Demineralized bone fibers having controlled geometry and shapes and methods thereof

• US 9,572,912 B2
• Filed: 04/18/2014
• Issued: 02/21/2017
• Est. Priority Date: 04/19/2013
• Status: Active Grant

• Current Assignee: Theracell LLC
• Original Assignee: Theracell, Inc. (Titan Pharmaceuticals, Inc.)
• Inventors: Scarborough, Nelson L., Patt, Bradley, Carter, Andrew J.
• Primary Examiner(s): Love, Trevor
• Application Number:
  US14/256,911
• Publication Number:
  US 20140314822A1
• Time in Patent Office: 1,040 Days
• US Class Current: 1/1
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/365 Bones
• CPC Class Codes: A61L 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/3847 Bones
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

A bone repair composition and methods thereof include elongated bone fibers made from cortical bone in which a plurality of approximately uniform bone fibers is made into various implant shapes conducive for various applications. The bone fiber compositions may be in the form of a cavity, ball, pellet, wrap, strip, cylinder, cone, putty, gel, or injectable slurry.

Claims

1. A bone repair composition, comprising:

a plurality of elongated bone fibers cut from cortical bone demineralized to a calcium content of no more than 10%;

the plurality of elongated bone fibers cut along the direction of collagen fibers in the demineralized bone;

the plurality of elongated bone fibers having a length from about 1 cm to about 30 cm, a width from about 0.05 mm to about 4 mm, and a thickness from about 0.05 mm to about 4 mm; and

the plurality of elongated bone fibers having a plurality of cross sections with at least 60% uniformity within one standard deviation.

2. The bone repair composition of claim 1, wherein the plurality of elongated bone fibers are in a form selected from the group consisting of a cavity, ball, pellet, sheet, strip, cylinder, cone, putty, and gel.

3. The bone repair composition of claim 2, wherein the cavity is selected from a boat, cup, or box shape.

4. The bone repair composition of claim 1, wherein the plurality of demineralized elongated bone fibers is in a form of a sheet.

5. The bone repair composition of claim 4, wherein the sheet has a thickness from about 0.5 to about 10 mm, a length from about 2 inches to about 8 inches, and a width from about 2 inches to about 8 inches.

6. The bone repair composition of claim 4, wherein the sheet comprises a first region of demineralized elongated bone fibers and a second region of demineralized elongated bone fibers, in which the demineralized elongated bone fibers of the first region are more dense than the demineralized elongated bone fibers of the second region.

7. The bone repair composition of claim 6, wherein the first region of demineralized elongated bone fibers and the second region of demineralized elongated bone fibers form a grid pattern.

8. The bone repair composition of claim 4, wherein the sheet comprises holes.

9. The bone repair composition of claim 1, further comprising an additive selected from the group consisting of autologous bone chips, bone marrow aspirate, a morcellized autograft, bone marrow cells, mesenchymal stem cells, oxygenating materials, oxygen generating compounds, growth factors, antibiotics, anti-neoplastic agents, and combinations thereof.

10. The bone repair composition of claim 1, wherein the plurality of demineralized elongated bone fibers is in a form of a putty.

11. The bone repair composition of claim 10, wherein the putty further comprises an excipient.

12. The bone repair composition of claim 11, wherein the excipient is selected from the group of glycerol, lecithin, sodium carboxy methyl cellulose, polyoxamer, hyaluronic acid, and derivatized hyaluronic acid.

13. The bone repair composition of claim 1, wherein the at least 60% uniformity is at least 90% uniformity.

14. The bone repair composition of claim 1, wherein the plurality of elongated bone fibers have a width from about 0.2 mm to about 1 mm.