Claims for Patent: 7,371,409

Summary for Patent: 7,371,409

Title:	Bone graft substitute composition
Abstract:	A bone graft substitute composition can include essentially of calcium sulfate, a mixing solution, and a plasticizing substance. A bone graft substitute composition can include calcium sulfate, demineralized bone matrix, cancellous bone, a plasticizing substance, and a mixing solution.
Inventor(s):	Petersen; Donald W. (Bessemer, AL), Blum; Barbara E. (Memphis, TN)
Assignee:	Wright Medical Technology, Inc. (Arlington, TN)
Application Number:	09/947,833
Patent Claims:	1. A bone graft substitute composition, comprising: about 80 to about 120 parts by weight of calcium sulfate; about 10 to about 100 parts by weight of demineralized bone matrix; about 20 to about 130 parts by weight of cancellous bone; about 1 to about 40 parts by weight of a plasticizing substance; and about 21 to about 250 parts by weight of a mixing solution, wherein the cancellous bone has a particle size between about 1 and about 4 mm. 2. The composition of claim 1, wherein the calcium sulfate comprises calcium sulfate hemihydrate. 3. The composition of claim 1, wherein the plasticizing substance comprises a cellulose derivative. 4. The composition of claim 1, wherein the plasticizing substance is selected from a group consisting of sodium carboxymethylcellulose, methylcellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, ethylcellulose, hydroxyethylcellulose, and cellulose acetate butyrate. 5. The composition of claim 1, wherein the mixing solution is selected from a group consisting of sterile water, inorganic salt, and cationic surface active agent. 6. The composition of claim 5, wherein the cationic surface active agent is selected from a group consisting of sodium chloride, phosphate buffered saline, potassium chloride, sodium sulfate, ammonium sulfate, ammonium acetate, and sodium acetate. 7. The composition of claim 1, wherein the mixing solution comprises sterile water. 8. The composition of claim 1, wherein the mixing solution comprises a material selected from a group consisting of bone marrow aspirate, platelet concentrate, blood, an antibiotic, a chemotherapeutic agent, a growth factor, and an analgesic. 9. The composition of claim 1, comprising: about 90 to about 110 parts by weight of calcium sulfate; about 10 to about 50 parts by weight of demineralized bone matrix; about 15 to about 50 parts by weight of cancellous bone; about 5 to about 20 parts by weight of a plasticizing substance; and about 80 to about 120 parts by weight of a mixing solution. 10. The composition of claim 1, comprising: about 98 to about 102 parts by weight of calcium sulfate; about 13 to about 23 parts by weight of demineralized bone matrix; about 37 to about 46 parts by weight of cancellous bone; about 15 to about 20 parts by weight of a plasticizing substance; and about 95 to about 105 parts by weight of a mixing solution. 11. The composition of claim 1, comprising: about 100 parts by weight of calcium sulfate; about 18 to about 19 parts by weight of demineralized bone matrix; about 40 to about 42 parts by weight of cancellous bone; about 17 to about 18 parts by weight of a plasticizing substance; and about 101 to about 102 parts by weight of a mixing solution. 12. A bone graft substitute composition, comprising: about 80 to about 120 parts by weight of calcium sulfate; about 10 to about 120 parts by weight of demineralized bone matrix; about 20 to about 150 parts by weight of cancellous bone; about 1 to about 40 parts by weight of a plasticizing substance; and about 50 to about 300 parts by weight of a mixing solution, wherein the cancellous bone has a particle size between about 4 and about 10 mm. 13. The composition of claim 12, wherein the calcium sulfate comprises calcium sulfate hemihydrate. 14. The composition of claim 12, wherein the plasticizing substance comprises a cellulose derivative. 15. The composition of claim 12, wherein the plasticizing substance is selected from a group consisting of sodium carboxymethylcellulose, methylcellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, ethylcellulose, hydroxyethylcellulose, and cellulose acetate butyrate. 16. The composition of claim 12, wherein the mixing solution is selected from a group consisting of sterile water, inorganic salt, and cationic surface active agent. 17. The composition of claim 16, wherein the cationic surface active agent is selected from a group consisting of sodium chloride, phosphate buffered saline, potassium chloride, sodium sulfate, ammonium sulfate, ammonium acetate, and sodium acetate. 18. The composition of claim 12, wherein the mixing solution comprises sterile water. 19. The composition of claim 12, wherein the mixing solution comprises a material selected from a group consisting of bone marrow aspirate, platelet concentrate, blood, an antibiotic, a chemotherapeutic agent, a growth factor, and an analgesic. 20. The composition of claim 12, comprising: about 90 to about 110 parts by weight of calcium sulfate; about 10 to about 60 parts by weight of demineralized bone matrix; about 40 to about 120 parts by weight of cancellous bone; about 5 to about 20 parts by weight of a plasticizing substance; and about 140 to about 180 parts by weight of a mixing solution. 21. The composition of claim 12, comprising: about 98 to about 102 parts by weight of calcium sulfate; about 25 to about 35 parts by weight of demineralized bone matrix; about 44 to about 110 parts by weight of cancellous bone; about 15 to about 20 parts by weight of a plasticizing substance; and about 160 to about 170 parts by weight of a mixing solution. 22. The composition of claim 12, comprising: about 100 parts by weight of calcium sulfate; about 30 to about 32 parts by weight of demineralized bone matrix; about 99 to about 105 parts by weight of cancellous bone; about 17 to about 18 parts by weight of a plasticizing substance; and about 162 to about 168 parts by weight of a mixing solution. 23. A kit for making a bone graft substitute composition, the kit comprising: a first portion comprising: about 80 to about 120 parts by weight of calcium sulfate; about 10 to about 120 parts by weight of demineralized bone matrix; a first portion of cancellous bone having a particle size between about 4 and about 10 mm; and about 1 to about 40 parts by weight of a plasticizing substance; a second portion comprising: a second portion of cancellous bone having a particle size between about 4 and about 10 mm; and a third portion comprising: about 50 to about 300 parts by weight of a mixing solution, wherein the first and second portions of cancellous bone total about 20 to about 150 parts by weight of cancellous bone. 24. The kit of claim 23, wherein the first portion comprises about 40 to about 50 parts by weight of cancellous bone. 25. A method of preparing a bone graft substitute composition, the method comprising: providing a first portion comprising: about 80 to about 120 parts by weight of calcium sulfate; about 10 to about 120 parts by weight of demineralized bone matrix; a first portion of cancellous bone having a particle size between about 4 and about 10 mm; and about 1 to about 40 parts by weight of a plasticizing substance; providing a second portion comprising: a second portion of cancellous bone having a particle size between about 4 and about 10 mm, wherein the first and second portions of cancellous bone total about 20 to about 150 parts by weight of cancellous bone; providing a third portion comprising: about 50 to about 300 parts by weight of a mixing solution; and mixing the third portion with the first portion to form a bone graft substitute composition. 26. The method of claim 25, further comprising mixing a portion of the second portion with the third and first portions.

Details for Patent 7,371,409

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		2039-09-22