ACL repair system

Abstract

A system for repairing ruptured tissue is provided. Aspects of the invention include a repair device comprising a combination of a stent and a graft attached to one or more fixation devices by one or more sutures and inserted into a repair site via an arthroscopic apparatus or open surgery. The system can be used to treat tissue damage, including rupture of ligaments, tendons and cartilages.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 345,401, filed on May 24, 2022, the contents of which are hereby incorporated in their entirety. Technical Field

[0002] The present disclosure generally relates to systems and methods for repairing ruptured tissue using an arthroscopic repair system or open surgical procedure with a combination of a stent graft and a graft. Background Art

[0003] Intra-articular tissues are difficult to heal after rupture. Similarly, the menisci and articular cartilage in human joints usually do not recover from injuries. Unlike tissues outside the joints that heal by forming fibrin clots (which eventually turn into scars), joint injuries hinder the formation of this clot or cause it to dissolve quickly. Therefore, a minor injury to the knee cannot trigger the formation of a clot, thereby preventing the development of joint arthrosis and joint stiffness. The synovial fluid in the joint naturally prevents clot formation, disrupting the healing process and the formation of fibrin clot scaffolds within the joint or intra-articular tissues. Summary of the invention

[0004] Embodiments of the present disclosure include a tissue repair system. The tissue repair system includes a repair device. The repair device includes an implant that is sized and shaped to be placed in a repair site of a torn tissue. The implant is compressible and expandable and is configured to absorb repair material. The tissue repair system also includes a graft configured to be connected to the implant. The tissue repair system also includes at least one implant suture that is configured to position the implant along or adjacent to the ruptured end of the torn tissue. The tissue repair system also includes a first fixture that is configured to couple the at least one implant suture to a first bone. The tissue repair system also includes at least one graft suture that is configured to position the graft along or adjacent to the ruptured end of an implant or torn ligament. The tissue repair system also includes a second fixture that is configured to couple the at least one graft suture to a first bone.

[0005] Another embodiment of the present disclosure includes a method for repairing ruptured tissue. The method includes inserting a repair device including a stent and a graft near the ruptured end of the torn tissue of the patient. The method also includes fixing the stent to the suture and the first bone with a first fixing device. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The drawings are merely illustrative and are not necessary to enable the inventions disclosed herein to be practiced.

[0007] Figure 1 is a schematic representation of a tissue repair system according to an embodiment of the present disclosure;

[0008] Figure 2 yes Figure 1 Schematic representation of the bracket shown;

[0009] Figure 3 yes Figure 1 Schematic representation of the graft shown;

[0010] Figure 4 is a schematic representation of a repair device according to an embodiment of the present disclosure;

[0011] Figure 5 is a schematic representation of a repair device according to an embodiment of the present disclosure;

[0012] Figure 6 is a schematic representation of an arthroscopic repair system according to an embodiment of the present disclosure;

[0013] Figure 7 is a schematic diagram depicting a tissue repair system for ligament repair in the ACL;

[0014] Figure 8 It is a depiction Figure 8 A schematic diagram of a repair device shown being inserted into a repair site;

[0015] Fig. 9 It is a depiction Figures 7 and 8 A schematic diagram showing a tissue repair system fully inserted into a repair site;

[0016] Fig.10 It is a depiction Figures 7 and 8 A schematic diagram of a tissue repair system shown being fixed in a repair site;

[0017] Fig.11 is a schematic diagram depicting a tissue repair system for tendon repair in the Achilles tendon;

[0018] Fig.12 It is a depiction Fig.12 A schematic diagram of a tissue repair system shown being inserted into a repair site;

[0019] Fig.13 is a schematic diagram depicting a tissue repair system for cartilage repair in the elbow;

[0020] Fig.14 It is a depiction Fig.14 A schematic diagram of a tissue repair system shown being inserted into a repair site; and

[0021] Fig.15 It is shown Figure 14 to Figure 15 Schematic diagram showing the repair of ruptured cartilage by the tissue repair system. DETAILED DESCRIPTION

[0022] Reference will now be made in detail to various embodiments of the present disclosure illustrated in the accompanying drawings. Where possible, the same or similar reference numerals will be used throughout the drawings to refer to the same or similar features. It should be noted that the drawings are in simplified form and are not drawn to exact scale. With reference to the disclosure herein, directional terms such as top, bottom, left, right, above, below, and diagonal are used with respect to the drawings for purposes of convenience and clarity only. Such directional terms used in conjunction with the following description of the drawings should not be construed as limiting the scope of the present disclosure in any manner not expressly set forth.

[0023] refer to Figure 1 , system 1 includes a repair device 10, which includes a stent 14 and a graft 18, each of which is configured to be inserted into a repair site to repair ruptured or damaged tissue. The tissue here may include a ligament (e.g., anterior cruciate ligament or "ACL"), a tendon (e.g., Achilles tendon), or cartilage (e.g., elbow cartilage). System 1 also includes one or more fixtures 20, which are configured to fix the repair device 10 in place. System 1 also includes one or more sutures 24, which are connected to the stent 14 and the graft 18 to form the repair device 10 and are configured to connect the repair device 10 to the repair site, as described below.

[0024] The repair device 10 is configured to heal or repair tissue. More specifically, the repair device 10 allows the subject's body to form a network of capillaries, arteries and veins at the torn or ruptured tissue. The well-vascularized connective tissue heals due to the migration of fibroblasts into the repair device 10. The method and system of the present disclosure establish links between damaged tissues by surrounding or connecting to the torn tissue, promoting the repair process of the ruptured or torn tissue while maintaining its integrity and structure. The scaffold can be used as an insoluble or biodegradable regulator of cell function, or as a delivery carrier for a support structure for cell migration or synthesis, and a network or structure can be provided to promote cell growth and vascularization. The graft can provide additional mechanical stability during the healing stage.

[0025] The present disclosure provides a repair device 10, which includes a three-dimensional (3-D) scaffold 14 and a graft 18 for repairing ruptured or torn tissue. The scaffold 14 and the graft 18 are combined to provide a connection between the ruptured or torn parts of the tissue and the fiber after the injury, or to form around the torn tissue, and promote the migration of appropriate healing cells to form scars and new tissues. The scaffold 14 is a bioengineered substitute for clots and is implanted with a graft 18. Therefore, the repair device 10 is implanted between the ruptured or torn parts of the tissue, or is wound around the tissue, or is placed adjacent to the ruptured or torn tissue. In other embodiments, the repair device 10 can form a connection between bones, or is formed around the torn tissue, so that the integrity and structure of the tissue are maintained. Therefore, the repair device 10 is designed to stimulate cell proliferation and extracellular matrix production in the gap between the ruptured ends of the tissue or in the tear in the tissue, thereby promoting healing and regeneration.

[0026] As used herein, injury is torn tissue, including torn or ruptured ligaments, tendons or cartilage. Torn tissue can be manifested as partial tearing or complete tearing. When a portion of tissue is damaged but still remains connected, a partial tear occurs. The degree and shape of the tear can vary. On the other hand, ruptured tissue (also referred to as complete tearing) involves the complete cutting of tissue, resulting in two different ends. These ends can have similar or different lengths. In some cases, a tissue stump can be formed at one end. For example, in a complete tear of the anterior cruciate ligament ("ACL"), the ligament stump includes a tibial stump connected to the tibia and a femoral stump connected to the femur.

[0027] refer to Figure 2 , the stent 14 is a compressible and biocompatible implant that is configured to absorb fluids, such as blood and / or blood components. The stent can be a compressible and expandable, biodegradable porous material that has a certain resistance to degradation by fluids (e.g., synovial fluid) in the tissue repair site. In the illustrated embodiment, the stent 14 is a collagen implant that includes a self-assembly of interconnected collagen fibers that does not contain any cross-linking agent. The collagen itself can include a collagen-glycosaminoglycan ("GAG") copolymer composed of soluble type I collagen. In one example, the stent 14 has a collagen content greater than 400 mg / g, a GAG content greater than 100 μg / g, a DNA content less than 50,000 ng / g, a phospholipid count less than 3,000 μM / g, and a pepsin content less than 12.5 mg / g. Although the stent 14 can be type I collagen, the stent can include other collagen types. Preferably, the collagen is soluble, such as acidic or alkaline. For example, in another embodiment, the collagen can be type II, III, IV, V, IX, or X.

[0028] The stent may have a size and shape that complements the specific anatomical tissue present, as further explained below. In one example, the stent 14 may be a generally elongated structure having a first end 15, a second end 16 opposite the first end 15, and a sidewall 17 extending from the first end 15 to the second end 16. In this way, the stent 14 is a cylindrical shape having a length L1 that extends from the first end 15 to the second end 16 along the central axis A. The length L1 may be in the range between 15 mm and 35 mm. In one example, the length L1 is at least 25 mm. The stent 14 may have a cross-sectional dimension D1 perpendicular to the length L1 that ranges between 10 mm and 30 mm. In one example, the cross-sectional dimension is between 20 mm and 25 mm. In another example, the cross-sectional dimension D1 is about 22 mm. Therefore, in a generally elongated stent, the length L1 is greater than the cross-sectional dimension D1. The cylindrical stent is suitable for ACL surgery, as described below. However, the size and shape of the stent 14 may vary according to the needs of other anatomical structures and tissue sites.

[0029] The scaffold 14 is hydrophilic and is capable of absorbing plasma, blood, other body fluids, liquids, hydrogels, or other materials that the scaffold comes into contact with or that are added to the scaffold. The scaffold 14 may hereinafter be referred to as a collagen scaffold, sponge, or collagen sponge.

[0030] In the illustrated embodiment, the support 14 is treated with a repair material before being inserted into the repair site. As shown, the repair material is blood. Specifically, the support 14 is treated with 5-10 mL of autologous blood. The repair device 10 can be soaked in the repair material, or the repair material can be injected into the repair device 10 before or during implantation into the repair site. In other examples, the repair material can be an autologous or allogeneic blood composition, plasma or other fluid present in the repair site, added to the support 14 or added to the repair site.

[0031] Although cylindrical is shown as being suitable for some tissue repairs, support 14 can be any shape that can be used for implantation into tissue and repairing tissue. Support 14 can be, for example, tubular, semi-tubular, flat planar sheet or rolled into a tube to define a flat sheet of a hollow cavity. Other shapes that are suitable for device supports known to those of ordinary skill in the art are also considered in the present invention.

[0032] In addition, in alternative embodiments, the scaffold may include additional components that assist healing, cell ingrowth, and angiogenesis. For therapeutic purposes, such additional components may include proteins, including but not limited to hormones, cytokines, growth factors, coagulation factors, antiprotease proteins (e.g., α1-antitrypsin), angiogenic proteins (e.g., vascular endothelial growth factor, fibroblast growth factor), anti-angiogenic proteins (e.g., endostatin, angiostatin) and other proteins present in blood, bone morphogenetic proteins (BMP), bone formation induction factor (IFO), fibronectin (FN), endothelial cell growth factor (ECGF), cecal attachment extract (CAE), katanlin, 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). A lyophilized material is a material that is capable of swelling when a liquid, gel or other fluid is added to or comes in contact with it.

[0033] The stent 14 can be compressed before or during implantation in the repair site. The compressed stent allows the stent to expand within the repair site. The stent 14 can be lyophilized and / or compressed when placed in the repair site, and expand once in place. The expansion of the stent 14 can occur after contact with blood or other fluids in the repair site or addition to the repair site.

[0034] In another embodiment, the stent 14 can be saturated or coated with a gel or hydrogel repair material before implantation into the repair site. Coating or saturation of the stent 14 can facilitate implantation into relatively undefined defect areas, as well as help fill particularly large defect areas. In a preferred embodiment, the stent 14 is treated with a hydrogel. Examples of stents and repair materials that can be used according to the present disclosure can be found in U.S. Patent No. 6,964,685 and U.S. Patent Application Nos. 2004 / 0059416 and 2005 / 0261736, the entire contents of which are incorporated herein by reference.

[0035] The biological characteristics of cell infiltration rate and scaffold degradation can also be changed by changing the pore size, degree of cross-linking and use of additional proteins (e.g., glycosaminoglycans, growth factors and cytokines) in the scaffold 14. In addition, collagen-based biomaterials can be made from the patient's own skin, thereby minimizing the antigenicity of the implant. However, the preferred collagen scaffold does not include any cross-linking agent.

[0036] refer to Figure 3, the graft 18 is used to provide some mechanical stability and can be used as a support for the stent. In the illustrated embodiment, the graft 18 is a flat sheet structure that is configured to partially or completely wrap around the stent 14. The graft 18 has a first surface 19, a second surface 22 opposite to 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. When in a flat state, the length L2, the width D2 and the thickness T are perpendicular to each other. The length L2 can be in the range between 15mm and 35mm. In one example, the length L2 is about 25mm. The width D2 can be between 0.05mm and 35mm. In one example, the width D2 is about 35mm. The thickness T can vary between 0.01mm and 0.05mm. In one example, the thickness T is about 0.01mm. The length L2 can be less than the length L1, which allows the ends 15, 16 of the stent to be exposed and can help promote attachment to bone or other tissues as needed. As shown, the graft length L is greater than the graft width W. In alternative embodiments, the dimensions of the graft 18 may be defined during manufacture to any particular size. The graft 18 may be folded or rolled to achieve a desired length and width.

[0037] Several types of grafts can be used for tissue reconstruction and repair. In the illustrated embodiment, graft 18 can be an autologous graft or self-graft collected from a patient, such as a patella-tendon-bone graft or a hamstring graft. Alternatively, graft 18 may include one or more xenografts, allografts, homografts or synthetic polymer grafts, alone or in any combination. In one embodiment, graft 18 is an allograft. Allografts include ligament tissue collected from a corpse, and are properly treated and disinfected, preferably sterilized. In another embodiment, graft 18 is a xenograft. Xenografts include connective tissue collected from animal sources such as porcine tissue. Typically, xenografts must be properly treated to eliminate or minimize immune responses. In yet another embodiment, graft 18 is a synthetic graft. Synthetic grafts include grafts made of synthetic polymers and / or polymer filaments, such as polyurethane, polyethylene, polyester and other conventional biocompatible bioabsorbable or non-absorbable polymers and composite materials, such as stents described herein. Materials used for synthetic grafts may include, but are not limited to, or Carbon fiber grafts, ABC grafts, Trevia, Leeds-Keio, and or

[0038] exist Figure 4 and Figure 5 An example of a combination of a stent 14 and a graft 18 for forming a repair device 10 is depicted in FIG. Figure 4 In one illustrated embodiment, the graft 18 is attached to the stent 14 such that the graft 18 is coupled to only a portion of the stent 14. Thus, in the illustrated embodiment, the graft 18 may be positioned along or adjacent to the stent 14. The stent 14 may be attached to the graft 18 via one or more sutures 24. In alternative embodiments, the stent 14 may be attached to the graft via other mechanisms known in the art.

[0039] refer to Figure 5 In another illustrated embodiment, the graft 18 is wrapped around the stent 14 so that the graft 18 surrounds the stent 14. In alternative embodiments, the graft 18 may be wrapped around a portion of the stent 14 or a majority of the stent 14. In the illustrated embodiment, the graft 18 may be wrapped around the stent 14 via sutures 24 to maintain the repair device 10 in place within the patient's body. In alternative embodiments, the graft 18 may be wrapped around the stent 14 via other mechanisms known in the art.

[0040] In one example, the brace 14 can be attached between the femoral insertion point and the tibial insertion point and can be integrated with the graft 18. In another example, the graft 18 can be inserted or pushed through the brace 14.

[0041] For example, in another embodiment, the stent 14 and the graft 18 may be attached to one or more sutures 24 and one or more fixation devices 20. Figure 1 B and Figure 1 C, the one or more fixation devices 20 can be attached to the one or more sutures 24 through the eyelets 10 of the one or more fixation devices 20. In this configuration, the one or more fixation devices 20 are attached to a bone. The bone can be a femur 4 or a tibia 6.

[0042] In one embodiment, both the support 14 and the graft 18 are pretreated with a repair material. The support 14 and the graft 18 can be soaked in the repair material before or during implantation in the repair site. The repair material includes, but is not limited to, gels, such as hydrogels or liquids, or any material that can form an aqueous material, a suspension, or a solution that can be injected into the support and can contribute to tissue repair or growth. In one example, the repair material is blood. In an alternative embodiment, the repair material can include a composition that includes plasma, platelets, growth factors, antibiotics, thrombin, stem cells, genetically altered fibroblasts, platelets, plasma, extracellular proteins, and / or cell culture medium supplements. Additional repair materials can be added to affect cell proliferation, extracellular matrix production, consistency, inhibition of disease or infection, tension, until the cell nutrients and pH of the repair material that form a nutrient pathway. All or part of these additional materials can be mixed with the repair material before or during implantation, or alternatively, additional materials can be implanted near the defective area after the repair material is in place.

[0043] In certain embodiments, platelets can be obtained as platelet-rich plasma (PRP). In a non-limiting example, platelets can be separated from subject blood using techniques known to those of ordinary skill in the art. For example, a blood sample can be centrifuged at 700 rpm for 20 minutes, and the platelet-rich plasma upper layer is removed.

[0044] Reference Figure 4 and Figure 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 connect the stent 14 to the repair site via one or more sutures 24. The second fixture 20B is configured to indirectly connect the graft 18 to the repair site via one or more sutures 24. The first fixture 20A and the second fixture 20B can be similar to each other, so only one is described below. Each fixture 20 is a device that can be inserted into the repair site and helps to form a stable attachment of the repair device to the surrounding tissue. In some cases, if necessary, the one or more fixtures 20 can be removed from the repair site.

[0045] The fixture 20 is also configured to be connected to one or more sutures 24. In one example, the fixture can be an elongated plate having a plurality of holes or openings extending through the plate. The length of the plate is greater than its width and thickness. The profile allows the fixture 20 to be inserted through the cannula and bone channel as needed. The opening is suitable for allowing the one or more sutures 24 to pass through the one or more fixtures 20 and be fastened to a position in the repair site. The one or more openings 21 can be oval or circular and can have any size suitable for allowing the one or more sutures 24 to pass through and remain in the one or more openings 21. A known example of such a fixture is the Endobutton.

[0046] The fixing device may have other configurations. The fixing device 20 may include, but is not limited to, a screw, a barb, an anchor, a spiral anchor, a staple, a clip, a snap, a rivet, or a crimp-type anchor. The length of the body of one or more fixing devices 20 may vary. Examples of fixing devices include, but are not limited to: IN-FAST TM Bone Screw System (Influence, Inc., San Francisco, CA), IN-TAC TM Bone Anchor System (Influence, Inc., San Francisco, CA), Model 3000AXYALOOP TM Titanium bone anchor (Axya Medical Inc., Beverly, MA), OPUS Anchor with insert (Opus Medical, Inc., San Juan Capistrano, CA), ANCHRON TM ,HEXALON TM ,TRINION TM (both available from Inion Inc., Oklahoma City, OK) and TwinFix AB absorbable suture anchors (Smith & Nephew, Inc., Andover, MA).

[0047] In the illustrated embodiment, the first fixation device 20A is coupled to the first bone at the repair site and the bracket 14 is indirectly attached to the first bone via one or more sutures 24 attached to the repair device 10. The first fixation device 20A helps position and secure the repair device 10 to the first bone at the repair site. The first fixation device 20A can be inserted and anchored to the first bone.

[0048] The second fixture 20B is coupled to the second bone at the repair site and indirectly attaches the graft 18 to the first bone via one or more sutures 24 attached to the repair device 10. The second fixture 20B helps position and secure the repair device 10 at the repair site. The second fixture 20B can be inserted and anchored to the second bone.

[0049] In one embodiment, the system utilizes only one fixation device 20 that is attached to the stent 14 and graft 18 and further connected to the repair site. In an alternative embodiment, the system utilizes more than one fixation device 20, and the fixation device 20 can be directly attached to the repair device 10 via one or more sutures 24. In this configuration, one or more fixation devices 20 are swaged directly onto the stent 14 and / or graft 18.

[0050] The one or more fixation devices 20 may be made of a non-degradable material, such as metal, stainless steel, CoCrMo alloy or Nitinol alloy, or a polymer material. The one or more fixation devices 20 are preferably bioabsorbable, such that the subject is able to break down the one or more fixation devices 20 and absorb it.

[0051] Continue to refer Figure 4 and Figure 5 In the illustrated embodiment, one or more fixation devices 20 are attached to the repair device 10 via one or more sutures 24. The one or more sutures 24 are passed through the eyelets 21 of the one or more fixation devices 20 and retained within the one or more openings 21, such that the one or more fixation devices 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 exposed from 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 stent 14. However, in other embodiments, only one suture is required to position the graft 18 along or adjacent to the stent 14.

[0052] In the illustrated embodiment, the one or more sutures 24 are bioabsorbable, such that the subject is able to break down the one or more sutures 24 and absorb it. The one or more sutures 24 are also synthetic, such that the sutures may not come from a natural source. In other embodiments, the one or more sutures 24 may be permanent, such that the subject cannot break down the sutures and the one or more sutures 24 remain in the subject. The one or more sutures 24 may be rigid or hard, or may be stretchable or flexible. Examples of sutures include, but are not limited to, VICRYL TM polyglactin910、PANACRYL TMAbsorbable sutures, EXCEL polyester suture thread, Polydioxanone sutures and Polypropylene Suture. Sutures are commercially available from manufacturers such as MITEK PRODUCTS, a division of ETHICON, INC, of ​​Westwood, Mass.

[0053] refer to Figure 6 , the arthroscopic device 30 is configured to insert one or more sutures 24 through the stent 14 and the graft 18. The arthroscopic device 30 is configured to accommodate the stent 14, the graft 18, and the one or more sutures 24. During implantation, the arthroscopic device 30 introduces the stent 14, the graft 18, and the one or more sutures 24 into the tissue defect. In the illustrated embodiment, the arthroscopic device 30 introduces the repair device by pushing or releasing the repair device from a container into the repair site.

[0054] Arthroscopic device 30 is also configured to position stent 14 and graft 18 in a repair site. Arthroscopic device 30 includes an elongated delivery member 31. Elongated delivery member 31 includes a channel extending from a proximal end to a distal end of elongated delivery member 31. Elongated delivery member 31 is sized and shaped to accommodate stent 14 and graft 18 attached to one or more sutures 24 in the channel. At least a portion of elongated delivery member 31 is further sized and shaped to be inserted into a repair site.

[0055] In the illustrated embodiment, the arthroscopic device 30 is a syringe. The syringe can hold one or more sutures 24 and the stent 14 and the graft 18 in the proper position within the elongated delivery member 31 of the syringe. The syringe can include a plunger 32, which is configured to push the one or more sutures 24, the stent 14 and the graft 18 into the repair site so that the stent 14 and the graft 18 are positioned along the one or more sutures 24 and at least one rupture end of the adjacent tissue. In an alternative embodiment, the arthroscopic device 30 may include a sleeve, a container and a pressure pump. In another embodiment, the arthroscopic device 30 may also include a guide suture extending out of the distal end of the elongated delivery member, wherein the guide suture is configured to pull and position the one or more sutures 24 and the stent 14 into the repair site. In yet another embodiment, the system can be inserted into the repair site without using an arthroscopic device, and is instead inserted into the repair site by open surgery.

[0056] refer to Figures 7 to 10, aspects of the present invention relate to methods of repairing a ruptured or torn ligament, such as the ACL, at a repair site 140. In some embodiments, a stent 114, a graft 118, and one or more sutures 124 are inserted into a repair site 140 of a ruptured or torn ligament 102 via an arthroscopic device 130.

[0057] Repair site 140 is the area around ruptured or torn ligament 102 into which devices may be inserted. Stent 114 and graft 118 may be inserted into repair site 140 during a surgical procedure via arthroscopic apparatus 130. Stent 114 is expandable and may fill repair site 140 with graft 118 or partially fill repair site 140 with graft 118. Stent 114 may partially fill repair site 140 upon insertion and expansion to fill repair site 140 in the presence of blood, plasma, or other fluid in or added to repair site 140.

[0058] In the illustrated embodiment, the scaffold 114 and the graft 118 are coupled to form a repair device 110, and the repair device 110 is attached directly or indirectly to the bone and contacts the ruptured or torn ligament 102. In another embodiment, the repair device 110 can be formed around the ruptured or torn 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 retained within the repair device 110. In yet another embodiment, the repair device 110 can be a "Chinese finger trap" design, where one end is placed on the stump of the ruptured ligament and the second end is placed on the other end of the ruptured ligament.

[0059] In an alternative embodiment, the graft 118 is coupled to one or more sutures 124 and one or more fixation devices 120 to form a graft construct having a desired size. The graft 118 is advanced into a first bone and coupled to the one or more fixation devices 120 on the first bone. The graft 118 is also coupled to a second bone via the one or more fixation devices 120 and tensioned in extension. The graft 118 is then coupled to the stent 114.

[0060] Figure 7 An example of a ruptured anterior cruciate ligament is depicted in FIG. The anterior cruciate ligament (ACL) 102 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 on the knee joint. It restrains the lower leg bone, tibia 106 from excessive forward movement relative to the thigh bone, femur 104, and limits rotational movement of the knee.

[0061] like Figures 7 to 10As shown, the anterior cruciate ligament 102 is ruptured such that it no longer forms a connection between the femur 104 and the tibia 106. The formed ends of the ruptured ACL 102 can have any length. The ends can have similar lengths, or one end can be longer in length than the other end. The end on the femur 104 includes a femoral ACL stump 107. The end on the tibia 106 includes a tibial stump 109. In some cases, it is believed that repair is desired when the tibial stump length SL is less than about 75% of the effective ligament length LL but greater than 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 linear axis from the femoral footprint to the tibial footprint.

[0062] The knee joint includes a tibial spine on the tibia 106 and an intercondylar notch of the femur 104. In some cases, the methods described herein may include performing a notchplasty of the intercondylar notch of the femur to provide space for the formation of a larger ligament after surgical repair using a scaffold. This notchplasty improves the size of the healing ligament, particularly resulting in a larger cross-sectional area of ​​the ligament. Since the mechanical strength of the ligament and subsequently its ability to maintain the distance between the femur and tibia is directly related to its cross-sectional area, enlarging the notch using notchplasty can help to make a stronger repaired ACL, and the inventors have found that it is beneficial in ACL repair using a scaffold as described in the present disclosure.

[0063] Aspects of the present invention provide methods for repairing a ruptured ligament 102, involving drilling one or more holes 144 at or near a repair site 140 of the ruptured ligament 102. The bone at or near the repair site is a bone close to the repair site and can be utilized using the methods and devices of the present invention. For example, the bone at or near the repair site of the torn anterior cruciate ligament is the femur 104 bone and / or the tibia 106 bone. The hole 144 can be drilled in the bone using a device such as a Kirschner wire (e.g., a small Kirschner wire) and a drill bit or a microfracture post or a sharp drill (pics or awls). One or more holes can be drilled in the bone surrounding the repair site 140 to promote bleeding into the repair site 140. Repair can be supplemented by drilling holes in the surrounding bones to cause bleeding. Allowing bleeding to enter the repair site can promote the formation of blood clots and enhance the healing process of the injury.

[0064] exist Figure 7In the present invention, holes 144A, 144B are drilled in the femur 104 and tibia 106 at the repair site 140, respectively. Hole 144A may be further referred to as femoral tunnel 144A below, and hole 144B may be further referred to as tibial tunnel 144BA below, and a first suture 124A is placed through the tibial stump 109 using an oblique suture. The first suture 124A is attached to the first fixture 120A via a first end 126A. The second suture 124B and the third suture 124C are coupled to the fixture 120A at respective first ends 126B, 126C. The fixture 120A is then passed through the femoral tunnel 144A and coupled to the femur 104. In the present invention, holes 144A, 144B are drilled in the femur 104 and tibia 106, respectively. Hole 144A may be further referred to as femoral tunnel 144A below, and hole 144B may be further referred to as tibial tunnel 144BA below, and a first suture 124A is placed through the tibial stump 109 using an oblique suture. The first suture 124A is attached to the first fixture 120A via a first end 126A. The second suture 124B and the third suture 124C are coupled to the fixture 120A at respective first ends 126B, 126C. The fixture 120A is then passed through the femoral tunnel 144A and coupled to the femur 104. Figure 8 In the embodiment, the repair device 110 is loaded onto the second suture 124B and the third suture 124C. The repair material as described above is then injected into the repair device 110. The repair device 110 and the second and third sutures 124 can be inserted into the repair site 140 via the arthroscopic device 130. Fig. 9 In the embodiment, the free ends 128B, 128C of the second suture 124B and the third suture 124C are passed through the tibial tunnel 144B and coupled to the second fixation device 120B coupled to the tibia 106. The repair device 110 is then positioned between the two ends of the torn ACL 2. Fig.10 In the embodiment of the present invention, the knee is extended and the sutures 124A, 124B, 124C and fixation devices 120A, 120B are secured.

[0065] In another embodiment, the repair device 110 can be indirectly coupled to the first fixture 120A and the second fixture 120B and maintained in place in the repair site 140 by the additional suture 124. In addition, in another embodiment, any of the first suture 124A, the second suture 124B, or the additional suture 124n can be attached to one or both ends of the ruptured ligament 102 by its first end 126A, 126B, 126n and / or its second end 128A, 128B, 128n. In addition, in another embodiment, the additional fixture 120 and suture 124 can be directly or indirectly attached to the tibia 6 or the femur 104 to fix the bracket 114 and the graft 118 in place. In an alternative embodiment, the bracket 114 and the graft 118 can be directly or indirectly attached to the femur 104. For example, the graft 118 can be attached to the bracket 114 via sutures or via another mechanism. In another embodiment, the graft 118 can be positioned along or adjacent to the stent 113. In one example, the stent 114 can be attached between the femoral insertion point and the tibial insertion point and can be integrated with the graft 118. In another example, the graft 118 can be inserted or pushed through the stent 114.

[0066] refer to Fig.11 and Fig.12 , aspects of the present invention are directed to methods of repairing a ruptured or torn tendon 202 at a repair site 240, and involve a repair device 210 including a scaffold 214 and a graft 218, one or more fixation devices 220, and one or more sutures 224. In some embodiments, the scaffold 214, the graft 218, and the one or more sutures 224 are inserted into the repair site 240 of the ruptured or torn tendon 202 via an arthroscopic device 130 (not shown).

[0067] Repair site 240 is the area around the ruptured or torn tendon 202 into which the device may be inserted. Repair device 210 may be inserted into repair site 240 via arthroscopic instrument 130 during a surgical procedure using techniques known to one of ordinary skill in the art. Stent 214 is expandable and may fill repair site 240 with graft 218 or partially fill repair site 240 with graft 218. Stent 214 may partially fill repair site 240 upon insertion and expansion to fill repair site 240 in the presence of blood, plasma, or other fluid within or added to repair site 240.

[0068] Fig.12 An example of a ruptured calcaneal ("Achilles") tendon is depicted in FIG. The Achilles tendon 202 is an important structure that connects the calf muscle 204 to the calcaneus 206. The Achilles tendon helps transfer force from the calf muscle 204 to the foot, enabling movements such as walking, running, and jumping. It acts as a stabilizer for the ankle joint, preventing excessive motion and providing support during various activities. Additionally, the Achilles tendon limits rotational motion of the foot and ankle, contributing to overall joint stability and minimizing stress on surrounding structures.

[0069] like Fig.11 and Fig.12 As shown, the Achilles tendon 202 is ruptured so that it no longer forms a connection between the calf muscle 204 and the calcaneus 206. The ends formed by the ruptured tendon 202 can have any length. These ends can have similar lengths, or one end can be longer than the other. The end on the calf muscle 204 includes the calf stump 207. The end on the calcaneus 206 includes the calcaneus stump 209. The total length of the tendon is considered to be the length of the ligament along the linear axis from the calf impression to the calcaneus impression.

[0070] Prior to inserting the repair device 210, the affected end is prepared and covered in a standard aseptic manner. A tourniquet may be used if indicated. The ruptured tendon 202 is identified and defined, and the tissue ends are mechanically or chemically pretreated. One or more sutures 224 are attached to the one or more fixation devices 220.

[0071] Prior to entering the repair site 240, the arthroscopic instrument 130 attaches one or more sutures 24 to the repair device 210. The repair device 210 is treated with the repair material. In one embodiment, the repair device 10 may also be pre-treated in an antibiotic solution prior to implantation.

[0072] In the illustrated embodiment, one or more sutures 224 are then connected to the ruptured end of the tendon 202 at a first end 226. In one embodiment, the one or more sutures 224 are placed through the ruptured end of the ligament 202 using an oblique suture. One or more fixation devices 220 are passed through the calcaneus 206, carrying the one or more sutures 224. The one or more fixation devices 220 and the one or more sutures 224 are attached to the bone 206.

[0073] Arthroscopic device 130 (not shown) positions repair device 210 between the ruptured ends of ligament 202 along one or more sutures 224. In alternative embodiments, arthroscopic device 130 positions repair device 210 directly or indirectly to calf muscle 204 and / or calcaneus 206. The present disclosure can be used by insertion through an open incision. The repair device is compressible to allow introduction through an arthroscopic portal, incision, and device.

[0074] The repair device 210 is then bonded to the surrounding tissue using the methods described herein. This can be accomplished by adding chemical or physical agents such as ultraviolet light, laser, or heat. The repair device 210 can be reinforced by placing additional sutures or clips. The arthroscopic access port is closed and a sterile dressing is placed. Postoperative rehabilitation depends on the type and size of the lesion being treated and the tissue involved.

[0075] refer to Figures 13 to 15 , aspects of the present invention are directed to methods of repairing ruptured or torn cartilage 302 at a repair site 340, the methods involving a repair device 310, the repair device 310 comprising a scaffold 314 and a graft 318, one or more fixation devices 320, and one or more sutures 324. In some embodiments, the scaffold 314, the graft 318, and the one or more sutures 324 are inserted into the repair site 1340 of the ruptured or torn cartilage 302 via an arthroscopic device 230 (not shown).

[0076] Repair site 340 is the area surrounding the ruptured or torn cartilage 302 into which the device may be inserted. Repair device 310 may be inserted into repair site 340 via arthroscopic instrument 230 during a surgical procedure using techniques known to one of ordinary skill in the art. Stent 314 is expandable and may fill repair site 340 with graft 318, or partially fill repair site 340 with graft 318. Stent 314 may partially fill repair site 340 upon insertion and expansion to fill repair site 340 in the presence of blood, plasma, or other fluid within or added to repair site 340.

[0077] exist Figure 14 to Figure 15 An example of broken cartilage in the elbow is depicted in FIG. Elbow cartilage 302 is a key component within the joint that connects the humerus 304 to the radius 306 and ulna 305. Its primary function is to provide stability and reduce stress on the elbow joint. The elbow cartilage effectively limits excessive forward or backward movement of the forearm bones relative to the humerus 304, thereby maintaining joint alignment.

[0078] like Fig.12 and Fig.13 As shown, the elbow cartilage 302 is ruptured such that it forms a separation of the cartilage in the zonules of the humerus 304. Prior to inserting the repair device 310, the affected end is prepared and covered in a standard aseptic manner. A tourniquet may be used if indicated. The ruptured cartilage 302 is identified and defined, and the tissue ends are mechanically or chemically pretreated. One or more sutures 324 are connected to the one or more fixation devices 320.

[0079] Prior to entering the repair site 340, the arthroscopic instrument 230 attaches one or more sutures 324 to the repair device 310. The repair device 310 is treated with the repair material. In one embodiment, the repair device 310 may also be pre-treated in an antibiotic solution prior to implantation.

[0080] In the illustrated embodiment, one or more sutures 324 are then connected to the radius via a first fixture 320A at a first end 326. The first fixture 320A passes through the radius 306, carrying the one or more sutures 324. The first fixture 320A and the one or more sutures 324 are attached to the radius 306. In one embodiment, the one or more sutures 324 may also be connected to the humerus 304 at a second end 328 via a second fixture 320B.

[0081] Arthroscopic device 230 (not shown) positions repair device 310 along one or more sutures 324 through the ruptured portion of cartilage 302. In alternative embodiments, arthroscopic device 230 positions repair device 310 directly or indirectly to humerus 304 and / or radius 306. The present disclosure can be used by inserting through an open incision. The repair device can be compressed to allow introduction through an arthroscopic portal, incision, and device.

[0082] The repair device 310 is then bonded to the surrounding tissue using the methods described herein. This can be accomplished by adding chemical or physical agents such as ultraviolet light, laser, or heat. The repair device 310 can be reinforced by placing additional sutures or clips. The arthroscopic access port is closed and a sterile dressing is placed. Postoperative rehabilitation depends on the type and size of the lesion being treated and the tissue involved.

[0083] In the present disclosure, patients include, but are not limited to, any mammal, such as humans, non-human primates, mice, rats, dogs, cats, horses, or cattle. In certain embodiments, the patient is a human. The present disclosure may also include a kit for repairing a ruptured or torn ligament. The kit may include a stent of the present invention having at least one fixture attached to the stent and instructions for use. The stent may also include one or more sutures for attaching the fixture to the stent. The kit may also include a container for containing a repair material as described herein.

[0084] The foregoing written description is considered sufficient to enable those skilled in the art to practice the present invention. The scope of the present invention is not limited to the embodiments provided, as the embodiments are intended to be a single illustration of one aspect of the present invention, and other functionally equivalent embodiments are within the scope of the present invention. Various modifications of the present invention, except those shown and described herein, will become apparent to those skilled in the art from the foregoing description and fall within the scope of the appended claims. The advantages and purposes of the present invention are not necessarily covered by each embodiment of the present invention. Those skilled in the art will recognize or be able to determine many equivalents to the specific embodiments of the present invention described herein using no more than routine experiments. Such equivalents are intended to be covered by the appended claims.

Claims

1. A tissue repair system, comprising: A repair device, comprising: An implant sized and shaped for placement in a repair site of torn tissue, the implant being compressible and expandable and configured to absorb repair material, and a graft configured to be coupled to the implant; at least one implant suture configured to position the implant along or adjacent to the ruptured end of the torn tissue; a first fixation device configured to couple the at least one implant suture to a first bone; at least one graft suture configured to position the graft along or adjacent to the ruptured end of the implant or torn ligament; and A second fixation device is configured to couple the 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.

3. The tissue repair system according to claim 2, wherein: The ligament is the ACL.

4. The tissue repair system according to claim 1, wherein: The torn tissue is a tendon.

5. The tissue repair system according to claim 1, wherein: The torn tissue is cartilage.

6. The tissue repair system according to claim 1, wherein: The implant is a collagen scaffold configured to allow for cellular ingrowth.

7. The tissue repair system according to claim 1, wherein: The graft is configured to be placed adjacent to the implant along a length of the implant.

8. The tissue repair system according to claim 1, wherein: The graft is configured to be wrapped around the stent.

9. The tissue repair system according to claim 1, wherein: The first fixation device is configured for placement against the first bone.

10. The tissue repair system according to claim 1, wherein: The second fixation device is configured for placement against a second bone.

11. The tissue repair system according to claim 1, wherein: The graft is selected from the group consisting of an autologous tendon graft, an allograft, and a synthetic tendon graft.

12. The tissue repair system according to claim 1, wherein: The repair device and at least one first suture are preloaded and insertable through an arthroscopic cannula.

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

14. The tissue repair system according to claim 1, wherein: The repair device also includes a repair material.

15. The tissue repair system according to claim 14, wherein: The repair material is platelets or plasma.

16. A method for repairing ruptured tissue, comprising: inserting a repair device including a stent and a graft proximate the ruptured end of the torn tissue of the patient; as well as The bracket is secured to the suture and the first bone with a first securing device.

17. The method of claim 16, further comprising coupling the prosthetic device to a second bone with a second fixation device.

18. The method of claim 17, further comprising positioning the repair device between the ruptured end of the ligament and a femur, and attaching the first fixation device to the femur and the second fixation device to the tibia.

19. The method of claim 17, further comprising positioning the repair device between disrupted portions of cartilage.

20. The method of claim 16, further comprising positioning the repair device between the ruptured end of the tendon and the calcaneus bone, and attaching the first fixation device to the calcaneus bone.

21. The method of claim 16, further comprising attaching the first fixation device only indirectly to the prosthetic device.

22. The method according to claim 16, wherein: The scaffold comprises a porous collagen sponge.

23. The method of claim 16, further comprising treating the scaffold with a repair material.

24. The method of claim 16, further comprising: harvesting a portion of a hamstring from the patient; as well as The graft is formed from the portion of the hamstring.

25. The method of claim 16, further comprising: harvesting a portion of a hamstring from another patient, and The graft is formed from the portion of the hamstring.

26. The method of claim 16, further comprising: Bundles of synthetic polymer having a longitudinal dimension are assembled into the implant.

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