Sutureless connectors and methods of making and using same

Abstract

A tissue connector may include a body formed of one or more layers of material, and at least one barbed suture attached to the body. Related methods of forming a tissue connector may include forming a body from one or more layers of material and attaching at least one barbed suture to the body. Further, an associated method of repairing tissue using the tissue connector may include orienting the tissue connector about engaged or damaged tissue such that the engaged or damaged tissue is in contact with an inner surface of the tissue connector, and twisting an end of the at least one barbed suture such that the at least one barbed suture is in contact with the inner surface of the tissue connector. Thereby engaging the at least one barbed suture with the engaged or damaged tissue.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to U.S. non-provisional patent application No. 18 / 306,351 filed on April 25, 2023, which claims priority under 35 U.S.C. §120 to U.S. provisional patent application No. 63 / 363,648 filed on April 27, 2022, the entire contents of which are incorporated into this specification by reference. Technical Field

[0002] Various embodiments of the present disclosure generally relate to tissue connector devices and related methods, and more particularly, to tissue connector devices having at least one barbed suture and methods of making and using the same. Background Art

[0003] Tissue connectors can be used to perform one or more of the following: connecting severed or cross-cut tissue ends at a joint, protecting a portion of damaged tissue, protecting the ends of a jointed tissue, removing tension at a joint, and / or stabilizing coapted or damaged tissue during tissue healing. Known tissue connectors may require the use of sutures to attach the tissue connector to the protected and / or repaired tissue. In particular, fixing a tissue connector to a nerve joint or damaged nerve tissue site may require a surgeon to pass a perineurial suture through the connector and tissue by microsuturing. When passing through the tissue, the perineurial suture may damage the nerve tissue, for example, via nerve bundles or other nearby structures such as blood vessels that interfere with the nerve. In addition, the tensile strength of such tissue connectors may also be limited.

[0004] Therefore, there is a need for a tissue connector that does not require microsuturing, such as suturing with epineurial sutures, and that has relatively greater tensile strength. The present disclosure is intended to overcome one or more of these challenges. Summary of the invention

[0005] According to certain aspects of the present disclosure, systems and methods are disclosed. In one aspect, a tissue connector can include: a body formed of one or more layers of at least one material, and at least one barbed suture attached to the body such that at least a portion of the at least one barbed suture is exposed along a surface of the body.

[0006] On the other hand, a method of forming a tissue connector may include forming a body from one or more layers of at least one material, and attaching at least one barbed suture to the body such that at least a portion of the at least one barbed suture is exposed along a surface of the body.

[0007] On the other hand, the method of repairing tissue using a tissue connector as described above in the present specification may include: orienting the above-mentioned tissue connector around the joined or damaged tissue so that the above-mentioned joined or damaged tissue contacts the inner surface of the above-mentioned tissue connector, and twisting the end of the above-mentioned at least one barbed suture so that the above-mentioned at least one barbed suture engages with the above-mentioned joined or damaged tissue.

[0008] Other objects and advantages of the disclosed embodiments will be described in part below, and in part will be apparent from the description, or may be learned by practice of the disclosed embodiments. The objects and advantages of the disclosed embodiments may be realized and obtained by the elements and combinations specifically indicated in the appended claims. One of the advantages of the disclosed tissue connector device and related methods is that the tissue can be joined by relatively easy placement and fixation of the tissue connector device without causing damage to the joined or otherwise damaged tissue or surrounding structures, while being able to provide a tissue connector device with sufficient tensile strength.

[0009] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosed embodiments, as claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments.

[0011] According to one or more embodiments, Figure 1 A tissue connector is shown and reference is included to steps of a method of using the tissue connector.

[0012] According to one or more embodiments, Figure 2 is a perspective view of a barbed suture included in a tissue connector.

[0013] According to one or more embodiments, Figure 3 A tissue connector is shown, including details of the structure of a barbed suture.

[0014] According to one or more embodiments, Figure 4A A flow chart of a method for forming a tissue connector.

[0015] According to one or more embodiments, Figure 4B is a flow chart of a method of forming an organization connector, and Figure 4C To form Figure 4B A visual representation of the way connectors are organized.

[0016] According to one or more embodiments, Figure 5 A flowchart for a method of using an organization connector.

[0017] According to one or more embodiments, Figure 6 is a graph exemplarily depicting the suture retention strength of a tissue connector. DETAILED DESCRIPTION

[0018] The terms used below, even when used in conjunction with the detailed description of certain specific examples of the present disclosure, are intended to be interpreted in the broadest reasonable manner. In fact, certain terms may even be emphasized below. However, in this detailed description section, any term that is intended to be interpreted in any restricted manner is openly and explicitly defined.

[0019] In the present disclosure, the term "based on" means "based at least in part on". Unless the context dictates otherwise, the singular forms "a", "an", "above" include plural references. The term "exemplary" means "example", not "ideal". The terms "include", "comprises", "contains", "has" or other variations thereof are intended to cover non-exclusive inclusion, so that the process, method, article or apparatus including a list of components includes not only these components, but may also include other elements not explicitly listed or components inherent to such. Relative terms such as "about" and "approximately" are generally used to indicate that relative terms (e.g., "approximately" and "around") are generally used to indicate possible differences of ±10% or ±10% of the understood value, unless otherwise specified in the specification. In addition, the term "between" describing a range of numerical values ​​is intended to include the minimum and maximum values ​​described in this specification. The term "or" used in the claims and the specification is used to mean "and / or", unless it is explicitly stated that only alternatives are referred to or the alternatives are mutually exclusive, although the present disclosure supports only alternatives and "and / or". As used in this specification, "another" may mean at least a second or more.

[0020] Tissue connectors that require suturing, such as microsuturing, may cause damage to the joined tissue and / or other nearby structures due to suturing, and the tensile strength may be limited. The tissue connectors and related methods disclosed herein can provide an alternative method for tissue joining and tissue protection that does not require suturing, and can therefore be relatively easily placed and fixed to a joint site or a site of tissue damage. In addition, the tissue connectors and related methods disclosed herein can provide reliable engagement for tissues, such as the perineurium, which is only neural tissue, thereby reducing the risk of damage to tissues and other structures. In addition, the tissue connectors and related methods disclosed herein can provide a tissue connector with a relatively large tensile strength for use at a joint site or a site of tissue damage.

[0021] Examples of tissues that can use the tissue connectors described in this specification include neural tissue, such as peripheral neural tissue or central nervous system tissue. Other types of tissues suitable for the present disclosure include, but are not limited to, epithelial tissue, connective tissue, muscle tissue, tendon tissue, ligament tissue, vascular tissue, intestinal tissue, skin tissue, and cardiac tissue. The tissue can be mammalian tissue, including human tissue and tissue of other primates, rodent tissue, horse tissue, canine tissue, rabbit tissue, pig tissue, or sheep tissue. In addition, the tissue can be a non-mammalian tissue selected from fish, amphibian, or insect tissue. The tissue can be allogeneic or xenogeneic to the object in which the transplant is implanted. The tissue can be a synthetic tissue, such as, but not limited to, laboratory-cultured tissue or 3D-printed tissue.

[0022] According to one or more embodiments, Figure 1 Tissue connector 100 is shown. Tissue connector 100 includes a body 102 formed by one or more layers of material, and at least one barbed suture 104 attached to body 102. Body 102 can be in the form of a sheet (e.g., a rolled sheet) or a hollow tube and can have any suitable size or shape. In the case where body 102 can be in the form of a sheet, the sheet can be rolled into a tube before being attached to the tissue, or can be wrapped around the tissue for attachment. The material of one or more layers forming body 102 can include 1 layer to about 20 layers, such as 1 layer to about 12 layers of material. When two or more layers form body 102, these layers can overlap or align. The material of each layer in one or more layers used as body 102 can be small intestinal submucosa (SIS), such as SIS manufactured by Cook Pharmaceuticals, which can be obtained from animal sources, and in some embodiments, can be obtained from porcine small intestine. Alternatively, the material can be any flexible material suitable for forming a tissue connector. In embodiments of body 102 that include multiple layers, each layer may be formed from the same material or different materials.

[0023] The barbed suture 104 can have a handle 106 at each end thereof, which can facilitate the manipulation of the tissue connector 100. For example, the handle 106 can allow a surgeon (directly or indirectly via one or more medical devices) to clamp the ends of the suture 104 while placing the tissue connector 100 relative to the tissue. In one embodiment, the suture 104 can be, for example, a Corza Medical As an example, a barbed suture of the brand is shown in perspective view. Figure 2 The barbed suture 104 may include a body 200 and a plurality of barbs 202 protruding from the body 200. The body 200 may have a constant diameter, such as Figure 2 The barbs 202 may be arranged, for example, in a longitudinal configuration, wherein the barbs 202 are aligned relative to an axis parallel to the longitudinal axis of the body 200; a circumferential configuration, wherein the barbs 202 are aligned relative to the circumference of the body 200; a mesh configuration, wherein the barbs 202 are arranged on the body 200 in a mesh or grid pattern; or a helical configuration, wherein the barbs 202 are arranged in a helical shape relative to the length of the body 200 (e.g., the barbs 202 may be arranged in a helical shape along the length of the body 200). In other embodiments, the barbs 202 may be irregularly and / or randomly spaced along the body 200. The suture barbs may be directionally oriented in any suitable manner.

[0024] like Figure 1 As shown, the barbed suture 104 can be sewn through one or more layers of the body 102, so that one or more portions of each suture 104 pass through all of the multiple layers. Alternatively, in the case where the body 102 is composed of two or more layers, the barbed suture 104 can be sewn through at least the innermost layer, so that the suture 104 is embedded or trapped in or between the layers of the body 102. In such an arrangement, one or more portions of the barbed suture 104 can be exposed to the innermost surface 108 of the body 102, and alternating portions can be embedded between the layers of the body 102. As used in this specification, the term "innermost" refers to the surface or surface layer facing the inner cavity of the body 102, which is configured to contact the tissue, or, in an embodiment where the body 102 is a sheet, the surface of the body 102 is configured to face the tissue to which the tissue connector 100 is to be applied. The use of the tissue connector 100 will be further described below.

[0025] Figure 3 A tissue connector 300 according to another embodiment is shown. Figure 1 In the illustrated embodiment of the tissue connector 100, the tissue connector 300 includes a body 302 formed from multiple layers of material, which may overlap or align. The tissue connector 300 includes one or more barbed sutures 304 attached to the body 302. The body 302 may be in the form of a sheet (e.g., a rolled sheet) or a hollow tube, as discussed with respect to the tissue connector 100. The material used as one or more layers of the body 302 may be SIS, which may be obtained from an animal source, and in one embodiment, may be obtained from porcine small intestine. Alternatively, the material may be any flexible material suitable for forming a tissue connector, as described above. The multiple layers may be formed from the same material or from one or more different materials. The multiple barbed sutures 304 may be the same as described above with respect to the tissue connector 100. Figure 2 The described sutures 104 are the same or similar.

[0026] exist Figure 3In an embodiment, the barbed suture 304 can be embedded in the body 302, so that a portion of the barbed suture 304 is exposed to the innermost surface 310 of the body 302, and alternating portions of the barbed suture 304 are buried in the multi-layer body 302. Figure 3 An exposed portion 306 of the barbed suture 304 along the innermost surface 310 and an embedded portion 308 of the barbed suture 304 are depicted (e.g., note that a gap where the suture is not visible along the innermost surface 310). The embedded portion 308 can be embedded within the innermost layer of the body 302, within a layer radially outward of the innermost layer, or between layers. Figure 3 A plurality of barbed sutures 304 are depicted as being longitudinally arranged along the length of the body 302, but the one or more barbed sutures 304 can be arranged in any suitable manner, such as a circumferential, mesh, grid, spiral, one or more separate or connected linear arrangements, etc., with a portion of the barbed sutures 304 embedded in the innermost surface and a portion of the barbed sutures 304 exposed at the innermost surface. For example, the one or more barbed sutures 304 can be embedded in a serpentine configuration, can be configured to extend in one direction and then turn and extend in the opposite direction, or can have an irregular configuration.

[0027] According to one or more embodiments, reference Figure 4A The method 400a for forming a tissue connector is shown and described. Specifically, Figure 4A Shown forming tissue connectors such as Figure 1 The tissue connector 100 or Figure 3 Method 400a of the tissue connector 300 shown. Method 400a may include: step 401a, which forms a body from one or more layers of material, and another or next step 402a, which attaches at least one barbed suture to the body. As described above, the material forming the one or more layers of the body may be small intestinal submucosa (SIS), which may be obtained from an animal source such as porcine small intestine. Alternatively, the material may be any flexible material or materials suitable for forming a tissue connector.

[0028] The step 402a of attaching sutures may include sewing each suture into the body. Sewing the sutures may include inserting each suture through all of one or more layers of the body, e.g. Figure 1 As shown, first from the outer surface near one end of the body to the inner surface, and then from the inner surface near the other end of the body to the outer surface. When performing this step, the body can be a sheet or a tube. This step 402a can further include tying a knot at least at one end of each suture (for example, Figure 1In one embodiment, knots 110A, 110B may be tied at both ends of each suture. In some aspects, a first knot 110A may be tied at one end of each suture 104, for example before or when the suture 104 is sewn into the body 102. In addition, a last or second knot 110B may be tied at the other end of the suture 104, for example after the suture is sewn into the body 102. Knots 110A, 110B help to secure the suture 104 relative to the body 102. A medical professional may perform step 402a before using the tissue connector on a subject, or step 402a may be performed by a manufacturer during manufacture of the tissue connector. In some embodiments, step 402a may include attaching a handle (e.g., handle 106, such as handle 106) to the end of each suture. Figure 1 for user convenience.

[0029] In embodiments where the tissue connector has two or more layers, step 402a of attaching sutures may include sewing each suture into the body. Suturing the sutures may include, for example, first inserting each suture from the inner surface of the innermost layer of the body through or into the innermost layer at one or more locations along the length of the body to embed the suture into the layer of the body or between adjacent layers of the body, and then passing through the innermost layer at alternating locations along the length of the body back to the inner surface of the body. When performing this step, the body may be a sheet or a tube. Step 402a may further include tying a knot at least at one end of each suture. In one embodiment, the knot (e.g. Figure 1 The knots 110A, 110B in the figure can be tied at both ends of each suture. A medical professional can perform step 402a before using the tissue connector on a subject, or step 402 can be performed by a manufacturer during the manufacture of the tissue connector. Although not shown in FIG. Figure 3 , one or more handles (e.g. Figure 1 A handle 106 ) is shown also may be attached to one or more of the body 302 or the suture 304 .

[0030] Figure 4B The different steps of the method 400b for forming a body are described, and Figure 4C The state 400c of the main body in each step of the different steps is described. In one or more embodiments, as Figure 4CAs shown in state 401c, method 400b may include step 401b of forming a body, which may include aligning the barbed sutures or material layers. For example, as described above, the material layers can be aligned or overlapped in various arrangements. The barbed sutures can be arranged in different patterns, depending on the desired arrangement of the barbed sutures within the material. In addition, in some embodiments, step 401b may include aligning the barbed sutures and layers relative to each other. Figure 4C As shown in state 402c, method 400b may also include step 402b, which places a suture in the material. The suture may be sewn into the material, for example, in various arrangements described in this specification. The suture may be inserted into the body when the material is dry. Figure 4C As shown in state 403c, method 400b may also include step 403b, wherein once the barbed suture has been placed in the material or after the barbed suture has been placed in the material, the material is dried. Figure 4C As shown in state 404c, method 400b may include optional step 404b, which wets the material layer to shape the tissue connector and then dries it again. In step 404b, wetting the material layer to shape the tissue connector may also include rolling the material layer into, for example, a tubular shape, while the material layer is wet. If the tissue connector is formed as a sheet in some embodiments, the forming step 404b may not be performed. In other aspects, the forming step 404b may include reshaping or otherwise modifying the shape of the tissue connector. In some aspects, the barbed suture may be sewn into at least the innermost layer of the material, and after the barbed suture is attached, an additional material layer may be added to one side of the innermost layer of the material to form the outer layer of the material. In such an embodiment, after inserting each barbed suture, the innermost layer of the material may be dried before adding an additional material layer. In other aspects, an additional material layer may be added while the innermost layer of the material is wet.

[0031] As described herein, a tissue connector formed according to one of the above methods 400a, 400b, and 400c can be formed in a coated configuration or as a flat sheet. In the case where the tissue connector is a nerve tissue connector in a coated configuration, the diameter of the tissue connector can range in value from about 0.5 mm to about 10 mm, and the length of the tissue connector can range in value from about 5 mm to about 20 mm, for example. Exemplary sizes of nerve tissue connectors can include: 1.5 mm x 10 mm, 2 mm x 10 mm, 3 mm x 10 mm, 4 mm x 10 mm, 5 mm x 10 mm, 6 mm x 10 mm, 7 mm x 10 mm, 1.5 mm x 15 mm, 2 mm x 15 mm, 3 mm x 15 mm, 4 mm x 15 mm, 5 mm x 15 mm, 6 mm x 15 mm, and 7 mm x 15 mm, where the size is represented by diameter x length. Furthermore, in the case where the tissue connector is a nerve tissue connector configured as a flat sheet, the width of the tissue connector may range in value from about 1 mm to about 15 mm, and the length of the tissue connector may range in value from, for example, about 10 mm to about 50 mm. Exemplary dimensions of the nerve tissue connector may include: 2 mm x 20 mm, 3.5 mm x 20 mm, 5 mm x 20 mm, 7 mm x 20 mm, 10 mm x 20 mm, 3.5 mm x 40 mm, 5 mm x 40 mm, 7 mm x 40 mm, and 10 mm x 40 mm, where the dimensions are expressed as diameter x length. Furthermore, the dimensions of the tissue connector, whether in a sheathed configuration or a flat sheet configuration, may be determined based on the type of tissue to which the tissue connector is to be attached.

[0032] According to any embodiment disclosed in this specification, reference Figure 5As shown and described, a method 500 for repairing tissue using a tissue connector including one or more barbed sutures. Specifically, method 500 may include step 501, which directs the tissue connector at the junction or repair site of two adjacent tissue ends or adjacent damaged tissues. If the tissue connector is not yet formed into a tube, method 500 may further include step 502, which encapsulates the body of the tissue connector as a tube. For example, the tube shape can form a roughly cylindrical shape and have an open top and bottom. Method 500 may also include step 503, which twists one or more ends of the barbed suture, and step 504, which trims or cuts the ends of the suture. In step 501 of directing the tissue connector at the junction or repair site, the tissue connector can be in sheet form, formed by one or more layers of material. In optional step 502, for example, the body can be encapsulated into a tubular shape, so that the tissue connector can be entubulated or otherwise surround the two tissue ends when the tissue is cut, or otherwise surround the damaged tissue when the tissue is damaged but not cut. The body may be wrapped, for example, similar to a burrito or taco to form a generally tubular or open cylindrical shape. For example, the lateral edges of the body may at least partially overlap to form a tubular or open cylindrical shape. If the body is already in tubular form, step 502 may not be performed.

[0033] In step 503, the ends of the suture may be twisted in the same direction (for example, the two ends may be twisted clockwise or counterclockwise). Figure 1 As shown, the end of the suture 104 can be twisted in direction A. Figure 1 As shown, by twisting a handle 106 coupled to the end of the suture 104, the end of the corresponding suture 104 is twisted. Alternatively, in some aspects, the ends of the suture can be twisted in opposite directions (for example, one end can be twisted clockwise and the other end can be twisted counterclockwise). Twisting the end of the suture causes the barbs of the suture to at least partially engage or entangle with the surface of the tissue, attaching the tissue connector to the tissue. For example, in the case of neural tissue, twisting the end of the suture can cause the barbs of the suture to at least partially engage or entangle in the epineurium or external connective tissue to attach the tissue connector to the neural tissue. The end of the suture can have a handle, such as Figure 1The handle 106 of the illustrated embodiment provides the surgeon or medical professional with a grip on the suture for ease of twisting. As a result of step 503 of twisting the suture ends, the tissue connector can be at least partially fixed to the tissue. In the case of joined tissues, the ends of severed tissue, such as severed nerve tissue, can be held in position relative to each other within the tissue connector. After performing step 503, an optional step of tying a securing knot at one or both ends of the suture can be performed. For example, step 503 can include tying knot 110B. In addition, in step 504, for example, Figure 1 As shown, the free end of the suture can be optionally trimmed using one or more trimming devices 112 (e.g., scissors) in a manner relatively close to the end of the suture protruding from the tissue connector. Figure 1 In the illustrated embodiment, the tissue connector is trimmed at a location between the knots (e.g., knots 110A, 110B) at each end of the suture and the handles (e.g., handle 106). The resulting sutureless connector can be secured to tissue, e.g., to the end of a nerve, with a strength equal to or greater than that of an 8-0 suture.

[0034] According to one or more embodiments, Figure 6 Graphs are provided to exemplarily depict retention strength of a tissue connector versus displacement. More specifically, tissue connectors according to embodiments described herein are capable of providing relatively greater retention strength than known connectors using epineurial sutures. Retention testing was performed on tissue connectors using ASTM suture retention tests according to one of the embodiments described herein. Figure 6 The results of these retention tests are depicted and specifically show that the exemplary tissue connectors of the present disclosure have relatively greater retention strengths because they withstand greater forces before their ends are displaced. Specifically, prototypes of tissue connectors according to embodiments described in this specification exhibit retention strengths of about 0.5N to about 3N, as shown in FIG. Figure 6 As shown in at least lines 602, 604 and 606 in the diagram of Figure 6 The three lines that achieved the highest measurement of suture holding strength in terms of force were correlated.

[0035] By considering the description and practice of the invention disclosed in this specification, other embodiments of the present disclosure will be apparent to those of ordinary skill in the art to which the invention belongs. The description and embodiments are intended to be considered as exemplary only, and the actual scope and spirit of the present invention are indicated by the scope of the appended claims.

Claims

1. A tissue connector, characterized in that: include: a body formed of one or more layers of at least one material, and At least one barbed suture is attached to the body such that at least a portion of the at least one barbed suture is exposed along a surface of the body.

2. The tissue connector of claim 1, wherein the body is a hollow tube, and wherein the surface is the innermost surface of the hollow tube. The tissue connector of claim 1 , wherein the body is a sheet.

4. The tissue connector of claim 1, wherein the at least one material is small intestinal submucosa (SIS).

5. The tissue connector of claim 1, wherein the at least one barbed suture is sutured through the one or more layers forming the body so that a portion of the at least one barbed suture passes through all of the one or more layers.

6. A tissue connector as described in claim 1, wherein the one or more layers include two or more layers, and wherein the at least one barbed suture is sutured within or between the two or more layers, so that a portion of the at least one barbed suture is retained within or between the two or more layers.

7. A tissue connector as described in claim 1, wherein the body is a hollow tube, the one or more layers include two or more layers, and the at least one barbed suture is sutured into the body and some portions of the at least one barbed suture are exposed to the innermost surface of the hollow tube, and alternating portions of the at least one barbed suture are buried in the two or more layers.

8. The tissue connector of claim 1, wherein the one or more layers include 1 to about 12 layers.

9. The tissue connector of claim 1, wherein the at least one barbed suture is oriented relative to the body of the tissue connector as one of: Vertical configuration; Circumferential configuration; Mesh configuration, and Spiral configuration.

10. A method of forming a tissue connector, characterized in that: include: forming a body from one or more layers of at least one material, and At least one barbed suture is attached to the body such that at least a portion of the at least one barbed suture is exposed along a surface of the body.

11. The method of claim 10, wherein the at least one material is small intestinal submucosa (SIS).

12. The method of claim 10, wherein the body is a sheet.

13. The method of claim 10, wherein attaching the at least one barbed suture comprises: inserting each of the at least one barbed suture through all of the one or more layers of the body: (a) from the outer surface to the inner surface near one end of the body, and (b) from the inner surface to the outer surface near the other end of the body, and Tie a knot at at least one end of each suture.

14. The method of claim 13, wherein: Forming the body includes: providing the one or more layers in a wet state, and allowing the one or more layers to dry, Wherein the insertion of each suture is performed after the one or more layers have dried.

15. The method of claim 10, wherein the one or more layers include two or more layers, and attaching the at least one barbed suture includes: Each of the at least one barbed suture is inserted (a) from the inner surface of the two or more layers of the body through the innermost layer at one or more locations along the length of the body, and (b) from the innermost layer back to the inner surface at alternating locations along the length of the body.

16. The method of claim 15, wherein attaching the at least one barbed suture to the body comprises inserting each suture while the innermost layer of the material is wet, and wherein the method further comprises: After each suture is inserted, the innermost layer of the material is allowed to dry, and One or more additional layers of material are added to the outer surface of the dried innermost layer.

17. The method of claim 10, wherein: Forming the body includes: aligning the layers of said material, and The layers of material are rolled into a tube.

18. The method of claim 10, wherein the one or more layers comprises 1 to about 12 layers.

19. The method of claim 10, wherein the at least one barbed suture is oriented relative to the body of the tissue connector as one of: Vertical configuration; Circumferential configuration; Mesh configuration, and Spiral configuration.

20. A method for repairing tissue using the tissue connector according to claim 1, the method comprising: orienting the tissue connector about the tissue to be engaged or damaged so that the tissue to be engaged or damaged contacts the inner surface of the tissue connector, and The end of the at least one barbed suture is twisted to engage the at least one barbed suture with the engaged or damaged tissue.

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