Abstract: The subject invention provides devices and methods for alleviating discomfort associated with neuroma formation. The devices and methods of the invention effectively use the body's natural response of reconstructing implanted biomaterials to minimize the size of, isolate, and protect a neuroma. In preferred embodiments, the subject device is a cylindrical cap, wherein the internal chamber of the cylindrical cap physically partitions the nerve to enable an arrangement of nerve fibers (as opposed to haphazardly arranged nerve fibers often produced in neuromas). Tabs arranged on the outside of the cap can be used to manipulate the cap into place on a nerve. The open end can also be configured with flaps that can be used to widen the open end for easier insertion of the nerve into the cap. In addition, the cap's material remodels into a tissue cushion after implantation, which protects the neuroma from being stimulated and inducing pain.

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: The subject invention provides devices and methods for alleviating discomfort associated with neuroma formation. The devices and methods of the invention effectively use the body's natural response of reconstructing implanted biomaterials to minimize the size of, isolate, and protect a neuroma. In preferred embodiments, the subject device is a cylindrical cap, wherein the internal chamber of the cylindrical cap physically partitions the nerve to enable an arrangement of nerve fibers (as opposed to haphazardly arranged nerve fibers often produced in neuromas). Tabs arranged on the outside of the cap can be used to manipulate the cap into place on a nerve. The open end can also be configured with flaps that can be used to widen the open end for easier insertion of the nerve into the cap. In addition, the cap's material remodels into a tissue cushion after implantation, which protects the neuroma from being stimulated and inducing pain.

Abstract: The invention generally relates to devices for manufacture of tissue products, and, more particularly, to material layering assemblies for processing tissue layers to produce a multi-layered tissue product. The invention provides a material layering system to support and/or hold various layers of material to form a multi-layered product.

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 for conducting an in vitro assay of a biomaterial may include freezing a sample of biomaterial and sectioning the frozen sample of biomaterial into at least one section of biomaterial. The at least one section of biomaterial may have a thickness of about 10 ?m to about 50 ?m. The method may further include placing the at least one section of biomaterial onto a slide; affixing a neuron or a group of neurons to one end portion of the at least one section of biomaterial to create a test construct; incubating the test construct; and determining an amount of neurite growth from the neuron or the group of neurons along the at least one section of biomaterial.

Abstract: The problem of attaching a donor nerve stump to a recipient nerve for an end-to-side coaptation is solved by the use of a tissue connector. The tissue connector can have a body for receiving the donor nerve stump and one or more overflaps for attaching the tissue connector with the donor nerve stump therein to the epineurium on the side of the recipient nerve. Sutures can also be used to secure the tissue connector and nerves in place.

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 packaging system is provided. The packaging system may include a packaging body defining a cavity. The packaging system may also include a tissue cradle configured to be disposed within the cavity. The packaging system may also include a seal configured to be joined to the packaging body to fluidly seal the cavity. Such packaging systems may be used in the storage of wet-preserved or dry-preserved human or animal tissue. Also provided are a packaged tissue specimen and a method for packaging 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: The present disclosure provides fasciculated nerve grafts of customizable lengths and diameters, and methods of preparing the same. The grafts are made by digesting native extracellular matrix (ECM) around the nerve fascicles of a nerve tissue, and the epineurial sheath. One or more of the individual fascicles may then be entubulated in an entubulation material, embedded in or coated with a coating material, or both, to form a fasciculated nerve graft. The fasciculated nerve grafts are customizable and designed to bridge nerve gaps; the modularity of the fasciculated nerve graft allows for restoring continuity to nerve defects of virtually any length and allows for matching the diameter of the patient's recipient nerve.

Abstract: The present disclosure pertains to membranous tissue grafts comprising one or more pre-made attachment points. The one or more pre-made attachment points may include pre-made markings and/or pre-made suture holes. The membranous tissue grafts can be in the form of a tube. The membranous tissue grafts can also be rectangular in shape and can be used in a nerve repair by wrapping the severed or damaged nerve. In some embodiments, the membranous tissue grafts are suitable for repairing severed nerves that have a short gap or no gap with a gap of less than 5 mm between the severed stumps. Accordingly, methods are provided for repairing a damaged or severed nerve by implanting the membranous tissue grafts on to the damaged or severed nerve.

Abstract: An electrical stimulation device may include a handle having a proximal end, a distal end, one or more actuators, and a display. The electrical stimulation device may also include a probe attached to and extending from the distal end of the handle, the probe including a stimulation portion and a return portion, wherein a spacing between the stimulation portion and the return portion is adjustable.

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: The present disclosure provides engineered nerve grafts, methods of making engineered nerve grafts, and methods of using an engineered nerve graft to repair a nerve. Engineered nerve grafts of the present disclosure may include a body extending from a first end to a second end, the body being formed of a biocompatible hydrogel, and a plurality of microchannels extending continuously through the body from the first end to the second end, wherein each of the plurality of microchannels may have an effective diameter of about 1 micrometer to about 200 micrometers.

Abstract: A method of preparing an implantable biomaterial film includes inputting a combination of a polymer and a neuro-regenerative agent or an immunosuppressive agent into an extruder. The method includes melting the polymer within the extruder. The method also includes extruding the combined polymer and the neuro-regenerative agent or the immunosuppressive agent to form the implantable biomaterial film.

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 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: 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: The present disclosure provides fasciculated nerve grafts of customizable lengths and diameters, and methods of preparing the same. The grafts are made by digesting native extracellular matrix (ECM) around the nerve fascicles of a nerve tissue, and the epineurial sheath. One or more of the individual fascicles may then be entubulated in an entubulation material, embedded in or coated with a coating material, or both, to form a fasciculated nerve graft. The fasciculated nerve grafts are customizable and designed to bridge nerve gaps; the modularity of the fasciculated nerve graft allows for restoring continuity to nerve defects of virtually any length and allows for matching the diameter of the patient's recipient nerve.