mm, approximately 0.100 mm to approximately 0.249 mm, or approximately 0.150 mm to approximately 0.199 mm. The barbs 2305 can be arranged to the left of the barbed suture 2300 as the first group of barbs 2305, such as... Figure 23 As shown, a second group of barbs 2305 are arranged to the right of the barb suture 2300, all facing the central region 2310 of the barb suture 2300. That is, the barbs 2305 can be arranged in both directions. The span length FF of the first group and the second group of barbs 2305 is approximately 15.0 ± 0.5 mm in this example. The gap GG can extend between the first group and the second group of barbs 2305, and in this example, it can have a length of approximately 5.0 ± 0.5 mm. The total length HH of the barb suture 2300 can be any suitable length, depending on its intended use. In this example, the total length HH can be approximately 75.0 ± 1.0 mm. In some respects, the barbed suture 2300 may also include a barbless end portion 2305, wherein in this example, the length II of the end portion is approximately 20.0 ± 1.0 mm. (Refer to...) Figure 24 In this example, the angle JJ between the extending axis of the barb 2305 and the extending longitudinal axis of the cut forming the barb 2305 can be approximately 60° ± 5°. The height KK of each barb 2305 can be approximately 0.30 ± 0.03 mm, and the spacing LL between the barb 2305 and the cut of the adjacent barb 2305 is as follows: Figure 24 As shown, it can be approximately 0.900±0.1 mm. Figure 25 , 26 and 27 for Figure 23 , 24 A schematic detailed view of the barbed suture 2300 shown. Specifically, Figure 25 The diagram shows three adjacent barbs 2305 along the length of the barb suture 2300, and a cut 2315 made in the surface of the barb suture 2300, thereby forming the barbs. Figure 26 This shows two adjacent barbs 2305 along the length of the barb suture line 2300, and a cut 2315 formed in the surface of the barb suture line 2300. Figure 27A barb 2305 on the barbed suture 2300 is shown, and a cut 2315 is made in the surface of the barbed suture 2300, thereby forming the barb 2305.

[0134] Figure 28 This is a schematic diagram of another example of a barbed suture 2800 having multiple barbs 2805 on its surface. Figure 29A Depicting Figure 28 Detailed views of three adjacent barbs 2805 of the barb suture 2800 shown, and Figure 29B For those attached to it Figure 28 and 29A Image of the tissue end of the barbed suture. The barbs 2805 can be arranged to the left of the barbed suture 2800 to form the first group of barbs 2805, as shown below. Figure 28 As shown, a second group of barbs 2805 are arranged to the right of the barb suture 2800, all facing the central region 2810 of the barb suture 2800. That is, the barbs 2805 can be arranged in both directions. The span length MM of the first group and the second group of barbs 2805 is approximately 22.5 ± 0.5 mm in this example. The gap NN can extend between the first group and the second group of barbs 2805, and in this example, it can have a length of approximately 10.0 ± 0.5 mm. The total length OO of the barb suture 2800 can be approximately 95.0 ± 1.0 mm, but any suitable length is acceptable, depending on the intended use of the barb suture 2800. In some respects, the barbed suture 2800 may also include an end portion without barbs 2805, wherein if an end portion is included, the length PP of the end portion is approximately 20.0 ± 1.0 mm. (Refer to...) Figure 29A The angle QQ between the axis along which the barb 2805 extends and the longitudinal axis along which the cut forming the barb 2805 extends can be approximately 60°±5°. The height RR of each barb 2805 can be approximately 0.10±0.03 mm, and the spacing SS between the barb 2805 and the cut of the adjacent barb 2805 is as follows: Figure 29A As shown, it can be approximately 2 ± 0.1 mm. As mentioned above, Figure 29B For those attached to it Figure 28 and 29AAn image showing the tissue ends of a plurality of barbed sutures 2800 held in place relative to each other. As shown, the plurality of barbed sutures 2800 extend longitudinally, parallel to the axis of the tissue ends. The barbs 2805 of the barbed sutures 2800 engage with the surfaces of the tissue ends, thereby holding the tissue ends together. The gap NN extending between the segments of the barbs 2805 can be positioned relative to the tissue ends, thereby extending to the tissue ends held together. A first set of barbs can engage with a first tissue, and a second set of barbs can engage with a second tissue, so that the bidirectional nature of the barbed sutures holds the two tissue portions in place relative to each other.

[0135] Although reference Figure 29B The discussion of transversely cut tissue ends suggests that this tissue repair device can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow underlying tissue to heal, or to secure tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but rather are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect underlying tissue.

[0136] As mentioned above, in some respects, the barbed suture of this disclosure may have barbs located in more than one plane, such as two planes, three planes, four planes or more planes. Figure 30 This is a schematic diagram of an exemplary biplane barbed suture 3000, which has a plurality of barbs 3005 on its surface, the barbs 3005 extending on two planes. Figure 31 Depicts detailed views of three adjacent barbs 3005 in one plane and three adjacent barbs 3005 in another plane, while Figure 32 A cross-sectional view depicting barbed sutures 3000, wherein one barb 3005 extends in one plane and the other barb 3005 extends in another plane. Figures 30 to 32 In the illustrated embodiment, the barbed suture 3000 may be a size 3-0 suture with a diameter ranging from approximately 0.300 mm to approximately 0.339 mm. In other aspects, the barbed suture 3000 may be a size 5-0 suture, a size 4-0 suture, a size 3-0 suture, or other suitable thickness, with a diameter ranging from approximately 0.100 mm to approximately 0.339 mm, approximately 0.100 mm to approximately 0.249 mm, or approximately 0.150 mm to approximately 0.199 mm. The barbs 3005 may be arranged to the left of the barbed suture 3000 as a first group of barbs 3005, such as... Figure 30As shown, a second group of barbs 3005, all facing the central region 3010 of the barbed suture 3000, and arranged to the right of the barbed suture 3000, also faces the central region 3010 of the barbed suture 3000. That is, the barbs 3005 can be arranged in both directions. The span length TT of the first group of barbs 3005 and the second group of barbs 3005 is respectively. In this example, the length TT can be approximately 15.0 ± 0.5 mm. The gap UU can extend between the first group of barbs 3005 and the second group of barbs 3005. In this example, the gap UU can have a length of approximately 5.0 ± 0.5 mm. The total length VV of the barbed suture 3000 can be approximately 75.0 ± 1.0 mm, although the exact length may depend on, for example, the intended use of the barbed suture 3000. In some respects, the barbed suture 3000 may also include an end portion without barbs 3005, and if such an end portion is included, the length WW of the end portion is approximately 20.0 ± 1.0 mm. (Refer to...) Figure 31 The angle XX between the axis along which the barb 3005 extends and the longitudinal axis along which the cut forming the barb 3005 extends can be approximately 60°±5°. The height YY of each barb 3005 can be approximately 0.30±0.03 mm, and the spacing ZZ between the cuts of the barb 3005 and the adjacent barb 3005 is as follows: Figure 31 As shown, it can be approximately 0.900 ± 0.1 mm. Figure 32 Depicting along Figure 30 A cross-sectional view of the barbed suture 3000 cut by line 32-32, wherein one of the barbs 3005 is in the first direction (e.g. Figure 32 Extending in the upward direction, and the other hook 3005 in the second direction (e.g.) Figure 32 (Extending to the left in the middle). The angle AAA between the two barbs 3005 can be roughly perpendicular to each other, for example, about 90° ± 5°. Figure 33 and 34 Image of a barbed suture 3000 as another example, where the barbs are oriented in two planes.

[0137] While the description of the exemplary barbed sutures includes a range of dimensions, such as barb height, length of different sections or the overall length of the barbed suture, diameter, and relative angles between barbs, it should be understood that the specific dimensions included herein as examples are not limiting and other dimensions may be used. The size of any single barbed suture may depend at least in part on the material used, the intended use of the barbed suture, etc.

[0138] To improve the ability of barbs, thereby enhancing the ability of barbed sutures to engage and penetrate tissue or a portion of tissue, such as the epineurium of nerve tissue, and thus improving the coaptation strength of tissues repaired or joined using barbed sutures while suppressing tissue damage, certain parameters are considered, including the number of barbs, barb height, barb spacing (i.e., the distance between barbs or the distance between a barb and the incision forming an adjacent barb), the plane in which the barbs extend in both direction and number, the shape of each barb tip, the sharpness of each barb tip, and one or more of the angle between the surface of the barb facing the barbed suture and the adjacent surface of the barbed suture (also known as the barb contact angle). In embodiments where barbs are formed by cutting the surface of the suture, the cutting angle used to form the barbs and the cutting depth used to form each barb (i.e., the distance along the surface length of the suture to form the barb) may also be considered as parameters for improvement. In other embodiments where barbs are formed using laser cutting or injection molding, such as barbs with custom-shaped tips or micro-hooks, these parameters are also taken into consideration.

[0139] Figure 35 This is a schematic diagram of a barbed suture 3500 having two adjacent barbs 3505, formed by mechanical cutting using a blade (not shown). In some embodiments, laser cutting or compression molding can be used to form the barbs 3505. Specifically, Figure 35 The cutting angle 3510 and cutting depth 3515 of the barb 3505 are depicted. As an example, the cutting angle may be approximately 45° and the cutting depth may be approximately 0.75 mm. Figure 36 This is a schematic diagram of a barbed suture 3600, which has two adjacent barbs 3605, formed by injection microforming to create microhoops. Specifically, Figure 36 Describe the contact angle 3610, the shape of the barb, the distance 3615 between adjacent barbs 3605, and the height of the barb 3605 from the surface of the barb suture line 3600. III. Methods for forming barbed sutures

[0140] According to one or more implementation methods Figure 37A flowchart depicting a method 3700 for forming a barbed suture is provided. According to any of the above embodiments, method 3700 can be used to form a suture having at least one barb. Method 3700 may include a step 3705 of providing the suture and a step 3710 of forming one or more barbs on the suture. Step 3710 of forming one or more barbs may be a step of mechanically cutting the suture to form one or more barbs. Step 3710 may alternatively be a step of laser-cutting the suture to form one or more barbs. Alternatively, step 3710 may be a step of injection molding one or more barbs by placing the suture in a mold and injecting material to form barbs, or a step of injection molding and attaching barbs to the suture. Generally, the barbs of the barbed suture described herein can be formed in any suitable manner, such as by cutting with a blade or other instrument, laser cutting, injection molding, etc.

[0141] According to one or more implementation methods Figure 38 A flowchart depicting a method 3800 for forming a barbed suture. According to any of the above embodiments, method 3800 can be used to form a suture having at least one bidirectional barb. Method 3800 includes step 3805, which involves making a first incision in the suture body to form a first protrusion. The first protrusion may be oriented in a first direction. The first incision does not extend completely through the suture body. Method 3800 further includes step 3810, which involves making a second incision in the suture body to form a second protrusion, the second protrusion being oriented in a second direction. The second incision does not extend completely through the suture body. The first direction is different from the second direction. Specifically, the first direction may be substantially opposite to the second direction. Alternatively, the first direction may be at an angle relative to the second direction. The first and second incisions may be at the same or different angles, or at the same or different depths into the suture body.

[0142] Although method 3800 may include steps 3805 and 3810 as described above, method 3800 may include additional steps. For example, method 3800 may include the step of twisting the suture body before making the first incision in the suture body. The suture body may be twisted a predetermined number of turns (one turn represents a 360° rotation) within each suture length. In some respects, the suture body may be twisted up to 10 turns per linear inch, up to about 5 turns per linear inch, less than about 1 turn per linear inch, about 1 to about 10 turns per linear inch, about 4 to about 8 turns per linear inch, about 1 to about 5 turns per linear inch, or 5 to about 10 turns per linear inch. As an example, Figure 21In the illustrated embodiment, the suture body may be twisted 5.7 times per linear inch before barbs are formed in the suture body. Alternatively, the suture body may remain untwisted (i.e., unrotated) before steps 3805 and 3810. Furthermore, steps 3805 and 3810 may be performed on one side of the suture body, thereby forming barbs only on one side of the suture body. In some aspects, steps 3805 and 3810 may be repeated to form barbs on the suture body as described above or... Figures 3 to 36 Any arrangement shown can form any number of barbs.

[0143] Furthermore, although reference Figure 38 Only two steps and thus two incisions are described, but method 3800 may include additional steps to create additional incisions. For example, additional steps may be included to create a third incision in the suture body to form a third protrusion of barbs oriented in a third direction.

[0144] Once formed, barbed sutures can be used alone to attach portions of tissue to each other, to attach two different tissues to each other, or to attach one or more devices to tissue. (See reference) Figure 29B This example is depicted and described. Alternatively, the barbed sutures described herein can be used to form the tissue junction portion of larger tissue repair devices such as mesh, as will be described in further detail below. IV. Barbed Tissue Repair Device

[0145] Figures 39 to 118 Various embodiments of a barb tissue repair device and components are illustrated. Exemplary barb tissue repair devices may include one or more barbed sutures, mesh, basement membranes, etc., as will be further described herein. In each embodiment, the barb device may include one or more... Figures 1 to 36 The described barbed suture may include alternative barbed formations, as described below. In some cases, conventional barbs may be used in conjunction with reference to... Figures 39 to 118 Used together with the aforementioned barb device.

[0146] Furthermore, in each of these embodiments, the components of the barb device (e.g., including barb sutures, mesh, and base membrane) may be formed of materials such as absorbable polymers or other polymers, such as polyester, cyclohexanone polymers (e.g., poly(p-dioxanone), poliglecaprone (e.g., poliglecaprone 25 sold under the trade name Monocryl®), polyglytone (e.g., polyglytone 6211 sold under the trade name Caprosyn®), catgut, collagen, polyglycidyl lactide, polylactic acid (e.g., poly(L-lactide)), polyhydroxyalkanoates, or one or more other suitable materials, and in some respects, one or more of the barb sutures, mesh, or base membrane may be absorbable. In other respects, the barb device may be formed of a biodegradable metal or metal alloy, such as biodegradable magnesium, zinc, or iron, or alloys thereof. A. Base film

[0147] Figure 39 This is a schematic diagram of a base film 3900, which can be used in conjunction with barbs, mesh, barbed sutures, or barbed devices formed from barbed sutures to form a tissue repair device according to any embodiment described herein. The base film 3900 may be referred to as a package, film, or film sheet. For example, the base film 3900 may have barbs attached to its surface, or the base film 3900 may have one or more barbed sutures or barbed devices attached thereto. As another example, the base film 3900 may be applied over or around a barbed device. Alternatively, the base film 3900 may be applied to a portion of the tissue, and then the barbed device may be applied to or around the base film 3900 located below. In some aspects, the ends of the base film 3900 may be secured, for example, using sutures and / or adhesives, after the base film 3900 has been applied to or around the barbed sutures or barbed devices. In some respects, the use of the basement membrane 3900 can provide additional protection for tissue undergoing repair, acting as a barrier to prevent barbed sutures or barbed devices from rubbing against surrounding structures, or it can be used to deliver one or more drugs or chemicals to the tissue repair site. If the tissue undergoing repair is neural tissue, the presence of the basement membrane 3900 may inhibit axonal escape during axonal regrowth from the neural tissue.

[0148] The basement membrane 3900 can be formed from any suitable biocompatible material for use in tissue repair procedures. The basement membrane 3900 can be formed from natural materials, synthetic materials, or combinations thereof. Natural materials may include, for example, extracellular matrix (ECM) materials such as the small intestinal submucosa (SIS), or more specifically, porcine SIS, amniotic membrane-based tissues (e.g., amniotic / villous membranes or amnion), dermis, decellularized fascia, recombinant denatured collagen, elastin, thrombin, fibronectin, starch, poly(amino acids), gelatin, alginate, pectin, fibrin, oxidized cellulose, chitin, chitosan, proelastin, hyaluronic acid, fibrin-based materials, collagen-based materials, hyaluronic acid-based materials, glycoprotein-based materials, cellulose-based materials, filaments, and combinations thereof. Natural materials may be derived from human or animal sources and may be autogenic, allogenic, or xenogenic for the subject of implantation or placement of a tissue repair device comprising a basement membrane 3900. Synthetic materials may be one or more of absorbable polymers, homopolymers, copolymers, and / or polymeric blends, comprising one or more of the following monomers: glycolide, lactide, caprolactone (including α-caprolactone), dioxane (including ρ-dioxane), trimethylene carbonate, monomers of cellulose derivatives, and monomers polymerized to form polyesters. The polymer may include cyclohexanone polymer (PDS), polycaprolactone (PCL), polytrimethylene carbonate, polyglycolic acid (PGL), poly-3-hydroxybutyrate (PHB), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly(propylene carbonate) (PPC), polybutylene succinate (PBS), propylene fumarate polymer (PPF), polyhydroxyalkanoate, or one or more other suitable materials.

[0149] The basement membrane 3900 can be configured to remodel into host tissue (i.e., tissue into which a tissue repair device with the basement membrane 3900 is implanted) and may not leave permanent or extensive permanent components. That is, the basement membrane 3900 can be partially or completely remodeled into host tissue. In cases where tubular tissue is the intended application site (e.g., nerves, blood vessels), the basement membrane 3900 can provide peripheral coverage of the tissue repair site, such as a transplant site or coaptation site, once applied. Once applied, the basement membrane 3900 protects the covered area of ​​the tissue and, if used in cases of tissue transsection, protects the coaptation site from becoming a damaged tissue bed.

[0150] The base membrane 3900 may be formed of a material different from that of other components forming the barbs, barbed sutures, or barbed devices, and therefore, the base membrane 3900 may have mechanical properties different from those of the other components of the barbs, barbed sutures, or barbed devices. For example, the base membrane 3900 may be more flexible, while the barbs, barbed sutures, or barbed devices may be relatively more rigid in order to extend into and engage with the tissue. In some respects, the base membrane 3900 may be configured to reabsorb at a different rate (e.g., faster or slower) than the barbs, barbed sutures, or barbed devices, or the base membrane 3900 may be designed to reabsorb at a rate similar to that of other components.

[0151] In some embodiments, the base film 3900 may also include a protective layer or coating 3905 on one or both of its surfaces. Coating 3905 may contain one or more of, for example, hyaluronic acid, alginate, antibiotics, lubricants, growth promoters, growth inhibitors, anti-inflammatory agents, analgesics or anesthetics, or other suitable chemical compounds. The surface of the base film 3900 may be as follows: Figure 39 The images shown are textured, smooth, or a combination thereof. The shape and size of the base film 3900 may depend at least in part on the shape and size of the tissue to be repaired using the base film 3900, or on the shape and size of the barb device to which the base film 3900 is a component or to be used. When the barb device and the base film 3900 are used together, the shape and size of the base film 3900 generally correspond to the shape and size of the barb device. However, one or both of the size and shape of the base film 3900 may differ from the barb device. For example, in one or more embodiments, the base film 3900 may be larger in width and length than the barb device, thereby covering the barbless side of the barb device. B. Attachment of barbs, barbed sutures, mesh, etc., used to form barbed devices to the base film. a. Attachment using adhesives or glues

[0152] One or more barbs, barbed sutures, or meshes can be attached to the base film in any suitable manner. For example, adhesives or mortises can be used to attach the barbs, barbed sutures, or meshes to the base film. In some cases, the adhesive or mortises may be applied only between the base film and the barbs, barbed sutures, or meshes, with minimal or no overflow of adhesive or mortises at other locations on the base film. The adhesive or mortises can be applied by one or more of the following methods: smearing, fluid dispensing, spraying, pipetting, inkjet printing, or 3D printing. The adhesive or mortises can be applied to the base film first, followed by placing the barbs, barbed sutures, or meshes on the adhesive on the base film. Alternatively or additionally, adhesive can be applied to the surface of the barbs, barbed sutures, or meshes configured to be attached to the base film, followed by placing the barbs, barbed sutures, or meshes on the base film. In some aspects, barbs, barbed sutures, or mesh may have notches or recesses on their bottom surface, and adhesive or glue may be applied into the notches, after which the barbs, barbed sutures, or mesh can be placed on the base film. The notches serve to contain the adhesive or glue and prevent it from seeping beyond the coverage area of ​​the barbs, barbed sutures, or mesh. In some aspects, individual barbs can be formed and applied individually, one after another, or several can be applied at once. In other aspects, barbs can be formed on a linear structure, such as... Figure 40 As shown, it can be applied to the base membrane to attach multiple barbs at once. These barb structures may be shorter or less flexible than barb sutures, but can perform a similar function and may have a barb arrangement similar to that described above with reference to barb sutures.

[0153] According to some embodiments of the invention, the adhesive may be a polymeric adhesive, which may be biocompatible, i.e., safe for use in humans or animals. The polymeric adhesive may be biodegradable, i.e., the polymer may completely or partially degrade over time without leaving behind a large amount of permanent material. This polymeric adhesive is suitable for clinical use.

[0154] Many polymers have a long history of safe use in various clinical products (e.g., sutures) and may therefore be suitable for use in the disclosed embodiments. In some aspects, the polymeric adhesive may have an adjustable degradation rate; that is, the polymeric composition can be modified to improve the degradation rate based on one or more tissue types to which the tissue repair device is intended to be applied or the intended use of the tissue repair device. In some examples, the polymeric adhesive may be used for potential applications of controlled, continuous, and localized delivery of drugs / therapeutic agents. In this embodiment, the selected polymeric adhesive may also be used as a drug delivery device.

[0155] In some respects, glues or adhesives can be used in conjunction with crosslinking agents, such as one or more polysaccharides like methacrylated gelatin (Gel-MA), methacrylated hyaluronic acid (MA-HA), and glycidyl methcrylated hyaluronic acid (GM-HA), which can also be used as adhesives.

[0156] Depending on the specific application, polymeric adhesives can be polycaprolactone (PCL), poly(α-caprolactone-co-lactide) (PLCA), polyhydroxyalkanoates (PHAs), or polylactic-co-glycolic acid (PLGA). PLGA is a synthetic copolymer of polylactic acid (PLA) and polyglycolic acid (PGA), and due to its biodegradability and biocompatibility, it is suitable for clinical applications. This copolymer is soluble in organic solvents such as acetone, dichloromethane (DCM), chloroform, ethyl acetate, dimethyl sulfoxide (DMSO), and tetrahydrofuran.

[0157] Although PLGA is soluble in organic solvents, it biodegrades in the presence of water via the hydrolysis of its ester bonds. This biodegradation is a gradual process that can be improved by adjusting parameters such as the polymer molecular weight and the ratio of lactide to glycolic acid monomers to achieve the desired degradation rate.

[0158] According to certain aspects of this disclosure, PLGA solutions can be prepared using organic solvents such as DCM and acetone. After PLGA is dissolved in the solvent, the solution can be used as an adhesive to attach barbs, barbed sutures, or meshes to a base membrane, such as an SIS membrane, to form a tissue repair device. The tissue repair device can be air-dried to allow the solvent (e.g., DCM or acetone) to evaporate, thereby securely adhering the barbs, barbed sutures, or barbed devices to the base membrane. In some aspects, the tissue repair device can be dried for one hour or more, such as about 1 hour, about 2 hours, about 3 hours, about 4 hours, about 30 minutes to about 4 hours, about 30 minutes to about 3 hours, about 30 minutes to about 2 hours, about 1 hour to about 2 hours, etc.

[0159] Figure 40A detailed schematic side view is shown of a base film 4000, a barb structure 4005 (such as a barbed suture or part of a barb structure), and a layer of polymer 4010 therebetween as an adhesive or bonding agent. The layer of polymer 4010 may be referred to as a polymer interface and may attach the barb structure 4005 to the base film 4000. The base film 4000 may be formed of any of the aforementioned materials. The barb structure 4005 may be a micro-molded barb structure, such as… Figure 40 As shown, it may be a single barb, a barb suture, or any other barb component described herein. Polymer 4010 may be any polymer described above as an adhesive, and as an example, it may be formed from PLGA dissolved in a solvent. In this example, once the solvent evaporates, polymer 4010 can bond the barb structure 4005 to the base film 4000.

[0160] The manufacturing method of the aforementioned tissue repair device was preliminarily tested using a PLGA solution containing organic solvents such as DCM and acetone. After dissolving the PLGA, the solution was used as an adhesive to attach the barbed suture to the base membrane. The tissue repair device was then air-dried for approximately two hours. Once the solvent evaporated, the barbed suture adhered to the SIS base membrane. The adhesion between the barbed suture and the SIS base membrane was tested by immersing the barbed suture and the SIS base membrane in a saline solution and examining the adhesion through vigorous movement over time. Figure 41 and 42 The image shows the barbed sutures adhering to the basement membrane during the test. At T=0, Figure 41 In the image, the basement membrane 4100 and the side with the barbed suture 4105 attached, facing downwards in the direction of gravity, are shown together. At T=14 days, after two weeks of continuous hydration, as... Figure 42 As shown, the basement membrane 4200 is shown together with the side of the image facing left, to which the barbed suture 4205 is attached. These images demonstrate the slow hydrolysis of PLGA, making it a biocompatible adhesive suitable for in vivo application in applications such as tissue repair and neural bonding.

[0161] Although PLGA was tested in the initial prototype, other biodegradable polymers that are soluble in organic solvents and slowly hydrolyzed in water can be used as alternatives to PLGA as polymer binders. Non-exhaustive examples include polycaprolactone (PCL), polylactic acid (PLA), polyglycolic acid (PGA), poly(α-caprolactone-co-lactic acid) (PCLA), polyhydroxyalkanoates (PHA), etc. Furthermore, different forms of PLGA can be obtained by varying the ratio of lactide to glycolic acid used in the polymerization process. These forms are typically identified by the molar ratio of the monomers used (e.g., PLGA 75:25 indicates a copolymer composed of 75% lactic acid and 25% glycolic acid). The composition of the PLGA monomers determines its dissolution rate. Polymers with higher lactide content are generally soluble in chlorinated solvents, while polymers with higher glycolic acid content are soluble in fluorinated solvents.

[0162] In addition, common kitchen ingredients can also be used as polymer binders. These natural binders are easy to make and are inherently non-toxic. For example, starch paste, gelatin, honey, molasses, rice paste, syrup, etc., can be used. b. Attachment using thermal bonding

[0163] As an alternative, thermal bonding can be used to attach barbs, barb sutures, or mesh to the base film. Specific examples of thermal bonding include spot welding, applying ultrasonic heat, or otherwise applying energy to melt and entangle the barbs, barb sutures, or mesh, or portions thereof, into the base film. That is, heat can be used to attach the barb components, for example, by melting the barb components at specific locations on the base film, since the barb components are located on top of the base film. Figure 43 A base film 4300 is shown, which has a barbed structure 4305 on its top. A spot welding probe 4310 is also shown. Figure 44 This is a detailed view of the interface between the thermally bonded barbed structure 4305 and the base film 4300. Figure 45 A detailed view of the alternative interface between the thermally bonded barbed structure 4305 and the base film 4300. c. Using woven or sewn attachments

[0164] As an alternative, barbed components, such as barbed sutures, can be attached to the base membrane by weaving or sewing barbed sutures into or through the base membrane. Figure 46One embodiment is shown in which barbed sutures 4605 are woven through a base membrane 4600. One or more barbed sutures 4605 may have barbed portions 4610 with barbs 4615 thereon, and barbless portions 4620 located in the central region of the barbed suture 4605. The barbless portions 4620 may be woven through the base membrane, while the barbed portions 4610 extend from the sides of the base membrane 4600, as shown. Alternatively, although not shown, the barbs 4615 may extend along the entire length of the barbed suture 4605, and the barbless portions 4620 may be woven through the base membrane 4600. Weaving one or more barbed sutures 4605 in this manner can form a permanent attachment between the base membrane 4600 and the barbed sutures 4605.

[0165] Figure 47 Another embodiment is shown, wherein a barbed suture 4705 is sewn into place on a base membrane 4700. In one aspect, the barbed suture 4705 can be sewn through holes 4710 in the base membrane 4700. The holes 4710 may be uniformly distributed along the base membrane 4700, as shown. In other embodiments, the holes 4710 may be non-uniformly distributed along the base membrane 4700. Figure 46 In the illustrated embodiment, each barbed suture 4705 may have a barbed portion 4715 with barbs 4720 thereon, and a barbless portion 4725 located in the central region of the barbed suture 4705, or it may have barbs 4720 extending along its entire length. In this embodiment, both the barbed portion 4715 and the barbless portion 4725 of the barbed suture 4705 are located on the base membrane 4700. Suturing the barbed suture 4705 in this manner can form a permanent attachment between the base membrane 4700 and the barbed suture 4705.

[0166] In other respects, the hole 4710 can be replaced by a needle 4710, and one or more barbed sutures 4705 can be placed on the surface of the basement membrane 4700, and then the barbed sutures 4705 are sewn and positioned above the surface of the basement membrane 4700, so that the barbs 4720 extend away from the base.

[0167] In some implementations, the barbed suture can be attached to the basement membrane by forming an incision or notch, such as a J-shaped incision or an S-shaped incision, and inserting or hooking the barbed suture into the incision. Figure 48A basement membrane 4800 is depicted, wherein barbed sutures 4805 are attached using incisions or hooks 4810 in the basement membrane 4800. Incisions 4810 may be positioned along one or more edges of the basement membrane 4800, such that barbed sutures may be inserted into or hooked onto the incisions 4810 and thereby attached to the basement membrane 4800. In some respects, each incision 4810 may be formed on an edge opposite to another incision 4810, as shown. Each barbed suture 4805 may have a barbed portion 4815 with barbs 4820, and a barbless portion 4825 in the central region of the barbed suture. The barbed suture 4805 may be hooked into the basement membrane 4800, such that the barbless portion 4825 overlaps with the basement membrane 4800, and the barbed portion 4815 extends from the side of the basement membrane 4800, as shown. In other respects, the barb 4820 can extend the entire length of the barb suture 4805 and can cover the base membrane 4800. The barb suture 4805 hooked in this way can form a non-permanent attachment between the base membrane 4800 and the barb suture 4805. That is, with this configuration, the barb suture 4805 can be detachably attached to the base membrane 4800.

[0168] In other embodiments, the barbed suture can be attached to the base membrane by forming small holes or incisions in the base membrane, passing the barbed suture through these holes, and tying the end of the barbed suture after passing through the holes. Figure 49 A base membrane 4900 with holes 4910 is depicted, wherein barbed sutures 4905 are attached through holes 4910 in the base membrane 4900. Holes 4910 may be positioned along one or more edges of the base membrane 4900 so that barbed sutures 4905 can be inserted through the holes 4910. In some respects, each hole 4910 may be located on an opposite edge relative to another hole 4910, as shown. Each barbed suture 4905 may have a barbed portion 4915 with barbs 4920 and a barbless portion 4925 located in the central region of the barbed suture. The barbed suture 4905 may be attached to the base membrane 4900 such that both the barbed portion 4915 and the barbless portion 4925 overlap the base membrane 4900. In other respects, the barbs 4920 may extend the entire length of the barbed suture 4905 and may cover the base membrane 4900.

[0169] Figure 50 The back side of the base film 4900 is shown, and Figure 49The end 5000 of the barbed suture 4905, which passes through the hole 4910 and is knotted, is shown. Knotting the end 5000 of the barbed suture 4905 creates a permanent attachment between the base membrane 4900 and the barbed suture 4905. In some embodiments, an adhesive or glue containing any of the aforementioned ingredients may be used between the barbed suture 4905 and the base membrane 4900 to provide additional support and connection, replacing or supplementing the use of a knot to secure the end 5000 of the barbed suture 4905. In some aspects, the end 5000 may also be knotted, with or without adhesive, and the middle portion of the barbed suture 4905 may be secured in place using adhesive or suture. d. Attachment using sutures formed in barbed sutures

[0170] As another example, the base membrane can be attached to the barbed suture by inserting it into a slit or incision that extends through the barbed suture. Figure 51 The barbed sutures 5105 attached to the base membrane 5100 in this manner are depicted. Each barbed suture 5105 may have a barbed portion 5110 with barbs 5115 and a barbless portion 5120 located in the central region of the barbed suture 5105. Figure 52 This is a detailed view of the suture 5125 in the barbless portion 5120 of the barbed suture 5105, through which the base membrane 5100 passes. The suture 5125 may have a length and width sufficient to allow the base membrane 5100 to pass through. As the base membrane 5100 passes through the barbless portion 5120 of the barbed suture 5105, the base membrane 5100 overlaps with the barbless portion 5120, while the barbed portion 5110 extends from the side of the base membrane 5100, as shown... Figure 51 As shown. In other respects, the barb 5115 may extend along the entire length of the barb suture line 5105, and thus a seam 5125 may be formed through the barb area of ​​the barb suture line 5105, thereby overlapping the barb 5115 with the base film 5100. In some respects, glue or adhesive may be used to hold the base film 5100 within the seam 5125, while in other respects, no adhesive or glue may be used.

[0171] Figure 53 Another embodiment is depicted, wherein the barbed sutures 5305 are attached to the base membrane 5300 in this manner. Each barbed suture 5305 may have a barbed portion 5310 having barbs 5315 and a barbless portion 5320 located in the central region of the barbed suture 5305. Figure 54A detailed view of suture 5325 is provided, which passes through the barbed portion 5310 and the barbless portion 5320 of the barbed suture 5305, and the base membrane 5300 passes through suture 5325. Suture 5325 may have a length and width sufficient to allow the base membrane 5300 to pass through. When the base membrane 5300 passes through the barbed portion 5310 and the barbless portion 5320 of the barbed suture 5305, the base membrane 5300 overlaps with both the barbed portion 5310 and the barbless portion 5320, as shown. Figure 53 As shown. Alternatively, as previously described, the barb 5315 may extend along the entire length of the barb suture line 5305, or the barb 5315 may not overlap with the base film 5300. In some respects, glue or adhesive may be used to hold the base film 5300 within the seam 5325, while in others, adhesive or glue may not be used.

[0172] As another example, instead of using barbed sutures with sutures formed within the suture body, two barbed sutures, or one barbed suture and one barbless suture, can be attached together, leaving a gap between the two sutures. This arrangement can form a slit-like opening, and the basement membrane can be arranged as described above. Figures 51 to 54 The suture is passed through the slit-like opening in a similar manner. In one example, the base membrane can be attached to the barbed sutures by attaching two barbed sutures together with adhesive and inserting the base membrane through the opening formed between the attached barbed sutures. e. Attachment using sandwiching of the base film

[0173] In another example, the base film can be attached to the barbed suture or other barbed component by sandwiching the barbed suture or other barbed component between multiple layers of base film material. Figure 55 The barbed sutures 5505 attached to the base membrane 5500 in this manner are depicted. Each barbed suture 5505 may have a barbed portion 5510 with barbs 5515 and a barbless portion 5520 located in the central region of the barbed suture 5505. Alternatively, the barbs 5515 may extend the entire length of the barbed suture 5505. Figure 56 A base film 5500 is depicted having an opening 5525 extending through it. The openings 5525 can be patterned on the base film 5500 and can be spaced apart from each other in an arrangement complementary to the arrangement of barbed sutures 5505 on another layer of the base film 5500. Once the barbed sutures 5505 are placed on the first or bottom layer of the base film 5500, a second or top layer of the base film 5500 can be placed on top of the barbed sutures, sandwiching the barbed sutures 5505 between the layers of the base film 5500, while allowing barbs 5515 to extend through the openings 5525 formed in the top layer of the base film 5500, as shown. Figure 55 and 56As shown. The layers of the base film 5500 can be attached or fastened together using any of the above-described adhesives or other suitable methods. For example, they can be sewn, welded, or dehydrated to bond the base film layers together. f. Attachment using etching

[0174] As another example, barbed sutures can be attached to a base membrane using etching, wherein the barbed sutures are arranged in a desired orientation within a container, and a material for forming the base membrane (such as an absorbable polymer or any other material listed above for forming a base membrane) is cast around the barbed sutures arranged in the container, such that the barbed sutures are completely covered by the material. The material can then be selectively etched to expose the barbed sutures at at least one end, and the other end of the material can be sliced ​​to cut a membrane, thereby forming a tissue repair device in which the barbed sutures are embedded within the base membrane. c. Arrangement of barbed sutures on the basement membrane

[0175] In embodiments where barbed sutures or other barbed components are attached to one or more basement membranes, factors including the length and diameter of the barbed components, the spacing between the barbed components on the basement membrane, the position of the barbed components on the basement membrane, the length and width of the basement membrane, and the number of barbed components on the basement membrane may vary depending on the intended use and function of the tissue repair device. One or more of these factors may depend at least in part on the type or size of the tissue to which the tissue repair device will be applied, or on the procedure of the tissue repair device to be used.

[0176] Figure 57 This is a schematic cross-sectional view of a barbed component on the basement membrane 5700, which in this example is a barbed suture 5705. As shown, the barbed suture 5705 has a circular cross-sectional shape. While a circular cross-sectional shape is suitable for use with the tissue repair device described herein, it may cause the barbed suture 5705 to tip or roll over on the basement membrane 5700. Ideally, for engagement with the tissue to which the tissue repair device will be applied, the barbs of the barbed suture 5705 should face away from the basement membrane 5700, for example, generally perpendicular to or at an angle to the basement membrane 5700. However, rolling or tipping of the barbed suture 5705 may cause the barbs on the barbed suture 5705 to not face away from the basement membrane 5700, for example, parallel to the basement membrane 5700, toward the basement membrane 5700, or at a smaller angle than intended.

[0177] To prevent the barb part from rolling or tipping over on the base film 5700, the barb part may be formed with a substantially flat side or surface along which it is attached to the base film. The flat surface also helps attach the barb suture 5805 to the base film 5800 by inhibiting rolling motion during attachment (as described above). For example, by providing a flat surface for applying adhesive, the flat surface makes it easier to sew or weave the barb suture 5805 into place. Figure 58A This is a schematic cross-sectional view of the barbed suture 5805 on the base membrane 5800. As shown, the barbed suture 5805 has a triangular cross-sectional shape, which provides a flat surface to prevent the barbed suture 5805 from tipping over or rolling. Similar to the barbed suture 5805, other triangular barb components, such as triangular barbs or barb structures, can be used.

[0178] Figure 58B A cross-sectional image of a barbed suture suture for a multi-bladed structure, such as a three-bladed structure. (By...) Figure 58B The diameters of the circles defined by the blades of the multi-bladed barbed suture shown, BBB, CCC, and DDD, can be, for example, about 148.7 μm, about 142.0 μm, or about 150.8 μm. Although the three-bladed barbed suture may not have a flat surface, the blades can similarly inhibit the tipping or rolling of the barbed suture. In some respects, the cross-sectional shape of the multi-bladed, such as three-bladed, suture can also facilitate the attachment of the barbed suture to the base film as described above, or may additionally provide indentations or ridges for the application of adhesives or bonding agents. Other multi-bladed, such as three-bladed, barbed components, such as barbs or barbed parts in the shape of three blades, can be used.

[0179] Figure 59 This is a schematic end view of the barbed suture 5905 on the base membrane 5900. As shown, the barbed suture 5905 has a rectangular cross-sectional shape, which provides a flat surface for easy attachment to the base membrane and prevents the barbed suture 5905 from tipping over or rolling. Compared to barbs formed on a circular barbed suture, Figure 58A , 58B The barbed sutures shown in 59 can also provide relatively sharp barbs, for example, when barbs are formed by cutting. An incision formed along the corner of a triangular suture can be sharper than an incision formed along a portion of a circular suture. Similarly, other three-lobed barb components, such as triangular barbs or barb structures, can also be used.

[0180] Figure 60 , 61AImages of different examples of tissue repair devices, such as 61B, with barbed sutures attached to a basement membrane. These images include a measuring ruler for reference to show the relative closeness or distance between sutures. However, the specific measurements shown in these prototypes should not be construed as limiting, and any suitable spacing can be used depending on the intended use of the tissue repair device, manufacturing limitations, etc. Specifically, as... Figure 61A As shown, the left side of the figure depicts a tissue repair device with barbed sutures of a larger diameter, while the right side depicts a tissue repair device with a smaller diameter. Low density indicates that the barbed sutures are arranged with relatively large spacing, while high density indicates that the barbed sutures are arranged with relatively small spacing. Some of the tissue repair devices shown have relatively short barbed sutures, which may be useful, for example, in confined anatomical spaces. In some embodiments, the barbed sutures extend longitudinally along the length of the tissue repair device, while in other embodiments, the barbed sutures extend substantially perpendicular to the length of the tissue repair device. Furthermore, the barbed sutures can be arranged to provide a barbless or barbless suture-free space in the central region of the basement membrane, such as... Figure 60 , 61A As shown in the example of 61B. This can be achieved by arranging the barbed sutures in two columns, each column containing aligned barbed sutures. Alternatively, this can be achieved by using barbed sutures that include a barbless portion in the central area.

[0181] Figure 60 , 61A The example shown in 61B may have a single layer or more than one layer, such as two, three, four, or five or more layers of base film.

[0182] As shown in the figure, barbed components such as barbed sutures can be like... Figure 61A As shown, they are spaced apart along the entire base film, or as... Figure 60 and 61B The barbs are clustered in one or more areas of the basement membrane. In some respects, the positioning of the barb components on the basement membrane may affect, for example, how the tissue repair device is applied to the underlying tissue during use, as further described below.

[0183] In embodiments that include barbed components, such as barbed sutures, along the entire basement membrane, the tissue repair device can engage with the underlying tissue regardless of where it is applied. For example, if the underlying tissue is tubular, such as in the case of a nerve, a first portion of the tissue repair device can engage with the underlying tissue, and subsequent portions of the tissue repair device can also engage with the underlying tissue. The final portion of the tissue repair device applied to the tissue can be held in place by the barbed components located there, or it can be held in place by sutures, adhesives, glues, or other fastening mechanisms, or by capillary action. If the underlying tissue is tubular, such as in the case of a nerve, a first portion of the tissue repair device can engage with the underlying tissue, and subsequent portions of the tissue repair device may not engage with the underlying tissue.

[0184] In embodiments where barbed components, such as barbed sutures, are positioned along a portion less than the entire basement membrane—for example, along approximately 2 / 3, 3 / 4, half, less than half, or 1 / 3 or 1 / 4 of the basement membrane—only the first or last portion of the basement membrane may contact the underlying tissue. The final portion of the tissue repair device applied to the tissue may be held in place by sutures, adhesives, glues, or other fastening mechanisms, or by capillary action.

[0185] In some respects, a tissue repair device may have one or more so-called "landing zones," where a landing zone refers to an area on the basement membrane where tissue will be positioned. Figure 62 depicts a tissue repair device 6200 having a basement membrane 6205, barbed sutures 6210, and a landing zone 6215 on which tissue, such as two tissue ends, will be placed. As shown, there may be a relatively higher density of barbed sutures within the landing zone, with six barbed sutures located within the landing zone, grouped in sets of three with relatively small spacing between them, and four barbed sutures located outside the landing zone with relatively large spacing between adjacent barbed sutures. Figure 63 Another tissue repair device 6300 is shown, which has a base membrane 6305 and barbed sutures 6310, and a landing area 6315 is provided along the left side of the base membrane 6305. The tissue repair device 6300 may also have additional barbed sutures in a region 6320 adjacent to the landing area, allowing the tissue to engage with the landing area at an angle of approximately 180° once the tissue is encapsulated within the tissue repair device 6300, in the case of tubular tissue. A flap 6325, or an area on the base membrane 6305 without barbed sutures, may also be provided to facilitate tissue encapsulation and closure of the tissue repair device 6300 around the tissue. After tissue encapsulation, excess material can be trimmed from the flap 6325. Figure 62 and 63In the landing area of ​​the illustrated embodiment, the barbs may be angled to facilitate adhesion to the tissue. In one exemplary embodiment, the barbs may be angled at approximately 45° relative to the surface of the basement membrane, although an angle of approximately 20° to approximately 90° may be suitable.

[0186] like Figure 61B Examples and Figure 62 and 63 As illustrated in this embodiment, clustering barbed components, such as barbed sutures, in the landing area helps attach the tissue repair device to the tissue to be positioned. For example, when the tissue repair device is applied to small or thin tissues such as nerves, the clustered barbed sutures make it easier for the user to position the tissue repair device relative to the tissue, thereby achieving barb-tissue engagement. A single row of barbed sutures may be more difficult to position relative to a nerve, and vice versa, but a higher density of barbed sutures in the landing area increases the likelihood of at least some barbs engaging with the tissue. b. Barbed wire mesh

[0187] According to one implementation method, Figure 64A This is a schematic diagram of a tissue repair device 6400, which has a barbed mesh 6402 as a barb device. The barbed mesh 6402 may be formed by a plurality of barbed sutures 6405, for example, by a plurality of longitudinal and lateral barbed sutures 6405 arranged in a grid pattern. Each barbed suture 6405 may include one or more barbs 6410 extending from the surface of the barbed suture 6405 that are configured to contact the tissue. Figure 64A In the illustrated embodiment, each barbed suture 6405 may include a plurality of barbs 6410 along the length of the barbed suture 6405. The barbs 6410 may be evenly spaced along each barbed suture 6405, or the barbs 6410 may be arranged at varying intervals or randomly.

[0188] The dimensions of the barbed sutures 6405 and the barbed mesh 6402 may depend on one or both of the type of barbs used (i.e., the orientation of the barbs, the material of the barbs, the shape of the barbs, the size of the barbs, etc.), the intended use of the barbed mesh 6402 (e.g., tissue type or procedure type), and the target anatomical region. Furthermore, the type of barbs used may at least partially determine the number of barbs required to achieve adequate attachment of the barbed mesh 6402 to the tissue. The target anatomical region may at least partially determine the required total coverage area and the adhesion force required to secure the barbed mesh 6402 to the tissue surface. The spacing between the barbed sutures 6405 may range from approximately 100 micrometers (e.g., the width of a 10-0 gauge suture) to approximately 2 centimeters. Conversely, the length and / or width of the barbed mesh 6402 may range from approximately 300 micrometers to approximately 10 centimeters.

[0189] Although Figure 64A depicts barbs on barbed suture 6405 extending in both longitudinal and lateral directions, barbed suture 6405 may be used only in one of the longitudinal or lateral directions, while sutures without barbs may be used in the other direction. In other respects, not all sutures extending in a given direction may have barbs. For example, sutures extending only along a portion (e.g., half of the tissue repair device 6400, or along one or more edges of the tissue repair device 6400) may include barbs, while sutures using mesh located in other locations may not have barbs.

[0190] Each barbed suture 6405 may be woven together with other barbed sutures 6405 or cover other barbed sutures 6405, or the barbed sutures 6405 may be connected to each other at the intersection of two or more barbed sutures 6405, or may be a uniform mesh rather than woven or covering barbed sutures 6405. In some respects, the barbed mesh 6402 may be 3D printed, woven from barbed sutures 6405, or formed in any other suitable manner.

[0191] although Figure 64A The diagram shows unidirectional barbs 6410, but in one or more embodiments, barbs 6410 may be multidirectional. As a specific example, barbs 6410 on one half of barbed wire mesh 6402 may point in or extend in a first direction, while barbs 6410 on the other half of barbed wire mesh 6402 may point in or extend in a second direction. Furthermore, barbs 6410 may be multidirectional because each barb 6410 extends toward or away from a point or line along barbed wire mesh 6402 (e.g., along a lateral line, longitudinal line, or angled line of barbed wire mesh 6402, more specifically including the center line between the two halves of barbed wire mesh 6402). Specifically, in one or more embodiments, barbs 6410 on the two "sides" of barbed wire mesh 6402 may point toward or extend toward the center line, or point toward or extend away from the center line, with respect to the center line crossing barbed wire mesh 6402. Furthermore, similarly, in one or more embodiments, the barbs 6410 may point toward or extend toward a single point, or point away from or extend away from a single point, which may be any point on the barbed wire 6402 that includes a center point (i.e., the center of the barbed wire 6402).

[0192] Other directional patterns or arrangements of the barbs 6410 may also be used, and such arrangements may constitute a specific type of surface for attaching the barbed mesh 6402 to the tissue, such as a curved surface, including convex curved surfaces, concave curved surfaces, planar or flat surfaces, tubular surfaces, and combinations thereof. In some embodiments, the directional pattern of the barbs 6410 may be random, so that the barbs 6410 of the barbed mesh 6402 randomly wrap around the barbed mesh 6402 to any surface morphology of the tissue, thereby holding and securing the tissue.

[0193] In an arrangement where the barbs 6410 point toward or extend towards the center point, the barbed mesh 6402 can be configured as a spherical surface to be attached to the tissue. In an arrangement where the barbs 6410 point away from the center point, the barbs 6410 can be used to attach the barbed mesh 6402 to a concave surface (e.g., an inverted ellipsoidal tissue surface). In an arrangement where the barbs 6410 point toward or extend towards a line on the barbed mesh 6402, such that the barbs 6410 are parallel to each other and converge toward that line, the barbed mesh 6402 can be configured as an attachment to a cylindrical tissue surface, wherein the line toward which the barbs 6410 point is determined based on the target anatomical region or tissue.

[0194] During use, as will be further described below, the tissue repair device 6400 can cover or be placed on tissue, or placed on multiple portions of tissue, such as a transversely cut nerve. The barbs 6410 can hold the barbed mesh 6402 on the tissue and / or hold the tissue in place relative to each other. As previously described, the holding or fixation of tissue containing nerve tissue or tissue types other than nerve tissue can be achieved by the unidirectional or multidirectional arrangement of the barbs 6410. The tissue repair device 6400 can be used alone or can be covered together with a basement membrane, as will be further described below.

[0195] In some respects, the barbed wire 6402 may be in sheet form, while in others, it may be pre-formed into a generally cylindrical shape, as shown in Figures 64B and 64C. That is, the barbed wire 6402 can be rolled into a cylindrical shape. Then, tissue ends can be inserted into the ends of the rolled-up barbed wire 6402, or the barbed wire 6402 can be unfolded or bent outwards and positioned around the tissue ends to hold and secure the tissue ends relative to each other. Although transversely cut tissue ends have been discussed with reference to this embodiment, the tissue repair device of this embodiment can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow the underlying tissue to heal, or to tighten the tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but rather can wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect the underlying tissue. a. The barbed wire mesh may or may not be used with the base film.

[0196] According to one implementation method, Figure 65 for Figure 64A This diagram illustrates the use of the tissue repair device 6400 in the tissue repair process. Specifically, Figure 65A barbed mesh 6402 is shown, comprising barbed sutures 6405 and barbs 6410, and two transversely cut tissue ends 6500a and 6500b. The two transversely cut tissue ends 6500a and 6500b can be placed on the barbed mesh 6402 such that a portion of the barbed mesh 6402 rests on one of the transversely cut tissue ends 6500a or 6500b, and another portion rests on the other transversely cut tissue end 6500a or 6500b. The transversely cut tissue ends 6500a and 6500b can be arranged such that the end regions of the transversely cut tissue ends 6500a and 6500b lie on the barbed mesh 6402. The transversely cut tissue ends 6500a and 6500b can be positioned relative to each other, thereby forming a gap G between them. 65 It can be approximately 0 mm or less than approximately 5 mm. The transversely cut tissue ends 6500a and 6500b may be in contact or nearly in contact. In other respects, the gap G... 65 It can be greater than about 0 mm, for example, up to about 10 mm or up to about 5 mm. For example, the gap can be about 0 mm to about 10 mm, about 0 mm to about 8 mm, about 1 mm to about 10 mm, about 1 mm to about 8 mm, about 2 mm to about 8 mm, about 3 mm to about 7 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, etc. Once the tissue ends are positioned relative to each other, the barbed wire 6402 can be wrapped around the surface of each of the transversely cut tissue ends 6500a and 6500b.

[0197] The tissue repair device 6400 may include a barbed mesh 6402 that is physically moved (e.g., rolled, twisted, or pulled) along the surface of the tissue and placed on the outer surface of transversely cut tissue ends 6500a and 6500b, the transversely cut tissue ends 6500a and 6500b being rolled onto the barbed mesh 6402, or a combination thereof. In some aspects, the ends of the barbed mesh 6402 may be secured after covering, for example, by using sutures, adhesives, glue, or capillary action. In other aspects, the barbs 6410 may be sufficient to hold the tissue ends 6500a and 6500b in place relative to the barbed mesh 6402. With this configuration, the barbed mesh 6402 secures the transversely cut tissue ends 6500a and 6500b together, thereby enabling the tissue repair process. More specifically, the barbs 6410 on the barbed suture 6405 of the barbed mesh 6402 may protrude into or otherwise engage with the outer surface of each of the transversely cut tissue ends 6500a and 6500b, and the barbs 6410 may, together with the barbed suture 6405 of the barbed mesh 6402, inhibit the movement and separation of the transversely cut tissue ends 6500a and 6500b.

[0198] According to one implementation method, Figure 66 This is a schematic diagram of the configuration of the tissue repair device 6400 during the tissue repair process, including: a basement membrane 6415, which has... Figure 39 One or more properties of the base film 3900 shown; and Figure 64A The barbed wire sheet 6402 shown is an example. Specifically, Figure 66 The tissue repair device 6400 is shown, comprising a barbed wire mesh 6402 and a base membrane 6415, and two transversely cut tissue ends 6600a and 6600b. The base membrane can be separated from and aligned with the barbed wire mesh 6402, or it can be attached to the barbed wire mesh 6402. If the base membrane 6415 and the barbed wire mesh 6402 are separated from each other rather than attached together, they can be packaged together and sold in pairs, or they can be packaged and sold separately.

[0199] and Figure 65 Similar to the configuration shown, in this configuration, two transversely cut tissue ends 6600a and 6600b can be placed on the barbed wire 6402. However, in this embodiment, the barbed wire 6402 and the base film 6415 are layered, so that the barbed wire 6402 is located between the base film 6415 and the transversely cut tissue ends 6600a and 6600b. A portion of the barbed wire 6402 and a portion of the base film 6415 are located on one of the transversely cut tissue ends 6600a or 6600b, while another portion of the barbed wire 6402 and another portion of the base film 6415 are located on the other transversely cut tissue end 6600a or 6600b. The transversely cut tissue ends 6600a and 6600b can be arranged such that the end regions of the transversely cut tissue ends 6600a and 6600b are located on the barbed wire 6402 and the base film 6415. The transversely cut tissue ends 6600a and 6600b can be positioned relative to each other, thereby forming a gap G between the transversely cut tissue ends 6600a and 6600b. 66It can be approximately 0 mm or less than approximately 5 mm. The barbed mesh 6402 and base membrane 6415 can then be wrapped around the outer surface of each of the transversely cut tissue ends 6600a and 6600b. In some aspects, the barbed mesh 6402 can be wrapped around the transversely cut tissue end first, and then the base membrane 6415 can be wrapped around the tissue end, covering the barbed mesh 6402. In other aspects, the wrapping can occur substantially simultaneously. In yet another aspect, the barbed mesh 6402 can be attached to the base membrane 6415, for example, in any of the ways described above regarding the attachment of barbed sutures to the base membrane, and thus the tissue repair device 6400 can be wrapped around the tissue end as a whole. Although not shown, in some respects, a separate base membrane 6415 may first be wrapped around the tissue end, and then a separate barbed mesh 6402 may be wrapped over the base membrane 6415, thereby holding the base membrane 6415 in place with the underlying tissue.

[0200] The tissue repair device 6400 may include physically moving (e.g., rolling, twisting, or pulling) the barbed mesh 6402 and the base membrane 6415 individually or together, placing them on the outer surfaces of transversely cut tissue ends 6600a and 6600b, and winding the transversely cut tissue ends 6600a and 6600b around the barbed mesh 6402 and the base membrane 6415, wherein the barbed mesh 6402 is positioned between the transversely cut tissue ends 6600a and 6600b and the base membrane 6415, or a combination thereof. In some aspects, the ends of the barbed mesh 6402 and / or the ends of the base membrane 6415 may be secured after coverage, for example, using sutures, adhesives, glue, or by capillary action. With this configuration, the tissue repair device 6400, including the barbed mesh 6402 and the base membrane 6415, can fasten the transversely cut tissue ends 6600a and 6600b together, thereby performing the tissue repair process. More specifically, the barbs 6410 of the barbed mesh 6402 can protrude into or otherwise engage with the outer surface of each of the transversely cut tissue ends 6600a and 6600b, and the barbs 6410 and the base membrane 6415 of the barbed mesh 6402 can prevent the transversely cut tissue ends 6600a and 6600b from moving apart.

[0201] As described above, the basement membrane 6415, when used in conjunction with the barbed mesh 6402, provides additional protection to the tissue being repaired. It can act as a barrier to prevent the barbed mesh 6402 from rubbing against surrounding structures, or it can be used to deliver one or more drugs or chemicals to the tissue repair site. If the tissue being repaired is neural tissue, the presence of the basement membrane 6415 may inhibit axonal extrusion during axonal regrowth. The basement membrane 6415 can further provide one or more protections to the neurotrophy formed by the barbed mesh 6402, preventing ingrowth of fibrotic tissue and outgrowth of axons. Furthermore, the basement membrane 6415 can be configured to attach to tissue ends with gaps to provide coverage of the gap areas.

[0202] Although transversely cut tissue ends have been discussed with reference to Figures 64 to 66, the tissue repair apparatus of this embodiment can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow the underlying tissue to heal, or to secure the tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place the two tissue ends together, but are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect the underlying tissue. E. Base film with barbed wire mesh

[0203] According to yet another implementation method Figure 67 This is a schematic diagram of the configuration of the tissue repair device 6400, including the barbed mesh 6402 and the base membrane 6415 during the tissue repair process. Specifically, Figure 67 The tissue repair device 6400 is shown, comprising a barbed mesh 6402 and a base membrane 6415, and two transversely cut tissue ends 6700a and 6700b. Figure 66 The configuration shown is similar, in which two transversely cut tissue ends 6700a and 6700b can be placed on the barbed wire mesh 6402 and the base membrane 6415, but in this configuration, the gap G between them is... 67 It can be greater than approximately 0 mm. Because tissues often experience a certain amount of tension within the body, a gap G may form between the transversely cut tissue ends 6700a and 6700b, for example, due to the tendency of tissues such as nerve tissue to retract. 67 Therefore, once the tissue is transversely cut and the tension is released, the transversely cut tissue ends 6700a and 6700b may pull apart from each other. Furthermore, the tissue damage resulting from the transverse cut may similarly create a gap G between the tissue ends 6700a and 6700b. 67Furthermore, the surgeon can trim away the material from the transversely cut tissue ends 6700a and 6700b to remove damaged or injured tissue and expose healthy tissue. The transversely cut tissue ends 6700a and 6700b are forcibly pulled together to close the gap G. 67 It may exert tension on the tissue, which could then have an adverse effect on tissue regeneration.

[0204] Gap G 67 The gap can be greater than approximately 0 mm, for example, up to approximately 10 mm or up to approximately 5 mm. For example, the gap can be approximately 0 mm to approximately 10 mm, approximately 0 mm to approximately 8 mm, approximately 1 mm to approximately 10 mm, approximately 1 mm to approximately 8 mm, approximately 2 mm to approximately 8 mm, approximately 3 mm to approximately 7 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, etc. The covering and fastening of the barbed wire 6402 and the base film 6415 of this configuration can be related to... Figure 66 The same applies to what is shown and described.

[0205] Figure 68 This is a schematic diagram of another barbed mesh 6802, which is part of the tissue repair device 6800 and does not have a base membrane. (As shown) Figure 64A In the embodiment shown, the barbed mesh 6802 is formed by a plurality of barbed stitches 6805, but in this embodiment, the barbed mesh 6802 also includes barbless stitches 6810. The barbed stitches 6805 are... Figure 68 The barbed sutures 6805 are arranged longitudinally, while the barbed sutures 6810 are arranged laterally. Each barbed suture 6805 may include one or more barbs 6815 extending from the surface of the barbed suture 6805, which constitute contact tissue. Figure 68 In the illustrated embodiment, each barbed suture 6805 has a plurality of barbs 6815 along its length, wherein barbed portions 6820 include barbs 6815, while barbless portions 6825 do not have barbs. One of the barbed portions 6820 located on one side of the central axis BBB of the barbed mesh 6802 may have barbs 6815 pointing in a first direction, such as towards the central axis BBB, and another barbed portion 6820 located on the other side of the central axis BBB may have barbs 6815 pointing in a second direction, such as towards the central axis BBB. That is, the barbed mesh 6802 of this embodiment may have barbs 6815 pointing in one of two directions. In other embodiments, the barbed mesh may have barbs pointing in more than two directions. The barbs 6815 may be evenly spaced within the barbed portions 6820 of the barbed mesh 6802.

[0206] The dimensions of the barbed mesh 6802, including the dimensions of the barbed portion 6820 and the barbless portion 6825, as well as the spacing of the barbed sutures 6805 and the spacing between the barbless sutures 6810 and adjacent sutures, may depend on the type of barbs used (e.g., the direction of the barbs, the material of the barbs, the shape of the barbs, the size of the barbs, etc.), the type of tissue to which the tissue repair device is to be applied and / or the procedure, and one or both of the target anatomical region or tissue to be covered and repaired by the tissue repair device 6800. For example, the length L of the barbed mesh 6802... 6802 The width W of the barbed wire 6802 can be approximately 35 mm. 6802 It can be approximately 15 mm long, with a barb portion length of 6820 L. 6820 It can be approximately 15 mm long, with a length L of 6825 for the barbless portion. 6825 The spacing S between the barbed suture lines 6805 can be approximately 5 mm. 6805 The spacing S between the barbless sutures 6810 can be approximately 2.5 mm or approximately 3 mm. 6810 It can be approximately 7.5 mm. However, these dimensions are for illustrative purposes only and not as limitations. Other dimensions may also be applicable depending on the usage and the factors mentioned above.

[0207] The barbed suture 6805 may be formed from oxycyclohexanone polymer (PDO) and may be, for example, one of suture type 3-0, 4-0, or 5-0, although any of the materials or sizes applicable to barbed sutures described above may be used. The barbless suture 6810 may be formed from oxycyclohexanone polymer (PDO) and may be, for example, suture type 5-0, although any of the materials or sizes applicable to barbed sutures described above may be used. When the tissue fastened using the barbed mesh 6802 is nerve tissue, the size of the barbed suture 6805 may be based on the size of the nerve tissue. For example, if the diameter of the nerve tissue is about 5 mm and the circumference is about 15.7 mm, then the barbed suture 6805 may be a 3-0 size suture with a diameter of about 300 μm to 339 μm. As another example, if the diameter of the nerve tissue is about 4 mm and the circumference is about 12.6 mm, then the barbed suture 6805 can be a 5-0 size thread with a diameter of about 150 μm to 199 μm.

[0208] The barbed sutures 6805 and the barbless sutures 6810 may be woven together or covered with other sutures, or the sutures may be joined to each other at their intersections. Alternatively, the sutures may be formed as a uniform, non-woven mesh. In some respects, the barbed mesh 6802 may be 3D printed, woven from individual sutures, or formed in any other suitable manner.

[0209] Similar to the use of tissue repair device 6400, tissue repair device 6800 can cover or be placed on tissue, such as a transversely cut nerve. Barbs 6815 can hold the barbed mesh 6802 onto the tissue and / or hold the tissue in place relative to each other. As described above, the multidirectional arrangement of barbs 6815 can achieve retention or fixation of tissue containing nerve tissue or tissue types other than nerve tissue. Tissue repair device 6800 can be used alone or as... Figure 66 and 67 In general, it is covered together with the base film. On the other hand, the barbed wire 6802 can be attached to the base film, as described above.

[0210] According to one implementation method, Figure 69 A tissue repair device 6800 is shown, wherein a strip of base membrane 6900 is placed on top of the barbless portion 6825 of the barbed suture 6805 of barbed mesh 6802. In this embodiment, the gap formed between tissue ends 6500a and 6500b and the very ends of tissue ends 6500a and 6500b may be located on top of the strip of base membrane 6900. The strip of base membrane 6900 may have one or more of the characteristics of the base membrane 3900 described above. Although the strip of base membrane 6900 is shown as layered between barbed mesh 6802 and tissue ends 6500a and 6500b, the strip of base membrane 6900 may also be located on the opposite side of the barbless portion 6825 of barbed mesh 6802, sandwiching the barbless portion 6825 between the strip of base membrane 6900 and tissue ends 6500a and 6500b.

[0211] Although reference Figure 67 , 68 Sections 69 and 69 discuss transversely cut tissue ends. These embodiments of the tissue repair apparatus can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow underlying tissue to heal, or to secure tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect underlying tissue. F. Base membrane with barbs

[0212] Figure 70This is a schematic diagram of a tissue repair device 7000, which has a base membrane 7002 and a plurality of barbs 7005 extending from the surface of the base membrane 7002, which are configured to contact tissue. The characteristics of the base membrane 7002 may be the same as those described above with respect to base membrane 6415. The barbs 7005 may be formed of the same material as the material forming the base membrane 7002 or a different material. In some aspects, according to one embodiment, the barbs 7005 may be formed by laser cutting or embossing the base membrane 7002, or according to another embodiment, the barbs 7005 may be ceramic barbs 7005 attached to the base membrane 7002, or a combination thereof. The tissue repair device 7000, which includes a base membrane 7002 with barbs 7005, can be used in a manner similar to or the same as that of the tissue repair device 6400 of the embodiments shown in Figures 64 to 67. The barbs 7005 may be arranged on the base membrane 7002 in a grid configuration or other pattern. Other configurations containing randomly spaced barbs 7005 can also be used. Furthermore, although... Figure 70 The barb 7005 is depicted protruding from the entire basement membrane 7002, but the barb 7005 may also protrude only from a portion of the basement membrane 7002, such as along one or more edges of the basement membrane 7002, along half or less of the basement membrane 7002, as described above regarding a portion of the basement membrane that may include the barb structure. In embodiments where the barb 7005 is a ceramic barb, the barb 7005 may be formed of absorbable ceramic such as bioglass. If the barb 7005 and the basement membrane 7002 are formed of different materials, such as different absorbable materials, the barb 7005 and the basement membrane 7002 may have different mechanical properties. For example, the basement membrane 7002 may be more flexible, while the barb 7005 may be relatively more rigid in order to extend into and engage with the tissue to which the tissue repair device 7000 is applied. In some respects, the basement membrane 7002 may be configured to reabsorb at a different rate (e.g., faster or slower) than the barb 7005, or they may be configured to reabsorb substantially simultaneously. G. Barbed strips and base film

[0213] According to one implementation method, Figure 71This is a schematic diagram of a tissue repair device 7100, which includes a barbed strip 7102 formed by barbed sutures 7110. This barbed strip may be similar to or identical to the barbed sutures described above, and is attached to or embedded in a basement membrane 7105. The characteristics of the basement membrane 7105 may be the same as those described above regarding basement membrane 3900. The barbed strip 7102 may be formed by a plurality of laterally and longitudinally arranged barbed sutures 7110, wherein barbs 7115 are self-contained as extensions of the surface of each barbed suture 7110 in contact with tissue. In other aspects, the lateral sutures may not include barbs, while only the longitudinally arranged barbed sutures may include barbs. In some aspects, the plurality of barbed sutures 7110 may be arranged in a grid pattern. For example, the barb strip 7102 may include two or more longitudinal barb sutures 7110a and two or more lateral barb sutures 7110b, wherein the length of the two or more longitudinal barb sutures 7110a is longer than the length of the two or more lateral barb sutures 7110b, thereby forming the barb strip 7102. Each barb suture 7110 may include one or more barbs 7115. Although referenced... Figure 71 Two longitudinal barbed sutures 7110a are described, but additional longitudinal barbed sutures may be included, as well as more or fewer lateral barbed sutures 7110b. Each barbed suture 7110 may be a separate barbed suture, for example, woven together with other barbed sutures 7110 or covering with other barbed sutures 7110, or the barbed sutures 7110 may be connected to each other at the intersection of two or more barbed sutures 7110, or may be a uniform mesh rather than woven or covering barbed sutures. In some respects, the barbed strip 7102 may be 3D printed, woven from the barbed sutures 7110, or formed in any other suitable manner.

[0214] The barbed suture 7110 can be attached to the base membrane 7105 in any suitable manner. For example, glue or adhesive can be used to attach the barbed suture 7110, as described above. As another example, the barbed suture 7110 can be physically attached, for example by weaving or sewing the barbed suture 7110 through the base membrane 7105, or by making a J-shaped or S-shaped cut in the base membrane 7105 or making a small hole on the side of the base membrane 7105, through which the barbed suture 7110 is passed and knotted at the end of the barbed suture 7110, thereby hooking the barbed suture 7110 to the base membrane 7105, as described above. As another example, the base film 7105 can be inserted into a slit or the barbed suture 7110 can be cut, or two barbed sutures 7110 can be glued together at their ends and the base film 7105 can be inserted into the attached barbed suture 7110, thereby attaching the base film 7105 to the barbed suture 7110, as described above. As yet another example, the barbed suture 7110 can be attached using heat, for example by melting the barbed suture 7110 at a specific location when it is on top of the base film 7105, as described above.

[0215] As yet another example, barbed sutures 7110 can be attached to a base membrane 7105 using etching, wherein the barbed sutures 7110 are aligned in a desired direction, and a material forming the base membrane 7105 (e.g., an absorbable polymer or any other material listed above for forming the base membrane 3900) is cast around the barbed sutures 7110, such that the barbed sutures 7110 are completely covered by the material. The material can then be selectively etched to expose the barbed sutures 7110 at at least one end, and the other end of the material can be sliced ​​to cut a thin film, thereby forming a tissue repair device 7100 in which the barbed sutures 7110 are embedded within the base membrane 7105. The tissue repair device 7100 may include one or more barbed strips 7102, which can be applied to tissue to attach tissues to each other. a. Use of barbed strips and base film

[0216] According to one implementation method, Figure 72 To illustrate the use of, for example, in the tissue repair process Figure 71 A schematic diagram of the two tissue repair devices 7100 shown. Specifically, Figure 72Two tissue repair devices 7100 and two transversely cut tissue ends 7200a and 7200b are shown. Two barbed strips 7102 of the tissue repair device 7100 can be placed on the transversely cut tissue ends 7200a and 7200b, such that a portion of each barbed strip 7102 is located on one of the transversely cut tissue ends 7200a and 7200b, and another portion of each barbed strip 7102 is located on the other of the transversely cut tissue ends 7200a and 7200b, thereby "tape" the transversely cut tissue ends 7200a and 7200b together. The transversely cut tissue ends 7200a and 7200b can be arranged such that the end regions of the transversely cut tissue ends 7200a and 7200b are located on the barbed strips 7102. The transversely cut tissue ends 7200a and 7200b can be positioned relative to each other, thereby forming a gap G between the transversely cut tissue ends 7200a and 7200b. 72 It can be approximately 0 mm or less than approximately 5 mm. Although Figure 72 Two barbed strips 7102 are depicted placed on opposite sides of the transversely cut tissue ends 7200a and 7200b to "bundle" the transversely cut tissue ends 7200a and 7200b together, but one or more barbed strips 7102 may be used.

[0217] When the barbed strip 7102 is placed on the transversely cut tissue ends 7200a and 7200b (or vice versa), the width W of the barbed strip 7102 is... 7102 It can be located on or adhered to a portion of the outer surface of the transversely cut tissue ends 7200a and 7200b, such as Figure 72 As shown. That is, the barb strips 7102 may extend only around a portion of the surface of the transversely cut tissue ends 7200a and 7200b, because the width W of each barb strip 7102 is... STRIP The width of the barbed strip 7102 may be smaller than that of the tissue ends 7200a and 7200b. With this configuration, the barbed strip 7102 can secure the transversely cut tissue ends 7200a and 7200b relative to each other, thereby enabling tissue repair processes. More specifically, the barbs 7115 of the barbed strip 7102 may protrude into or otherwise engage with the outer surface of each of the transversely cut tissue ends 7200a and 7200b, and the barbs 7115 of the barbed strip 7102 may inhibit the transversely cut tissue ends 7200a and 7200b from moving apart.

[0218] According to another embodiment, Figure 73 For use in tissue repair processes, such as Figure 71A schematic diagram showing two tissue repair devices 7100 and a separate base membrane 7305 that is larger than the base membrane 7105 that forms part of the tissue repair device 7100. Specifically, Figure 73 Two barbed strips 7102, a separate base membrane 7305, and two transversely cut tissue ends 7300a and 7300b are shown. The characteristics of the separate base membrane 7305 may be the same as those of the base membrane 3900 described above.

[0219] and Figure 72 A similar configuration is shown, in which the barb strip 7102 can be placed on the two transversely cut tissue ends 7300a and 7300b (or vice versa). However, in this embodiment, once the barb strip 7102 is in place, a separate base film 7305 can cover the barb strip 7102 and the tissue ends 7300a and 7300b. A portion of each barb strip 7102 can be located on one of the transversely cut tissue ends 7300a and 7300b, and another portion of each barb strip 7102 can be located on the other transversely cut tissue ends 7300a and 7300b. The transversely cut tissue ends 7300a and 7300b can be arranged such that the terminal regions of the transversely cut tissue ends 7300a and 7300b lie on the barbed strip 7102, and the transversely cut tissue ends 7300a and 7300b, as well as portions of the barbed strip 7102, lie on a separate basement membrane 7305. The transversely cut tissue ends 7300a and 7300b can be positioned relative to each other, thereby forming a gap G between the transversely cut tissue ends 7300a and 7300b. 73 It can be approximately 0 mm or less than approximately 5 mm. Although this embodiment describes the use of two barbed strips 7102 in the process, one or more barbed strips 7102 may also be used.

[0220] The width W of the barbed strip 7102 7102 This allows the entire width W of each barb strip 7102 to be such that when the barb strips 7102 are placed on the transversely cut tissue ends 7300a and 7300b, 7102 Located on or attached to a portion of the outer surface of the transversely cut tissue ends 7300a and 7300b, such as Figure 73 As shown. That is, the barbed strip 7102 may extend only around a portion of the outer surface of the transversely cut tissue ends 7300a and 7300b, because the width W 7102 It may be smaller than the width of the tissue ends 7300a and 7300b. Then, a separate base film 7305 may be applied to the entire surface of each of the transversely cut tissue ends 7300a and 7300b and around the barb strip 7102.

[0221] Encasing the transversely cut tissue ends 7300a and 7300b in a separate base membrane 7305 may involve physically moving (e.g., rolling, twisting, or pulling) the separate base membrane 7305 and placing it on the surface of the transversely cut tissue ends 7300a and 7300b, rolling the transversely cut tissue ends 7300a and 7300b around the separate base membrane 7305, or a combination thereof. In some aspects, the ends of the separate base membrane 7305 may be secured after encasing, for example, using sutures, adhesives, glue, or capillary action. With this configuration, the tissue repair device 7100, including the barbed strip 7102 and the separate base membrane 7305, can secure the transversely cut tissue ends 7300a and 7300b together, thereby enabling a tissue repair process. More specifically, the barbs 7115 on the barbed strip 7102 may protrude into or otherwise engage with the outer surface of each of the transversely cut tissue ends 7300a and 7300b, and the barbs 7115 of the barbed strip 7102 and the separate basement membrane 7305 may inhibit the movement and separation of the transversely cut tissue ends 7300a and 7300b. If the transversely cut tissue ends 7300a and 7300b are nerve ends, the axons that may grow from one or both of the transversely cut tissue ends 7300a and 7300b can be prevented from escaping by covering the transversely cut tissue ends 7300a and 7300b held together by the barbed strip 7102 with the separate basement membrane 7305. That is, the axons are prevented from extending outward away from the other of the transversely cut tissue ends 7300a and 7300b. Although Figure 73 The use of two tissue repair devices 7100 is described, but one or more tissue repair devices 7100 may be used.

[0222] According to yet another implementation method Figure 74 This describes a scenario where two tissue repair devices 7100 and a separate basement membrane 7305 are used during tissue repair. Specifically, Figure 74 The barbed strips 7102 applied to the two transversely cut tissue ends 7400a and 7400b are shown. See reference... Figure 73 The procedure may also utilize a separate base membrane 7305, with a larger gap between the two transversely cut tissue ends 7400a and 7400b. Figure 73 Similar to the configuration shown, in this configuration, the barbed strip 7102 can be applied to two transversely cut tissue ends 7400a and 7400b (or vice versa), but in this configuration, the transversely cut tissue ends 7400a and 7400b can be arranged relative to each other with a gap G between them. 74 The reason is as mentioned above regarding the gap G. 67 The gap G is discussed. 74It can be greater than about 0 mm, for example, up to about 10 mm or up to about 5 mm. For example, gap G 74 It can be about 0 mm to about 10 mm, about 0 mm to about 8 mm, about 1 mm to about 10 mm, about 1 mm to about 8 mm, about 2 mm to about 8 mm, about 3 mm to about 7 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, etc.

[0223] The encapsulation and fastening of the individual 7305 base film in this configuration can be compared with the reference. Figure 73 The same applies to what is shown and described. If the transversely cut tissue ends 7400a and 7400b are nerve ends, then using a separate basement membrane 7305 and barbed strips 7102 on the transversely cut tissue ends 7400a and 7400b can prevent axons growing from one or both of the transversely cut tissue ends 7400a and 7400b from escaping, that is, preventing the axons from moving outward away from the other of the transversely cut tissue ends 7400a and 7400b and from the interstitial space G. 74 Extending outwards. Despite Figure 74 Two tissue repair devices 7100 are shown on transversely cut tissue ends 7400a and 7400b, but one or more barbed strips 7102 may be used.

[0224] Although reference Figures 71 to 74 The discussion concerns transversely cut tissue ends. These embodiments of tissue repair devices can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow underlying tissue to heal, or to secure tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but rather are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect underlying tissue. H. Strips of basement membrane with barbs

[0225] Figure 75 This is a schematic diagram of a tissue repair device 7500, which includes a strip of base membrane 7502. The base membrane 7502 has barbs 7505 extending from its surface, the barbs 7505 being configured to contact tissue. One or more characteristics of the base membrane 7502 may be the same as those described above with respect to base membrane 3900. In some aspects, the barbs 7505 may extend from the distal region of the base membrane 7502. In some aspects, the central region of the base membrane 7502 may not contain the barbs 7505, while in other aspects, the central region of the base membrane 7502 may contain the barbs 7505. The barbs 7505 may be configured to engage with the tissue to which they are applied. This allows for contact with... Figures 71 to 74The tissue repair device 7500, which includes a base membrane 7502 having barbs 7505, is used in a similar manner to the tissue repair device 7100 including barbs 7102 in the embodiment shown. When according to Figures 72 to 74 When used according to the application method shown, the barbs 7505 at the distal region of the basement membrane 7502 can contact and engage two different regions or ends of the tissue. In a configuration of the basement membrane 7502 where the central region of the basement membrane 7502 does not have barbs 7505, this barbless central region can be positioned as a gap (e.g., gap G) between the basement membrane 7502 and the tissue. 72 G 73 or G 74 (Approximately aligned.) As described above with reference to these figures, one or more tissue repair devices 7500 can be used in a manner similar to the barbed strip 7102, including a separate base film with or without covering the tissue repair device 7500.

[0226] The barbs 7505 may be arranged in rows, columns, or a grid configuration and are evenly spaced. Other configurations may be used, including randomly spaced barbs 7505 or offset barbs 7505. The barbs 7505 may have a shape similar to or different from the barbs in the embodiments described herein. The tissue repair device 7500 may be formed of, for example, an absorbable polymer or metal, and may be a micro-injection molded strip with molded barbs, or may be 3D printed, or formed in any other suitable manner. In some aspects, the barbs 7505 may be laser-cut or embossed in a base membrane 7502, in which case the base membrane 7502 may be formed of the same material. In other aspects, the barbs 7505 may be formed separately from the base membrane 7502 and then attached to the base membrane 7502 in any of the foregoing manner. In some aspects, the barbs 7505 may be formed of an absorbable material different from the base membrane 7502. If the barbs 7505 and the base membrane 7502 are formed from different materials, such as different absorbable polymers or metals, then the barbs 7505 and the base membrane 7502 may have different mechanical properties. For example, the base membrane 7502 may be more flexible, while the barbs 7505 may be relatively more rigid in order to extend into and engage with the tissue. In some respects, the strips of the base membrane 7502 may be configured to reabsorb at a different speed (e.g., faster or slower) or at substantially the same speed as the barbs 7505. I. Base film and ceramic barbs

[0227] According to another embodiment, Figure 76This is a schematic diagram of a tissue repair device 7600, which includes a base membrane 7602, wherein ceramic barbs 7605 are attached to or embedded within the base membrane 7602. One or more characteristics of the base membrane 7602 may be the same as those described above with respect to base membrane 3900. The ceramic barbs 7605 may extend from the surface of the base membrane 7602, configured to contact tissue and may be configured to adhere to the tissue to which they are applied. In some aspects, the barbs 7605 may extend from the distal regions of the base membrane 7602. In some aspects, the central region of the base membrane 7602 may not contain barbs 7605, while in other aspects, the central region of the base membrane 7602 may contain barbs 7605. It is capable of being used with... Figures 71 to 74 The barbed strip 7102 and / or the tissue repair device 7100 of the embodiment shown Figure 75 The base membrane 7502 of the tissue repair device 7500 shown in the embodiment uses a base membrane 7602 with ceramic barbs 7605 in a similar or identical manner. When according to Figures 72 to 74 When used according to the application method shown, the barbs 7505 at the end region of the strip of base membrane 7602 can contact and engage the end regions of two different tissues or two different regions of a tissue. In a configuration of base membrane 7602 where the central region of the strip of base membrane 7602 does not have barbs 7605, this barbless central region can be positioned as a gap (e.g., gap G) between the base membrane 7602 and the tissue end. 72 G 73 or G 74 They are roughly aligned. As described above with reference to these figures, one or more base films 7602 can be used in a manner similar to the barbed strip 7102 and / or base film 7502.

[0228] and Figure 75Similar to the embodiments shown, the ceramic barbs 7605 of this embodiment can be arranged in rows, columns, or a grid configuration and are uniformly spaced. Other configurations can be used, including randomly spaced barbs 7605 or offset barbs 7605. The barbs 7605 may have a shape similar to or different from the barbs in the embodiments described herein. In embodiments where the barbs 7605 are ceramic barbs, the barbs 7605 may be formed of absorbable ceramics such as bioglass. The base membrane 7602 may be formed of, for example, an absorbable polymer. If the barbs 7605 and the base membrane 7602 are formed of different materials, such as different absorbable materials, the barbs 7605 and the base membrane 7602 may have different mechanical properties. For example, the strips of the base membrane 7602 may be more flexible, while the barbs 7605 may be relatively more rigid in order to extend into and engage with the tissue. In some respects, the base film 7602 may be configured to reabsorb at a different speed (e.g., faster or slower) than the barbs 7605, or at a substantially similar speed. In one aspect, to form the tissue repair device 7600, the barbs 7605 may be placed in a desired configuration or orientation, for example, in a container, and a material forming the base film 7602, such as an absorbable polymer, may be cast around the barbs 7605 placed in the container, such that the material completely covers the barbs 7605. The material may then be selectively etched to expose the barbs 7605 at one end, and the other end of the material may be sliced ​​to cut a film, thereby forming the tissue repair device 7600, wherein the barbs 7605 are embedded within the base film 7602. The material may be selectively etched to produce barbs 7605 of a predetermined height. J. Barbed structure and base film

[0229] According to one implementation method, Figure 77 This is a schematic diagram of a tissue repair device 7700 comprising two barbed sutures 7702 and a basement membrane 7705. The characteristics of the basement membrane 7705 are the same as those described above regarding the basement membrane 3900. Specifically, Figure 77 Two barbed sutures 7702 are shown, wherein the barbs 7710 are self-constructed to extend from the surface of each barbed suture 7702 in contact with the tissue, and the barbed sutures 7702 extend longitudinally. Figure 77 The base membrane 7705 is also shown. The barbed sutures 7702 of this embodiment are referred to as anchors and can be arranged individually, i.e., the barbed sutures 7702 can be arranged to be spaced apart from one or more additional barbed sutures 7702 on the base membrane 7705. The longitudinal length L of the barbed sutures 7702 is... 7702 The width W can be greater than that of the 7705 base film. 7705 Thus, the barbed suture 7702 extends from the edge of the basement membrane 7705. Although Figure 77Two barbed sutures 7702 are shown, but the tissue repair device 7700 may include one or more barbed sutures 7702. Additionally, the barbed sutures 7702 may be located in one or more terminal regions of the basement membrane 7705, in the central region of the basement membrane 7705 and one or more terminal regions (as shown in Figure 77), only in the central region of the basement membrane 7705, or may be spaced apart along the basement membrane 7705 in both the central and terminal regions. Although Figure 77 The barbed suture 7702 is depicted extending generally perpendicular to the basement membrane 7705, wherein the longest edge of the basement membrane 7705 is perpendicular to the length of the barbed suture 7702. Other relative orientations of the basement membrane 7705 and the barbed suture 7702 are also possible. For example, the barbed suture 7702 may extend generally parallel to the longest edge of the basement membrane 7705, or the barbed suture 7702 may extend at an angle greater than or less than 90 degrees relative to the edge of the basement membrane 7705.

[0230] The barbed suture 7702 can be attached to the base membrane 7705 in any suitable manner, as described above. For example, the barbed suture 7702 can be braided or sewn through or onto the base membrane 7705, as... Figure 77 As shown, or they can be obtained through pores defined in the base film 7705, such as Figure 78 As shown, they may be sandwiched between two or more base membranes 7705. The barbed sutures 7702 may include barbs 7710 in certain portions, while lacking barbs 7710 in portions extending across the base membrane 7705. The portions of the barbed sutures 7702 with barbs 7710 may extend outward from the base membrane 7705, as shown. With this arrangement, in some respects, no barbs 7710 can penetrate the base membrane 7705.

[0231] During use, it is possible to relate to... Figures 72 to 74 The tissue repair device 7100 applies the base membrane 7705 of the tissue repair device 7700 with barbed sutures 7702 in a manner similar to that described above. The difference is that instead of applying separate barbed strips to the tissue ends and then covering these strips and the tissue ends with a separate base membrane, the barbed sutures 7702 are essentially used as barbed strips 7102, and the base membrane 7705 is used as an integrated base membrane covering the tissue. This is not as... Figure 73 and 74Instead of using separate components, the barbed suture 7702 can be integrated with the basement membrane 7705 in the form of a barbed suture 7702. Thus, the distal region of the tissue can be secured relative to each other using the barbed ends of the barbed suture 7702, and the basement membrane 7705 can cover the periphery of the secured tissue distal region. To secure the barbed suture 7702 to the tissue distal region or portion, the barbed suture 7702 can engage with the outer surface of the tissue distal region before and / or while the basement membrane 7705 is covering the periphery of the tissue distal region. In some respects, the barbed sutures 7702 can be spaced apart along the basement membrane 7705, so that the barbed sutures 7702 can be positioned on generally opposite sides or distal ends of the tissue when applied, or they can be positioned along different portions of the tissue because the basement membrane 7705 can cover the periphery of the tissue.

[0232] Although reference Figure 77 The discussion concerns transversely cut tissue ends. This embodiment of the tissue repair device can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow underlying tissue to heal, or to secure tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but rather are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect underlying tissue. K. The group of parallel sutures and basement membrane

[0233] According to another embodiment, Figure 78 This is a schematic diagram of a tissue repair device 7800, which includes two sets of side-by-side barbed sutures 7802 and a basement membrane 7805. Specifically, Figure 78 Two sets of barbed sutures 7802 with barbs 7810 and a base membrane 7805 are shown, the barbed sutures 7802 extending longitudinally. One or more characteristics of the base membrane 7805 may be the same as those described above regarding the base membrane 3900. The barbed sutures 7802 of this embodiment may be arranged in groups, wherein each group of barbed sutures 7802 comprises two or more individual barbed sutures 7802. Although two sets of barbed sutures 7802 are shown, there may also be more sets of barbed sutures 7802, such as three sets of barbed sutures 7802, four sets of barbed sutures 7802, etc.

[0234] The groups of barbed sutures 7802 can be connected to each other. For example, multiple groups of barbed sutures 7802 can be welded together or attached via coupling sutures, cable ties, straps, or any other suitable fasteners. The groups of barbed sutures 7802 can be arranged to be spaced apart from one or more additional groups of barbed sutures 7802 on the base membrane 7805. The groups of barbed sutures 7802 can be arranged as described above regarding... Figure 77 Any arrangement or relative orientation of the base membrane 7705 and the barbed sutures 7702 is spaced apart along the base membrane 7805.

[0235] The assembly of barbed sutures 7802 may have a width W greater than that of the base membrane 7805. 7805 Longitudinal length L 7802 .although Figure 78 Two sets of barbed sutures 7802 are shown, but a single set of barbed sutures 7802 or two or more sets of barbed sutures 7802 may be used. The sets of barbed sutures 7802 may be attached to the basement membrane 7805 in any of the manner described above. For example, as... Figure 78 As shown, multiple sets of barbed sutures 7802 can pass through the holes in the basement membrane 7805, or they can be woven or sewn through the basement membrane 7805, as... Figure 77 As shown, it may be sandwiched between two layers of the multilayer base film 7805. Furthermore, with... Figure 77 Similarly, in the illustrated embodiment, the barbed suture 7802 may include a portion with barbs 7810 located at a position extending across the basement membrane 7805 and a portion without barbs 7810. The portion of the barbed suture 7802 with barbs 7810 may extend outward from the basement membrane 7805, as shown. With this arrangement, in some respects, the portion without barbs 7810 can penetrate the basement membrane 7805. L. Barbed strips and base film

[0236] According to yet another implementation method Figure 79 This is a schematic diagram of a tissue repair device 7900 having two barbed strips 7902 integrated with a basement membrane 7905. Specifically, Figure 79 Two barbed strips 7902 with barbs 7910 integrated with the base membrane 7905 are shown. One or more characteristics of the base membrane 7905 may be the same as those described above regarding the base membrane 3900. In this embodiment, it is not an integrated barbed suture or a group of barbed sutures ( Figure 77 and 78 Instead, refer to the previous text. Figures 71 to 74 The strips or meshes described herein may be integrated as part of the base membrane 7905. The barbed strips 7902 may be formed from a plurality of laterally and longitudinally arranged barbed sutures, or a combination of barbed and barbless sutures, or in other words, formed from a plurality of barbed sutures, or a combination of barbed and barbless sutures, in the form of a thin grid pattern or mesh. Each barbed strip 7902 may include one or more barbs 7910 extending from the surface of the barbed strip 7902 that are self-contained as being in contact with tissue. The barbed strips 7902 can be configured as described above. Figure 77 and 78The barbs 7902 are arranged or oriented in any suitable manner to be spaced apart from one or more additional barbed strips 7902 on the integrated base film 7905. The barbed strips 7902 may have a width W greater than that of the base film 7905. 7905 Longitudinal length L 7902 .although Figure 79 A tissue repair device 7900 with two barbed strips 7902 is shown, but it may also include a single barbed strip 7902 or two or more barbed strips 7902. The barbed strips 7902 may be sandwiched between two or more layers of a multilayer base membrane 7905, or may be sewn, woven, or passed through pores in the base membrane 7905, such as... Figure 79 As shown. And, with Figure 77 and 78 Similarly, in the illustrated embodiment, the barbed strip 7902 may include barbs 7910 in some portions, while the portion extending across the base film 7905 may not contain barbs 7910. The portion of the barbed strip 7902 with barbs 7910 may extend outward from the base film 7905, as shown. With this arrangement, in some respects, no barbs 7910 can penetrate the base film 7905. a. Use of a tissue repair device with barbed strips that integrate with the basement membrane

[0237] According to one implementation method, Figure 80 This is a schematic diagram of a tissue repair device 7900 used in the tissue repair process, which includes... Figure 79 The two barbed strips 7902 integrated with the base film 7905 are shown. Specifically, Figure 80 The diagram shows two barbed strips 7902 with barbs 7910, an integrated basement membrane 7905, and two transversely cut tissue ends 8000a and 8000b. The two transversely cut tissue ends 8000a and 8000b can be placed on the basement membrane 7905, with the barbed strips 7902 generally aligned with the two transversely cut tissue ends 8000a and 8000b. A portion of the basement membrane 7905 and a portion of each barbed strip 7902 extending beyond the basement membrane 7905 can be positioned on one of the transversely cut tissue ends 8000a and 8000b, and another portion of the basement membrane 7905 and another portion of each barbed strip 7902 can be generally aligned with the other transversely cut tissue end 8000a and 8000b. The transversely cut tissue ends 8000a and 8000b can be arranged such that the ends of the transversely cut tissue ends 8000a and 8000b are located on the basement membrane 7905, and the terminal regions and central portions of the transversely cut tissue ends 8000a and 8000b are located on the barbed strip 7902. The transversely cut tissue ends 8000a and 8000b can be positioned relative to each other, thereby forming a gap G between them. 80 The reason is as mentioned above regarding the gap G. 67The gap G is discussed. 80 It can be about 0 mm, or it can be greater than about 0 mm, such as up to about 5 mm or up to about 10 mm. For example, the gap can be about 0 mm to about 10 mm, about 0 mm to about 8 mm, about 1 mm to about 10 mm, about 1 mm to about 8 mm, about 2 mm to about 8 mm, about 3 mm to about 7 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, etc.

[0238] The width W of the barbed strip 7902 7902 This allows the width of each barb strip 7902 to lie on or adhere to the portion of the transversely cut tissue ends 8000a and 8000b that is outside the transversely cut tissue ends 8000a and 8000b when they are placed on the base membrane 7905. Figure 80 As shown. That is, the barbed strips 7902 can collectively extend around the outer surface of each of the transversely cut tissue portions 8000a and 8000b, and each barbed strip 7902 extends substantially in a straight line along the transversely cut tissue ends 8000a and 8000b. The base membrane 7905 can cover the entire outer surface of each of the transversely cut tissue ends 8000a and 8000b, thereby surrounding or closing the gap G. 80 .

[0239] The covering may involve physically moving (e.g., rolling, twisting, or pulling) the base membrane 7905 and placing it on the surface of the transversely cut tissue ends 8000a and 8000b, rolling the transversely cut tissue ends 8000a and 8000b around the base membrane 7905, or a combination thereof. In some respects, the ends of the base membrane 7905 may be secured after covering, for example, using sutures, adhesives, glue, or capillary action. With this configuration, the barbed strip 7902 and the base membrane 7905 securely hold the transversely cut tissue ends 8000a and 8000b in place, thereby enabling the tissue repair process. More specifically, the barbs 7910 on the barbed strip 7902 may protrude into or otherwise engage with the outer surface of each of the transversely cut tissue ends 8000a and 8000b, and the barbs 7910 and the basement membrane 7905 may inhibit the transversely cut tissue ends 8000a and 8000b from moving apart. In the case that the transversely cut tissue ends 8000a and 8000b are nerve tissue, the basement membrane 7905 may also prevent axons that may grow from one or both ends of the tissue ends 8000a and 8000b from escaping or extending outward away from the other of the tissue ends 8000a and 8000b.

[0240] Although reference Figure 79 and 80The discussion concerns transversely cut tissue ends. This embodiment of the tissue repair device can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow underlying tissue to heal, or to secure tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but rather are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect underlying tissue. M. The barbed strips on the first base film and the second base film.

[0241] According to yet another implementation method Figure 81 This is a schematic diagram of a tissue repair device 8100, which includes two barbed strips 8102, each attached to a strip of a first base membrane 8105 and integrated with a second base membrane 8110. One or more characteristics of the first base membrane 8105 and the second base membrane 8110 may be the same as those described above regarding base membrane 3900. The barbed strips 8102 can be similarly referenced. Figure 71 The tissue repair device 7100 is described above. Figure 81 The implementation method can be similar to Figure 79 The implementation method can be similar to Figure 79 This method is used in a manner different from the previous one, except that individual barbed strips 8102 can be adhered to or otherwise attached to the strips of the base film as a backing. Specifically, Figure 81 This diagram shows two barbed strips 8102 with barbs 8115, two strips of first base film 8105 attached to the back side of the barbed strips 8102 (i.e., the side opposite to the protruding surface of the barbs 8115), and a second base film 8110. Figure 79 Similar to the embodiment shown, the barbed strip 8102 may be formed by a plurality of laterally and longitudinally arranged barbed sutures, or a combination of barbed sutures and barbless sutures, or in other words, formed by a plurality of barbed sutures or a combination of barbed sutures and barbless sutures, in the form of a thin grid pattern or mesh, which may be fixed to the strip of the first base film 8105. Each barbed strip 8102 may include one or more barbs 8115 extending from the surface of the barbed strip 8102 that are configured to contact the tissue. The strips and barbed strips 8102 of the first base film 8105 may be arranged to be spaced apart from one or more additional strips and barbed strips 8102 of the first base film 8105 on the second base film 8110, as referred to above. Figure 77 and 78 As stated above.

[0242] The strip of the first base film 8105 with barbed strips 8102 may have a width W greater than that of the second base film 8110. 8010 Longitudinal length L 8105 .although Figure 81 The diagram illustrates a tissue repair device 8100 comprising two first basement membranes 8105 and two barbed strips 8102, but it may also comprise one first basement membrane 8105 and one barbed strip 8102, or more than two first basement membranes 8105 and more than two barbed strips 8102. Furthermore, the barbed strips 8102 may be located in one or more end regions of the second basement membrane 8110, in the central region of the second basement membrane 8110, and in one or more end regions (e.g., Figure 81 (As shown), located only in the central region of the second base film 8110, or spaced apart along the second base film 8110 in both the central and end regions. Although Figure 81 The diagram shows the barbed strip 8102 extending generally perpendicular to the second base film 8110, with the longest edge of the second base film 8110 perpendicular to the length of the barbed strip 8102. However, other relative orientations of the second base film 8110 and the barbed strip 8102 are also possible. For example, the barbed strip 8102 may extend generally parallel to the longest edge of the second base film 8110, or the barbed strip 8102 may extend at an angle greater than or less than 90 degrees relative to the edge of the second base film 8110. The barbed strip 8102 may be sandwiched between two or more layers of the multilayer second base film 8110, such as... Figure 81 As shown, it may be sewn or passed through a hole in the second base film 8110, or be able to be attached in any suitable manner as described above. Furthermore, with Figure 77 and 78 Similar to the embodiment shown, the barbed strip 8102 may include barbs 8115 in some portions, while lacking barbs 8115 in other portions extending across the second base film 8110. The portions of the barbed strip 8102 with barbs 8115 may extend outward from the second base film 8110, as shown. With this arrangement, in some respects, no barbs 8115 can penetrate the second base film 8110. During use, the second base film 8110 may be configured according to... Figure 77 and 78 The same approach is applied to organizations. N. Barbed wire mesh and base film

[0243] According to one or more implementation methods Figure 82 This is a schematic diagram of a tissue repair device 8200, which includes barbed wire 8202 adhered to or embedded within a base membrane 8210. One or more characteristics of the base membrane 8210 may be the same as those described above regarding the base membrane 3900. Figure 82In the illustrated embodiment, the barbed wire 8202 may extend from both sides of the base film 8210, for example, opposite sides. For example, the base film 8210 may extend between portions of the barbed wire 8202. The barbed wire 8202 may extend uniformly from both sides of the base film 8210, or may extend non-uniformly from both sides of the base film 8210. In some aspects, the barbed wire 8202 may extend integrally along both sides of the base film 8210, while in other aspects, the barbed wire 8202 may not extend integrally along both sides, or may extend beyond both sides of the base film 8210.

[0244] In some respects, the barbed mesh 8202 may be formed from a plurality of barbed sutures 8205. The barbed mesh 8202 may include barbed sutures 8205 and barbs 8215, and a base membrane 8210. The barbed mesh 8202 may be formed from a plurality of laterally and longitudinally arranged barbed sutures 8205, or from a combination of barbed sutures and barbless sutures, for example, in a grid pattern. Each barbed suture 8205 may include one or more barbs 8215 extending from the surface of each barbed suture 8205 that is self-contained as contact with tissue. Each barbed suture 8205 may be a separate barbed suture, for example, woven together with or covering other barbed sutures, or the barbed sutures 8205 may be connected to each other at the intersection of two or more barbed sutures 8205, or may be a uniform mesh rather than woven or covering barbed sutures 8205. The longitudinal length L of the barbed suture 8205 8205 The width W can be greater than that of the base film 8210. 8210 In an embodiment where the barbed stitch line 8205 of the barbed mesh 8202 extends along the surface of the base film 8210, the barbed stitch line 8205 may not contain barbs at the location where it extends across the base film 8210 (in other words, there may be no barbs in the area of ​​the base film 8210 where the barbed mesh 8202 with barbed stitch line 8205 is placed).

[0245] The barbed suture 8205 may be formed of the materials described herein. The barbed suture 8205 and the base membrane 8210 may be formed of the same material, or they may be formed of different materials, both of which may be, for example, absorbable polymers or metals. For example, if the barbed suture 8205 and the base membrane 8210 are formed of different absorbable polymers or metals, the barbed mesh 8202 and the base membrane 8210 may have different mechanical properties. For example, the base membrane 8210 may be more flexible, while the barbs 8215 may be relatively more rigid in order to extend into and engage with the tissue. In some respects, the base membrane 8210 may be configured to reabsorb at a different rate (e.g., faster or slower) or at a substantially similar rate compared to the barbs 8215.

[0246] Furthermore, when the barbed wire 8202 is attached to the base film 8210, the barbed wire 8202 can be attached to the base film 8210 in a suitable manner. For example, the barbed wire 8202 can be attached to the base film 8210 by taping or heat welding, as described above. Alternatively, the barbed wire 8202 can be attached to the base film 8210 using glue or adhesive. The glue or adhesive may be composed of one or more of the materials described above.

[0247] As another example, the barbed mesh 8202 can be attached by weaving or sewing the barbed suture 8205 through the base membrane 8210, or by making J-shaped or S-shaped cuts or small holes in the base membrane 8210, through which the barbed suture 8205 is passed, and knotted at the end of the barbed suture 8205 after passing through the cuts or holes, thereby hooking the barbed suture 8205 onto the base membrane 8210. As yet another example, the barbed suture 8205 can be attached using heat, for example by melting the barbed suture 8205 at a specific location when it is on top of the base membrane 8210.

[0248] As another example, barbed sutures 8205 can be attached to a base membrane 8210 using etching, wherein the barbed sutures 8205 are arranged in a desired orientation within the container, and a material forming the base membrane 8210 (e.g., an absorbable polymer) can be cast around the barbed sutures 8205 within the container, so that the barbed sutures 8205 are completely covered by the material. The material can then be selectively etched to expose the barbed sutures 8205 at at least one end, and the other end of the material can be sliced ​​to cut a film, thereby forming a tissue repair device 8200, wherein a barbed mesh 8202 is embedded in the base membrane 8210. The shape and size of the base membrane 8210 can be determined so that the barbless portions of the barbed mesh 8202 are located on the base membrane 8210, such as... Figure 82 As shown. a. Use of tissue repair devices with barbed mesh and basement membrane

[0249] During use, the base film 8210 can be used in accordance with... Figures 77 to 81 The same method is applied to the organization. According to one embodiment, Figure 83 This is a schematic diagram of the tissue repair device 8200 during the tissue repair process, which includes... Figure 82 The barbed mesh 8202 is shown attached to the base film 8210. Specifically, Figure 83The diagram shows a barbed wire mesh 8202, a base membrane 8210, and two transversely cut tissue ends 8300a and 8300b. The two transversely cut tissue ends 8300a and 8300b can be positioned on the barbed wire mesh 8202 and the base membrane base 8210, such that a portion of the barbed wire mesh 8202 and a portion of the base membrane 8210 are located on one of the transversely cut tissue ends 8300a and 8300b, while another portion of the barbed wire mesh 8202 and another portion of the base membrane 8210 are located on the other transversely cut tissue ends 8300a and 8300b. The transversely cut tissue ends 8300a and 8300b can be arranged such that the end regions of the transversely cut tissue ends 8300a and 8300b are located on the base membrane 8210, and the portions of the transversely cut tissue ends 8300a and 8300b disposed back from their end regions are located on the barbed wire 8202. The transversely cut tissue ends 8300a and 8300b can be positioned relative to each other, thereby forming a gap G between the transversely cut tissue ends 8300a and 8300b. 83 It is approximately 0 mm or less than approximately 5 mm. Then, the barbed wire 8202 and the base film 8210 can be wrapped around the outer surface of each of the transversely cut tissue ends 8300a and 8300b.

[0250] Covering the barbed wire 8202 and the base film 8210 may involve physically moving (e.g., rolling, twisting, or pulling) the barbed wire 8202 and the base film 8210 and placing them on the surface of the transversely cut tissue ends 8300a and 8300b, rolling the transversely cut tissue ends 8300a and 8300b around the barbed wire 8202 and the base film 8210, or a combination thereof. In some aspects, the ends of the barbed wire 8202, the base film 8210, or both may be secured in place after covering, for example, using sutures, adhesives, glue, or capillary action. Alternatively, the engagement of the barbed wire 8202 with the tissue may be sufficient to secure the barbed wire 8202 and the base film 8210 in place. With this configuration, the barbed mesh 8202 and the base membrane 8210 can secure the transversely cut tissue ends 8300a and 8300b together, thereby enabling the tissue repair process. More specifically, the barbs 8215 on the barbed suture 8205 of the barbed mesh 8202 can protrude to or otherwise engage with the outer surface of each of the transversely cut tissue ends 8300a and 8300b, and the barbs 8215, together with the barbed mesh 8202 and the base membrane 8210, can inhibit the transversely cut tissue ends 8300a and 8300b from moving apart.

[0251] According to another embodiment, Figure 84 for Figure 82This diagram illustrates the tissue repair device 8200 during the tissue repair process. Specifically, Figure 84 The barbed wire mesh 8202, the base membrane 8210, and two transversely cut tissue ends 8400a and 8400b are shown. Figure 83 Similar to the configuration shown, in this configuration, two transversely cut tissue ends 8400a and 8400b can be positioned on the barbed mesh 8202 of the barbed suture 8205 and the basement membrane 8210. However, in this configuration, the transversely cut tissue ends 8400a and 8400b can be arranged such that the terminal regions of the transversely cut tissue ends 8400a and 8400b are located on the basement membrane 8210, and the portions of the transversely cut tissue ends 8400a and 8400b closer to the terminal regions are located on the barbed mesh 8202. The transversely cut tissue ends 8400a and 8400b can be positioned relative to each other, thereby forming a gap G between them. 84 The reason is as mentioned above regarding the gap G. 67 The gap G is discussed. 84 It can be greater than approximately 0 mm, such as up to approximately 10 mm or up to approximately 5 mm. For example, gap G 84 The diameter can be approximately 0 mm to approximately 10 mm, approximately 0 mm to approximately 8 mm, approximately 1 mm to approximately 10 mm, approximately 1 mm to approximately 8 mm, approximately 2 mm to approximately 8 mm, approximately 3 mm to approximately 7 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, etc. The covering and fastening of the barbed wire 8202 and the base film 8210 of this configuration can be related to... Figure 83 The same as those shown and described.

[0252] Although reference Figures 82 to 84 The discussion concerns transversely cut tissue ends. This embodiment of the tissue repair device can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow underlying tissue to heal, or to secure tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but rather are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect underlying tissue. O. Mesh within the strip of the base film

[0253] According to one implementation method, Figure 85 This is a schematic diagram of a tissue repair device 8500, which includes a mesh 8502 adhered to or embedded within a strip of a base membrane 8510. One or more characteristics of the base membrane 8510 may be the same as those described above regarding the base membrane 3900. Figure 85The mesh 8502 is shown, which may include barbs 8515 and barbless portions 8520. The mesh 8502 may be, for example, 3D printed, or may be formed from a plurality of laterally and longitudinally arranged barbed sutures 8505, or a combination of barbed and barbless sutures, or in other words, formed from a plurality of barbed sutures 8505, or a combination of barbed and barbless sutures, arranged in a grid pattern. Each barbed suture 8505 may include one or more barbs 8515 extending from the surface of the barbed suture 8505 that are configured to contact tissue, and as described above... Figure 82 As shown, the mesh 8502 may include a portion 8520 without barbs 8515. The portion 8520 without barbs 8515 may be located in the central region of the mesh 8502, as shown, but in other embodiments, the portion 8520 without barbs 8515 may be located at one or both ends of the mesh 8502.

[0254] The mesh 8502 can be attached to the strip of the base film 8510 using glue or adhesive or any other method described above. As another example, the mesh 8502 can be attached by weaving or sewing a barbed thread 8505 through the strip of the base film 8510, or by making a J-shaped or S-shaped cut in the base film 8510 or creating small holes on the side of the base film 8510, through which the barbed thread 8505 is passed, and knotted at the end of the barbed thread after passing through the cut or hole, thereby hooking the barbed thread 8505 onto the strip of the base film 8510. As yet another example, the barbed thread can be attached using heat, for example by melting the barbed thread 8505 at a specific location when it is on top of the strip of the base film 8510. As a further example, barbed sutures 8505 can be attached to a base membrane 8510 using etching, wherein the barbed sutures 8505 are arranged in a desired orientation within a container, and a material forming the base membrane 8510 (e.g., an absorbable polymer) can be cast around the barbed sutures within the container, so that the barbed sutures 8505 are completely covered by the material. The material can then be selectively etched to expose the barbed sutures 8505 at at least one end, and the other end of the material can be sliced ​​to cut a film, thereby forming a tissue repair device 8500, wherein a mesh 8502 is embedded in strips of the base membrane 8510. a. Use of tissue repair devices with mesh within strips of the basement membrane

[0255] According to one implementation method, Figure 86 This is a schematic diagram of the tissue repair device 8500 during the tissue repair process. Specifically, Figure 86Two tissue repair devices 8500 and two transversely cut tissue ends 8600a and 8600b are shown. The two tissue repair devices 8500 can be aligned on the transversely cut tissue ends 8600a and 8600b, such that a portion of the strip of each base membrane 8510 and a portion of each mesh 8502 with barbs 8515 are located on one of the transversely cut tissue ends 8600a and 8600b, and another portion of the strip of each base membrane 8510 and another portion of each mesh 8502 with barbs 8515 are located on the other of the transversely cut tissue ends 8600a and 8600b. The transversely cut tissue ends 8600a and 8600b can be arranged such that the end regions of the transversely cut tissue ends 8600a and 8600b, arranged from the very end back, are located on the mesh 8502, and the ends of the transversely cut tissue ends 8600a and 8600b are located on the strips of the base film 8510. The transversely cut tissue ends 8600a and 8600b can be positioned relative to each other, thereby forming a gap G between the transversely cut tissue ends 8600a and 8600b. 86 It can be approximately 0 mm or less than approximately 5 mm. Figure 86 In the embodiment shown, the barbless portion 8520 of the mesh 8502 8515 can be positioned to span the gap G between the transversely cut tissue ends 8600a and 8600b. 86 superior.

[0256] The width W of the strip of the base film 8510 having mesh 8502 8510 This allows the entire width W of each strip of the base membrane 8510 to be such that when the transversely cut tissue ends 8600a and 8600b are placed on the strips and mesh 8502 of the base membrane 8510 (or when the strips of the base membrane 8510 with mesh 8502 are placed on the transversely cut tissue ends 8600a and 8600b), 8510 Located or adhered to the outer surfaces of the transversely cut tissue ends 8600a and 8600b, such as Figure 86 As shown. That is, the strips of the base membrane 8510 can extend around a portion of the surface of the transversely cut tissue ends 8600a and 8600b to "bundle" the transversely cut tissue ends 8600a and 8600b together. With this configuration, the strips of the base membrane 8510 and the mesh 8502 can fasten the transversely cut tissue ends 8600a and 8600b together, thereby enabling the tissue repair process. More specifically, the barbs 8515 of the mesh 8502 can protrude into or otherwise engage with the outer surface of each of the transversely cut tissue ends 8600a and 8600b, and the barbs 8515 can work together with the strips of the base membrane 8510 to prevent the transversely cut tissue ends 8600a and 8600b from moving apart. Although Figures 86 to 88 Two tissue repair devices 8500 are described, but one or more tissue repair devices 8500 may be used in the program.

[0257] According to one implementation method, Figure 87 This is a schematic diagram illustrating the tissue repair process using two tissue repair devices 8500 and a separate basement membrane 8705. Specifically, Figure 87 The diagram shows strips of a base membrane 8510 with barbed mesh 8502, each including a portion 8520 containing barbs 8515 and a portion without barbs 8515; a separate base membrane 8705; and two transversely cut tissue ends 8700a and 8700b of the strip onto which the base membrane 8510 is applied. The tissue repair device 8500 can be applied to the two transversely cut tissue ends 8700a and 8700b, as shown in reference... Figure 86 However, in this embodiment, a separate base membrane 8705 covers the top of at least the central portion of the tissue repair device 8500. When positioned in place, the separate base membrane 8705 can cover the gap G between the transversely cut tissue ends 8700a and 8700b. 87 And can cover at least a portion of the barbless portion 8520. The transversely cut tissue ends 8700a and 8700b can be arranged such that the gap G between the transversely cut tissue ends 8700a and 8700b is... 49 It can be approximately 0 mm or less than approximately 5 mm. The shape and size of the individual base membrane 8705 can be determined so that the barbless portion 8520 of the tissue repair device 8500 8515 is located on the individual base membrane 8705, such as... Figure 87 As shown. During use, the individual base film 8705 can be referenced in conjunction with... Figure 73 and 74 Similar methods are applied to organizations.

[0258] According to another embodiment, Figure 88 for Figure 85 The two tissue repair devices 8500 shown are Figure 87 A schematic diagram of the individual base film 8705 is shown. Specifically, Figure 88 The diagram shows a strip of base membrane 8510 with mesh 8502, a separate base membrane 8705, and two transversely cut tissue ends 8800a and 8800b. The tissue repair device 8500 can be described as follows: Figure 86 As described above, and the base film 8705 alone can be applied as referred to Figure 87 The above-mentioned application, but Figure 88 In one embodiment, the transversely cut tissue ends 8800a and 8800b can be positioned relative to each other, thereby forming a gap G between them. 88 The reason is as mentioned above regarding the gap G. 67 The gap G is discussed.88 It can be greater than about 0 mm, up to about 10 mm, or up to about 5 mm. For example, gap G 88 The thickness can be approximately 0 mm to approximately 10 mm, approximately 0 mm to approximately 8 mm, approximately 1 mm to approximately 10 mm, approximately 1 mm to approximately 8 mm, approximately 2 mm to approximately 8 mm, approximately 3 mm to approximately 7 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, etc. The encapsulation and fastening of the individual base film 8705 in this configuration can be related to... Figure 87 The same applies to the description. If the transversely cut tissue ends 8800a and 8800b are nerve ends, then by covering the transversely cut tissue ends 8800a and 8800b, which are fastened together via strips of basement membrane 8510 and mesh 8502, with a separate basement membrane 8705, it may be possible to prevent axons growing from one or both of the transversely cut tissue ends 8800a and 8800b from escaping, i.e., preventing axons from moving outward away from the other of the transversely cut tissue ends 8800a and 8800b and from the gap G. 88 Extend outwards.

[0259] Although reference Figures 85 to 88 The discussion concerns transversely cut tissue ends. This embodiment of the tissue repair device can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow underlying tissue to heal, or to secure tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but rather are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect underlying tissue. P. Strips of base film with barbed mesh

[0260] According to another embodiment, Figures 89 to 91 This is a schematic diagram of a tissue repair device 8900 formed by strips of a separate base membrane 8905 and barbed mesh 8910. The base membrane 8905 may have one or more of the characteristics of the base membrane 3900 described above. Figure 89 A strip of basement membrane 8905 is shown, on which two tissue ends 8915a and 8915b are placed. The strip of basement membrane 8905 may initially cover the tissue ends 8915a and 8915b. Figure 90 The tissue ends 8915a and 8915b are shown, surrounded by strips of base membrane 8905, and placed on a barbed mesh 8910. The barbed mesh 8910 may have a barbed portion 8920 with barbs 8925 and a barbless portion 8930 without barbs. The barbless portion 8930 may be aligned with the strips of base membrane 8905, as shown. Figure 91The strips of the base membrane 8905 and the barbed mesh 8910 are shown to be wrapped around the tissue ends 8915a and 8915b. The barbed mesh 8910 can wrap around the tissue ends 8915a and 8915b and the strips of the base membrane 8905 to complete the bonding of the tissue ends 8915a and 8915b. The barbed portions 8920 of the barbed mesh 8910 can be attached to the tissue ends 8915a and 8915b without physically restricting the wrapped base membrane 8905.

[0261] According to another embodiment, Figure 92 , 93 Figure 94 shows another embodiment of the tissue repair device 9200, which is formed of strips of a base membrane 9205 and barbed mesh 9210. The strips of the base membrane 9205 may have one or more of the characteristics of the base membrane 3900 described above. Figure 92 A barbed wire mesh 9210 is shown, on which two tissue ends 9215a and 9215b are placed. The barbed wire mesh 9210 may have a barbed portion 9220 with barbs 9225 and a barbless portion 9230 without barbs. The barbed wire mesh 9210 may initially cover the tissue ends 9215a and 9215b, securing the tissue ends 9215a and 9215b together. Figure 93 The tissue ends 9215a and 9215b are shown, which are surrounded by barbed mesh 9210 and placed on the strip of base film 9205. Figure 94 The diagram shows that the strips of the base membrane 9205 and the barbed mesh 9210 are both wrapped around the tissue ends 9215a and 9215b. The strips of the base membrane 9205 can wrap around the tissue ends 9215a and 9215b and the barbed mesh 9210 to complete the bonding of the tissue ends 9215a and 9215b. The barbed portions 9220 of the barbed mesh 9210 can be attached to the tissue ends 9215a and 9215b to achieve bonding, and the strips of the base membrane 9205 wrap around the bonded tissue ends 9215a and 9215b.

[0262] Although reference Figures 89 to 94 The discussion concerns transversely cut tissue ends. These embodiments of tissue repair devices can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow underlying tissue to heal, or to secure tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but rather are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect underlying tissue. Q. Base membrane with barbed sutures

[0263] Figures 95 to 97Another embodiment of the tissue repair device 9500 is shown, which is formed by a base membrane 9505 and a plurality of barbed sutures 9520. The base membrane 9505 has large protrusions 9510 and small protrusions 9515, the small protrusions 9515 forming a relatively narrow portion of the base membrane 9505. The base membrane 9505 may have one or more of the characteristics of the base membrane 3900 described above. The barbed sutures 9520 may be bidirectional barbed sutures because they include a plurality of barbs 9530 pointing in one direction and a plurality of barbs 9530 pointing in another direction.

[0264] Figure 95 A base film 9505 is shown, which has a large tab 9510 and a small tab 9515. In one example embodiment, the width W of the large tab 9510 is... 9510 The width W of the small protrusion 9515 can be approximately 2 cm to approximately 2.5 cm. 9515 The width can be from approximately 1 cm to approximately 1.5 cm, but a narrower width and a relatively wider width may be used depending on the intended use of the tissue repair device 9500. The total length L of the base membrane 9505... 9505 The size or diameter of the tissue to be repaired can be based on the tissue repair device 9500 to be used.

[0265] As mentioned above Figure 48 The method involves creating an incision 9535 within the edge of the small protrusion 9515 and hooking a barbed suture 9520 into the incision 9535. The barbed suture 9520 can be attached to the small protrusion 9515. Figure 95 As shown. Figure 96 The back of the tissue repair device 9500 is shown, and specifically, the barbed portion 9525 with barbed sutures 9520 having barbs 9530 and the barbless portion 9540 without barbs 9520 are shown. (As previously mentioned...) Figure 48 In the described embodiment, the barbed suture 9520 can be hooked onto the small protrusion 9515, such that the barbed portion 9525 extends outward from the small protrusion 9515, and the barbless portion 9540 overlaps with the small protrusion 9515, as shown in the figure. That is, the barbed suture 9520 can be attached to the small protrusion 9515 by any suitable method described above, such as adhesive, sewing, weaving, heating, etc.

[0266] Figure 97Two tissue ends 9700a and 9700b are shown arranged longitudinally, aligned with and overlapping at least one barbed suture 9520, and small protrusions 9515 of the basement membrane 9505 are positioned relative to tissue ends 9700a and 9700b. The tissue repair device 9500 can cover and surround the tissue ends 9700a and 9700b, such that the small flap 9515 and the barbed suture 9520 cover and surround the tissue ends 9700a and 9700b, wherein the barbs 9530 of the barbed suture 9520 engage with the tissue ends 9700a and 9700b to achieve coaptation, and the large flap 9510 also covers and surrounds the tissue ends 9700a and 9700b to further provide mechanical stability, thereby minimizing the risk of axonal extrusion when used with nerves and protecting a larger area of ​​the tissue ends 9700a and 9700b around the coaptation site.

[0267] The small protrusion 9515 with barbed sutures 9520 helps to bring the bidirectional barbs 9530 closer to the junction between tissue ends 9700a and 9700b, thus helping to maintain the alignment of tissue ends 9700a and 9700b. As an example, when tissue ends 9700a and 9700b are nerve tissue ends, the small protrusion 9515 and the bidirectional barbs 9530 help maintain a bundle arrangement, that is, the arrangement between bundles within the nerve tissue ends. Then, the large protrusion 9510 covers the small protrusion and provides mechanical stability, minimizing the risk of axonal extrusion and protecting a larger area around the junction when tissue ends 9700a and 9700b are nerve tissue ends.

[0268] Although reference Figures 95 to 97 The discussion concerns transversely cut tissue ends. This embodiment of the tissue repair device can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow underlying tissue to heal, or to secure tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but rather are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect underlying tissue. R. A base film having barbed mesh-like protrusions.

[0269] Figures 98 to 100Another embodiment of the tissue repair device 9800 is shown, which is formed of a base membrane 9805 and barbed mesh 9820. The base membrane 9805 has large protrusions 9810 and small protrusions 9815. The base membrane 9805 may have one or more of the characteristics of the base membrane 3900 described above. The barbed mesh 9820 may be formed of a plurality of bidirectional barbed sutures, as they include a plurality of barbs 9830 pointing in one direction and a plurality of barbs 9830 pointing in another direction.

[0270] Figure 98 A base film 9805 is shown, which has a large protrusion 9810 and a small protrusion 9815. In one exemplary embodiment, the width W of the large protrusion 9810 is... 9810 The width W of the small protrusion 9815 can be approximately 2 cm to approximately 2.5 cm. 9815 The width can be from approximately 1 cm to approximately 1.5 cm, but a narrower width and a relatively wider width can be used depending on the intended use of the tissue repair device 9800. The total length L of the basement membrane 9805... 9805 The size or diameter of the tissue to be repaired can be based on the tissue repair device 9800 to be used.

[0271] As mentioned above Figure 48 As described above, by making a cut 9835 within the edge of the small protrusion 9815 and hooking the barbed wire 9820 into the cut 9835, the barbed wire 9820 can be attached to the small protrusion 9815, as... Figure 98 As shown. Figure 99 The dorsal side of the tissue repair device 9800 is shown, and specifically, the barbed portion 9825 of the barbed mesh 9820 with barbs 9830 and the barbless portion 9840 of the barbed mesh 9820 without barbs are shown. (As mentioned above...) Figure 48 In the described embodiment, the barbed wire 9820 can be hooked onto the small protrusion 9815, such that the barbed portion 9825 extends outward from the small protrusion 9815, and the barbless portion 9840 overlaps with the small protrusion 9815, as shown in the figure. That is to say, the barbed wire 9820 can be attached to the small protrusion 9815 by any suitable method described above, such as adhesive, sewing, weaving, heating, etc.

[0272] Figure 100Two tissue ends 10000a and 10000b are shown arranged longitudinally, aligned with and overlapping at least a portion of the barbed wire 9820, and small protrusions 9815 of the base film 9805 are positioned relative to the tissue ends 10000a and 10000b. The tissue repair device 9800 can cover the tissue ends 10000a and 10000b, so that the small protrusion 9815 and the barbed mesh 9820 hooked into the small protrusion 9815 cover the tissue ends 10000a and 10000b, and the barbs 9830 of the barbed mesh 9820 engage with the tissue ends 10000a and 10000b to achieve engagement. The large protrusion 9810 also covers the tissue ends 10000a and 10000b to further provide mechanical stability, minimizing the risk of axon extrusion and protecting a larger area of ​​the tissue ends 10000a and 10000b around the engagement site, as described above. Figure 97 As stated above.

[0273] like Figures 95 to 97 As shown in the embodiment, the small protrusions 9815 with barbed mesh 9820 help to bring the bidirectional barbs 9830 closer to the junction between tissue ends 10000a and 10000b, thus helping to maintain the alignment of tissue ends 10000a and 10000b. The use of barbed mesh 9820 also helps to prevent misalignment of the barbed sutures and ensures that the barbs 9830 of the barbed sutures always face and engage with tissue ends 10000a and 10000b. As an example, when tissue ends 10000a and 10000b are nerve tissue ends, the small protrusions 9815 and the bidirectional barbs 9830 help to maintain a bundle-like arrangement, that is, the arrangement between bundles within the nerve tissue ends. When the tissue ends 10000a and 10000b are nerve tissue ends, the large lamina 9810 can provide mechanical stability, minimize the risk of axonal extrusion, and protect a larger area around the junction.

[0274] Although reference Figures 98 to 100 The discussion concerns transversely cut tissue ends. This embodiment of the tissue repair device can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow underlying tissue to heal, or to secure tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but rather are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect underlying tissue. S. Base membrane with barbed sutures

[0275] Figure 101Another embodiment of the tissue repair device 10100 is shown, which is formed of a base membrane 10105 and a plurality of barbed sutures 10110. The base membrane 10105 may have one or more of the characteristics of the base membrane 3900 described above. The barbed sutures 10110 may be bidirectional barbed sutures, as they include a plurality of barbs 10115 pointing in one direction and a plurality of barbs 10115 pointing in another direction.

[0276] The width W of the base film 10105 10105 It can be approximately 2 cm to approximately 2.5 cm, and the length L 10105 The size or diameter of the tissue to be repaired by the tissue repair device 10100 can be used, although any suitable length and width can be used. As mentioned above... Figure 48 The method involves creating an incision 10120 at the edge of the base membrane 10105 and hooking a barbed suture 10110 into the incision 10120. The barbed suture 10110 can then be attached to the base membrane 10105. Figure 101 As shown. Although this attachment mechanism is shown, any suitable attachment method described herein can be used. The barbed sutures 10110 can be attached to one side of the basement membrane 10105, i.e., they can all be located on one side of the centerline 10130 of the basement membrane 10105. The barbed sutures 10110 can also be positioned at a predetermined distance S. 10110 Arrangement, spacing S 10110 The choice of which to be made depends on the type of tissue to be repaired by the tissue repair device 10100 or the type of repair procedure. The barbed suture 10110 may have a barbed portion 10125 with barbs 10115 and a barbless portion (not shown) without barbs 10115. (As mentioned above...) Figure 48 In the described embodiment, the barbed suture 10110 can be hooked onto the basement membrane 10105, so that the barbed portion 10125 extends outward from the basement membrane 10105, and the barbless portion overlaps with the basement membrane 10105.

[0277] Because the base film 10105 has a rectangular shape, such as Figure 101 As shown, and lacking small protrusions, therefore... Figures 95 to 97 Compared to other implementations, although they may function in a similar manner, the tissue repair device 10100 can be manufactured relatively more easily or simply.

[0278] Figure 102 Another embodiment of the tissue repair device 10200 is shown, which is formed of a basement membrane 10205 and a plurality of barbed sutures 10210. The tissue repair device 10200 can be used with... Figure 101The tissue repair device 10100 shown is the same, but differs in that the barbed sutures 10210 can be centrally attached to the basement membrane 10205, that is, they can be symmetrically arranged around the centerline 10230 of the basement membrane 10205 and at a distance S. 10110 In comparison, the barbed suture 10210 can maintain a relatively large predetermined distance S. 10210 Arrangement, although any suitable spacing can be used.

[0279] like Figure 101 In this embodiment, since the base film 10205 has a rectangular shape, such as Figure 102 As shown, and without small protrusions, the tissue repair device 10200 can be manufactured relatively more easily or simply, and can function in a similar manner. T. Base film with barbed wire mesh

[0280] Figure 103 Another embodiment of the tissue repair device 10300 is shown, which is formed of a base membrane 10305 and a barbed mesh 10310. The base membrane 10305 may have one or more of the characteristics of the base membrane 3900 described above. The barbed mesh 10310 may be formed of a plurality of bidirectional barbed sutures, each including a plurality of barbs 10315 pointing in one direction and a plurality of barbs 10315 pointing in the other direction.

[0281] The width W of the 10305 base film 10305 It can be approximately 2 cm to approximately 2.5 cm, and the length L 10305 The size or diameter of the tissue to be repaired by the tissue repair device 10300 can be used, although any suitable length and width can be used. As mentioned above... Figure 48 The method involves creating a slit 10320 at the edge of the base film 10305 and hooking a barbed wire 10310 into the slit 10320. The barbed wire 10310 can then be attached to the base film 10305. Figure 103 As shown. Although this attachment mechanism is shown, any suitable attachment method described herein can be used. The barbed mesh 10310 can be attached to one side of the base film 10305, that is, the barbed mesh 10310 is located on one side of the centerline 10330 of the base film 10305. The barbed mesh 10310 can also have a predetermined spacing S between the longitudinal sutures forming the barbed mesh 10310. 10310 Spacing S 10310 The type of tissue to be repaired by the tissue repair device 10300 or the type of repair procedure can be determined. The barbed mesh 10310 may have a barbed portion 10325 with barbs 10315 and a barbless portion (not shown) without barbs 10315. (As mentioned above...) Figure 48In the described embodiment, the barbed mesh 10310 can be hooked onto the base film 10305, so that the barbed portion 10325 extends outward from the base film 10305, and the barbless portion overlaps with the base film 10305.

[0282] Because the base film 10305 has a rectangular shape, such as Figure 103 As shown, and without small protrusions, the tissue repair device 10300 can be manufactured relatively more easily or simply, and can function in a similar manner.

[0283] Figure 104 Another embodiment of the tissue repair device 10400 is shown, which is formed of a base membrane 10405 and barbed mesh 10410. The tissue repair device 10400 can be used with... Figure 103 The tissue repair device 10300 shown is the same, but differs in that the barbed mesh 10410 can be centrally attached to the base membrane 10405, that is, the barbed mesh 10410 can be centrally located on the center line 10430 of the base membrane 10405, and is aligned with the spacing S. 10310 In comparison, the predetermined distance S between the longitudinal sutures forming the barbed mesh 10410 10410 It can be relatively large, although any suitable spacing can be used.

[0284] like Figure 103 In this embodiment, since the base film 10405 has a rectangular shape, such as Figure 104 As shown, and without small protrusions, the tissue repair device 10400 can be manufactured relatively more easily or simply, and can be used in a similar manner. U. Basement membrane with longitudinally arranged barbed sutures

[0285] According to another implementation, Figure 105 This is a schematic diagram of a tissue repair device 10500, which includes a plurality of barbed sutures 10502 mounted on or embedded in a basement membrane 10505. One or more characteristics of the basement membrane 10505 may be the same as those described above with respect to basement membrane 3900. Figure 105 Also shown are two tissue ends 10501a and 10501b placed on the tissue repair device 10500 during the tissue repair process. Specifically, Figure 105 Four sets of barbed sutures 10502 are shown, with two sets of barbed sutures 10502 located near the tissue ends 10501a and 10501b, and two sets of barbed sutures 10502 located below the tissue ends 10501a and 10501b.

[0286] The length L of the 10505 base film 10505 It can be approximately 35 mm, and the width W of the base film 1050510505 It can be approximately 18 mm. The barbed suture 10502 can be parallel to the long side of the base membrane 10505, as shown in the figure. When a set of barbed sutures 10502 is provided, the length L of the barbed suture 10502 is... 10502 It can be approximately 15 mm. Alternatively, the length L is approximately 15 mm. 10502 The length of the barbed portion of the barbed suture 10502 can be considered as such, and the total length of the barbed suture 10502, which is a continuous longitudinal suture, can be the same as the length L of the basement membrane 10505. 10505 Same. The spacing S between adjacent sutures. 10502 It can be approximately 3 mm. However, it should be understood that the example dimensions provided herein are merely illustrative and not limiting, as the specific dimensions may depend at least in part on the tissue to be secured by the tissue repair device or the intended use of the tissue repair device.

[0287] When multiple sets of barbed sutures 10502 are configured, a gap G can be set between the barbed sutures 10502. 10502 The paired barbed sutures are positioned at opposite ends of the base membrane 10505. Alternatively, the barbed sutures 10502 may be long, continuous barbed sutures extending along the length of the base membrane 10505, wherein the central portion of the barbed sutures 10502 is woven through the base membrane 10505, thereby forming spaces between the barbed portions of the barbed sutures 10502 on the surface of the base membrane 10505.

[0288] The barbed suture 10502 may be, for example, a barbed suture according to one of the embodiments described herein. Alternatively, the barbed suture 10502 may be 3D printed. Each barbed suture 10502 may include one or more barbs 10515 extending from the surface of the barbed suture 10502 that are configured to contact tissue. Figure 105 As depicted, the barbed sutures 10502 can be arranged such that one or more barbs 10515 of the barbed sutures 10502 are oriented in different directions. The multidirectional arrangement of one or more barbs 10515 can assist the tissue repair device 10500 in resisting movement or displacement in one or more directions. For example, the multidirectional arrangement of one or more barbs 10515 can prevent tissue ends 10501a and 10501b from pulling apart from each other.

[0289] The barbed suture 10502 can be attached to the base membrane 10505 using glue or adhesive. The glue or adhesive may contain the ingredients described above. Figures 24 to 28 One or more materials as described in the embodiments shown.

[0290] As another example, the barbed suture 10502 can be attached by weaving or sewing it through the base membrane 10505, or by making a J-shaped or S-shaped cut in the base membrane 10505 or a small hole on one side of the base membrane 10505, through which the barbed suture 10502 is passed, and then knotted at the end of the barbed suture 10502 after passing through the cut or hole, thereby hooking the barbed suture 10502 onto the base membrane 10505. As yet another example, the barbed suture 10502 can be attached using heat, for example by melting the barbed suture 10502 at a specific location when it is on top of the base membrane 10505.

[0291] As another example, the barbed suture 10502 can be attached to the base film 10505 by etching, as described above.

[0292] Although reference Figure 105 The discussion concerns transversely cut tissue ends. This embodiment of the tissue repair device can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow underlying tissue to heal, or to secure tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but rather are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect underlying tissue. V. Strips of basement membrane with barbed sutures

[0293] According to yet another implementation method Figure 106 This is a schematic diagram of a tissue repair device 10600 used in a tissue repair process. It includes a barbed suture 10602, which intersects with a barbed suture 10603 to form a mesh 10604, and is integrated with strips of a basement membrane 10605. One or more characteristics of the basement membrane 10605 may be the same as those described above regarding the basement membrane 3900. Figure 106The illustration shows a plurality of barbed sutures 10602 with barbs 10610, barbless sutures 10603, a strip of integrated basement membrane 10605, and two transversely cut tissue ends 10601a and 10601b. The two transversely cut tissue ends 10601a and 10601b can be placed on the basement membrane 10605, wherein the barbed sutures 10602 are substantially aligned with the two transversely cut tissue ends 10601a and 10601b. A portion of the basement membrane 10605 and a portion of each barbed suture 10602 extending beyond the basement membrane 10605 can be positioned on one of the transversely cut tissue ends 10601a and 10601b, and another portion of the basement membrane 10605 and another portion of each barbed suture 10602 can be substantially aligned with the other transversely cut tissue end 10601a and 10601b. The transversely cut tissue ends 10601a and 10601b can be arranged such that the ends of the transversely cut tissue ends 10601a and 10601b are located on the basement membrane 10605, and the terminal regions and central portions of the transversely cut tissue ends 10601a and 10601b are located on the barbed suture line 10602. The transversely cut tissue ends 10601a and 10601b can be positioned relative to each other, thereby forming a gap G between them. 106 The reason is as mentioned above regarding the gap G. 67 The gap G is discussed. 106 It can be approximately 0 mm, or it can be greater than approximately 0 mm, such as up to approximately 5 mm or up to approximately 10 mm. For example, gap G 106 It can be about 0 mm to about 10 mm, about 0 mm to about 8 mm, about 1 mm to about 10 mm, about 1 mm to about 8 mm, about 2 mm to about 8 mm, about 3 mm to about 7 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, etc.

[0294] The length L of the strip of base film 10605 10605 The width W of the 10605 base film can be approximately 5 mm. 10605 It can be approximately 18 mm. The barbed suture 10502 can be perpendicular to the long side of the base membrane 10505, as shown in the figure. The length L of the barbed suture 10602 is... 10602 It can be approximately 35 mm. The spacing S between adjacent barbed suture lines 10502 10602 It can be approximately 3 mm. The barbless suture 10603 can be parallel to the long side of the base membrane 10505, as shown in the figure. The width W of the barbless suture 10603 is... 10603 It can be approximately 15 mm. However, it should be understood that these dimensions are merely exemplary and any suitable size may be used, for example, based on the intended use of the tissue repair device or the type of tissue to which it will be attached.

[0295] The length L of the 10602 barbed suture can be determined. 10602 and the width W of the barbless suture 10603 10603 Thus, when the transversely cut tissue ends 10601a and 10601b are placed on the basement membrane 10605, the width of each barbed suture 10602 lies on or adheres to the portion of the outer surface of the transversely cut tissue ends 10601a and 10601b, such as... Figure 106 As shown. That is, the barbed sutures 10602 can collectively extend around the outer surface of each of the transversely cut tissue ends 10601a and 10601b, and each barbed suture 10602 extends substantially in a straight line along the transversely cut tissue ends 10601a and 10601b. The basement membrane 10605 can cover the entire outer surface surrounding each of the transversely cut tissue ends 10601a and 10601b, thereby surrounding or closing the gap G. 106 In this embodiment, the width W 10602 The size can be set as the coverage gap G. 106 And the ends of the transversely cut tissue ends 10601a and 10601b, but most of the transversely cut tissue ends 10601a and 10601b can be joined by multiple barbed sutures 10602.

[0296] The covering may involve physically moving (e.g., rolling, twisting, or pulling) the base membrane 10605 and placing it on the surface of the transversely cut tissue ends 10601a and 10601b, wrapping the transversely cut tissue ends 10601a and 10601b around the base membrane 10605, or a combination thereof. In some respects, the ends of the base membrane 10605 may be secured after covering, for example, using sutures, adhesives, glue, or capillary action. With this configuration, the barbed sutures 10602 and the base membrane 10605 secure the transversely cut tissue ends 10601a and 10601b in place, thereby enabling the tissue repair process. More specifically, the barbs 10610 on the barbed suture 10602 may protrude into or otherwise engage with the outer surface of each of the transversely cut tissue ends 10601a and 10601b, and the barbs 10610 and the basement membrane 10605 may inhibit the transversely cut tissue ends 10601a and 10601b from moving apart. In the case that the transversely cut tissue ends 10601a and 10601b are nerve tissue, the barbs 10610 may engage with the epineurium. The basement membrane 10605 also prevents axons growing from one or both ends of the tissue ends 10601a and 10601b from escaping or extending outward away from the other of the tissue ends 10601a and 10601b.

[0297] Although reference Figure 106 The discussion concerns transversely cut tissue ends. This embodiment of the tissue repair device can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow underlying tissue to heal, or to secure tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but rather are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect underlying tissue. W. Base membrane with sutures and longitudinal barbed sutures

[0298] Figure 107 This is a schematic diagram of a tissue repair device 10700, which includes a base membrane 10705. The base membrane 10705 has sutures or openings 10710 and longitudinally arranged barbed sutures 10715. The sutures or openings 10710 are positioned away from one or more edges of the tissue repair device 10700, i.e., the sutures extend within the base membrane 10705. The tissue repair device 10700 can be similar. Figure 105 The tissue repair device 10500 shown is different in that the suture 10710 is disposed within the basement membrane 10705.

[0299] Figure 108 This is a schematic diagram of a tissue repair device 10800, which includes a base membrane 10805. The base membrane 10805 has slits or openings 10810 and longitudinally arranged barbs 10815. The slits or openings 10810 are positioned along one or more edges of the base membrane 10805, i.e., the slits extend toward the outer edge of the base membrane 10805. The tissue repair device 10800 can be used with... Figure 105 The tissue repair device 10500 shown is the same, but the difference is that a suture 10810 is set inside the basement membrane 10705.

[0300] Sutures or openings 10710 and 10810 may be contained within a base membrane to allow the tissue to expand, contract, bend, rotate, or otherwise move after the tissue repair device is applied, without impacting, compressing, or applying excessive pressure to the tissue. For example, expansion, wrinkling, or bending may occur between barb attachment sites at the suture location. Even if the material forming the base membrane has low elasticity or extensibility, the base membranes on both sides of a given suture can more easily move toward or away from each other, or open or bend.

[0301] Figures 109 to 111 For example Figure 105 Images of tissue repair devices, and Figure 109 Describe a basement membrane with longitudinally arranged barbed sutures attached. Figure 110Depict the tissue tip of the sample, in this example, the nerve tip, which is encased in the basement membrane and secured in place with barbed sutures. Figure 111 The image depicts the covered tissue end, the fixed basement membrane, and the barbed sutures, demonstrating the ability of the tissue repair device to remain in place and engage with the tissue end. (Although referenced...) Figures 107 to 111 The discussion concerns transversely cut tissue ends. This embodiment of the tissue repair device can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow underlying tissue to heal, or to secure tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but rather are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect underlying tissue. X. Base film with barbed structure

[0302] According to another embodiment, Figure 112 This is a schematic diagram of a tissue repair device 11200. The tissue repair device 11200 has a base membrane 11205 and barb structures 11210 with barbs 11215. In some aspects, the barbs 11215 may be microinjection molded. The base membrane 11205 may have one or more of the properties of the base membrane 3900 described above. Each barb structure 11210 may be formed as a thin substrate and may be formed of the same material as the barbs 11215. The barb structures 11210 can be arranged in a grid pattern on the base membrane 11205, as shown, and when placed on the base membrane, the long sides of each barb structure 11210 are parallel to the tissue ends 11201a and 11201b. Other arrangements, orientations, or configurations of the barb structures 11210 may be used, such as vertical arrangement, offset, or other arrangements of the barb structures 11210. In some respects, the barb structure 11210 may be attached along the entire base film 11205, or in other respects, the barb structure 11210 may be attached along a portion less than the entire base film 11205, such as along one or more edges of the base film 11205, or along approximately half or less of the base film 11205.

[0303] Figure 113 This is a detailed view of an example of a barb 11215 formed by microinjection molding. The thin substrate forming the barb structure 11210 can be part of a mold used to form the barb 11215. A polymer can then be added to the mold, thereby forming the barb 11215. Any polymer listed herein can be used to form the barb 11215, including absorbable polymers.

[0304] Figure 114The tissue repair device 11200 is depicted covering tissue ends 11201a and 11201b. The barbs of the barb structure 11210 engage with the surfaces of the tissue ends 11201a and 11201b, achieving engagement of the tissue ends 11201a and 11201b, while a base membrane 11205 surrounds the engaged tissue ends 11201a and 11201b. As in other embodiments, the base membrane 11205 provides mechanical stability, minimizes the risk of axonal extrusion, and protects a larger area of ​​the tissue ends 11201a and 11201b around the engagement site.

[0305] Figure 115 A side cross-sectional view of a strip 11510 and barbs 11515 formed thereon according to one embodiment is shown. The strip 11510 may have a rectangular cross-sectional shape, while the barbs 11515 may have a triangular cross-sectional shape. According to another embodiment, Figure 116 A side cross-sectional view of the strip 11610 and the barb 11615 is shown. The strip 11610 may have a generally rectangular cross-sectional shape, wherein the upper edge or corner of the strip 11610 has a chamfered edge. The barb 11615 may have a triangular cross-sectional shape. According to yet another embodiment, Figure 117 A side cross-sectional view of the strip 11710 and the barb 11715 is shown. The strip 11710 may have a generally rectangular cross-sectional shape, wherein the upper edge or corners of the strip 11710 have rounded edges. The barb 11715 may have a triangular shape. According to yet another embodiment, Figure 118 A side cross-sectional view of strip 11810 and multi-directional barbs 11815 is shown. Strip 11810 may have a generally rectangular cross-sectional shape, wherein the upper edge or corners of strip 11810 have rounded edges. Multi-directional barbs 11815 may have two partially overlapping triangular shapes, as shown, such that barbs 11815 have two points 11815a and 11815b. Figures 115 to 118 Any of the cross-sectional shapes of the strips and barbs can be used in the tissue repair device 11200 described above. Furthermore, the barb structure 11210 formed by microinjection molding can achieve a variety of different potential cross-sectional shapes. Figures 115 to 118 Only one sample is depicted in the text.

[0306] Although reference Figure 112The discussion concerns transversely cut tissue ends. This embodiment of the tissue repair device can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow underlying tissue to heal, or to secure tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not place two tissue ends together, but rather are able to wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect underlying tissue. Y. Methods of using tissue repair devices

[0307] Figure 119 This is a flowchart of a method 11900 for fastening two tissue ends together using a tissue repair device. The method may include step 11905 of attaching the two tissue ends to the tissue repair device. Step 11905 may include orienting the tissue repair device so that the barbed surface faces the transversely cut tissue ends. Then, step 11905 may include attaching a portion of the barbs of the tissue repair device to a portion of a first transversely cut tissue end region, and attaching another portion of the barbs of the tissue repair device to a portion of a second transversely cut tissue end region by engaging the barbs with the outer surface of the transversely cut tissue end region.

[0308] In some embodiments, step 11905 may further include aligning the first and second transversely cut tissue ends with each other on the tissue repair device and placing the first and second transversely cut tissue ends at a predetermined distance from each other to form a gap therebetween (e.g., any of the gaps described herein).

[0309] Method 11900 may further include a subsequent step 11910, which involves covering the outer surface of each of the two tissue ends into a tissue repair device. According to some embodiments, step 11910 may include covering the tissue repair device containing the base membrane around the outer surfaces of the first and second transversely cut tissue ends, rolling the first and second transversely cut tissue ends onto the tissue repair device, or a combination thereof. In some embodiments, a separate base membrane may also be covered around the tissue repair device.

[0310] Method 11900 may include attaching additional barbed sutures, barbed meshes, or barbed strips to the first and second tissue end regions while the tissue repair device is covered around the tissue surface.

[0311] Method 11900 may also optionally include step 12000, such as Figure 120As shown, the ends of the tissue repair device are secured after covering the outer surfaces of the two tissue ends. The securing of the ends of the tissue repair device may involve one or more of the following: the use of sutures, adhesives, glue, or capillary action. Method 11900 may be part of a tissue repair process. In some embodiments, multiple tissue repair devices may be applied, or a single tissue repair device may be applied. As described above with respect to several embodiments, the covering may or may not be used as part of the tissue repair device.

[0312] In an embodiment using a base membrane, for example, a base membrane formed of SIS, a second layer of SIS base membrane can be disposed at one end of a first layer of SIS base membrane, such that a portion of the first layer of SIS base membrane can cover the tissue end once or multiple times. Then, the end of the first base membrane having the second layer of SIS base membrane can be positioned against the underlying covered portion of the first layer of SIS base membrane, and the first and second base membranes can be held in place by capillary effect.

[0313] In some embodiments, an additional gel layer may be applied to at least one end of the base membrane, such that a portion of the base membrane may cover the tissue end once or multiple times, and then the gel-covered end of the base membrane may be positioned to abut against and adhere to the covered portion of the base membrane below.

[0314] The gap between the two tissue ends placed on the tissue repair device can be approximately 0 mm, or the gap can be greater than approximately 0 mm, for example, up to approximately 10 mm or at most approximately 5 mm. (See the previous section regarding gap G.) 67 For the reasons stated above, the gap may be greater than approximately 0 mm. In some respects, the gap may be approximately 0 mm to approximately 10 mm, approximately 0 mm to approximately 8 mm, approximately 1 mm to approximately 10 mm, approximately 1 mm to approximately 8 mm, approximately 2 mm to approximately 8 mm, approximately 3 mm to approximately 7 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, etc.

[0315] The tissue repair device used in method 11900 may be, for example, referred to Figures 21 to 36 or Figures 46 to 118 Any of the tissue repair devices shown and described. In some aspects, it includes... Figures 64A to 67The tissue repair device 6400, as shown, with barbed mesh 6402, or the tissue repair device 7000 including the base membrane 7002 and barbs 7005 shown in Figures 70 to 72, may include at least one mesh. The mesh includes a plurality of barbed sutures, including a plurality of longitudinal barbed sutures and a plurality of lateral barbed sutures. Each barbed suture includes a suture body and at least one barb formed on the outer surface of the suture body. The at least one barb includes at least one protrusion. Alternatively, the tissue repair device used in method 11900 may be, for example, a tissue repair device 7000, which includes a base membrane 7002 having barbs 7005, as shown in Figure 70 to 72. Figure 70 Multiple barbs are formed by laser cutting or embossing. Furthermore, the tissue repair device can be: tissue repair device 7700, which includes two barbed sutures 7702 and a basement membrane 7705; tissue repair device 7800, which includes multiple sets of welded, side-by-side barbed sutures 7802 and a basement membrane 7805, as shown in... Figure 78 Tissue repair device 7900, comprising barbed strips 7902 and basement membrane 7905, is shown in Figure 79 ; or a tissue repair device 8100, which includes a barbed strip 8102 adhered to a basement membrane 8105 and a basement membrane 8110, as shown in Figure 81 In other words, the tissue repair device may include at least one covering and at least two barbed sutures, the longitudinal length of which is greater than the width of the covering, and each barbed suture includes a portion with barbs and a portion without barbs. This method allows two tissue ends to be fastened together, enabling the tissue repair process.

[0316] For reference Figures 2 to 114 Various configurations of the tissue repair device shown and described, as examples, may include transversely cut tissue ends that are nerve ends, and the tissue repair process may be nerve regeneration. Furthermore, method 11900 may be a method of fastening two tissue ends together, and this tissue may be nerve tissue, wherein the transversely cut tissue ends are transversely cut nerve ends. In the case where the tissue ends are nerve ends, refer to... Figures 2 to 114 The barbs of the tissue repair device described in the embodiment can protrude into the epineurium of each nerve tip or otherwise engage with the epineurium of each nerve tip without extending into the perineurium or nerve bundle of each nerve tip. Furthermore, although transversely cut tissue tips have been discussed, regarding... Figures 2 to 114The tissue repair device of the described embodiments can be applied to any type of damaged tissue, whether or not it is completely transversely cut, for example, to protect or allow the underlying tissue to heal, or to fasten tissue for any other suitable reason unrelated to healing. For example, embodiments of this disclosure do not involve placing two tissue ends together, but rather can wrap around or otherwise cover a portion of intact tissue to facilitate repair or otherwise protect the underlying tissue. The term "tissue end" as used herein should not be construed as limiting the use of the device, and the device can be used in a variety of different ways and for procedures other than joining. Furthermore, regarding Figures 2 to 114 The tissue repair device described in the embodiment can be used at the tissue end and to place the tissue graft between the transversely cut tissue ends. Z. Microscopic view of the etched surface

[0317] Figure 121 An image of glass fibers 12100 extending from an absorbable polymer surface 12105, which has been etched back to expose the glass fibers 12100. The glass fibers 12100 can form a height of H... 12100 For example, microneedles in the range of about 10 μm to about 500 μm. Etching to expose the glass fibers, according to one or more embodiments described herein, is an example of forming barbs or microneedles on a polymer surface. AA. Advantages and Uses

[0318] Embodiments of this disclosure allow for seamless suture fastening of tissues, such as securing nerves to other nerve ends or nerve adjunctive implants (e.g., protective coverings, connectors, transverse nerve junction aids, drug delivery systems). When barbed sutures or tissue repair devices are used for nerves, aspects of this disclosure allow the barbed sutures or tissue repair devices to fasten only to the external epineurial connective tissue and adipose tissue attached to the nerve, while leaving the internal nerve structures (nerve bundles, perineurium, endoneum, and blood vessels) substantially undisturbed. For example, the penetration depth of the barb or protrusion, barbed suture, or tissue repair device in the vertical y-axis direction may not exceed about 150 micrometers. As long as the vertical penetration depth along the y-axis does not exceed about 150 micrometers, the length of the incision used to form the barb, the barbed suture, or the tissue repair device (if applicable) may, for example, be as much as about 250 micrometers or longer. In some respects, the angle of the barbs, barbed sutures, or tissue repair devices (if applicable) may be up to about 45 degrees relative to the length of the suture, or up to about 60 degrees relative to the length of the suture. Examples of sutures containing multidirectional barbs may be, for example, size 3-0 or smaller, such as size 4-0, size 5-0, size 6-0, size 7-0, or size 8-0.

[0319] The embodiments of this disclosure also offer advantages over existing tissue fixation methods, such as suture placement or the absence of sutures, and over other forms of barbed sutures used for tissue fixation. The embodiments facilitate improved fixation, resisting movement of the barbed sutures in multiple directions. The embodiments facilitate improved fixation, resisting movement of the tissue repair device and distributing the bonding force of the tissue repair device across a wider surface of the tissue to which it is attached. For example, placing sutures directly at the repair site to repair tissue applies all the forces holding the tissue in place directly to the damaged area. In contrast, the tissue repair device of this disclosure distributes force over a wider portion of the tissue being repaired, which reduces the pressure applied to the repair site.

[0320] Prototypes of tissue repair devices prepared using the methods disclosed herein have demonstrated the effectiveness of adhering sutures to a basement membrane formed by SIS for the reattachment and repair of transversely cut nerve ends in a tabletop setting. The connection between the suture and the basement membrane provides structural support for the suture and circumferential coverage at the reattachment site of the tissue end to suppress the risk of axonal extrusion.

[0321] Although the barbed sutures and tissue repair devices of this disclosure are described for use with nerves, examples of tissues that can be used with the barbed sutures and tissue repair devices described herein include neural tissues such as peripheral nerve tissue or central nervous system tissue, as well as other types of tissue. Exemplary tissue types suitable for the barbed sutures and tissue repair devices of this disclosure include, but are not limited to, epithelial tissue, connective tissue, muscle tissue, tendon tissue, ligament tissue, vascular tissue, intestinal tissue, dermal tissue, and cardiac tissue. The tissue may be mammalian tissue, including human tissue and tissues of other primates, rodent tissue, horse tissue, canine tissue, rabbit tissue, pig tissue, or sheep tissue. In some aspects, the tissue may be non-mammalian tissue selected from fish, amphibian, or insect tissue. For the object to which the graft is implanted, the tissue may be allogeneic or xenogeneic. The tissue may be synthetic tissue, such as, but not limited to, laboratory-grown tissue or 3D-printed tissue.

[0322] It should be understood that although this disclosure has been made with reference to preferred embodiments, exemplary embodiments, and optional features, modifications and variations of the concepts disclosed herein can be made by those skilled in the art, and such modifications and variations are considered to fall within the scope of this disclosure as defined by the appended claims. The specific embodiments and examples provided herein are examples of useful embodiments of this disclosure and are non-limiting and illustrative only. It will be apparent to those skilled in the art that this disclosure can be implemented using numerous variations of the apparatus, apparatus components, methods, and steps set forth in this specification. Those skilled in the art will understand that the methods and apparatus used for this method may include a large number of various optional compositions and processing components and steps.

Claims

1. A barbed suture, comprising: The suture itself; and At least one multi-directional barb is formed on the outer surface of the suture body, the at least one multi-directional barb comprising a first protrusion and a second protrusion, wherein the first protrusion and the second protrusion extend in two different directions.

2. The barbed suture as described in claim 1, wherein the at least one multidirectional barb is formed in the following manner: A first incision is made in the suture body, the first incision having a first depth and a first length and formed at a first angle relative to the longitudinal axis of the suture body, and forming the first protrusion; and In the suture body, a second incision is made near the first incision, the second incision having a second depth and a second length and formed at a second angle relative to the longitudinal axis of the suture body, and forming the second protrusion.

3. The barbed suture as described in claim 2, wherein the first depth is less than the second depth.

4. The barbed suture as described in claim 2, wherein the first angle is smaller than the second angle.

5. The barbed suture as described in claim 2, wherein the first incision and the second incision overlap with respect to the radial axis of the suture body.

6. The barbed suture as described in claim 1, wherein the at least one multi-directional barb comprises a first barb and a second barb, and wherein at least one of the first barb and the second barb is one of the following: hook; It has multi-directional barbs with pointed protrusions; It has multi-directional barbs with rounded, blunt protrusions; or Geometric barbs.

7. The barbed suture as described in claim 1, wherein the two different directions are at an angle relative to each other.

8. The barbed suture as described in claim 1, wherein the two different directions are substantially opposite to each other.

9. The barbed suture of claim 1, wherein the at least one multi-directional barb comprises a plurality of multi-directional barbs arranged in one of the following ways: OK; List; ring; Spiral; or The geometric pattern on the surface of the suture body.

10. The barbed suture of claim 1, wherein the at least one multi-directional barb comprises at least a first barb and a second barb, and wherein the first protrusions of the first multi-directional barb and the second multi-directional barb are oriented in the same direction as each other, and the second protrusions of the first multi-directional barb and the second multi-directional barb are oriented in the same direction as each other.

11. The barbed suture of claim 1, wherein the at least one multidirectional barb comprises at least two barbs, and wherein the at least two barbs are arranged in a pattern, wherein a first protrusion of a first subset of the barbs points in a first direction, and a first protrusion of a second subset of the barbs points in a second direction different from the first direction.

12. A barbed suture, comprising: The suture itself; and At least two barbs are formed on the outer surface of the suture body, the first barb of the at least two barbs having a first protrusion pointing in a first direction, and the second barb of the at least two barbs having a first protrusion pointing in a second direction, wherein the first direction is different from the second direction.

13. The barbed suture as described in claim 12, wherein the first barb and the second barb are each unidirectional barbs.

14. The barbed suture as described in claim 12, wherein the first barb and the second barb are each multi-directional barbs.

15. The barbed suture as described in claim 12, wherein at least one of the first barb and the second barb is one of the following: hook; It has multi-directional barbs with pointed protrusions; It has multi-directional barbs with rounded, blunt protrusions; disc; A single, blunt barb; or Geometric barbs.

16. The barbed suture as described in claim 12, wherein the at least two barbs are arranged in one of the following order: OK; List; ring; Spiral; or The geometric pattern on the surface of the suture body.

17. The barbed suture of claim 12, wherein at least two barbs are formed on a portion of the length of the suture body, and no barbs are formed on another portion of the length of the suture body.

18. The barbed suture of claim 12, wherein at least two barbs are formed on a portion of the circumference of the suture body, and no barbs are formed on the other portion of the circumference of the suture body.

19. The barbed suture of claim 12, wherein the at least two barbs are oriented such that they form an angle with respect to the longitudinal axis of the suture body.

20. A method for manufacturing a barbed suture, the method comprising: A first incision is made in the suture body to form a first protrusion, the first protrusion being oriented in a first direction, wherein the first incision does not extend completely through the suture body; and A second incision is made in the suture body to form a second protrusion, the second protrusion being oriented in a second direction, wherein the second incision does not extend completely through the suture body. The first direction is different from the second direction.

21. A tissue repair device, comprising: At least one mesh panel, comprising: Multiple barbed sutures, comprising multiple longitudinal barbed sutures and multiple lateral barbed sutures, each of the barbed sutures comprising: The suture body; and At least one barb is formed on the outer surface of the suture body.

22. The tissue repair apparatus of claim 21, wherein the plurality of longitudinal barbed sutures and the plurality of lateral barbed sutures are arranged in a grid pattern.

23. The tissue repair apparatus of claim 21, further comprising a base membrane configured to cover the barbless surface of the plurality of barbed sutures during use.

24. The tissue repair apparatus of claim 21, further comprising a base membrane sheet attached to the barbless surface of the plurality of barbed sutures.

25. The tissue repair apparatus of claim 21, wherein the plurality of sutures comprises two or more lateral sutures and two or more longitudinal sutures, the length of the two or more lateral sutures being longer than the length of the two or more longitudinal sutures, thereby forming at least one strip of mesh.

26. The tissue repair apparatus of claim 25, further comprising at least one base film sheet, wherein strips of the at least one mesh sheet are attached to the base film sheet.

27. The tissue repair apparatus of claim 26, wherein the strip of the at least one mesh includes a barbless portion located in the longitudinal central region of the mesh.

28. The tissue repair apparatus of claim 26, further comprising a base film on the barbless surface of the strips attached to the mesh.

29. The tissue repair apparatus of claim 21, further comprising a base membrane, wherein the longitudinal length of each of the lateral barbed sutures is greater than the width of the base membrane, wherein the mesh includes a barbless portion located at the longitudinal center of each of the lateral barbed sutures, and wherein the base membrane extends over the barbless portion of the mesh.

30. A tissue repair device, comprising: Base film sheet; and Multiple barbs are formed on the base film sheet, the multiple barbs being formed by either laser cutting or embossing.

31. A tissue repair device, comprising: Base film; and Multiple barbs are formed on the base film, the multiple barbs being formed of absorbable ceramic and attached to the base film.

32. A tissue repair device, comprising: Base film; and At least two barbed sutures, each having a longitudinal length greater than the width of the base membrane, and each barbed suture including a barbed portion and a non-barbed portion.

33. The tissue repair apparatus of claim 32, wherein the at least two barbed sutures are spaced apart from each other and woven through the basement membrane such that the barbless portion of each of the barbed sutures is woven through the basement membrane, and the barbed portion of each of the barbed sutures extends outward from the basement membrane.

34. The tissue repair apparatus of claim 32, wherein the base membrane comprises at least two pre-formed holes, wherein the at least two barbed sutures comprise at least one set of fused barbed sutures, the at least one set of barbed sutures passing through the at least two pre-formed holes in the base membrane.

35. The tissue repair apparatus of claim 32, wherein the at least two barbed sutures comprise at least one strip of barbed sutures arranged in a fine grid pattern.

36. A tissue repair device, comprising: Strips of base film; and At least two barbed sutures are attached to the strip of the basement membrane.

37. The tissue repair device as described in claim 36, wherein each of the barbed sutures comprises a barbed portion and a barbed-free portion.

38. The tissue repair apparatus of claim 36, wherein the at least two barbed sutures are arranged to form a mesh.

39. A method for fastening two tissue ends relative to each other, the method comprising: The two tissue ends are attached to a tissue repair device, the tissue repair device comprising at least one mesh formed of a plurality of barbed sutures, wherein the plurality of barbed sutures includes a plurality of longitudinal barbed sutures and a plurality of lateral barbed sutures, each of the barbed sutures comprising a suture body and at least one barb formed on the outer surface of the suture body; and The outer surfaces of the two tissue ends are covered within the tissue repair device.

40. The method of claim 39, wherein the gap between the two tissues in the tissue repair apparatus is between 0 mm and about 5 mm.

41. The method of claim 39, further comprising securing the ends of the tissue repair device after covering the outer surfaces of the two tissue ends.

42. The method of claim 41, wherein the fastening comprises using one or more of a suture and an adhesive.

43. The method of claim 39, wherein the method further comprises covering the tissue repair device with a basement membrane.

44. The method of claim 43, wherein coating the base membrane and coating the tissue repair device occur simultaneously.

45. The method of claim 43, wherein coating the base membrane occurs after coating the tissue repair device.

46. ​​The method of claim 39, wherein the tissue repair apparatus further comprises a base membrane to which the at least one mesh is attached.

47. The method of claim 39, wherein the at least one mesh is a strip of at least one mesh, and the plurality of barbed sutures include two lateral barbed sutures and two or more longitudinal barbed sutures, the length of the two lateral barbed sutures being longer than the length of the two longitudinal barbed sutures.

48. The method of claim 47, further comprising at least one base film, wherein strips of the at least one mesh are attached to the base film.

49. The method of claim 48, wherein the strip of the at least one mesh includes a barbless portion located in the longitudinal central region of the mesh.

50. A method for fastening two tissue ends together, the method characterized by comprising: Two tissue ends are attached to a tissue repair device, the tissue repair device including a base membrane and a plurality of barbs formed on the base membrane, the plurality of barbs being formed by one of laser cutting or embossing; and The outer surfaces of the two tissue ends are covered within the tissue repair device.

51. A method for fastening two tissue ends together, the method comprising: Two tissue ends are attached to a tissue repair device, the tissue repair device including a base membrane and a plurality of barbs attached to the base membrane, the plurality of barbs being formed of absorbable ceramic; and The outer surfaces of the two tissue ends are covered within the tissue repair device.

52. A method for fastening two tissue ends together, the method characterized by comprising: Two tissue ends are attached to a tissue repair device, the tissue repair device including a base membrane and at least two barbed sutures, the longitudinal length of the barbed sutures being greater than the width of the base membrane, and each barbed suture including a barbed portion and a barbed-free portion; and The outer surfaces of the two tissue ends are covered within the tissue repair device.

53. The method of claim 52, wherein the at least two barbed sutures are spaced apart from each other and woven through the base membrane, such that the barbless portion of each of the barbed sutures is woven through the base membrane, and the barbed portion of each of the barbed sutures extends outward from the base membrane.

54. The method of claim 52, wherein the base film comprises at least two pre-formed holes, and wherein the at least two barbed sutures comprise at least one set of fused barbed sutures, the at least one set of barbed sutures passing through the at least two pre-formed holes in the base film.

55. The method of claim 52, wherein the at least two barbed sutures comprise at least one strip of barbed sutures arranged in a grid pattern.

56. The method of claim 55, further comprising at least one strip of base membrane, one side of the strip of the at least one barbed suture attached to the strip of the at least one base membrane.

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