# US 10,441,681 B2 · Materials and methods for nerve grafting

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- Number: US 10,441,681 B2
- Document ID: US10441681B2
- Status: Granted
- Kind: B2
- Application number: 15/226,409
- Filed: 2016-08-02
- Published: 2016-11-24
- Granted: 2019-10-15
- Earliest claimed: 2001-08-13
- Assignees: University of Florida Research Foundation, Inc.
- Applicants: University of Florida Research Foundation, Inc.
- Inventors: David F. Muir
- Web page: https://patentgrep.com/patent/US10441681B2

## CPC

- A61L 27/3687: {characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents}
- A61K 35/30: Nerves; Brain; Eyes; Corneal cells; Cerebrospinal fluid; Neuronal stem cells; Neuronal precursor cells; Glial cells; Oligodendrocytes; Schwann cells; Astroglia; Astrocytes; Choroid plexus; Spinal cord tissue
- A61K 38/51: Lyases (4)
- A61L 27/227: {Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24}
- A61L 27/3604: {characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel}
- A61L 27/3675: {Nerve tissue, e.g. brain, spinal cord, nerves, dura mater}
- A61L 27/3683: {subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment}
- A61L 27/383: {Nerve cells, e.g. dendritic cells, Schwann cells}
- A61L 27/3878: {Nerve tissue, brain, spinal cord, nerves, dura mater}
- A61L 31/047: {Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046}
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/02: for peripheral neuropathies
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61L 2430/32: for nerve reconstruction
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The subject invention pertains to compositions and methods for promoting repair of damaged nerve tissue using nerve grafts and preparation of nerve grafts. The compositions and methods of the subject invention can be employed to restore the continuity of nerve interrupted by disease, traumatic events or surgical procedures. Compositions of the subject invention comprise one or more chondroitin sulfate proteoglycan (CSPG)-degrading enzymes that promote axonal penetration into damaged nerve tissue and nerve graft. The invention also concerns methods for promoting repair of damaged nerve tissue using the present compositions and nerve tissue treated according to such methods. The invention also includes storage solutions for nerve tissue.

## Claims

### Claim 1

A human peripheral nerve graft, suitable for implantation into a human to coapt a severed peripheral nerve, wherein said graft is prepared by a method comprising treating human peripheral nerve graft tissue with a detergent to render the human nerve graft tissue acellular and further applying at least one chondroitinase to said human nerve graft tissue, wherein the resulting nerve graft comprises an intact basal lamina tube and is capable of supporting axonal ingress after implantation into a human to coapt a severed nerve, wherein the treatment with the chondroitinase conditions the nerve graft for enhanced post-implantation axonal ingress such the post-implantation axonal ingress is enhanced relative to a nerve graft to which the chondroitinase has not been applied.