Materials and methods for protecting against neuromas
View Patent ↗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). In addition, the cap's material remodels into a tissue cushion after implantation, which protects the neuroma from being stimulated and inducing pain.
1. A sterile device for protecting against a neuroma forming at a stump of a transected nerve, wherein the device comprises:
a body having an open proximal end and, integrally formed with the body, a closed distal end wherein the body of the device is less than 100 mm in diameter and less than 500 mm in length;
wherein the body, including the closed distal end, defines an internal chamber, without openings other than at the proximal end, thereby inhibiting axonal escape from the device when the device is implanted on the nerve stump by inserting the nerve stump through the opening in the proximal end; and
one or more separators within the internal chamber that divide the internal chamber thereby creating a plurality of separate volumes into which regenerating axons grow such that one or more regenerating axons are physically separated from one or more other regenerating axons;
and wherein the device comprises a biomaterial that remodels into a tissue cushion after implantation.
2. The device according to claim 1 , wherein the device comprises a biomaterial selected from the group consisting of: high density polyethylene (HDPE), polyethylene glycol (PEG) hydrogel, and purified proteins from human or sources.
3. The device according to claim 1 , wherein the device comprises a biomaterial selected from the group consisting of small intestine submucosa (SIS), amnion, dermis, collagen and decellularized fascia.
4. The device according to claim 1 , wherein the body is cylindrical in shape.
5. A method for protecting against neuromas comprising: inserting and securing a nerve stump into a device of claim 1 .