Abstract: Tissue grafts with reduced regenerative potential, methods of preparing such grafts, and related kits and methods of treatment are described. The method may include treating tissue with a digestion solution comprising trypsin, alpha-chymotrypsin (ACT) and optionally ethylenediaminetetraacetic acid (EDTA) to substantially remove one or more susceptible proteins from the tissue. The method may also include washing the treated tissue with a buffer solution and/or with a serine-containing serum. Nerve grafts prepared according to the disclosed methods may inhibit, or lessen (e.g., provide for reduced) neuroma formation and/or axonal outgrowth after implantation.

Abstract: Techniques and systems are disclosed for a bioassay that is an in vitro mimic of peripheral nerve generation using the sensory neurons that innervate the peripheral nervous system. In some embodiments, the techniques may assist in detecting the bioactivity or potency of nerve grafts (e.g., processed, acellular human allografts) for fostering or supporting peripheral nerve regeneration. In various embodiments, techniques comprise affixing a harvested sensory neuron (e.g., a DRG) to a nerve graft segment to form a test construct; culturing the test construct in a medium; analyzing the test construct to indicate the amount of outgrowing peripheral nerve structure; and determining the potency of the nerve graft from a metric derived from the analysis. In some embodiments, techniques and materials may be used to test the effect of a varied test condition on peripheral nerve growth.

Abstract: Tissue-processing containers are disclosed for facilitating multistep processing of tissue. Also disclosed are systems incorporating the tissue-processing containers that include shakers, incubators, controllers, and pumps. Multistep methods are disclosed for processing tissues using the tissue-processing containers. The tissue-processing containers are specially designed to achieve efficiencies in automated tissue processing, exposure of tissues to processing media, and multistep tissue processing protocols. The described tissue-processing containers comprise a cup-like cavity comprising a middle hole covered by a mesh screen, troughs for separate processing steps, and are stackable in a substantially airtight and substantially watertight manner. Tissues for processing using the described tissue-processing containers include nerve tissue.

Abstract: A capture-tool for manipulation of tissue utilizes vacuum to hold the tissue in place. An extension attached to a vacuum source at one end and a vacuum arm at another end creates a vacuum force through the extension and vacuum arm. The vacuum arm has a support surface with ports therein at which low pressure areas are formed by the vacuum force. The low pressure areas draw tissue against the supporting surface to hold it in place, as long as the vacuum force is active.

Abstract: A tissue connector may include a body formed of one or more layers of material, and at least one barbed suture attached to the body, wherein the barbed suture is formed of a biodegradable material. A method of forming a tissue connector may include forming a body from one or more layers of a material, and attaching at least one barbed suture to the body, wherein the barbed suture is formed of a biodegradable material. A method of repairing tissue using a tissue connector may include orienting the tissue connector around coapted or damaged tissue, so that the coapted or damaged tissue contacts the inner surface of the tissue connector, twisting ends of the at least one barbed suture so that the at least one barbed suture engages the coapted or damaged tissue, and allowing the tissue connector to remain in place, so that the barbed suture degrades over time.

Abstract: Techniques and systems are disclosed for a bioassay that is an in vitro mimic of peripheral nerve generation using the sensory neurons that innervate the peripheral nervous system. In some embodiments, the techniques may assist in detecting the bioactivity or potency of nerve grafts (e.g., processed, acellular human allografts) for fostering or supporting peripheral nerve regeneration. In various embodiments, techniques comprise affixing a harvested sensory neuron (e.g., a DRG) to a nerve graft segment to form a test construct; culturing the test construct in a medium; analyzing the test construct to indicate the amount of outgrowing peripheral nerve structure; and determining the potency of the nerve graft from a metric derived from the analysis. In some embodiments, techniques and materials may be used to test the effect of a varied test condition on peripheral nerve growth.

Abstract: A multi-layer amnion product may include a plurality of layers oriented on top of one another, wherein the plurality of layers includes at least one chorion membrane layer and at least two amnion layers. The plurality of layers may include at least four layers and less than ten layers. At least two of the at least two amnion layers may form outermost layers of the plurality of layers. Each amnion layer may include an epithelial layer, a basement membrane, and a fibroblast layer, and each chorion layer may include a reticular layer and a basement membrane.

Abstract: Techniques are described for determining the quality of a nerve graft by assessing quantitative structural characteristics of the nerve graft. Aspects of the techniques include obtaining an image identifying laminin-containing tissue in the nerve graft; creating a transformed image using a transformation function of an image processing application on the image; using an analysis function of the image processing application, analyzing the transformed image to identify one or more structures in accordance with one or more recognition criteria; and determining one or more structural characteristics of the nerve graft derived from a measurement of the one or more structures.

Abstract: A tissue connector may include a body formed of one or more layers of material, and at least one barbed suture attached to the body. A related method of forming a tissue connector may include forming a body from one or more layers of a material, and attaching at least one barbed suture to the body. In addition, a related method of repairing tissue using a tissue connector may include orienting the tissue connector around coapted or damaged tissue, so that the coapted or damaged tissue contacts the inner surface of the tissue connector, and twisting ends of the at least one barbed suture so that the at least one barbed suture engages the coapted or damaged tissue.

Abstract: A system and method are provided for wet storage of tissue. In an embodiment, a solution for the wet preservation of tissue may include between about 0.1% to about 50% by volume dimethyl sulfoxide (DMSO) and one or more soluble monovalent or divalent metal cationic salts. A wet-preserved tissue and method for preparing the wet-preserved tissue for ultimate use, is also provided.

Abstract: A method for performing an enzyme-linked immunosorbent assay (ELISA), the method comprising immobilizing a capture antibody to a substrate, wherein the capture antibody is configured to bind to a laminin beta-1 chain; adding a micronized tissue sample to the substrate containing the capture antibody; adding a detection antibody to the substrate containing the capture antibody and the micronized tissue sample, wherein the detection antibody is configured to bind to a laminin gamma-1 chain; detecting whether a complex of the capture antibody, a target antigen in the micronized tissue sample, and the detection antibody has been formed, wherein presence of the complex indicates presence of the target antigen with intact tertiary structure in the micronized tissue sample, and absence of the complex indicates absence of the target antigen with intact tertiary structure in the micronized tissue sample.

Abstract: The present disclosure provides tissue wrap devices with embedded three dimensional attachment features, methods of manufacturing three-dimensional attachment features for tissue wrap devices, and methods of using a nerve wrap device to protect a damaged nerve. Tissue wrap devices of the present disclosure may include a sheet of biocompatible material, the sheet having a first side, a second side, a middle portion, a first outer portion, and a second outer portion, the first side of the first outer portion being configured to overlap and interface with the second side of the second outer portion when the sheet is transitioned to a rolled configuration; wherein the first side of the first outer portion comprises a plurality of three dimensional attachment features; and wherein the plurality of three dimensional attachment features are configured to engage with the second side of the second outer portion to maintain the sheet in the rolled configuration.

Abstract: An electrode apparatus may include a handle, a cannula extending from a distal end of the handle and having at least one lumen, a ground wire extending through the cannula, and an electrode wire extending through the handle and the cannula, the electrode wire being extendable and retractable relative to a distal end of the cannula. The apparatus may also include a hook, provided in the cannula, and being extendable and retractable relative to the cannula.

Abstract: A method of preparing an implantable biomaterial includes combining a polymer with a neuro-regenerative agent or immunosuppressive agent selected from a group comprising at least one of: rapamycin, cyclosporine A, or analogs thereof, melting the polymer, and extruding the polymer and the neuro-regenerative agent or immunosuppressive agent to form the implantable biomaterial.

Abstract: A method for preserving a tissue graft includes submerging the tissue graft in a solution containing one or more antimicrobial and/or stabilizing agents and storing the tissue graft in the solution for a period of time of at least 24 hours while the solution is in an unfrozen state. A tissue preservation system includes a solution containing one or more antimicrobial and/or stabilizing agents and a tissue graft in the solution.

Abstract: A method of preparing a nerve graft includes submerging a nerve graft in a solution including FK506 and a solvent to promote incorporation of FK506 into the nerve graft. A tissue graft includes nerve tissue and FK506 incorporated within the nerve tissue. In the tissue graft, the FK506 is free of hydrogel and not encapsulated.

Abstract: The invention provides method for preparing amnion tissue grafts, as well as the grafts themselves. In specific embodiments, the tissue graft comprises a single layer of dried amnion from an umbilical cord.

Abstract: A method of preparing an implantable biomaterial includes combining a polymer comprising polydioxanone with a neuro-regenerative agent or an immunosuppressive agent comprising at least one immunophilin ligand, and melting the polymer. The method further includes extruding the combined polymer and the neuro-regenerative agent or immunosuppressive agent to form the implantable biomaterial.

Abstract: Techniques and systems are disclosed for a bioassay that is an in vitro mimic of peripheral nerve generation using the sensory neurons that innervate the peripheral nervous system. In some embodiments, the techniques may assist in detecting the bioactivity or potency of nerve grafts (e.g., processed, acellular human allografts) for fostering or supporting peripheral nerve regeneration. In various embodiments, techniques comprise affixing neurons (e.g., a DRG) to a nerve graft segment to form a test construct; culturing the test construct in a medium; analyzing the test construct to indicate the amount of outgrowing nerve structure; and determining the potency of the nerve graft from a metric derived from the analysis. In some embodiments, techniques and materials may be used to test the effect of a varied test condition on nerve growth.

Abstract: The problem of positioning one or more nerve ends inside a sheathing implant is solved by the use of a pulley and cinching systems that pull a nerve end into an implant and that can adjust the diameter of an implant to conform the implant to the diameter of the nerve, respectively. The pulley system utilizes a suture that traverses the wall of an implant leaving one end outside the implant wall and another end that can be attached to a nerve. Pulling the suture end outside the wall pulls the nerve attached to the other end of the suture into the bore of the implant. A cinching system utilizes specially arranged sutures within the wall of an implant to tighten or cinch up the wall after a nerve is placed therein, so as to conform at least part of the implant to the diameter of the nerve. Methods are also disclosed by which such pulley systems can be formed during an intraoperative procedure.