# US 12,109,326 B2 · Demineralized bone fiber composition for augmentation of fixation

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- Number: US 12,109,326 B2
- Document ID: US12109326B2
- Status: Granted
- Kind: B2
- Application number: 16/638,113
- Filed: 2018-08-10
- Published: 2020-07-30
- Granted: 2024-10-08
- Earliest claimed: 2017-08-11
- Assignees: Theracell, Inc.
- Applicants: Theracell, LLC
- Inventors: Andrew J. Carter; Bradley E. Patt; Gunnar Andersson; Ian McRury
- Web page: https://patentgrep.com/patent/US12109326B2

## CPC

- A61L 27/3608: {Bone, e.g. demineralised bone matrix [DBM], bone powder}
- A61B 17/686: {Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw}
- A61B 17/8872: {Instruments for putting said fixation devices against or away from the bone (A61B17/7074, A61B17/808 take precedence)}
- A61F 2/0811: {Fixation devices for tendons or ligaments}
- A61F 2/30734: {Modular inserts, sleeves or augments, e.g. placed on proximal part of stem for fixation purposes or wedges for bridging a bone defect}
- A61F 2/36: Femoral heads {; Femoral endoprostheses}
- A61F 2/4603: {for insertion or extraction of endoprosthetic joints or of accessories thereof}
- A61B 17/7001: {Screws or hooks combined with longitudinal elements which do not contact vertebrae (A61B17/7058 takes precedence)}
- A61B 2017/00526: {Methods of manufacturing}
- A61F 2/34: Acetabular cups
- A61F 2/40: for shoulders
- A61F 2002/30736: {Augments or augmentation pieces, e.g. wedges or blocks for bridging a bone defect}
- A61F 2002/30738: {Sleeves}
- A61F 2002/30919: {Sleeves}
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2310/00359: Bone or bony tissue
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- A61L 2430/10: for reconstruction of tendons or ligaments
- A61L 2430/24: for joint 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

Compositions and methods thereof include bone fibers made from cortical bone in which a plurality of bone fibers are made into shapes that are used to augment fixation of orthopedic implants and screws. Sheets of bone fibers may be used as an interface between bone and tissue, tendons, and/or ligaments. Cylindrical shaped implants that may be placed in drilled holes in bone prior to screw placement to enhance fixation of the screw. The physical presence of the fibers provides initial fixation, while the use of an osteoinductive material provides long term enhancement of bone formation around the screw and hence fixation. The bone fiber compositions may be in the form of a cylinder or a tube. A delivery system and methods of use are also provided.

## Claims

### Claim 1

An implant composition, comprising:
a plurality of demineralized bone fibers (DBFs) cut from demineralized bone and molded into a shape of a tapered cylinder by water-assisted molding,
wherein the implant has a distal end and a proximal end, and the distal end is narrower than the proximal end;
wherein the implant comprises a hole through its length;
wherein the implant comprises an indent at the proximal end to receive a screw; and
wherein the implant in a dried state is compact and upon wetting expands and swells.

### Claim 2 (depends on 1)

The implant composition of claim 1, wherein the water-assisted molding comprises 0.15 gram to 1.0 gram of DBF.

### Claim 3 (depends on 1)

The implant composition of claim 1, wherein the water-assisted molding comprises a ratio of fluid to DBF in a range from about 5-200 mls fluid to about 1 gram DBF.

### Claim 4 (depends on 1)

The implant composition of claim 1, wherein the implant composition has a length of from about 1 cm to about 15 cm in length.

### Claim 5 (depends on 4)

The implant composition of claim 4, wherein the implant composition has a length of about 1 cm to about 7 cm.

### Claim 6 (depends on 1)

The implant composition of claim 1, wherein the implant composition has a diameter of or between about 3 mm to about 15 mm.

### Claim 7 (depends on 6)

The implant composition of claim 6, wherein the implant composition has a diameter of or between about 2 mm to about 7 mm.

### Claim 8 (depends on 1)

The implant composition of claim 1, wherein the implant composition has a diameter of or between 2 to 5 mm and a length of or between 4 to 5 cm.

### Claim 9 (depends on 1)

The implant composition of claim 1, wherein the implant composition has a volume of 0.15 cm3 to 0.98 cm3.