Shaped materials derived from elongate bone particles

• US 5,507,813 A
• Filed: 12/09/1993
• Issued: 04/16/1996
• Est. Priority Date: 12/09/1993
• Status: Expired due to Term

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Osteotech Incorporated (Medtronic Plc)
• Inventors: Dowd, Michael, Dyke, Denis G.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/164,152
• Time in Patent Office: 859 Days
• Field of Search: 623/1, 623/11, 623/12, 623/16, 623/18, 623/66, 424/422
• US Class Current: 623/23.63
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• 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 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: 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
• CPC Class Codes: A61L 27/3695 characterised by the function or physical properties of the final product, where no specific conditions are defined to achieve this A61L27/3687, A61L27/3691 take precedence
• CPC Class Codes: A61L 27/3847 Bones

Abstract

Surgically implantable shaped materials, e.g., sheets, are fabricated from elongate bone particles, advantageously those that have been demineralized. The materials when applied to a bone repair site enhance or accelerate new bone ingrowth by any one of a variety of biological and/or mechanical mechanisms.

Claims

1. A shaped material comprising a coherent mass of elongate, mechanically entangled demineralized bone particles wherein at least about 60 weight percent of the bone particles possess a median length of from about 10 mm to about 100 mm, a median thickness of from about 0.02 mm to about 1 mm and a median width of from about 2 mm to about 5 mm.

2. The shaped material of claim 1 exhibiting osteogenic activity.

3. The shaped material of claim 1 wherein the bone particles are obtained from cortical, cancellous and corticocancellous bone of autogenous allogenic and xenogenic origin.

4. The shaped material of claim 1 wherein the bone particles are obtained from porcine bone.

5. The shaped material of claim 1 further comprising one or more additives selected from the group consisting of plasticizers, flexibilizing agents, biostatic agents, biocidal agents, surface active agents, binding and bonding agents and fillers.

6. The shaped material of claim 1 further comprising at least one additional ingredient selected from the group consisting of antiviral agent, antimicrobial agent, antibiotic agent, amino acid, peptide, vitamin, inorganic element, protein synthesis co-factor, hormone, endocrine tissue, synthesizer, enzyme, polymer-cell scaffolding agent with parenchymal cells, angiogenic drug, demineralized bone powder, collagen lattice, antigenic agent, cytoskeletal agent, mesenchymal stem cells, bone digester, antitumor agent, cellular attractant, fibronectin, growth hormone cellular attachment agent, immunosuppressant, nucleic acid, hydroxy apatite and penetration enhancer.

7. The shaped material of claim 1 in the form of a flat sheet, curved sheet, plate, disk, cone, pin, screw or tube.

14. The shaped material of claim 1 in the form of a flat sheet, curved sheet, plate, disk, cone, pin, screw or tube.

8. A shaped material comprising a coherent mass of elongate, mechanically entangled demineralized bone particles wherein at least about 60 weight percent of the bone particles possess a median length to median thickness ratio of from about 50:

1 to about 500;

1 and a median length to median width ratio of from about 10;

1 to about 200;

1.

9. The shaped material of claim 8 exhibiting osteogenic activity.

10. The shaped material of claim 8 wherein the bone particles are obtained from cortical, cancellous and corticocancellous bone of autogenous allogenic and xenogenic origin.

11. The shaped material of claim 8 wherein the bone particles are obtained from porcine bone.

12. The shaped material of claim 8 further comprising one or more additives selected from the group consisting of plasticizers, flexibilizing agents, biostatic agents, biocidal agents, surface active agents, binding and bonding agents and fillers.

13. The shaped material of claim 8 further comprising at least one additional ingredient selected from the group consisting of antiviral agent, antimicrobial agent, antibiotic agent, amino acid, peptide, vitamin, inorganic element, protein synthesis cofactor, hormone, endocrine tissue, synthesizer, enzyme, polymer-cell scaffolding agent with parenchymal cells, angiogenic drug, demineralized bone powder, collagen lattice, antigenic agent, cytoskeletal agent, mesenchymal stem cells, bone digester, antitumor agent, cellular attractant, fibronectin, growth hormone cellular attachment agent, immunosuppressant, nucleic acid, hydroxy apatite and penetration enhancer.

15. A shaped material comprising a coherent mass of elongate, mechanically entangled, demineralized bone particles wherein at least about 60 weight percent of the bone particles possess a median length to median thickness ratio of from about 50:

1 to about 100;

1 and a median length to median width ratio of from about 50;

1 to about 100;

1.

16. The shaped material of claim 15 exhibiting osteogenic activity.

17. The shaped material of claim 15 wherein the bone particles are obtained from cortical, cancellous and corticocancellous bone of autogenous allogenic and xenogenic origin.

18. The shaped material of claim 15 wherein the bone particles are obtained from porcine bone.

19. The shaped material of claim 15 further comprising one or more additives selected from the group consisting of plasticizers, flexibilizing agents, biostatic agents, biocidal agents, surface active agents, binding and bonding agents and fillers.

20. The shaped material of claim 15 further comprising at least one additional ingredient selected from the group consisting of antiviral agent, antimicrobial agent, antibiotic agent, amino acid, peptide, vitamin, inorganic element, protein synthesis cofactor, hormone, endocrine tissue, synthesizer, enzyme, polymer-cell scaffolding agent with parenchymal cells, angiogenic drug, demineralized bone powder, collagen lattice, antigenic agent, cytoskeletal agent, mesenchymal stem cells, bone digester, antitumor agent, cellular attractant, fibronectin, growth hormone cellular attachment agent, immunosuppressant, nucleic acid, hydroxy apatite and penetration enhancer.

21. The shaped material of claim 15 in the form of a flat sheet, curved sheet, plate, disk, cone, pin, screw or tube.