Irradiated implantable bone material

• US 20050244457A1
• Filed: 04/28/2004
• Published: 11/03/2005
• Est. Priority Date: 04/28/2004
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Reddi, A. Hari
• Granted Patent: US 7,678,385 B2
• Time in Patent Office: Days
• US Class Current: 424/425
• 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 2310/00359 Bone or bony tissue
• 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
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders

Abstract

A method for making an implantable bone material. The method includes providing a bone composition consisting essentially of demineralized human bone, and irradiating the composition at a temperature less than about 0° C.

Claims

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

(a) providing a bone composition consisting essentially of demineralized human bone; and

(b) irradiating the composition at a temperature less than about 0°

C.

2. A method according to claim 1, wherein irradiating further comprises cooling the composition using dry ice.

3. A method according to claim 1, wherein irradiating comprises administering a dose of radiation of at least about 1.0 Mrad to the composition.

4. A method according to claim 3, wherein the dose of radiation is from about 2.0 Mrad to about 10 Mrad.

5. A method according to claim 1, wherein irradiating comprises administering a sterilizing dose of radiation to the composition.

6. A method according to claim 1, wherein the composition additionally comprises a carrier.

7. A method according to claim 1, wherein the composition consists of demineralized human bone powder.

8. A method according to claim 1, wherein irradiating comprises selecting a dose of radiation for increasing osteoinductivity by at least two grade scores of the Osteoinduction Grading Scale.

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

adding a biocompatible carrier after irradiating; and

forming the mixture into an article.

10. A method according to claim 9, 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.

11. A method for improving the osteoinductivity of demineralized bone, comprising:

(a) providing a bone composition comprising human demineralized bone having little or no osteoinductivity; and

(b) irradiating the composition at a temperature less than about 0°

C., at a radiation dose sufficient to produce an increase in the osteoinductivity of the composition.

12. A method according to claim 11, wherein the increase in osteoinductivity is manifested by an increase of a grade score for the composition graded according to the Osteoinduction Grading Scale.

13. A method according to claim 12, wherein the grade score is 1 or less prior to irradiating, and the radiation dose is sufficient to increase the grade score of the composition to at least about 2.

14. A method according to claim 11, wherein the human demineralized bone comprises human demineralized bone powder.

15. A method according to claim 11, wherein irradiating comprises administering a sterilizing dose of radiation to the composition.

16. A method according to claim 11, wherein the composition additionally comprises a biocompatible carrier.

17. A method for producing demineralized bone compositions having uniform osteoinductivity, the method comprising:

(a) obtaining bone portions from a plurality of human donor subjects;

(b) demineralizing the bone portions to produce demineralized bone portions; and

(c) irradiating the demineralized bone portions at a temperature less than about 0°

C.

18. A method according to claim 17, wherein the donor subjects are human.

19. A method according to claim 17, wherein the demineralized bone portions comprise bone powder.

20. A method according to claim 17, wherein at least one of the demineralized bone portions has little or no osteoinductivity and irradiating is conducted at a radiation dose sufficient to produce an increase in the osteoinductivity of the at least one demineralized bone portion.

21. A method according to claim 20, wherein the increase in osteoinductivity is manifested by an increase in a grade score of the Osteoinduction Grading Scale for the at least one demineralized bone portion.

22. A method according to claim 21, wherein the grade score is 1 or less prior to irradiating, and irradiating increases the grade score to at least about 2.

23. A method according to claim 17, wherein irradiating comprises administering a sterilizing dose of radiation.

24. An implantable bone material, comprising:

(a) a demineralized bone material; and

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

(i) providing a bone composition consisting essentially of demineralized human bone; and

(ii) irradiating the composition at a temperature less than about 0°

C.

25. A material according to claim 24, wherein the composition is lyophilized.

26. A material according to claim 24, wherein the carrier comprises a bone-derived material.

27. A material according to claim 24, wherein the carrier comprises gelatin.

28. A material according to claim 24, wherein the bone-derived material comprises autoclaved bone powder.

29. A material according to claim 24, additionally comprising a growth factor.

30. A material according to claim 29, additionally comprising a growth factor mimetic.