# US 10,945,805 B2 · Materials and methods for protecting against neuromas

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- Number: US 10,945,805 B2
- Document ID: US10945805B2
- Status: Granted
- Kind: B2
- Application number: 16/786,042
- Filed: 2020-02-10
- Published: 2020-06-04
- Granted: 2021-03-16
- Earliest claimed: 2012-09-25
- Assignees: Axogen Corporation
- Applicants: Axogen Corporation
- Inventors: Curt Deister; Crystal Simon; Jennifer Faleris
- Web page: https://patentgrep.com/patent/US10945805B2

## CPC

- A61B 90/08: {Accessories or related features not otherwise provided for}
- A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61N 1/0558: {Anchoring or fixation means therefor}
- A61B 2090/0815: {Implantable devices for insertion in between organs or other soft tissues}
- A61L 27/3675: {Nerve tissue, e.g. brain, spinal cord, nerves, dura mater}
- A61L 31/005: {Ingredients of undetermined constitution or reaction products thereof}
- A61L 31/04: Macromolecular materials
- A61L 31/048: {obtained by reactions only involving carbon-to-carbon unsaturated bonds (A61L31/041 takes precedence)}
- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- A61L 2430/32: for nerve reconstruction
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## 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.

## Claims

### Claim 1

A device comprising:
a body having an open proximal end and a closed distal end integrally formed with the body, wherein the body, including the closed distal end, defines an internal chamber, without openings other than at the proximal end, wherein the internal chamber is physically partitioned; and
a biomaterial that remodels into a tissue cushion after implantation;
wherein the body of the device is between about 1 mm and about 100 mm in length.

### Claim 2 (depends on 1)

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 protein from human or other sources.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

The device according to claim 1, wherein the body is cylindrical in shape.

### Claim 5 (depends on 1)

A method of using the device according to claim 1, comprising inserting a nerve stump into the proximal end of the device.

### Claim 6 (depends on 5)

The method of claim 5. wherein a neuroma formed out of the inserted nerve stump is protected from external stimuli.

### Claim 7 (depends on 1)

A method for preventing or limiting neuroma formation comprising inserting and securing a nerve stump into a device according to claim 1.

### Claim 8 (depends on 7)

The method of claim 7, wherein neuroma formation is limited as compared to neuroma formation in the absence of said device.

### Claim 9 (depends on 1)

A method comprising:
inserting and securing a nerve stump into a device according to claim 1; and
decreasing the pain associated with a neuroma formation as compared to the pain associated with a neuroma formation in the absence of said device.