Plasticized bone grafts and methods of making and using same

• US 7,063,726 B2
• Filed: 11/07/2002
• Issued: 06/20/2006
• Est. Priority Date: 06/30/1998
• Status: Expired due to Term

• Current Assignee: LifeNet Health, Inc.
• Original Assignee: LifeNet Health, Inc.
• Inventors: Ford, Louis, O'Leary, Robert, Wolfinbarger, Lloyd, Crouch, Katrina
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): Priddy, Michael B.
• Application Number:
  US10/289,574
• Publication Number:
  US 20030135284A1
• Time in Patent Office: 1,321 Days
• Field of Search: 623/23.61
• US Class Current: 623/23.61
• 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 2002/2825 Femur
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/4646 Devices for cleaning bone graft
• CPC Class Codes: A61F 2002/4649 Bone graft or bone dowel harvest sites
• 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 27/3683 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 27/502 Plasticizers

Abstract

The invention provides a plasticized bone and/or soft tissue product that does not require special conditions of storage, for example refrigeration or freezing, exhibits materials properties that approximate those properties present in natural tissue, is not brittle, does not necessitate rehydration prior to clinical implantation and is not a potential source for disease transmission. Replacement of the chemical plasticizers by water prior to implantation is not required and thus, the plasticized bone or soft tissue product can be placed directly into an implant site without significant preparation in the operating room.

Claims

1. A method for producing a plasticized, load-bearing, bone graft, comprising:

incubating a cleaned, non-demineralized, load-bearing, bone graft with one or more plasticizer compositions comprising one or more plasticizers and one or more biocompatible solvents without altering orientation of collagen fibers.

2. The method of claim 1, said cleaned, non-demineralized, load-bearing, bone graft is essentially free from bone marrow elements.

3. The method of claim 1, said one or more biocompatible solvents comprise one or more alcohols.

4. The method of claim 3, said plasticizer is glycerol and said one or more alcohols is isopropyl alcohol.

5. The method of claim 1, said one or more plasticizers are present in said plasticizer composition at a concentration of from about 50% v/v to about 100% v/v and said one or more biocompatible solvents are present in said plasticizer composition at a concentration of from about 50% v/v to about 0% v/v.

6. The method of claim 4, said glycerol is present at about 80% v/v and said isopropyl alcohol is present at about 20% v/v.

7. The method of claim 5, said one or more plasticizers are present in said plasticizer composition at a concentration of from about 60% v/v to about 90% v/v and said one or more biocompatible solvents are present in said plasticizer composition at a concentration of from about 40% v/v to about 10% v/v.

8. The method of claim 7, said soaking is carried out under negative or positive pressure.

9. The method of claim 8, said incubating is carried out under negative pressure.

10. The method of claim 9, said negative pressure is from about 10 to about 50 mBarr for a period of time of from about 18 to about 36 hours.

11. The method of claim 1, said incubating comprising:

soaking said cleaned, non-demineralized, load-bearing, bone graft in said one or more plasticizer compositions.

12. The method of claim 1, said incubating comprising:

sonicating said cleaned, non-demineralized, load-bearing, bone graft with said one or more plasticizer compositions.

13. The method of claim 1, said incubating comprising:

agitating said cleaned, non-demineralized, load-bearing, bone graft with said one or more plasticizer compositions.

14. The method of any one of claims 7, 8, 12, or 13, said incubating is carried out under conditions sufficient to impregnate said bone graft with said one or more plasticizers.

15. The method of any one of claims 7, 8, 12, or 13, said incubating is carried out for a time sufficient to impregnate said bone graft with said one or more plasticizers.

16. A plasticized, non-demineralized load-bearing, bone graft produced by the process as claimed in any one of claims 1, 5, 6, 8, 12, or 13.

17. The method of claim 1, said incubating comprising:

centrifuging said cleaned, non-demineralized, load-bearing, bone graft with said one or more plasticizer compositions.

18. The method of claim 17, said centrifuging comprising centrifuging said cleaned, non-demineralized, load-bearing, bone graft with said one or more plasticizer compositions at a speed of from about 2,000 to 3,000 rpm for a time of from about 10 minutes to about 7 hours.

19. The method of claim 18, said speed is about 2,600 rpm and said time is from about 30 minutes to about 5 hours.

20. The method of claim 19, said centrifuging is carried out at a temperature of about 25°

C.

21. A method for producing a plasticized, load-bearing, bone graft, comprising;

subjecting a cleaned, non-demineralized, load-bearing, bone graft with one or more plasticizer compositions comprising one or more plasticizers and one or more biocompatible solvents to negative pressure under conditions sufficient to impregnate said bone graft with said one or more plasticizers.

25. A plasticized, non-demineralized load-bearing, bone graft produced by the process as claimed in any one of claims 21, 22, 23, or 24.

22. A method for producing a plasticized, load-bearing, bone graft, comprising;

subjecting a cleaned, non-demineralized, load-bearing, bone graft with one or more plasticizer compositions comprising one or more plasticizers and one more biocompatible solvents to negative pressure of from about 10 to about 50 mBarr for a period of time of from about 18 to about 36 hours, to produce an impregnated bone graft.

26. The method of any one of claims 22, or 24, further comprising:

removing excess plasticizer from said impregnated bone grafts to produce a plasticized bone graft; and

vacuum packaging said plasticized bone graft.

27. The method of claim 26, said removing comprising centrifuging.

28. The method of claim 26, said removing comprising blotting.

23. A method for producing a plasticized, load-bearing, bone graft, comprising:

centrifuging a cleaned, non-demineralized, load-bearing, bone graft with one or more plasticizer compositions comprising one or more plasticizers and one or more biocompatible solvents, under conditions sufficient to impregnate said bone graft with said one or more plasticizers.

24. A method for producing a plasticized, load-bearing, bone graft, comprising:

centrifuging a cleaned, non-demineralized, load-bearing, bone graft with one or more plasticizer compositions comprising one or more plasticizers and one or more biocompatible solvents, at a speed of from about 2,000 to about 3,000 rpm for a period of time of from about 30 minutes to about 5 hours, to produce an impregnated bone graft.