Graft and scaffold ligament repair system

Abstract

An arthroscopic system for repairing torn ligaments is provided. An aspect of the present invention includes a scaffold that surrounds a graft, is attached to a fixation device by sutures, and is inserted into the repair site via an arthroscopic instrument. The scaffold, graft, and sutures are further fixed near or to the repair site via an arthroscopic instrument having an elongated delivery member containing the scaffold, graft, and sutures, prior to insertion of the scaffold, graft, and sutures into the repair site.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 527,655, filed on July 19, 2023, the entire content of which is incorporated herein by reference.

[0002] The present invention generally relates to systems and methods for the repair of torn ligaments that utilize arthroscopic repair systems having combinations of scaffold implants that encapsulate grafts.

Background Art

[0003] Intra - articular tissues such as the anterior cruciate ligament (ACL) do not heal after rupture. In addition, menisci and articular cartilage in human joints also often do not heal after injury. Tissues found outside the joint heal by forming fibrin clots, which connect the torn tissue ends and then are remodeled to form scars, which heal the tissue. Inside the synovial joint, fibrin clots either do not form or are rapidly dissolved after injury to the knee, thus preventing arthrosis and stiffness of the joint after minor injury. The joint contains synovial fluid that naturally prevents blood clot formation in the joint as part of normal joint activity. This fibrinolytic process results in early loss of the fibrin clot scaffold and disruption of the healing process for tissues within or within the joint.

[0004] Current treatments for repairing the anterior cruciate ligament (ACL) after rupture involve removing the torn ligamentous fan and replacing it with a bifurcation tendon graft (ACL reconstruction). While this procedure initially restores overall stability in most patients, long-term follow-up has demonstrated that many postoperative patients have abnormal structural laxity, suggesting that the reconstruction may not withstand the physiological forces applied over time (Dye, 325 Clin. Orthop. 130-139 (1996)). Loss of ACL function has been found to result in early and progressive radiographic changes consistent with joint deterioration (Hefti et al., 73A(3)J. Bone Joint Surg. 373-383 (1991)), and that more than 70% of patients who undergo ACL reconstruction develop osteoarthritis just 14 years after injury (von Porat et al., Ann Rheum Dis. 63(3):269-73 (2004)). Since anterior cruciate ligament (ACL) rupture is most commonly an injury in young athletes in their teens and twenties, early osteoarthritis in this group can have difficult consequences. [Overview of the project] [Problems that the invention aims to solve]

[0005] Embodiments of the present disclosure include a ligament repair system. The ligament repair system includes an implant sized and molded for placement in synovial fluid, the implant being configured to absorb repair material. The ligament repair system further includes one or more suture assemblies configured to position the implant along or adjacent to the torn end of an injured ligament. The ligament repair system further includes a first fixation device configured to bond one or more suture assemblies to a first bone. The ligament repair system further includes a tendon graft configured to be positioned adjacent to the implant. The ligament repair system further includes at least one graft suture configured to position the graft along or adjacent to the implant or the torn end of an injured ligament. The ligament repair system further includes a second fixation device configured to bond at least one graft suture to a first bone.

[0006] Further embodiments of the present disclosure include a method for repairing an anterior cruciate ligament. The method includes inserting a scaffold adjacent to the torn end of the injured ligament. The method includes fixing at least one scaffold to the scaffold and a first bone using a first fixation device. The method includes binding a graft to the scaffold. The method includes positioning the graft along the scaffold or the torn end of the injured ligament via at least one graft suture. The method further includes binding the scaffold to a second bone using a second fixation device.

[0007] Further embodiments of the present disclosure include a ligament repair system. The ligament repair system includes an implant sized and molded for placement in synovial fluid, the implant being configured to absorb repair material. The ligament repair system further includes one or more suture assemblies configured to position the implant along or adjacent to the torn end of an injured ligament. The ligament repair system further includes a first fixation device configured to bond one or more suture assemblies to a first bone. The ligament repair system further includes an autologous tendon graft configured to be positioned adjacent to the implant. The ligament repair system further includes at least one graft suture configured to position the graft along or adjacent to the implant or the torn end of an injured ligament. The ligament repair system further includes a second fixation device configured to bond at least one graft suture to a first bone.

[0008] Further embodiments of the present disclosure include a ligament repair system. The ligament repair system includes an implant sized and molded for placement in synovial fluid, the implant being configured to absorb repair material. The ligament repair system further includes one or more suture assemblies configured to position the implant along or adjacent to the torn end of an injured ligament. The ligament repair system further includes a first fixation device configured to bond one or more suture assemblies to a first bone. The ligament repair system further includes an allograft configured to be positioned adjacent to the implant. The ligament repair system further includes at least one graft suture configured to position the graft along or adjacent to the implant or the torn end of an injured ligament. The ligament repair system further includes a second fixation device configured to bond at least one graft suture to a first bone.

[0009] Further embodiments of the present disclosure include a ligament repair system. The ligament repair system includes an implant sized and molded for placement in synovial fluid, the implant being configured to absorb repair material. The ligament repair system further includes one or more suture assemblies configured to position the implant along or adjacent to the torn end of an injured ligament. The ligament repair system further includes a first fixation device configured to bond one or more suture assemblies to a first bone. The ligament repair system further includes a synthetic graft configured to be positioned adjacent to the implant. The ligament repair system further includes at least one graft suture configured to position the graft along or adjacent to the implant or the torn end of an injured ligament. The ligament repair system further includes a second fixation device configured to bond at least one graft suture to a first bone.

[0010] Further embodiments of the present disclosure include a tissue repair system. The tissue repair system includes a repair device comprising a graft sized and shaped for placement at a site of repair of damaged tissue, and an implant wrapped around the graft, the implant being compressible and expandable and configured to absorb repair material. The tissue repair device further includes at least one implant suture configured to position the implant along or adjacent to the torn end of the damaged tissue. The tissue repair device further includes a first fixation device configured to connect at least one implant suture to a first bone. The tissue repair device further includes at least one graft suture configured to position the graft along or adjacent to the implant or the torn end of the damaged ligament. The tissue repair device further includes a second fixation device configured to connect at least one graft suture to a first bone.

[0011] Further embodiments of the present disclosure include a method for repairing torn tissue. The method includes inserting a first suture through a graft. The method further includes wrapping a scaffold around the graft. The method further includes positioning the scaffold and graft in close proximity to the torn end of the patient's injured tissue. The method further includes fixing the scaffold to a first bone using a first fixation device via the first suture.

[0012] The drawings are merely illustrative and are not necessary for the applicability of the inventions disclosed herein. [Brief explanation of the drawing]

[0013] [Figure 1A] This is a schematic representation of a damaged anterior cruciate ligament. [Figure 1B] This is a schematic representation of a repair device having a fixation device and attached sutures. [Figure 2A] This is a schematic representation of an arthroscopic repair system according to one embodiment of the present disclosure. [Figure 2B] This is a schematic representation of the scaffolding shown in Figure 2A that surrounds the graft. [Figure 3A] This is a schematic representation of an arthroscopic repair system according to one embodiment of the present disclosure. [Figure 3B] This is a schematic representation of the scaffolding shown in Figure 3A, which is wrapped around the graft. [Figure 4] This is a schematic representation of an arthroscopic repair system according to one embodiment of the present disclosure. [Figure 5A] Figures 1A to 3B are schematic diagrams showing torn ligaments. [Figure 5B] Figure 4 is a schematic diagram showing a repair device inserted into the repair site using the arthroscopic repair system shown. [Figure 5C] These are schematic diagrams showing the sutures, fixation devices, and repair devices shown in Figures 1A to 3B, which are fixed to the repair site. [Figure 6A] This is a schematic diagram illustrating the repair system used for ligament repair in ACL (ACL) procedures. [Figure 6B] This is a schematic diagram illustrating the repair device shown in Figure 6A, which is inserted into the repair site. [Figure 6C] These are schematic diagrams illustrating the repair device shown in Figures 6A and 6B, fully inserted into the repair site. [Figure 6D] These are schematic diagrams illustrating the repair system shown in Figures 6A to 6C, which is fixed to the repair site. [Modes for carrying out the invention]

[0014] Aspects of the invention relate to systems and methods for repairing torn ligaments, such as the anterior cruciate ligament ("ACL"). The systems and methods described herein may be used, as necessary, for other ligaments, such as the Achilles tendon or other similar tissues. The systems include a combination of scaffolds and grafts configured for the repair of torn ligaments, fixation devices, and one or more suture assemblies. The combination of scaffolds and grafts allows the body of the subject to develop a network of capillaries, arteries, and veins while providing improved mechanical stability. The vascularized connective tissue heals as a result of the migration of fibroblasts to the scaffolds. The methods and systems of the disclosed herein provide a connection between the torn ligament or the morphology surrounding the injured ligament, and facilitate the repair of the torn or injured ligament while maintaining the integrity and structure of the ligament.

[0015] This disclosure provides a three-dimensional (3D) scaffold that wraps around or wraps around a graft for repairing torn or damaged ligaments such as the ACL. The scaffold and graft provide a connection between the torn ends and fibers of the ligament, or are formed around the damaged ligament after injury, and facilitate the migration of appropriate healing cells to form scar and new tissue within the scaffold. The scaffold is a bioengineered substitute for fibrin masses, and is, for example, implanted with a graft between the torn ends of ligament fiber bundles, or wrapped around or positioned adjacent to the damaged ligament. This substitute scaffold and graft are designed to stimulate cell proliferation and extracellular matrix production in the gap between the torn ends of the ligament or in the ligament injury, thereby promoting healing and regeneration.

[0016] As used herein, an injury can be a damaged ligament or a ruptured ligament. A damaged ligament can be a partial injury. A damaged ligament can also refer to a complete injury. A partial injury is one in which a portion of the ligament is damaged but the ligament remains attached. An injury can be of any length or shape. A ruptured ligament, also known as a complete injury, is one in which the ligament is completely severed, providing two separate ends of the ligament. A ruptured ligament can provide two ligament ends of the same or different lengths. The rupture can be such that ligament stumps are formed at one end. For example, there can be a tibial stump connected to the tibia and a femoral stump connected to the femur.

[0017] Exemplary ACL and anatomical structures An example of a ruptured anterior cruciate ligament is depicted in FIG. 1A. The anterior cruciate ligament (ACL) 2 is one of four strong ligaments that connect the bones of the knee joint. The function of the ACL is to provide stability to the knee and minimize stress across the knee joint. This inhibits excessive forward movement of the lower leg bone, i.e., the tibia 6, relative to the thigh bone, i.e., the femur 4, and restricts rotational movement of the knee.

[0018] As shown in FIG. 1A, the anterior cruciate ligament 2 is ruptured such that it no longer forms a connection between the femur 4 and the tibia 6. The resulting ends of the ruptured ACL 2 can be of any length. The ends can be of the same length or one end can be longer than the other. The end of the femur 4 includes the femoral ACL stump 7. The end of the tibia 6 includes the tibial stump 9. In some cases, when the tibial stump length SL is less than about 75% of the effective ligament length LL but more than 5% of the total length LL of the ACL, repair is considered desirable. The total length of the ACL is considered to be the length of the ligament from the femoral footprint to the tibial footprint along the linear axis.

[0019] The knee joint includes the tibial spine on the tibia 6 and the intercondylar notch of the femur 4. In some cases, methods such as those described herein may include notching of the intercondylar notch of the femur to provide space for forming a larger ligament after surgical repair using a scaffold. Such notching improves the size of the healing ligament, specifically resulting in a larger cross-sectional area of ​​the ligament. Since the mechanical strength of the ligament, and its subsequent ability to maintain the distance between the femur and tibia, is directly correlated with its cross-sectional area, enlarging the notch with notching can help create a stronger repaired ACL and has been found to be beneficial in ACL repair using a scaffold as described herein.

[0020] scaffold The scaffolds of this disclosure can be any shape useful for implantation into a target. The scaffolds can be, for example, cylindrical, including tubular, semi-tubular, solid cylinder, or cylinder with a hollow cavity; a tube; a flat sheet wrapped around a tube to define a hollow cavity; an amorphous shape conforming to the shape of a liquid or repair space; a "Chinese finger trap" design; a trough shape; or a square. Other shapes suitable for scaffolds of devices known to those skilled in the art are also contemplated in this invention.

[0021] Referring to Figure 1B, the arthroscopic repair system of the present disclosure includes a repair device comprising a scaffold 112 and a graft 116. The system may further include arthroscopic instruments (not shown). The present disclosure includes a scaffold 112 such that the scaffold 112 is configured for repair. The scaffold 112 can be inserted into an area requiring repair and promotes ligament regeneration. The scaffold 112 can be inserted into the repair site and may form either between the ends of the torn ligament, between the bones, or around the injured ligament so as to maintain the integrity and structure of the ligament. Regeneration offers several advantages over reconstruction previously used in ligament repair, including the preservation of the complex insertion site and fan shape of the ligament, as well as the preservation of remaining proprioceptive fibers within the ligamentous material.

[0022] For example, the scaffold 112 wraps around or encircles the graft 116. The scaffold 112 may wrap around the graft 116 via sutures 120 or another mechanism. The scaffold 112 and the graft 116 may be attached to the sutures 120 and the fixation device 122. The fixation device 122 may be attached to the sutures 120 through eyelets 124 of the fixation device 122, as shown in Figures 1B and 1C. In this configuration, the fixation device 122 is attached to a bone. The bone may be either the femur 4 or the tibia 6.

[0023] The scaffold 112 can function either as an insoluble or biodegradable regulator of cellular function, or simply as a delivery vehicle for supporting structures for cell migration or synthesis. Numerous matrices, made from either natural or synthetic components, are being studied for use in ligament repair and reconstruction. Natural matrices are made from processed or reconstituted tissue components (such as collagen and GAGs). Because natural matrices mimic the structures normally responsible for the interaction between cells and their environment, they act as cellular regulators with minimal modification, giving cells the ability to reconstruct transplanted material, a necessary condition for regeneration.

[0024] Synthetic matrices are primarily made from polymer materials. Synthetic matrices offer the advantage of a carefully defined range of chemical composition and structural arrangement. Some synthetic matrices are non-biodegradable. While non-biodegradable matrices can aid in repair, they cannot be replaced by reconstruction and therefore cannot be used to completely regenerate ligaments. Furthermore, due to problems associated with the generation of wear particles, it is undesirable to permanently leave foreign bodies in the joint; therefore, biodegradable materials are preferred for work in regeneration. Biodegradable synthetic scaffolds can be designed to control the rate of degradation.

[0025] The scaffold 112 is preferably made of a compressible elastic material that has some resistance to degradation by synovial fluid. Synovial fluid, as part of normal joint activity, naturally prevents clot formation. This fibrin-dissolving process leads to premature degradation of the scaffold and interferes with the ligament healing process. The material may be either a permanent material or a biodegradable material, such as polymers and copolymers. The scaffold 112 may consist of, for example, collagen fibers, collagen gel, foamed rubber, natural materials, rubber, silicone, and synthetic materials such as plastics, crushed and compressed materials, perforated materials, or compressible solid materials.

[0026] The scaffold 112 may be made of a solid material that maintains its shape, or a semi-solid material whose shape and / or size can be changed. The scaffold 112 may be made of an expandable material that can be contracted or expanded as needed. The material may be capable of absorbing plasma, blood, other bodily fluids, liquids, hydrogels, or other materials either in contact with the scaffold or added to the scaffold.

[0027] The scaffolding material may be a protein, a freeze-dried material, or any other suitable material. The protein may be synthetic, bioabsorbable, or naturally occurring. Examples of proteins include, but are not limited to, fibrin, hyaluronic acid, elastin, extracellular matrix proteins, or collagen. The scaffolding material may also be a plastic or a self-assembling peptide. The scaffold material may incorporate therapeutic proteins for therapeutic purposes, including, but not limited to, hormones, cytokines, growth factors, coagulation factors, anti-protease proteins (e.g., alpha-1 antitrypsin), angiogenic proteins (e.g., vascular endothelial growth factor, fibroblast growth factor), anti-angiogenic proteins (e.g., endostatin, angiostatin), and other proteins present in the blood, bone morphogenesis proteins (BMPs), bone induction factors (IFOs), fibronectin (FN), endothelial growth factor (ECGF), cementum adhesion extracts (CAEs), ketanserin, human growth hormone (HGH), animal growth hormone, epidermal growth factor (EGF), interleukin-1 (IL-1), human alpha-thrombin, transforming growth factor (TGF-β), insulin-like growth factor (IGF-1), platelet-derived growth factor (PDGF), fibroblast growth factor (FGF, bFGF, etc.), and periodontal ligament chemotactic factors (PDLGF). Freeze-dried materials are capable of swelling when a liquid, gel, or other fluid is added to them or comes into contact with them.

[0028] Many biological materials, including collagen compositions (either collagen fibers or collagen gels), compositions containing glycosaminoglycans (GAGs), hyaluronan compositions, and various synthetic compositions, are available for creating scaffolds. Collagen-glycosaminoglycan (CG) copolymers have been successfully used in the regeneration of the dermis and peripheral nerves. Porous natural polymers, fabricated as spongy and fibrous scaffolds, have been studied as implants to promote the regeneration of selected musculoskeletal tissues, including ligaments. In one embodiment, the scaffold 112 is a spongy scaffold fabricated from tendons (xenografts, allografts, autografts) or ligaments or skin or other connective tissue, which may be in its natural state or may be treated to promote intracellular proliferation or other biological features.

[0029] In the illustrated embodiments, the scaffold 112 is made of a sponge or sponge-like material. The sponge scaffold 112 may be absorbent or non-absorbent. The sponge scaffold 112 may contain collagen, elastin, extracellular matrix proteins, plastics, or self-assembling peptides. The sponge scaffold 112 may be hydrophilic. The sponge scaffold 112 is compressible and expandable as desired. For example, the sponge scaffold 112 may be compressed before or during implantation at the repair site. A compressed sponge scaffold allows the sponge scaffold to expand within the repair site. The sponge may be freeze-dried and / or compressed when placed at the repair site and expand once in place. The expansion of the sponge scaffold 112 may occur after contact with blood or other fluids at the repair site or after it has been applied to the repair site.

[0030] The sponge scaffold 112 may also be porous. The sponge scaffold 112 may be saturated or coated with a liquid, gel, or hydrogel restorative material prior to implantation into the repair site. Coating or saturating the sponge scaffold may facilitate implantation into relatively undefined defect areas and may particularly assist in filling large defect areas. The sponge scaffold 112 may consist of collagen. In preferred embodiments, the sponge scaffold 112 is treated with a hydrogel. Examples of useful scaffolds and restorative materials according to the present invention can be found in U.S. Patent No. 6,964,685 and U.S. Patent Application Publications 2004 / 0059416 and 2005 / 0261736, the full contents of which are incorporated herein by reference.

[0031] A significant subset of the natural matrix is ​​primarily derived from collagen, the main component of ligaments. Collagen can be of the soluble or insoluble type. Preferably, collagen is soluble and, for example, acidic or basic. For example, collagen can be type I, type II, type III, type IV, type V, type IX, or type X. Preferably, collagen is type I. More preferably, collagen is soluble type I collagen. Type I collagen is the main component of the extracellular matrix for human ACLs and provides an example of selection for the basis of biotechnological scaffolds. Collagen exists primarily in fibrous form, and by changing the volume fraction of collagen, fiber orientation, and degree of crosslinking, it is possible to design materials with very different mechanical properties. The biological properties of cell invasion rate and scaffold degradation can also be altered by changing pore size, degree of crosslinking, and the use of additional proteins such as glycosaminoglycans, growth factors, and cytokines. In addition, collagen-based biomaterials can be produced from the patient's own skin, thus minimizing the antigenicity of the graft (Ford et al., 105 Laryngoscope 944-948 (1995)).

[0032] Fixed device / Fixed The disclosure may also include one or more fixation devices 8. The fixation device 122 is a device that can be inserted into a bone to form a stable attachment to the bone. In some embodiments, the fixation device 122 may be removable from the bone as desired. The fixation device 122 may be conical in shape, having a body with a longitudinal axis and a sharp tip at one end. The body of the fixation device 122 may increase in diameter along its longitudinal axis. The body of the fixation device 122 may include grooves suitable for screwing the fixation device 122 into place. For example, as shown in Figure 1C, the fixation device 122 is screwed into the femur 4. The fixation device 122 may include an eyelet 124 at the base of the fixation device body through which one or more sutures can be passed. The eyelet 124 may be elliptical or circular and may be of any size suitable for allowing one or more sutures to pass through the eyelet 124 and be held therein.

[0033] The fixation device 122 may be attached to the bone by physical or mechanical means known to those skilled in the art. The fixation device 122 may be attached directly to the graft 116. Alternatively, the fixation device 122 may be attached indirectly to the graft 116 using sutures 120 or scaffold 112 to fix it in place. The fixation device 122 may have a central hole through which a fluid such as blood can pass. The hole 24 may allow such a fluid to flow over the attached scaffold 112 and graft 116.

[0034] The fastening device 122 includes, but is not limited to, screws, barbs, anchors, helical anchors, staples, clips, snaps, rivets, end buttons, or crimped anchors. The body of the fastening device 122 may vary in length. Examples of fixation devices include, but are not limited to, the IN-FAST® Bone Screw System (Influence, Inc., San Francisco, CA), the IN-TAC® Bone Anchor System (Influence, Inc., San Francisco, CA), the Model 3000 AXYALOOP® Titanium Bone Anchor (Axya Medical Inc., Beverly, MA), the OPUS MAGNUM® Anchor with Inserter (Opus Medical, Inc., San Juan Capistrano, CA), the ANCHRON®, HEXALON®, TRINION® (all available from Inion Inc., Oklahoma City, OK), and the TwinFix AB absorbable suture anchor (Smith & Nephew, Inc., Andover, MA). Immobilization devices are commercially available from manufacturers such as Influence, Inc., San Francisco, CA; Axya Medical Inc., Beverly, MA; Opus Medical, Inc., San Juan Capistrano, CA; Inion Inc., Oklahoma City, OK; and Smith & Nephew, Inc., Andover, MA.

[0035] The immobilization device 122 may be made of a non-degradable material such as a metal, for example, titanium 316 LVM stainless steel, CoCrMo alloy, or nitinol alloy, or plastic. The immobilization device 122 is preferably bioabsorbable so that the subject can decompose and absorb the immobilization device 122. Examples of bioabsorbable materials include MONOCRYL (polyglecapron 25), PDS II (polydioxanone), surgical intestinal suture (SGS), intestine, coated VICRYL (polyglactin 910, polyglactin 910 braid), human autologous tendon graft material, collagen fiber, POLYSORB, poly-L-lactic acid (PLLA), polylactic acid (PLA), polysulfone, polylactide (Pla), racemic polylactide (D,L-Pla), poly(L-lactide-co-D,L-lactide), 70 / 30 poly(L-lactide-co-D,L-lactide), polyglycolide (PGa), polyglycolic acid (PGa), polycaprolactone (PCL), polydioxanone (PDS), polyhydroxy acid, and absorbable plate materials (e.g., Orthopedics, October Examples include, but are not limited to, those mentioned (see 2002, Vol.25, No.10 / Supp.). The immobilized device 122 can be bioabsorbed over periods including, but not limited to, days, weeks, months, or years.

[0036] In the embodiments illustrated, the fixation device 122 is attached to the scaffold 112 and the graft 116 using sutures 120. Figure 1B illustrates an embodiment of the fixation device 122 attached to the scaffold 112 and the graft 116 using sutures 120. The sutures 120 are passed through the eyelets 124 of the fixation device 122 so that the fixation device 122 is attached to the scaffold 112 by the sutures 120. The sutures 120 have at least one free end. In some embodiments, the sutures have two free ends, a first end 128 and a second end 132.

[0037] Suture thread In one embodiment, the suture 120 is bioabsorbable, and therefore the subject can break down and absorb the suture; or it is synthetic, and therefore the suture may not originate from a natural source. In other embodiments, the suture 120 may be permanent, so that the subject cannot destroy the suture and the suture remains within the subject. The suture 120 may be rigid or inflexible, or elastic or flexible. The suture 120 may be circular in shape and may have a flat cross-section. Examples of sutures include, but are not limited to, VICRYL® polyglutin 910, PANACRYL® absorbable suture, ETHIBOND® EXCEL polyester suture, PDS® polydioxanone suture, and PROLENE® polypropylene suture. Sutures are commercially available from manufacturers such as the MITEK PRODUCTS division of ETHICON, INC. (Westwood, Mass.).

[0038] In the illustrated embodiment, the suture 120 may be attached to one or both ends of the torn ligament 2 by its first end 128 and / or its second end 132. In one embodiment, the suture 120 may be passed through the eyelet 124 of the fixation device 122, with the first end 128 and the second end 132 tied to the end of the distal ACL 2. The fixation device 122 is attached to the femur 4 by its sharp end. The scaffold 112 and graft 116 may be attached to the fixation device 122 by the suture 120 and held in place at the repair site 26. The fixation device 122 may be attached to either the tibia 6 or the femur 4 to fix the graft 116 and scaffold 112 in place. In an alternative embodiment, the scaffold 112 and graft 116 may be attached directly or indirectly to the femur 4. For example, the scaffold 112 may wrap around or be wrapped around the graft 116 via sutures or another mechanism.

[0039] Arthroscopic instruments The arthroscopic instrument may be configured to insert the suture 120 through the scaffold 112 and the graft 116. The arthroscopic instrument may be further configured to position the scaffold 112 and the graft 116 between the torn end of the ligament 2 and the bone. The arthroscopic instrument may include an elongated delivery member. The elongated delivery member may include a channel extending from the proximal end to the distal end of the elongated delivery member. The elongated delivery member may be sized and shaped to include the graft 116 attached to the scaffold 112 and the suture 120 within the channel. At least a portion of the elongated delivery member may be further sized and shaped to allow insertion into the repair site.

[0040] The arthroscopic instrument may be a syringe. The syringe may hold a suture 120 and a scaffold 112 enclosing a graft 116 in a predetermined position within the elongated delivery member of the syringe. The syringe may include a plunger configured to push the suture 120, the scaffold 112, and the graft 116 into the repair site so that the scaffold 112 and the graft 116 are positioned along the suture 120 between the torn ends of the ligament 2 and / or the bone. In an alternative embodiment, the arthroscopic instrument may include a cannula, a container, and a pressure pump. In another embodiment, the arthroscopic instrument may further include a guide suture extending from the distal end of the elongated delivery member. The guide suture may be configured to pull and position the suture and scaffold into the repair site.

[0041] Repair materials The scaffold 112 and graft 116 can be pre-treated with reparative material before implantation into the target. The scaffold 112 and graft 116 can be immersed in reparative material before or during implantation into the repair site 26. The reparative material can be directly injected into the scaffold 112 before or during implantation. The reparative material can be injected into the tubular scaffold during repair. The reparative material includes, but is not limited to, gels, e.g., hydrogels, liquids, or collagen. Liquids include aqueous materials, suspensions, or any material capable of forming a solution. The reparative material may include additional materials such as growth factors, antibiotics, insoluble or soluble collagen (in the form of fibrous, gel, sponge, or beads), crosslinking agents, thrombin, stem cells, genetically modified fibroblasts, platelets, water, plasma, extracellular proteins, and cell culture medium supplements. Additional reparative materials may be added to affect cell proliferation, extracellular matrix production, consistency, inhibition of disease or infection, tonicity, cellular nutrients until nutrient pathways are formed, and the pH of the reparative material. All or part of these additional materials may be mixed with the reconstructive material before or during transplantation, or alternatively, the additional materials may be transplanted adjacent to the defect area after the reconstructive material has been placed in place.

[0042] In certain embodiments, the reparative material may include collagen and platelets. In some embodiments, the platelets are derived from the subject being treated. In other embodiments, the platelets are derived from a donor that is allogeneic to the subject. In certain embodiments, the platelets may be obtained as platelet-rich plasma (PRP). In non-limiting embodiments, for example, platelets may be isolated from the subject's blood using techniques known to those skilled in the art. For example, a blood sample may be centrifuged at 700 rpm for 20 minutes to remove the upper layer of platelet-rich plasma. Platelet density may be determined using cell counts known to those skilled in the art. Platelet-rich plasma may be mixed with collagen and used as a scaffold. Platelet-rich plasma may be mixed with one or more of the scaffold materials of the present invention.

[0043] In one embodiment, the gel is a hydrogel. A hydrogel is a substance formed when organic polymers (natural or synthetic) are crosslinked via covalent, ionic, or hydrogen bonds to create a three-dimensional open lattice structure that traps water molecules and forms a gel. The polymer may be crosslinked to form a hydrogel either before or after implantation into a target. For example, the hydrogel may be formed in situ, for example, at the repair site. In certain embodiments, the polymer forms a hydrogel within the repair site upon contact with a crosslinking agent. Naturally occurring and synthetic hydrogel-forming polymers, polymer mixtures, and copolymers may be used as hydrogel precursors. See, for example, U.S. Patent No. 5,709,854. In certain embodiments, the hydrogel is a gel that begins to harden immediately after mixing and takes approximately 5 minutes to fully harden before closure of the defect and surgical area. The hardening time may vary depending on the gel mixture used and environmental factors.

[0044] For example, certain polymers capable of forming malleable ionic hydrogels can be used to form hydrogels. For instance, hydrogels can be produced by crosslinking the anionic salt of alginate, a carbohydrate polymer isolated from seaweed, with calcium cations, the strength of which increases with increasing concentration of either calcium ions or alginate. Modified alginate derivatives can be synthesized, for example, that have an improved ability to form hydrogels or that are derivatized with hydrophobic, water-unstable chains (e.g., e-caprolactone oligomers). Additionally, polysaccharides that gel upon exposure to monovalent cations, such as bacterial polysaccharides like gellan gum and plant polysaccharides like carrageenan, can be crosslinked to form hydrogels. Additional examples of materials that can be used to form hydrogels include ionically crosslinked polyphosphatidines and polyacrylates, or block copolymers such as PLURONICS® (polyoxyalkylene ethers) or TETRONICS® (nonionic polymerized alkylene oxides), which are crosslinked by temperature or pH, respectively, and polyethylene oxide-polypropylene glycol block copolymers. Other materials include proteins such as fibrin, and polymers such as polyvinylpyrrolidone, hyaluronic acid, and collagen. Polymers such as polysaccharides that are highly viscous liquids or thixotropic and form gels over time by slow structural evolution are also useful.

[0045] In another embodiment, the gel is a hydrogel acid. Hyaluronic acid that forms an injectable gel with a consistency similar to hair gel may be used. Modified hyaluronic acid derivatives are particularly useful. Hyaluronic acid is a linear polysaccharide. Many of its biological effects are a result of its ability to bind to water, with up to 500 ml of water being able to associate with 1 gram of hyaluronic acid. Esterification of hyaluronic acid with an uncharged organic moiety reduces its water solubility. Complete esterification with an organic alcohol such as benzyl makes hyaluronic acid derivatives substantially insoluble in water, and these compounds dissolve only in certain aprotic solvents. When a film of hyaluronic acid is made, the film is essentially a gel that hydrates and expands in the presence of water.

[0046] As used herein, the term “pharmaceutically acceptable” means a non-toxic material that does not impair the efficacy of the biological activity of the scaffolding or repair material. The term “physiologically acceptable” means a non-toxic material that is compatible with biological systems such as cells, cell cultures, tissues, or organisms. The characteristics of the carrier depend on the route of administration. Physiologically and pharmaceutically acceptable carriers include diluents, fillers, salts, buffers, stabilizers, solubilizers, and other materials well known in the art. The term “carrier” means a natural or synthetic organic or inorganic component that is combined with the scaffolding material to facilitate application. Components of the pharmaceutical composition can also be mixed with and with the devices of the present invention in such a manner that there are no interactions that substantially impair the desired pharmaceutically active effect.

[0047] graft In the illustrated embodiments, graft 116 is an ACL graft, but various types of grafts can be used. Various types of ACL grafts are available for use by surgeons in ACL reconstruction. Graft 116 may be an autologous graft or an autologous graft harvested from a patient. For example, these grafts may include a patellar tendon-bone graft or a hamstring muscle graft. Alternatively, graft 116 may include one or more xenografts, allografts, syngeneic grafts, or synthetic polymer grafts. Allografts include ligamentous tissue harvested from a cadaver, appropriately processed and disinfected, and preferably sterilized. Xenograft connective tissue includes connective tissue harvested from an animal source, such as pig tissue. Typically, xenografts must be appropriately processed to eliminate or minimize the immune response. Synthetic grafts include grafts made from synthetic polymers such as polyurethane, polyethylene, and polyester, as well as other conventional biocompatible bioabsorbable or non-absorbable polymers and composites, such as scaffolds as described herein. Materials for synthetic grafts may include, but are not limited to, Supramid®, Teflon® or Dacron®, Proplast®, carbon fiber grafts, ABC grafts, Kennedy-LAD®, Trevia, Leeds-Keio, Gore-Tex®, PDS®, EULIT®, and Polyflex® or LARS®.

[0048] The graft 116 has a length L extending along the longitudinal direction 2 and a width W extending along the transverse direction 4. The dimensions of the graft 116 can be defined to any specific size during manufacturing. In another embodiment, the graft 116 may be positioned along or adjacent to the scaffold 112.

[0049] Referring to Figures 2A and 2B, the scaffold 112 is a three-dimensional body configured to enclose the graft 116. In the illustrated embodiment, the scaffold 112 is cylindrical in shape, being hollow or tubular with one or more openings. The openings may be linear, curved, bent, looped, helical, zigzag, or any other shape. The graft 116 can be inserted and slide through the scaffold 112 along a linear, curved, helical, or winding path to enter and exit the scaffold. Thus, the scaffold 112 may have one or more openings on any surface of the scaffold 112.

[0050] In an alternative embodiment, the scaffolding 112 may have any shape or cross-section and may be solid throughout the entire scaffolding 112 or through a portion of the scaffolding 112. In this configuration, the graft 116 may be inserted through the scaffolding 112 to displace or remove (i.e., coring) the scaffolding 112. Inserting through a solid scaffolding allows for the displacement or pushing away of the scaffolding material while maintaining the same mass of the scaffolding.

[0051] The scaffolding 112 may cover the entire graft 116 or a portion of the graft 116. The scaffolding 112 is in direct contact with the graft 116 in at least a portion of it. The thickness of the scaffolding 112 covering the graft 116 may vary from region to region. For example, the scaffolding 112 may have a first thickness in the upper and bottom portions of the graft 116 and a second, larger thickness in the middle portion of the graft 116. The thickness of the scaffolding 112 in any region may be 0.00 mm, creating holes or windows in the scaffolding (e.g., mesh scaffolding). In one embodiment, the scaffolding 112 covers the graft 116 such that the scaffolding 112 wraps completely around the graft 116 without any gaps, in a 360-degree orientation around the longitudinal axis. In another embodiment, the scaffolding 112 wraps around the graft 116 in a 360-degree orientation around its longitudinal axis, with one or more gaps between the scaffolding 112 and the graft 116.

[0052] In another embodiment, the graft 116 is inserted through a scaffold 112. The scaffold 112 may have no joints and may require no operation or preparation. Insertion of the graft 116 may or may not be done with tools. The tool may act as a needle or guide for the graft 116 when it is inserted through the scaffold 112. Alternatively, the tool may act as a funnel for the scaffold 112.

[0053] Referring to Figures 3A and 3B, the scaffolding 112 is a sheet of a desired thickness and shape configured to be wrapped around, folded, or clamped around the graft 116. The scaffolding 112 may be a flat, pre-folded, or pre-formed sheet to fit around the graft 116. When the scaffolding 112 is a flat sheet, the scaffolding 112 adjusts its shape to match the graft 116 to achieve the desired configuration. In the illustrated embodiment, the sheet is a rectangular sheet. In alternative embodiments, the sheet may be any other desired shape, including a trapezoid. The scaffolding 112 may require manipulation to fit around the graft 116 and may include visible seams corresponding to where the scaffolding 112 has been manipulated. Wrapping, folding, and / or clamping the scaffolding 112 around the graft 116 allows the scaffolding 112 to wrap around the longitudinal portion of the graft. This configuration brings one or more layers of scaffolding 112 around the graft 116 in order to achieve the desired overall thickness of the scaffolding material.

[0054] In one embodiment, the scaffolding sheet 14 may be spirally wrapped around the graft 116 such that the sheet has a length greater than its width and requires multiple wraps around the graft 116. This configuration allows for uncovered grafts between spiral steps. In other embodiments, the sheet may be wrapped around the graft 116 in a single wrap.

[0055] Referring to Figure 4, the scaffold 112 may be formed directly around the graft 116 by various manual or automated casting, molding, or forming methods. In the illustrated embodiment, the scaffold 112 is formed directly around the graft 116 via die casting. In an alternative embodiment, the scaffold 112 is formed directly around the graft 116 via molding cast. The graft 116 is placed in a die or mold that closes around the graft 116. The scaffold material may then be inserted or injected into the die or mold to form the scaffold 112 in the desired geometric shape. The scaffold material may be loosened or specified to be molded or formed around the graft 116. The scaffold material may then be assembled to form the desired scaffold and cast, molded, or formed around the graft 116 for a desired final configuration having the desired thickness or profile. The casting, molding, and / or forming processes may be chemical, mechanical, or electrical.

[0056] method Referring to Figures 1 to 4, aspects of the present invention relate to a method for repairing a torn or damaged ligament. In some embodiments, a scaffold 112, a graft 116, and sutures 120 are inserted into the repair site 26 of the torn or damaged ligament 2 via an arthroscopic instrument. In certain embodiments, a hole is drilled into the bone at or near the repair site of the torn or damaged ligament 2, and the sutures 120 are attached to the bone through the hole.

[0057] The repair site 26 is the area surrounding the torn or damaged ligament 2 into which the device can be inserted. The scaffold 112 and graft 116 can be inserted into the repair site 26 during surgery via arthroscopic instruments using techniques known to those skilled in the art. The scaffold 112 is inflatable and can fill the repair site 26 or partially fill the repair site 26 while wrapping around or wrapping around the graft 116. When inserted, the scaffold 112 can be inflated to partially fill the repair site 26, either by filling the repair site 26 with blood, plasma, or other fluids, either by being present in or added to the repair site 26.

[0058] In one embodiment, the graft 116 may be connected to one or more sutures and anchors to form a graft structure of desired dimensions. The graft 116 may be encased in a scaffold 112, advanced into the tibia, and connected to an anchor on the tibia. The graft 116 and / or scaffold 112 are further connected to the femur 4 via the anchor and subjected to tension when the leg is extended.

[0059] In another embodiment, the scaffold 112 and graft 116 may be attached directly or indirectly to the femur 4 and may be in contact with the torn ligament 2. In another embodiment, the scaffold 112 and graft 116 may be formed around the torn or damaged ligament 2 at the repair site 26. For example, in one embodiment, the scaffold 112 and graft 116 may be formed in a tubular shape and wrapped around the ligament 2. In another embodiment, the scaffold 112 and graft 116 may be positioned behind the ligament so that the ligament is held within the scaffold 112 and graft 116. In yet another embodiment, the scaffold 112 and graft 116 may be in a "Chinese finger trap" design, with one end positioned to cover the torn end of the ligament and the second end positioned to cover the other end of the ligament. In another embodiment, the graft may be positioned along or adjacent to the scaffold 112.

[0060] Aspects of the present invention provide a method for repairing a torn ligament 2, comprising drilling holes in or near the repair site 26 of the torn ligament 2. The bone at or near the repair site is within a range close to the repair site and can be utilized using the method and devices of the present invention. For example, the bone at or near the repair site of a torn anterior cruciate ligament is the femur 4 and / or tibia 6. Holes can be drilled into the bone using a Kirschner wire (e.g., a small Kirschner wire) and a drill, or a device such as a microfracture pick or microfracture owl. One or more holes may be drilled into the bone surrounding the repair site 26 to promote bleeding into the repair site 26. Repair can be supplemented by drilling holes in the surrounding bone to induce bleeding. Promoting bleeding into the repair site can promote the formation of a blood clot and enhance the healing process of the injury.

[0061] A hole may be drilled in the femur 4 opposite the repair site 26. The scaffold 112, graft 116, and suture 120 may be inserted into the repair site 26 via an arthroscopic instrument. The suture 120 may be passed through a hole in the bone and attached to the bone. The torn ligament 2 provides two ends of a previously connected ligament. In one embodiment, the scaffold 112 and graft 116 may be attached by the suture 120 to one or both ends 128, 132 of the torn ligament 2. In another embodiment, the scaffold 112 and graft 116 may be attached to one or both ends of the femur 4 and tibia 6. The suture 120 may be attached to a second bone site in or near the repair site 26. In another embodiment, a hole may be drilled on the opposite side of the femur 4. The suture 120 is attached to the opposite side of the femur 4 through the hole 20 via an arthroscopic instrument, using the first end 128 and the second end 132. In yet another embodiment, the hole is drilled in the tibia 6 near the end of the torn ligament 2, and the suture 120 is attached to the tibia 6 through the hole via an arthroscopic instrument.

[0062] Referring here to Figures 5A to 5C, this disclosure includes examples of surgical procedures that can be performed using the disclosed systems and methods. Prior to the insertion of the scaffold 112 surrounding the graft 116, the affected limb is prepared and draped in a standard sterile manner. A tourniquet may be used if indicated. In Figure 5A, after a diagnostic arthroscopy is performed, the torn ligament 2 is identified and demarcated, and the tissue ends are pre-treated either mechanically or chemically. A suture 120 is connected to the fixation device.

[0063] In Figure 5B, before entering the repair site, the arthroscopic instrument 30 attaches sutures 120 to a scaffold 112 surrounding the graft 116. The scaffold 112 and graft 116 may be treated with the repair material. In one embodiment, the scaffold 112 and graft 116 may also be pre-treated in an antibiotic solution before implantation. The arthroscopic instrument 30 is configured to include the scaffold 112, graft 116, and sutures 120. During implantation, the arthroscopic instrument 30 introduces the scaffold 112, graft 116, and sutures 120 into the tissue defect. In the illustrated embodiment, the arthroscopic instrument 30 introduces the repair device by pushing the repair device from its container into the repair site or releasing it.

[0064] In the illustrated embodiment, the suture 120 is then connected to the torn end of the ligament 2 at a first end 128. In one embodiment, the suture 120 is positioned through the torn end of the ligament 2 using a whip stitch. In Figure 6B, the fixation device 122 carries the suture 120 and passes through the bone. The fixation device 122 and the suture 120 are attached to the bone.

[0065] In Figure 5C, the arthroscopic instrument 30 (not shown) positions the scaffold 112 and graft 116 along the suture between the torn ends of the ligament 2. In an alternative embodiment, the arthroscopic instrument 30 positions the scaffold 112 and graft 116 directly or indirectly on the femur 4 and / or tibia 6. This disclosure may be used by insertion through an open incision. The scaffold 112 and graft 116 are compressible to allow introduction through the arthroscopic portal, incision, and instrument.

[0066] The scaffold 112 and graft 116 are then joined to the surrounding tissue using the methods described herein. This can be done by adding chemical or physical agents such as ultraviolet light, laser, or heat. The scaffold 112 and graft 116 may be reinforced by the placement of additional sutures or clips. The arthroscopic portal is closed and a sterile bandage is placed. Postoperative rehabilitation depends on the type and size of the lesion being treated, and the arrangement of the tissues involved.

[0067] Referring to Figures 6A to 6D, an aspect of the present invention relates to a method for repairing a torn or damaged ligament, such as the ACL, at a repair site 140. In some embodiments, a scaffold 112, a graft 116, and one or more sutures 120 are inserted into the repair site 140 of the torn or damaged ligament 102 via an arthroscopic instrument 130.

[0068] The repair site 140 is the area surrounding the torn or damaged ligament 102 into which the device can be inserted. The scaffold 112 and graft 116 can be inserted into the repair site 140 via arthroscopic instruments 130 during surgery. The scaffold 112 is inflatable and can either fill the repair site 140 with the graft 116 or partially fill the repair site 140 with the graft 116. When inserted, the scaffold 112 can be inflated to partially fill the repair site 140, either by filling the repair site 140 with blood, plasma, or other fluids, either by being present within the repair site 140 or by being added to it.

[0069] In an illustrated embodiment, the scaffold 112 and the graft 116 are joined to form a repair device 110, which is attached directly or indirectly to the bone and in contact with the torn or damaged ligament 102. In another embodiment, the repair device 110 may be formed around the torn or damaged ligament 102 at the repair site 140. For example, in one embodiment, the repair device 110 is wrapped around the ligament 102, and in another embodiment, the repair device 110 is positioned behind the ligament so that the ligament is held within the repair device 110. In yet another embodiment, the repair device 110 may be a "Chinese finger trap" design, with one end positioned to cover the torn end of the ligament and the second end positioned to cover the other end of the ligament.

[0070] In an alternative embodiment, the graft 116 may be joined to one or more sutures 120 and one or more fixation devices 122 to form a graft structure having desired dimensions. The graft 116 is advanced into the first bone and joined to one or more fixation devices 122 on the first bone. The graft 116 is further joined to the second bone via one or more fixation devices 122 and subjected to tension in an elongated state. The graft 116 is then joined to the scaffold 112.

[0071] An example of a torn anterior cruciate ligament is illustrated in Figure 6A. The anterior cruciate ligament (ACL) 102 is one of the four strong ligaments that connect the bones of the knee joint. The function of the ACL is to provide stability to the knee and minimize stress across the knee joint. This is because it restricts excessive forward movement of the tibia 106 relative to the femur 104, and limits rotational movement of the knee.

[0072] As shown in Figures 6A to 6D, the anterior cruciate ligament 102 is torn in such a way that it no longer forms a connection between the femur 104 and the tibia 106. The end of the femur 104 includes the femoral ACL stump 107. The end of the tibia 106 includes the tibial stump 109. An aspect of the present invention provides a method for repairing a torn ligament 102, comprising drilling one or more holes 144 in or near the repair site 140 of the torn ligament 102. In Figure 6A, holes 144A and 144B are drilled in the femur 104 and tibia 106 at the repair site 140, respectively. Hole 144A may hereafter be additionally referred to as the femoral tunnel 144A, and hole 144B may hereafter be additionally referred to as the tibial tunnel 144B. A first suture 120A is placed through the tibial stump 109 using a whip stitch. The first suture 120A is attached to the first fixation device 122A via its first end 126A. The second suture 120B and the third suture 120C are joined to the fixation device 122A at their respective first ends 126B and 126C. The fixation device 122A then passes through the femoral tunnel 144A and is joined to the femur 104. In Figure 6B, the repair device 110 is loaded onto the second suture 120B and the third suture 120C. The scaffold 112 is then injected with repair material as described. The repair device 110 and the second and third sutures 120 can be inserted into the repair site 140 via an arthroscopic instrument 130. In Figure 6C, the free ends 128B, 128C of the second suture 120B and the third suture 120C are passed through the tibial tunnel 144B and connected to the second fixation device 122B which is connected to the tibia 106. The repair device 110 is then positioned between the two ends of the injured ACL 2. In Figure 6D, the knee is extended and the sutures 120A, 120B, 120C and the fixation devices 122A, 122B are fixed in place.

[0073] In alternative embodiments, the scaffold 112 and the graft 116 may be attached directly or indirectly to the femur 104. For example, the graft 116 may be attached to the scaffold 112 via sutures or via another mechanism. In another embodiment, the graft 116 may be positioned along or adjacent to the scaffold 112. In one embodiment, the scaffold 112 may be attached between the femoral insertion point and the tibial insertion point and may be positioned in conjunction with the graft 116. In another embodiment, the graft 116 may be inserted or pushed through the scaffold 112.

[0074] In this disclosure, the subject matter includes, but is not limited to, any mammal such as humans, non-human primates, mice, rats, dogs, cats, horses, or cattle. In certain embodiments, the subject matter is humans. This disclosure may also include a kit for repairing torn or damaged ligaments. The kit may include a scaffold of the present invention having at least one fixation device attached to the scaffold, and instructions for use. The scaffold may further include one or more sutures for attaching the fixation device to the scaffold. The kit may further include a container for containing repair materials as described herein.

[0075] The specification of the aforementioned document is considered sufficient to enable those skilled in the art to carry out the present invention. The examples are intended as single illustrative examples of one aspect of the present invention, and other functionally equivalent embodiments are within the scope of the present invention; therefore, the present invention is not limited by the examples provided. In addition to those illustrated and described herein, various modifications of the present invention will be apparent to those skilled in the art from the aforementioned specification and will fall within the scope of the appended claims. The advantages and objectives of the present invention are not necessarily encompassed by each embodiment of the present invention. Those skilled in the art can recognize or confirm many equivalents to the specific embodiments of the present invention described herein by means of routine experimentation alone. Such equivalents are intended to be encompassed by the following claims.

[0076] All references disclosed herein are incorporated in their entirety by reference.

Claims

1. It is a ligament repair system, A repair device configured to repair a ligament and for placement in synovial fluid, wherein the repair device has a hydrophilic scaffold covering a graft. The repair device comprises one or more suture assemblies configured to be positioned along or adjacent to the torn end of the injured ligament, A ligament repair system comprising: a fixation device configured to bond one or more suture assemblies to bone.

2. The ligament repair system according to claim 1, wherein the hydrophilic scaffold is a collagen scaffold.

3. The ligament repair system according to claim 1, wherein the fixation device is configured for placement on the bone.

4. The ligament repair system according to claim 1, wherein the graft is an ACL graft.

5. The ligament repair system according to claim 4, wherein the graft is an autograft, an allograft, or a synthetic graft.

6. The ligament repair system according to claim 1, wherein the scaffold and one or more suture assemblies are pre-loaded and insertable through an arthroscopic cannula.

7. The ligament repair system according to claim 1, wherein the graft and the one or more suture assemblies are pre-loaded and insertable through an arthroscopic cannula.

8. The ligament repair system according to claim 1, wherein the scaffold, the graft, and the one or more suture assemblies are pre-loaded and insertable through an arthroscopic cannula.

9. The ligament repair system according to claim 1, wherein the ligament is ACL, and the scaffold is configured to allow intracellular proliferation.

10. The ligament repair system according to claim 1, wherein the fixing device is selected from the group consisting of screws, barbs, helical fixing devices, staples, clips, snaps, and rivets.

11. The ligament repair system according to claim 1, further comprising a repair material.

12. The ligament repair system according to claim 11, wherein the repair material is platelets or plasma.

13. The ligament repair system according to claim 1, wherein the scaffold is in direct contact with the graft.

14. The ligament repair system according to claim 1, wherein the scaffold covers the entire graft.

15. The ligament repair system according to claim 1, wherein the scaffold covers a portion of the graft.

16. The ligament repair system according to claim 1, wherein the scaffold is spirally wrapped around the graft.

17. The ligament repair system according to claim 1, wherein the scaffold is wrapped around the graft.

18. The ligament repair system according to claim 1, wherein the graft is inserted through the scaffold.

19. The ligament repair system according to claim 18, wherein the scaffold is a hollow tubular shape having a central channel and one or more openings to the channel.

20. The ligament repair system according to claim 18, wherein the graft displaces the scaffolding material when it is inserted into the scaffolding so as not to change the mass of the scaffolding.

21. The ligament repair system according to claim 18, wherein the graft replaces the scaffolding material when it is inserted into the scaffolding such that the mass of the scaffolding changes.

22. The ligament repair system according to claim 1, wherein the scaffold is wrapped around, folded, or clamped around the graft.

23. The ligament repair system according to claim 1, wherein the scaffold is initially pre-formed to fit on or around the graft when combined with the graft, such that the scaffold adjusts its shape relative to the graft.

24. The ligament repair system according to claim 1, wherein the scaffold includes one or more layers surrounding the graft.

25. The ligament repair system according to claim 1, wherein the scaffold is molded around the graft.

26. A method for repairing the anterior cruciate ligament, a. Inserting a repair device adjacent to the torn end of the patient's injured ligament, wherein the repair device comprises a combination of a scaffold and a graft, b. Fixing the repair device to the sutures and the first bone using the first fixation device, c. A method comprising bonding the repair device to a second bone using a second fixation device.

27. The method according to claim 26, further comprising attaching the first fixing device to the repair device only indirectly.

28. The method according to claim 26, further comprising attaching the first fixation device to the femur.

29. The method according to claim 26, further comprising positioning the repair device between the torn end of the ligament and the femur.

30. The method according to claim 26, wherein the scaffolding comprises a porous collagen sponge.

31. The method according to claim 26, further comprising treating the scaffolding with a repair material.

32. The method according to claim 31, wherein the repair material is blood, platelets, or plasma.

33. The method according to claim 26, wherein the first fixation device is bioabsorbable.

34. The method according to claim 26, wherein the suture is bioabsorbable.

35. The method according to claim 26, wherein the first fixing device is an end button.

36. The method according to claim 26, wherein the graft is an autograft.

37. To take a portion of the hamstring muscle from the aforementioned patient, The method according to claim 36, further comprising forming the graft from the portion of the hamstring muscle.

38. The method according to claim 26, wherein the graft is an allograft.

39. Taking a portion of the hamstring muscle from another patient, The method according to claim 38, further comprising forming the graft from the portion of the hamstring muscle.

40. The method according to claim 26, wherein the graft is a synthetic graft.

41. The method according to claim 40, further comprising assembling a bundle of synthetic polymers having a longitudinal dimension within the graft.

42. It is a tissue repair system, A repair device, Grafts that have been sized and shaped for placement within the repair site of damaged tissue, A restorative device comprising: an implant wrapped around the graft, wherein the implant is compressible and expandable and configured to absorb restorative material; At least one implant suture configured to position the implant along or adjacent to the torn end of the damaged tissue, A first fixation device configured to connect at least one implant suture to the first bone, At least one graft suture configured to position the graft along or adjacent to the implant or the torn end of the injured ligament, A tissue repair system comprising: a second fixation device configured to connect at least one transplant suture to the first bone.

43. A method for repairing torn tissue, Inserting the first suture through the graft, Wrapping a scaffold around the aforementioned graft, Positioning the scaffold and the graft close to the torn end of the patient's injured tissue, A method comprising fixing the scaffold to a first bone using a first fixation device via the first suture.

Images