Plasticized bone and soft tissue grafts and methods of making and using same

• US 9,579,420 B2
• Filed: 02/08/2010
• Issued: 02/28/2017
• Est. Priority Date: 06/30/1998
• Status: Expired due to Fees

• Current Assignee: LifeNet Health, Inc.
• Original Assignee: LifeNet Health, Inc.
• Inventors: Wolfinbarger, Lloyd Jr., O'Leary, Robert K., Anderson, Billy G.
• Primary Examiner(s): Philogene, Pedro
• Assistant Examiner(s): COMSTOCK, DAVID C
• Application Number:
  US12/701,634
• Publication Number:
  US 20110015757A1
• Time in Patent Office: 2,577 Days
• Field of Search: 623/11.11, 623/16.11, 623/23.51, 623/23.58, 623/23.59, 623/23.61, 623/23.63, 424/422, 424/423, 435/1.2, 435/1.3
• US Class Current: 1/1
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• 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 2002/30535 Special structural features of bone or joint prostheses not otherwise provided for
• 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: A61F 2250/0058 Additional features; Implant or prostheses properties not otherwise provided for
• 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 27/362 Skin, e.g. dermal papillae
• 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 present invention provides a plasticized dehydrated or freeze-dried 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 normal hydrated tissue, is not brittle, does not necessitate rehydration prior to clinical implantation and is not a potential source for disease transmission. The invention replaces water in the molecular structure of the bone or soft tissue matrix with one or more plasticizers allowing for dehydration of the tissue, yet not resulting in an increase in brittleness of the plasticized product, and resulting in compressive and/or tensile properties similar to those of normal hydrated bone. Replacement of the chemical plasticizers by water prior to implantation is not required and thus, the dehydrated bone or soft tissue plasticized product can be placed directly into an implant site without significant preparation in the operating room.

Claims

1. A plasticized soft tissue graft suitable for transplantation into a human, comprising:

a cleaned soft tissue graft having an internal matrix; and

one or more plasticizers contained in said internal matrix,

wherein said cleaned soft tissue graft comprise collagen fibers and the native orientation of the collagen fibers is maintained in said plasticized soft tissue graft.

4. The plasticized soft tissue graft of any one of claim 1, 2, or 3, wherein said plasticized soft tissue graft is suitable for direct transplant into a human without rehydration.

5. The plasticized soft tissue graft of any one of claim 1, 2, or 3, wherein said cleaned soft tissue graft is a load-bearing soft tissue graft.

6. The plasticized soft tissue graft of any one of claim 1, 2, or 3, wherein said cleaned soft tissue graft is a non load-bearing soft tissue graft.

7. The plasticized soft tissue graft of any one of claim 1, 2, or 3, wherein said cleaned soft tissue graft is selected from the group consisting of:

dura, pericardium, fascia lata, tendons and ligaments.

8. The plasticized soft tissue graft of any one of claim 1, 2, or 3, wherein said plasticized soft tissue graft is sterile.

9. The plasticized soft tissue graft of any one of claim 1, 2, or 3, wherein said plasticized soft tissue graft does not require refrigeration or freezing.

10. The plasticized soft tissue graft of any one of claim 1, 2, or 3, wherein said plasticizer comprises glycerol.

11. The plasticized soft tissue graft of any one of claim 1, 2, or 3, wherein said plasticized soft tissue graft is suitable for storage at room temperature.

12. The plasticized soft tissue graft of any one of claim 1, 2, or 3, wherein said cleaned soft tissue graft comprises cadaveric skin.

13. The plasticized soft tissue graft of any one of claim 1, 2, or 3, wherein said plasticized soft tissue graft is essentially free from cellular elements.

14. The plasticized soft tissue graft of any one of claim 1, 2, or 3, wherein the plasticized soft tissue graft has mechanical properties approximating mechanical properties of natural soft tissue.

2. A plasticized soft tissue graft, comprising:

a cleaned soft tissue graft; and

one or more plasticizers, wherein said cleaned soft tissue graft is impregnated with said one or more plasticizers, and wherein said cleaned soft tissue graft comprise collagen fibers and the native orientation of the collagen fibers is maintained in said plasticized soft tissue graft.

3. A plasticized soft tissue graft, comprising:

a cleaned, soft tissue graft comprising one or more plasticizers, wherein said cleaned soft tissue graft comprise collagen fibers and the native orientation of the collagen fibers is maintained in said plasticized soft tissue graft.

15. A plasticized load-bearing soft tissue graft, comprising:

a cleaned load-bearing soft tissue graft comprising one or more plasticizers, wherein said cleaned soft tissue graft comprises collagen fibers and the native orientation of the collagen fibers is maintained in said plasticized soft tissue graft.

16. A method for producing a plasticized soft tissue graft suitable for transplantation into a human, comprising:

impregnating a cleaned soft tissue graft with one or more plasticizers to produce a plasticized soft tissue graft, wherein said cleaned soft tissue graft comprise collagen fibers, and the orientation of the collagen fibers is not altered by the step of impregnating, such that the native orientation of the collagen fibers is maintained in said plasticized soft tissue graft.

17. The method of claim 16, said step of impregnating, comprising:

incubating said cleaned soft tissue graft with a plasticizer composition comprising one or more plasticizers and one or more biocompatible solvents.

18. The method of claim 17, wherein incubating comprises soaking said cleaned soft tissue graft in said plasticizer composition.

19. The method of claim 18, wherein said soaking is carried out under negative pressure.

20. The method of claim 17, wherein said one or more biocompatible solvents comprise one or more alcohols.

21. The method of claim 20, wherein said one or more plasticizers are present in said plasticizer composition In a weight ratio of from 30 to 90 wt %, and said one or more alcohols are present in said plasticizer composition in a weight ratio of from 10 to 70 wt %.

22. The method of claim 20, wherein said plasticizer comprises glycerol and said alcohol is isopropyl alcohol.

23. The method of claim 22, wherein said glycerol is present at 30 wt % and said isopropyl alcohol is present at 70 wt %.

24. The method of claim 17, wherein said cleaned soft tissue graft is incubated with said plasticizer composition for at least 30 minutes.

25. The method of claim 17, wherein said cleaned soft tissue graft is incubated with said plasticizer composition by soaking.

26. The method of claim 17, wherein said one or more plasticizers are present in said plasticizer composition in a weight ratio of from 30 to 90 wt %.

27. The method of claim 26, wherein the plasticizer composition comprises glycerol.

28. The method of claim 16, wherein said plasticized soft tissue graft is sterile.

29. The method of claim 16, wherein said plasticized soft tissue graft does not require refrigeration or freezing.

30. The method of claim 16, wherein said plasticizer comprises glycerol.

31. The method of claim 16, wherein said plasticized soft tissue graft is suitable for storage at room temperature.

32. The method of claim 16, wherein said cleaned soft tissue graft comprises cadaveric skin.

33. The method of claim 16, wherein said one or more plasticizers are present in said plasticizer composition in a weight ratio of at least 10 wt %.

34. The method of claim 16, further comprising:

producing said cleaned soft tissue graft by removing cellular elements.

35. The method of claim 16, wherein said step of impregnating comprises replacing water in the soft tissue graft with the one or more plasticizers.

36. The method of claim 16, comprising obtaining said cleaned soft tissue graft by using a detergent composition.