Osteogenic implants with combined implant materials, and materials and methods for same
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61F-002/00
A61F-002/02
A61F-002/28
A61K-038/00
A61K-038/16
A61K-038/17
A61K-038/18
C07K-014/78
C07K-014/51
출원번호
UP-0361026
(2006-02-23)
등록번호
US-7722895
(2010-06-14)
발명자
/ 주소
McKay, William F.
Boden, Scott D.
Beals, Neil
출원인 / 주소
Warsaw Orthopedic, Inc.
인용정보
피인용 횟수 :
15인용 특허 :
21
초록▼
Described are osteogenic implants that include a first implant material covered at least in part by a second implant material carrying an osteogenic protein such as a bone morphogenic protein. The first implant material can comprise a mineral and provide an inner scaffolding portion for supporting b
Described are osteogenic implants that include a first implant material covered at least in part by a second implant material carrying an osteogenic protein such as a bone morphogenic protein. The first implant material can comprise a mineral and provide an inner scaffolding portion for supporting bone ingrowth, and the second implant material can comprise a collagen or other sponge carrier covering the first implant material and having a liquid osteogenic protein formulation imbibed therein. Related implant materials and methods of preparation and use constitute additional aspects of the invention.
대표청구항▼
What is claimed is: 1. An osteogenic implant for promoting bone growth between first and second bone surfaces, comprising: a first resorbable implant material defining an implant body configured for receipt between the first and second bone surfaces, said first resorbable implant material comprisin
What is claimed is: 1. An osteogenic implant for promoting bone growth between first and second bone surfaces, comprising: a first resorbable implant material defining an implant body configured for receipt between the first and second bone surfaces, said first resorbable implant material comprising a porous collagenous matrix containing mineral particles, said implant body having an outer surface, the first resorbable implant material being substantially free of an osteogenic protein; a second resorbable implant material wrapped around at least a portion of said outer surface of said implant body and positioned to contact said first and second bone surfaces, said second resorbable implant material comprising a porous collagen sheet and being substantially free from mineral particles; and an osteogenic protein carried by said second resorbable implant material. 2. The osteogenic implant of claim 1, wherein: said implant body is dimensioned for receipt between adjacent upper and lower transverse processes in a human spine. 3. The osteogenic implant of claim 1, wherein: said osteogenic protein is a bone morphogenic protein (BMP). 4. The osteogenic implant of claim 3, wherein: said BMP is BMP-2 or BMP-7. 5. The osteogenic implant of claim 4, wherein: said BMP is BMP-2. 6. The osteogenic implant of claim 5, wherein: said BMP-2 is recombinant human BMP-2. 7. The osteogenic implant of claim 1, wherein: said implant body is configured for receipt between adjacent transverse processes in a human spine; and said osteogenic protein is a BMP. 8. The osteogenic implant of claim 7, wherein: said BMP is BMP-2. 9. The osteogenic implant of claim 8, wherein: said BMP-2 is recombinant human BMP-2. 10. The osteogenic implant of claim 1, wherein: said mineral particles comprise bone. 11. The osteogenic implant of claim 1, wherein: said mineral particles comprise synthetic ceramic. 12. The osteogenic implant of claim 11, wherein: said synthetic ceramic comprises tricalcium phosphate. 13. The osteogenic implant of claim 12, wherein: said synthetic ceramic comprises biphasic calcium phosphate. 14. The osteogenic implant of claim 13, wherein: said biphasic calcium phosphate has a weight ratio of tricalcium phosphate to hydroxyapatite of about 50:50 to about 95:5. 15. The osteogenic implant of claim 14, wherein: said ratio of tricalcium phosphate to hydroxyapatite is about 80:20 to about 90:10. 16. The osteogenic implant of claim 15, wherein: said ratio of tricalcium phosphate to hydroxyapatite is about 15:85. 17. The osteogenic implant of claim 3, wherein: said BMP is substantially homogeneously incorporated in said second resorbable implant material. 18. The osteogenic implant of claim 17, wherein: said BMP is incorporated in said second resorbable implant material in an amount providing a BMP concentration of at least about 0.4 mg per cc of the second resorbable implant material. 19. The osteogenic implant of claim 18, wherein: said level is in the range of about 0.6 mg per cc to about 4 mg per cc of the second resorbable implant material. 20. The osteogenic implant of claim 1, wherein: said second resorbable implant material comprises a collagenous sponge sheet. 21. An implant configured to promote posterolateral spinal fusion between first and second transverse processes in a patient, comprising: a first resorbable implant material defining an implant body configured for receipt between the first and second transverse processes, said first resorbable implant material comprising a porous collagen-containing matrix incorporating mineral particles, said implant body having an outer surface, the first resorbable implant material being free of a bone morphogenic protein; a collagen sponge sheet wrapped around at least a portion of said outer surface of said implant body and positioned to contact the first and second transverse processes, said collagen sponge sheet being substantially free from mineral particles; and a bone morphogenic protein (BMP) incorporated in said collagen sponge sheet. 22. The implant of claim 21, wherein: said collagen sponge sheet comprises the BMP at a concentration of about 0.6 mg/cc to about 4 mg/cc. 23. The implant of claim 22, wherein: said BMP is BMP-2. 24. The implant of claim 23, wherein: said BMP-2 is recombinant human BMP-2. 25. The implant of claim 22, wherein: said implant has a total dose of said BMP not exceeding about 12 mg. 26. The implant of claim 25, wherein: said implant has a total dose of BMP of about 1 mg to about 12 mg. 27. A medical implant for promoting bone growth between first and second bone surfaces, comprising: a first bioresorbable implant material comprising mineral and configured to occupy a volume for bone in growth between the first and second bone surfaces; and a second bioresorbable implant material comprising a porous collagen sponge matrix sheet and wrapped around at least a portion of said first implant material, said second bioresorbable implant material configured to contact the first and second bone surfaces, said porous collagen sponge sheet being substantially free from mineral particles; said medical implant comprising a total amount of osteogenic factor, and wherein all of said total amount of osteogenic factor is localized to said second bioresorbable implant material. 28. An implant suitable for carrying an osteogenic protein to induce bone growth between first and second bone surfaces in a patient, the implant comprising: a first resorbable implant material defining an implant body configured for receipt between the first and second bone surfaces, said first resorbable implant material comprising a porous collagenous matrix containing mineral particles, said implant body having an outer surface, the first resorbable implant material being free of an osteogenic protein; and a second resorbable implant material effective to carry an osteogenic protein and to wrap around at least a portion of said outer surface of said implant body and be positioned to contact the first and second bone surfaces, wherein the second resorbable implant material comprises a porous collagen matrix sheet that is substantially free from mineral particles and contains the osteogenic protein. 29. The implant of claim 28, which is configured for receipt between and contacting adjacent upper and lower transverse processes of a human spine. 30. A medical kit for promoting bone growth between first and second bone surfaces of a patient, comprising: a first resorbable implant material comprising a matrix having particulate mineral embedded therein, the first resorbable implant material being substantially free of an osteogenic protein; a second resorbable implant material configured to wrap around at least a portion of a surface of the first resorbable implant material, said second resorbable implant material comprising a porous collagen sheet that is substantially free from mineral particles; and an osteogenic protein contained in the collagen sheet. 31. The medical kit of claim 30, wherein: said first and second resorbable implant materials are dimensioned to form an implant configured for receipt between and contacting adjacent upper and lower transverse processes of a human spine. 32. A medical implant for promoting bone growth, comprising: an outer osteogenic implant material, the outer osteogenic implant material including a wetted, porous bioresorbable sponge sheet having absorbed therein an aqueous medium including an osteogenic protein, said outer osteogenic implant material not containing an osteoconductive mineral component; and an inner scaffolding implant material including an osteoconductive mineral component, the inner scaffolding implant material being substantially free of the osteogenic protein and configured to occupy a three-dimensional volume for bone ingrowth initiated by said outer osteogenic implant material, wherein said outer osteogenic implant material is wrapped around said inner scaffolding implant material. 33. The medical implant of claim 32, wherein said medical implant includes a total dose of said osteogenic protein, and wherein all of said total dose is retained by said outer osteogenic implant material. 34. The medical implant of claim 32, wherein the osteogenic protein is a bone morphogenic protein. 35. The medical implant of claim 34, wherein the bone morphogenic protein is BMP-2 or BMP-7. 36. A method for inducing bone growth in a patient, comprising implanting the osteogenic implant of any of claim 1-20, 21-27, 28, or 29 into a patient at a site so as to induce bone growth. 37. A method for inducing bone growth in a patient, comprising implanting the medical implant of any of claims 32-35 into a patient at a site so as to induce bone growth. 38. A method for inducing spinal fusion between first and second bone surfaces in a patient, the method comprising implanting the implant of any of claim 2, 7, 21-26, 29, or 31 between adjacent upper and lower transverse processes of a human spine, such that the implant occupies a volume for bone growth to create a fusion mass between the adjacent upper and lower transverse processes of the human spine.
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