# US 10,245,146 B2 · Fenestrated bone graft

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- Number: US 10,245,146 B2
- Document ID: US10245146B2
- Status: Granted
- Kind: B2
- Application number: 14/679,137
- Filed: 2015-04-06
- Published: 2016-06-02
- Granted: 2019-04-02
- Earliest claimed: 2014-12-01
- Assignees: Vivex Biomedical, Inc.
- Applicants: Vivex Biomedical, Inc.
- Inventors: Harry Thomas Temple; Tracy Scott Anderson; Edgar S. Maldonado; Sonya A. Cooper
- Web page: https://patentgrep.com/patent/US10245146B2

## CPC

- A61F 2/2846: {Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects (nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006)}
- A61F 2/28: Bones
- A61F 2/3094: {Designing or manufacturing processes}
- A61L 27/3608: {Bone, e.g. demineralised bone matrix [DBM], bone powder}
- A61L 27/3687: {characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents}
- A61L 27/3691: {characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61F 2002/2839: {Bone plugs or bone graft dowels}
- A61F 2002/30235: {tubular, e.g. sleeves}
- A61F 2002/30784: {Plurality of holes}
- A61F 2210/0004: bioabsorbable
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2230/0021: square
- A61F 2230/0069: cylindrical
- A61F 2310/00359: Bone or bony tissue
- A61L 2300/412: Tissue-regenerating or healing or proliferative agents
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- 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)
- 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)

## Abstract

The present invention relates to a fenestrated bone graft and a method of preparing cortical bone in thin strips then fully demineralizing it to give it formed flexibility and then creating fenestrations in the cortical bone in a fashion similar to but not identical to skin grafts.

## Claims

### Claim 1

A fenestrated cortical bone graft comprises:
a textured and flexible allograft bone structure, the allograft bone structure being made from a single piece of long cortical bone of 8 cm length or greater from a rib or 10 cm length or greater from a tibia, the rib treated in 1N-HCL for 1 to 3 hours whereas the tibia is treated in 1N-HCL for 4 to 6 hours to texture the cortical bone and make pliable or flexible, the cortical bone being cut along a length of the bone and laid flat in a flat sheet, the structure having an outer surface and an inner surface, the structure being fenestrated along a length of the bone structure with a plurality of cut slits sized to uniformly extend through from the outer surface to the inner surface to form a plurality of open passages when the bone structure is stretched, the fenestrated cortical bone graft being freeze-dried and packaged sterilely for clinical use, the freeze-dried fenestrated cortical bone graft being hydrated and reconstituted in saline with or without antibiotics or lactated ringers with or without antibiotics for clinical use to resume the pliable or flexible condition of the freeze-dried fenestrated cortical bone graft, the open passages being bounded by an interconnected network of bone struts defined by pairs of adjacent slits, each bone strut having a width of 0.8 to 1.2 mm that doubles at connective portions, the bone struts in combination with the slits giving the hydrated and reconstituted fenestrated cortical bone graft stretchability and flexibility wherein the allograft bone structure is formed as the flat sheet, the flat sheet of the allograft bone structure is made pliable and conformable by the treatment in 1N-HCL which also demineralizes the bone allowing the flat sheet to be formed into different shapes, wherein the bone allograft structure has a thickness of 0.2 mm to 1 mm as measured from the inner surface to the outer surface and wherein the structure when stretched has the slits opened, the slits being sized in length allows the open passages to be of an oblong shape in the range of 0.2 mm to 5 mm when the sheet is stretched and the plurality of slits are configured by cutting through the flat sheet using a bone cutter with cutting blades, cutting fenestrations in the flat sheet which open when the flat sheet is stretched, wherein each slit is of a length prior to stretching and the openness of each of the slits varies dependent on the amount of stretch on the fenestrated cortical bone graft.