Porous sutures and methods of use

Abstract

The porous suture for tissue repair includes a planar body having a length between first and second ends and a width between first and second sides, the planar body being formed from a porous material with a plurality of pores along the length of the planar body between the first and second ends, and configured to substantially maintain its width even as a longitudinal force acting on the planar body increases.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to sutures for implantation in human or other animal tissue, as well as suturing methods for implanting and securing sutures in tissue. [Background technology]

[0002] Sutures are used to hold tissue together or to create stitches to position or support tissue for healing and / or regrowth, such as to close wounds, repair tissue defects, or any other type of tissue repair. Sutures are used in surgical procedures for wound closure, to close skin in plastic surgery, to securely hold damaged or severed tendons, to repair muscle or other internal tissue, or to attach implants to tissue. Sutures can be introduced into tissue by a fixation device, which may include an introducer device, such as a needle or other insertion device, attached to one or more ends of the suture. Generally, the suture needle or device is intended to pass through and pull the suture through the tissue. For example, the needle may be passed through opposing surfaces of the tissue so that the opposing surfaces are drawn together when the suture is tensioned. The suture may be knotted, tied, or secured in some way to secure it. Once the stitch or set of stitches is completed, the suture is cut or the needle is removed from the end of the suture. Summary of the Invention [Problem to be solved by the invention]

[0003] This Summary is provided to introduce a selection of concepts that are further described below in the Detailed Description. This Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of the claimed subject matter. [Means for solving the problem]

[0004] In one aspect of the present disclosure, a porous suture for tissue repair includes a planar body having a length between first and second ends and a width between first and second sides, the planar body being formed from a porous material with a plurality of pores along the length of the planar body between the first and second ends, and configured to substantially maintain its width even as a longitudinal force acting on the planar body increases.

[0005] In one embodiment, as the longitudinal force increases to 16 N, the width of the suture decreases by no more than 40% compared to the width in the absence of the longitudinal force.

[0006] In another embodiment, as the longitudinal force increases to 32 N, the width of the suture decreases by no more than 40% compared to the width in the absence of the longitudinal force.

[0007] In another embodiment, as the longitudinal force increases to 50 N, the width of the suture decreases by no more than 40% compared to the width in the absence of the longitudinal force.

[0008] In another embodiment, as the longitudinal force increases to 16 N, the width of the suture decreases by no more than 30% compared to the width in the absence of the longitudinal force.

[0009] In another embodiment, as the longitudinal force increases to 16 N, the width of the suture decreases by no more than 20% compared to the width in the absence of the longitudinal force.

[0010] In another embodiment, as the longitudinal force increases to 16 N, the width of the suture decreases by no more than 10% compared to the width in the absence of the longitudinal force.

[0011] In another embodiment, the planar body is configured to remain flat along its width despite increasing longitudinal forces.

[0012] In another embodiment, the plane comprises a plurality of strands forming a chain stitch along its length.

[0013] In another embodiment, the planar body comprises a single layer of porous material.

[0014] In another embodiment, the porous material is a mesh.

[0015] In another embodiment, the porous material is a mesh and further comprises a set of cross-connecting strands connecting the chain stitches to form the mesh.

[0016] In another embodiment, the porous material is a mesh, the mesh defining a plurality of pores, the pore size of the plurality of pores being consistent along the length of the planar body.

[0017] In another embodiment, the porous material is a mesh, the mesh defining a plurality of pores, the pore size of the plurality of pores being larger near the first end and / or second end than in a central portion of the planar body.

[0018] In another embodiment, the porous material is a mesh, the mesh defining a plurality of pores, the pore size of the plurality of pores being larger near the longitudinal centerline of the planar body than on the first side or the second side.

[0019] In another embodiment, the porous material is a continuous sheet and the plurality of pores are formed through the continuous sheet.

[0020] In another embodiment, the plurality of pores are aligned along the longitudinal centerline of the planar body.

[0021] In another embodiment, at least a portion of the plurality of pores are sized to accommodate a porous suture passing therethrough such that the porous suture is configured to pass therethrough.

[0022] In another embodiment, at least a portion of the plurality of pores is sized so that a porous suture is configured to pass through it to create a self-locking stitch.

[0023] In another embodiment, each of the plurality of pores is sized to accommodate a porous suture passing therethrough such that the porous suture is configured to pass therethrough.

[0024] In another embodiment, the plurality of pores are uniformly spaced along the length of the body between the first end and the second end.

[0025] In another embodiment, the porous suture has a width of at least 4 mm.

[0026] In another embodiment, the porous suture is configured such that the width to length ratio of the planar body does not change substantially when the porous suture is under high tension compared to the ratio in the absence of longitudinal force.

[0027] In another embodiment, when the porous suture is under no longitudinal force and is under high tension, the width to length ratio of the planar body is at least 1:10.

[0028] In another embodiment, when the porous suture is under no longitudinal force and is under high tension, the width to length ratio of the planar body is at least 1:20.

[0029] In another embodiment, the porous suture comprises a first surgical needle secured to a first end of the planar body and a second surgical needle secured to a second end of the planar body.

[0030] In another aspect of the present disclosure, a method of repairing tissue with a porous suture is provided, the porous suture comprising a planar body having a length between first and second ends and a width between first and second sides, with a plurality of pores formed along the length of the planar body between the first and second ends, the method including passing the first end of the porous suture through tissue on each of a first side of a tissue repair site and a second side of the tissue repair site to create at least one stitch, and passing the suture over itself to create a self-locking stitch to create a finish anchor at the first end of the porous suture.

[0031] In one embodiment, the method includes passing a first end of a porous suture multiple times through tissue on each of a first side and a second side of the tissue repair site to create a series of stitches to close the wound, with a self-locking stitch following the series of stitches.

[0032] In another aspect of the present disclosure, a porous suture for tissue repair includes a planar body having a length between first and second ends and a width between first and second sides, the planar body being formed from a porous material having a plurality of pores along the length of the planar body between the first and second ends, at least one end of the planar body being formed into a fixation device configured to introduce the porous suture into tissue.

[0033] In one embodiment, a plastic sheath is formed over at least one end of the planar body, the plastic sheath forming a fixation device having a sharp tip configured to penetrate tissue.

[0034] In a further embodiment, the fixation device exposes the plastic sheath and porous suture to heat, which bonds them together into a unitary piece and transforms them into a point.

[0035] In another embodiment, the porous material of the planar body is formed from fiber strands, and the fiber strands at at least one end are bonded to each other to form a fixation device. Optionally, the fixation device has a pointed tip configured to penetrate tissue.

[0036] In another embodiment, the fiber strands comprise a biocompatible metal and / or a biocompatible synthetic polymer, and the fiber strands are exposed to heat or chemicals such that they adhere to one another to form the fixation device. Optionally, the fixation device has a sharp tip configured to penetrate tissue.

[0037] This disclosure includes the following figures: [Brief explanation of the drawings]

[0038] [Figure 1A] FIG. 1A shows an embodiment of a porous suture with a curved fixation device and a straight fixation device. [Figure 1B] FIG. 1B shows an embodiment of a porous suture with a curved fixation device and a straight fixation device. [Figure 1C] FIG. 1C shows an embodiment of a porous suture with a curved fixation device and a straight fixation device.

[0039] [Figure 2A] FIG. 2A shows another embodiment of a porous suture configured as a mesh suture. [Figure 2B] FIG. 2B shows another embodiment of a porous suture configured as a mesh suture. [Figure 2C] FIG. 2C shows another embodiment of a porous suture configured as a mesh suture.

[0040] [Figure 3A] FIG. 3A illustrates a method for anchoring a porous suture to a target surface using a clinch knot. [Figure 3B] FIG. 3B illustrates a method for anchoring a porous suture to a target surface using a clinch knot. [Figure 3C] FIG. 3C illustrates a method for anchoring a porous suture to a target surface using a clinch knot. [Figure 3D] FIG. 3D illustrates a method for anchoring a porous suture to a target surface using a clinch knot.

[0041] [Figure 4A] FIG. 4A illustrates a method for anchoring a porous suture to a target surface using a self-locking backstitch. [Figure 4B]FIG. 4B illustrates a method for anchoring a porous suture to a target surface using a self-locking backstitch. [Figure 4C] FIG. 4C illustrates a method for anchoring a porous suture to a target surface using a self-locking backstitch. [Figure 4D] FIG. 4D illustrates a method for anchoring a porous suture to a target surface using a self-locking backstitch.

[0042] [Figure 5A] FIG. 5A illustrates a method for anchoring a porous suture to a target surface using an alternative self-locking weave pattern. [Figure 5B] FIG. 5B illustrates a method for anchoring a porous suture to a target surface using an alternative self-locking weave pattern. [Figure 5C] FIG. 5C illustrates a method for anchoring a porous suture to a target surface using an alternative self-locking weave pattern. [Figure 5D] FIG. 5D illustrates a method for anchoring a porous suture to a target surface using an alternative self-locking weave pattern.

[0043] [Figure 6A] FIG. 6A shows an embodiment of a mesh suture that includes at least one barbed filament. [Figure 6B] FIG. 6B shows an embodiment of a mesh suture that includes at least one barbed filament. [Figure 6C] FIG. 6C shows an embodiment of a mesh suture that includes at least one barbed filament. DETAILED DESCRIPTION OF THE INVENTION

[0044] Specific terms have been used herein for brevity, clarity, and understanding. Such terms are used for descriptive purposes only and are intended to be broadly construed, and no unnecessary limitations should be inferred therefrom beyond the requirements of the prior art.

[0045] Use of the terms "including," "comprising," or "having" and variations thereof herein is meant to encompass the subsequently listed elements and equivalents thereof, as well as additional elements. Embodiments recited as "including," "comprising," or "having" particular elements are also contemplated as "consisting essentially of" and "consisting of" those specific elements.

[0046] Through experience and research in the related field, the inventors have recognized several problems with solid sutures. After a suture is embedded in tissue, the tissue begins to heal, forming scar tissue around the suture. This creates a tubular structure of scar tissue surrounding the suture with a small surface area. Available solid or other tubular sutures generally have smooth outer surfaces that do not adhere to or engage with scar tissue. Therefore, solid sutures can slide through the surrounding scar tissue with little resistance. Therefore, existing sutures can be easily removed and tend to cut tissue when used in high-tensile applications. When a thin solid suture is acted upon by internal or external forces, it can dig into and damage surrounding tissue. This "cheese wiring" effect allows the suture to cut and pull out of the tissue to which it is anchored.

[0047] In consideration of the aforementioned problems and challenges in the related art, the present inventors have developed a novel porous suture configured to improve performance in high-tension applications. An embodiment of a porous suture disclosed herein includes a generally planar body having a plurality of pores formed therethrough. As tissue heals around the porous suture, new scar tissue growth extends into the pores. This ingrowth connects the porous suture to the surrounding tissue and inhibits sliding movement of the porous suture relative to the tissue. Furthermore, the tissue ingrowth, combined with the wide body of the novel porous suture, distributes the forces acting on the tissue to prevent the porous suture from cutting the surrounding tissue when placed under tension.

[0048] Additionally, porous sutures are configured to allow for threading of the suture through itself at the pores to improve fixation. The pores of the porous suture are configured to allow for threading of the suture and / or a fixation device, such as a needle, through the suture body to form a locking backstitch or other anchor stitch. By threading the suture through itself, a flatter, less bulky knot is created that remains relatively flush at the anchor location. This flatter knot profile is less palpable, causes less patient discomfort, and is less likely to cause tissue erosion or infection at the anchor location.

[0049] 1A-1C illustrate an embodiment of a novel porous suture 50 configured for biological applications such as wound closure and / or high-tensile tissue repair. FIG. 1A shows a plan view of the porous suture 50, and FIGS. 1B and 1C show cross sections along the line indicated in FIG. 1A. The suture 50 has a flexible, generally planar body 52 extending longitudinally from a first end 54 to an opposite second end 56 and laterally between opposite first and second sides 58, 60. In some embodiments, the porous suture may have three or more ends, such as a length of porous suture that splits into multiple lengths of porous suture at a point along its length L, thus providing multiple ends on one side. The body 52 of the porous suture 50 may be formed from an elastically deformable material configured to maintain a planar shape while the porous suture 50 is under tension. This can be useful, for example, to maximize the surface area of ​​the porous suture 50 on the target surface, thereby reducing stresses and distributing forces within the target surface and reducing the risk of anchor point failure. The planar body 52 can also provide a thin cross-sectional area that can be easily penetrated by the first or second ends 54, 56 of the porous suture 50 for fixation to the target surface.

[0050] The body 52 of the porous suture 50 can be constructed from any biocompatible material and can be configured to be permanent, removable, or degradable. For example, the porous suture 50 can include one or more materials or filaments, which may include biocompatible metals, either permanent (e.g., stainless steel, titanium, etc.) or degradable (e.g., magnesium alloy, etc.); biocompatible synthetic polymers, either permanent (e.g., polypropylene, polyester, etc.) or degradable (e.g., polylactic acid, polypropylene fumarate, polylactic-co-glycolic acid, etc.); and / or collagen-based materials (e.g., allograft, xenograft, etc.). For example, the body 52 of the porous suture 50 can be formed from multiple filaments or fiber strands, which may include a mixture of any of the above-mentioned materials, and may be a knitted, woven, stitched, spun, and / or braided textile body 52. ​​Alternatively or additionally, the porous suture can be formed from a drug-eluting material containing a therapeutic agent or a material treated with a therapeutic agent. Alternatively or additionally, the porous suture may be formed by cutting (e.g., laser, die, etc.) and / or printing (e.g., FDM, SLA, DLP, SLM, etc.).

[0051] Embodiments of the suture 50 may include at least one fixation device 114 attached to the first end 54 and / or the second end 56 of the body 52, or to each of the multiple ends. The fixation devices 114a, 114b may be any element or series of elements that enable fixation of the porous suture 50 to a target surface. Exemplary fixation devices 114 include, but are not limited to, surgical needles or other rigid or semi-rigid bodies formed at one or both ends of the suture, staples, tacks, screws, laser-assisted tissue joining, fibrin sealants, adhesives, salute "Q" rings, Mitek anchors, and / or other sutures. Each fixation device 114 may be permanently, removably, or removably attached to the suture location. 1, the fixation device 114 may be permanently or removably attached to the first and / or second ends 54, 56 of the porous suture 50. Alternatively or additionally, the fixation device 114 may be permanently, removably, or removably attached to another portion of the body 52. ​​Furthermore, the fixation device 114 may be an element that is permanently or temporarily implanted in the patient, or that is removed from the porous suture 50 after being implanted in the patient.

[0052] The fixation devices 114a, 114b shown in FIG. 1 are surgical needles configured to assist in securing the porous suture 50 to a target surface, i.e., to allow a user to thread the porous suture 50 through the target surface and / or thread the suture itself or form a stitch to securely hold it in tissue, as described in more detail below. In particular, the porous suture 50 of FIG. 1 includes a first fixation device 114a configured as a curved needle attached to a first end 54 of the body 52 and a second fixation device 114b configured as a straight needle attached to a second end 56. In other embodiments, the needles may be "S" shaped or have other multidirectional shapes configured to form a predetermined path through tissue. The needles 114a, 114b may be formed of metal or any rigid material suitable for penetrating tissue. Alternatively, the fixation device may be a flexible shaft that includes the ends of the porous suture. One or both ends may have fixation devices of the same type or different types. For example, it may be useful to include multiple fixation devices so that the surgeon can work in multiple directions and select a preferred needle type (i.e., preceding the first end 54 or the second end 56). Once the porous suture 50 is securely held on the target surface, the body 52 may be cut at the first end 54 and / or the second end 56 to remove the fixation device(s) 114a, 114b. However, some embodiments may be configured differently. For example, some embodiments may include only one fixation device attached to one end of the suture or at a location other than the end. In other embodiments, elements may be formed on the ends of the porous suture 50, examples of which are described in more detail below.

[0053] 1A-1C, the porous suture 50 includes a plurality of pores 70 formed along the length L of the body 52 between its first and second ends 54, 56. As described in further detail below, each of the pores 70 is configured to allow the porous suture 50 to pass through the body 52 therethrough during attachment of the porous suture 50 to a target surface. In the illustrated embodiment, the pores 70 are uniformly spaced along the length L of the body 52 between the first and second ends 54, 56. In the embodiment of FIG. 1, the pores 70 are aligned along the longitudinal centerline of the planar body. However, other embodiments may be configured with a non-uniform arrangement of pores 70, which may be positioned along the centerline and / or elsewhere across the width W and length L of the body 52. As described in further detail below, the size of the pores 70, the shape of the pores 70, the spacing between the pores 70, and / or the location of the pores 70 in the suture body 52 may differ from that of the porous suture 50 of FIG. 1.

[0054] In the embodiment of FIGS. 1A-1C, the body 52 of the porous suture 50 is generally a continuous sheet or relatively dense material, and the pores 120 are holes formed through the sheet body 52. ​​However, some embodiments may be configured differently. For example, with reference to FIGS. 2A-2C, an embodiment of a porous suture 100 is shown having a mesh suture body 102. Similar to the embodiment of FIG. 1, the body 102 of the porous mesh suture 100 extends longitudinally from a first end 104 to a second end 106 and laterally between opposing first and second sides 108, 110. Although not shown in FIGS. 2A-2C, embodiments of the mesh suture 100 may include fixation devices fixedly or removably attached to the first end 104 and / or second end 106 of the body 102, similar to those shown in and described above for the porous suture 50 of FIGS. 1A-1C.

[0055] The body 52, 102 of the porous suture 50, 100 of FIGS. 1 and 2 is generally flat, e.g., having a width W that is substantially greater than its thickness depth (the length L is substantially greater than the width W). The width W is substantially wider than that of standard sutures, such as standard sutures that have typical widths in the range of 0.1 mm to 0.7 mm, to provide the adhesive and tensile support advantages described herein. For example, the width may be at least 2 mm, and for many tissue repair applications, may preferably be greater than 3 mm, or in some embodiments, at least 4 mm, or in some embodiments, at least 5 mm. Exemplary lengths L, widths W, and thicknesses, as well as desirable proportions of such dimensions, are described below. The generally flat body 52, 102 may be formed from a single layer of material or fabric. Alternatively, it may be formed from a multi-ply fabric in which pores 70, 120 provide passageways or pathways through all plies or layers. As described in more detail below, the material of the body 52, 102 may be configured to maintain its width W when under longitudinal tension, or to maintain at least a substantial portion of its original width W when not under tension, thereby enabling the porous suture 50, 100, when implanted, to distribute loads over a wider area of ​​tissue compared to prior art sutures and also permit tissue ingrowth and adhesion, providing superior performance in high tension applications (such as tendon repair, muscle repair, ligament repair, fascia repair, and breast tissue repair).

[0056] The body 102 of the mesh porous suture 100 may be an arrangement of biocompatible fiber strands 130 that are knitted, woven, stitched, braided, and / or otherwise connected to form a continuous, flexible material. The body 52 of the continuous sheet suture 50 may also be formed from fiber strands that are more densely arranged than those of the mesh suture body 102. Each of the fiber strands 130 forming the body 52, 102 may be, for example, a monofilament, a braided filament, a combination of monofilament and braided filament, and / or another thread, filament, or strand-like structure. The fiber strands 130 may be formed from filaments comprising one or more of: biocompatible metals, either permanent (e.g., stainless steel, titanium, etc.) or degradable (e.g., magnesium alloy, etc.); biocompatible synthetic polymers, either permanent (e.g., polypropylene, polyester, etc.) or degradable (e.g., polylactic acid, polypropylene fumarate, polylactic-co-glycolic acid, etc.); and / or collagen-based materials (e.g., allograft, xenograft, etc.). In some embodiments, the mesh suture body 102 comprises a synthetic mesh, which is a mesh made from biocompatible and synthetic materials, such as polypropylene, polyethylene terephthalate polyester, expanded polytetrafluoroethylene (ePTFE), polyglactin, polyglycolic acid, trimethylene carbonate, poly-4-hydroxybutyrate (P4HB), polyglycolide, polylactide, and / or trimethylene carbonate (TMC). In some embodiments, the suture body 52, 102 comprises a biological sheet or mesh, which is a sheet or mesh made from a biocompatible and biological material, such as human dermis, porcine dermis, porcine intestine, bovine dermis, and / or bovine pericardium. Additionally or alternatively, the body 52, 102 may be comprised of a combination of synthetic and biological materials and / or a combination of degradable and non-degradable materials, examples of which are described in more detail below.

[0057] In knitted, woven, and / or braided sutures, the fiber strands 130 may be organized to optimize biomechanical properties such as tensile strength, as well as porosity, morphology, and geometry for tensile strength and bioincorporation, which also affect tensile strength and abrasion resistance. Various knitting techniques known in the art may be used to create the mesh suture body 102 of the suture 100. These include, but are not limited to, warp knitting, weft knitting, crochet knitting, and raschel knitting. Alternatively or additionally, various weaving techniques known in the art may be used to create the mesh suture body 102 of the suture 100. These include, but are not limited to, hexagonal open stitches (e.g., PARIETINE® mesh), interlocking fiber joints (e.g., PROLENE® mesh, SURGIPRO Pro® mesh), diamond-shaped open stitches (e.g., ULTRAPRO® mesh), two-dimensional weaves, and three-dimensional weaves.

[0058] The mesh material forms a pattern of pores across the width W and length L of the porous suture 100, which may include one or several pores across the width and several pores along the length L. Similarly, the porous suture 50 may include any number of pores 70 across each of the width W and length L. The pores 70, 120 may be distributed in a consistent pattern across the length L and / or width W, or may be concentrated in specific regions along the length L or width W, as described in more detail below. The pores 70 in FIG. 1A are shown as substantially circular, while the pores 120 in FIG. 2A are substantially diamond-shaped. However, the pores 70, 120 may be any shape opening that allows the suture to pass through them, formed by knitting, weaving, sewing, braiding, or otherwise interlocking fiber strands or other materials. In other embodiments, the pores 70, 120 may be circular, oval, triangular, hexagonal, square, rectangular, or other shapes. In still other embodiments, the pores 70, 120 may be slits or elongated narrow openings, where the pores are not readily visible when the body 52, 102 is laid flat, but the material on either side of the slit can be split to expose the opening.

[0059] 2A-2C, the fiber strands 130 of the mesh suture body 102 may collectively be formed with an openwork structure or pattern defining a plurality of pores 120, 122 disposed along the length L of the body 102 between the first and second ends 104, 106 and across the width W of the body 102 between the first and second sides 108, 110. For example, as shown in FIGS. 1 and 2, the mesh suture 100 includes a plurality of central pores 120 disposed along the lateral midpoint of the body 102 between the first and second ends 104, 106 and a plurality of lateral pores 122 laterally offset relative to the central pore 120 toward the first or second side 108, 110.

[0060] As described in further detail below, the pores 70, 120, 122 are configured to allow the suture 50, 100 to pass through itself when anchoring the suture 50, 100 to a target surface. Additionally, the plurality of pores 70, 120, 122 provide the suture body 52, 102 with a lattice structure that may be useful, for example, for promoting tissue ingrowth. As tissue adjacent the embedded porous suture 50, 100 heals, scar tissue or other tissue types may form, grow, or otherwise extend into at least some of the pores 70, 120, 122. The engagement between the invaginating tissue and the pores 70, 120, 122 inhibits movement of the suture 100, thereby reducing movement of the suture 100 relative to the target surface once anchored thereto.

[0061] Similar to the embodiment of FIG. 1, the body 102 of the mesh porous suture 100 may be configured to maintain a planar shape while the suture 50, 100 is under tension. This may be useful, for example, to increase the surface area of ​​the suture 50, 100 on the target surface, thereby reducing stresses and distributed forces within the target surface to reduce the risk of anchor point failure, and to prevent the pores 120 from deforming to the point that they do not allow the ends 104, 106 of the suture 100 and / or fixation device 114 to pass through the pores 70, 120, 122 while the suture 100 is under tension. The porous sutures 50, 100 of FIGS. 1 and 2 have bodies 52, 102 configured to maintain a planar shape, but they are also sufficiently deformable so that they can be compressed, squeezed, folded, and / or rolled to allow the suture 50, 100 to pass through the pores 70, 120.

[0062] While the illustrated embodiments are generally or substantially flat in thickness, in other embodiments, the suture body 52, 102 may have a more substantial depth. While the porous suture 50, 100 of FIGS. 1 and 2 is shown as having a generally flat body 52, 102 formed of a single layer, some embodiments may have multiple layers and / or cross-sections of greater depth, such as circular, square, or triangular cross-sections, to provide just a few examples. In such deeper embodiments, the suture body 52, 102 may have a solid or hollow cross-section. Optionally, such a deeper suture may be configured so that it is substantially flat in thickness when implanted, but substantially maintains its width W.

[0063] In some embodiments, the suture 50, 100 is configured to maintain its width W, or a substantial portion of its width W, under longitudinal tension. For example, the suture 50, 100 is configured to remain flat and not arch, collapse, or change shape or width when the longitudinal force on the suture (i.e., in a direction along the length L between the first and second ends) is increased. This may be preferable in certain surgical applications to provide force distribution and adhesion, as described herein. In some embodiments, the material of the suture body 52, 102 is configured to maintain at least 50% of its width under a longitudinal force of up to 16 N. In further embodiments, the material of the suture body 52, 102 is configured to substantially maintain its width by maintaining at least 50% of its width under a longitudinal force of up to 32 N / cm at the fixation site with tissue using a tissue bite of 0.5 cm (small bite standard). In further embodiments, the material of the suture body 52, 102 may be configured to substantially maintain its width by maintaining at least 60%, 70%, 80%, or 90% or more of its width under a longitudinal force of up to 16 N, or in some embodiments, up to 32 N, or up to some width or force value therebetween. Conversely, the suture is configured to reduce its width by no more than a given percentage under a predetermined longitudinal force, such as 16 N, 32 N, 50 N, etc., compared to the width W in the absence of longitudinal force, or compared to a minimum longitudinal force, e.g., a given percentage reduction of no more than 40%, 30%, 20%, or 10%. In further embodiments, the material of the suture body 52, 102 may be configured to substantially maintain its width by maintaining at least 60%, 70%, 80%, or 90% or more of its width under a longitudinal force of up to 50 N or more, or up to 200 N or more. For example, a group of porous sutures configured for Achilles tendon repair, such as via the Bunnell technique, may be configured to collectively withstand loads of up to 200N.For example, the force may be distributed across a group of four porous sutures 50, 100, each configured to withstand up to 50 N or more without attachment or suture failure. Other surgical applications may require load capacity of up to 100 N, or up to 200 N or more without suture or attachment failure. The porous sutures 50, 100 are appropriately sized based on the load, such as having an appropriate width and structure to maintain sufficient width under the load.

[0064] The suture body 52, 102 may be formed from a material structure having low elongation along the axis of the length L of the suture 50, 100, such as by using a knit pattern configured to minimize such elongation. This minimizes the amount of collapse of the fiber strands under longitudinal tension. For example, the mesh suture body 102 may be formed using a chain knit pattern in the machine direction (along the length of the fiber strands). This minimizes the amount of collapse and deformation of the mesh along its length L under longitudinal tension. Alternatively or additionally, the suture 50, 100 may be configured to have a width under longitudinal tension that is greater than its width W at rest; for example, the suture body 52, 102 is configured to collapse in depth (i.e., thickness dimension) and increase in width W when a threshold amount of longitudinal tension is applied.

[0065] Thus, multiple strands extending longitudinally within the body may each be formed into a chain stitch. The chain-stitched strands may then be connected across width W by one or more cross-connecting strands, such as a set of weft strands woven or otherwise knitted or linked to the chain-stitched warp strands. The weave or knit pattern may be loose, leaving space between the chain-stitched longitudinal strands to form a meshed porous material in which the mesh openings form multiple pore sizes to accommodate the passage of a porous suture, such as porous suture 100 shown in FIGS. 2-3D. Alternatively, the weave or knit pattern may be tighter, leaving minimal space between the chain-stitched longitudinal strands to form a continuous sheet with minimal or no visible openings other than multiple pores strategically formed to allow the passage of a porous suture, such as porous suture 50 shown in FIGS. 1A-1C. In one embodiment, the multiple pores 70 may be formed by the weave or knit pattern to prevent the strands of porous suture 50 within the continuous sheet from being cut. Alternatively, the plurality of pores 70 may be formed in the sheet by punching holes in a continuous sheet of fabric.

[0066] The material(s) selected for use in the porous suture 50, 100 of Figures 1A-1C and / or 2A-2C may be selected based on one or more desired parameters or properties of the porous suture 50, 100. For example, at least one material forming the suture 50, 100 may be selected based on a desired modulus of elasticity and / or bending stiffness such that the porous suture 50, 100 is sufficiently flexible to be threaded back and forth through its body 52, 102 through a target surface (e.g., tissue) and via the pores 70, 120. Additionally or alternatively, embodiments of the porous suture 50 of Figure 1 and / or the suture 100 of Figure 2 may be configured with a length dimension L, a width dimension W, and / or a thickness dimension T selected based on one or more desired parameter(s) of the porous suture 50, 100. For example, at least one of the length L, width W, and thickness T of the porous suture 50, 100 may be sized based on the desired bending stiffness of the porous suture 50, 100. In exemplary embodiments, the porous suture 50, 100 may be configured to have a bending stiffness of 0.001 Pa*m^4 or less. However, some embodiments may be configured to have a bending stiffness of greater than 0.001 Pa*m^4.

[0067] In some embodiments, the body 52, 102 of the porous suture 50, 100 may have a length L that allows for multiple anchor points within the target surface upon implantation. An anchor point is a location where the suture 100 passes through a portion of the target surface to provide a force that resists migration or tearing. For example, as described in more detail below, each suture 50, 100 may be passed through the target surface multiple times, such as by weaving or suturing the porous suture 50, 100 into tissue using at least one fixation device 114. This may allow the porous suture 50, 100 to withstand substantial forces, including, for example, tensile stress, without fracture. In exemplary embodiments, the length L of the suture 50, 100 may be between 80 mm and 1000 mm. However, some embodiments may have a length L that is shorter than 80 mm or longer than 1000 mm. For example, the length L of the suture 50, 100 may be 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 1100 mm, 1200 mm, 1300 mm, 1400 mm, 1500 mm, or any other length L suitable for the intended use of the suture 50, 100, including lengths L longer or shorter than the recited lengths L, and lengths L between any of the recited lengths L.

[0068] In some embodiments, the body 52, 102 of the porous suture 50, 100 may be dimensioned to have a width W sufficient to distribute the force(s) acting on the target surface so that the porous suture 50, 100 will not shear or pull out of the target surface when acted upon by an internal or external force. In exemplary embodiments, the width W of the suture 50, 100 may be between 2 mm and 15 mm. However, some embodiments may have a width W less than 2 mm or greater than 15 mm. For example, the width W of the suture 50, 100 may be 0.5 mm, 1 mm, 1.5 mm, 20 mm, 40 mm, 60 mm, 80 mm, or any other width W suitable for the intended use of the suture 50, 100, including widths W greater than or less than the recited widths W and widths W between any of the recited widths W.

[0069] In exemplary embodiments, the thickness T of the suture 50, 100 may be between 0.1 mm and 2 mm. However, some embodiments may have a thickness T less than 0.1 mm or greater than 2 mm. For example, the thickness T of the suture 50, 100 may be 0.02 mm, 0.04 mm, 0.06 mm, 0.08 mm, 4 mm, 6 mm, 8 mm, 10 mm, or any other thickness T suitable for the intended use of the suture 50, 100, including thicknesses T greater than, less than, or between any of the recited thicknesses T.

[0070] In some embodiments, the length L of suture 100 may be related to the width W of suture 100. That is, suture 100 may be configured with length and width dimensions selected based on a desired length-to-width aspect ratio (L:W) of suture 100. Furthermore, as described herein, mesh suture 100 may be configured to not deform under longitudinal load, and thus may be configured such that the aspect ratio (L:W or W:L) does not change substantially (e.g., bounded by the percentage change described above) when the porous suture is under high tension compared to the longitudinal unforced ratio. In exemplary embodiments, sutures 50, 100 may be dimensioned to have a length-to-width aspect ratio of at least ten to one (10:1). For example, the suture 50, 100 may be 50 mm long and 5 mm wide (10:1), 100 mm long and 4 mm wide (25:1), 100 mm long and 2.5 mm wide (40:1), 1000 mm long and 15 mm wide (66.66:1), 1000 mm long and 2 mm wide (500:1), and / or any other combination of length and width that results in an aspect ratio of greater than 10 to 1, including aspect ratios between any of the listed aspect ratios. However, some embodiments may have an aspect ratio of less than 10 to 1. For example, the suture 50, 100 may be 100 mm long and 15 mm wide (6.66:1), 50 mm long and 10 mm wide (5:1), 50 mm long and 15 mm wide (3.33:1), and / or any other combination of length and width that results in an aspect ratio of less than 10 to 1, including aspect ratios between any of the listed aspect ratios.

[0071] As previously mentioned, embodiments of the porous suture 50, 100 may be configured with pores 70, 120 sized and / or positioned within the suture body 52, 102. The pores may be sized and shaped such that the suture 50, 100 may pass itself through the pores 70, 120 to anchor the suture 100 to the target surface. In some embodiments, the dimensions of the pores 70, 120 may be based on at least one of the dimensions of the fixation device(s) 114; the length L, width W, and / or thickness T of the suture body 52, 102; the properties of the material(s) forming the porous suture 50, 100; the properties of the target surface; the placement of the pores 70, 120 within the suture body 52, 102; and any other parameters or characteristics of the porous suture 50, 100.

[0072] In exemplary embodiments of the porous suture 50, 100, the pores 70, 120 may be sized to have an effective diameter of 0.16 mm to 3.5 mm. For example, at least one pore 70, 120 may have a diameter of 1.75 mm, thereby providing a pore 70, 120 with an effective diameter of 2.5 mm. 2 However, some embodiments may be configured with at least one pore 70, 120 having a diameter less than 0.16 mm or greater than 3.5 mm. For example, the diameter of the at least one pore 70, 120 may be 0.05 mm, 0.1 mm, 4 mm, 4.5 mm, 5 mm, or any suitable diameter at least less than the width of the porous suture, including diameters greater than or less than the recited diameters and diameters between any of the recited diameters.

[0073] In some embodiments, the spacing between the pores 70, 120 may be based on at least one of the dimensions of the fixation device(s) 114; the length L, width W, and / or thickness T of the suture body 52, 102; the diameter of the pores 70, 120; the properties of the material(s) forming the porous suture 50, 100; the properties of the target surface; and any other parameters or characteristics of the porous suture 50, 100. In exemplary embodiments of the porous suture 50, 100, the pores 70, 120 may be spaced 0.5 mm to 20 mm apart, center-to-center. For example, at least two adjacent pores 70, 120 may be spaced 5 mm apart. However, some embodiments may be configured to have at least two adjacent pores 70, 120 spaced less than 0.5 mm and / or more than 20 mm apart. For example, at least two adjacent pores 70, 120 may be 0.1 mm apart, 0.25 mm apart, 30 mm apart, 50 mm apart, 100 mm apart, and / or any other suitable distance, including distances greater or less than the recited distances and distances between any of the recited distances.

[0074] Additionally or alternatively, the size, spacing, and / or arrangement of the pores 70, 120 may vary along the length L and / or width W of the suture body 52, 102. For example, one embodiment of the porous suture 50, 100 may be configured with the pores 70, 120 more densely spaced at different locations on the porous suture 50, 100. The suture body 52, 102 may include a certain concentration of pores 70, 120 at locations through which the porous suture 50, 100 will pass and a lesser density of pores 70, 120 at other locations through which the porous suture 50, 100 will not pass. For example, the suture body 52, 102 may include multiple pores 70, 120 proximate the first end 54, 104 and / or the second end 56, 106, and may have zero or relatively few pores 70, 120 in an intermediate portion of the suture body 52, 102, as compared to one or both of the ends near the first and / or second ends. This may provide multiple possible locations and options for threading the porous suture 50, 100 itself near where anchor stitches may be formed or where increased tissue ingrowth is desired, while omitting pores 70, 120 in other locations where they are not needed, or may be useful where a stronger and / or more rigid length of suture may be desired or required or where reduced tissue ingrowth is desired. Alternatively, the suture body 52, 102 may include concentrated pores 70, 120 in some or all of the central portion of the suture length L, for example, for applications where the porous suture 50, 100 passes through itself to create anchor points that are more likely to align with or reduce foreign material in that central portion.

[0075] The pore size may be adapted for various embodiments and applications. In one embodiment, the pore size of the plurality of pores 70, 120 is consistent across the length L and / or width W of the suture body 52, 102. Alternatively, the pore size may vary along the length L of the suture body 52, 102. For example, to enable initial anchoring of the proximal end of the porous suture 50, 100, the pores 70, 120 at or nearest the first end 54, 104 and / or second end 56, 106 may be larger than the pores 70, 120 in the intermediate portion.

[0076] In addition to, or as an alternative to, varying along the longitudinal length of the porous suture 50, 100, the pore density and / or pore size may vary across the lateral width between the opposing side surfaces 58, 60, 108, 110 of the suture body 52, 102. For example, along at least a portion of the porous suture 50, 100, the pores 70, 120 may be offset from the lateral midpoint of the suture body 52, 102 such that the pores 70, 120 are contained closer to one or both of the side surfaces 58, 60, 108, 110 and are omitted or less densely spaced along the longitudinal centerline of the suture body 52, 102. In the case of a porous mesh suture 100, a portion of the suture body 102 may be configured with the lateral pores 122 still included but with the central pore 120 omitted. In some embodiments of the porous mesh suture 100, the density of the pores 120, 122 may be increased (and the size of the pores may be decreased) by weaving, sewing, and / or braiding the fiber strands 130 more tightly, or the density of the pores 120, 122 may be decreased (and the size of the pores may be increased) by weaving, sewing, and / or braiding the fiber strands 130 more loosely. The pores may be configured to contract when the suture is placed under tension, thereby tightening around the porous suture through which it passes.

[0077] It is understood that other lengths L, widths W, thicknesses T, aspect ratios, pore sizes, pore shapes, and / or materials are considered within the scope of the present disclosure, and one of ordinary skill in the art would understand that various dimensions, materials, and configurations may be appropriate depending on various parameters, such as the tissue defect or reconstruction to which the porous suture 50, 100 is applied and the surgical approach.

[0078] Figures 3A-3D, 4A-4D, and 5A-5D illustrate exemplary methods of anchoring the porous sutures 50, 100 of Figures 1 and 2 to a target surface. While Figures 3A-3D, 4A-4D, and 5A-5D illustrate the use of mesh suture 100 according to Figures 2A-2C, it should be understood that the illustrated procedures may also be used with sutures having a substantially dense or tightly woven continuous sheet body, such as porous suture 50 of Figures 1A-1C.

[0079] 3A-3D, porous suture 100 having fixation device 114 at its first end 104 may be threaded through itself near edge 92 of target surface 90 to create a clinch knot 178 to anchor suture 100 to target surface 90. As shown in FIG. 3A, fixation device 114 at first end 104 passes through target surface 90 proximate edge 92 of said surface 90 in the direction of arrow 170. As shown in FIG. 3B, fixation device 114 then passes through central pore 120 proximate second end 106 of suture 100 in the direction of arrow 172. (Note: in FIG. 3B, first end 104 of suture 100 is obscured by a positioning instrument used to manipulate suture 100.) Suture 100 is then pulled by first end 104 through central slot 120 in the direction of arrow 174 to create a loop, as shown in Figure 3C. Suture 100 is then pulled tight in the direction of arrow 176 to clinch a knot on target surface 90, as shown in Figure 3D, thereby securing suture 100 to target surface 90 with clinched knot 178 formed proximate second end 106 of suture 100.

[0080] 4A-4D , a porous suture 100 having a fixation device 114 at its first end 104 may be passed over itself and the target surface 90, or alternatively, may be passed to create a clinch knot across a wound, such as for tissue reapproximation. A locking stitch, in which the porous suture is threaded over itself, may be used alone as an independent stitch or, for example, as a finishing anchor following a series of stitches to repair tissue. As shown in FIG. 4A , the fixation device 114 of the suture's first end 104 is threaded through the target surface 90 at the first bite entrance 94 and returns from the target surface 90 at the first bite exit 95 in the direction of arrow 180. The first end 104 of the suture 100 is then withdrawn from the target surface 90 at the first bite exit 95 in the direction of arrow 182a and withdrawn toward the first bite entrance 94, as shown in FIG. 4B . The fixation device 144 then passes through the central slot 120 of the suture 100 and returns to the target surface 90 in the direction of arrow 182b through the first bite entrance 94. The suture 100 is then pulled up through the target surface 90 in the direction of arrow 182c at the second bite exit 97, which is located just beyond the first bite exit 95. In the illustrated embodiment, the second bite exit 97 is located approximately 1 to 2 mm beyond the first bite exit 95. However, in some embodiments, the second bite exit 97 may be positioned more than 2 mm beyond the first bite exit 95, or less than 1 mm beyond the first bite exit 95.

[0081] After the first end 104 is pulled in the direction of arrow 184a through the second bite exit 97 to create the snug loop, the fixation device 114 is threaded in the direction of arrow 184b through a second centrally located slot 120 located between the first bite entrance 94 and the first bite exit 95, as shown in FIG. 4C. Referring to FIG. 4D, the first end 104 of the suture 100 is pulled snug in the direction of arrow 186, thereby locking the loop in place and forming a non-retracting self-locking backstitch 188. The suture 100 may then be cut proximate to the first end 104, at least 0.5 cm, and preferably 1 cm or more, from the last point of exit 120, to remove excess material from the fixation device 114 and the suture 100.

[0082] For example, wound closure using a porous suture may be performed by securing a first end of the suture to tissue using a clinch knot, followed by a series of continuous stitches, and finishing with a self-locking backstitch to anchor and secure the second end. Figures 5A-5D show an exemplary self-locking stitch 190 for anchoring a mesh suture 100 having a fixation device 114 at its first end 104 to a target surface 90, such as for repairing tissue. As shown in Figure 5A, the fixation device 114 at the first end 104 of the suture is threaded through the target surface 90 at a first bite entrance 94 and returns from the target surface 90 at a first bite exit 95 laterally spaced from the first bite entrance 94, such as at a first bite entrance 94 on a first side of the tissue repair site and a first bite exit 95 on a second side of the tissue repair site. This process is repeated by moving the fixation device 114 in and out of the target surface 90 at second bite entrances 96 and second bite exits 97, such as on the first and second sides, to draw the porous suture multiple times across the tissue repair site to create a series of stitches across the tissue repair site, as shown in FIG. 5B. The implantation of the porous suture to repair tissue then continues in a similar manner, such as to close an incision or wound. Now, as shown in FIG. 5C, the fixation device 114 moves in and out of the target surface 90 at third bite entrances 98 and third bite exits 99, returning to the first side of the tissue repair site. A locking stitch is then performed to finish the series of stitches, anchoring the first end 104 by threading the porous suture 100 over itself. Now, to create a finished anchor, the first end 104 and its attached fixation device 114 pass through the central pore 120 of the suture 100 and return to the target surface 90 via the third bite entrance 98. 5D, the fixation device is then passed back from the target surface 90 via the third interlocking outlet 99 and through the second central slot 120 adjacent the third interlocking outlet 99. The same steps and methods for creating a series of stitches and finish anchors can be performed using the continuous sheet porous suture 50 shown in FIGS. 1A-1C by passing the fixation device 114a through the appropriate slots 70.

[0083] Embodiments of the porous suture 50, 100 may additionally or alternatively be anchored to a target surface using other stitching methods or weave patterns. For example, the suture 50, 100 may be woven into the target surface in an x-weave pattern, a locking x-weave pattern, a plus weave pattern, a long-hand weave pattern, a varied long-hand weave pattern, or any other stitching weave pattern.

[0084] As illustrated in Figures 4A-5D and variously described herein, threading a suture over itself allows for superior anchoring. Superior anchoring is made possible by the wider suture width, which distributes force, and by the ability to thread the suture over itself. Threading a suture over itself to create a self-locking stitch provides a flatter, less bulky knot with fewer layers of crossing material compared to traditional knotting techniques. Self-locking stitches provide a less palpable knot that lies relatively flat against the tissue and is less likely to cause tissue erosion. Furthermore, the flatter knots made possible by porous sutures are less likely to harbor infection-causing bacteria, thus reducing the incidence of "stitch abscesses" or other infections that occur with larger knots that have more gaps to harbor bacteria.

[0085] In some embodiments, the fiber strands 130 comprising the body 52, 102 of the suture 50, 100 and / or mesh suture body 102, or the suture body 102, may be partially or fully coated to enhance at least one of tensile strength, frictional resistance, lubricity, adhesion prevention, tissue response, and bio-uptake. Additionally or alternatively, the body 52, 102 of the suture 50, 100 and / or the fiber strands 130 comprising the mesh suture body 102 may be treated with a drug coating configured to deliver a drug to a target surface at the site of the porous suture 50, 100.

[0086] Some embodiments of the mesh porous suture 100 may be formed using more than one type of fiber strand 130. In some embodiments, such as those of FIGS. 2A-2C , the fiber strands 130 forming the mesh suture body 102 of the suture 100 may have smooth sides to reduce friction and / or other forces resisting movement of the suture 100 through and over the target surface. However, some embodiments of the mesh porous suture 100 may include at least one barbed strand 132 having rough edges and / or barbs configured to engage the target surface and / or another portion of the suture body 102 to increase the force required to draw the suture 100 through the target surface and / or pores 120 of the body 102. This may be useful, for example, to maintain tension in the mesh suture 100 as it is inserted into the target surface. The roughened surface and / or barbs on each barbed strand 132 may be configured to equally resist movement of the strand 132 in both directions, or may be configured to create more resistance in one direction relative to the opposite direction so that the suture 100 is easier to pull in one direction through tissue and / or through itself than in the opposite direction. Alternatively, the roughened surface and / or barbs may protrude from the mesh suture body when tensioned.

[0087] 6A-6C show an embodiment of a mesh suture 100 including at least one barbed strand 132, which may be a strand including one or more barbed filaments. Each barbed strand 132 may be interwoven with non-barbed fiber strands 130 to form the mesh suture body 102. For example, FIG. 6A shows an embodiment of a mesh suture 100 including two barbed strands 132 incorporated into the mesh suture body 102. Barbs may be created by, without limitation, knitting a mesh with portions of fibers protruding from one or both sides of the mesh suture body; in some embodiments, the protruding fibers are cut to create barbs, or the mesh suture body is knitted in a double-sided configuration and the connecting fibers are cut to create two separate, one-sided barbed mesh sutures, or to incorporate loose fibers into the mesh suture body during the knitting process. Additionally or alternatively, barbs or barbed textures can be manufactured after knitting / forming to affect one or both sides in a particular orientation by post-processing cutting, spraying, etc. For example, barbs may be molded into the strands, or may be welded / glued to either individual strands or the mesh suture body, or may be created by "backcutting" the strands leaving a nick, or the edges of the mesh suture body are cut to roughly expose the barbed features.

[0088] Some embodiments of mesh suture 100 may include at least one barbed strand 132 incorporated into mesh suture body 102 formed from non-barber textile strand 130. For example, FIG. 6B shows an embodiment of mesh suture 100 including one barbed strand 132 extending longitudinally along the length of suture 100. In FIG. 6B, the illustrated barbed strand 132 extends along the lateral center of suture body 102 and extends through central pore 120. However, some embodiments may include a barbed strand 132 that is offset from the lateral center of the suture body.

[0089] Some embodiments of the mesh porous suture 100 may include at least one barbed filament extending along one of the side edges 108, 110 of the suture body 102. For example, FIG. 6C shows an embodiment of a mesh suture 100 including barbed filaments extending along the first side 108 and the second side 110 of the suture body 102. In FIG. 6C , the barbed strands 132 extending along the first side 108 are interwoven with other fiber strands 130 to form the mesh suture body 102, while the barbed strands 132 extending along the second side 110 are embedded with non-barbed fiber strands 130 and extend linearly between the first and second ends 104, 106 of the suture body 102.

[0090] Additionally or alternatively, some embodiments of the porous suture 50, 100 may include at least one biodegradable filament and / or fiber strand 130 configured to degrade over time after the biodegradable filament and / or fiber strand 130 is inserted into tissue or another target surface. In such embodiments, the biodegradable filament may hold tissue together during healing before degrading when additional filaments are no longer needed. For example, the porous suture 50, 100 may include biodegradable barbed strands 132 or at least some biodegradable filaments configured to retain tension in the inserted suture 100 after insertion before degrading. In such embodiments, the strand 132 of the barbed suture(s) may be configured to degrade completely, or the barbed or barbed filaments on the barbed strand 132 may degrade while the main body of the strand 132 remains.

[0091] Embodiments of the porous suture 50, 100 may include different amounts, arrangements, and combinations of biodegradable filaments and / or fiber strands 130. For example, some embodiments may be comprised of 25% to 75% biodegradable filaments and / or fiber strands 130. However, other embodiments may be comprised of less than 25% or more than 75% biodegradable filaments and / or fiber strands 130. In some embodiments, at least one fiber strand 130 may include some biodegradable filaments and some non-biodegradable filaments. For example, a fiber strand 130 may include 50% biodegradable filaments and 50% non-biodegradable filaments. Other fiber strands 130 may be comprised of less than 50% biodegradable filaments or more than 50% biodegradable filaments.

[0092] Some embodiments of the porous sutures 50, 100 may include biodegradable filaments and / or fiber strands 130 at selected locations on the suture body 102, with non-biodegradable filaments and / or fiber strands 130 included at other locations on the suture body 102. For example, a porous mesh suture 100 may include at least a portion of biodegradable strands or filaments extending longitudinally across the mesh suture body 102 and / or at least a portion of biodegradable filaments extending transversely across the mesh suture body 102. In such embodiments, the biodegradable filaments may be arranged in a pattern that results in a desired shape and / or size of the suture body 102 as the biodegradable filaments degrade and the non-biodegradable filaments remain. The same may be true for continuous sheet porous suture embodiments 50, where the mesh body 52 may include degradable strands or filaments comprising some or all of its material. In embodiments incorporating both biodegradable materials or both biodegradable and non-biodegradable / permanent strands or filaments, longitudinal stiffness may decrease over time as the tissue heals and the biodegradable strands degrade over time.

[0093] Some embodiments of the porous suture 50, 100 may include an encapsulating material (not shown) that is wrapped around, formed on, or otherwise coated around a portion of the suture body 52, 102. The encapsulating material may be configured to change the cross-sectional shape of the suture body 52, 102 when applied thereto and / or may provide an outer surface with properties that differ from those of the uncoated porous suture 50, 100. This may be useful to assist the user in inserting or passing the porous suture 50, 100 into or through a target surface, or in anchoring the porous suture 50, 100 to a target surface.

[0094] For example, embodiments of the porous suture 50, 100 may include an encapsulating material that encapsulates a portion of the first end 54, 104 or second end 56, 106 of the body 52, 102 and / or any fixation device 114 attached thereto. The encapsulating material may be configured to compress the coated portion of the porous suture 50, 100, causing the suture body 52, 102 to deform from its planar shape to have a smaller, narrower, or more circular cross-section with a smooth outer surface. This may be useful, for example, to allow the porous suture 50, 100 to more easily pass through the target surface and / or pores 70, 120. Additionally or alternatively, the encapsulating material may have a surface texture that is more easily gripped by a user's hand or surgical instrument. In some embodiments, the encapsulating material may encapsulate one or each of the first or second ends 54, 56, 104, 106 to create a rigid or semi-rigid end structure on the suture that can be used to facilitate fixation. For example, the encapsulated end may function similarly to a needle and may be curved, straight, or S-shaped. In other embodiments, the encapsulating material may encapsulate one or each of the first or second ends 54, 56, 104, 106 and may provide a narrower and / or more rigid attachment location to allow attachment to another fixation device 114, such as a needle. In other embodiments, the encapsulating material may encapsulate one or each of the first or second ends 54, 56, 104, 106 and a portion of the attached fixation device 114 (such as a needle) such that the encapsulating material covers the hub of the fixation device 114 at the connection between the fixation device 114 and the suture body 52, 102.

[0095] Embodiments of the encapsulating material may take a variety of different forms that can be applied to the suture body 52, 102. For example, the encapsulating material may be configured as an elongated strip of material wrapped around the suture body 52, 102; a material placed on the suture body 52, 102 in a liquid or semi-liquid form before solidifying; a sheath having a tubular body that can be slid over the suture body 52, 102; a deformable material crimped around the suture body 52, 102; a thin thread wrapped around the end of the suture body 52, 102; and / or any other type or arrangement of material that can be used to encapsulate a portion of the suture body 52, 102. In embodiments in which the encapsulating material is configured as a sheath, the sheath can be slid over the suture body 52, 102 by passing the first or second end 54, 56, 104, 106 and / or any attached fixation device 114 through the tubular sheath. In some embodiments, the sheath may be configured as a heat-sensitive shrink wrap configured to shrink when exposed to a heat source, such as constructed of medical-grade PET or FEP heat-shrink tubing. The shrink wrap may have an initial diameter that allows it to slide easily over the suture body 52, 102. After the shrink wrap is in a desired position over the porous suture 50, 100, heat may be applied to the sheath, causing the shrink wrap to shrink over the suture body 52, 102, encapsulating the body 52, 102 and compressing the body 52, 102 into a circular cross-section.

[0096] In some embodiments, a fixation device may be formed on a suture body 52, 102 by applying an encapsulating material to the first end 54, 104 and / or second end 56, 106 of a porous suture 50, 100. For example, an encapsulating material configured to compress the suture body 52, 102 may be applied to its first end 54, 104 and / or second end 56, 106. The encapsulating material compresses the ends 54, 56, 104, 106 and causes the suture body 52, 102 to taper from a flat cross-section to a streamlined cross-section that can easily penetrate a target surface and / or pass through the suture body 52, 102. For example, a shrink-wrap sheath may be placed over the suture body 52, 102 such that a portion of the sheath extends beyond the first or second end 54, 56, 104, 106 of the suture body 52, 102. When heat is applied to the shrink wrap, the portion of the shrink wrap extending beyond the ends 54, 56, 104, 106 of the suture body 52, 102 may be deformed into a generally pointed shape capable of penetrating the target surface. The encapsulating material may be used to form a fixation device having a specific shape that allows the porous suture 50, 100 to pass through the target surface and suture body 52, 102 in a specific manner according to a desired anchoring stitch pattern. For example, the encapsulating material may be used to form a fixation device on the first end 54, 104 and / or second end 56, 106 of the porous suture 50, 100 that is straight, curved, S-shaped, and / or any other desired shape.

[0097] Additionally or alternatively, some embodiments of the porous suture 50, 100 may be configured with first ends 54, 104 and / or second ends 56, 106 that can be formed into fixation devices without additional encapsulating material. For example, in one embodiment of the porous mesh suture 100, the fiber strands 130 can be melted by exposure to heat or chemical application, allowing the exposed portions of the material to deform into a streamlined shape to form a rigid or semi-rigid fixation device or attachment point for a fixation device. Similar to fixation devices formed with an encapsulating material, the ends 54, 56, 104, 106 of the suture body 52, 102 may be modified to form fixation devices having desired shapes, including straight fixation devices, curved fixation devices, S-shaped fixation devices, and / or fixation devices having any other desired shape. [Example]

[0098] The following examples, test embodiments, test settings, and test data are intended to be illustrative only and are not intended to be limitations on the invention or claims.

[0099] Example A: A porous suture was tested against a standard-of-care #0 polypropylene suture, specifically to test the comparative mechanical strength of the porous suture compared to a standard-of-care (SOC) suture when used to form a locking stitch for anchoring to tissue. The porous suture utilized a mesh porous suture comprising a 6 mm wide polypropylene mesh formed in a Crochet warp knit pattern. Each end of the mesh porous suture and the SOC suture was anchored to a slab of porcine abdominal wall tissue using a fixed GS21 needle. One end of the mesh porous suture was anchored to the tissue using a locking backstitch as disclosed herein, and the porous suture was passed over itself as shown and described with respect to Figures 4A-4D. One end of the SOC suture was anchored to the tissue using a standard surgeon's knot followed by four throws.

[0100] The maximum load capacity of the anchorage was then tested by vertical extension (Image A2) using an Instron Model 1321 testing system. The free ends of the porous suture and the SOC suture were connected to an Instron, as shown below, and a tensile test was adapted from USP 881 (Tensile Strength of Surgical Sutures). Vertical displacement was increased at a rate of 16 cm / min, and the load was recorded at a rate of 100 Hz until failure occurred, which included one of the following: i) suture failure, where the suture completely tears or otherwise breaks; ii) tissue failure, where the suture remained attached to a portion of the tissue, detaching from the rest of the tissue; or iii) fixation failure, where the suture knot or anchor point unravels or otherwise fails to slide through and out of the tissue.

[0101] The maximum anchoring load was determined for both the SOC suture and the mesh porous suture. The results demonstrate that the porous suture has a significantly higher maximum load than the SOC suture. The porous suture anchor utilizing the disclosed locking backstitch was able to withstand more than twice the maximum load capacity compared to the SOC suture anchored with a standard surgeon's knot, exceeding 90 N in the test results (Image A3). [Table 1] [Table 2]

[0102] Example B: Various porous sutures with widths ranging from 2 mm to 6 mm were fabricated and tested to compare the mechanical strength and stiffness of mesh porous sutures of various widths, including mesh porous sutures with widths of 2 mm, 4 mm, and 6 mm. Each porous suture was fabricated from a cross section of 10 mm wide polypropylene mesh formed from a Crochet warp knit pattern, and the 10 mm wide piece of mesh was cut into a 2 mm wide piece, a second 4 mm wide piece, and a third 6 mm wide piece.

[0103] Each of the three mesh widths (N=5), representing the porous suture widths described above, was placed in an Instron Model 1321 testing system and tested for vertical extension per ASTM D5035 (Break Force and Elongation of Textiles), thereby testing the maximum load for each piece. Starting with a preload of 2 N, the vertical displacement was increased at a rate of 100 mm / min until complete failure (tear) of the mesh piece.

[0104] The failure load of each mesh porous suture was determined. The longitudinal stiffness value (load / displacement) was also determined for each mesh porous suture. The results demonstrate that for the dimensions tested, increasing the width of the porous suture increases the maximum load of the porous suture and increases the longitudinal stiffness of the porous suture. [Table 3] [Table 4] [Table 5] [Table 6] [Table 7]

[0105] This specification uses examples to disclose the invention and enable those skilled in the art to make and use it. Specific terminology has been used for brevity, clarity, and understanding. Such terminology is used for descriptive purposes only and is intended to be broadly interpreted, so that unnecessary limitations beyond the requirements of the prior art should not be inferred therefrom. The patentable scope of the invention is defined by the claims and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have features or structural elements that do not differ from the literal language of the claims, or if they contain equivalent features or structural elements that do not differ substantially from the literal language of the claims.

Claims

1. 1. A porous suture for tissue repair, comprising: a flat body having a length between a first end and a second end and a width between a first side and a second side; Equipped with the planar body is formed from a porous material having a plurality of pores along the length of the planar body between the first end and the second end; The planar body is configured to substantially maintain the width even when a longitudinal force acting on the planar body increases. Porous sutures for tissue repair.

2. 10. The porous suture of claim 1, wherein an increase in the longitudinal force to 16 N causes the width of the suture to decrease by no more than 40% compared to its width in the absence of the longitudinal force.

3. 10. The porous suture of claim 1, wherein as the longitudinal force increases to 32 N, the width of the suture decreases by no more than 40% compared to its width in the absence of the longitudinal force.

4. 10. The porous suture of claim 1, wherein as the longitudinal force increases to 50 N, the width of the suture decreases by no more than 40% compared to its width in the absence of the longitudinal force.

5. 10. The porous suture of claim 1, wherein as the longitudinal force increases to 16 N, the width of the suture decreases by no more than 30% compared to its width in the absence of the longitudinal force.

6. 10. The porous suture of claim 1, wherein as the longitudinal force increases to 16 N, the width of the suture decreases by no more than 10% compared to its width in the absence of the longitudinal force.

7. 10. The porous suture of any one of the preceding claims, wherein the planar body is configured to remain flat along its width despite increasing longitudinal forces.

8. 10. The porous suture of any one of the preceding claims, wherein the planar body includes a plurality of strands forming a chain stitch along the length.

9. 10. The porous suture of any one of the preceding claims, wherein the porous material is a mesh and further comprises a set of cross-connecting strands connecting a plurality of chain-stitched strands to form the mesh.

10. The porous suture of claim 9, wherein the mesh defines the plurality of pores, the pore size of the plurality of pores being consistent along the length of the planar body.

11. 11. The porous suture according to claim 9, wherein the mesh forms the plurality of pores, and the pore diameters of the plurality of pores are larger near the first end and / or the second end than in a central portion of the plane body.

12. 12. The porous suture according to claim 9, wherein the mesh forms the plurality of pores, and the pore diameter of the plurality of pores is larger near the longitudinal center line of the planar body than on the first side surface or the second side surface.

13. 10. The porous suture of any one of the preceding claims, wherein the porous material is a continuous sheet and the plurality of pores are formed throughout the sheet.

14. 10. The porous body of any one of the preceding claims, wherein the plurality of pores are aligned along a longitudinal centerline of the body.

15. 10. The porous suture of any one of the preceding claims, wherein at least a portion of the plurality of pores are sized to accommodate the porous suture passing therethrough such that the porous suture is configured to pass therethrough.

16. 10. The porous suture of any one of the preceding claims, wherein the plurality of pores are uniformly spaced along the length of the body between the first end and the second end.

17. 10. The porous suture of any one of the preceding claims, wherein the width is at least 4 mm.

18. 10. The porous suture of any one of the preceding claims, wherein the ratio of the width to the length of the planar body is at least 1:10, and wherein the ratio does not change substantially when the porous suture is under high tension compared to the ratio in the absence of longitudinal force.

19. 10. The porous suture of any one of the preceding claims, wherein the ratio of the width to the length of the planar body does not change substantially when the porous suture is under high tension compared to when there is no longitudinal force.

20. 10. The porous suture of any one of the preceding claims, wherein the planar body comprises a single layer of the porous material.

21. 10. The porous suture of any one of the preceding claims, further comprising a first surgical needle secured to the first end of the planar body and a second surgical needle secured to the second end of the planar body.

22. 10. The porous suture of any one of the preceding claims, wherein at least a portion of the plurality of pores are sized to accommodate a surgical needle through which the porous suture passes such that the porous suture is configured to pass through itself.

23. 1. A method of repairing tissue with a porous suture, the porous suture comprising a planar body having a length between a first end and a second end and a width between a first side and a second side, the planar body having a plurality of pores formed along the length between the first end and the second end, the method comprising: passing the first end of the porous suture through tissue on each of a first side of a tissue repair site and a second side of the tissue repair site to create at least one stitch; threading the porous suture over itself to create a self-locking stitch to create a finish anchor at the first end of the porous suture; A method comprising:

24. 24. The method of claim 23, further comprising passing the first end of the porous suture multiple times through tissue on each of the first and second sides of the tissue repair site to create a series of stitches to close a wound, the self-locking stitch following the series of stitches.

25. 1. A porous suture for tissue repair, comprising: a flat body having a length between a first end and a second end and a width between a first side and a second side; Equipped with the planar body is formed from a porous material having a plurality of pores along the length of the planar body between the first end and the second end; At least one end of the planar body is formed into a fixation device configured to introduce the porous suture into tissue. Porous sutures for tissue repair.

26. 26. The porous suture of claim 25, further comprising a plastic sheath over the at least one end of the plane body, the plastic sheath forming the fixation device having a pointed tip configured to penetrate the tissue.

27. 27. The porous suture of claim 25 or 26, wherein the porous material of the planar body is formed from fiber strands, and the fiber strands at the at least one end are bonded to one another to form the fixation device.

28. 10. The porous suture of any one of the preceding claims, wherein the fiber strands comprise a biocompatible metal and / or a biocompatible synthetic polymer, and wherein the fiber strands are exposed to heat or chemicals to bond to one another to form the fixation device.

29. 29. The porous suture of any one of claims 25, 27, or 28, wherein the fixation device has a sharp tip configured to penetrate the tissue.

30. 29. The porous suture of claim 25, 27, or 28, wherein the fixation device and the planar body are configured to allow the fixation device to pass through the plurality of pores.

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