Abstract: The present disclosure provides a mechanically-actuated tool for cutting a tissue graft having a hollow core and methods for use thereof. A portion of a biological structure, such as a nerve, is attached to the hollow core to form an implantable neural graft assembly. The tool has a cutter mechanism and a grasper mechanism. The grasper mechanism has one or more component(s) that open and close via an actuation mechanism, like a handle, and rotate via a controller component, like a rotatable wheel. The cutter mechanism may be a cutting tube component that harvests the tissue graft. The tool may also have an ejector mechanism to remove the tissue graft as part of the implantable neural graft assembly. Such devices and methods are particularly suitable for treating neuromas and other neural regeneration procedures.

Abstract: The present disclosure provides a mechanically-actuated tool for cutting a tissue graft having a hollow core and methods for use thereof. A portion of a biological structure, such as a nerve, is attached to the hollow core to form an implantable neural graft assembly. The tool has a cutter mechanism and a grasper mechanism. The grasper mechanism has one or more component(s) that open and close via an actuation mechanism, like a handle, and rotate via a controller component, like a rotatable wheel. The cutter mechanism may be a cutting tube component that harvests the tissue graft. The tool may also have an ejector mechanism to remove the tissue graft as part of the implantable neural graft assembly. Such devices and methods are particularly suitable for treating neuromas and other neural regeneration procedures.

Abstract: An everter device to facilitate preparation of ends of arterial segments for end-to-end microvascular anastomosis. The device includes structure that provides sufficient support to prevent unwanted buckling of arterial tissue. The everter device offsets the tendency of the arterial tissue wall to recover its natural shape and fall off securement posts or pins of a coupler ring. The structure may be in the form of an intraluminal catheter balloon. Alternately, the structure may be in the form of a plunger. Alternately, the structure may be in the form of a radially expanding member provided on a shaft. The device further has a contoured surface on an everter end to evert a free end of arterial tissue over a coupler ring, and to cause the posts or pins of the coupler ring to pierce through the everted arterial tissue. The everter end is provided with one or more openings therein, such as a circumferential slot, to receive the posts or pins of the coupler ring.

Abstract: An everter device to facilitate preparation of ends of arterial segments for end-to-end microvascular anastomosis. The device includes structure that provides sufficient support to prevent unwanted buckling of arterial tissue. The everter device offsets the tendency of the arterial tissue wall to recover its natural shape and fall off securement posts or pins of a coupler ring. The structure may be in the form of an intraluminal catheter balloon. Alternately, the structure may be in the form of a plunger. Alternately, the structure may be in the form of a radially expanding member provided on a shaft. The device further has a contoured surface on an everter end to evert a free end of arterial tissue over a coupler ring, and to cause the posts or pins of the coupler ring to pierce through the everted arterial tissue. The everter end is provided with one or more openings therein, such as a circumferential slot, to receive the posts or pins of the coupler ring.

Abstract: The present disclosure provides methods and systems for receiving, with processing circuitry of an implant device, an electrical signal from a free tissue graft attached to a portion of a nerve (e.g., a nerve branch or fascicle) through an electrical conductor in electrical communication with the free tissue graft (e.g., muscle graft), the nerve having reinnervated the free tissue graft. The electrical signal from the free tissue graft has a voltage amplitude of greater than or equal to about 150 microvolts. The processing circuitry stores signal data corresponding to the electrical signal from the free tissue graft in a memory accessible to the processing circuitry.

Abstract: The present disclosure provides methods and systems for receiving, with processing circuitry of an implant device, an electrical signal from a free tissue graft attached to a portion of a nerve (e.g., a nerve branch or fascicle) through an electrical conductor in electrical communication with the free tissue graft (e.g., muscle graft), the nerve having reinnervated the free tissue graft. The electrical signal from the free tissue graft has a voltage amplitude of greater than or equal to about 150 microvolts. The processing circuitry stores signal data corresponding to the electrical signal from the free tissue graft in a memory accessible to the processing circuitry.

Abstract: The present disclosure provides methods and systems for receiving, with processing circuitry of an implant device, an electrical signal from a free tissue graft attached to a portion of a nerve (e.g., a nerve branch or fascicle) through an electrical conductor in electrical communication with the free tissue graft (e.g., muscle graft), the nerve having reinnervated the free tissue graft. The electrical signal from the free tissue graft has a voltage amplitude of greater than or equal to about 150 microvolts. The processing circuitry stores signal data corresponding to the electrical signal from the free tissue graft in a memory accessible to the processing circuitry.

Abstract: The present disclosure provides a mechanically-actuated tool for cutting a tissue graft having a hollow core and methods for use thereof. A portion of a biological structure, such as a nerve, is attached to the hollow core to form an implantable neural graft assembly. The tool has a cutter mechanism and a grasper mechanism. The grasper mechanism has one or more component(s) that open and close via an actuation mechanism, like a handle, and rotate via a controller component, like a rotatable wheel. The cutter mechanism may be a cutting tube component that harvests the tissue graft. The tool may also have an ejector mechanism to remove the tissue graft as part of the implantable neural graft assembly. Such devices and methods are particularly suitable for treating neuromas and other neural regeneration procedures.

Abstract: The present disclosure provides a regenerative peripheral nerve interface (RPNI) for a subject comprising an insulating substrate, at least one metallic electrode deposited onto the insulating substrate forming a thin-film array; a portion of the at least one metallic electrode surface having a layer of a first conductive polymer and a layer of decellularized small intestinal submucosa (SIS) coating a portion of the electrode, wherein a second conductive polymer is electrochemically polymerized through the SIS to form the regenerative peripheral nerve interface. The present disclosure also provides that a layer of muscle tissue contacts the regenerative peripheral nerve interface.

Abstract: The present disclosure provides nerve interface devices, such as passive or active nerve caps or regenerative peripheral nerve interface devices (RPNI), for a subject in need thereof. The nerve interface devices include nerve interface cap devices capable of treating, minimizing, or preventing formation of neuromas in severed or damaged nerve endings. Such a nerve interface device includes a housing that may be formed of a scaffold, such as a biotic material or hydrogel, an autograft, and optionally an electrode and/or conducting polymer. The autograft may be free muscle or free skin tissue, which is attached to the nerve ending to permit reinnervation. The present disclosure also provides methods for treating, minimizing, or preventing neuroma formation in a subject having a severed or damaged nerve, especially a peripheral nerve.

Abstract: The present disclosure provides methods and systems for receiving, with processing circuitry of an implant device, an electrical signal from a free tissue graft attached to a portion of a nerve (e.g., a nerve branch or fascicle) through an electrical conductor in electrical communication with the free tissue graft (e.g., muscle graft), the nerve having reinnervated the free tissue graft. The electrical signal from the free tissue graft has a voltage amplitude of greater than or equal to about 150 microvolts. The processing circuitry stores signal data corresponding to the electrical signal from the free tissue graft in a memory accessible to the processing circuitry.

Abstract: A hybrid bioelectrical interface (HBI) device can be an implantable device comprising an abiotic component operable to transmit charge via electrons or ions; a biological component interfacing with the neural tissue, the biological component being sourced from biologic, biologically-derived, or bio-functionalized material; and a conjugated polymer component that together provide a way to chronically interface living neural tissue with electronic devices for extended durations (e.g. greater than 10 years). In some embodiments, conjugated polymers provide a functional electrical interface for charge transfer and signal transduction between the nervous system and an electronic device (e.g. robotic prosthetic limb, retinal implant, microchip).

Abstract: A hybrid bioelectrical interface (HBI) device can be an implantable device comprising an abiotic component operable to transmit charge via electrons or ions; a biological component interfacing with the neural tissue, the biological component being sourced from biologic, biologically-derived, or bio-functionalized material; and a conjugated polymer component that together provide a means to chronically interface living neural tissue with electronic devices for extended durations (e.g. greater than 10 years). In some embodiments, conjugated polymers provide a functional electrical interface for charge transfer and signal transduction between the nervous system and an electronic device (e.g. robotic prosthetic limb, retinal implant, microchip).

Abstract: The present disclosure provides a regenerative peripheral nerve interface (RPNI) for a subject comprising an insulating substrate, at least one metallic electrode deposited onto the insulating substrate forming a thin-film array; a portion of the at least one metallic electrode surface having a layer of a first conductive polymer and a layer of decellularized small intestinal submucosa (SIS) coating a portion of the electrode, wherein a second conductive polymer is electrochemically polymerized through the SIS to form the regenerative peripheral nerve interface. The present disclosure also provides that a layer of muscle tissue contacts the regenerative peripheral nerve interface.

Abstract: The present disclosure provides nerve interface devices, such as passive or active nerve caps or regenerative peripheral nerve interface devices (RPNI), for a subject in need thereof. The nerve interface devices include nerve interface cap devices capable of treating, minimizing, or preventing formation of neuromas in severed or damaged nerve endings. Such a nerve interface device includes a housing that may be formed of a scaffold, such as a biotic material or hydrogel, an autograft, and optionally an electrode and/or conducting polymer. The autograft may be free muscle or free skin tissue, which is attached to the nerve ending to permit reinnervation. The present disclosure also provides methods for treating, minimizing, or preventing neuroma formation in a subject having a severed or damaged nerve, especially a peripheral nerve.

Abstract: A hybrid bioelectrical interface (HBI) device can be an implantable device comprising an abiotic component operable to transmit charge via electrons or ions; a biological component interfacing with the neural tissue, the biological component being sourced from biologic, biologically-derived, or bio-functionalized material; and a conjugated polymer component that together provide a means to chronically interface living neural tissue with electronic devices for extended durations (e.g. greater than 10 years). In some embodiments, conjugated polymers provide a functional electrical interface for charge transfer and signal transduction between the nervous system and an electronic device (e.g. robotic prosthetic limb, retinal implant, microchip).

Abstract: A method for chemically acellularizing a biological tissue sample, such as a peripheral nerve, is provided. The method includes disrupting the cell membranes of the biological tissue sample, and then denaturing intracellular proteins within the cells of the tissue sample and removing the denatured proteins from the cells while preserving the extracellular matrix to produce an acellularized tissue construct.

Abstract: A method for chemically acellularizing a biological tissue sample, such as a peripheral nerve, is provided. The method includes disrupting the cell membranes of the biological tissue sample, and then denaturing intracellular proteins within the cells of the tissue sample and removing the denatured proteins from the cells while preserving the extracellular matrix to produce an acellularized tissue construct.