Heat-treated implantable bone material

• US 20050244450A1
• Filed: 04/28/2004
• Published: 11/03/2005
• Est. Priority Date: 04/28/2004
• Status: Abandoned Application

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Reddi, A. Hari
• Application Number:
  US10/835,519
• Publication Number:
  US 20050244450A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/4644 Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material bone material A61F2/28; disintegrating or milling devices B02C
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/00383 Gelatin
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• 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 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation

Abstract

A method of making an implantable bone material and a product made by the method. The method includes forming a mixture of water and demineralized bone powder comprising collagen, and heating the mixture under non-denaturing conditions.

Claims

1. A method of making an implantable bone material, the method comprising:

(a) forming a mixture of water and demineralized bone comprising collagen;

and

(b) heating the mixture under non-denaturing conditions.

2. A method according to claim 1, wherein heating is conducted under conditions effective to physically alter the collagen.

3. A method according to claim 2, wherein heating is conducted under ambient pressure, at a temperature from about 45°

C. to about 65°

C.

4. A method according to claim 3, wherein the temperature is from about 56°

C. to about 60°

C.

5. A method according to claim 2, wherein heating is conducted for about 1 hour to about 24 hours.

6. A method according to claim 1, additionally comprising removing excess water after heating.

7. A method according to claim 6, additionally comprising irradiating the demineralized bone after removing excess water.

8. A method according to claim 7, wherein said irradiating comprises exposing the demineralized bone to gamma irradiation at a dose of from about 1 to about 10 mRad, while maintaining the demineralized bone a temperature less than about 0°

C.

9. A method according to claim 1, wherein the demineralized bone is human demineralized bone.

10. A method according to claim 1, wherein the mixture is irradiated.

11. A product made by a method according to claim 1.

12. A method according to claim 1, wherein heating comprises heating below a temperature effective to create gelatin from collagen.

13. A method according to claim 1, wherein heating comprises heating for about six hours.

14. A method according to claim 1, further comprising lyophilizing the mixture to a dry powder after heating.

15. A method according to claim 13, further comprising dissolving the dry powder in a solution suitable for injection.

16. A method according to claim 1, further comprising:

(a) adding a biocompatible carrier after heating; and

(b) forming the mixture into an article.

17. A method according to claim 15, wherein the article is selected from the group consisting of a sheet, an elongated member, a plate, a plug, a ball, and a porous member.

18. A method according to claim 1, further comprising:

(a) adding a biocompatible carrier after heating; and

(b) forming the mixture into formable putty.

19. A method according to claim 1, further comprising:

(a) after heating maintaining the mixture at a freezing temperature; and

(b) irradiating the mixture.

20. A method according to claim 18, wherein maintaining the mixture at a freezing temperature comprises freezing at temperature below about 0°

C.

21. A method according to claim 18, further comprising packaging the mixture in dry ice.

22. A method according to claim 18, wherein irradiating comprises irradiating at a dose of about 1 to 10 Mrad.

23. An implantable bone material made by a method according to claim 18.

24. A method according to claim 1, wherein the demineralized bone powder further comprises non-collagenous proteins.

25. A method according to claim 1, wherein forming a mixture of water and demineralized bone powder comprising collagen, comprises forming by a process consisting essentially of demineralizing bone powder and mixing the demineralized bone powder with water.

26. An implantable bone material composition, comprising:

(a) a demineralized bone material; and

(b) a pharmaceutically-acceptable carrier, wherein the demineralized bone material is made by a process comprising;

(i) forming a mixture of water and demineralized bone powder comprising collagen, by a process consisting essentially of demineralizing bone powder and mixing said powder with water; and

(ii) heating the mixture under non-denaturing conditions.

27. A method according to claim 26, wherein heating is conducted under conditions effective to physically alter the collagen.

28. A method according to claim 27, wherein heating is conducted under ambient pressure, at a temperature from about 45°

C. to about 65°

C.

29. The composition of claim 26, wherein the composition is lyophilized.

30. The composition of claim 26, wherein the carrier comprises a bone-derived material.

31. The composition of claim 28, wherein the carrier comprises gelatin.

32. The composition of claim 28, wherein the bone-derived material comprises autoclaved bone powder.