ACL Repair System

Abstract

A system for repairing disrupted tissue is provided. Aspects of the present invention include a scaffold and a repair device having a combination with a graft attached to one or more fixation devices by one or more sutures and inserted into a repair site by arthroscopic surgical instruments or open surgical procedures. The system can be used to treat tissue trauma including ruptured ligaments, tendons, and cartilage.

Description

Technical Field

[0001] The present disclosure generally relates to systems and methods for repairing disrupted tissue using an arthroscopic repair system or an open surgical procedure having a combination of a scaffold implant and a graft.

[0002] This application is a continuation-in-part application claiming priority to U.S. Provisional Patent Application No. 63 / 345,401, filed May 24, 2022, which is hereby incorporated by reference in its entirety.

Background Art

[0003] Intra-articular tissues are difficult to heal after disruption. Similarly, the menisci and articular cartilage within the human joint often do not recover from trauma. Unlike extra-articular tissues that heal by forming a fibrin clot that ultimately transforms into scar, joint trauma inhibits the formation of this clot or causes its rapid dissolution. As a result, minor trauma to the knee joint impairs the triggering of clot formation that prevents the development of arthritis and stiffness. Synovial fluid, in its natural state, prevents clot formation and disrupts the healing process and the formation of fibrin clot scaffolds within the joint or intra-articular tissues.

Summary of the Invention

[0004] One embodiment of the present disclosure includes a tissue repair system. The tissue repair system includes a repair device. The repair device has an implant sized and shaped to be disposed within a repair site of a fractured tissue. The implant is compressible and expandable and is configured to absorb a repair substance. The tissue repair system further includes a graft configured to be coupled to the implant. The tissue repair system further includes at least one implant suture configured to position the implant along or adjacent to a broken end of the fractured tissue. The tissue repair system further includes a first fixture configured to couple the at least one implant suture to a first bone. The tissue repair system further includes at least one graft suture configured to position the graft along or adjacent to the implant or a broken end of the fractured tissue. The tissue repair system further includes a second fixture configured to couple the at least one graft suture to the first bone.

[0005] Another embodiment of the present disclosure includes a method of repairing a fractured tissue. The method includes inserting a repair device having a scaffold and a graft near a broken end of a patient's fractured tissue. The method further includes fixing the scaffold to a suture and a first bone with a first fixture.

[0006] The figures are merely illustrative and not necessary for the practicability of the invention disclosed herein.

Brief Description of the Drawings

[0007]

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DETAILED DESCRIPTION OF THE INVENTION

[0008] Now, refer in detail to various embodiments of the present invention described in the accompanying drawings. Similar or identical reference numerals are used throughout the drawings as much as possible to indicate similar or identical features. It should be noted that the drawings are in a simplified form and are not drawn to an exact scale. When referring to the disclosure herein, for purposes of convenience and to make it understandable, terms indicating directions such as up (top), down (bottom), left, right, above, below, and diagonal are used with respect to the accompanying drawings. Such terms indicating directions used in connection with the following description of the drawings should not be construed as limiting in a way that does not explicitly describe the scope of the present disclosure.

[0009] Referring to FIG. 1, system 1 shows a repair device 10 having a scaffold 14 and a graft 18, and the scaffold 14 and the graft 18 are each configured to be inserted at a repair site to repair a broken or damaged tissue. Tissues referred to in this specification include ligaments (e.g., anterior cruciate ligament or "ACL" taking the English initials), tendons (e.g., Achilles tendon), or cartilage (e.g., elbow cartilage). System 1 further includes one or more fixtures 20 configured to fix the repair device 10 in a fixed position. System 1 further includes one or more sutures 24 that are coupled to the scaffold 14 and the graft 18 to form the repair device 10 and are configured to connect the repair device 10 to the repair site, which will be described later.

[0010] The repair device 10 is configured to heal or repair tissue. Specifically, with the repair device 10, the patient's body can generate a network of capillaries, arteries, and veins at the tissue fracture or break site. The connective tissue with good angiogenesis heals as a result of the migration of fibroblasts into the repair device 10. The methods and systems of the present disclosure create a link between damaged tissues by either surrounding or connecting to the fractured tissue, promoting the repair process of the fractured or broken tissue while maintaining the integrity and structure of the tissue. The scaffold can function either as an insoluble or biodegradable regulator of cell function or as a delivery vehicle for a support structure for cell migration or synthesis, and can also serve as a network or structure to facilitate in-growth of cells and angiogenesis. The graft can provide additional mechanical stability during the healing phase.

[0011] The present invention provides a repair instrument 10 having a three-dimensional (3D) scaffold 14 for repairing fractured or broken tissue. The scaffold 14 and the graft 18 are combined to become a joint between the fractured or broken tissue of the tissue and fibers after trauma, or to form a joint around the fractured tissue, and promote the movement of appropriate healing cells to form scars and new tissue. The scaffold 14 is a biotechnological alternative to a clot, and this scaffold is implanted together with the graft 18. Thus, the repair instrument 10 is implanted between tissues, or wrapped around this tissue, or placed adjacent to the fractured or broken tissue. In other embodiments, the repair instrument 10 can form a joint between bones or around the fractured tissue, so that the integrity and structure of the tissue are maintained. Therefore, this repair instrument 10 is designed to stimulate cell proliferation and extracellular matrix production in the gap between the broken ends of the tissue or within the fracture in the tissue, thus facilitating healing and regeneration.

[0012] As used herein, the term trauma refers to a torn or ruptured ligament, tendon, or cartilage. The torn tissue may appear as either a partial or a complete tear. A partial tear occurs when a portion of the tissue is damaged but remains connected. The spread and shape of the tear can vary. On the other hand, a ruptured tissue, also called a complete tear, involves a complete cut of the tissue, resulting in two separate ends. These ends may have approximately the same or different lengths. In some cases, a tissue stump may be created at one end. For example, in a complete anterior cruciate ligament (ACL) tear, the ligament stumps include a tibial stump connected to the tibia and a femoral stump connected to the femur.

[0013] Referring to FIG. 2, the scaffold 14 is a compressible and biocompatible implant configured to absorb a fluid (this term may be used interchangeably with “liquid” or “fluid”), such as blood and / or blood components. The scaffold is preferably a compressible, expandable (or extensible), biodegradable porous material that has some resistance to degradation by a fluid (e.g., synovial fluid) within the tissue repair site. In the illustrated embodiment, the scaffold 14 includes a self-assembly of interconnected collagen fibers and is a collagen implant that does not contain any cross-linking agents. The collagen itself may comprise a collagen-glycosaminoglycan (“GAG”) copolymer composed of soluble type I collagen. In one example, the scaffold 14 has a collagen content of greater than 400 mg / g, a GAG content of greater than 100 μg / g, a DNA content of less than 50,000 ng / g, a phospholipid calculated value of less than 3,000 μM / g, and a pepsin content of less than 12.5 mg / g. The scaffold 14 is preferably type I collagen, although the scaffold can include other collagen types. Preferably, the collagen is soluble, e.g., acidic or basic. For example, in another embodiment, the collagen may be type II, III, IV, V, IX, or X.

[0014] The scaffold preferably has a dimensional shape selected to complement the specific anatomical tissue to be further described below. In one embodiment, the scaffold 14 is preferably of an overall elongated structure, having a first end 15, a second end 16 opposite the first end 15, and a side wall 17 extending from the first end 15 to the second end 16. Thus, the scaffold 14 has a cylindrical shape with a length L1, where the length L1 is the distance extending from the first end 15 to the second end 16 along the central axis A. The length L1 is preferably in the range of 15 mm to 35 mm. In one embodiment, the length L1 is at least 25 mm. The scaffold 14 preferably has a cross-sectional dimension D1 perpendicular to the length L1, and D1 is in the range of 10 mm to 30 mm. In one embodiment, the cross-sectional dimension is 20 mm to 25 mm. In another embodiment, the cross-sectional dimension D1 is about 22 mm. Thus, for an overall elongated scaffold, the length L1 is greater than the cross-sectional dimension D1. The cylindrical scaffold is suitable for use in ACL procedures as described below. However, the dimensional shape of the scaffold 14 may vary as required for other anatomical structures and tissue sites.

[0015] The scaffold 14 is hydrophilic and can absorb plasma, blood, other in-body fluids, body fluids, hydrogels, or other substances that contact or adhere to the scaffold. Hereinafter, the scaffold 14 may be referred to as a collagen scaffold, a sponge, or a collagen sponge.

[0016] In the illustrated embodiment, the scaffold 14 is treated with a repair substance prior to insertion into the repair site. As shown, the repair substance is blood. Specifically, the scaffold 14 is treated with 5 - 10 mL of autologous blood. Prior to or during implantation into the repair site, it is preferable to immerse the repair device 10 in the repair substance, or inject the repair substance into the repair device 10. In other embodiments, the repair substance may be autologous or allogeneic blood composition, plasma, or other fluid present within the repair site or adhered to the scaffold 14 or added into the repair site.

[0017] Although shown as being suitable for several tissue repairs having a cylindrical shape, the scaffold 14 can be of any shape useful for implantation into tissue and tissue repair. The scaffold 14 can be, for example, tubular, semi-tubular, a flat planar sheet, or a flat sheet rolled into a tubular state to form a hollow cavity. Other shapes suitable for scaffolds of instruments known to those skilled in the art are also envisioned in the present invention.

[0018] In addition, in a variant embodiment, the scaffold preferably contains additional components that assist in healing, cell proliferation and vascularization. Such additional components may preferably include proteins, and such therapeutic proteins include hormones, cytokines, growth factors, coagulation factors, anti-proteolytic enzymes (e.g., α1-antitrypsin), angiogenesis proteins (e.g., vascular endothelial growth factor, fibroblast growth factor), anti-angiogenesis proteins (e.g., endostatin, angiostatin), and other proteins present in the blood, bone morphogenetic proteins (BMP), bone inductive factors (IFO), fibronectin (FN), endothelial cell growth factor (ECGF), cementum attachment extract (CAE), ketanserin, human growth hormone (HGH), animal growth hormone, epidermal growth factor (EGF), interleukin 1 (IL-1), human α-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 factor (PDLGF), but are not limited thereto. A lyophilized material is a material that can swell when a liquid, gel, or other fluid is added to or contacts it.

[0019] The scaffold 14 may be compressed prior to or during implantation into the repair site. By compressing the scaffold, the scaffold can expand within the repair site. The scaffold 14 may be in a lyophilized state and / or a compressed state when placed within the repair site and can expand once placed in a fixed position. The expansion of the scaffold 14 may occur after contact with blood or other fluids present within or added to the repair site.

[0020] In another embodiment, the scaffold 14 may be saturated or coated with a gel or hydrogel repair substance prior to implantation into the repair site. Coating or saturating the scaffold 14 can facilitate implantation into a relatively ill-defined defect area and / or help fill particularly large defect areas. In a preferred embodiment, the scaffold 14 is treated with a hydrogel. Examples of scaffolds and repair substances that can be used in accordance with the present disclosure can be found in U.S. Patent No. 6,964,685 and U.S. Patent Applications Nos. 2004 / 0059416 and 2005 / 0261736, each of which is hereby incorporated by reference in its entirety and made a part of this specification.

[0021] The biological properties of the cell infiltration rate and scaffold degradation can also be varied by changing the pore size, degree of crosslinking, and the amount of additional proteins, such as glycosaminoglycans, growth factors, and cytokines, in the scaffold 14. In addition, the biomaterial having collagen as a main component is preferably made from the patient's own skin, thus minimizing the antigenicity of the implant. However, the preferred collagen scaffold does not contain any crosslinking agents.

[0022] Referring to FIG. 3, the graft 18 is used to provide some mechanical stability and can serve as a scaffold support. In the illustrated embodiment, the graft 18 is a flat sheet-like structure configured to partially or fully wrap around the scaffold 14. The graft 18 has a first surface 19, a second surface 22 opposite the first surface 19, a thickness T extending from the first surface to the second surface, a length L2 extending along the longitudinal direction 2, and a cross-sectional dimension D2 extending along the transverse direction 4 perpendicular to the longitudinal direction 2. The length L2, width D2, and thickness T are perpendicular to each other when in the flat state. The length L2 is preferably in the range of 15 mm to 35 mm. In one embodiment, the length L2 is about 25 mm. The width D2 is preferably in the range of 0.05 mm to 35 mm. In one embodiment, the width D2 is about 35 mm. The thickness T is preferably in the range of 0.01 mm to 0.05 mm. In one embodiment, the thickness T is about 0.01 mm. The length L2 is preferably smaller than the length L1, thereby allowing exposure of the first and second ends 15, 16 of the scaffold and facilitating attachment to bone or other tissue if desired. As shown, the length L of the graft is greater than the graft width W. In an alternative embodiment, the dimensions of the graft 18 may be set to any specific size during manufacture. The graft 18 may be bent or rolled to achieve the desired length and width.

[0023] Several forms of grafts are available for use in tissue reconstruction and repair. In the illustrated embodiment, graft 18 may be an autograft or autologous graft harvested from the patient, such as a patellar-tendon-bone graft, or a popliteal tendon (hamstring) graft. As a variant, graft 18 can include one or more types of xenografts, allografts, isografts, or synthetic polymer grafts, either alone or in any combination. In one embodiment, graft 18 is an allograft. Examples of allografts include tendon tissue harvested from cadavers and appropriately processed and sterilized, preferably sterilized. In another embodiment, graft 18 is a xenograft. Examples of xenografts include connective tissue harvested from animals, such as porcine tissue. Typically, xenografts must be appropriately processed to eliminate or minimize the immune response. In yet another embodiment, graft 18 is a synthetic graft. Examples of synthetic grafts include grafts made from synthetic polymers and / or polymer filaments, such as polyurethane, polyethylene, polyester, and other conventional biocompatible bioabsorbable or non-absorbable polymers and compositions, such as scaffolds described herein. Examples of materials for synthetic grafts include, but are not limited to, Supramid®, Teflon®, Dacron®, Proplast®, carbon fiber grafts, ABC grafts, Kennedy-LAD®, Trevia, Leeds-Keio, Gore-Tex®, PDS®, EULIT®, and Polyflex® or LARS®.

[0024] An example of a combination of a scaffold 14 and a graft 18 for making a repair device 10 is shown in FIGS. 4 and 5. Referring to FIG. 4, in one exemplary embodiment, the graft 18 is attached to the scaffold 14 such that the graft 18 is coupled only to a portion of the scaffold 14. Thus, in the illustrated embodiment, the graft 18 may be positioned along or adjacent to the scaffold 14. The scaffold 14 may be attached to the graft 18 by one or more sutures 24. In alternative embodiments, the scaffold 14 may be attached to the graft by other mechanisms known in the art.

[0025] Referring to FIG. 5, in another exemplary embodiment, the graft 18 is wrapped around the scaffold 14 such that the graft 18 surrounds the scaffold 14. In alternative embodiments, the graft 18 may be wrapped around a portion or a majority of the scaffold 14. In the illustrated embodiment, the graft 18 may be wrapped around the scaffold 14 by sutures 24 to hold the repair device 10 in a fixed position within the patient's body. In alternative embodiments, the graft 18 may be wrapped around the scaffold 14 by other mechanisms known in the art.

[0026] In one example, the scaffold 14 may be attached between the femoral insertion site and the tibial insertion site and may be positioned in a state of being connected to the graft 18. In another example, the graft 18 may be inserted or pushed through the scaffold 14.

[0027] For example, in another embodiment, the scaffold 14 and the graft 18 may be attached to one or more sutures 24 and one or more fixtures 20. The one or more fixtures 20 may be attached to the one or more sutures 24 through the eyelets 10 of the one or more fixtures 20, as shown in FIGS. 1B and 1C. In this exemplary configuration, the one or more fixtures 20 are attached into the bone. The bone may be either the femur 4 or the tibia 6.

[0028] In one embodiment, both the scaffold 14 and the graft 18 are pre-treated with a repair substance. The scaffold 14 and the graft 18 may be immersed in the repair substance prior to or during implantation into the repair site 26. Examples of the repair substance include, but are not limited to, gels such as hydrogels, liquids, any substance capable of generating a hydrate, suspensions, and solutions injectable into the scaffold, and the repair substance can assist in tissue repair or growth. In one example, the repair substance is blood. In an alternative embodiment, the repair substance may include components including plasma, platelets, growth factors, antibiotics, thrombin, stem cells, genetically modified fibroblasts, platelets, plasma, extracellular proteins, and / or cell culture supplements. Additional repair substances may be added to affect cell proliferation, extracellular matrix production, consistency, suppression of disease or infection symptoms, muscle tone, cell nutrients until a nutrient pathway is formed, and the pH of the repair substance. All or a portion of these additional materials may be mixed with the repair substance before or during implantation, or, as an alternative, the additional materials may be implanted near the defect region after the repair substance is in place.

[0029] In some embodiments, platelets can be obtained as platelet-rich plasma (PRP). In a non-limiting example, the platelets may be isolated from a patient's blood using techniques known to those skilled in the art. As an example, a blood sample may be centrifuged at 700 rpm for 20 minutes and the upper layer of platelet-rich plasma removed.

[0030] Referring to FIGS. 4 and 5, system 1 includes one or more fixtures 20, such as a first fixture 20A and a second fixture 20B. The first fixture 20A is configured to indirectly couple the scaffold 14 to the repair site by one or more sutures 24. The second fixture 20B is configured to indirectly couple the graft 18 to the repair site by one or more sutures 24. The first fixture 20A and the second fixture 20B are preferably similar to each other, and thus only one of them will be described below. Each fixture 20 is an instrument that can be inserted into the repair site and that helps to form a stable attachment of the repair instrument to the surrounding tissue. In some cases, one or more fixtures 20 are removable from the repair site if desired.

[0031] The fixture 20 is further configured to couple to one or more sutures 24. In one embodiment, the fixture is preferably an elongated plate, and the elongated plate includes a plurality of eyelets or openings therethrough. The plate has a length that is greater than its width and thickness. This profile allows the fixture 20 to be inserted into a cannula or bone tunnel as needed. The openings are suitable for allowing one or more sutures 24 to be passed through one or more fixtures 20 and fastened in a fixed position within the repair site. The one or more openings 21 are preferably oval or circular, and such openings may be of any size suitable for allowing one or more sutures 24 to be held within such openings 21 as they pass through the one or more openings 21. An example of such a fixture is known as an Endobutton.

[0032] The fixture can take other forms. Examples of the fixture 20 include, but are not limited to, screws, barbs, anchors, spiral anchors, staples, clips, snaps, rivets, or crimp-type anchors. The length of the body of one or more fixtures 20 can vary. Examples of fixtures include the IN-FAST (trademark) Bone Screw System (Influence, Inc., located in San Francisco, California), the IN-TAC (trademark) Bone Anchor System (Influence, Inc., located in San Francisco, California), the Model 3000 AXYALOOP (trademark) Titanium Bone Anchor (Axya Medical Inc., located in Beverly, Massachusetts), the OPUS MAGNUM (registered trademark) Anchor with inserter (Opus Medical, Inc., located in San Juan Capistrano, California), the ANCHRON (trademark), the HEXALON (trademark), the TRINION (trademark) (all available from Inion Inc., located in Oklahoma City, Oklahoma), and the TwinFix AB absorbable suture anchor (Smith & Nephew, Inc., located in Andover, Massachusetts), but are not limited to these.

[0033] In the illustrated embodiment, the first fixture 20A is coupled to the first bone at the repair site and is indirectly attached to the first bone by one or more sutures 24 that attach the scaffold 14 to the repair device 10. The first fixture 20A serves to position and secure the repair device 10 at the repair site to the first bone. The first fixture 20A is preferably inserted into and secured to the first bone.

[0034] The second fixture 20B is coupled to the second bone at the repair site and is indirectly attached to the first bone by one or more sutures 24 that attach the graft 18 to the repair device 10. The second fixture 20B helps to position and secure the repair device 10 at the repair site. The second fixture 20A may be inserted into and secured to the second bone.

[0035] In one embodiment, the system utilizes only one fixture 20 that is attached to the scaffold 14 and the graft 18 and further coupled to the repair site. In an alternative embodiment, the system utilizes two or more fixtures 20, and the fixtures 20 may be directly attached to the repair device 10 by one or more sutures 24. In this configuration example, one or more fixtures 20 are directly swaged onto the scaffold 14 and / or the graft 18.

[0036] One or more fixtures 20 may be composed of a non-degradable material, such as metal, stainless steel, CoCrMo alloy, or nitinol alloy, or a polymeric material. One or more fixtures 20 are preferably bioabsorbable such that the patient can degrade and absorb one or more fixtures 20.

[0037] Continuing to refer to FIGS. 4 and 5, in the illustrated embodiment, one or more fixtures 20 are attached to the repair device 10 by one or more sutures 24. The one or more sutures 24 are passed through the eyelets 21 of the one or more fixtures 20 and retained within the one or more openings 21 such that the one or more fixtures 20 are attached to the repair device 10 by the one or more sutures 24. In the illustrated embodiment, the one or more sutures 24 have two free ends, namely, a first end 26 and a second end 28 that exit the repair device 10. In the illustrated embodiment, at least one additional suture is configured to position the graft 18 along or adjacent to the scaffold 14. However, in other embodiments, only one suture is required to position the graft 18 along or adjacent to the scaffold 14.

[0038] In the illustrated embodiment, one or more sutures 24 are bioabsorbable, such that the patient is able to degrade and absorb the one or more sutures 24. The one or more sutures 24 are also synthetic, such that the sutures may not be of natural origin. In other embodiments, the one or more sutures 24 may be permanent such that the patient is unable to degrade the sutures and the one or more sutures 24 remain in the patient's body. The one or more sutures 24 may be rigid or stiff, or alternatively stretchable or soft. Examples of sutures include, but are not limited to, VICRYL™ poliglecaprone 910, PANACRYL™ absorbable suture, ETHIBOND® EXCEL polyester suture, PDS® polydioxanone suture, PROLENE® polypropylene suture. Sutures are commercially available from manufacturers such as the MITEK PRODUCTS division of ETHICON, INC. located in Westwood, Massachusetts.

[0039] Referring to FIG. 6, arthroscopic surgical instrument 30 is configured to insert one or more sutures 24 into scaffold 14 and graft 18. Arthroscopic surgical instrument 30 is configured to receive scaffold 14, graft 18, and one or more sutures 24. During implantation, arthroscopic surgical instrument 30 is configured to introduce scaffold 14, graft 18, and one or more sutures 24 into the tissue defect. In the illustrated embodiment, arthroscopic surgical instrument 30 introduces the repair device by pushing or releasing the repair device from a container into the repair site.

[0040] The arthroscopic surgical instrument 30 is further configured to position the scaffold 14 and the graft 18 within the repair site. The arthroscopic surgical instrument 30 has an elongated delivery member 31. The elongated delivery member 31 has a channel extending from the proximal end to the distal end of the elongated delivery member 31. The elongated delivery member 31 is sized and shaped to receive the scaffold 14 and the graft 18 attached to one or more sutures 24 within the channel. At least a portion of the elongated delivery member 31 is further sized and shaped to be insertable into the repair site.

[0041] In the illustrated embodiment, the arthroscopic surgical instrument 30 is an injector or syringe. The injector can hold one or more sutures 24 and the scaffold 14 and the graft 18 in fixed positions within the elongated delivery member 31 of the injector. The injector preferably has a plunger 32 configured to push one or more sutures 24, the scaffold 14, and the graft 18 into the repair site, and the scaffold 14 and the graft 18 are positioned along one or more sutures 24 and adjacent to at least one broken end of the element. In an alternative embodiment, the arthroscopic surgical instrument 30 may have a cannula, a container, and a pressure pump. In another embodiment, the arthroscopic surgical instrument 30 may further have a guide suture extending from the distal end of the elongated delivery member, the guide suture being configured to draw and position one or more sutures 24 and the scaffold 14 into the repair site. In yet another embodiment, the system may be inserted into the repair site by an open surgical procedure instead of using the arthroscopic surgical instrument.

[0042] Referring to FIGS. 7-10, aspects of the present invention relate to a method of repairing a ruptured or torn ligament, such as the ACL, at the repair site 140. In some embodiments, the scaffold 114, the graft 118, and one or more sutures 124 are inserted into the repair site 140 of the ruptured or torn ligament 102 by an arthroscopic surgical instrument 130.

[0043] The repair site 140 is the area (field) around the torn or ruptured ligament 102 into which the instrument can be inserted. During surgery, the arthroscopic surgical instrument 130 inserts the scaffold 114 and the graft 118 into the repair site 140. The scaffold 114 is expandable and can fill the repair site 140 with the graft 118 or can partially fill the repair site 140 with the graft 118. The scaffold 114 can partially fill the repair site 140 upon insertion and be present within the repair site 140 or can expand to fill the repair site 140 in the presence of blood, plasma, or other fluid added into the repair site 140.

[0044] In the illustrated embodiment, the scaffold 114 and the graft 118 are joined together to form the repair instrument 110, and the repair instrument 110 is attached directly or indirectly to the bone so that it contacts the torn or ruptured ligament 102. In another embodiment, the repair instrument 110 can be shaped around the torn or ruptured ligament 102 at the repair site 140. For example, in one embodiment, the repair instrument 110 is wrapped around the ligament 102, and in another embodiment, the repair instrument 110 is positioned behind the ligament so that the ligament is held within the repair instrument 110. In yet another embodiment, the repair instrument 110 can be of a "Chinese finger trap" design, in which case one end is placed over the stump of the torn ligament and the second end is placed over the other end of the torn ligament.

[0045] In an alternative embodiment, the graft 118 is joined to one or more sutures 124 and one or more fixtures 120 to form a graft construct having a desired dimension. The graft 118 is advanced into the first bone and joined to one or more fixtures 120 on the first bone. The graft 118 is further joined to the second bone by one or more fixtures 120 and pulled into a stretched state. Next, the graft 118 is joined to the scaffold 114.

[0046] An example of a ruptured anterior cruciate ligament is shown in FIG. 7. The anterior cruciate ligament (ACL) 102 is one of four strong ligaments that connect the bones of the knee joint to each other. The function of the ACL is to provide stability to the knee joint and minimize the stress applied to the knee joint. The ACL limits excessive forward movement of the leg bone, i.e., the tibia 6, in relation to the thigh bone, i.e., the femur 4, and also limits the rotational movement of the knee joint.

[0047] As shown in FIGS. 7-10, the anterior cruciate ligament 102 is ruptured so that it no longer forms a connection between the femur 104 and the tibia 106. The resulting ends of the ruptured ACL 2 can be of any length. These ends may be of approximately the same length, or one end may be longer than the other end. The end of the femur 104 includes the femoral ACL stump 107. The end of the tibia 106 includes the tibial stump 109. In some cases, the length SL of the tibial stump is about 75% or less of the effective ligament length LL, but repair is considered desirable when it exceeds 5% of the total length LL of the ACL. The total length of the ACL is considered to be the length of the ligament along a straight axis from the femoral footprint to the tibial footprint.

[0048] The knee joint includes the tibial spine of the tibia 106 and the intercondylar notch of the femur 104. In some cases, the method as described herein may include performing a notchplasty on the intercondylar notch of the femur to provide space for the large ligament that results after surgical repair using a scaffold. Such notchplasty improves the size of the healing ligament, and as a particular result, a large cross-sectional area of the ligament is obtained. Since the mechanical strength of the ligament and, as a result, the functional ability of the ligament to maintain the distance between the femur and the tibia are directly correlated with its cross-sectional area, expanding the notch by notchplasty can help create a strong repaired ACL, and this has been found by the inventors to be beneficial in ACL repair using a scaffold as described in the present disclosure.

[0049] Aspects of the present invention provide a method of repairing a ruptured ligament 102 that includes the step of creating one or more holes 144 at or near the repair site 140 of the ruptured ligament 102. The bone at or near the repair site is one that is located within the area in close proximity to the repair site, and this bone may be utilized using the methods and instruments of the present invention. For example, the bone at or near the repair site of a ruptured anterior cruciate ligament may be the femur 104 and / or the tibia 106. The holes 144 may be created in the bone using a Kirschner wire (e.g., a small Kirschner wire) and drill, or an instrument such as a microfracture pick or awl. One or more holes may be created in the bone located around the repair site 140 so as to promote bleeding into the repair site 140. It may be beneficial to complement the repair by creating holes in the surrounding bone to cause bleeding. By promoting bleeding into the repair site, the formation of a blood clot can be facilitated and the healing process of the traumatized area can be facilitated.

[0050] In FIG. 7, holes 144A and 144B are drilled into the femur 104 and tibia 106 at the repair site 140, respectively. Hole 144A may additionally be referred to hereinafter as the femoral tunnel 144A, and hole 144B may additionally be referred to hereinafter as the tibial tunnel 144B. A first suture 124A is passed through the tibial stump 109 using a whipstitch. The first suture 124A is attached to a first fixture 120A via a first end 126A. A second suture 124B and a third suture 124C are coupled to the fixture 120A at their respective first ends 126B and 126C. The fixture 120A is then passed through the femoral tunnel 144A and coupled to the femur 104. In FIG. 8, the repair device 110 is loaded onto the second and third sutures 124B and 124C. Next, as described for the repair device 110, it is injected with the repair material in a state where it is provided. The repair device 110 and the second and third sutures 124 may be inserted into the repair site 140 via the arthroscopic surgical instrument 130. In FIG. 9, the free ends 128B and 128C of the second and third sutures 124B and 124C are passed through the tibial tunnel 144B and coupled to a second fixture 120B coupled to the tibia 106. Next, the repair device 110 is positioned between the two ends of the torn ACL2. In FIG. 10, the knee is extended and the sutures 124A, 124B, 124C and the fixtures 120A, 120B are fixed.

[0051] In another embodiment, the repair device 110 may be indirectly coupled to the first and second fixtures 120A, 120B and held in a fixed position within the repair site 140 by additional suture 124. Additionally, in another embodiment, any of the first, second, or additional sutures 124A, 124B,... 124n may be attached to one or both ends of the ruptured ligament 102 by these first ends 126A, 126B,... 126n and / or these second ends 128A, 128B,... 128n. Further, in another embodiment, the additional fixture 120 and suture 124 may be directly or indirectly attached to either the tibia 6 or the femur 104 to fix the scaffold 114 and the graft 118 in a fixed position. In a variant embodiment, the scaffold 114 and the graft 118 may be directly or indirectly attached to the femur 104. For example, the graft 118 can be attached to the scaffold 114 by a suture or another mechanism. In another embodiment, the graft 118 can be positioned along or adjacent to the scaffold 114. In one example, the scaffold 114 may be attached between the femoral insertion site and the tibial insertion site, and moreover, the scaffold may be positioned in a state connected to the graft 118. In another example, the graft 118 may be inserted or pushed through the scaffold 114.

[0052] Referring to FIGS. 11 and 12, aspects of the present invention relate to a method of repairing a ruptured or torn tendon 202 at a repair site 240, such method requiring a repair device 210, 218 having a scaffold 214 and a graft 218, one or more fixtures 220, and one or more sutures 224. In some embodiments, the scaffold 214, the graft 218, and one or more sutures 224 are inserted into the repair site 240 of the ruptured or torn tendon 202 by an arthroscopic surgical instrument 130 (not shown).

[0053] The repair site 240 is the area (field) around the broken or ruptured tendon 202 into which the instrument can be inserted. During the surgery, the repair instrument 210 can be inserted into the repair site 240 using techniques known to those skilled in the art with the arthroscopic surgical instrument 130. The scaffold 214 is expandable and this scaffold can fill the repair site 240 with the graft 218 or can partially fill the repair site 240 with the graft 218. The scaffold 214 can partially fill the repair site 240 upon insertion and exist within the repair site 240 or can expand to fill the repair site 240 in the presence of blood, plasma, or other fluid added into the repair site 240.

[0054] An example of a broken calcaneal ("Achilles") tendon is shown in FIG. 12. The Achilles tendon 202 is a very important structure that connects the gastrocnemius muscle 204 to the calcaneus bone 206. The Achilles tendon helps transmit the force from the gastrocnemius muscle 204 to the foot, thereby enabling movements such as walking, running, jumping, etc. The Achilles tendon functions as a stabilizer of the ankle joint, preventing excessive movement and serving as a support during various activities. In addition, the Achilles tendon limits the rotational movement of the foot and ankle, contributes to the overall stability of the joint, and minimizes the stress applied to the surrounding structures.

[0055] As shown in FIGS. 11 and 12, the Achilles tendon 202 is broken such that it no longer forms a connection between the gastrocnemius muscle 204 and the calcaneus bone 206. The resulting ends of the broken tendon 202 can be of any length. These ends can be of similar lengths or one end can be longer than the other end. The end on the gastrocnemius muscle 204 includes the gastrocnemius stump 207. The end on the calcaneus bone 206 includes the calcaneal stump 209. The total length of the tendon is considered to be the length of the ligament from the gastrocnemius footprint to the calcaneal footprint along the linear axis.

[0056] Prior to the insertion of the repair device 210, the affected distal end is pre-treated and then draped in a standard aseptic manner. A tourniquet (hemostatic band) can be used if applicable. Locate and identify the ruptured tendon 202 and pre-treat the tissue ends either mechanically or chemically. Attach one or more sutures 224 to one or more fixtures 220.

[0057] Prior to entering the repair site 240, the arthroscopic surgical instrument 130 attaches one or more sutures 224 to the repair device 210. Treat the repair device 210 with a repair substance. In one embodiment, the repair device 10 may also be pre-treated with an antibiotic solution prior to implantation.

[0058] In the illustrated embodiment, one or more sutures 224 are then connected to the ruptured end of the tendon 202 at the first end 226. In one embodiment, one or more sutures 224 are passed through the ruptured end of the ligament 202 using a whipstitch. Pass one or more fixtures 220 through the calcaneus 206 while carrying one or more sutures 224. Attach one or more fixtures 220 and one or more sutures 224 to the bone 206.

[0059] The arthroscopic surgical instrument 130 (not shown) positions the repair device 210 along one or more sutures 224 between the ruptured ends of the ligament 202. In an alternative embodiment, the arthroscopic surgical instrument 130 positions the repair device 210 directly or indirectly on the gastrocnemius 204 and / or the calcaneus 206. The present disclosure can be utilized by insertion through an open incision. The repair device is compressible to allow for introduction through an arthroscopic portal, an incision, and an instrument.

[0060] Next, the repair device 210 is bonded to the surrounding tissue using the methods described herein. This may be done by the addition of a chemical or physical agent, such as ultraviolet light, laser, or heat. The repair device 210 may be reinforced by the placement of additional sutures or clips. The arthroscopic surgery portal is closed and a sterile dressing is applied. Post-operative rehabilitation is determined by the type and size of the lesion treated, as well as the tissues involved.

[0061] Referring to FIGS. 13-15, aspects of the present invention relate to a method of repairing broken or torn cartilage 302 at a repair site 340, the method using a repair device 310 having a scaffold 314 and a graft 318, one or more fixtures 320, and one or more sutures 324. In some embodiments, the scaffold 314, graft 318, and one or more sutures 324 are inserted into the repair site 134 of the broken or torn cartilage 302 by an arthroscopic surgical instrument 230 (not shown).

[0062] The repair site 340 is the area (field) around the broken or torn cartilage 302 into which the instrument can be inserted. During surgery, the repair device 310 can be inserted into the repair site 340 using techniques known to those skilled in the art with an arthroscopic surgical instrument 230. The scaffold 314 is expandable and can fill the repair site 340 with the graft 318 or can partially fill the repair site 340 with the graft 318. The scaffold 314 can partially fill the repair site 340 upon insertion and be present within the repair site 340 or can expand to fill the repair site 340 in the presence of blood, plasma, or other fluid added to the repair site 340.

[0063] An example of a ruptured cartilage within the elbow is shown in FIGS. 14 and 15. The elbow cartilage 302 is located within the joint and is a cruciform component that connects the humerus 304 to the radius 306 and ulna 305. Its main role is to provide stability across the entire elbow joint and to reduce stress. The elbow cartilage effectively limits excessive forward or backward movement of the forearm bone relative to the humerus 304, thereby maintaining joint alignment.

[0064] As shown in FIGS. 12 and 13, the elbow cartilage 302 is ruptured such that it forms a separated portion of cartilage within the bone of the humerus 304. Prior to the insertion of the repair device 310, the affected end portion is pre-treated and draped in a standard sterilization manner. A tourniquet may be used if applicable. Locate and identify the ruptured cartilage 302 and pre-treat the tissue ends either mechanically or chemically. Attach one or more sutures 324 to one or more fixtures 320.

[0065] Prior to introduction into the repair site, arthroscopic surgical instruments 320 attach one or more sutures 324 to the repair device 310. Treat the repair device 310 with a repair substance. In one embodiment, the repair device 310 may be pre-treated with an antibiotic solution prior to implantation.

[0066] In the illustrated embodiment, next, one or more sutures 324 are attached to the radius at the first end 326 by the first fixture 320A. Pass the first fixture 320A through the radius 306 while carrying one or more sutures 324. Attach the first fixture 320A and one or more sutures 324 to the radius 306. In one embodiment, it may be further advisable to attach one or more sutures 324 to the humerus 304 at the second end 328 by the second fixture 320B.

[0067] An arthroscopic surgical instrument 230 (not shown) positions the repair device 310 along one or more sutures 224 through the fractured end of the cartilage 302. In an alternative embodiment, the arthroscopic surgical instrument 230 positions the repair device 310 directly or indirectly on the humerus 304 and / or the radius 306. The present disclosure can be utilized by insertion into an open incision. The repair device is compressible to allow introduction through an arthroscopic portal, an incision, and an instrument.

[0068] Next, the repair device 310 is attached to the surrounding tissue using the methods described herein. This can be accomplished by the addition of a chemical or physical agent, such as ultraviolet light, a laser, or heat. The repair device 310 may be reinforced by the placement of additional sutures or clips. The arthroscopic portal is closed and a sterile dressing is wrapped. Post-operative rehabilitation depends on the type and size of the lesion being treated, as well as the type and size of the tissue involved.

[0069] In the present invention, the patient can be any mammal, such as, but not limited to, a human, a non-human primate, a mouse, a rat, a dog, a cat, a horse, or a cow. In some embodiments, the patient is a human. The present invention can also include a kit for the repair of a ligament in a broken or torn state. The kit may include a scaffold of the present invention with at least one fixing device attached thereto and instructions for use. The scaffold may further include one or more sutures for attaching the fixing device to the scaffold. The kit may further include a container for containing a repair substance as described herein.

[0070] The content of the above specification is considered to be sufficient for those skilled in the art to be able to implement the present invention. The present disclosure is not limited to the scope by the provided examples, because the examples are intended as a single illustration of one aspect of the present invention, and other functionally equivalent embodiments are included in the scope of the present invention. Various modifications of the present invention in addition to the modifications described herein will be apparent to those skilled in the art from the above description, and thus belong to the scope of the present invention as recited in the claims. The advantages and objectives of the present invention are not necessarily included by each embodiment of the present invention. Those skilled in the art will be able to recognize or confirm many equivalent examples corresponding to the specific embodiments of the present invention described herein without performing more than routine experiments. Such equivalent examples are included in the present invention as recited in the following claims.

Claims

1. It is a tissue repair system, This includes repair tools, and the said repair tools are The implant has dimensions and shape that allow it to be placed within the repair site of torn tissue, and the implant is compressible and expandable, and is configured to absorb repair material. Having a graft configured to be connected to the implant, The implant comprises at least one implant suture configured to position the implant along or adjacent to the fractured end of the torn tissue, The device has a first fixation device configured to connect at least one implant suture to the first bone, The graft has at least one graft suture configured to position the graft along or adjacent to the fractured end of the implant or the torn tissue, A tissue repair system comprising a second fixation device configured to connect at least one graft suture to the first bone.

2. The tissue repair system according to claim 1, wherein the torn tissue is a ligament, tendon, or cartilage, and optionally the ligament is the ACL.

3. The tissue repair system according to claim 1, wherein the implant is a collagen scaffold configured to enable intracellular growth.

4. The tissue repair system according to claim 1, wherein the graft is configured to be positioned adjacent to the implant along the length of the implant, or the graft is configured to wrap around the scaffold.

5. The first fixation device is configured to be positioned against the first bone, or the second fixation device is configured to be positioned against the second bone, and at least one of these is provided. The tissue repair system according to claim 1.

6. The tissue repair system according to claim 1, wherein the graft is selected from the group consisting of autologous tendon grafts, autografts, and synthetic tendon grafts.

7. The tissue repair system according to claim 1, wherein the repair instrument and the at least one first suture are pre-loaded and can be inserted into the arthroscopic cannula.

8. The tissue repair system according to claim 1, wherein the first and second fasteners are selected from the group consisting of screws, barbs, spiral fasteners, staples, clips, snaps, and rivets.

9. The tissue repair system according to claim 1, wherein the repair device further comprises a repair substance, optionally the repair substance being platelets or plasma.

10. A method for repairing fractured tissue, The steps include inserting a repair device having a scaffold and graft near the fractured end of the patient's fractured tissue, A method comprising the step of fixing the scaffold to sutures and a first bone with a first fastener.

11. The method according to claim 10, further comprising the step of attaching the repair device to the second bone with a second fixation device.

12. The method according to claim 11, further comprising the steps of positioning the repair device between the torn end of the ligament and the femur, attaching the first fixation device to the femur, and attaching the second fixation device to the tibia.

13. The method according to claim 11, further comprising the step of positioning the repair device between the fractured ends of the cartilage.

14. The method according to claim 10, further comprising the steps of positioning the repair device between the torn end of the tendon and the calcaneus, and attaching the first fixation device to the calcaneus.

15. The method according to claim 10, further comprising the step of indirectly attaching the first fastener only to the repair device.

16. The method according to claim 10, wherein the scaffolding is made of a porous collagen sponge.

17. The method according to claim 10, further comprising the step of treating the scaffold with a repair material.

18. The method according to claim 10, further comprising the steps of: taking a portion of the popliteal tendon from the patient and forming the graft from the portion of the popliteal tendon; or taking a portion of the popliteal tendon from another patient and forming the graft from the portion of the popliteal tendon.

19. The method according to claim 10, further comprising the step of assembling bundles of synthetic polymers having longitudinal dimensions to form the graft.

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