Claims for Patent: 7,981,156

Summary for Patent: 7,981,156

Title:	Bone grafts
Abstract:	Spinal spacers 20 are provided for fusion of a motion segment. The spacers include a load bearing member 21 having a wall 22 sized for engagement within a space between adjacent vertebrae to maintain the space and an effective amount of an osteogenic composition to stimulate osteoinduction. The osteogenic composition includes a substantially pure osteogenic factor in a pharmaceutically acceptable carrier. In one embodiment the load bearing member includes a bone graft impregnated in an osteogenic composition. In another embodiment, the osteogenic composition 30 is packed within a chamber 25 defined in the graft. Any suitable configuration of a bone graft is contemplated, including bone dowels, D-shaped spacers and cortical rings.
Inventor(s):	Pafford; John (Germantown, TN), Boyd; Lawrence M. (Memphis, TN), McKay; William F. (Memphis, TN), Ray, III; Eddie F. (Cordova, TN), Van Hoeck; James E. (Cordova, TN)
Assignee:	Warsaw Orthopedic, Inc. (Warsaw, IN)
Application Number:	10/781,058
Patent Claims:	1. A spinal spacer for insertion into a disc space between adjacent vertebrae, said spacer comprising a cylindrical bone dowel configured for engagement within a concave space cut in the adjacent vertebrae, said bone dowel comprising a cortical bone section cut from a bone of a donor, said cortical bone section having impregnated therein an effective amount of a first osteogenic composition including a first substantially pure osteogenic factor. 2. The spacer of claim 1 wherein said osteogenic factor is a purified bone morphogenic protein isolated from bone. 3. The spacer of claim 1 wherein said osteogenic factor is selected from the group consisting of BMP-1, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, a mixture thereof and a heterodimer thereof. 4. The spacer of claim 1 wherein the bone dowel is configured with threads for engaging in the concave space cut in the adjacent vertebrae. 5. The spacer of claim 1 wherein the bone dowel is configured to be impacted into the concave space. 6. The spacer of claim 1 wherein said osteogenic factor is a recombinant human protein. 7. The spacer of claim 6 wherein said osteogenic factor is rhBMP-2, rhBMP-4, rhBMP-7 or a mixture or heterodimer thereof. 8. The spacer of claim 1 wherein said dowel is porous and said first osteogenic composition is contained within said pores. 9. The spacer of claim 1 wherein said bone dowel defines a chamber. 10. The spacer of claim 9 wherein said bone dowel is obtained from the diaphysis of a long bone having a medullary canal and wherein the chamber comprises a portion of said medullary canal. 11. The spacer of claim 9 further comprising an effective amount of a second osteogenic composition to stimulate osteoinduction, said second composition packed within said chamber. 12. The spacer of claim 11 wherein said second osteogenic composition includes a pharmaceutically acceptable carrier having a length which is greater than a length of said chamber and said second osteogenic composition is disposed within said chamber to contact the endplates of adjacent vertebrae when the spacer is implanted between the vertebrae. 13. The spacer of claim 12 wherein said second osteogenic composition is selected from the group consisting of autograft, allograft, demineralized bone, calcium phosphate ceramics, and an osteoinductive factor disposed within a pharmaceutically acceptable matrix. 14. The spacer of claim 12 wherein said carrier is provided as a sponge, a strip, or a sheet. 15. The spacer of claim 1 wherein said bone dowel includes an anterior wall and said anterior wall defines a tool engaging hole for receiving an implanting tool. 16. The spacer of claim 1 wherein said bone dowel has an outer surface defining a thread, said thread including plurality of teeth each tooth of the plurality of teeth having a crest between a leading flank and an opposite trailing flank. 17. The spacer of claim 16 wherein said crest of each said tooth is flat. 18. The spacer of claim 16 wherein said dowel includes a tool engaging portion defining a tool engaging hole for receiving an implanting tool. 19. The spacer of claim 18 wherein said tool engaging hole is threaded to receive a threaded implanting tool. 20. The spacer of claim 1 wherein said first osteogenic factor is provided in a pharmaceutically acceptable carrier. 21. The spacer of claim 20 wherein said carrier is physiological saline. 22. The spacer of claim 20 wherein said carrier is buffered sterile water. 23. A spinal spacer for insertion into a disc space, said spacer comprising a bone graft comprising a cortical bone section cut from a bone of a donor, said cortical bone section having impregnated therein an effective amount of a first osteogenic composition including a first substantially pure osteogenic factor, said bone graft including a chamber and having a wall sized to maintain a desired disc space height, and an effective amount of a second osteogenic composition including a second substantially pure osteogenic factor packed within said chamber. 24. The spacer of claim 23 wherein said bone graft is obtained from the diaphysis of a long bone having a medullary canal. 25. The spacer of claim 23 wherein at least one of said first and second osteogenic factors comprises a purified bone morphogenic protein isolated from bone. 26. The spacer of claim 25 wherein at least one of said first and second osteogenic factors is selected from the group consisting of BMP-1, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, a mixture thereof and a heterodimer thereof. 27. The spacer of claim 23 wherein at least one of said first and second osteogenic factors comprises a recombinant human bone morphogenic protein. 28. The spacer of claim 27 wherein said bone morphogenic protein is rhBMP-2, rhBMP-4, rhBMP-7, or a mixture or heterodimer thereof. 29. The spacer of claim 23 wherein said second osteogenic factor is provided in a pharmaceutically acceptable matrix packed within said chamber. 30. The spacer of claim 29 wherein said matrix is selected from the group consisting of calcium sulphates, polylactic acids, polyanhydrides, collagen, calcium phosphates, polymeric acrylic esters, and mixtures thereof. 31. The spacer of claim 29 wherein said matrix is a biphasic calcium phosphate ceramic including hydroxyapatite and tricalcium phosphate. 32. The spacer of claim 31 wherein the ratio of hydroxyapatite to tricalcium phosphate is between about 0:100 and about 65:35. 33. The spacer of claim 29 wherein said pharmaceutically-acceptable matrix is provided as a sponge, a strip, or a sheet. 34. The spacer of claim 23 wherein said spacer includes a tool engaging hole for receiving an implanting tool. 35. The spacer of claim 34 wherein said tool engaging hole is threaded. 36. The spacer of claim 23 wherein said spacer comprises an outer surface defining a thread. 37. The spacer of claim 36 wherein said thread has a flat crest having a width of between about 0.020 inches and about 0.030 inches. 38. The spacer of claim 36 wherein said thread has a leading flank and a trailing flank defining an angle therebetween of between about 50 degrees and about 70 degrees. 39. The spacer of claim 36 wherein each said thread has a height between about 0.030 inches and about 0.045 inches. 40. The spacer of claim 23 wherein said graft is a cortical ring obtained by a cross-sectional slice of the diaphysis, said ring including superior and inferior surfaces and wherein at least one of said first and second osteogenic factors comprises a bone morphogenic protein. 41. The spacer of claim 40 adapted to withstand a compressive force of at least 10,000 N. 42. The spacer of claim 41 adapted to withstand a compressive force of at least 20,000 N. 43. The spacer of claim 40 adapted to exhibit a fatigue strength of at least 3200 N at five million cycles. 44. The spacer of claim 43 adapted to exhibit a fatigue strength of at least 7000 N at five million cycles. 45. The spacer of claim 23 wherein said wall comprising a thru-hole into said chamber.

Details for Patent 7,981,156

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2015-10-16