Claims for Patent: 7,291,179

Summary for Patent: 7,291,179

Title:	Bone graft substitute composition
Abstract:	Bone graft substitute compositions and methods of making the compositions are disclosed. In some embodiments, a method of making a composition includes contacting a mixing solution with a first mixture having calcium sulfate hemihydrate and a plasticizing material to form a second mixture; waiting a predetermined period of time after forming said second mixture; and then contacting demineralized bone with the second mixture to form the composition. A composition can be formed from a kit including a first mixture having calcium sulfate hemihydrate and a plasticizing substance, a second mixture having demineralized bone, and a mixing solution. The first and second mixtures and the mixing solution are unblended.
Inventor(s):	Miller; Leasa C. (Covington, TN), Richelsoph; Kelly Coupe (Memphis, TN), Moseley; Jon P. (Arlington, TN)
Assignee:	Wright Medical Technology, Inc. (Arlington, TN)
Application Number:	10/448,885
Patent Claims:	1. A method of making a composition, comprising: contacting a mixing solution with a first mixture comprising calcium sulfate hemihydrate and a plasticizing material to form a second mixture; waiting a predetermined period of time after forming said second mixture, wherein said predetermined period of time is at least about thirty seconds after the second mixture is formed; and then contacting demineralized bone with the second mixture to form the composition. 2. The method of claim 1, wherein said predetermined period of time is at least about one minute after the second mixture is formed. 3. The method of claim 1, wherein the first mixture further comprises a first material that accelerates formation of calcium sulfate dihydrate from the calcium sulfate hemihydrate. 4. The method of claim 3, wherein the first material comprises calcium sulfate dihydrate. 5. The method of claim 4, wherein the calcium sulfate dihydrate is coated with sucrose. 6. The method of claim 1, wherein the plasticizing material comprises a material selected from a group consisting of sodium carboxymethylcellulose, methylcellulose, hydroxypropylcellulose, ethylcellulose, hydroxyethylcellulose, cellulose acetate butyrate, glycerol, vinyl alcohols, stearic acid, and hyaluronic acid. 7. The method of claim 1, wherein the plasticizing material comprises hydroxypropylmethylcellulose. 8. The method of claim 1, wherein the calcium sulfate hemihydrate is surgical grade. 9. The method of claim 1, wherein the mixing solution comprises sterile water. 10. The method of claim 1, wherein the composition comprises 100 parts of calcium sulfate hemihydrate; about 0.5 to about 5 parts of the plasticizing material; and about 10 to about 30 parts of demineralized bone. 11. The method of claim 1, wherein the composition comprises 100 parts of calcium sulfate hemihydrate; about 1 to about 3 parts of the plasticizing material; and about 15 to about 25 parts of demineralized bone. 12. A method of making a composition, comprising: contacting sterile water with a first mixture comprising surgical-grade calcium sulfate hemihydrate, calcium sulfate dihydrate, and hydroxymethylcellulose to form a second mixture; waiting a predetermined period of time after forming said second mixture, wherein said predetermined period of time is at least about thirty seconds after said second mixture is formed; and then contacting demineralized bone with the second mixture to form the composition. 13. The method of claim 12, wherein the composition comprises 100 parts of calcium sulfate hemihydrate; about 0.5 to about 5 parts of calcium sulfate dihydrate; about 0.5 to about 5 parts of hydroxymethylcellulose; and about 10 to about 30 parts of demineralized bone. 14. The method of claim 12, wherein the composition comprises 100 parts of calcium sulfate hemihydrate; about 3 to about 5 parts of calcium sulfate dihydrate; about 1 to about 3 parts of hydroxymethylcellulose; and about 15 to about 25 parts of demineralized bone. 15. The method of claim 14, wherein the demineralized bone is contacted with the second mixture at least about one minute after the second mixture is formed. 16. A kit, comprising: a first mixture comprising calcium sulfate hemihydrate and a plasticizing substance; a second mixture comprising demineralized bone, the second mixture being unblended with the first mixture; and a mixing solution unblended with the first and second mixtures. 17. The kit of claim 16, wherein the first mixture further comprises a first material capable of accelerating formation of calcium sulfate dihydrate from the calcium sulfate hemihydrate. 18. The kit of claim 17, wherein the first material comprises calcium sulfate dihydrate. 19. The kit of claim 18, wherein the calcium sulfate dihydrate is coated with sucrose. 20. The kit of claim 16, wherein the plasticizing material comprises hydroxypropylmethylcellulose. 21. The kit of claim 16, wherein the plasticizing material comprises a material selected from a group consisting of sodium carboxymethylcellulose, methylcellulose, hydroxypropylcellulose, ethylcellulose, hydroxyethylcellulose, cellulose acetate butyrate, glycerol, vinyl alcohols, stearic acid, and hyaluronic acid. 22. The kit of claim 16, wherein the mixing solution comprises sterile water. 23. The kit of claim 16, wherein the mixing solution comprises a material selected from a group consisting of sodium chloride, phosphate buffered saline, potassium chloride, sodium sulfate, potassium sulfate, EDTA, ammonium sulfate, ammonium acetate, and sodium acetate. 24. The kit of claim 16, comprising: 100 parts of calcium sulfate hemihydrate; about 0.5 to about 5 parts of the plasticizing material; and about 10 to about 30 parts of the demineralized bone. 25. The kit of claim 16, comprising 100 parts of calcium sulfate hemihydrate; about 1 to about 3 parts of the plasticizing material; and about 15 to about 25 parts of the demineralized bone. 26. A kit, comprising: a first mixture comprising surgical-grade calcium sulfate hemihydrate, calcium sulfate dihydrate, and hydroxypropylmethylcellulose; a second mixture comprising demineralized bone, the second mixture being unblended with the first mixture; and a mixing solution comprising sterile water unblended with the first and second mixtures. 27. The kit of claim 26, comprising: 100 parts of calcium sulfate hemihydrate; about 0.5 to about 5 parts of calcium sulfate dihydrate; about 0.5 to about 5 parts of hydroxymethylcellulose; and about 10 to about 30 parts of demineralized bone. 28. The kit of claim 26, comprising: 100 parts of calcium sulfate hemihydrate; about 1 to about 4 parts of calcium sulfate dihydrate; about 1 to about 3 parts of hydroxymethylcellulose; and about 15 to about 25 parts of demineralized bone.

Details for Patent 7,291,179

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		2022-06-24