Bone graft substitute composition
View Patent ↗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.
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.