[미국특허]
Plasticized bone and soft tissue grafts and methods of making and using same
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61F-002/28
A61L-027/36
A61F-002/46
A61L-027/50
A61F-002/30
A61F-002/02
출원번호
US-0701634
(2010-02-08)
등록번호
US-9579420
(2017-02-28)
발명자
/ 주소
Wolfinbarger, Jr., Lloyd
O'Leary, Robert K.
Anderson, Billy G.
출원인 / 주소
Lifenet Health
대리인 / 주소
RatnerPrestia
인용정보
피인용 횟수 :
0인용 특허 :
121
초록▼
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 no
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.
대표청구항▼
1. A plasticized soft tissue graft suitable for transplantation into a human, comprising: a cleaned soft tissue graft having an internal matrix; andone or more plasticizers contained in said internal matrix,wherein said cleaned soft tissue graft comprise collagen fibers and the native orientation of
1. A plasticized soft tissue graft suitable for transplantation into a human, comprising: a cleaned soft tissue graft having an internal matrix; andone 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. 2. A plasticized soft tissue graft, comprising: a cleaned soft tissue graft; andone 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. 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. 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.
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