Demineralized bone fibers having controlled geometry and shapes and methods thereof

• US 9,486,557 B2
• Filed: 12/11/2014
• Issued: 11/08/2016
• Est. Priority Date: 04/19/2013
• Status: Active Grant

• Current Assignee: Theracell LLC
• Original Assignee: Theracell, Inc. (Titan Pharmaceuticals, Inc.)
• Inventors: Carter, Andrew J., Scarborough, Nelson L., Patt, Bradley
• Primary Examiner(s): LOVE, TREVOR M
• Application Number:
  US14/567,788
• Publication Number:
  US 20150093429A1
• Time in Patent Office: 698 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 method of producing a bone composition comprising a plurality of demineralized elongated bone fibers having approximately uniform geometry, the method, comprising:

cutting cortical bone into struts;

demineralizing the cortical bone struts to form demineralized bone having a calcium content of no more than 10%;

fixturing the demineralized cortical struts to a cutting apparatus with collagen fibers of the demineralized cortical struts aligned parallel to a cutting direction of the cutting apparatus; and

repeatedly cutting the demineralized bone to form the plurality of demineralized elongated bone fibers having a length from about 1 cm to about 30 cm.

2. The method of claim 1, wherein the demineralization comprises soaking the bone in a dilute acid having a concentration of about 0.3 N to about 3 N.

3. The method of claim 1, further comprising:

rinsing the demineralized bone to form a rinsed demineralized bone; and

freezing the rinsed demineralized bone.

4. The method of claim 1, further comprising adding an excipient and/or an additive to the demineralized elongated bone fibers.

5. The method of claim 1, wherein of the plurality of elongated bone fibers, at least 60% are approximately uniform within one standard deviation.

6. The method of claim 1, wherein the plurality of elongated bone fibers are formed into a cavity, ball, pellet, wrap, strip, cylinder, cone, putty, gel, and injectable slurry.

7. The method of claim 1, the method further comprising:

suspending the plurality of elongated bone fibers in an aqueous solution to form a suspension of elongated bone fibers;

adding the suspension of elongated bone fibers to a mold to form a mold of elongated bone fibers; and

draining the suspension of the aqueous solution from the mold of elongated bone fibers.

8. The method of claim 7, further comprising:

compressing the elongated bone fibers in the mold.

9. The method of claim 8, wherein the mold comprises raised areas and the compressing of the elongated bone fibers comprises more compression along the elongated bone fibers corresponding to the raised areas of the mold relative to the elongated bone fibers.

10. The method of claim 7, further comprising:

heating the mold of elongated bone fibers.

11. The method of claim 7, further comprising:

drying the mold of elongated bone fibers.

12. The method of claim 11, wherein the drying comprises heating, vacuum, and/or lyophilization.

13. The method of claim 7, wherein the mold is cylindrical and forms a cylindrical shape of elongated bone fibers.

14. The method of claim 13, further comprising loading the cylindrical shape of elongated bone fibers into a cannula.

15. The method of claim 7, wherein the plurality of elongated bone fibers comprises a first group of bone fibers and a second group of bone fibers, wherein the first group is treated to remove osteoinductive matter to form a treated group of bone fibers and the second group is an untreated group of bone fibers, and the treated group of bone fibers and the untreated group of bone fibers are added to the mold to form elongated bone fibers having at least one osteoinductive region and at least one non-osteoinductive region.

16. The method of claim 2, wherein the dilute acid has a concentration of about 0.3 N to about 0.6 N.

17. The method of claim 1, wherein the struts have a maximum thickness of 8 mm.